PraiseforAlteredGenes,TwistedTruth

“Withoutdoubt,oneofthemostimportantbooksofthelast50years.IshallurgeeveryoneIknowwhocaresaboutlifeonearth,andthefutureoftheirchildren,andchildren’schildren,toreadit.Itwillgoalongwaytowarddispellingtheconfusionanddelusionthathasbeencreatedregardingthegeneticengineeringprocessandthefoodsitproduces....StevenDrukerisahero.HedeservesatleastaNobelPrize.”

—JaneGoodall,PhD,DBE,UNMessengerofPeace(fromtheForeword)

“Afascinatingbook:highlyinformative,eminentlyreadable,andmostenjoyable.It’sarealpage-turnerandaneye-opener.”

—RichardC.Jennings,PhD,DepartmentofHistoryandPhilosophyofScience,UniversityofCambridge,UK

“Thisincisiveandinsightfulbookistrulyoutstanding.Notonlyisitwell-reasonedandscientificallysolid,it’sapleasuretoread–andamust-read.Throughitsmasterfulmarshallingoffacts,itdispelsthecloudofdisinformationthathasmisledpeopleintobelievingthatGEfoodshavebeenadequatelytestedanddon’tentailabnormalrisk.”

—DavidSchubert,PhD,molecularbiologistandHeadofCellularNeurobiology,SalkInstituteforBiologicalStudies

“AlteredGenes,TwistedTruthislucid,illuminating,andalarming.AsaformerNewYorkCityprosecutor,IwasshockedtodiscoverhowtheFDAillegallyexemptedGEfoodsfromtherigoroustestingmandatedbyfederalstatute.Andasthemotherofthreeyoungkids,IwasoutragedtolearnhowAmerica’schildrenarebeingcallouslyexposedtoexperimentalfoodsthatweredeemedabnormallyriskybytheFDA’sownexperts.”

—Tara-CookLittman,JD

“StevenDrukerhaswrittenagreatbookthatcouldwellbeamilestoneintheendeavortoestablishascientificallysoundpolicyongeneticallyengineeredfoods.Theevidenceiscomprehensiveandirrefutable;thereasoningisclearandcompelling.NoonehasdocumentedothercasesofirresponsiblebehaviorbygovernmentregulatorsandthescientificestablishmentnearlyaswellasDrukerdocumentsthisone.Hisbookshouldbewidelyreadandthoroughlyheeded.”

—JohnIkerd,PhD,ProfessorEmeritusofAgriculturalandAppliedEconomics,UniversityofMissouri–Columbia

“AlteredGenes,TwistedTruthwillstandasalandmark.Itshouldberequiredreadingineveryuniversitybiologycourse.”

—JosephCummins,PhD,ProfessorEmeritusofGenetics,WesternUniversity,London,Ontario

“StevenDruker’smeticulouslydocumented,well-crafted,andspellbindingnarrativeshouldserveasaclarioncalltoallofus.Inparticular,hischapterdetailingthedeadlyepidemicof1989-90thatwaslinkedwithageneticallyengineeredfoodsupplementisespeciallysignificant.IandmyMayoCliniccolleagueswereactiveparticipantsintheattempttoidentifythecauseofthisepidemic.Drukerprovidesacomprehensiveanalysisofalltheevidenceandalsopresentsnewfindingsfromourwork.Overallhisdiscussionofthistragicevent,aswellasitsominousimplications,isthemostcomprehensive,evenly-balancedandaccurateaccountthatIhaveread.”

—StephenNaylor,PhD,CEOandChairmanofMaiHealthInc.ProfessorofBiochemistryandMolecularBiology,&PharmacologyMayoClinic(1991-2001)

“AlteredGenes,TwistedTruthisveryreadable,thorough,logicalandthought-provoking.StevenDrukerexposesshenanigansemployedtopromotegeneticengineeringthatwillsurpriseeventhosewhohavefollowedtheag-biotechindustrycloselyforyears.Istronglyrecommendhisbook.”

—BelindaMartineau,PhD,molecularbiologist,aco-developerofthefirstgeneticallyengineeredwholefood,andauthorofFirstFruit:TheCreationoftheFlavrSavr™TomatoandtheBirthofBiotechFoods

“StevenDrukerhasdoneabeautifuljobofweavingacompellingscientificargumentintoanengagingnarrativethatoftenreadslikeadetectivestory,andhemakeshispointsdramaticallyandclearly.Theexaminationofgeneticengineeringfromthestandpointofsoftwareengineeringisespeciallyinsightful,exposinghowtheformerismorelikea‘hackathon’thanacareful,systematicmethodologyforrevisingcomplexinformationsystems.Iwillrecommendthisbooktomyfriends.”

—ThomasJ.McCabe,developerofthecyclomaticcomplexitysoftwaremetric,akeyanalytictoolincomputerprogrammingemployedthroughouttheworld

“Basedonover30yearsofteachingcomputerscienceatuniversitiesandonextensiveexperienceasaprogrammerinprivateindustry,IcanstatethatStevenDrukerhasdoneanexcellentjobofdemonstratingtherecklessnessofthecurrentpracticesofgeneticengineeringincomparisontotheestablishedpracticesofsoftwareengineering.Hisbookpresentsastrikingcontrastbetweenthetwofields,showinghowsoftwareengineersprogressivelydevelopedgreaterawarenessoftheinherentrisksofalteringcomplexinformationsystems–andaccordinglydevelopedmorerigorousproceduresformanagingthem–whilegenetictechnicianshavelargelyfailedtodoeither,despitethefactthattheinformationsystemstheyalterarefarmorecomplex,andfarlesscomprehended,thananyhuman-madesystem.”

—RalphBunker,PhD

“StevenDrukerhaswrittenoneofthefewbooksIhaveencountered,inmymanyyearsofpublicinterestwork,withthecapacitytodrivemajorchangeinamajorissue.WhatRalphNader’sUnsafeatAnySpeedwastotheautoindustryandwhatRachelCarson’sSilentSpringwastosyntheticpesticides,AlteredGenes,TwistedTruthwillbetogeneticallyengineeredfood.Itisprofoundlypenetrating,illuminating,andcompelling,anditcouldstimulateamonumentalandbeneficialshiftinoursystemoffoodproduction.

—JoanLevin,JD,MPH

“Druker’sbrilliantexposécatchesthepromotersofGEfoodred-handed:falsifyingdata,corruptingregulators,lyingtoCongress.Hethoroughlydemonstrateshowdistortionsanddeceptionshavebeenpiledoneontopofanother,yearafteryear,producingaglobalindustrythatteetersonafoundationoffraudanddenial.Thisbookissuretosendshockwavesaroundtheworld.”

—JeffreyM.Smith,internationalbestsellingauthorofSeedsofDeception&GeneticRoulette

“AlteredGenes,TwistedTruthrevealshowtheinceptionofmolecularbiotechnologyignitedabattlebetweenthosecommittedtoscientificaccuracyandthepublicinterestandthosewhosawgeneticengineering’scommercialpotential.StevenDruker’smeticulouslyresearchedbookpiecestogetherthedeeplydisturbingandtremendouslyimportanthistoryoftheintertwinedscienceandpoliticsofGMOs.Understandingthisongoingstruggleisakeytounderstandingscienceinthemodernworld.”

—AllisonWilson,PhD,moleculargeneticistScienceDirector,TheBioscienceResourceProject

“AlteredGenes,TwistedTruthisaremarkableworkthatmaywellchangethepublicconversationononeofthemostimportantissuesofourday.Ifthenumerousrevelationsitcontainsbecomewidelyknown,theargumentsbeingusedtodefendgeneticallyengineeredfoodswillbeuntenable.”

—FrederickKirschenmann,PhD,DistinguishedFellow,LeopoldCenterforSustainableAgriculture,IowaStateUniversityAuthorofCultivatinganEcologicalConscience

“StevenDruker’sexceptionallywell-researchedandwell-writtenbookelucidatesthescientificfactsaboutgeneticallyengineeredfoodsthatthePRmythshavebeenobscuring.Itprovidesauniqueandinvaluableresourcenotonlyforconcernedcitizens,butforhistoriansofscienceandtechnologyaswell.Inacomprehensiveandskillfulmanner,itdemonstrateshowtheintegrityofsciencewascompromisedasahighlyinfluentialcommunityofbiologistswithspecialinterestsingeneticengineeringmuddledscientifictruthinordertoprotecttheimageofbioengineeredfoodsandtoadvancetheirgrowingpartnershipswithbigbusinessandgovernment.Ultimately,thebookrevealsthatwhat’satstakehereisnotonlythesafetyofourfoodsupply,butthefutureofscience.

IampleasedthatStevenmadegooduseoftheextensivefirsthandinformationIsharedabouttheunsavorybehind-the-scenesmachinationsofbiotechpromotersinbothscientificinstitutionsandgovernmentagencies,andIamveryimpressedwiththebookasawhole–andexpectthatalargenumberofotherscientistswillbetoo.”

—PhilipRegal,PhD,ProfessorEmeritus,CollegeofBiologicalSciences,UniversityofMinnesota

AlteredGenes,TwistedTruthHowtheVenturetoGeneticallyEngineerOurFoodHasSubvertedScience,CorruptedGovernment,andSystematicallyDeceivedthePublicStevenM.Druker

Copyright©2015StevenM.DrukerForeword©2015JaneGoodall

AllRightsReserved.Nopartofthisbookmaybeusedorreproducedinanymannerwhatsoeverwithoutpriorwrittenpermissionfromthepublisher,exceptfortheinclusionofbriefquotationsinreviews.

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ISBN978-0-9856169-1-5(Hardcover)ISBN978-0-9856169-0-8(Softcover)ClearRiverPressP.O.Box520022SaltLakeCity,UT84152www.alteredgenestwistedtruth.com

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Neithertheauthornorthepublisherassumesresponsibilityforerrorsininternetaddressesorforchangesintheaddressesafterpublication.Noraretheyresponsibleforthecontentofwebsitestheydonotown.

TrademarkAcknowledgements:Roundup®RoundupReady®andYieldGard®areregisteredtrademarksofMonsantoCompany.Prozac®isaregisteredtrademarkofEliLillyandCompany.FlavrSavr™isaregisteredtrademarkofCalgeneandMonsantoCompany.

DEDICATION

Tothecourageousscientistswhohaveendeavoredtoupholdtruthandscientificintegrityregardingtherisksofgeneticengineering,especiallythosewhoseclarityofvisionandpowerofexpression

inspiredawaveofremedialaction.

CONTENTS

FOREWORDbyJaneGoodall

INTRODUCTION:HowIReluctantlyBecameanActivist–AndUncoveredtheCrimethatEnabledtheCommercializationofGeneticallyEngineeredFoods

1.ThePoliticizationofScience–AndtheInstitutionalizationofIllusion2.TheExpansionoftheBiotechAgenda

–AndtheIntensificationofthePoliticization3.DisappearingaDisaster

HowtheFactsAboutaDeadlyEpidemicCausedbyaGeneticallyEngineeredFoodHaveBeenConsistentlyClouded4.Genes,Ingenuity,andDisingenuousness

ReprogrammingtheSoftwareofLifewhileRefashioningtheFacts

5.IllegalEntryTheGovernmentalFraudthatPutGEFoodsontheUSMarket

6.GlobalizationofRegulatoryIrregularityHowFoodSafetyOfficialsinCanada,theEU,andOtherRegionsalsoSidesteppedScienceandSoundPolicy7.ErosionofEnvironmentalProtection

MultipleRisks,MinimalCaution

8.MalfunctionoftheAmericanMediaPliantAccomplicesinCover-upandDeception

9.MethodicalMisrepresentationofRiskOversights,Anomalies,andDelinquencies

10.ACropofDisturbingDataHowtheResearchonGEFoodsHasFailedtoShowThey’reSafe–andInsteadConfirmedTheyShouldBeOfftheMarket

11.OverlookedLessonsfromComputerScienceTheInescapableRisksofAlteringComplexInformationSystems

12.UnfoundedFoundationalAssumptionsTheFlawedBeliefsthatUndergirdAgriculturalBioengineering

13.TheDevolutionofScientistsintoSpinDoctorsGeneticEngineering’sMostMalignantMutation

14.NewDirectionsandExpandedHorizonsAbandoningGeneticEngineeringandAdvancingtoSafe,Sustainable,andSensibleModesofFarmingAppendixA:ExtendedExaminationoftheJudge’sDecisioninAllianceforBio-Integrityv.Shalala

AppendixB:TwoReportsbyOtherRespectedOrganizationsthatMisrepresenttheRisksofGEFoods

Notes

Acknowledgements

AbouttheAuthor

Note:AppendicesCandDandtheExecutiveSummaryareavailableonlineat:http://alteredgenestwistedtruth.com/appendix-c/http://alteredgenestwistedtruth.com/appendix-d/http://alteredgenestwistedtruth.com/executive-summary/

FOREWORD

JANEGOODALL

IwellrememberhowhorrifiedIfeltwhenIlearnedthatscientistshadsucceededinreconfiguringthegeneticsofplantsandanimals.Thefirstgeneticallyengineered(GE)plantswerecreatedinthe1980s,butIdidnothearaboutthemuntilthe1990swhentheywerefirstcommercialized.Itseemedashockingcorruptionofthelifeformsoftheplanet,anditwasnotsurprisingthatmanypeoplewereasappalledasIwas–andthatthesealteredorganismsbecameknownas‘Frankenfoods’.

Infact,thereweregoodscience-basedreasonstomistrustthenewfoods;yetGEcropshavespreadthroughoutNorthAmericaandseveralotherpartsoftheworld.Howhasthiscomeabout?TheanswertothatquestionistobefoundinStevenDruker’smeticulouslyresearchedbook.Severalyearsinthemaking,itisafascinating,ifchillingstory.

Ididnotrealizewhataformidabletaskthebioengineersfacedastheystruggledtointroducenewgenesintoavarietyofagriculturalcrops.Theirintentwastomakethemproducetoxinsthatwoulddeterinsectpests,orenablethemtoresistherbicides,andsoon.Amajorchallengewastheneedtoovercomethevariousdefensivemechanismsoftheplantsthemselves,whichdidtheirbesttorepelthealienmaterial.Anotherwastocompeltheforeigngenestofunctioninacellularenvironmentwheretheywouldordinarilyremaindormant.Itisatestamenttohumanpersistenceandingenuitythatthescientistsfinallysucceeded!

Butthereconfiguredplantstheyeventuallycreatedwere,asDrukerexplainsinengagingdetail,differentinavarietyofwaysfromtheirparents;andfromtheoutsetmanyqualifiedscientistsexpressedconcernsaboutthesafetyofthenewcropsforboththeenvironmentandhumanandanimalhealth.HefurtherdemonstratesthatthisveryrealdifferencebetweenGEplantsandtheirconventionalcounterpartsisoneofthebasictruthsthatbiotechproponentshaveendeavoredtoobscure.Aspartoftheprocess,theyportrayedthevariousconcernsasmerelytheignorantopinionsofmisinformedindividuals–andderidedthemasnotonlyunscientific,butanti-science.Theythensettoworktoconvincethepublicandgovernmentofficials,throughthedisseminationoffalseinformation,thattherewasanoverwhelmingexpertconsensus,basedonsolidevidence,thatthenewfoodsweresafe.Yetthis,asDrukerpointsout,wasclearlynottrue.

Asthechaptersprogress,wereadhowtheadvocatesofgeneticengineeringhavesteadfastlymaintainedthatthecropscreatedbythisradicaltechnologyareessentiallysimilartothosefromwhichtheyhavebeenderived,thattheprocessissplendidlyexact,andthatGEfoods,therefore,areifanythingsaferthantheirtraditionallybred‘parents’–wheninfact,there’ssignificantdissimilarity,theprocessisfarfromexact,andtherisksaregreater,especiallytheriskofcreatingunexpectedtoxinsthataredifficulttodetect.

Drukerdescribeshowamazinglysuccessfulthebiotechlobbyhasbeen–andtheextenttowhichthegeneralpublicandgovernmentdecision-makershavebeenhoodwinkedbythecleverandmethodicaltwistingofthefactsandthepropagationofmanymyths.Moreover,itappearsthatanumberofrespectedscientificinstitutions,aswellasmanyeminentscientists,werecomplicitinthisrelentlessspreadingofdisinformation.

Chapter5showshowthekeystepinthecommercializationofGEfoodsoccurredthroughtheunbelievablypoorjudgment–ifnotdownrightcorruption–oftheUSFoodandDrugAdministration(theFDA).Thisregulatorybodyissupposedtoensurethatnewadditivestofoodsaresafebeforetheycome

tomarket,andithadaresponsibilitytorequirethatGEfoodswereprovensafethroughstandardscientifictesting.ButtheinformationthatDrukerpriedfromtheagency’sfilesthroughalawsuitrevealedthatitapparentlyignored(andcoveredup)theconcernsofitsownscientistsandthenviolatedafederalstatuteanditsownregulationsbypermittingGEfoodstobemarketedwithoutanytestingwhatsoever.TheevidencefurthershowshowtheagencyassuredconsumersthatGEfoodsarejustassafeasnaturallyproducedones–andthattheirsafetyhasbeenconfirmedbysolidscientificevidence–despitethefactitknewthatnosuchevidenceexisted.

DrukermakesthecasethatitwasthisfraudthattrulyenabledtheGEfoodventuretotakeoff.AndheassertsthatthefraudcontinuestodeceivethepublicandCongress,despitethefactthatthelawsuitheinitiatedthoroughlyexposedit.Hisdescriptionoftheproceedingssurroundingthislawsuitwas,tome,oneofthemostastoundingandchillingpartsofthebook.

Andwhatoftheroleofthemedia?HowhavetheAmericanpublicbeensolargelykeptinthedarkabouttherealitiesofGEfoods–totheextentthatuntilquiterecently,avastmajorityofthepopulacedidnotevenknowtheywereregularlyconsumingthem?Drukerdescribes,inChapter8,howthemainstreammediahavebeenhighlyselectiveinwhattheyreport–andhaveconsistentlyfailedtoconveyinformationthatwouldcauseconcernabouttheseengineeredproducts.Moreover,Drukerdemonstratesthatthepoliciesimposedbythemediamagnateshavebeen,inhiswords,“notmerelyselective,butsuppressive.”Andherelatesseveraldramaticincidentsinwhichjournalistswhotriedtobringunsettlingfactstolighthadtheirstoriesalteredortotallyquashedbyhigherlevelexecutives.SoitisnotsurprisingthattheAmericanpublic,andagoodmanykeydecision-makers,believethattherearenolegitimateconcernsregardingGEfoods.

IampersonallygratefultoStevenDrukerforwritingthisbook.Ithasbeenamonumentaltaskandreflectsthepassionatedesireofamanwithatruescientificspirittoreveal,aspreciselyaspossible,thetruthbehindthemisrepresentationsofthetruth.Nonetheless,despiteitsintegrity,AlteredGenes,TwistedTruthcanbeexpectedtomeetfiercecriticismfromthosewhopromotetheGEfoodventure;and,likeallwhoattempttodisclosetheventure’sunderside,itsauthorwillprobablybeattackedandbrandedasanti-scienceandanti-progress.BUTitseemstomethatitisnotthosewhopointtotheproblemsoftheventurewhoareanti-science:itisquitetheotherwayaround.Nevertheless,DrukerwillalmostsurelybesubjectedtothesamesortofcriticismsasthoseleveledagainstRachelCarsonwhenshepublishedSilentSpringin1962.

Ithinkitisimportantthatyoureadthisbookcarefully,assessingforyourselfhowfirmlyitisgroundedinfactandlogic.YoumaywellcometothesameconclusionasIhave:thatStevenDrukerisupholdingthetraditionofgoodscience.Thenreadsomeofthebooksandarticleswrittenbypro-GEscientists–especiallysomeofthosebyprominentbiologists–andyoumaywelldecidethattheirstandardsoftenfallsignificantlyshortofhis.

Infact,hepointsoutseveralinstancesinwhichitappearsthatsuchpublicationsaredownrightdeceptive,notonlyportrayinggeneticengineeringinamisleadingmanner,butevenmisrepresentingsomebasicfeaturesofbiology.Further,althoughthesescientistsmaygenuinelybelievethatGEfoodsarethesolutionforworldhunger,itappearsthatmanyofthemhavevastlyoverestimatedthebenefitsofthesefoods–andthateveniftheseproductsdidnotentailhigherrisks,it’sdoubtfultheycouldsignificantlyreducemalnutritionorsolveanymajorproblemsofagriculture.

Althoughthisbooktellsastorythat’sinmanywaysdistressing,it’simportantthatithasfinallybeentoldbecausesomuchconfusionhasbeenspreadandsomanyimportantdecision-makershaveapparentlybeendeluded.Fortunately,thefinalchaptershowshowthestorycanhaveahappyending,anditclearlypointsthewaytowardrealisticandsustainablesolutionsthatdonotinvolvegeneticengineering.Thus,justasmyownbooksaimtoinstillhope,thisbookisultimatelyahope-inspiringonetoo.Foritdescribesnotonlysomeofthemistakesthatwehavemadebuthowtheycanberectifiedincreativeandlife-

supportingways.Drukerhas,withoutdoubt,writtenoneofthemostimportantbooksofthelast50years;andIshall

urgeeveryoneIknow,whocaresaboutlifeonearth,andthefutureoftheirchildren,andchildren’schildren,toreadit.Itwillgoalongwaytowarddispellingtheconfusionanddelusionthathasbeencreatedregardingthegeneticengineeringprocessandthefoodsitproduces.

Tome,StevenDrukerisahero.HedeservesatleastaNobelPrize.

–JaneGoodall,PhD,DBEandUNMessengerofPeace

INTRODUCTION

HOWIRELUCTANTLYBECAMEANACTIVIST

–AndUncoveredtheCrimethatEnabledtheCommercializationofGeneticallyEngineeredFoods

MostpeoplewouldbesurprisedtolearnthatBillClinton,BillGates,andBarackObama(alongwithahostofotherastuteandinfluentialindividuals)werealltakeninbythesameelaboratefraud.

They’dbeevenmoresurprisedtolearnthatitwasnotperpetratedbyaforeignintelligenceagency,aninternationalcrimesyndicate,oracabalofcunningfinanciersbutbyanetworkofdistinguishedscientists–andthatitdidnotinvolvechangeintheclimatebutchangestoourfood.

And,ifthey’reAmericans,theywouldbeshockedtodiscoverthattheUSFoodandDrugAdministrationhasbeenamajoraccomplice–andthatbecauseofitsdeceptions,formorethanfifteenyearstheyandtheirchildrenhavebeenregularlyingestingagroupofnovelproductsthattheagency’sscientificstaffhadpreviouslydeterminedtobeundulyhazardoustohumanhealth.

Thisbooktellsthefascinatingandfrequentlyastoundingstoryofhowsucharemarkablestateofaffairshascometobe;andI’muniquelypositionedtotellit,becauseIuncoveredoneofitskeycomponents.

Inearly1996,IdidsomethingfewAmericanswerethendoing:Idecidedtolearnthefactsaboutthemassiveventuretorestructurethegeneticcoreoftheworld’sfoodsupply.AndthemoreIlearned,themoreIbecameconcerned.Itgrewincreasinglyclearthattheclaimsmadeinsupportofgeneticallyengineeredfoodsweresubstantiallyatoddswiththetruth–andthattherewerestrongscientificgroundsforviewingsuchproductswithacautiouseye.

OfspecialconcernwasthebehavioroftheFoodandDrugAdministration(FDA),whichhasrefusedtoregulategeneticallyengineeredfoodsandinsteadhasenergeticallypromotedthem.1Ifounditproblematicthisagencyhadadoptedapresumptionthatgeneticallyengineered(GE)foodsareassafeasnaturalonesandwasallowingthemtobemarketednotonlywithouttestingbutevenwithoutlabelstoinformconsumersaboutthegeneticreconfigurationthathadoccurred.Ibelievedthiswasunscientific,irresponsible,andfundamentallywrong.

Ialsohadahunchitwasillegal–ahunchmyresearcheventuallyconfirmed.Asmyknowledgegrew,therealsogrewaconvictionthatalawsuitshouldbebroughtagainsttheFDA

tooverturnitspolicyonGEfoodsandcompelittorequirethesafetytestingandlabelingthatconsumerswerebeingwrongfullydenied.Atthatpoint,Ididn’tenvisionplayinganactiveroleinthelegalproceedingsorevengettingextensivelyinvolvedinthedevelopmentalphaseofthesuit.Myintentionwastopresenttheideatootherswhohadgreaterexpertiseandresourcesandinspirethemtocarryitout.AlthoughIhavealawdegreefromtheUniversityofCaliforniaatBerkeley,practicinglawhasnotbeenthecentralfocusofmyprofessionallife,andIhadscantexperienceinlitigation.Further,Iwasimmersedinaprojectthatwasdeartomyheartanddidn’twanttogetsidetracked.

Yet,intheprocessoftryingtoinspireotherstodothelawsuit,Igraduallybecamethemainpersonorganizingitanddrivingitforward.TheexecutivesofpublicinterestorganizationswithwhomIspokeall

thoughtthesuitwasagreatidea,butnonefeltreadytotakeiton.Aftersomeweeksofattemptingtofindanorganizationthatwouldshoulderthesuit,IdiscussedthesituationwithamolecularbiologistwhowasconcernedthatinthepushforrapidcommercializationofGEfoods,theriskswerebeingundulydiscountedandtestingirresponsiblyneglected.AsIexplainedhowmyideasforthelawsuithadbeenuniformlygreetedwithenthusiasmbutthatnoneofthegroupswaspreparedtoturnthemintoreality,hesaid:“Steve,don’tyourealizethisisyourbaby?Ifyoudon’tdoit,it’snotgoingtohappen.”MuchasIdesiredtohavesomeoneelsedothesuitsoIcouldgetbacktomyotherproject,andmuchasIwantedtorejecthisassessment,deepdownIhadaninescapablefeelinghewasright.

SoIsetmyprojectaside,foundedtheAllianceforBio-Integrity(anonprofitpublicinterestorganization),andasitsexecutivedirector,devotedmyselffull-timetoorganizingthelawsuit.Inafewmonths,IgainedthecollaborationoftheInternationalCenterforTechnologyAssessment,arespectedpublicinterestorganizationinWashington,D.C.withaskilledteamoflawyers.Theyhadsubstantialexperienceinlitigationwithfederaladministrativeagencies,andtheyagreedtobetheattorneysofrecord,ontheconditionthatIwouldcontinuetocoordinatethevariouselementsoftheprojectandtoraisethenecessaryfinances.Intime,Ialsobecameactivelyinvolvedasanattorney,undertakingkeyresearchandcontributingtothebriefsandotherdocumentsfiledwiththecourt.

Duringthepreparationphase,aprimarygoalwastoattainanimpressivesetofplaintiffs.Overthefollowingmonths,throughnumerousphonecalls,emails,andjourneystopersonalmeetings,IassembledanunprecedentedcoalitiontojointhesuitandsignthecomplaintagainsttheFDAthatwassubmittedtothecourt.ForthefirsttimeinUShistory,agroupofscientificexpertsbecameinvolvedinalawsuitchallengingthepolicyofafederaladministrativeagency,notasadvisersorexpertwitnesses,butasplaintiffs–plaintiffswhoformallyobjectedtothepolicyonscientificgrounds.Inaboldmovehighlightingtheunsoundnessofthatpolicy,ninewell-credentialedlifescientists(includingtenuredprofessorsatUCBerkeley,Rutgers,theUniversityofMinnesota,andtheNYUSchoolofMedicine)steppeduptosuetheFDAandformallyassertthatitspresumptionaboutthesafetyofGEfoodsisscientificallyflawedbecausetheyposeabnormalrisksthatmustbescreenedbyrigoroustesting.

Equallyunparalleled,theywereco-plaintiffswithadistinguishedgroupofspiritualleadersfromdiversefaithswhoobjectedtotheFDA’spolicyonreligiousgrounds.WithinthisgroupwerethePresidentoftheNorthAmericanCoalitiononReligionandEcology,thechaplainatNortheasternUniversity,andalecturerintheologyatGeorgetownUniversity.Inall,thereweresevenordainedpriestsandministersfromabroadrangeofChristiandenominations(includingEpiscopalian,Lutheran,Baptist,andRomanCatholic);threerabbis(Orthodox,Conservative,andReform);thechancelloroftheAmericasDharmaRealmBuddhistUniversity;andathousand-memberHinduorganizationfromChicago.Theseplaintiffsstatedthatintheirview,themannerinwhichbiotechniciansarereconfiguringthegenomesoffood-yieldingorganismsisaradicalandirreverentdisruptionoftheintegrityofGod’screation–andthattheyfeltobligedtoavoidconsumingtheproductsofsuchinterventionsasamatterofreligiousprinciple.Theyallegedthatbyfailingtorequireproperlabeling,theFDAwasunavoidablyexposingthemtothesefoodsandpreventingthemfromthefreeexerciseoftheirreligiousbeliefs.(Someofthereligious-basedreasonsforrejectingGEfoodsaremorefullydescribedinChapter14.)

AlthoughproponentsofGEfoodsattempttoportrayanyreligiouslymotivatedoppositionasduetoignoranceaboutthefactsofgeneticengineeringandaresultantfailuretoappreciateitssimilaritytotraditionalbreeding,theseplaintiffswerewell-informed;andtheythereforeunderstoodhowdeeplyitdoesdifferfromnaturalprocesses.(ThesedifferencesarethoroughlydiscussedinChapter4).

AllianceforBio-Integrity,etal.v.Shalala,etal.wasfiledinUSDistrictCourtinWashington,D.C.in

May1998.ThefirstnameddefendantwasDonnaShalalabecause,astheSecretaryoftheDepartmentofHealthandHumanServicesatthattime,sheoversawtheFDA,whichisoneoftheagencieswithinthatdepartment.TheactingcommissioneroftheFDAwastheotherdefendant.

Thesuitquicklyachievedamajoreffectbecause,aspartofthediscoveryprocess,itforcedtheFDAtohandovercopiesofallitsinternalfilesonGEfoods.Eagertodelvebeneaththeagency’spublicpronouncementsandseeiftheyjibedwithwhatitreallyknewandhowithadactuallyoperated,Iassumedresponsibilityforanalyzingthistroveofdocuments.AsIcombedthroughthemorethan44,000pagesofreports,messages,andmemoranda,Imadeseveralstartlingdiscoveries.Bythetimemyinvestigationwasfinished,Ihadcompiledextensiveevidenceofanenormousongoingfraud.ItrevealedthattheFDAhadusheredthesecontroversialproductsontothemarketbyevadingthestandardsofscience,deliberatelybreakingthelaw,andseriouslymisrepresentingthefacts–andthattheAmericanpeoplewerebeingregularly(andunknowingly)subjectedtonovelfoodsthatwereabnormallyriskyintheeyesoftheagency’sownscientists.

Thisfraudhasbeenthepivotaleventinthecommercializationofgeneticallyengineeredfoods.NotonlydiditenabletheirmarketingandacceptanceintheUnitedStates,itsetthestagefortheirsaleinnumerousothernationsaswell.IftheFDAhadnotevadedthefoodsafetylaws,everyGEfoodwouldhavebeenrequiredtoundergorigorouslong-termtesting;andifithadnotcovereduptheconcernsofitsscientistsandfalselyreportedthefacts,thepublicwouldhavebeenalertedtotherisks.Consequently,theintroductionofGEfoodswouldatminimumhavebeendelayedmanyyears–andmostlikelywouldneverhavehappened.

Soit’svitalthatthestoryoftheFDA’scrimebefullytold;andthisbookdoessoinacomprehensiveandvividmanner,disclosinghowagovernmentagencywiththedutytosafeguardthenation’sfoodsupplywasinducedtoperpetratesuchafraud,howthefraudwascarriedoff,andhow,evenafterbeingexposedandconclusivelydocumented,ithasmaintaineditsstrengthandcontinuedtodeceivethepublic.

Moreover,infullytellingthisstory,thebookrelatesamuchbiggerone,astoryinwhichtheFDA’sbehaviordoesnotstandasanisolatedaberrationbutformsanintegralpartofabroaderpatternofmisconduct.Itpresentsagraphicaccountofhowthegeneticengineeringventurearose,thestagesthroughwhichithasadvanced,andhow,ateverystage,theadvancementrelieduponthesustaineddisseminationoffalsehoods.Inlinewithitstitle,itdemonstratesthatthebroad-scalealteringofgeneshasbeenchronicallyandcruciallydependentonthewholesaletwistingoftruth–andshowshowformorethanthirtyyears,hundreds(ifnotthousands)ofbiotechadvocateswithinscientificinstitutions,governmentbureaus,andcorporateofficesthroughouttheworldhavesystematicallycompromisedscienceandcontortedthefactsinordertofosterthegrowthofgeneticengineering,andgetthefoodsitproducesontoourdinnerplates.

Thus,thenarrativethatunfoldsinthefollowingpagesisfundamentallyastoryaboutthecorruptionofscienceanditsconcomitantcorruptionofgovernment,notthroughthemachinationsofascientificfringegroupinleaguewithapackofpowerfulpoliticalideologues,butthroughtheworkingsofthemainstreamscientificestablishmentinconcertwithlargemulti-nationalcorporations–andtheirco-optationofgovernmentofficialsacrossthepoliticalspectrum,andacrosstheglobe.Further,bythetimethestoryends,itwillbeclearthatthedegradationofscienceitdepictshasnotonlybeenunsavorybutunprecedented:thatinnootherinstancehavesomanyscientistssoseriouslysubvertedthestandardstheyweretrainedtouphold,misledsomanypeople,andimposedsuchmagnitudeofriskonbothhumanhealthandthehealthoftheenvironment.

Avarietyofdocuments(includingtranscriptsofscientificconferences,statementsbygovernment

agencies,newspaperreports,journalarticles,andbooksbyhistoriansofscience)collectivelychroniclethebioengineeringventure.Together,theyamplyillumineitsunderside,revealinghowtheintegrityofscienceandtheintegrityofgovernmenthavebothbeenroutinelysacrificedsotheenterprisecouldadvance.Ihavedrawndeeplyfromtheseresources,oftencrystallizingkeyfactsthatwerenotwidelyknown.Additionally,becauseIwasengagedinthecampaigntoproperlyregulateGEfoodsformanyyearsonseveralcontinents(meetingabroadrangeofgovernmentofficials,interactingwithscientistsandjournalists,andparticipatinginconferencesanddebates),Ihaverepeatedlywitnessedthecorrosiveprocessesfirsthand;andthenarrativehasbeenenhancedbyanumberoftheseexperiences.

Further,manystrikingaccountsofthecorrosionwereimpartedbyscientistswhohavestriventostopit.OneoftheforemostistheeminentbiologistPhilipRegal,whofortwentyyearsspear-headedtheendeavortogetthegeneticengineeringenterprisealignedwithsolidscienceandtemperedbyresponsibleregulation.Hisstory,whichformspartofseveralsubsequentchapters,illustratesthediverseandoftenshockingwaysinwhichthescientificestablishmentandthegovernmentconsistentlyfrustratedthisendeavor–totheextenthebecameconvincedthatwhendealingwithGEfoods,theUSexecutivebranchwouldnothonorscienceandthelawunlesscompelledbyacourt,andsodecidedtobecomeaplaintiffinthelawsuitIorganized.Bysharinghisinsightsandexperienceswithmeoverthecourseofmanypersonalmeetings,phoneconversations,andemails,andbygivingmetheextensivesetofrecollectionshehadrecorded,hehasenabledmetoexposetheinfirmitiesanddelinquenciesofthebioengineeringventureinamuchricherwaythanwouldotherwisehavebeenpossible.

LikeDr.Regal,agrowingnumberofexpertshaverecognizedthatthisenormousventurerestsonshakyassumptionsandreliesonquestionableclaims–andthatincreasedcreativityisrequiredtochartthebestwayforward.AmongthemisEvelynFoxKeller,adistinguishedprofessorofthehistoryandphilosophyofscienceattheMassachusettsInstituteofTechnology.Inherbook,TheCenturyoftheGene,shenotesthattheapparentefficacyofgeneticengineeringprovidesnoassurancethatit’sfreefromunintendedharmfuleffects.2Shefurtherpointsoutthatwiththeriseofthistechnology,an“unprecedented”bondhasgrownbetweenscienceandcommerce–andthatasthisbondhastightened,scientistshavebecomeincreasinglyinvestedintherhetoricalpowerofapersuasivemodeof“genetalk”thatimputesaprecisionandpredictabilitytobioengineeringthatitdoesnotpossess.3Kelleremphasizesthatthe“shortcomings”ofsuchgenetalknecessitateitstransformation.4Herbookconcludeswiththehope“...thatnewconceptscanopeninnovativegroundwherescientistsandlaypersonscanthinkandacttogethertodeveloppolicythatisbothpoliticallyandscientificallyrealistic.” 5

Thefollowingchaptersaimtohelpclearthewaytosuchinnovativegroundbyrevealingthatthemostscientificallyrealisticpolicycaneasilycoincidewiththemostpoliticallyrealisticone–andthatit’sonlybecausethepoliticsofgeneticengineeringbecamedetachedfromthescientificrealitiesthatthecurrentproblemswefacewereallowedtoarise.It’smyhopethattheinformationtheycontainandtheinsightstheyconveywillendtheconfusionthathascausedthesplitandspeedtheimplementationofneededreforms,thereinstatementofscientificstandards,andthegrowthofanagriculturalsystemthatyieldsabundantwholesomefoodinasafeandsustainablemanner.

WaystoEnhanceYourEnjoymentofthisBook:UtilizingtheExecutiveSummaryandEasilyAccessingtheEndnotesI’veendeavoredtomakethisbookagoodstoryandhaveemployedanarrativestyleasmuchasfeasible.

Butbecausethestoryisaboutscience–andthecorruptionofsciencebymanyofitspractitioners–itwasnecessarytoexplainmanytechnicalfactsandexaminesomerathercomplexscientificissues.AndbecauseI’veaimedtoproduceabookthat’snotonlyaccessibleandenjoyableforthegeneralreaderbutalsoservesasareliableandcomprehensiveresourceforexperts,somechaptersdiscussasubstantialamountofinformation.Manyreaderswillfindthesediscussionsstimulatingandwillappreciatetheirdepth;butothersmay,atsomestageinoneofthelongerchapters,developadesiretosimplygetthegistoftheremainderandmoveontothenextchapter.

Intheeventsuchafeelingarises,youcanskiptotheExecutiveSummaryandreadthatchapter’smainpoints.(Itcanbedownloadedat:http://alteredgenestwistedtruth.com/executive-summary/)Youcanalsolookatachapter’ssummaryafteryou’vecompleteditinordertocrystallizethebasicfacts.Andevenifyoureadtheentirebookwithoutglancingatthesummary,youmaythenwishtoreadittogainaholisticoverviewandsolidifyyourunderstanding.

Ofcourse,someindividualswithlimitedtimemayprefertoreadtheExecutiveSummaryfirstandlaterreadtheentirebook(orselectedchapters)togainmoredetailedknowledge.

However,Idon’tencouragethis,becauseifyoureaditfirst,itmightspoiltheexperiencethatcanbegainedbyallowingthestorytounfoldchapterbychapter.Severalofthosewhoreviewedthebookhaveremarkedthatit’sengagingandoftenimbuedwithdrama,andsomehavedescribeditasa“page-turner.”Butthedramacouldbedampenedbyreadingasummaryofeachchapteraheadoftime.

So,ifyouintendtoreadtheentirebook,IadvisethatyouinitiallyignoretheExecutiveSummary.Further,ifyouwanttoexaminetheissuesevenmorethoroughlythanisdoneinthemaintext,youwillfindthatmanysignificantpointsarediscussedingreaterdepthintheappendicesandtheendnotes–whichleadstoanimportantnoteaboutthesenotes.

Forthoseofyoureadingthee-bookversion,hoppingtoanendnoteandreturningtothetextissimple.Butifyou’rereadingtheprintedbook,itwouldordinarilybealotmorecomplicatedandtimeconsuming.Sotomaketheendnotesmorereadilyaccessibleinthissituation,they’relocatednotonlyattheendofthephysicalbookbutalsoonlineat:http://alteredgenestwistedtruth.com/endnotes/.Thatway,youcandownloadtheendnotesectionandeitherprintitorstoreitonyourcomputer,tablet,ore-reader.Then,asyoureadachapter,youcanhaveacopyofitsendnotesnearbyandeasilytransitionbetweenthetwo.

Further,soyouwon’tneedtotravelbackandforthbetweenthenotesandabibliographythatcontainsthefullreferencesforthesourcesthatarecited,whenasourceiscitedinachapter’snotesectionforthefirsttime,itwillbefullyreferenced(evenifit’salreadybeenfullyreferencedinthenotesforanearlierchapter).Then,subsequentcitationsofthatsourcewillindicateatwhatprecedingnotewithinthatsectionthefullreferencecanbefound.

ANoteRegardingTerminologyTheterm“biotechnology”issometimesbroadlyemployedtorefertoalltechniquesthatutilize(ormodify)biologicalprocesses,includingancientpracticesthatrelyonfermentationsuchasmakingwine,brewingbeer,andleaveningbread.Butthetermcanalsobeusedinanarrowersense,toreferexclusivelytomoderntechniques,suchasgeneticengineering,thatdependonhighlyartificialinterventionsandthathavenoestablishedhistoryofsafeuse.Inthisbook,Iemploytheterms“biotechnology”and“biotech”intheirrestrictedsensetodenoteonlythislattergroupoftechniquesthathavenotstoodthetestoftime.

Further,becauseinstancesof“misrepresentation,”“misstatement,”“misinformation,”“inaccuracy,”and“falsehood”canoccurthroughignoranceofthetruth,andnoneofthetermsnecessarilydenotesanintenttodeceive,Idonotusethemtoimplythatoneexisted–eventhoughitmayhave.Instead,Ireservethewords“fraud,”“lie,”“deception,”and“disinformation”todenotedeceit.Moreover,whenIrefertoa

fraud,deception,ordisinformationcampaignthatwaspropagatedbymanyindividuals,Idonotimplythateverypersonwhoinsomewayabettedithasbeenguiltyofdeception–merelythatsomehave.Furthermore,duetothedifficultyofdiscerningwhospokefromignoranceandwhodidnot,unlessIspecificallyassignguilt,itshouldnotbeassumedthatanyoneinparticularhasbeenaccused.

CHAPTERONE

ThePoliticizationofScience

–AndtheInstitutionalizationofIllusion

Ashereturnedthephonetoitscradle,PhilipRegalknewthathisscientificcareerwasabouttoenteranimportantanddistinctlychallengingphase.ErnstMayrhadjusturgedhimtoassumeacrucialroleinconnectionwiththemostprofoundtechnologicalrevolutionsincethesplittingoftheatom.

Mayrwasatoweringfigureinthelifesciences.Numerouscolleagues,includingseveralofhisfellowHarvardprofessors,consideredhimtobethegreatestbiologistofthe20thcentury,andhewaswidelyregardedasthemostinfluentialtheoristinthefieldsinceDarwin.1

Forseveralweeksduringthatyearof1983,heandRegalhadbeenengagedinaseriesofdiscussionsviaphoneandmailabouttheunprecedentedpowerofgeneticengineeringandthepressingneedtomanageitwisely.Butthisconversationhadtakenanewturn.BesidesendorsingRegal’sconcernsaboutthedeficienciesinthewaytheventurewasbeingconductedandthedamagethatmightresultfrompushingaheadabsentadequateknowledge,Mayraskedhimtodosomethingaboutit.Heencouragedhimtotaketheleadinorganizingaconcertedendeavortoinducechangeandensurethatgeneticengineeringwouldbedeployedinaccordwithsoundscientificprinciples–andthatthenovelorganismsitproduceswouldnotbereleasedintotheenvironmentwithoutsufficientforethought.Hecounseledhimtocontinuehisriskanalyses,tostimulatesimilarassessmentsbyothers,andtofosteradialoguewithinthescientificcommunitythatwouldengenderfullerunderstandingofthistechnologyandamoreresponsiblemannerofemployingit.Mayrbelievedthatunlesstherewassuchdeliberationanddialogue,lifescientists,thebiotechnologyindustry,andgovernmentregulatorswouldnotbepreparedtointelligentlyhandlethenewpotenciesthathadbeenbroughtwithinhumangrasp.

Yet,evenasMayrurgedRegalahead,hewarnedhimtoproceedwithcaution.Heremindedhimthatthebiotechindustryanditsalliesinthemolecularbiologyestablishmentwieldedgreateconomic,academic,andpoliticalpower–andnotedthatanyattemptstosubjecttheirprojectstothoroughscientificscrutinywouldberegardednotonlyasunnecessaryimpedimentstoprogressbutasmajorprovocations.Then,hisvoicegrowingmoresolemn,MayrspokewordsthatstillresonateinRegal’smemory:“Theywilltrytocrushyou.”Accordingly,headvisedRegalthatalthoughhiscredentialswereexcellentandhewaswell-respected,heshouldnotgoitaloneandshouldgetotherrespectedbiologiststojoinhim.

Mayr’swordswerecompelling,anddespitethedifficultiesthatwouldbeentailed,Regalresolvedtoundertakethetask.Butwhathedidn’trealizeatthattimewasjusthowformidableataskitwouldturnouttobe–andhowmassivewouldbetheresistance,notonlywithintheconfinesofthebiotechnologyindustry,butwithinthecorridorsofgovernmentandthehallsofacademiaaswell.Nordidheforeseethatoverthenextthreedecades,theresistancewouldinlargepartprevail.

Regal’sconcernsaboutgeneticengineeringwerefirstarousedintheearly1980’swhenwordspreadamonglifescientiststhatallitspracticesandproductsweresoontobefullyderegulated.Becauseforseveralyearstheproponentsofthisrevolutionarytechnologyhadbeenpromisingthatitwouldbecarefullyregulated,hewassurprisedatthisnews–andequallysurprisedathowmanybiologistswere

elatedbyit.AttheUniversityofMinnesota,whereRegalwasaprofessorintheCollegeofBiologicalSciences,thecollege’sdeanenthusiasticallyannouncedthatthemolecularbiologistsintheNationalInstitutesofHealthandtheNationalAcademyofSciences,alongwithkeyofficialsingovernment,haddecidedthatgeneticengineeringwassafeandweregoingtogiveunconditionalapprovaltoallitsapplications.

ButRegaldidnotsharetheenthusiasm–nor,ashewastolearn,didnumerousotherscientists.Foronething,hefounditstrangethatgeneticengineeringwasbeingtreatedasaprocessthatcouldbeconsideredsafeinitselfirrespectiveofthediverseusestowhichitwasput–andthatitsproponentsassumedthisinherentqualityofsafetywouldthenautomaticallyadheretoallitsvariousproducts.Thisapproachstruckhimasfundamentallyflawed,becausetheseproductscouldbeenormouslydifferentfromoneanotherinmanybiologicallyimportantways.

Geneticengineering(technicallytermed“recombinantDNAtechnology”andalsoreferredtoas“bioengineering”and“gene-splicing” 2)comprisesasetofnovelandpowerfulproceduresthatrestructurethegenomesoflivingorganismsbymoving,splicing,andotherwisere-arrangingpiecesofDNAinwaysthatwereformerlyimpossible.Throughit,awiderangeofoutcomescanarise.Itcanendowanorganismwithextracopiesofsomeofitsowngenes,reconfigurethesequencesofsomeofitsgenes,andre-programthewaysinwhichitsgenesareturnedonoroff,ortransplantgenesfromadistinctanddistantspeciesintoitsgeneticprogram.Further,itcantransformanykindoforganism,whetherabacterium,aplant,orananimal;andeachtransformationcouldgiverisetoauniquesetofeffects(bothintendedandunintended)dependingontheorganisminvolved,thegeneticalterationsperformed,theirlocationontheDNAmolecule,andtheenvironmentinwhichtheorganismisplaced.Therefore,Regalregardedtheclaimthatgeneticengineeringwouldalwaysbesafetobejustasbizarreastheclaimthatallartwouldbenon-offensive.

Yet,molecularbiologistspromotedthisclaimasscientificallysound;andmostweresosureofitthattheyshunneddiscussingtheissuewithanyscientistswhodisagreed,evenifthosescientistspossessedgreaterexpertiseinsomerelevantareasofknowledge.Norweretheypreparedtoconsiderwhethertheirownexpertisewasbroadenoughtoadequatelymanageallthefacetsofgeneticengineering.

RegalhadfirstencounteredthisinsularattitudewhileservingonacommitteeattheUniversityofMinnesotathatreviewedgraduatedegreeprograms.Tokeeptheuniversityapacewiththelatestdevelopmentsinbiotechnology,anewgraduatecurriculuminmicrobialengineeringhadbeenproposed.Aswastypicalofsuchprogramsatotheruniversities,thecourseworklargelyconsistedofchemistry,biochemistry,moleculargenetics,andsomephysiology.Duringthecommittee’sdiscussionoftheproposal,Regalexpressedtheopinionthatthestudentsshouldalsostudyecology,biologicaladaptation,andpopulationgenetics(fieldsinwhichhehadexpertise)sotheycouldbettercomprehendthefulldynamicsofgeneticallyengineeredorganisms.Heemphasizedthatwithoutsuchexpansionofthecurriculum,thegraduateswouldonlyknowhowsomeofthemicroscopiccomponentsoftheseneworganismsfunctionedinisolatedbiochemicalpathwaysbutwouldnotbeabletounderstandhowtheyfunctionedaswholes,especiallyinrelationtootherorganisms.Hepointedoutthatbecausebiotechnicianswereplanningtoreleasetheircreationsintotheenvironment,itwasimportantthattheybeabletoassesshowtheselivingentitieswouldinteractwithinecosystems.

Buthisinputprovokedanindignantresponsefromthepromotersofgeneticengineering,whoflatlyassertedthatbroadertrainingwasnotnecessarybecausegene-splicingwouldbeinvariablysafe.Theyfurthermaintainedthatgeneticengineeringwasanintenselycompetitivefield,thatnouniversitiesrequiredbuddingpractitionersto“wastetime”instudyingthetopicsRegalhadsuggested,andthatiftheUniversityofMinnesotadidimposesuchanextraneousburdenitcouldnotkeepupwiththeotherschools.

Regalwasbothstunnedandstirredbythesestatements.Ashelaterwrote:

Iwentawayfromthatmeetingwalkingslowlyacrosscampus,eyesonthepavement,ponderingtheflockofseriousquestionsthathadbeenrousedinmythinking.Howcouldpeoplewhoseexpertisewaslimitedtochemistrybesosurethatradicalmodificationsofcomplexbiologicalorganismslivingonfarmsorwithinbroaderpopulationsinnaturewouldnecessarilybesafeandeffective?Howcouldtheybesocertain?Thepromotersofgeneticengineeringatthatcommitteehearinghadnottheslightestscientificcredentialsforestimatingecologicaladaptationsanddisturbances.Itwasnotsimplythattheydidnothavedegreesorhadnottakencourses.Onecancertainlybeself-taught.Buttheyhadnocredibleknowledge.Yet,theywereclaimingtheydidnotneedtoacquireanyadditionalunderstandingorseekadvicefromexpertsbeyondtheboundsoftheirnarrowtraining–andthatnoothermolecularbiologistsrecognizedsuchaneedeither.Thiswasanastonishingprospectformetocontemplateatthetime,butitturnedoutthiswasindeedtheprevailingattitudeamongmolecularbiologiststheworldover.3

Regalbelieveditwashighlymisleadingforscientistswhoseexpertisewasrestrictedtomolecularbiologytopresentthemselvesasfullyqualifiedtoestimatetheecologicaleffectsofgeneticallyengineeredorganisms.Inhismind,itwaslikesomeonewhoknowsthedetailsinvolvedintheprintingofdollarbillspurportingtobeanexpertforecasteronhowthedollarwillbevaluedagainsttheeuroandtheyen,despitethefacthistechnicalknowledgeofdollarswaslimitedtotherealmofengravingplates,inks,andprintingpressesandhehadnotrainingormeaningfulexperienceineconomicsandtheintricaciesofinternationalcurrencymarkets.Nonetheless,thecategoricalclaimsofthemolecularbiologistswouldincreasinglybeacceptedasauthoritative,andwouldpowerfullyshapegovernmentpolicy.

Giventheboldnessoftheirpronouncements,someonehearingthemolecularbiologistsin1983forthefirsttimewouldhavebeensurprisedtolearnthattheyhadnotalwaysexudedsuchunqualifiedconfidenceinthesafetyofgeneticengineering–andhadevencalledformajorprecautions.Butthatwasadecadeearlier,whenthetechnologywasastartlingnewphenomenonandtheyopenlyacknowledgedtheirlimitedabilitytopredictandcontrolitseffects.Thestoryofhowtheirinitialmessagemutated,andtheirinfluenceconcurrentlyexpanded,providesastrikingexampleofthepoliticizationofscience–andtheminimizationoftheroleofevidenceinsettingpublicpolicythat’ssupposedtobescience-based.

TheAdventofanAstonishingTechnologyIn1969,theattentionofpeoplethroughouttheworldwasrivetedonanovelpathogenicmicroorganismthatthreatenedglobaldevastationofhumanlife.Nothinglikeithadeverbeenencounteredandthemostsophisticatedcontrolstrategieswerebeingfoiledbyitsawesomedestructivecapacity.What’smore,thismalevolentmicrobewastheproductofhumaninvention.

Buttheinventionwaspurelyliterary,andtheominousentitycametolifeonlywithinthepagesofabook–MichaelCrichton’sbest-sellingscience-fictionthriller,TheAndromedaStrain.AndalthoughinthisstorythedeadlyorganismmakesitsappearancethroughtheeffortsoftheUSArmytoobtainbiologicalweapons,ithasnotbeencreatedbyscientists.That’sbecauseCrichtonaimedforrealism;andatthattime,itwouldhavebeenfancifultoportraythisnovelcreatureastheproductofhumanengineering.SinceDNAwasstilllargelyunmanageable,atechnologythatcouldpreciselycopygenesandthensplicethemintolivingorganismswaswellbeyondtherealmofwhatwaspracticallyachievable.Consequently,itseemedmoreplausiblethatultra-lethal(andcompletelynovel)microbeswouldbefoundbeyondearth’satmospherethanformedwithinitslaboratories;andCrichtoncraftedaplotinwhichthearmysendssatelliteprobesintospacetocollectpathogensforthebioweaponsprogram.Inthisscenario,thenewmicrobialmenacearrivesinasatellitethatcrashestoearthinsteadofemergingfromaterrestrially-boundtesttube.

Aftergeneticengineeringhadbecomeareality,Crichtonseizedonitandmadeitanessentialfeature

ofJurassicPark,thebest-sellerhepublishedin1990.ButwhenhebegantowriteTheAndromedaStrain,eventhoughscientistshaddetailedknowledgeaboutthestructureofDNAandthenatureofthegeneticcode,theywerefarfromthestageofcontrolledgene-splicing;andwhiletherewasabuzzaboutthepossibilityof“geneticengineering”amongbiologistswhobelievedthatthemeansforsucharadicaltechnologywouldeventuallybedeveloped,itappearedthatnoonewasanywhereclosetodoingso.4

Yet,asimprobableasitmighthaveseemedwhenTheAndromedaStrainfirsthitthebookstoresin1969,earth-basedlaboratorieswouldsoonsupplantplummetingspaceprobesasthemostlikelypointofentryforperilousnewmicrobes.Thenextyear,scientistsfinallydiscoveredthemeansbywhichtheDNAmoleculecouldbecutwithprecision;andwithinfourmore,ateamofresearcherssucceededincopyingagenefromoneorganismandsplicingitintotheDNAofanother,creatingthefirstgeneticallyengineeredbacterium.5(ThestepsofthisprocessaredescribedinChapter4.)

Soon,dozensofothernewmicrobialstrainshadbeensimilarlyproduced.And,althoughthesenovelorganismswerecreatedonearth,inthemindsofmanypeople,theywerealmostasalienasifthey’dcomefromouterspace.Notonlydidtheycontainunprecedentedcombinationsofgeneticmaterial,itwashighlyunlikelythatmostoftheseconglomeratescouldhavearisenundernaturalconditions.Instead,theyowedtheirexistencetoextensivehumancontrivance.Further,regardlessofthedegreetowhichpeopleconsideredthemalien,alargepartofthepublicfearedthatsomeofthesecreaturesmightprovetobenearlyasdangerousastheunearthlyterrorportrayedinCrichton’sbook.Moreover,theywerenotaloneintheirapprehension.Itwastoasignificantextentsharedbythelifesciencecommunity.Infact,theconcernsofthepublicweresparkedbywarningsthathadissuedfromthemouthsandpensofmolecularbiologists.

ScientistsSoundtheAlarmIntheearlyphaseoftherecombinantDNArevolution,severalmolecularbiologistsbecamestruckbytheenormityofthenewpowerswithwhichthey’dsuddenlybeenendowed–anddeeplyconcernedabouttheircapacitytocausewidespreadharm.Itseemedthatunlessthistechnologywasmanagedverycarefully,eventhebest-intentionedresearcherscouldproduceahighdegreeofaccidentaldamage.

Oneofthefirstscientiststoapprehendthedanger,andvoiceconcern,wasRobertPollack,whowasrunningalaboratoryatColdSpringHarbor,LongIslandthatwasdirectedbytheNobellaureateJamesWatson,aco-discovererofthestructureofDNA.Inthesummerof1971,helearnedthattheStanfordbiochemist,PaulBerg,wasplanningtoconstructapieceofrecombinantDNAthatcontainedagenefromavirusthatcaninducemalignanttumorsinmonkeys,rodents,andhumans.6AndthegeneBergwasgoingtoemploywasthegenethatcausesthetumors.What’smore,heintendedtoinsertthatrecombinantsegmentintotheDNAofanothervirusthatinfectsabacterialspecies(namedE.coli)thatabundantlyinhabitstheintestinesofhumansandmanyotheranimals.AlthoughBerghopedtogainvaluableknowledgefromsuchanexperiment,andhadnotintendedtoputthevirusintothebacteria,Pollackwasconcernedthatsuchanincursioncouldinadvertentlyhappen,transforminganordinarilyfriendlyoccupantofourgutintoanagentofdisease.Thiswouldinturncreateariskthatsuchradicallytransformedmicrobesmightescapethelab,widelyinfecttheintestinesofpeopleandlivestock,andcausealotofcancer.7

SohecalledBerg,explainedhisconcerns,andaskedifhehadalsobeentroubledbysuchconsiderations.Bergsaidthathehadn’t;butPollack’scallgothimthinking.AsBerglaterrecounted,“Ibegantoaskmyselfiftherewasasmallpossibilityofrisk.Andifthereis,doIwanttodotheexperiment?” 8Hethenconsultedanotherscientist,whotoldhimtherewaspotentialforharmandthathewouldhavetoacceptresponsibilityforanymishaps.AccordingtoBerg,“AtthatpointIsteppedbackandasked,‘DoIwanttogoaheadanddoexperimentswhichcouldhavecatastrophicconsequences,nomatter

howslimthelikelihood?’” 9Hedecidedthathedidn’t;andtheexperimentwasplacedonhold.Healsodecideditwasimportanttoinitiateadialoguewithinthescientificcommunitysothatthe

potentialproblemswouldbeappreciatedandadequatesafeguardsemployed.Andsodidanumberofotherbiologists.

OneofthesediscussionsoccurredattheGordonResearchConferenceonNucleicAcidsinJune1973.ItresultedinaletterthatappearedintheSeptember21,1973issueoftheinfluentialjournalSciencecautioningthatthenewabilitytotransfergeneticsequencesbetweenorganismswas“amatterofdeepconcern”–andthat“[c]ertain...hybridmoleculesmayprovehazardoustolaboratoryworkersandtothepublic.” 10Airingthisconcerninsuchaprominentforumwasaboldstep,andoneoftheeditorsofSciencereportedlyquestionedthewisdomofdoingso.11Manyconferenceparticipantsalsohadreservationsaboutgoingpublic,andtheresolutiontopublishtheletteronlypassedbyasix-votemargin(48to42).12

Soonthereafter,theNationalAcademyofSciencesestablishedacommitteeonrecombinantDNA(rDNA),whichissuedaletterthatwentmuchfartherthanitsforerunnerbyurgingscientiststorefrainfromspecifictypesofgeneticengineering“...untilthepotentialhazardsofsuchrecombinantDNAmoleculeshavebeenbetterevaluatedoruntiladequatemethodsaredevelopedtopreventtheirspread....” 13Thisletterbecameknownas“theBergletter”becauseitsleadsignatorywasPaulBerg,whowasthedrivingforcebehindthecommittee’screationandtheletter’sproduction.Likeitspredecessor,theletterwaspublishedinScience;anditspurredevengreaterrepercussions.Itwasunprecedentedforagroupofscientiststovoluntarilyrestricttheirresearchandcallontheircolleaguestodothesame.Notonlydiditshowanadmirablelevelofsocialresponsibility,itrevealedtheformidableuncertaintiesthatsurroundedgeneticengineering–andlegitimizedconcernsaboutthem.

TheBergletteraskedtheNationalInstitutesofHealth(NIH)toestablishresearchguidelinesandoverseeexperimentation.ItalsosoughtinvolvementofthebroaderrDNAresearchcommunity,soitproposedaninternationalmeetingto“discussappropriatewaystodealwithpotentialbiohazardsofrecombinantDNAmolecules.” 14

RestrictingtheReleaseofEngineeredOrganismsBothrecommendationssoonborefruit.OnOctober7,1974theNIHestablishedanadvisorypanel(eventuallynamedtheRecombinantDNAAdvisoryCommittee[RAC])whichplayedasignificantroleinpolicyformationovermanyyears.AndthefollowingFebruaryaninternationalmeetingofoverahundredresearchersconvenedattheAsilomarConferenceCenterinMonterey,California.Itsmainfocuswasonformulatingguidelinesthatweresufficientlyrigoroustopreventcatastrophesyetliberalenoughsobiologistscouldendtheirbroadmoratoriumandgetonwithresearch.AsanarticleinSciencedescribedtheoutcome:“Aftermuchhaggling,thegroupsettledonasetofsafetyguidelinesthatinvolvedworkingwithdisabledbacteriathatcouldnotsurviveoutsidethelab.TheguidelinesnotonlyallowedtheresearchtoresumebutalsohelpedpersuadeCongressthatlegislativerestrictionswerenotneeded–thatscientistscouldgovernthemselves.” 15

Inreachingtheirdecisions,themolecularbiologistsdidnotseekinputfromotherperspectives,andnoavenueswereprovidedforpublicinterestgroupstoparticipate.Further,it’sclearthiswasnotanoversightbutanessentialaspectofpolicy–apolicytorestrictthoseoutsidethemolecularbiologists’foldfrominfluencingthewaysinwhichrDNAresearchwasconductedandapplied.JamesWatsonunabashedlyacknowledgedthatheandhiscolleaguesatAsilomarembracedsuchanexclusionarypolicy:“Althoughsomefringegroups...thoughtthiswasamattertobedebatedbyallandsundry,itwasnevertheintentionofthosewhomightbecalledthemolecularbiologyestablishmenttotaketheissuetothegeneralpublictodecide.Wedidnotwantourexperimentstobeblockedbyover-confidentlawyers,much

lessbyself-appointedbioethicistswithnoinherentknowledgeof,orinterestin,ourwork.Theirdecisionscouldonlybearbitrary.” 16InthewordsofSusanWright,ahistorianofscienceattheUniversityofMichiganwhoisanauthorityonbioengineering’sfirstdecade:“[P]olicy-makingdecisionswereclaimedtobetherightandresponsibilityofscientistsalone.” 17

Accordingly,mostofthemolecularbiologistsexpectedtheself-imposedresearchrestrictionstoassuagepublicconcernsandallowthemtomaintainexclusivecontroloverthewaysinwhichthegeneticengineeringenterprisewoulddevelop.WatsonhaswrittenthatastheydepartedAsilomar,theywere“asexhilaratedastheywereexhausted”because“[h]avingdemonstratedtheirintegrity,theynaivelybelievedthattheywouldnowbefreeofoutsideintervention,supervision,andbureaucracy.” 18

However,contrarytotheexpectationsofitspractitioners,rDNAresearchdidnotstayfreefromgovernmentsupervision.ThedayaftertheAsilomarconferenceended,planningbeganforNIHresearchguidelines;andtheinitialsetwasissuedonJune23,1976.Despitetheabsenceoflegalpenaltiesforviolatingthem,therewereconstraints,becausetheyappliedtoanyorganizationreceivingNIHfunds–andtheywereeventuallyextendedthroughpresidentialordertoencompassallfederallyfundedresearch.Sofundingcouldbecurtailedifaprojectignoredthem.Further,theNIHguidelineswentbeyondthoseagreeduponatAsilomarandbannedthedeliberatereleaseintotheenvironmentofanyorganismcontainingrecombinantDNA.

UneasyEquilibriumBecausetheopenairingofconcernshadstirredwidespreadanxiety,thebanonreleasinggene-splicedorganismswasnecessarytocalmthepublicenoughsothatlaboratoryresearchwithrDNAtechnologycouldmoveahead.Butmanyscientistsgrewdissatisfiedwiththerestrictionsandregrettedthereadinesswithwhichearlyapprehensionswerepublicized.Ithadbecomeclearthatbioengineeringwasahighlyvolatileissueandthatanymisgivingsexpressedbyitspractitionerswouldbeseizeduponbythemedia.Already,headlineshadappearedproclaiming:“GeneticScientistsSeekBan–WorldHealthPerilFeared”(PhiladelphiaBulletin),“ScientistsFearReleaseofBacteria”(LosAngelesTimes),and“ANewFear:BuildingViciousGerms”(WashingtonStarNews).19EventhestaidAtlanticMonthlypublishedanarticleentitled“SciencethatFrightensScientists.” 20Suchreportssignificantlyunsettledthecitizenry.

Notonlywerealargenumberofmolecularbiologistsdisappointedbythisoutcome,asoneobservernotes,most“feltbetrayed.” 21Althoughtheyhadhopedtheirself-imposedbanwouldconvincethepublicthattheycouldbetrustedtomanagethisnewtechnologywithoutgovernmentsupervision,itinsteadhadfannedpublicfearsandinducedtheimpositionofsuchsupervision.Further,during1976morethanadozenbillswereintroducedinCongresstoregulaterDNAresearch.22Andone,initiatedbySenatorEdwardKennedy,calledforregulationbyapresidentialcommission.23

Astheefforttoimposerestrictionsgainedmomentum,Americanmolecularbiologistsworriedtheywouldfallbehindscientistsincountrieswhereresearchwasunregulated–andthattheUSwouldloseitsleadinthefield.24Accordingly,manypubliclydisavowedtheirformerprecautionarystance.Inoneofthemoredramaticturnabouts,JamesWatson,asignatoryoftheBergletter,declaredthatthedangerinitiallyimputedtobioengineeringwas“animaginarymonster,” 25andheregisteredregretthathe’dsignedtheletter.26

Inretreatingfromtheirpreviously-voicedconcernssotheycouldassertthesafetyofbioengineeredorganisms,thesescientistswerefallingbackonthefoundationalfaithoftheirfield.Molecularbiologywasdevelopedasadistinctdisciplineduringthe1930’slargelythroughtheeffortsoftheRockefellerFoundation,undertheleadershipofMaxMasonandWarrenWeaver.27Thesetwo

mathematician/scientistswereuncomfortablewithquantummechanics,whichduringthefirstthirdofthe20thcenturyhadascendedtoprominenceinphysics.Thisnewtheorywasmuchmorecomplicatedthantheclassicaltheoryitsupplanted,and,asWeaveracknowledged,heandMasondislikedwhattheyregardedtobeits“essentiallyunpleasant‘messiness.’” 28Further,theythoughtitwouldeventuallybereplacedbysomethingthatwouldbesimplerand“moreelegant”–andconsequently“muchmoresatisfying.” 29

And,havingrealizedthattheythemselvescouldnotreshapephysicsalongthelinestheydesired,theyenthusiasticallyembracedtheopportunitytodosoforbiology.Infact,theywantedtogroundbiologyinphysics;andtheybelievedthatbyturningitintoanextensionofthelatter,theycoulddevelopascienceoflifethatwouldbeessentiallysimple,precise,andpredictable.PhilRegalhasobservedthattheirapproachwasfullyreductionist:“Thesocialsciencesandhumanitieswillultimatelybereduced...tobiologywithnoresidue....Biologywillinturnbereducedtochemistry,whichwillreducetophysics,whichwillreducetoasimpledeterministicunitythatwillallowprecisepredictionsatalllevelsoflife.” 30Thisprecisionwouldenablecomprehensivecontrol.AsWeaverhaswritten,itwas“reasonable”toexpectthatawell-foundedbiologycouldfurnish“asimilardegreeofcontrolovermanyoftheaspectsoflivingmatter”asthephysicalsciencesexertovernonlivingmatter.31

MasonandWeaverinstilledtheirfaithintheultimatesimplicity,predictability,andcontrollabilityoflifeprocessesinthephysicistsandchemiststheyrecruitedtobecomethepioneersofmolecularbiology.32Intheirvision,thisnewsciencewouldsolvemostofhumanity’smajorproblemsthroughprecisegeneticandchemicalmanipulationsthatwouldbecomprehensivelycontrolledbyhumanintelligence–withscantspaceforunintendedconsequences.Thus,asRegalhasremarked,“Theagendaformolecularbiologyandtheengineeringoflife...wasinfusedwithcompleteoptimismfromthestart,andtherewasonlyapositiveviewofthepromiseofthenewscienceandthebiotechnologiesitwassupposedtoproduce.Risksandothernegativedevelopmentswerenotconsideredorplannedfor.”

Moreover,whenconfrontedbythepossibilityofadverseoutcomes,thebioengineersdisplayedunrealisticconfidenceintheirabilitytomanagethem.Forinstance,ataconferenceRegalattendedin1984,amolecularbiologistgaveatalkdescribingallthehoped-forbenefitsofrDNAtechnologyasiftheywerevirtuallycertainoutcomes.Whensomeoneasked,“Whatifyouaccidentallycreateanewdisease?”sheseemedoffended,butunhesitatinglydeclared,“We’lldevelopacureforit.”Regalthenqueried,“Don’tyouthinkitwouldbeagoodideaforgeneticengineerstofirstdevelopcuresforAIDSandthecommoncoldbeforemakingsuchboldpromises?”Sheappearedstunnedandwasunabletomusteraresponse.

Regalnotesthatovertime,theevidencehasincreasinglycounteredthemolecularbiologists’convictionsintheprecisionandpredictivepoweroftheirdiscipline.“Abundantdatahasexposedabigdiscrepancybetweentheworldtheyinitiallyenvisionedandtheworldasitreallyis–andshownthatnatureismorefrustratinglysubtlethanthey’dassumedbothatthemicroscopiclevelandonthelevelofecosystems.”

AmongU.Smolecularbiologists,thedenialoftherisksofgene-splicingwassodeeplyseatedthatmanymaintaineditcouldnotcauseharmevenifpurposelyemployedtodoso.KenAlibek,whoplayedanimportantroleintheSovietUnion’sbio-weaponryprogrambeforeemigratingtotheUS,saysheencountered“analarminglevelofignorance”aboutbiologicalweaponswithintheexpertcommunityofhisadoptedcountry.Hereports:“SomeofthebestscientistsI’vemetintheWestsayitisn’tpossibletoaltervirusesgeneticallytomakereliableweapons....Myknowledgeandexperiencetellmethattheyarewrong.” 33

RegalconfirmsAlibek’sobservation.“IhadlongheardthesamenaiveopinionsfromleadingAmericanbiotechadvocates....Mysenseisthatmanyofthemhadtalkedthemselvesintosincerely

believingthatrDNAhadnoweaponspotentialbecausetheyfeltconstantlyonthedefenseandexperiencedaneedtoprotecttheimageofbiotechnology–andtosustaintheirownfaithinthefullybenignnatureoftheirmanipulations.Theseargumentsspreadandtookholdas‘commonwisdom’amongAmericanbiotechnologists,despitetheirdissonancewithreality.”

Yet,notallmolecularbiologistswereaversetoacknowledgingrisk;andseveralspokeforcefullyabouttheproblemstheyperceived.Anespeciallystrongwarningwasreleasedbyoneofthefield’smajorpioneers,ErwinChargaff.InanessayinSciencetitled“OntheDangersofGeneticMeddling”hecalledbioengineering“warfareagainstnature”andemphasizeditsirrevocableconsequences.Hedeclared:“Youcanstopsplittingtheatom;youcanstopvisitingthemoon;youcanstopusingaerosols...Butyoucannotrecallanewformoflife....Itwillsurviveyouandyourchildrenandyourchildren’schildren....Havewetherighttocounteractirreversiblytheevolutionarywisdomofmillionsofyearsinordertosatisfytheambitionandthecuriosityofafewscientists?” 34Incontrasttothemolecularbiologistswhoarguedforlessregulation,Chargaffurgedgreatergovernmentintervention.Further,heexpresseddoubtthattheRACcouldhandlethevariousproblems,andhedeploredthatalmostallitsmemberswereproponentsofgeneticengineering.35

AnothereminentmolecularbiologistwhoadvocatedprecautionwasJonathanKing,aprofessorattheMassachusettsInstituteofTechnology.Moreover,likeChargaff,hecritiquedwhatheperceivedtobetheRAC’spromotionalproclivitiesandallegedthatitfunctioned“toprotectgeneticists,notthepublic.” 36AndHarvardbiologyprofessorGeorgeWald,aNobellaureate,warnedthatrDNAtechnologyentails“problemsunprecedentednotonlyinthehistoryofscience,butoflifeontheEarth.” 37Heemphasizedthattheradicaltypeofinterventionitperforms“mustnotbeconfusedwithpreviousintrusionsuponthenaturalorderoflivingorganisms” 38–andbrandedit“thebiggestbreakinnaturethathasoccurredinhumanhistory.” 39Hecautionedthat“goingaheadinthisdirectionmaybenotonlyunwise,butdangerous.” 40

Therewerealsoindividualsinthebiotechindustrywithmisgivings.AsPhilRegalsoughtperspectivefromitsmembers,heencounteredseveralofthem,includingafriendfromgraduateschoolwhohadadvancedfromcorporateresearchertoadministrator.Notonlywashisfriendpleasedtohearfromhim,likeMayr,heurgedhimtotakeonthesafetyissue.Asheexplained:

Phil,webadlyneedinputfromecologistsandorganismicbiologistslikeyou.Wemolecularbiologistsareoutherebyourselvesonthis,andwe’vegotnowayofevaluatingthesafetyofourownwork,orofevenknowingifourhypeaboutsocialbenefitsmakessense.Weneverstudiedthesortsofthingsyouguysstudied.Therewasneverthetimeortheinterest.Thisisaverycompetitivebusiness.Alotofpeoplearetryinganythingtheycanthinkofwhenanewtechniquecomesalongoranewgeneisavailable.“You’veisolatedanewgene?LendittomeandletmeseewhatIcangetitinto.Let’sseewhathappens.”

Competitivegenejocksareadimeadozen.Thewaytooutshinethenextguy,togetanofferfromanothercompany,thewaytogetaraise,istodosomethingsensational.There’sacompetitiontodosensationalthings.Nobodyhastimetothinkdeeplyaboutsafetyorreallyhowmuchgoodwillcomefromthis.

Tosomeextent,theconflictingpressuresexertedbythevariousfactionsinthegeneticengineeringcontroversysustainedanequilibriumoverafewyearswhich,thoughnotdeeplysatisfyingtoanyonegroup,didnottiltveryfarinanydirection.Theoveralllevelofconcernremainedhighenoughsothatsomefederaloversightwasmaintained,butnotsohighastotriggertheimpositionofadditionalrules.

Then,in1977,theequilibriumdecisivelyshiftedinfavorofthebiotechnicians.Publicconcern

waned;andtheinitiativeforregulationonCapitolHilllostitsmomentum.41Sosubstantialwastheshiftthat,asSusanWrightputsit,“by1979thehazardquestionwasalmostanon-issue.” 42Themainfactorbehindthistransformationalsounderlaythegeneticengineers’displayofnew-foundcertitudeaboutthesafetyoftheircreations.Itwastheallegedemergenceofimportantnewevidence.

TheRiseof‘MolecularPolitics’–andtheForceofPhantomEvidenceThepivotalnewsaboutnewevidencearoseastheresultofthreemeetingsheldtoevaluatethesafetyofengineeredorganisms.Thefirstoccurredin1976inBethesda,Maryland,thesecondduringthefollowingyearinFalmouth,Massachusetts,andthethirdin1978inAscot,England.Collectively,theyconveyedtheimpressionthatsufficientevidencehadamassedtodemonstratethatgeneticallyengineeredorganismsaresafe–andthattherewerenolongeranyconcernsamongexperts.However,thisimpressionwasmisleading.

Foronething,althoughthemeetingspurportedtobescientific,theydifferedinsignificantwaysfromstandardscientificgatherings.Incontrasttoconventionalnorms,theorganizerscarefullycontrolledwhoattended,howissueswerediscussed,andwhatinformationgotdisseminated.Theconferenceswerenotannouncedbynormalprocedures,participationwasbyinvitationonly,andtheinviteespredominantlyfavoredminimalcontrolsonrDNAresearch.43JonathanKingofMIT,oneofonlytwoscientistsattheFalmouthconferencewhoadvocatedstrongerprecaution,notedthatmanylike-mindedexpertswhoordinarilywouldhaveattended“wereratherupset...tofindoutthatarisk-assessmentconferencewastakingplaceandtheydidn’tevenknowaboutituntilafterthefact.” 44TheBethesdameetinghadgoneevenfartherthanFalmouthinmaintainingprivacy,totheextentthatadecadeafteritoccurred,eventheidentitiesoftheparticipants(otherthanthetwochairmen)hadnotbeenofficiallyrevealed.AndtheorganizersoftheAscotmeetingdidnotinviteanymembersoftheBritishGeneticManipulationAdvisoryGroup(GMAG),anomissionthatseemedhighlyirregularandpromptedonememberofthatgrouptostate:“Itmightbethoughtadiscourtesytorunaninternationalconferenceonanimportantpolicyquestionwithoutinvolvingthecorrespondingorganizationinthehostcountry....”HesurmisedthattheGMAGwassnubbedbecauseitfeatured“strongrepresentation...ofthepublicinterest”and“wouldhavesuppliedacriticalpresence.” 45

SusanWrighthasobserved,basedonthoroughstudyofthetranscriptsandherinterviewswithparticipants,thatthemeetingsdidnotmerelyengageinthetechnicalassessmentofriskbutwereatleastasconcernedwithhowpublicperceptionsofriskcouldbemanaged.46ThisconcernwasespeciallysalientatBethesda.Wrightnotesthata“stronginformaltheme”oftheconference“wasasharedsenseofapressingneed,beyondcontainingpossiblehazardsofrecombinantDNAwork,tocontainthespreadofthecontroversyaswell.” 47Shereportsthatthediscussionsreveal“asiege-likefeeling...,asharedsenseofthreat,ofpolarization,ofscientistsversussociety”;andshenotesatendencytoemploy“polarizedcategories”andspeakintermsofscientistsversus“thesky-is-fallingpeople”and“theprophetsofdoom.” 48

Thispolarizedmoodandthemeeting’spoliticalaswellasscientificaimsweremanifestinthechairman’sopeningremarks:“Partoftheagendatodayistogetyouguysinvolvedandgetyourvoicesheard...IfIcouldsaytotheprophetsofdoom:‘Look,theseguyshavecomeoutandsaidthatthereisnothingtoworryabouthere,solet’s...getonwithseriousbusiness.’That’swhatIhopewecanaccomplish.” 49

Thisaimforconsensusplayedoutinthewayissueswerehandled.AlthoughtheparticipantsrecognizedthatrDNAtechnologycouldentailseveralhazards,thefocuswassystematicallynarrowedtoresearchemployingoneparticulartypeofbacteriacalledE.coliK-12,becauseitappearedtoposevirtuallynothreat.

Aspreviouslynoted,E.coliisabacterialspeciesthatinhabitstheintestinesofhumansandseveralotheranimals;andE.coliK-12isadistinctstrainthatwasdevelopedinlaboratoriesforresearchpurposes.BecauseK-12hasbeenusedforsomanyyearsinlabs,ithasbecomequiteweakincomparisontootherbacteria(includingotherstrainsofE.coli)andwouldhavegreatdifficultysurvivingoutsidetheprotectedlabenvironment.Asonemicrobiologistputsit:“K-12...wouldn’tstandachanceinthehugelycompetitiveenvironmentthatisyourgutwherebacteriaareconstantlyevolvingtokeeptheir‘cuttingedge’andnotbepushedoutbyothermicrobes.GettingK-12toestablishitselfinthegutwouldbeliketryingtoqualifyforaFormula1racewithacarfrom1922(whichiswhenK-12wastakenfromsomebody’sgut)!Itwascompetitiveatthetime,butisnowwayoffthepace.” 50

Consequently,expertscouldfeelconfidentthatnomatterwhatforeigngenesgotimplantedwithinE.coliK-12,therewasscantlikelihoodsuchfeeblebacteriacouldcauseanepidemiciftheyescapedthelab(whichaccountedfortheirfrequentutilizationinrDNAresearch).However,manyoftheconferenceparticipantsdidhaveotherconcerns.Foronething,NIHguidelinesdidn’tbarresearchwithmicroorganismsbetterequippedtosurviveoutsidethelabthanK-12.51Further,evenifresearchremainedconfinedtoK-12,therewasrecognizedpotentialforproblematicgenestotransferfromittootherorganismswhichcouldthenbecomeagentsfornoveldiseases.Oneparticipantpointedoutafewpotentialscenariosandremarked:“Tome,thosearefrightening.” 52

Yet,asWrightobserves,theseandotheroutstandingsafetyissues“tendedtobefactoredoutofconsiderationratherthanconfronted.” 53Shesaysthatinstead,“thesense...thatbiomedicalresearchwasthreatenedcameincreasinglyintofocus,”accompaniedbywarningsthatsciencewasunder“veryseriousattack.” 54Shereportsthatthetranscriptrevealsameeting“dominated”by“visionsoflaboratoriesswathedinredtape,”andthatinthiscontext,theargumentthatK-12couldnotbecomeanepidemic-causingpathogenwasseenasthebestmeansfor“defusing”controversy.55

AccordingtoWright,mostparticipantsappeartohaveacceptedthis“politicalstrategy.” 56Asonebiologiststated:“...intermsofPR,youhavetohitepidemics,becausethatiswhatpeopleareafraidofandifwecanmakeastrongargumentaboutepidemicsandmakeitstick,thenalotofthepublicthingwillgoaway.” 57Shenotesthatattheendofthemorningsession,oneparticipant“summarizedthesenseofthegroup”bystatingthattheprimarytaskwastoconvincethepublic.Hethendeclared:“[T]hatisveryeasytodo.It’smolecularpolitics,notmolecularbiology....” 58

InreportingtheresultsoftheBethesdameetingtotheRAC,thechairmanstatedtherewasconsensusthatthepossibilityofepidemicsis“extremelyremote”–andasharedopinionthatthisconcept“shouldbediscussedinapublicforum.” 59Accordingly,anorganizingcommitteewasformed,andinJune1977theFalmouthconferenceconvened.However,thefactsindicatethatthecallforapublicforumwasmerelypublicrelations–andthattheonlythingtheorganizerswantedtomakepublicwasanadvantageousoutcome,nottheprocessthroughwhichitwouldbeproduced.Otherwise,theywouldnothavekepttheconferenceaprivateaffairtowhichthemediawerenotinvited(andaboutwhichtheywereuninformed)–ashadalsobeenthecaseatBethesda,andwouldcontinuetobeatAscot.60

TheconferencemanagerslikewisefollowedtheBethesdastrategyinkeepingthefocusonE.coliK-12.Evenso,participantsraisedcontroversialissues;andtheydebatedwhetherforeigngenesinsertedinK-12couldthentransfertorobustorganisms–orinstead,whileremainingwithinit,couldpropagatedangeroustoxinsorhormonestothesurroundings.

AccordingtoSusanWright,thepublishedproceedingsrevealthatthese“troublesomequestions”werenotresolved.61Theinconclusivenessofthediscussionsisevidentfromalistofproposalsforfurtherresearch,introducedbyastatementthat“...fromthecauldronofvigorousscientificdebatewillfinallyemergecriticalexperimentstoassessthepotentialhazardsinrecombinantDNAtechnology.” 62

Thus,eveninaneventwhereparticipationwasalmostexclusivelylimitedtoscientistswhowantedminimalrestrictionsonrDNAresearch,andwheretheformatwassotightlycontrolledthatoneattendeecharacterizeditas“choreographed”andanotheras“arealset-up,” 63potentialhazardswereacknowledged–alongwiththefactthat“critical”experimentstoaccuratelyassessthemhadyettobedone.However,neitherthepublicnorthewiderscientificcommunitywasgiventheimpressionthattheparticipantsrecognizedtheneedforhardscientificevidenceand“vigorousscientificdebate”tostimulateitsproduction.That’sbecause,withthepressexcludedandtheofficialconferencereportleftunpublisheduntilelevenmonthshadelapsed,therewasleewayforselectivecommunication.

Themaininformationreleasedinatimelymannerwasinalettersentimmediatelyaftertheconferenceendedbythechairmanoftheorganizingcommittee,SherwoodGorbachofTuftsUniversity,totheNIHDirector.Thisletter,whichwaswidelycirculatedinthesummerof1977,primarilyshapedpublicperceptionsoftheresults.SusanWrightsaysthatitcenteredontheepidemicpathogenquestion“tothevirtualexclusionofotherissues”andpresented“anessentiallysoothingview...inwhichuncertaintiesandunresolvedissueswereobscuredbytheemphasisontheremotenessofpossiblehazards.” 64

However,someoftheparticipantstriedtooffsetwhattheyconsideredtobeamisleadingreportofwhathadhappened,includingRichardGoldstein,oneoftheconferenceorganizers.HesentalettertotheNIHDirectorpointingoutthat“thoughtherewasgeneralconsensusthattheconversionofE.coliK12itselftoanepidemicstrainisunlikely(thoughnotimpossible)...therewasnotconsensusthattransfertowildstrainsisunlikely.”Hethenstated:“Onthecontrary,theevidencepresentedindicatedthatthisisaseriousconcern.” 65Severalotherparticipantswroteconcurringletters.66

But,asaresearcherwiththeStanfordSchoolofMedicineobserved,itwasGorbach’ssummarythat“drewattentiononCapitolHillandinthemedia.” 67Andthemedia,whichassumeditwasaccurate,relayeditsmessagewithoutqualification.TheWashingtonPostdeclaredthescientistshad“unanimouslyconcludedthatthedangerofrunawayepidemics[was]virtuallynonexistent;”andaheadlineintheNewYorkTimesannounced“NoSci-FiNightmareAfterAll.” 68Further,asSusanWrightnotes,thisversionoftheresultswasnotonlyacceptedbythepressandpublicbut“quicklyachievedscientificrespectability”andwasadvancedbydistinguishedbiologists.69Moreover,manyoftheirstatements(includinganeditorialinScience)exceededtheclaimthatE.coliK-12couldnotbecomepathogenicandassertedtherewasconsensusthatallresearchemployingitwassafe.70TheNationalAcademyofSciences(theNAS)evenextendedthedistortion,declaringtheevidenceshowedthattherisksofgeneticengineeringingeneralwereinsignificant.71

Mostimportantforthebiotechproponents,andcongruentwiththeaimsoftheconference,theGorbachreportbecameapowerfulpoliticaltool.Armedwithitspurportedlyevidence-basedassurances,boththeindustrialandacademiccomponentsofthemolecularbiologyestablishmentmountedamassivelobbyingcampaign,describedbySusanWrightas“oneofthelargest”everrelatedtoatechnicalissue.72ParticipantsincludedleadinginvestigatorsattheAmericanSocietyforMicrobiologyandalsotheNAS;anduniversitiesweighedinthroughalobbyinggroupcalled“FriendsofDNA,”whosemembersincludedpresidentsof“themostprestigiousAmericanacademicinstitutions.” 73Harvardevenhiredtwoprofessionallobbyiststohelpout.74SoextraordinarywasthecampaigninbothmembershipandmagnitudethatsomeCongressionalstaffersremarked“theyhadneverseenanythinglikeit.” 75

Thegoalofthesescientist/lobbyistswastothwartregulation,andakeytargetwastheproposedlegislationchampionedbySenatorKennedy,thebillthathadachievedthemostformidablemomentum.SusanWrightreportsthatithad“sailedthrough”therelevantSenatecommitteeswhenintroducedandseemed“assuredofapproval”atthetimethebiotechproponentsinitiatedtheircampaign.76

Sotheyswiftlysetouttoscuttleit.LessthanaweekaftertheFalmouthconference,agroupofeminent

biologistsmetwithKennedyandarguedthatinlightofthe“newinformation,”hisproposedlegislationwasunnecessaryandshouldbedropped.77Butheheldhisgroundandreassertedtheneedforaregulatorycommission.

However,manylegislatorsweremorereadilywonover,andlessthenthreemonthsaftertheproponentsofunfetteredrDNAresearchwererebuffedbyKennedy,theirpersistentcampaignhadeffectedadecisiveshiftinthelegislativemood.SenatorAdlaiStevensonIIIexpressedthisnewattitudeinaspeechtohiscolleaguesonSeptember22ndassertingthat“recentevidence”aboutthedecreasedrisksofsuchresearchrequiredthemto“carefully”reassesswhetherthebenefitsofregulationwouldoutweighitsadverseimpactsonscientificresearch.78

Withsomanylegislatorsnowalignedagainstregulation,Kennedywasfinallycompelledtocapitulate.OnSeptember27th,inaspeechtotheAssociationofMedicalWriters,heannouncedthathewouldnolongersupporthisownbill,statingthat“theinformationbeforeustodaydifferssignificantlyfromthedataavailablewhenourcommitteerecommendedthe...legislation.” 79

AccordingtoSusanWright,thisreversalwasamajoreventinthehistoryofgeneticengineering,“...demonstratingthepowerofthebiomedicalresearchcommunitytoretaincontroloverregulatingthefieldandtodictatethetermsoftechnicaldiscourseonthehazards.” 80Italsodemonstratedthatthispowercouldbegainedandmaintainedthroughpromotionalclaimsthatwereunsubstantiatedandseriouslydubious,solongastheywereprofessedtobescience-based.

Moreover,thefabricationsfromFalmouthwerenottheonlydeceptivedataemployedtoquashtheKennedybill.AreportonresearchconductedbyStanleyN.CohenofStanfordUniversityalsoplayedakeyrole.Cohen,aco-inventorofrecombinantDNAtechnology,wasamongthescientistswhowerenotcontentmerelytoargueforthesafetyofresearchwithE.coliK-12.Instead,hemaintainedthatthetechnologyhehelpeddevelopisingeneralsafe–andevenaverredthatitcouldnotentailspecialhazards.81In1977,heperformedastudytosupporthisstance.Hewantedtodemonstratethatthekindsofgeneticrecombinationsachievedintesttubesalsooccurnaturallyinlivingorganisms–andthus,thatthesplicingofgenesbetweenunrelatedspeciesisnotaradicallynewandartificialdevelopmentbutsomethingthat’sbeeninnocentlyoccurringinnatureforeons.Whentheresultswerein,hedeclaredsuccess,becausehe(andhiscollaborator,ShingChang)hadbeenabletocreateasituationinwhichfragmentsofmouseDNAweretakenupbyE.coliK-12andthenintegratedwithsomeoftheDNAthattheycarried.82

Cohenclaimedbroadimplicationsforhisresearch,arguingitshowedthat“scientistscanonlyduplicatewhatnaturecanalreadydo.” 83HesoundedthisthemeevenmoreboldlyinalettertotheNIHDirectoronSeptember6,1977inwhichheassertedthattheoutcomewas“compellingevidence”thatrecombinantDNAmoleculesconstructedinthelaboratory“simplyrepresentselectedinstancesofaprocessthatoccursbynaturalmeans.” 84

Further,itappearsthatCohentimedthereleaseofhisnewstoaidthelobbyingcampaign.Notonlydidhetakewhatheadmittedtobethe“unusualstep”ofissuingtheannouncementabouthisfindingswellinadvanceoftheirpublicationinascientificjournal,hesaidhedidsoduetotheir“importancewithregardtotheregulationofrecombinantDNA.” 85

Thecampaignersseizedonhisprematurepronouncement,andbecauseitmaintainedthatbioengineeringasawholeisessentiallynatural(andthereforesafe),itstronglyaugmenteddeclarationsfromtheFalmouthconference.Accordingly,ithelpedconvincelegislatorsthattheirpriorconcernswereunfounded;andduetoitsbreadthanditsapparentlyevidentialbasis,SenatorKennedyreliedonitasthemainjustificationforhismomentousreversal.86

However,asinthecaseoftheclaimsfromFalmouth,theimpressionthatCohen’sclaimsderivedfrom

soundevidencewasillusory.Althoughheavowedthattheexperimentwasconductedundernaturalconditions,therealitywasotherwise;becauseinordertoinducethebacteriatoaccepttheforeignDNA,notonlydidheandChanghavetotreatthemwithacalciumsalt,theyalsohadtosubjectthemtoamajorheatshock(byrapidlyraisingthetemperatureby42degreesCentigrade,whichequalsaboostof107.6degreesFahrenheit).

Theseconditionswerefarfromnatural;andmostscientistsknewtheywere.Moreover,theNIHhadspecialreasontobeawareofit.OnlysixmonthsbeforeCohen’sletterdeclaringthenaturalnessoftheconditionsunderwhichhe’dinducedtheinter-speciesexchangereachedtheDirector’sdesk,theprominentmicrobiologistRoyCurtisshadsentonewithastarklycontrastingview.Ironically,thoughCurtiss’swasalsoinstrumentalinthecampaignagainstregulation(itwasanopenletterthatwaswidelydistributed),itunderminedtheclaimthatCohenwouldlatermakebecauseitsargumentforthesafetyofrDNAresearchwasinpartbasedonthefactthattheconditionsCohenimposedwerehighlyunusual.IncontendingthattheinsertionofforeignDNAintoE.ColiK-12“offersnodangerwhatsoever,”CurtissassertedthatevenifsuchDNAwerelaterreleased,therewasscantchancethatotherbacteriawouldtakeitup,unlesstheyweretreatedwithasaltandalsosubjectedtoarapid42-degreeCentigraderiseintemperature–conditionswhich,hepointedout,“wereunlikelytobeencounteredinnature.” 87

Despitethefactthattheletterscontradictedoneanother,theNIHusedbothassupportingevidenceforitspolicystatementsbefriendingbiotechnology,whilenevernotingtheglaringdiscrepancybetweenthem.88TheagencywasfinallyforcedtoconfronttheillegitimacyofCohen’sclaimduringameetingtheDirectorheldwithhisadvisorycommitteeinDecember1977,whentheartificialityoftheresearchsetupwasemphaticallydrivenhomebythedistinguishedbiologistRobertSinsheimer.89Althoughthispotentdis-creditationdeterredtheNIHfromcitingtheresearchinsubsequentpublications,itsresponseremainedminimal,anditapparentlydidnothingtocorrectthefalseimpressionsthathadbeeninstilledwithinthemindsofCongressandthepublic.Thus,legislatorswereneverproperlyinformedthatthepurportedlyevidence-backedproclamationonwhichthey’dsostronglyreliedwasbogus;norwasSenatorKennedymadeawarethat,halfayearpriortohiscapitulationbasedonthatpronouncement,theNIHpossessedinformationundercuttingitinadvance–andthatlessthanthreemonthsafterhisreversal,itsinfirmitywasagainrevealedtotheNIH,thistimesodirectlyandbeforesomanyexpertsthattheagencydidn’tdarerefertoitagain.90

AscotCompoundstheConfusionDespitetheanti-regulatoryvictoriesof1977,restrictionsremainedonsomeformsofrDNAresearch,andmanyvirologistsweredissatisfiedthattheNIHguidelinescontinuedtoclassifythecloningofanimalvirusDNAinE.colias“highrisk.” 91EncouragedbythewaytheFalmouthconferencealteredperceptions,theyhopedthatasimilarconferencefocusedontheirareaofresearchcouldachievelikeresults.AndsotheAscotmeetingwasheldinJanuary1978.AswasthecaseatFalmouth,discussionwaslimitedtoscenariosinvolvingE.coliK-12;andtherewaslikewiseameagerstoreofevidenceonwhichtoformdefinitiveconclusions.Basedonherreviewoftheproceedings,Wrightnotes:“Thetenorofthesediscussions...showsthatatmanypoints,predictionswerespeculative.Toolittlewasknownaboutthemechanismsofviralinfectionsandtransformationtobeabletopredicttheeffectsofcloningthesegenes.” 92Asoneparticipantremarked:“Yousee,thewholediscussionhas[thefeelingof]asortofAristotelianacademybecausewearereallyjustdiscussingextremelytheoreticalthingsandwe’rederivingmodelswhicharebasedonnoexperimentswhatsoever....that’swhywe’retalkingsomuch.” 93Nonetheless,theconference’sfinal“consensus”statementconfidentlyassertedthathazardstothepublicfromcloningviralDNAwere“sosmallastobeofnopracticalconsequence.” 94AsWrightobserves:“Theoverwhelmingimpressionproducedbythereportwasoneofreassurance.Almostallhazard

scenarioswereconsidered‘remote,’‘mostunlikely,’or‘impossible.’” 95ShefurthernotesthatbecausethesoleexperimenttoassesstherisksofcloningviralDNAwasayearawayfromyieldingresults,suchconclusions“weresurprisinglyemphatic.” 96Moreover,it’sevidentthattheconsensuswasnotasbroadasthedocumentimpliedandthatseveralparticipantshadconcernsthatwereneveradequatelyaddressed.Instead,whenapprehensionswereexpressedaboutoneoranotherperceivedrisk,theywererebuffedbyassertionsthattheFalmouthconferencehaddeterminedsuchaproblemcouldnotoccur.Inthewordsofoneparticipant:“ThetroublewiththeAscotmeetingwasthatthemomentoneraisedascenario,onewouldbeshouteddownby[those]sayingthattheFalmouthmeetinghadsaidthatthecloneswerenotmobilizable,thattheywouldnevergetoutofE.coliK12...andcouldnotbecomeanepidemicstrain.” 97

IftheactualconferencereportfromFalmouthhadbeenavailable,itwouldhavebeenclearthattheparticipantshadnotreachedsuchconclusionsandthatthepossibilityofforeignDNAtransferringfromK-12torobustorganismshadnotbeenruledout–andwasalivelyconcerninthemindsofmany.Butthatreportremainedunpublishedforanotherfivemonths,andtheonlyseeminglyofficialaccountthenathandwastheoverlyassuring(andinsomewaysmisrepresentative)Gorbachletter.Thus,thosewhoopposedaprecautionaryapproachtogeneticengineeringprevailedovercolleagueswhoraisedlegitimatesafetyissuesbycitingtheauthorityofanillusoryscientificconsensusinordertoclaimthatthoseissueshadbeendefinitivelyresolved–apracticethatwouldbecomeroutineoversucceedingyears.

Inall,anyAscotparticipantcouldjustifiablyhavefeltmanipulated;andsomeclearlydid.Asoneremarked:“Itwasveryobviouslyapoliticalmeeting...Wewerebeingusedinthenameofbeingadisinterestedgroupofvirologistsbutitwasfairlyclearbytheendofthemeetingthat[theorganizers]wantedtogobackwitharesultthatcouldbeexploitedforderegulation.” 98

“Political”SciencePrevailsThelopsidedreportfromtheAscotmeetingcomplementedtheGorbachsummaryfromFalmouth,andtheircombinedeffectwassubstantial.NotonlydidproponentsofbiotechnologyproclaimthatemployingE.coliK-12inrecombinantresearchissafe,severalwentmuchfurther(ashadStanleyCohentheyearbefore)andclaimedtherewasnewevidencedemonstratingthatrDNAtechnologyasawholeposesnegligiblerisk.99Thismisleadingversionofthefactsquicklyspread.InMarch1978,afewmonthsaftertheAscotmeeting,itwasvigorouslyadvancedbymembersofboththeacademicandindustrialsectorsataconferenceco-sponsoredbytheWorldHealthOrganizationinMilan.100Thesamemonth,theSenateSubcommitteeonScienceandTechnologypreparedareportstatingthatrDNAresearchpresentednounusualrisks;101andthenextmonththeNIHDirectordeclaredthattheburdenofproofshouldshiftfromthetechnology’spromoterstothosewhowantedtoregulateit–ashiftthatdidoccur,alongwithrevisionandsubstantialweakeningofNIHguidelines.102Thistransferofburdenwashistoric,because,aswillbedescribedinthenextchapter,itwouldcarryovertoallsubsequentgovernmentpolicyongeneticallymodifiedorganisms(GMOs).

Further,theinfluenceoftheinflatedpronouncementsextendedwellbeyondAmerica.SusanWrightnotesthattheyimpactedregulatorysystemsinmanynationsbecause“[o]ncethediscourseof...‘negligiblehazard’becameestablishedintheUnitedStates,thepowerfulgeopoliticalpositionofthatcountryvirtuallyassuredthediffusionofthediscourseelsewhere.” 103

Andsowasbornmolecularpolitics,throughwhichovergeneralizationsandunsubstantiatedopinionshavebeenpassedoffassoundscientificconclusionsbasedonhardevidence.Becauseofthecredentialsofthosemakingtheassertions,neitherthemedianorthepopulacedoubtedtheexistenceorsolidityofthepurportedevidence;andevenindividualsasastuteasSenatorKennedywereledtobelieveinitdespitethefactitwasjustaschimericalastheexpertconsensusthatwasclaimedtobebaseduponit.Further,

duetotheboldnessandpersistencewithwhichtheseassertionswereadvanced,thebulkofthelifesciencecommunitycametoacceptthemaswell,includingmanybiologistswhoshouldhaverealizedhowexaggeratedtheywere.Sopowerfullydidthesefalseimpressionstakeholdthattheywereessentiallyimpervioustocontraryinput,nomatterhowwellfounded.EvenadebunkingbytheeminentjournalNaturehadlittleeffect.AlthoughitsreportontheMilanconferencestatedthat“thenewevidence...doesnotseemsubstantial”andthattheattendees“witnessedsomeunseemlyclutchingatstraws,”therewasnoretardationofthebiotechjuggernaut.104Thus,althoughtheFalmouthandAscotmeetingshadlittledatatogoonandonlyreachedaconsensusabouttheimprobabilityofE.coliK-12beingtransformedintoanepidemicpathogen,anillusionwasinculcatedwithinthemindsofnonscientistsandscientistsalikethatnewevidencehadbeenpresentedwhichuniformlyconvincedtheparticipantsthatrDNAtechnologyingeneralisessentiallysafe.

Moreover,whengenuineevidencewasgarnered(asincreasinglyoccurredaftertheAscotmeeting),itoftenclashedwiththestandardpromotionalclaims.AccordingtoSusanWright:“Inmanyrespects,thisnewevidenceposedmoreproblemsthanitresolved...[and]manyinthescientificcommunity...sawsomeoftheresultsassurprisingandthereforeasraisingnewquestionsabouthazards.” 105Yet,Congressandthepublichadvirtuallynoideathatsuchsurprisingevidencewasemerging,becausethemolecularbiologyestablishmentimpededcommunicationofthefacts.Timeaftertime,whenfacedwithresearchresultstheydidn’tlike,thebiotechproponentswouldroutinelyfailtoacknowledgethem–orelsesubstantiallymischaracterizethem.

AprimeexampleistheRowe-Martinexperiment,oneofthemostinfluentialeverconductedonbioengineering,whichwassupposedtoprovidedefinitiveanswerstopersistentquestionsaboutthesafetyofrDNAresearch.106SusanWrightreportsthatduring1975and1976,therewerestill“seriousdifferences”amongexpertsaboutwhethersomeaspectsoftheresearchmightbeunreasonablyrisky–andinsufficientevidencetoruleoutthepossibilitythataseriouslyharmfulorganismcouldinsomecircumstancesbecreated.107SherelatesthatsuchconcernssurfacedattheNIHRecombinantAdvisoryCommitteemeetingheldinDecember1975andthatbecausetherewasnoevidencedemonstratingthatgene-splicingwasthoroughlysafe,onemolecularbiologistproposedthata“dangerous”experimentshouldbeperformedthatwouldattempttomakeE.coliK-12hazardous.108Ifitfailedtodoso,itwouldstrengthenthecasethattheextensiverDNAresearchemployingthesebacteriaissafe.

Thecommitteelikedtheproposal,andoneofitsmembers,WallaceRowe,assumedresponsibilitytoimplementitinconjunctionwithMalcolmMartin,acolleagueattheNIHresearchlabhedirected.Aspartoftheirplanning,theyorganizedtheBethesdaconference,whichtheyco-chaired,tofurnishadviceonhowtheexperimentshouldbedesigned.

Astheprecedingexaminationoftheconferenceindicates,RoweandMartinintendedittodomorethanmerelyadvisethemontheirresearch,andtheyinitiatedbroaderdiscussionsthattheyhopedwouldconvincelegislatorsandthepublicthatgene-splicingissafe.Theyledthediscussionsabouttheirprospectiveresearchinthesamespirit,focusingonhowitcouldbestbefashionedtocalmpublicfears.Inthisvein,oneparticipantarguedtheyshoulddemonstratethatE.coli“can’tkillamouse”nomatterwhat’sdonetoit.Thisideawaswell-received,andsomeonesuggesteditcouldbeeffectedbysplicingDNAfromavirusthatcaninducecanceroustumorsinrodentsintoE.coliK-12andthenimplantingthealteredbacteriawithinmice.However,someofthescientistsprotestedthatsuchanexperimentwould,atbest,onlyrelatetomanipulationsofK-12andwouldhavelittlebearingonthesafetyofrDNAresearchingeneral.Further,theyemphasizedthatbecausetheK-12strainwassodebilitated,therewaslittlechanceitcoulddoanydamage.Theyarguedthattheexperimentwouldthereforebeofslightscientificvalue–andthattheresearchersshould“taketheopportunitytodoagoodexperiment”byemployinganorganismwithagreatercapacityforharm.109

However,RoweandMartin,alongwithmostofthosepresent,appeartohavebeenlessinterestedinsecuringtheexperiment’sscientificvaluethaninmaximizingitspoliticalclout.110Sothediscussionstayedfocusedonpublicrelations,exemplifiedbyascientistwhoadvocatedtheuseofE.coliK-12bynotingthatbecausetherewasscantchanceitcouldbemadeharmful,thestudywouldbea“‘slickNewYorkTimeskindofanexperiment’”thatwouldgainlotsofpositivepublicity.111Accordingly,themajorityeschewedthetypeofexperimentthatcouldhaverevealedembarrassingrisksinfavorofonethatwasalmostsuretobeimage-enhancing–optingforlessthanoptimalscientificworthinexchangefortheapparentcertaintyofasoothingoutcome.

Therefore,whenRoweandMartinadoptedthisPR-drivenapproach,they,alongwiththecommunityofpro-GEscientists,expectedtheirstudytoyieldfullyfavorableresults.Sowhenitconcluded,noonewassurprisedthatsuchresultswereclaimedforit.Andtheclaimswerebynomeansmodest.Ata1979pressconference,thetwoscientistsunequivocallydeclaredtheyhaddemonstratedthattherecombinantresearchtheyinvestigatedwas“perfectlysafe.” 112

However,whenoneprobesbeneaththeirrosyrepresentationsandexaminestheactualdata,it’sclearthattheterm“perfectlysafe”wasimperfectlyapplied.113TheinvestigationencompassedseveralaspectsoftheE.coli-basedresearchsystem,and(contrarytotheexpectationsoftheresearchers–andthegistoftheirpublicpronouncements)notallofthemwerefoundtobeproblem-free.Forinstance,cleavingtheDNAofthecancer-causingvirus(whichmustbedoneinordertoworkwithitsdiscretegenes)substantiallyincreaseditscapacitytoinducetumors.114Therewereothertroublingresultsaswell,andsomeeminentbiologistswarnedtheyshowedthatsplicingviralgenesintothebacteriacouldenablethevirustoexpanditsinfectiverange.115Butnoneoftheadversefindingswerementionedatthepressconferenceorintheotherreferencestotheresearchthatwereemployedforpromotionalpurposes.Accordingly,CongressandtheAmericanpeoplewereledtobelievethattheresultswhollysupportedreductionofregulation,remainingunawarethatsignificantproblemshadbeendiscovered–andthatseveralexpertsviewedthemassignalingtheneedforstrongersafeguards.

NorweretheyinformedthatRoweandMartinhadnotevenemployedthestrainofE.coliroutinelyusedinrDNAresearchbutastrainthathadbeenpurposelyrenderedmuchweaker,totheextentithadbecome(inthewordsofonebiologist)“severelydisabled.” 116Thisoccurredbecause,despiteE.coliK-12’sinfirmities,NIHguidelinesbarredthetransferoftumor-causinggenesintoitwithoutanexceptionfromtheDirector;andherefusedtograntone.Sotheresearchershadtousethemoreenfeebledstraininstead.Consequently,althoughtheexperiment’sproblematicfindingswereapplicabletothehardierstrainofE.coliactuallyusedinmostresearch,thefavorableresultswerenot;and,asSusanWrightpointsout,itwas“notjustifiable”totreatthemasiftheywere.117Butmostpeoplewereunawareofthisfact;andthebiotechproponentsfeltnoneedtoacknowledgeit,orberestrainedbyit.Norweretheypreparedtoacknowledge,ortoinformthepublic,thateveniftheRowe-MartinresultshadbeenfullyapplicabletothestrainofE.colithatresearchersactuallyused,andeveniftheyhadallbeenfullyfavorable,theywouldstillhavebeenirrelevanttogene-splicingwithotherorganisms,whichwastobecomeaprevalentpractice.118

Thus,thekeyexperimentdesignedtoreassurethepublicprimarilydidsobynotbeingfullypublicized;and,withitsdeficienciesundisclosed,thepromotersofbioengineeringwereabletomilkitforfarmorethanitsscientificworth.Besidesemployingittocalmqualmsandpreservethehands-offattitudeonCapitolHill,theyusedittosubstantiallyreduceNIHresearchrestrictionsandsignificantlyexpandgene-splicing’spermissiblerange.Intheprocess,justastheyhadportrayedthelimiteddiscussionsatFalmouthandAscotaspertainingtobioengineeringingeneral,theyfrequentlystretchedtherelevanceoftheRowe-Martinexperimentwellbeyondlegitimatebounds–notonlyaverringithaddemonstratedthesafetyofallformsofrecombinantresearch,butsometimesevenclaimingithaddoneso

forgeneticengineeringasawhole.Andthesefalseclaimscontinuedformorethanthreedecades.Oneofthemwaspresentonthewebsite

ofTheNationalInstituteofAllergyandInfectiousDiseasesuntilatleastNovember2010.ThatinstituteispartoftheNIH,andthuspartoftheUnitedStatesGovernment.Thefalsehoodappearedonthepagethatdescribedthecredentialsandaccomplishmentsofoneoftheinstitute’slong-servinglaboratorychiefs:Dr.MalcolmMartin.Thus,it’sreasonabletoassumenotonlythathewasfamiliarwiththecontentofthestatement,butthathewroteit.And,duetotheauthoritativecontext,anyonewhodidn’tknowthedetailsoftheexperimentthatheandWallaceRoweconductedwouldhavealsobeenledtoassumethatthestatementwasaccurate–astatementwhich,withoutatraceofqualification,declaredthattheexperiment“establishedthesafetyofrecombinantDNA.” 119

Onbalance,notonlyweretheclaimsthatabettedtherapid–andlargelyunregulated–advanceofthebioengineeringventureduringitsfirstsevenyearsmorepoliticalthanscientific,thescientistsmakingthemdisplayedtheparochialattitudeofatypicalspecialinterestgroupmorepredominantlythanthepublic-spiritednesstraditionallyassociatedwiththescientificendeavor.AsSusanWrightputsit:

[T]herefusalofthescientificestablishmentintheUnitedStatestocallforhardexperimentalevidence...andthealacritywithwhichbiomedicalresearchersingeneralralliedroundtopromotethepublicresultsofbrainstormingsessionsas‘newevidence’,bothsuggestthatthemostimmediateconcern...wasneitherpublicsafetynorscientificrigor.Infact,thehistoryofthecontroversyindicatessomethingentirelydifferent:theinsistenceofresearchscientiststhattheirfreedomofinvestigationtakeprecedenceoverthecompetingneedsofthepublic.120

Inthefollowingyears,asthemolecularbiologistsconsolidatedtheirpoliticalpower,theiragendawouldexpandandincreasinglyprevail;andtheneedsofthepublicwouldcontinuetobecompromised.

CHAPTERTWO

THEEXPANSIONOFTHEBIOTECHAGENDA

–AndtheIntensificationofthePoliticization

ANewPhase:ThePushforEnvironmentalReleaseDespitetheirsuccessinwhittlingdowntheregulatoryframework,thebiotechnicianseventuallygrewrestlesswithwhatremainedandsoughtaradicalchange.Thisoccurredbecausebiotechnologybroadened.

Duringtheearlyyearsofgeneticengineering,themainfocuswasonmedicalresearchandapplications,andthealteredentitiesweremicroorganismsthatcouldbefullyutilizedwithinlaboratorysettings.Accordingly,environmentalreleasewasviewednotasagoalbutanunwantedaccident.Therefore,solongasrDNAtechnologywaslimitedtothemedicalarena,thoughitspractitionerscouldresentsomeoftherestrictionstheyfaced,theyhadnocausetofightthebanonreleases;andthebioengineeringventurecouldco-existwithit.

Butthesituationdrasticallychangedastheenterpriseexpandedtoagriculture.Geneticallymodifiedorganisms(GMOs)designedtoserveasagriculturalcropsmustbegrowninopenfields,andmuchoftheresearchontheirefficacyhastobeperformedinoutsidesettingsaswell.Further,microorganismstailoredforagriculturalapplicationslikewisemustleavethelabs.Thus,inorderforthismajorphaseofbiotechnologytoadvance,theblanketbanonreleaseshadtobelifted.

Thestakesseemedhigh,becauseitappearedtomanywithinboththeprivateandpublicsectorsthatthegreatestbenefitsofgeneticengineeringwouldaccruefromapplyingittoagriculture.Thereweregrandexpectationsthatengineeredcropswouldboostyields,increasenutrientlevels,andreducedependenceonsyntheticfertilizersandpesticides.ButnoneofthehighhopescouldberealizedunlessGMOswereallowedtobedeployedbeyondlaboratorywalls.

However,liftingthebanwouldnotbeeasy,becauseforyearsithadbeenthekeyfactorincalmingpeoples’fears.Further,theclaimsabouttheinabilityofengineeredorganismstocausewidespreaddamagewererelatedtobiomedicallaboratoryresearch.Butnowtheissuewasnotwhetherlaboratorybacteriaenfeebledbydecadesofconfinementinartificialconditionscouldsurviveintheexternalenvironmentandcauseanepidemic,butwhethergeneticallyalteredplantsandmicrobesflourishinginfarmers’fieldscouldcauseecologicalharm.1Andtherewasnoevidencetoshowtheywouldnot.Attestingtotheuncertainty,thethenDeputyDirectorofBiotechnologyPermitsattheUSDAhasremarked:“Inthe1970s,wewerealltryingtokeepthegenieinthebottle.Theninthe1980s,therewasaswitchtowantingtoletthegenieout.Andeverybodywaswondering,‘Willitbeanevilgenie?’” 2

ExpandingtheArgumentsforSafetyTocountertherenewedanxietiesaboutbioengineering,molecularbiologistsinsistedthatGMOsdesignedforagriculturalapplicationsarejustassafeasbacteriathatcannotsurviveoutsidethelaboratory.Theyarguedthattherisksarenogreaterbecausegeneticengineering,likechroniclabconfinement,crimpsanorganism’scapacitytosurvivebeyonditsintendedlocation.

However,althoughthisclaimwaspresentedasscience-based,therewasnoevidencetosupportit;anditwasbackedbyasetofassumptionswhich,duetotheirproponents’lackoftrainingintherelevant

fieldsofbiology,clashedwithscientificknowledge.Butthisinfirmitywasnotexposedformanyyears(adevelopmentdescribedlaterinthischapter).Consequently,theclaimpassedasascientificfactforasubstantialspanoftime.

Moreover,evenwhensomebiotechadvocatesdidarguealongdifferentlines,theircontentionswerestillun-buttressedbyeitherevidenceorsoundlogic.Forinstance,in1978agroupofplantspecialistsmettodiscussthecontainmentconditionsthatwouldbeneededwhenorganismsthathadbeenengineeredforagriculturalpurposeswerefieldtested.Oneofthemainissuesinvolvedtheuseofmicrobesthatarenaturallypathogenictoplantsandplantpests.Althoughthescientistsdidnotattempttoestablishananalogybetweenthesealteredorganismsandcrippledlaboratorybacteria,theynonethelessanchoredtheirargumentinflimsythinking.Theyclaimedthatbecausethenaturalparentalformsofthesepathogenshadapparentlycausednoharminagriculture,thegene-splicedversionswouldnotcreateproblemseither–eventhoughthey’dbeenendowedwithtraitsthattheparentsdidnotpossess.3Whilethisconclusiondelightedthebiotechcommunity,severalexpertswereastonishedthatcredentialedscientistswouldsoreadilypresumepracticalequivalencebetweenthebioengineeredandnaturalversionsofvariousvirusesandbacteriaintheabsenceofsupportingevidence.TheformerdirectoroftheNationalBiologicalImpactAssessmentProgramsaidthathereactedwith“disbelief.” 4

TheImpactofIllusionDespitethedearthofdataandthemisgivingsofmanyexperts,theillusionthatallGMOs(evenrobustplantsandmicrobesdestinedforfarmers’fields)hadbeenscientificallydeterminedtobesafewassoartfullyinstilledthatitlargelytookhold;anditbecamebigcapitalonCapitolHill.MostlegislatorsnowbelievedtheyhadanevenstrongerbasisforrelaxingregulationofthebiotechnologyindustryandinsteadfocusingonhowtofosteritsgrowthandattainUSdominanceofthefield,therebyboostingthenation’seconomy.5

ThisdovetailedwiththeagendaoftheReaganadministration,whichcametopowerinJanuary1981.UnderPresidentReagan,thefederalexecutivebranchbecamecommittedtopromotingindustryandsubstantiallyfreeingitfromregulatoryrestrictions–andgrewinherentlyhostiletowardregulation.ThisattitudebecamemoreprevalentwithinCongressaswell,sincetheRepublicanshadwoncontroloftheSenateintheelectionthatbroughtReagantotheWhiteHouse,increasingthenumberoflegislatorswhowereideologicallyopposedtoregulationingeneral.6Accordingly,withinboththeexecutiveandlegislativebranches,attemptstoregulateGMOswereincreasinglyregardedasunnecessaryandunwelcome.

TheCampaigntoDeregulateBioengineeringCoincidingwiththeascendanceofananti-regulatoryagendawithingovernment,someprominentmolecularbiologistslaunchedaninitiativeinApril1981toremoveallmandatoryrestrictionsfromgeneticengineering.TwomembersoftheRecombinantDNAAdvisoryCommittee(RAC)fortheNationalInstitutesofHealthsubmittedaproposalcallingforthatagency’sguidelinestobetransformedintoacompletelyvoluntarycodeofconduct,whichwouldhavepermittedexperimentsthatwerepreviouslybanned,includingenvironmentalreleaseofGMOs,toproceedwithoutoversight.7OthermolecularbiologistspromptlysoundedthethemethatbecauseGMOsposednoextraordinaryrisks,theNIHrestrictionsimposedanunnecessaryburden.Ironically,severalscientistswhosupportedexcisionoftheguidelines’regulatorymusclehadsevenyearsearliersignedtheBergletter–andthusbeeninstrumentalinestablishingthoseguidelinesinthefirstplace.8EvenPaulBergcalledforrescindingthemandatoryrestrictionsthathadensuedfromtheBergletter.9

It’snoteworthythatwhentheysignedthatletterin1974,Bergandhiscolleagueshadadvocated

restrictionsonresearch“untilthepotentialhazardsof...recombinantDNAmoleculeshavebeenbetterevaluated...”Andtheyspecifiedthatanappropriatelevelofevaluationwouldatminimumentailthat“someresolutionoftheoutstandingquestionshasbeenachieved.” 10Accordingly,membersofthepublicwouldhavebeenjustifiedinassumingthattheirturnaboutin1981signaledthatextensiveriskassessmenthadbeenconducted–andjustifiablydismayedtolearnthattheonlyrisk-relatedresearchwasstilllimitedtooneenfeebledstrainofbacteriaunfittosurviveoutsidelaboratories,thatthisresearchwasnotentirelyconclusive(andraisedsomereasonabledoubts),andthatthislimiteddataservedasthesoleevidentiarybasisfortheclaimthatitwassafetoproceedwithunbridledresearchon,andreleaseof,GMOsingeneral.11

Yet,despitethesignificantuncertainties,thederegulationbandwagonsteadilygainedmembersandmomentum.However,manybiologistsrefusedtogetonboard.Moreover,theypointedoutthatseveralwhorodeithadfinancialtiestobiotechenterprises.OneofthemostglaringcasesofallegedconflictofinterestwasNobellaureateDavidBaltimore,whohadco-authoredtheproposaltoeliminatethemandatoryguidelines.12PhilRegalnotesthatinmanyinstances,thestakeswerehuge,andtheincentiveswentfarbeyondreceiptofconsultingfees:“Molecularbiologistshadbecomeentrepreneursandnotmerelyconsultantstoindustry.Manyhadbettheirpersonalfinancesaswellastheircareersonthefinancialsuccessofbiotech.”

LettingtheGenieLooseAsthepressurestoreducerestrictionsmounted,theRACsubstantiallyloosenedthem.Andevenbeforethecampaigntoeradicateallcontrolshadbegun,itremovedthemainprecautionarymeasure.Itliftedtheblanketbanonreleases.IttookthismomentousstepinJune1980byapprovingarequesttofieldtestatypeofbioengineeredcorn,despitethefactithadnotreceivedcompleteinformationabouthowthetransformationofthecornwouldbeachieved–orevenspecificinformationaboutwherethetestfieldwaslocated.13Norhadtherebeenathoroughdescriptionofhowthepollenwastobepreventedfromspreadingbeyondthatparticularfield.14

Asitturnedout,notonlywastheapprovaloftherequestpremature,sowastherequestitself.AsChapter4describes,ittookseveralmoreyearsbeforeanyGEplantscouldactuallybecreated,andevenlongerbeforecorncouldbetransformed.Thus,becausetheapplicants’aspirationsoutstrippedtheirtechnicalcapacities,theywereneverabletoimplementtheirplan.

Nonetheless,thisincidentrevealedthatalthoughtheRACwaswillingtoletthegenieloose,itwasunpreparedtodosowithreasonablecare–andwasinoveritshead.ThecommitteehadbeenprimarilyestablishedtodealwithcloselycontainedrDNAbiomedicalresearch,butnowitwasalsoresponsibleforpassingjudgmentonproposedreleasesofbioengineeredplants(andmicroorganismsinvolvedintheircultivation).AstheRACeventuallywentontoapproveadditionalreleases,therewasrenewedconcernwithinboththepublicandCongress,becauseitbecameobviousthatsuchreleasesshouldberegulatedbyanagencywithbroaderexpertise.

However,nootheragencyseemeduptothetaskeither.Accordingtothe1983reportofacongressionalsubcommittee,“...nosingleagencyorentity[possessed]boththeexpertiseandauthoritytoproperlyevaluatetheenvironmentalimplicationsofreleasesfromallsources.” 15Inparticular,thereportreferredtothecapacityoftheEnvironmentalProtectionAgency(EPA)as“unknown,”theexperienceoftheDepartmentofAgriculture(USDA)as“limited,”andtheexpertiseoftheRACas“inadequate.”ItalsonotedthattheUSDAdisplayed“adisinclinationtowardoversightinthisarea.” 16

Moreover,theUSDAwasnottheonlyfederalagencywithadisinclinationtoregulateGMOs.ConsistentwiththeReaganAdministration’spolicy,theFoodandDrugAdministration(FDA)andtheNationalScienceFoundationalsofavoredminimaloversight;andalthoughtheNIHwasprovidingsome

monitoring,itssentimentswereinharmonywiththoseoftheWhiteHouse,anditdidnotwanttoimplementarigorousreviewsystemeither.17

CounteringtheGenericSafetyArgumentswithSolidScienceBecausethegovernmentwasideologicallyinclinedtowardderegulation,andbecausethebiotechadvocatespressedtheircampaignforitsovigorously,theyachievedsteadyprogresstowardtheirgoal.Itwasin1983,whentheywereonthebrinkofsuccess,thatErnstMayrandPhilipRegalresolvedtopressbackwithgenuinescience.

Regalreports:“Overthenextseveralmonths,ItalkedwithasmanymolecularbiologistsandbiotechpromotersasIcouldsoI’dbeabletomakeasystematiclistoftheargumentsthatwerebeingusedtosupportderegulationanddealwiththempointbypoint.” 18Hereferstotheseargumentsas“generic”becausetheyextendedtovirtuallyallGMOs,basedonthesimplisticassumptionthatwhenitcametoassessingtheirsafety,theycouldbetreatedasauniformclass.19Hesoonrecognizedthatthevariousideasbeingexpoundedboileddowntoafewbasicargumentsthatwerenotonly“disturbinglysuperficial”butbasedonoutdatednotionsaboutbothecologyandbiologicaladaptation.

Accordingtooneofthesenotions,thebiosphereissotightlyintegrateditaffordsnonichesforGMOs.Regalsaysthisideastemsfromthebeliefthatevolutionhassofinelytunedthebiospherethatanyunnaturalalterationwilldropoffunlesssustainedbyhumanintercession–that“naturewillcleanseitselfofanythingartificial.” 20Thosewhoheldthisbeliefarguedthattheengineeredentitieswouldinevitablybesoimpairedbythemodificationstowhichthey’dbeensubjectedthattheycouldnotcompetewithotherorganismsoutsidecontrolledagriculturalsettings–andcouldthereforenotspreadthroughtheenvironmentandcausedamage.AnarticleinGeneticEngineeringNewsin1984expressedthisideabyassertingthateachspecieshasbecomeadaptedforaparticularecologicalnicheandthat“...anygeneticmodificationintroducedinthelaboratoryisinfinitelymorelikelytoimpairratherthantoimprovetheadaptation,unlesstheenvironmentisalsochanged.” 21

Regalstatesthatalthoughthebeliefthatspeciesareoptimallyadaptedhadseemedscientificinthe19thcenturyandthefirstdecadesofthe20th,researchbyecologistsandexpertsinbiologicaladaptationeventuallyrevealedittobeunsound.Ashenotes:“Thereisabundantevidencethatorganismsareonlyadequatelyadaptedforsurvivalandarenotoptimallyorperfectlyadapted.Carefulbiomechanicalanalysisandcomparativestudiesshowthatthereisusuallyroomforimprovement.” 22Heemphasizesthatgene-splicingwouldnotalwayscrippleanorganism’ssurvivalcapacity–andthatsomealterationsmightbestowacompetitiveedgethatwouldenableittoflourishinthewildandbecomeamajorpest.

Ofcourse,evenifthis“noavailableniche”argumenthadbeenscientificallysound,itstillwouldhavebeenpsychologicallyinconvenientbecauseitportrayedGMOsasunnatural–andunnaturallyimpaired.Incontrast,manybiotechproponentstookanapproachinwhichtheycoulddepictgene-splicingasessentiallynaturalinsteadofentirelyartificial.Nonetheless,thoughtheyallegedthetechnology’snaturalness,theystillmaintainedthatitwouldinevitablyreducethefitnessofitsprogeny.Theydidsothroughatwo-stepargument.Theyfirstassertedthatbioengineeringisakintotraditionalbreedingviasexualreproductionbecauseeachismerelyaprocessofcombininggenes.Theythenclaimedthatjustascreatingdomesticatedlinesofplantsandanimalsthroughthetraditionalprocessrendersthemunfittosurvivewithouthumansupport,producingorganismsthroughthemoremodernmodelikewisecurtailstheircapacitytocompeteinthewild.Theycouldthusdeclarethenaturalnessofgeneticengineeringwhileyetinsistingthatitscreationswouldnotbecomeenvironmentalpests.

However,thoughitmayhavesoundedscientifictomanyears,Regaldeemedthisargumenttobejustasflawedastheotherbecause,ashepointsout,rDNAtechnologycombinesgenesin“aradicallydifferentway”thandoestraditionalbreeding.Thisdifferenceisobviouswhenoneconsidersthefactsthat

thepromotionalargumentignored.Therearealternativeversionsofeverygene,whicharereferredtoasitsalleles.Eachgenehas

multiplealleles,andsomepossessmany.Differentallelesgiverisetodifferenttraits.Forinstance,thegenethatdeterminestheshapeofgardenpeashasoneallelethatmakesthemsmoothlyroundandanotheronethatinsteadgivesthemwrinkles.23

Intheprocessofdomestication(whichusuallyentailsmultiplecyclesofselectivebreeding),severalallelespossessedbytheformsofthespeciesthatexistinthewild(referredtoaswild-typealleles)aregraduallyreplacedbyotheralleles,givingrisetonewcharacteristics.Thus,it’saprocessoftrade-offs;and,asRegalexplains,thetrade-offsarenoteasytomanage.

Inpractice,thebreedercannotnormallyswapsingleallelesatonlyonesiteatatime,andthusflankingchunksofunwantedallelesmay‘hitch-hike’along,andtheallelesthatoriginallyoccupiedallofthosesitescangetlostintheprocess.Thus,intraditionalbreedingtherearetypicallytrade-offsthatsometimesrequirethebreedertoswapthegeneticfeaturesthatcontributetosurvivalinnatureforthosethatthebreederwantsforcommercialreasons.Consequently,manytraditionallybredorganismshavelostsomeoftheirnaturalcompetitivenessandarequiteunlikelytobecomeecologicalpestsundernormalcircumstances.Forexample,cornhasbeensohighlydomesticatedthatitcannotcompeteinnature.Theseedcoatshavebecomethin,whichmakesforeasyeating,butwhichprovideslittleprotection.Moreover,theseedsstayonthecob,aboonforharvestingbutahandicapinthewild,becauseacompetitiveplantshouldhaveseedsthatfalloffandscatter.

Inmarkedcontrast,biotechniciansspliceinnewgeneswhilemaintainingalltheothers,addingnewtraitswithoutsacrificinganytheorganismalreadypossesses.Regalemphasizesthatinthisnovelprocess,onedoesnothaveto“tradeaway”thenaturalvigorofanorganismandcantherebyincreasethecompetitivenessofanalreadycompetitivewild-typeorganism–something“nearlyimpossible”todowithtraditionalbreeding.24

Yet,despitetheirdissonancewithreality,thegenericsafetyargumentsusuallywentunchallenged;and,backedbytheprestigeandinfluenceoftheirproponents,theywereacceptedasauthoritativebythoseingovernmentandthemedia.Norhadthesearguments,ortheenvironmentalsafetyissueitself,beenseriouslyanalyzedbythescientificcommunity.ErnstMayrinformedRegalthatwithintheNationalAcademyofSciences(NAS),discussionshadbeenlimitedtotheescapeofdisabledlaboratorymicrobes–andthattheissueofwhetheritwasreasonabletopresumethatallotherGMOswouldbeequallyimpairedhadnotbeenproperlyaddressed.HeexplainedthatalthoughtheAcademyshouldhaveconductedsuchanexamination,theinternalpoliticshadpreventedit.Themolecularbiologistsweretoowarytheywouldlosecontroloftheissue.

So,asRegalbegantosystematicallyanalyzetheenvironmentalhazardsofengineeredorganisms,andtheargumentsofthosewhosoughttheirunregulatedrelease,hewasbreakingnewground.Mayrcollaborated,asdidPeterRaven,who,likeMayr,wasahighlyinfluentialbiologist,amemberoftheNationalAcademyofSciences,andanauthoritywhoseexpertiseextendedwellbeyondthelevelofmoleculesandcells.Hetoowastroubledbytherateatwhichbioengineeringwasbeingcommercializedinthefaceofongoingignoranceaboutrisks;andheagreedthatitwasimperativetoinitiategenuinedialoguewithinthebiosciencecommunity–especiallybecausethebiologistswhowerefamiliarwiththerecentadvancesinecologicalgeneticsandthestudyofadaptationhadnevermettoachieveageneralintegrationofallthisnewinformation,letalonetoexaminehowitappliedtothereleaseofGMOs.25

Accordingly,Mayr,Raven,andRegalbelieveditwasessentialtopresentthepreliminaryanalysisRegalhadpreparedtootherexpertsinthesefieldsfortheirassessment.Regalnotes:

Peter,Ernst,andIwerenotsurewhattheoutcomemightbe.Wouldtheseotherexpertsendorsemyanalysis,orwouldtheyfindholesinitthatnoneofthethreeofuscouldfind?Itrulyhopedthattheywouldfindholesinit,becauseifIwasright,theimplicationswereprofoundlydisturbing.Societywouldbemovingintotheeraofdeliberatereleaseswitheachprojectaveritablecrapshoot.Andintheworstcase,therewouldbearapidlygrowingnumberoffloatingcrapgames,withthestakesrisingovertimeastherDNAtechniquesbecameeachyearmorepowerful.

Besidesinvolvingtheleadersinecologyandrelatedfields,itwasnecessarytoconfrontleadingmolecularbiologistswiththecurrentstateoftheevidence–andtomakesuretheyunderstooditsimplications.SoMayrandRavenencouragedRegaltoorganizeaworkshopatwhichsuchinteractionscouldbefacilitated.

Asthefirststep,heflewtoWashington,D.C.toexplorefundingpossibilities.Healsowantedtogetfirst-handknowledgeofhowwellthegovernmentwasdealingwiththevariousissuessurroundingGMOs.AshevisiteddivisionandprogramdirectorsattheNationalScienceFoundation,andkeyindividualsinotheragencies,thedisclosureshereceivedwereeye-opening–andoftenprefacedwithwordshewastohearrepeatedlyasheinterfacedwithgovernmentofficials:“Ifyouquoteme,I’lldenyit,butitisimportantforyoutoknowthat...”Manyweredeeplyconcernedandweregladhewasgettinginvolvedandwillingto“stickhisneckout.”Theyexpressedhopethathe’dbebetterattacklingthetoughissuesthantheWashingtoninsiders,who,duetothepoliticalclimateinthecapital,wereafraidtosticktheirownnecksout.

TheseofficialsexplainedthatitwasdifficultforthemtotakeappropriateactionsbecauseeminentmolecularbiologistsandleadersfromthebiotechindustryhadcapturedtheearoftheReaganAdministrationandconvinceditthatbiotechnologywascrucialforrevivingtheeconomyandshouldthereforebegivenspecialtreatment.AsRegalrelates:“IwasinformedthattheAdministrationhadtakenthepositionthatmostofthenation’seconomicproblemscouldbesolvedbyontheonehandreducinggovernmentregulationsoncredit,trade,andenvironmentalpollution,andontheother,promotingacolossalshifttohigh-techindustry.Further,becauseithadproveddifficultforUScorporationstomaintainamonopolyoverthecomputerindustry,theAdministrationwasdeterminedthatthenationwouldpreserveitssupremacyinbiotechnology.26Soithadchargedfederalofficialstofostertherapiddevelopmentofbiotech–and(accordingtothosewithwhomIspoke)itwasgivingthemolecularbiologistsvirtuallyanythingtheywanted.”

NotonlyweretheprogramdirectorsattheNSFunderpressuretopromotebiotech,Regallearnedtheywere“insomethingofapanic”becausetheReaganAdministrationwasabouttocutnearlyallfundingforanybiologicalresearchthatwasnotdirectlycontributingtothenationaleffortinbiotechnology.Thus,outofninety-threeresearchproposalsinecologysuggestedbytheNSFstaff,theonlythreeregardedfavorablybytheAdministrationinvolvedthestudyofbacteriathatinhabithotsprings,becausebesidestheirpotentialtoyieldimportantthermalstableenzymes,theymightfacilitatethedevelopmentofengineeredmicroorganismsthatcouldbeincubatedathighertemperaturesandthusproducechemicalsatfasterrates.Regalreportsthatthedirectorswere“bitterlylamenting”thisabandonmentofbasicscience.

Insuchaclimate,Regal’srequestscouldnotbefulfilled.AlthoughseveralNSFofficialswishedtoassist,theyacknowledgeditwouldbetoopoliticallyriskyforthemtofundaworkshopthatwouldraisesafetyissuesregardingGMOs.AndtheyexplainedthatthedifficultywascompoundedbythefacttheReaganAdministrationwasnotevenwillingtotalkwithecologists,letalonefundaforumthatwouldparadetheirconcerns.Itsmembersheldthemisconceptionthencommonamongpoliticiansthattheterm“ecologist”wassynonymouswith“environmentalist,”andtheybelievedthatindividualstowhomthelabelappliedweremerelyadvocatesofasetofvaluesandpoliciesthatwereinimicaltoeconomic

development.Theywereunawarethat,unlikeenvironmentalism,ecologyisnotasetofpolicypreferencesbutanestablishedsciencethatinvestigatesthecomplexinteractionsbetweengroupsoforganismsandbetweenorganismsandtheirnon-livingenvironment.Nordidtheyrealizethatecologistsvaryintheirpoliticalleaningsandvaluesystems–andthatsomestronglydisagreewithmanyenvironmentalistsonparticularpolicyissues.

Tomakemattersworse,manymolecularbiologistslikewiseconfusedecologywithenvironmentalism;andeventhosewhorecognizedthatit’sabranchofbiologyandnotmerelyapolicyagendastillvieweditwithdisdain.Becausethemajorityofthemhadbeentrainedinphysicsorchemistry,theyhadalimitedunderstandingofwhattraditionalbiologyentailsandtendedtoregarditsmainactivityasthemerecollectionandcategorizationofthevariouslifeforms–whichledseveralofthemostinfluentialtodismissitas“stampcollecting.” 27Thesescientistsbelievedthatthetraditionalbiologistswerenotstudyinglifeinawaythatrevealsitsbasiclaws;andtheywereconvincedthatonlytheyhadthecorrectapproach.AsRegalexplains:“Intheirminds,thetrulylegitimatewaytostudythelivingworldisfromthemoleculesup.Becausetheyweretheexpertsonmolecules,andbecausemoleculesarethebasicbuildingblocksoflife,theybelievedtheywereinprimepositiontodeducehoweverythingupthechainofcomplexityshouldbehave–farbetterpositionedthaneventheorganismalbiologists,ecologists,andotherscientistswhostudiedhigherlevelsofcomplexitydirectly.Sotheysawlittlevalueincommunicatingwiththesescientistsandwerepredisposedtorejectwhateverinputtheymightofferthatcounteredtheirownassumptions.Thus,thosewiththeworm’seyeviewscornedtheperspectiveofthosewiththebird’seyeview.”

Havingcomeuplongoninsideinformationbutshortonfunding,RegalhadtoreturntoWashingtonforanothertryatsecuringtheresourcesthatwouldenabletheoverduedialoguebetweenecologistsandmolecularbiologiststocommence.OneofthemaindestinationswasthestatelybuildingthathousestheNationalAcademyofSciences,wherehehopedtoconvinceadministratorsoftheNationalResearchCouncil(NRC),thearmoftheNASthatconductsstudiesandissuesreports,tosponsortheworkshopheenvisioned.Buthequicklylearnedthathishopesweremisplaced.

WhilemeetingwithagroupofNRCsenioradministrativestaff,hewasinformedthatthe“powerplayers”intheAcademyfearedthatanyecologicalanalysisofGMOsthatwasnottightlymanagedcouldgiveammunitiontothosewhoopposedthem.Further,itsoonbecameobviousthatNASpolicywascolorednotonlybyfearofecologicalanalysisbutbydisrespectforecologists.Herelates:“IwastoldthatthemostinfluentialfactionsintheAcademy(thedefacto‘bosses’ofthepeoplewithwhomIwasspeaking)definedtruescienceasbasedsquarelyonphysicsandchemistry–andinsistedthatonlysuchsciencecouldbesufficientlypredictive.TheythereforewereaversetoallowingecologistsanyroleinevaluatingGMOs.”

Struckbytheincongruitybetweentheinternalworkingsofthenation’spremierscientificinstitutionanditsaugustpublicimage(whichitcultivatesby,amongotherthings,describingitsheadquartersas“aTempleofScience”),Regalcalledtheadministrators’attentiontothedangersofallowingnationalpolicytobedictatedbytheproponentsofonenarrowviewpointaboutsciencethatwasrejectedbynumerousscientistsandcouldnotjustlyclaimsuperiorityoveralternative,andbroader,perspectives.28AlthoughtheyagreeditwouldbevaluabletobroadentheoutlookofthoseatthehelmoftheNAS/NRC,andtogetthemtofosteraseriousdialoguebetweenmolecularbiologistsandecologists(andother“traditional”biologists),theysaidsuchdevelopmentswerehighlyunlikelyintheforeseeablefuture.

Regalnotesthatashewasdeparting,oneoftheadministratorssaid,“Letmeshowyousomethingbeforeyouleave.”HethenledhimoutsidetoasereneelmandhollygroveinwhichstoodagrandmemorialtooneoftheAcademy’sgreatestmembers.Regalreports:

ImarveledatamagnificentbronzestatueofAlbertEinstein,sprawledoutlikeafascinatedchild,

withtheuniverseasthefloorofhisplaypen.“Look,”myhostsaid,pointingtoaninscriptionaroundthebaseofthesculptureconveyingEinstein’sadmonitiontothoseengagedinthescientificendeavor:Therighttosearchfortruthimpliesalsoaduty;onemustnotconcealanypartofwhatonehasrecognizedtobetrue.AfterI’dreadit,helookedmeintheeyeandsmiledknowinglyuntilhewassurethathe’dgottenmethinkingdeeplyaboutitspotentmessage.29

WitharesolvethatwouldhaveearnedEinstein’sapplause,Regalpersistedinhisefforttogettheevidencefromecologyintothebiotecharena,andhefinallyobtainedfundingfromtheonefederalagencywhichatthattimerecognizedboththeneedtocarefullyregulatethereleaseofGMOsandthevalueofecologicalscience:theEPA.

NotonlydidtheEPAagreetofundtheworkshop,itdesiredtobeactivelyinvolvedintheplanning;andanEPAscientist(JackFowle)becameRegal’sco-organizer.MayrandRavenwerealsoactiveintheplanning;andRegalspentextensivetimeonthephonewitheach,discussingwhoshouldbeinvitedandwhatshouldbeincludedintheworkshop’sagenda.

Anotherimportantconsiderationwaswhattheworkshop’scharacterwouldbe.Increasinglyawareofhowpoliticalpreferencesandpressureshadbeendegradingthediscourseofscientistsinregardtogeneticengineering,Regalattemptedtomitigatesuchinfluences.“Iwantedallthescientiststospeakfrankly,asscientists,aboutasubjectchargedwithenormouspoliticalsensitivity,”hesays.“Iinsistedthatalltheparticipantsfromgovernmentandindustryshouldbescientists,eveniftheyhadgoneintoadministrationaftergettingtheirPhDs.Imadeitclearthatthiswastobeascientificdiscussion–notapolicydiscussion.Andtominimizethetemptationforgrandstanding,Ididnotinvitethepress.”Thisdecisionwaspromptednotonlybyhisawarenessthatmediapresencewouldinduceexcessfromsomeattendees,butthatitwouldhaveanopposite,inhibitingeffectongovernmentscientists,severalofwhomhadexpressedfearthatthey’dlosetheirjobsiftheircandidcommentswerepublished.Thus,incontrasttotheorganizersoftheBethesda,Falmouth,andAscotmeetings,whoexcludedthemediasothatpolicy-drivenpresumptionscouldbepassedoffasscientificconclusions,Regalexcludedthemtopreservethescientificintegrityoftheproceedings.

AlthoughtheEPAwaspleasedwithhowplanswereprogressing,theNASwasnot.Fromthestandpointofitsleadership,theprospectofaworkshopontheenvironmentalrisksofGMOsthatwasledbyecologists–andatwhichtheywouldhaveequalrepresentationwiththemolecularbiologistsandampleopportunitytocritiquetheirideas–wasworrisome.Soitattemptedtointervene.Regalreports:“WhenwordspreadthatIwasgoingtogetEPAfundingfortheworkshop,theNAStriedtotakeitover.IgotacallfromJackFowleinformingmethattheNAShadcontactedtheEPAandofferedtoconducttheirownstudyoftherisksifEPAwoulddropitsplans.ButastheNASenvisionedit,onlyoneecologistwouldbeallowedtoparticipate:me.FowleaskedifIfoundtheideaappealing.ItwassucharidiculouslytransparentattempttokeepmolecularbiologistsintightcontroloftheissuethatIlaughedoutloud.FowletoldmethatthefolksatEPAdidnotliketheideaeitherandhadassumedIwouldrejectit.”

InAugust1984,theworkshopfinallygotdowntowork–attheBanburyCenteroftherenownedColdSpringHarborLaboratoriesinNewYorkState.RegalexplainsthattheEPAselectedthissitebecausethelaboratorieswerethendirectedbyJamesWatson,oneofthemostinfluentialandoutspokenproponentsofgeneticengineering.Theagencywantedtoliterallybringtheissueofenvironmentalriskhometohim,notonlysohe’dbefacedwiththelatestevidencefromecology,buttofindoutifhecoulddiscernanyflawsinRegal’sanalysis.AnaddedbenefitofholdingtheeventtherewasthatBarbaraMcClintocklivedatthefacilityandcouldparticipate.LikeWatson,shewasagiantofgeneticsandhadwonaNobelPrizeforagroundbreakingdiscovery;butunlikehim,shehadbroaderknowledgeoftheorganismiclevelofbiology.

Notonlywastheworkshoparevelationforallwhoattended,thesurprisesitdeliveredwereunsettlingtobothsides.TheecologistsandotherorganismicbiologistsquicklyconcurredwithRegal’s

analysisoftheflawsinthegenericsafetyarguments–andaffirmedthattheassumptionsonwhichtheyrestedwereoutdated.Moreover,Regalreportstheywere“shocked”tolearnthatsomanyinfluentialscientistshadbeenclaimingthatallGMOswouldbesafeonthebasisofnotionsthattheyregardedas“scientificnonsense.”“Theywerefurthershocked,”hesays,“atsomeoftheprojectsthatpeoplefromgovernmentandindustrytoldusweregoingon.Theyhadnoinklingthatsuchpatentlyhazardousorganismswereevenbeingdeveloped,letaloneslatedfornear-termrelease.”

Inturn,themolecularbiologistswere“shockedandincredulousthattheirsafetyargumentsweresocompletelydisreputableintheeyesofthosewhoheldexpertiseinsuchmatters.”However,theirdiscomfortwasmitigatedbythefactthatalthoughtheecologistsrejectedtheargumentsthatallGMOswouldbeharmless,theybelievedthatmostwouldnotcauseproblems.AsRegalrelates:“AlltheecologistsagreedthatthegreatmajorityofevenecologicallycompetentGMOswouldnotbethreatstotheenvironment.However,weconcludedthatasmallfractioncouldwellcausevastandirreversibleproblems.Wemadeitcleartothemolecularbiologistsandgovernmentscientiststhatalthoughtheprobabilityofproducingharmwaslow,inthesmallfractionofreleasesthatdidbecomeharmfulthedamagecouldbeenormous.Thisshouldhaveconvincedthemthatit’snecessarytocarefullyevaluateeachGMO–andfoolishtopresumethatsuchprecautioncanbedispensedwith.”

Theecologistswenttosomelengthstoexplainwhytheassumptionsthatunderlaythegenericsafetyargumentswereflawed;andatonepoint,BarbaraMcClintockenteredthediscussionandavidlyassistedinmakingthecase.Regalremarks:“Manyofthenon-ecologistsreceivedyetanothershockasoneoftheiconsofmoderngeneticsdismissedassimple-mindedandmisleadingtheviewsofbiologicaladaptationthattheyhaduntilthenassumedwerescientificallysolidandevenself-evident.”

Tothedismayofmanymolecularbiologists,thesubjectionoftheirpresumptionstoopen,science-basedcritiquewouldnotceasewiththecloseoftheBanburyconferencebutwouldrecurninemonthslateronanevenlargerscale–ataconferenceinspiredbyBanburythatwasnotonlybigger,butopentothemedia.Further,thisconference(whichconvenedinPhiladelphiainJune1985)hadmuchbroaderbackingthantheBanburymeetingandwassponsoredbytheAmericanSocietyforMicrobiologyalongwithsixteenscientificgroupsandgovernmentagencies.

Yet,despitethebroadsponsorship,therewasconsiderablediscord.Regal,whowasinvitedtodelivertheopeningaddress,recounts:“Overall,themeetingwasfarfromcongenial,andmanymolecularbiologistswereutterlyfuriousthatecologistshadbeeninvitedtocommenton‘their’science.”Theirangerwasintensifiedbecause,withthesciencepresscoveringthemeeting,thesecommentsmightgainwidepublicity.Theyworriedthatsuchanunbridleddiscussionofriskswouldnotonlystokepublicfears,butsourinvestorsandpolicy-makers.

Further,sominimallyhadtherevelationsatBanburypenetratedthemolecularbiologycommunitythatmanyofitsmemberswhocametoPhiladelphiawerecompletelyunawareofwhathadhappenedthere.Consequently,Regal’spresentationwastheirfirstexposuretosomesoberingscientificrealities.Init,hedescribedtheadvancesthathadoccurredinthestudyofecologyandecologicalgeneticsintheprecedingdecadesandhowtheyinvalidatedtheargumentsthatallGMOswouldbesafe.Overthecourseofthemeeting,theotherecologistsmorefullyexplainedtheevidence–andhowitexposedtheflawsinthegenericsafetyarguments.Regalsays,“Theydidasplendidjobofdemonstratingthattheirconcernswerebasedonsystematicscienceandnot,assomecriticswereaccusing,onanemotionalobjectiontoprogress.”

Theimpactwassubstantial,and,asthesciencepressreported,theneteffectoftheconferencewastoclearlydemonstratetheneedforinputfromecologistsinsettingbiotechguidelinesandinriskassessmentsofGMOs.Thistranslatedintochangesingovernmentalpolicy.RegalwasinformedbyWashingtoninsidersthatduetotheinfluenceoftheBanburyandPhiladelphiameetings,planstoderegulatebiotechwerereevaluated,scheduledcutsinfundingforbasicresearchinecologywere

canceled,andtheEPAbegantomoreactivelyseekadvicefromecologistsregardingGMOs.

SomeIll-ConceivedProjectsCollidewithRealityTherecognitionofriskscamenonetoosoon.Regalsaysit’sestimatedthatatthetimeofthePhiladelphiaconference,hundredsofthenovelmicrobesbeingcultivatedinvariouslaboratorieswereonthefasttrackforrelease.Andseveralposedrisksthatwerebothobviousandominous.

Creatingnewformsofmicrobiallifedesignedtothriveoutsideoflaboratoryconditionsisariskyendeavorbecausetheintentthatthemicrobeswillbehaveinaparticularmannerdoesnotresidewithinthemicrobesbutonlyinthemindsofthepeoplewhocreatethem;andthosemindscannotfullyfathomwhatthemicrobeswillultimatelydo.Regalsaysthatalthoughit’sfairlystraightforwardtocreateanewtypeofbacteriathroughgene-splicing,adequatelypredictinghowitwillbehaveinnatureisalmostimpossible.Scienceknowstoolittleaboutwhichspecieswillbeinteractingwiththenewbacterialetalonewhatthedynamicswillbe.

Thus,evenifthegeneinsertedintoanewbacterialstraincodesforatraitthat’spresumedtobeharmless,there’sstillalotofuncertainty;andifitinsteadcodesforatraitknowntobeharmful,thesituationisespeciallyrisky.Nonetheless,suchhigh-riskprojectswereunderway.

Oneofthemorealarmingwasspawnedbyabiotechcorporationinsearchofanewwaytodestroygardenpests.Pursuanttothisgoal,itstechnicianscreatedanovelstrainofbacteriaintowhichthey’dsplicedthegenethatrendersaparticulartoadstooltoxic.Thehopewasthatwhenspreadinthegarden,thepoison-packedbacteriawoulderadicatesnailsandotherpests,makinggardenownershappyandthecorporationwealthy.Butamidallthecalculationsofthestepsofthebioengineering,thecoststheywouldincur,andtheprofitsthatcouldaccrue,scantattentionhadbeengiventotheissueofhowthebacteriamightaffectthemyriadotherspeciesthatinhabitgardens–andthepetsandchildrenthatplayinthem.Therehadonlybeensomepoorlydesignedstudiesonpotentialimpactsonhoneybeesandearthworms.Norhadtherebeenanalysisofwhetherthebacteriacouldmigratebeyondthegardens–andwhatwouldhappeniftheydid.AsRegalremarks,“Itwassimplyassumedthatthebacteriawouldkillonlythepestswhilecooperativelystayingput.”

Fortunately,duetothegrowingrealizationofrisks,thisprojectandseveralequallyill-conceivedotherswerecurtailed.Yet,industryshortsightednesswasfarfromcured.Misbegottenprojectscontinuedtoarise,eventhoughmanyentailedrisksthatwerenotonlymajor,butmanifest.Forinstance,onebiotechcorporationdevelopedfood-yieldingplantsendowedwiththevenom-producinggenesfromscorpions.Theaimwastomakethecropsinvulnerabletopredators,sinceanyhaplessinsectthatbitintothemwouldatoncesufferthesameresultashavingbeenstungbyascorpion.However,inengineeringtheseplantsthatcouldineffectbiteback,theinventorshadbeensurprisinglynaïve.Aswithsomanyotherbiotechnicians,theyoperatedundertheassumptionthattheyweredealingwithabiologicallysimplesituationandthatnounexpectedriskswouldbegeneratedbytheircross-speciesmanipulation.

Aftertheirvenomousplantswereflourishingingreenhouses,theexecutiveswantedtoconductfieldtrialsonfarms.Luckily,theydecideditwouldbeprudenttofirstgetafullerassessmentoftherisks;andtheycalledinRegaltoperformareview.Asheconversedwiththestaffscientists,itwasapparentthatupuntilthentheirconcernshadbeenlimitedtothepotentialtoxiceffectsonthehumansandothermammalsthatwouldeatthealteredorganisms.Consequently,theywereunpreparedformanyofthequestionsheposed.

Hadtheystudiedtheeffectsofthetoxinonbeesthatwouldgatherpollenandnectarfromtheplants?No,theyhadn’t–butperhapssomeoneelsewoulddealwiththatdowntheline.Whataboutstudiestodeterminewhetherbeneficialinsectsorbirdsthatordinarilyfeedontheplantwouldbepoisoned–orwhetherthosethatfeedontheplant’spredatorswouldbeharmedbyconsumingcarcasseslacedwithscorpiontoxin?Theyhadn’tdoneanyofthosestudieseither.Astheyexplained,

theirjobhadbeentobuildanewfoodcropthatwouldfendoffpests;andtheirfocushadcenteredonhowtheplant’sknownpests,andmammalianconsumers,wouldbeaffected.Whataboutassessmentsofeffectsonthesoilanditsindwellingmicroorganisms?Couldwide-scalecultivationofplantswhoserootscontinuallyexudedthispotenttoxin,andwhosedecayingstalksandleaveswereladenwithit,causelong-termdisruptionstotheecologyofthesurroundingsoil?Thatwasanotheronetheyhadn’tconsidered.Whatabouttheplants’potentialforpollinatingweedyrelativeswiththescorpiongeneandintensifyingtheiradverseaffects?Blankstaresallaround.

TheirgreatestembarrassmentcamewhenRegalpointedoutapotentialthreattohumanhealththeyhadoverlooked.Previously,theyfeltconfidenttherewouldbenorisktohumanconsumersbecausethevenomsoftheparticularspeciesofscorpionsfromwhichtheyhadtakenthegeneswereconsiderednon-toxictomammals.However,theirconfidencewasshakenwhenRegalexplainedthattoxicityisquitedistinctfromallergenicity,andthatasubstancecouldbenon-toxicyethighlyallergenic.Heinformedthemthatmanypeopleareseverelyallergictoinsectvenomsandthatthousandseitherdieorarebadlysickenedeachyearfromadversereactionswhenstungbybeesandspiders.Whatwouldbetheimplications,heasked,ofputtingthesefoodsontosupermarketshelves?Additionally,howmightpeopleinvolvedintheproductionandprocessingofthecropsbeaffected?Wouldthedustfromthecropscauseproblemsforfarmworkersandgrainhandlers?Howmightitimpacttheairaroundfarmingcommunities?Thescientistswerevisiblystunnedthattheyhadtakentheprojectsofarwithoutconsideringtheseissues–andduetothedoseofrealityRegalinjected,itdidnotadvancefarther.

Yet,evenasbioengineersdevelopedbetterunderstandingoftherisks,theywereloathtodiscussthemopenly.AsRegalnotes:“Theindustry’sdebtshadincreasedenormously,andthepressurestorushon,showprofits,andpayoffinvestorsremainedintense.Therewerefearsthatanyforthright,properlyscientificdiscussionofriskswoulddiscourageinvestors,entaillegalvulnerabilities,andcalldowngovernmentregulationwithrealteethinit.”

Throughthepracticeofmolecularpolitics,suchteethneverformed–although,aswillbeseen,thepublicwasledtobelievethatastrongsetofthemwasinplace.

PoliticsContinuetoPreemptScienceTheairingofscientificknowledgeatthePhiladelphiaconferencemadeitdifficulttoovertlyderegulategeneticengineering;andtheReaganAdministrationfeltobligedtorespondtolingeringpublicconcerns.30However,itsaimwastomanipulatepublicperceptionsratherthanimplementnewsafeguards,therebyplacatingdemandsforgreaterenvironmentalandconsumerprotectionwithoutimpedingitsagendatospurthegrowthoftheUSbiotechnologyindustry.

Toprovidetheindustryanopenroad,theReaganteamdeterminedthereshouldbenonewlawsonbiotechnology,andithadsufficientcloutonCapitolHilltoblockanynewlegislation.Additionally,becausethefederaladministrativeagenciescouldyethaveissuedsomenewregulationsspecificallytailoredtoGMOsundertheexistentlaws,theWhiteHouseorderedthemtostaywithintheregulationsthenonthebooksandtorefrainfrommakingnewones.31

Moreover,itrevisedlinesofauthorityinordertorestricttheroleoftheEPA.ThisseemednecessarybecausethatagencywantedtosuperviseGMOsandwasarguingthatbecausetheycontainednewchemicalsubstances,itcouldregulatethemundertheToxicSubstancesControlAct,whichempoweredittorequiretestingofindustrialchemicalsthatmayposeanenvironmentalorhuman-healthhazard.32ThisambitiousattitudeperturbedthoseattheWhiteHouse.Sotothefullestextentpossible,theyvestedresponsibilityfortheenvironmentalsafetyofGMOs,notwiththeagencypossessingthebroadestlevelofenvironmentalexpertise,butwiththeUSDA,becauseofitsfriendlierattitudetowardbiotechnologyandreluctancetosubjectittoregulation.33

However,theEPAcouldnotbetotallystrippedofauthorityoverGMOs,sinceithadthestatutorilygrantedpowertoregulatepesticidesandwasthereforeentitledtooverseeorganismsthatexpresspesticidalproteins.Nonetheless,throughappointmentsandothermeans,theWhiteHouse(underReaganandthenGeorgeH.W.Bush)wasincreasinglysuccessfulatbringingtheagency’soutlookmoreintolinewithitsown.

Toformalizeitspromotionalpolicy,theReaganAdministrationwantedapublicationthatwoulddemarcatethepartitionofauthorityitfavored,setprinciplestoguidethevariousagencies,andconvincethepublicthatscience-basedoversightwasbeingprovided.TheresultwastheCoordinatedFrameworkforRegulationofBiotechnology,signedbythepresidentJune18,1986.

AchieffeaturewastheincorporationofaWhiteHousedirective“toregulatetheproduct,nottheprocess.”Inthisapproach,GEorganismsweretobedealtwithbasedontheirspecificcharacteristicsratherthantheirmethodofproduction–preventingthemfrombeingsubjectedtospecialrequirementsmerelybecausethey’dbeengeneratedthroughrDNAtechnology.

However,applyingthisprinciplepresentedadditionalissues,becauseit’shardtodeterminewhatalltheeffectsofaGMO’sspecificcharacteristicswillbewithoutconductingtests.Sothecrucialquestionwashowmuchtestingwouldbeconsiderednecessary.InlinewiththeWhiteHouseaimtokeepregulationminimal,theUSDAadoptedakeypresumption:theproductsofbioengineeringweretoberegardedasenvironmentallysafeunlessprovenotherwise.34Eventually,theEPAalsoadoptedthispresumption;andtheFDAthenextendedittofoodsafety(aswillbediscussedinChapter5).Inconsequence,thekindsoftestsneededtodetectpotentialdangerswerenotrequiredandinsteadlefttothemanufacturers’discretion–effectivelyforeclosingmeaningfulregulation.AsPhilRegalnotes,“Notwithstandingthelitanyaboutregulatingtheproductandnottheprocess,themainthrustofthepolicywastoavoidexaminationoftheproduct.”

Thus,thenotionthatit’sscientificallyjustifiedtoregardGMOsingeneralassafe,initiallypromulgatedonthebasisofthealleged“newevidence”presentedattheBethesda,Falmouth,andAscotconferences,wasinstitutedasafoundationalprincipleofUSregulatorypolicy;andtheshiftinburdenofproofthattheNIHimplementedin1978inthewakeofthoseconferencesbecamestandardthroughouttheregulatoryagencies.Thisoccurreddespitetherealitythatthe“newevidence”wasessentiallyasetofconjectures;thatthelimiteddataonwhichtheconjectureswerebased,aswellasthelogictheyemployed,werelargelyirrelevanttogeneticallyengineeredplantsandanimals(oreventomicroorganismsdesignedtosurviveoutsidethelaboratory);andthattheevidencethatwasavailabledidnotsupportageneralpresumptionofsafety–andinsteadindicatedthereweregoodreasonstoexercisecaution.

AlthoughtheWhiteHousepresentedthisoutcomeasscience-driven,it’sclearthatthedominantforceswerepolitical.AsMaryEllenJones’extensivestudyledhertoconcludeinadoctoraldissertationinScienceandTechnologyStudiesatVirginiaPolytechnicInstitute:“...theU.S.CoordinatedFrameworkforBiotechnologyRegulationisbasedprincipallyinpoliticalcriteria,notsolidlybasedinscienceasitsproponentsclaimed.” 35Sosalientwastheroleofpoliticsthatshetitledherdissertation“PoliticallyCorrectedScience.”However,realitynotwithstanding,theimpressionthattheFrameworkwasscience-basedlargelytookhold;and,ashadtheRACGuidelinesadecadeearlier,itsubstantiallycalmedthepublic.36

TheNASAddsItsAssurancesYet,theFrameworkcouldnotentirelyclosethecontroversy,andseveralscientistsandpublicinterestgroupscriticizeditforfailingtoprovideadequatesafety.AstheneedtofieldtestmoreGMOsincreased,andconcernsagainbegantomount,theNationalAcademyofSciencesendeavoredtofurnishgreaterassurancebyproducingashortpositionpaper,whichitissuedinAugust1987.Whilethepapermentioned

somepointsraisedbytheecologistsatBanburyandPhiladelphia,itsmainthrustwastodownplayproblems.Itassertedthereareno“uniquehazards”associatedwithGMOsandthattherisksofreleasingthemintotheenvironmentarethesameasinthecaseofunalteredorganisms.37Itfurtherstatedthatmanyoftheprospectiveprojects“areeithervirtuallyrisk-freeorhaverisk-to-benefitratioswellwithinacceptablebounds,” 38anditconcludedthat“strictandrigidcontrols”forallreleasesofbioengineeredorganisms“arenotjustified.” 39

Overall,thepaperservedtopromotetherapiddeploymentofGMOs.AsanarticleintheHarvardJournalofLawandTechnologynotes:“TheNASreport,whichwaswidelypublicized,appearedtovindicatetheviewthattherisksfromdeliberatereleaseareoverstated,andthattherealdangeristhatexcessiveregulationcouldstifletheyoungbiotechnologyindustry.” 40Accordingly,twoseasonedobserversscoredit“amajorvictoryforthebiotechnologysector.” 41

Butmanyexpertsdidnotviewthevictoryasfairlywon.EcologistDavidPimentalofCornellUniversitychargedthatthecompositionofthefive-memberpanelthatwrotethereport“washeavilyweightedtowardgeneticengineering,”withonlyoneecologistincluded;42andSheldonKrimsky,ofTuftsUniversity,arguedthattheassertionaboutnouniquehazards“haslesstodowithgoodsciencethanitdoesaboutpoliticalcorrectnesswithinthescientificfraternity.” 43

PhilRegalalsoregardedthereportasdrivenmorestronglybypoliticalthanscientificconsiderations.Hesoonreceivedstunningconfirmationthathewasright.Duringabreakatanacademicconference,heapproachedoneofthereport’sauthors(withwhomhewasalreadyacquainted)andattemptedtoengagehiminadiscussionofthebiologyhethoughthadbeenmishandled.Butthemancuthimoff,exclaiming,“Phil,youkeepinsistingontreatingthisasascientificissue;butIcan’tdiscussitwithyouonthatbasis.It’sapoliticalissue.”Regalrealizeditwasfutiletopersist.“Sowewentoffandhadabeerwithsomeotherbiologists,”hereports,“andtalkedaboutothermatters.”

Becausethe1987paperhadbeencriticizedastooshortandsuperficial,theNASendeavoredtoproduceamorecompleteandauthoritativestatement;anditissuedamuchlongerandmoreextensivelyreferencedreportin1989(throughtheNationalResearchCouncil,oneofitsdivisions).AccordingtoRegal,theauthorswerenotonlyobligedtoacknowledgekeyconcernsraisedatBanburyandPhiladelphia,theywere“forcedtoadmitthattherewererisksandthatecologicalinputwouldbeneededinthedesignandevaluationofGMOstobereleasedintonature.”Theseadmissionsoccurredinthereport’smid-section,whichcontainedscientificallymeaningfulanalysis–alongwithdisclosurethatnoconclusionscouldbereachedonsomeissuesofseriousconcern,especiallythereleaseofbioengineeredmicroorganisms,whichtheauthorsconsideredtobeabigquestionmark.However,asRegalpointsout,this“scientificmeat”inthemiddlewassandwichedbetweenopeningandclosingchaptersofadistinctlydifferentcharacter.Hesays:“ThesechapterswerelargelywrittenbytheNRCstaff,employeesdirectlyobligatedtothepowerstructureintheAcademy,whichhadasubstantialstakeinadvancingbiotechnology.Accordingly,theirtextcontainedseveralbroadgeneralitiesexpressinggreatoptimismaboutthesafetyofgeneticengineering–andprovidedrichmaterialforitsadvocatestoquote.”

HabituationofExaggerationTheadvocatesliberallyexploitedtheopportunitythattheNRCfunctionarieshadfurnishedthem.Indoingso,notonlydidtheymisrepresentthereport’scontentbyignoringitscautionsandcitingonlythepositivepronouncementsappendedtoit,theyclaimedthatthesepronouncementsappliedtoGMOsingeneral,therebymisrepresentingitsscope.ThereportdealtsolelywiththeissueoffieldtrialsofGEcropplantsandmicroorganismsinthecontinentalUS.Accordingly,itdidnotevenpertaintofieldtestsinHawaiiandPuertoRico,letalonetolarge-scalecommercialreleasewithintheUSorothercountries.Moreover,itwasfocusedexclusivelyonenvironmentaleffectsanddidnottouchonthequestionoffoodsafety,which

isadistinctandunrelatedissue,sinceaplantcanbeenvironmentallybenignandyetdevastatingtohumanhealth.Regalemphasizesthatitcontained“noscientificdataortheorywhatsoeverforanyextrapolationbeyonditsnarrowconfines.”Therefore,evenifithadbeenlegitimatetoextractthereport’ssoothinggeneralitiesfromthecontextthatqualifiedthemandtoacceptthematfacevalue,itwasillegitimatetoapplythembeyondthediscretesetofissuesthereportofficiallyaddressed.

Nonetheless,justasthey’dexaggeratedtherelevanceofthelimiteddiscussionsoftheBethesda,Falmouth,andAscotconferences(andalsothelimitedfindingsoftheRowe-Martinresearch),mostbiotechpromoterspresentedthesegeneralpronouncementsasauthoritativeconclusionsregardingallthevariousfacetsofbioengineering,includingfoodsafety;andtheyfrequentlycitedthemasscientificbackingforthepermissiveUSregulatorypolicyintheseareas.TheylikewisestretchedtheapplicationofthepreviousNASreportwellbeyonditsrightfulrange,purportingthatitdealtwithGMOsingeneraleventhough,asatechnicalmatter,itwasjustasnarrowlyfocusedasthereportthatfollowedit.Further,justastheAmericanmediahaduncriticallycirculatedtheexaggerationsabouttheBethesda,Falmouth,andAscotconferencesandtheRowe-Martinresearch,sotheytendedtoacceptanddisseminatethefalseclaimsabouttheNASreportswithoutreservation,eventhoughaquickskimoftheactualdocumentscouldrevealtheirlimitedscope–especiallysincethelimitationswereexplicitlystatedearlyon.

Regalrecallsseveralinstancesinwhichscientistswhoweremisrepresentingoneofthereportsemployeddramaticflourishes(suchaswavingthedocumentwhilespeaking)tobemorepersuasive.OneofthemostamusingoccurredatameetingofataskforcethatwasdeliberatingwhetherthestateofMinnesotaneededtoenactregulations.Herecounts:“Oneofthemolecularbiologistsbroughtinastackofthe1989reports,ceremoniouslypassedthemaround,andadamantlyassertedthattheexpertshadconcludedthateverythingwassafe.WhenIaskedifhehadactuallyreadthereport,hegotangryandsaid‘no’butthatheandhisfellowmolecularbiologistsknewverywellwhatwasinit.Inthiscase,hisauthoritygamesandtheatricsdidn’tflybecauseenoughpeopleonourcommitteewerefamiliarwiththereport’scontents,buthowmanyAmericansweregoingtoreadthatreportandavoidbeingtakenin?” 44Asitturnedout,notverymany.

Duetothescientificcredentialsofthosewhoadvancedtheexaggerations,theirpersistenceindoingso,andtheunquestioningrepetitionoftheclaimsbyprominentinstitutionsandthemedia,theintendedillusionsbroadlytookholdwithintheUnitedStates.Moreover,theyhavestronglyendured,totheextentthateventheEnvironmentalMediaService,whichfavoredaprecautionaryapproachandendeavoredtocutthroughpromotionalhype,wassochronicallymisledthatthemediaguideitpublishedin2000portrayedthe1989reportashavingconcludedthereis“noreason”totreatGMOsdifferentlythanconventionalorganismsinanyrespect–evenwhenitcomestofoodsafety.45

However,spreadingtheillusionsabroadwasmoredifficult.ThedeferentialattitudeoftheAmericanmediatowardbiotechproponentsdidnotcatchoninEurope,andtheattemptstopassofftheNASreportsasscientificconclusionsaboutthegeneralsafetyofGMOsfailedbecausejournalistsandpolicyanalystsonthatcontinentroutinelycheckedthepromotionalclaimsagainsttheactualdocuments.Regalremembershowrefreshingitwastobeapproachedbyjournalistswhohadactuallyreadthereports,incontrasttohisexperiencewiththeirAmericancounterparts.AndhenotesthatfortheseastuteEuropeans,thegrossdisparitybetweentheconcretetextandtheinflatedclaimsengendered“angerandmistrust.”

ThefactthatEuropeanjournalistsexercisedtheircriticalfacultiesbyreadingtheoriginaldocuments(despitethefacttheywerewritteninaforeignlanguage)whilemostAmericanjournalistsdidnot(eventhoughitwouldhavebeeneasytodoso)isindicativeofbasicdifferencesbetweentheirapproachestobiotechnology–whichmaygoalongwaytowardaccountingforthesubstantialdifferencesinpublicawarenessandattitudesinthetworegions.

PerpetuationofthePoliticization

DuringthepresidencyofGeorgeH.W.Bush,theCoordinatedFrameworkwasmaintained(asithasbeenbyallsubsequentadministrations);andthepro-biotech,anti-regulatorypolicyoftheReaganAdministrationcontinued,withscientificissuesroutinelyresolvedaccordingtoeconomicandpoliticalpriorities.In1990,thePresident’sCouncilonCompetitiveness,chairedbyVice-PresidentDanQuayle,assumedoversightoffederalpolicyonbiotechnologyandmadeitclearthatboostingthedevelopmentofthebiotechindustrywouldremainamajorobjective–andshouldnotbeconstrainedbyconcernsaboutsafety.

ThisoccurredeventhoughPhilRegalhadpublishedthreepeer-reviewedscientificarticlesthatcollectivelywentfartherthanhadthediscussionsatBanburyandPhiladelphiainrefutingthevariousgenericsafetyarguments–andtheEcologicalSocietyofAmericahadpublishedawidelypraisedarticle(co-authoredbyRegalandsixotherscientists)thatexplainedtheenvironmentalrisksofGMOsandthekindsofregulatoryoversighttheynecessitated.46Yet,accordingtoRegal,mostofthemolecularbiologistspromotinggeneticengineeringignoredthesearticlesandcontinuedtousetheoldargumentsandanalogiesthathadbeenthoroughlydiscredited.Asheexplains:“Theywereabletoproceedinthismannerbecausetheyhadpoliticalmuscleontheirside.TheBushAdministrationsharedtheirdesireforeffectivederegulationandwassimilarlyreadytodismissanyevidenceandgenuinescientificanalysisthatrancontrarytothisgoal.Soitacceptedtheirassertionsas‘soundscience’becausethisallowedtheCouncilonCompetitivenesstoclaimscientificbackingforwhattheyfeltwassoundeconomicpolicy.”

EisenhowerasProphet:TheAscendancyofaScientific-TechnologicalEliteWhenhedeliveredhispresidentialfarewelladdressin1796,GeorgeWashingtonissuedastrongwarningagainstentanglingallianceswithforeignnations.Onehundredandsixty-fiveyearsandthirty-threepresidentslater,suchalliancesweredeemedessentialfornationalsecurity.Soin1961,noonewassurprisedthatthefarewelladdressofthethirty-fourthpresident,DwightD.Eisenhower(whohadbeenthefirstSupremeCommanderoftheNorthAtlanticTreatyOrganization),containednocautionsaboutthem.Butmostpeopleweresurprisedthatthisformergenerallaunchedastrongwarningaboutanothertypeofentanglingalliance–notbetweenthegovernmentandforeignpowersbutbetweenthegovernmentandacolossaldomesticpowerhereferredtoas“themilitary-industrialcomplex.” 47

Further,evenmostofthosewhoarefamiliarwiththisparticularcaveataresurprisedtolearnitwaspartofalargerwarningthatwasnotlimitedtothemilitary-industrialcomplexbutextendedtoabroaderphenomenon.Eisenhowernotedhowscientificresearchhadbeendramaticallytransformedintoanendeavorpracticedonalargescaleby“taskforcesofscientists”withmassivefunding;andhenotedthesubstantialinterconnectionsthathaddevelopedbetweenscientistsandthegovernment.Hethencautioned,“...inholdingscientificresearchanddiscoveryinrespect,asweshould,wemustalsobealerttotheequalandoppositedangerthatpublicpolicycoulditselfbecomethecaptiveofascientific-technologicalelite.” 48

Inlightofthesubsequenthistoryofthebiotechnologyventure,thosewordsappearprophetic.Duringitsfirsttwodecades,thegeneticengineeringestablishmentgainedsomuchinfluenceover

publicpolicythatvirtuallyitsentireagendawasadoptedandardentlypromotedbytwoconsecutivenationaladministrations–andwouldcontinuetobebythenextthreeaswell.Itsindividualmembersreceived(andwouldcontinuetoreceive)lavishgovernmentgrantstopursuetheirresearch;anditscorporateconstituentsweregivenlicensetodevelopanddeployaslewofnovelproductswithminimaloversight,eventhoughnumerousexpertshadconcludedtheymightentailenormousrisks.Moreover,itexertedbroadcontroloverthedisseminationandinterpretationofinformationandcoulddeftly

manipulatetheimpressionsofgovernmentofficials,themedia,andthepublic–passingoffconjecturesashardevidenceandlimitedconclusionsasgeneraltruths,whilesuppressingfactsthatthreateneditsinterests.

Sogreatwasitspowerthatitwasevenabletoavoidanyinhibitingconsequencesfromthebiggestdocumentedcatastrophecausedbyaproductofgeneticengineering–afood-borneepidemicthatdealtextensivedeathanddisabilitythroughoutAmerica–byinstillingtheillusionthatnosuchthinghadeverhappened.

CHAPTERTHREE

DisappearingaDisaster

HowtheFactsAboutaDeadlyEpidemicCausedbyaGEFoodHaveBeenConsistentlyClouded

ASetofUnsettlingFactsInSeptember1989,asthesoothinggeneralizationsintheNationalResearchCouncil’sreportfirstcirculated,otherreportswereemergingthatinducedadistinctlyoppositeeffect.Thesereportsdidnotcomefrominstitutionsengagedintheoreticaldiscussionsofriskbutfromofficesofmedicaldoctorsandpublichealthofficials;andinsteadofupbeatpronouncementsgearedtocalmconcerns,theycontainedstartlingaccountsofanunusualnewdisease.

Duringthatyear,thousandsofpeoplethroughouttheUnitedStatesexperiencedtheonsetofseveremuscleandjointpainaccompaniedbyswellingofthelegsandarms,extensiveskinrashes,andsignificantbreathingdifficulties.Somealsodevelopedcongestiveheartfailure,whileotherssuccumbedtocompleteparalysis,witharespiratorrequiredinordertobreathe.Buteveniftheyavoidedtheselattertwooutcomes,mostofthosewiththebasicsetofsymptomssufferedgreatly.

OnewomanfromCaliforniareported:“Iwasinsomuchpain–joints,bones,skin,everything–thatIcouldbarelystandtobetouched.Ilostabout60percentofmyhair,hadnoenergy,andwasusuallyasleep.Atvarioustimes,I...hadmouthulcers,nausea,shortnessofbreath,severemusclespasms,itchingandpainfulrashesallover,edema(swellingofextremities),concentrationandmemorydifficulties,handwritingproblems,balanceproblems,irritablebowelsyndrome,weightgain,visualperceptionproblems,justtonameafewsymptoms!” 1

AnordainedCatholicdeaconinCincinnatirecalls:“ThepainwassointenseinmybodythatifIweretolieonthemattressatnighttimewhenIwenttobed,itwouldhurttoobad.Iwouldsituponthesideofthebedandtrytosleepsittingupbecauseoftheintensityofthepain.Mylegsbecame–youwouldn’tbelieveitunlessyousawit–theybecameasbigasatelephonepole.Theysplitandwateroozedfromthem.Noamountofmedicinetheygaveme...calmedthepain.” 2Aftersixyearsofsuchagony,duringwhichtimehecouldn’twork,hisstaminafinallystartedtoimprove;buthecontinuestoendureconstantmusclepainandphysicaldisabilities.

AwomanfromSkokie,Illinoiswhohadalwaysenjoyedexcellenthealthandabundantenergyinitiallydevelopedarashalloverherbody,thenahorriblecough,andeventuallyadegreeofmuscleweaknessandpainsoextremethat“itwashardtowalk,hardtodoanything.”Attimes,herhandorjawwouldsuddenlyclampshutoranothermusclewouldabruptlylockdown.Asthingsdeteriorated,shehadtoleavework.Eventually,shebecamebedriddenforsixmonths,withpainsostrongthatthemereactofrollingoverwasanalmostunbearableordealthattooktwofullminutes.3

Astheseaccountsindicate,thepainassociatedwiththisstrangesetofsymptomswasunusuallyintense.ThechiefoftheDivisionofRheumatologyatTheGraduateHospitalinPhiladelphia,whotreatedseveralafflictedindividuals,describeditas“theseverest”hehadseeninhisentirepractice.Further,besidesthehighlevelofpain,thelevelofthewhitebloodcellscalledeosinophilsalsoranhigh.Thesecellsfightinfectionsandalsocontrolmechanismsassociatedwithallergies.Theirnormalcountisabout100to200permicroliterofblood.Forsomeonewithanallergicreactionorasthma,thecountcanriseto

600or800–sometimesevento1,000ormore.Butpeoplewiththisnovelmaladyhadaveragecountsof4,000;andmanyhadcountsthatranmuchhigher.4Whenthelevelofthesecellsgoestoohigh,thearsenalofmoleculeswithwhichthey’rearmedtobattleinvadersstartattackingthebody’snormaltissueinstead,resultinginmassivesystemicdamageandintensepain.

Doctorswerebaffledbythisextraordinarydisease,andthetreatmentstheyattemptedwerelargelyineffective.Moreover,althoughmanypeoplewerestrickenduringthesummerof1989,becausethesymptomsoftenvariedandtheoutbreakwasdispersed(withmostpractitionersobservingbutasinglecase),ittookseveralmonthsbeforethemedicalcommunityevenrecognizedthatanewdiseasehadarisen,letalonethatitwassurgingasanation-wideepidemic.Ittookevenlongertolearnwhatwascausingthedisease.Finally,byearlyNovember,therewasenoughdatatodeterminethecriticalcommonalitybetweenthevictims:theyhadallbeeningestingL-tryptophansupplements.

L-tryptophan(LT)isoneoftheaminoacids,aclassofchemicalsthatformthebuildingblocksofproteins.It’sessentialforhumanlife,and,amongotherthings,itparticipatesintheproductionoftheneurotransmitterserotonin,whichpromotesrelaxationandsleep.Someofthebestnaturalsourcesaredairyproducts,soybeans,fish,poultryandmeat.Inthe1980’s,LTwasalsoavailableasanover-the-countersupplement.Formanyyears,doctorshadrecommendeditincasesofinsomnia,premenstrualtension,stress,anddepression.Further,althoughatonepointapproximately2%oftheUSpopulationwastakingit,therehadneverbeendocumentedproblemswhenitwasproperlyemployed.5

Butnowithadbecomeassociatedwithanovelandnastydisease.Becausethisailmentwascharacterizedbyanelevatedeosinophilcount(aconditioncalledeosinophilia)alongwithseveremusclepain(myalgia),itwasnamedeosinophilia-myalgiasyndrome(EMS).ByearlyDecember,therewere707reportedcasesin48states,withatleastonedeath.ByApril1990,1,411tryptophan-linkedEMScaseshadbeenreported,alongwith19deaths.AccordingtothefinalestimateoftheCenterforDiseaseControl(CDC),between5,000and10,000peoplewerestricken.6Ofthese,atleast80diedandaround1,500havebeenpermanentlydisabled.7

IdentifyingtheSourceoftheDisease-LinkedTryptophanItwasimportanttoknowifalltryptophansupplementsweretrulydangerousoriftherewassomethinguniqueaboutthesupplementstheEMSvictimshadconsumed.ManydifferentretailbrandsofLTwereinvolvedwiththedisease,andinvestigatorswantedtolearnif,beneaththedifferencesinbrandnames,thevariousbatchesofEMS-associatedLThadanyfeaturesincommon.Becausetherewerefarmoreretailbrandsthanactualmanufacturers,andbecausetheconnectionsbetweenbrandsandmanufacturerswereunclear,thefirstthingtoascertainwastheproductionfacilityatwhicheachcase-relatedbatchhadoriginated.

Onlysixmanufacturers,allJapanese,suppliedL-tryptophantotheUSmarket.Intheearlymonthsof1990,CDCresearchersdiligentlytracedthebatchesofLTthatwereassociatedwithEMSbackthroughthecomplexnetworkofwholesalers,distributors,tabletmakers,encapsulatorsandimporterstotheirpointoforigin.InlateApril,theyannouncedanimportantdiscovery.TheirinvestigationrevealedthateverybatchofEMS-associatedLTthatcouldbedefinitivelytracedbacktoamanufacturer(accountingfor95%ofallsuchbatches)camefromasinglesource:ShowaDenkoKK,Japan’sfourthlargestchemicalcompanyandthebiggestsupplierofLTtotheUnitedStates.8

TryingtoDeterminetheDeadlyDifferenceThenextstepwastodetermineiftherewassomethingdistinctlydifferentaboutShowaDenko’stryptophan–somethingthatsetitapartandmadeituniquelyharmful.

Formanyyears,allmanufacturershadusedamethodinwhichbacteriaareinducedtosynthesizeLTthroughfermentation.Becauseadditional(andunwanted)substancesgetgeneratedaswell,thecontentsof

thefermentationtankarethenputthroughamulti-stagedprocessofpurification,culminatingwithcarbonfiltration.Rigorousanalyticaltestsarethenconductedtoassurethattheendproductispure.

InvestigatorssoondiscoveredthatShowaDenko’sLTdiddifferfromtheproductsmadebyothermanufacturers.Foronething,itwasuniquelycontaminated.Notthattheotherswerecontaminant-free.It’svirtuallyimpossibletoremoveeverybitofunwantedsubstances,andanalyticaltestingrevealedthateverymanufacturer’sLTcontainedtracecontaminants.ButShowaDenkoLTcontainedmorethan60,amuchgreaternumberthandidtheothers.9

Further,itwasclearthatoneormoreofthesecontaminantspackedanabnormallypotentpunch.That’sbecauseShowaDenkoroutinelytesteditsLTtomakesurethatitmettheUnitedStatesPharmacopoeiastandardsforpurity(atleast98.5%pure).Infact,thelevelsofeachcontaminantwereextremelylow:10orfewerpartspermillion.10Consequently,eventhoughSD’sproductcontainedagreaternumberofcontaminantsthanusual,nonewaspresentatalevelhighenoughtoposeproblemsintheusualcase.Sothefactthatone(ormore)ofthemmadethousandsofpeopleverysickmeantthatitwas(ortheywere)extraordinarilytoxic.

Moreover,anotherimportantdifferencehadcometolightbetweenShowaDenko’sLTandtheproductsofcompetitors:ithadbeenmanufacturedinadifferentmanner.InordertogetthebacteriatoyieldsubstantiallymoreLT,ShowaDenkohadbrokennewgroundandalteredtheirgenomesviarecombinantDNAtechnology.

ThenewsthatShowaDenko’sdeadlyLThadbeenproducedbygeneticallyengineeredbacteriawasfirstannouncedinJuly1990intheJournaloftheAmericanMedicalAssociation.11Itsoonspreadtothepopularpress.Newsdayledthewaywithanarticletitled“GeneticEngineeringFlawBlamedforToxicDeaths.” 12Init,MichaelOsterholm,anepidemiologistwiththeMinnesotaHealthDepartmentwhohadbeenresearchingtheepidemic,assertedthatShowaDenkohad“crankedup”itsbacteriatoincreaseLTproductionandthat“somethinghadgonewrong.”Hethenremarked,“Thisobviouslyleadstothatwholedebateaboutgeneticengineering.”

BiotechproponentswatchedindismayasnumerousothernewspapersfollowedwithstoriesthatlinkedtheEMScatastrophetogeneticengineering,andtheyhopedforanauthoritativerejoinderthatwouldblunttheforceofOsterholm’sallegations.TheFDApromptlyrosetotheoccasion.WhenareporterfromScienceinterviewedanagencyofficial,he“blasted”Osterholmfor“propagatinghysteria;”andhedeclaredthatitwas“premature”tosuggestthattheepidemicwasrelatedtogeneticengineering–“especiallygiventheimpactontheindustry.” 13ButOsterholmstoodhisgroundandcountered:“Anyonewholooksatthedatacomestothesameconclusion....” 14

TheSciencearticlewentontodisclosethattheFDA’sconcernforprotectingtheimageofbiotechnologywassostrongthat,althoughtheagencyhadknownaboutShowaDenko’suseofgeneticengineeringformonths,ithadwithheldthisinformationfromthepublic“apparentlyhopingtokeeptherecombinantlinkquietuntiltheycoulddeterminewhetheritinfactdidplayaroleintheoutbreak.” 15However,aswillbeseen,itwasundulycharitabletohavepresumedthattheFDAwasearnestlyseekingthetruth–orwouldhavevoluntarilydivulgedanyfindingsadversetotheinterestsofthebiotechindustry.

TheQuestforClarificationFortunately,severalinvestigatorswerededicatedtodiscoveringtherelevantfactsandascertainingwhetherbioengineeringplayedakeyroleinthecalamity.Todoso,itwasnecessarytodeterminewhichcontaminant(orcombinationofcontaminants)causedtheEMSandhowithadcomeintoexistence.

ThefirstmajorstepwasreportedinAugust1990byTheNewEnglandJournalofMedicine.ResearchersdeterminedthatoneofthecontaminantswasnotonlyassociatedwithEMScasesbutthatitwasanovelchemicalsubstanceformedbythefusionoftwoLTmolecules,somethingneverseen

before.16Theydubbedthisnewsubstance“EBT.” 17However,althoughtheyknewitschemicalstructure,theydidn’thaveenoughevidencetoknowifitwasthecauseoftheepidemic.

Foralmosttwoyears,EBTwastheonlycontaminantknowntobeassociatedwithEMS.Then,inJune1992,researchersdeterminedtherewasatleastonemore,acompoundcalled3-phenyl-amino-alanine(3-PAA).WhileEBThadneverbeenseenbeforeitsappearanceinSD’sL-tryptophan,3-PAAhad;butithadneverbeenfoundinfoodgradeLTproducedthroughconventionalmeans.However,asinthecaseofEBT,therewasinsufficientevidencetoconcludethatithadcausedtheepidemic.

Eventually,fourothercontaminantsweredeterminedtobecase-associatedaswell.ButnonecouldbeproclaimedthecauseofEMSeither.Theevidencewasstilltooscantytoestablishthatanyofthesixcase-associatedcontaminantswastheculprit–orevenaminoraccomplice.That’sbecausemereassociationdoesnotequalcausation,andfarmoredataisrequiredtoprovethatasubstancecausedanepidemicthantoshowthatit’smerelyassociatedwithit.Chemicalscanqualifyasassociatedeveniftheyarefoundinonlyasmallportionofthebatchesthatcauseillness.

Theuncertaintyaboutwhathadcausedthecontaminationwasnotmerelypuzzlingforresearchers,itwasdeeplydisturbingforbiotechproponents.Bythetimetheepidemichit,insulinsynthesizedthroughgeneticengineeringwasinwideuseandanenzymetosubstituteforanimalrennetincheeseproductionwasbeingprimedforsale.AsinthecaseofShowaDenko’sLT,thesesubstanceswerechurnedoutinlargequantitiesbymicroorganismsthathadbeenartificiallyendowedwithnewgeneticmaterial.IfemployingsuchalteredorganismshadinduceddeadlysideeffectsintheproductionofLT,theiruseinproducingtheseothersubstancesmightlikewiseberisky.Further,ifbioengineeringhadcausedordinarilytrustworthybacteriatogenerateunexpectedtoxins,itmightdothesamewhenusedinproducingmorecomplexorganismssuchasfruits,grains,andvegetables.Consequently,thefutureofgeneticengineeringwastoalargeextentridingonwhetherornotthetechnologywouldbeimplicatedasacauseoftheEMS,becauseifitwere,theprojectsemployingitmightlosetheircommercialviability.Moreover,evenabsentconclusiveproofofthetechnology’sguilt,lingeringsuspicionsaboutitsinvolvementcouldhamperitscontinueddevelopment.Soitsadvocatesstrovemightilytoexonerateit.

AKeyQuestion:AtWhatStageoftheProcessDidtheContaminationOccur?

FallaciesRegardingFiltration

Oneoftheirmaindefenseswastopintheblameonsomethingelse.Theypointedoutthatjustbeforetheepidemic-relatedbatchesofLTwereproduced,ShowaDenkohadcutcostsbyreducingtheamountofcharcoalusedduringthefinalphaseofthefiltrationprocess;andtheyarguedthatthischange,notthebioengineering,wasthekeyfactorinthecontamination.Accordingtothethrustofthisargument,itwasnolongerimportanttodiscerntheroleplayedbythegene-splicing,becauseonceitwasclearthatthecontaminantshadnotbeenproperlycontained,itlittlematteredhowtheyhadarisen.

Butitwasillogicaltodenytherelevanceofthecontaminants’source.Placingsolecondemnationonthechangeinfiltrationwaslikeassertingthatasoldier’sdeathwascausedbyadefectivehelmetwhileignoringthebulletthatpiercedthehelmet,andthegunfromwhichitwasfired.AsanarticleinTheNewEnglandJournalofMedicinepointedout,althoughthereductionincarbonmayhavebeenacontributingfactor,itdidnotexplainhowthelethalagententeredtheproductinthefirstplace.18Thus,contrarytotheimpressioninducedbythebiotechproponents,itwasstillcriticaltoassesstheroleofthegene-splicing–andtolearnwhetherthekillercontaminantwasitssideeffect.

Theirrationalityofcenteringblameonthereductionofcarbonwasunderscoredbythefactthatduetothepotencyofthelethalcontaminant(s)atextremelylowconcentrations,casesofEMSstillarose(albeitatalowerrate)frombioengineeredLTproducedduringperiodswhenthecarbonwasrestoredtoadequatelevels.Accordingly,thereductionincarbonwasnotthekeyeventthatcausedtheEMS;it

merelyallowedthediseasetostrikemorepeople.Further,theissueofcarbonlevelsisirrelevanttoGEfruitsandvegetablesbecause,incontrastto

isolatedsubstances,wholefoodsdon’tpassthroughfilterspriortosale.Therefore,anytoxinsformedduringproductionwouldbefullypresentwhenconsumed–whichhighlightstheimportanceofknowingwhetherthoseinShowaDenko’sLTemergedviabioengineering.

Nonetheless,despitetheillogicoffixatingonthereductionofcarbon,manybiotechproponentscontinuedtodosobecauseitfedconfusionanddeflectedattentionfromthebioengineering.Andtheconfusionwaswidelyspread.Forinstance,LordsoftheHarvest,aninfluentialbookaboutgeneticengineeringbyasciencereporterforNationalPublicRadio,indicatedthat“inadequatefiltration”mightbefullytoblamefortheepidemic.19

DidaDifferentPartofthePurificationProcessGeneratetheToxin?

Yet,evenscientistswhorecognizedthefallacyinthisfixationcouldn’tjumptotheconclusionthat,becausethereductionincarbonhadnotcausedthecontamination,thebioengineeringmusthave.Therewasanotherpossibility:thatthetoxinshadinsteadbeengeneratedduringthepartofthepurificationprocessthatprecededthecharcoalfiltering.

Whileitmayseemoddthatatoxicsubstancewouldbegeneratedduringtheveryprocessthat’sdesignedtoremovetoxins,itcanhappen;andatthatpointoftheinvestigation,therewasinsufficientevidencetoruleitout.Soresearcherssoughttodetermineatwhatstageofproductionthelethalcontaminanthadbeengenerated.Ifitwasalreadypresentinthefermentationbrothbeforefiltrationbegan,thatwouldimplyitwasaneffectofthebioengineering;butifitonlyappearedafterthebrothhadenteredthefilters,thatwouldimplyitformedduringthelatterprocess–andthatthebioengineeringwasinnocent.

IfthealteredbacteriathatShowaDenkousedinproducingthecontaminatedLThadbeenavailable,researcherscouldhaveresolvedtheissuebyusingthemtomakenewbatchesunderthesameconditionsthatSDhadusedandanalyzingthecontentsbeforeandafterfiltration.Butthebacteriawerenotathand,andanarticleinSciencereportedthatShowaDenkohaddestroyedthemwhentheproblemsfirstarose.20

Soresearchershadtoproceedinlessdirectways.AlthoughthebacteriaSDusedcouldnotbeemployed,otherfeaturesofitsproductionprocesscouldbe;andresearchersfoundthatthesystemitusedmighthavegeneratedsomeofthecase-associatedcontaminantsafterthealteredbacteriahaddonetheirwork.Oneteamfoundthatwhentryptophanwaspurifiedusingthecompany’sprocedures,itcouldgenerateEBT.21AnotherteamthendiscoveredthatPAAcouldalsobeformedfromchemicalspresentduringthatparticularprocessofpurification.22

Advocatesofbioengineeringwerequicktodeclarethatthetechnologyhadbeenexoneratedbythisevidence,andthisclaimhasbeenpersistentlyrepeatedandwidelyspread.

Butit’sfalse.It’sbasedontheassumptionthateitherEBTorPAAwascriticaltotheepidemic,andthisassumptionignoresasubstantialbodyofevidencethatindicatestheywerenot.Forinstance,astudypublishedintheNewEnglandJournalofMedicineexaminedtwelvecaselotsthatwerealllinkedtotheepidemicanddidnotdetectanyEBTinthreeofthem(25%ofthetotal).23SothisstudyaloneshowsthatEBTwasnotanecessaryfactorincausingthedisease.Further,besidesbeingunnecessaryforthecausationofharm,EBTwasnotevensignificantlyrelatedtoalot’sharmfulstatus,afactrevealedthroughsubsequentstatisticalanalysisthatcomparedlotsmanufacturedwithinashorttimeofoneanother(onlysomeofwhichweredisease-associated).24Otherresearchfoundthatwhencase-associatedLTwasadministeredtorats,itcausedmoreimmunecellactivationthandidEBTadministeredalone,eventhoughthatdoseofEBTwasover100timeshigherthantheamounttheratsreceivedfromtheLT.25Inlightofthese(andadditionalfindings),it’sevidentthatEBTitselfwasnotthekeycauseoftheEMSandthatthecrucialrolemusthavebeenplayedbysomethingelse.26

AndthatsomethingelsewasnotPAA.TheevidenceshowedthatitsrelationshiptotheepidemicwasevenweakerthaninthecaseofEBT.27Thus,thefactthatthesetwocontaminantscouldhavebeenformedduringpurificationinsteadofduringfermentationwasirrelevanttothequestionofwhetherthegeneticalterationsweretoblamefortheepidemic.

Moreover,therestoftheavailableevidencedidnotresolvethisimportantquestioneither.Whileresearchershadidentifiedthechemicalstructuresofthreeothercase-associatedcontaminants,comprehensiveanalysisrevealedthattheywerenomorestronglylinkedtotheepidemicthanwereEBTandPAA.Butitdidrevealthatoneothercase-associatedcontaminantwassignificantlyrelated.28However,littlewasknownaboutthissubstance(referredtoasAAA),anditschemicalstructurehadnotbeenidentified.Sotherewasnoclueastowhetherithadbeensynthesizedwithinthebacteriaorwithinthepurificationsystem.Theissuewasfurthercomplicatedbythefactthat,intheeyesofseveralscientists,theevidenceasawholesuggestedthattheEMShadbeencausedbymultiplefactorsactingtogether–andthecompositionofthecrucialcombinationwasnotknown.29

WhyBioengineeringCouldHaveBeentheKeyCause

However,althoughtherewasnobasisformakinganyfinaljudgmentaboutwhethergeneticengineeringhadbeeninstrumentalincausingthefatalcontamination,thereweresoundreasonstothinkthatitcouldhavebeen.Bioengineeringhasinherentpotentialtodisruptthenormalprocesseswithinalivingcellandcreateunintendedandunusualsideeffectsthatcangiverisetodeleterioussubstances.WhenthistechnologyisemployedtoacceleratebacterialsynthesisofLT,suchunintendedeffectscouldreadilyoccur.

ProfessorCharlesYanofskyofStanfordUniversity,aleadingauthorityontryptophanbiosynthesis,hasstated:“Geneticengineeringresultsintheformationofhigherthannormalconcentrationsofcertainenzymesandproducts;thesecouldprovidethebasisforthesynthesisofhigherlevelsoftoxicsubstances.” 30Andhenotedthatmerelyincreasingtherateoftryptophansynthesis(thegoalofSD’sgene-splicing)canleadtosuchilleffects:“Themoretryptophanisproducedinthecell,thegreaterthechancethatsomesidereactionwilloccuratagreaterrate,producingmoreofsomecontaminant.” 31Ashehasfurtherexplained:“Overallthiswouldmeanthatthebacteriumisproducinglargeamountsofabout10-15metabolitesthatarenotnormallyproducedinexcess.Theaccumulationofthesemetaboliteswould,insomecases,leadtomodificationbyotherenzymes,togiveproductsthatnormallyareneverproducedbythebacterium.Oneormoreoftheseunnaturalproductscouldbeacompoundtoxictoman.Similarly,theoverproductionofenzymesofthearomaticandtryptophanbiosyntheticpathwayscouldleadtothesynthesisofunnaturalproductsbysidereactionsthatnormallydonotoccur.Again,toxicproductscouldbeproduced.” 32

Further,inthecaseofthebacteriausedbyShowaDenko,someunusualsidereactionsmighthaveoccurredasactsofself-defenseratherthanasundirectedaccidents,sinceanoverabundanceofLTistoxictothem.Sotheymayhaveactivateduncommonmechanismsasameansofself-protection.

Moreover,notonlywasthepresenceofnovelcontaminantsconsistentwithwhatcouldbeexpectedfromgeneticengineering,sowerethefluctuationsintheirlevels.Forinstance,whilethelotsofLTthatShowaDenkoproducedinMarch,April,andMayof1989containedhighamountsofoverallcontamination,thelevelofoneparticularcontaminantdroppedsubstantiallytowardtheendofApril,andmanyothersweremarkedlydiminishedwithinayear.33Suchvariationsuggestserraticbiologicalactivityratherthanchangesinthemanufacturingprocess;andthereareseveralwaysinwhichgeneticengineeringcouldhaveinducedit.

AMajorIssue:WhenWereGEBacteriaFirstEmployedtoProduceLT?

However,defendersofbiotechhadanostensiblypowerfulargumenttoparrythethrustoftheforegoingevidence.AndtheFDAwieldeditartfully.InJuly1996,freelancejournalistWilliamCristphonedtheagency’sbiotechnologymanager,JamesMaryanski,inanattempttogainclarificationaboutthecauseoftheEMSandwastoldthattheevidencepointedawayfromgeneticengineering.AsMaryanskiputit:“...weareawareofclosetotwodozencasesofL-tryptophanlinkedEMSthatoccurredbeforeShowaDenkobeganusingtheirengineeredstrain.So,therewouldhavetobeacauseotherthanjustthemereengineeringofthestrains.”Whileheconcededthatgeneticengineeringcouldnotbeconclusivelyruledout,hemaintainedthat“themorelikelycause”wasL-tryptophanitself,orLT“incombinationwithsomethingthatwastheresultofthepurificationprocess.” 34

Althoughthisinformationseemedtoabsolvegeneticengineering,Crist’sresearchhadalreadymadehimwaryoftheFDA’sreliabilitywhenthereputationofbiotechnologywasontheline.Sohedecidedtodomoredigging.Whatheunearthedwasstartling.Yes,therewerecasesofEMSthatpredatedtheepidemic;infact,therewerefarmorethantwodozen.However,ratherthanexoneratinggeneticengineering,theexistenceoftheseearliercasesinsteadimplicatedit.Buttheimplicationwasonlyvisibleinthelightofotherevidencethathadgonelargelyunnoticed–andthattheFDAwasaversetodisclose.

Cristcompiledthisevidenceinstages.HefirstsoughttolearnifLTfromamanufacturerotherthanShowaDenkohadbeenlinkedtoanyoftheearlyEMSincidents.HesearchedthescientificliteratureandfoundthreestudiesbytheCDCthatpeggedpre-epidemicEMStoShowaDenko’sLTbutnostudiesinvolvingtheproductofanyothercompany.HealsocontactedaboutadozenlawfirmsthathadrepresentedEMSvictimsandlearnedthatallthelawsuits(includingthosebasedonpre-epidemiccases)hadbeenbroughtagainstShowaDenko–andthatnoneofthefirmsknewofanEMSincidentconnectedwithadifferentmanufacturer.

Thisevidence,inconjunctionwiththeextensivedatarelatingtotheepidemic,clearlyrefutesthecontentionthatLTitselfcouldhavecausedEMS.AsCDCepidemiologistEdwinKilbournehaspointedout,ifLTwerethecause,thenallproductsofequaldosefromdifferentcompaniesshouldhavehadthesameeffect–ascenariounsupportedbytheevidence.35GeraldGleich(amedicaldoctorwhostudiedtheepidemicthoroughlywhileattheMayoclinic)hassoundedasimilarnote:“TryptophanitselfclearlyisnotthecauseofEMSinthatindividualswhoconsumedproductsfromcompaniesotherthanShowaDenkodidnotdevelopEMS.TheevidencepointstoShowaDenkoproductastheculpritandtothecontaminantsasthecause.” 36Moreover,CristeventuallydiscoveredthattheevidencenotonlypointedtoSD’sproduct,itrevealedthatduringthefourandahalfyearsprecedingtheepidemic,allofthecompany’stryptophanhadbeenproducedwithgeneticallyengineeredbacteria.

TheengineeredstrainthatcausedtheepidemicwasintroducedinDecember1988.ItwasnamedStrainV,whichimpliestherewereatleastfourearlierstrains.Cristlearnedthatsuchstrainshadinfactexisted–andthatallbutoneweredevelopedviageneticengineering.Thatlonenon-engineeredlinewascalledStrainI.Alltheothershadbeencreatedfromitthroughsuccessivelymorepowerfulformsofgenealteration,yieldingprogressiveincreasesintheoutputofLT.

Althoughthisinformationwasapparentlynotwell-known,ithadappearedinascientificjournalinSeptember1994–almosttwoyearsbeforeMaryanskitoldCristthatthepre-epidemiccaseswerelinkedwithnon-engineeredstrains.37GiventhecriticalbearingofsuchinformationonanissueaboutwhichtheFDAhaddisplayedkeeninterest,it’sreasonabletopresumethattheagencywouldhavebeenawareofit.ButevenifthisarticlehadsomehowescapedtheFDA’sattention,itdidn’treallymatter,becausetheagencyhadalreadylearnedthefactsthroughadifferentchannel.

CristdiscoveredthiswhenheobtainedacopyofafaxtheFDAhadsentajournalistlistingthevariousstrainsofengineeredbacteriaSDhadusedanddescribingthegeneticmanipulationsthroughwhicheachhadbeencreated.Almostassurprising,thefaxwasdatedSeptember17,1990.Moreover,the

FDAhadacquiredtheinformationmuchearlier.AccordingtoanattorneywhosuedShowaDenkoonbehalfofanEMSvictim,thecompanysentittotheagencytheprecedingFebruary.38So,shortlyaftertheepidemicwasfirstdetected,theFDAhadlearnedabouttheseotherengineeredstrains;yet,foryearsthereafter,itprofessedthatnosuchstrainswereeverused.

Infact,SDstartedproducingLTwithgeneticallyengineeredbacteriainOctober1984andcontinuedusingthetechnologyfromthenon.AndaseachsuccessivestrainwasmanipulatedtoproducemoreLTthanitspredecessor,itappearstohavealsoproducedmoredisease,withtheincidenceofEMSsteadilyrisinguntiltheupsurgeinducedbyStrainV.39Further,thetotalnumberofpre-epidemiccases,whilefarsmallerthanthenumbercausedbyStrainV,wassubstantial.EmployingdatafromCDCresearchers,Cristestimatedthatbetween350and700peoplewerestricken.40

Moreover,althoughittookmanyyears(andanepidemic)beforethoseearlycasescouldbelinkedtoSD’sbioengineeredtryptophan,duringthatearlierperioditbecamecleartothecompanythattheproducthadproblems.Forinstance,SDinternaldocumentsshowthatinthesummerof1988(monthsbeforeStrainVwasused),aGermanfirmfoundasuspiciousimpurityinashipmentofitsLT–andthatitsscientistswereunabletodeterminewhetherornotthesubstancewastoxicbecausetheycouldn’tfigureoutwhatitwas.41

ButthatwasnottheonlyconundrumconfrontingShowaDenkoscientistsduringthatyear.Foranextendedtime,theyhadtograpplewithamorebafflingone.AccordingtoSD’sdocuments,problems“brokeout”withoneengineeredstrainduetoanonslaughtofviruses.42Moreover,theviruseswerenotinvadingfromtheoutside.Theyhadinhabitedtheprecedingstrainsofbacteriaallthewaybacktotheinitialnon-engineeredversion,buttheyhadexistedinaquiescentstateandwerethereforeunnoticed.

Whatsparkedtheirtransformationfrompeacefullodgerstohostileaggressors?WhenIposedthisquestiontoarenownedvirologist,AdrianGibbs,hesaidsuchchangesaretriggeredbystresstothebacteria“thatstirsuptheirmetabolism.” 43AndforcingthemtochurnoutalotmoreLTclearlywouldhavestirreduptheirmetabolism.Accordingly,heremarkedthatthecriticalstresscouldhaveresultedfrom“muckingaboutwiththebacteria”onthegeneticlevel.Thelikelihoodthatsuch“muckingabout”didactivatethevirusesincreasesinlightofdocumentsindicatingthattheeruptionentailedmajordifficulties,andthatsubstantialtimeelapsedbeforeavirus-freestraincouldbeisolated.WhenIinformedDr.Gibbsofthesefacts,henotedthatiftheproblemhadresultedfromalocalizedstresslikeheatshock,therewouldprobablyhavebeenareserveofundisturbedbacteria–andthatbecausetheentirestockofthebacterialstrainSDwasthenemployingseemstohavebeenaffectedinasustainedmanner,“itsuggeststhattheproblemwasgeneticinorigin.”

SDwasbesetbyotherseriousproblemsaswell.TherecordsrevealthatwhenStrainIVwasfirstusedincommercialproduction,SDpulleditafteronlytwoweeksandrevertedtoStrainIII.Further,SDstayedwiththatearlierstrainforeightmonthsbeforeattemptingtouseIVagain(inearlySeptember1988),whichsuggeststherewasanunexpecteddifficultythattookalongtimetoclearup.44Then,afteronlyafewdayswithIV,productionwasapparentlyshutdownformorethanthreeweeks.45SinceSDhademployedbioengineeringtoincreaseLTproduction,thislonglapseimpliesthatanothermajordilemmahadarisen.Further,becauseSDdocumentsstatethatthevirusproblemhadbythenbeensolved,thedifficultymusthaveinvolvedsomethingelse.And,althoughthevirusoutbreakhadcomeasasurprise,theemergenceofadditionalproblemsdidnot,asevidencedbyascientist’smemowrittenaftervirus-freebacteriawereagaininusepredictingtherewouldbe“othertroubles.” 46Moreover,itappearsthatevenafterproductionfinallyresumed,SDstillhadqualmsaboutStrainIV,becauseitoncemorerevertedtoStrainIIIanddidn’temployIVagainuntilmid-November–andthenforonlyafive-weekrun,whereuponitwassupplantedbyStrainV(whichwascreatedthroughfurthermanipulationstoit).

Thus,theevidencestronglysuggeststhatasthebacteriawerealteredtooutputincreasinglyhigher

levelsofLT,therewasconcomitantincreaseinstress,creatingdisturbancesthatmadetroubleforthetechnicians.Further,it’splausiblethatbesidescausingheadachesforSD’sstaff,themetabolicimbalancesinthebacteriainducedtoxinsthatcausedchronicachesforthousandsofconsumersthatwerefarmoreexcruciating.Andit’sindisputablethatanyaccountoftheepidemicwhichignorestheearlierstrainsofengineeredbacteriaisitselfseriouslyimbalanced.

TheFDASustainsItsDistortionsDespitetheimportanceoftheevidenceaboutthepre-epidemicGEstrains,theFDAstubbornlyrefrainedfrommentioningit–andconsistentlyevadedconfrontingit.OnOctober9,2001CristsentlettersbycertifiedmailtobothMaryanskiandJosephLevitt,DirectoroftheFDA’sCenterforFoodSafetyandAppliedNutrition,pointingouthowtheFDA’s1990faxprovesthatitknewofthiscrucialevidencebutnonethelessinsistedthatnoengineeredstrainspredatedtheepidemic.Hethenasserted,“ItappearsthatFDAhastriedtodefuseanddownplaytheissueofgeneticengineeringbyshiftingtheblametotryptophanitself,usingpre-epidemicEMS...casesasjustification...” 47Finally,afterathoroughexpositionoftheotherdiscrepanciesbetweentheFDA’spronouncementsandthefacts(asreportedinstandardscientificjournals),hestated:“Iamleftwiththeperplexingquestion:DidFDAhaveanysolidevidenceatallsupportingitspositiononL-tryptophan?”WhileforCristthisquestionwasperplexing,MaryanskiandLevittseemtohavefounditvexing.Theyneverreplied.

TheFDAwasequallyunresponsivewhenCristconfronteditwithotheruncomfortablequestions.OnesoughttoclarifyhowdiligenttheagencyhadbeenintryingtoobtainSD’sbacteria.Aspreviouslynoted,thebestwaytodeterminewhetherthefataltoxin(s)hadbeenproducedbythegene-alteredbacteriaorthepurificationprocesswouldhavebeentoobtainStrainVandruntests.AlthoughitwasgenerallybelievedthatShowaDenkodestroyedthebacteriabeforeinvestigatorscouldapprehendthem,whenCristcontactedDonMorgan,anattorneywhorepresentedSD,hewasinformedthatithadinsteadtriedtocooperate.AccordingtoMorgan,althoughtheFDAinspectedSD’splantinMay1990,itdidn’trequestsamplesofthebacteriathenandonlyaskedforthemsubsequently.Butthecompanywas“reluctant”tomailthebacteriaoverseasbecausethatmightinducechangesthatwouldimpairtheaccuracyofthetests.MorganexplainedthatSDwantedtoturnthebacteriaovertoFDArepresentativesandshowthemhowtoproperlyhandletheculturesbutthattheagencyneverfollowedthroughonthisoffer.Hefurtherrevealedthatalthoughthecompanyeventuallydestroyedthebacteria,theywaiteduntil1996todoso,providingtheFDAampleopportunitytosendsomeonetogetthem.48

TolearntheFDA’ssideofthestory,CristsentalettertoSamPage,ascientificdirectorattheagency,recountingMorgan’sallegationsandaskingthatherespondtothem.Butheneverdid.NorwastheagencyresponsivetothevariousFreedomofInformation(FOI)requestshesent.Althoughhedidreceivesomeperfunctoryreplies,hewasnotgiventheinformationaskedfor.Instead,hewastoldthattheinformation“waslost”or“couldnotbefound”andthattheindividualsinvolvedhadalllefttheFDA.However,CristverifiedthatthesepeoplewerestillattheFDA,butwhenheraisedthispointtoanFDAstaffmember,hewasagaintoldthattheyhadleft.HisFOIrequeststotheCentersforDiseaseControlwerelikewiserebuffed.49

Cristhasnotedthattheevasionoftheseimportantquestionssuggestssomethingsinister:“FormorethanadecadethequestionofwhetherSD’sgeneticallyengineeredbacteriawereacausalfactorinEMShasbeendownplayedordeniedoutrightbytheseagencies.Now,itappearsthattheybothmayhaveknownallalongthattheGEstrainsdidplayacrucialroleinEMSandthattheyconcealedthisinformationtoprotecttheU.S.biotechindustry.” 50

CulturingtheCloudsofConfusionInall,theeffortsofthesegovernmentagencies,alongwiththoseofotherbiotechproponents,haveindeed

protectedtheindustry.Thesustainedsuppressionoffacts,conjoinedwiththesteadyspreadoffalsehoods,hascreatedsomuchconfusionthat,althoughgeneticengineeringcannotberuledoutasthemaincauseofthecatastrophe,andalthoughtherearegoodreasonstothinkthatitplayedthekeyrole,neitherthepublicnormostofthejournalistsandscientistswhohavesoughtthetruthareawareofthis.

Aprimeforcefordelusionhasbeentheclaimthatthefiltrationprocesswasprovenguilty–andthatthegene-splicinghasthusbeenacquitted.Despitethestrengthoftheevidencearrayedagainstit,thisassertionhasbeensostaunchlymaintainedthatithasevenmisledexpertswhoendeavoredtostayinformed.Morethanadecadeaftertheepidemic,Imetwithadistinguishedbiologistataleadinguniversitywho,despitehavingfollowedthestoryofthetoxictryptophanmorecloselythanmostscientists,hadbecomeconvincedthatthelethalcontaminationemergedduringthestepsofpurification.Hewasquitesurprisedtolearnthattherewasnoevidencetocompelthisconclusion–andthatitwasquiteplausibletheepidemicstemmedfromthegeneticalteration.ThisnewswouldhavealsosurprisedthebiologistwhowroteabookonbiotechpublishedbyOxfordUniversityPressin1993assertingthat“theproblemwaseventuallytracedtoachemicalgeneratedduringthe(perfectlyconventional)purificationprocedure,andhadnothingtodowithrecombinantDNA.” 51

Duetothevolumeandpersistenceofthemisinformation,theconfusionhascompoundedovertimeandspawnedextremeoutcomes.Someofthemoststrikingappearedinthe2001reportofNewZealand’sRoyalCommissiononGeneticModification.Thisblue-ribbonpanelwassupposedtohelpthegovernmentsetpolicybyassessingthemainissuesregardinggeneticengineering.Afterconductingmonthsofhearings,itissueditsreport.Onesectionofthefourthchapterdealtwiththetoxictryptophan.Inamethodicalmannerandanauthoritativetone,itfullyabsolvedgeneticengineeringofresponsibilityforthelethalcontamination.Butitdidsobyradicallyreshapingreality.

Besidesdistortingseveralfacts,itseemedtopullsomeoutofthinair,makingassertionsthatwerenotonlyutterlyunfoundedbutcompletelynovel.Forinstance,itfalsely(anduniquely)statedthatallthedisease-linkedbottlescamefromasinglebatch,whichimpliedtheproblemwasararequirkthatwasnotassociatedwiththeGEproductionprocessinanyongoingway.52ItadditionallydeclaredthatothermanufacturersbesidesShowaDenkohadmarketedLTderivedthroughbioengineering–andthatbecausenoneoftheseproductsharmedanyone,it’sunlikelythegene-splicinghadcausedEMS.53Yet,therewasnoevidencetosupportthiscontention,itcontradictedcommonunderstanding,andtherewasnoindicationithadpreviouslyappearedinprint.

Thereportthenmovedontoostensiblyclosethecase.Initsmostastoundingpronouncement,itclaimedthatUScourtshadactuallyresolvedtheissueandhaddeterminedthattheepidemicwasnotcausedbythegeneticmodificationbutbyanotheraspectofthemanufacturingprocess.54However,notwithstandingtheboldnessoftheassertionandtheaugustauraofthedocumentinwhichit’scontained,itisflat-outfalse.Andit’shardtocomprehendhowthecommissionevencameupwithit.

WhenIfirstsawthereport,Iwasespeciallystruckbythisstatementbecause,althoughIhadextensivelyresearchedtheepidemic,notonlyhadIneverreadnorheardsuchanallegation,Ihadstronggroundstodoubtit.SoIcontactedCristbecausehehadstudiedthetopicfarmorethoroughly.He,too,wasamazed,becausehe’dneverencounteredsuchanassertioneither.Athisadvice,IphonedDonMorgan,whoselawfirmdefendedShowaDenkoinallofthemorethan2,000lawsuitsbroughtagainstitintheUSHetoldmethatalmostallthesuitsweresettledoutofcourtandthatonlythreewenttotrial.Further,hesaidthatduetothenatureofproductliabilitylaw,thebasicissuewaswhetherSD’sproducthadcausedharm–andthatconsequently,ithadnotbeennecessarytodeterminetheroleofgeneticengineering.Therefore,theissuewasneverraised,andnoneoftheverdictsinanywaytouchedonit.

Notonlyisitsurprisingthatthecommissionadvancedsomanydemonstrablyfalseassertions,it’shardtoknowwhofabricatedthemandhowtheygotincluded.That’sbecausetherewasaserious

deficiencyinthewaythereferencesfortheLTsectionwereprovided.Notonlydidthismakeitpracticallyimpossibletoascertainthesourceofanyparticularstatement,itallowedthepossibilitythatsomeofthefalseoneswerenotevenbasedonthepublichearingsbutinsteadderivedfrominputthatslippedinthroughirregularchannels.55

However,althoughit’sunclearhowthefalsehoodsenteredthedocument,itiscleartheycouldneverhavedonesoifthefactsaboutthetoxicLThadnotbecomethicklyclouded.It’sonlybecausesomuchconfusionhadbeensownforsolongthatamajorreportbyaroyalcommissioncouldhaveharboredsomanybogusassertions–andthatthesefabricationscouldhavebeenacceptedbythemediaandtheNewZealandgovernment.

TheEnduringEffacementofFactsAlthoughitwasmistake-riddled,atleastthecommission’sreportacknowledgedthatGEbacteriawereassociatedwiththeEMS.Butovertime,thiskeyfacthasgraduallyfadedfromgeneralawareness;andthelapseisnotwhollyattributabletomassforgetfulness.Toasubstantialdegree,it’stheresultofasustainedendeavortobefogthatfact.

AndoneofthechiefbefoggerswastheFDA.Whenevertheagencycouldcontroltheflowofcommunication,itstayedsilentaboutgeneticengineeringwhileliberallyimpugningtryptophanitself.AstrikingexampleoccurredonJuly18,1991whenthedeputydirectoroftheCenterforFoodSafetyandAppliedNutrition,DouglasArcher,appearedbeforeacongressionalcommitteetopresenttheFDA’sofficialpositionontheepidemic.Althoughbythatdateitwaswell-knownwithintheagencythatthedisease-linkedbacteriahadbeengeneticallyengineered,Archerdidnotmentionthatfact–nordidheevenrefertothetechnology.Instead,hetargetedtryptophaningeneral,usingtheepidemicasameanstoadvancetheagency’sprotractedcampaignagainstdietarysupplements.HeassertedthatitconfirmedFDA’swarningsaboutthehazardsofsuchproductsandthatthedeathsandinjuries“demonstratethedangersinherentinthevarioushealthfraudschemesthatarebeingperpetratedonsegmentsoftheAmericanPublic.” 56

Foralongtime,theFDAhadarguedthattoprotectthepublicfromsuchschemes,allvitamins,minerals,andaminoacidsindietarysupplementsshouldbebroughtunderitssupervision;andArcheracknowledgedtherewasanagencydesireto“closelyregulate”them.However,mostAmericanswantedfreeaccesstonaturalhealthsupplements,andCongresssidedwiththem,amendingtheFood,DrugandCosmeticActin1976soastolimittheFDA’sauthoritytoregulatevitaminsandminerals.Theagency’sreachoversupplementswasfurtherrestrictedbyseveralcourtdecisions,includingtwothatblockedattemptsitmadetoremoveover-the-counterLTfromthemarket.

ButtheFDA’sdesiretorestrictsupplementsstillsimmered.Anditwassubstantiallyfueledbydubiousmotives.ThisisclearfromareportbyitsDietarySupplementTaskForcestatingthatdeliberationshadincluded“...whatstepsarenecessarytoensurethattheexistenceofdietarysupplementsonthemarketdoesnotactasadisincentivetodrugdevelopment.” 57Reflectingonthis“particularlydisturbing”statement,anarticleintheRutgersLawJournalnotedthattheagency’spolicyinthisarea“hasfarmoretodowitheliminatingcompetitioninthepharmaceuticalindustrythanpreservingthepublichealth.” 58

InthewakeoftheEMSepidemic,theagencysawanopportunitytoadvancethisanti-competitiveaimandachievewhatithadtwicefailedtodoincourt;anditbannedallLTsupplements.Ofcourse,todoso,ithadtopretendthatLTcouldhavecausedtheEMSallbyitself(andignorethecompellingevidencetothecontrary)whileremainingmuteaboutthebioengineeringemployedinitsproduction.Butitsinsinceritywasrevealedbyitsinconsistency.DespiteitsprofessedconcernaboutthehazardsofLT,theagencydisplayedsignificantselectivityinrestrictingit,forbiddingitssaleasanutritionalsupplement

whileallowingpharmaceuticalcompaniestovenditasaprescriptionmedicine(ataroundfivetimesthepriceithadborneasanover-the-countersupplement)–therebyeliminatingapopularandrelativelyinexpensivecompetitortoProzac®andotherantidepressantprescriptiondrugswhich,likeLT,enhancedthelevelofserotonin.59Sodisingenuouswastheagency’sanxietyaboutL-tryptophanthatitevenpermittedthechemical’scontinueduseinbabyfood.

Thus,bymisrepresentingthedetailsoftheEMSincident,theFDAwasabletosimultaneouslyadvancethreeofitscherishedaims.ItcreatedostensiblysolidgroundsfortakingLTsupplementsoffthemarket,itstrengthenedthecaseforstrictlyregulatingallsupplements,anditshieldedgeneticengineering.Moreover,theshieldingwaseffective.Eventhoughthefactswarrantedaprecautionarypolicyonbioengineering,theunequivocalnatureofArcher’spronouncements,conjoinedwiththeconfusionthathadalreadybeencreated,divertedattentionfromit.Accordingly,Congressdidnotinvestigatefurther,andthemediaroutinelyfailedtomentionthetechnologyinregardtotheepidemic,whilefrequentlyparrotingtheFDA’sindictmentofunregulatedsupplements.

By1994,theFDA’sefforttoeffacethefactsofthetoxictryptophanincidenthadgrownsobrazenthattheagencynotonlyignoredtheroleofbioengineeringinthesupplement’sproduction,itevenpretendedthatthesupplementhadneverbeenproduced.Thus,anFDApublicationaboutbiotechfoodsreleasedinthatyearcontainednotawordaboutShowaDenko’sGE-derivedfoodsupplement–whiledeclaringthattheenzymeforcheeseproductionhadbeen“thefirstbiotechnologyfoodproduct,”despitethefactitwasnotintroduceduntilsixyearsafterthetryptophansupplementwasinitiallymarketed.60

Moreover,evenwheninteractingwithexpertswhocouldnotbefooledaboutthefactthetoxicsupplementhadonceexisted,theFDAstilltriedtopinsoleblameforthetoxicityonLTitself.Anespeciallyegregiousattemptoccurredatascientificconferencein2004.AccordingtoStephenNaylor,whoinvestigatedtheepidemicthoroughlywhilehewasaprofessorofbiochemistry,molecularbiology,andpharmacologyattheMayoClinic,anFDArepresentativemadeclaimsabouttheroleofLTinthecausationofEMSthatwereso“bizarre”they“defiedbelief.” 61

So,althoughwhenqueriedabouttherelationbetweentheepidemicandgeneticengineering,theFDAhassometimesconcededthatitcannotberuledoutasthecause,theneteffectoftheagency’sEMS-relatedstatementshasbeennotmerelytoruleitout,buttoblotitout.AndtheFDAhasnotbeenaloneingivingthetechnologythesilenttreatment.Whenevertheycould,otherindividualsandorganizationsthatpromotebioengineeringhavealsoavoideditsmentioninregardtoEMS.Further,they’veincreasinglyproclaimedthatnofoodproducedbyithasevercausedanydisease.Forexample,abrochurebytheAustralia/NewZealandFoodAuthoritytoutingthesafetyofgeneticallymodifiedfoodsdeclared:“...therehasbeennocasereportedworldwideofaGMfoodcausinganadverseeffectonhumanhealth....” 62Intheexceptionalcaseswhereapropounderofsuchclaimshasbeenchallengedbysomeonewithknowledgeofthefacts,heorshewouldcontendthatbecausebioengineeringhadnotbeenproventobetheepidemic’scause,itwasvalidtoassertthatnoneofitsproductshadcausedanyailment–andunwarrantedtostatethatonehad.Butthisargumentisclearlyfalse.It’saccuratetoassertthatafoodproducedthroughbioengineeringcausedadiseaseifit’sobviousthatonedid.Thisdoesnotentailthattheprocesswasthecause,butitdoesimplythepossibility.OnlybyacknowledgingthataGE-derivedfoodhascausedaproblemcanonethenaddressthequestionofwhetherthetechnologywasasignificantfactor.ButbydenyingthatanyGEfoodhascauseddisease,onedistortsrealityandimpliesthere’snothingtoinvestigate.

Despitetheirillegitimacy,thesedenials(andrelateddeceptions)havecontinued;andastheresultantillusionstookhold,scientistsfeltfreetoignoretheEMSdisasterwhenwritingbooksthatpromoteGEfoods.Forinstance,althoughtheypurporttobebalanced,neitherMendelintheKitchen(byamolecularbiologistwho’samemberoftheNationalAcademyofScience)norTomorrow’sTable(byaplant

scientistattheUniversityofCalifornia)mentionsanythingrelatedtotheepidemic–whichenablesthemtopresentamoreappealingpicture.63Nonetheless,theseinfluentialbookshavebeenpraisedfortheirscientificapproach,eventhoughtheyalsoomit(ordistort)manyotherunfriendlyfacts,asthenextchapterreveals.

Theongoinginaccuraciesandomissionshavecausedwidespreaddelusion,evenamongpeoplewhowouldordinarilyhavemaintainedclarity.Thus,althoughseveraljournalistsdidkeepsightofthefactthatGEwasusedinproducingthetoxicproduct,theyweremisledbyothermisrepresentations.Forinstance,thesciencereporterwhoauthoredLordsoftheHarveststatedthatbecausecasesofLTpoisoningoccurredbeforetheintroductionofbioengineering,itwasunlikelytohavecausedtheepidemic.Hethendeclared:“Indeed,ifthetryptophancaseshowedanything,itwasthedangersresidinginfoodsupplementsthatoftenaresoldinhealthfoodstores,notgeneticallyengineeredfoods.” 64Worse,duetotheextentofthedistortions,manycommentatorsdidn’tevenrealizethatgeneticengineeringwaspartofthepicture.AmongthemwastheBritishscientist,SusanAldridge.Inherbook,TheThreadofLife:TheStoryofGenesandGeneticEngineering,notonlydidshefailtonotethetechnology’sinvolvement,shemadeanassertionabouttheepidemic’scausethatwasdevoidofevidentiarysupport.Sheindicatedtheproblemwasinherentinthebacterialstrainitself–andremarkedthatSD’stechnicians“wereunlucky”becausetheychoseonethatproducedatoxiccontaminant.65Thataseasonedsciencewritercommittedsuchablunder,andthattheeditorsatCambridgeUniversityPressletitslideby,indicatehowmuddledthefactshadbecome.

EquallyindicativeisareportonL-tryptophanissuedbyaprominentnaturalhealthcenter.IndiscussingthecontaminationthatcausedtheEMS,itstates:“Themanufacturingerrorwasidentifiedandcorrectedrelativelyquickly.” 66ThisreportwaswritteninDecember2009byamedicaldoctorwhoisapast-presidentoftheAmericanHolisticMedicalAssociation,andithascirculatedwidelyforseveralyears,appearingwithinanumberofhealth-relatedmagazinesandwebsites.Further,it’snoteworthythatthehealthcentersponsoringthearticleappearstobeopposedtoGEfoods(anotherarticleonitssitecautionsagainsteatingthembecausethey’re“notnatural”).67Nonetheless,despitethepreferencefornaturalapproachessharedbythecenterandtheauthor,anddespitethelatter’sexpertise,notonlywasheunawarethatbioengineeringhadbeenusedtoproducethedisease-linkedLT,andthatitmaywellhavebeentheepidemic’scause,heabsorbedthefalseimpressionthatasimplemanufacturingerrorwasconclusivelyidentifiedasthecausativefactor.Further,themassofmisinformationhasbeensoconfoundingthatmanycommentatorsevenlostsightoftheepidemic,includingtwojournalistswhocoveredGEfoodsforyearsbutwhosepopularbooksonthetopicfailedtomentionthecalamityatall.68

Notsurprisingly,theconfusionismorewidespreadwithinthegeneralpublicthanamongexperts.ThevastmajorityofpeoplewithwhomI’vespokenovertheyearshadnoinklingthatafoodsupplementproducedthroughbioengineeringwasassociatedwithamajorcatastrophe;andit’slikelythatmostreadersofthisbookarelearningaboutitforthefirsttime.

TheThalidomideofGeneticEngineeringWhiletheobfuscationoftheepidemichasbeensignificantlynefarious,itsinitialdetectionwaslargelyfortuitous.Thediscoverywasduetoanomaly;andifthesymptomsofEMShadnotbeensounusual,theepidemicwouldprobablyhavegoneunnoticed.Crist,alongwithabiochemistandamedicaldoctor,emphasizedthispointinanarticlecomparingtheGEtryptophantothalidomide,adrugusedbetween1957and1961thateasedmorningsicknessinpregnantwomenwhileunexpectedlyinducingseveredeformitiesintheirfetuses.Theystatedthat“ifthalidomidehadhappenedtocauseatypeofbirthdefectthatwasalreadycommon,e.g.,cleftpalateorseverementalretardation,wewouldstillnotknowabouttheharm,andpregnantwomenwouldhavekeptontakingit”because“thefractionaladditiontofigures

thatwerealreadyrelativelylargewouldnothavebeenstatisticallysignificant.” 69Theynotedthattheadverseeffectsweredetectedonlybecausetheywereextraordinary(majormalformationsofthearmsandlegs)andthat,similarly,thediseasecausedbySD’stryptophan“stoodout”becauseitwasnovel.Theyobservedthatifinsteadithadcausedthesamequantityofacommonillness,“wewouldstillnotknowaboutit.”Likewise,“ifithadcauseddelayedharm,suchascancer20-30yearslater,orseniledementiainsomewhosemothershadtakenitearlyinpregnancy,therewouldhavebeennowaytoattributetheharmtothecause.”

It’ssoberingthat,despitethenoveltyofEMS,manyyearshadtopass(andanepidemichadtoerupt)beforeitwasfinallydetected;andevenafterthatdramaticoutbreak,severalmonthselapsedbeforethedetectioncouldbeaccomplished.Further,severalmoremonthspassedbeforethediseasecouldbelinkedtoSD’stryptophan.ThisprovidesgroundsforquestioningthesafetyofthemanysupplementsandadditivesderivedfromGEbacteriathatarecurrentlyinuse.Themerefactthattheysatisfynormalstandardsofpuritydoesnotruleoutthepresenceofcontaminantsthatarehighlytoxicatextremelylowconcentrations(aswasthecasewithSD’sproduct).Nordoesthefactthatthere’sbeennoobservedlinktodisease,sinceatoxinmightbecausingacommonmaladythat’sgoingundetected.TheuncertaintyisunderscoredwhenonerealizesthatifSD’slethaltryptophanwasfirstappearingtoday,itcouldenterthemarketjustasfreelyasitdidtwenty-fiveyearsago,inEuropeaswellastheUS.70Accordingly,manyexpertshavewarnedthatGE-derivedadditivesshouldundergothoroughsafetytestingbeforethey’reapprovedforsale–warningsignoredbythosewiththeauthoritytoimplementthereformtheycallfor.

TheEvidenceImplicatesBioengineeringastheMostLikelyCauseoftheCalamityAswe’veseen,theEMSstoryisrepletewithanomaly,surprise,andparadox.Althoughgeneticengineeringcannotberuledoutasthecalamity’scause,duetoanexceptionaldegreeofmisinformation,notonlydomostexpertsbelieveit’sbeenabsolved,manydon’tknowitwaseveninvolved.Moreover,onlyafewofthepeoplewhocomprehendthattheengineeringcouldhavebeenthecriticalcauserealizehowstronglytheevidenceimpliesthatitactuallywas.Sostrongisthecaseagainstthetechnologythat,althoughtheRoyalCommissionfalselyassertedthatUScourtshadfounditblameless(despitethefactitsinvolvementwasnotatissue),ifitsroleactuallyhadbeenthedecisivefactor,theverdictswouldmostlikelyhavedeemeditculpable.That’sbecauseinaciviltrial,whereonlymonetarydamages(notthedefendant’slifeorliberty)areatstake,theplaintiffdoesnotneedtoprovehiscasebeyondareasonabledoubt.It’ssufficienttodemonstratethatthepreponderanceofevidenceisonhisside.ThatmeanstheEMSvictimscouldhavewonsimplybyshowingitwasmorelikelythannotthatGEcausedthecriticaltoxicity.Andtheevidenceclearlytiltstowardsuchanoutcome:

EvenpeopleconsuminghighdosesofconventionallyproducedLTdidnotcontractEMS,whichindicatesthatLTalonewasnotthecause.

AlltheLTthatwasdefinitelylinkedtoEMSwasproducedbyShowaDenko.

SDwastheonlymanufacturerthatusedgeneticallyengineeredbacteria.

NotonlywerealltheepidemiccasesofEMSthatcouldbetracedlinkedtoGEbacteria,everypre-epidemiccaseappearstohavebeenlinkedtostrainsofGEbacteriaaswell.

AsSD’sbacteriawereincreasinglyalteredtooutputgreaterlevelsofLT,itappearstherewasconcomitantincreaseinstress,resultinginmetabolicimbalances.Italsoappearsthatasthegeneticmanipulationsbecamemorepowerful,theLTbecameproportionatelymoreharmful.

(a)Thepresenceofunusualcontaminants,(b)thelethaltoxicityofatleastoneofthematanextremelylowconcentration,and(c)theoddwayinwhichtheirconcentrationsfluctuatedovertime

arephenomenamorereadilyexplicableaseffectsofgeneticengineeringthanasoutcomesofanotheraspectoftheproductionprocess–especiallysincethereisnoevidenceindicatingthatthecriticalcontaminantwasgeneratedduringthepurificationphase.

ImportantNewEvidenceIncreasestheLikelihoodthatBioengineeringWastheCauseFurther,theprecedingsummaryonlyreflectsfactsthatwereavailablewhenthesuitsweredecided.Today,thecaseagainstgeneticengineeringisevenstronger.AstheneurobiologistDavidSchubertpointsout,althoughformanyyearsitwashardtoexplainhowanextremelyminutecontaminant(wellbelow0.01%byweight)couldhavecausedfataldysregulationoftheimmunesystem,wenowhaveabetterperspective.Henotesthatseveralstudieshaverevealedthatmetabolites(derivatives)ofLTcontrolimportantstepsoftheimmuneresponse,whichpresentsthepossibilitythatunusual(butanalogous)metabolitesinducedbytheoverproductionofLTcouldhavedisplacedtheordinaryversionsanddisruptedpeople’simmunefunctionindisastrousways.71

Moreover,thestructureofthecontaminantmostcloselycorrelatedwithEMShasfinallybeenascertained;andit’sanovel,metabolicallyderivedcompoundoftryptophan.Aspreviouslynoted,thatcontaminantwasdubbedAAA,anditsstructurehadremainedunknown,eventhoughanalysisbyCDCscientistsshowedittobetheonlycontaminantlinkedwithEMStoastatisticallysignificantdegree–promptingthemtourgethat“highpriority”beplacedonthequesttoidentifyit.72Nonetheless,despitethisplea,ittookanothersixyearsbeforetheidentificationwasachieved;and,asIwrite,onlyafewpeopleareawareithashappened.

IlearnedofitbecauseIheardthatStephenNaylorandGeraldGleich,whohadidentifiedthestructuresofthefiveothercase-associatedcontaminantswhiletheywereattheMayoClinic,hadalsoinvestigatedAAAduringtheirtenurethere.SoIcontactedDr.Naylor,andaseriesofcommunicationsensuedduringwhichheconveyedthedetailsoftheresearch.

Beforetheinvestigationbegan,NaylorhadhypothesizedthatinorderforatoxiccontaminantingestedinextremelyminutequantitiestoinduceEMS,itwouldhavetoavoidimmediateexcretionandremaininthebodyforaprolongedtimesothattheeffectsofsuccessivedosescouldaccumulate.Thiswouldrequireittobefatsolubleratherthanwatersoluble,whichwouldenableittolodgewithinfattytissuesandthenslowlyseepintothesurroundings.Butthestructuresoftheotherfivecase-associatedcontaminantswerewatersoluble–andhencefataversive.WouldthestructureofAAA,thecontaminantlinkedwithEMStoanexceptionallyhighdegree,provetobeanexceptioninthisregardaswell?

Inthelatterpartof1998,NaylorandGleichhadachancetofindout.TheyobtainedsometabletsfromabatchofSDtryptophanthathadcausedanextraordinarilylargenumberofEMScases.Then,employingsophisticatedanalyticalseparationtechniques,theydeterminedthat,whiletheoverallconcentrationofAAAwasminute,itwasnonethelessquitehighinrelationtoitslevelsintabletsfromlesstoxicbatches.Further,itwastheonlycontaminantofthesixcase-implicatedcompoundsthatwasmarkedlyelevated.

Thenextstepwastoascertainitsstructure.Throughmassspectrometry,andgreatperseverance,theyultimatelydeterminedthatAAAhadbeenformedbythefusionoftwocompounds.OnewastheLTmolecule(minusasinglehydrogenatom),andtheotherwasalongchainhydrocarbonderivedfromafattyacidthat’sfoundinallbacteria.73Basedonthisstructure,theresearcherscoulddrawsomeimportantconclusions.

AccordingtoDr.Naylor,it’sabiologicalcertaintythatsuchacompoundcouldnothavearisenduringpurification.WhenIspokewithhim,hemadethispointatleasttwice,withoutatraceofqualification.Hefurthernotedthatchainsofthiskindareformedwithinbacteria–andthattheywouldhavetobesynthesizedviabiologicallyproducedenzymes.Consequently,hestatedthere’sa“highprobability”thattheAAAmoleculeshadanintra-bacterialbirth.Moreover,althoughheacknowledgedthepossibilitythey

wereproducedoutsidethebacteria(withinthefermentationbrothbeforeitenteredthepurificationphase),hesaidthispossibilityhad“lowprobability.”Headdedthateveninthatcase,thesynthesiswouldhavereliedonenzymesfromthebacteriaactinguponLT;andheemphasizedthatineitherinstance,thesynthesiswouldalmostsurelybeattributabletothealterationofthebacterialDNAandthemassiveoverproductionofLTitinduced,whichmostlikelydestabilizedtheorganisms’metabolismandcausedunusualsidereactionsresultingintheformationofAAA.

Thus,it’sbeendemonstratedthatthecontaminantmostsignificantlyassociatedwithEMSisanovelcompoundformedbybacteriallyproducedenzymesactingonL-tryptophanwellbeforethepurificationprocesscouldhaveexertedaneffect–whichstronglyimpliesthattheengineeringofthebacteriawastherootcauseofitscreation.Further,accordingtoNaylor,“Notonlyisitvirtuallycertainthatthiscontaminantwasformedthroughtheactionofbacterialenzymes,itschemicalstructurerendersitfatsoluble.Incontrasttotheothercase-associatedcontaminants,theseuniquechemicalpropertiesofAAAfacilitateuptakebyfattytissue,allowingaccumulationandconcentrationbythebody–potentiallyresultinginthestimulationofeosinophilsand,ultimately,theonsetofEMS.” 74Therefore,althoughwecannotsayforsurethatAAAtriggeredtheillness,wedoknowthatit’squiteplausible;andwealsoknowit’shighlyprobablethatthisnovelandpotentiallytoxiccompoundemergedthroughabnormalmetabolicactivitycausedbythehyper-productionofL-tryptophan.

However,despitetheimportanceofthisdiscovery,theresultshaveyettobepublished.WhenIaskedDr.Naylorwhy,heexplainedthatalthoughheandGleichhaddefinitelydeterminedthatAAAconsistsofanLT-likeskeletonconjoinedwithaninecarbonlinearchain,thereisstillsomeuncertaintyabouttwominorpoints.First,whileit’sclearthatthechainisattachedtotheskeleton,it’snotclearatwhichoftwoadjacentplacestheattachmentismade.Further,althoughtheyknowthatthechaincontainseightsinglebondsandonedoublebond,it’snotevidentatwhichoftwoneighboringpositionsthedoublebondoccurs.

ButistheexistenceofthesetwosmalluncertaintiesrelevanttotheissueofhowAAAemerged?WhenIposedthisquestion,Naylorrepliedthattheambiguitieshadabsolutelynobearingonthatissue.However,theydidaffectthechancesofgettingtheresearchpublished.HeexplainedthatscientificjournalswouldrequirethedeterminationofAAA’sstructuretobecomplete–andthatafterheleftMayoin1999totakeanotherposition,theresearchcouldnotbesustainedwiththesameintensity.Further,afewyearsthereafterDr.Gleichalsomovedontoassumenewresponsibilities;soit’snotclearwheneitherofthemwillhavethetimeorresourcesrequiredtogainthefinalbitsofknowledge.Yet,becausetheevidencealreadyacquiredhasprofoundimplications,Dr.Naylorhasagreedforittobepresentedinthischapteras“unpublishedwork.” 75

WiththeunveilingoftheevidenceaboutAAA,theEMSstorycomestoaclose–atleastfornow.It’sastorythatbeginswithagonyandendsinirony.EvenwithouttherevelationsregardingAAA,thefactsplainlypointtowardgeneticengineeringastheunderlyingcauseoftheEMS;butthey’vebeensobefoggedthatmanyscientistsdon’tevenknowthetoxictabletswereproducedthroughit,whilemostofthosewhodoknowbelievethatit’sbeenproveninnocent.Moreover,notonlyhastherebeensystematicobfuscationoftheepidemic’scause,there’sbeensubstantialobfuscationoftheepidemicitself–tosuchanextentthat,althoughtheGE-linkeddisasterwasdetectedonlythroughitsuncommonsymptoms,mostpeopleareasobliviousofitastheywouldbeifthesymptomshadinsteadbeencommonplace.

Thus,justasthesmoothadvanceofthebioengineeringventurehad,intheyearspreceding1989,dependeduponthecloudingofunfavorablefacts,soitscontinuedprogresswasenabledbyobscuringthefactsaboutthetoxictryptophan,thefirstingestibleproductofrecombinantDNAtechnology.Yet,inthelattercase,thefactswerenotmerelycloudedbutessentiallyshrouded–andultimatelyburied.Absentsuchinterment,thedevelopmentofbioengineeredfoodswouldalmostcertainlyhavebeendelayed,andprobablyderailed.

Moreover,inordertokeepGEfoodsonthefasttracktocommercialization,itwasinsufficientmerelytoobfuscatethedisasteronehadcaused.Inthefollowingyears,asthecampaigntobringthemtomarketacceleratedanditsattendantcontroversiesflared,theirproponentswouldfinditincreasinglynecessarytodistortandevensuppresskeyfactsabouttheveryprocessbywhichsuchfoodsareproduced.

CHAPTERFOUR

GENES,INGENUITY,ANDDISINGENUOUSNESS

ReprogrammingtheSoftwareofLifewhileRefashioningtheFacts

“...thereisaseamlesscontinuumbetweenconventionaland‘new’GM[geneticmodification].” 1HenryI.Miller,FoundingDirector,FDAOfficeofBiotechnology(ontherelationbetweenconventionalbreedingandrecombinantDNAtechnology)

“RecombinantDNAtechnologyfacesoursocietywithproblemsunprecedentednotonlyinthehistoryofscience,butoflifeontheEarth.Itplacesinhumanhandsthecapacitytoredesignlivingorganisms....Suchinterventionmustnotbeconfusedwithpreviousintrusionsuponthenaturalorderoflivingorganisms....2[Itis]thebiggestbreakinnaturethathasoccurredinhumanhistory.” 3GeorgeWald,NobelLaureate;ProfessorofBiologyEmeritus,HarvardUniversity

PressurestoRepresstheFactsIn1993,OxfordUniversityPresspublishedBiotechnologyfromAtoZ,aguidetotheterminologyandtechniquesofwhathadbecomeoneofthemostimportantandcontroversialfieldsofappliedscience.Itwaswrittenbyaprofessionalbiologist,itpresentedapositivepictureofthisremarkablenewphaseofhumanenterprise,anditwaspraisedbyseveralscientificjournals.Theintroductionwaswrittenbythepresidentofacorporationattheforefrontofbiotechnologyandexpressedwhatformanyyearshasbeenastandardthemeinthestatementsofitsproponents:thatitiscrucialtoeducatethepublicaboutthisinnovativeendeavorandtoensurethattheinformationtheyreceiveisaccurate.4

Butinasubsequentsectionofthebook,itsauthor,WilliamBaines,indicatedthatsuchaneducationalinitiativewouldlikelybackfire.Henotedthatresearchhasrevealedaninverserelationbetweenthepublic’sknowledgeaboutbiotechnologyandtheiracceptanceofit,withpeoplelessreceptivethemoretheylearnthedetails.Heobservedthatinlightofthisphenomenon,biotechadvocatesmighthavegreatersuccessbyprovidingthepopulacefewerfactsandmore“mythicimages.” 5Andheunderscoredthesignificantroleofmyth-makinginthebiotechventurebygivingthetopicitsowndistinctheading:Mythogenesis.

Fromsuchaperspective,itappearsthere’snofieldofbiotechnologyinwhichtheneedformythcreationhasbeengreaterthanthatofgeneticallyengineeredfood.Becausefoodsafetyissuchavitalandvisceralissue,peopletendtobeespeciallywaryaboutwhattheyperceiveasartificialtinkeringwiththeDNAofplantsandanimalsthatarebasictotheirdiets,andmostdisplaysignificantreservationswhentheyfirsthearabouttheagriculturalbiotechagenda.Further,becausethisinitialresistancegenerallyintensifiesaspeoples’knowledgeofthefactsincreases(atrendthatcontinuestobeconfirmedbyresearchinavarietyofnations),6biotechadvocateshavefrequentlyfounditexpedienttofollowthecoursesuggestedbyDr.Bainesandoptforcreativityovercandor–fashioningagroupofmythicimagestoaidtheircause.Forinstance,amemorandumfromtheworld’slargestpublicrelationsfirm,Burson-Marsteller,totheEuropeanbiotechindustry(whichwasleakedtoapublicinterestgroup)counseledittoeschew“logic”andinsteademploy“symbols,”particularlythose“elicitinghope,satisfaction,caringandself-esteem.” 7

However,atleastoneaspectofthepublic’swarinesscouldnotbeeasilyassuagedwithevocativesymbols:theperceptionthatproducingnewvarietiesofcropsthroughgeneticengineeringisaradicalandunnaturaldeparturefromtraditionalbreeding.Soproponentsofgeneticengineeringtriedtooverwhelmthisperceptionbyinducingacompellingcounter-impression:thattheprocessismerelyaminorextensionoftraditionalbreedingpractices.Moreover,manyprominentadvocateshaveinsistedthattheconnectionisquiteclose,withHenryI.Miller,thefoundingdirectoroftheFDAOfficeofBiotechnology,proclaiming(inawidelycirculatedstatement)thatthere’s“aseamlesscontinuum”betweengeneticengineeringandwhatcamebefore.8

Andtofurtherblurthedistinctionbetweenthenovelandtraditionalprocesses,biotechproponentstransformedtheirterminology.AlthoughtheyhadinitiallyreferredtotheuseofrecombinantDNAtechnologyas“geneticengineering”becauseofthepositiveassociationstheyexpectedittoconvey,theyeventuallylearnedthatinmostpeoples’minds,thetermdidnotprimarilyconnotecontrolandprecisionbutartificial–andpotentiallydetrimental–intervention.Sotheydecidedtorecasttheprocessasmere“geneticmodification,”whichseemedtostrikethepublicaslessthreatening.Moreover,whereas“geneticengineering”hadbeenexclusivelyappliedtorDNAtechnology,thenewtermofchoicewasnotsorestrictedandwasemployedinreferencetoallformsofbreeding(evensimplesexualreproduction),withgene-splicingpresentedasthe“new”or“modern”phaseofgeneticmodification.

Additionally,whiledownplayingdifferencesthatcouldcauseconcern,theproponentsadvancedtheideathatthisnewtechnologydoesdifferfromconventionalpracticesinonekeyrespect.Theyclaimed

thatit’smoreprecise;andtheycontendedthatbyvirtueofthisprecision,itismorepredictablethanconventionaltechniquesandisconsequentlyasaferwaytogeneratenewvarietiesoffood.Andtheseclaimscouldbemarkedlyimmodest.DuringaBBCinterviewin2000,thepresidentofBritain’sRoyalSociety(whoforfiveyearshadservedasthegovernment’schiefscientist)declaredthatgeneticengineeringis“vastlysafer”and“vast,vastlymorecontrolled”thanconventionalbreeding.9

However,notwithstandingitsprevalence,andtheprominenceofmanywhoadvancedit,theportrayalofgeneticengineeringasaminor,precision-enhancingextensionofnaturalbreedingwasstarklyatoddswithreality.Itwasyetanotherinstanceofmyth-making:biotech’sown“creationmyth,”depictingthegenesisofGEOsinanattractivebutessentiallyfictitiousmanner.

Theextentofthefictionbecomesevidentwhenoneexaminesthevariousmanipulationsthatarenecessarytoproduceanewtypeoffood-yieldingorganismviageneticengineeringanddiscovershowimpreciselytheyfunction,howmanynaturalbarrierstheyhadtosurmount,andhowunpredictablehavebeentheresults.Asweshallsee,notonlyisthereadeepdisparitybetweentheelegantproceduresthroughwhichneworganismsaregeneratedandsustainedundernaturalconditionsandthecrudecontrivancesofgeneticengineering,inseveralrespects,thetwomethodsinduceopposingoutcomes.

HowNatureFunctions:TheEssentialDynamicsofLivingSystemsLivingorganismsarecomprisedoflivingcells.10Thesimplestorganisms,suchasbacteria,consistofasinglecell,whileplantsandanimalscontainmillionsortrillionsofdiverseandspecializedcellsthatgiverisetoavarietyoftissuesandorgans.Butwhetheranorganismconsistsofonecelloramyriad,itstandsinstarkcontrasttoitsnonlivingsurroundings.Everylivingentitydisplaysahighdegreeoforganizedcomplexity,andeachintegratesamultitudeofdiversepartsintoaharmoniouslyfunctioningwhole.Suchorderlinessisabsentwithintheinanimaterealmofnature,andnoneofitsstructurescomesanywhereclosetothedegreeoforganizationexhibitedbyeventhesimplestbacteria.Further,duetothedistinctwayinwhichorganismsarestructured,theycanaltertheordinarycourseinwhichenergyflows.Inthenonlivingworld,energytendstodissipate,anditdiffusesinafairlyuniformandundirectedmanner.Butenergyflowsotherwisewithinanorganism.Itissystematicallyabsorbed,stored,andthenefficientlyutilizedtopowerahostofprecisemanufacturingprocesses,yieldinganenormousrangeofproductsthatsustaintheorganism’sexistence.11

Theseprocesses,andtheenergytransformationsthatdrivethem,occurthroughavastvarietyofchemicalreactions.And,aswiththeotherfeaturesoforganisms,mostofthesereactionsareinasignificantwayuniquetotheanimateworld.Thevastmajorityneverhappeninnonlivingnature,andofthosethatdo,mostoccurfartooinfrequentlytofulfilltheneedsoflife.Iforganismshadtowaitforthesereactionstooccurattheirnormalpace,theycouldnotsurvive–andcouldneverhavecometoexist.Fortunately,andmarvelously,allorganismspossesstheabilitytoinducereactionsthatneveroccurinthenonlivingworldandtoprofoundlyincreasetherateofthosethatdo.Theyaccomplishthesefeatsbyproducingaspecialsetoftoolsintheformofproteins.Whilemanyproteinsserveascomponentsofacell’sstructure,thosethatserveasitsreaction-enhancingtoolsarecatalysts–agentsthatfacilitatetheinteractionandtransformationofotherchemicalswhilenotbeingchangedthemselves.

Althoughcatalystsexistinnonlivingnature,theyarefarmoreabundant(andmorevaried)withinlivingcells.Suchcell-dwellingcatalystsarecalledenzymes,andtheyarethebiggestclassofproteinswithinanorganism.Theaveragemammaliancellcontainsabout3,000ofthem.12Eventhesimplestbacteriumrequireshundredsofenzymestofunction,andwithoutthem,therewouldbenolifeonearth.

Moreover,cellsmustnotmerelybeabletocreatecatalysts,theymustdososelectively.It’snecessarythattheystimulatetheproductionofspecificreactionsonlyasneeded–andjustasnecessarythattheykeepthemyriadproductionprocessescoordinated.Otherwise,inattemptingtomakeenoughofthe

materialsonwhichtheydepend,theycouldbeoverwhelmedbytoomuchofaparticularproductevenwhenitisneeded,ordisruptedbyitsappearance(eveninaminuteamount)whenitisn’t.

Theremarkableprocessesbywhichlivingorganismscreatethekindsofenzymestheyneed,attherighttimes,andintheproperamountsandplaces,relyonasourceoforderthatishighlystablewhileenablinggreatadaptability.Sinceinformationtheoryrecognizesacloserelationshipbetweeninformationandorderanddefinesinformationintermsoforderliness,it’snotsurprisingthatthebasisoftheorderunderlyingthestabilityandflexibilityoflifeprocessesisanexquisiteinformationsystem.

DNAasaRepositoryofFoundationalBiologicalInformationThisinformationsystemiswithineverycell;andeachcell,whateveritstype,functionsasapowerfulinformationprocessingmachine.13Althoughportionsoftheinformationaredispersedthroughoutseveralcellulardomains,alargeandessentialpartofitisencodedwithinanextraordinarymoleculereferredtoasdeoxyribonucleicacid,orDNA,thatresidesattheheartofthecell.BacterialcellsusuallycontainonemainDNAmoleculewhilehigherorganisms,whichpossesslargerandmorecomplexinformationsystems,areendowedwithasubstantialnumber.14Butwhethercontainedwithinonemoleculeorspreadamongmany,theinformationencodedbyDNAisfoundationalforthecoordinatedgrowthandfunctionoftheorganism.Itisthereforeimmense–andmustbehighlycondensed.Infact,itismoredenselyandefficientlystoredthantheinformationinanyman-madesystem.15

DNA’sprofoundinformation-bearingcapacityisduetoitsstructure.Thebasicconstituentsarecallednucleotides,andthey’recomposedofaphosphatemolecule,afive-sidedsugarmolecule,andanitrogen-bearingmoleculecalledabase.Whilethephosphatesandsugarsarethesamefromnucleotidetonucleotide,thebasesvary.Therearefourdifferentones,eachwithadistinctchemicalstructure:adenine,thymine,cytosine,andguanine(commonlydesignatedbytheirfirstlettersA,T,CandG).

Nucleotidesnaturallypairupbecausethere’sachemicalattractionbetweenadenineandthymineandbetweencytosineandguanine,whichcausesthemtobondtogether.Thisresultsinsegmentsthathavephosphateandsugarmoleculesateachendandbasepairsofeitheradenineandthymineorcytosineandguanineinthecenter.(SeeFigure4.1)InaDNAmolecule,numeroussegmentsarealignedinaladder-likestructure,withthephosphateandsugarcomplexesformingtheouterrailsandthebondedbasepairstherungs.Further,thisladderisnotessentiallyaflattwo-dimensionalstructurebutistwistedintoahelix,sothatinthree-dimensionalspace,itismorelikeaspiralstaircase.(SeeFigure4.2)

AlthoughitsspiralstructureendowsDNAwithimportantproperties,thekeyfactorunderlyingitsprofoundinformation-bearingcapacityisthevariabilityofthebasesembeddedwithinthespiral–andtheselectivewaytheybondtooneanother.Thesebasesconveyinformationthroughthesequenceinwhichtheyappear,becausethesequenceservesasacode.Thecodeconsistsofequal-sizedunitsofmeaningcomprisedofthreebases.Thesethree-baseunitsarereferredtoascodons,andwhattheyspecificallycodeforareaminoacids,thebuildingblocksofproteins.Becausethemeaningisinthesequence,threecontiguousthymines(TTT)bearadifferentsignificancethandotwothyminesfollowedbyadenine(TTA),andeachoftheseunitscodesforadifferentaminoacid.However,becausetherearetwentybasicaminoacids,andbecausethefourbasescanbearrangedtoformsixty-fourcodons,mostaminoacidsaresignifiedbymorethanone.Forinstance,bothTTTandTTCcodeforphenylalanine,whileTTA,CTA,andfourothercodonsdenoteleucine.

Proteinsareformedfromchainsoflinkedaminoacids,andeachtypeofproteinhasadistinctsequenceofthem.Theseprotein-specifyingsequencesofaminoacidsarederivedfromcorrespondingsequencesofcodonswithinspecialregionsofDNA.Theseinformation-richcodingregionsarecalledgenes.Humanshaveover20,000ofthem,andevensomebacteriacontain5,000.

Cellshaveseveralfinelytunedtoolstoconvertthesequencesofcodonswithingenesintoproteins,andtheprocesshastwobasicstages.Inthefirst,aspecializedenzymetravelsthelengthofthegeneandtranscribesitsinformationintoastrandofanother(butsimilar)typeofnucleicacidcalledribonucleicacid,orRNA.Inthesecondstage,thisRNAstrandbecomesamessengerandcarriestheinformationtoanintricatestructurethatcantranslateitintoachainofaminoacidsthatwillthenfoldintoaprotein.16(SeeFigure4.3)

PropagationandProgress:ContinuityEnrichedbyDiversityBesidesDNA’sessentialroleinthedevelopmentandsurvivaloftheindividualorganism,itenablesthesurvivaloftheorganism’sspecies.Byvirtueofitsuniqueattributes,organismscanpropagateneworganismsendowedwiththeessentialstockofgeneticinformationthattheythemselvespossess,preservingthespecies’fundamentalcharacteristics.

Althoughthisprocessofpreservationthroughpropagationoccursinallspecies,itsmechanicsvary.Forsingle-celledentitieslikebacteria,propagationoccursthroughcelldivision,whichyieldstwoorganismsinplaceofone.ThisispossiblebecausetheDNAmoleculecanbereplicated,furnishinganidenticalcopyaroundwhichanothercellcancoalesce.(SeeFigure4.4)However,whilethisprocessassurescontinuity,itdoesnotfosterdiversity–andlackofdiversitycanleadtoproblems,becauseifaspecies’genomeremainsuniformfromgenerationtogeneration,ithasdifficultyadaptingtoenvironmentalchange.Ofcourse,genomescanchangeviaspontaneousmutations;andalthoughmostaremaladaptive,somearebeneficialandcanbeconservedinthespeciesovertime.Butbacteriahaveadditionalwaystoincreasetheirgeneticdiversity–waysthroughwhichtheyacquiregenesfromotherbacterialspecies.

Author’sNote:ThisillustrationdepictstranscriptionofDNAintomessengerRNA(mRNA),anditshowsthatthemRNAtravelsoutsidethenuclearmembraneintothesurroundingcytoplasmfortranslationintoanaminoacidchain.Butitdoesnotdepictthattranslationprocess.

Oneway,calledconjugation,reliesondirectcontactbetweentwobacteria,oneofwhichisthedonor

andtheothertherecipient.Atubuleextendsfromthedonor,andcopiesofsomeofthegenesaretransmittedtotherecipient’sinterior.Althoughtheentiregenomeisrarelytransferred,asubstantialamountofgeneticmaterialcanbeconveyed.Therearetwootherwaysinwhichsomebacteriacangainforeigngenes,andwhileneitherrequirescontactwithanotherbacterium,onedoesdependontheagencyofanotherentity–butinthiscase,it’savirus.Sometimes,wheninfectingabacterium,aviruspullsone(orafew)genesfromitsDNA,movesontoinfectabacteriumofadifferentspecies,andtransferstheforeigngeneticmaterialtoit.Further,insomeinstances,decomposingbacteriareleaseabitofDNAthat’sdirectlyabsorbedthroughtheouterwallofanotherbacterium.

Incontrasttobacteria,mostplantsandanimalsenhancetheirgeneticdiversityinamorecomprehensivemanner:sexualreproduction.Inthisprocess,DNAfromtwoorganismsiscombinedtoformanewone;andevenwhentheparentsarefromthesamespecies(theusualsituation),there’sasignificantincreaseingeneticdiversity.That’sbecauseofthewayDNAisarrangedwithinhigherorganisms–andisdeployedduringtheirreproduction.

Aspreviouslynoted,whilemostbacteriahavebutonemainDNAmolecule(whichisgenerallycircular),plantsandanimalshaveseveral.Thesemoleculesareusuallylinearand,incombinationwithspecializedproteins,eachformsanorganizedstructurereferredtoasachromosome.Moreover,eachchromosomehasapartner,whichcontainsthesamegenesinthesamesequence.17However,althoughthecorrespondinggenesarethesame,theycanstilldifferfromoneanother.That’sbecause(aswasdiscussedinChapter2)therearealternativeversionsofagene,calleditsalleles,justastherearedifferentversionsofaparticularmodelofacar.Inpreparationforsexualreproduction,anorganismformsspecialcells(calledgametes)towhichitcontributesonlyonesetofchromosomes.Butbeforethepartnerchromosomesareseparatedandencasedinseparategametes,theyexchangesomecomplementarysectionsofDNA.Inthisway,eachendsupwithadifferentsetofallelesthanitpreviouslypossessed,enhancingdiversity.

Gametescomeintwobasictypes:maleandfemale.Andmostanimalscomeindistinctmaleandfemaletypestoo.Amaleanimalproducesonlymalegametes(sperm),femalesproduceonlyfemalegametes(eggs),andthespermfromthemalescombinewiththeeggsofafemale.Incontrasttoanimals,mostfloweringplantsarebi-sexual,andasingleorganismcommonlycreatesbothmaleandfemalegametes.Aplant’smalegametesareusuallyencasedinpollengrainsthattravelviaeitherthewindorinsectstofertilizethefemalegametesofotherplants,whileitsownfemalegametesreceivepollenflowinginfromothers.18

Whateverthespecies,whenthemaleandfemalegametesunite,everychromosomeinthespermispartneredwiththecorrespondingchromosomeintheegg.Theresultantcellisthusendowedwithafullcomplementofchromosomesandcandevelopintoamatureorganism.Further,becausethatorganism’sgenomeisablendofchromosomesfromeachparent,andbecauseseveralcombinationsofalleleswithinthosechromosomeswererearrangedpriortogameteformation,theorganismwillnotonlybegeneticallydistinctfromeachparentbutwillpossesssomefeaturesfoundinneither.

TheModesofConventionalBreedingFormillennia,farmersaddeddirectiontothereproductiveprocessofcultivatedplantsbyselectingthemostdesirablespecimensfromeachyear’sharvestandreplantingtheirseeds.Then,inthemodernera,breederslearnedtheycouldmorecloselyguidetheprocessbyselectingwhichplantswouldmate.Bytakingpollenfromaplantwithonesetofvaluabletraitsandplacingitonthepollenreceptorofaplantwithotherdesirablefeatures,offspringexhibitingbothsetsofqualitiescouldresult.

Throughthenaturalmodesofbreeding,tremendousdiversityhasarisen.Forinstance,over100,000varietiesofricehavebeendeveloped.19However,whilenaturepromotesabundantgeneticvarietywithinthevariousspecies,itrestrictstheexchangeofgenesbetweenthem.Withinnature’ssystemofboundaries,notonlyisitimpossibletointerbreeddistantandunrelatedorganisms,manyspeciescannotevenbecrossedwiththeircousins.Thus,therearenoavenuesformatingtomatoeswithfish,and,althoughpeachesandcherriesarecloselyrelated,placingthepollenofoneonthereceptorsoftheotherwillnotbeproductive.

Duringthe20thcentury,agronomistssoughtwaysaroundthenaturalbarriers.Oneofthetechniquestheydeveloped,calledembryorescue,enablesthematurationofsometypesofseedsthatwouldotherwisebeinfertile.Suchenfeebledseedscanresultwhenplantsofrelatedspeciesareinterbred.Inmanycases,breedersareabletorevivethembyplacingtheminanutrientmediumconducivetotheirgrowth.Moreover,besidesdevelopingwaystowidentherangeofinterspeciesgenecommingling,breedersalsocreatednewintraspeciesalterationsbymutatinganorganism’sDNAthroughradiationorchemicals.

However,althoughthevarioustechniquessignificantlyexpandedtherangeofgenomicchange,therewerestillmajorrestrictionsonwhatcouldbeaccomplishedthroughthem.Embryorescueisnotanoptionunlesstwospeciesaresufficientlysimilartoproducesomeformofrescuableseed;andthevastmajorityofcombinationsareincompatible.Further,whenemployingradiationandchemicals,breederscannotselectaspecificgeneandmutateitinaparticularway.Instead,theyhavetoirradiate(orinundate)thousandsofseparatecellsandhopethatsomebeneficialnewtraitwillbecreatedinatleastoneofthembyafortuitousalterationofoneormoreofitsgenes.

Speciesbarriersalsolimitedtheextenttowhichscientistscouldinducegenetictransferbetweenbacteria.Generally,onlycloselyrelatedspeciesconjugate;andbecausevirusesusuallyinfectalimitedrangeofbacteria,theydon’tprovideavenuesforunrestrictedgenetransfereither.Further,itappearsthatonlyaverysmallpercentageofbacterialspeciescanordinarilyabsorbDNAfragmentsfromtheenvironment.20

GeneticEngineering:BreakingNewGroundbyBreakingAncientBoundariesAsmolecularbiologyadvanced,severalofitspractitionersdreamedofovercomingtheconstraintsofnaturebydevelopingthepowerstoisolateandpreciselymanipulateindividualgenes–andtoselectivelymovethembetweendistantanddisparatespecies.But,aswesawinChapter1,evenafterdiscoveringthestructureofDNAandthenatureofthegeneticcode,theywerestillsofarfromthisgoalthatitwasbeyondtherealmofserioussciencefiction.

TheseeminglyinsurmountableobstaclewasinherentinthenatureofDNA.Inordertoexamineageneandthentocopyit,biologistsneededtoisolateitfromthesurroundingDNA.Butthiswasnosmalltask,becauseDNAisnosmall,oreasilydivided,molecule.AlthoughscientistscouldisolateDNAfromlivingtissue,theycouldnottaketheisolationprocessfurtherbydifferentiatinganyofitscomponents.Astandardgeneticstextbooknotesthatwithinthetesttube,themoleculeisa“tangledmassofDNAthreads”that“lookslikeaglobofmucus”–andthatittherefore“seemedimpossible”toisolateindividualgenesfromit.21TherewerenomechanicalmeansforneatlyseparatingDNAintomanageablesegments,nor

coulditbedonewithanyofthechemicalsthenavailable.Consequently,upuntiltheearly1970’s,allknowledgeaboutgeneshadcomefromindirectinferences.22

Andbiologistswouldhaveremainedatthestageofindirectknowledgehaditnotbeenforaluckybreak–thatenabledabreakthrough.In1970,researchersbegandiscoveringaclassofchemicalsthatcancleaveDNAintodiscrete,manageablepackets.Thesechemicalsareenzymesthatexistwithinseveralspeciesofbacteria,andscientistseventuallyfoundhundredsofthem.Thesechemicalscandefendagainstvirusesbyrestrictingtheiractivity,whichiswhytheycametobecalledrestrictionenzymes.

Whenunrestricted,virusesareprolificparasitesthatusurptheresourcesoflivingcells.Theydosobecausetheyarenotcells,andtheylackthecapacitytoreproduceandsustainthemselves.Inordertoreplicateitsgenesortotransformitsgeneticinformationintoproteins,avirusmustcommandeertheresourceswithinalivingcellandcompelthemtogeneratemoreofitsowncomponents–which,comparedtoeventhesimplestbacterium,areminimal.TheyconsistoftheviralDNA(usuallywithfewerthanthirtygenes)andasetofproteinsthatactasasurroundingcoat.Besidesprovidingprotectionforthegenes,thecoatenablesthevirustoattachtoatargetcell.

Numerousspeciesofvirusarespecializedtotargetbacterialcells.Afteroneofthesevirusesbindswithsuchacell,itinjectsitsDNAintotheinterior,leavingthecoatontheoutside.ThisviralDNAthenre-directsthemetabolicmachinerytomakecopiesofitselfandtosynthesizethevariousproteinsthatitcodesfor.Thesefreshly-formedgenesandproteinsthencombinetomakenew,coat-encasedviruses.Asthevirusesaccumulate,theystresstheinvadedcellandeventuallyburstit.However,whenabacteriumharborsrestrictionenzymes,theycancutupthenakedviralDNAbeforeitstartstoreproduce.

WhatmakesrestrictionenzymessoimportantingeneticengineeringisnotmerelytheircapacitytocutDNA,buttheirabilitytodoitinaprecisemanner.EachparticularrestrictionenzymerecognizesaspecificsequenceofbasesandcutstheDNAonlyatlocationsalongthestrandwithsuchasequence.SinceeveryDNAmolecule(regardlessofspecies)containsrestrictionenzymetargetsitespurelybychance,bioengineerscanutilizethevariousrestrictionenzymestocutanyDNAintoshortenoughsegmentstoworkwith.

There’syetanotherfeatureofrestrictionenzymesthathasgreatlyaidedthepracticeofbioengineering.BesidesmakingitpossibletoconsistentlycleaveDNA,theyalsoenabletheselectivefusionofdiversefragmentsproducedbythecleaving.That’sbecausemanyofthemmakestaggeredcutsinDNAinsuchawaythatanysegmentscreatedbythesamerestrictionenzymewillpossessprotrudingendsthatarecomplementarytooneanotherandcanreadilybindtogether–whichiswhythey’recalledstickyends.23ThestaggeredcuttingperformedbytheenzymesandthecomplementaryendsthataregeneratedmadeitpossibletoneatlyspliceasegmentcleavedfromoneDNAstrandintoastrandofadifferentspecies.

Thus,withoutthediscoveryofrestrictionenzymes,geneticengineeringwouldhaveremainedanunrealizeddream;andtheycontinuetobeindispensableforitspractice.Consequently,theGEventurehas,fromitsoutset,projectedaparadox,becausetheroletheseenzymeshavebeenmadetoassumeinthelaboratorystarklycontrastswiththeessentialroletheyplayinnature.Whiletheirmainnaturalfunctionistopreventforeigngenesfromenteringacellandalteringitsoperation,biotechnicianshaveemployedthemtopromotethatverything,effectingtheforcedentryofaliengenesintocreaturesthathaveneverknownthem.Sodeepisthedichotomybetweennaturalfunctionandhumanapplication,onecouldreasonablyarguethatthelatterdoesnotmerelycontortnature,butstandsitonitshead.24

Ofcourse,biotechproponentswouldprobablyarguethatthere’snoperversionoffunctionbecause,whiletheDNAthattheenzymesattackwithintheirhomecellsispathogenic,theDNAthat’stransferredtootherorganismsinthelaboratoryisnotharmfultotherecipients.Yet,asweshallsee,suchalieninsertstendtoinducestress,andinotherkeyrespectsaswell,theyfunctionmorelikevirusesthancooperativeconstituentsoftheorganism.

CreatingtheFirstTransgenicOrganisms:IngeniousIncursionsintoBacteriaBiotechadvocatesoftenimparttheimpressionthattrans-speciesbioengineeringismerelyamatteroftakingagenefromoneorganismandpoppingitintotheDNAofanother,whereit’sgracefullyreceivedandfullyreadytofunction.Inreality,manystepsarerequired,entailingextensivemanipulationandmodification.

Beforeagenecanbeutilized,itmustbeisolated;andisolatingaparticulargeneisabigjob.Biotechnicianscan’tjustgoinandcutitoutwithrestrictionenzymesunlesstheyknowwherewithintheglobofDNAthatgeneresides,andtheycanonlygainthatknowledgebydoingextensiveanalysis–whichitselfentailsalotofcutting(usuallyemployingseveralrestrictionenzymes).

Oncethegenehasbeenisolated,itmustbecopied.Andoneortwocopieswon’tsuffice.Forreasonsthatwillsoonbecomeapparent,avastnumberareneeded;andseveralstepsarerequiredtoachievethemassivemultiplication.

Thencomesthetaskofgettingthegenesintothetargetorganisms.Duringthefirstphaseofthebioengineeringventure,thetargetswerelimitedtothesimplestorganisms:bacteria–withE.colitheusualmicrobeofchoice.ButavehiclewasneededtoconveytheforeignDNAintothebacteria,andthemostobviousoptionwastoemploytheentitiesthebacteriausewhentransferringgenesamongthemselves.Theseentitiesarecalledplasmids,andthey’resmall,usuallycircularDNAmoleculesthatresidewithinbacteriabutarenotpartofthebacterialchromosome.(SeeFigure4.5)Ifageneissplicedintoaplasmidandtheplasmidistransferredtothebacterium,thatgenecanbetranscribedintoRNAandtranslatedintoprotein;andbecausetheplasmidwillreplicate,thegenewillcontinuetoappearinsuccessivegenerationsofbacterialcells.

Topreparetheplasmidsfortheinsertionofthegenes,they’recutopenwiththesamerestrictionenzymesthatwereusedtocutthegenesfromtheirsurroundingstrandofDNA.Inthisway,theopenendsintheplasmidswillbecomplementarytotheendsofthesegmentcarryingthegene,enablingtheendstofittogether.Further,becausethecomplementaryendsare“sticky”inrelationtooneanother,theattractiveforcebetweenthecomplementarybasesfacilitatesbonding.

However,there’sastickingpoint:thestickyendsarenotstickyenough.Althoughbondsformbetweenthecomplementarybasesontheinnersurfacesoftheadjoiningsegments,gapsremainbetweenthesugar-phosphatebackbonesontheoutersurfacesbecausethere’snoattractiveforcebetweenneighboringunits.Andunlesstheseunitsarefused,therecombinantmoleculecanreadilycomeapart,sincethebondsbetweenthebasesarenot,ontheirown,strongenoughtokeeptheinsertedsegmentinplace.Sobiotechnicianshavetoapplyanenzyme(calledaligase)thatcellsordinarilyusetorepairbreaksintheirownDNA.Inthisway,astablebondisformed.

ThenextstepistogettheplasmidsintotheE.coli.However,althoughthesebacteriacanreceiveplasmidsconveyedviadirectcontactwithmembersoftheirownspecies,theywon’tordinarilytakeupisolatedDNAfromtheirsurroundings–anditappearsthatthevastmajorityoftheotherbacterialspecieswillnoteither.SotorendertheE.colireceptive,biotechniciansresorttoartificialmanipulation.25AswesawinChapter1,acommonapproachistosubjectthebacteriatocalciumsaltandamajorheatshock.However,eventhisapproachfailsinthecaseoflargeplasmids(whichareneededforcarryingbigDNAinserts).Insuchsituations,biotechniciansmustemployamoredrasticmethod.Insteadofheatshock,theyapplyelectricalshock,openingporesinthecellwallwithpulsesofhigh-voltagecurrent.

Moreover,evenpriortoinsertingthegenesintheplasmids,otherartificialinterventionsarenecessary–directednotattheplasmidsorthebacteria,butattheDNAthat’sgoingtobetransferredtothem.First,becauselargenumbersofengineeredplasmidsaregoingtobemixedwithlargenumbersofbacteria,andbecauseonlyasmallfractionofthebacteriawillendupcontainingoneoftheplasmids,biotechniciansneedsomewaytoidentifytheonesinthatlattergroup.Sotheyaddanothergenetothegenetheywanttotransfer,onethatwillproduceadistinctandeasilyobservedeffect.Inmostcases,thegenesemployedasmarkersconferresistancetoaparticularantibiotic,enablingbiotechnicianstoisolatetheplasmid-endowedbacteriabydousingtheentirebatchwiththatantibiotic–whichkillsallthecellsexceptthosewithresistancebornoftheengineeredplasmid.

Further,inmostcases,theinitialalterationoftheDNAisnotlimitedtotheadditionofmarkergenes.That’sbecausethemajorityofthechemicalsthatbioengineerswantbacteriatoproduceingreatvolumecomefromthegenesoforganismsfarmorecomplexthanthebacteria,suchasplants,animals,andpeople.And,duetothevastbiologicalgulfbetweenbacteriaandthesespecies,themicrobesarenotuptothetaskofexpressingtheirgenes.

Foronething,thegenesofhigherorganismscontainelementsthatthegenesofmostbacteriadon’tpossess.26Inbacteria,alltheDNAwithinageneisexpressedintoprotein,butthegenesofplantsandanimalscontainmanysegmentsofnucleotidesthatdonotgetexpressed,andthesenon-expressed

segmentsareinterspersedbetweenthesegmentsthatareexpressed.Theexpressedregionsarecalledexons,andthenon-expressedonesarecalledintrons.Buttheintronswerenotdiscovereduntil1977,afterthegeneticengineeringventurewaswellunderway.Notonlyweretheyamajorsurprise,foralongtime,theywereamystery.Althoughthey’retranscribedintoRNAalongwiththeexons,theyaretheneditedoutbeforetheRNAtravelstothecell’sproteinassemblysites.Sobiologistscouldn’tfigureoutwhytheywerethereinthefirstplace.Eventually,itbecameclearthatintronsdohaveanimportantfunction;butforseveralyears,fromtheperspectiveofthebiotechnicianstheyweremorethannonfunctional,theyweredysfunctional,becausethegeneexpressionmachineryofthebacteriaintowhichtheywereinsertedcouldn’tdealwiththem,preventingexpressionoftheexonsthatneighboredthem.

So,inordertoovercomethisnaturalbarrier,bioengineershadtodeviseawaytogettheintronsoutofplantandanimalgenes.Theyeventuallysucceeded;andthefirstmethodtheyemployedwastoconstructthedesiredgenenucleotidebynucleotide,synthesizingtheexonswhileexcludingtheintrons.

Later,theydevelopedanothermethod;andithasbecomepredominant.Ratherthandirectlyconstructingthedesiredgene,theytakethemessengerRNAtranscriptsthatarisefromitaftertheintronshavebeenexcisedandthenreversethetranscriptionprocess,producingaDNAsegmentfromtheRNAthatcontainsthedesiredsequenceofexonsyetisdevoidofinterveningintrons.Buttheycanonlyaccomplishthisfeatbyusinganenzymederivedfromaretrovirus.Retroviruses(suchastheAIDSvirus)haveanexceptionalfeature:theydon’tcontainanyDNA,andtheirgeneticinformationsolelyresideswithinRNA.Nonetheless,theyachievereplicationinanindirectmanner.TheymakeanenzymethattranscribestheirRNAintoDNA,thisDNAistheninsertedintothetargetorganism’sgenome,andfromthereitistranscribedintonewviralRNA.

It’stheenzymeinthefirststageofthisprocessthat’semployedbybioengineerstoinducereversetranscription.Yet,becauseitdoesn’tworkaswellwiththeRNAtranscriptsofhigherorganismsaswiththeRNAofviruses,theyneedtodosometinkering.Theymustaddchemicalprimerstothetranscriptssotheenzymecantranscribethemwithgreaterefficiency.27

Nonetheless,regardlessofthewayit’saccomplished,sheddingtheintronsstillcannotshedallthedifficulties.Eventhoughthegeneticcodeisutilizedbybothbacteriaandhigherorganisms,insignificantrespects,there’salanguagebarrierbetweenthem,becausetheyusethecodeindifferentways.Thisoccursbecause,aspreviouslydiscussed,mostaminoacidsaredesignatedbyseveraldistinctcodons;andbacterialDNAtendstoplayfavorites,routinelyemployingspecificcodonswhileexcludingtheircounterparts.Ontheotherhand,plantsandanimalsoftenfavorthecodonsthatbacteriashun.Soevenafteragenefromahigherorganismhasbeenshornofitsintrons,bacteriastillwon’teffectivelyexpressitduetothepresenceofincompatiblecodons.Accordingly,biotechniciansneedtosubstantiallyreconfiguresuchgenes,replacingthecodonsthatbacteriadislikewiththosetheyprefer.

Yet,evenwhendevoidofintronsandendowedwithcompatiblecodons,genesfromhigherorganismsrequireadditionalmodificationbeforebacteriacanexpressthem.That’sbecause,besidestheregionsthatcodeforprotein,ageneisflankedbyelementsthatregulateitsexpression;andthere’ssignificantdisparitybetweentheregulatoryelementsofhigherorganismsandthoseofbacteria.Oneoftheseelementsiscalledapromoter,becauseitpromotestheprocessofexpression.However,itsregulatoryroleisbroaderthanthisnameimplies.Itdoesnotmerelypromoteexpression,itpreventstheprocessfromstartingwheninappropriate,anditshutstheprocessdownwhenexpressionofthegeneisnolongernecessary.Inotherwords,it’sthegene’sbasicon/offswitch;anditdeploysinoneortheothermodedependingontheorganism’srequirements.Accordingly,it’sfinelyattunedtospecificbiochemicalsignalssothattheexpressionofthegeneharmonizeswiththeorganism’sneeds.Therefore,whenageneistakenfromonespeciesandsplicedintoanunrelatedone,thepromoterwillrarely(ifever)receivesignalstowhichit’ssensitive–andwillkeepthegeneinactive.Hence,beforetransferringaplantoranimalgenetoabacterium,biotechnicianshavetoremovethenativepromoterandaffixonethatwillfunctionwithinthe

foreignsurroundings.Further,incaseswherethebioengineersneedtheforeigngenestobeexpressedatextremelyhigh

levels,they’vesometimesfusedthemtopromotersthatoperatefullyoutsidetheplant’sregulatorysystemandcanboosttheirexpressiontoabnormalheights.Thesepromoterscomefromvirusesthatinfectthebacteria;andtheyenabletheprocessbycompellingincessanttranscriptionofthevirus’sgenesregardlessofbacterialwelfare.Forinstance,whenShowaDenkowanteditsbacteriatocrankoutexcessivetryptophan,itnotonlyendowedthemwithadditionalcopiesofsomeoftheirowngenes,itplacedaviralpromoterinfrontofoneofthem,whichkickeditintoaberrantoverdrive.

Butreplacingthepromoterisnotenough.There’sanotherelementthat’sessentialforexpressionofthegene–andittoomustberemovedandreplaced.Whilethepromoterresidesatthestartofthegene,thisentitycomesattheend;anditsroleistodemarcatethisterminus,andhaltthetranscriptionprocess.Suchdemarcationiscrucial,becausetheenzymethattranscribesthegeneintoRNAneedstorecognizewhentranscriptionshouldstoporelseitwillextendtheprocessbeyondtheboundsofthegene,addingextraneousinformationtotheRNAthatwillthwarttheproperproductionofprotein.Therefore,becausethisregulatoryelementhaltstranscription,it’scalledaterminatorsequence.Andbecauseterminatorsfromplantsandanimalsarenotadequatelyrecognizedbythetranscriptionenzymesofbacteria(andthereforedonotinduceterminationwhenthey’resupposedto),theyneedtobereplacedbysequencesthatthebacterialenzymesdorecognize.

So,contrarytothesimplisticimpressionthatbiotechproponentsoftenimpart,geneticengineeringisnotmerelyaprocessoftransferringagenefromoneorganismtoanother.It’saprocessoftransferringagenealongwiththeregulatoryelementsthatwillenableittofunctioninthealienorganism–conjoinedwithamarkergenethatwillenablebioengineerstodetectwhichcellsithasentered.Thus,genesarenottransplantedalonebutonlyaspartofaconglomeratethatincludesapromoter,terminator,andmarker.Suchconglomeratesarereferredtoascassettes.Andthecassettesaretypicallydesignedtobehyper-active.

However,aswe’llsoondiscuss,thishyper-activityentailsrisks.Moreover,regardlessofthehealthrisksitmaypose,themassiveoutputofforeignproteinhascausedbigtechnicalproblems.That’sbecause,asthesechemicalsaccumulateinanon-nativeenvironment,asubstantialnumbercancondenseandbecomedenaturedorotherwiseinactivated.Theseclumpsofnonfunctionalproteinsarecalledinclusionbodies,and,inthewordsofonescientist,“theywerethebaneofearlyrecombinantDNAproductionmethods.” 28PriortorDNAtechnology,inclusionbodiesonlyappearedasaresultofviralinfection,sincethatwasthesolewayinwhichhyper-productionofforeignproteinoccurred.So,havinginducedtheirformationthroughunnaturalmeans,bioengineershadtostrugglewiththemforseveralyearsbeforediscoveringmethodsthatreducedtheiroccurrence.

FathomingtheDepthoftheDominantDeceptionAstheprecedingdiscussionmakesobvious,gettingagenefromahigherorganismintoabacterium–andinducingittofunctionthere–canhardlybelikenedtoanaturalprocess.Nevertheless,despitethedisparitybetweenbacteriaforcedtobearthegenesofhigherorganismsandthosefunctioningundernaturalconditions,bioengineershaveroutinelyassertedtheiressentialcongruence;and,asChapter1demonstrated,suchassertionswereinstrumentalinforestallinggovernmentoversight.Nowwe’reinabetterpositiontodiscernthedegreeofdeceptionbehindtheclaimthatcarriedthemostclout:StanleyCohen’sdeclaration(discussedinChapter1)thatgeneticengineeringmerely“duplicates”processesthatoccurwithinnature.CohenprofessedhehadproventhispointbydemonstratingthatE.coliwillassimilategenesderivedfromamouse.However,aswesaw,inordertoinducethebacteriatoaccepttheforeignDNA,heandhiscollaborator(ShingChang)hadtosubjectthemtocalciumsaltandamajorheatshock–afactthatundercutshisclaimofnaturalness.29Aswealsosaw,becausethatfactwasnot

publicized,theboldnessofCohen’scontentionsconvincedamajorityofthoseinCongresstodropplansforregulatingGMOs.We’llnowseehowhisunequivocalclaimsnotonlyevokedfalseimpressionsaboutthenaturalnessofhisexperimentaldesign,butaboutwhattheexperimentactuallyachieved.

BecauseCohn’sassertionspertainedtothebioengineeringprocessingeneral,andbecausethecentralgoalofthatprocessisnotmerelytotransfergenesintotheDNAofanalienorganismbuttoalsoachieveproductionoftheproteinsthattheycodefor,onecouldreadilyassumethathehadaccomplishedthesecondstepaswellasthefirst.30Icertainlydid;anditappearsthatmostothersdidaswell.Yet,thoughIassumedhehadsucceededingettingthemousegenestoexpress,Iwonderedhowhehadbeenabletodoso.

Aswe’veseen,bacteriacannotaccuratelyexpressgenestakenfromthenucleiofanimalsbecausethey’reunabletodealwiththeintrons,thedifferenttypesofpromotersandterminators,andsomeoftheanimal-preferredcodons.Butallthegeneswithinthenucleusofamousecellcontainsuchcomponents.SoCohencouldnothaveinducedsuchgenestoexpresswithinbacteriaunlesshehadsubstantiallymodifiedthem.

Yet,therearegenesoutsidethenucleusthatdon’tpossessalltheinhibitingfeaturesoftheirnuclear-boundneighbors.Thesegenesinhabitthesmallstructures,calledmitochondria,thatserveasthecell’spowerstations.Mitochondriaproducetheenergysourcethatdrivescellularprocesses;andtheirgenesaremorelikethegenesofbacteriathanarethoseinthenearbynucleus.Notonlydotheylackintrons,theyresemblebacterialgenesinotherrespects;andbythe1970’s,manybiologistshadacceptedthetheorythattheyoriginallyderivedfrombacteria.

Therefore,asCohenandChangnoted,ifanymammalianDNAcouldbeexpressedinbacteria,mitochondrialDNAwasthe“probablecandidate.” 31Sotheybypassedthemouse’smaingenome,whichresidesinthecellularnucleus,andemployedgenesfromthemitochondriainstead.However,eventhoughthesegenesbearsignificantresemblancetobacterialgenes,theystilldifferfromtheminseveralways;andduetothesedifferences,theE.coliweren’tabletoaccuratelyexpressthem.Theevidenceindicatesthatonlysomeofthesegenesweretranslatedintoprotein;andthateventhen,noneoftheproteinswascomplete.Thus,insteadofproducingthefull-sizedproteinsthatareformedwithinamouse’smitochondria,thebacterialexpressionmachinerycouldonlyproduceversionsthatweresignificantlytruncated.32

Accordingly,Cohen’scategoricalclaimabouthavingduplicatedthefeatsofgeneticengineeringthroughnaturalmeansentailedathree-folddeception.First,itinstilledthefalseimpressionthattheuptakeofthealiengenesoccurrednaturally.Second,itinducedbeliefthattheproteinsencodedbytheforeigngeneswereadequatelyexpressed,wheninfact,theywerenot–eventhoughhehademployedtheoneclassofmammaliangenesthatmighthavebeenexpectedtoproperlyfunctionwithinbacteriaintheirnaturalstate.Third,itimpliedthathisexperimentpertainedtoallplantandanimalgenes,wheninreality,itwasonlyrelevanttomitochondrialgenes.Therefore,evenifitsconditionshadbeenfullynaturalanditsaimshadbeenfullyachieved,itwouldhavebeenessentiallyirrelevanttothegeneralpracticeofgeneticengineering,inwhichthegenesemployedcomeexclusivelyfromthecellularnuclei.Andthesegenescannotbeexpressedinbacteriaunlessthey’refirstsubjectedtoextensivemodificationsthatneveroccurundernaturalconditions.

However,onecouldnothaveknownthatCohen’sclaimabouthisresearchseverelydistortedrealitywithoutreadingthereportthatwaspublishedinascientificjournal;and,aswaspointedoutinChapter1,Cohenissuedhisclaimlongbeforethatreportwaspublished.Hiswell-publicizedlettertotheNIHdirectorwassentonSeptember7,1977,buthisscientificpaperdidn’tappearuntilNovember–morethanamonthafterhispronouncementhadderailedabillbySenatorKennedythatwouldhaveestablishedbettersafeguardsontheapplicationsofgeneticengineering.Moreover,becausethatpaperisdensewith

technicallanguage(Ihadtoconsultamolecularbiologisttofullycomprehendthefacts),evenifanylegislatorshadsubsequentlyseenit,theywouldalmostsurelyhavefailedtorealizethatthey’dbeenhoodwinked.

Thus,despiteitsdeepdiscordwiththetruth,Cohen’sdeclarationplayedakeyroleinrestrictingtheregulationofgeneticengineeringbythwartingthemostpromisinglegislativeeffortandeffectingachangeofmoodonCapitolHillthatsetthestageforthelaxapproachtheUSgovernmenthastakeneversince.

Ironically,whenproponentsofgeneticengineeringwerenotproclaimingitssafetytolegislatorsbutwereinsteadpitchingitscommercialpotentialtoinvestors,theywereeagertocontrastitwithnaturalprocessestohighlighthowitwouldyieldvaluableproductsthatcouldnototherwisebeobtained.Accordingly,theyemphasizedthevirtualimpossibilitythatanyusefulgenefromahigherorganismwouldeverbefullyexpressedwithinbacteriathroughsolelynaturalmeans.Forinstance,ina1975reporttoprospectivefunders,theCetuscorporationpointedoutthat“noprocessofmutationorevolution”wouldeverenableabacteriumtomanufactureavaluableanimalproteinbecause“[t]hechangesinDNAnecessarytodothataresocomplicatedthatitisstatisticallyvalidtosaythattheywillneverhappenrandomly.”Itthendeclared,“Genesplicingcanandwillmakethesethingspossible.” 33

Andwhenbiotechniciansdidfinallyinducebacteriatoproduceamammalianprotein,theyhadtoemploysubstantialartifice.Notonlydidtheyeliminatetheimpedingintronsbybuildingasyntheticversionofthenecessarygeneinthemannerpreviouslydiscussed,theyavoidedcodonsthatbacteriadon’texpresswellbysubstitutingsynonymouscodonsthatthemicrobescanworkwith.Moreover,theydidn’tincludethemammalianpromoterandterminatorsequences,whichwouldn’thavefunctionedproperly.Instead,theyputtheirsyntheticgeneunderthecontrolofabacterialpromoterandterminator.34

ThisbreakthroughwasreportedinScienceonDecember9,1977,onlytenweeksafterSenatorKennedy’scapitulation.And,althoughKennedyandmostotherlegislatorsnodoubtheardofthisbroadly-trumpetedtriumph,theyprobablyneverlearnedthedetailsofhowithadbeenaccomplished–orrealizedhowthesefactsrevealedthatthey’dbeensorecently,andsodeeply,deceived.

Yet,despitethedegreetowhichCohenandotherbioengineershaddeceptivelydescribedtheirdoingsinordertothwartregulationandinducepublicacceptance,intheyearsbeyondthe1970’sthissubterfugecouldnotsuffice.Andasbioengineersextendedtherangeoftheirgeneticrestructuringsfrombacteriatoedibleplants,theyfounditnecessarytoexpandthescaleofthedeception.

CreatingGeneticallyEngineeredPlants:BroadeningtheBreachofNaturalBarriersAsdifficultasithadbeentoendowbacteriawithgenesfromdisparatespecies,evengreaterobstacleswereencounteredinthecaseofplants;andthetechniquesemployedtoslipalienDNAthroughthemembranesoftheformerdidnotworkagainstthedefensesofthelatter.Sodauntingwerethedifficulties,andsonumerousthefailedattempts,mostscientistsconcludedthattheonlywayplantswouldacceptgenesisthroughpollination.35Althoughbiologistsfinallydevisedthemeanstosurmountthebarriersagainstthepiecemealreprogrammingofplantlife,thetaskwassoarduousthatclosetonineyearselapsedbetweentheappearanceofthefirstgeneticallyengineeredbacteriumandthecreationofthefirstfunctionalengineeredplant.And,inordertoachievesuchatransformation,itwasagainessentialtoenlistthepowersofapathogen.

However,thistimethedisease-dealingagentwasnotavirusbutabacterium–onewithaskillthat’svirtuallyuniqueamongmembersofthebacterialkingdom.Likeavirus,itcantrickplantsintoexpressingsomeofitsgenes–foritsbenefitbuttotheirdetriment.Thebacterium’stechnicalnameisAgrobacteriumtumefaciens,andthegenesitdeploystoinfectplantcellsarepartofalargeplasmidthatitcarries.36

Themaraudingstartswhenahordeofbacteriadetectchemicalsthatarereleasedwhenaplantiswounded.Theythenadvancetotheinjury,surgethroughthebreakinthesurface,andformmatingtubes

thatconnectwithadjacentplantcells(aswouldhappeniftheywereconjugatingwithotherbacteria).ThisallowsthemtosendlargesegmentsofDNAfromtheirplasmidsthroughthewallsofthetargetedcellsandintothenuclei,wherethesegmentsareintegratedwithinthenativeDNA.Thealiengenesthenstartaprocessthattransformstheirhaplesshostsintotumorcellsproducingsubstancesthatserveasbacterialfood.And,astheafflictedcellsmultiply,theyformaprominentbulge,referredtoasagall.

Asthefeatsofthisbacteriumcametolight,severalscientistsrealizeditcouldserveasavehiclefortransferringgenesoftheirchoosing–iftheycouldexcisethetumor-inducing(Ti)genesandreplacethemwiththeonestheywanted.However,reconfiguringtheplasmidinaworkablewaywasfarfromeasy.Inthewordsofonemolecularbiologist,itwas“alaboriousprocess,involvingseveralpainstakingsteps.” 37Eventually,thepainpaidoff,andbiotechnicianswereabletotransfergenestheyselectedintotheDNAofseveralspeciesofplantsusingAgrobacteriaasvehicles.

Yet,theystillfacedotherdifficulties.Ashadbeenthecasewhenalteringbacteria,achievingintegrationofageneintotheDNAofanorganismtowhichitwasanutterstrangercouldnotinitselfinducetheexpressionofthatgene.Foronething,justasgenesfromplantsare,intheirnaturalstate,incompatiblewiththegeneexpressionmachineryofbacteria,sogenesfrombacteriaclashwiththeexpressionsystemofplants.Butseveralofthebioengineers’prizedprojectsinvolvedsuchinter-kingdomtransfers.Therefore,thecodonsofabacterialgenehadtoberevisedsotheywouldmeshwiththepredilectionsofplants.Further,thepromotersandterminatorsthatadjoinedthebacterialgenesdestinedforGEfoodshadtoberemoved,becausetheycouldn’tcoordinatewiththeplants’processeseither.However,thereweresomeexceptionalpromoter/terminatorsetsinthebacterialrealmthatcouldfunctioninplants,andtheyweretheonesenablingtheTigenesofAgrobacteriatoworktheirmischief.Similartoplantviruses,thesebacteriahadevolvedpromotersandterminatorsthatweresufficientlyplant-liketocommunewith(andcommandeer)aplant’stranscriptionmachinery.SoalthoughthebioengineersdiscardedtheTigenes,theyusedthepromoter/terminatorsetsofthosegenestoachievetheexpressionofthe“designer”genesthatreplacedthem.

Nevertheless,eventhoughtheinsertedDNAwasnowgettingexpressed,therewasstillaproblem.TheAgrobacterium’spromotersdidn’treliablygeneratethelevelofproteinthatwasneededinmostcommercialapplications.Sothey,too,hadtobereplaced.

Fortunatelyforthebiotechnicians,amuchstrongersurrogatewasavailable,onethatcouldboostexpressionfarbeyondthelimitofanypromoteryettried.Buttoacquireit,theyagainhadtodrawontheresourcesoftheviralrealm–inparticular,thoseofavirusadeptatvictimizingvegetablessuchascauliflower,cabbage,andbroccoli.Itsinfectiveprowesswasinlargepartduetothepotentpromoterthatforcedtheinvadedplanttoexpressitsgenescopiouslyandconstantly.Thispathogenwasnamedthecauliflowermosaicvirus,and,fortechnicalreasons,itsmusculargeneactivatorwascalledthe35Spromoter.Notonlywasthispromoterextremelypowerful,itwasversatile.Itcouldsubjugatethetranscribingenzymesofalmostanyplantintowhichitwasinserted.

Asitturnedout,notonlydidbiotechniciansresorttothe35Spromoterwheninsertingbacterialgenesinplants,theyevenhadtorecruititwhentransferringgenesfromoneplanttoanother.That’sbecausepromotersinhigherorganismstendtobespeciesspecific,whichmeansthatwhenagenefromoneplantisplacedwithinaplantthat’snotcloselyrelated,thepromoterattachedtoitwillseldombeactivated.Consequently,the35ShasbeenaffixedtotheforeigngenesinvirtuallyalltheGEfoodscurrentlyonthemarket.38Infact,becausethebioengineersusuallyseekamuchhigherlevelofexpressionthanmostgeneswilldeliverevenwithintheirhomeenvironment,the35Susuallyreplacesthenativepromoterwhenaplantisgivenanextracopyofoneofitsowngenes.Further,becausetherearesomespeciesinwhicheventhe35Sisinsufficientlyforceful,biotechnicianshadtoalteritsstructuretomakeithyper-activesoitcouldadequatelyfunctionwithintheseplantsaswell.

Yet,althoughthesouped-up35Scouldspurprodigioustranscriptioninvirtuallyanyplantspecies,

Agrobacteriacouldnotdeliverit(anditsaffixedforeigngene)intoallofthem.Despitetheirbroadinfectiverange,severalplantswouldnotsuccumbtotheirtransformationalpowers;and,tothedismayofthebioengineers,amongthemwerethetwomostvaluablecrops:cornandsoy.

Soywasacuriouscase.Althoughthebacteriacouldinfectmanyofthecellsthebioengineerspresentedtothem,thosethathadbeeninfected(andwerethusendowedwithaforeigngeneandanaccompanyingmarkergene)couldnotbeseparatedfromthosethathadn’t.Whenthelethalchemicalwasappliedtokillthevulnerablecellsthatlackedthemarker,theirneighborsthatdidhaveresistancetoitneverthelessdiedalongwiththem–inwhat’sbeentermeda“cooperativecollapse.” 39

Cornwasevenmorerecalcitrant.Aswasthecasewithseveralothertypesofgrain,Agrobacteriacouldnotinfectanyofitscellsinthefirstplace.Moreover,attemptstotransformcornthroughelectricalshockdidn’tworkeither.40

Soanothertechniquewasneeded,buttheonlyonebeingattemptedseemedsooutlandish(andsodestinedforfailure)thatmostbiologistsscoffedatit.Yet,despitethedoubtsandderision,afterseveralyearsofeffort,thisbizarretechniquefinallysucceeded.Itwasreferredtoasparticlebombardment(orbioballistics),anditwasimplementedbyadevicecalledagenegun.Initially,thegunthatwasemployedfireda.22-caliberbulletcoatedwithmetallicparticleswhichinturnhadbeencoatedwithDNA.Whenthebulletslammedintoabarrier,theparticleswouldflyintoamassofcorncellsinapetridish.Numerouscellswouldbedestroyed,buttheforeignDNAwouldworkitswayintothegenomesofatinyfractionofthesurvivors(only“oneinamillion,”accordingtoaMonsantoscientist).41Asthegunevolved,macroscopicbulletswerenolongerused,andthemicroscopicparticleswerepropelledbyablastofair.

Aftertheirsuccesswithcorn,biotechniciansnexttrainedtheirsitesonsoy,targetingatypeofcelllesssusceptibletocooperativecollapse.Eventually,byblastingDNA-dustedparticlesintoclumpsofthesecells,theywerefinallyabletoproducegeneticallytransformedsoyplants.

Unnatural,Uncontrollable,andUnpredictableThus,thetwochiefGEcropswerebornofmicro-ballisticmayhem,andtheremainderofthoseonthemarketwerewroughtwiththeweaponsofanaggressivepathogen.Further,besidesbeingcoarse,thesecontrivedmodesofgenetransferarehighlyimprecise.ThefragmentsofforeignDNAenterthetargetgenomeinanessentiallyrandommanner;andresearchindicatesthattheyusuallydisrupttheDNAoftheregionsintowhichtheywedge.42Accordingtoscientistswhoconductedareview:“Itisapparentthatsmallandlarge-scaledeletions,rearrangementsofplantDNA,andinsertionofsuperfluousDNAareeachcommonoccurrences....” 43Moreover,theinsertionsalsocausedisruptionsthroughoutthegenome.AccordingtomolecularbiologistMichaelAntoniouofKing’sCollegeLondonSchoolofMedicine,“...thegenetransferprocessingeneralisknowntointroduce...hundredsoreventhousandsofadditionalmutationaldefectsintheDNA,withpotentiallydevastatingconsequencesonglobalhostgenefunction.” 44Inonestrikinginstance,scientistsusedmicroarraytechnologytostudyhowgeneexpressioninhumancellswaseffectedbyinsertionofasinglecopyofahumangene.Theydiscoveredthat5%oftheassessedgenesunderwentsignificantchangesintheirexpressionlevels(eitherupwardordownward).45AccordingtomolecularbiologistDavidSchubert,aprofessorattheSalkInstitute,thecomplexityofinsertionaleffectsiscompoundedbythefactthateachcelltypeoftheorganismtendstoresponddifferently.46Hefurthernotesthatwhenorganismsarealteredbytheinsertionofagenethatisforeigninsteadofnative(asisalmostalwaysthecasewithengineeredfoodcrops),themagnitudeofthechangescouldbefargreater.47

Thedisruptivepotentialisamplifiedbythepresenceofthe35Spromoterineachhaphazardlyplacedfragment.Becausethisviral-derivedboosterissopowerful,itcaninduceerraticexpressionofsome

nativegenes–oractivatebiochemicalpathwaysthatareordinarilyinactive.48Eachoftheseoutcomescouldspurtheproductionofunintendedtoxinsorinducedamagingimbalances.

Moreover,duetotheiralways-onpromoters,thetransplantedgenesactindependentlyofthehostorganism’sintricatecontrolsystem,asdothegenesofaninvadingvirus,incontrasttotheharmoniouscoordinationthatexistsamongthenativegenes.Consequently,notonlyiseverycelloftheorganismforcedtoproducesubstancesthathaveneverbeeninthatspecies,it’sforcedtoproducetheminanunregulatedmanner–whichcandisruptcomplexbiochemicalfeedbackloops(andinduceunintendedtoxins).AswesawinthechapterontheEMSepidemic,theforcedover-expressionofafewgenesapparentlycausedadisruptionthatresultedintheformationofoneormoretoxicby-products.Andinthatincident,thehyper-expressedelementswerenotforeignbutweremerelyextracopiesofsomeoftheorganisms’owngenes.Whenforeigngenesareinvolved,theriskscouldbegreater.

Thisunrestrainedactivityishighlyunnatural,anditviolatesabasicprincipleoflivingsystems:energyefficiency.49Organismsordinarilyadheretothisprinciplestrictly.Forinstance,topowertheiractivities,E.colicandrawontwotypesofsugar:glucoseandlactose.Buttoutilizelactose,theymustsynthesizeonemoreenzymethanisrequiredwhenusingglucose.Therefore,aslongasglucoseispresent,thepromotersthatgoverntheproductionofthelactose-processingenzymesremainidle–evenifthere’slotsoflactosearound.Theyonlyrevupifalltheglucosehasbeenconsumed,whichrendersthemoreenergyintensiveprocesstheytriggeressentialratherthanoptional.

Incontrast,theviralpromoterspushorganismsoffthepathoffrugalityandforcethemtoexpendconsiderableenergytoproducesubstancestheydonotneed.ThisincessantenergydrainmaybethereasonthatGEcropssometimesunderproduce.Forinstance,Monsanto’sGERoundupReady

®

soybeanwasdeterminedtohavea5%decreaseinyieldthat’sdirectlyattributabletothegeneticalteration.50

So,notonlyhavethebioengineersbeenadeptatkeepinggovernmentregulationoftheirenterpriseminimal,they’vebeenabletoderegulatetheforeigngenestheyinsertinthetargetcrops.Butinthelattercase,thederegulationhasbeencomplete–andtheregulatorysystemthat’sbeenevadedbelongstonature.

There’syetanotherunnaturalfacetofGEcrops.BecausetransferringDNAtoacellbyinfectingitwithAgrobacteriaorblastingitwithagenegundoesnotproduceafertileseed(asdoestheunionofgametes),biotechnicianscannotgrowitintoamatureplantbyputtingitdirectlyintothesoil.Instead,theymustfirstdevelopitwithanartificialprocesscalledtissueculture,inwhichitiscoaxedtomatureviaapplicationsofhormonesandantibioticsinwaysthatwouldnotnaturallyoccur.Infact,thephrase“coaxedtomature”maybeabitmild.Somescientistshavedescribedtheprocessasoneinwhichthecellis“forcedtoundergoabnormaldevelopmentalchanges.” 51Andsomespeciesrequiresubstantialforcing.Forinstance,aschallengingasithadbeentoinsertforeigngenesintothecellsofcorn,itwasevenmoredifficulttogetthetransformedcellstodevelopintoviablecornplants,andconsiderableeffortwasneededtomakeithappen.52

Further,whateverthespecies,tissuecultureimpartsabroadjoltknownas“genomicshock.” 53Thisshockinducesextensivegeneticperturbations–andisanotherwayinwhichunintendedharmfulsubstancescanbeformed.54

Moreover,notonlyarenativegenesfrequentlydestabilizedduetotheunnaturalnessofthedevelopmentalprocess,theinsertedforeigngenesarefrequentlydestabilizedduetotheunnaturalnessoftheirpresence.OrganismsaregearedtodefendagainsttheinvasionofforeignDNA,andtheyhavemechanismstoinactivateit.Accordingly,thealiengenesarefrequentlyincapacitatedbythesedefensesandpreventedfromexpressinginsubsequentgenerations.By1994,thisphenomenonwasalreadyasignificantproblem.Reflectingitsseriousness,areviewwaspublishedthatyearinthejournalBiotechnologytitled:“Transgeneinactivation:plantsfightback!”Init,theauthorsstated,“Whiletherearesomeexamplesofplantswhichshowstableexpressionofatransgenethesemayprovetobethe

exceptionstotherule.Inaninformalsurveyofover30companiesinvolvedinthecommercializationoftransgeniccropplants...almostalloftherespondentsindicatedthattheyhadobservedsomeleveloftransgeneinactivation.”Theyalsonotedthattheproblemislikelytobebiggerthangenerallyperceivedbecause,accordingtomanyoftherespondents,“mostcasesoftransgeneinactivationneverreachtheliterature.” 55AndasthecultivationofGEcropsexpanded,therehavebeenseveralconspicuouscasesoffailedperformancethatmayhavebeencausedbysuchgeneticshutdown.56

Thus,notonlydoGEplantsgetcreatedthroughmultiplebreachesofnature’sboundaries,theforeigngeneswithinthemcanonlycontinuetofunctionbyescapingtheplant’snaturaldefenses.Contrarytothecontentionsaboutthenaturalnessofsuchorganisms,boththeirbirthandtheirongoingutilityarecriticallydependentonthefoilingofnaturalsystemsthatpreservegeneticintegrity.

Consequently,duetotheirunnaturalness,andtothedisruptionscausedbytheircreation,fewGEplantsthrive;andasizablepercentagedon’tevensurvive.Thisisinmarkedcontrasttonaturalpropagation.Pollinationisrarelyalethalevent,andthevastmajorityofseedsproducedthroughitgrowintonormaladults.Butasubstantialportionofthecellsalteredthroughbioengineeringarekilledoutright;andalargefractionofthosethataren’teitherdevelopwithgrossdeformitiesorfailtoadequatelyexpresstheintendedtrait.57

ReapingBizarreResultsBesidesbeingnumerous,theunintendedoutcomesofgeneticengineeringarefrequentlysurprising,andoftenbizarre.Someofthestrangestarosewhenpigswereengineeredwithahumangenethatcodesforagrowthhormone.Althoughtheaimwastoproducefast-growing“superpigs,”thenovelcreaturesdidnotgrowfasterthantheirparentalstock;buttheydidgrowalotweirder.Onefemalewasbornabsentananus–andalsowithoutavagina.Severaloftheothersweretoolethargictostandup.58Additionalafflictionsincludedarthritis,enlargedhearts,ulcers,dermatitis,kidneydisease,andimpairedvision.59Andbecausetheirimmunesystemsweredysfunctional,theywerepronetopneumonia.60Butmostoftheengineeredembryosdidn’tdomuchgrowinginthefirstplace.Onlyonein200reachedthestateofmalformedmaturity.61AndwhenresearchersinsertedaforeigngeneintocowDNAtoalterthecompositionofthemilk,mostattemptstogeneratelivecalvesfromtheengineeredcellsfailed.Moreover,theonecalfthatdidresultwas“unexpectedly”bornwithoutatail.62

Plantshaveprovenasunpredictableasanimals.Forinstance,whentobaccowasengineeredtoproduceaparticularacid,italsogeneratedatoxiccompoundthat’snotanaturalcomponentoftobacco.63Andwhenbioengineersalteredyeasttoincreaseitsfermentation,theyweresurprisedtofindthatatoxinthatnaturallyoccursatlowlevelsappearedatlevels40to200timeshigher.Theshockwasintensifiedbythefactthat(asinthecaseofShowaDenko’stryptophan-producingbacteria)noforeigngeneshadbeeninserted,justextracopiesofsomeoftheyeast’sowngenes.Indiscussingtheincident,thescientistsacknowledgedthatit“mayraisesomequestionsregardingthesafetyandacceptabilityofgeneticallyengineeredfood....” 64Anothershockarosewhenscientiststriedtosuppressanenzymeinapotatoandinadvertentlyraiseditsstarchcontent.Oneofthemadmitted,“Wewereassurprisedasanyone.”Headded:“Nothinginourcurrentunderstandingofthemetabolicpathwaysofplantswouldhavesuggestedthatourenzymewouldhavesuchaprofoundinfluenceonstarchproduction.” 65

EventheWallStreetJournal,whichusuallypresentsbiotechinafavorablelight,couldn’tresistfeaturingitsfreakisheffects;andanarticletitled“GeneticVegomaticsSpliceandDiceWithWeirdResults”describedseveral.66Forinstance,whenbiotechniciansemployedgene-splicingtoimprovetheshelflifeoftomatoes,someofthefruithadregionsthatripenedveryfastalongwiththosethatdidn’tripenatall.Accordingtooneofthescientists,the“greenislands”ofunripetissueinterspersedamongpatchesofredmadethetomatoeslooklike“Christmastreebulbs.”Whenotherscientiststriedtocreateasmall,sweetredpeppertheygotsomesurprisingspecimens,including“squat-shapedpeppers[that]grewstraightup,perchedonstems.”Oneoftheresearchersnoted,“Youwon’tseethatanywhereelseintheworld.”Andwhenanotherteamtriedtocreatebruise-resistantpotatoesbyendowingthemwithsyntheticgenesbuiltwithbitsofchickenandmothDNA,manyofthespudswereshockers.Somehad“alligator-hide-typeskin,”somehad“thumb-likeprotrusionsandeyebrows,”somehad“arms,”andothershad“nosesthatlooklikePinocchio’s.”Reflectingonthegrotesqueresults,onescientistremarked,“It’snotnicetofoolnature.Sometimesyougetslapped.Andsomepeoplegetslappedaroundalot.”

ANeedtoRefashiontheFactsHowever,despiterepeatedslapsfromnature,thebiotechnicianspressedonwiththeventuretoreprogramourfood–allthewhileclaimingthattheircreationsconformtowhat’snatural.Buttosustainthisclaim,notonlydidtheyhavetodistortthestoryofwhattheyweredoing,theyhadtorecastsomebasictruthsofbiologytoboot.

Andsomehighlyinfluentialscientistshavecreatedconsiderableconfusion.AprimeexampleisthemolecularbiologistNinaFedoroff,amemberoftheNationalAcademyofSciencesandarecipientoftheNationalMedalofScience,whoservedastheScienceandTechnologyAdvisertotheUSSecretaryofStatefrom2007to2010andthenbecamePresidentoftheAmericanAssociationfortheAdvancementof

Science.Inherbook,MendelintheKitchen:AScientist’sViewofGeneticallyModifiedFoods,sheblursthedistinctionbetweentraditionalplantbreedingandgeneticengineeringbyassertingthatfarmershavebeenmodifyingplants’genesformorethan10,000yearsandthatthetransformationofawildplantintoafoodplant,aswellasthetransformationofalow-yieldingplantintoahigheryieldingone,entailsachangeinthegenes.67Shehasalsoclaimed:“There’salmostnofoodthatisn’tgeneticallymodified.” 68

Butsheconsistentlyfailstonotethatwhengenesmovebetweenorganismsvianaturalpathways,theydonotundergothealterationsthatoccurthroughbioengineering.Newgenesdonotabruptlyappear,noraretheinternalstructuresofthosealreadypresentroutinelymodifiedinradicalways.Theprimarychangeisinthewaythegenesarecombined.Therearenewarrangementsofthevariousallelesofparticulargenesthathavebeeninthespecies’genomeformillennia.Further,thegenescontinuetobegovernedbythesameregulatoryelements,andthecoordinationbetweenthemispreserved.Evenintherareinstanceswhenaspontaneousmutationarisesandismaintainedinthespecies’genepool,thechangeinthegene’sstructureordinarilyoccursatjustonepoint(withonlyasinglebasepairaffected).69Moreover,theregulatoryelementsareusuallyconserved.70

Geneticengineeringstandsinstarkcontrast.Genesareinsertedintospeciesthathavenevercontainedthem;and,priortoinsertion,they’resubjectedtosignificantrestructuring.Inseveralcases,intronsareexcisedandcodonsreconfigured,orterminatorsequencesarereplaced.AndinthecaseofvirtuallyeveryGEplantcurrentlyonthemarket,thenativepromoterhasbeenremovedandreplacedwithapowerfulonederivedfromviruses–apromoterthatoperatesoutsidethefinelytunedregulatorysystemofthetargetcells,perturbingtheirpatternsofenergyconsumptionandpotentiallycausingotherimbalancesaswell.Additionally,theinsertionsarerandom,andtheytendtocauseextensivedisruptiontothefunctioningofnativegenes.

Nonetheless,despitethefactthatsuchdisruptiveeffectshavebeendocumentedinnumerousscientificjournals,notonlydoesFederofffailtoacknowledgethem,sheflatlyassertsthatnosuchproblemsoccur.Ina2008NewYorkTimesinterview,shedeclaredthatGEtechniques“introducejustonegenewithoutdisturbingtherest.” 71

Shefurtherdistortsherdepictionofbioengineeringbyfailingtonotethenecessityforexcisingintronsandre-writingcodonswhentransferringgenesfromplantsandanimalstobacteria–andforalsorevisingcodonswhenmovinggenesfrombacteriatothehigherkingdoms.72Acknowledgingsuchrealitieswouldmakebioengineeringlookalotmoreunnaturalthaninthepictureshepaints.

Moreover,toenhancetheimpressionthatthetechnologyiscloselyalignedwithtraditionalpractices,sheclaimsit’sessentiallyequivalenttotheancientartofgrafting.However,shecanonlydosobysignificantlymischaracterizingthenatureofthattime-honoredtechnique.

Graftingiswidelyusedinhorticulture,anditplaysanimportantroleinfruitproduction.Inthelatter,abudorbranchfromonetreeissplicedontotherootstockofanother;andthecompositethengrowsintoamaturetree.Inmanycases,graftingisdonetoincreasehardiness,aswhentheupperpartofthetreeisjoinedtotherootstockofanothertypeoftreebettersuitedtoparticularvarietyofsoilthanisitsownstock.Itservesotherendsaswell,achiefonebeingthepreservationofgenomicintegrityfromgenerationtogeneration.

Graftingcanpreserveadistinctgenomebecauseit’saformofcloning.Thebranchthat’sjoinedtotherootstockwillproducefruitgeneticallyidenticaltothefruitonthetreefromwhichitwastaken.Incontrast,ifthefruitonthedonortreepollinateswithneighboringtrees,geneticvariationwilloccurandtheprecisecharacteristicsofthefruitwillnotbefullymaintainedintheprogeny,evenwhenpollinationislimitedtothesamespecies.

Whilegraftinggenerallyinvolvesmembersofthesamespecies,thepartsaresometimesdrawnfromdifferentones.However,althoughsuchtreescontaincomponentsfromdistinctspecies,asdomolecules

constructedthroughrDNAtechnology,thesimilaritystopsthere.Whilethelatterareformedfromfusionsofdiversely-sourcedDNAfragments,there’snosuchcomminglingofDNAingrafting.Thedistinctpartsofthetreecooperateinthemovementofwaterandnutrientsbetweenthem,butthegenesintheirnucleistayput.73Eachgeneremainswithinthenucleusofitsowncell,underthecontrolofthecell’sregulatorysystem.Further,whereasrDNAtechnologycanmoveDNAbetweenbiologicalkingdoms,therangeofgraftingisquitelimited.Onlysimilarspeciescanbegrafted,andsometrees(likethecherry)can’tevenbefusedtotheirclosestcousins.Moreover,there’snowaytomergeelmsoroakswithfruittrees.

Ofcourse,there’sanothergreatgapbetweengraftedtreesandengineeredorganisms.Whereasallthegenesintheformerareintheirnaturalstate,thoseinthelatterarenot.Aspreviouslydescribed,everycellofalmosteveryGMOcontainsoneormoregenesthathavebeenartificiallyrestructured.74

Nonetheless,althoughthediscrepanciesbetweengraftedtreesandgeneticallyrestructuredorganismsareglaring,Fedoroffgliblyglossesoverthem–declaringthatthelatterare“nodifferent”thantheformer.Andinafinalflourish,sheproclaimsthataGMOisjustasnatural,andnomoreartificial,thananappletree.75

Butheronlysupportforthisastonishingclaimisthesimplisticassertionthatgeneticengineeringandgraftingbothrequirehumanintervention–alongwiththefalseassertionthat“eachtechniquecombinesgenesfromdifferentspecies.” 76Infact,tothebestofourknowledge,there’snogreaterfusionofforeigngeneswithinagraftedtreethaninabowlofmixedfruit.77

Theinanityofherassertionsisunderscoredbyrememberingthatthetwotechniquesserveoppositeaims.Whereasbioengineeringaltersgenomesinradicalways,graftingpreventsgeneticchangeandpreservesthestatusquo.Yet,sheinsiststhatthetwoprocessesyieldthesamekindofresults.

Additionally,inherardortoportraybioengineeringasmorenaturalthanitis,Fedoroffcreatesfurtherdistortionbyequatingthemanipulationsofbiotechnicianswiththebehaviorofabacterium.Asdomostbiotechboosters,shepointstoAgrobacteriumtumefaciensasa“naturalgeneticengineer”andarguesthatbecauseithasmoveditsgenesintoplantsforages,geneticengineersarehardlydoinganythingnewwhentheyemployitforthesamepurpose.78Rather,shesaysthatthenoveltyliesintheexpansionofpossibility:“What’snewisthatthepoolofpossiblegenesfromwhichplantbreederscannowchoosehasgrownverymuchlarger.” 79

However,thisclaimdisregardsthefactthatwhentheAgrobacteriafunctionnaturally,theycreatetumorsinplants,notnewvarietiesofplants.Theyinfectpre-formedplants,notsinglecellsthatwillbegrownintothem.Thealiengenesareonlyinjectedintoaportionoftheplant’scells,andit’sextremelyunlikelythey’dbetransferredtosubsequentgenerations.80Nordotheforeigngenesenterthefruitofinfectedtrees.Incontrast,whenthebacteriaareemployedinbioengineering,theyinfectisolatedcellsthatwillbecomewholeplants.Therefore,thealiengenesthataretransferredendupineverycellofthematureplant(includingthefruitofengineeredtrees);andtheypasstotheplant’sprogeny.Thisisaradicalre-workingofanaturalprocess.

Ofcourse,it’salothardertopassthegenegunoffassomethingnatural,soFedoroffsayslittleaboutit.Sheonlymentionsitinafewsentences,andshegivesnoindicationthatit’sthetechniquethroughwhichmostoftheGEfoodthat’sbeeneatenwasgenerated.81

Unfortunately,Fedoroff’sproclivitytorecastrealityinregardtoGEfoodsissharedbymany(ifnotmost)oftheirotherproponents.Andaphenomenonthey’reparticularlypronetorefashionisthecriticalroleofviralpromoters.Afterall,it’sespeciallytoughtomakethecasethatgeneticengineeringissubstantiallysimilartonaturalbreedingwhenvirtuallyalltheforeigngenesitimplantsinfoodcropscannotevengetexpressedwithouttheaidofapotentboosterthatnotonlyenablestheirexpression,butpropelsitnonstop,independentoftheorganism’sregulatorysystemandcontrarytoitsneeds.Sobiotechadvocatesrarelygiveafairaccountofwhatsuchpromotersaredoing.Forinstance,whileFedoroffdoes

discusstheuseofthe35Spromoterandacknowledgesthatit’spowerful,shedoesnotexplicitlydisclosethatitderegulatestheexpressionoftheforeigngenesandcompelstheirtranscription24/7;andmostreaderswhodidn’tknowthisalreadywouldprobablynotdrawsuchaninferencefromwhat’swritten.Moreover,shedownplaysthepossibilitythattheuseofthatpromoterposesrisks,despitethefactmanyexpertsthinkthatitdoes.

Inordertoobscurethepromoter’strueeffects,someproponentsevenmisrepresenthowitoperates.Anespeciallyegregiousexampleoccurredinaguideforconsumerspublishedin2000bythefoodstandardsagencyforAustraliaandNewZealand(which,liketheFDA,endeavorstofosterbiotechnology).IndescribinghowaforeigngeneisexpressedinaGEorganism,thedocumentstatedthatthe35Spromoter“tellstheplanttoturnthegeneon”andthattheterminatorsequence“tellstheplanttoturnthegeneoff.” 82Thisisflat-outfalse.Inreality,thepromoterisboththe“on”andthe“off”switch.Althoughtheterminatorsstopthetranscribingenzymesfromproceedingbeyondthem,theydonotterminatethetranscriptionprocessitself.Aslongasthepromoterremainsinthe“on”mode,onetranscribingenzymeafteranotherwillaffixtotheDNAstrandandtravelalongituntilreachingtheterminator.Thus,theterminatorsequenceactslikeaninstructionthattellsacomputer’sprintertostopafterthetwelfthpageofaverylongdocument,whiletheviralpromoteractslikeaninstructiontokeepchurningoutcopiesofthattwelve-pagesection.

Bymisrepresentingtheroleofthe35Spromoter,theconsumerguideactuallyguidedconsumersintothemistakennotionthattheforeigngeneisbeingregulatedandthatitstranscriptionisshutoffasneeded.Accordingly,theyweregivennoinklingthatthepromoter’sinnatepurposeistooverwhelmaplantwiththeproductsofitsowngenes,indisregardforthehealthofthatplant,andthatanygeneattachedtoitwillthereforebetranscribedincessantly.

Moreover,justastheviralpromoterrelentlesslyexpressesitsadjoinedgenewithnoregardfortheplant,theagencycontinuedtodisseminatethefalsehoodwithnoregardforthetruth;anddespitebeingformallyapprisedoftheerror(aswellasseveralothers),itcontinuedtodispensethemisleadingguidetothepublicforalongtime.83Thus,regulatoryintegritywasbreachedatthegovernmentalleveltobeclouditsbreachattheleveloftheengineeredgenome.

Soawkwardatopicisthedependenceonviralpromotersthatmostbiotechadvocatesprefertocompletelyavoidit.ThisisthecoursetakenbySusanAldridgeinTheThreadofLife:TheStoryofGenesandGeneticEngineering,publishedbyCambridgeUniversityPressin1996,andalsobyWilliamBainesinBiotechnologyfromAtoZ.84AvoidanceisalsotheruleinTomorrow’sTable:OrganicFarming,Genetics,andtheFutureofFood,co-authoredbyPamelaRonald,aprofessorofplantpathologyattheUniversityofCalifornia,Davis,andherhusband,RaoulAdamchak,anorganicgardener.Publishedin2008byOxfordUniversityPress,ithasbeenhighlyinfluentialandhighlytouted.Inanopeningsection,theauthorsproclaimthatitis“accurate,thorough,andbalanced;”andseveralauthoritieshavehaileditassuch.Forinstance,thejournalNatureBiotechnologycalledit“Oneofthebest,mostbalancedaccountsoftransgenicagriculture,”andthesimilarlyprestigiousjournalSciencepraisedtheauthors’“clear,rationalapproach”whilenotingthat“thebalancetheypresentissorelyneeded.” 85Yet,accoladesforitsbalancenotwithstanding,noneofthebook’schaptersevenmentionspromoters.86Apparently,tohaveacknowledgedthetechnology’sneedforviralpromoters,andtohavedescribedtheireffects,wouldhaveclashedwiththebook’scontentionthatGEfoodsaresosimilartonaturallyproducedonesthattheyoughttobeallowedinorganicagriculture.

Moreover,theuseofviralpromotersisnottheonlyimportantaspectofbioengineeringthatthispurportedlybalancedbookignores.It’salsosilentabouttheuseofparticlebombardment–andthefactthatthetwomainGEcropswerecreatedbyit.87

Thus,intheirattempttoimputeclosenessbetweenbioengineeringandconventionalbreeding,several

supposedlyreliablepublicationshavestretchedthetruthintrulyunseemlyways.Butthemostextremeassertionofsimilitudeappearsinthe1989reportoftheNationalResearchCouncil(theNRC,adivisionoftheNationalAcademyofSciences).Itboldlydeclaresthat“noconceptualdistinctionexistsbetweengeneticmodificationofplantsandmicroorganismsbyclassicalmethodsorbymolecularmethodsthatmodifyDNAandtransfergenes.” 88

Thisisanastoundingstatement.Itdoesnotmerelyassertthatgeneticengineeringissubstantiallyequivalenttoallotherformsofplantbreeding(includingnaturalsexualreproduction),itproclaimsthatthetechnologyisessentiallyidenticaltothem.Afterall,ifonecannotmakeaconceptualdistinctionbetweenGEandsexualreproduction,theymustnecessarilybethesamething.Butthat’sobviouslyabsurd.Therestofthereportdrawsnumerousconceptualdistinctionsbetweenthem.Furthermore,merelybycategorizingtraditionalmethodsas“classical”andrecombinanttechniquesas“molecular,”thestatementitselfmakessuchadistinction–andisthusself-contradictory.

Italsocontradictstheunderstandingofscientistswhoemploygeneticengineeringbutarenotpreparedtodistortitsrealities.Forinstance,themoleculargeneticistMichaelAntoniou,whousesgeneticengineeringinhumangenetherapy,statesthatit“technicallyandconceptuallybearsnoresemblancetonaturalbreeding.” 89Thus,theassertionisabsurdnotonlyasamatteroflogic,butasamatteroffact.

HowcouldsuchanabsurdityhavemadeitswayintoareportbytheUnitedStates’premierscientificinstitution?Although(aswesawinChapter2)theNationalAcademyofScienceshadanagendatopromotebiotechnology,it’sstillsurprisingthatsuchanoutlandishcontentionevenenteredthefirstdraft,letalonesurvivedsubsequentlayersofeditorialreview.90Apparently,thepersonnelinvolvedweresointentonestablishingthecongruenceofgeneticengineeringandothermethodsthattheylostsightofhowirrationaltheirwordshadbecome.Andthefactthatthroughoutsucceedingdecades,theirabsurdstatementhasbeenperceivedasauthoritative,repeatedlycited,andunwittinglyreliedon,atteststothestayingpowerofeventhemostpreposterousclaimsadvancedonthetechnology’sbehalf.

PublicConfusion:TheGEVenture’sMostConsistentlyProducedEffectWhiletheeffectsofgeneticengineeringhavebeenquitevariable(andoftensurprising),thedistortionsdispensedtoadvanceithavefunctionedfarmorereliablythanthetechnologyitself.Unlikethelatter,theyhaveconsistentlyachievedtheirintendedresult:widespreadconfusion.Andthere’sbeenparticularsuccessinobscuringthetechnology’smostunappealingaspects–especiallyitsdependenceonviralpromoters.ItraveledandlecturedextensivelyaboutGEfoodsbetween1998and2004,andIrarelymetamemberofthegeneralpubliconanycontinentwhoknewaboutthem.Further,mostpeoplewereastonishedwhenIprovidedthefacts,becauseeminentindividualsandinstitutionshadrepeatedlytoldthemthatthetransplantedgenesbehavejustlikethenativegenes.

Moreover,confusionaboutviralpromotersalsoexistsamonglifescientistswhohaven’tspecializedinmolecularbiology–evenwhenthey’vestudieditsapplicationsextensively.AstrikingexampleisthebiologistEricS.Grace,whowasinvitedbyapublishertowriteabookaboutbiotechnology.TheresultwasBiotechnologyUnzipped:PromisesandRealities,whichappearedin1997.

BecauseDr.Grace(whoreceivedhisPhDinzoology)didnotknowthedetailsofgeneticengineering,heneededtodosubstantialresearch.Ashereportsinthepreface:“Mygoalwassimplytofindoutwhatwasgoingon,usingasmanydifferentsourcesaspossible,andtomakemyowninterpretationsasIwentalong.” 91Hethenstates:“Itwasareasonablystraightforwardmattertofindinformationaboutthetechniquesofbiotechnology–suchashowtocutandspliceDNA...ormaketransgenicorganisms(animals,plants,ormicrobescarryingtheactivegenesofotherspecies)....Thedifficultpartwasevaluatingthefinaloutcomes,separatingfactsfromspeculation,andsciencefrompolitics.” 92

However,discoveringthedetailsaboutthecreationoftransgenicplantsandanimalswasnotas“straightforward”aprocessashewasledtobelieve,because,despitehisextensiveefforts,hecameupshortonsomekeyfacts.Forinstance,inthechapter,“ToolsintheGeneticEngineeringWorkshop,”althoughhecorrectlynotesthatpromotersarelikeswitchesthatregulatetheexpressionofgenes,hethenstates:“Whengeneticengineerstransplantgenesformakingproducts,theymustincludetheswitchesthatcontrolgeneexpressionaswellasthegenesthemselves.” 93

Thisstatementisdoublyerroneous.Itimpliesthatagene’sownpromoteristransferredalongwithit,whilealsoimplyingthatthepromotercaninduceadequateexpressionofthatgenewithinaforeigncell.Accordingly,there’snomentionoftheneedforviralpromoters;andthebookneversetsthingsstraight.

Butitdoestwistotherimportantfacts.Inoneofitsbiggestdistortions,thebookdeclares:“Outsideofitscell,thereisnodistinctionbetweenahumangene,acatgene,awheatgene,orabacterialgene.” 94Yet,aswe’veseen,therearemajordifferencesbetweenbacterialgenesandthoseofplantsandanimals.Andbecauseofthem,genesfrombacteriamustbeextensivelymodifiedbeforetheycanfunctionwithinthecellsofhigherorganisms,justasgenesfromthoseorganismsmustbereconfiguredbeforetheycanoperatewithincellsofbacteria.Somehow,Dr.Gracedidnotdiscoverthisessentialinformation.Thislackofknowledge(coupledwithhisconfusionaboutthewaysofpromoters),causedhimtoconveytheimpressionthatsuchcross-kingdomtransfersarerathersimplematters.Further,thereareotherrespectsinwhichhispresentationisnotassolidorbalancedasheapparentlythoughtitwas.

Thus,asDr.Graceattemptedtounzipbiotechnology,thezippergotstuck–which,inanimportantrespect,revealsmoreabouttheGEfoodventurethanalltheinformationthathedidaccuratelyconvey.Whenhebeganresearchforthebook,healreadyhadagoodgraspofthefundamentalsofbiologicalscience.Further,hewasanaccomplishedsciencewriter.Yet,someofthemostbasicfactsofgeneticengineeringweresoobscuredthatevensomeonewithhisknowledgeandabilitiesdidnotdiscernthem.Moreover,althoughhewassincerelyendeavoringtocommunicatethefacts,itseemsthatothersassociatedwithhisbookwerequitecontentforunattractiveonestoremainhidden–andforfalsehoodstostandintheirstead.

Accordingly,itshouldnotbenotsurprisingthatthebookwaspublishedbytheNationalAcademiesPress,anorganoftheNationalAcademyofSciences.

Aswe’veseen,theAcademyhasbeenalong-timeproponentofbioengineering;andsevenyearsafterreleasingGrace’sbook,itpublishedNinaFedoroff’sMendelintheKitchen,whichpresentedahighlypartisancaseforGEfoods.Ofcourse,Graceendeavoredtobeaccurateandnonpartisan,butthoseresponsibleforeditingandvettinghisbookapparentlydidnot.Itwasthoroughlyanalyzedbyateamofreviewersthatincludedseveralscientists,anditsbackcovercontainsastrongendorsementfromFedoroffexpressingherintentiontouseitinheruniversitycourses.95Somehow,itserroneousdiscussionofpromotersdidnottroubleherortheotherexpertswhoreviewedit,oranyoneonthepublishingstaff.Nordiditsfalseattributionofsimilaritybetweenbacterialgenesandthoseofhigherorganisms.Otherwise,therewouldhavebeendemandsforrevision–demandsthatalmostsurelywouldhavebeenmadeifthemistakeshadworsenedtheimageofgeneticengineeringinsteadofmakingitlookfarlessradical,andmuchmorenatural,thanitreallyis.

Inlightoftheevidencediscussedabove,it’snotanexaggerationtosaythatanycitizenswhoendeavoredtogetanaccuratepictureofhowGEfoodsareproducedbyreadingtheaccountsprovidedbyscientistsandscientificorganizationsthatendorsetheprocesshavehadthedeckstackedagainstthem.Evenreadingbooksonthetopicpublishedbyprestigiousacademicpresseswouldhaveleftthemignorantofseveralkeyfactsandwithfalseimpressionsofmanyothers.ApersoncouldhavereadtwobookspublishedbyOxfordUniversityPress,onebyCambridgeUniversityPress,andonebytheNationalAcademiesPressfromcovertocoverandneverknownabouttheneedtoaddviralpromoterstothe

transferredgenes.AndevenifheorshestudiedanotherbookfromtheNationalAcademiesPressthatdidnotetheuseofsuchpromoters(Fedoroff’s),therewouldstillhavebeennoexplicitindicationthattheycausethegenestobehaveinanuncontrolled–andpotentiallydisruptive–way.Moreover,afterfinishingallfivebooks,heorshewouldhaveacquiredapicturethatwasnotonlyincomplete,butseverelydistortedbyextensivemisstatements.Andthiswouldhavebeentheresultofconsultingbooksthatmetthestandardsofpremierpresses.Thesourcesfromwhichmostpeoplegaintheirinformation(newspapers,magazines,radio,andtelevision)havetendedtopresentstatementsfrombiotechadvocatesthatareevenmoremisleading.

Thedegreeofdifficultyingainingbasicknowledgeisconveyedbythefollowingfact:sixteenyearsafterEricGracebeganhisquest“tosimplyfindoutwhatwasgoingon,”hestilldidnotknowabouttheneedforviralpromotersintheproductionofalmostallGEfoods–ortheabnormaleffectstheyinduce.Hisreplytoanemailquerymadethisclear.96

IfabiologistwhoextensivelystudiedgeneticengineeringinordertowriteabookaboutitfortheNationalAcademiesPress,andwhoevidentlyremainedkeenlyinterestedinthetopicoverthesubsequentsixteenyears,hadnotyetlearnedoneofthecrucialfactsthatrenderGEfoodsdifferentfromtheirconventionalcounterparts,howmuchmoreconfusedmusttheaveragecitizenbe?

Sadly,theconfusionhasbeenthickenedbecausethebiologistswhofosteritclaimtospeakonbehalfofthescientificcommunity,portrayingtheiropinionsastheofficialstanceofscienceandanyopposingviewsasscientificallyillegitimate.Accordingly,manyofthemimparttheimpressionthatonlynonscientistshaveconcerns.Forinstance,PamelaRonalddeclaredonanationallybroadcasttelevisionprogramthat“thescientificcommunityisperfectlycomfortablewithgeneticallyengineeredcrops.” 97AndwhileNinaFedoroffatleastacknowledgesthatsomescientistsopposetheuseofgeneticengineeringinfoodproduction,shesaysthereareonlya“few”–andthat“theyarerarelythosewhoknowthisnewsciencewell.” 98

However,aswe’vealreadyseen(andassucceedingchapterswillmakemoreobvious),therearenumerouswell-credentialedandwell-informedexpertswhoregardgeneticallyengineeredfoodsasdeeplydifferentfrom,andmoredangerousthan,thoseproducedbyanypriormeans.ThesescientistshavetriedtocounteracttheconfusionspreadbyFedoroffandsomanyotherbiotechboosters–andtocorrectthefalsebutwidelyheldimpressionthatgeneticengineeringissubstantiallysimilartoconventionalformsofbreeding.Thischapterbeganwithastatementfromoneofthem:anassertionbyaNobellaureatebiologistthatgeneticengineeringis“thebiggestbreakinnaturethathasoccurredinhumanhistory.”Andatthisclosingstage,it’sfittingtofeaturewordsfromanother:amolecularbiologistwhowasselectedtorepresentthepositionofthescientificcommunityataforumonGEfoodsinWashingtonD.C.sponsoredbytheAmericanAssociationfortheAdvancementofScience.OnthemorningofMay8,1998,inthestatelyedificethathousedtheorganizationoverwhichNinaFedoroffwouldlaterpresideaspresident,Dr.LiebeCavalierideliveredtheday’sfirstsubstantiveaddress,systematicallyrefutingthekindsofargumentsforthesimilaritybetweengeneticengineeringandconventionalmethodsthatwerebythenquitecommon–andthatFedoroffwouldsubsequentlyadvanceinherbook.99

However,althoughDr.Cavalieri’sconcernswereobvious,nooneintheaudience(exceptme)knewthattheyhadmotivatedhimtosignonasaplaintiffinthelawsuitthattheAllianceforBio-IntegritywouldfileagainsttheFDAlaterthatmonth–andthatinafewweekshewouldbebackinWashingtonspeakingatapressconferencethedaythesuitwasfiled.Onthatoccasion,heelaboratedonhispriorassertionthatitis“simplistic,ifnotdownrightsimple-minded”toclaimthatgeneticengineeringissubstantiallythesameastraditionalbreeding;andheemphasizedtheirresponsibilityofdoingso.Hisconcludingcommentwasforthright.Lookingintotherowofcameras,hedeclaredit’s“disgraceful”thateminentscientistshaveengagedinthispractice–andhedenounceditasa“sham.” 100

Thus,throughtheingeniouscircumventionofseveralnaturalbarriers,thebioengineeringventuremanagedtocreatefoodswithfunctionalforeigngenes;andthroughthedisingenuousdepictionofwhattheprocessentailed,itmaintainedgovernmentsupportandmitigatedpublicconcern.Yet,itstillfacedaformidablebarrierofadistinctlydifferentkind,imposednotbythelawsofnaturebutbythelawsoftheUnitedStates.

Itwasconfrontedbyavenerableconsumerprotectionstatutethatformorethanthirtyyearshadbeenregulatingtheintroductionoffoodswithnewadditives.Thisstatutemandatedthatsuchfoodsbeprovensafe,thusblockingthefasttracktocommercializationthatbiotechproponentsdesired.Tocircumventthisobstaclewhileconveyingtheimpressionthatnolawshadbeenbroken(orevenbent)wouldrequireanotherroundofingenuity–andanadditionallayerofdeception.ItwouldalsorequirethecollusionoftheUSFoodandDrugAdministration.

CHAPTERFIVE

IllegalEntry

TheGovernmentalFraudthatPutGEFoodsontheUSMarket

TryingtoBringFoodSafetytotheForeDuringthemid-1980’s,asPhilipRegalcontemplatedthedeepdifferencesbetweentraditionallyproducedfoodsandthosebeingdevelopedviageneticengineering,herealizedthattheissueofwhetherthesenovelentitiesmightharmtheenvironmenthadtendedtoovershadowtheissueofwhethertheyweresafetoeat–andthattheriskstheyposedtoconsumerhealthwereinsomerespectsmoreserious.

Ofspecialconcernwasthepotentialforunintendedtoxins.Asherecounts:“Ithoughtitwasimportanttorecognizethatplantsarelittlebiochemicalfactoriesthatproducescoresofbioactivecompoundsinordertomessupthemetabolismofagreatvarietyofpredatorsandpathogens.That’swhyallthefirstdrugswerediscoveredinplants.Eveninsmallamountssomeplantchemicalsaregoodforusandsomearedangerous,soethnobotanistsseekknowledgefromlocaltribalpeopleaboutwhicharewhich.”

Becauseheknewthataplant’sbiochemicalpathwayscan“switchtracks,”andthatasmallshiftcanmakeabigdifferenceinthesuitabilityofaplantforfood,Regalwasconvincedthatedibleplantsproducedthroughbioengineeringmustbecarefullytestedforfoodsafety.Henotes:“Wehaveextensiveevidencethatgeneticengineeringcandisruptbiochemicaltrafficinwaysthatcausebizarresideeffects.Andifthepathwaysinvolvedareonesthatproducebioactivecompounds,andiftheyareinducedtorerouteintonewpathsortoopenupauxiliaryones,thatcanspelltrouble,becauseitcanleadtothesynthesisofnovelsubstancesthatareharmful.That’swhyIkeptstressingtogovernmentregulatorsandindustryscientiststhatevenifwedeterminedthataparticularcropbioengineeredinaspecificwaywouldbeecologicallysafe,thiswasnoassuranceitwassafetoeat.Todeterminewhetheritwasgoingtobeawholesomefoodwouldrequireothersortsofstudies.MyassociatesandIweretryingtogetthemolecularbiologists,thegovernmentpeople,andtheindustrytothinkaboutareasofscientificknowledgeandlevelsofbiologicalcomplexitythattheyhadpreviouslyignored.”

TokenGestures,BrokenPromisesInlightofthevariousfacts,RegalthoughtitwasmistakentopresumethatGEfoodswouldbeinvariablyassafeastheirconventionallyproducedcounterparts–andmorerealistictoviewthemasentailinghigherrisk.Further,helearnedthatmanyotherbiologistssharedthisview.Hethereforesoughttoalertthepeoplewithwhomheinteractednotonlythatthereweresignificanthealthrisks,butthattheycouldinsomewaysbemoreproblematicthantheenvironmentalones.

Inseveralcases,industryscientistsreadilyunderstoodandagreedthatthereweregroundsforconcern.TheyconfessedtheywereinaracesimplytogetnewDNAintoplantcells(andthentofunctionwithintheforeignsurroundings)andthatthisracetookalltheirattention.Buttheyassuredhimthattheyandtheircolleagueswouldgivemoreheedtothefoodsafetyissuesoncetheyhadfinallyproducedviabletransgenicplants.Further,virtuallyallthebiotechproponentshemet,whetherornottheyacknowledgedthatfoodsafetyhadbeenslighteduptillthen,guaranteedthatampleprecautionswouldbeimplemented.AsRegalrelates:

Duringastringofworkshopsandconferencesbetween1984and1988,Ihadnumerousinformal

conversationsduringmeals,breaks,andwalkswithbiotechadvocateswhoinsistedIcouldbanishallconcernsaboutthepossibilityofsomegeneticallyengineeredfoodscausingpublichealthdisasters.Theyassertedthatnobioengineeredproductwouldevergetintogrocerystoresunlessithadbeenthoroughlytestedandconfirmedsafe;andtheyassuredmethatanyproblemsofthesortthatIhadraisedwouldbedealtwithbywhatiscalled“goodagriculturalpractice,”and“goodlaboratorypractice,”and“goodindustrialpractice.”IndustryandgovernmentpeopleemphasizedrepeatedlythatwhiletheyneededmyadviceonthepotentialecologicalproblemsthatGMOsmightcause,issuesoffoodsafetywouldbediligentlyaddressed–andtheintegrityoftheAmericanfoodsupplycarefullyguarded.TimeandagainIwasurgednottothinkaboutfoodsafetyissuesbecausetheFDAandUSDAhadverystrictregulationsthatwouldprotectthepublic.

Iknewlittlethenaboutthebiotechfoodindustryandwasnaiveenoughtolargelybelievetheassurancesofitsvariousproponents.AndIsuspectthatmostofthembelievedtheirownrhetoric.Eventheterm“geneticengineering”impliesfaithinadegreeofprecisionthathasalwaysbeenfarbeyondthecapacityofrecombinantDNAtechnology;andmanybiotechenthusiastsfirmly(albeitunrealistically)expectedthistechnologywouldroutinelymatchtheexactnessandreliabilityofelectricalandmechanicalengineering.

Moreover,itseemsthatmostbiotechadvocatescouldnolongerevendiscernthedifferencebetweenhardfactandpromotionalfluff.AsoneindustryinsiderconfidedtoRegal:“We’vehypedourselvessomuchaboutgeneticengineeringthatwedon’tknowwhat’shypeandwhatisn’tanymore.Financingthiswholebusinesshasabsolutelydependedonhypeandonpromisingtheworldtoventurecapitalistsandeventoeachother.”

NotonlydidRegalaccepttheassuranceshe’dbeengiven,heregularlypassedthemontorepresentativesfrompublicinterestgroupswhoquestionedhimaboutthedirectioninwhichfoodsafetypolicywasheading.Buthestoppeddoingsoafterhewasinvitedtoparticipateina1988interagencybiotechpolicymeetinginAnnapolis,MarylandattendedbynumerousgovernmentofficialsfromnearbyWashington,D.C.Althoughtheconferencestartedonareassuringnote,withspokespersonsforUSDA,FDA,andEPAassertingtherewouldbescience-basedprocedurestoguaranteethesafetyofgeneticallyengineeredfoods,ominousovertonessoonarose.Forinstance,aftermakingsuchapledge,theActingDirectoroftheFDA’sCenterforFoodSafetyandAppliedNutritionconfessed:“IwishIcouldtellyouthatweknowhowwewillapproachtransgenicplants.Infact,weorganizedthisconferencewithUSDAandEPAbecausethereareimportantscientificquestionsthatwehavenotresolved.”Buthethenwentontosay,“Weshouldsetasidequestionsforthemomentthatcannotbeanswered.” 1

Regalfoundthisfarfromcomforting,andheconsidereditfancifultopromisethatsafetywouldbescientificallycertifiedwhileimportantunresolvedscientificissueswereducked.Moretroubling,overthecourseoftheconferencehelearnedthatmany,ifnotmost,oftheexpertsinattendancebelievedthatthequestionofsafetycouldneverbefullyresolvedinfavorofGEfoodsbecausesignificantuncertaintyisinherentinthetechnologyandcannotbeeliminated.Herecalls:“Ininformaldiscussionsatmealsandonwalks,governmentscientistafterscientistinsistedthattherewasnowaytobesureaboutthesafetyofgeneticallyengineeredfoods.” 2Intheirview,arigoroussystemoftestingcouldbehelpfulbutnotfullyreliable.ItcouldweedoutmanydangerousGEfoods,butitmightnotcatchthemall.Whileitcouldidentifyaproductasharmful,itcouldnevercertifysafety.

Thoughsomescientistsweremoreoptimisticaboutthepotentialoftesting,virtuallyallconcurredthatnomatterhowgreatthedegreeofscientificuncertaintyorhowlongitmightpersist,thecommercializationofGEfoodswouldnotbedelayedonaccountofit.Nordidtheybelievethatameaningfulsystemoftestingwouldbeinstituted,becausetheyknewitwouldentailacostthatthebiotechcorporationswereunwillingtobear–andamplyabletoavoid.Thesecorporationshadalreadyinvested

farmoreinthedevelopmentofGEfoodsthanisnormalforconventionalones.Whileittakes10yearstodevelopaGEseedandonlybetween5and8yearstodevelopanewnon-engineeredone,thecostdifferentialisfargreater.3MajorGoodman,aplantbreederatNorthCarolinaStateUniversity,haspeggeditatfiftytimeshigher.4Andthatdoesn’tincludeanypricetagfortestsrelatedtofoodsafety.Expertshaveestimatedthatjustacombinationofshortandmedium-termtoxicologicalfeedingtestswouldcostatleastanadditional$25million–which,accordingtoGoodman’sfigures,wouldboosttheoverallexpensebymorethan40%.5Fulllong-termtestingwouldbesubstantiallymoreexpensive.Further,anymeaningfulsafetytestingwouldsignificantlyextendthetimerequiredbeforemarketingcouldcommence.

Suchextracost(inbothtimeandmoney)foreachproductwouldhavebeenaburdenthatthemanufacturerscouldprobablynothaveborne.TheywereunderpressuretorecouptheirvastinvestmentsandprojectahealthyimageonWallStreet,andthisimagewouldhavebeensulliedbynewsthateachinsertionevententailedrisksthatnecessitatedextensive,andexpensive,tests.

Theindustry’sprioritywastogetthenewproductsmarketedasquicklyaspossible,nottominimizetheattendantrisks;andithadbecomesopowerfulthatitcouldlargelybendtheinstitutionsofgovernmenttoitswill.SopervasivelyhadindustrypreferencemergedwithgovernmentpolicythatseveralscientistsemployedbyregulatoryagenciesconfidedtoRegalthatalthoughtheyweredistressedbythewaythingsweregoing,theyfearedreprisalsiftheyraisedconcernsthatcouldretardtheintroductionofGEfoods.

Insuchcircumstances,itwasobviousthatasoundsystemoftestingwasnotgoingtobeafeatureoftheGEfoodenterprise,andthebiotechproponentswerenolongerevenattemptingtopersuadeRegalthatitwouldbe.Healsolearnedthattheotherhopesthey’dinstilledinhimduringthepreviousfouryearswereequallybaseless.Ashesays:“The1988conferencewassobering,andsignificantlyshocking,becausealthoughmanyofushadbeenledtoexpectthatgeneticallyalteredfoodswouldbethoroughlytestedandthattheagencieswereontopofthings,itwasnowbeingopenlyadmittedbyeveryagencyorindustrypersonwithwhomIhadacupofcoffeeortookawalkthatthefoodswouldnotbewell-tested–andthatinsteadofbeingontopofthetechnicalproblems,theagencieshadnodefiniteplansfordealingwiththem.Infact,ourbreak-outworkgroupsrevealedthatindustryandgovernmentscientistswereonlyjuststartingtothinkseriouslyabouttheproblems.” 6Moreover,anattitudeherepeatedlyheardexpressed,notonlyfromindustryrepresentativesbutfromgovernmentofficials,was:“IftheAmericanpeoplewantprogress,theyaregoingtohavetobetheguineapigs.”

Asitbecameincreasinglyclearthatthepressuresofeconomicsandpoliticswouldtrumpthebasicrequirementsofscience,Regalfeltdismayedandmorethanalittlebetrayed.“AfteryearsofbeingfedassurancesthatGEfoodswouldbethoroughlytested–andthenpassingontheseassurancesmyself–Iwasnowhearingthatmeaningfultestingwouldnotbeimplementedbecauseitwasfinanciallyimpractical,regardlessofthedegreetowhichitwastechnicallyfeasibleandscientificallyimportant.Notonlyhadmyeffortstogettheenterpriseinlinewithsciencebeenlargelyrejected,Ihadservedasanunwittingaccompliceinspreadingmisinformationtomanyothers.”

RetreatfromRealityWhenRegalexpressedhisopinionthatthepublicneededsomegenuineprotectionandaskedifanywastobeprovided,hewasfrequentlytoldthatsufficientprotectivemechanismswouldbeprovidedbythefreemarketsystem.Thethreatoflawsuitswouldmotivatethemanufacturerstokeeptheirproductssafe,andifanydidcauseharm,consumerscouldgetcompensatedbywinningjudgmentsincourt,whichwouldultimatelyforceharmfulproductstobewithdrawn.Further,theindustryhadpromisedthattofacilitatethejustimpositionofliability,GEfoodswouldbelabeled,makingiteasiertoestablishcausallinks.

However,whiletheseargumentsseemedappealingtothosewhomadethem,theywerelargelydetachedfromreality.AsRegalandotherexpertswellknew,unlessaparticularGEfoodregularlycausedacuteillnessafteronlyoneorafewexposures,itwouldbeextremelydifficultforanyonetoproveincourtthatheorshehadbeendamagedbyit,evenifithadinducedwidespreadharm.Mostfood-borneillnessarisesoveralongtimethroughrepeatedexposure,andthemaladiesareoftennotuniquebutareones(likecancer)thatcanarisefromdiversecauses.Soinmostcases,plaintiffswouldbeunabletomeettheburdenofproof.Andbecausetheweaknessoftheconsumers’positionwasobvious,therewouldbelittleincentiveforindustrytoincurthecostsofmeaningfulsafetytests–aswasalreadyquiteevident.

WhenRegalpointedthisout,hereceivednosatisfactoryresponses.Inmostcases,hewasmetwithshrugsandlooksofresignation.OneundauntedadvocatesuggestedthefoodwouldfirstbesoldabroadandnotintroducedintheUSuntilitwasclearthatnocatastropheshadoccurredinforeignpopulations.Amongthemanyindividualsattheconferencewithpositionsofresponsibility,noneseemedwillingtodoanythingtore-directthecourseonwhichtheGEfoodventurewasproceedingorreducetherateatwhichitwasaccelerating.AsRegalrecounts:

ThemoreIinteractedwithbiotechdevelopersovertheyears,themoreevidentitbecamethattheywerenotcreatingascience-basedsystemforassessingandmanagingrisks.Andasmomentumbuiltandpressurestobeonthebandwagonmounted,peopleinindustryandgovernmentwhowerealertedtopotentialproblemswereincreasinglyreluctanttopasstheinformationontosuperiorsortodealwithitthemselves.Virtuallynoonewantedtoappearasaspoileroranobstructiontothedevelopmentofbiotechnology.BytheendoftheAnnapolisevent,itwasclearerthaneverthatthecareersoftoomanythousandsofbright,respected,andwell-connectedpeoplewereatstake–andthattoomuchinvestmentneededtoberecovered–forindustryorgovernmenttoturnback.ThecommercializationofGEfoodswouldbeallowedtoadvancewithoutregardtothedemandsofscience;andthesupportingrhetoricwouldstaystretchedwellbeyondthelimitsoffact.

ADisregardedDimension:USLawIronically,oneofthemanyrealitiestowhichthebiotechproponentsandmostoftheirgovernmentallieshadbecomeobliviouswasthatthenation’slegalsystemformedabulwarkagainstwhattheywereplanningtodo–andthattopushGEfoodsontothemarketabsentmeaningfultesting,theywouldnotonlyhavetobreaktheirpromisestoRegalandhiscollaborators,theywouldhavetobreakthelawaswell.

Whattheproponentsfailedtograspwasthatthefederalfoodsafetylawsdonotintendformarketforcestobethebasicmodeofprotection–andthattheyweredesignedtoreducethechancesthatanovelproductwillcausemassmiseryandonlythereafterbedrivenfromthemarketbyliabilitylawsuits.Accordingly,inthecaseofnewproductslikegeneticallyengineeredfoods,thelawsrequirethekindofscience-basedtestingthatthebiotechboosterswereresolvedtoshirk.

Ofcourse,notallthegovernmentofficialswereignorantofwhatthefoodsafetylawsrequired.ThoseintheFDAwerewellawareofthemandates,andtheagencyhadevencreatedsomeofthem.Buttoomanyoftheseofficialswerepreparedtocircumventtherequirementsinordertoadvancegovernment

policyandspeedtheentryofGEfoodsintothenation’ssupermarkets.However,duetotherigorofthelaw’sprovisions,significantcunningwouldberequiredtodoso.

ConfrontingaClassicConsumerProtectionStatuteTheprecautionaryfeaturesofUSfoodsafetylawareneithernewnornuanced.They’reexplicit,andthey’vebeeninplacesince1958,whenCongresssignificantlyupgradedtheFood,DrugandCosmeticAct(theFDCA).Thatstatute,initiallysignedintolawin1938,establishedstandardsforthesafetyandpurityofthethreecategoriesofproductsnamedinitstitle;andovertheyears,itbecameoneofthenation’smostveneratedconsumerprotectionlaws.Fromitsinception,thestatutetookastrongprecautionarystanceinthecaseofdrugs,mandatingthateachbeprovensafebeforeitcouldbemarketed.Butin1938,itappearedtothelegislatorsthatthesafetyoffoodscouldbemaintainedwithoutsuchstricturesbecause,incontrasttodrugs,mostfoodshadbeensafelyconsumedforcenturies.Thus,whileithadbeenfoundnecessarytoregulatetheconditionsunderwhichmanywereproducedinordertopreventtheiradulteration,itseemedunreasonabletodemandthatthesafetyofthefoodsthemselvesbedemonstrated.Intheirpureforms,theywerepresumedtobesafeandwereonlyexpectedtoposeriskintheeventtheybecametainted.Consequently,foodscouldbepurveyedwithoutpriortesting,andprotectivemeasuresonlycameintoplayifparticularbatchesclearlyproducedharm,inwhichcasetheFDAcouldrecallorseizethem.Moreover,althoughmanysubstanceswereaddedtoprocessedfoods,alargeproportion(likesalt,vinegar,andspices)hadbeensafelyusedthroughouttheages,andmanyoftheothersdidnotappearthreatening.So(exceptforsubstancessuchasformaldehyde,whichwerespecificallybanned)additiveswerepresumedsafeunlessprovenotherwise–andtheburdenofprooffellontheFDA.7

Yet,thoughthisapproachseemedsensiblein1938,by1958itwassignificantlyoutdated.Duringthosetwentyyears,thevolumeofprocessedfoodsdramaticallyburgeoned,asdidthenumberofsubstancesaddedduringprocessing,resultinginwhat’sbeentermeda“chemogastricrevolution.” 8Notonlyhadthemajorityoftheseadditivesneverappearedinfood,manyhadneverevenexistedandwererecentconcoctionsofchemistrylabs.Accordingly,therewasnoevidencetoshowthattheyweresafe,andgoodreasontosuspectthatmanymightnotbe.

Therefore,CongressdecidedtostrengthentheFDCAsoitcouldbetterdealwiththeinfluxofnoveladditives.TheresultwastheFoodAdditiveAmendmentof1958.Itsfirmintentwastoprioritizeprecaution,evenifthatmoderatedthepaceoftechnicalinnovation–afactmadeclearbyanofficialSenatereportwhichstated:“WhileCongressdidnotwanttounnecessarilystifletechnologicaladvances,itneverthelessintendedthatadditivescreatedthroughnewtechnologiesbeprovensafebeforetheygotomarket.” 9Underthenewprovisions,additivestofoodwerenolongerpresumedsafebutinsteadwerepresumedtobeharmful;andtheindustryhadtheburdenofprovingtheywerenot.Absentsuchproof,anewadditivewasprohibitedfromenteringthefoodsupply.

Further,becauseitwouldbeunreasonabletodemandthatthingslikesaltandspicesundergosuchsafetytesting,theamendmentestablishedacategoryofadditivesexemptfromthisrequirement:thosethatwere“generallyrecognizedassafe”(commonlyreferredtoas“GRAS”).Substanceswithahistoryofsafeusepriorto1958wereplacedinthiscategory,andtheycouldcontinuetobeemployedwithoutanytesting.Moreover,Congressrecognizedthatevenifasubstance’ssafetyhadnotbeenestablishedthroughcommonexperiencebefore1958,therewouldstillbecasesinwhichithadbeensubsequentlydemonstrated,obviatingtheneedforfurthertesting.Consequently,thelawstatedthatasubstancecouldalsobedeemedGRASiftherewasaconsensusamongexpertsthatitssafetyhadalreadybeenfirmlyestablishedthrough“scientificprocedures.” 10And,asweshallsee,thestandardofproofwasrigorous.

TheseprovisionsoftheFoodSafetyAmendmenthavebeenwidelyregardedbybothliberalsand

conservativesasnecessary;andwhentheRepublicanRichardNixonwaspresident,hedirectedtheFDAtotightenitsregulationoftheGRASlist.Moreover,therehasbeennoseriousattempttoderegulatefoodadditivesandallowthemtobegovernedsolelybymarketforces.11

Therefore,iftheFDAwasgoingtoletGEfoodsontothemarketwithoutpriorproofofsafety,itwouldhavetodomorethanmerelybendawell-respectedlaw.Itwouldhavetobreakit.Moreover,notonlywouldithavetodisregardthelaw,itwouldhavetodisregardtheopinionsofitsownscientists.

FDAScientistsVoiceTheirConcernsIntheearly1990’s,theFDAestablishedascientifictaskforce,withexpertsfromalltherelevantdisciplines,toaidindevelopingitspolicyonGEfoods.Andastheirinputaccumulated,itexpressedacommontheme:theneedforcaution.Inmemoaftermemo,agencyexpertsexplainedhowGEfoodsposeproblemsthattheirconventionallyproducedcounterpartsdonot–andassertedthattheirsafetycannotbepresumedbutmustbeestablishedviatesting.

Forexample,microbiologistDr.LouisPribylcriticizedtheadministrators’effortstoequatetheunintendedeffectsofbioengineeringwiththoseofconventionalbreeding.Hewrote:“Theunintendedeffectscannotbewrittenoffsoeasilybyjustimplyingthattheytoooccurintraditionalbreeding.Thereisaprofounddifferencebetweenthetypesofunexpectedeffectsfromtraditionalbreedingandgeneticengineering....”Hebrandedtheassertionofsimilarityas“theindustry’spetidea”andpointedout“thatthereisnodatatobackuptheircontention....” 12HealsonotedthatbecausetheaddedgenescannotbeinsertedpreciselybutinsteadentertheDNAstrandrandomly,“...itseemsapparentthatmanypleiotropic[unintended]effectswilloccur.”Hefurtherexplainedthatseveralaspectsofgene-splicing“maybemorehazardous,”includingtheriskthatthepromotersfusedtotheforeigngeneswillactivatedormant(“cryptic”)metabolicpathways.Asheexplained:“...breedershavenothadtofacetheissueofnew,powerfulregulatoryelementsbeingrandomlyinsertedintothegenome.Sothereisnocertaintythattheywillbeabletopickupeffectsthatmightnotbeobvious,suchascrypticpathwayactivation.ThissituationISdifferentthanthatexperiencedbytraditionalbreedingtechniques.” 13(emphasisinoriginal)

Dr.Pribylalsopointedtotheriskthattheenzymeproducedbytheinsertedgene“...whileactingononespecific,intendedsubstratetoproduceadesiredeffect,willalsoaffectothercellularmolecules,eitherassubstrates,orbyswampingtheplant’sregulatory/metabolicsystemanddeprivingtheplantofresourcesneededforotherthings.”Headded,“Itisnotprudenttorelyonplantbreedersalwaysfindingthesetypesofchanges(especiallywhentheyareunderpressuretogetaproductout).” 14Inasubsequentmemo,heagainwarnedabouttheriskassociatedwiththehyper-activityoftheforeigngene,citing“thepotentialforthenewlyintroducedgene(orgeneproduct)toswamptheplant’sresources.”Henotedthatthiscouldresultin“shuttingdownothergenes....” 15

Dr.E.J.MatthewsoftheFDA’sToxicologyGrouplikewiseemphasizedtheriskofunintendedeffects.Heassertedthat“...geneticallymodifiedplantscould...containunexpectedhighconcentrationsofplanttoxicants...,”andhecautionedthatsomeofthesetoxicantscouldbeunexpectedandcould“...beuniquelydifferentchemicalsthatareusuallyexpressedinunrelatedplants.” 16

TheDivisionofFoodChemistryandTechnologysimilarlycitedtheriskofnoveltoxins,whilecallingattentiontoafewothersaswell;anditnotedtheneedfortesting.Itsmemostated:“...someundesirableeffectssuchasincreasedlevelsofknownnaturallyoccurringtoxins,appearanceofnew,notpreviouslyidentifiedtoxicants,increasedcapabilityofconcentratingtoxicsubstancesfromtheenvironment(e.g.,pesticidesorheavymetals),andundesirablealterationsinthelevelsofnutrientsmayescapebreeders’attentionunlessgeneticallyengineeredplantsareevaluatedspecificallyforthesechanges.Suchevaluationsshouldbeperformedonacase-by-casebasis,i.e.,everytransformantshouldbeevaluatedbeforeitentersthemarketplace.” 17Thememofurtheradvisedthattheevaluationsshouldincludetoxicologicaltests.Moreover,itstatedthattestsshouldextendtotheplants’edibleextracts,notingthat“itwould...benecessarytodemonstratethatedibleseedandoilsproducedfromgeneticallyengineeredplantsdonotcontainunintendedpotentiallyharmfulsubstancesatlevelsthatwouldcauseconcern.” 18Inanothermemo,theDivisionagainwarnedaboutunintendedoutcomes,statingthat“DNAinsertionmayaffecttheexpressionofmanygenes.” 19

Anotherexpertwhodiscussedtherisksofunintendedeffects(andtherelatedneedfortoxicologicaltesting)wasDr.CarlB.JohnsonoftheAdditivesEvaluationBranch.Henotedthatthe“inabilityof

analyticalormolecularmethodstodetectthepresenceofanunknowntoxinproducedbyactivationofapreviouslycrypticgene”provides“justification”fortoxicologicaltesting.Andhecriticizedtheproposedpolicystatement’simplicationthatifgeneinsertionoccurredatonlyonesite,theriskofsuchunintendedeffectswouldbenegligible.Hestatedthatlimitinginsertiontoasinglesitewould“reduce,butnoteliminate”thelikelihoodofunintendedeffects;andhetwicepointedoutthatthedocumentprovidednoevidencetoshowthattheriskwouldbenegligible.20

TheDirectorofFDA’sCenterforVeterinaryMedicine(CVM)alsounderscoredtheneedforscrutiny–andtheabsenceofevidence.Hewrote:“IandotherscientistsatCVMhaveconcludedthatthereisamplescientificjustificationtosupportapre-marketreviewoftheseproducts....Ithasalwaysbeenourpositionthatthesponsorneedstogeneratetheappropriatescientificinformationtodemonstrateproductsafety....”Further,henotedthatGEfoodsposeexceptionalproblems,stating:“...CVMbelievesthatanimalfeedsderivedfromgeneticallymodifiedplantspresentuniqueanimalandfoodsafetyconcerns.” 21[emphasisadded]Amongtheuniqueconcernshelistedwastheriskthatresiduesofunexpectedtoxicantsinengineeredanimalfeedcouldappearinmeatandmilkproducts,makingthemunsafeforhumans.Andhepointedoutthataslightshiftinchemicalcompositioncouldhaveamajorimpact.“Unlikethehumandiet,asingleplantproductmayconstituteasignificantportionoftheanimaldiet....Therefore,achangeinnutrientortoxicantcompositionthatisconsideredinsignificantforhumanconsumptionmaybeaverysignificantchangeintheanimaldiet.” 22ThiswarningwasespeciallypertinentbecauseGEcropswereexpectedtocomprisealargepartofthedietofUSlivestock.

Further,besidesstressingtheneedfortesting,Dr.Guestdecriedtheagency’sattempttoexploititsabsence.Incritiquingadraftoftheproposedpolicyhewrote:“Iwouldurgeyoutoeliminatestatementsthatsuggestthatthelackofinformationcanbeusedasevidencefornoregulatoryconcern.”

LikeDr.Guest,theheadoftheBiologicalandOrganicChemistrySectionemphasizedthatlackofproofthataGEfoodisdangerousdoesnotconfirmitssafety,notingthat“inthisinstanceignoranceisnotbliss.” 23Healsofaultedtheproposedpolicystatementbecauseit“turnstheconventionalconnotationoffoodadditiveonitshead”–and“conveystheimpressionthatthepublicneednotknowwhenitisbeingexposedto‘newfoodadditives’....”[emphasisinoriginal]Headditionallyremarkedthataparticularsectionofthestatement“seemsveryarbitrary.”

ThepervasivenessoftheopinionabouttheuniquenessofbioengineeringandthedistinctnessofitsrisksisattestedbyamemoofJanuary8,1992totheBiotechnologyCoordinatorwrittenbyDr.LindaKahl,anFDAcomplianceofficerresponsibleformonitoringtheexpertinput.Init,sheprotestedthattheagencywas“...tryingtofitasquarepegintoaroundhole...[by]tryingtoforceanultimateconclusionthatthereisnodifferencebetweenfoodsmodifiedbygeneticengineeringandfoodsmodifiedbytraditionalbreedingpractices.”Shethendeclared:“Theprocessesofgeneticengineeringandtraditionalbreedingaredifferent,andaccordingtothetechnicalexpertsintheagency,theyleadtodifferentrisks.” 24

IndustryAgendaTrumpsExpertAssessmentAlthoughtheconsensusamongFDAscientistswasclear,theircollectiveopinionwouldhavelittlebearinginshapingapolicythatwassupposedtobescience-based.That’sbecauseagencyadministratorswereapparentlymuchmorewillingtoignoretheadviceoftheirexpertsthantoignorethewishesofthebiotechindustry.

Aswe’veseen,formanyyearsthosewisheshadbeeneffectivelytranslatedintoprioritiesoftheU.Sgovernment;andtheindustry’sinfluencewasstillontherise.Further,therisingpowerwithinthatindustrywasMonsanto.ThisSt.Louis-basedcorporationhadbecomethelargestdeveloperofgeneticallyengineeredplants,anditsinfluencewasenormous.AsaJanuary2001articleintheNewYorkTimesreported,throughthreeconsecutiveadministrations(Reagan,Bush,andClinton),“WhatMonsantowishedforfromWashington,Monsanto–and,byextension,thebiotechnologyindustry–got.” 25(Thisphenomenonwouldcontinuethroughthefollowingtwoadministrationsaswell.)

Moreover,thearticlerevealedthattheindustryhadessentiallydictatedpolicy.InthewordsofHenryI.Miller,whodealtwithbiotechnologyissuesattheFDAbetween1974and1994anddirectedtheOfficeofBiotechnologyforfiveofthoseyears,“theU.S.governmentagencieshavedoneexactlywhatbigagribusinesshasaskedthemtodoandtoldthemtodo.”[emphasisadded]

WhatMonsantowanted(anddemanded)fromtheFDAwasapolicythatprojectedtheillusionthatitsfoodswerebeingresponsiblyregulatedbutthatinrealityimposednoregulatoryrequirementsatall.However,althoughtheadministrationofGeorgeH.W.BushembracedthisplanandapparentlyinducedtheFDAdecision-makerstogoalongwithit,theagency’stechnicalexpertswerenotpersuadedthatsciencewasanenterprisetobefreelyshapedbypoliticalandeconomicagendas.Astheirmemosattest,theyrefusedtoserveasspindoctorsforMonsanto,andtheyinsteadendeavoredtofashionapolicybasedonthebestavailableevidenceandsupportedbysoundscientificreasoning.Consequently,earlydraftsofthepolicysignificantlyclashedwiththegoalsofthepoliticiansandthepoliticallyappointedadministrators.

ThetensionsbetweentheapproachofthescientistsandtheagendaofthepoliticianstoalargeextentreflectedthedisparitiesbetweenthefoodsafetylawsandtheCoordinatedFrameworkforRegulationofBiotechnologythattheReaganAdministrationhadfashionedin1986.AswesawinChapterTwo,theFrameworkmandatedtheadministrativeagencies“toregulatetheproduct,nottheprocess.”Butthispreceptentailedthepresumptionthatgeneticengineeringisessentiallyassafeastraditionalbreeding–andthatitposesnorisksofunintendedeffectsthatwarrantsafetytesting.26AsFDAcomplianceofficerKahlnoted,itwasduetothismandatethattheagency’sadministratorstried“toforceanultimateconclusion”thatGEfoodsareessentiallythesameastheirconventionalcounterparts.27

ButalthoughtheFrameworkinducedFDAofficialstoforcetheadoptionofanunscientificprecept,itlackedtheforceoflaw–andithadnopowertomodifylaws.Therefore,itcouldnottechnicallyoverridethestatutoryrequirementthatsafetybedemonstratedthroughscientificprocedures–andthatdecisionsbebasedonevidenceratherthanspeculation.Soincallingforteststoscreenforbioengineering’sinherentriskofunintendedconsequences,andinstressingthatthepresumptionofsafetylackedevidentiarybackup,theFDAexpertswereadheringtothelaw.AndintryingtoconformtotheCoordinatedFramework,theadministratorswereskirtingit.

BecausethedissonancebetweenthescientificstaffandtheadministratorswasimpedingdevelopmentofapolicystatementinlinewithWhiteHousepreference,theFDAdecidedtobringinsomeonetogettheprocessmovingmoredecisivelytowardthedesiredoutcome.SoinJuly1991,anewpositionwascreated,DeputyCommissionerforPolicy;andtheindividualappointedtofillitwasnotonlywiseinthewaysoftheagency,butadroitinadvancingtheaimsoftheindustry.HewasMichaelTaylor,amanwhohadworkedattheFDAfrom1976to1981asastafflawyerandExecutiveAssistanttotheCommissioner.

HethenbecameapartnerinthelawfirmofKing&Spalding,wheretheclientswhoseinterestsherepresentedincludedMonsantoandtheInternationalFoodBiotechnologyCouncil.Thus,hisselectionastheofficialtooverseethedevelopmentofFDApolicyonGEfoodswasyetanotherindicationofMonsanto’sclout.

WithTaylorincharge,assuccessivedraftsofthepolicystatementwerewritten,sectionsdescribingdifferencesbetweenGEfoodsandtheirconventionalcounterpartswereprogressivelypurged.However,scientistsweredispleasedbytheexcisions,andmicrobiologistPribylwasmovedtoprotest.“Whathashappenedtothescientificelementsofthisdocument?”hedemanded.“IftheFDAwantstohaveadocumentbaseduponscientificprinciples,theseprinciplesmustbeincluded,otherwiseitwilllooklikeandprobablybejustapoliticaldocument....Itreadsverypro-industry,especiallyintheareaofunintendedeffects....” 28

Butthefactthatthedocumenthada“verypro-industry”slantwasanessentialpartoftheplan;andamemofromtheofficeoftheFDACommissioner,DavidKessler,totheSecretaryofHealthandHumanServicesdatedMarch20,1992touteditsconformitywiththeWhiteHouse’seconomicaims.Asthememopointedout,“TheapproachandprovisionsofthepolicystatementareconsistentwiththegeneralbiotechnologypolicyestablishedbytheOfficeofthePresident....ItalsorespondstoWhiteHouseinterestinassuringthesafe,speedydevelopmentoftheU.S.biotechnologyindustry.” 29Thedocumentadditionallyemphasizedthatthepolicystatementwouldplaya“critical”roleinhelpingtheindustry“winpublicacceptanceofthesenewproducts”by“assuring”consumersabouttheirsafety.

Yet,fromthestandpointoftheupperechelons,eventhisversionofthepolicystatement,whichPribylhadderidedasshortonscienceandlongonpro-industrypap,wasnotsufficientlysanitized.Forinstance,anadministratorintheofficeoftheAssistantSecretaryforHealthattheDepartmentofHealthandHumanServiceswasdisconcertedbytheextensiveairingofpotentialproblemsthatGEcropscouldposefortheenvironment.Sohefiredoffanobjectionwhichdeclared:“Theextensivetwelvepagediscussionseemstobe...dangerouslydetailedanddrawn-out....Incontrasttothesectionsonfoodsafety,whichproperlyimplythatbiotechnologyisafundamentallyinnocuoustooloffoodproductionandthatthefruitsofbiotechnologywillbesubstantiallyequivalenttothosewithwhichwearealreadyfamiliar,the[environmental]sectiongivesanincorrectimpressionthatbiotechnologyraisessignificantnewagriculturalandenvironmentalconcerns.” 30Inresponsetohiscomplaint,theenvironmentalsectionwasdrasticallycutandrevisedsoastobecleansedof“dangerouslydetailed”discussion–andtheimpartationofanyimpressiondeemed“incorrect”bynon-scientistsuperiors.

Butdespiteitssuccessivesurgeries,intheeyesoftheWhiteHouseteam,thedocumentwasstillinneedofcosmeticadjustments.AndJamesB.MacRae,Jr.,anadministratorintheOfficeofManagementandBudget,sentamemotoPresidentBush’sWhiteHousecounselthatcalledforseveralcorrections.31Hetermedthe“tone”ofoneparagraph“inappropriate”becauseitimpliedtheremightbe“obligatoryFDAreviewandoversight,”andheproposedanalternativeparagraphto“stresstheroleofdecentralizedsafetyreviewsbyproducers.”Healsofaultedthedocumentforinsufficientlystressingthatthemethodbywhichafoodisproducedisessentially“irrelevant”totheissueofitssafety,andhesuggestedthattwooffendingsentencesbereplacedwithtextthathesetforth.Andtomorefullyminimizetheimportanceofmethod,heevenrecommendedremovingthereferenceto“plantsdevelopedbyrecombinantDNAtechniques”fromthedocument’stitleandchangingittoread:“StatementofPolicy:FoodsDerivedfromNewPlantVarieties.”Moreover,hesaidthatthedocument“shouldstate”thatrDNAtechniques“actuallymayproducesaferfoods.”Accordingly,herequestedtheinclusionofthefollowingsentence:“Sincethesetechniquesaremoreprecise,theyincreasethepotentialforsafe,bettercharacterized,andmorepredictablefoods.”

BecauseMacRae’srequestscamefromtheexecutiveofficeofthepresident,theywereextremely

effective.32WhereastheFDA’sexpertslaboredformanymonthstofashionascience-basedfootingforthepolicystatement,onlytohavemostofitdeletedordeformed,amereeightdaysafterMacRaewrotehismemo,thefinaldocumentwaspublishedintheFederalRegisterwithallhisprofferedtextincluded–andthealteredtitleheproposedatitshead.

SlightingtheLawthroughSleightofHandJustastheBushAdministrationhadacceleratedthepolicy’scompletion,itlikewisehastenedpublicintroduction.OnMay26,1992,threedaysbeforethepolicywaspublished,Vice-PresidentDanQuaylestoodbeforeacrowdofexecutivesandreportersandpresenteditasamajorachievementintheWhiteHouse’scampaignforwhatwastermedregulatoryrelief.“Thereformsweannouncetodaywillspeedupandsimplifytheprocessofbringingbetteragriculturalproducts,developedthroughbiotech,toconsumers,foodprocessorsandfarmers,”hedeclared.“Wewillensurethatbiotechproductswillreceivethesameoversightasotherproducts,insteadofbeinghamperedbyunnecessaryregulation.”And,tosootheconcernsthatinrevvinguptheprocess,hazardscouldgoundetected,heavowed:“Wewillnotcompromisesafetyonebit.” 33

Moreover,thepolicystatementitselfwentMr.Quayleonebetterbyallegingthattherereallywasn’tanissueaboutthesafetyofGEfoodsinthefirstplace.ItdescribedrDNAtechniquesasmere“extensionsatthemolecularleveloftraditionalmethods,”anditconsistentlydepictedtheirproductsasnoriskierthanotherfoods.34Then,tocapthingsoff,itproclaimed:“Theagencyisnotawareofanyinformationshowingthatfoodsderivedbythesenewmethodsdifferfromotherfoodsinanymeaningfuloruniformway,orthat,asaclass,foodsdevelopedbythenewtechniquespresentanydifferentorgreatersafetyconcernthanfoodsdevelopedbytraditionalplantbreeding.” 35

Butthisoutrightdenialwasanoutrightlie.Aswe’veseen,theFDAhadreceivedabundantinformationfromitsownexpertsalertingittoseveraldifferencesthatwereindeedmeaningful–andthatcreatedaneedforsafetytesting.However,thememostheexpertshadwrittenwerelodgedintheagency’sfiles,andmostoftheirinputtothepolicystatementhadbeenexcisedbythetimethefinaldraftwasproduced.Socitizenswerenotawareofthefraud.

NorweretheyawarethattheVice-President’sassertionthatGEfoodswouldbegiventhestandarddegreeofoversightwasalsofalse.Inhisrendition,whilethelawwouldbefullyapplied,itwouldnotbebloatedby“unnecessaryregulation”thatwouldhamperthedevelopmentofanimportanttechnology.Butinreality,GEfoodswerenotbeingfreedfromextraneousburdens;theywerebeingillegallyexemptedfromthecentralprovisionsofoneofthenation’smostimportantconsumerprotectionstatutes.

Aspreviouslynoted,theFood,DrugandCosmeticActstipulatesthatnewfoodadditiveswithoutahistoryofsafeusepriorto1958mustbeprovensafebeforetheyaremarketed.Anditdefinesafoodadditiveas“anysubstancetheintendeduseofwhichresultsormayreasonablybeexpectedtoresult,directlyorindirectly,initsbecomingacomponentorotherwiseaffectingthecharacteristicsofanyfood....” 36[emphasisadded].Thisisabroaddefinition,anditclearlycoversthetransferredgeneticmaterialinbioengineeredfoodsaswellastheirexpressionproducts.However,thestatutemodifiesthedefinitionbystatingthatasubstancewillnotbeclassifiedasanadditiveifitis“generallyrecognized”byexpertstobesafe.37ThisistheGRASexemption;andtheFDA’spolicystatementclaimedthatinvirtuallyeveryinstance,theDNAinsertedintoGEfoodsandthesubstancesitproducescouldbereasonablypresumedtoqualify.38

Butit’sdifficulttoaccordthisclaimrespect,becausetheFDAclearlyknewthatGEfoodswerenotgenerallyrecognizedassafebyexperts.First,theoverwhelmingconsensusofitsownexpertswas(a)thattheseproductsposepotentialproblems,(b)thattheirsafetycannotbepresumed,and(c)thateachmustbedemonstratedsafeviatesting.Second,FDAofficialsknewtherewasnotaconsensusaboutthesafetyof

GEfoodsamongscientistsoutsidetheagencyeither–afactacknowledgedbytheFDA’sBiotechnologyCoordinatorinalettertoaCanadianhealthofficialdatedOctober23,1991.IncommentingonadocumentthatdiscussedGEfoods,hestated:“AsIknowyouareaware,thereareanumberofspecificissuesaddressedinthedocumentforwhichascientificconsensusdoesnotexistcurrently,especiallytheneedforspecifictoxicologytests.” 39

Moreover,eveniftherehadbeenagenuineconsensusaboutsafety,thelawalsorequiresthatitbebasedonsolidevidence.Theserequirementsarequitestrict.They’recontainedinthestatuteitselfandelaboratedinitsassociatedregulations.SuchregulationsresultwhenCongressauthorizestheagencythat’sgoingtoadministerastatutetomakeadditionalrulesthatwillfacilitateitsimplementation.Theseregulationsthenbecomepartofthelaw.

InthecaseoftheGRASexemption,Congresshadalreadymandatedthatasubstancewithoutapriorhistoryofsafeusecannotqualifyunlessevidenceforitssafetyhasbeengeneratedthrough“scientificprocedures;”andin1971theFDAissuedaregulationthatstrengthenedthemandatebystipulatingthatthisevidencehastobeofthe“samequantityandquality”asisrequiredtogainapprovalasafoodadditive–andthatitmustdemonstratea“reasonablecertainty”thatthesubstanceisnotharmfulunderitsintendedconditionsofuse.40Theregulationfurtherstatedthatbecausetheevidencemustbewidelyknownbyexperts,itshould“ordinarily”bereportedin“publishedstudies,whichmaybecorroboratedwithunpublishedstudiesandotherdataandinformation.” 41

Thus,theGRASexemptiondoesnotrelaxthedegreeofrequiredevidencebutratherrelievesaproducerfromperformingnewtestsforsubstancesalreadyknowntobesafeonthebasisofpreviousones.AndtheFDAwaswellawarethattherewasnoreliableevidencedemonstratingthesafetyofGEfoods.Aswe’veseen,memosbyseveralofitsexpertshadnotedthepaucityofsuchevidence–andrebukedtheadministratorsforpretendingthatalackofdatademonstratingharmcancountasconcreteproofofsafety.Further,microbiologistPribylhademphasizedthattherewasnoevidencetosupporttheclaimthattheunexpectedeffectsofgeneticengineeringaresimilartothoseoftraditionalbreeding.AndDr.JohnsonoftheAdditivesEvaluationBranchhademphasizedtherewasnobackingforthenotionthattherisksofsucheffectscouldberenderednegligible.PerhapsthestrongestacknowledgementoftheevidentiaryvoidappearedinamemofromcomplianceofficerKahl,whodemanded:“[A]reweaskingthescientificexpertstogeneratethebasisforthispolicystatementintheabsenceofanydata?” 42

However,althoughFDAofficialswerewillfullybreakingthelawbytreatingGEfoodsasiftheywereGRAS,theywereabletocreatetheimpressionthatnothingillicitwashappening.Theyhadgrappledwiththeissueofhowtopullthisoffforsometime,andadocumentwrittenduringthesummerof1991providesinsightintotheircalculations.43Indiscussingthebasicoptionsopentotheagency,thedocumentnotedthat“someregulatorymiddlegroundisneeded”betweencompletelackofpre-marketregulationand“routineimpositionofthefoodadditive/GRASregime,withitsrequirementofpetitionsastheonlybasisforobtaininganyFDAinvolvementinthetaskofsafetyassurance.” 44However,itobservedthatsucharoutewouldhavedrawbacks,becausebyallowingGEfoodstobemarketedwithoutfoodadditivepetitionsandthesafetytestingthatmustaccompanythem,theFDAwouldgive“...theappearanceoflooseningrequirementsofanexistingregulatorycategorytofitbiotechfoods....” 45Therefore,itsaidthatprocedureswouldhavetobeimplementedtoavoidsuchanappearance–andalso“[t]oavoidtheappearanceofcompleteindustryself-regulation...”Inelaboratingonproceduresthatmightdothetrick,thedocumentsuggestedthattheFDAcouldpromulgateguidelinesthroughwhichthemanufacturerswouldmaketheirownsafetyassessments,determinethattheirproductsareGRAS,andtheninformtheagencyoftheirdeterminations.

Thisisthebasicapproachthatthe1992policystatementadopted.And,althoughthewholeprocesswascompletelyvoluntary,becauseitprojectedtheappearanceofregulation,andbecausethe

pronouncementsofgovernmentandindustryroutinelymaintainedthatresponsibleregulationwasinplace,mostpeoplewerefooled.Thus,thevastmajorityofAmericans(includingthoseinCongress)wereledtobelievethatGEfoodswerebeingcarefullyregulatedandrigorouslytestedwheninrealitythebiotechindustryhad,ineffect,beengrantedself-regulationandthevoluntaryassessmentprocesswasincompetenttoassurethesafetyofanyproductthatpassedthroughit.

Contrarytothegovernment’spretensions,thisprocessisnotonly“informal”butremarkablysuperficial.AstheFDA’sBiotechnologyStrategicManagerhasdescribedit,wheninacandidmode:“TheFDArequeststhatfirmssubmitasummaryoftheirassessmenttotheagency.TheFDAdoesnotrequesttheoriginaldataand,therefore,doesnotconductascientificreviewofthefirm’sdecision.” 46Moreover,theagencydoesnotevenmakeadeterminationthatthefirm’sdecisionisvalid–andthushasneverofficiallydeterminedthatanyGEfoodcurrentlyonthemarketisactuallysafe.

TakingtheFDAtoCourtAlthoughtheFDAhaddeludedthepublicandCongress,itseemedhighlyimprobablethatthecharadewouldsurvivethescrutinyofafederalcourt.AndwhentheAllianceforBio-Integrityanditsco-plaintiffsfiledtheirlawsuitinMay1998,therewasamplebasisforoptimism.Foronething,numerousscientistsandscientificorganizations(suchastheBritishMedicalAssociation)hadindicatedthattheywerenotconvincedthatGEfoodsareassafeasconventionalones,soitwasclearthattherewasnotageneralrecognitionofsafetywithinthescientificcommunity.Further,themerefilingofthesuitestablishedthatpoint,becausenineoftheplaintiffswerescientificexpertswhoallegedthatgeneticengineeringposeshigherrisksthantraditionalbreeding–andthatitsproductscannotbepresumedsafe.ThisgroupcomprisedsevenprofessorsfrominstitutionssuchasUC,Berkeley,Rutgers,andtheNYUSchoolofMedicinealongwiththeAssociateDirectorofTargetedMutagenicsatNorthwesternUniversityMedicalSchoolandacomputationalbiologistwiththeHumanGenomeProject.Accordingly,itcontainedmorethanenoughexpertstorefutetheFDA’sclaimthatthere’sageneralrecognitionofsafety–especiallyconsideringthatinapriorjudicialproceeding,theFDAhaddefeatedamanufacturer’sGRASclaimbyproducingjusttwoexpertswhocontestedit.

TodrivehometheinvalidityoftheGRASpresumption,threeexpertssubmitteddeclarationsdetailingthedifferencesbetweengeneticengineeringandtraditionalbreeding,explainingthekindsofteststhatarerequiredtoassessthesafetyofGEfoods,andpointingoutthatnoneofthesefoodshadyettobedemonstratedsafeonthebasisofsuchtesting.Twoofthedeclarationscamefromplaintiffs,andonewassubmittedbyRichardLacey,M.D.,Ph.D.,aProfessorofMedicalMicrobiologyattheUniversityofLeedsintheU.K.,whocouldn’tbeaplaintiffbecauseheisnotaUScitizen.Dr.Lacey,aleadingauthorityonfoodsafety,hadwrittenfivebooksonthetopicandpublishedover200articlesinscientificjournals.Hehadalsodistinguishedhimselfbypredictingamajorfood-borneperil,whichnotonlydemonstratedhisprowess,butultimatelydemonstratedhowcrucialitisforgovernmentstoheedthewarningsofexperts–andhowdisastrousitcanbewhentheyforgoprecaution.Ashisdeclarationexplained:

In1989,IanticipatedthattherecouldbeserioushealthriskstotheBritishcattleandhumanpopulationsfromthepracticeoffeedingcattlerenderedmeatfromsheepandotheranimals.IpublishedmywarningsinFoodMicrobiology,1990.Inthisarticle,Iexplainedthenatureofthemaladythatcouldresult.Thiswasthefirstpredictionofwhateventuallybecamethe“madcow”epidemicintheUnitedKingdom.Unfortunately,thegovernmentalauthoritieswereslowtorespondtomywarning.HadtheyproperlyassessedandactedupontheinformationIpresented,muchhardshipwouldhavebeenavoided,andthecitizenswouldnothavebeensubjectedtoashighadegreeofrisk.(Becauseofthelonglatencyperiodbetweenexposuretotheinfectiousagentanddevelopmentofsymptoms,thereisapotentialforwidespreadincidenceofinfectionwithintheBritishpublicoverthenextfortyyears.)47

InthecaseofGEfoods,Dr.Laceyhadagainissuedwarningsforthesakeofavertingwidespreadharm;andhehopedthathisdeclarationtothecourtwouldhaveamoreimmediateeffectonUSgovernmentalpolicyregardingthoseproductsthanhiswarningsaboutmadcowdiseasehadonthepolicyoftheU.K.government.

Hisdeclarationinpartasserted:

ItismyconsideredjudgmentthatemployingtheprocessofrecombinantDNAtechnology(geneticengineering)inproducingnewplantvarietiesentailsasetofriskstothehealthoftheconsumerthatarenotordinarilypresentedbytraditionalbreedingtechniques.Itisalsomyconsidered

judgmentthatfoodproductsderivedfromsuchgeneticallyengineeredorganismsarenotgenerallyrecognizedassafeonthebasisofscientificprocedureswithinthecommunityofexpertsqualifiedtoassesstheirsafety....

RecombinantDNAtechnologyisaninherentlyriskymethodforproducingnewfoods.Itsrisksareinlargepartduetothecomplexityandinterdependencyofthepartsofalivingsystem,includingitsDNA.

...whereaswecangenerallypredictthatfoodproducedthroughconventionalbreedingwillbesafe,wecannotmakeasimilarpredictioninthecaseofanygeneticallyengineeredfood.Therefore,theonlywayeventobegintoassureourselvesaboutthesafetyofageneticallyengineeredfood-yieldingorganismisthroughcarefullydesignedlong-termfeedingstudiesemployingthewholefood....Evenifthemostrigoroustypesoftestingwereperformedoneachgeneticallyengineeredfood,itmightnotbepossibletoestablishthatanyissafetoareasonabledegreeofcertainty,asispossibleinthecaseofmostordinarychemicaladditives.However,weatleastwouldbeinafarbetterpositionthannowtohavegreaterconfidenceinthesenewfoods.

OneofthetwoplaintiffswhosubmitteddeclarationswasJohnFagan,amolecularbiologistwhohadledaresearchgroupattheNationalInstitutesofHealthandhadreceivedaResearchCareerDevelopmentAwardfromtheNationalCancerInstitute.TheotherwasPhilipRegal.HehadbecomeaplaintiffbecausesuingtheFDAappearedtobetheonlyremainingpaththatheldpromise.Duringthepreviousfifteenyears,hehadinteractedwiththescientificcommunity,thecorporateestablishment,andthegovernmentagenciesthroughstandardproceduresforeducatingandpersuading.Hehadendeavoredtogenerateawarenessoftherisksandtheimplementationofpracticesthatwouldmakegeneticengineeringsafer.Hehaddiligentlyrespondedtotherepeatedrequestsofgovernmentofficials(includingPresidentReagan’s“BiotechnologyCzar”andadministratorsfromtheNationalScienceFoundationandtheregulatoryagencies)forinputthatwouldhelpshapethegovernment’sGEfoodpolicy–andhadotherwisecooperatedwiththemastheyasked.Hehadmetwithdozensofcorporateexecutivesandrepresentatives.Hehadattendedforty-fourscientificconferencesandworkshops,hadpresentedpapersatthirty-two,andhadorganizedfourofthem(includingameetingoftheAmericanAssociationfortheAdvancementofScience).Hehadpublishedninearticlesonbioengineeredorganismsinscientificjournalsandcontributedsixchaptersonthetopictoacademicbooks.Yet,littlehadcomeofit;andregardlessofwhathe’dbeenpromised,hardlyanyconcretereformhadoccurred.Further,theFDA’sactionshadconvincedhimthatitsadministratorsweredeterminedtopromoteGEfoodsregardlessofscientificdataorlegalduty–andwouldnotdesistunlesscoercedbyacourt.

Accordingly,hisdeclarationdenouncedtheagency’smisbehavior.AfteradetailedexplanationofwhyeveryGEfoodshouldbepresumedtoentailhigherriskthanitsconventionalcounterpart,andafterassertingthathewasunawareofanyreliablescientificstudydemonstratingthatevenonesuchfoodwassafe,hestated:

Toignorethefactthatthelivingsystemsinvolvedhavecomplexbiochemicalanddevelopmentaldynamicsandthatunusualhigh-technologygeneticinterventionshavetherealpotentialforunpredicteddeleterioussideeffectsis,atbest,biologicallynaive.

However,whileitmightbenomorethannaiveforalaypersontomakesuchsimplisticassumptions,itisotherwiseinthecaseofagovernmentregulatoryagencythathasbeenrepeatedlyinformedofthefacts.Whensuchanagencypersistsinignoringthesefacts,eventhoughthesafetyofthefoodsupplyisatstake,itsbehaviorisnotmerelyscientificallyunsoundbutmorallyirresponsible.

ItisbecauseIviewtheFDA’spolicyandpracticesregardinggeneticallyengineeredfoodto

beirresponsible–andbecauseIregardtheconsequentriskposedforpublichealthtobesubstantial–thatIhavetakenthestepofjoiningtheabove-namedlawsuitasaplaintiff.Bystandingasaplaintiffratherthanmerelyparticipatingasanexpertwitness,IhopetomakecleartothepublicandtheCourtnotonlytheextenttowhichIdisagreewiththeagency’sassumptionsasapurelyintellectualmatter,butthedegreetowhichIdeploreitsbehavioronethicalgrounds.Ultimately,Iwascompelledbymyconsciencetobecomeaplaintiff,andIamproudtostandwithsomanyotherscientificexpertswhohavesimilarlyactedonthebasisofethicalaswellasstrictlyscientificprinciples.48

Afterthesedeclarationsweresubmitted,theplaintiffs’positionwasstrengthenedevenfurtherbynumerousdocumentsofequalpotency:documentsfromtheFDA’sownfiles.ThecontentsofthesefileswereunknowntouswhenweinitiatedthesuitandonlybecameaccessiblebecausetheFDAwasrequiredtohandovercopiesofallitsrecordsrelatingtoGEfoodsaspartofthediscoveryprocess.ThismassofinformationcontainedextensiveevidencedemonstratingthatGEfoodsarenotGRAS,andeveryagencydocumentquotedinthepreviouspageswaspartofit.Consideringtheexpectedcombinedimpactoftheserevelations,theinvolvementofourninescientist-plaintiffs,andthepowerofthesubmitteddeclarations,Iandtheotherattorneysontheplaintiffs’teamhadgoodreasontoexpectvictory.

(Astheintroductionexplains,theattorneysofrecordwerewiththeInternationalCenterforTechnologyAssessmentinWashington,D.C.Theyhadextensiveexperienceinlitigationwithfederalagencies,andtheymanagedthebulkofthelawsuit.IspentconsiderabletimeintheICTAofficesassistingwithseveralaspectsofthesuit,andIcontributedsignificantlytothesectionsofthebriefsdealingwiththeGRASandlabelingissues.WhenIusetheterms“we”and“our,”I’mreferringtomyselfandtheICTAlawyerscollectively.)

Despitethestrengthoftheevidenceagainstitsclaims,thegovernmentwasnotabouttoconcede;anditcommittedsubstantialresourcestodefeatingoursuit.Duringtheensuingmonths,manygovernmentattorneysengagedinthefight;andtheydidnotalwaysfightcleanly.Inoneoftheirsubmissions,theyimpugnedtheplaintiffs’motivesandallegedthatthesuitwasfiledforanumberofunsavorypurposes,including“fearmongering.” 49Thisaspersionwasespeciallyegregious,consideringthatseveraloftheplaintiffswereeminentscientistsandtenwereordainedmembersoftheclergy.Andtherewereseveralotherrespectsinwhichitseemedthatwewereconfrontingcageyindustrylawyersinsteadofpublicservantsdedicatedtoupholdinglawandjustice.

HowtheSuitProceeded:Arguments,Counterarguments,andaCounterfactualRulingOvertheyears,numerouspeoplehaveaskedmetorecountthehighpointsofthetrial,andthey’reusuallysurprisedwhenIinformthemthatatrialwasnotheld.Butlawyersaren’tsurprised,becausetrialsareonlynecessarytoresolvedisputesaboutthefacts,andinourcase,therelevantfactswerecontainedwithinthedocumentsthatwefiledandthe44,000pagesoftheFDA’sadministrativerecord.Sincethesefactswerenotdisputed,thepartiesagreedthatthecaseshouldbedeterminedviasummaryjudgment,inwhicheachsidesubmitsargumentsattemptingtoshowhow,inlightofthefacts,thelawsupportsitsposition.

Inall,bothsidessubmittedthreewrittenarguments:amotionforsummaryjudgment,acritiqueoftheother’smotion,andareplytotheother’scritique.Althoughweexpectedthatthejudge(ColeenKollar-Kotelly)wouldthenrequestanoralargumentsoshecouldprobemoredeeplyintopointsraisedinthewrittensubmissions,shedidnotcallforone.OnSeptember29,2000,morethanayearafterthelastroundofargumentswassubmitted,shereleasedheropinion,addressingeachissueintheorderithadbeenraisedinthewrittenarguments.

FDAPrevailsonProceduralIssuesDuetotheRebuttableNatureoftheGRASPresumption

Thefirstissuewasprocedural.ItinvolvedthemandateoftheAdministrativeProcedureActthatbeforemakingasubstantiverule,afederalagencymustimplementformalnoticeandcommentproceedingssothatinterestedpartiescansubmittheirpointsofview.Wehadarguedthatbecausethestatementofpolicyisineffectasubstantiverule,theFDAhadviolatedthislawbynotgoingthroughsuchprocedures.However,thejudgeheldthatthestatementisnotasubstantiverulebecauseitisn’tbindingoneithertheFDAortheindustry.ShestatedthattheFDAisnotboundbecauseitsGRASpresumptionisrebuttableratherthanfinal–andthatindustryisnotboundbecausethepolicydoesnot“imposeanynew...obligations.” 50

Thenextissuewasalsoprocedural,anditpertainedtotherequirementoftheNationalEnvironmentalProtectionAct(NEPA)thatbeforeimplementinganyactionthatcouldsignificantlyaffecttheenvironment,anagencymustperformanEnvironmentalAssessmentorprepareanEnvironmentalImpactStatement.WearguedthatbecausetheFDAhaddoneneither,itspolicyhadbeenissuedinviolationofthatparticularlaw.Butthejudgeagaindisagreedduetotheinsubstantialnatureofwhattheagencyhaddone.SheconcurredwiththeFDA’scontentionthatitspolicyisnotsubjecttotheserequirementsbecauseitisnotasignificantfederalaction.SheoncemoreemphasizedtherebuttablenatureoftheGRASpresumption;andsheheldthatthepolicyrepresentsinaction,statingthatitis“notproperlyan‘agencyaction.’”SheagreedwiththeFDAthatthepolicydoesnotregulateGEfoodsanydifferentlythanwasthecasepriortoitsissuance.51

Althoughwetechnicallylostonthesetwoproceduralissues,theneteffectwashelpful,sincethecourtcertifiedthattheFDAisnotexercisingoneiotaofpre-marketregulationoverGEfoods.52

WasThereGeneralRecognitionofSafety?TheGRASPresumptionBecomesNon-Rebuttable

JudgeKollar-Kotellynextaddressedthecentralissue:IsitlegalfortheFDAtopresumethatallGEfoodsaregenerallyrecognizedassafe?Asshewasnodoubtaware,iftheanswerwas“no,”therewouldbefar-rangingconsequences,becauseitwouldentailthatlegitimatesafetyconcernsexisted–andthateveryproductonsupermarketshelveswithaningredientderivedfromageneticallyengineeredplantwasbeingsoldinviolationofthelaw.And,fromallappearances,shewasreluctanttoinstigatesuchasystem-shakingoutcome.53

ShebeganbyacknowledgingthattoqualifyasGRAS,asubstance“...mustmeettwocriteria:(1)itmusthavetechnicalevidenceofsafety,usuallyinpublishedscientificstudies,and(2)thistechnicalevidencemustbegenerallyknownandacceptedinthescientificcommunity.” 54Shealsonotedthat“‘Asevereconflictamongexperts...precludesafindingofgeneralrecognition.’” 55Regardingthesecondcriteria,oursubmissionshadassertedthattherewasclearlyasevereconflictamongexperts.Thejudgeagreed,stating:“Plaintiffshaveproducedseveraldocumentsshowingsignificantdisagreementsamongscientificexperts.” 56

Mostpeoplewouldthinkthat,withsuchafinding,thecasewasclosed.Afterall,thejudgehadineffectacknowledgedthatasofthetimewefiledoursuit,therewasnotageneralconsensusaboutsafetyinthescientificcommunity.However,shestatedthatthecriticaltimeforassessingtheexistenceofconsensuswasnotMay1998(whenwefiledthesuit)butMay1992(whentheFDAissueditspolicystatement).Shesaidthatasamatterofadministrativelaw,shecouldonlyconsidertheinformationtheFDAadministratorshadbeforethematthattime.Consequently,sheruledthatallthenewevidencewehadintroducedwaslegallyirrelevant.

Althoughtheapproachthejudgetookmayseemunfairorillogical,inthegeneralcaseit’ssound.Ajudgeisnotentitledtousurptheroleoftheadministratorsandfashionthepolicythatheorshethinksbest.

Thejudge’sjobistomakesurethattheadministratorshavefollowedproperproceduresinsettingthepolicy;andit’sanestablishedprinciplethatunlesstheadministratorshaveactedarbitrarilyorcapriciously,areviewingcourtshouldgrantthemgreatdiscretion–anddefertotheirdecision.Aslongastherewasareasonablebasisforthedecision,acourtcannotlegallyclassifyitasarbitraryorcapricious.Andinordertofairlyassesswhethersuchareasonablebasisexisted,thejudgeisonlysupposedtoconsidertheinformationtheadministratorshadbeforethematthetimetheirdecisionwasmade.

Asnoted,thisapproachmakessenseintheusualcase.Butourcasewasnotusual.ThejudgeemphasizedthattheFDA’sGRASpresumptiondoesnotamounttoordinaryagencyactionbecauseitisfullyrebuttableandinnowaybinding.ThisentailsthatevidencebeyondMay1992hastoberelevant,sinceitisonlythroughsuchevidencethatthepresumptioncouldberebutted.

However,althoughthejudgeineffectconcededthattheevidenceweintroducedrebuttedthepresumption,shenonethelessheldthatitandallotherpost-1992evidencemustbeignored,thusconvertingarebuttablepresumptionintoanon-rebuttableone.Theparadoxisglaring,sinceontheonehandsheexcusedtheFDAfromfollowingtherequirementsoftheAdministrativeProcedureActandNEPAbecauseitspresumptionisrebuttablebyfutureevidence,whileontheother,shefullyinsulatedthepresumptionfromallsuchevidence.

Yet,evendeprivedofthepost-1992evidence,ourcasewasstillsufficientlystrongbecausetheFDA’sownfilescontainedextensiveevidencedemonstratingthatGEfoodsdonotmeettheGRAScriteria–andthisevidencewasknowntotheadministratorspriortotheir1992decision.Foronething,thenumerousmemosfromFDAexpertsabouttheuniquehazardsofGEfoodsclearlyindicatedthatgeneralrecognitionofsafetydidnotevenexistwithintheFDA’sscientificstaff.WepointedoutthatthisshouldhavebarredtheagencyfrommakingaGRASpresumption,especiallysinceithadpreviouslyconvincedafederalcourtthattheopinionsofeventwoexpertsaresufficienttodenyanadditiveGRASstatus.57Moreover,inthatcase,theexpertsmerelystatedthattheywerenotawareofanystudiesinthestandardliteraturedemonstratingthesubstancewassafe.InthecaseofGEfoods,theFDAexpertspointedtoseveralhazardsthatareposed.

Surprisingly,thejudgeruledthattheevidencecontainedintheexperts’memoswasalsoirrelevant.Shearguedthatbecausethesescientistswere“lower-levelFDAofficials,”theagency’sadministratorsdidnothavetopayattentiontotheiropinionswhensettingpolicy.

Butjustashertransformationofarebuttablepresumptionintoanon-rebuttableonewasillogical,sowasherargumentstrippingthescientists’statementsoflegalimport.Foronething,thewrittenopinionsoftheagency’sscientistsrepresentedfarmorethanmerepolicypreferences.TheyconstitutedsolidevidencethatasignificantnumberofexpertsdidnotrecognizeGEfoodsassafe.Ineffect,thejudgesaidthattheadministratorswereentitledtopresumethatthereisanoverwhelmingconsensusamongscientiststhatGEfoodsaresafedespitetheobviousfactthatmostoftheirownexpertsdidnotregardthemtobe.Moreover,notonlydidthejudgeallowtheadministratorstodisregardtheirexperts’warnings,sheherselfignoredthefactthattheycoveredthemupandissuedafalsestatementimplyingthatnosuchwarningsexisted.Aspreviouslynoted,theirofficialpolicystatementdeclared:“Theagencyisnotawareofanyinformationshowingthatfoodsderivedbythesenewmethodsdifferfromotherfoodsinanymeaningfuloruniformway....” 58Althoughourbriefsfullydocumentedthisfraudulentmisrepresentation,thejudgeneglectedtomentionit,notwithstandingthefactitdemonstratesthattheadministratorswereactinginamannerthatwasnotonlyarbitraryandcapricious,butimmoral.

BiasedCitationfromtheParties’Submissions

Remarkably,althoughthejudgefailedtonotemanysignificantfactsandpertinentcasesthatwehad

broughttoherattention(andevenignoredtheglaringfalsehoodinthepolicystatementclaimingthattheFDAwas“notaware”ofinformationshowingthatGEfoodsaredifferent),sheuncriticallyrepeatedoneofthespuriousclaimsinthegovernment’ssubmissionstoher–eventhoughwehaddemonstratedthatitwasfalseandmisleading.Shesaid:“Moreover,pointingtoa44,000pagerecord,theFDAnotesthatPlaintiffshavechosentohighlightaselectedfewcommentsofFDAemployees,whichwereultimatelyaddressedintheagency’sfinalPolicyStatement.”Infact,asourbriefshadshown,thecautionarycommentsmadebyFDAstaffwerenot“few”butnumerous;andtheirauthorswerenotmereemployeesbutscientificexperts,manyofwhomheldpositionsofsignificantresponsibility,includingtheheadoftheBiologicalandOrganicChemistrySection,theDirectoroftheCenterforVeterinaryMedicine,andeventheBiotechnologyCoordinator.

Further,wehaddemonstratedthatthesafetyconcernsreflectedthedominantopinionoftheagency’sscientists–andtheFDAdidn’tproduceasinglememofromanagencyscientistassertingthatGEfoodscanberegardedassafe.Additionally,wehadpointedoutthatthefinalpolicystatementdidnot“address”theexperts’concerns(astheFDAalleged)butinsteaddisregardedthem(sometimesovertheirauthors’protests),suppressedthem,andultimatelymademisrepresentativestatementsaboutthem.

However,althoughthejudgeincludedtheFDA’sfalseassertioninheropinion,thatdidnotconstituteaformaldeterminationaboutthedegreeofdisagreementwithintheFDA;andherreferencetotheclaimthatwehadselectedonlyafewcommentswasnotadefinitivefindingthattherewereinfactonlyafew.Inlightoftheevidencethatthecommentswereextensive,shecouldnothavemadesuchafinding–althoughmanypeoplehavebeenmisledintobelievingthatshedid.

IgnoringthatGeneralRecognitionofSafetyDidn’tExistOutsidetheFDAEither

Ofcourse,eveniftheinputoftheFDA’sscientistsisdisregarded,theadministrativerecordcontainsampleevidenceshowingthatscientistsoutsidetheFDAhadsimilarconcerns.Aswepointedout,therewerecautionarystatementsbyexpertsfromtheDepartmentofMolecularBiologyoftheCentreforPlantBreedingandReproductionResearchinTheNetherlands59andtheUnitedKingdom’sMinistryofAgriculture,FisheriesandFood.60Andwealsoemphasizedthefactthat,aspreviouslydescribed,therewasaletterinthefileswrittenbytheFDA’sbiotechnologycoordinatoracknowledgingthattherewasnotaconsensusaboutsafetywithinthescientificcommunity.61

Theadministratorsweredefinitelynotentitledtodisregardsuchevidence,andtherewasnolegitimatewaythejudgecouldarguethattheyhadbeen.Soshedidn’ttrytomakethatargument.Instead,sheignoredthisevidenceandnevermentionedit,despitethefactitunequivocallyestablished(a)thattherewasnotgeneralrecognitionofsafetyand(b)thatthiswasknownbytheFDAinMayof1992.

DuckingtheIssueofWhetherThereWasTechnicalEvidenceofSafety

Buttheissueofwhetheragenuineconsensusexistedwasnotthesoleissue.Aswe’veseen,thelawalsorequiresthataconsensusmustbebasedon“technicalevidence”ofsafety.Andinregardtothiscrucialissue,ourpositionwaslikewisestrong.Infact,itappearedtobeinvincible.Aswasdiscussedearlierinthischapter(andaswepointedouttothejudge),theadministrativerecordunequivocallyatteststotheutterabsenceoftherequisiteevidence–withanFDAcomplianceofficercomplaining:“[A]reweaskingthescientificexpertstogeneratethebasisforthispolicystatementintheabsenceofanydata?...itisanexerciseinhypothesesforcedonindividualswhosejobsandtrainingordinarilydealwithfacts....” 62

HerassertionthatFDA’spolicyreliedonhypothesesisespeciallysignificantbecausetheagencyhadpreviouslymaintainedthatGRASstatuscannotbebasedonhypothesesandinferencesbutmustbegroundedinsolidevidence;andthecourtshaveconcurred.

TheFDAstronglyadvanceditsargumentabouttheinsufficiencyofhypothesesinaproceedingagainst

asupplementforswinefeed(calledFerro-Lac)thatitallegedcontainedunsafefoodadditives.63Inthatcase,themanufacturerpresentedanaffidavitfromascientificexpertallegingthatbecausethethreecontestedconstituentsofthecompoundwereGRASwhenusedalone,“‘itisareasonablescientificcertainty’”thattheiruseincombinationwouldalsobesafe.Theaffidavitfurtherclaimedthatsuchaconclusionisbasedupon“principlesofchemistry”andthat“anychemistwould‘necessarilyrecognize’theresultstated.”Inopposition,theFDA,submittedtwoexpertaffidavitsassertingthattheuseofthethreeingredientsincombinationwasanewuse–andthattheirsafeuseinisolationdidnotsupportaninferencethattheycouldbesafelyusedtogether.Theseaffidavitsstatedthattheonlywaytodeterminewhetherthecompoundissafeisthrough“actualtesting...todemonstratethatlongtermingestionofpotentialresiduesofthechemicalinedibletissueswillnotbeharmfultohumans.” 64Bothexpertsalsostatedthattheywerenotawareofanyreportsoftestsofthisparticularcompoundinthepharmacological-toxicologicalliterature.

ThecourtruledinfavoroftheFDA,statingthattheaffidavitsitsubmittedestablishedthattheevidentiaryunderpinningforageneralrecognitionofsafetywaslacking.Itdismissedtheaffidavitsubmittedbythemanufacturerbecauseitwassolelybasedon“theoreticalevaluation”andcontained“atbest,aninferencethatsafetymightbeshownbyscientifictestingandprocedures.” 65

Inoursubmissions,weexplainedthattherewereevenstrongerreasonstoregardGEfoodsascontainingnon-GRASadditivesthanhadbeenthecasewithFerro-Lac.First,whilethecontestedconstituentsofFerro-Lacwereeachrecognizedtobesafeinseparation,mostoftheintendedexpressionproductsofthegenesinsertedviabioengineeringarenotthemselvesrecognizedassafe.Rather,theFDAadministratorsinferthemtobesafe.Second,FDAscientistshadpointedoutthatthebioengineeringprocesscouldyieldawiderangeofunintendedandunexpecteddeleterioussubstances.Third,eventhoughtherewastestimonythatthesafetyoftheconcertedactionofthecomponentsofFerro-Laccouldbeinferredwithareasonablescientificcertainty,thecourtheldthiswasinsufficienttoestablishthesupplement’ssafety.GEfoodsareinanevenweakerposition,becauseintheircase,suchaninferencecannotjustifiablybemade.ScientistsbothwithinandwithouttheFDAstatedthatthedynamicsofDNAandlivingsystemsaresocomplex,andthedisruptivepotentialofrDNAtechnologysogreat,thatitisnotpossibletoinferthesafetyofanyGEfoodwithreasonablecertainty.

Despiteitssignificance,JudgeKollar-KotellytooknoaccountoftheFerro-Laccase,anditisnotmentionedinheropinion.NordidshenotetheestablishedprinciplethatGRASstatuscannotbebasedoninferenceandhypotheses.Infact,shedisregardedtheentireissueofwhethertherequisitetechnicalevidenceexisted.Althoughinherinitialstatementofthelaw,shehadacknowledgedthenecessityofsuchevidence,shethencompletelysidesteppedthetopicandavoidedfurtherdiscussionofit.Hadsheconfrontedit,there’snorationalwayinwhichshecouldhaveupheldthepresumptionthatGEfoodsareGRAS.66

AsWithGRAS,SoWithLabeling:DecreeinganIntimateLinkage

Theopinionthenmovedontoanotherimportantissue.Thelawrequiresthat“material”factsaboutfoodbedisclosedthroughlabeling.67Contrarytoourarguments,theFDAcontendedthatthefactafoodwasproducedviarDNAtechnologyisnotmaterial,evenifthere’swidespreadconsumerinterestinknowingthatfact.Theagencyassertedthatunlessaprocessentailsuniquerisktohumanhealthorcausesauniformchangeinthefood,itsuseislegallyimmaterial,andthere’snodutytoinformconsumersaboutit.

Thejudgeupheldthisinterpretationofthelaw,andshealsodeferredtotheFDA’sdeterminationthatGEfoodsdonot(intheagency’swords)“presentanydifferentorgreatersafetyconcernthanfoodsdevelopedbytraditionalplantbreeding.” 68Accordingly,sheruledthattheFDAhadnoobligationtolabelthem.Thus,shelinkedthelabelingissuetotheGRASissue,ineffectholdingthatbecausetheFDA

wasentitledtopresumethatGEfoodsaresafe,itwasalsoentitledtorejectconsumerdemandsforlabeling.

SummingUp:WhattheJudgeActuallySaid–andWhatSheIgnoredinOrdertoSayIt

Inoneofitssubmissionstothecourt,theFDAclaimedthatithadbeendelegated“completelyunfettereddiscretion”toimplementtheFood,DrugandCosmeticActinwhateverwayitwants.69WhenIandtheotherattorneysreadthispronouncement,wewereastonishedbyitsarrogance;andbecauseoursubmissionsdemonstratedthatcourtsroutinelyrestrictagencydiscretionwhentheydetectthekindsofderelictionsthattheFDAhaddisplayed,therewereamplegroundstoexpectthatJudgeKollar-Kotellywouldrebuffitsargument.However,toouramazement,sheessentiallygrantedtheFDAtheunfettereddiscretiontowhichitlaidclaim.Ineffect,shegavetheadministratorstherighttoignorelegalprecedent,theirownpriorpolicies,thereasonedopinionsoftheirownexperts,andanyotherfactstheyfoundinconvenient–andthentolieaboutthewholeaffairbydenyingtheyhadreceivedanyinformationcontrarytothepresumptiontheywerepushing.

Andinissuingherruling,sheherselfhadtoignoreasubstantialamountofcriticalinformation.ShedeclaredthatinMay1992,FDAadministratorshadarationalbasisforpresumingthatGEfoodsaregenerallyrecognizedassafe–eventhoughit’sclearfromtheFDA’sownfilesthat:(a)suchgeneralrecognitionhasneverexistedand(b)thetechnicalevidenceofsafetyuponwhichsuchrecognitionisrequiredtoresthasneverexistedeither.

Further,inreachingherdecision,notonlydidsheignoretheabovetwofacts,sheignoredtheestablishedprinciplethatGRASstatuscannotrelyonhypotheses.ShealsodisregardedthefactthattheFDA’s1992policysharplyreverseditspreviouspositiononGRAS–whileshelikewisedisregardedthelineofjudicialdecisions(repeatedlycalledtoherattention)assertingthatsuchshiftsdepriveanagency’sdecisionofthedeferenceitwouldordinarilydeserve.

Unfortunately,mostpeoplehavenoideahowmuchthejudgehadtooverlookinordertorenderherruling;nordotheyunderstandhowlimiteditreallywas.ShedidnotrulethatGEfoodshaveactuallybeenshowntobesafe;nordidshedeterminethatthereeverwasageneralrecognitionofsafetyamongtheFDAscientistsorwithinthescientificcommunity.ShedidnotevensaythattheFDAcouldjustifiablycontinuetopresumethatGEfoodsaresafe.HerdecisionwasstrictlylimitedtotheparticularexerciseofdiscretionmadebytheFDAinMayof1992.Sheruledthatatthatspecificpointintime,theFDAhadbeenentitledtopresumethattherewasageneralrecognitionofsafetyamongscientificexperts;butsheindicatedthatwepresentedevidenceshowingtherewasnotageneralrecognitionofsafetyatthetimewefiledoursuit.AndsheemphasizedthattheFDA’spresumptionissupposedtoberebuttablebyevidenceitreceivestothecontrary.

ImaginethereactionofAmerica’smothersonlearningthatthegeneticallyengineeredfoodsthey’vebeenroutinelyfeedingtheirchildrenhaveneverbeengenerallyrecognizedassafeamongexperts,havenotbeenprovensafeasrequiredbylaw,andweredeterminedbytheFDA’sownscientiststoentailunusualrisks.Andconsiderwhetherthey’dbecomfortedbytheknowledgethatafederaljudgeallowedthesefoodstostayonthemarket,notbecausesheconcludedthattheymetthestandardsofthelaw,butbecausesheignoredtheevidencethatdemonstratedtheydidnot–andruledthatFDAexecutiveshaddiscretiontodothesame.

(AppendixAprovidesadditionalanalysisoftheerrorsinthejudge’sopinion;anditmorefullydemonstrateshowherargumentsareundercutbypriordecisionsoffederalcourts.)

EnhancedAnomaly:HowtheFDAPolicyWasSavedbyWithdrawalofaPlantoReformItInlightoftheopinion’sseriousflaws,youmaybewonderingwhyitwasnotreversedonappeal.Theexplanationisnotonlyremarkable,likesomanyotherfacetsofthelawsuit’sstory,itcontainsanomalous

twists.InJanuary2001,afterwehadfiledanappealbutbeforeourargumentsweresubmitted,theFDA

proposedanewruleonGEfoods.Thisrulechangedverylittle.ItmaintainedtheGRASpresumption,anditrefrainedfromrequiringsafetytestingorlabeling.ItmerelyaddedamandatethatmanufacturersmustgivetheFDAnoticeatleast120daysbeforetheymarketaGEfood.Nonetheless,despitetheminimaldegreeofproposedreform,hadtherulebeenimplemented,itwouldhavehadamajorimpactonourlawsuit.Byreplacingtheinformalpolicydecisionagainstwhichthesuithadbeenbrought,itwouldhavemadethesuitirrelevantandrenderedtheappealawasteoftime,becausewewouldhaveneededtoproceedagainstthenewrulebyfilinganewaction.Further,startinganewlawsuitwouldhavebeenadvantageous,becausealltheevidencethatthejudgeexcludedinourinitialsuitwouldhavebeenadmissible,sinceitwasknowntotheFDAatthetimethenewrulewasproposed.Moreover,duringthenoticeandcommentperiodontheproposedrule,theFDAhadbeenopenlyinformedaboutotherrecentevidencethatGEfoodswerenotGRAS,includingaJanuary2001reportbytheRoyalSocietyofCanadathatdeclareditis“scientificallyunjustified”topresumethey’resafe.Withallthisevidenceinplay,itwouldhavebeenvirtuallyimpossibleforacourttoupholdtheFDA’sGRASpresumption.

Therefore,theAllianceforBio-Integrityandtheotherplaintiffsdroppedourappeal,intendingtobringanewsuitwhentheruletookeffect.However,afterwedid,theFDAdelayedfinalactionontheproposedruleformorethantwoyearsandthenannouncedthatitwasbeingwithdrawn.Butbythen,ourappealcouldnotberevived.

Thus,iftheFDAhadimprovedthe1992policybyrequiringnotificationbeforeanewGEfoodhitsthemarket,thepolicywouldhavebeenstruckdownbyacourt,becauseitsGRASpresumptionwouldnolongerhavebeeninsulatedfromtheabundantevidencethatrefutesit.Butbyabandoningtheproposedreform,theagencycontinuedtoshieldthepolicyfromsuchevidence,therebysavingit.

Fewpeoplerealizehowvulnerabletheproposedrulewas.Itwouldhavebeenquashednotonlythroughtheforceofopposingevidence,butthroughself-contradiction.WhenpublishedintheFederalRegister,itwasaccompaniedbyextensivesupplementaryinformationdescribing,amongotherthings,itsbackgroundandwhyitwasneeded;andthis32-pagedocumentwaspatentlyatoddswithitself.Ontheonehand,itassertedthatthe1992GRASpresumptionwasstillvalid,whileontheother,itacknowledgedthatmanyimpendingGEfoodsmightposesafetyissuesthatwouldbarthemfromGRASclassification.Forinstance,itnoted“...thatbecausebreedersutilizingrDNAtechnologycanintroducegeneticmaterialfromamuchwiderrangeofsourcesthanpreviouslypossible,thereisagreaterlikelihoodthatthemodifiedfoodwillcontainsubstancesthataresignificantlydifferentfrom...counterpartsubstanceshistoricallyconsumedinfood.Insuchcircumstances,thenewsubstancesmaynotbeGRAS....” 70Thetextfurtheracknowledgedthattheinsertedgenes“maydisruptorinactivateanimportantgeneoraregulatorysequencethateffectstheexpressionofoneorseveralgenes,therebypotentiallyaffectingadverselythesafetyofthefood....” 71Anditobservedthatasbiotechniciansincreasinglyinsertmultiplegenesintothetargetorganisms,suchunintendedeffects“maybecomemorecommon.” 72Elaboratingonthepotentialfortheseunintendedeffectstocauseharm,thedocumentcontinued:“FDAbelievesthattheuseofrDNAtechniquesinplantbreedingmayleadtounintendedchangesinfoodsthatraiseadulterationormisbrandingquestions.Theseunintendedchangesmaycauseafoodtobeadulteratedbecausethefoodmayberenderedinjurioustohealth....” 73

Accordingly,thedocumentstressedtheneedforpre-marketnotification,explaining:“BecauseofitsroleinensuringthesafetyoftheU.S.foodsupply,FDAneedstobeawareofthemodificationstofoodsourceplantsfromtheapplicationofrDNAtechnologyandanyunintendedeffectsinfoodthatresultsothattheagencycanevaluatewhetherthefoodsfromsuchplantsareadulteratedormisbranded.” 74Additionally,itunderscoredtheuniquenessoftheproblemsposedbyrDNAtechnology,explainingthat

althoughnotificationisnotneededfornewplantvarietiesproducedbyothermethods,“...rDNAtechniqueshaveagreaterpotential,relativetoconventionalmethodsofbreeding,toresultinthedevelopmentoffoodsthatpresentlegalstatusquestions.” 75

Theseacknowledgementsregardingtheunintendedeffectsofgeneticengineeringandtheiruniquelyproblematicnaturewereadramaticdeparturefromthe1992policystatement.Infact,theywerethesametypeofscience-basedassertionsthathadbeenmethodicallyexcisedfromthedraftsofthatdocumentduetopoliticalpressuresfromtheBushWhiteHouse.However,althoughin1992suchpassageswerepurgedinordertopreservetheplausibilityoftheGRASpresumption,in2001,theFDAattemptedintegration.Ittriedtomergeameasureofscientificrealitywiththecoreofthe1992statement.Buttheattemptfailed.Althoughtheagencypretendedthatthetwocomponentswereharmonized,asthetwoprecedingparagraphsreveal,theywereinherentlyincompatible.Theassertionsabouttheproblematicnatureofbioengineeringwereeitherdirectlycontradictedbyassertionsheldoverfrom1992,orelsetheirimportwasmitigated.Forinstance,thestatementstressingtheagency’sneedtobeinformedaboutunintendedeffectsofthegeneticmanipulationsseemedinsincereinlightoftheclaimthatthevoluntaryassessmentprogramwasstilladequatetoassurefoodsafety,eventhoughitdidnotevenrequiresuperficialtests,letalonetherigoroustoxicologicaltestingthat’snecessaryfordetectingunintendedeffects.

AlthoughIcan’tproveit,IsuspectthattheFDAdecidedtowithdrawtheproposedrulewhenawarenessdawnedthat,duetoitsinternalinfirmitiesandtheevidencearrayedagainstit,itcouldnotsurvivealawsuit.IassumethatupperlevelofficialsrealizedthattheonlywaytopreservetheGRASpresumption(andkeepthebiotechindustryfreetoforgomeaningfultesting)wastoretreattotheconfinesofthe1992policy,becauseithadbeenupheldincourtbyarulingthatwasnolongersubjecttoappeal.Ifurtherassumethatinretractingtheproposedrule,theadministratorshopedthatitsembarrassingadmissionswouldquicklyfadefrompublicmemory–which,byallappearances,hashappened.

ADecisionthatHasStayedUnscrutinizedEventhoughJudgeKollar-Kotelly’sdecisionhad,throughastrangeturnofevents,escapedthescrutinyofanappellatecourt,onecouldhavereasonablyexpectedthatitsdefectswouldbeapparenttoastuteobserversandexposedinthemediaandprofessionaljournals.Butthisneveroccurred,despitethefactthattheparticipationofnineexpertplaintiffsshouldhavemadeitobviousthatGEfoodswerenotGRAS–andraisedquestionsabouthowthejudgewasabletodiscounttheirsignificance.Instead,thenewspaperreportsonthesuit’soutcomeuncriticallyacceptedthejudge’srulings,andnoneofthemanyI’veseennotedthesignificanceofthescientist-plaintiffs.

Moresurprising,althoughtherehavebeenseveralarticlesinlegaljournalsdiscussingthecase,theyhavenotdiscernedtheopinion’skeyerrorseither.Foronething,itseemsthatnoneoftheauthorsobtainedcopiesofthebriefswefiled,sotheyweren’tawareofwhatthejudgeignoredinordertoreachherruling.Itfurtherappearsthatsomeauthorsevenneglectedtoreadtheentireruling(oratleastneglectedtoreaditcarefully).Suchalapseseemstohaveaffectedthefirstarticle,whichappearedintheTempleEnvironmentalLawandTechnologyJournal.76Thisarticlestatedthattheplaintiffs“failed”toshowasufficientconflictamongexperts–andthatduetothisfailure,thecourtrejectedtheircontentionthattheGRASpresumptionwasinvalid.77Infact,thejudgestated:“Plaintiffshaveproducedseveraldocumentsshowingsignificantdisagreementsamongscientificexperts.”Somehow,theauthormissedthisstatement.Consequently,shealsofailedtorealizethatthejudgeupheldtheGRASpresumptiononlybecause,asaproceduralmatter,sheruledthatthisevidenceofconflictcouldnotbetakenintoaccount.NordidtheauthorrecognizethattheFDAhadtheburdenofdemonstratingtherewastechnicalevidenceofsafety–andthatthejudgehadavoidedconfrontingthatissue.

Subsequentarticleshaveyettosetthingsstraight.Liketheinitialone,severalalsoindicatedthatwefailedtoshowsufficientdisagreementamongexperts,missingthefactthatwehad–andthefactthatthe

judgeupheldtheGRASpresumptioninthefaceofevidencethatGEfoodswereclearlynotGRAS.78Further,ofthemanyarticlesI’veread,eventhosethatavoidedmakingsuchanerroneousassertionneverthelessfailedtonotethatwehadshownsubstantialdisagreementamongexperts.AndnoneseemedtorealizethatthejudgetreatedtheGRASpresumptionasrebuttableforsomepurposesandnon-rebuttableforothers.

Nordidanydetectthatshehaddodgedthequestionabouttechnicalevidence;andseveralauthorsseemedunawarethatsuchevidencewaslegallyrequired.Forinstance,onearticlestatedthatunderFDApolicy,thepartychallengingaGEfoodhastheburdenof“presentingphysicalevidenceofasafetyhazard”–neverevennotingthatthelawexplicitlyplacestheburdenonthepartydefendingthefood.79Nonetheless,afacultypanelattheUniversityofCalifornia,BerkeleySchoolofLawawardedthearticleaprizeforgovernmentlawwriting,whichindicatesthatthememberssharedtheauthor’sconfusion.

Unfortunately,suchconfusioniswidespreadwithinthelegalcommunity,andevenjuristswhohavestrivenforproficiencyinthelegalaspectsofbiotechnologyhavenotstayedclearofit.Forinstance,anotherarticlethatsimilarlymisrepresentedthelawwasco-authoredbythethenChiefJusticeoftheSupremeCourtofOhio,whowasadrivingforcebehindthefoundingofaresourcecenterforpreparingjudgestodealwithcasesinvolvingbiotechnology.80

HowaReignofConfusionPreservesIndustry’sFreeReinTheFDA’spolicyonGEfoodshassurvivedonlythroughwidespreadconfusion.Mostpeople(includingmostanti-GEactivists)believethattheFDAhasfollowedthelaw,wheninreality,theagencyhasbeenwillfullyviolatingitfortwodecades.Socomprehensiveistheconfusionthatevenseasonedjournalistshavebeentakenin–includingBillLambrecht,whoreportedongeneticengineeringfortheSt.LouisPost-Dispatchforfifteenyearsbeforepublishingabookonthetopic.Inthatbook,hestatedthattheFDAhad“religiously”appliedthesameregulatorystandardstoGEfoodsthatapplytootherfoods,wheninfact,theagencyhadscornedthosestandardsbyillicitlyexemptingGEfoodsfromtheirmandates.81

Further,mostcriticsofGEfoodsbelievethatthey’vesuffusedtheAmericanmarketbecausethelawistooweaktoproperlydealwiththemwhen,infact,thelawissostrongthathaditbeenobeyed,there’slittlelikelihoodthatanyGEfoodwouldyethaveenteredthenation’skitchens.Andthat’snotbecausethelawisunreasonablydemanding.It’sbecausethelaw’ssensiblerequirementfordemonstrationofareasonablecertaintyofnoharmcouldnothavebeenmetbyanyofthesenovelproducts.Asthischapterhasalreadyshown,andasChapters10and11establishingreaterdetail,theteststhatwouldbeevenminimallyadequatearemuchlonger,morerigorous,andmorecostlythanthemanufacturerswerepreparedtoemploy.Moreover,themereannouncementthatGEfoodscouldnotbepresumedsafeandmustbesubjectedtorigoroustestingwouldmostlikelyhaveinducedawaveofconcernthatwouldhavedoomedtheenterprisethatwasproducingandpromotingthem(apointthat’sdramaticallyelucidatedinChapter6).

Thus,inregardtothesafetyassessmentofbioengineeredfoods,theUSgovernmenthasreversedthestatutorilyimposedburdenofproofwithhardlyanyonecatchingon–notevencommentatorsinlawreviews.Thistransformationoccurredinstages.AswesawinChapter1,itbeganin1978whentheNIHreliedonpurportedevidenceaboutthesafetyofrDNAresearchtoshifttheburdenfromtheproponentsofthetechnologytothosewhosoughttoregulateit.Further,mostpeople(includingmostofthoseinCongress)wereunawarethatthe“evidence”wasnothingmorethanunsubstantiatedconjecturesthatwerefloatedattheFalmouthandAscotconferences.

However,withinlessthanadecade,thatNIHpolicyrequiredbroadeningtosuittheneedsoftheGEventure.Whenitwasimplemented,themainsafetyissueinvolvedmicroorganismsemployedinbiomedicalresearch.Butastherangeofrecombinanttechnologyexpanded,biotechproponentswanted

therangeoftheshiftedburdentoexpandalongwithit.AswesawinChapter2,theCoordinatedFrameworkestablishedbytheReaganAdministrationin1986effectedthisexpansionbyinstructingtheadministrativeagenciestoapplytheshifttothenewvarietiesofplantsbeingcreatedthroughgeneticengineering.Butthispolicychangelackedscientificlegitimacy.Aswiththeprecedingshiftin1978,althoughtherewasgreatpretenseofscientificbacking,noneexisted.

Further,thischapterhasrevealedthatwhentheshiftwasextendedbeyondtheenvironmentalsafetyofGMOstoimpacttheissueoffoodsafety,notonlydiditlackscientificauthority,ithadnolegalauthorityeither.Infact,itviolatedexplicitmandatesoftheFood,DrugandCosmeticAct.Accordingly,theFDAgrappledwiththechallengeofhowtoinstituteitwithoutrevealingthatthelawhadbeentransgressedintheprocess.Incraftingaconducivepolicy,administratorsnotonlyhadtosacrificethelawtopoliticaldemands,theyalsohadtosacrificescience,subordinatingtheopinionsoftheirownexpertstothedirectivesfromtheBushWhiteHouse.Andtopullitalloff,theyhadtocoverupthefactsandissueastringoflies–deceivingCongressandthepublicintooncemorebelievingthatagovernmentpolicyonGMOswasbasedonoverwhelmingscientificconsensusandsolidevidencewhenitactuallyopposedthejudgmentsofmanyscientistsandhadnoevidentiarybackingatall.

Moreover,inthiscasepeoplewerealsoledtobelievethatresponsibleoversightwasbeingexercisedandthatstricttestingwasbeingconducted.TheFDAengenderedtheseillusions,andtheyhavebeenprogressivelystrengthenedbyastreamofmisrepresentationsfromgovernmentofficialsactingas“cheerleadersforbiotechnology”(inthewordsofBillClinton’sSecretaryofAgriculture,DanGlickman).82Glickmanhimselfhadbeenoneofthebiggestcheerleaders–andutteredsomeoftheboldestfalsehoods.Hedeclaredthat“testafterrigorousscientifictest”hadproventhatGEfoodsweresafe;83andheproclaimedthateveryoneonthemarkethadbeensocertified:“Withoutexception,thebiotechproductsonourshelveshaveprovensafe.” 84OtherofficialshaveassertedthatthetestswereactuallyperformedbytheFDA.Forinstance,anundersecretaryatthedepartmentofagricultureannounced:“TheFoodandDrugAdministrationtestsallgeneticallymodifiedfoodsbeforetheygoonthemarket....We’redoingeverythingtoprotectourfood.” 85Andsomehigh-rankingofficialshaveboastedthatgovernment-runtestshavenotmerelyproventhatGEfoodsaresafe,butprovenitabsolutely.Thus,TommyThompson,SecretaryofHealthandHumanServicesinGeorgeW.Bush’sadministration,proclaimed:“GM(geneticallymodified)foodisabsolutelysafe,ourexpertshavedonetestsandfounditcompletelysafe.” 86

Further,althoughtheseofficialsfedtheconfusion,theywerealsoitsvictims;anditseemsthatnonerealizedthefalsityofhisstatements.AsGlickmanlateradmitted:“...Iprettymuchspoutedtherhetoricthateverybodyelsearoundherespouted;itwaswrittenintomyspeeches.” 87Thefalsehoodsthatheandtheotherswereexpressinghadbecomeconventionalwisdomthroughoutthefederalgovernment,andevenpresidentsweretakenin.Forinstance,BillClintonassuredthenation:“WehaveconfidenceinthefindingsofourFoodandDrugAdministrationthatthese[biotech]foodsaresafe.Andifwedidn’tbelievethat,wewouldn’tbesellingthemandwecertainlywouldn’tbeeatingthem....IwouldneverpermitanAmericanchildtoeatanythingIthoughtwasunsafe.” 88HadhelearnedthattheFDA’s“findings”werenotbasedonscientificevidenceorevenonsoundscientificreasoningbutweremerelyunfoundedpresumptionsthatcounteredthejudgmentofitsscientificstaff,hisconfidencewouldhavecollapsed.

Overtheyears,theFDAnotonlycultivatedtheconfusion,itintensifiedthemisrepresentation.AlthoughthepresumptionthatGEfoodsareGRAStechnicallyimpliedthattheirsafetyhadbeenscientificallydemonstrated,the1992policystatementrefrainedfromexplicitlypropoundingsuchafalseassertionandinsteadreliedontheoreticalarguments.89Buttheagencyeventuallygrewbolder.Insteadofmerelyprofferingsuchargumentsinsupportofsafety,itproclaimedthatsafetyhadbeenpositively

demonstrated.Forexample,onMay3,2000,CommissionerJaneHenneydeclared:“FDA’sscientificreviewcontinuestoshowthatallbioengineeredfoodssoldhereintheUnitedStatestodayareassafeastheirnon-bioengineeredcounterparts.” 90Butthepreviousyear,theagencyhadacknowledgedthatitwasnotperformingscientificreviews,stating:“FDAhasnotfounditnecessarytoconductcomprehensivescientificreviewsoffoodsderivedfrombioengineeredplants...consistentwithits1992policy.” 91Further,aswe’veseen,theinformationthatmanufacturershavechosentosubmittotheagencyisincompetenttoestablishthatevenoneGEfoodisassafeasitsconventionalcounterpart,letalonethattheyallare.

Nonetheless,theFDAhaspersistedinitsbogusclaimaboutthedemonstrationofsafety.OnenotableinstanceoccurredinOctober2002,whentheagencymadewhatUSATodaycalled“anunusualmove”andsentawellpublicizedlettertothegovernorofOregonthathelpeddefeataballotinitiativeforthemandatorylabelingofGEfoodsinthatstate.92Amongtheletter’sfalsehoodswastherenewedassertionthat“FDA’sscientificevaluationofbioengineeredfoodscontinuestoshowthatthesefoods,ascurrentlymarketedintheUnitedStates,areassafeastheirconventionalcounterparts.” 93

TheagencysimilarlydeceivedCongress.OnJune14,2005,anFDAofficialonceagaindeliveredmisleadingtestimonyaboutgeneticengineeringtoalegislativecommitteebydeclaring:“Overthelasttenyears,FDAhasreviewedthedataonmorethan60bioengineeredfoodproducts....Todate,theevidenceshowsthatthesefoodsareassafeastheirconventionalcounterparts.” 94

Throughchronicexposuretosuchdisinformation,mostAmericanshavehadnocluethattheindustrywasessentiallygrantedself-regulation.Apollconductedin2004bythenon-profitPewInitiativeforFoodandBiotechnologyrevealedhowwidespreadthedelusionhadbythenbecome.AsreportedbytheIPSNewsAgency,“Accordingtoanexpertfamiliarwiththepoll,Americanshavetremendousfaithintheirregulators,butwronglybelieveGEfoodshavebeenapprovedandtestedbytheFDA.‘They’reunderthefalseimpressionthereisthoroughtestinglike...fordrugs,’saidtheexpert,askingtobeunnamed.WhenpeoplelearnedthatGEfoodsarenottested,theywereveryuncomfortableandindicatedtheywantmandatory,uniformtestingandevaluationofGEfoods,notedtheexpert.” 95

TheIPSreportalsoobserved:“...theU.S.publicdoesnotwanttotakeriskswithitsfood....Indeed,81percentofthosesurveyedbyPewbelievedtheFDAshouldapprovethesafetyofGEfoodsbeforetheycometomarket,evenifthatwouldmean‘substantialdelays.’” 96

TheCentralityoftheFDA’sFraudtotheSurvivalofGEFoodAspreviouspageshaveshown,althoughthereisnotaseamlesscontinuumbetweengeneticengineeringandconventionalpractices(asitsproponentsclaim),formorethanthreedecadestherehasbeenanessentiallyseamlesscontinuumbetweenthepreferencesofthebiotechindustryandtheagendaoftheUSgovernment–whichhascausedadrasticdiscontinuitybetweenFDApolicyandthelaw.Socloseistheconnectionbetweenindustryandgovernmentthatnumerousindividualshavesmoothlytransitionedbetweenthetwosectors,sometimesrepeatedly.ThemoststrikingexampleisMichaelTaylor,whoafterservingforfiveyearsasanFDAattorney,becameaprivate-practicelawyerrepresentingMonsanto,thenreturnedtotheFDAasDeputyCommissionerforPolicytooverseethepolicyonGEfoods,and,aftergivingMonsantowhatitwanted,joinedthecompanyasVicePresidentforPublicPolicy.Then,in2009,heagainreturnedtotheFDA,thistimeassenioradvisoronfoodsafety–apositionthat’sbeenreferredtoas“foodczar.” 97AndinJanuary2010,hewasagainelevatedtotherankofdeputycommissioner:thistimeasDeputyCommissionerforFoods,anewpositionthathewasthefirstindividualtohold.98

Duetoindustryinfluence,GEfoodshaveenteredtheUSmarket,notthroughatransparent,science-basedprocess,butthroughsleightofhand.Andtheconsequenceshavebeenanythingbutslight.Formorethanadecade,themajorityofprocessedfoodsintheUShavecontainedingredientsderivedfrom

engineeredorganisms(withthecurrentpercentagecloseto90%);andthenumberofcropsthathavebeengeneticallyrestructuredkeepsgrowing.Moreover,thedeceptionsnotonlyallowedGEfoodstopervadetheUnitedStatesbuttopermeatemuchoftheworld.

WithouttheFDA’sfraud,theGEfoodventurewouldnothaveexpandedbutimploded.Theeffectofthefactsonconsumers,legislators,andinvestorswouldhavequicklydoomedtheentireenterprise.Thisisevidenttoanyonewhounderstandsthesocio-economicrealities.Forinstance,whenImetin2001withthechiefscientistofthefoodsafetyauthorityforAustraliaandNewZealand(whohadafavorableattitudetowardGEfoods),IpresentedtheinformationabouttheFDA’scoverupandthenaskedwhatshethoughtwouldhavehappenedif,in1992,theagencyhadannouncedthatitsscientistshadconcludedthatthesenovelproductsentailunusualrisksandthateachshouldundergoextensivetoxicologicaltesting.Shepromptlyrepliedthatitwouldhave“killed”thewholeindustry.99

Intakingstockofthefirstfivechapters,it’sclearthattheventuretogeneticallyengineerourfoodshasbeenchronicallydependentonsystematicsuppressionoffactsconjoinedwiththepersistentspreadofmisinformation–andcouldnothavesurvivedwithouteither.It’sequallyobviousthat,besidesthenecessitytoexceedtheboundsoftruth,there’sbeenaneedtobreachimportantregulatoryboundariesonboththenaturalandsocietallevels.Tocreateorganismswithfunctionalforeigngenes,biotechnicianshadtosurmountaseriesofregulatorymechanismsthatmaintainthestructuralandoperationalintegrityofgenomes.Then,tomarketsuchproductswithoutpropertesting,theyhadtoinducepublicofficialstoletthemevadetheregulationsthatpreservetheintegrityofthefoodsupply.

And,justasnature’sregulatorysafeguardsweresunderedthroughoutthevariousbiologicalkingdoms,sothebreachofsociety’sregulatorysafeguardsintheUnitedStatessetthestageforsimilarinfractionsbyofficialsinmanyothernations–accompaniedbyasimilarstreamofdoubletalktoconveytheimpressionthatnothingirregularhadhappened.

CHAPTERSIX

GlobalizationofRegulatoryIrregularity

HowFoodSafetyOfficialsinCanada,theEU,andOtherRegionsalsoSidesteppedScienceandSoundPolicy

PeoplediscouragedbyhowpoorlyGEfoodsareregulatedintheUSmighthavehopedthattheregulatorysystemsinEuropeandotherregionswouldprovideaback-up,forcingproductsthatreceiveanessentiallyfreepassthroughtheAmericansystemtoundergoadequatesafetytestingbeforethey’remarketedelsewhere.However,anysuchhopeshavebeenmisplaced.AlthoughtheEUandmostotherindustrialnationshaveimposedsometestingrequirementsonthesenovelproducts,they’vebeentoofeebletofurnishevenamodestassuranceofsafety.

TheInsubstantialityof‘SubstantialEquivalence’Thecentralconceptthathasunderlaintheinternationalregulatorysystemisreferredtoassubstantialequivalence–andit’sbeenaccompaniedbysubstantialconfusion.Foronething,mostpeoplethinkthatitisalsoabasicfeatureoftheUSsystemwhen,inreality,it’squiteforeigntotheofficialAmericanapproach.Aswesawinthelastchapter,USfoodsafetylawrequiresthatallnewfoodadditivesberegardedasunsafeuntilprovensafe;anditimposestheburdenofproofonthemanufacturers.Further,inorderforanadditivetoqualifyfortheGenerallyRecognizedasSafe(GRAS)exemption,andbeexcusedfromundergoingtesting,itssafetymustalreadyhavebeendemonstratedviarigoroustestingratherthanthroughtheoreticalreasoning.Moreover,anoverwhelmingconsensusmustexistwithinthescientificcommunitythatsuchproofhasinfactoccurred.However,aswealsosaw,inordertoputGEfoodsonthemarket,theFDAillegally(andfraudulently)presumedthattheyareGRAS,eventhoughnoneofthemfulfilledeitheroftheGRASrequirements.

IncontrasttotheUSsystem(asitexistsonthebooks),theapproachbasedontheconceptofsubstantialequivalencedoesnotdemandsolidproofofsafetyandsignificantlyreliesontheoreticalassumptionsandreasoning.Inthisapproach,ifabioengineeredfoodorganismcanbeascertainedtobe“substantiallyequivalent”toitsconventionalcounterpart,itwillbeconsideredassafeasthatnon-engineeredorganism,evenwithoutthekindsofteststhatarenecessarytoestablishthatitactuallyis.

Butthere’sgreatuncertaintyastowhattheconceptactuallymeans.InfurthercontrasttoUSfoodsafetylaw,wherethetermsandconceptsarestrictlydefined,“substantialequivalence”asaregulatoryprinciplehasremainedquitevague.Itwasintroducedin1993bytheOrganizationforEconomicCooperationandDevelopment(OECD),andin1996,theUnitedNationsendorseditthroughtheFoodandAgricultureOrganizationandtheWorldHealthOrganization.1However,numerousexpertshavecriticizedthedegreetowhichithasstayedlooselydelineated.Forinstance,threescientistswritinginthejournalNaturenoted:“Giventheweighttheconcepthasbeenrequiredtocarry,itisremarkablehowill-defineditremains....”Theypointedoutthatatthetimetheywerewriting(1999),thefollowingstatementfromtheOECDwastheclosestthingtoanofficialdefinition:“Theconceptofsubstantialequivalenceembodiestheideathatexistingorganismsusedasfoods,orasasourceoffood,canbeusedasthebasisforcomparisonwhenassessingthesafetyofhumanconsumptionofafoodorfoodcomponentthathasbeenmodifiedorisnew.” 2

Suchvaguenesshasworkedinfavorofthebiotechindustry.AstheauthorsoftheletterinNatureobserved:“TheadoptionoftheconceptofsubstantialequivalencebythegovernmentsoftheindustrializedcountriessignalledtotheGMfoodindustrythataslongascompaniesdidnottrytomarketGMfoodsthathadagrosslydifferentchemicalcompositionfromthoseoffoodsalreadyonthemarket,theirnewGMproductswouldbepermittedwithoutanysafetyortoxicologytests.” 3Inpractice,thishasallowedtheassessmentstofocussolelyontheintendedorexpectedeffectsofthegeneinsertion,basedontheassumptionthattherewillbenounintendedeffectsthatneedtobemonitored.Soacrude(andincomplete)chemicalprofileoftheengineeredorganismiscomparedtothatofthenon-engineeredparentalline,andifnomajordiscrepanciesarenoted,theformerisdeemedsubstantiallyequivalenttothelatter.Ofcourse,eventhoughit’sobviousthatthetwoorganismsdodifferinregardtotheexpressionproductoftheinsertedgene,ifanalysissupportstheideathatthissubstanceisnotdangerous,thentheentireengineeredorganismisregardedashavingbeenshowntobesafe.

Thus,whensubstantialequivalencehasbeentheoperativeprinciple,ithasrelievedmanufacturersofanyobligationtoperformthoroughtestingtodiscoverwhetherunexpectedchangeshaveoccurredthatcan’tbedetectedthroughsimplechemicalanalysis.Insuchcircumstances,thekindsofteststhattheFDAexpertssaidarenecessary(toxicologicaltestsemployingthewholefood)havenotbeendone–andthetestinghasbeenuniformlylax.Forinstance,in2000,ProfessorE.AnnClarkofGuelphUniversity,OntarioreviewedtheGEcropsthathadbeenapprovedinCanadaandfoundthat70%(28of40)hadnotbeensubjectedtoanyactuallaboranimaltoxicitytesting.Intheremaining30%,althoughsometypesofanimalstudieswereperformed,theanimalswerenotfedthewholeGEorganism.Instead,theywerefedtheisolatedproteinthatwasexpressedbytheforeigngene.Further,thisproteinwasnotevenproducedwithintheengineeredplant.Itwasderivedfromlaboratorybacteriaintowhichthegenehadbeeninserted.4Accordingly,suchtestingwasincapableofdetectinganyunintended,deleteriouseffectswithintheplantcausedbydisruptionsassociatedwiththegeneticmanipulation–thekindsofunexpectedhazardsaboutwhichtheFDAexpertsrepeatedlywarned.

Andthisdeficientapproachwasuniversallyutilized.TheyearafterDr.Clark’sreview,ascientistatIowaStateUniversitypublishedapaperverifyingthattotheextenttoxicologicalstudieshadbeenperformedonGEcrops,theydidnotinvolvethewholeplantbutwerelimitedtotheknownforeignproteins.Shestatedthatotherformsofsafetytestingwerenotconsiderednecessary.5

AlsointheyearfollowingDr.Clark’sreview,anexpertpaneloftheRoyalSocietyofCanadapublishedamoreextensiveexaminationoftheCanadianregulatoryregime–andleveledsomeharshcriticism.TheSociety’sreporthadespeciallydisparagingwordsforthewaytheconceptofsubstantialequivalencewasbeingemployed.Itbrandedtheconceptas“scientificallyunjustifiableandinconsistentwithprecautionaryregulationofthetechnology”–andnotedthatitwasbeingusedtoexcusemanufacturersfromperformingfullriskassessments.6Althoughtheregulatorshadcontendedthattheirreviewswererigorous,theSociety’sexpertsrejectedtheirclaims.AsreportedinTheTorontoStar,theydeclaredthatthereviewsystemwas“fatallyflawed...andexposesCanadianstoseveralpotentialhealthrisks,includingtoxicityandallergicreactions.” 7

InstarkcontrasttoboththeFDA’sofficial(butfraudulent)policyandthesuppositionsunderlyingtheconceptofsubstantialequivalence,theCanadianexpertsstatedthatthe“defaultpresumption”foreveryGEfoodshouldbethatthegeneticalterationhasinducedunintendedandpotentiallyhazardoussideeffects,encompassing“arangeofcollateralchangesinexpressionofothergenes,changesinthepatternofproteinsproducedand/orchangesinmetabolicactivities.” 8TheydeclaredthatapprovalsofGEfoodsshouldnolongerbebasedonthelooseapproachassociatedwiththeconceptofsubstantialequivalenceandinstead“shouldbebasedonrigorousscientificassessment.” 9

Moreover,it’sobviousthattheactionsoftheCanadiangovernmentcannotbeexcusedasinnocent

oversights–andthatitsattitudehasbeennotonlyirresponsiblebutreprehensible.Forinstance,althoughtheRoyalSocietyundertookitsinvestigationofGEfoodsattherequestofthegovernment,thegovernmenteventuallybecameuncooperative.AsreportedbytheTorontoStar,iteven“barred”theSociety’sexpertpanel“fromseeingevidencethatsafetytestshadactuallybeendoneongeneticallymodifiedfoods.” 10Further,althoughtheexpertscriticizedthegovernmentforexcessivesecrecy,tothisday,CanadianregulatorscontinuetoconductsafetyassessmentsonGEfoodsinaclandestinemannerthatprecludesexternalscrutiny.11

ContinuationofShoddySafetyAssessmentsDespitethepublicscoldingitreceived,theCanadiangovernmentheldtoitscourse;anditfailedtoimplementtheessentialreformstheRoyalSocietyhadcalledfor.Further,theconceptofsubstantialequivalencecontinuedtoreigninmostothernationsaswell;andtheflimsyresearchonwhichtheCanadianapprovalswerebasedwassimilarlyacceptedbyregulatorsthroughouttheworld.Consequently,formanyyearsGEfoodsenteredthemarketonthebasisofsafetyassessmentsthatweresorelydefective.

AstrikingexampleoftheextentofthedeficienciesisprovidedbytheexperienceoftheeminentfoodsafetyresearchersArpadPusztaiandSusanBardocz(hiswife)whentheywereattheUK’sRowettInstituteofNutritionandHealth.AsreportedbyinvestigativejournalistJeffreySmith,inApril1998theInstitute’sdirectoraskedthetwoscientiststoevaluatealargestackofdocuments(totalingaround700pages)thatcomprisedsixorsevenrequestsforapprovalsofspecificGEfoods(includingvarietiesoftomatoes,soy,andcorn).12HeexplainedthatanimportantEUmeetingonbioengineeredfoodswouldsoonconveneinBrusselsandthattheheadoftheBritishMinistryofAgriculture,ForestryandFisheries(MAFF)wasgoingtoattendandwantedascientificbasisforrecommendingthesesubmissions.Hethenaddedajoltingpieceofnews.Theministerneededtheevaluationswithintwoandahalfhours.

Inordertomeetthisdemand,theteamhonedinonthecriticalpartsofeachsubmission:theresearchdesignandthedata.Whattheydiscoveredwasdeeplydisturbing.“Asascientist,Iwasreallyshocked,”saidPusztai,inrelatinghisexperiencetoSmith.“ThiswasthefirsttimeIrealizedwhatflimsyevidencewasbeingpresented....Therewasmissingdata,poorresearchdesign,andverysuperficialtestsindeed....Andsomeoftheworkwasreallyverypoorlydone.Iwanttoimpressonyou,itwasarealshock.” 13

Althoughheandhiswifehadinitiallyassumedthattwoandahalfhourswouldbeinsufficient,wellbeforethetimewasup,theywerepreparedtodefinitivelystatethattheresearchfellfarshortofdemonstratingthatanyofthefoodswassafeforhumanoranimalconsumption.ButwhenPusztaiphonedtheministeroftheMAFFtoinformhim,hereceivedanothershock.TheministertoldhimthatallofthesubmissionshadalreadybeenapprovedintheUK.ThereviewthatheandSusanperformedhadnotbeenintendedtoassisttheUKgovernmentindecidingwhethertoapprovethoseparticularGEproductsbutwasmerelysupposedtoprovidetheministerwithscientificassurancesaboutthemthathecouldemployintheEUmeeting.WithintheUK,thepopulacehadalreadybeenconsumingthosefoodsforclosetotwoyears.Moreover,theyhadbeeneatingthemunknowingly,becausetheapprovalshadallbeenmadeinsecret.

Unfortunately,thestudiesthatPusztaiandBardoczdiscreditedwerenotrarities.Timeandagain,investigationoftheregulatoryprocess(inwhateverthenation)hasrevealedresearchthatwasdeficientlydesigned,poorlyconducted,andirresponsiblyreviewed.OneofthemoreunsettlingepisodesinvolvedthreeofMonsanto’sapplicationstotheAustraliaNewZealandFoodAuthority(ANZFA)forapprovalofGEplants(varietiesofherbicideresistantcorn(maize)andcanola,andapesticide-producingcorn).14PriortoANZFA’sfinalaction,thePublicHealthAssociationofAustralia(PHAA)reviewedtheapplicationsanddiscoveredsometroublingdata.AsexplainedinthecommentstheAssociationsentto

ANZFAinOctober2000,inallthreecases,theGEplantdifferedsignificantlyfromitsparentallineinaminoacidcomposition,andthereweresignificantdifferencesinotherareasaswell.15ThePHAAexpertspointedoutthatthevariationsinaminoacidprofilesalonewarrantedrigoroustoxicologicaltestingofthewholeGEfoods.Theynotedthatthesealterationswereofsuchmagnitudethattheycouldnotbeattributedsolelytotheknownproductsoftheinsertedforeigngenes.Theyfurtherexplainedthatsinceaminoacidsarethebuildingblocksofproteins,eithertheconcentrationsofsomeoftheproteinsnaturallypresentintheplantshadbeenalteredorelseoneormorenewproteinshadbeenproducedthatdonotnaturallyoccurintheplant.Theycautionedthatineithercase,harmfuleffectstoconsumerscouldresultandthatadditionaltestingwasrequiredtodemonstratetheplantswereinfactsafe.

MonsantohadattemptedtominimizetheimportanceofthesealterationsbyarguingthatthelevelsofaminoacidsintheGEplantsstillfellwithintherangeofpreviouslyreportedvaluesforconventionalvarietiesoftheparticularplantsinvolved.ButthePHAAcounteredthatitwasillegitimatetocomparetheGEplanttoanaveragerangecompiledfromnon-GEplantscultivatedinwidelydifferinggrowingconditions.ItstatedthatthepropercomparisonwasbetweentheGEplantandtheplantsthathadbeenusedascontrolsinMonsanto’sfieldtrials.ThoseplantsbelongedtothelinefromwhichtheGEplantwasderived(theparentalline)andweregrownatthesametimeastheGEplantsunderthesameconditions.Therefore,thestatisticallysignificantdifferencesbetweentheGEplantsandthecontrolscouldbeassumedtohaveresultedfromthegeneticengineeringprocessitself,notfromnaturallyoccurringfactors.Accordingly,ashiftinaminoacidconcentrationcouldbeindicativeofauniqueproteincompositionthatdoesnotordinarilyoccurinconventionalplants–andthatmightbehazardoustohumanhealth.ThePHAAnotedthatusingdatagatheredfromplantsinwidelyvaryingconditionswouldunderminetheverypurposeofhavingusedcontrols,sinceitwouldallowentryofallthevariablesthatareexcludedbythecontrolledexperiment–suchasdifferencesinclimate,soil,andcultivationtechniques,whichareunrelatedtotheengineeringprocessandcanonlyservetoobfuscatecollateralchangesitmayhavecaused.16

Amazingly,ANZFAsidedwithMonsantoinsteadofthePHAA.Insteadofupholdingtheintegrityofthecontrolledexperiment,theagencycircumventedthecontrolsandcomparedtheGEplantstoplantsgrownunderwidelyvaryingconditions.Onlyinthatwaywasitabletorulethatthethreeplantsweresubstantiallyequivalenttotheirconventionalcounterparts–andthereforesuitableforhumanconsumption.

Besidesdisregardingthewarningsignsgeneratedbycontrolledexperiments,ANZFAalsooverlookedtheabsenceofkeyelementsofstandardscientificinvestigation.Forexample,thePHAAnotedthatMonsanto’sstatisticalanalysesreportedonlyafewvalueswhileomittingseveralpiecesofinformationthatarenecessarytoenableotherscientiststoassessthedata–andthatarerequiredbypeer-reviewedjournals.AndwhentheseexpertsthenexaminedfourotherGEfoodapplicationssubmittedtoANZFA,theydiscoveredsimilaromissions.17Forthisreasonalone,noneofthesevensubmissionswassuitableforpublicationinastandardscientificjournal.Moreover,thesamplesizesusedincomparisonsweresurprisinglysmall.AsthePHAAnoted,“WithsuchlownumbersitisalmostaforegoneconclusionthatastatisticallysignificantdifferencewillNOTbefoundbetweentheGEfoodandthenon-GEfoodformostanalyses,evenifoneexistsinnature.” 18Further,itpointedoutthatbecauseinseveralcasespotentiallyimportantstatisticaldifferenceshadstillbeendetected,evenwithsuchsmallsamplesizes,thosedifferencesmightwellbe“substantialindeed.”

Nonetheless,ANZFAapprovedtheotherfoursubmissionsaswell.Moreover,itwasnottheonlyregulatorybodywillingtoacceptsuchshoddyresearch.SixofthosesevensubmissionshadalreadybeenapprovedintheEU.

Thus,manufacturershaveregularlydeclaredsubstantialequivalenceinthefaceofsubstantial

differences;andtheregulatorshavegonealongwithit.Oneofthemorestrikingexamplesofsuchinaptlyproclaimedequivalenceinvolvestheworld’smostwidelyplantedGEcrop:Monsanto’sRoundupReady

®

soybean,engineeredtotoleratethepotentherbicideglyphosate.AsdescribedintheletterinNaturecitedpreviously,regulatorsbegan“byassumingthattheknowngeneticandbiochemicaldifferences”betweentheengineeredbeansandtheircounterparts“aretoxicologicallyinsignificant.”Thentheyfocusedona“arestrictedsetofcompositionalvariables,suchastheamountsofprotein,carbohydrate,vitaminsandminerals,aminoacids,fattyacids,fibre,ash,isoflavonesandlecithins.” 19However,thecomparisonwasdeeplyflawed.Foronething,conventionalsoybeanscannotbesprayedwithglyphosatebecauseitwouldkillthem.Incontrast,theGEbeanswouldbesubjectedtosubstantialdosesofglyphosateintheprocessofdestroyingsurroundingweeds.Further,astheNatureletterpointedout,ithadbeenknownformanyyearsthatapplyingglyphosatetosoybeans“significantlychangestheirchemicalcomposition.”Yet,insteadofcomparingsprayedGEbeanstotheconventional,unsprayedbeans,somekeycompositionaltestsemployedengineeredbeansthathadnotbeensubjectedtotheherbicide,eventhoughpeopleandlivestockwouldbeconsumingthesprayedbeans.20

ButthedefectswiththeassessmentsofMonsanto’sRoundupReady®

soybeandonotstopthere.InvestigationbyscientistsatJapan’sNagoyaUniversityofthedatasubmittedtoregulatorsinthatnationrevealedthattheGEbeansemployedintheanimalfeedingtestshadnotbeensprayedwithglyphosateeither.21Further,theseindependentinvestigatorsreportedthatalthoughadifferenceinbodyweightbetweenratsfedtheGEsoyandthosefedtheconventionaltypewasdescribedas“statisticallysignificant”inthedatasheet,thecompany’sconclusiondeclaredthat“nostatisticalsignificanceisobserved.”Atleastastroubling,thesescientistsdiscoveredstrikingdiscrepanciesinchemicalcompositionafterthebeansweretoastedinthestandardmannerforturningthemintoanimalfeed(108degreescentigradefor30minutes).Notonlyweremajorcomponentslikewatercontent,protein,fat,fiberandashdifferentintheGEbeanscomparedtothenon-GEones,theGEbeanscontainedsignificantlyhigherconcentrationsofthreespecificproteinsthatareknowntobeharmful(trypsin-inhibitor,lectinandurease).TheseproteinsremainedactiveintheGEbeanswhileinthenon-GEbeanstheyweredenaturedandinactivated.Moreover,theirlevelswereaboveacceptedstandardsforanimalfeed.

AccordingtotheNagoyateam’sreport,ratherthanacknowledgingthataproblemexisted,Monsantoclaimedthatthebeanshadbeen“insufficiently”toastedandinstructedthelabthathadperformedthetesttotoastthemat220degreescentigradefor25minutes.Althoughthisisconsiderablyhigherthannormalprocessingtemperature,itactuallywidenedthedifferenceintheactivitybetweenthetwostrains,withGEbeansshowingahighlevelofheatresistance.Yet,insteadofadmittingthatthebeansweresubstantiallydifferent,Monsantoclaimedthatthissecondtoastingwasstillinsufficient.Soithadthebeanssubjectedtotwomoreroundsoftoastingatincreasinglevelsoftemperatureuntilalltheproteinsweredenaturedandinactivated.Astheinvestigativereportpointsout,onlybyputtingtheGEbeansthroughsuchanextraordinaryseriesofheattreatmentsdidMonsantorendertheharmfulproteinsasinactiveasthoseinthenon-GEbeans.ButbecausesuchextrememeasuresarenotemployedwhentheGEbeansareprocessedforanimalfeed,itraisesdoubtabouttheproduct’ssafetyforthatuse.

Inall,theJapaneseinvestigatorsfoundsomanyirregularitiesinthesafetyassessmentoftheGEsoytheyconcludeditwas“inadequateandincomplete.”Theirreportconcludes:“ThesafetyassessmentoftheMonsantoRoundupReadysoybeanneedstobereassessed.”Butregulatorshavenotdoneso,eventhoughtheirinitialreviewswereshowntohavebeenexceedinglysloppy.Accordingly,theproductcontinuestobeingestedbypeopleandlivestocktheworldover.

Regulatorshaverarelydistinguishedthemselvesinotherrespectseither.Forinstance,besidesallowingmanyofthefeedingtestsonGEfoodstoemployonlytheexpressionproductoftheforeigngeneratherthanthewholeGEfood,they’veapprovedtestsonthewholefoodsthatwerewhollydeficient.For

instance,duringtestsonAventis’sbioengineeredT25corn,twiceasmanychickensdiedinthegroupthatateitthaninthecontrolgroupfedthenon-engineeredparentalstock.22Despitethisresult(andseveraldefectsinthewaythestudywasconducted),EUauthoritiesapprovedtheproduct.ThechairofaUKgovernmentadvisorycommitteelateradmittedthatthechickenstudyshouldhavebeenreanalyzed.Healsoadmittedthatatthetimeapprovalwasgiven,hiscommitteehadonlyseenasummaryofthestudy.23Otherexpertswhosubsequentlyreviewedthestudyemphasizeditsflaws–withoneuniversityscientiststatingitwas“notreallygoodenoughtobaseastudentprojecton,letaloneamarketingconsentforaGM[geneticallymodified]product.” 24

SubstantialirregularitiesalsooccurredinconnectionwithSyngenta’sapplicationforEUapprovalofBt11sweetcorn(maize).Thishighprofilecasewasintenselydebatedduring2004becauseatthatpoint,therehadbeenasix-yearmoratoriumonapprovalsofGEfoodsintheEuropeanUnion,andapprovingBt11wouldendit.

Butevenknowingtherewouldbeaspotlightontheapplication,Syngentacutcorners.Itundertooknolong-termtoxicologicaltestsusingthewholeplant,andthemoresuperficialnutritionalfeedingstudiesitperformedwithcattleandhensdidnotemploythesweetcornunderconsideration(thatwasintendedforhumanconsumption)butavarietyofengineeredfieldcornintendedforlivestock–whichtheFrenchFoodSafetyAgency(AFFSA)notedhad“significantgeneticdifferences”fromthesweetcorn.25TheAFFSAwarnedthat“unforeseeneffects”fromthesweetcorn“cannotbediscounted,”anditcalledfornewtests.ThereportoftheAustrianagencywasalsocritical.Itnotedthatnotonlyweretheallergytestsinsufficient,butthatSyngenta’sclaimofsafetywasprimarilybasedonhypothesesratherthandirectevidence–andthatseveralofitspresumptionswerefalse.

Nonetheless,theEuropeanCommission,theEU’smainexecutivebody,approvedtheproduct.Moreover,itjustifieditsactionthroughmisrepresentativestatements,withtheHealthandConsumerProtectionCommissionerdeclaringthatBt11“hasbeenscientificallyassessedasbeingassafeasanyconventionalmaize[corn].” 26Andalthoughtherewasnoevidencetosupportsuchaboldpronouncement,heimpliedthattherewas,proclaimingthatBt11“hasbeensubjecttothemostrigorouspre-marketingassessmentintheworld.” 27Butthisisfalse.ItimpliesthatBt11successfullypassedeverytypeofsafetytestthat’sbeenappliedtoafoodorfoodadditive,andthateachwasadministeredtothehigheststandards,whichclearlyneverhappened.28

FurtherInadequaciesoftheTesting

TheGMO-GeneratedProteinsAreNotDirectlyTested

Besidesdispensingwithessentialfeedingtestsandtoleratingslackperformanceoftheremainder,thecurrentregulatorysystemreliesonanalyticteststhatdon’tprovideadequatedata.Forinstance,thetestsitacceptsforassessingthesafetyoftheforeignproteincannotfullydoso.Aspreviouslynoted,themainreasonisthatthetestedproteinsarenormallynottheonesthataresynthesizedwithintheengineeredplant.Rather,they’reproducedbyinsertingtherelatedgeneintobacteria,becauseit’smucheasiertogarnerasufficientamountoftheproteininthismanner.Butevenifthesebacterially-derivedsurrogatespossessexactlythesamesequenceofaminoacidsastheirplant-producedcounterparts,theycanyetbesignificantlydifferent–andmoredangerous.

That’sbecauseaprotein’seffectsarenotsolelydeterminedbythearrangementofitsconstituentaminoacids.They’realsoaproductofotherfactors,andthesefactorscanbeunexpectedlyalteredasgenesaretransferredbetweenspeciesthatcannotbreedthroughnaturalmeans.

TheNewProteinsMadeWithinGMOsCanHaveDeleteriousAdditions

Onefactoriswhethertheproteingainsadd-ons–andthespecificsofwhatgetsadded.Theadjoinedsubstancescanbesugars,fats,orothertypesofmolecules;andwhetherandtowhatextentthey’reattachedtoaproteindependsontheconditionsinthecellswheretheproteinisformed.AccordingtoDavidSchubert,amolecularbiologistandproteinchemistwiththeSalkInstitute,althoughweknowthatsuchmodificationscanrenderanotherwiseharmlessproteintoxicorallergenic,wedon’tknowenoughtopredicthowandwhensuchmaleficmodificationswilloccur.29

However,wedoknowthatplantcellscaninducesuchmodificationsinawaythatbacterialcellscannot.Theparticularprocessiscalledglycosylation,anditinvolvestheadditionofsugarchainstoaprotein.Whilethisprocessdoesnotoccurinbacteria,itdoesinplantsandanimals.Consequently,whenabacterialgeneistransferredtoaplantviageneticengineering,theresultantproteincouldbecomeglycosylated;andalthoughsugar-coated,itcouldcauseeffectsthatarenotatallsweet.

Moreover,ifsuchaharmfulalterationdidtakeplace,itwouldneverbedetectedmerelybytestingtheeffectsofthebacterially-produced,unsugaredprotein.Thatproteincouldpasseverytest,whiletheplant-builtversioncouldmakepeoplepassaway.InlightofthefactthatmostoftheGEplantsonthemarketpossessgenestransferredfrombacteria,thisregulatorydeficiencyisserious.

Further,whentheinter-speciestransferinsteadoccursbetweenplants,theglycosylationpatternoftheassociatedproteincouldstillbeadverselyalteredwithintheforeignenvironment–eveniftheplantsarecloselyrelated.Thiswasdiscoveredwhenaproteinnormallyproducedinakidneybeanwassynthesizedwithinapea.Althoughtheproteinasmadebythebeanissafeforhumanswhenfullycooked,somethingchangedfortheworsewhenthesourcegenewasinsertedinpeas–despitethefactthetwospeciesbelongtothesamebiologicalfamily(andaremembersofthesub-groupreferredtoaspulses).Testsonmicebroughtthischangetolight.30Alltheanimalswerefedastandarddietforfourweeks;andtwiceperweek,onegroupwasalsofedbeans,anotherwasfednon-GEpeas,andthethirdwasgiventheGEpeas.Themicethenunderwentimmuneresponseteststhataresupposedtoindicatewhetherasubstancewillbeallergenicforhumans.Surprisingly,althoughtheproteinproducedinthealteredpeasandtheproteinproducedinthebeanshadidenticalaminoacidsequences,onlytheformerprovokedanimmuneresponse.Wheninjectedintothefootpadsofthemicethathadconsumedit,significantswellingoccurred.Theirlymphnodesalsoreactedagainstit.Andwhentheirtracheaswereexposedtoit,tissueinflammationandmildlungdamageresulted.

Thus,aftertheentryofthispea-producedproteinintotheanimals’diet,theirimmunesystemsbecameprimedtorepelit.Intryingtoaccountforthedramaticdifferencebetweentheeffectsofthisaberrantproteinanditsbean-builtcounterpart,theresearchersemployedanadvancedtestthatprobesthepatternsofsugarchainsthathavebeenaddedtoproteins.Thisrevealedsmallchangeshadoccurredwhentheproteinwasmadeinpeasinsteadofbeans.Thescientistsconcludedthistinyshiftinsugarpatternwasthemostprobablefactorunderlyingtheshiftinallergenicity–andthatitexplainedwhyonepulse-producedproteindidnotrousetherodents’defensemechanismswhilethesameproteinmadebyanotherpulsewasrepulsed.

What’smore,theeffectsofthisshiftwerebroad.Thealteredproteinnotonlyinducedtheanimals’immunesystemstoreactagainstit,itpredisposedthemtomountaresponseagainstotherconcurrentlyconsumedproteinsaswell.Incontrast,themicefedthenormalversionoftheproteinshowednosuchinappropriatesensitivity.Onlythemicethatingestedthemodifiedversionwereinducedtoreactagainstotherordinarilyinoffensiveproteinsasiftheytoowereallergens.

Inafurthersurprise,theallergenicpropertiesofthemodifiedproteinpersistedevenaftertheGEpeashadbeenboiledfor20minutes.Althoughthisdenaturedtheprotein,andcurtaileditsusualeffects,itdidnotdeactivatetheextraordinaryeffectonthemouseimmunesystem–whichrefutesthewidelyheldassumptionthatwhenGEplantsarecooked,anyallergenicattributeswilldisappearthroughproteindenaturing.

Thisunderscorestheimportancenotonlyoftestingtheproteinthat’sactuallyproducedbytheengineeredplant,butoftestingitthoroughly.However,asnoted,theplant-producedversionoftheproteinisrarelytested;andevenintheexceptionalcaseswhenitis,themeasuresarenotsufficientlysensitive.Althoughthetestthatrevealedtheallergenicnatureofthepea-producedproteiniscommonlyusedinassessingmedicines,ithadnotbeenpreviouslyemployedinthescreeningofcommercializedGEplants–andit’sstilllargelyignored.Noristhespecialtestthatdetectedthesubtlechangeinglycosylationregularlyused.Inthosecaseswhenaprotein’sstructureisexamined,alesssensitivetestisemployedthatdoesnotprovidedetailedinformationaboutglycosylationpatterns–andcouldnothavedetectedthatthoseofthepea-madeandbean-madeproteinsweredifferent.31Moreover,becausethatinferiortypeoftesthadbeenemployedwhentheGEpeawasinitiallydeveloped(severalyearspriortothemoreextensivetesting),scientistswereledtobelievethatthetwoversionsoftheproteinwereidentical.

Soifthatgeneticallyalteredpeahadbeensubjectedonlytotheusualmodesoftesting,itwouldhavebeenclearedforhumanconsumption–andmighthavecausedsubstantialsuffering.

TheShapesoftheGMO-GeneratedProteinsCouldBeDangerouslyAltered

Butevenifnothinggetsaddedtotheforeignproteinafterinsertioninaneworganism,itcouldstillcauseunexpectedharm.Onewayisthroughchangeofshape.Aprotein’sfunctionisprimarilydeterminedbyitsuniquethree-dimensionalstructure;andthatstructure,althoughverycomplex,istightlyorganized.Further,thisorganizationisnotachievedwhentheproteinissynthesized;andanewlysynthesizedproteinhasalargelytwo-dimensional,ribbon-likeform.Thistwo-dimensionalformmustthenbefoldedintothecorrectthree-dimensionalconfiguration.

ThecellularbiologistBarryCommonerhasnotedthatscientistsusedtothinktheprotein“alwaysfoldeditselfupintherightwayonceitsaminoacidsequencehadbeendetermined.”But,ashepointedout,thisnotionchangedinthe1980swhenscientistsdiscoveredthatsomeproteins“are,ontheirown,likelytobecomemisfolded–andthereforeremainbiochemicallyinactive–unlesstheycomeincontactwithaspecifictypeof‘chaperone’proteinthatproperlyfoldsthem.” 32Accordingly,Commonercautionedthatwhenaproteinthathasco-evolvedwithaparticularchaperoneistransferredtoaforeignenvironment,itmightnotfoldinthepropermanner.Withouttheassistanceofitsownchaperone,misfoldingmightoccur;whileifit’sinsteadinfluencedbyanalienchaperone,itcouldalsobemisshaped.Further,althoughinsomecasesmisfoldingwoulddeactivatetheprotein,inothersitcouldcausetheproteintoactinadangerousway.Forinstance,MadCowDiseaseiscausedbyanerrantlyfoldedprotein.33

Moreover,likeproteinsinGEfoodsthatareharmfullyglycosylated,thosethataremalignantlymisfoldedwouldlikewiseslipthroughthecurrentregulatorysystemundetected.Andthere’satleastonecaseinwhichtheevidencesuggeststhattheforeignproteininaGEplantmayindeedhavebecomemisshapen.34

TheAminoAcidSequencesoftheProteinsCanBeChanged

There’syetanotherwayinwhichaproteinmadefromageneinsertedinaplantcansignificantlydifferfromtheproteinproducedwhenthatgeneisinsteadinsertedinabacteria.Notonlycanitbecomemisshapenoralteredbyharmfuladd-ons,eventhesequenceofitsaminoacidscanbeunintentionallychanged.Thiscanhappenbecause,incontrasttothemodeinwhichbiotechniciansaddnewgenestobacteria,theinsertionprocessinplantsisroutinelyunruly–andofteninducesthedeletionofDNAthat’ssupposedtobewithintheaddedgeneortheadditionofsomethat’snotsupposedtobethere.

Further,besidesbeingcommon,someofthesealterationsaredifficulttodetect.AccordingtoDougGurian-Sherman,aplantbiologistwhohadperformedriskassessmentsonGEcropsfortheUS

EnvironmentalProtectionAgency,“Rearrangementofthenucleotidesequenceofageneoftenoccursduringtheinsertionofthatgeneintothegenomeoftherecipientplant....Mostofthoserandomchangesimpairoreveneliminatethefunctionoftheproteincodedbythegeneandmaybeeasilydetectedbybioassays.Somechanges,however,maybemoresubtleandlesseasilydetermined.Evensinglenucleotidechangescanalteraprotein’saminoacidsequenceandaffecttheprotein’sproperties.” 35

However,despitetheknownriskofsuchsubtleyetpotentiallyharmfulchanges,regulatorswerelaxinresponding.AsGurian-Shermanpointedout:“FDAprovideslittleguidanceforassuringthatpotentiallydeleteriouschangeshavenotoccurredinthetransgene,andconsequentlytotheGEprotein,duetotransformationoftheplant.”Andhenotedthatthesechangescan“alterthepropertiesoftheGEprotein”andthat“detectionofmanyplantcharacteristicsofhealthconcernrequirespecifictesting.” 36

Yet,ashealsonoted,therewasstillaneedfordetermininghowtoassesssuchchangesintheproteinsaddedtoplantsviatheengineeringprocess.Andthatwasin2003.SoalthoughGEcropshadbeenenteringthefoodsupplyformorethaneightyears,regulatorshadnotyetdevisedaprotocolfordetectingwhethersuchpotentiallydeleteriousalterationshadoccurredwithinthem.37

AdditionalProteinsCanBeAccidentallyAdded

Moreover,besidestheriskthattheintendedproteinswillbealtered,there’sariskthatanunintendedonecanbeintroduced.AsChapter11explainsinmoredetail,thesamesectionofDNAcanbeinvolvedintheproductionofmorethanoneprotein;andthisentailsthatpiecesofunwantedproteincouldbegeneratedbyaninsertedsegmentofDNA.Further,evenregionsofDNAthatappeartobenon-protein-codingcancontainprotein-codingsequences;andthesepotentiallyproblematicsequencescangounnoticedbyregulatorsformanyyears.Indeed,thishasactuallyhappened–notmerelyinoneGEcrop,butinthemajorityofthosethathaveenteredthemarket.

Thisunsettlingsituationaroseduetothewidespreadrelianceonthepowerful35Spromoterfromthecauliflowermosaicvirustodrivetheexpressionoftheinsertedgenes.Becauseinitsviralhomethispromotercomesinfrontofthegenewhoseexpressionitinfluences,theregulatoryagenciesassumeditdidn’tcontainanyprotein-codingsequencesitself.Buttheywerewrong.Infact,there’sanothergeneontheothersideofthepromoter(“upstream”ofit)knownasGeneVI;anditscodingsequenceextendsintothe35Spromoter.Asaresult,manyofthatpromoter’snucleotidesalsoencodeasegmentoftheGeneVIprotein.

Butthisunpleasantrealitywasn’tdiscoveredbyanyregulatorsuntil2012;andthediscoverywasnotmadebytheFDA(becauseitsreviewsofGEfoodsaresosuperficial),butbyanotherregulatoryagency:theEuropeanFoodSafetyAuthority(EFSA).38AndbecauseitwasalreadyknownthatsimilarfragmentsofGeneVIcanexpressactiveproteins,39theEFSAscientistshadtoacknowledgethatthepresenceofthisgenefragmentinaGEplanthasthepotentialtoinducechangesintheplant’straits.Nonetheless,theytriedtodownplaytherisks–despitethefactthattheproteinproducedbyGeneVIisnotonlytoxictoplants40

butinterfereswithabasicmechanismofproteinsynthesisreliedonbyhumansaswellasplants41–whilealsointerferingwithanotherimportantbiologicalmechanismthat’scommontoboth(RNAsilencing).42

Accordingly,otherexpertshavenotbeenascomfortablewiththesecircumstancesashavetheregulators.Andtwowho’velucidlyexpressedtheirconcernsareJonathanLatham,amolecularbiologistandplantvirologist,andAllisonWilson,amoleculargeneticist.InJanuary2013theypublishedanarticlecautioningthatthepresenceofthisgenefragmentinGEplantsposeshumanhealthconcerns,especiallybecausemanyviralproteinsworktodisabletheirhost.Andtheyasserted,“Thedataclearlyindicateapotentialforsignificantharm.” 43Therefore,theyadvocatedarecallofallGEcropsthatharborapieceofGeneVI–whichbesidespullingallthosewiththe35Spromoterfromthecauliflowermosaicvirusoffthemarket,wouldhaveremovedanothersetthatcontainedapromoterderivedfromthefigwortmosaic

virus.Unsurprisingly,theEFSAwasnotenamoredwiththiscallforarecall;norwastheAustralia/New

Zealandfoodsafetyagency.SoeachcounteredwithargumentspurportingtoshowthatthepartialpresenceofGeneVIdoesn’tentailsignificantrisk.44Butinrebuttal,LathamandWilsonpresentedanincisiveanalysisthatexposedseveralflawsinthesedefensivearguments.45And,basedonthisanalysis,theyassertedthattheregulators’argumentsarenotonly“inadequatetomeetapotentiallymajorfoodcrisis”but“scientificallymisleading.”Theyfurtherallegedthatthearguments“donotaddressthekeyagronomicandhumansafetyconcernsraisedbyGeneVI,”are“irrelevantandillogical,”and“restonscientificallyunverifiedorunsupportedassertions.”Moreover,theyissuedastrongadmonition:“Itispotentiallyacceptableforregulatorstocondenseorsimplifycomplexscientificinformationtoeducateorinformalaypublic.Whatisnotacceptable,however,isto‘inform’thepublicwithmisinformation.”

Theirrebuttaliswell-reasonedandwell-worthreadingandcanbefreelyaccessedatthelinkprovidedinendnote45.

RegulatorsRefusetoRecognizeTheseRisks–andHaveMadeNoEfforttoControlThem

Yet,despitetheknownpotentialfortheforeignproteinstobealteredandtheinsertedsequencestomutate,thoseresponsiblefortheregulatorysystemhaveremainedunresponsivetotheseadditionalrisks–andcaustictowardcallsforgreatercaution.

ThrowingCautiontotheWindThroughouttheages,societieshaverecognizedthewisdomofexercisingcautionbeforerushingintonewactivitiesthatcouldentailsubstantialrisk.Thisunderstandinghasbeenconveyedinseveraladages,suchas:“lookbeforeyouleap,”“bettersafethansorry,”and“anounceofpreventionisworthapoundofcure.”Inthelate20thcentury,aspolicymakersandexpertsattemptedtointelligentlydealwithseveraltechnologiesthat,despitetheirapparentpromise,alsoappearedtohavesignificantpotentialtodamagehumanhealthorthehealthoftheenvironment,theyendeavoredtoexpressthisfolkwisdominamoreformalmanner.Theresultbecameknownastheprecautionaryprinciple.Althoughthisprinciplehasbeenarticulatedinseveralways,onegroupofexpertspointsoutthatallofthemcontainthefollowingconcepts:

1. Whenwehaveareasonablesuspicionofharm,and

2. Whenthereisscientificuncertaintyaboutcauseandeffect,then

3. Wehaveadutytopreventharm.46

Onewayofstatingtheprincipleinthecontextoffoodsafetyisthatwhenthereissignificantdisagreementamongexpertsaboutwhetheranadditivemightposeanunacceptablelevelofrisk,theproponentsoftheadditivehavetheburdenofprovingthatit’ssafe.

AswesawinChapter5,longbeforeanyonestartedtalkingaboutaprecautionaryprinciplebyname,theUSCongressestablishedastrictmandateforprecautionasthecentralfeatureofthenation’spolicyonfoodadditives.Moreover,that1958lawismorestringentthananyversionoftheprecautionaryprinciplearticulatedthereafter.Whereassuchformulationsspecifythattheremustbereasonablesuspicionofharm(alongwithsignificantexpertdisagreementaboutrisk)beforetheprincipleistriggered,theUSlawlaysdownnosuchconditions.Itcategoricallypresumesthatalladditivesintroducedafter1958aredangerousuntilprovensafe,anditplacestheburdenofproofsquarelyonthemanufacturers.47However,asChapter

5revealed(andaswasnotedatthebeginningofthischapter),inordertopromoteGEfoods,theFDAillegallyexemptedthemfromtheprecautionaryrequirements;anditcontinuestopretendthatthey’reallGenerallyRecognizedasSafe,despiteoverwhelmingevidencetothecontrary.(TheRoyalSocietyofCanada’sreportaloneclearlyestablishesthattheyarenotGRAS).

Sadly,thesituationhasnotbeenmuchbetterinothernations.Althoughmanypurporttoapplytheprecautionaryprincipletofoodsafety,inthecaseofGEfoods,theyhavetendedtoturntheirbacksonit.TheexampleoftheEUisinstructive.OnApril30,1997,theEuropeanCommissionissuedapaperonconsumerhealthandfoodsafetystatingthatit“willbeguidedinitsriskanalysisbytheprecautionaryprinciple,incaseswherethescientificbasisisinsufficientorsomeuncertaintyexists.”48OnMarch10,1998,theEuropeanParliamentissuedaresolutionaffirmingthisprecautionaryapproach.ItstatedthatEUfoodlawis“basedonthepreventiveprotectionofconsumerhealth...foundedonascientifically-basedriskanalysissupplemented,wherenecessary,byappropriateriskmanagementbasedontheprecautionaryprinciple...” 49Andthenextyear,TheJointParliamentaryCommitteeoftheEuropeanEconomicArea(whichcomprisestheEUandthreeneighboringnations),adoptedaresolutionreaffirming“theover-ridingneedforaprecautionaryapproach”inregardtotheapprovalofGEfoods.50Then,in2000,theEuropeanCommissionissuedamajordocumentontheprecautionaryprinciplestatingthatitsimplementationshouldstartwithascientificevaluationthatis“ascompleteaspossible.” 51

However,itisnotpossibletosustainthisprecautionaryapproachwhilepermittingtheconceptofsubstantialequivalencetoholdsway.Thetwoapproachesaresoincompatiblethatapplyingthelatterunderminestheformer.Yet,EUofficialshavecontinuedtoassessGEfoodsaccordingtotherelaxedstandardsofsubstantialequivalence–evenwhileprofessingthatthey’reimposingstrictercriteria.

Thispretensioneventuallyentailedachangeinterminology.Becausetheconceptofsubstantialequivalencehadreceivedsomuchcriticism,thechairoftheGMOPaneloftheEU’sEuropeanFoodSafetyAuthorityco-authoredanarticlein2003advisingthatthetermbereplacedbythephrase“comparativesafetyassessment”inordertoevadethe“controversy”associatedwiththeolderterm.However,heandhisco-authoradmittedthatalthoughthewordswouldbenew,theunderlyingregulatoryapproachwouldremainthesame.52

Further,notonlyhavetheEUregulatorscontinuedtogiveundueweighttothesuperficialcomparisonsofthesubstantialequivalenceparadigm,theystillsanctioncomparisonsthatarescientificallyillegitimate,permittingproducerstocompareaGEcroptovarietiesthatnotonlydiffergeneticallyfromthenon-GEparentallinebutthatweregrownmanyyearsbeforeinwidelyvaryinglocales.Someofthedataallowedtoskewthestudiesevenpre-dateWorldWarII.53

However,despitetheinfirmitiesintheEU’sapproach,officialsclaimthatit’smoreprecautionarythananyalternative.Forinstance,onMarch17,2011,theCommissionerforHealthandConsumerPolicy(JohnDalli)deliveredapresentationinwhichhedeploredthe“misunderstandings”thathaveledpeople“towronglybelievethatthepotentialrisksofGMOs...arenotadequatelyassessed....”Buthissubsequentremarksrevealedthatitwashewhohadfallenintomisunderstanding.Heassertedthatthe“thoroughcomparisonbetweenaGMOandaconventionalsafecounterpart”whichoccursviatheEU’sapproach“allowstheidentificationofallthedifferencescreatedbythegeneticmodification.”Andhealleged:“Allthesedifferencesaretheninvestigatedindetailwithrespecttopossibletoxicological,environmental,allergenicornutritionalaspects.”Hethendeclared:“Thereisnostricteralternativeavailabletothiscomparativeapproach.” 54

Somehow,Mr.Dallifailedtorealizethatthecomparisonsbeingmadedonotbyalongshotidentify“allthedifferencescreatedbythegeneticmodification.”Eveniftheywererestrictedtocontrolledstudiesemployingthenon-GEparentalstrain,theystillcouldnotdetectthefullrangeofunintendedeffects.Foronething,althoughmanyGEcropshavenowundergone90-dayratfeedingstudiesemployingthewhole

food,a2011articleinapeer-reviewedjournalbysixscientistsemphasizedthatsuchmedium-termtestsare“insufficienttoevaluatechronictoxicity.” 55Theauthorspointedout,basedonsolidscientificprinciples,whyonlylong-termstudiesthatincludereproductiveandmultigenerationalanalysescanadequatelyscreenforthepotentialdeleteriouseffectsofthegeneticmanipulations.ButneithertheEUnoranyotherregulatorsrequiresuchtests.Forthisreasonalone(nottomentionseveralpreviouslydiscussed),theassessmentsconductedbyEUregulatorscannotbedeemedthestrictestalternative.

Moreover,theEUdidnotevenrequirethe90-dayfeedingtestsuntil2013,andwhensuchtestswerevoluntarilyperformedpriortothat,itwasusuallynotuntilatleast10yearsaftertheGEcropstheyassessedhadbeenapprovedbyvariousregulatorsandhadenteredthefoodsupplyinnumerousnations–which,accordingtotheauthorsoftheabovearticleis“amatterofgraveconcern.” 56Theseexpertsalsonotedthatthesamplesizesinthetestshaveinseveralinstancesbeentoosmalltoensurereliability,afactthatdidn’tdetertheEUregulatorsfromacceptingthosetests.

Evenmoretroubling,whenthesescientistsreviewedthedatafrom19ofthefeedingstudies(onsoyandcornvarietiescomprising83%oftheGEfoodsthatpeoplehavebeenregularlyeating),theyfoundthat9%ofthemeasuredparameters,includingbloodandurinebiochemistryandorganweights,weresignificantlydisruptedintheanimalsthatatetheGEfeed.Moreover,thegreatestdisturbancesweretothekidneysofthemalesandtheliversofthefemales;andthescientistsemphasizedthatbecauseliversandkidneys“arethemajorreactiveorgans”incasesofchronicfoodtoxicity,theseresultsshouldbeviewedasdangersigns–somethingtheregulatorshavenotseenfittodo.57

Inlightofthesefacts,it’sclearthatCommissionerDallihasbeenseriouslymisinformedabouttheriskofunintendedeffects.Andtherearepro-GEscientistswell-positionedtokeephimandhisco-commissionersconfused.OneisAnneGlover,who(atthetimeofthiswriting)istheEUCommission’sChiefScientificAdvisor.Thisinfluence-wieldingscientistrecentlydeclared:“Thereisnosubstantiatedcaseofanyadverseimpactonhumanhealth,animalhealthorenvironmentalhealth,sothat’sprettyrobustevidence,andIwouldbeconfidentinsayingthatthereisnomoreriskineatingGMOfoodthaneatingconventionallyfarmedfood.” 58Shewentontoannouncethat,asaconsequence,theprecautionaryprinciplenolongerapplies.But,asthischapterhasdocumented(andasChapter10willdemonstratemorethoroughly),thereissubstantialevidenceofadverseimpactsonthehealthofanimalsthathaveconsumedGEfoods.Moreover,evenifsuchevidencehadneverbeengenerated,Dr.Gloverwouldnotbejustifiedintreatingitsabsenceas“robustevidence”forthesafetyofGEfoods–andasgroundsforabandoningtheprecautionaryprinciple.Unfortunately,thecommissionerssheadvisesareunawareofherdisregardforfactsandherloosenesswithlogic.

Yet,despitethesignificantinfluenceofmisinformation,theregulatoryirregularitieshavenotalwaysstemmedfromit.Thereareregulatorswhohavebeenproperlyinformedandyethavebrushedtheinformationoff.Forinstance,byFebruary2001,theAustraliaNewZealandFoodAuthority(ANZFA)hadbeeninformedaboutseveralproblemsofGEfoodsbythePublicHealthAssociationofAustralia,andtheywereawareoftherecentlyreleasedreportbytheRoyalSocietyofCanada.AndwhenImetwiththeagency’schiefscientist,biotechnologymanager,andgeneralmanagerofstandardsonFebruary15ofthatyear,Iemphasizedthekeypointsconveyedbybothofthosesources,especiallytheconclusionoftheCanadianexpertsthatthe“defaultpresumption”foreveryGEfoodshouldbethatthegeneticalterationhasinducedunintendedandpotentiallyhazardoussideeffects.IalsoinformedthemaboutthememoswrittenbytheFDA’sscientistsandemphasizedhowtheyhadrepeatedlycautionedaboutgeneticengineering’sunusualpotentialtogenerateunintendedsideeffects.Butthechiefscientistsummarilydismissedsuchthinkingas“merespeculation.” 59Thisattitudeisreflectedinheragency’spublishedacknowledgementthatitregardsGEfoodstobesafeuntilprovendangerous.60

Throughsuchbehavior,thisagencythat’sduty-boundtoprotectthecitizensofAustraliaandNew

Zealandfromunsafefoodshasprovidedyetanothercasestudyinregulatoryirresponsibility.61Thus,byinadequatelymonitoringforunintendedharmfuleffects,andbyignoringsignificantsignsof

problems,regulatorsintheEUandseveralotherregionshaveretreatedfromtheprecautionarypaththattheyweresupposedtohavebeenfollowing.Asthereviewersofthose19disquietingfeedingstudieshaveasserted,it’s“unacceptable”thatbillionsofconsumersworldwidearebeingsubjectedtoGEfoodsonthebasisofthesubstandardtestingthat’sperformedunderthecurrentregulatorysystem.62It’salsounacceptablethatinordertoperformadequateindependentreviewsofthisshoddytesting(onbehalfofthepublicinterest),thesescientistshadtogetcourtorderstoobtainallthenecessarydataforthreeoftheGEfoods–despitethefactithadbeensubmittedtogovernmentregulatorsandshouldhavebeenreadilyaccessible.63

ConflictedMissions:RegulationisIncompatiblewithPromotionTheirresponsiblebehaviorofthevariousregulatoryagenciesislargelyduetothefactthat(liketheUSFDA)althoughtheyaresupposedtoregulateGEfoods,theyalsohaveamissiontopromotethem.Thishasengenderedseriousconflictsofinterest.

Commentingonthepervasivenessoftheseconflicts,SuzanneWuerthele,atoxicologistwiththeUSEnvironmentalProtectionAgency,stated:“Thistechnologyisbeingpromoted,inthefaceofconcernsbyrespectablescientistsandinthefaceofdatatothecontrary,bytheveryagencieswhicharesupposedtobeprotectinghumanhealthandtheenvironment.Thebottomlineinmyviewisthatweareconfrontedwiththemostpowerfultechnologytheworldhaseverknown,anditisbeingrapidlydeployedwithalmostnothoughtwhatsoevertoitsconsequences.” 64

TheexpertpaneloftheRoyalSocietyofCanadaalsoemphasizedthecorrosiveeffectsofthegovernment/industrycollusion.Itsreportobserved:“InmeetingswithseniormanagersfromthevariousCanadianregulatorydepartments...theirresponsesuniformlystressedtheimportanceofmaintainingafavorableclimateforthebiotechnologyindustrytodevelopnewproducts....Theconflictofinterestinvolvedinbothpromotingandregulatinganindustryortechnology...isalsoafactorintheissueofmaintainingthetransparency,andthereforethescientificintegrity,oftheregulatoryprocess.Ineffect,thepublicinterestinaregulatorysystemthatis‘sciencebased’–thatmeetsscientificstandardsofobjectivity,amajoraspectofwhichisfullopennesstoscientificpeerreview–issignificantlycompromisedwhenthatopennessisnegotiatedawaybyregulatorsinexchangeforcordialandsupportiverelationshipswiththeindustriesbeingregulated.” 65

Inseveralcases,theconnectionsbetweenregulatorsandindustryhavenotmerelybeenclosebutunsavory.AccordingtoareportbyFriendsoftheEarth,asof2004,oneofthescientistsattheEuropeanFoodSafetyAuthority(EFSA)haddirectfinanciallinkstothebiotechindustry,severalhadindirectlinks,andtwohadappearedinpromotionalvideossponsoredbytheindustry.66

It’sthereforenotsurprisingthatthisagencyhasissuedseveralhighlyquestionableopinionssupportingthesafetyofGEfoods.Oneeyebrow-raiserinvolvedMonsanto’sYieldGard

®

RootwormCorn(MON863maize),avarietydesignedtoexpresstheBtpesticide.AsreportedbyFriendsoftheEarth,thereviewersfromEUmemberstatesraised“alargenumberofconcernsaboutthequalityoftheassessment,”andsomeofthestrongestrelatedtoafeedingstudyonrats.67TheywereespeciallyconcernedaboutthesignificantdifferenceinwhitebloodcellcountsforratsfedtheGEcorncomparedtotheanimalsthatatethenon-GEvariety.ButtheEFSAdismissedthedifferencesasnot“biologicallymeaningful.”Theagencyalsodismissedeveryotherconcern,includingthoseaboutdifferencesinadditionalbloodcellparameters,kidneyweights,andkidneystructure.68Buttheotherexpertswerenotsodismissive.Forinstance,theFrenchCommissionforGeneticEngineeringdeterminedthatthedatafellshortofdemonstratinganabsenceofharm;andtheDirectorofaFrenchnationalresearchbodydeclared:

“...whatstruckmeinthisfileisthenumberofanomalies.Therearetoomanyelementsherewheresignificantvariationsareobserved.Ineversawthatinanotherfile.” 69

Manyotherreviewersweresimilarlystruckbythevariations,andataregulatorycommitteemeetinginSeptember2004,onlyafewcountriessupportedtheYieldGard

®

corn.(FriendsoftheEarthwasinformeditwasfouroutof25.)Accordingly,theEuropeanCommissionaskedtheEFSAtoconsideranewevaluationsubmittedbytheGermannationalauthoritiesthatadvisedanadditionalfeedingtestbetterdesignedtodetectwhetheranyoftheunintendedeffectswerelinkedtounintendedalterationsinthecorn.ButtheEFSAcounteredthatthiswouldonlybe“worthwhile”inacasewith“indicationsoftheoccurrenceofunintendedeffects”andthattherewerenosuchindicationsinregardtothiscorn.Soitreaffirmeditsoriginalconclusionthattheproductissafe–whichconfirmsthatwhentheagencyisassessingaGEcrop,eventhepresenceofanunusualnumberofsignificantvariationsbetweentheexperimentalandcontrolgroupsofratsisstillnotconsideredindicativeofunintendedeffects.70

TheconcernsthattheEFSAdismissedweresubsequentlyproventohavebeenwell-justifiedwhenateamofindependentexpertsobtainedtherawdatafromthe90-dayfeedingstudyMonsantohadconductedandsubjectedittothekindofrigorousanalysisthatthisregulatorybodyshouldhaveperformeditself.Thethreemembersofthatteamwerealsopartofthefive-membergroupthatlaterperformedthetellingreviewofthe19feedingstudies;andthisparticularMonsantostudywasalsoincludedinthatset.Further,itwasoneofthestudiesforwhichtheresearcherscouldnotobtainsufficientdatawithoutfirstobtainingacourtordertocompelitsreleasefromtheregulators.Andthisclosely-guardeddatawasilluminating.Whenthescientistspublishedtheresultsoftheirre-analysisintheArchivesofEnvironmentalContaminationandToxicology,theyreportedseveraldifferencesbetweentheratsthatatetheGEcornandtheconventionallyfedcontrols,includingchemicalchangesthat“revealsignsofhepatorenal[liverandkidney]toxicity.” 71IftheEFSAhadbeenmoreintentonregulationratherthanpromotion,suchdifferenceswouldhaveinitiallybeendetectedandfullyacknowledged–andpreventedtheproductfrombeingapproved.

Throughitsprolongedpromotionalefforts(andconcomitantdereliction),theEuropeanFoodSafetyAuthority’sactualauthorityhasbeensodegradedthateventheEuropeanCommissionlosttrustinit–whileconcurrentlygainingawarenessthattherearegoodgroundsforgreatercaution.ThiswasdisclosedwhenFriendsoftheEarthobtaineddocumentstheEChadsubmittedtotheWorldTradeOrganization(WTO)inresponsetochargesbytheUnitedStatesthatitsrestrictionsonGEfoodconstituteanillegitimaterestraintontrade.Indefendingtheneedforitsmodest(andinadequate)foodsafetyregulationsagainstanationthatarguedtherewasnoscientificjustificationforthem,theECassertedthattherearereasonablescientificconcernsaboutthesafetyofGEfoods,thattheresearchconductedbythebiotechindustrytendstobeoflowquality,andthatindustry’sapplicationsforproductapprovalsarefrequentlyflawed.Moreover,besidescriticizingthesubmissionsofindustry,thecommissioncriticizedthesafetyassessmentsoftheEFSA.72

However,becausethecommissionisalsomotivatedtopromotetheseproducts(thoughperhapslessstronglythanistheEFSA),itspublicstatementshaveimpartedanoppositeimpression.AccordingtotheFriendsoftheEarth,theEChasconsistentlyassuredthepublicthattheGEfoodsithasapprovedare“completelysafe;”andithas“continuallyusedEFSAopinionstojustifyitsdecisions”–oneofwhichgrantedapprovalforMonsanto’shotlydebated(andhighlydubious)YieldGard

®

corntoentertheEUfoodsupply.73

Throughsuchduplicity,thecommissionhasdupedalotofpeople–andhelpedsustainaregulatoryregimethat’soverdueforanoverhaul.

Thus,inaddressingtherisksposedbygeneticengineering,therehasbeenregulatoryirresponsibilityonaglobalscale.Further,asweshallsee,thederelictionhasnotbeenconfinedtoagenciesentrustedwiththepreservationoffoodsafety.Ithasalsoinfectedthosethataresupposedtoprotecttheenvironment.And,onceagain,manyofthemostegregiousoffenseshaveoccurredintheUnitedStates.

CHAPTERSEVEN

EROSIONOFENVIRONMENTALPROTECTION

MultipleRisks,MinimalCaution

ThetwoUSfederalagenciesresponsibleforprotectingtheenvironmentfromhazardsofbioengineeredorganisms,theEnvironmentalProtectionAgency(EPA)andtheDepartmentofAgriculture(USDA),havenotlaggedfarbehindtheFDAinsubordinatingthestandardsofscienceandthedemandsofthelawtotheinterestsofthebiotechindustry.AlthoughPhilRegal’seffortsduringthe1980’shadhaltedthereleaseofseveralhigh-riskorganisms,theoverallbehavioroftheEPAandUSDAhasnotbeenencouraging.WhiletheagenciesdidimplementsomeguidelinesinresponsetoenvironmentalconcernsthathadbeenraisedbyRegalandotherscientists,theytendedtobeminimal.Theydemandedlittleinthewayofgenuinebiosafetyanalysis,andtheyprovidedscantprotection.

TheUSgovernmentdidnotevenundertakeafullenvironmentalimpactstudyofaGMO(undertheguidelinesoftheNationalEnvironmentalProtectionAct)until2005.ThelevelofregulationissolaxthatpermitsforperformingfieldtestsonGEcropsareusuallyissuedwithoutaskingthemanufacturertodoanythingmorethanprovidingnoticeofintenttodosuchatest.Andoversightrarelyapproachesrigorthereafter.

MishandlingaHazard:TheAlarmingCaseofK.PlanticolaThedepthofthesystem’sdeficiencyisrevealedbyitsobtusehandlingofageneticallyengineeredsoilbacteriumthatturnedouttobefarlessinnocuousthanexpected.ThealteredbacteriumwasdevelopedbyaGermancorporation;andin1994,preparationswereunderwayforitsrelease.Hopeswerehigh,becauseithadbeendesignedtoincreaseethanolproductionwithinfermentorsthatprocessagriculturalwaste.Thissystemwouldproduceatwo-foldbenefit.Besidesconvertingfieldwasteintoanautomobilefuelthat’scleanerburningthangasoline,theprocesswouldyieldanutrient-richsludgethatcouldbespreadonthesoilasafertilizer.

However,theengineeredorganismsalsohadsignificantdownsidepotential.Theywerederivedfromaparticularstrainofasoil-dwellingbacteriumnamedKlebsiellaplanticola.AndK.planticoladonotonlycongregateonplantmatterthat’sdeadanddecaying,theyalsoinhabitplantsthatarealive.Further,theirresidenceistherootsystem,towhichtheyadherebyexudingastickylayerofslime.Moreover,althoughtheirpresenceontheplantisstrictlylocalized,theirgeographicaldispersionisglobal.They’veattachedthemselvestoplantrootstheworldoverandthereisnotasingletypeofplanttestedfortheminwhichtheyhavenotbeenfound.1

Consequently,becauseviableK.planticolawouldbepresentinthesludgespreadonthefields,itwouldhavebeenprudenttocarefullyassesstheeffectsoftheseengineeredorganismsonplantsthatarelivingaswellasthosethatarealreadydead.Thisisespeciallysoinlightofresearchthatindicatedbioengineeredmicroorganismscandisturbmicrobialpopulationsinnaturalenvironments,insomecasesinducinglossofafungusthat’sanormalcomponentofthesoil.2Further,scientistshadobservedthatevenalowlevelofethanolcannegativelyaffectsomebiologicalsystems.3ButthetestsbeingconductedonK.planticolawerenotrigorousenoughtoprovideanadequateassessment,eventhoughmostwereoccurringattheOregonlaboratoriesoftheEPA.

Fortunately,afewsoilscientistsatOregonStateUniversityrecognizedthatabioengineeredbacterial

strainwiththepotentialtocontinuallyeffuseethylalcoholamidtherootsofplantsshouldbemorethoroughlystudiedbeforeitwasallowedtoproliferateinnature.Sotheydesignedanexperimenttodoso.TheyputwheatseedlingsintojarsfilledwithidenticalsamplesofsoilandthenaddedtheengineeredvarietyofK.planticolatosomeofthejarsandthestrainfromwhichtheyhadbeenderivedtoanequalnumberofothers.

Alltheplantsgrewwellforthefirstweek.Butthen,everyplantinthesoilcontainingtheengineeredbacteriawiltedanddied.Incontrast,alltheplantsgrowingamidthenormalversionofthebacteriumremainedhealthy.Theresearchdesignwashealthytoo,andtheensuingreportwaseventuallypublishedinaprofessionalscientificjournal.4

Thedataindicatedthattheengineeredbacteriaalteredthepopulationofsoilmicroorganismsinawaythatcouldhaveaffectedthenutrientcyclingprocesseswheatplantsrelyon.Further,becausetheevidencealsoindicatedthattheengineeredbacteriapersistedinthesoilaswellasdidtheunalteredstrain,itraisedthepossibilitythatifreleased,theycouldhavebecomeestablishedinthefields.5Moreover,iftheywereabletosurviveinavarietyofenvironments,giventherapidratesatwhichbacteriamultiplyandmigrate,theycouldhavebeenvirtuallyimpossibletocontrol.

Accordingly,severalexpertsbelievethattheseengineeredmicrobesposedamajorrisk.ElaineIngham,who,asanOregonStateprofessor,participatedintheresearchthatdiscoveredtheirlethaleffects,pointsoutthatbecauseK.planticolaareintherootsystemofallterrestrialplants,it’sjustifiedtothinkthatthecommercialreleaseoftheengineeredstrainwouldhaveendangeredplantsonabroadscale–and,inthemostextremeoutcome,couldhavedestroyedallplantlifeonanentirecontinent,orevenontheentireearth.Thisinturnwouldhavewipedoutanimallife,includinghumankind.Whereasbacteriallifeandsomehigherspeciescouldhavecontinued,thebiosphereasweknowitwouldhavebeendrasticallydepleted.6AnotherscientistwhothinksthatacolossalthreatwascreatedistherenownedCanadiangeneticistandecologistDavidSuzuki.Asheputsit:“ThegeneticallyengineeredKlebsiellacouldhaveendedallplantlifeonthiscontinent.Theimplicationsofthissinglecasearenothingshortofterrifying.” 7

However,otherscientiststhinkthere’sscantlikelihoodthatsuchadevastatingoutcomecouldhaveoccurred.Theynotethattheexperimentonlyemployedoneparticulartypeofsandysoilandthatthere’snoevidencetheengineeredbacteriacouldhaveinducedsimilaraffectsinothersoiltypes.Theyfurtherarguethatit’sunlikelythebacteriacouldhavebecomebroadlyestablishedthroughoutawiderangeofvaryingecosystems.

Unfortunately,there’snotenoughdatatodefinitivelyresolvetheseissues.It’snotevenclearwhethertheethanolwasafactorinharmingtheplantsorwhethertheywerefelledbyanunintendedeffectofthebioengineeringprocess–inducedbyanunplannedperturbationofthebacterium’snormalmodeoffunction.

ButitisclearthattheengineeredKlebsiellacausedtheplantsinthatparticularexperimentalset-uptodie–andthatmoreresearchshouldhavebeenconductedtoascertainexactlyhowithadhappened,andwhetheritwouldhappenagainindifferentsoiltypes.PhilRegalemphasizesthatthestudy“raisedaredflag”andthatitineffect“demandedfurtherdetailedresearch.”Hesaysthatwithoutmoreevidence,“therewasnowayofknowinghowtheengineeredbacteriamightbehaveinthefield.”

Hecontinues:

TheEPAhadpartlyfundedtheresearchconductedbytheOregonStatescientists,andIthoughttheagencyshouldsponsormorestudiestofindoutexactlywhatwashappeningsothatwewouldbuildourknowledgebaseandprovideafirmerfoundationforassessingsubsequentengineeredorganisms.Thatwouldhavebeentheproperthingtodoinscience.Butinstead,someoneupthe

EPAladder,orpossiblyintheWhiteHouse,cutthefundingaltogether.Apparently,thoseempoweredtosettheagendadidnotwantmorelightshedonthisissueand

werehopingitwouldquicklysubside.Itseemsthattheyeveninstructedtheirsubordinatestostoptalkingaboutit,becausethemiddle-levelagencypeoplewithwhomIhadbeencommunicatingabruptlyinformedme,withshakyandapologeticvoices,thattheycouldnotdiscussthematteranyfurther–eventhoughIhadknownthemforyearsandhadbeenontheEPA’sScienceAdvisoryBoard.

Thegeneticengineershadenormouspoliticalclout,andthoseatmiddlelevelswereafraidtosticktheirnecksout.

Moreover,notonlydidtheEPAshutdownfurtherresearchinvolvingtheengineeredKlebsiella,itinitiallyresistedthecriticalevidenceandtookanadversarialattitudetowardthescientistswhobroughtitout–despitethefactithadfundedtheirresearch.ElaineInghamreports:“Whenthedatafirststartedcomingin,theEPAchargedthatwecouldn’thaveperformedtheresearchcorrectly.Theywentthrougheverythingwithafinetoothcombandtheycouldn’tfindanythingwrongwiththeexperimentaldesign–buttheytriedashardastheycould.Atthattime,someEPAresearchersdidnotunderstand‘ecologically-based’testingsystemsdesignedtolookatthemicrobialinteractionsandnutrientcyclingprocessesthatwouldoccurifKlebsiellaplanticolawerereleasedintotheenvironment.Thefactisthattheregulatorysystemasitstandstodayistotallyinadequatetocatchthesekindsofunexpectedeffects.Ifwehadn’tdonethisresearch,theKlebsiellawouldhavepassedtheapprovalprocessforcommercialrelease.” 8Anditseemsthattherevelationcamejustinthenickoftime.InIngham’sunderstanding,theimpendingreleasewas“mereweeksaway”whenthedatawaspresentedtotheEPA.9

BesidestheKlebsiellaincident,Inghamhadadditionalfirst-handexperienceonwhichtobaseherjudgmentaboutregulatoryinadequacy.Assheexplains:“I’veworkedwithfolksintheEnvironmentalProtectionAgencyandIknowtheteststheEPAperformsonorganisms.Theyoftenbegintheirtestswith‘sterilesoil.’Butifit’ssterile,thenit’snotreallysoil.Soilimplieslivingorganismspresent.Ifyouuse‘sterilesoil’andaddageneticallyengineeredorganismtothatsterilematerial,areyoulikelytoseetheeffectsofthatorganismonthewaynutrientsarecycled,orontheotherorganismsinthatsystem?No,you’renotlikelyto.Soit’sprobablynosurprisethatnoecologicaleffectsarefoundwhentheytestgeneticallyengineeredorganismsinsterilesoil.Theyreallyneedtoputtogethertestingsystemswhichassesstheeffectsofthetestorganismonalloftheorganismspresentinsoil.” 10Sheemphasizestheimportanceofsuchanapproachbecauserealsoilisdenselypackedwithdiverseformsofmicroscopiclife,mostofwhichplayanimportantroleinfosteringfavorableconditionsforplantstoflourish.

However,despitethedeficienciesoftheirexperimentalsystem,theregulatorsseemedsetonstickingwithitastenaciouslyasKlebsiellaclingtoplantroots.11TheynotonlyappearedunconcernedbyitsinabilitytodetectthefulleffectsofGMOs,butundeterredbytheproblemsthathadcometolight.Forthem,promotionratherthanprecautionwouldremainthepriority.Further,thoughunperturbedbytheprospectthatsomeGMOscouldbehighlyharmful,theywereupsetbyinvestigatorswhorevealedactualdangers–not(itseems)fromconcernaboutthedamagethatmightbefallthebiospherebutfromirritationovertheinjuredimageofGMOs.Andthisprovocationcoloredtheirbehaviortowardthoseresearchers.

Thus,despitethefactthatInghamandhercolleagueshadperformedahighlyvaluableservice–andmayhaveavertedamassivecatastrophe–ratherthanhonoringheraccomplishment,theEPAapparentlytriedtopunishherforit.AlthoughshehadregularlyreceivedsignificantfundingfromtheEPApriortoherworkonKlebsiella,thesituationsuddenlychanged.Aftersubmittingseveralresearchproposalsthatwereconsistentlyrejected,shefinallygaveupanddecidedtostopwastinghertime.12

Beforemovingon,it’simportanttoaddressthebottomlinequestion:Eventhoughwelackdetailed

dataaboutmanyaspectsoftheengineeredKlebsiella,canwejustlyconcludethattheyposedameaningfulrisk?Toanswerit,weneedtobeclearaboutwhatriskis.Aswe’llexaminemorethoroughlyinChapter9,riskistechnicallydefinedastheproductofthemultiplicationoftwoquantities:(1)theprobabilitythatapotentialproblemcouldactuallyresultinharmand(2)theamountoftheharmthatwouldresult.Thus,iftheprobabilityofharmishighbuttheharmthatwouldbecausedisminiscule,thentheriskislow.Conversely,evenwhenthelikelihoodofharmislow,iftheresultantdamagewouldbecolossal,thentheriskissignificant.Therefore,eveniftheworst-casescenariosenvisionedbyDrs.InghamandSuzukiwereextremelyunlikely,becausethey’recatastrophesofincalculableproportions,theriskshouldbedeemedsignificant.

AnImbalancedSystem:PromotionTopsPreventionAlthoughtheriskposedbytheengineeredKlebsiellawasfarfromtrivial,theregulatoryresponsewasalltootypical;andtheincidentissymptomaticoftheillsofthesystem,illsstemmingfromarigidpoliticalagendatopromotebioengineering.OneofthemoredramaticdisplaysoftheardorwithwhichthisagendaisadvancedwaspromptedbyaspeechPhilipRegaldeliveredataconferenceonGMOsheldinWashington,D.C.onJanuary31,1989.Theeventwasco-sponsoredbytheNationalWildlifeFederationandtheCorporateConservationCouncilandwaswell-attendedbyrepresentativesfrombothindustryandgovernment.Bythatdate,Regalhadseenmorethanenoughevidencetoconvincehimthatthegovernment’spromotionalbiaswashinderingtheimplementationofrationalregulation.Sohedecidedtoshakethingsupbyboldlycallingattentiontotheproblem.Attheendofhisspeech,heforthrightlydescribedtherealitiesashesawthemandemphasizedhowtheEPAwas“bendingoverbackward”toaccommodatethewishesofthebiotechindustry.

Afterhehadfinished,andastheensuingbreakbegan,oneofthetopEPAofficials,accompaniedbyhisassistant,advancedtowardhiminwhatappearedtobeastateofexcitation.Bracinghimselfforascorchingglareandaharshharangue,hewasastonishedtoinsteadencountereyesbeamingwithpleasureandavoiceeruptinginpraise.ThemantoldRegalthatheandhiscolleagueshadbeenlaboringtoconvincetheindustrythattheEPAwasontheirsideandwouldaccedetotheirplans,andhecommendedhimforsoclearlymakingthiscase.AsRegal’ssurprisesubsided,herealizedthatbyreceivinghiscritiqueasacompliment,theofficialnotonlyconfirmeditsvaliditybutrevealedthattheagency’sintegrityhaddegradedevenfartherthanhehadthought.

Thepromotionalprejudiceofthegovernmentagencies,andthedeficienciesitbreeds,haveremainedconstantfeaturesoftheUSregulatoryregimefromtheadventofgeneticengineeringtothepresentday.DefectswereapparenttoRegalin1983,andseriousdefectswerestillreadilydiscerniblebythegovernment’sGeneralAccountingOfficein1988whenitreviewedhowtheUSDA,theEPA,theFDA,andtheNIHweredealingwithGMOs–andfaultedallofthemformakingsafetydeterminationswithoutanadequatescientificbasis.13Moreover,despitecontinualpronouncementsfromgovernmentofficialsthatgeneticengineeringisbeingcarefullyregulated,thesituationhasnotimproved.

ByJanuary2000,thesystemhadbecomesobiasedtowardpromotingthistechnology,andsoaversetoestablishingsensiblesafeguards,thePublicEmployeesforEnvironmentalResponsibility(PEER)felttheneedtore-releaseareportthatitdescribedas“adevastatingcritiqueoftheriskassessmentsemployedbytheUnitedStatespriortothewidespread,commercialreleaseofgeneticallymodifiedorganisms(GMOs)intotheenvironment.” 14Thereport,titled“GeneticGenie,”hadfirstbeenissuedinSeptember1995inanattempttodetertheEPAfromapprovingthereleaseofanengineeredbacterium(RhizobiummelilotiRMBPC-2)thatnumerousagencyscientistsregardedasposingunreasonableriskstobothhumanandenvironmentalhealth.ItwaswrittenbyseveraloftheseEPAexpertsandreviewedbyfacultymembersofmajoruniversities.BecausetheEPAhadsooftenbeenfoundinviolationofwhistleblowerprotectionstatutes,theauthorshadtoremainanonymoustoavoidretaliationbytheir

supervisors.TheirreportchargedthatbesidesthefacttheEPA’sriskassessmentwasseriouslydeficient,theassessmentofbenefitwasalsofatallyflawed.Althoughtheorganismhadbeendesignedtoincreasenitrogenfixationinalfalfaandtherebyboostyields,thedataindicatedthatyieldsmightnotsignificantlyimprove.However,theEPAignoredtheevidencethatthefarmersbuyingthebacteriamightreceivenobenefitandinsteadonlytookintoaccounttheprojectedeconomicbenefitthecorporationwouldgainfromsalestothefarmers.Anditdecidedthatthisbenefitwassufficienttooutweightherisks–which,accordingtothePEERreport,weredrasticallydownplayed.

Liketheinternalexpertswhowrotethecritique,theEPA’soutsideadvisorypanelreadilyrecognizedtheweaknessesoftheagency’swork;andfiveofthesixmembersrefusedtoendorseitsproposedapprovalofthebacterium.15Whentheagencyindicatedthatitplannedtoproceedwiththeapprovalanyway,onememberresignedinprotest.16TheEPAapprovedthebacteriumforcommercialreleasein1997and,accordingtooneoftheagency’sownrisk-assessmentexperts,asofJuly2001ithadnotperformedanyfollowupstudiestodetectadverseimpacts–oreventodetermineifcropyieldshadactuallyincreased.17

PEERre-releaseditsreportin2000becauseitdecidedthesituationhadnotimproved.Itsaccompanyingstatementdeclares:“ThepassageoftimehasnotdiminishedtheaccuracyortheurgencyofthescientificcritiquecontainedinGeneticGenie.Thesamecommerce-drivendynamicsdescribedinGeneticGenieareoccurringtodayasAmericanregulatoryagenciesstrugglewithoverwhelminguncertaintieswhileassuringanincreasinglyskepticalworldthateverythingissafe.” 18

Unfortunately,thebehavioroftheDepartmentofAgriculturehasbeenjustasdismalastheEPA’s.ItshandlingofbiotechnologyhasstayedsoshoddythatinDecember2005,twenty-oneyearsafterRegalorganizedthefirstmajorscientificworkshopontheecologicalrisksofGMOsattherenownedColdSpringHarborLaboratories,nineteenyearsafterthefirstpermitwasissuedforreleasingoneintotheenvironment,andaftermorethan10,000fieldtrialshadbeenauthorized,theagency’sinspectorgeneralissuedwhattheNewYorkTimestermeda“stinging” 19reportrebukingitforfailuretoproperlyoverseesuchtrials.ThedocumentdeclaredthattheUSDA“lacksbasicinformation”onwherethetestsareorwhat’sdonewiththecropsaftertheyareharvested,anditpointedoutthatagencyregulatorshavetoofrequentlyeitherfailedtonoticeviolationsoftherulesorcommittedviolationsthemselves.Itcharged:“Current(USDA)regulations,policiesandproceduresdonotgofarenoughtoensurethesafeintroductionofagriculturalbiotechnology.” 20

Thischronicregulatoryinfirmity,coupledwithrecurrentcorporatecarelessness,hasresultedinastringofseriousaccidents.Forinstance,althoughavarietyofGElonggrainricedevelopedbyBayernevergainedapprovalforcommercialplanting,itwaswidelyfoundintheUSricecrop.ThislargescalecontaminationoccurreddespitethefacttheengineeredricewasonlyfieldtestedinLouisiana–andonlybetween1999and2001.Moreover,thecontaminationwentonforfiveyearsbeforeitwasdiscovered.21

Further,theerrantricewasnottheonlyGEcropmismanagedduring2001.Inthatyear,problemsaroseatanIowatestfieldwhenthemanufacturerofanexperimentalvarietyofcornengineeredtoproducepharmaceuticalmedicinesfailedtotakeadequatemeasurestopreventthegene-alteredpollenfromridingthewindandtransformingthecornonsurroundingfarms–necessitatingthedestructionof155acresofproduce.22AndacrosstheMissouriRiverinNebraska,anothertestplotofthatpharmaceuticalcropalsocausedproblemswhensomecornaccidentallycommingledwithsoybeans,ultimatelyadulterating500,000bushels.23

Moreover,amongnumerousotherincidentsofcontamination,pollenfromanunapprovedvarietyofGEherbicide-resistantbentgrassescapedanOregontestplotandalteredothervarietiesofgrass.Thisescapewentunreportedforseveralyears,andsomeexpertssuspectthatbynowthere’sbeensubstantialcontaminationofthecommercialgrassseedsupply,70percentofwhichiscultivatedinOregon.24The

EPAhasdiscoveredseveralotherinstancesinwhichpollenfromherbicideresistantGEbentgrassescapedfieldtrialsandtransferreditsreconfiguredgenestonativegrassesseveralmilesaway–includingacasewhereanationalgrasslandwascontaminated.25

KeepingScore:HowtheMainGECropsareNotHelpingtheEnvironmentbutHarmingItProponentsofGEcropshaveroutinelyclaimedthatthetwotypesmostprevalentlygrown(thosethatproducetheirownpesticideandthosethatareresistanttooneormorecommercialherbicides)are,onthewhole,beneficialfortheenvironment.Butextensiveevidencerefutesthisclaim–andrevealsthattheneteffectofthesecropsontheenvironmentisharmful.

TheHazardsofPesticide-ProducingPlants

BiotechadvocateshaveboastedthatGEcropswouldreducepesticideusebecausealargepercentagewouldbedesignedtoproducetheirowninsect-repellingpesticides.Todate,suchinsect-killingcropshaveallbeenengineeredtoexpressapesticidethat’smadebyacommonsoilbacterium.Thepesticideiscalled“Bt;”andinitsnaturalform,ithaslongbeenusedasaspraytocontrolinsects.Becauseitisgenerallysafeformammalsandnon-targetorganisms,includingbeneficialinsects,ithasevenbeenapprovedforuseinorganicagriculture.

However,whenacopyofagenethatsynthesizesBtpesticidalproteinisengineeredintocornorcotton(thetwobasiccommercializedBtcrops),theresultsdon’treplicatethenaturalsituation.Foronething,theplant-generatedproteinsdonotalwayshavethesamestructureasthenaturalones,andtheireffectsaredifferent.26NaturalBtproteinbreaksdownrapidlyindaylightanddoesnotaccumulateinsoilorwaterways.Incontrast,becauseeverycellofaBtcropexpressestheBttoxininactiveform,therootscontinuallyexudethetoxicproteinsintothesoil.Further,whenresiduesofBtcornareploughedunderatharvest,theBtintheirtissuesdoesn’treadilybreakdownandpersistsinthesoilformonths.27Thishasnegativeeffects.Researchershavefoundthatmycorrhizalfungi(whichcolonizetherootsofplantsandhelpthemtoabsorbnutrients,resistdisease,andtoleratedrought)arelessabundantintherootsofcornengineeredtoexpressBtthanoncornthatisnot.28Scientistshavealsodiscoveredreducedconcentrationsofanotherbeneficialfungus(Arbuscularmycorrhizalfungi)intherootsofBtcorn.29

Further,unlikenaturalBtproteins,thoseproducedinengineeredplantshaveharmfulimpactsonwaterwaysandaquaticlife.Onestudy(conductedinIndiana)foundthatcorn-generatedBtproteinswerepolluting25%ofthestreamsthatweretested.30AnotherstudydeterminedthatthebiomassofBtcornistoxictoaquaticorganisms.31AndwhenBtcornwasfedtowaterfleas(anorganismoftenusedasanindicatorofenvironmentaltoxicity),toxiceffectswereobserved,includingreducedfitness,highermortality,andimpairedreproduction.32

Moreover,researchershavefoundthatBtcropsexerttoxiceffectsonnon-targetinsectpopulationssuchasbutterfliesandthattheymayevenimpairtheabilityofbeestofindnectarsources.33Additionally,theevidenceindicatesthattheyharmbeneficialinsectsthatpreyonplantpests.34

Btcropsposeotherthreatsaswell.OneofthebiggestisthattheymightultimatelyunderminetheeffectivenessofBtitself.ThiscouldhappenthroughthedevelopmentofwidespreadresistancetoBtwithinthetargetpestpopulations.

Justasoveruseofantibioticshasgivenrisetodrug-resistantsupergerms,soexcessiveuseofBttoxincouldleadtoBt-resistantinsectpests.However,untiltheadventofgeneticengineering,therewasneverathreatofsuchanoverload.Initsnaturalform,Btisnotextensivelyemployedinlarge-scaleagriculturebecauseitsrapidbreakdownnecessitatesintensivemanagement(includingprecisetiminginapplication)thatisill-suitedtomostindustrializedfarms.35AndalthoughBthasbeenutilizedonmanyorganicfarms

(andonfarmsemployingintegratedpestmanagement,asystemthatuseslesssyntheticpesticidesthanthetypicalindustrialoperation),ithasbeenappliedsparingly,providingnopressureforresistantinsectstodevelop.ButthewidespreadplantingofBt-endowedcropshascausedinsectstobecontinuallyexposedtothetoxin.Accordingly,thosethatpossessamutationconferringresistancetoitgainabigcompetitiveadvantageovertheirvulnerablespeciesmates;and,overtime,theybecomethedominantpopulation.

ThedevelopmentofBt-resistantpestsisnotjustahypotheticalpossibility.Forinstance,ittookonlysixyearsforthewesterncornrootwormtoevolveresistancetotheBtcornthatwasspecificallydesignedtocurtailit.36AndpopulationsofBt-resistantrootwormshavebeenobservedinIowaandIllinois.37Assuchresistantstrainsproliferate,farmersmustresorttopesticidestocontrolthem.

Further,evenwhentheBtcropsinitiallyknockoutmostofthepestsagainstwhichtheywereintended,otherpestsoftenoccupytheresultinggapintheecosystem.38BecausethesetroublesomespeciesarenotinherentlyvulnerabletoBt,theyalsoinducetheapplicationofpesticides.

Consequently,althoughBtcropshavesofaraccountedforareductioninpesticideuse,thedrophasbeenfarlesssubstantialthananticipated.Moreover,thereductioncanbeexpectedtosteadilyshrinkasBt-resistantpestscontinuetopropagate–andaspeststhatsuccumbtoBtprovideopportunityforimperviouspeststotaketheirplace.Further,ifBtresistancebecomessoprevalentthatnaturalBtspraysarerenderedineffective,itwouldbeamajorblowtoorganicagricultureandtofarmsthatemployintegratedpestmanagement.Asseveralexpertshaveobserved,it’slikelythatnoothernaturallyproducedpesticidecombinestheefficacyofBtwiththesamedegreeofsafety.

HerbicideOverdose

Twomajorkindsofpesticidesarethosethatkillinsects(insecticides)andthosethatpoisonweeds(herbicides).EventhoughBtcropshavetodateenabledadecreaseinuseofinsecticides,overall,GEcropshavecausedanincreaseinpesticideuse.That’sbecausethebulkofcommercializedGEcropsdon’tproduceinsecticidesbuthavebeenengineeredtowithstandherbicides;and84%ofthelandplantedinGEcropscontainstheseherbicide-resistantvarieties.39Consequently,herbicideusehassharplyescalated.EmployingofficialUSDepartmentofAgriculturedata,agronomistCharlesBenbrookfoundthatduringthefirstthirteenyearsoftheircultivationintheUnitedStates(1996to2008),GEcropsinducedanincreaseof383millionpoundsofweed-killingchemicals.40AccordingtoDr.Benbrook,“Thisdramaticincrease...swampsthedecreaseininsecticideuseattributabletoGEcornandcotton,makingtheoverallchemicalfootprintoftoday’sGEcropsdecidedlynegative....” 41

Further,mostofthisadditionalusagewasduetoaphenomenonaboutwhichecologistshadrepeatedlywarned–andregulatorsandbiotechproponentshadshownscantconcern:theemergenceofherbicide-resistantsuperweeds.Suchweedsdevelopintwoways.Thefirstisthroughherbicideoverdose,withsuperweedsarisingasdoBt-resistantinsects.Althoughthesteadyonslaughtofpoisonkillsmostweeds,mutationseventuallydevelopinafewofthemthatconferresistancetoit.Thoseresistantweedsthenrapidlymultiply,sincetherearevirtuallynoweedsleftwithinthesprayedareastocompetewiththemfornutriment.

Incontrast,thesecondroutedoesnotinvolvemutationbutcross-pollination.Becausecanolacanfertilizesomeofitswildandweedyrelatives,canolapollencontainingthegenesforherbicideresistancecanendowthoseweedswiththeengineeredtrait.

Superweedsdon’temergeimmediately,butoncetheydo,theirspreadaccelerates.IttookaroundfouryearsaftertheinitialplantingsofMonsanto’sRoundupReady

®

(RR)soy(whichresiststheherbicideglyphosate)beforethefirstspeciesofglyphosate-resistantweedsappeared;andtheirpresencewasoriginallyconfinedtothestateofDelaware.Butwithinanother10years,therewere10resistantspeciesin22statesinfestingupto10millionacresintheUSalone.42

Andtheimpacthasbeenenormous.AccordingtothepresidentoftheArkansasAssociationofConservationDistricts,“Itisthesinglelargestthreattoproductionagriculturethatwehaveeverseen.” 43Foronething,thedatademonstratesthatsuperweedsnotonlyemergedduetoexcessiveuseofherbicide,butthattheirsubsequentproliferationhasledtoabundantadditionalspraying.Dr.Benbrookhasdeterminedthatthissuperweed-inducedsprayingis“theprimarycause”oftheincreasedvolumeofherbicideattributedtoGEcrops.44Inotherwords,moreherbicidehasbeendeployedintryingtocontrolthesenovelweedsthanwasdispensedduringtheprolongedprocessthroughwhichtheyweregivenbirthandcausedtowidelyspread.

Moreover,becausesuchweedshavebecomeresistanttoglyphosate,farmershavebeenforcedtouseanoldergenerationofherbicidestodealwiththem–herbicidesthataregenerallyconsideredtobemoreharmfulthanglyphosate.ButoneofthebigsellingpointsofRoundupReadycropswasthattheywouldshiftusefromtheseolderherbicidestothemoreenvironmentallyfriendlyglyphosate.Thus,notonlyhaveGEcropscausedamajorincreaseinherbicideuse,theyhavestimulatedasignificantreturntotheharsherherbicideswhoseusetheyweresupposedtohaveminimized.

Oneoftheseherbicidesis2,4-D.ItwasanactiveingredientinAgentOrange,adefoliantusedextensivelybytheUSmilitaryduringtheVietnamWar.2,4-Disverypotent,anditsvaporcausesdamagetomostbroadleafplants(plantsthatarenotgrasses)atextremelylowlevels.45Twosurveysofstatepesticideregulatorsindicatethatitsdrifthascausedmoreinstancesofcropinjurythanhasanyotherpesticide.46Somespeciesthatareespeciallysensitivetoitincludegrapes,soybeans,sunflower,beans,tomatoes,andcotton.47Further,besidesbeingmoretoxicthanglyphosateingeneral,2,4-Disespeciallybrutalonsuchsensitivespecies:atleast300timesmoretoxicthanglyphosatetotheemergingseedlingsandninetimesmoretoxictotheplants.48

Anotherherbicidethatfarmershavebeenturningtointhebattleagainstsuperweedsisdicamba.Like2,4-D,itpacksamoreharmfulenvironmentalpunchthanglyphosate.Infact,chemicallyspeaking,dicambaisaclosecousinof2,4-D.

Moreover,despitethefactthat2,4-Danddicambaareharsherontheenvironmentthanglyphosate,thelatterishardlybenign.Forinstance,researchershavedemonstratedthatglyphosatecausedbirthdefectsinfrogandchickenembryosatdosesfarlowerthanthoseusedinagriculturalspraying.49ThemalformationsintheembryosweresimilartohumanbirthdefectsobservedinareasofSouthAmericawithheavyplantingofRRsoy.Monsanto’sherbicide“Roundup

®

”(whichhasglyphosateasitsactiveingredient)hasalsobeenfoundtobeapotentendocrinedisruptoratlevelsupto800timeslowerthanresiduelevelsallowedinfoodandfeed.AnditwasobservedtobetoxictohumancellsandalsotodamageDNAatdosesfarbelowthoseusedinagriculture.50

Amongthemanyotherdownsidesofglyphosateisitstendencytostimulatethegrowthofharmfulfungiinthesoil.OneoftheworstisFusarium,afungusthatcauseswiltdiseaseandsuddendeathsyndromeinsoyplants.51Further,Fusariumnotonlyaffectsplants,itgeneratestoxinsthatcanenterthefoodchainandharmhumansandlivestock.52Inpigs,ithasbeenfoundtoimpairreproductionandincreasestillbirths.53

HowIndustryCompoundstheProblems–WhileAmplyProfitingfromThemFacedwiththeemergenceofglyphosate-resistantsuperweeds,andfarmers’increasingneedtoemployherbicidesthataremuchmorepotentthanglyphosatetodealwiththem,thebiotechindustryhasrespondedinapredictable,butregrettable,fashion.Althoughtheproblemswerecausedbygeneticengineering,Monsantoandtheothergiantcorporationshavedecidedtotrytosolvethemthroughadditionalgeneticengineering.Thus,toenablefarmerstoapplystrongerherbicidesmoreprofuselyinawaythatwon’tkilltheircrops,theindustryhasdevelopedanewlineofGEplantsthatareresistanttothosetoxicchemicals.Forinstance,theDowcorporationhascreatedasoybeanthat’sresistantto2,4-D;

and,forgoodmeasure,italsoengineeredthebeantotolerateglyphosateandglufosinate(anherbicidethatcanbeusedagainstplantsthatareglyphosate-resistant).Ithasalsoproducedcornthatcanbedousedwith2,4-Dandseveralotherherbicidesaswell.54Nottobeoutdone,Monsantohasdevelopedasoybeanthat’sresistanttobothdicambaandglyphosate–anddesignedcornandcottonendowedwithtripleherbicideresistance.

Whilethismakessensefromapurelycommercialstandpoint,sincethecorporationsprofithandsomelyfromsellingfarmerspremium-pricedseedsalongwiththeherbicidestowhichthey’reresistant,fromascientificperspective,it’sunwiseandirresponsible.AsBillFreese,asciencepolicyanalystwiththeCenterforFoodSafetyhasnoted,“Increasinglytoxicherbicidecocktailswillbeusedonmultipleherbicide-resistant(HR)crops,spawningweedswithmultipleresistances.ThechemicalarmsracewithweedstriggeredbytheseHRcropsentailsanever-escalatingspiralofpesticideuseandpollution,andattendantadverseimpactsonpublichealthandtheenvironment.” 55

BesidesstackingmoreherbicideresistanttraitsontotheirGEseeds,themanufacturersaresteadilyexpandingthenumberofcropspeciesendowedwithsuchresistance.OneoftherecentadditionsisRoundup-resistantalfalfa.Thiswasamajoreventbecausealfalfaisamajorcrop.It’sthefourth-largestonegrownintheUS,anditranksnumberthreeinvalue.Further,itisprimarilyusedasfeedfordairycowsandbeefcattle;andit’sheavilyreliedonbyorganicdairyoperations.

Butonlyorganicallygrownalfalfacanbeusedinorganicdairyproduction;andbecausealfalfaispollinatedviatheactionoffar-rangingbees,organicalfalfafieldswillbeincreasinglyencroachedbypollenthat’sbeengeneticallyengineered.Andthecontaminatedcropsthatemergewillbeunsuitableforusebyorganicdairyfarmers.

WhenalawsuitwasbroughtinUSfederalcourtin2006tohalttheuseoftheGEalfalfa,thejudgedeterminedthatsignificantcontaminationhadalreadyoccurred,stating:“Suchcontaminationisirreparableenvironmentalharm.Thecontaminationcannotbeundone.” 56Healsoruledthatinapprovingthecrop,theUSDepartmentofAgriculture(USDA)hadviolatedenvironmentallawsbyfailingtoanalyzesuchrisks.Accordingly,hebannedfurtheruseofthecropuntiltheagencyperformedathoroughenvironmentalimpactstatement(EIS)thatwouldincludeanalysisoftheeffectonfarmerstryingtogrowGE-freealfalfa.

InitsEIS,theUSDAadmittedthatcontaminationofconventionalandorganicalfalfacouldoccurandthattheeconomicinterestsofthegrowerscouldbeharmed.Nonetheless,ityieldedtointensepressurefromtheindustryandderegulatedGEalfalfa,anactionthatsupersededthecourt’srulingandpermittedthecroptobeplantedwithoutanyrestrictions.57

Unfortunately,theshort-sightednessdisplayedbytheindustryinaddressingthepredicamentscausedbyherbicideresistantGEcropsalsocharacterizesthewayithasdealtwiththedifficultiesofBtcrops.TheresponsetotheproblemsofBtcornhasbeenespeciallyunenlightened.Becausethesegene-alteredvarietieshavefailedtocontrolalargerangeofpests,manufacturershavealteredtheirseedsinanadditionalway.Theyhavecoatedthemwithpowerfulinsecticides–andtheyhavechosenonesthatarehighlycontroversial.58

Thesepotentchemicalsarecalledneonicotinoids,andtheyareaggressive.Astheplantgrows,theyspreadthroughoutallitstissues,evenenteringthepollenandnectar.Neonicotinoidsdifferfromsprayedinsecticides(asdotheBttoxinsexpressedwithinGEcrops)becausetheyendurewithinthegrowingplantandareeveractive.Accordingly,there’samuchgreaterprobabilitythatpestswillbecomeresistant.There’salsogreaterlikelihoodthatbeneficialinsectswillbeharmed,especiallysinceneonicotinoidsaretoxictoawidevarietyofthem.Further,thetoxiceffectsaresubstantialevenatverylowdosesbecausethechemicalspersistoverlongperiodsinsoilandwater.59Moreover,evidencesuggeststhatneonicotinoidsmayplayaroleinbeedie-offandcolonycollapse.60

ACrucialChoice:ToKeeponHittingtheWall,ortoHitUponaBetterWayForwardInsurveyingtheevidence,it’sclearthatGEcropshavenotdeliveredenvironmentalbenefitsaswaspromisedbuthaveinsteadcreatedseriousproblems.Ratherthanreducingpesticideuse,they’vesubstantiallyelevatedit.Andbyinducingthegrowthofsuperweeds,they’realsoinducingcontinualincreaseinthevolumeofpesticideneeded–aswellasrelianceonchemicalsmoredamagingthantheglyphosatewithwhichtheyweredesignedtobeused.Further,thefailureofBtcropstocontrolpestswithoutapplicationofsyntheticpesticideshascausedthemanufacturerstointensifythetoxicityoftheentireplant.Intheirinitialphase,everycellexpressedtheBttoxininactiveform,whichentailedasubstantialrangeofhazards.Butintheircurrentphase,theplantsareevenmorehazardous,becausebesidescontainingtheBttoxin,everycellnowalsocontainsatoxicneonicotinoid.

Duetotheseunintendedoutcomes,otheranticipatedbenefitshavenotmaterializedeither.Forinstance,herbicideresistantcropsweresupposedtohavegreatlyexpandedtheemploymentof“no-till”practicesthathadbeenontherisefordecades,becausetheabilitytokillsurroundingweedsevenwhilethesoyorothercropwasgrowingwouldpresumablyeliminatetheneedtoinhibittheweedsbyplowingthelandpriortosowing.Inturn,reductioninplowingwassupposedtoreducesoilerosionandtheharmfulrunoffoffertilizerandpesticide.

However,oneresearchstudyindicatesthatevenwhenno-tillpracticeshavebeenadoptedbygrowersofGEsoy,thenetenvironmentalimpactisstillnegative,largelyduetothehighuseofherbicide.61Further,evenassumingthatsomefarmershaveproducednetpositiveimpactsthroughcombiningGEcropswiththeno-tillsystem,theriseofsuperweedsisimpedingtheirabilitytocontinuethepractice.InMay2010theNewYorkTimesreportedthataretreatfromtheno-tillapproachwasoccurringthroughoutAmerica’sEast,Midwest,andSouth;anditcitedthecaseofaTennesseefarmerwhohadadheredtotheno-tillsystemfor15yearsbutwhowasstartingtoplowagaininanefforttocombatsuperweeds.Reflectingonthesituation,thefarmerremarked:“We’rebacktowherewewere20yearsago.” 62

Butthisstatementisonlypartlytrue.Whilemanyfarmershavebeenforcedtore-adoptpracticestheyemployedtwodecadespreviously,thatdoesn’tmeanthattheproblemsofthattimewereasgreatasthoseoftoday.DuetotheeffectsofGEcrops,today’sdilemmasaremuchworse.Twentyyearsago,farmersdidnotfacesuperweedinfestations,andtheywereusingalotlessherbicide.Further,noplantshadpesticidalchemicalsgeneticallyinfusedwithineverycell.Accordingly,thevariousriskscurrentlyposedbysuchplantswerenon-existent;andtherewasnothreatthatBtspraywouldceasetobeaneffectivetoolinorganicfarmingandintegratedpestmanagement.Norwasthereathreatthatorganicdairyfarmingmightnolongerbeviablebecausetrulyorganicalfalfamightnolongerbeavailable.Inevenlessthan20years,agriculturalbioengineeringhasproducedalltheseproblems–andseveralmore.

Thus,throughthewidespreaduseofGEcrops,agriculturehasessentiallyhitawall.Inresponse,thebiotechindustryhasmadethewallmuchthicker–whileencouragingfarmerstokeepdrivingintoit.However,anotherapproachisavailable,onethatoffersanopenandmuchmorepromisingroad.Insuchanapproach,geneticengineeringanditsattendantproblemswouldnolongerbefeaturesoffarming.Andagriculturewouldbesafe,sustainable,andproductive.Wewillexaminethisattractive(andrealistic)alternativeinthebook’sfinalchapter.

Aswe’veseen,althoughsomegeneticallyengineeredorganismshavesignificantlyimperiledtheenvironment,andalthoughtheGEcropscurrentlyinuseimposeenvironmentalimpactsthatarepredominantlynegative,theUSDepartmentofAgricultureandtheEnvironmentalProtectionAgencyhavelargelyignoredtherisksandcontinuedtopromote(andapprove)thesecropsasiftheyentailedno

unusualproblemsatall.AlongwiththeFoodandDrugAdministration’sfraudulentclaimsthatGEfoodshavebeenprovensafetoeat,thepronouncementsandpracticesoftheseagencieshavelefttheAmericanpublicdeeplyconfusedaboutthefacts–andmorecomplacentaboutGEfoodsthancitizensinmostotherindustrializednations.

However,notalltheconfusionandcomplacencycanbeattributedtotheactionsofgovernmentagencies,evenincombinationwiththeextensivedeceptionsofthescientificestablishmentthathavebeendocumentedinpreviouschapters.AsignificantrolehasalsobeenplayedbythemainstreamAmericanmedia.

CHAPTEREIGHT

MalfunctionoftheAmericanMedia

PliantAccomplicesinCover-upandDeception

AsIwalkedtolunchonMay27,1998,Iwaselated.TheAllianceforBio-IntegrityandtheInternationalCenterforTechnologyAssessmenthadjustheldapressconferenceattheNationalPressClubinWashington,D.C.announcingthefilingoftheirlawsuitagainsttheFDA;anditseemedtherewasgoodreasontobebuoyant.Theconferencehadbeenwell-attended,withnumerousprintreportersandcameracrewsfromthemajornationalTVnetworks.IandotherspeakershaddescribedthemanyflawsoftheFDA’spolicyonGEfoodsandemphasizedthat,despiteitspretensionstheagencywasnotregulatingtheseproductsintheslightestdegree.Wehadalsodrivenhomethefactthatamongtheplaintiffswereninewell-credentialedscientists,whoseparticipationrefutedtheFDA’sclaimthatGEfoodsare“GenerallyRecognizedasSafe.”

Consequently,IexpressedgreatoptimismaboutthekindofmediacoverageIwasexpectingtothefriendswhohadattendedtheconferenceandwereaccompanyingmetoarestaurant.Butoneofthemdidn’tsharemyoptimism.ShehadextensiveexperiencewiththepressandduringtheconferencesheheardasoberingstatementfromamemberofthemediathatshefeltIneededtohearaswell.ShehadbeensittingnexttoacorrespondentforoneofthenationalTVnetworks.1HeregularlyprovidedreportsduringthenationalnewsaboutimportantstoriesoriginatingfromWashington,andhiscameracrewwastapingtheconference.Towardtheendofthesession,heturnedtoherandremarked:“Thisisanimportantstory.Itshouldbewidelytold.Butitwon’tbe.I’llfilemyreportthisafternoon,butit’snotgoingtogoanyfurther.Itwon’tmakeitontotheeveningnews,anditwon’tbeonthemorningnewseither.”

WhenIheardthis,Ifoundithardtobelieve.Whywouldsuchanimportantstorynotbebroadcast?Afterall,itwasvitallyrelevanttoallAmericansbecausetheywereregularlyconsumingGEfoodswithouttheirknowledge.Didn’ttheyhavearighttoknowthat,contrarytotheassertionsoftheirproponents,theseproductshavenotbeencarefullytestedandthattheclaimsabouttheirsafetywerebasedexclusivelyondubiousassumptions?Moreover,shouldn’ttheshamaboutgeneralrecognitionofsafetybeexposed?Shouldn’tcitizensbeinformedthat,inreality,therewasnotaconsensusamongexpertsthatGEfoodsaresafe–andthatnineweresoconcernedabouttherisksthattheyweresuingtheFDA?

So,whilemyoptimismwassomewhattempered,Imaintainedabeliefthatalthoughforcesatthatparticularnewsnetworkmightobstructthereportingofourstory,conditionswouldbedifferentattheothers–andthattheyandtherestofthemediawoulddutifullyconveythekeyfactstothepublic.

ButIwaswrong.Despitethepresenceoftheircrewsatthepressconference,noneofthenationaltelevisionnetworksreportedonourlawsuit.NorwasitmentionedintheNewYorkTimes,theWashingtonPost,ortheWallStreetJournal–thenation’sthreemostinfluentialnewspapers.NationalPublicRadiodidn’tevenrefertoit.Further,althoughreportsonthesuitdidcirculatethroughsomenewsservicesandappearinseveralnewspapers,theyfurnishednogroundsforcelebration.Whiletheynotedthatscientistswereincludedamongthevariousplaintiffs,theydidn’trevealthattherewerenineofthem,andtheyfailedtopointoutthattheinvolvementofsomanyexpertsunderminedtheFDA’sclaimaboutgeneralrecognitionofsafety.

Infact,thearticlesdidnotevenreportthebasicmessagethatourscientistswerecommunicating,eventhoughitwasamplyconveyedbyspeakersatthepressconferenceandthesupplementarydocumentswe

provided.Consequently,readershadnoideathattheseexpertshadbrandedtheFDA’spolicyasscientificallyunsound,warnedabouttheunusualpotentialofGEfoodstocauseharmfulunintendedeffects,andcalledforrigoroussafetytesting.Moreover,inblackingoutourscientists’assertions,somedramaticoneshadtobedisregarded.Forinstance,duringthequestionandanswersession,themolecularbiologistLiebeCavalieriwasaskedtocommentonthefactthatmanyeminentscientistsdeclaregeneticengineeringtobesubstantiallythesameastraditionalbreeding.AsnotedinChapter4,hisanswerwasnottimid.Hedenouncedtheirbehavioras“disgraceful”–andtheirclaimasa“sham.” 2Hethenadded,“Andyoucanquotemeonthat.”

Butnoneofthearticlesdid.Instead,theyquotedseveralspuriousassertionsfromproponentsofGEfoodsissuedinresponsetooursuit.OneofthemostoutrageouswasfromStephenZiller,vicepresidentoftheGroceryManufacturersofAmerica,whosemembersproducemostofthenamebrandfoodsandbeveragessoldintheUSInextollingthesafetyofGEfoodsandthesoundnessofFDApolicy,Zillerpaintedtheplaintiffsas“opponentsofprogressandscience-basedresearch.” 3InlightofthefactthattheplaintiffswereactuallysuingtheFDAforignoringscience-basedresearch,andweredemandingthatmoreresearchbeperformed,thisaccusationwasabsurd.Butduetothedeficientreporting,readerscouldnotdiscernitsabsurdity–andmanywereprobablybeingtakeninbyit.Forthesamereason,manymayhavealsobeendeludedbyanotherabsurdassertion,madebyanFDAofficialtotrivializethedifferencesbetweenGEfoodsandconventionalonesthatourcallforlabelingwaslikedemandingthatlabelsbeplacedongrapespickedbynon-unionworkers.4

ALong-Standing,Pro-BioengineeringBiasAsIeventuallylearned,themedia’sbiastowardbioengineeringhasbeenlong-standing.Forinstance,whenresearchersanalyzedmediacoverageofamajorGMO-relatedcontroversyintheearly1980’s,theyfoundsignificantimbalanceinhowriskswerereported.Astheynoted,“withveryfewexceptions,theprimarybearersofriskinformation...formeddichotomousgroups.” 5Eventhoughmanyscientistshadissuedcautions,whenwarningswerecitedbythemedia,theycamefromthemouthsofnon-experts,whilescientistswerealmostalwayspresentedasassurorsofsafety.6

Thisportrayalofdisputesaboutthesafetyofbioengineeringasaconflictbetweenscientificexpertsandnon-expert“critics”hasremainedageneralfeatureofUSmediacoverageofgeneticengineering.Extensivedataindicatesthat,onthewhole,theAmericanmediahavebeenhighlyselectiveinthescientiststheycite–andsoreflectiveofthelifescienceestablishmentthatthey’veonlybeenwillingtoassociateconcernsaboutGMOswithscientistssolongassuchconcernswerevoicedbyprominentmembersofthepro-biotechmainstream.Accordingly,whentheestablishmentstoppedexpressingconcernsandbegantoconsistentlyassertsafety,themediastartedportrayingsuchconcernsasphenomenafoundonlyamongnon-experts,despitethefactthatnumerouswell-credentialedbiologistscontinuedtowarnaboutrisks.7

Thestudycitedaboveisnotananomaly.ResearchhasconsistentlydetectedabiastowardgeneticengineeringinthereportsoftheUSmedia.Forinstance,threeresearchersatCornellUniversityconductedasurveyofmediacoverageofbiotechnologyfrom1970to1996anddeterminedthatithasbeen“overwhelminglypositive.” 8AndastudybyresearchersatTexasA&MUniversityindicatedthatnewspapercoverageofbiotechnologyisheavilydominatedbytheindividualsinuniversitiesandindustrieswhopromoteit.9Eightyearsafterthatstudy,oneoftheresearchersnotedthecontinuingimbalanceincoverage,stating:“Thebottomlineisthatthevoicespromoting(biotechnology)aremoreprominentthanthosethatobject.” 10

Further,itwouldbeamistaketoblamethebulkofthebiasedreportingonthereportersthemselves.Tolargeextent,it’sattributabletotheireditors–andtheexecutiveswhoseteditorialpolicy.PhilRegal

recountsthatwhenheengagedreportersinextensiveconversations,theyoftentoldhimthattheyhad“tobeverycareful”aboutwhattheysubmittedbecausetheireditors“wereverypro-biotech.”Hesurmisesthatthisinpartreflectsthefactthatseveralmediacompanieshavebeenacquiredbymassivecorporationswithsubstantialinterestsinsectorsthatwouldbeadverselyimpactedbynegativenewsaboutbioengineering.Further,asingredientsfromGEcropsbecameincreasinglyintegratedintotheprocessedfoodsonAmericansupermarketshelves,allmediacorporationsdevelopedafinancialstakeinthepublicimageofbiotechnology,eveniftheydidnotownbiotech-relatedbusinesses.That’sbecauseasubstantialportionoftheiradvertisingrevenuecomesfromfoodproducers;andtheUSfoodindustrynotonlypromotesGEproducts,itaimstosquelchreportsthatcouldmartheirreputation.Accordingly,it’snotsurprisingthattheassertionsbytheGroceryManufacturersofAmerica,whosemembersaccountforsomuchofthemedia’sadvertisingincome,havebeenroutinelyquoted,regardlessoftheiraccuracy.

Butmediaeffortstofavorbiotechnologyhavenotbeenlimitedtolinkingsafetyconcernswithignoranceandtoprovidingavenuefortheunchallengedpresentationofpropaganda.Therehasalsobeensystematicsuppressionofcontraryviews.Thispracticewasalreadywell-established,andwell-documented,by2002.Inthatyear,FoodFirst,aninstitutethatfocusesonfoodpolicyreleasedtheresultsofareviewitconductedof11majornewspapers(includingtheNewYorkTimes,theWashingtonPost,andUSAToday)andthreeweeklynewsmagazines(Time,Newsweek,andtheEconomist)betweenSeptember1999andAugust2001.Accordingtotheresearchers,thesepublications“haveallbutshutoutcriticismofgeneticallymodified(GM)foodandcropsfromtheiropinionpages.” 11Theypointedoutthat“anoverwhelmingbiasinfavorofGMfoods”wasrevealednotonlywithintheeditorialpages,butalsoontheop-edpages,aforumusuallyreservedforavarietyofopinions.

Commentingonthesefindings,theinstitute’sco-directorstated:“ItisagreatdisservicetotheAmericanpublicwhenthemediafiltersoutcriticalviewpointsonissuesthatarecentraltoourtimes.Thisisanissuewherethereissignificantdifferenceofopinionamongbothscientistsandthegeneralpublic,andthosedifferencesmustberepresentedinthemediaifthepublicistobeabletoexerciseitsdemocraticrighttomakeinformeddecisionsaboutnewtechnologies.” 12

Moreover,mediamagnateshavenotmerelypromotedtheGEagendabyslantingthecontentthat’sconveyedthroughthevariousoutletstheycontrol.Theyhavesometimeswieldedtheirconsiderableinfluenceinperson.AstrikinginstanceoccurredduringtheSpringof1998,when(aswaslaterreportedbyTheGuardian)therewasaseriesofmeetingsatwhichtheClintonAdministrationput“intensivepressure”ontheUKgovernmenttoopenupBritishandEUmarketstoAmerica’sGEfoods.Attwoofthemeetings,theAmericanteamwasnotlimitedtogovernmentofficialsbutincludedtopexecutivesfromtheprivatesector,includingtheCEOoftheUSinternationalmediacompany,Warner-Lambert(whichisnowTime-Warner).13

CapitulationtoIndustryThreatsEvenwhenthemediahaveendeavoredtoreportunflatteringfactsaboutbioengineering,industrythreatshaveoftendeterredthem.Insomeinstances,theynotonlycowered,butweredownrightcowardly.Moreover,toachievefullappeasement,theircowardicecoupledwithdeviousness.

Aglaringexampleoccurredin1997,whenaFox-ownedTVstationinTampa,Florida(WTVT)becamesointimidatedbyMonsantothatittriedtofraudulentlyalterareportononeofthatcompany’sgeneticallyengineeredproducts:recombinantBovineGrowthHormone.Thisproduct,commonlyreferredtoasrBGH,isadrugdesignedtoboostmilkproductionincows.AlthoughtheFDAallowedrBGHtoentertheUSmarket,mostindustrializednations(includingCanadaandthoseintheEU)havebanneditduetoconcernsthatitcouldcauseharmfulchangestothecompositionofmilk.Oneofthebiggestconcerns,expressedbyseveralscientists,isthatmilkfromrBGH-treatedcowscontainssignificantlyelevatedlevelsofahormonecalled“insulin-likegrowthfactor1”(IGF-1).Researchsuggeststhatpre-

menopausalwomenunderage50withhighlevelsofIGF-1areseventimesmorelikelytodevelopbreastcancer–andthatmenwithhighlevelsarefourtimesmorelikelytodevelopprostatecancer.14

During1996,ahusbandandwifeteamatWTVTbegantoinvestigatetherBGHstory.Theybothhaddistinguishedbackgrounds.JaneAkrewasaformerCNNanchorwomanandreporter.SteveWilsonhadwonthreeEmmyAwardsforexposinghazardousdefectsinChryslerandFordvehicles.WTVThadhiredthemtoaddpunchtoitsreporting.Forthreemonths,theydugintothefactssurroundingrBGH,compilingsufficientinformationforapowerfulfour-partseries.OneofitsstartlingfeatureswasanexcerptfromaCanadiantelevisionprograminwhichagovernmentofficialrecountedhowaMonsantorepresentativebribedhercommitteebyofferingabigsumofmoneyiftheyrecommendedthatrBGHbeapprovedwithnofurtherstudies.15(InpresentingMonsanto’sversionofthestory,aspokesmanstatedthattheofficialshadmisunderstoodthesituationandthattheofferwasmerelytofurnish“research”funds.)

WTVTwasenthusiasticabouttheseries,whichwasduetoaironFebruary24,1997;anditpaidforextensiveradiobroadcastingtopromoteit.Butonthe21st,aMonsantoattorneyfaxedalettertoRogerAiles,theheadofFoxNews,athisNewYorkoffice.Theletterwasdesignedtodampenenthusiasmabouttheseries,anditsucceeded.Itallegedthattheserieswasbiasedandunscientific;anditwarned,“ThereisalotatstakeinwhatisgoingoninFlorida,notonlyforMonsanto,butalsoforFoxNewsanditsowner.” 16InAkreandWilson’sopinion,thiswasthepartoftheletterthatAilesfoundmosttroubling.NotonlywasMonsantoamajornationaladvertiseronFox,itusedtheservicesoftheActmediaadvertisingagency–whichwasownedbyRupertMurdoch,whoalsoownedFox.17Thus,ifMonsantowithdrewitsadvertisingfromFoxandalsoswitchedadagencies,Murdochwouldtakeadoublefinancialhit.

WTVTwasabruptlynotifiedthatitsheraldedserieswaspostponedpending“furtherreview,”despitethefactithadalreadypassedathoroughreviewbyattorneys.Butthestation’sgeneralmanager,aformerinvestigativereporter,wasinnomoodtoretreat.Heandthestation’slawyersscrutinizedtheepisodesanddeterminedthattheywereaccurateandfair.Sohere-scheduledtheseriesforthefollowingweek.

ThispromptedanevenstrongerlettertoAilesfromtheMonsantoattorney.Itthreatenedthatairingthereport“couldleadtoseriousdamagestoMonsantoanddireconsequencesforFoxNews.” 18ThiswastoomuchforFox,andtheserieswasonceagainputonhold.Further,withinashorttime,WTVT’sgeneralmanagerandnewsmanagerwerefired.

Notsurprisingly,thenewgeneralmanagerwasfarlesssympathetictowhatAkreandWilsonweretryingtoaccomplish;and,accordingtoWilson,hewasdeeplyconcernedabouttheadvertisingrevenuesthatwouldbesacrificediftheserieswerebroadcast.BesidesthebiglossesthatFoxwouldincuronanationalscaleifMonsantopulleditsadvertisingfromthecorporation,hecalculatedthatthedairyindustryandmanysupermarketswouldreducetheiradvertisingonWTVT.19

AkreandWilsonreportthatthemanagertriedtofindoutwhattheywoulddoifthestorywaskilled.“Wouldyoutellanyone?”heinquired.“Onlyiftheyask,”repliedWilson.20Thereportersrelatethathesubsequentlyofferedthemasubstantialsumofmoneyiftheywouldleavethestation.Butheimposedanonerouscondition.Theywouldhavetoagreenottopublishanydetailsthey’dlearnedaboutrBGH–ortodisclosehowFoxhaddealtwiththestory.21Shockedandrepelledbythisoffer,thereportersrefusedtogagthemselvesanddenythepublictheimportantinformationtheyhadaccumulated.Instead,theyofferedtorewritetheirdocumentarytomakeitmoreacceptable.

Althoughtheywerepermittedtotry,theirscriptswerescrutinizedbyattorneysatFox’sregionalofficeinAtlanta,whoroutinelyrequiredthatthecontentberenderedmorefavorabletoMonsanto.Amongotherdemands,thereportersweretoldtocuttheinformationthattheFDAhadapprovedrBGHbasedonlyonshort-termtesting,todeleteallmentionofIGF-1,andtorefrainfromusingtheword“cancer.” 22Butaftersixmonthsand73rewrites,theattorneysstillwantedtomodifythelanguagesoastomollify

Monsanto.Moreover,theydidnotmerelyinstructAkreandWilsontoreviseorremovestatements;theyorderedthemtoaddsomefalseonesbyMonsanto’sdairyresearchdirector.TheyevencommandedthemtoincludeanassertionthatmilkfromrBGH-treatedcowswasthesameasmilkfromuntreatedones.AccordingtoaLondonnewspaper,“Monsantoinsistedthatthisstatementbeaired.” 23Andaccordingtothereporters,theywerethreatenedthatthey’dbeterminatedifitwasn’t.

Buttheywouldnotcomplybecausetheyknewthatthestatementwasnottrue.Further,theypointedouttomanagementthatMonsanto’sowndatademonstratedthereweredifferences,includingelevatedlevelsofIGF-1.YetFoxwouldnotriskrunningtheserieswithoutfalsifyingthefacts,soitsuspendedthereportersfor“insubordination,”andultimatelyfiredthem.Then,inanextraordinarystep,ithiredanotherreportertoprepareabroadcastwithMonsanto’sstatementintact.WilsonemphasizestheaberrantnatureofFox’saction:“It’snosecretinjournalismthatstoriesaresometimeskilled.WhatissounusualandegregiousaboutourcaseisthatthisisthefirsttimeIknowofthatanewspaperorbroadcasterhasoptednottokillastorybuttomoldthestoryintoashapethatthepotentiallitigantandadvertiserwouldlike.” 24

AkrethensuedthestationallegingthatherdismissalwasaninfractionofFlorida’swhistle-blowerstatute.Thejuryagreed,anditfoundthatFoxhadfiredherforthreateningtoinformtheFederalCommunicationsCommission(FCC)abouttheattempttofalsifyanewsreport.Italsoawardedher$425,000.25

Foxappealedtheverdict,claimingthatnoinfractionoftheFloridastatutehadoccurred.Itnotedthatthewhistle-blowerprotectiononlycoversemployeeswhotrytoreportviolationofalaw,rule,orregulation;anditarguedthattherewasnoruleorregulationforbiddingabroadcasterfromfalsifyingthenews.AkrecounteredthattheFCC’spolicyagainstintentionaldistortionofthenewsconstitutesarulewithinthestatute’spurview.

TheFloridaappellatecourtsidedwithFox,anditoverturnedtheawardofdamages.ItdeclaredthattheFCCpolicydoesnotqualifyasaruleorregulationunderthestatestatuteandthatAkrewasthereforenotentitledtothewhistle-blowerprotections.26Thus,ineffect,thejudgesheldthatwhileit’sillegalforFloridabroadcasterstoretaliateagainstemployeesforreportingaminorinfractionofthebuildingcode,theyhaveanunbridledrighttofireanyonewhoblowsthewhistleondeliberatefalsificationofthenews.

Self-CensorshipandtheChronicSuppressionofFactsAlthoughitmaybeespeciallyegregiousinregardtoitsparticulars,Fox’sstiflingofreporterstoprotectGEfoodsisnotexceptionalintermsofgeneraleditorialpolicy.ThemagnateswhosteerthemainstreamAmericanmediahaveroutinelysidedwiththepromotersofagriculturalbiotechnologyandhaveconsistentlyimposedrestraintsthatwerenotmerelyselective,butsuppressive.Asaresult,anyeffortsoftheirsubordinatestofairlyinformthepublichavebeensystematicallystymied.Further,whileit’shardtogaugehowmuchsuppressionofnegativenewshasstemmedfromovertindustrythreats,itisclearthateveryactofrestraintwasultimatelyacaseofmediaself-censorship.Eachensuedfromeithercommercialcalculationorideologicalcommitment,notfromgovernmentcompulsion–themaindriverofcensorshipinmostotherpartsoftheworld.

SuchvoluntarymuzzlingonbehalfofGEfoodshasbeenaconstantphenomenonintheUnitedStatesandhassquelchedstoriesthatwouldordinarilyhavebeenjumpedonasjournalisticgoldmines.ItevenblockedtransmissionofthemostmomentousbiotechnewseverhandedtotheAmericanmedia:therevelationthattheFDAfraudulentlyconcealedthewarningsofitsscientificstaffabouttheabnormalrisksofGEfoods.

I’mintimatelyfamiliarwiththiscaseofsuppression,becauseIwastheonewhogavethemediatheincriminatingfacts.InJune1999,atawell-attendedpressconferenceinWashington,D.C.,atwhichseveralexpertsspokeabouttheproblemsofGEfoods,IexposedtheFDA’scover-upandmadecopiesof

keymemosfromitsfilesavailabletothemedia.Despitethedisappointingcoverageofthe1998conferencethathadannouncedthelawsuit,Iwasconfidentthatthingswouldbedifferentthistime.Afterall,theseclear-talking,hard-hittingmemoswerewrittenbyFDAexperts,andtheyrefutedthebasicclaimstheagencyhadbeenmakingaboutGEfoodsforthelastsevenyears.Theyalsoprovedthatithadbeenlying.Therefore,Iassumedthatwithinafewweeks,thepublicwouldbeawakenedtotherisks,theirtrustintheFDAwoulddissolve,andtheirvoiceswouldberaisedinanoverwhelmingdemandforthereformofitspolicyandtheremovalofGEfoodsfromthemarket.

Sodidmanyotherexperiencedobservers.Forinstance,becausewordofmyrevelationsreachedothercountries,IwasquicklycontactedbyareporterinBrusselswhohadbeencoveringbiotechissuesforyears.Afteraskingmetofaxhimcopiesofsomeofthememos,heremarkedthatiftheywereindeedgenuine,withinamonththeentireGEfoodventurewouldbewellonitswaytoextinction.27

ButheandIweremistaken.OurexpectationswerebasedontheassumptionthatthemainstreamAmericanmediawouldcommunicatetheimportantinformationithadbeengiven.However,thisassumptionwastoooptimistic.Eventhoughtheconferencewasattendedbyreportersfromthenation’smajornewspapersandnewsmagazines,noneofthesepublicationsinformedtheirreadersaboutwhattheFDAscientistshadsaid–andhowagencyadministratorshadcoveredupthewarningsandliedaboutthefacts.Andthisblackoutwasnotduetolackofinterestonthepartofthereportersinattendance.

Forinstance,RickWeiss,asciencereporterwithTheWashingtonPost,calledmeshortlyaftertheconferenceandinterviewedmeextensively.HerequestedthatIfaxhimcopiesofthekeymemosandthatIalsotellhimhowtocontactseveralofourscientist-plaintiffs.Ashepreparedhisstory,wespokeseveralmoretimes;andIhadhighhopesthathisreportwouldinitiateamajorbreakthrough.Butwhenthearticlefinallyran,Iwasshocked–anddeeplydisappointed.TherewasnomentionoftheFDAmemos,noquotesfromourscientist-plaintiffs,andnoindicationthatmanyexpertshadseriousconcernsaboutthepotentialtoxicityofGEfoods.28Equallyegregious,althoughthearticlenotedthatalawsuithadbeeninitiatedagainsttheFDAtocompelsafetytesting,ittermedtheplaintiffs“activists,”withnohintthatthegroupincludednineknowledgeablelifescientists.

IwasjustabouttophoneWeissanddemandtoknowwhyhehadfailedtoincludethecriticalinformationhehadgatheredwhenhephonedme.HesaidthatheknewIwasverydisappointed,andhewantedmetounderstandthathewasdisappointedtoo.Asheexplainedwhathadhappened,Ibegantofeelsorryforhim.ThearticlehewrotehadexposedtheFDAfraud,quotedfromthememosofthescientificstaff,andalsoquotedscientistswhowereplaintiffsinourlawsuit.Buthiseditorrefusedtoletitstand–anddemandeddeletionsandrevisions.Weissobjected,buttheeditorwasadamant.So,withtheeditor’sactiveparticipation,substantialexcisionsandrevisionsweremade;andthearticlethatthepublicreadwasfarfromtheoneWeisshadintendedtoproduce.

Further,evenwhenthefirstranksofeditorsandexecutiveshavebeeneagertoreportthecrucialfacts,individualswithgreaterauthorityhavequashedtheirattempts.AstrikingexampleoccurredafewmonthsafterthepressconferencewhenaproduceratCBSnationalnewsphonedmerequestinganinterviewthatwouldberunonanupcomingeveningbroadcast.Hewassointerestedthathewasnotdeterredwhenherecognizedtherewouldbesignificantproblemsinsettingthingsup.BecauseIwastobeinterviewedbyanewscasteratthenationalstudio,theexchangeneededtotakeplaceataCBSaffiliatestationsothatavideolinkcouldbeestablishedenablinghimandmetoseeandhearoneanother.ButtheneareststationtowhereIlivedwasinCedarRapids,Iowa,almost95milesaway.Further,acrewwouldhavetobeflownfromChicagotoCedarRapidstocoordinateeverythingandtotapeme.

WhentheproduceraskedifI’dbewillingtodrivetoCedarRapidstodotheinterview,Iwasfrank.IexplainedthatIhadgrowntiredofspendingtimeandenergytodointerviewsabouttheFDAfraudthatwerenevercommunicatedtothepublic.SoItoldhimthatIwouldonlydrivethe185totalmilesandconsumethebetterpartofadayontheconditionthatquotesfromtheFDAscientistswouldbeaired,

alongwithademonstrationthattheFDAhadlied.Heagreedtothiscondition.However,hepointedoutthatalthoughtheinterviewwouldgoforabout15minutes,itwouldbesubstantiallyediteddownandthatbecausetheentiresegmentabouttheGEfoodcontroversywouldonlybeonairforaroundfiveminutes,withotherintervieweesaswellasme,Icouldnotexpecttobeonscreenforeventhatamountoftime.ItoldhimthatIunderstood;butImadeitclearthatifIdidtheinterview,IplannedtospendalmostallofthetimereadingfromthememosoftheFDAexperts,andIwantedanassurancethatsomeofthatfootagewouldbebroadcast.Heguaranteedthatitwouldbe.SoIagreedtodotheinterview.

WhileIwasintheCedarRapidsstudio,thenewscasterwhoconductedtheinterviewallowedmetoquoteextensivelyfromtheFDAmemosandtomaketheotherpointsIintended.Onlyhislastquestionshiftedthefocus.Heaskedmetonamesomeofthereligiousdenominationsthatwererepresentedinourlawsuit.SoIgaveabriefone-sentenceanswerspecifyingseveralofthem.

Idrovehomeinanupbeatmood.BecauseCBShadinvestedsomuchintheinterview,andbecauseoftheproducer’sguarantee,IwasconfidentthattherewouldfinallybenationalexposureofhowtheFDA’spolicyonGEfoodsdidnotconformtothefindingsofitsscientistsbutinsteadcounteredthem.However,myconfidencewasonceagainmisplaced.Whenthestoryaired,theonlystatementsaboutfoodsafetycamefromtheproponentsofgeneticengineering,andtheycontainedthestandardassurancesthatGEfoodsareaswholesomeasnaturalonesandthattheFDAhadcertifiedtheirsafety.NoneofthestatementsfromtheFDAscientistsmadeitintothebroadcast;andtheonlytimeIappearedwasinansweringthatlastquestionaboutthereligiousdenominations.Eventhen,myfullone-sentencereplywasnotused.Rather,itwascuttoaboutthreesecondsinwhichonlyafewofthedenominationswerementioned.

It’sobviousthatthedecisiontodeleteallthesignificantinformationIprovideddidnotcomefromtheproducerwhosettheinterviewup.HeknewwhatIplannedtosay,heguaranteedthatasignificantpartofitwouldbeincluded,andheexpendedsubstantialresourcesinordertomaketheinterviewpossible.Yet,despitehisdesiretoincludestatementsfromtheFDAscientists,oneormoreindividualsinCBS’supperechelonsapparentlycouldnotabidethebroadcastofsuchpotentinformationandforbidhimfromdoingso,eventhoughitentailedasubstantialwasteofresources–andthebreakingofapromise.

Further,althoughafewexcerptsfrommemosbyFDAscientistswerefinallydisseminatedbyamajorUSmediaoutlet(17monthsafterthemediahadfirstbeeninformedofthem),theimpactwasminimalbecausetheirsignificancewasmuted.TheexcerptsappearedwithinaNewYorkTimesarticlechroniclingthehistoryofGEfoods,andtheirappearancewasremarkablebecausethereporterwhostartedthearticle,MelodyPetersen,hadencounteredsustainedresistancefromhereditors.

Shefirstinterviewedmeinthesummerof1999,whileIwasworkingonthelawsuitintheofficesoftheICTAinWashington,D.C.ShealsointerviewedICTAattorneys.ShewaskeenlyinterestedintheFDAmemos,andasshelearnedthefacts,sherecognizedthattheagencyhadeffectedamajorcoverupandthatitspolicyonGEfoodswasbasedondubiousclaims.Further,itwasapparentthatshewantedherarticletoclearlyconveythisinformation.Shealsowantedtocontactsomeofourscientist-plaintiffsandpresenttheirconcerns.

Buthereditorsdidnotshareherinclinations.Infact,theyseemedintentonhinderingherfromproducingtheexposéthatsheenvisioned.ThisbecameobviousoverthefollowingmonthsassheandIcommunicatedbyphone.Sheinformedmethatshewasrepeatedlyinstructedtodoadditionalresearchsothepiecewouldbemorebalanced.Andinresponsetoherinclusionofstatementsfromourscientist-plaintiffs,shewastoldtoinsteadfindscientistswhowere“objective,”asifbyexpressingscientificreasonsforquestioningthesafetyofGEfoods,one’sobjectivitywasforfeited.Because,whenIhadlastheardfromher,shewasstillfrustrated,Iassumedthatthearticlewouldnevermakeitintoprint–orthatifitdid,thecriticalinformationwouldbeabsent.

PhilRegalrelatesthatPetersenalsohadsomelongphoneconversationswithhim,andthatshecontactedseveralothers“intheknow.”Hesaysthatshestruckhimandtheothersassomewhatnaïve

becauseshereallyseemedtobelievethattheTimeswasgoingtopublishtheinformationshewasgarnering.Bythen,hehadlearnedtoexpectthatlittleofwhatheandotherscientistssaidabouttherisksofGEfoodwouldmakeitpastthelayersofeditorialreview.Asherecounts:“Onejustgotusedtoreportersgatheringmaterialthatnevergotpublished.Ifyoudidn’ttakeitinstrideitwouldhavebeenverydiscouraging.Soyoujustsloshedalong.IcametoregarditlikethesandpaintingsoftheHopiandtheTibetans.Itwasaritualthatjusthadtobeperformed,evenifyouknewthewindwouldblowyoureffortsaway.Thetraditionoftruth-tellinghadtobepreserved–evenifthewordsthatonespokewerenot.”

SobothRegalandIweresurprisedwhen,onThursday,January25,2001,thearticlewasactuallypublished.29AndIwasamazedtoseethatafewexcerptsfromFDAmemoshadsurvivedtheeditingprocess.ButIwasnotsurprisedbythearticle’sbasicthrust,whichdownplayedthesafetyissueandinsteadfocusedonhowMonsanto’smarketingandpublicrelationsmistakeshadprovokedsomuchconsumeroppositionabroad,andenoughresistancefromactivistsathome,topreventtheGEfoodventurefromrealizingitsfullpotential.TherewerenostatementsfromRegaloranyofourotherscientist-plaintiffs,andthequotesfromthescientistswhomtheeditorspresumablyregardedas“objective”weregenerallysupportiveofbioengineering.

Evenmoretelling,theFDAmemoswerenotgivenprominence.Thearticlewasexceptionallylong,andtheyweren’tmentioneduntilaboutthree-quartersofthewaythroughit.Asiswellknown,newspaperarticlesareordinarilystructuredtoprovidethemostimportantinformationnearthebeginning.Soiftheeditorshadwantedtoemphasizetheimportofthememos,theywouldhavefeaturedthemmuchearlier,andquotedthemmoreextensively.Butthatwasnottheaimofthearticle.Itwastitled:“BiotechnologyFood:FromtheLabtoaDebacle.”Itwasnottitled:“FDAFraudonBioengineeredFoodsExposed.”TherewasnomentionofthefactthattheFDAhadcoveredupitsscientists’warnings,orthefactthatithadissuedlies,orthefactthattheagency’sfiles(inconjunctionwithourplaintiffgroup)demonstratedthatGEfoodsarenotGenerallyRecognizedasSafe.

AlthoughMelodyPetersenhadseemedtowanttohighlightthosefacts,shewaseventuallyreplacedbyajournalistwhowaspreparedtotakeadifferenttack.Whenthearticleran,shewasnotlistedastheauthorbutwasmerelycreditedashavingcontributedreporting.Iftheeditorshaddesiredtoshakethingsupbymakingfulluseoftheinformationourlawsuithadgenerated,thearticlewouldhavebeentheonethatshehadenvisioned;anditwouldhavehadaprofoundeffect.Butaswritten,itsimpactwasinsubstantial;andtheTimesdidnothingmoretoenhanceit.ThepaperneverfollowedupontherevelationsintheFDAfilesand(tothebestofmyknowledge)printednofurtherreferencetowhatagencyscientistshadwritten.

ThisbehaviorsubstantiallydiffersfromhowtheTimeshashandledotherinstancesofFDAmalfeasance.Forinstance,thefrontpageoftheSundayeditionforJuly15,2012featuredanarticleheadlined:“VastF.D.A.EffortTrackedE-MailsOfItsScientists.” 30Anditwasthetopstoryintheemailednewsfeedforthatday.31Inthisincident,severalagencyscientistsclaimedthatfaultyreviewprocedureshadresultedintheapprovalofparticularmedicalimagingdevicesformammogramsandcolonoscopiesthatexposedpatientstodangerouslevelsofradiation.AndtheycommunicatedtheirconcernstojournalistsandmembersofCongress.TheTimes’articlerevealedthattheFDAhadused“so-calledspysoftware”tomonitoremailssentbyfiveofthescientists;anditpointedoutthatwhilegovernmentagencieshavesubstantialdiscretiontomonitoremployeecomputeruse,theagencymayhavegonetoofar(andbrokenthelaw)“bygrabbingandanalyzing”legallyprotectedconfidentialinformationsuchasattorney-clientcommunicationsandwhistle-blowercomplaintstoCongress.

Moreover,theTimesdidnotletthestorydrop.Itpublishedthreefollowuparticleswithinthenexttwoweeks.Duetosuchprominentandpersistentcoverage,theissuegrabbedtheattentionofthepublic

andthoseonCapitolHill.Thus,thepaperappearstohavenopenchantforprotectingtheimageofmedicalimaging–andnohesitationaboutfullydisclosingdisputesbetweenFDAadministratorsandscientistsoverthedangersofsomeofthedevices.

ButinthecaseofGEfoods,notonlywastheTimes’coverageofthewarningsbyFDAexpertssubduedanddevoidoffollowup,itssubsequentreportingontheproductshaslargelyprojectedapositivepicture,oftenpresentingtheindustry’spromotionalclaimsasestablishedfacts.Atypicalpiece,writtenbythepaper’spersonalhealthcolumnist,wastitled:“FacingBiotechFoodsWithouttheFearFactor.”Inthesectionheaded“Ignorancevs.Progress,”shedismissedfoodsafetyconcernsasduetothepublics’lackofknowledge.Andinafollowingsectionsheportrayedgeneticengineeringaspreferabletotraditionalbreeding.Sheindicatedthatwhenoneplantpollinatesanother,that’saformof“geneticmodification;”andsheemphasizedthatitentailsthetransferof“dozens,hundreds,eventhousandsofgenesofunknownfunction.”Incontrast,shedescribedrecombinantDNAtechnologyas“themostrefined,preciseandpredictablemethodofgeneticmodificationbecausethefunctionofthetransferredgeneorgenesisknown.” 32

Since1897,themottooftheNewYorkTimeshasbeen:“AlltheNewsThat’sFittoPrint.”Butforthelastfewdecades,thissloganhasbecomeinaccurateinatleastonekeyrespect.Itwouldbetterreflectrealityifitwererevisedtostate:“AlltheNewsThat’sFittoPrint–UnlessItCastsDoubtontheSafetyofGEFoods.”

Ofcourse,tocompensateforthecommercialmedia’scowardice,NationalPublicRadiocouldhavedutifullysteppedforward.Butitdidnot;and,despitebeinggivenampleopportunity,itdisplayedatleastasmuchreluctancetoinformthepublicabouttheFDAfraudasitscommercialcounterparts.Perhapssuchtimiditystemsfromthefactthatthisnonprofitorganizationmustseeksubstantialfundingfromprivatecorporations–andthatformanyyears,Monsanto,GeneralMills,andotherbusinesseswithabigstakeinGEfoodshavebeensponsors.

WatergateandthePentagonPapersvs.GEFoods:AStrikingContrastinMediaAttitudeTheAmericanmedia’swillingnesstosuppresskeyfactsaboutGEfoodsisevenmoreastoundingwhencomparedtothestanceittookwhenaddressingtwoothermajorinstancesofgovernmentdeception:(1)theWatergatecover-upand(2)themisdeedsrevealedbyasetofofficialdocumentsabouttheVietnamWar.

Watergate

IntheWatergateaffair,whichbeganinJune1972,operativesinleaguewithkeyadvisorsofPresidentRichardNixonwerecaughtintheactofburglarizingtheNationalDemocraticCommitteeheadquarters;andtheWhiteHouseundertookasustainedefforttoconcealitsincriminatingconnectionstothem.Butthroughrelentlessinvestigation,theWashingtonPostsystematicallydugoutthefactsthatwerebeingsuppressedandexposedtheminaseriesofhard-hittingarticles.Further,thepaperpersistedinthefaceofrepeateddenunciationsbytheNixonadministration–andalsodespiteitsthreatsandharassment.33ThePostalsopushedoneventhoughtherestofthemedia,aswellasmostofthecountry,doubtedthesoundnessofitsreports.34Andthroughsuchcourageandperseverance,itultimatelybroughtdownseveraltopWhiteHouseofficials–andeventhepresidenthimself.

Thecontrastbetweenthenewspaper’sdeterminationtoexposegovernmentdeceptioninthecaseofWatergateanditsdistinctdisinclinationtodosoinregardtoGEfoodsisdramatic.In1972,itwassostronglycommittedtouncovergovernmentwrongdoing,eventothepointofbringingdownaUSpresidentthatitpressedaheaddespitethedangertoitsreputationanditsverysurvival.35Butin1999,itchosetobecomplicitinthecontinuationofacover-upratherthanexposegovernmentdelinquencythatwould

endangertheimageofthebiotechindustryandthenovelproductsithadplacedonthenation’ssupermarketshelves.InordertodisclosethetruthaboutWatergate,ithadexertedextensiveeffortandtakenmajorrisks;yetitrefusedtopublishkeytruthsaboutGEfoods,eventhoughthatwouldnothaveentailedinvestigativeeffort,orbeenopentodoubt.Despitethefactareporterhadbeenhandedrock-solidevidencefromtheFDA’sownfilesestablishingthatGEfoodswerenot“generallyrecognizedassafe”asdefinedbylaw–andthattheFDAhadbeenconcealingthisthroughfraudulentmisrepresentations,thePostpreventedhimfrombringingthesefactstolight–andexcisedallreferencetothemfromthearticlehe’dwritten.

ThePentagonPapers

AlthoughthecaseofGEfoodsmaymarktheonlytimetheWashingtonPosthasdeliberatelyabettedthecover-upofgovernmentwrongdoing,Watergatewasnottheonlyinstanceinwhichthepaperincurredsignificantriskinordertoexposeit.36Intheprecedingyear,ithadalsoactedcourageouslyinthatcause;andonthatoccasion,itwasnotalone.TheNewYorkTimesandseveralothernewspaperswerepartofthesameendeavor.

Thesenewsorganizationsweredeterminedtopublicizeimportantinformationcontainedina7,000pagestudyofUSinvolvementinVietnambetween1945and1967.Thedocumentscomprisingthisstudycametobeknownas“thePentagonPapers”becausetheywerepreparedbyataskforcewithintheDefenseDepartment.TheywereproducedduringtheVietnamWar,andtheywereclassifiedas“TopSecret–Sensitive.”Fifteencopiesofthestudywereproduced,andtwoweregiventotheRANDCorporation,athink-tankthathadoftenprovidedresearchandanalysistotheDefenseDepartment.

Thestudycontainedmanyunsettlingfacts.Notonlydiditrevealthegovernmenthadrealizedatanearlystagethattherewaslittlelikelihoodthewarcouldbewon,italsoexposedextensivegovernmentdeception.AsaNewYorkTimeseditorlaterobserved,thedocuments“demonstrated...thattheJohnsonAdministrationhadsystematicallylied,notonlytothepublicbutalsotoCongress,aboutasubjectoftranscendentnationalinterestandsignificance.” 37

AnanalystatRANDwhohadcontributedtothestudy,DanielEllsberg,decidedtomakeseveralphotocopiesandreleasetheminordertohastenanendtowhatheconsideredanimmoralwar.InMarch1971,hegaveoutthefirstcopyofthestudy–toaNewYorkTimesreporter,whobroughtthemtotheattentionofhissuperiors.Althoughtheseexecutivesrecognizedthestudy’simportanceandwantedtopublishsomeofthosethatweremostrevealing,theyhaddoubtsaboutthelegalityofdoingso.Notonlywerethedocumentstop-secret,theyhadbeenstolen.Further,theycontainedsensitiveinformationthat,ifpublicized,mightweakenthegovernment’scapacitytoconductamajorwar.

Sotheexecutivessoughttheadviceofthelawfirmthatservedastheiroutsidecounsel.Whattheywantedtoknowwas:EventhoughthetransmissionofthedocumentstotheTimeshadbeenillegal,couldpublishingthemnonethelessbelawful?Andwhattheyhopedtoreceivewasago-ahead.Buttheanswertheygotwasnotencouraging.ThelawyersadvisedthemtoholdoffbecausetheymightbeprosecutedforviolatingtheEspionageActof1917,whichmadeitacrimetotransmitclassifiedinformationtounauthorizedpersonsortopublishsuchinformation“inanymannerprejudicialtothesafetyorinterestoftheUnitedStates.” 38

However,theirin-houselawyersawthingsdifferently.HearguedthatthroughtheFirstAmendmentoftheUSConstitution,thepresshadtherighttopublishinformationprovidingcitizenscrucialinsightintogovernmentpolicy.Andhiswordswonout.Insteadofoptingforthecautious(andcomfortable)stancecounseledbytheoutsideexperts,thepaper’sexecutiveswentwiththebolderthinkingoftheirstaffattorney;andonJune13,despitetheseriousrisks,theTimesbeganpublishingkeyexcerptsfromthestolenstudy.

AninfuriatedNixonadministrationpromptlydemandedthatitstop;butitrefused.SotheJusticeDepartmentsoughtatemporaryrestrainingorderfromafederalcourt,assertingthatfurtherpublicationoftheclassifieddocumentswouldcause“immediateandirreparableharm”tonationaldefenseinterests.Thecourtissuedtheorder,andtheTimeswasforcedtoceaseafteronlythreearticleshadbeenpublished.

However,thatdidnotpreventthesensitivedocumentsfromappearinginamajornewspaper.EllsberghadalsogivensomeofthemtotheWashingtonPost,anditbegantopublishexcerptsonJune18.

TheJusticeDepartmentagainobtainedarestrainingorder.Meanwhile,theNewYorkTimessoughttoremovetheonethathadbeenissuedagainstitbyfilinganappeal.OnJune26,theUSSupremeCourtagreedtohearitscase–inconjunctionwiththecaseinvolvingtheWashingtonPost.Fourdayslater,theCourtruledthatthegovernmentcouldnotenjoinpublicationbecauseithadfailedtomeetthe“heavyburdenofshowingjustificationfortheenforcementofsucharestraint.” 39However,fiveoftheninejusticesstatedthateventhoughthegovernmentcouldnotrestrainthenewspapersfrompublishingthesecretdocuments,itcouldneverthelesscriminallyprosecutethemforhavingdoneso.40

Moreover,duringtheperiodtheTimesandPosthadtodesistbecauseofrestrainingorders,othernewspapersshowednoinclinationforrestraint.Ellsberghadpassedcopiesofthestudytoseveral,andtheytoobegantopublish.TheBostonGlobe,theChicagoSun-Times,andtheSt.LouisPost-Dispatchsoongotintotheact;andthebeleagueredJusticeDepartmentcouldnotstayontopofthings.AccordingtoareportinAirForceMagazine,“Assoonasonenewspaperwasenjoined,thenextonepickeduppublication.” 41Inall,fifteenpapersinadditiontotheTimesandPostjoinedtheeffort.42

AswithWatergate,thereareglaringcontrastsbetweenthecaseofthePentagonPapersandthecaseoftheFDA’sGEfoodfiles.Althoughbothsetsofdocumentsrevealedthatthegovernmenthadliedaboutmattersofgreatimportance,thesimilaritystopsthere.Theformerweretop-secretclassifieddocumentsthatwerestolenandthenpassedtonewspapersinviolationoffederalstatute.Notonlywastherereasontothinkthatpublishingthemcouldhinderthenation’swareffort,itseemedthatanynewspaperexecutiveswhodidwouldbetechnicallyguiltyoftreason.Nonetheless,despitetheriskofcriminalprosecution,twoofthenation’smostinfluentialpapersstartedpublishingthesecretreport;andwhenthegovernmentrestrainedthemthroughthecourts,fifteenothernewspapersleapedintokeepthedocumentsrollingoffthepresses–eventhoughthelegalityoftheiractionswasstillindoubtandthethreatofprosecutionloomedlively.43

Incontrast,theFDAfileswereunclassifiedandirrelevanttonationalsecurity.Andinsteadofhavingtheirdisseminationblockedbyacourtorder,theywereobtainedthroughacourtorderandpresentedtothemediainalegalmanner;andtherewasneveranydoubttheycouldbelawfullypublished.Moreover,althoughthePentagonPapershadnodirectbearingonthehealthorwell-beingofanycitizensoutsidethemilitary,theFDApapersdid,sincetheyrevealedthatfoodsbeingregularlyconsumedbymostAmericansposeunusualrisks.

Yet,themanagersofthemediaconsistentlypreventedthecontentofthesedocumentsfrombeingconveyedtothepublic.Eventhoughtheiractionswouldhavebeenperfectlylawfulandhighlylaudable,theyrefusedtoinformthecitizenrythatthegovernmenthadbeendefraudingthem–notwhenthefraudhadbeenessentialingettingGEfoodsonthemarketandwasstillessentialforkeepingthemthere.In1971,thenation’snewspapershadcourageouslypublishedthePentagonPapersdespitetheriskofcriminalprosecution;butfrom1999onward,they(alongwiththeotherorgansofthemainstreammedia)havebalkedatdisseminatingthedocumentsthatwouldexposethegovernment’sGEfoodfrauds–formotivespresumablyfarlessnoblethanthoseoperativeduringthatearlierepisode.

It’salsonoteworthythat,likethedeceptionsrevealedinthePentagonPapers,theWatergatecover-updidnotposeathreattopublichealtheither.YettheWashingtonPostwascommittedtouncoverthedeceptions–whileitwouldlaterremaincomplacentinthefaceofafraudthatdidputthehealthofthe

nation’scitizensatrisk.It’salsonoteworthythat,inpreludetothe40thanniversaryofWatergate,LeonardDownie,Jr.,thePost’sexecutiveeditorduringtheperiodwhenitsapparentlyprotective(andrestrictive)stanceonGEfoodswasadopted,wroteanarticlewarningthatduetothepressuresofthedigitalage,thefutureofinvestigativereportingis“atrisk.”Unawareoftheinherentironyinhiseffort,themanwhodirectededitorialpolicywhenRickWeiss’sattemptedexposéwasquashedsoughttoenhanceappreciationfortheverykindofresponsiblereportingthatthePosthadthwartedinthatinstance–assertingthatAmericawouldbe“bestserved...[through]widespreadrecognitionoftheimportanceofaccountabilityjournalisminourdemocracy–andtheneedtoensurethatitsurvivesandflourishes.” 44

AlthoughonemightquestiontheconsistencyofDownie’spracticalpositiononthematter,hisdeclarationabouttheimportanceof“accountabilityjournalism”inademocracyisbeyonddispute–andthecentralityofitsrolehasbeenwidelyandregularlyrecognized.OneofthemostforcefulacknowledgementswasissuedaspartoftheSupremeCourt’srulingthatthegovernmentcouldnotplacepriorrestraintonthepublicationofthePentagonPapers.Inhisoft-citedopinion,JusticeHugoBlackdeclared:“Onlyafreeandunrestrainedpresscaneffectivelyexposedeceptioningovernment.” 45Inthatcase,thedeceptionwasexposedbecausethemediaheroicallyfoughtofftheimpositionofgovernmentrestraint.Butinthecaseofgeneticallyengineeredfoods,themediahavevoluntarily(andspinelessly)imposedrestraintsuponthemselves.Whilesuchself-censorshipwouldhavebeenathomeinStalin’sSovietUnion,it’sincompatiblewiththeneedsofanopenanddemocraticsociety.Andbecauseofitspersistence,oneofthebiggestandmostdangerousdeceptionseverperpetratedbytheUnitedStatesgovernmenthasbeenallowedtomaintainitsforcemorethanfifteenyearspastthepointitshouldhavebeenfullybroughttolight.

AnotherMajorContrast:America’sMediavs.Europe’sBesidesthedramaticcontrastbetweenhowtheAmericanmediacoveredWatergateandthePentagonPapersandhowthey’vedealtwithcriticalinformationaboutGEfoods,there’sanenormousdifferencebetweenthelatterandthecorrespondingperformanceofthemediainEurope.InChapterTwo,wesawthattheEuropeanmediaweremuchlesspronetoprintunsubstantiatedpromotionalclaimsasestablishedtruths,andmorewillingtoscrutinizeandchallengethem.AndwhenIstartedgivingpressconferencesonthatcontinent,Iquicklylearnedthatthemediatherewerealsomorewillingtounstintinglyreportthefacts,regardlessoftheeffectontheimageofGEfoods.IhadbecomesoaccustomedtothesuppressionprevalentwithintheUSthatitwasinitiallysomewhatoverwhelmingtoseestoriesabouttheFDA’smisbehaviorfeaturedonthefrontpagesofmajornewspapersandintheprime-timebroadcastsofmainstreamtelevision.AssuchcoveragecontinueditbecameclearthatthefreefunctioningoftheEuropeanmediaontheGEfoodissuehadsignificantlyfacilitatedtheinformedconsumerresistancethathadkeptmostofthesefoodsoutoftheirsupermarkets.AndIwasincreasinglystruckbytheironythatalthoughrevelationsaboutthismajorfraudwerebeingopenlydisseminatedwithincountriesminimallyaffectedbyit,thecitizensofthenationthatwasmostdirectlyaffected–andadverselyimpacted–werebeingkeptinthedarkbytheirresponsiblepoliciesofthepressandthebroadcasters.

Thus,duetothemalfunctionoftheAmericanmedia,falsenotionsaboutGEfoodscontinuetoprevail.Eventhoughthemanagersofmasscommunicationhavebeengivenincontestableevidenceofagovernmentfraudthat’sarecklessgamblewithpublichealth,they’veconsistentlyfailedtoreportit.Whiletheyhaveaccommodatedthebiotechproponentsanduncriticallycommunicatedtheirmisrepresentationsasfact,theyhaverecoiledfromconveyingwhattheFDAscientistssaid.Andthey’vegivenscantcoveragetootherscientistswhohavelikewiseexpresseddoubtsaboutGEfoods.

Accordingly,mostAmericanshaveremainedundertheillusionthatGEfoodsaresubstantiallythesameasconventionalones–andthattheyaregenerallyrecognizedassafe.Andthey’restillnotawarethattheFDA’sexpertsdeterminedthattheseproductsposeunusualrisks.

Moreover,thepublics’confusionaboutrisksrunsfardeeperthanthis;anditisnotmerelytheresultofdeficientmediareporting.Overtheyears,theproponentsofGEfoodsinindustryandacademiahavepersistentlymisrepresentedtherisksthatareassociatedwiththem–anddoneitsomethodicallythatthey’veevendistortedtheveryconceptofwhatriskis.

CHAPTERNINE

MethodicalMisrepresentationofRisk

Oversights,Anomalies,andDelinquencies

Asthepreviouschaptershaverevealed,theriskthathasmosttroubledtheproponentsofGEfoodsistherisktheseproductswillbeperceivedasabnormallyrisky.Consequently,thisistherisktheyhaveprimarilysoughttomanage.Andintheprocess,they’veconsistentlycontortedbothlogicandthebasicfacts.

Thistendencytowarddistortionhaspersistedfromthebirthofbioengineeringtothepresent.AswesawinChapter1,duringtheearlyyearsofthetechnology,whentherangeofGMOswaslimitedtomicroorganisms,themolecularbiologyestablishmentcalmedpublicconcernsandfendedoffregulationbyimpartingfalseimpressionsaboutrisks.Notonlydidtheyfeigntherewasanoverwhelmingexpertconsensusthatresearchemployingengineeredmicrobesissafe,theyclaimedthatthisallegedconsensuswasbasedonnewevidence,wheninfactnosuchevidencehadbeengeneratedandtheclaimsofsafetywereessentiallybasedonconjectures.Further,oneofthefoundersofrDNAtechnologydeclaredhehaddemonstratedthatitmerelymimicswhatnaturalprocessesarealreadydoing,despitethefactthepurportedlynaturalprocessinhisexperimentwashighlyunnatural–andeventhenfailedtoreplicatetheradicalresultsofgeneticengineering.Moreover,whenresearchwithactualbearingonriskswaseventuallyconducted,thebiotechnicianssuppressedtheoutcomesthatwereinconvenient–orsignificantlymisrepresentedthem.

Then,aswesawinChapter2,whengeneticengineeringexpandedtotheplantkingdom,therangeofmisrepresentationalsoexpanded.Asthetechnology’sadvocatesstroveforunregulatedreleaseofengineeredorganisms,theyarguedthatvirtuallyallsuchentitieswouldbeenvironmentallysafe.Butalthoughtheseargumentswereadvancedinthenameofscience,theyreliedonassumptionsthatwerescientificallyunsound.Further,mostadvocatescontinuedtoasserttheseargumentsevenafterscientistswhodidhavetherelevantexpertisehadsolidlyrefutedthem.

Addingtothecorrosionofscience,a1987reportbytheNationalAcademyofSciencesdeclaredthatGMOsposenounusualrisks,despitethefactthisdeclarationwasfarmorepoliticalthanscientific.Unabashed,theAcademyissuedafollow-upreportin1989thatagainmadebroadpronouncementsaboutthesafetyofGMOsthatwerescientificallyunwarranted.Exacerbatingtheseexcesses,biotechproponentspresentedtheunjustifiedgeneralitiesasauthoritativeconclusionsaboutallaspectsofGMOs,eventhoughthescopeofthereportswasrestrictedtoenvironmentalrisksoffieldtrialsconductedwithinthecontinentalUS.

Chapter3revealedhowmisinformationbecameevenmorecrucialtotheadvanceofbioengineeringafterafoodsupplementproducedthroughthetechnologywaslinkedtoadeadlyepidemicthatswepttheUSin1989.Althoughtheevidenceimplicatestheengineeringprocessasthemostlikelycauseofthecontaminationthatturnedthesupplementtoxic,theproponentsofthetechnologyhavespuntheimpressionthatit’sbeenfullyabsolved.Moreover,they’veevenbeenabletobecloudthefactthatitplayedaroleinthelethalsupplement’sproduction.

Yet,althoughobfuscatingthefactsaboutthedisasteraGEproductcausedwasessentialinpavingthewayfortheircommercialization,itwasnotsufficient;andChapter4showedhowbiotechproponentshaveneededtodistortthestoryofhowengineeredfoodsarecreated.Throughsuchmisrepresentations,

andthroughmisstatingbasicfactsofbiology,they’veimpartedtheillusionthatthesenovelproductsareessentiallyasnaturalas–andnoriskierthan–theirconventionalcounterparts.

Wenextsaw,inChapter5,howinorderforGEfoodstobeallowedontothemarket,theUnitedStatesFoodandDrugAdministrationhadtore-asserttheclaims,firstissuedbybiotechproponentsduringthe1970’s,thatthere’sanoverwhelmingscientificconsensusaboutthesafetyofgeneticengineering–andthatthisconsensusrestsonsolidevidence.Further,althoughtheearlierclaimsrelatedtoresearchwithmicrobialGMOswhilethosein1992involvedthewholesomenessofengineeredplantsasfood,thelatterwerejustasbold–andbogus–asweretheirpredecessors.Infact,theyweremorebrazen,sinceeventheFDA’sownfilesattestedtheirfalsehood.

Chapter6wentontodemonstratethatregulatoryirregularityinregardtoGEfoodwasnotconfinedtotheUnitesStates.WesawhowofficialsinCanada,Europe,Australia,andAsiaemployedsuperficialreasoningtojustifysuperficialtesting–turningtheirbacksonsoundscientificknowledgeandstandardscientificprotocolsinordertograntapprovalstoGEfoodsandprojecttheimpressionthatthey’renomoredangerousthanconventionalones.

Chapter7thenshowedhowtheenvironmentalrisksofGEcropshavebeenroutinelyunderestimatedandmismanaged.AndChapter8revealedhowtheAmericanmediahave,throughsuppressionofkeyinformationandslantedreportingoftheremainder,presentedasignificantlyimbalancedpictureofboththehealthandenvironmentalrisksposedbyengineeredorganisms.

Nowit’stimetotakeourexaminationdeeper.It’stimetomoreclearlyunderstandwhytherehasbeen,andcontinuestobe,majordisagreementabouttherisksofGEfoodswithinthescientificcommunity.WeneedtodiscoverhownumerousesteemedscientistsandscientificinstitutionscandeclarethattherisksofGEfoodsaresimilartothoseofconventionallyproducedfoodswhilemanyequallyqualifiedexpertsmaintainthattherisksaregreater.Havebothgroupsbeenexaminingthesamesetofevidenceaccordingtothesamescientificprotocolsandwithanequaldegreeoflogicalrigor?Ifso,itwillindicatethattheavailableevidencedoesnotyieldclear-cutanswersandcanbeinterpretedindifferentwaysbyequallyearnestexperts.Orhasonegroupoverlookedsignificantfacts,ignoredimportantstandards,andappliedlooselogic?Ifthisisthecase,itwouldshowthatthedisagreementstemslessfromalackofadequatedatathanfromalackofscientificintegrity.

Butbeforeproceeding,it’simportanttorecognizethattherearemanymoreexpertscounselingcaution–andfarfewerreportsdeclaringsafety–thanthepublichasbeenledtobelieve.

MisrepresentingtheDegreeofConsensusthatGEFoodsAreSafeGEproponentspresentthemselvesaschampionsofscience,andtheypromotetheimpressionthatscientistsandscientificinstitutionshaveuniformlyconcludedthatGEfoodsaresafe.Buttodoso,they’veneededtomisrepresenttherecord–totheextentthatreportsfromscientificconferencesandesteemedinstitutionshavefrequentlybeentwistedtomakeitseemtheycontaindefinitiveconclusionsaboutthesafetyofGEfoodseveniftheydonot.Further,themischaracterizationsarefrequentlypropagatedbyorganizationswieldingsignificantauthority.

Forexample,inOctober2012,theboardofdirectorsoftheAmericanAssociationfortheAdvancementofScience(AAAS)issuedastatementinoppositiontothelabelingofGMfoodsthat,aspartofitsargumentfortheirsafety,assertedthattheWorldHealthOrganizationhasdeterminedGEfoodstobe“noriskier”thanconventionallyproducedones.1Butinreality,theWHOhasstatedthat“itisnotpossibletomakegeneralstatementsonthesafetyofallGMfoods”andthattheirsafetyshouldthereforebeassessedonacase-by-casebasis.2Moreover,theWHOnotedthatwhilesafetyassessmentsarenotrequiredfor“traditional”foods,mostnationalauthoritiesrequirethemforbioengineeredproducts–andthatoneofitsobjectivesistoassistinthisprocess.

Truthnotwithstanding,theAAASstatementwentontoproclaimthat“everyrespectedorganization”

thathasexaminedtheevidencehaslikewisedeterminedGEfoodstobe“noriskier”thanconventionalones.Butinfact,severalrespectedscientificorganizationshaveconcludedotherwise.

Forinstance,in2001theexpertpaneloftheRoyalSocietyofCanada(thatnation’sacademyofscience)issuedanextensivereportdeclaringthat(a)itis“scientificallyunjustifiable”topresumethatGEfoodsaresafeand(b)the“defaultpresumption”foreveryGEfoodshouldbethatthegeneticalterationhasinducedunintendedandpotentiallyharmfulsideeffects.3Indescribingthereport’scriticismofthecurrentapproachtoregulatingGEfoods,theTorontoStarstated:“Theexpertssaythisapproachisfatallyflawed...andexposesCanadianstoseveralpotentialhealthrisks,includingtoxicityandallergicreactions.” 4

TheBritishMedicalAssociationisanotherrespectedorganizationthathasexpressedreservationsaboutthesafetyofthesenovelproducts.5AsdescribedintheBritishMedicalJournal,theAssociationreleaseda2004reportstatingthat“moreresearchisneededtoshowthatgeneticallymodified(GM)foodcropsandingredientsaresafeforpeopleandtheenvironmentandthattheyofferrealbenefitsovertraditionallygrownfoods.” 6And,asChapter6noted,thePublicHealthAssociationofAustralia(PHAA)hasexpressedconcernsabouttherisksposedbythebioengineeringprocessandhasstronglycriticizedwhatitregardstobethe“flawed”regulatoryprocessthroughwhichGEfoodshavegainedapproval.7

TheeminentmedicaljournalTheLancethasalsocriticizedthepresumptionthatGEfoodsarenoriskierthanconventionalones.Inaneditorialtitled“Healthrisksofgeneticallymodifiedfoods,”itstatedthatthereare“goodreasonstobelievethatspecificrisksmayexist;”anditdeclaredthat“governmentsshouldneverhaveallowedtheseproductsintothefoodchainwithoutinsistingonrigoroustestingforeffectsonhealth.” 8

Moreover,asChapter5demonstrated,it’sappropriatetoincludetheUSFoodandDrugAdministrationamongtheorganizationswhosescientificreviewshavedeterminedthattherisksofGEfoodsshouldnotbeequatedwiththoseofconventionalones.Onthebasisofathoroughanalysis,thescientistsontheagency’sbiotechnologytaskforceconcludedthatthesenewproductsposeanunusualdegreeofrisk.However,theywerenotempoweredtoexpresstheirconclusionsintheagency’spolicieson,andstatementsabout,GEfoods.Instead,aswesaw,thosepoliciesandstatementswereissuedbyadministratorsandwereskewedbypoliticalandeconomicfactorsdivorcedfromscience.Consequently,theFDA’sofficialstatementsaboutGEfoodshavenotonlydisregardedtheconclusionsofitsownscientists,butcontradictedthem.Therefore,althoughit’scommonpracticeforbiotechproponentsandmediapersonneltoassertthattheFDAhasdeterminedGEfoodstobesafe,becausesuchassertionsimplythatthedeterminationwasascientificone,they’reinaccurate.Infact,they’redoublymistaken,sincetheagencyhasnotevenmadeaformaldeterminationaboutGEfoods.Ithasmerelymadea“rebuttable”presumptionthatthey’regenerallyrecognizedassafe–apresumptionthathasalwaysclashedwithreality,andhasgratedevermoreglaringlyascautionaryreportslikethosejustcitedhavebeenreleased.

Ofcourse,thereportsbytheFDAscientistsweresuppressed,sotheAAASboardcanbeexcusedfornotknowingaboutthem.ButthoseoftheWHO,theRoyalSocietyofCanada,theBritishMedicalAssociation,thePHAA,andTheLancetwerepublic,andquitenoteworthy.Yet,theywerecarelesslyoverlooked–orcallouslymisrepresented.Further,asweshallsee,theAAASstatementispepperedwithotherfalsehoods.

Althoughsuchfact-fracturingisregrettable,especiallywhencommittedbythedirectorsofoneofAmerica’spremierscientificorganizations,bynowitshouldnotbesurprising.Aswe’verepeatedlyseen,pro-GEscientiststendtobeblinkeredbytheirbiases–andtoboldlyexpressthemviaassertionsthatareoverlybroadorutterlybogus.Moreover,theAAASboardwaschairedbyoneofthemostbiasedof

biotechboosters:NinaFedoroff.AsChapter4demonstrated,whenitcomestoGEfoods,Dr.Fedoroffapparentlyharborsseveralillusions,andhaspromulgatedseveraldelusions,oneofwhichisthatonlya“few”scientistshaveseriousdoubtsabouttheirsafety–andthat“theyarerarelythosewhoknowthisnewsciencewell.” 9Evidently,thiserroneousnotionengenderedtheboard’sinvalidclaimthat“everyrespectedorganization”hassidedwiththepositionitespouses.

TheCanadianExpertsvs.theNAS:AssessingtheAsymmetries,DisclosingtheAnomaliesSo,despitewhattheproponentsofGEfoodswouldhaveusbelieve,it’sclearthatthereisnotnow,norhasthereeverbeen,ascientificconsensusaboutthesafetyofthesenovelproducts–whichbringsustoourinvestigationintohowthesubstantialsplitinexpertopinionhascomeabout.

Twoprominentreportsembodythatsplit:the2001reportbytheRoyalSocietyofCanadaandoneissuedin2004bytheUSNationalAcademyofSciences.10Althougheachsetsforthanextensivecase,theformermaintainsthatGEfoodsshouldbetreatedasriskierthantheirconventionalcounterparts,whilethesecondassertsthattherisksareessentiallythesame.

Comparingtheproceduresthroughwhichthesecontrastingreportsweregeneratedshouldbeilluminating.Itcanrevealwhethertheprocessesofanalysishavebeensubstantiallysimilarandtheonlydifferenceslieinhowthefinaljudgmentcallsweremade(aswhenajudicialpanelexaminesaparticularcaseandissuesadividedopinion),orwhetherinsteadthemaindifferencesresideintheprocessofanalysisitself(asiftwoseparatepanelsofjudgeshadtriedtodetermineanissuebyconsideringrelated,yetdistinct,setsofevidenceaccordingtodissimilarjudicialstandards).Throughthisinquiry,wecanclarifyhowstronglyeachoftheclashingconclusionsisbackedbysoundscientificthinking–andtowhatextent(ifany)thescientificbasisofoneortheotherisillusory.

TheCanadianReport

ThereportissuedbytheCanadianexpertpaneltookissuewiththecommoncharacterizationofgeneticengineeringasmore“precise”thantraditionalbreeding;anditpointedoutthattheimplicationofsafetyimpartedbythetermisunwarranted.Intheprocess,itcritiquedthewayregulatorsinCanadaandothernationshavebeenassessingandapprovingGEfoods.

Thepanel’sreasoningcanbesummarizedasfollows:

Geneticengineeringcanonlybedeemedpreciseincaseswhereitseffectsarelimitedtothosethatareintended(andpredicted)–anddonotperturbtheactivitiesoftheorganisminunexpectedways.

However,whilethetechnology’sadvocatesadvancea“simplelinearmodel[inwhich]theactionofonegeneanditsproductswillhavenosignificanteffectsonothergenes,geneproducts,ormetabolicfunctions...,empiricalevidencesuggeststhatlinearmodelsarenotgoodpredictorsofcomplexbiologicalsystems,whichinvolveextensiveinteractionsbetweencellularcomponentsatalllevels.” 11

“Itisclearthatlivingcellsareexquisitelytunedtoboththeirinternalandexternalenvironments.Perturbationsineitherwilltypicallyinduceaspectrumofchangesingeneexpression,proteinsynthesisandmetabolicpatterns....” 12

Moreover,“[m]utationsinsinglegeneshavelongbeenknownusuallytoproducemultipleeffects...withinthemutatedorganism.” 13

Thereareseveralwaysinwhich“collateralimpacts”couldarisefrombioengineering.Oneisviathe“strong”viralpromotersthatareaffixedtotheinsertedgenesinordertoinduceahighlevelofexpression.Amongtheirdrawbacks,thesepromotersimposea“metaboliccosttotheplantofhavingtoaccumulateproductsunnecessarily.” 14

Inlightofallthefacts,“[t]hedefaultpredictionfortheimpactsofexpressionofanewgene(anditsproducts)withinatransgenicorganismwouldtherefore...bethatthisexpressionwillbeaccompaniedbyarangeofcollateralchangesinexpressionofothergenes,changesinthepatternofproteinsproducedand/orchangesinmetabolicactivities.” 15

Consequently,geneticengineeringcannotbeconsideredmoreprecisethanconventionalbreeding,becauseit’smorelikelytocauseagreaterextentofunintendedalterationsintheorganism’scellularprocesses–someofwhichcouldbeharmful.

Extensiveexperienceindicatesthattheproductsofconventionalbreedinghavealmostalwaysbeensafetoeat.Incontrast,notonlydowelacksuchanexperientialbasiswithGEfoods,wealsolackasoundtheoreticalbasisforpresumingthatthey’llbesafe–butdohavegoodreasontoviewthemwithcaution.

Accordingly,wecanonlydeemaparticularGEfoodsafeifcomprehensivetestinghasdemonstratedittobe.Andsuchtestsmustbeabletodetectunintendedresultsthatmightnotbeevidentthrougheithervisualobservationorthekindsofchemicalanalysisthatarecurrentlyreliedon.Theremustbe“directtestingforharmfuloutcomes”employingthewholefood,notmerelyanextractoftheexpectednewsubstance(s).Testsshouldincludethosefor“shortandlong-termhumantoxicity,allergenicityandotherhealtheffects.” 16

OnlywhenaGEfoodhassuccessfullycompletedthiscomprehensivetestingshoulditbedeclared“substantiallyequivalent”toitsconventionalcounterpart.Absentthistesting,suchadeclarationis

“scientificallyunjustifiable.” 17

Butsuchtestingisnotcurrentlyrequired.Further,regulatorsarenotevenpreparedtoimplementit.Thereareno“validatedstudyprotocolscurrentlyavailabletoassessthesafetyofGMfoodsintheirentirety...inabiologicallyandstatisticallymeaningfulmanner.”Thus,it’simperativetodevelop“practicalandscientificallyrobustapproachesforthesafetyassessmentofsuchfoods.” 18

TheNASReport

ThereportreleasedbytheNationalAcademyofSciencesin2004stoodinstarkcontrasttoitsCanadianpredecessor.WhereastheCanadianexpertshadconcludedthatthe“defaultprediction”foreveryengineeredfoodisthat“collateralchanges”haveoccurredthatcouldmakeitriskierthanitsconventionalcounterpart,theNASpanelassertedthattheengineeringprocessisnotinherentlyriskierthanconventionalbreeding.Therefore,althoughtheCanadianscientistsstatedit’s“scientificallyunjustifiable”topresumethataGEfoodissubstantiallyequivalenttoitscounterpartwithoutestablishingequivalencethroughrigoroustesting,thoseoftheNASdeclaredthatit’s“scientificallyunjustified”torequiresuchtestingmerelybecausethefoodwasproducedthroughgeneticengineering.

DiscerningHowtheDifferencesDeveloped

Howdidtheseoppositeoutcomesarise?Bothgroupspurporttohavereachedtheirconclusionsbasedoncarefulexaminationofthebestavailableevidence.Accordingly,ifeachgrouphadactuallydoneso,itwouldimplythatonehadtakenaccountofevidencenotconsideredbytheother.AndbecausetheNASreportwaspublishedthreeandahalfyearsaftertheCanadianone,itwouldsuggestthatduringthatperiod,importantdatahadbeengeneratedindicatingthatGEfoodsarenotinfactmorelikelytocauseharmfulsideeffectsthanareconventionalones.

Isthisthecase?Asitturnsout,onereportdoesdiscusssubstantiallymoreevidencewithdirectbearingontherisksofGEfoodsthandoestheother.However,it’snottheonethatcamelatest.Contrarytoreasonableexpectations(andasweshallsee),theCanadianreportisbolsteredbymoresuchevidence,eventhoughitwasproducedmuchearlierthantheother.

Moreover,notonlydoestheNASreportdisregardaconsiderablestoreofdatathatcountersitsmaincontentions,itproffersscantevidencetopropthem.Equallyodd,besidesitsevidentiarydeficiencies,itlackssoundlogic.Aswe’llsee,itsmainargumentsareinkeyrespectsincoherentandeveninconsistent–sometimestotheextentofsevereself-contradiction.Moreover,intryingtoestablishthatGEfoodspresentminimalrisk,theycontorttheverymeaningoftheterm.

Becausethissemanticshiftispivotal,andbecauseitoccurscovertly,it’simportanttoexamineitcarefully.Andtodothat,wefirstneedtogetafirmunderstandingofwhatriskis.

CovertlyContortingtheConceptofRisk

AswediscussedinChapter7,calculatingriskisaprocessofidentifyingpotentialproblems,assessingtheprobabilitythattheywilloccur,andgaugingthedegreeofharmthatwouldresult.Inperformingsuchanalyses,hazardsaredistinguishedfromrisks.Althoughincommonparlancethetwotermsareusedinterchangeably,intechnicalcontexts,theyhavedistinctdenotations.19Ahazardisaspecificaspectofanobjectorsituationthathaspotentialforharm,whiletheriskposedbythehazardisafunctionof(1)thelikelihoodthatthepotentialwillbeactualized,multipliedby(2)theseverityoftheconsequentharm.Forinstance,walkingintheopenspacesofArizonaentailsthehazardofreceivingalethalsnakebite.SodoesstrollingthefieldsofOhio.Butdespitethepresenceofthesamehazard,therisksarehardlythesame,becauseafargreaternumberofvenomoussnakesareslitheringaboutinArizona.Therefore,anArizonaambleentailsahigherriskoffang-induceddeath.20

Therefore,inassessingrisk,it’snecessarytoconsidernotonlythehazards,buttheprobabilitytheywillactualize.Thisisunderscoredbythefactthatonemethodologycanentaileveryhazardposedbyanother,andevensomeadditionalones,andyetbemuchsafer.Acomparisonofflyingwithdrivingprovidesastrikingexample.

Onfirstimpression,airtravelappearsmoreperilous.Notonlydoesitentailvirtuallyeveryhazardinherentinautomobiletravel,itincludesadditionaldangers.Asdocars,airplanescancollidewithland-travelingvehicles(thevansandtrucksthattraversetherunways,andotherplanestaxiingthem),andsuchon-the-groundcollisionshavebecomethebiggestproblem.21Alsolikecars,theycansuffertheconsequencesofbrakefailure,blowatireandskidoutofcontrol,andsoon.But,unlikecars,theycanplummettoearthfromgreataltitudesduetoavarietyofmishapsthatareuniquelyaeronautic(suchashittingaflockofbirds).So,ifwefocusonlyonthemerepresenceofhazards,becauseairtravelentailsmoreofthemthandoestravelingbycar,we’dbecompelledtoconcludethatit’smoredangerous.(Orelsewe’dhavetobelievethat,onaverage,thehazardsofaviationcauselessharmwhentheymanifestthandothoseofdriving–whichisobviouslyfalse.)

However,weknowfromextensivedatathatairtravelismuchsafer–toanastoundingdegree.22Andthat’sbecause,pervehiclemile,there’samuchlowerprobabilitythatanyofitshazardswillactualize.In

contrast,althoughthehazardsposedbyautomobiletravelarefewerinnumber,thelikelihoodthatoneoranotherwillresultinconcretecatastropheissignificantlygreater.Therefore,althoughthehazardsofflyingaremorenumerous(andinsomecasesmuchscarier)thanthoseofdriving,flyingentailsfarlessrisk.

Thus,merelyidentifyinghazards(potentialproblems)doesnotinitselfrevealwhatriskisposed.Forthat,weneedtoknowtheprobabilitythatthepotentialproblemswillactuallydodamage.And,asearliernoted,wealsoneedtogaugehowextensivethatdamageislikelytobe.

However,althoughtheconceptofriskiseasytograsp,theNAShasbeenchronicallyincapableofcorrectlyapplyingitinthecaseofgeneticengineering.Thisdeficiencydatesfromtheacademy’sfirstformalstatementaboutthetechnology:itspositionpaperissuedin1987.Aspresentedinthedocument’soverview,thereweretwo“keyfindings.”

1. “ThereisnoevidencethatuniquehazardsexisteitherintheuseofR-DNAtechniquesorinthemovementofgenesbetweenunrelatedorganisms.”

2. “TherisksassociatedwiththeintroductionofR-DNAengineeredorganismsarethesameinkindasthoseassociatedwiththeintroductionofunmodifiedorganismsandorganismsmodifiedbyothermethods.” 23

Then,toensurethesefindingswereimplantedinpublicawareness,theywererestatedattheendofthedocument,toppingthelistofconclusions.24

Yet,despitebeingissuedbyaneminentscientificbody,thecombinedclaimoftheseconclusionsisillogical.Evenifwegrantthatthehazardsofgeneticengineeringarethesameasthehazardsofconventionalbreeding(which,aswillbeshown,isnottrue)itprovidesnobasisfordeclaringthattherisksarethesame.Aswe’veseen,merelyestablishingthattwosituationsentailidenticalhazardsdoesnotentailthattherisksarealsoidentical.Togaugetherelativerisks,deeperanalysisisrequired.

Ofcourse,it’spossiblethattheNAScommitteemighthaveengagedinthistypeofanalysis.Butthefactsweighagainstit.First,examinationofthedocumentprovidesnoindicationthatacarefulscientificanalysiswasmade.Second,aswesawinChapter2,whenPhilRegalconfrontedoneoftheauthorsaboutthewayscientificissueshadbeenmishandled,themanrefusedtoengageinadiscussiononthatlevelbecause,asheexplained,thepaperwasnotprimarilyscientificbut“political.”Third,theverylanguageoftheconclusionaboutrisksrevealsthatthecommitteehadnotseriouslyconsideredthem.

ThatconclusiondeclaredtherisksofGEorganismstobe“thesameinkind”asthoseofotherorganisms.Butsuchadeclarationisnotscientific,becauseitspeaksofrisksasifthey’rehazards,despitethedifferencebetweenthetwoconcepts.Aswe’veseen,whilehazardidentificationinvolvesrecognitionofvariouskindsofdangers,riskassessmentdoesnotprimarilydealwithkindbutwithdegree.Itseekstomeasuretheprobabilitythatoneoranotherkindofpotentialdangerwillactuallymanifest.Itdoesn’tfocusonqualitybutonquantity.Itdoesnotmerelyask“Whatkind?”but“Howmuch?”

So,byproclaimingthattherisksarethesame“inkind,”thecommitteedemonstratedthatithadn’tventuredtomovebeyondhazardidentificationandengageingenuineriskassessment.Italsodisclosedthateitheritwasseriouslyconfusedabouttheconceptofrisk–orwasintentonconfusingothers.

TheAcademyincreasedtheconfusionwithitsnextreportonGMOsin1989.Whereasthefirstreporthadconflatedhazardsandrisks,thesecondblurredtheboundariesbetweengeneticengineeringandconventionalbreeding.Infact,itattemptedtoequatetheprocesses,assertingthatthere’s“noconceptualdistinction”betweenthem.25AswesawinChapter4,althoughthisstatementislogicallyabsurd,ithasbeenextensivelyemployedbybiotechadvocates–andpassedoffasanauthoritativescientificconclusion.

TheAcademycouldhavesetthingsstraightinthereportitreleasedin2000.Butinstead,thatreportendorsedtheloosethinkingoftheinitialone–andevenexpandeditsscope.Becausethat1987report(aswellastheoneissuedin1989)waslimitedtotheenvironmentalrisksoffieldtrialswithinthecontinentalUS,itsstatementthattherisksofengineeredorganisms“arethesameinkind”asthoseofconventionaloneswas,asatechnicalmatter,similarlyrestricted.Buttheauthorsofthe2000reportnotonlyrepeatedly(andapprovingly)citedthatflawedstatement,theyextendedittotheissueoffoodsafety.26

However,althoughthescopeofthe2000reportwasbroaderthaneitherofitspredecessors,itwasnonethelesslimited.Itonlydealtwithplantsengineeredtoresistpests,suchasthoseendowedwiththeBtgene(whichwerediscussedinChapter7).SotherewasstillaneedforanNASreportthatappliedtoGEcropsingeneral.

Theoneissuedin2004addressedthatneed;anditwasrequestedandfundedbythreefederalagencies:theFDA,USDA,andEPA.27Yet,althoughitsrangewaswiderthanthe2000report,itsthinkingwasjustasnarrow.28Anditsreasoningaboutriskswasevenmoremuddled.

StrainingtoUpholdthe‘ProductNotProcess’Doctrine

Suchmuddlingwastheresultofasustained(andstrained)attempttoestablishthattheproductsofgeneticengineeringshouldnotberegulatedanydifferentlythanthoseofconventionalbreeding.Thisnotionwasthereport’scentralmessage,anditwasunequivocallyexpressedinthefirstsentenceofthepressreleaseheraldingthedocument’spublication.29Thatsentenceannounced,asthekeyconclusionoftheauthoringcommittee,thatallnewvarietiesoffood,whetherderivedthroughconventionalbreedingorgeneticengineering,shouldbeassessedforsafety“onacase-by-casebasis,”notonthebasisofwhattechniqueproducedthem.Thenextsentenceprovidedtherationaleforthatconclusion:“...becauseeventraditionalmethodssuchascross-breedingcancauseunexpectedchanges.”

Todrivethismessagehome,thesecondparagraphofthereleaseelaborateditinastatementfromthescientistwhochairedthecommittee:

“Allevidencetodateindicatesthatanybreedingtechniquethataltersaplantoranimal–whetherbygeneticengineeringorothermethods–hasthepotentialtocreateunintendedchangesinthequalityoramountsoffoodcomponentsthatcouldharmhealth.Thepossibleimpactofsuchcompositionalchangesshouldbeexaminedonacase-by-casebasistodeterminewhetherandhowmuchfurtherevaluationisneeded.”

Afewparagraphslater,thethemewasagainsoundedinhighlightingthereport’sleadfinding:thatsubjectingGEfoods(asaclass)toahigherlevelofsafetytestingthanconventionallyproducedonesis“scientificallyunjustified.” 30

And,toassurethatthebasicmessagewasclearlydisseminated,itwasalsorepeatedwhencommitteemembersspokewiththemedia.Forinstance,inatelephonenewsconference,onememberdeclared:“Themostimportantmessagefromthisreportisthatit’stheproductthatmatters,notthesystemyouareusingtoproduceit.” 31MajornewsoutletssuchastheNewYorkTimesgavethisstatementprominentplacementintheirstories.

Thus,the2004reportvigorouslyupholdsthemaxim,firstissuedasadirectivetofederalagenciesbytheReaganAdministrationin1986(androutinelyvoicedbybiotechproponentsthereafter),thatregulationshouldfocusontheproduct,nottheprocess.However,aswesawinChapter2,whilethisphraseiswell-worn,itisnotwell-founded;andalthoughitwaspresentedasascientificallybackedprinciple,itdidnotderivefromsoundscientificanalysisbutfromapurelypoliticalandeconomicagenda.

Nonetheless,manyinfluentialdocumentshavesubsequentlyespousedit,tothedetrimentoftheir

purportedlyscientificnature.OneofthemostimportantwastheFDA’s1992policystatement,whichpresumedthatallGEfoodsaresosafetheyneednotesting.AswesawinChapter5,anFDAcomplianceofficerprotestedtheagencywas“...tryingtofitasquarepegintoaroundhole...[by]tryingtoforceanultimateconclusionthatthereisnodifferencebetweenfoodsmodifiedbygeneticengineeringandfoodsmodifiedbytraditionalbreedingpractices.”Andsheblamedthisforcingon“themandatetoregulatetheproduct,nottheprocess.” 32

AlthoughthecommitteesthatwrotethevariousNASreportsongeneticengineeringwerenotofficiallymandatedtoembracethis‘productnotprocess’mantra(aswastheFDA),theyhaveneverthelesschosentodoso–whileendeavoringtoenhanceitsauraofscientificauthority.Themaximwaspropoundedasthe“fundamentalprinciple”oftheAcademy’sfirstreportonGEcropsin1987,andtheauthorsoftheonethatfollowedin1989indicatedtheirintentto“reemphasize”it–whichtheydidunstintingly.33Itwasemphasizedagaininthereportof2000;andtheonereleasedin2004firmlyupheldthetradition.Yet,asweshallsee,thatreportcouldnotupholdthemaximwhilealsoupholdingscience–orlogic;andthecommitteethatproduceditflounderedinthefaceofinconvenientfacts.

Forinstance,althoughtheauthorsofthe2004reportstressedthateverymethodofbreedingcanproduceunintendedeffects,theyalsohadtoacknowledgethatsomearemorelikelytodosothanothers–andthatgeneticengineeringhasoneofthegreatesttendencies.Nonetheless,inordertosupportthenotionthatthiserratictechnologyshouldnotbesubjecttostricterstandards,theymaintainedthatitdoesnotposegreaterrisks–evencomparedtothesimplest,mostnaturalprocessemployedsinceancienttimes.

Butinstrivingtosustainthiscontention,theirargumentsbecamecircuitous,andsometimesludicrous.

LooseLanguageandLameLogic

Intryingtomaketheircase,theyproducedachartpresentingtheirconclusionsabouthowthevariousmodesofplantbreedingdifferinpropensityforunintendedeffects.

SeeFigure9.1,whichisareproductionofthechart.Itcanalsobeviewedat:http://www.nap.edu/openbook.php?record_id=10977&page=64

Themodesarelistedalongtheverticalaxis,descendingfromlowesttohighestpropensity,withashadedbaralongsideeachtoindicatethemagnitudeofitslikelihoodforunintendedeffects.Consequently,eachsuccessivebarislongerthantheoneaboveit.Accordingtothereport,the“graytails”indicate“therangeofpotentialunintendedchanges”whilethedarksectionsindicate“therelativedegreeofgeneticdisruption.” 34Althoughthemeaningofthesestatementsisnotcrystalclear,itseemsthecommitteeissayingthattheentirelengthofthelinerepresentsthenumber(andkinds)ofeffectsthatthemethodislikelytoinducewhilethedarkareasrepresentthenetseverityofthevariousdisruptions.Butthere’snoneedtobelaborthisissue,becausethelongerthecompositebar,thegreaterthedarkareawithinit;soonecanfocusonoveralllengthasthekeydistinguishingfeature.

Themodeatthetopofthelisthastheshortestbar–andthelongesthistory.It’ssimpleselection:thetime-honoredpracticeoflettingplantspropagatenaturallyandthenchoosingthosethataremostdesirabletoprovideseedforthenextgeneration.35Accordingtothereport,thismethod“isleastlikelytoexpressunintendedeffects,andtherangeofthosethatdoappearisquitelimited.”Atthelist’sbottomisacategorythatincludestwotechniquesofinducingmutations:oneviaradiationandtheotherviachemicals.Thesetechniqueswereassignedthelongest(anddarkest)barbecause,inthecommittees’words,theyare“themostgeneticallydisruptiveand,consequently,mostlikelytodisplayunintendedeffectsfromthewidestpotentialrange....” 36

Geneticengineeringappearsatmorethanonepositionbecauseitcanbeperformedinmorethanonemanner;and,inthecommittees’opinion,eachhasadistinctdisruptivepotential.AsChapter4explained,therearetwomainmethodsfortransferringrecombinantDNAintoplants.OneemployspathogenicbacteriatoinserttherDNAbyinfectinganisolatedarrayofplantcells;theotherblaststherDNAintothecellswithagenegun.37Becauseresearchhasshownthatthelattertendstocausemoreextensivesideeffects,thecommitteerankeditasmoredisruptivethantheformer.Moreover,theyalsodeemedthatthedegreeofbiologicaldisparitybetweentheorganismsinvolvedinthegenetictransfermakesadifference.Therefore,theyclassifiedbacterialtransferbetweencloselyrelatedspeciesaslessdisruptivethanbacterialtransfersbetweendistantlyrelatedones,whilerecognizingasimilardistinctionforgene-guntransfers.Thus,fourmodesofgeneticengineeringappearalongtheverticalaxis,atpositions4,9,10,and11(specifiedbymethodofinsertionaswellasdistancebetweentheparticipantspecies),withgene-guntransferbetweenremotelyrelatedorganismsrankedasthemostdisruptiveofthefour–andsecondmostdisruptiveoverall,justshortofradiationandchemical-basedbreeding.Bacterialtransferbetweendistantspeciescomesinaclosethird,withanadjoiningbarthat’salmostaslongasthatofitsballistic-basedcounterpart.

However(asweshallsee),despitethecommittees’pretensionofprecision,therankingsforgeneticengineeringaredeeplyflawed,andallofitsmodesaredepictedassubstantiallylessdisruptivethanisactuallythecase.Buteveniftheserankingsareacceptedasaccurate,solongasthestandardsofreasonareadheredto,theaccompanyingclaimscannotbe.Inoneofthemostastounding,thecommitteetriedtoallayconcernstheirchartmayhaveraisedbyassuringthereaderthatevenifatechniqueincreasesthelikelihoodofunintendedeffects,itdoesnottherebyincreaserisk.Astheyputit:“Placementalongthiscontinuumhasnobearingonriskofadverseoutcomes,butonlyontheprobabilityofunintendedchanges,whichneednotbehazardous.” 38

However,whileitistruethatnotallunintendedchangesinplantbreedingwillbeharmful,it’sabsurdtoassertthere’snoconnectionbetweenaprocess’spropensitytoinducethemandthedegreeofriskthat’sposedbyitsproducts.Alittleanalysismakesthisobvious.

Therearevariouskindsofunintendedalterationsthatcanadverselyaffectconsumerhealth.Forinstance,somecanreducethequantityofoneormorenutrients.Ornutrientintakecouldbeimpededbyinadvertentlyincreasingtheconcentrationofsubstancesthatimpairthedigestionorassimilationofparticularnutrients–orbycreatinganti-nutritivesubstancesthatwerenotalreadythere.Further,otherchangescouldmakethefooddirectlydangerousbyintroducingnewallergensorbyperilouslyelevatingtheleveloftoxinsthatnormallyexistatlowlevels.Ornewtoxinscouldevenbecreated.

Further,thesetypesofchangesinvolvedifferentdegreesofrisk.Forinstance,aslightreductioninaparticularnutrientwouldordinarilyposelessdangerthanthecreationofanallergenthatcouldseverelysickentensofthousandsofpeople.Andmakingafoodtoxiccouldbefarmoredangerousthanthat,becausetoxinstendtoaffecteveryone,whileanallergenisonlyproblematicforasmallportionofthepopulation.Moreover,elevatingatoxinthat’salreadyintheplantwouldgenerallyinducelessoverallharmthancreatingonethathadneverbeentherebefore,becausemostnativetoxinsareknown,enablingbreederstodetecttheproblemandpreventcommercialization.Incontrast,unknowntoxinscouldeasilygounnoticed.Thepotentialfortotalharmalsodependsonhowquicklyatoxinacts.Thosethatcauseanimmediateandnoticeablereactioncansubsequentlybeavoided,whilethosethatinduceincrementalharmovermanyyearsaredifficulttodiscover,eveniftheircumulativeeffectishuge.That’swhytobaccohaskilledmillionsmorepeoplethanhavetoxictoadstools.Althoughthelatterarefarmorelethalperunitconsumed,becausethey’redramaticallydeadly,humanshavelongknowntoshunthem.Conversely,becausenoonedropsdeadafterhisfirst(oreventhousandth)cigarette,ittookcenturiesbeforetheiraggregateeffectswerefinallyrecognized.

Inthisregard,it’simportanttounderstandthat,liketobacco-induceddisease,mostfood-borne

illnessesarenotacute,butchronic.Theydevelopslowlythroughrepeatedexposure,andthey’remoredifficulttodetectthanthoseinducingarapidandnoticeablereaction.Therefore,theyentailgreatertotalrisk.

Thus,weagainseethattheriskentailedbyanunintendedchangeisafunctionofboththelikelihooditwillcauseharmandhowgreattheharmislikelytobe.Butthecommitteelostsightofthisfact–andalsolosttouchwithcommonsense.Justconsidertheimplicationsoftheirclaims.

Ontheonehand,theyacknowledgedthatthemainformsofgeneticengineering(aswellasradiationandchemicalbreeding)entailafargreaterlikelihoodofunintendedeffectsthandoespollen-basedbreeding,whileontheother,theyallegedthatthesemoredisruptivetechniquesdonotnecessarilyposehigherrisk.Therefore,ifthesehigh-techmethodsinduceunintendedeffectsmorefrequentlythanpollen-basedbreedingandyetdonotengenderhigherrisk,thentheeffectstheydogeneratemust,onaverage,belessdangerousthanthelessfrequentlyinducedsideeffectsofthatnaturalmethod.Or,tolookatittheotherwayaround,ifthepotentialsideeffectsofboththeinvasiveandthenaturalmethodsposethesamedegreeofrisk,butthelatteraretentimeslesslikelytomanifest,theymustbetentimesmoredangerous.39

Thisresultisclearlyridiculous;anditatteststheAcademy’songoingwillingnesstomanglethemeaningofriskonbehalfofgeneticengineering.

Yet,thesnubbingofreasondidnotstopthere,andasthecommitteepressedon,theydescendedmoredeeplyintologicaldysfunction.Forexample,tobuttresstheirbasicclaim,theyassertedthatnoneofthevariousmethodsofbreeding,whetherbasedonsimpleselection,radiation,orgeneticengineering,is“inherentlyhazardous.” 40Notonlyisthispronouncementmomentous,it’scurious;andonemaywellwonderonwhatgroundsitrests.Here’stheirexplanation:“Ifaparticularmethodwereinherentlyhazardous,allproductsresultingfromitsusewouldbepotentiallyharmful.However,itisknownthateachmethodcanprovidesafeproducts....” 41

Thisrationaleisdubiousinmultiplerespects.Foronething,justbecauseamethodcansometimesyieldsafeproductsdoesnotimplyit’sinherentlynonhazardous.Forinstance,ifatechnologycrankedout100harmfulproductsforeverysafeoneitdelivered,wewouldnotregarditasinnatelyinnocuous,despitethefactitcanoccasionallyyieldanon-injuriousresult.

Further,it’sconfusing(andmisleading)toassertthatnoneoftheprocessesisinherentlyhazardous.Afterall,thereportitselfrepeatedlyemphasizesthateachmethodcaninduceunintendedeffects.Accordingly,itwouldbemoreaccurate(andhonest)toacknowledgethatallofthementailinherenthazard–andtothenengageinanearnestassessmentofcomparativeriskbyexaminingtheprobabilitiesthattherespectivehazardswillmanifest.

ButitappearsthatthemembersofthecommitteewerelessconcernedwithaccuracyandhonestythanwithportrayingrDNAtechnologyasnoriskierthanconventionalprocesses.Otherwise,theywouldn’thaveappendedtheircuriousassertionwiththeclause:“sothekeyforbreedersandregulatoryagencies...istoidentifytherelativelyrare,potentiallyhazardousproductsresultingfromanymethod.” 42

Thisstatementcouldwinamedalforlengthoflogicalleap.It’saprodigiousfeattostartwiththepropositionthateverymethodcanproducesomesafeproductsandjumptotheconclusionthateachproducesthemsoroutinelythatitspotentiallyhazardousproductsare“relativelyrare.”

Thus,inthespaceoftwosentences,thecommitteeostensiblydemonstratedthatgeneticengineering(aswellasradiationandchemicalbreeding)entailnegligiblerisk,becauseifit’sindeedthecasethatthesemethodsrarelyproduceafoodthat’seven“potentially”hazardous,theycanhardlyposeanydanger.Butthispurporteddemonstrationwascarriedoffwithoutcitinganyevidence–andbywrenchingtherulesoflogic.

So,justastheReaganAdministrationestablishedthe‘productnotprocess’maximbyedictratherthanevidence(orearnestanalysis),thecommitteetriedtoestablishthesafetyofgeneticengineeringinthe

samemanner.Accordingly,theirassertionismoreimperialthanempirical–andmorelaughablethanlogical.Althoughtheirconvolutedverbiageandpretensionstoscientificprocesstendtoobscureit,inessencetheydeclared,“Geneticengineeringissafebecausewesayitis.”

Theassertion’sdubiousnesshasyetanotherdimension:itisnot“known”thatbioengineering(orradiationbreedingandchemicalbreeding)canprovidesafeproducts.43That’sbecauseknowingentailsahighdegreeofcertitude.Forinstance,weknowthat2plus2equals4andthattheareaofarectangleequalsitsheighttimesitslength.Further,althoughphilosophersdebatetheextenttowhichwecanactuallyknowthingsoutsidetherealmoftruthsthatcanbeproventhroughpurededuction,inourcommonunderstanding,whenagroupofscientistsstatethatsomethingisknown,they’reimplyingit’sbackedbyalotofsolidevidence–toadegreethatleaveslittleroomfordoubt.Theyarethusindicatingthattheirallegedknowledgeisbasedonfarmorethanareasonablepresumption,aninformedopinion,orevenanearnestassessmentoffactsthat,whilesuggestingaparticularconclusion,arenotfullyconclusive.

Butthecommittee’sclaimsaboutradiationbreedingandgeneticengineeringhavenohardevidencebehindthem.Aspreviouschaptershavediscussed,andastheCanadianreportconfirms(andthenextchapterwillmorethoroughlydemonstrate),noneoftheproductsofbioengineeringhasbeenprovensafeviaadequatetesting.44Andinthecaseoffoodscreatedviaradiation,nosafetytestshaveevenbeenconducted.45Furthermore,thecommitteeacknowledged“itisalmostcertain”thatplantsbredviaradiationcontainmutationsinadditiontothosethatareselectedfor–andthatthesechangescouldremainundetectedandinduce“unknowneffects.” 46

Thebestthecommitteecansayinregardtoradiationisthatitsproductsare“widelyusedandaccepted”andthatnoharmhasbeenlinkedtoany.47Butthesamecouldhavebeensaidabouttobaccopriorto1960.Further,tobaccowasfinallylinkedtodiseaseonlythroughlong-termepidemiologicalstudies,whilenosuchstudieshaveevenbeenstartedfortheproductsofradiationorbioengineering–andnorecordskeptthatcouldenablethem.48Soifanyofthefoodsproducedviaradiationorbioengineeringhavebeencausingcommonailmentssuchascancerorcolitis,expertscouldnothavediscernedit.Further,asDavidSchubert(aprofessorattheSalkInstitute)hasnoted,evenifadequatemonitoringwereinplace,anyincreaseinacommondiseaseinducedbyanovelfoodcouldstillnotbedetectedunlessitatleastdoubledtheordinaryfrequencyofnewcases.49

Moreover,atleastoneoftheproductsofgeneticengineering(atryptophansupplement)hasbeenclearlylinkedtoharm.Andtheharmwasnotaminorannoyancebutadeadlyepidemicthatharmedthousandsofpeople.However,aswesawinChapter3,GEadvocatestendtoobscurethisfact–andtrytojustifytheirrefusaltoreportitbyarguingthatbecausetheengineeringprocessitselfwasnotshowntohavecausedthedisease,they’reexcusedfromacknowledgingthatthedisasterarosethroughoneofitsproducts.Yet,asthatchapterdemonstrates,thisargumentisnotonlylogicallyinvalidit’sempiricallyoff-base,becausetheevidenceindicatesthattheprocesswasthekeycause.50

Thetryptophandisasterunderscoresthefact,pointedoutbytheFDAexperts(andmanyothers),thatinassessingwhetherGEfoodscauseharmfuleffects,absenceofevidenceisnotevidenceofabsence–evenifnoproblemsareobservedovermanyyears.Afterall,if(backin1989)theengineeredtryptophansupplementhadharmedallthosepeopleviaacommonplacemaladyinsteadofahighlyunusualone,scientistswouldstillnotbeawareitwastoxic–anditwouldprobablystillbeonthemarket,continuingtodealdeathanddisability.

Yet,ashavesomanyotherswhowishtoprotecttheimageofgeneticengineering,thecommitteeneglectedtomentiontheepidemic,whilealsoneglectingtofaceanotherunpleasantreality.TheyexpressedconfidenceinthecurrentregulatorysystemandcontendedthatithasadequatelyscreenedtheGEfoodsonthemarketforharmfulchanges–despitethefacttheCanadianexpertshadchargedthatthesystemisseriouslyill-suitedtodoso.51

Thus,it’sclearthatthecommitteeoverstatedthestateofourknowledge.Contrarytotheirunequivocalclaim,wedonotknowthatgeneticengineering,orradiationbreeding,canprovidesafeproducts,becausethere’snosolidevidencetoconfirmthatanythey’vecreatedisactuallysafe–and,aswe’veseen(andwillsoonmorefullyappreciate),there’sgoodreasontothinkthattheycouldbeharmful.

Nonetheless,biotechadvocateshavebeenemboldenedbythecommittees’pronouncement,andhaveevenunwarrantedlyamplifiedit.Forinstance,althoughthecommitteesaidweknowthatgeneticengineeringiscapableofproducingsomesafefoods,PamelaRonald(theUniversityofCaliforniascientistwhosedistortionswerediscussedinChapter4)reliesontheirreporttodeclaresheknowsthatalltheGEfoodsonthemarketarejustassafeastherestofthefoodsinherrefrigerator.52Andbecausethisunconditionalassertionappearsinanostensiblyauthoritative(andhighlyinfluential)book,ithascoloredthethinkingofmanyintelligentpeople,despitethefactit’sfalse.Astheforegoingdiscussionhasdemonstrated,althoughRonaldcanthinkthatthesefoodsaresafe,andmayevenferventlybelieveit,shortofdivinerevelation,shecannotactuallyknowit.53

Duetothecommittees’devotiontothe‘productnotprocess’doctrine,theirargumentscontinuedtobeclumsy.Forinstance,inattemptingtoestablishthattheprocessofproductionisnotareliablepredictorofproblems,theyclassedallsuchprocesses(includingsimplepollination)as“methodsforgeneticmodification”andthendeclared,“Thepotentialforhazardresidesinspecificproductsofthemodification....” 54Thisimpliesthattheproductionprocessisdisconnectedfromhazard–anotionthat’sclearlymistaken.Althoughconsumersarenotdirectlyinjuredbytheproductionprocess(aslaboratoryorfactoryworkerscanbe)andareinsteadharmedbywhateverdeleteriousfoodsitmayproduce,ifaparticularprocesshasahighlikelihoodofchurningoutpoisonousproducts,it’sfairtosaythatitishazardous.Afterall,ahazardisaconditionwiththepotentialtocauseharm.Butaccordingtothecommittee’sstrangelogic,suchaprocesscannotevenbesaidtoentailthepotentialforhazard.

Howeverit’sexpressed(andthecommitteeexpressesitinseveralways),thenotionthattheprocessofproductionisessentiallyneutralinregardtorisk,andthatregulationcanbeprimarilybasedonthespecificproductsthemselves,isfallacious.AstheCanadianreportexplained,wecanonlydeterminewhatinitiallevelofregulationisappropriatebyassessingtherisksposedbyeachprocess.Wecannotdosobyassumingtherisksareessentiallyequalsimplybecauseeachprocesshasthepotentialtoinduceinjuriousoutcomes–whileignoringthefactthatsomewilldosofarlessfrequentlythanothers.Iftheproductsofgeneticengineeringaremuchmorelikelytocontainharmfulingredientsthanarethoseoftraditionalmethods,thenit’sreasonable(andnecessary)torequirethateachbetestedmorerigorously.Thisisespeciallysobecauseanumberofharmfuleffectswouldbedifficulttodetectwithoutextensivetesting.Soifsuperficialanalysesarerelieduponinstead,anddeepertestingisnotperformedunlesssuchanalyseshappentodiscoversignsofproblems,manyactualproblemscouldescapenotice.

Thus,tofocusontheproductwithoutconsideringtherisksoftheprocessthroughwhichitemergedistorunthesignificantriskofignoringnoxioussubstancesitmaycontain.AndbecausetheNAScommittees’ownchartacknowledgesthatthemodesofgeneticengineeringbehindmostofthecropscurrentlyconsumedaremuchmorelikelytoproduceunintendedeffectsthanalmosteveryotherformofbreeding,it’sclearthattheregulatorypaththeyendorseisnotonlyunsound,butirresponsible.

What’smore,it’sillegal–atleastintheUnitedStates,whosegovernmentrequestedthereport.AsChapter5demonstrated,accordingtoUSlaw,everyGEfoodmustbepresumedunsafeuntilprovensafebystandardscientificprocedures–evenifitisclaimedtobe“generallyrecognizedassafe.”However,incommonwithmostAmericans,thecommitteememberswereconfusedabouthowthelawrelatestoGEfoods–andwereapparentlyundertheillusion(fosteredbytheFDA)thatthemanufacturershavenoburdentodemonstratetheirsafety.55

UnderstatingHazardsbyOverlookingFacts

Thecommittee’scommitmenttothe‘productnotprocess’maximskewedanotherimportantfacetoftheirreportaswell.Notonlydiditsullydiscussionofhowthecomparativechartrelatestorisk,itcausedeverybarassociatedwithbioengineeringtobedrawntooshort.Andtheinaccuracyofthelengthsisattestedbythechartitself.Abitofanalysismakesthisclear.

Whenthereportdescribesthegeneticengineeringprocess,itgivestheimpressionthatafteranisolatedcellhasincorporatedthecassetteoftransferredrDNA,it’sasimplemattertoregenerateitintoamatureplant.56However,asChapter4noted,suchregenerationcouldnotoccurwithoutsubstantialhumanintervention,usuallyintheformoftheartificialprocesscalledtissueculture–whichimpartswhatexpertshavereferredtoasa“genomicshock”thattriggerssubstantialmutations.57

Accordingly,plantbreedershavesometimesemployedtissuecultureinthehopesofcreatingusefulchange,justasthey’vedonewithradiation.Yet,likeradiation,tissueculturegeneratesabroadrangeofunintendeddisruptions–someofwhichcouldbeharmfultothepeopleandanimalsthatconsumethealteredproduct.

Indescribingthevariousmodesofplantproduction,theNASreportdevotestwoparagraphstotissueculture.58However,notonlydotheseparagraphsfailtomentionitsessentialroleinthegeneticengineeringprocess,theyimplythatthelatterhasnoneedofit.Thereaderistoldthatalthoughsomebreedersstillusetissueculturetogeneratemutations,thepracticeisnowlargelyconfinedtodevelopingcountriesbecauseit“haslargelybeensupplantedbymorepredictablegeneticengineeringtechnologies.” 59Andwhen,onthefollowingtwopages,thecommitteedescribedhowGEplantsareproduced,therewasnomentionoftissueculture.60Buttheseomissionsbeliethefactthatalthoughmostbreedersnolongeremploytissuecultureinthequestforfavorablemutations,theystillmustuseitiftheywanttotransformgeneticallyengineeredcellsintofullplants–andthatinstickingwithitforthatpurpose,they’realsostuckwithundesirabledisruptionsitcreates.61

However,they’renotstuckwithallofthem.That’sbecauseafteraregeneratedplanthasbeenproducedwithtissueculture,it’susuallyputthroughrepeatedroundsofsexualcrossingthroughwhichmutationsthatresultineasilyobservedabnormalitiescanbegraduallyremoved.Andthisisdonebybioengineersaswellasbybreederswhoemploytissueculturetoproduceusefulmutationsinnon-engineeredplants.

Yet,whilethisprocessreducesthenumberofcollateralchanges,itwouldusuallyfailtoeliminatethem.Accordingtotheauthorsofanextensivereviewofthechangesthattissuecultureinduces,“thereisahighprobability”thatregeneratedplants(evenwhenmarket-ready)willbearalterationstotheirgenomesaswellastoareasthataretrans-genomic.Consequently,theyassertedthatthisreality“shouldbecarefullyconsidered”inallofthetechnique’spracticalapplications;andtheynotedthatoneoftheseistheproductionofGEcrops.62

Nonetheless,althoughtissuecultureiswidelyemployedincreatingGEplants,andalthoughit’shighlylikelytoinduceunwantedalterationsthatwillremaininthefinalproduct,thecommitteefailedtoaccountfortheseeffectswhen,indevisingtheircomparativechart,theydecidedhowlongthebarsaffixedtothemodesofbioengineeringshouldbe.

Andthatwasnotbecausetheyfailedtorecognizethatthefinalproductsoftissueculturewillalmostsurelyharborsucheffects.Theyrecognizedthisreality;andthisisreflectedinthebartheyassignedtotheprocess,whichmarksitasoneofthemoredisruptivetechniques.Infact,it’sportrayedasfarmoredisruptivethanoneofthemodesofgeneticengineering(bacterialrDNAtransferbetweencloselyrelatedspecies),withabarmorethanfourtimeslongerthantheoneaccompanyingthatGE-basedprocess.(Comparebars4and8inFigure9.1)63

Butthat’sbizarre,consideringthatthelatterprocessreliesontissueculturetoturntheengineeredcellsintoadultplants.Thisanomalyimpliesthecommitteetooknoaccountofculture-inducedeffectswhenestimatingthelengthofthatmethod’sbar.Accordingly,onemightquicklyconcludethatthebarshouldbeincreasedbyalengthequaltotheentirebarfortissueculture–andthatthebarsassociatedwiththethreeothermodesofbioengineeringshouldbelikewiseelongated.

Ifthisweredone,importantchangeswouldoccurintherankings.AlthoughthebarsdepictingthedisruptivetendenciesofthemodesofGE-basedmethodswouldhavelengthened(anddarkened),theonebelongingtoradiationwouldremainunchanged.That’sbecausetheradiationisdirectedatseedsratherthanisolatedcells,andtheseedsgrowintoplantswithoutassistancefromtissueculture.Consequently,threeoftheapplicationsofgeneticengineeringwouldbecomethemostdisruptivemethodsinthechart–significantlysurpassingradiation.

Yet,it’sprobablyunwarrantedtoreadjusttherankingstosuchadegree.That’sbecause,althoughbothbioengineersandthebreederswhoactuallyaimtocausemutationsviatissueculturetrytoreduceunwantedchangesinthesamewayaftertheculturingprocesshasresultedinaregeneratedplant,theytendtoperformtheprocessthatgivesrisetotheplantindifferentways.Andthedifferencescanreducetheinitialnumberofmutations.

There’sflexibilitybecausethenumberandseverityofthemutationsareinfluencedbyfactorsthatcanvaryfromcasetocase,andseveralofthesecantosomeextentbeadjustedbythebreeders.Forinstance,ifcellsaresubjectedtotheculturingprocessforshortertimes,mutationstendtolessen.Loweringthelevelofappliedhormonescanhavethesameeffect.64Accordingly,geneticengineerstrytomanageconditionssoastoavoidmutations,whereasthebreederswhowanttoinducethemrequireconditionsthatfavortheirformation.Therefore,theplantsthesebreedersregeneratewouldbeexpectedtocontain,onaverage,moreunwantedculture-inducedmutationsthandoengineeredplants,whichincreasesthelikelihoodthatmoreofthemwouldremainafterthesubsequentbreedingcyclehasended.65

Inlightofthisdifference,isitplausiblethatthecommitteeaccountedfortheroleoftissuecultureingeneticengineeringafterall?Intheirassessmentsofthelatter’smutationalpropensity,didtheyassumethattheeffortsofthebiotechnicianshavesignificantlysoftenedtheperturbationalpunchoftissueculture–andthenadjusttheircalculationsaccordingly?It’scleartheydidnot.Althoughtheyprovidedscantexplanationofthereasoningbehindtheirrankings,it’salmostcertainthattheydidn’ttaketheeffectsoftissuecultureintoaccountatall.Forinstance,thebarassociatedwithbacterial-basedtransferofrDNAbetweendifferent,butcloselyrelated,species(bar4)isquitesmall,andalmostidenticaltotheoneaffixedtoselectingfromagroupofnon-identicalplantswithinthesamespecies–plantsthatwerepropagatedviathenaturalprocessofpollination(bar2).Soifmerely5%ofthatGE-relatedbarrepresentedtheeffectsoftissueculture,itwouldentailthatrandomlywedgingachunkofDNAfromonespeciesintotheDNAofadifferent(thoughcloselyrelated)speciesviabacterialinfectionis,initself,lesslikelytoinduceunintendedchangesthanistheflowofpollenbetweentwozucchinis.66

It’sextremelyunlikelythatsuchadifferentialexists;andit’salsounlikelythecommitteeintendedtoimplythatitdoes,becausethatwouldhavecontradictedapremisetheyconsistentlyappliedinthechart:thepremisethatthegreaterthebiologicaldistancebetweentheorganismsinvolvedingenetransfer,thegreaterthetendencyforunexpectedchanges.Soit’sevidenttheydisregardedtheeffectsoftissueculture.

Accordingly,theirchartshouldbeadjustedtoproperlyaccountfortheseeffects.However,it’sdifficulttodeterminehowtodoso,becauseseveralvariablesareinvolved.Notonlydodifferentbiotechcompaniesprobablyhavetheirownmethodsofdoingthecultures,it’smorechallengingtomitigatemutationsinsomespeciesthaninothers;andadditionalfactorscanalsocomeintoplay.So,whileitwouldlikelybemistakentoamendthechartbyincreasingthebarsassociatedwiththemodesofbioengineeringbythefulllengthofthebarassignedtotissueculture(whenemployedasapurposely

mutationalprocess),failingtoenlargethembyatleastone-thirdthatlengthwouldprobablyalsobeerrant.

So,ifwestayconservativeandstretchthebarsassociatedwithGEbyaddingjustone-thirdthelengthofthebarthecommitteeassignedtotissueculture(bar8),thetwomodesthathaveproducedmostoftheengineeredcropsonthemarketnolongerlagbehindradiationbreedinginpropensityforunintendedeffects.Onebecomesequal(ifnotslightlygreater),andtheother,theoneresponsibleforthebulkoftheGEfoodssittingongroceryshelves,exceedsradiationbyanoticeablemargin.67

Therefore,accordingtothecommittee’sowncalculations(whenconservativelyadjustedtocorrectforacrucialoversight),geneticengineeringstandsasthemostdisruptivetechniqueonthechart:withoneofitspredominantcommercialmodessurpassingtheperturbationalpowerofblastingseedswithDNA-damagingradiation,andtheotherequalingit.Moreover,iftherankingsareinsteadadjustedbyincreasingthebarsdepictingtheGEmodesbyhalfthelengthofthebarfortissueculture(whichmaybemoreappropriate),radiationbreedingdecisivelydropstothirdplace,wellbehindeachofthosetwoGEmodesindisruptivepotential.68

Consequently,settingtherankingsstraightfullyunderminesoneofthemainargumentsthereportpromoted:thecontentionthatbecauseradiation-basedbreedingisevenmoredisruptivethanbioengineering,andbecauseit’ssafe,thelattermustbesafeaswell.We’vealreadyseenthatthesecondpremiseofthisargument(thatradiationbreedingisknowntobesafe)isfalse;andnowweknowthatthefirstpremiseisalsowrong–evenwithintheconfinesofthecommittees’ownthinking,becausewhentheirchartisadjustedtoaccommodatecommonlyrecognizedfacts(whichtheyoverlooked),thepremiseiscontradicted.

Further,evenifoneacceptstheassertionaboutthesafetyofradiation,thelargerargumentstillfails–whichishighlysignificant,consideringhowheavilybiotechadvocateshavereliedonit.Forinstance,inTomorrow’sTable,PamelaRonaldcitesthe2004reportasevidencethatmutationbreedingviaradiation“isconsideredverysafe”despitethefactitposes“evengreaterrisks”thangeneticengineering.69HadsherealizedthatthereportactuallyshowsthemodeofbioengineeringbehindmostGEfoodsonthemarkettobesubstantiallymoredisruptivethanradiationbreeding,shewouldhavealsorealizedthatevenifthelatterhadbeenprovensafe,itwouldnotconfirmthesafetyoftheformer.

Moreover,inadditiontodisregardingtheeffectsoftissueculture,thecommitteeoverlookedseveralotherwaysinwhichgeneticengineeringcausesunwantedchanges.And,asweshallsee,whenallrelevantfactsareproperlyassessed,it’sobviousthattheaggregatefoodsafetyriskposedbythisnewestmodeofbreedingexceedstheriskposedbyeveryothermodebyafargreatermarginthanwouldbeindicatedbymerelyadjustingthecharttoaccountfortissueculture–andthat,ifthechartwerere-drawntofairlyreflectreality,thebarassociatedwitheverymodeofbioengineeringwouldbesignificantlylonger(anddarker)thanthebarofanyotherformofbreeding,includingradiation.

Solet’sdiscoverwhythosebarsshouldbere-drawn.

HowtheRisksofGeneticEngineeringWereConsistentlyMisrepresented

TheNAScommittees’aversiontoaforthrightconfrontationwiththeunintendedeffectsofbioengineeringwassostrongthattheyignoredseveralkeyfacts–whilemisrepresentingothersthattheydidmention.Thesefaultswillbeobviousasweexaminehowtheydealtwithsomeimportantissues.

a.TheUseofViralPromoters

Thecommitteewasespeciallycavalierregardingthepromoterfromthecauliflowermosaicvirus(the35Spromoter)that’spresentinmostGEfoods.Asdiscussedinpreviouschapters,thispowerfulpromoterisattachedtotheinsertedgenesandimpelsthemtoconstantlyexpresstheproteinstheyencode

outsidethecontrolsoftheplant’sintricateregulatorysystem.Thisabnormalactivitycandisruptcomplexbiochemicalfeedbackloopsandinduceadverseoutcomes.Suchdisruptionscanalsoresultfromthecontinuousdrainofenergytopowerfunctionsthattheplantdoesn’tneed.Moreover,thepromoterscaninduceerraticexpressionofnearby(andevendistant)nativegenesorcanactivatebiochemicalpathwaysthatareordinarilyinactive–eitherofwhichcouldleadtotheproductionofharmfulsubstances.

Yet,althoughatthetimethereportwaswrittensuchhyper-activepromoterswereoperatingwithintheDNAofvirtuallyeveryGEfoodonthemarket,andalthoughmanyexperts(includingtheCanadianpanel)hadraisedconcernsabouttheabove-describedrisks,thecommitteedidnotdeigntosomuchasmentionevenoneofthem.Infact,onlyasinglesentenceintheirreportreferstoviralpromoterswithinGEplants,andbesidesbeingunrelatedtotheaboveconcerns,itprovidesnoinklingaboutwhatthepromotersare,howtheyfunction,andwhythey’reneeded.70Soapersonwhodidnotalreadyhavesuchknowledgewouldstillbeuninformedafterreadingthefullreport.

Further,althoughsomeGEadvocatesdoatleastacknowledgethevariouspromoter-relatedconcerns,theydismissthembyarguingthatmanyconventionallyproducedandwidelyconsumedvegetableshavebeeninfectedbythecauliflowermosaicvirus–andthattheactivityofthe35SpromoterinthosecasesisnoriskierthaninthecaseofGEproducts.Butthisargumentdisregardsanimportantfact:the35Spromotersinnaturallyinfectedplantsareinadifferentlocationthanarethosethatentertheplantsviageneticengineering.And,asinrealestate,locationisofprimeimportanceinthiscasetoo–anditmustbetakenintoaccount.

Ingeneticengineering,therecombinantcassettesandthe35Spromoterswithinthemwedgedirectlyintotheplants’DNA,whilethepromoterswithinaninvadingcauliflowermosaicvirusdonot.Instead,theyremainoutsidetheplants’DNA.Consequently,thepromotersinnaturallyinfectedplantsdon’texertthesamedisruptiveinfluenceonthenativeDNAasdothosethatthatareartificiallyinserted;and,accordingtotheplantvirologistJonathanLatham,thelatterare“almostcertain”tocausedifferenteffects–andcanalterexpressionoftheplants’genesinwaysthatthenaturallyintroducedpromoterswon’t.71

Sothepromotersthatdriveexpressionoftheinsertedgenesposedifferentfoodsafetyrisksthanthosetuckedwithintheviruses,anditwasamajoroversightforthecommitteetoignorethisreality.

b.DisruptionsCausedbytheInsertionProcess

Inthesamesectionofthereportinwhichitdodgedadiscussionofviralpromoters,thecommitteealsoevadedanearnestexaminationofthedisruptionscausedbytheinsertionofrecombinantDNA.WhiletheydiddiscussalterationsthatcanoccurwhenonesectionofDNAinsertsintoanother,theirdiscussionwasundulyfocusedonthedisruptivepotentialofanaturalphenomenon:theabilityofsomeDNAsegmentstobecomemobileandre-insertintoanewregionofthegenome.

Thesemobilesegmentsaretechnicallytermedtransposableelementsortransposons–andthey’recommonlycalled“jumpinggenes.”And,althoughthecommitteedidn’trefertothembythelatterterm,theyapparentlydidwanttomakepeoplefeeljumpyaboutthem.Thus,thesectiononinsertionaldisruptionsbegins,notwithadescriptionofthosethatareknowntoresultfromgeneticengineering,butwithadiscussionofdisturbancesthattransposonscancause.Itnotesthatwhentransposonsmove,theysometimesre-insertintogenesanddisrupttheirfunction.Italsopointsoutthatevenifageneisnotdirectlydisrupted,theinsertiondisruptstheDNAsequencethat’sinvolved–andcanalsoinducerearrangementsofsurroundingDNA.72

ThecommitteethentriedtoshowthattheinsertionofDNAcassettesviabioengineeringposeslessrisk.Theystatedthatit’s“rare”fortransferredDNAtoinsertintoimportantgenes–andthatevenifitdoes,theresultantundesirablechangewillbenoticedduringsubsequentscreeningandthattheplantlinecontainingitwillbediscarded.73Buttheyfailedtonotethattransposonsdon’tordinarilyposeanygreater

insertion-relatedrisks.Intheabsenceofextraordinarystresses,thesepotentiallymobileelementsrarelymobilize;somostoftheircurrentpositioningsoccurredintheancientpast.74Thismeansthatoverthevaststretchofbiologicaltime,anyinsertionsthatimpairedthehealthoftheplantwouldhavebeeneliminated.Andthosethatimpairedthehealthoftheplant’sconsumerswouldhavealsobeendiscarded.Further,totheextentthatanytransposon-relatedproblemsremain,they’rejustassalientinaGEplantasinthenon-engineeredvarietyfromwhichit’sdeveloped.

Infact,abioengineeredplantcarriesgreatertransposon-relatedriskthanitsparentbecausetheengineeringprocesstendstoactivatetransposonsandgetthemjumping.Butnotonlydidthecommitteeignorethisfact,theyimpliedtheopposite.Similartotheirportrayaloftissueculture,theirdiscussionoftransposonactivationimpartsthefalseimpressionthatit’saphenomenonunconnectedto(andmoreworrisomethan)thebioengineeringprocess.

Yet,inreality,thatprocesscaninducetransposonmovementinthreeways.First,theinsertionofthecassettecanitselfcausetransposonstoshiftlocations.75Further,aspreviouslynoted,theengineeredcellsarethensubjectedtotissueculture,whichimpartsa“genomicshock.”Duetothisjolt,transposonsoftenjump.76Additionally,the35Spromotercanstirnearbytransposonsintoamobilemode.77

Conversely,theprocessofpollinationrarelycausestransposonstomobilize.78Therefore,contrarytotheimpressionthecommitteecreated,whateverrisksareentailedbytransposonactivationareinherentinbioengineeringbutlargelyabsentfrommostpollen-basedmodesofbreeding.79

Moreover,intryingtodepicttherelocationofatransposonasariskiereventthantheinsertionofanrDNAcassette,thecommitteeobscuredanimportantfact.Itfailedtoacknowledgethat,likeare-enteringtransposon,theprocessofimplantingacassettecanlikewisealterthesurroundingDNA.Althoughthisisawell-documentedeffectofbioengineering,fromthecommittees’wording,onewouldneverknowit.Whiletheylinkedsucheffectstotransposonshifts,theyignoredtheminregardtocassetteinsertions–implyingthatthelatterdon’tinduceany.

Butinducethemtheydo–andinprofusion.Inonestudy,researchersexamined112linesofThalecressintowhichrDNAcassetteshadbeeninsertedviaAgrobacteriuminfectionanddiscoveredinsertion-relatedaberrationsinalmosteveryplanttheyexamined.Inmostcases,thereweresmalldeletionsoftheplant’sDNAatthesitethecassettehadentered.Andin21%oftheplants,thealterationswerelarge-scale,withsizablesectionsofthecressDNAeitherexcisedorrearranged.Intwoofthesecases,asectionfromonechromosomehadrelocatedtoanotherchromosome–amajorchange.80

Further,notonlywasDNAthatshouldhavebeenintheplantsdeleted,unintendedsequenceswereinadvertentlyadded.EightoftheplantshadlargeinsertionsofextraneousDNAthatcamefromeithertheplasmidthathadconveyedthecassetteintotheAgrobacteriumorfromthecassetteitself.AndmostoftherestcontainedsmallerinsertionsofDNAofundeterminedorigin.Innoneofthesecaseswerethesuperfluoussequencessupposedtobethere.

Suchmessyinsertionsarenottheexceptionbuttherule.Threebiologistswhoconductedanextensivereviewofthescientificliteratureobserved:“Itisapparentthatsmallandlarge-scaledeletions,rearrangementsofplantDNA,andinsertionofsuperfluousDNAareeachcommonoccurrencesatAgrobacterium-mediatedtransgeneinsertionsites.” 81Andtheynotedthatparticlebombardmentseemstomakeanevenbiggermess.Asstatedintheirreport,insertinggenesthroughthatexplosivemethod“isusuallyoralwaysaccompaniedbysubstantialdisruptionofplantDNAandinsertionofsuperfluousDNA.” 82

Aswe’veseen,theNAScommitteealsorecognizedthegreaterperturbationalpoweroftheballisticmethod.Yet,theyfailedtoacknowledgeitsfulldisruptiverange.TheyonlynotedthatitupstheoddstheinsertionwilldisruptcrucialsequencesofDNA,buttheysaidnothingaboutitspropensitytodisrupttheregionssurroundingtheinsertionsite–ortointroduceunintendedsequenceswithinthesite.83

Eachtypeofalteration,whethercausedbybacterial-mediatedinsertionsorthoseresultingfromthegenegun,canadverselyimpacttheplant’sfunction.Asthereviewarticlepointsout,whennativeDNAisdeleted,importantsequencescanbelostorimpaired;andunwantedeffectscanalsoensuefromalterationofthesurroundingDNAortheadditionofsuperfluoussequences.Further,eveniftherewerenodeletionsorotherunintendedstructuralchanges,thecodingsequencesandpromoterregionsthatareintentionallyaddedcouldexertadisruptiveinfluenceontheoperationofnativegenes.84Thisinfluencecanbeextensive–andcanaltertheexpressionofgenesthatarethousandsofbasepairsawayfromtheinsertionsite.85

Moreover,bioengineering’spotentialforsuchalterationsentailsauniquehazard.AsthemolecularbiologistDavidSchuberthasstated,theinsertionprocess“generatesunpredictablechangesingeneexpressionthataregoingtobedifferentinkindfromthoseproducedbytraditionalbreeding.” 86Thus,besidesthecommittees’multiplemisstatementsaboutrisks,eventheirbasiccontentionabouthazardsisfalse,because,contrarytotheirclaim,bioengineeringhasinthiscaseintroducedhazardsthatarenotposedbyothermodesofbreeding.And,asweshallsee,ithaswroughtothernewonesaswell.

Sogreatisthedisruptivepoweroftheplantbioengineeringprocessthatitcancausedisruptionsthroughoutthegenome.Themajorityoftheseareapparentlycausedbytissueculture,whichisusuallyemployedina“particularlymutagenicform”whenregeneratingengineeredplants.87Butit’sprobablethatsomearecausedbytheprocessofAgrobacteriuminfection–andpossiblethatparticlebombardmentcanalsoactasacause.88

Thesemutationsaremultitudinous.SeveralstudiesindicatethatGEplantstypicallycontainhundredsoreventhousandsofthem.89Moreover,theirmagnitudeisprobablymuchgreaterthanwasmeasured.Threescientistswhoreviewedthestudiesobservedthatbecausetheresearchersemployedanalyticaltechniquesthatcannotreliablydetectpointmutationsandsmalldeletions,it’s“likely”theymissedmostofthem.90

AlthoughaGEplantiscommonlyout-crossedorback-crossedwithothernon-GElinesseveraltimes,whichcaneliminatemanymutationsthataredistantfromtheinsertionsite,it’sdifficulttoremoveallofthem(aswaspreviouslynotedwhendiscussingtissueculture).91Manyexpertsthinkthatanyoftheseremainingmutationscouldpotentiallyrenderaplantunsafetoeat–andthatthisriskhasnotbeenadequatelyreducedbytheregulatorysystem.92Foronething,thebiotechniciansdon’tevenperformgenomicanalysesthatcoulddetectwhether(andhowmany)wide-spreadmutationsremain.93

Further,multipleroundsofcrossingcan’tremovethemutationsintheareasadjacenttotheinsertionsite;andtheassessmentsroutinelyfailtoexaminetheseregionsproperly.Moreover,theyusuallydon’tevenexaminetheinsertionsiteswithadequatecare.94ThesystemhasbeensolaxthatsignificantdisruptionshavegoneundetectedinseveralGEcropsthathavebeenclearedforsaleandextensivelymarketed.95

Thus,althoughthedisruptiveeffectsofinsertingrDNAarewell-documented,andsosubstantialthatsomescientistshavereferredtothemas“genomescrambling,”thecommitteedisregardedmostofthemandinsteadprojectedtheimpressionthattheydon’texist.96It’sdifficulttoviewthisasaninadvertentoversight–especiallysincethecommitteefreelydescribedtheinsertionaldisruptionsthattransposonscause.Further,theydidn’trefertoanyoftherelevantpublicationscitedbytheresearchreviewmentionedabove,despitethefactmanywerereadilyavailabletothem.97

Aggravatingtheimbalanceoftheiraccount,notonlydidthecommitteeignoresomewell-knownhazardsofcassetteinsertion,theyminimizedtherisksofthosethattheydidmention,statingthatbreederswouldbeabletonoticeplantswithdeleteriousdisruptionsofimportantgenesandscreenthemout.However,thisignoresthefact,emphasizedbytheCanadianexperts,thatmanyalterationsmightnotcause

noticeableeffectsbutcouldstillinduceunexpectedtoxinsthattheregulatorysystemisnotdesignedtodetect.Manyotherexpertshavealsodiscussedthesystem’sinabilitytoensurethesafetyoftheengineeredproductspassingthroughit.98But,astheforegoinganalysisreveals,thecommitteewasapparentlymoreintentonmaintainingthepaceofthatpassagethanonacknowledgingevidencethatcouldimplythere’saneedtocontroltheflowwithgreatercare.Theexistenceofsuchanintentionismorefirmlyimplicatedbythefactthat,inportrayingradiation-bredplantsasthetypemostpronetobearunintendedeffects,theywerequitewillingtopointoutthattheseproductscanharborunwantedmutationsthathaveeludedthescreeningprocess.99

c.ProductionofUnintendedHarmfulSubstances

Besidesarisingviainsertionaldisruptions,unsuspected(andevennovel)toxinscouldbeformedwithinbioengineeredplantsthroughseveralotheravenues.AndthishazardwasacentralconcernoftheCanadianexpertpanel.AlthoughtheNAScommitteeneverspecificallyacknowledgedanyoftheconcernsraisedbythatpanel,theydidacknowledgethatGEplantscanposesuchaproblem.Yet,theyarguedthatconventionalcropscandothesame–inanapparentattempttodilutethisGE-relatedconcernbystretchingittoencompasstraditionalbreedingaswell.

Buttheirattemptfellflat.Foronething,theycouldonlypointtoafewinstances(involvingsomevarietiesofpotatoesandcelery)inwhichharmfullevelsofatoxinresultedfromconventionalbreeding.100Further,noneofthesubstanceswasnovelorunexpected.101Instead,toxinsthatareordinarilypresentinlowconcentrationshadbeendangerouslyelevated.Moreover,breedershavebeenlongawareofthesetoxinsandusuallymonitortheplantstoensuretheirlevelsstaywithinreasonablelimits.

However,thecommitteedidnotkeeptheirargumentwithinsuchlimits.Forinstance,theyclaimedthatconventionalbreedingisnotonlyliabletoelevateexistingtoxinsbuttogeneratesomethataretotallynovel.Yet,theycouldcitenomorethanoneexample–andbesidesbeingsolitary,itwasspurious.Intheiraccount,crossingadomesticatedpotatowithaparticularwildvarietyofthespecies“...producednotonlytheusualglycoalkaloids,butalsothetoxindemissidine,whichisnotproducedineitherparent.” 102Andtoproptheimportanceofthispoint,theyrepeateditseveralpageslater,assertingthetoxinwas“noveltobothparents.” 103

Butwhatwasnovelwastheclaimitself.That’sbecausepotatoesproducesignificantquantitiesofdemissidineastheydevelop.Yettheprocessnormallystopsbeforetheyripen.104Sotheextraordinaryfeatureofthecasethecommitteecitedwasnottheproductionofthesubstance,butitscontinuationinplantsthatwereripe.Therefore,theassertionthatthetoxinhadnotpreviouslyappearedintheparentswasblatantlyfalse–andhighlymisleading.

Anditwasstillmoremisleadingforthecommitteetoimputeoutsizesignificancetothissingularincident–andwouldhavebeenevenwereitaccurate.Besidesclaimingtheincident“showsthatnon-geneticengineeringbreedingmethodscanhaveunintendedeffectsandgeneratepotentiallyhazardousnewproducts,”thecommitteewentontowarnthatsuchdangerousnewchemicalscanemerge“anytime”thesemethodsareemployed.105Butinreality,there’sessentiallynoriskofthishappeningthroughconventionalmethods.Thisfactisunderscoredbyeightexpertswhoco-authoredanarticlepublishedin2013inthejournalPlantPhysiology.Intheirwords:“Althoughbreedersrecombinetensofthousandsofgeneswithvirtuallyinfinitepotentialinteractions,toourknowledge,therehasneverbeenareportofacompletelynoveltoxinorallergenappearinginagenusasaresultofconventionalbreeding.”Theythereforeconcludedthatbecausehundredsofthousandsofvarietieshavebeengeneratedwithouttheemergenceofsuchnovelsubstances,thelikelihoodthatanywilloccurthroughconventionalmethods“isvirtuallyzero.” 106

Thus,thethreatofnoveltoxinsisitselfnovel–anduniquetobioengineering.Soit’syetanother

hazardthat’sabsentfromothermethods.Theillegitimacyofthecommittees’contentionbecomesmoreglaringinlightofthefactthat,as

Chapter4described,therearenumerouscasesinwhichgeneticengineeringhascausedweirdandtotallyunexpectedresults,includingtheproductionofanoveltoxininareconfiguredplant.AswesawinChapter5,FDAexpertswerewellawarethatGEplantshaveauniquepotentialforinducingsuchodditiesandwarnedtheirsuperiorsaboutit.Further,Chapter3demonstratedthatatoxicfoodsupplementproducedthroughgeneticengineeringcontainedastrange,never-before-seensubstancewhichwassignificantlylinkedtoadeadlyepidemic–andthatthiscontaminantmostlikelyemergedthroughtheengineeringprocess.Moreover,thealteredorganismsthatspawnedthisqueercontaminanthadnotbeenendowedwithanyforeigngenesbutmerelywithextracopiesofsomeoftheirown,oneofwhichwasfusedtoaviralpromoterthatforcedittohyper-express.AstheCanadianpanel,theFDAexperts,andmanyothershavepointedout,thegeneticengineeringprocessitselfcanproducesuchunexpectedandextraordinarydangers,regardlessofthespecificgenethat’sinserted;andtheycautionedthatthislikelihoodshouldnotbetakenlightly.

Additionally,asChapter6described,bioengineeringcaneventurnanordinarilyharmlessproteinproducedbytheinsertedgeneintoaninjuriousagent.Aswesaw,evenwhenthesequenceofaminoacidsthatcompriseaproteinremainsthesame,otherfactorsthataffectitsstructurecanbeunexpectedly(anddangerously)alteredasgenesaretransferredbetweenspeciesthatcannotbreedthroughconventionalmeans.Andweexaminedpublishedresearchdemonstratingthatwhenabeanproteinwasproducedwithinapea,itnotonlybecameabnormallyallergenicitself,iteveninducedthelaboratorymicetodevelopallergicreactionstowardunalteredproteinsthatwereconsumedalongwithit.

Therefore,thepotentialforproteinreconfigurationrepresentsanotherhazarduniquetogeneticengineering;anditposesaseriousrisk,becausetheharmfulchangesthatcouldoccurwouldmostlikelyescapedetectionbythecurrentregulatorysystem–inEuropeaswellasAmerica.DavidSchuberthasemphasizedthemagnitudeoftheriskbyassertingthattheresearchontheGEpea“isprobablythesinglemostimportantstudypublishedtodateshowingthepotentialdangersofGEcropsbecauseallergenscanbedangerousatincrediblylowlevels,andmostifnotallGEproteinshaveantigenicpropertiesthataredifferentfromtheirnormalcounterpart.” 107

Chapter6alsodiscussedhowtheshapeofaproteincouldbedeleteriouslychangedwhenit’sproducedwithinanalienenvironment.Thistooisahazardofbioengineeringthat’sabsentfromconventionalplantbreeding.Moreover,there’sindicationthatsuchmisfoldinghasinatleastoneinstanceoccurred.108

Yet,thecommitteeremainedunmindfulofthecriticalfactsthatbearonthethreatofunintendedsubstances.109Althougheveryinstanceofgeneticengineeringentailssomeriskofinducingnoveltoxinsorallergens,andalthoughtheprobabilitythatanywillarisethroughconventionalmeansisessentiallynil,theypushedthenotionthatthetwoapproachesareequallypronetoproducethem.

Inlightoftheforegoingdiscussion,it’sclearthatthebarsassociatedwithgeneticengineeringinthereport’scomparativechartmustbeadjustedtoreflectfarmorethantheunintendedeffectsoftissueculture,becausethoseeffectsarenottheonlyonesthecommitteeignored.Aswe’veseen,theynotonlyoverlookedtherangeofdisruptionsthatcouldoccurthroughboththeviralpromotersandtheinsertionalprocessitself,theyfailedtocomprehendbioengineering’sunprecedentedcapacityforformingharmfulsubstances–andduetosuchoversights,theywouldsurelyhaveunderestimateditsfullperturbationalpower.

Thishasimportantimplications.Aswe’vealreadyseen,conservativelyrevisingthecharttoreflecta

measureofinfluencefromtissueculturebooststherankofonemajormodeofbioengineeringbeyondradiationbreeding(andwelloffthechart)–renderingitthemostdisruptivemethodofall.Andthetechnology’sothermaincommercialmodegetsliftedintoavirtualtiewithradiationbreeding.Soifthecommittees’conclusionsarefurtherrecalibratedtoregisteranadditional(andsizable)groupofneglectedeffects,thebarsassociatedwithboththeseformsofbioengineeringwillhavetobestretchedalotfarther.And,althoughit’snotclearexactlyhowfarthestretchingshouldgo,itisobviousthatthebarsforbothofthesemodesshouldsurpasstheoneforradiationbysowideamarginthateachextendswaybeyondtheborderofthechart,decisivelybrandingthemthemostperturbationalandunpredictabletechniques.Andbecause(aswaspreviouslydemonstrated)thelengthofthebarsultimatelydepictsthedegreeofdangertohumanhealth,thesetechniquesalsostandforthastheriskiest.

Further,whenacarefulcomparisonismadebetweengeneticengineeringandthemutativemethodsbasedonradiationandchemicals,it’sevidentthattherevisedchartproposedabovefairlyreflectstheriskdifferential.SuchacomparisonappearsinAppendixD,whichsupplementsChapter11andshouldbereadinconjunctionwithit.

However,evenaftermakingtheadjustmentsprescribedabove,thechartwouldstillneedfurtherrevision–nottothelengthoftheGE-associatedbars,buttotheirnumber.That’sbecausethereshouldonlybetwoofthem,notfour;andtheyoughtonlytoregisterthemodeofgenetransfer,notthebiologicaldistancebetweenthespeciesinvolved.

Irealizethatthisassertionmayseemquestionable,consideringthatbiologicaldistanceishighlyrelevantinconventionalcontexts,wherecrossingplantsthatarecloselyrelatedissaferthancrossingthosethataredistant.Butgeneticengineeringisdifferent.Althoughtheproductsofgenesfromdistinctlyforeignspeciescouldcauseproblemsduetotheirforeignness,equal(orgreater)riskscouldalsoresultwhenthespeciesaresimilar.110Afterall,theuncontrolledhyper-expressionofaproteinthatordinarilyinteractswithaplant’snativechemicalsinahighlyregulatedandwell-coordinatedmannercouldcauseriskiersidereactionsthantheoverexpressionofonethat’scompletelyforeigntothecellularsystem–andmayhavescantimpactuponit.AswesawinChapter3,whenbacteriawereengineeredtoover-produceL-tryptophan,asubstancetheyroutinelymake,metabolicdisruptionsoccurredthatinducedformationofatleastonenovelsubstance–whichmaywellhavebeenthesourceofthetoxicitythatcausedanepidemic.Further,theoverexpressionofproteinisinitselfproblematic;andimpellingaplanttoproduceanyprotein(fromanysource)inabnormalabundancecouldcauseimbalancesthatleadtoundesirable,andpotentiallyharmful,results.111Thisisyetanotherhazardthat’sessentiallyuniquetogeneticengineering,andtheriskitentailswillbemorethoroughlydiscussedinChapter11.

Thus,there’sgoodreasontothinkthatdangerousunintendedeffectscouldaccompanyallinstancesofagriculturalbioengineering;andgiventhecurrentstateofourknowledge,wecannotaccuratelydetermineifthere’sadifferentialinriskbetweentheaveragecaseinvolvingdistantlyrelatedspeciesandtheaverageinstanceinwhichtheyareclose.Accordingly,it’sreasonabletoconcludethatthereshouldbeasinglebarforbacteriallymediatedrDNAtransferandasingleoneforbioballistictransferaswell–andthat,whilethelatterwillbelongerthantheformer,bothwillbesignificantlylongerthanthebarforradiationbreeding.

FinalConclusions:HowtheDisagreementaboutRisksHasArisenEarlyinthischapter,animportantquestionwasraisedabouthowthedisagreementwithinthescientificcommunityregardingtherisksofGEfoodshasarisen.Inparticular,itasked:Doesthedisparityprimarilystemfromalackofadequateevidenceorfromalackofscientificintegrityonthepartofonefaction?Toanswerthisquery,wewantedtodiscoverwhetherbothgroupshavebeenexaminingthesamesetoffactsaccordingtothesamescientificstandardsandwithanequaldegreeoflogicalrigor.AndthereportsissuedbytheRoyalSocietyofCanadain2001andtheNationalAcademyofSciencesin2004

wereselectedtoserveasexamples.Nowwehaveasoundbasisforprovidingadefinitiveanswer.Ourinvestigationhasrevealedthatthe

NASreportreachedanoppositeconclusionfromthatofitsCanadianpredecessorduetorecurrentderelictionandadearthofscientificintegrity.We’veobservedhowthecommitteethatproducedthatreportsystematicallydisregardedsignificantfacts,misrepresentedseveralofthosetheydidmention,andrepeatedlybreachedthelawsoflogic.We’vealsoseenhowtheyevendistortedtheveryconceptofrisk–andhowthesevariousdelinquencieswereapparentlydrivenbyadeterminationtoupholdboththeimageofbioengineeringandthepresumptionsonwhichthelaxregulatorypolicyoftheUSgovernmentisbased.Further,we’veseenthatwhenthecommittees’owncalculationsarecuredofinconsistencyandadjustedtoaccommodateneglectedfacts,theydesignategeneticengineeringastheriskiestformofbreeding,witheverymannerinwhichit’sappliedposingamuchlargerdegreeofdangerthandoesanyothermethod–confirmingtheCanadianreport’sconclusionthatitis“scientificallyunjustifiable”todeclareanyGEfoodsafeunlessitssafetyhasbeenconfirmedthroughrigoroustesting.

Thus,it’sclearthatthepurportedscientificbasisoftheNASreportislargelyillusory.Andarevealingmeasureofthedegreetowhichit’sestrangedfromscience,anddivorcedfromreality,ishowittreatsitsCanadianprecursor.Althoughthatreporthadbeenissuedamerethreeandahalfyearsearlier,andalthoughitwasproducedbyaneminentgroupofscientists,nowheredoestheNASreportsomuchasmentionit–therebydodgingthedifficultyofconfrontingitscontraryarguments,whileprojectingtheimpressionthatnoscientificbodyhasreachedaconclusionatoddswithitsown.

Yet,despiteitsdeepdefects,thisreporthasbeenextolledandextensivelyreliedon.Forinstance,intheirinfluentialbook,Tomorrow’sTable,PamelaRonaldandRaoulAdamchakrepeatedlyciteitastheprimarysupportfortheirclaimsaboutthesafetyofGEfoods,andmanyoftheproducts’otherproponentshavedonethesame.Further,duetotheAcademy’sstatus,themediaandthepublichaveacceptedthereport’sconclusions,assumingtheyderivedfromanassessmentthatwasalignedwithsciencewhentheprocesshadinfactdishonoredit.

OtherEsteemedOrganizationsHaveLikewiseReleasedDefectiveReportsSadly,the2004NASreportisfarfromunique.ManyrespectedorganizationshavealsoreleasedfavorableevaluationsofGEfoodsthatareremarkablyshoddy–likethe2012reportoftheAmericanMedicalAssociation(AMA)that’ssostrangelyreasoneditpromptedaprofessorofpublichealthatNewYorkUniversitytodeclarethatit“doesn’tmakesense.” 112However,althoughthestatementmaynotmakesensefromascientificstandpoint,itdoesfromapoliticalone;andit’sinperfectaccordwiththeAMA’savowedintention,firstannouncedina1990policystatementonagriculturalbiotechnology,“toendorseorimplementprogramsthatwillconvincethepublicandgovernmentofficialsthatgeneticmanipulationisnotinherentlyhazardous....” 113Further,besidesannouncingacommitmenttobelittletherisks,theorganizationpledged“toactivelyparticipateinthedevelopmentofnationalprogramstoeducatethepublicaboutthebenefitsofagriculturalbiotechnology.”Infurtheranceofthiseducationalendeavor,itdeclaredanintent“toencouragephysicians,throughtheirstatemedicalsocieties,tobepublicspokespersons”forthetechnology.Therefore,it’snotsurprisingthattheAssociationhasremainedmorededicatedtopromotingGEfoodsthantosustainingbalanceandaccuracyinreportingonthem.

Inaprimeinstanceofsucherrancy,the2012reportbeginsthesectionthatdiscusses(andminimizes)thepotentialhumanhealtheffectswiththeassertionthatduringthenearly20yearsGEfoodshavebeenmarketed,“noovertconsequencesonhumanhealthhavebeenreportedand/orsubstantiatedinthepeer-reviewedliterature.” 114Butthisissignificantlymisleadingbecausetheauthorsneglecttonotethatafewyearspriortotheirselectedtimeframeabioengineeredfoodsupplementcausedawell-documentedepidemic.Further,besidesfailingtoacknowledgethisinconvenientfact,theyavoidedacknowledginganotherone:thefactthatevenacompletelackofevidenceofharmcannotcountasevidenceforits

absencebecause(1)noclinicaltoxicologicalstudieswithhumansubjectshavebeenperformedand(2)noepidemiologicalstudiestodetectadversechroniceffectshavebeenconductedeither–norcouldtheyhave,giventhelackoflabelingandofothermeansformonitoring.

Evenworse,notonlyhastheAMArefusedtoadmitthatthelackoflabelshasimpededproperassessment,andnotonlyhasitrefusedtoinsistonthemandatorylabelingthat’sbeeninstitutedinmostindustrializednations,ithasactivelyopposedsuchastep,despitethefactthatlabelingiswidelydemandedbyconsumersandnecessitatedfortheresponsiblemonitoringofpublichealth.115So,theAssociationhasontheonehandworkedtothwartthegatheringofdatathatcouldhelpassesswhetherGEfoodsareinducingadversechroniceffects,whileontheother,itpointstothelackofdataasanindicationthatsucheffectsdon’texist.

It’sdisquietingthatAmerica’spremiermedicalorganizationwouldpromoteagroupofdistinctlynewandunprovenfoodsinsuchanunseemlymanner,especiallysincethisblatantpromotionalpolicystandsinstarkcontrasttotheearlierstanceofthemedicalcommunityinregardtotobacco.Duringthe1950’s,althoughasubstantialpercentageofAmericandoctorssmoked,theywerebarredbytheirethicalcodefromappearingincigaretteadvertisements.Sotobaccocompanieshadtopayactorstoposeasdoctorsintheiradsinordertoprojecttheimpressiontheircigaretteswereendorsedbythisesteemedclassofhealthprofessionals.ButwhenGEfoodsweredevelopedafewdecadeslater,theAMAitselfunreservedlychampionedthem–andevenencouragedindividualmemberstoendorsethemasagentsofitsofficialpolicy.

Equallyremarkable,theintensityofitsintentdroveittoinitiateitseffortwhentheGEfoodventurewasstillinanearlystage.TheAMAfirstproclaimedtheinherentsafetyofagriculturalbiotechnology,anddeclaredthatthebenefits“greatlyexceedanyriskposedtosociety,”twoyearsbeforetheFDAissueditspolicystatementonGEfoods,fouryearsbeforeonewasbroughttomarket,andlongbeforesafetytestshadevenbeenconducted,letalonepublished.116Theevidentialdeficitisunderscoredbythefactthat,twoyearsaftertheAssociation’sboldpronouncements,anFDAofficialacknowledgedtherewasnoscientificdatathatcouldsupportadeterminationthatGEfoodsaresafe.117ButthisevidentiaryvoiddidnotdetertheAMAfromissuingassertionsthatrequiredanevidentiarybase–andthusprojectingthefalseimpressionthatoneactuallyexisted.

LiketheNASandtheAMA,severalothereminentinstitutionshavebehavedmoreaspromotersofagriculturalbioengineeringthanasobjectiveevaluatorsofitsrisks;andtheirreportshavelikewisebeenslack.AppendixBdiscussestwoofthem:onefromtheUK’sRoyalSocietyandonefromtheInstituteofFoodTechnologists.Andtheseareonlyarepresentativesample.HadtheappendixexaminedeveryreportthatpropoundsflawedargumentsforthesafetyofGEfoods,itwouldhaverunformanymorepages.

Thus,althoughtheNASandotherprestigiousorganizationspresenttheirassertionsaboutthesafetyofbioengineeredcropsasscience-based,analysisrevealsthatthey’renotbasedonsoundscientificassessmentbutonitscircumvention.Andtheyallbefogthefactthat,comparedtoeveryformofconventionalbreeding,geneticengineeringentailsuniquehazardsandimposeshigherrisks.

What’smore,besidesmisstatingtherisks,theymisrepresentthebenefits.

TheBenefits:HowThey’reInflated–andWhyThey’reIrrelevantProponentsofGEfoodsroutinelyarguethattherisksnotonlymustbeconsideredincontextofbenefits,butbeoffsetbythem.Andjustastheyillegitimatelyminimizetheformer,theyliberallyexaggeratethelatter.Moreover,inadditiontooverstatingthebenefitsthatwilldirectlyderivefromwhateverGEcropisbeingconsidered,theyfurtherinflatethembylinkingthatproductwiththeaggregateboonsthatareexpectedtoaccruefromthetechnologyasawhole.Thus,althoughthefirstgenerationofGEcropswerewidelyrecognizedasgeneratingscantbenefitforthepublic,theyweretoutedasintegralpartsofamonumentalprocesswherebyyieldswouldbebountifullyincreased,theenvironmentwouldbebetter

protected,andfoodwouldbecomemorenutritious.118Forexample,despitethefactthatthemostextensivelyplantedGEcrop(Monsanto’sRoundupReady

®

soybean)wasactuallyreducingyields,expandingherbicideuse,andincreasingherbicideresiduesinfood,itwasallowedtoridethewaveoftheseexpectations–andbeadjoinedwithattractiveoutcomesitwasactuallyobstructing.119

So,althoughbiotechadvocatesaredevotedtothedoctrinethattheprocessofgeneticengineeringshouldnotitselfbeassociatedwithrisks–andthatanyrisksareseparateattributesofoneoranotherofitsindividualproducts,theyreversethisapproachwhenitcomestothetechnology’sbenefits.Inthatcase,everybenefitthatanyGEproductmighteventuallybestowisdeemedanaspectoftheengineeringprocessperse,andeveryfooditproducesissomehowconnectedwithaplethoraofmarvelsthataresupposedlysoontomanifest.

Buteveniftheevaluationofbenefitswereperformedinalegitimatefashion,itwouldbeirrelevanttothequestionoffoodsafety.Andifitimpactedtheapprovalprocess,itwouldalsobeillegal–atleastintheUnitedStates,thenationinwhichGEfoodsaremostwidelyconsumed.That’sbecauseUSlawrequiresthatnewadditivestofoodmustbedemonstratedsafe;andinthiscontext,“safety”isdefinedas“areasonablecertainty...thatthesubstanceisnotharmfulundertheintendedconditionsofuse.” 120Consequently,potentialbenefitsareirrelevant,andit’sunlawfultoconsiderthem.

Manypeoplemayfindthissurprising(andconfusing),includingthoseintheAmericanMedicalAssociation,which(aswe’veseen)promotesGEfoodsandhasastatedgoalto“convincethepublicandgovernmentofficials...thatthehealthandeconomicbenefitsofrecombinantDNAtechnologygreatlyexceedanyriskposedtosociety.” 121Theconfusionstemsfromthefactthatbenefitsareweighedagainstrisksindeterminingthesafetyofprescriptiondrugs.Butit’sappropriatetodosointhatcontext,becausethedrugisintendedforsituationsinwhichtheindividualisalreadyatriskandadecisionmustbemadeastowhetherthebenefitsofthedrugwilloutweightheriskposedbythediseaseincombinationwiththeriskposedbythedrug’ssideeffects.

However,althoughtheregulatorysystemacceptsthesideeffectsofdrugsasnecessaryrisksinthecuringofdisease,foodisadifferentcase.It’ssupposedtobesafeandfreeofharmfulsideeffects.Therefore,itisreasonabletorequirethatafoodadditivemustnotimposeasignificantriskofharm,regardlessofanybenefitsitmightalsoconfer.Thisisespeciallyimportantinlightofthefactthat,incontrasttoprescriptiondrugs,foodsaresold“over-the-counter”andareconsumedbyeveryone,notjustbyindividualsinneedofspecialphysician-monitoredinterventions.

Thus,thenotionthatinordertoassessthesafetyofGEfoods,it’snecessarytoweightheirbenefitsiswayoutoflinewithbothreasonandUSlaw.

Whenthefactsarethoroughlyexamined,it’sclearthatthetitleofthischapterisnotanexaggeration–andthattherisksofGEfoodshaveindeedbeenmethodicallymisrepresented.Andthecomplicitpartiesincludemanyeminentscientistsandscientificinstitutions.Ofthese,theUSNationalAcademyofScienceshasplayedthemostprominentrole;andalthoughitsinfluentialreportof2004hasbeenhailedasaparadigmofscientificriskassessment,analysisrevealsittobemoreparodythanparadigm.Despiteitsauraofauthority,itisempiricallydeficientandlogicallydysfunctional;anditscaseforthesafetyofgeneticengineeringisoverlyreliantontheoverlookingofdataandthewrenchingofreason.Further,itmisrepresentsalotoftheinformationthatitdoesdiscuss,andtheweightoftheevidencerunscountertoitsmaincontentions.Moreover,whenitsowncalculationsarealignedwithreality,theyattestthehigh-risknatureofgeneticengineering,distinctlydesignatingitthemostdangerousformofbreeding.

Ontheotherhand,thereportissuedbytheRoyalSocietyofCanadain2001,whichpresentsacase

forregardingGEfoodsasabnormallyrisky,displaysnoneofthedefectsofitsNAScounterpart–oroftheotherreportswithasimilarslant.Furthermore,becauseitcounterstheillusionofconsensusthatGEpromotersproject,mostofthosereportshaveignoredit;andnonehasrefuteditsreasoning.Norhasanyevidenceappearedthatdemonstratesitsprecautionarystanceisnolongerappropriate.

However,asweshallnextsee,extensiveevidencehasaccumulatedconfirmingtheneedforprecautionandthenecessityofstrengtheningratherthanlooseningtheregulatoryrequirements.Inlightoftherisksdescribedinthischapter,theemergenceofsuchevidenceisnotsurprising.And,consideringhowbiotechproponentshaveconsistentlymisrepresentedtheserisks,it’salsonotsurprisingthatthey’vejustasvigorouslydistortedthisportentousevidence–andevenvilifiedthescientistswhopublishedit.

CHAPTERTEN

ACropofDisturbingData

HowtheResearchonGEFoodsHasFailedtoShowThey’reSafe–andInsteadConfirmedTheyShouldBeOfftheMarket

Astheprecedingchapterdemonstrated,whenrisksareassessedinamannerthatupholdslogicandregisterstherelevantfacts,geneticengineeringloomsforthasthemostdangerousmethodforproducingnewvarietiesoffood.Moreover,aswe’veseeninotherchapters,andwillmorefullycomprehendinthisone,theriskshavenotremainedsolelytheoretical;andwhenonelooksbeyondpromotionalclaimstofocusonconcreteevidence,it’sclearthattheedibleoutputofrecombinantDNAtechnologyhasoftenbeenlinkedwithadverseeffects.

Theseunsettlingoutcomesdatefromtheearliestphaseoffood-centeredbioengineering.AsChapter3documented,longbeforethetechnologyhadbeenabletodevelopanymarket-readygrains,fruits,orvegetables,ithadproducedafoodsupplementoftheessentialaminoacidL-tryptophan;andthatseeminglyinnocuoussupplement,theGEventure’sfirstingestibleoffspring,spawnedamajorepidemic.Further,theepidemicwascausedbyatoxiccontaminantthatmostlikelyarosefromtheengineeringprocessitself.Moreover,asthechapteralsodocumented,thecatastrophewasofsuchmagnitudethatbiotechproponentsweredriventothoroughlyobfuscatewhathadhappenedinordertopreventtheGEfoodenterprisefrombeinghalted.Absentsuchobfuscation,it’sdoubtfultherewouldhavebeenaneedtowritethisbookbecause,eveniftheventurehadbeenallowedtoproceed,publicpressurewouldalmostcertainlyhavecompelledittobeconductedfarmoreresponsiblythanhasbeenthecase.

However,althoughskirtingthefactsofthisinitialdisasterenabledtheGEfoodventuretocontinue,ithasnotbeenpossibletoskirtthetechnology’scontinuingilleffects.Andyearsafterthetoxictryptophanfirsthitthemarket,whenbioengineershadfinallydevelopedaplantthatwasdestinedfordinnertables,ittooentailedproblems.

TheFlavrSavr™tomato:AShakyStartfortheProduceofAgriculturalBioengineeringThisfirstbioengineeredwholefoodwasatomato.And,liketheinjurioustryptophansupplementthathadgonebefore,theprimarygeneinsertedintoitsDNAwasnotaforeignone.Infact,thistomatohadarguablybeenalteredtoalesserdegreethanhadthetryptophan-producingbacteriabecause,incontrasttothem,itscellsweren’tevenengineeredtoproduceahighervolumeofanativeprotein.Instead,theyweremodifiedsoastosuppresstheproductionofaninnateprotein.

Thistargetedproteinwasanenzyme(calledthePGenzyme)thatcausesthefruittogrowincreasinglysoft.Andbydiminishingitsoutput,thedeveloper(Calgene,Inc.)aimedtoenablethefruittobepickedafterithadripenedandyetremainfirmthroughouttheshippingprocess–settingitapartfrommostcommercialtomatoes,whicharepickedprematurelyandreachfinalripeningawayfromthevine.Inthisway,thenewtomatowassupposedtobemoreflavorfulwhenharvestedbutnottoosquishybythetimeitreachedsupermarketshelves.Accordingly,itwasdubbedtheFlavrSavrTMtomato.

Inordertoachievetheirgoal,Calgene’sbiotechniciansmadeacopyofthePGgene(theoneresponsibleforthefruit-softeningenzyme)andreversedtheorderofitssequence.Inthisway,theycreatedanewgenethatgeneratesanRNAtranscriptthattheyhypothesizedwouldbindtothemessenger

RNAofthenativePGgeneandpreventitfrombeingtranslatedintoanenzyme.1Butinordertogetthenewgeneinserted,theyhadtoemployAgrobacteriatowedgethegeneintothetomato’sDNA;andinordertogetthatnewgenetoexpressRNAatahighenoughlevel,theydidn’trelyonanyoftheplant’snativepromotersbutinsteadboostedtheoutputthroughtheinsertionofthepowerful35Spromoterfromthecauliflowermosaicvirus.Andtogetthereconfiguredcellstogrowintowholetomatoplants,theyhadtoputthemthroughtissueculture.2

Sotherewereampleavenuesthroughwhichadversealterationscouldhaveoccurred.Anditappearsthatsomedid.

ButthisonlybecameapparentbecauseCalgenedidmorethantheFDArequiredittodo.Wellbeforetheagencyhadissuedits1992policystatementthatillegallypresumedGEfoodsareGenerallyRecognizedasSafe(GRAS)–andfalselyinformedmanufacturerstheyweren’trequiredtotestthem–thecorporationhadrequestedtheFDAtoissueanadvisoryopinionregardingthetomato’sGRASstatus.And,atthattime,theFDAapparentlythoughtitwouldaidtheimageofGEfoodsiftherewereteststosupportthesafetyofthefirstbioengineeredplantthatwasheadedformarket.SotheagencyencouragedCalgenetoperform28-dayfeedingstudieswithrats.3And,althoughthisencouragementwasnotacommand,thecorporationdecidedtohaveanoutsidelaboratoryputthreeofthemostpromisingtomatolinesithaddevelopedthroughsuchshort-termtesting.4

However,althoughthisvoluntarydecisionwas,fromthepublic’sperspective,commendable,fromthesideofCalgene,itwasprobablyregrettable.

Initially,twostudieswereconducted.Inthefirst,onlyoneofthethreeFlavrSavrTMlineswasemployed;andinthesecond,theothertwowereused.Tothecorporation’sdismay,someoftheratsconsumingoneoftheengineeredlinesinthesecondstudydisplayeddisturbingabnormalities.Thelabdetectedthat10percentofthem(4outof40)developedgrosslesionsintheirstomachs(whichmeanttheirstomachswerebleeding).5Incontrast,nolesionswereobservedinanyoftheratsinthecontrolgroupthatatenaturaltomatoes.

Theselesionspresentedreasonablecauseforconcern;andthefoodsafetyexpertArpadPusztaihaspointedoutthatcomparableerosionsinhumanscouldresultin“life-threatening”hemorrhage–particularlyamongtheelderlyandindividualsregularlytakingaspirin.Accordingly,henotedit’s“notlegitimate”tocallsuchlesions“mild”inthecaseofhumanpathology–andthatbecausetheratswerebeingusedasmodelsforhumans,thetermcouldnotbelegitimatelyusedinthecontextofthesestudies.6

Facedwiththeemergenceofsuchproblems,Calgenedecidedtorunanothertestonthelinethatwaslinkedwiththem.Itthenhiredateamofpathologiststoassesstheresultsandtoreevaluatethoseofthefirsttwostudiesaswell.However,insteadoffindingthattheinitialobservationsoflesionsinthesecondstudywereflawed(asCalgenepresumablyhopedwouldhappen),thisteamdiscoveredlesionsinfouradditionalratsthatwerefedtheproblematicvarietyofengineeredtomato.Thisboostedthepercentageoflesion-afflictedratsconsumingthatproductto20percent,ahighlyunwelcomeoutcome.7

Buttheresultsforthethirdstudy(inwhichlesionsoccurredinsomeratsnotfedtheFlavrSavr)weremoreencouraging–totheextentthatCalgene,alongwithotheroutsideevaluatorsitemployed,believedthatwhenthedatafromallthreestudieswereassessed,areasonablecasecouldbemadethatthelesionswere“incidental”andnotinducedbyanychangerelatedtotheengineeringprocess.Accordingly,whentheysubmittedthedataandtheirargumentstotheFDA,theywereoptimistictheagencywouldagreethattheFlavrSavrwassafe.

TheFDAExpertsAreNotConvincedHowever,theFDA’sscientistswerenotwonover–asisclearlyrevealedbydocumentspriedfromtheagencyfilesbytheAllianceforBio-Integritylawsuit.Forinstance,amemowrittenonJune16,1993bya

toxicologicalpathologistthatwasalsosignedbyboththeChiefofthePathologyBranchandtheLeaderoftheDiagnosticPathologySectionnotedthat“thecriteriaforqualifyingalesionasincidentalwerenotprovided;”anditalsoobservedtherewas“considerabledisparity”betweenthevariousstudiesthat“hasnotbeenadequatelyaddressedorexplained.” 8Thememoconsequentlyconcludedtherewasinsufficientevidencetoruleouttheroleoftheengineeredtomatoincausingthelesions.

Thecorporationrespondedandtriedtoallaytheseconcerns,buttheFDAexpertsdeemedtheresponseunsatisfactory.Anothermemosignedbythesamethreepathologistsstatedthat“Calgenefailedtoadequatelyaddress...someofthemajorissuesraisedbythePathologyBranch....”Itfurtherassertedthattheunresolvedissues“leavedoubtsastothevalidityofanyscientificconclusion(s)whichmaybedrawnfromthestudies’findings.” 9Moreover,thepathologistsdidnotstandalone.AscientistwiththeAdditivesEvaluationBranchconcurredthatCalgene’sresponses“wereinsufficient”andnotedthat“...unresolvedquestionsstillremain.”Healsostated:“Untilthesequestionsareanswered,PathologywillbeunabletoconcludewhetherornotthereisatreatmentrelatedeffectinratsconsumingFlavrSavrtomatoes.” 10TheDirectoroftheOfficeofSpecialResearchSkillswasnotpersuadedeither.Hewrotethatthedata“raiseaquestionofsafety”–andthatthey“fallshort”ofsatisfactorilyresolvingit.11

Accordingly,itwasclearthatthesescientistswouldnotbeconvincedofthetomato’ssafetywithoutadditionaldata;butbythattime,itwasalsoclearthatCalgenewouldnothavetoprovideany.DespitethefacttheFDAexpertshadconcludedthat,asamatterofscience,thedatawereinadequate,theFDAadministratorshadbythendecidedthat,asamatterofpolicy,itwasadequatetohaveinadequatedata–orevennodataatall.Sotheydidn’taskCalgenetodomoretesting,andCalgenewascontenttostandpat.

Déjàvu:TheFDAOnceAgainMisrepresentstheConclusionsofItsScientificStaffHowever,althoughtheFDAdecidedtoproceedwithoutlegitimateevidenceofsafety,itneededtoprojecttheimpressionthatsuchevidencewasinhand.Ithadpreviouslypublicizedthefactthatthetomatowasundergoingtesting;andifitnowconcededthattheresultantdataraisedanunresolvedsafetyissue,theGRASpresumptionithadrecentlyissuedonbehalfofGEfoodswouldhavebeencalledintoquestion.Consequently,asithaddonein1992whenissuingapolicystatementthatclashedwiththeopinionsofitsownexperts,theFDAonceagainsuppressedthoseopinions.Butwhereasthepreviouscover-uphadenabledittodeclarethatGEfoodscanbepresumedsafe,thisoneenabledittoproclaimthatthefirstbioengineeredwholefoodhadactuallybeenprovensafe.

Toprovidebackupforthisaction,CommissionerDavidKesslerdecidedtoholdameetingoftheagency’sFoodAdvisoryCommittee,astandinggroupofscientistsoccasionallyconsultedonimportantmatters.12Kesslerhadprobablyappointedmany(ifnotmost)ofthemembers;andforthisparticularreview,headdedsometemporarymembersandconsultants.13

Further,itappearsthatthecommitteewasconstitutedinamannerconducivetotheagency’sdesiredoutcome–andthatKesslerandhiscolleaguesseemedhighlyconfidentofobtainingit.Thisisevidencedbythefactthataweekbeforethemeetingcommenced,theagencyreleasedadocumentassertingithaddeterminedthat“FlavrSavrtomatoesareassafeasothertomatoes.” 14Thisboldmovebrokewiththeagency’spolicyofnotcommentingonproductsthatwereunderreview,15anditsignaledtheadministrators’certaintythatthecommitteewouldupholdtheirposition.Afterall,iftheyhadbelievedtherewasevenamodestchancethecommitteewouldopposethem,theywouldalmostcertainlyhaverefrainedfromissuingthatstatement,sincebeingrebuffedbytheiradvisorsatapublicmeetingwouldhavecreatedanextremelyawkwardpredicament.That’swhythispre-meetingpronouncementpromptedoneCalgeneexecutivetoregardtheupcomingevent“primarilyasaPRexercisefortheFDA.” 16

Butthedocument’stimingwasnotitsonlycuriousfeature.Italsopurportedthatthedeterminationofsafetyhadbeenmadebythescientificstaff,eventhoughseveralagencyexpertswhoexaminedthefeedingstudieshadassertedthattheydidnotsupportsuchadetermination–andthatwithinthisgroup(whichapparentlycomprisedthemajorityofthosewhohadscrutinizedthestudies)weretheDirectoroftheOfficeofSpecialResearchSkills,theLeaderoftheDiagnosticPathologyBranch,andeventheChiefofthePathologyBranch,thebranchthatspecializesintheassessmentofadversechanges.Consequently,themediaandthepublicwereseriouslydeceived,asattestedbyareportintheSacramentoBeeheadlined:“FDAscientistsfindFlavrSavrsafe.” 17

Theadvisorycommitteewasdeceivedaswell.Duringthemeeting(heldfromApril6ththrough8th,1994)noneoftheagencyscientistswhocalledformoretestingwasselectedtospeak,andnomentionwasmadeoftheirconcerns.Instead,theFDApickedtwoscientistswhosidedwiththeadministratorstorepresentthepositionofagencyexpertsonthefoodsafetyissue.Further,notonlydidtheirviewsdifferfromthoseofthescientistswhoexpresseddoubtsabouttheFlavrSavr,theyclashedwiththeopinionoftheexpertsontheagency’sbiotechnologytaskforceabouttheneedforrigoroustestingofGEfoodsingeneral.Thus,theonewholedoffsaidtheFDAhadmadethe“correct”decisioninleavinganimalstudiesoptionalratherthanmandatory.18Moreover,whenhediscussedtheFlavrSavr,hedownplayedthesignificanceofthestomachlesions;andalthough(aswe’veseen)itwasillegitimateeventotermthem“mild,”hedeclaredtheywere“verymild.” 19Inall,heconveyedtheimpressionthat,intheviewofthescientificstaff,therewasnounresolvedissueandnoneedforfurtherstudies;andthesecondscientistdidthesame.20

Anycommitteememberwhoheardthesepresentationswouldhavebeensurprisedtolearnthatasubstantialnumberofagencyscientists(includingtheChiefofthePathologyBranch)werenotsosanguineaboutthelesionsandhadconcludedthatadditionaltestingmustbedone.Onlybycoveringupthisfactandpreventingtheconcernsofthoseexpertsfrombeingpresentedcouldtheagencyhavebeensoconfidentitsdesiredoutcomewouldbeachieved.

Andthesubterfugesucceeded.Bytheendofthemeeting’sthirdday,mostofthemembersoftheadvisorycommitteewereinsuchaccordwiththeFDA’spositionthatoneattendeedescribedthewrap-upasa“lovefest.” 21Ifthefactshadbeenfairlyreported,andthecommitteehadlearnedthattheagency’spre-meetingproclamationwasdeceitful,thefestwouldalmostsurelyhaveinvolvedsomefestering.

Regrettably,theFDAwasnotpreparedtoamenditsways,andafterthemeetingended,itcontinued(andevendeepened)itsdeceptionsregardingtheFlavrSavr.Inasubsequentpressrelease,CommissionerKesslerdeclared:“Wehaveapproachedourreviewofthisproductwithscientificrigorandacommitmenttofull,publicdisclosureofthatscience.” 22Buttheagency’sstyleofdisclosurefellsoshortof“full”itwasfraudulent.Thus,thedocumentwentontoassertthat,accordingtotheagency’sassessment,“allrelevantsafetyquestionsaboutthenewtomatohadbeenresolved,”wheninreality,keymembersofthescientificstaffhadinsistedthat“majorissues”werenotadequatelyaddressedandthat“unresolved”safetyquestionsstillremained.

Andtofurthergivethelietotheassuranceoffulldisclosure,theFDAnotonlysolidifiedtheillusionthatitsscientistshaddeterminedthetomatowassafe,itobfuscatedtheembarrassingfeedingstudies.Forinstance,inareleaseissuedthesamedayastheoneboastingacommitmenttofulldisclosure,theagencyprovidedapurportedlycomprehensivesummaryof“allthedata”submittedbyCalgenethathadbeenreviewedbyitsexperts.Butwhileitnotedtherewereanalysesofthetomato’scomposition,theidentityandstabilityoftheinsertedgeneticmaterial,andissuesregardingtheantibioticresistantmarker,itsaidnothingaboutthetestinginwhichratssufferedstomachlesions.23Anotherofficialaccountpublishedthenextyearwassimilarlymuteinthisregard.24Andthissanitizedstoryofwhatevidencewasexamined,whichomitsmentionofthemostcrucial(andtroubling)tests,hasbecometheonemostwidelycirculated.

So,althoughwhentheFDAinitiallyencouragedCalgenetoconductthefeedingteststherewasamutualfeelingthat“everyonewouldbreathealittleeasier”iftheywerecarriedout,25aftertheresultswerein,theagencyapparentlyfeltthateasybreathingwouldinsteadbefosteredbypretendingthatthetestshadneverhappened.

DéjàvuII:TheFDABreakstheLawAgainTooWhat’smore,besidesbeingdeceitful,theFDA’sbehaviorwasillegal.JustasitsgeneralpresumptionthatGEfoodsareGRASwascontrarytolaw(aswesawinChapter5),sowereitsactionsregardingtheFlavrSavr.Infact,theywereillegalinmorethanonerespect.

TheFDAwassupposedtobeevaluatingthetomatoaccordingtotheGRASstandard,which(asChapter5discussed)requiresanoverwhelmingconsensusaboutsafetyamongexperts–andalsorequiresthattheconsensusbebasedonadequatetechnicalevidence.Butneitherrequirementwasmet.It’scleartherewasnotaconsensusinfavorofsafetywithintheFDA’sexpertstaff,andit’sclearthattherequisitetechnicalevidencewaslikewiselacking.Forinstance,thepreviouslycitedmemooftheDirectoroftheOfficeofSpecialResearchSkills(Dr.RobertScheuplein)statedthat“...thedatafallshortof‘ademonstrationofsafety’orofa‘demonstrationofreasonablecertaintyofnoharm’whichisthestandardwetypicallyapplytofoodadditives.” 26

However,inanattempttoeasethetomato’spassagethroughthereviewprocess,theFDAhadinstructeditsscientiststodisregardthisstandardandapplyalessrigorousone.AsDr.ScheupleinwroteinregardtoCalgene’ssubmission:“...ithasbeenmadecleartousthat...thesafetystandardisnotthefoodadditivestandard.ItislessthanthatbutIamnotsureexactlyhowmuchless.” 27

Ofcourse,thereasonhewasunsureabouthowmuchlooserthestandardwassupposedtobeisthatnolowerstandardexists.AccordingtoUSlaw,allsubstancesaddedtofoodfallintooneoftwocategoriesinregardtotesting.Inthefirstarethosethatdon’thavetobebackedbyanytestingbecausetheyhaveahistoryofsafeusepriorto1958.28Allothersfallintothesecondcategory;andtheirsafetymustbedemonstratedthroughscientificprocedures,whethertheyseekentrytothemarketviatheformalfoodadditiveprocessorbyvirtueofbeingGRAS.And,asChapter5hasmadeclear,thestandardfortestingisthesameineachinstance.29There’snospecialcategoryforwhichalowerstandardapplies,andtheFDA’sadhocefforttocreateonewasillegal.

Yet,theFDA(throughitsadministrators)wasnotpreparedtolettherequirementsofthelawimpedetheintroductionofthefirstGEwholefood,andinitsendeavortocircumventthem,iteventuallydecidedtodenyanylegalsignificancetotheproblematicfeedingstudies.So,althoughtheagencyhadoriginallyinstigatedthetesting,itultimatelyarguedthattestinghadn’tactuallybeenneededanyway,thattheresultscouldbeignored,andthatthestatusofthetomatoescouldbeadequatelyassessedthroughanalyticalmeansalone.And,inafinalflourish,itassertedthat,accordingtoitsownanalysis,thesetomatoes“havenotbeensignificantlyaltered”inalegallymeaningfulway.30

Butitwastheargumentitselfthatwasnotlegallymeaningful;anditsnonsensicalnatureisexposedinAppendixC,whichelucidatesjusthowarbitraryandcapricioustheFDA’sactionsinregardtotheFlavrSavr,andtoGEfoodsingeneral,havebeen.Further,evenifwehumortheagencybyassumingthattherehadnotbeenaninitialrequirementfortesting,thefactisthatfeedingtestshadbeendone(attheFDA’sencouragement)andthat,accordingtoitsownscientists,theyraisedasafetyissuethatwasnotsatisfactorilyresolved.Thus,itwasclearthatasignificantnumberofqualifiedexpertsdidnotregardthetomatoassafeaccordingtostandardcriteria–andthatitthereforecouldnotbeGRAS.

AnotherWrinkle:ThereWereIllEffectsWorsethanLesionsMoreover,besidesbeinglinkedwiththelesions,theFlavrSavrwasassociatedwithoutcomesthatwere

farmoresevere.Sevenoftheoriginal20ratsthatateoneoftheGElinesdiedwithintwoweeks.Butineachoftheothergroups(inwhichtheratswerefedtheotherGEline,anaturaltomato,orawatercontrol)onlyonedeathoccurred.31Further,thedeath-linkedlinewasnottheonelinkedwithlesions;32soeachoftheGElinesinthatparticularstudywasconnectedwithadverseeffects.

Thedataondeathswascontainedinanendnoteinoneoftheresearchreports;anditwasonlybroughttomyattentionbecausein2000,ArpadPusztaicontactedmeandrequestedcopiesofCalgene’ssubmissions.33Itwasthroughhisdiligencethattheportentousendnotewasdiscoveredandeventuallyreportedmorewidely.34

Thisdiscoveryshockedhim,notmerelybecauseofthenumberofratsthatdied,butbecausetheresponseoftheresearchershadbeensoabysmal.Intheircrucialendnote,theycursorilyattributedthecauseofdeathtoahusbandryerrorwhilefurnishingnoevidentiaryback-upforthisdetermination–andnofurtherexplanation.Moreover,theyreplacedthedeadanimalswithnewonesandkeptthestudygoingasifnothinghadhappened.AsDr.PusztaiexplainedtotheinvestigativejournalistJeffreySmith,theseactionsviolatedstandardproceduresinseveralrespects.Smithreports:“Hetoldmeemphaticallythatinproperstudies,youneverjustdismissthecauseofdeathwithanunsupportedfootnote.Hesaidthatthedetailsofthepostmortemanalysismustbeincludedinordertoruleoutpossiblecausesortoraisequestionsforadditionalresearch.Furthermore,yousimplyneverreplacetestanimalsoncetheresearchbegins.” 35

Dr.Pusztaiandhistwocolleaguesfoundseveralotherflawsintheresearchaswell.Foronething,therangeoftherats’startingweightswas“unacceptablywide”–muchwiderthanispermittedby“high-quality”nutritionaljournals.36Moreover,theyfaultedtheresearchersforfailingtoprobemoredeeply,especiallyafterhavingdiscoveredthedisruptionstotherats’stomachs.Suchresults,theysaid,“clearly...shouldhavepromptedmoreexperimentation,”notonlytoinvestigatetheeffectoftheGEtomatoesonstomachhistology,but“evenmoreimportant,”tolookforeffectsonthesmallandlargeintestines.37

Overall,theseexpertsfoundit“regrettable”thatthefeedingstudieswere“poorlydesigned”–especiallyconsideringthat“somuchrestedontheoutcome.”Andtheyassertedthatduetothevariousdefects,theFDA’sconclusionthattheFlavrSavrwasassafeasordinarytomatoes“doesnotthereforeappeartorestongoodscienceandevidencewhichcouldstanduptocriticalexamination.” 38

Ofcourse,thatflimsilyfoundedconclusionwasnotmadebythespecialistswhohadevaluatedthedataaccordingtothelegallymandatedstandards.LikeDr.Pusztaiandhiscolleagues,thosescientistsdeterminedthatthedatawasinsufficienttoserveasademonstrationofsafety.Thespeciousconclusionwasinsteadmadebyadministrators,whowerenotactingasagentsofscienceandthelawbutasservantsofadirectivetofosterbiotechnology–andwerethereforemoreintentonpromotingitsproductsthanonprotectingthepublic.39

DéjàvuIII:TheAdministratorsSpurnYetAnotherSetofExpertWarningsMoreover,notonlydidagencyadministratorssnubscienceandinfringethelawbydismissingtheconclusionsoftheirexpertsaboutthefeedingstudies,theyalsodidsoinregardtoanotherimportantfeatureoftheFlavrSavr:itspossessionofanantibiotic-resistancemarkergene.

AsChapter4explained,becausemostcellssubjectedtogeneimplantationtechniquesfailtoincorporatethecassettesofrecombinantDNA,alargenumbermustbetargeted;andtheremustbesomewayofrecognizingthetinyfractionthathavetakenitup.Consequently,thecassettesarealmostalwaysendowedwithamarkergenethatexpressesaproteinwhichrendersthecellresistanttoaparticularantibiotic.Thisenablesbiotechnicianstoselectthecellsthathaveacquiredthenewcassettebyexposingallofthemtothatantibioticandeliminatingthosethatwerenottransformedbykillingthemoff.40

Calgenehadchosenamarkergeneconferringresistancetokanamycin,abroad-spectrumantibiotic

withasignificantmedicaluse.Andthewidedeploymentofthisgeneraisedtheriskofwidelyspreadingsuchresistance–which,intheviewofmanyexperts,wasarisknottobetakenlightly.41SoitwasimportantfortheprospectsoftheGEfoodventurethatthismarkerbeapproved,notonlybecauseCalgeneplannedtouseitinadditionalGEcrops,butbecauseothermanufacturersintendedtoemployitinproducingtheirs.

Accordingly,theFDAbelieveditwasimperativenotonlyforthekanamycin-resistancegenetogainagencyapproval,butpublicconfidence–andthatthiswouldbestbeachievedifitwascertifiedassafeviathestandardfoodadditivepetitionprocess.Therefore,theagencyaskedCalgenetosubmitaseparatefoodadditivepetitionfortheenzymethegeneproduces.42Andalthoughthepetitionultimatelygainedapproval,thestoryofhowithappenedisasordidone–asisgraphicallyexposedbymemosobtainedthroughthelawsuit.

Monthsbeforefilingthepetition,Calgenehadsubmittedseveraldocumentsinsupportofitscaseforthesafetyofthemarkergenesystem;andtheFDAhadrequesteditsDivisionofAnti-InfectiveDrugProductstoevaluatethem.43Itwasthedivisionwithgreatestexpertiseinassessingthespecificrisksposedbythepresenceofthisgenewithineverycellofawidelyconsumedfood.Andthisprospectrouseditsconcerns.Accordingly,agencyexpertsonceagaindidnotdelivertheresponsetheadministratorswanted;andtheDivision’sscientistsinsteadexpressedstrongreservationsaboutthemarkergene’suse.Further,perhapsbecausetheyknewhowtheadministratorshaddisregardedpreviousmemosfromexpertstaffthatdescribedrisksofbioengineering,theyemphasizedthedepthoftheirconcernsbycapitalizingallthelettersinthekeysentenceoftheirconclusion:“ITWOULDBEASERIOUSHEALTHHAZARDTOINTRODUCEAGENETHATCODESFORANTIBIOTICRESISTANCEINTOTHENORMALFLORAOFTHEGENERALPOPULATION.” 44

Becausethisdocumentcouldhaveseverelyundercuttheagency’sagendatopromoteGEfoods,theDivisiondirectorsentittoanotherFDAofficialwithacoverlettertitled,“ThetomatoesthatwilleatAkron.”Inithestated:“Youreallyneedtoreadthisconsult.TheDivisioncomesdownfairlysquarelyagainstthekangenemarkerinthegeneticallyengineeredtomatoes.Iknowthiscouldhaveseriousramifications.” 45

Butsuchramificationscouldonlyensueifthewarningswereheededbytheadministrators–orelsebecameknownbythepublic.Andneitheroftheseconditionsoccurred.Inwhatwasbecomingastandardprocedure,theadministratorsagainspurnedthewarningsoftheirexperts,eventhoughthemainadmonitionhadbeenconveyedinanemphatic,anddramatic,manner.Further,alsoinlinewiththeirpreviouspractice,theymadesuretheconcernswerecoveredup.

However,inpursuingthiscallouscourse,theynotonlyhadtobrushofftheinitialreportfromtheDivisionofAnti-InfectiveDrugProducts,theyhadtoignoreastronglystatedfollow-upfromitsSupervisoryMicrobiologist.Inanefforttodrivehometherealityoftherisks,hedelineatedthevariousweaknessesinCalgene’sargumentsandexplainedwhyitssubmissionfailedtodemonstratethatuseofthekanamycin-resistancegenewouldbesafe.Henextpointedoutthatalthoughothermarkerswereavailablethatdidnotposeappreciablerisk,theindustrypreferredtheantibioticresistantonesbecausethey’reeasiertouse.Then,inforthrightwordsthathehopedwouldbegiventheattentiontheydeserved,hedeclareditwaswrongtoletindustryconveniencetrumppublicsafety.“Inmyopinion,”hewrote,“thebenefittobegainedbytheuseofthekanamycinresistancemarkerintransgenicplantsisoutweight[sic]bytheriskimposedinusingthismarkerandaidingitsdisseminationnationwide.Ifweallowthisproposal,wewillbeaddingatremendousquantitativeloadofgeneticmaterialtotheenvironmentwhichwillprobablyassuredisseminationofkanamycinresistance.” 46

Buthiseffortswereinvain.TheadministratorsultimatelyshunnedallthecautionaryinputthatheandhiscolleagueshadprovidedandinsteadgaveCalgeneformalapprovaltousetheantibiotic-resistance

markergenenotonlyinitsFlavrSavrtomatoes,butintheGEcanolaandcottonitplannedtoproduceinthefuture.Andtojustifytheiraction,theyprojectedtheimpressionthattheagency’sscientistshadnoqualmsaboutthemarkergeneandwereuniformlyconvincedofitssafety.

Moreover,asinthecaseofthefeedingstudies,effectingthisfraudentailedhoodwinkingtheFoodAdvisoryCommittee–andfalselypurportingtherewasconsensusaboutsafetyamongagencyexperts.Thus,ashadhappenedduringthatearlierdeception,whenthemarkergenewasdiscussed,noneoftheexpertswithreservationswasselectedtoappear;andthediscussionwasinsteadconductedbyascientistwhowaswell-attunedwiththeagency’sagenda.Indeed,shebelongedtotheBiotechnologyPolicyBranch,whichwaskeentopromoteGEfoodsandhadhelpedcrafttheagency’slaxandillicitpolicystatement.47Accordingly,inassertingthattheagencydeemedthegenesafe,48sheskirtedthefactthattheentireDivisionofAnti-InfectiveDrugProducts(comprisingthescientistswiththegreatestexpertiseinevaluatingtherelevantrisks)haddeterminedthatitssafetyhadnotbeendemonstrated–andthatitposedanunacceptablethreat.

Withinafewweeksofthemeeting’send,theFDAformalizedthisdeceptionbyapprovingCalgene’sfoodadditivepetition–andspuriouslycertifyingthatusingthekanmarkergeneintheproductionofthecorporation’sbioengineeredtomatoes,canola,andcottonwas,fromthestandpointsofbothscienceandthelaw,safe.

FinalTakeonHowtheFDAPuttheTomatoontheMarket:MultipleFraudsandaFour-foldBreachoftheLawTheFDAannouncedtheapprovalofthemarkergeneonMay18,1994,thesamedayitnotifiedCalgenethatithadnoobjectiontothemarketingofthetomatoitself.49Further,theagencyexpressednoreservationsabouteitherofthelinesthathadbeenlinkedwithharmfuleffects;anditappearsthattheoneCalgenecommercializedwasthelineassociatedwiththecuriousdeaths.50

ButprobablynooneoutsidetheFDAknewthatthisfirstbioengineeredwholefoodwasreachingthenation’sdinnertablesthroughtheorganization’ssystematicmisrepresentationsandrepeatedactsoflaw-breaking–andthatwithoutsuchmalfeasance,thisnovelfruitwouldhaveessentiallydiedonthevine.

Thefraudswerecrucialtothelaw-breaking,andthelaw-breakingwascrucialtocommercialization.Therewerefourdistincttransgressions;andthefirstwastheworst,sinceitlaidthegroundworkforthemarketingofallGEfoods.Itoccurredin1992,whentheFDAbrazenlybreachedthelawbypretendingthatGEfoodswereGRASwhenitfullyknewtheyweren’t.Thenextyear,theagencybrokeitagainbytellingitsexpertstoassesstheFlavrSavraccordingtoalooserstandardthanthelawprescribes.Andwhentheagencysubsequentlydeclaredthetomatoproblem-free,thatwasanotherbreach,becauseitdidsointhefaceofagencyexpertswhomaintainedthatsafetyhadnotbeendemonstrated–andthatanimportantissuewasunresolved.Butthattransgressionwasnotinitselfsufficienttoenablecommercialization.Inorderforthetomatotoappearonsupermarketshelves,thefoodadditivepetitionforthekanamycinresistancegenehadtobeapproved;andtheFDAcouldonlydosobybreakingthelawonemoretime–andcertifyingtheadditivesafeeventhoughakeydivisionofagencyexpertshadconcludeditentailedunreasonablerisk.

Further,becausesomuchconfusionhasbeencreatedaboutwhatthelawrequires,it’simportanttopointoutnotonlythatthetomato’sentrytothemarketwasillegal,butthatitwouldhaveremainedillegaleveniftheadvisorycommitteehadbeenfullyinformedofthesuppressedstaffmemosbutsupportedtheadministrators’positionanyway.That’sbecausegeneralrecognitionofsafetycannotbeachievedbygettingonegroupofexpertstodisagreewithanothergroup–andeventwoexpertshavesufficedtodefeataclaimofGRASinfederalcourt.51Therefore,thefactthatasignificantnumberofagencyexpertsconcludedthatthesafetyofthetomatohadnotbeendemonstratednullifiesthenotionthatitwasGRAS.

Althoughtheadministratorscouldbefogthatfact,theycouldnotexpungeit–andduetothatobstinatereality,theproductreachedthemarketthroughabreachofthelaw.

Additionally,theapprovalofthemarkergene’sfoodadditivepetitionwasnot(andcouldnothavebeen)legitimizedbytheopinionofthecommitteeeither.TheexpertsintheDivisionofAnti-InfectiveProductswereespeciallyconcernedabouttheriskthatkanamycinresistancewouldbespreadtohumangutbacteria;andtheynotedthatCalgenehadnotpresentedaconcretedemonstrationtoruleoutthisproblembutonlytheoreticalarguments.52Theyfurtherstatedthateventhoughsomeofthemwere“plausible,”Calgeneneededto“demonstratetheseargumentsasfact.” 53Accordingly,theyadvisedthatacontrolledanimalstudyshouldbeconductedtotestthem.

Inhisfollow-upmemo,theDivision’sSupervisoryMicrobiologistemphasizedtheunreliabilityofCalgene’sassumptions.Hepointedoutthatseveralwerebasedonthebeliefthatscientistshave“adequately”understoodimportantmechanismsatplayinthebacterialworld,andhethendeclared:“Inmyopinion,nothingcouldbefurtherfromthetruth.” 54HeadditionallyemphasizedthattherewasnosolidbasistosupportCalgene’scalculationsabouttheeffectsofdeployingthemarkergene;andheasserted:“Wecannotpredictwhattheconsequencesofthisactionwillbe.” 55

However,althoughtheseexpertsconcludedthatsafetycouldnotbeestablishedonthebasisofCalgene’sassumptionsandarguments,andthatconcreteexperimentaldatawasrequired,Calgenedidnotsubmitany.56Therefore,it’sobviousthatthemarkergenefailedtomeetthelegalstandardofsafety,whichrequires“areasonablecertaintyinthemindsofcompetentscientiststhatthesubstanceisnotharmfulundertheintendedconditionsofuse.” 57AndeventhoughtheFDAsucceededingettingsomeotherscientistsonitsstafftosaytheysawnoproblemswithusingthegene,andeventhoughiteventuallywasabletoconvincemostofthescientistsonitsadvisorycommitteetoconcurwiththisviewpoint,thatcouldnotovercomethefactthatthegroupofscientistsmostskilledatassessingthegene’ssafetyremaineddubious.58

TheFailureoftheTomato’sBasicHypothesis–andItsFailureontheMarketNotonlywerethepotentiallycomplexconsequencesofemployingtheantibiotic-resistancemarkergeneunpredictable,eventheseeminglystraightforwardeffectoftheenzyme-inhibitinggenewasnotaccuratelyanticipated.Thecentralhypothesisonwhichthetomato’ssuccesshadbeenstakedwastheassumptionthatdecreasingthecrucialsofteningenzymewouldenablethefruittoripenonthevineandyetstayfirmenoughtoresistdamageduringshipping.Butthisassumptiondidnotholdup–afailurewhich,incombinationwithpoorbusinessplanning,inducedtheproduct’sdemiseonlyafewyearsafteritsdebut.59

Moreover,thiscollapsewasinnowayconnectedwithpublicresistancetogeneticengineering.60SodefthadbeentheFDA’sdeceptionsthatevenprominentopponentsofthetechnologywereconvincedthetomato’ssafetyhadbeenestablished.61Thus,thefruitfailed,notbecauseofoppositiontobioengineering,butduetothefailureofbioengineeringtoyieldthedesiredresults.62Ofcourse,hadthefactsbeenfullyaired,andthepublicinformedofwhattheFDAexpertshadactuallysaid,theywouldalmostsurelyhavereacteddifferently–andnotonlyrejectedthisfirstfruitofbioengineering,butservednoticethatnootherswouldbeacceptedeither.

Thus,thecommercializedphaseoftheGEfoodventurehadaremarkablymarredbeginning.Andthefactsconnectedwithitsfirstfoodsupplementandfirstwholefoodweresounsettlingthat,ifthey’dbeenhonestlyreportedinsteadofstubbornlyobfuscatedorsystematicallymisrepresented,theentireenterprisewouldhavebeenhalted–andyouwouldnotbereadingthisbookbecausetherewouldhavebeennoneed

towriteit.Butyouarereadingit;andasyoucontinue,youwilllearnhow,astheventurecontinued,itcontinued

toyieldtroublingresults–andhowitsproponentswerecontinuallydriventokeeponobfuscatingordistortingthem.

TheCaliberofTestingSlackensThesafety-relatedstudiesontheFlavrSavrthatCalgenesubmittedtotheFDAwereneverpublishedasresearchpapersinpeer-reviewedjournals,and,aswe’veseen,theydidnotmeettheminimalstandardsformainstreamscientificjournalsthatpublishsuchstudies.Yet,despitetheirflaws,theywereofasignificantlyhighercaliberthanmostofthetestingofGEfoodsformanyyearsthereafter.IntheUnitedStates,theFDAprofessedthatthetestsonthetomatohadsosuccessfullydemonstratedsafetythattestsonotherGEfoodswouldnotbenecessary–andthatthesoundnessofitspolicytonotrequireanyhadbeenconfirmed.63Butevenifthetestshadactuallyshownthetomatotobesafe,itwouldstillhavebeenillegitimatetosoboldlygeneralize,because(aswilllaterbeexplainedinmoredetail)beingabletodemonstratethatoneGEfoodissafewouldnotestablishthatanyothersare.AndalthoughmostotherindustrializednationsdidnotadopttheFDA’shands-offpolicy,nonerequiredthekindoftestingtowhichtheFlavrSavrhadbeensubjected;andtheyallsettledforastandardthatwasmuchlower.

AsChapter6explained,thisstandard,whichistermed“substantialequivalence,”isfarlesssubstantialthantheGRASstandard,whichistheonebywhichtheFlavrSavrwassupposedtohavebeenassessed.Infact,it’ssolaxthatformanyyears,onlyafewstudiesonGEfoodswerepublishedinpeer-reviewedjournalsbecause(asChapter6alsorevealed)theregulatoryrequirementswerefarbelowthestandardsthejournalsupheld.Accordingly,mostGEfoodsthatenteredthemarkethadscanthardevidencetoattesttheirsafety.

Sodeficientwasthesystemofassessmentthatin2001,fiveyearsafterthewaveofpost-FlavrSavrGEfoodshadbegunspreadingthroughoutNorthAmericanmarkets,areportbytheRoyalSocietyofCanada(discussedinthepreviouschapter)notonlylamentedthelackofadequatetestingofthesefoods,butnotedthatthereweren’tevenanyvalidatedtestprotocolstoassesstheirsafety“inabiologicallyandstatisticallymeaningfulmanner.” 64Thus,allofthemanyclaimsuptothenallegingthatsafetyhadbeenprovenwere,fromagenuinelyscientificstandpoint,baseless.

HowanEfforttoImprovetheMeansforDetectingIllEffectsWasViciouslyAttackedforActuallyDetectingSome:TheAstonishingStoryofArpadPusztai

AnAward-WinningResearchDesign

ButtheSociety’slamentwasnotthefirsttimethedearthofmeaningfultestprotocolswasprominentlyacknowledged.Sixyearsearlier,beforeanybioengineeredsoy,cornandcanolaappearedonthemarket,theScottishAgriculture,EnvironmentandFisheriesDepartment(SOAEFD)recognizedthelackandendeavoredtoremedyitbystimulatingthedevelopmentofamodelprocedurethatcouldreliablyverifyaGEfoodwassafetoeat.Soitcalledforresearchproposals,andoutof28submittedfromthroughoutEurope,itselectedtheonefromagroupheadedbyArpadPusztai,whom,asnotedearlier,wasarenownedfoodsafetyexpert.65Thisproposal,whichhadwonoutoversomanycompetitors,wasawardeda1.6million-poundgrant,withtheexpectationitwouldestablishbettermethodsforreliableriskassessmentofGEcropsandleadtosoundpublishedstudies,noneofwhichweretheninexistence.66

ThispromisingprojectwascoordinatedthroughtheRowettResearchInstituteinAberdeen,Scotland,oneoftheworld’smostprestigiousnutritionalresearchcenters,andtheplacewherePusztaihadbeenemployedfor32years.OtherparticipantsweretheScottishCropResearchInstituteandtheUniversityofDurhamSchoolofBiology.TheGEcroptheprojectaimedtotestwasapotatoengineeredtofendoffpredatorsbyproducingapesticide.Thiswouldbeachievedbyendowingthespudswithagenederivedfromthesnowdropplantthatexpressesatypeofprotein(calledalectin)toxictoaphidsandseveralotherinsects.Theresearchershopedthat,wheninsertedinpotatoes,itwouldprovidethesameprotectionitaffordsthesnowdrop.

Anothervarietyofpesticide-producingpotato(producedbyMonsanto)wassoontobemarketedinAmerica,containingadifferentkindofinsecticidalproteinthatwasderivedfromasoilbacteriuminsteadofaplant.Butthiswasnotthemostimportantdifferencebetweenthetwotypesofalteredpotatoes.AlthoughMonsanto’swouldbeconsumedbyalargenumberofpeople,theywouldnotbemeaningfullysafety-tested,whereasthosedevelopedbyPusztai’sgroupwouldundergothemoststringenttestingyetappliedtoaGEcrop.

Thistestingwasdesignednotonlytodetectilleffects,buttodiscernifanywereattributablesolelytosomeaspectofthebioengineering.Tothatend,thereweretwogroupsofcontrolratsagainstwhichtheratsfedtheengineeredpotatoeswerecompared.Onewasfedpotatoesfromthenatural-stateparentallinefromwhichtheGElineshadbeenderived,andtheotherconsumedpotatoesfromtheparentallinethathadbeenspikedwithlectinatthesamelevelproducedwithintheGElines.AndtoensurethatnoextraneousdifferencesexistedbetweentheGEandparent-linepotatoes,theyweregrownalongsideeachotherinatunnelthatwasisolatedfromtheenvironmentandwereotherwiseexposedtoidenticalconditionsaswell.67

Further,toprovidefullerinsight,thereweretwodistinctGElines,eachcreatedfromtheparentlinethroughaseparateinsertionalevent.Inall,fourseparatestudieswereconducted,withtwoemployingoneoftheGElinesandtwoemployingtheother.Ineachcase,thedetailsdiffered.Forinstance,onestudytestedrawpotatoesfor10dayswhileanothertestedcookedonesfor30.

However,despitethefacttheset-upwasrigorous,Pusztaiwasconfidentitwouldnotdetectanyadverseeffectsfromthelectin.Hewastheleadingauthorityonlectins,andhispriorresearchhaddemonstratedthat,althoughthesnowdrop’sversionwreakedhavocontheinnardsofinsects,itwassafeformammals–evenatlevelshundredsoftimeshigherthantheGEpotatoeswouldcontain.Soheassumedthatifanyproblemswerediscovered,theywouldbesideeffectsofthegeneticengineeringprocess.Moreover,becauselikesomanyscientistsatthattime,hehadbeenledtobelievethatthisprocesswasessentiallysafe,healsoassumedthatitwouldn’tbelinkedtoproblemseither–andthattheseGEpotatoeswouldbecomeabeneficialadditiontoagriculture.ThislatterassumptionwasalsoheldbytheRowettInstitute,whichplannedtocommercializetheproduct.68Buttheassumptionwaswrong.

Unexpected,andTroubling,Results

Whenthetestswerefinallycompleted,andtheresultsregistered,theyweredisquietinginseveralrespects.ChemicalanalysisrevealedthatneitherlineofGEpotatowassubstantiallyequivalenttotheparentlineandthattherewerestatisticallysignificantdifferencesinseveralconstituentsthatareofmajornutritionalimportance.ItalsorevealedthatthetwoGElineswerenotevensubstantiallyequivalenttooneanother–whichwasprobablyduetothefactthatthebacterial-deliveredcassetteshadbeenwedgedintodifferentregionsofthegenomesandhadthereforeinduceddisparateeffects.69

What’smore,thefeedingstudiesrevealedthatthechemicalchangescorrelatedwithsubstantialphysiologicalchanges.TheratseatingtheGEpotatoesdifferedfromthosefedtheparentallineinmanymeasuresofgeneralmetabolismandorgandevelopment,andtheirimmunesystemswereweakened.70Inall,39statisticallysignificantdifferenceswerefound(byindependentmultivariatestatisticalanalysis),ofwhichnomorethanfivecouldhavebeentheresultofrandomerror.71Mostofthesedifferenceswereobservableafteramere10days.72Further,theywerefoundevenwhentheGE-fedratswerecomparedtothosethatatetheparentalpotatoesspikedwiththelectin.73

OneofthemoreworrisomeoutcomeswasthattheGEpotatoesinducedabnormalproliferativecellgrowthinthemiddlesectionofthesmallintestines(thejejunum).74Suchgrowthcanbeaprecursorofcancer.75Further,bothlinesofGEpotatoeswereassociatedwithintestinalabnormalities,andbothwere

alsolinkedtoalteredorgangrowthanddiminishedimmuneresponse.76

RespondingtoaSensedDutyandProvidingthePublictheFacts

InPusztai’sassessment,thedataclearlyindicatedthatthetroublingchangeshadnotbeencausedbythemerepresenceofthelectinbutinsteadhadbeeninducedbysomeaspectoraspectsofthegeneticengineering.Andthisconcernedhim,becauseheknewthattheseperturbingpotatoesnotonlycouldhaveeffortlesslyenteredtheUSmarketbutwouldhavepassedthroughthesuperficialregulatoryregimesinrestoftheworldwithoutahitch.AndhefurtherrealizedthatthevariousGEfoodsalreadybeingconsumedbymultitudesofpeoplemightbeharmingtheminasimilarwaythathispotatoeshadharmedtherats–andthatevenifadverseeffectswereprogressivelycumulating,therewaslittlechancethey’dbelinkedtothebioengineeredproductsthatwerecausingthem.77

Moreover,hewasdisheartenedbythefactitwouldtakealongtimetobringoutthefacts–ifhestucktostandardprocedures.That’sbecause,accordingtoconvention,ascientistisnotsupposedtocommunicateresearchfindingspriortopresentingthemataconferenceorviaapublishedarticle.Andobservingthisconventionwouldcreateasubstantialdelay.Ashelaterexplained,“Ihadfactsthatindicatedtometherewereseriousproblemswithtransgenicfood....Itcantake2to3yearstogetsciencepaperspublishedandthesefoodswerealreadyontheshelveswithoutrigorousbiologicaltesting....” 78

SowhentheBritishTVshow,“WorldinAction,”requestedtointerviewhimabouthisresearchandhisviewsonGEfoods,itofferedanopportunitytoprovidethepublicwithimportantinformationhebelievedtheyhadarighttoknow–especiallysincetheresearchthatproducedithadbeenfundedbytheirtaxes.However,hewasreluctanttotakesuchaboldstepwithoutgainingthepermissionoftheRowettInstitute’sdirector,ProfessorPhillipJames–permissionthatwasreadilygranted.

Pusztai’swasonlyoneofseveralstoriesintheprogram,andhisinterviewwasediteddownto150secondsforbroadcast.Butthose150secondswerepotent.Inthem,PusztainotedsomeoftheadverseeffectsthathadbeeninducedbytheGEpotatoesandemphasizedtheimportanceoftighteningupthetestingstandards.Moreover,heexpressedhisconcernsaboutGEfoodsandstronglycriticizedthefacttheywereonthemarketeventhoughtheirsafetyhadnotbeenadequatelydemonstrated.Asheputit,“Ifindthatitisvery,veryunfairtouseourfellowcitizensasguineapigs.Wehavetofindtheguineapigsinthelaboratory.” 79

ColossalControversyandCruelReprisals

Notsurprisingly,whentheinterviewairedonAugust10,1998,itcreatedacolossalstir;andimmenseattentionwasdirectedontoPusztaiandtheRowettinstitute.ProfessorJameswasinitiallydelightedwiththisattention,andhespokeofPusztaiandhisresearchinglowingterms.80WhenPusztaimetwithJamesbeforeleavingforhomethefollowingafternoon,thelatter’sattitudetowardhimhadnotnoticeablychanged.81ButthingstookadrasticturnonAugust12th.Pusztaiwasabruptlyfired,theresearchwasterminated,andallthedatawasconfiscated.82Andtoaggravatetheinsult,Pusztaiwasputunderagagorderthatforbidhimfromspeakingabouttheresearch–andthreatenedlegalactionifhedid.

Suchadramaticreversalcriesoutforanexplanation.HowdidPusztaimorphfromherotooutcastinlessthan24hours,andwhydidhisresearchsosuddenlyturnrepugnant?ItappearsthatthisabruptattitudinalshiftdidnotoriginatewithintheRowettInstitute–andhadnobasisinscience.Instead,evidencepointstotheinterventionofanoutsideinfluencethatwasnotonlypowerful,butpolitical.Accordingtoa2003articleinTheDailyMail,PusztaiallegedhewasseparatelyinformedbytwoemployeesatRowettthatthedayafterthebroadcast(whichwasthedaybeforehegotsacked)ProfessorJamesreceivedtwocallsfromtheofficeofthePrimeMinister,TonyBlair.HealsoallegedthataseniormanagerattheinstitutetoldhimandhiswifethatBlairintercededafterbeingcalledbythenUSPresident,BillClinton,whoseadministrationwasheavilypromotingGEfoods–andpressuringothernationstoacceptthem.83

TheDailyMailarticlefurtherreportedthatthestoryofClinton’srolewascorroboratedbytwoothereminentresearchersatRowett,oneofwhomstatedhewasinformedofitbyaseniorofficialattheinstitute.ThearticlealsopointedoutthatalthoughProfessorJamesstronglydeniedhewascontactedbyBlair,itwasevidentthattheBlairgovernmentwasalliedwithpro-GEforcesandevenparticipatedwiththemin“acoordinatedcounter-attack”againstPusztai.

Intense,Unjust,andHypocriticalAttacks

Thisattackwasvehement,andoftenvicious,anditberatedhisbehavioraswellashisresearch.Further,besidesbeingunfair,itwashypocritical.Afterall,considerthatPusztaiwasscoldedforviolatingprotocolbyspeakingprematurelydespitethefactnoprotestswereraisedwhen(aswesawinChapter1)StanleyCohenannouncedhisresearchresultswellaheadofpublicationinordertoderaillegislativeattemptstoregulatebioengineering.And,incontrasttoPusztai’scase,hismainclaimwasn’teventrueandwasatoddswithhisactualstudy.NorwerethereoutcrieswhentheFDAbrokewithalong-standingpolicybyprematurely(andfraudulently)declaringtheFlavrSavr’ssafety.Soit’sclearthatbiotechproponentsapproveofprematurepronouncementsthatservetoprotecttheGEventureandonlyobjectwhentheaimistoinsteadprotectthepublicfromitsroutinely-deniedrisks.

Andthehypocrisydidn’tstopthere.AlthoughthescientistswhopraisedGEfoodshadpreviouslyignoredtheprotocolsofsciencesotheycouldproclaimtheirsafetyonthebasisoftestingthatwasglaringlydeficient,nowthatonehadbeenprominentlylinkedwithproblems,theysuddenlybecameardentlydevotedtotheprinciplestheyhadformerlybeenwillingtoscrap.Moreover,althoughtheydemandedthatthisunwelcomeresearchbesubjectedtothehigheststandards,theirrediscoveredscrupleswerenotstrongenoughtodeterthemfromdecryingdefectsthatdidn’tevenexist.

Consequently,theyderideditsdesignforseveralallegedflaws,despitethefactitactuallydidconformtotherigorousstandardstheynowprofessedtochampion.Andit’sdifficulttoseehowtheycouldhavehonestlydoneso.Thestudy’sessentialdesignhadalreadybeenemployedindozensofpublishedstudiesconductedatRowett,andithadwonoutover27otherproposalsinacompetitionheldbyadepartmentoftheScottishgovernment.Moreover,accordingtoPusztai,ithadalsobeenapprovedbytheUK’sBiotechnologyandBiologicalSciencesResearchCouncil.84

Oneofthemostdeplorableattackswasmountedbytheinstitutionthathadforcenturiesbeenregardedasaparagonofscientificrectitude:theRoyalSociety.Thisaugustorganization(whichistheUK’snationalacademyofscience)wasfoundedin1660andistheoldestscientificacademyincontinuousexistence.85And,althoughformostofitshistorytheSocietyhadrefrainedfromtakingsidesonissuesorfromevenexpressinganofficialopiniononatopic,86bythemid-1990’s,ithadbecomeapartisandefenderofGEfoodsandembracedaproactivepolicyontheirbehalf.87Pursuanttothispolicy,itendeavoredtoquelltheunnervinginfluenceofPusztai’sinterviewbyimpugninghimandhisresearch.Aspartofthiseffort,19oftheSociety’sfellowswroteanopenletterattackinghiswork.88Andamonthlater,inMarch1999,theSocietyitselfinitiatedamajor,andunconventional,phaseinthecampaign.

Upuntilthen,ithadneveroperatedasapeer-reviewingbody,leavingthatfunctiontojournalsandotherinstitutions.Yet,asChapter9andAppendixBhaveshown,theSocietywaspreparedtostrayfromitsstandardpracticesinordertoprotectGEfoods,soitbrokewithitslongtraditionandundertookthefirstpeerreviewinitshistory.

Andthispeerreviewwastrulypeerless.NotonlywasitunprecedentedinregardtotheSociety’sownpast,itwaswithoutpeerinregardtootherpeerreviews.However,itsuniquenesswasnotduetoexceptionalmerit,butdistinctivedereliction.

Ordinarily,apeerreviewexaminesacompletedatapackage,becausethat’stheonlywayresearchcanbeproperlyassessed.ButtheRoyalSocietydidnotreviewallofPusztai’sdata,becausetheRowettInstituteonlysentanincompletereportthathadbeenpreparedforusebyscientistsontheresearchteamwhowerefamiliarwiththebasicdetails.Accordingly,thatabbreviatedreportdidn’tdescribeseveralkeyfacetsofthedesign–andwasnotwhatPusztaiandhiscolleagueswouldhavesubmittedtoarefereedjournal.However,althoughastandardjournalwouldneverhaveacceptedsuchasubmission,theRoyalSocietydid.AnditevenrefusedPusztai’soffertoprovideadequatedata,whichhehadfinallyobtainedinlate1998whenRowettwasobligedtoreleaseittohimsohecouldtestifybeforeaParliamentarycommittee.89Thus,insteadofobtainingaproperpackage,thispremierscientificinstitutionsawfittoreviewonethatwasclearlyunfit–andtothenroundlycritiquethelackoffitnessforwhichititselfwaslargelyresponsible.90

Moreover,althoughtheresearchdesignwasnotdeficient,thecompositionofthereviewpanelwas.AccordingtoPusztai,noneofthemembershadexpertiseinnutritionalstudies,andthereforenonewasproperlyqualifiedtoassesssomeimportantaspectsoftheresearch.91Thisledtoerror.Forinstance,oneofthereviewersclaimedthatthereweretoofewratsineachgrouptoobtainreliableresults,unawarethatthenumberwasindeedsufficient,thatPusztaihadpreviouslyconductedmorethan40nutritionalstudiesinwhichthisnumberwasemployed,andthatallthosestudieswerepublishedinrespectedjournalsbecausetheyhadsatisfiedreviewerswhowereproperlyqualified.92Further,thesamerefereemadeseveralothererroneousstatements,oneofwhich,accordingtoPusztai,was“notonlyoutrageous,”butrevealedthatindividual“hadnoideahowsuchanexperimentisconducted.” 93Healsonotedthatthe“poor”qualityofanotherreviewer’scommentsimpliedthatheorshewas“outoftouchwithpresentdaynutritionalscience.” 94Andnotonlydidyetanotherreviewerdisplayignoranceofanimportantfactaboutnutritionalresearchthatshouldhavebeenknownbyscientistsreviewingthisnutritionalstudy,heorsheapparentlyreadthedocumentscarelessly(ifatall),becauseeveryfactaboutthestudythatwasrecitedwaswrong.95

Therefore,allthereviewers’criticismswerebaseless.Mostpertainedonlytothesubstandardsubmission,nottotheresearchasactuallydesignedandexecuted;andtherestwereduetoignoranceaboutimportantfactsthatshouldhavebeenknownbyacompetentreviewteam.

However,althoughthisreviewmorecloselyresembledtheproceedingsofakangaroocourtthanthose

ofanobjectivescientificpanel,thecriticalverdictthatwasissuedinJune1999nonethelessservedtostronglydiscreditPusztaiandhisresearch.ButthosewhoknewtheuglydetailsrealizedthattheSocietyhadactuallydiscrediteditself.AstheeditoroftheprestigiousjournalTheLancetdeclared,theSociety’sactionwas“agestureofbreathtakingimpertinencetotheRowettInstitutescientistswhoshouldbejudgedonlyonthefullandfinalpublicationoftheirwork.” 96Andhesubsequentlybrandedita“recklessdecision”thatabandoned“theprincipleofdueprocess.” 97

ButtheRoyalSocietyremainedundaunted;andhavingunjustlydamagedPusztai’sreputation,wasdeterminedtosquelchanyendeavorthatmightrehabilitateit.Consequently,ittriedtopreventhisresearchfrombeingpublished,anditsactionswereonceagainunsavory.98What’smore,they“intensified”whentheSocietylearnedthatTheLancetwasplanningtoprintsomeofit.99

HowPublicationinaPremierJournalWasDeniedItsProperEffect

Thatjournalhadreceivedapaperco-authoredbyPusztaiandDr.StanleyEwen,apathologistattheUniversityofAberdeen,describingoneofthestudiesthatdetectedabnormalcellgrowthintheintestines.Giventhevolatilityofthetopic,theeditorselectedateamofsixreviewerstoscrutinizethepaper,twicetheusualnumber.Anditsurvivedthisincreaseddegreeofscrutiny,withonlyonereviewer(whoworkedatagovernment-fundedinstitute)sidingagainstpublication.100Accordingly,itwasslatedforinclusionintheissuetobepublishedonOctober15,1999.

Thiswasbadnewsfortheboostersofbiotechnology.IfthequalityofPusztai’sresearch,andthevalidityofhisfindingsabouttheintestinalabnormalities,werevindicatedbysuchaneminentjournal,itwouldcastreasonabledoubtonthesafetyofbioengineeredfoodingeneral.Itwouldalsocastdoubtonthereliabilityofthescientistsandscientificinstitutionsthathadsosavagelydisparagedtheresearch.Accordingly,severalGEproponentsurgedthejournaltoabandonitsplans.AndtheRoyalSocietywasamongthem.Thejournal’seditor,RichardHorton,toldtheGuardian,“[T]herewasintensepressureonTheLancetfromallquarters,includingtheRoyalSociety,tosuppresspublication.” 101

AlotofthepressurewasexertedinaphonecallHortonreceivedonOctober13fromaseniormemberoftheSocietythathesaidbeganina“veryaggressivemanner.” 102Thecallertoldhimhewas“immoral”forplanningtopublishapaperwhichhe“knewtobeuntrue”–andsubsequentlytoldhimthatifheproceeded,itwould“haveimplicationsforhispersonalposition”aseditor.

However,unlikethescientistswhowerepilloryingPusztai,Hortonmaintainedhisintegrity,andhepublishedthepaperasplanned.Yet,thisimportantoccurrencedidnotinducethesignificanteffectsitshouldhave.Andthat’sbecausethepro-GEbrigadeintensifiedtheirattack,relentlesslydistortingthefactsabouttheresearchandthecircumstancesofitspublication.

TheunrepentantRoyalSocietyremainedattheforefront,addingmightilytothebarrageofdisinformation.In2002,itsBiologicalSecretaryfalselyassertedintheSociety’sjournal,ScienceandPublicAffairs,thattheLancetpublishedPusztai’sresearch“inthefaceofobjectionsbyitsstatistically-competentreferees.” 103Andinthesameyear,itreleasedareportthatmorethoroughlymisrepresentedtheresearch.

TheDeplorablePowerofDisinformation

That’sthereportonGEfoodscritiquedinAppendixB;anditsfoultreatmentofPusztai,whichisnotdescribedinthatappendix,wasworsethananyoftheoffensesthatare.Notonlydidthereportrelegatehisresearchtooneshortparagraph,thatparagraphpackedabigdeception.ItpurportedthattheSocietyhadpublishedareviewin1999thatscrutinizedtheresearchaspublishedinTheLancetandfounditflawed,withnoconvincingadverseeffectsdemonstrated.104Butthatpublicationwasoftheshoddypeerreviewpreviouslydiscussed,anditappearedmorethanthreemonthsbeforePusztai’sresearchwaspublished.105Accordingly,themembersofthatreviewpanelhadnotevenseenthecompletedatapackagesubmittedtothejournalandhadinsteadpassedjudgmentontheincompleteonetheRowettInstitutehadprovided.Thus,theparagraphdeceitfullyimpliedthattheSocietyhadanalyzedthepublishedstudyanddetermineditwasdefectivewhen,inreality,itsassessmenthadnotevenconsideredthatstudyandhadinsteadfocusedonanabbreviatedsummaryitknewwasdeficientevenbeforetheassessmentbegan.106

Further,the1999reviewwasatleastasdeviousasthe2002reportthatfraudulentlymisrepresentedit.Forinstance,afterdeclaringthat“...wehavereviewedallavailabledatarelatedtoworkattheRowettResearchInstitute,”thedocumentthenclaimedthat“Dr.Pusztaiindicatedtousthatfurtherinformationexisted,butdidnotprovideit.” 107Yet,aspreviouslyrevealed,Pusztaididoffertoprovideitandwasrebuffed–apparentlysotheSocietywouldhaveapackagewithamplefodderforcritique.

Bypersistentlyspreadingsuchdisinformation,theSocietyanditsalliesinthescientificestablishmentmisledandemboldenedGEproponentswhowerenotscientists.Forinstance,LordDickTaverne,aninfluentialmemberofParliamentandfounderoftheorganizationSenseAboutScience,displayedapeculiarscientificsensibilityinregardtoPusztai’sresearchbydeclaringthattheratshadbeenfed“harmfullectinsinsertedinpotatoes”–therebyimplyingthattheproblemswerenotcausedbybasicfeaturesofbioengineering.108Ironically,Taverne’sgrosslyinaccuratecommentcameincontextofacomplaintaboutthe“irresponsibleandrecklessdisregardforfactandevidencewhichhascharacterisedthereportingofmanyscientificissues....” 109

Ofcourse,theirresponsibleandrecklessdisregardforfactandevidencehadactuallybeendisplayedbytheRoyalSocietyandotherinfluentialvoicesofscience,anditwasthroughtheconfusiontheyintentionallyfosteredthatthemediafellintoerroneousreporting–withtheerrorsprejudicialnottobiotechnology,buttoPusztai.Inoneofthemosttellingexamples,thetechnologyeditorofTheIndependentdemonstratedhisfailuretostayindependentofsuchdeceptiveinfluencebystatingthatwhenTheLancetevaluatedPusztai’swork,“thereviewersrefuseditforpublication,citingnumerousflawsinitsmethods–notablythattheratsintheexperimenthadnotbeenfedGMpotatoes,butnormalonesspikedwithatoxinthatGMpotatoesmighthavemade.” 110ThefactthatthetechnologyeditorofamajorBritishnewspaperwasundertheimpressiontheresearchhadn’tbeenpublishedandthattheratshadnotevenbeenfedengineeredpotatoesshowshowstunninglysuccessfulthedisinformationcampaignhadbeen.

Further,thenotionthattheresearchnevergotpublishedinapeer-reviewedjournalhadgainedconsiderabletractionwellbeforebeingbolsteredbyTheIndependent.Forinstance,itwasprominentlypromotedbythereportofNewZealand’sRoyalCommissiononGeneticModificationissuedin2001.IncommentingondefectsthatitpurportedtohaverecognizedinPusztai’sresearch,thereportstates:“Itwasunfortunatethattheprocessofpeerreviewwaspre-emptedbyprematuremediarelease,thuspreventingfurtherscientificassessment.” 111ButtheresearchwasadequatelyassessedinTheLancet’speerreview,anditwastheCommission’sassessmentthatgotobstructed–notbyanyflawsinPusztai’swork,butbyitsownpreferenceforfalseclaimsfromGEproponentsoverthegenuinefactsobtaineddirectlyfromhim.Thus,althoughtheCommissionreceivedextensivewrittenbriefsfromDrs.PusztaiandEwenandalsoreceivedoraltestimonyfromboth,itsreportontheirresearchnonethelessmisrepresentsitinseveral

additional(andsignificant)respects.112Moreover,itomitsseveralimportantfactsofwhichtheCommissionhadbeenapprised;andconsonantwithitsclaimthatpeerreviewwasprevented,oneoftheomissionsisthefactthattheresearchwaspublishedinTheLancet.Whereasmanyreferencesarelistedforthereport’sdiscussionofPusztai’sresearch,nowhereinthemaintextorthereferencesectionisthereanymentionofTheLancet,whichisstrangeindeed.Thatagovernment-appointed,blue-ribboncommissioncouldhavebecomesoseriouslybefuddledaboutthebasicsofthePusztairesearchisinitselfcompellingproofthat,eventhoughitssoundnessissolidlysupportedbythefacts,theforcesthatdesiretodiscreditithavesubstantiallytriumphed.

Sopowerfulhasbeentheinfluenceofdisinformationthatthemainomissioninsomereportshasbeen,notthefailuretomentionthattheresearchwaspublished,butthefailuretomentiontheresearchatall.Forinstance,the2004reportbytheNationalAcademyofSciencesthatwasanalyzed(andrebutted)intheprecedingchaptersaysnaryawordaboutit.Presumably,thecommitteethatwrotethereportthoughttheresearchhadbeensothoroughlydiscreditedthattherewasnoneedtonoteit.Moredisturbing,eventhe2001reportbytheRoyalSocietyofCanada(alsodiscussedinChapter9)saysnothingaboutiteither.Althoughthatreportexaminesasubstantiallylargeramountofrisk-relevantinformationthandoesitsNAScounterpart,andalthoughitcautionsabouttherisksinsteadoftryingtominimizethemastheotheronedoes,theauthorsnonethelessappeartohavefallenundertheillusionthatPusztai’sresearchwassodevoidofmerititcouldbejustlyignored.Accordingly,it’snotsurprisingthatPamelaRonald’sbook,Tomorrow’sTable,isalsomuteregardingPusztai.

AndwhileNinaFedoroffdiddiscusshisresearchinMendelintheKitchen,herdiscussionaugmentstheinaccuracies.Althoughsheinitiallyprovidedafullerandmoreaccurateaccountthanhavemostotherpro-GEcommentators,sheultimatelycouldnotsteerclearoferror,andshewentontomakeamisstatementthat’snotonlymajor,butnovel–andstandsasheruniquecontributiontotheongoingconfusion.Herfalsereportcameintheformofacritique.DespitethefactPusztaiandhisgrouphadtakenseveralstepstoensurethatthecontrolandGEpotatoeshadbeengrownunderthesameconditions,Fedoroffclaimedtherewasabigfaultintheirsetup;andshefaultedPusztaiforallowingit,andforfailingtorecognizethatitcouldhavecausedthedifferencesbetweenthetwosetsofspuds.Inparticular,shealleged(a)thathehad“jumpedtotheconclusion”thedifferenceswereduetosomeaspectofthebioengineering,(b)thatthisconclusionwas“unwarranted,”and(c)thatitwaslikelyduetoignoranceofacriticalfact.113Assheexplained,“Whatheprobablydidn’tknow–becausehewasneitheraplantbreedernoraplantbiologist–wasthattheveryprocessthroughwhichtheplantsareputduringtheintroductionofthetransgene–culturingthroughacallusstageandthenregenerationoftheplant–cancausemarkedchangesinboththestructureandexpressionofgenes.” 114ShethereforeassertedthatthiscomparisonofGEpotatoeswithinappropriatecontrolswasthe“centralflaw”intheexperiment;andshemarveledthat,despitealltheattentiongiventotheresearch,noonebeforeherseemedtohaveappreciatedthiscrucialpoint.115

Butwhatshefailedtoappreciateisthatnoonehadseenthis“centralflaw”becauseitdidn’texist–andthatshe’d‘seen’itonlybecauseshefailedtoseeallthefacts.Inreality,Pusztaiwaswellawarethatgeneratingplantsviaformationofanamorphousmassofcellsknownasacallustendstoinducesubstantialalterations,andhedesignedtheexperimenttoavoidit.That’sonereasonhechosepotatoes,becausetheycannaturallypropagateinanasexualmanneranddonotrequiretheextremeformofcallus-inducingtissueculturethatordinarilymustbeemployedtoregenerateawholeplantfromasinglecell.Therefore,unlikemostGEplants,theengineeredpotatoeshedevelopedhadnotgonethroughthisdisruptiveprocess.Further,hehadtakenadditionalstepstominimizeanydifferencesthatmighthavearisenduringthegentlerculturingtheydidendure.Thus,thetroublingdisparitiesbetweenhisGEpotatoesandthecontrolsweremostlikelyduetosomeaspectofthebioengineeringotherthantissue

culture.Further,eveniftheywereattributabletothetissueculture,thatwouldn’tvindicatethebioengineeringprocess,becausetissuecultureisoneofitsessentialcomponents.

However,ashadtheNAScommitteein2004,Fedoroffpretendedthetissuecultureprocessissoseparatefrombioengineeringthatitsrisksareirrelevantwhenassessingthelatter’ssafety.But,asChapter9explained,therisksposedbytissuecultureareinherenttobioengineering;andtheymustbeconsideredwhengaugingitsoverallrisks.Moreover,Pusztai’sresearchunderscoresjusthowsubstantialthoseaggregaterisksare.That’sbecause,byminimizingthedisruptiveinfluenceoftissueculture,andreducingtheprobabilityitwouldbethesourceofadverseeffects,thestudystronglyenhancedtheoddsthatthoseobservedwerecausedbybasicfeaturesoftheGEprocessdistinctfromtheculturing–especiallysinceithadshownthatthelectinproducedbytheforeigngenehadnotitselfcausedharm.Accordingly,becausemostGEcropsposeahighersetofculture-relatedrisks(duetothemoredisruptiveformoftissuecultureemployedintheirdevelopment),it’sreasonabletoregardthemas,inprinciple,ofevenhigherriskthanwerePusztai’spotatoes.

ButtheproponentsofGEfoodswerenotabouttoacknowledgethelogicalimplicationsoftheresearch;andtheyinsteadtriedtostripitofitsrightfulrelevance.TheRoyalSocietywasinthethickofthisendeavor.Its1999statementtookpainstopointoutthat:“Theworkconcernedoneparticularspeciesofanimal,whenfedwithoneparticularproductmodifiedbytheinsertionofoneparticulargenebyoneparticularmethod.”Itthengrandlydeclared:“Howeverskillfullytheexperimentsweredone,itwouldbeunjustifiabletodrawfromthemgeneralconclusionsaboutwhethergeneticallymodifiedfoodsareharmfultohumanbeingsornot.EachGMfoodmustbeassessedindividually.” 116

Characteristically,notonlywasthisassertionunsound,itwasduplicitous.AlthoughtheSocietywas,ontheonehand,anxioustorestrictthesignificanceoftheproblematicfindingstothatoneuniquesetofcircumstances,ontheother,itwaseagertoexpandtheapplicabilityofanystudythatcouldbeusedtorefutethosefindings–evenifitsparticularsweresubstantiallydissimilartothoseofPusztai’s.Thus,theSociety’s2002reporttriedtodiscreditPusztai’sresearchbyallegingthatsubsequentfeedingstudiesemployingGEsweetpeppers,tomatoes,andsoyahadtested“clearlydefinedhypothesesfocusedonthespecificeffectsreportedbyhim”andhadnotfoundanyadverseeffects.117

Butthisclaimhadnocrediblebacking–andwasacarefullycrafteddeceit.AlthoughtheSocietycitedapublisheddocumentinamannerthatimplieditwasareportoftheprimaryresearch,itwasnot.Itwasmerelyanopinionpiecethatbrieflyalludedtotworesearchstudies.AndneitherofthemcameclosetorefutingPusztai’sfindings.Foronething,theyweren’treliable.One,performedbyChinesescientistsonbothGEsweetpeppersandtomatoes,wasnotevenpublishedandhadnotyetundergonepeerreview.118Andalthoughtheother,whichtestedGEsoybeans,hadbeenpublishedinaJapanesejournal,itsmethodologywasdeeplyflawed.Forinstance,thesoybeansusedastheconventionalcomparatorwerenotfromtheparentallinethathadgivenrisetotheGEbeans,sothereweretoomanygeneticdifferencesbetweenthem.Further,itappearstheyweregrownunderdifferentenvironmentalconditionsthanhadtheGEbeans,whichadditionallydiminishedtheirfitnesstoserveascontrols.Moreover,allthebeanswereheatedtosuchadegreethatanyunintendedtoxicproteinsintheengineeredoneswouldhavebeendenatured.119Perhapsevenworse,thestudysodrasticallydepartedfromstandardproceduresthat,accordingtoPusztai,haditbeenconductedintheUK,“theresearcherswouldhavelosttheiranimallicenceandtheresearchwouldhavebeenforcefullyterminated.” 120That’sbecausetheanimalswereessentiallystarved–whichinitselfdestroyedthestudy’sreliability.121Inall,theshoddinessofthisstudycontrastssosharplywiththethoroughnessofPusztai’sthattheSalkInstitutebiologistDavidSchubertcalledit“ajoke.” 122

However,there’snothingfunnyabouttheoutsizeandutterlyunwarrantedinfluencethesesubstandardstudieshavewielded.Theirimpactwasestablishedin2001byanopinionpieceintheprestigiousjournal

NatureReviews–theonetheRoyalSociety’s2002reportartfullycitedasifitwereoriginalresearch.Thatdocumentdeclaredthatthestudiesonengineeredpeppers,tomatoes,andsoybeanshad“tested”Pusztai’sclaimbuthadn’tdetectedadverseeffects–implyingthathisclaimhadtherebybeenrefuted.123Laterthatyear,thereportbyNewZealand’sRoyalCommissiononGeneticModificationalsodisparagedPusztai’sstudybystating:“ExtensivetestingcarriedoutbyChineseresearchers,similartothatdescribedbyDrs.PusztaiandEwen,hasnotreplicatedtheirresults.” 124Thus,evenbeforetheRoyalSocietyweighedin,theimpressionthatPusztai’sresearchhadbeensolidlydiscreditedhadbeeninstilledwithinthescientificcommunityandthepublicmind.

Yet,what’smostunsettling–andamazing–isnotthattheRoyalSocietyandotherostensiblyauthoritativecommentatorshavetriedtodiscreditPusztai’sresearchwithstudiesonpeppers,tomatoes,andsoybeansthatweresubstandard,butthattheycitedstudiesonthosespeciesinthefirstplace.Afterall,Pusztai’sresearchinvolvedGEpotatoes,soitcan’tberefutedbytestsondifferentspeciesofplants.Andthisholdsevenmorestronglyforthestudiesthathavebeencitedforthatpurpose,sinceeventhetransferredforeigngenesinthosecasesweredifferent.Whilealectin-producinggenefromaplanthadbeeninsertedinthepotatoes,thesoybeanswereendowedwithanherbicideresistancegenefromabacterium,andthepeppersandtomatoesweretransformedwithagenefromavirusthatexpressesitscoatprotein.

TheIrrefutabilityofPusztai’sResearch

Moreover,eveniftheotherstudieshademployedpotatoesfromthesamespeciesasdidPusztaiandhadtransformedthemwiththesamecassettethathe’dinsertedinhis,andeveniftheyhadpreciselyreplicatedhisresearchdesign,theycouldnothaverefutedhisresults–nomatterhowmanytimestheymayhavefailedtoreproducethem.That’sbecause,astheRoyalSocietyhademphasizedwhentryingtorestricttherelevanceofPusztai’sstudy,itinvolved“oneparticularproduct,”andthatproductcontainedauniquesetofalterationsinducedbyauniqueinsertionalevent(andtosomedegreebyauniquetransitthroughtissueculture).Infact,becausetheinsertionofanrDNAcassetteissuchasingularevent,withasingularsetofeffects,thetwoGEpotatolinesPusztaicreatedsubstantiallydifferedfromoneanother,despitethefacttheyderivedfromthesameparentalstock,hadbeentransformedwithidenticalcassettes,andweregrownunderidenticalconditions.Accordingly,anydeleteriousattributesoftheGEvarietiescouldbetheresultsofwherethecassettehadlodgedwithintheDNA,orwhatkindofdisruptionsithadcaused,orhowtheviralpromoterwasaffectingsurroundinggenes–ormanyotherfactorsthatweredistinctlyassociatedwiththespecificinsertionalevents.

Thus,thereliabilityofPusztai’sfindingscouldonlybetestedbyemployingthesamelinesofGEpotatoesthatwereusedinhisexperiments;andthatwasrenderedimpossiblewhenthegovernmentandtheRowettInstituteshutdownhisresearchanddestroyedallthepotatoes.Consequently,hisfindingsabouttheadverseeffectsofthoseGEpotatoescanneverberefutedbyfurthertesting,nomatterhowwelldesigned,andthefactthattheRoyalSocietyandprominentscientistsappearoblivioustothisrealityisfurtherproofthattheydonotadequatelycomprehendthebasicworkingsofrDNAtechnology–orelsearewillingtomisrepresenttheminordertoprotectitsimageandpromoteitsproducts.

Giventheintensityofthecontroversyandthedegreeofdisinformationthat’sbeengenerated,it’simportanttobeclearabouttheimperviousnessofPusztai’sresearch.ThepaperEwenandPusztaipublishedinTheLancetonlydiscussedabnormalitiesintheratsinthatstudyandmadenoattempttogeneralizetheresultstootherGEfoodcrops.Consequently,theirfindingsinthatexperiment,andtheconclusionstheydrew,cannotbeimpugnedbyresearchonanyotherGEplants(includingpotatoes)–andtheyarethus,inregardtofurthertesting,irrefutable.125Theycanonlybechallengedbydiscerningflawsinthewaythestudywasdesignedorexecuted;and,aswe’veseen,therearenosolidgroundsonwhichto

doso.Thesituationissimilarregardingtheotherthreestudieswithintheresearchproject,someofwhichhavebeenpublishedasbookchapters.Theirfindingscannotberefutedbyfurtherresearcheither.

AndalthoughinothercontextsPusztaiopinedthatsomeoftheeffectsheobservedmightbeattributabletobroaderfeaturesoftheengineeringprocess–andthatsimilarproblemsmightthereforebeinducedbytransformingotherplantswiththetechnology–hedidnotassertthatthiswouldinvariablyhappen.Therefore,evenhisbroaderstatementscannotberefutedbytwoorthree(oreventen)testsonotherGMOs,nomatterhowrigorouslyconducted.That’sbecausedemonstratingthatoneoranotherparticularinsertioneventisnotlinkedwithadverseresultswouldnotdemonstratethateveryotherinsertionwilllikewisebeproblem-free.Ofcourse,ifthevastmajorityofwell-conductedtestsonGEcropsweretofindnoilleffects,thatwouldweighagainsttheideathatawiderrangeofGEfoodsmightalsobeharmful.However,assubsequentsectionsdemonstrate,nosuchevidencehasaccumulated,andthebulkoftherigoroustestinghasresultedinadverseoutcomes.

Nonetheless,despiteitsstrengths,andalthoughitsbasicfactsarebeyondreasonabledispute,notonlyisPusztai’sresearchstillshroudedbyconfusion,theimpressionprevailsthatithasbeendiscredited.Moreover,theproponentsofbioengineeringhavenotbeencontentmerelytorepeattheirfalsehooldsbuthaveaugmentedtheirstockofthem.Forinstance,DerekBurke,aformerPresidentoftheSocietyofGeneralMicrobiologyandaco-authorofthe2001opinionpiecethatunjustlyimpugnedtheresearch,jackedthedistortiontoanewlevelin2014.HeassertedthatPusztaihadclaimedinpressreleasesandonaTVprogram“thatGMpotatoescausedcancerwhenfedtorats.”Hethenembellishedthatbogusassertionbyalleging:“AclaimthatthiswastrueofallGMfoodswasthenmade,butneversustained.”Andinhisfinalflayingoffact,hedeclaredthat“theclaimsweredisputedandcouldnotbereproduced.” 126Butinreality,Pusztaihadsaidnothingaboutcancer;nordidheextendtheclaimsthatheactuallydidmaketoallengineeredcrops.127Further,becausethepotatoesheusedhadbeendestroyed,therewasneveralegitimateattempttoreproducehisresults–anditwasdeceptivetoimplythatstudiesondifferentspeciesemployingdifferentrecombinantcassetteswerevalidendeavorstodoso.

Evenworse,besidesinventingnewfalsehoods,GEproponentshavemaintainedthemevenafterbeingalertedtotheirinaccuracy.AnespeciallyegregiousexampleinvolvesNinaFedoroff.Aswe’veseen,in2004sheclaimedtohavediscovereda“centralflaw”thatnooneelsehaddetected,althoughinrealitytheflawwasinherownmisunderstandingofthefacts.Thatclaimappearedinherinfluentialbook;andinFebruary2006,sherepeateditwhenshepostedanexpandedversionofthebook’sdiscussionofPusztaionaninfluentialwebsite.Shortlyafterherpiecewasposted,Pusztaisenthercommentsthatpointedouthererror.Buthedidn’treceiveareply,andsevenyearslater,hererroneousaccusationwasstillstandingonthatwebsite–andstillspreadingthefalsenotionthattheresearchwasfatallyflawed.128

APerturbingTrend:AsAdverseOutcomesMount,Cover-upsContinueandPrecautionsDiminishPerhapsyou’venoticedthegrowthofapersistent,andperturbing,trend.Bioengineering’sfirstedibleproductcausedamajorepidemic.Itsfirstwholefoodwaslinkedwithharmtolabanimalsthat(intheeyesoftheFDA’spathologists)castitssafetyinreasonabledoubt.AndthefirstGEfoodtoundergothorough,industry-independenttestingwasfoundtocausesignificantadverseeffectsintheratsconsignedtodineonit.Further,ineachinstance,governmentalentitiescoveredupkeyevidenceandmisrepresentedkeyfacts;andinthetwomostvolatilecases,numerouseminentscientistsandscientificinstitutionsaidedandsubstantiallyexpandedthegovernment’seffort,turningitintoaslickandsystematicdisinformationcampaign.

Moreover,ifthefactsabouteitherofthefirsttwoincidentshadbeenfairlyreportedtothepublic,theGEfoodventurewouldhavebeenbroughttoastop–andprobablycouldn’thavecontinued.Andifithadrestarted,fulldisseminationofthefactsaboutthethirdincident,incombinationwithrevelationsregardingtheearliertwo,wouldalmostsurelyhaveendedit.However,suchdisseminationwas

prevented.Although,thankstoPusztai’sbravery,theessentialinformationwastransmittedthroughouttheUK,andeventuallyspreadthroughEurope,theAmericanmediakepttheUScitizenryinthedark.Andthiscrucialblack-out,conjoinedwiththeadroitdisinformationcampaignmountedbybiotechadvocates,hasrobbedtheresearchofitsrightfulinfluence.WhiletherevelationsinEuropesignificantlycontributedtothegrowthofwidespreadresistancetoGEfoodsthathaslargelykeptthemoutofthatcontinent’ssupermarkets,theag-biotechventurehascontinuedfullforceintheUSandCanadaandisstillbeingardentlypushedbyseveralgovernmentsandthemainstreamscientificestablishment.

Equallyappalling,despitetheirpretensionstothecontrary,theproponentsofgeneticengineeringandthegovernmentsthatabetthemhavenowishtofollowuponresearchthatraisesdoubtsaboutitssafety–andhaveconsistentlythwartedeffortstodoso.Infact,insteadofspurringincreasedscrutinyandtightenedprotocols,theadverseeffectsthatweredetectedduringthe1990’sactuallyinducedareductioninoversightandalooseningofstandards.129

Thus,aswesawinChapter3,althoughtheShowaDenkoCorporationendeavoredtogivetheFDAthebacteriausedinproducingthetoxictryptophansupplementssostudiescouldbedonetodeterminethespecificcauseofthecontamination,theagencywouldnotcooperate.Sothecorporationfinallydestroyedthemicrobes,curtailinganychanceofreachingadefinitiveconclusion.Andafewyearsafterthetryptophan-inducedepidemic,whenfacedwithproblematicresultsoftestsontheFlavrSavrtomato,theFDAagainchosetocurtailratherthanencourageadditionalresearch.Althoughitsexpertshadcalledforfurthertestingtoclarifytheextentofrisk,theagencynotonlyrefusedtodemandany,itdeclaredtherewasn’tevenaneedforthetestingthatalreadyhadbeendone,thattheproductcouldbemarketedwithoutrelianceonit,andthatfutureGEcropsdidnothavetoundergoanytestingatall.Aroundthesametime,(asChapter7revealed)theUSEnvironmentalProtectionAgencywasstiflingfollow-upstudiesonresearchthathadshownagene-alteredsoilbacteriumwaslethaltovegetation.Eventhoughtheassociatedriskwasenormous(promptingPhilRegaltoassertthatfurtherdetailedresearchwas“demanded”),andeventhoughtheEPAhadfundedtheinitialstudy,theagencynotonlyrefusedtofundanyfollow-upresearch,ittreatedtheuniversityprofessorwhoparticipatedinthatrevelatorystudyasapariah.

Fouryearslater,initshandlingofthePusztaiincident,theUKgovernmentdemonstrateditalsodesiredthedisablingofresearchthatcoulddamagetheimageofbiotech–andwasjustaswillingastheUSgovernmenttoeffectthisaiminaruthlessmanner.Accordingly,althoughPusztai’sresearchhadbeenfundedbytheScottishgovernment,andwassupposedtoestablishasounderprotocolforfuturestudiesonGEfood,whenitproducedembarrassingresults,thecentralgovernmentswiftlyshutitdownandmadesurethoseengineeredpotatoeswouldyieldnofurtherdistastefuldiscoveries.Further,notonlydidthegovernmentfoilanyfollow-upstudies,itrefusedtoimplementtheresearchprotocol(intowhichsomuchpublicmoneyhadbeeninvested)asanewstandard–andinsteadretreatedtothecomfortableconfinesofthesubstantialequivalencedoctrine,enablingGEfoodstoremainfreefromthescrutinythatcoulddetecttheirunintendedsideeffects.

AnotherContinuingTrend:ResearchthatProducesDisturbingResultsProvokesNastyAttacksHence,atthedawnofthe21stCentury,morethanadecadeafterthefirstedibleofferingofbioengineeringenteredthemarket,theventurestillrestedonaprecariouslyfeeblefooting.Notonlyhadsomeofitsproductscauseddiscernibleproblems,theRoyalSocietyofCanadareportedthattestingwasinadequateandthatvalidatedprotocolswerelacking.Andthefootingisevenfeeblertoday.Therearestillnorequirementsforadequatetesting,andseveraloftheteststhathavebeenconductedaugmentthestoreofdatathatraisereasonabledoubtsaboutsafety.

Amongtheunsettlingresultsarethefollowing:

MaleratsfedavarietyofBtmaizedevelopedbyMonsantofortheEgyptianmarketdifferedfromthosefedthenon-GEcontrolmaizeinorganandbodyweightsandinbloodchemistry,despitethefactthecontrolplantsweretheparentalvarietyandweregrownnexttotheirengineeredrelatives.130Thedifferencesweredetectedafter45days;andafter91days,severaltoxiceffectsweremeasured,includingabnormalitiesinlivercells,excessivegrowthofintestinalmembranes,congestedbloodvesselsinthekidneys,anddamagetocellsthatareessentialforspermproduction.131

FeedinganothertypeofBtmaizetobothyoungandoldmicewasassociatedwithamarkeddisturbanceoftheimmunesystemandofbiochemicalactivity.132

WhenmicewerefedforfiveconsecutivegenerationsonGEtriticale(ahybridofwheatandrye)theirlymphnodesenlargedandthenumberofsomeimportantimmunesystemcellssignificantlydecreased.133

RabbitsthatconsumedGEsoybeanshadadversechangesinenzymefunctionintheirheartsandkidneys.134

MicethatateGEsoybeansfortwoyearsdisplayedindicationsofacuteliveragingincomparisontothosefedonnon-GEsoy.135

Amoredetailedsummaryoftheseandseveralothertroublingstudiesisavailableat:http://earthopensource.org/gmomythsandtruths/sample-page/3-health-hazards-gm-foods/3-1-myth-gm-foods-safe-eat/

TheMaltreatmentofMalatesta

Further,notonlyhavetheresultsoftestingoftenbeenunsettling,soisthewayresearcherswho’vegeneratedthemhavebeenmistreated.Andinsomecases,theinflictedindignationshavebeenalltoosimilartothoseheapeduponPusztai.Forinstance,ManuelaMalatesta,aprofessorattheUniversityofUrbinoinItaly,ledateamthatconductedlong-termresearchonMonsanto’sglyphosate-resistantsoyandfoundthatthemicethatatethisGEfoodhaddisturbedfunctioningoftheirliversandpancreases–andthatthemalesalsohadalteredfunctionoftheirtestes.136Althoughcolleaguesadvisedhertorefrainfrompublishingherresults,shedecidedtodoitanyway–andreapedtheunfortunateconsequencesherfriendshadanticipated.Besidesbeingforcedfromherpostattheuniversity,shewasunabletogetfundingtodofollow-upresearch.Assherelated:“Ilosteverything:mylaboratory,myresearchteam.Ihadtobeginagainfromscratchatanotheruniversity.” 137

TheSearingofSéralini

Moreover,asinthecaseofPusztai,besidespunishingtheresearchers,biotechproponentshavesometimessavagelyassaultedtheresearch.Andthemoreimportantthefindings,themoreintensehavebeentheattacks.Thus,oneofthemostimportant,andalarming,studieswassubjectedtospecialabuse.LikeMalatesta’sresearch,itwasalong-termstudyonaglyphosate-tolerantGEcrop–butinthiscase,theproductwasMonsanto’sNK603maize,which,likethesoybeanshetested,wasdesignedtosurviveapplicationofthecompany’sRoundup

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herbicide.ItwasconductedbyaresearchteamledbyGilles-EricSéralini,aProfessorattheUniversityofCaen,France,anditwaspublishedinapeer-reviewedjournalin2012.138

TheresearchgrewoutofapriorstudytheteamhadconductedonthesameGEmaize.Itre-analyzedtherawdataMonsantohadgeneratedduringashort90-dayfeedingtrialtoconvinceregulatorsthattheproductwassafe.ButtheEuropeanFoodSafetyAuthority(EFSA)didn’tneedmuchconvincing.AlthoughdifferencesweredetectedbetweentheratseatingtheGEandnon-GEmaize,Monsanto’sresearchersdiscountedtheirimportance,statingtheyweren’t“biologicallymeaningful.” 139AndtheEFSAreadilyacceptedthisassessment.140

However,whenSéraliniandhiscolleaguesgottheirhandsonthedata(whichrequiredalegalactionandacourtorder),theydiscoveredsymptomsofliverandkidneytoxicityintheratsontheGEdiet;andtheypublishedtheirfindingsinastandardjournalin2009.141

Theythenconductedtheirnewstudy,feedingratstheengineeredmaizefortwoyearsinsteadofthreemonths,todetermineifthoseeffectsweretrulyinsignificantinthelongrun.Further,notonlywastheirstudylongerthanMonsanto’shadbeen,itwasmorecomprehensive.Itwasalsobetterdesigned,becauseitcoulddistinguishbetweeneffectsoftheRoundupherbicidethatwouldbeappliedtothecropandtheeffectsofthemaizeitself–thefirststudytoachievesuchdiscrimination.

TheresultswerehighlydamagingtotheimageofRoundup-resistantcropsbecausetheydemonstratedahighdegreeofdamagetotheratsthatatethem.TheyrevealedthatRoundupandtheGEmaizeeachindependentlycausedseriousinjurytotheliversandkidneys,abnormalonsetoflargetumors,andincreasedmortality.SuchproblemshadnotbeenseeninMonsanto’sstudybecausetheytakelongerthan90daystodevelop.Forinstance,thefirsttumorsdidn’tforminmaleratsuntilthestudyhadgoneamonthlongerthanMonsanto’s,thefirsttumorsinfemalesdidn’tappearuntilthe7thmonth,andmostofthetumorsweren’tapparentuntil18monthshadelapsed.

Further,thekidneysandliversweren’ttheonlyorgansadverselyimpacted.Statisticallysignificantdamagewasalsodetectedtopituitaryglandsandmammarytissues;andallthenegativeeffectswereobservedforthethreebasiccategoriesofexperimentalrats:thosethatateGEmaizesprayedwith

Roundup,thosethatateunsprayedGEmaize,andthosethatatenoGEmaizeandinsteadweregivenasmallamountofRoundupintheirdrinkingwater(anamountsimilartotheamountthatwouldhavebeeningestedinadoseofsprayedmaize).

Becauseregulatorshaveoftennotrequiredanytoxicologicalfeedingstudies,andhaveneverrequiredanythatarelongerthan90days,andbecauseSéralini’sstudyshowedthatabioengineeredproductthathadgainedworld-wideapprovalbasedona90-daytrialcouldnonethelessinducesevereandcomprehensiveharmwhenconsumedforalongerterm,itthreatenedtodiscredittheentireregulatorysystem–andtounderminetheentireGEfoodenterprise.Sotheproponentsofthatenterprisequicklysetouttodiscredititinstead.

Asusual,theirattackwasvigorous,venomous,deceptive–andeffective.Theirkeycontentionwasthatthestudyhadbeendefectivelydesigned;butthiscomplaintrestedonthe

notionthatitsobjectwastodetectcancer–despitethefactthatclearlyhadnotbeenitsaim.Consequently,theircritiquewaswayoff-base.Inreality,thestudywasnotintendedtomonitorsignsofcancerbuttodetectlong-termtoxicity;andthetwotypesoftrialshavedifferentdesignprotocols.Further,thestudySéraliniconductednotonlysatisfiedallthecriteriaforsuchatoxicitystudy,itexceededtheminsomerespects.Soallitsmeasuresoftoxiceffectswerereliablyobtained–and,evenwithouttakingthetumorsintoaccount,theyweremorethansufficienttocastreasonabledoubtontheproduct’ssafety.

Further,itislegitimatetoalsotakethetumorsintoaccount.AlthoughthecriticscomplainedthatcancerstudiesaresupposedtoemploymoreratspergroupthandidSéralini,thatguidelineismeanttomakethestudiesmoresensitivetotheabnormalincidenceoftumors.Intechnicallanguage,it’saprecautionarymeasuretoavoidfalsenegatives,nottopreventfalsepositives.Inotherwords,thepurposeofusingmoreratsistodecreasethelikelihoodthatanunusualrateoftumorincidencewillgoundetected,nottoguardagainstthewrongfulimputingofsignificancetodifferencesintumorratesbetweengroupsofratsthataren’tactuallymeaningful.142Therefore,asseveralexpertshaveemphasized,becauseSéralini’sstudywaslesssensitivethanthestandardtumor-detectingtrialbutnonethelessdetectednumeroustumors,itsresultsareevenmoreportentousthanifahighernumberofratshadbeenused.143

Thus,thecriticsareineffectclaimingthatbecausethestudyemployedfewerratsthanareordinarilyneededtodetecttumors,thetumorsitdetecteddon’treallycount–andthatthissomehowalsonullifiesthemultiplefindingsoftoxicitythatwereobtainedviathestandardproceduresoftoxicitytests.Obviously,thisargumentisnotonlyfalsebutridiculous.Andsoaretheothersthey’vemustered.

Forinstance,thestudyhasbeenattackedforusingastrainofratsespeciallypronetotumors–which,it’salleged,wouldleadtosuchgrowthsevenintheabsenceoftheGEmaizeandtheRoundup

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.ButtheresearchersusedthesamestrainthatMonsantohadusedinits90-daystudyonthemaizeandinitsratstudieswithglyphosate.Andthisstrainisastandardoneusedinlong-termtoxicitystudiesandincancerstudiesaswell.SoiftheuseofthatstraininvalidatesSéralini’sstudy,italsoinvalidatesthoseMonsantostudiesandthealltheotherstudiesinwhichit’sbeenemployed–studiesthatincludemanyotherGEfoods.

Moreover,theabsurdityoftheargumentloomslargerinlightofthefactthattheratsconsumingtheGEmaize(ortheRoundupalone)displayedaquickeronsetoftumors,andahigherincidenceofthem,thandidthecontrolrats–whichdemonstratedthatsomethingbesidestheirpedigreeexertedatumor-inducingeffect.144

Yet,althoughtheircriticismswereutterlyunwarranted,ahostofGEadvocatesdoggedlymaintainedtheefforttodiscreditthestudy.Especiallygallingtothemwasthefactithadbeenpublishedinarespectedpeer-reviewedjournal,FoodandChemicalToxicology(FCT),whichendoweditwithacredibilitythattheycouldnotabide.Sotheyputprodigiouspressureonthejournal;and,morethanayearafterthestudyhadbeenpublished,theeditorsfinallysuccumbedandtooktheextraordinarystepof

retractingit–astepthatmaywellhavebeenfacilitatedbytheappointmentofaformerMonsantoscientisttothejournal’seditorialboard.

And,justastheRoyalSociety’speerreviewofPusztaiwaswithoutpeer,sowastheretractionoftheSéralinistudyfromapeer-reviewedjournal.AccordingtotheCommitteeonPublicationEthics(COPE),theonlyvalidreasonsforretractinganarticleareunreliablefindings(dueeithertomisconductorhonesterror),plagiarism,redundantpublication,orresearchthat’sunethical.145Yet,inhisinitialstatementabouttheretraction,FCT’seditor-in-chief,A.WallaceHayes,didn’tciteanyofthesereasonsandinsteadlaythesoleblameon“inconclusive”outcomesregardingtheratesoftumorincidenceandmortality.Andheallegedthattheinconclusivenesswasduetotheuseoftoofewratsandalsototheparticularstrainofratthatwasemployed–allegationswhich,aswe’veseen,werewithoutmerit.

However,afterreceivingseveralletterscriticizinghisfailuretofollowtheCOPEguidelines,andbelatedlyrealizingthat“inconclusive”findingsareimpropergroundsforretraction,heabruptlyaugmentedhisargument.Becausetheguidelinespermitretractionifthere’s“clearevidencethatthefindingsareunreliable”duetomisconductor“honesterror,”hemadeanaudacious,andawkward,attempttoturntheallegedinconclusivenessintoacaseoferror-basedunreliability.Hegamelyassertedthatbecausethedataare“inconclusive...theclaim(i.e.,conclusion)thatRoundupReadymaizeNK603and/ortheRoundupherbicidehavealinktocancerisunreliable.”Andhethenattributedthis“unreliable”claimto“honesterror.” 146

Butthisattempttorehabilitatetheretraction,althoughgame,waslame–becauseitreliedonagrossmisrepresentation.And,althoughDr.HayesattributedSéralini’sallegedblunderto“honesterror,”it’sdifficulttodothesameregardinghis.That’sbecausenowhereinSéralini’spaperisthereaclaimthateithertheGEmaizeortheRoundupislinkedtocancer.Infact,theword“cancer”doesnotevenappear.147Yet,despitethisreality,Dr.HayeswasnotcontenttorestwiththefalseaccusationthatSéraliniandhisco-authorshadclaimedalinkbetweenNK603andcancer.Hewentontoexacerbatethefalsehoodbydeclaringthattheirpapercontained“theclaimthatthereisadefinitivelinkbetweenGMOandcancer”–therebypaintingthemashavingirresponsiblyextendedtheirclaimtoallengineeredorganisms.

Buttheonlyirresponsibilityondisplaywashisown.NotonlyhadSéralini’steambehavedresponsibly,theywouldhavebeenirresponsibleiftheyhadn’tmentionedthetumors.That’sbecause,accordingtostandardprotocols,researchersperformingchronictoxicitytestsmustreportthepresenceoftumors,eveniftheirstudiesaren’tdesignedtodetectthem.148AndthatisallthatSéralini’steamdid.Theydiligentlyreportedthedataonthetumorswithoutmakinganyclaimsaboutlinkstocancer.Andintryingtocastthisconscientiousbehaviorasadelinquency,Dr.Hayeshadtostrenuouslytwistthetruth.

Moreover,eveniftherehadbeenalegitimatebasisforrejectingtheirdiscussionofthetumors,itwouldnothaveprovidedvalidgroundsforretractingtheentirearticle.TheCOPEguidelinesstatethat“ifonlyasmallpartofanarticlereportsflaweddata,”the“best”courseistorectifyitviaacorrection.Andtheyemphasizethat:“Retractionshouldusuallybereservedforpublicationsthataresoseriouslyflawed...thattheirfindingsorconclusionsshouldnotbereliedupon.”ButSéralini’sfindingsregardingthemultipletoxiceffectsthatwerelinkedtoboththeGEmaizeandtheRoundupwerenotonlysolid,theywerethecentralfocusofhisstudy;andhisdiscussionofthetumorswasunconnectedwiththem.Soevenifthatdiscussionhadbeeninappropriateorunreliable,itstillwouldnothaveweakenedthosefindingsinanyway.Infact,Hayesacknowledgedthatthenumberofratswasadequatetosupportthosefindings,149

andhealsoacknowledgedthattherawdatawereaccurate.150Sotheretractionviolatesbasicstandardsandoffendslogic.

It’salsostarklyatoddswiththecourseofscience.Numerousscientistshaveprotestedtheretraction,emphasizingthatinconclusiveresearchcannonethelessbeimportant–andcannotbedismissedsolelyon

thatbasis.Reflectingthisview,DavidSchubertwrote:“Theeditorsclaimthereason[forretraction]wasthat‘nodefinitiveconclusionscanbereached.’Asascientist,Icanassureyouthatifthiswereavalidreasonforretractingapublication,alargefractionofthescientificliteraturewouldnotexist.” 151

Nonetheless,althoughtheyhadneitherfact,logic,norscienceontheirside,theforcesthatpromotetheGEfoodventurewereonceagainabletodiscreditawell-designedstudythatsolidlylinkedabioengineeredcropwithadverseaffectsonhealth–despitethefactithadbeenpeer-reviewedandpublishedinarespectedjournal.Further,insomerespects,theirattackonSéralini’sworkwasevenmoresuccessfulthantheonethey’dmountedagainstPusztai’s.Inthelattercase,theyfailedintheirattempttopreventtheresearchfrombeingpublished,andalthoughthedisinformationtheyspreaddeludedmanypeopleintobelievingthatitwaspublishedcontrarytothedecisionoftheexpertswhoreviewedit–andmanyothersintobelievingithadnotbeenpublishedatall–itnonethelessdoesstandasapeer-reviewedstudyinapremierjournal.ButinSéralini’scase,theypressuredthejournalintoretractingthestudy,whichstrippeditofthedistinctionofpublicationandformallybrandeditasunreliable.

Moreover,althoughbothstudieshadbroadimplications,duetothedisinformation,thoseimplicationshavebeenessentiallyignored.Pusztai’sresearchindicatedthattheharmsitdetectedcouldhavebeencausedbyoneormoregeneralfeaturesofthebioengineeringprocess,152whileSéralini’sindicatedthattheRoundup

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herbicideheavilysprayedonmanyvarietiesofGEcropsposesadisturbingdegreeofrisk–andthatavarietyofmaizeengineeredtotoleratetheRoundupdoesaswell(evenwhenunsprayed).Thus,theformercastsreasonabledoubtonmostoftheGEcropsonthemarket,whilethelattershowsthatRoundupitself(whichissprayedonthemajorityofGEplantscurrentlybeingconsumed)andatleastonevarietyofRoundup-resistantmaizeinitselfdocauseharmwhenfedtorats–whilecastingdoubtontheinherentsafetyofallotherRoundup-resistantcropsaswell.153However,notonlyhastherebeenscantrecognitionoftheserealities,becausetheimpressiongainedholdthatSéralini’sstudyfocusedsolelyoncancer,fewpeopleareevenawarethatitfoundseveretoxiceffectsinthekidneys,liversandpituitaryglands–andthatthejournal’schiefeditorhadnotcontestedthesefindings.

Thisdearthofawarenessisduetothecritics’consistentcomplaintsaboutthereportingoftumors–andutterdisregardoftheotherfindings.Likeamagicianwhomisdirectspeoples’attentionsotheywon’tseesomethingthatwouldordinarilybeobvious,thestudy’senemiesconcentratedtheircritiquesonthetumor-relatedfindingsandcreatedtheillusionthereweren’tanyothers.Andtheillusionwassostrongevenseasonedjournalistsweretakenin.Forinstance,inhisreportontheretraction,aNewYorkTimesreporterwhohadregularlycoveredbiotechissuesdiscussedonlythecontestedfindingsregardingtumorsandmadenomentionoftheothers,eventhoughtheyweresolidlyestablishedandbeyondreasonabledispute.154

AHearteningOutcome:TheStudy’sRestorationtoPublication

Fortunately,theSéralinistorynowhasahappierending.OnJune24,2014,hisunjustlymalignedstudywasrepublishedinyetanotherpeer-reviewedjournal:EnvironmentalSciencesEurope(ESEU).155Becauseithadalreadypassedthepeerreviewprocesstwice(oncetogainpublicationinFCTandasecondtimewhenthatjournalperformedaspecialreviewthatconfirmedtherewasnothing“incorrect”initsreportedresults),ESEUconcludedthatitdeservedaplaceinthepublishedliterature.

Butitremainstobeseenwhethertheproponentsofgeneticengineeringwillfinallyaffordittherespectitdeserves–andopenlyacknowledgeitsseriousimplications.Inlightoftheirpastbehavior,sucharesponse,thoughlongoverdue,andhighlybeneficial,wouldbehighlysurprising.

EntrenchmentofHypocrisy,Duplicity,andAudacityRegardlessofhowthepro-GEforcestreattheSéralinistudyinthefuture,theirpriortreatmenthasbeen

shameful–likemostoftheirpreviouspractices.Andit’sclearthatalthoughthatstudyandtheoneconductedbyPusztaiareoffarhigherqualitythananyonwhichclaimsofsafetyhavebeenbased(twogeneticistshavecalledSéralini’s“themostdetailedandthoroughstudyevercarriedoutonaGMfoodcrop.” 156),theproponentsofthebioengineeredfoodventurehaveunfairlyattackedthemfornon-existentfaultswhileoverlookingtheseriousdeficienciesinthestudiesonwhichtheventurerests.

Unfortunately,suchhypocrisyhasbecomethenorm–andadoublestandardhasbecomestandard.157EvenwhentheproponentshavenotfabricatedflawsinthestudiesthatrevealrisksofGEfoods,they’vedemandedthatsuchstudiesconformtocriteriafarhigherthananyemployedwhenapprovingthesefoodsforsale.Consequently,whenindependentresearchershavebeenabletoreassessthedataonwhichapprovalshavebeenbased,they’veroutinelydiscoveredadverseeffectsthattheregulatorseithermissedormisinterpreted.Thischapterhasalreadydiscussedoneimportantexample(thereassessmentofMonsanto’sNK603maize)andChapter6hasdiscussedseveralothers.Amorecomprehensivediscussionisavailableat:http://earthopensource.org/gmomythsandtruths/sample-page/3-health-hazards-gm-foods/3-1-myth-gm-foods-safe-eat/

Inlightofalltheprecedingfacts,onemaymarvelatthecertaintythat’sconstantlyexpressedaboutthesafetyofGEfoodsbythosewhopromotethem,becausetheevidenceclearlyputstheirsafetyinreasonabledoubt–and,atminimum,raisesapresumptionthateveryclaimassertingthatit’sbeenprovenisfalse.Further,wheneventhemostostensiblyauthoritativeoftheseassertionsaresubjectedtocarefulanalysis,theirfalsenessisconclusivelyconfirmed.

Forinstance,inOctober2012theBoardofDirectorsoftheAmericanAssociationfortheAdvancementofScience(theAAAS),issuedastatementinsupportofbioengineeredfoodswhichdeclaredthatextensivetestinghasshownthey’resafetoeat.158Andtosupportthisassertion,theyreliedonanapparentlyimpeccablesource:areportissuedin2010bytheEuropeanCommission(EC)reviewing131researchprojectstheEUhasfunded.159Buttheyfailedtonotethatonlytwenty-twoofthemrelatedtofoodsafety.Moreover,whenateamofindependentinvestigators(whichincludedtwomolecularbiologists)analyzedthetenmostrecentofthosetwenty-two,theyconcluded:“Withinthosetenprojects,thereisastonishinglylittledataofthetypethatcouldbeusedascredibleevidenceregardingthesafetyorharmfulnessofGMfoods.” 160Theyfoundthatonlyoneoftheprojectsresultedinpublishedstudiesonfoodsafety–andthatthosethreestudies“donotshowthesafetyofGMfoodbutrathergivecauseforconcern.”What’smore,becausenobioengineeredcropsthatareonthemarketwereinvolved,evenifthetestshaddemonstratedsafety,theresultscouldnotbeextendedtoanyoftheproductsthatpeopleareactuallyconsuming.

Further,noneoftheothertwelveprojectsdemonstratedfoodsafetyeither.Infact,theirtitlesindicatethattheywereprimarilyfocusedonevaluatingtestmethodologiesorgaugingconsumerattitudes.161Thus,totheextentthattheEUreporttheAAASdirectorscitedactuallyreflectsonfoodsafety,itgoesagainsttheirclaim.

Moreover,theothersupposedlysolidsourcetheycited(areviewof24animalfeedingstudies)doesn’tsupporttheirclaimeither;162andthesameinvestigativeteamthatexposedthedefectsintheECreportdemonstratedthatthisreviewisdeeplyflawedaswell.Accordingtotheiranalysis,theauthorsdismissedstatisticallysignificantdifferencesbetweenGEandnon-GEcropsfor“scientificallyunjustifiable”reasons;theyappliedadoublestandard,rejectingthereliabilityofstudiesthatdetectedharmwhileacceptingthesoundnessofthosethatdidn’t,despitethefactthelatterdisplayedthesamedesignfeaturesthattriggeredtheirdismissaloftheformer;andseveralofthepurportedlyfavorablestudieswereonanimals(suchascowsandfish)withdigestivesystemssodifferentfromoursthatthey’renotdeemedsuitableforassessinghumanhealtheffects.163Further,theauthorsevenacceptedstudiesassupportforsafetyinwhichtoofewanimalswereemployed(insomecasesonlysixpergroup)toenable

reliableconclusions–apparentlyoblivioustothefactthatGEproponentshadlambastedSéralini’sstudyforusing10pergroup,eventhoughthatnumberdidcomplywithacceptedstandards.Accordingly,theinvestigatorsdeterminedthisreviewtobeso“fatallybiased...[that]novalidconclusionscanbedrawnfromit.” 164

AnadditionalreviewthattheAAASdirectorswouldsurelyhavenotedifithadbeenpublishedpriortotheirstatement,andthatGEproponentshaveprofuselycitedsinceitappearedin2013,likewisefailstoestablishthatGEfoodsaresafe.ItwasconductedbyAlessandroNicoliaandthreecolleaguesandpurportedlyreviewed1700studies(over600ofwhichrelatedtofoodsafetyandtheresttoenvironmentalsafety).Butdespiteitsextolledcomprehensiveness,itleftoutmanyimportantstudieswithinconvenientresults.Foronething,itonlyreviewedthosepublishedbetween2002andOctober2012,soitautomaticallyexcludedPusztai’sandseveralotherswithunsettlingfindings.165Foranother,evenwithintheirchosentimeframe,theauthorsadmittedly“selected”thestudiesfortheirreview–butinexcusablyneglectedtodescribethecriteriabywhichtheydidso.166Moreover,accordingtotheteamthatdiscreditedthetworeviewsmentionedabove,manyrelevantstudies“aresimplyomitted”fromthelistwhileothersarementionedwithoutanydiscussionoftheirfindings,despitethefactthey’re“seminaltoanydiscussionofGMOsafety.” 167

AmongthosementionedbutthenignoredarethestudiesconductedbyMalatestaandhercolleagues,eventhough(unlikeanyofthestudiesallegedlydemonstratingsafety)theyperformedlong-termmonitoringofaglyphosate-tolerantGEcrop.

EventheSéralinistudywasomitted,despitethefactithadnotbeenretractedwhenthereviewwaspublished.Intryingtoexcusethiscrucialomission,theauthorsallegedthatthestudyis“ofnosignificance.”However,notonlydidtheyfailtoprovideanexplicitdefinitionof“significance,”theyfailedtoexplainwhythestudy’sstatisticallysignificantfindingsoforgandamageandhormonaldisruptionweresomehowinsignificant–amostsignificantdereliction.168

Thus,byunjustifiablyexcludingtheMalatestaandSéralinipapers,theauthorsofthisostensiblythoroughreviewdisregardedtwoseminallong-termtoxicologicalstudiesonthetypeofplantsthatcomprisemorethan80%oftheedibleGMOsonthemarket(theplantsresistanttoglyphosate)–essentiallythumbingtheirnoseatthenotionsofthoroughnessandfairness.169

Accordingly,duetotheabove-noteddefectsalone,thedocumentdeservesnodeference.Furthermore,thepreviously-citedinvestigativeteamhasdetailedseveralothersthatmoredecisivelydiscreditit.170Inall,thesedefectsrevealthatthepaperisnotthebalancedscientificassessmentitpurportstobebutisinsteadapartisan,unfair,andunconvincingefforttoproptheimageofGEfoods.

ACrucialTransgression:TheIllicitReversaloftheBurdenofProofThepreviouschapterestablishedthattherehasneverbeenaconsensuswithinthescientificcommunitythatGEfoodsaresafetoeat;andthisoneshowsthattheexpertswhosupportthecourseofcaution,andwhoassertthatthesafetyofthesefoodshasnotbeendemonstrated,areintheright.Itfurthershowsthatthosewithinthiscampwhotakeastrongerposition,andassertthattheevidencedoesnotmerelyfailtoestablishsafetybutcastsconsiderabledoubtuponit,arestillstandingonsolidempiricalground.

ItadditionallydemonstratesthatthecontinuedclaimsofsafetymadebythescientistswhosupportGEfoodssignificantlystemfromignoring,misinterpreting,ormisrepresentingkeyfacts.Buteventheclaimsthatdon’tderivefromsuchcognitivelapsesorintentionaldeceptionsarebasedonamajormisconception–oneonwhichtheotherclaimsaretoasubstantialpartfoundedaswell.It’sthemistakenbeliefthatthosewhoquestionthesafetyoftheseproductshavetheburdenofprovingthatthey’redangerous–andthatunlesstheydo,theproductscanbedeemedsafe.

Aspriorchaptershavedocumented,accordingtoUSfoodsafetylaw,theoppositeistrue,andthose

whointroduceanoveladditivehavetheburdenofdemonstratingthatitwon’tbeharmful.They’vefurthershownthateveryGEfoodissubjecttothisrequirement.Moreover,it’sastandardlegalprinciplethatthepartywhobearsaburdenofproofmustestablishitscasethroughapreponderanceoftheevidence–andthatunlessthishappens,theotherpartywins.Sothepartywithouttheburdenneednotproduceanyevidenceatallinordertoprevail,whiletheothersidemustnotonlyproduceit,butproduceittoadominantdegree.

However,asearlierchaptershavealsoshown,inthecaseofbioengineeringthisburdenhasbeensteadilyandillegallyshifted.AswesawinChapter1,thefirstillicitshiftoccurredin1978,whendeceptionsgeneratedbysuccessiveconferencesofpro-GEscientistspersuadedtheUSNationalInstitutesofHealthtodeclarethatthosewhoadvocatedtheregulationofresearchwithgeneticallyengineeredorganismswouldthereafterbeartheburdenofdemonstratingdanger.Chapter2thendescribedhowtheUSDepartmentofAgricultureextendedthisshifttotheenvironmentaleffectsofGMOs,andChapter5revealedhowthenation’sFoodandDrugAdministrationmadeitapplicabletofoodsafety,eventhoughtransferringtheburdencontravenedexplicitprovisionsoftherelevantstatutesandregulations.DespitetheFDA’spretensionsofpropriety,thisshiftwassoclearlyillegal,andsoutterlyunjustifiable,thatwhenFDAofficialshavebeenpubliclychallengedaboutit,they’vehadtolamelydenythatit’shappened.171

Nonetheless,thedevelopersandproponentsofGEfoodsareeitherobliviousofthelegally-imposedburdentheybear,orelse,liketheFDA,indenialaboutit.Consequently,theirargumentsroutinelyrelyonthenotionthatthosewhoquestionthesafetyofGEfoodsmustprovethatthey’reharmful–andthattheythemselvescancarrythedaybypersistentlycarpingatthreateningresearch.Thus,theydeemitsufficientmerelytocastdoubtonanydoubt-raisingdata,whilefailingtorecognizethatthey’reobligedtoprovideaseparateandsoliddemonstrationofsafetyforeveryGEfoodthat’sheadedformarket.

Moreover,notonlydothemanufacturersbeartheburdenofprovingthateachGEfoodissafe,theirburdenisextraordinarilyheavy.Inmostnon-criminaltrials,it’ssufficientforthepartywiththeburdentoestablishthattheweightoftheevidenceisonitsside–andthatitsargumentismorelikelythannottrue.ButUSlawimposesamuchhigherburdeninthecaseofnewadditivestoourfood.Amanufacturercannotprevailmerelybyshowingthattheadditiveismorelikelytobesafethanharmful.Itmustinsteaddemonstratethatthere’s“areasonablecertainty”itwon’tbeharmful.Althoughthisburdenisprobablynotasheavyastheonebornebytheprosecutioninacriminaltrial(wherethedefendant’sguiltmustbeprovenbeyondareasonabledoubt),itisclearlysupposedtobemoreonerousthantheonelaidonplaintiffsinnon-criminallitigation.

ThisisobviousfromhowtheFDAexperts,whoroutinelyworkwiththisrigorousstandard,applieditwhenevaluatingtheFlavrSavr.Forinstance,theDirectoroftheOfficeofSpecialResearchSkillsacknowledgedthathethoughtCalgenehadmadea“strong”casethatthefeedingstudies“donotshowharm.” 172Therefore,ifhe’demployedthestandardofproofoperativeinanordinarytrial,hewouldhavedecidedthatbecausetheevidenceindicatedthetomatowasmorelikelythannottobeharmless,itssafetyhadbeenadequatelyestablished.Butheappliedastricterstandard.HeemphasizedthatCalgenewasrequiredtoprovide“apositivedemonstrationofsafety;”andhethenexplainedwhyhethoughtithadfailedtodoso.Heassertedthatbecausethedata“raiseaquestionofsafety,”they“fallshortof‘ademonstrationofsafety’orof‘ademonstrationofreasonablecertaintyofnoharm’whichisthestandardwetypicallyapplytonewfoodadditives.” 173Hethenstatedthatinordertoprovidesuchademonstration,itwouldbenecessaryforCalgenetoconduct“astrongerstudythatresolvesthesafetyquestionraisedbythecurrentdata.” 174

Sowhentheagencyadministratorssubsequentlypermittedtheproduct’scommercializationwithoutrequiringanyadditionaltesting,theywerenotfollowingthelawbutfloutingit.Andthesameexactingstandardagainstwhichtheagency’sexpertsassessedtheFlavrSavrislegallymandatedinthecaseofall

otherGEfoodsaswell.Yet,despitethisstarkreality,theproducts’proponentsnotonlyinsistthattheburdenofproofmustbe

bornebytheotherside,manydemandthatthestandardofproofbeextraordinarilystrict–essentiallyarguingthataGEfoodcanbedeemedsafeaslongasnoonehasdemonstratedthere’sareasonablecertaintyit’sharmful(whichturnsthelegallymandatedstandardonitshead).Forinstance,thepro-biotechscientistsBruceChassyandWayneParrotthaveassertedthatevenifastudyonaGEfoodthatdetectsanadversehealtheffectispublishedinapeer-reviewedjournal,itstillmustbe“acceptedbyaconsensusofthescientificcommunity,” 175aconditionthatwouldlegitimatethecapacityofbaselessattackstodelegitimizeit.Moreover,theystateitisalso“necessary”thattheresultsbeverifiedbyfollow-upstudies.176Ofcourse,asisalltootypical,theirscruplesareinconsistentlyapplied,andtheyseemquitewillingtoacceptstudiesinsupportofsafetythatdon’tcomeclosetomeetingsuchstringentcriteria.

Therefore,thesescientistsare,inessence,advocatingthatchallengestothesafetyofbioengineeredfoodsbesubjectedtothestrictestevidentiarystandards–anddemandingthateachbegrantedthespecialevidentiaryprotectionextendedtodefendantsinacriminaltrial,withitssafetypresumedandacceptedunlessitsharmfulnesshasbeenprovenbeyondareasonabledoubt.Andnotonlydootherpro-biotechscientistspropoundsuchpreposterousmeasures,sometakeapositionthat’sevenmoreextreme.Forexample,accordingtoKevinFolta,aplantscientistattheUniversityofFlorida,“ThosethatsupportthehypothesisthatGMcropsaredangerousneedtohavethecleanestexperiments,perfectcontrols,[and]massivenumbers.”Why?Because,asheputsit,“Theyaretryingtooverturnaparadigm,ascientificconsensus.”Inhisversionofthefacts,this“paradigm”regardingthesafetyofGMOsis“asintuitiveasgravityformostplantscientists;”andhedrawsaparallelbetweenchallengingthisparadigmandtryingtodisprovethatgravityexists.Heaccordinglyassertsthatthosewhomountsuchachallengefacea“verydifferentevidencethreshold”thandothoseconductingresearchthatsupportstheparadigm.177Thus,thisprominentbiotechproponentwouldhaveusbelievethat,fromascientificstandpoint,thesafetyofbioengineeredfoodsissowell-establishedthatmostexpertsacceptitinthesamewaytheyaccepttheexistenceofgravity–anassertionsoabsurdit’sdifficulttobelieveitcamefromacredentialedscientist.Afterall,whilenorationalpersonwouldpresumegravitydoesn’texist,thelawpresumesthatGEfoodsarenotsafeunlessproventobe;andhundredsofscientistsregardthemasrisky.

TheDevelopersofGEFoodsHaveFallenFarShortofMeetingTheirBurdenofProofSoshiftingtheburdenofproof,withitsconcomitantfocusonwhethertheevidencehasprovenGEfoodsdangerous,hasshiftedattentionfromwhereitshouldbeplaced:thequestionofwhetheranyGEfoodhasbeenprovensafe.Andtoproperlyanswerthisquestion,weneedtounderstandwhatkindsoftestsareneededtotrulysatisfytherequirementsofUSlaw–teststhatcouldcollectivelydemonstratethere’s“areasonablecertainty”thataparticularGEfoodwon’tbeharmful.178

In2014themolecularbiologistsJohnFaganandMichaelAntonioudescribedasetofproceduresthattheyconsiderminimallynecessarytosupportsuchademonstration.179Intheirprescription,theinitialphaseofsafetyassessmentwouldstillcomprisecomparativeanalysis,butincontrasttothepresentsystem,itwouldnotbesuperficial.Instead,itwouldincludethefullrangeofavailablemolecularprofilingtechniques(genomics,transcriptomics,proteomics,andmetabolomics)thatprovideafarmoresensitiveassessmentofwhetherpotentiallyproblematicchangeshaveoccurredinthebioengineeredorganism.Thenextphasewouldaimtodeterminewhetherthatproductcausestroublingchangesinlaboratoryanimalsthateatit.And,infurthercontrasttothecurrentsystem,thetestingwouldentaillong-termfeedingstudiesthatnotonlystudytheanimalsthroughouttheirlifetime,butmonitortheiroffspring–andthenextgenerationaswell.Inthisway,researcherscouldgaugenotmerelywhetherthefoodisharmingthem,butisadverselyaffectingtheircapacitytoreproduce–oradverselyaffectingthehealthof

theirprogeny.Moreover,unlikesomuchcurrentlypermittedtesting,allthestudieswouldupholdproperscientificstandards,withappropriatecontrolsandrigorousadherencetoallotherbasicprotocols.

Additionally,thetestswouldinclude“comprehensiveanatomical,histological(microscopicexaminationofbodytissues),physiological,andbiochemicalanalysisoforgans,blood,andurine.” 180Therewouldalsobe“molecularprofilingofselectedorgansfromtestanimalstoevaluateeffectsongeneexpression,proteins,metabolites,andRNAinterference,whichcouldunderlieanynegativehealtheffectsobserved.” 181And,aftersuchthoroughfeedingstudieswithlabanimals,therewouldbesimilartestingoffarmanimalsfollowedbylong-termdoseescalationtrialswithhumanvolunteers.

Obviously,wheneventhemostrigorousteststhathavebeenemployedinthetestingofaGEfoodarecomparedtothesetoftestsprescribedabove,theyappeardismallydeficient;andevenifalessstringentsetofrequirementswereadoptedasastandard,aslongastheywerecapableofreliablymonitoringforlong-term,multi-generationaleffects,theywouldtowerfarabovethetypeoftestingthat’sbeenuseduptonow.

Moreover,notonlyhavethetestsbeendeficientandthemanufacturerswronglyrelievedoftheirburdentodemonstratethatGEfoodsaresafe,they’vebeenallowedtoignorethetroublingresultsthateventhisinadequatetestinghassooftengenerated.Andtheextentofthisderelictionisstriking.AsMichaelAntoniouhaspointedout:

IfthekindofdetrimentaleffectsseeninanimalsfedGEfoodwereobservedinaclinicalsetting,theproduct’susewouldbehaltedandfurtherresearchinstigatedtodeterminethecauseandtofindsolutions.However,whatrepeatedlyhappensinthecaseofGEfoodisthatdespiteincreasingevidenceofseriousadversehealthtestresults,governmentandindustrycontinueunabatedwiththedevelopment,endorsement,andmarketingofthesefoodsasifnothinghashappened–tothepointtheyevenseemtoignoretheresultsoftheirownresearch!ThereisclearlyapressingneedforindependentresearchintothepotentialilleffectsofGEfood–andthisresearchmustincludeextensiveanimalandhumanfeedingtrials.182

Therefore,inlightofalltheaboveconsiderations,it’seminentlyreasonabletoconcludethatnoGEfoodhassuccessfullyborneitsevidentiaryburden–andthatnonehasbeenprovensafe.

FacingUptoReality:GEFoodsAreIllegallyontheMarketTheprecedingsectionshaveamplydemonstratedthatifthefactsabouttheearliestGEfoodshadbeenfairlyreported,noneotherswouldhavecometomarket–andthat,accordingtothedictatesofthelaw,noneshouldhave.They’vefurthershownthatifthoserequirementshadbeenfollowed,noteventheFlavrSavrwouldhavebeencommercialized.

Moreover,it’sbynowevidentthateveniftherelevantUSlawswereaslaxastheFDAhaspretendedthemtobe,adherencetotheacceptedstandardsofsciencewouldinitselfhavelargelykepttheproductsoftheGEfoodventureoutofcommerce–thusfatallydeflatingitsprospects.

Additionally,asubstantialbodyofresearchhasraisedseriousdoubtsaboutsafety;andthestudiesthathavedetectedadverseeffectsare,onthewhole,significantlymoresolidthanthosepurportingtohavefoundnoproblems.Thestrengthofthisdisconcertingresearchisattestedbytherankunfairnessoftheattackstowhichit’sroutinelysubjected,sinceifitweretrulyasflawedasitsdetractorsallege,therewouldbenoneedtodistortit.Consequently,thosewho’veattemptedtheunjustdiscreditationhaveultimatelydiscreditedthemselves.

Althoughmanywillsurelycontesttheaboveassertions,theirrefutablefactremainsthatthereisextensiveandintensivecontroversyaboutthestatusoftheresearchwithinthescientificcommunity.Therefore,it’spatentlyclearthatthereisnotanexpertconsensusaboutthesafetyofGEfoods;anddueto

thisresolutereality,it’salsoclearthatallthoseontheUSmarkethavenotonlyenteredillegally,butillegallypersist,becausenoneofthemisgenerallyrecognizedassafe(GRAS),andnonehasbeenapprovedviaafoodadditivepetition.

Andthisconclusion,nomatterhowunpalatable,isinescapable.Thelawrequiresnotonlythattherebesolidevidenceofsafety,butthatthisevidencebewidelyacceptedbyexperts.Butneitheroftheseconditionshasbeensatisfied.There’stoolittlesoundevidenceofsafety,toomuchevidenceraisingdoubt,andtoomuchscientificcontroversyaboutwhattheevidenceindicates.AlthoughbiotechproponentslikeChassyandParrottassertthatstudiesreportingadverseeffectsofGEfoodsare,evenafterpublicationinpeer-reviewedjournals,stillofnoaccountunlesstheyandtheircohortsarewillingtoacceptthem,thelawactuallyprescribestheopposite.Intruth,thestudiesthatpurportnottofindproblemsaretheonesboundbyspecialstrictures,anditistheythatlacklegaleffectunlessthey’regenerallyrecognizedandacceptedwithinthescientificcommunity.Moreover,itdoesn’ttakemanydoubterstodelegitimizethem.Afederalcourthasruledthatthetestimonyoffiveexpertsissufficienttodefeataclaimthatsuchrecognitionandacceptanceexist–andinonecase,eventwosufficed.183

Ontheotherhand,becausethelawisprecautionary,anddemandsthatthesafetyofnoveladditivesbesowellestablishedthere’sareasonablecertaintytheywon’tbeharmful,anypublishedstudythatraisesdoubtsmustbegivenlegalweight;anditssignificancecannotbesnuffedbytheattacksofscientistswhodislikeitsfindings–especiallyiftheattacksappearunjustifiedintheeyesofotherequallycompetentexperts.

Consequently,it’sobviousthatGEfoodsarenotlegallyGRAS–andthattheFDA’srebuttablepresumptionthattheyarehasbeensolidlyandrepeatedlyrebuttedeversinceitwasannouncedin1992.It’salsoobviousthatthedegreeofrefutationthathasbynowoccurrediscolossal.Previouschaptershavedocumentednumerousinstancesofunequivocalrebuttal,andtheevidencethatevisceratestheclaimofconsensuscontinuestomount.Thus,asofJanuary2014,almostthreehundredscientistshadsignedastatementassertingthatthereisnotaconsensusaboutthesafetyofGEfoods,thattheirsafetyhasnotbeenadequatelydemonstrated,andthatsomestudies“giveseriouscauseforconcern.” 184Andoneofthem,theSalkInstitutebiologistDavidSchubert,had,intheyearpriortosigning,clearlyshownhowwell-foundedaretheconcernsabouttheevidentiarydeficiencies.InaletterpublishedbytheLosAngelesTimes,heasserted:“Asamedicalresearchscientistwhopublishedacomprehensive,peer-reviewedcritiqueofgeneticallymodifiedfoodsafetytesting,Icanstateconfidentlythatitisfalsetosaysuchfoodsandthetoxicchemicalstheyrequireareextensivelytestedandprovedsafe.” 185

Accordingly,thosewhopersistintheirclaimsofconsensusdemonstrateeitherhowthoroughistheirinsulationfromreality,orhowstaunchistheirresolvetomisrepresentit.And,whenweremaininreality,it’sindisputablethatdisputeexists–andcertainthatthe‘reasonablecertainty’standardhasnotbeensatisfied.Afterall,asubstantialnumberofexpertsregardGEfoodsasabnormallyrisky,donotthinktheirsafetyhasbeendemonstrated,anddoubtthatitwillbewithintheforeseeablefuture.Therefore,thelegallymandatedburdenofproofhasnotbeenmetandalmostsurelywon’tbewithinanyacceptabletimeframe–whichmeansthataslongasGEfoodsareontheUSmarket,theirpresencewillbeillegal.186

Thus,whenwetakeahardlookatthehardevidence,it’shardtoaccepttheassurancesthatthesafetyofGEfoodshasbeenscientificallydemonstrated.Infact,it’swell-nighimpossible.Andourinvestigationuptothisstagehasrevealedthatontheempiricalaswellasthetheoreticalplane,there’sgoodreasontoregardgeneticengineeringastheriskiestformoffoodproduction.

Moreover,thisevaluationhasstemmedsolelyfromthestandpointofbiologicalscience.Aswe’llsee,

fromtheperspectiveofcomputerscience,there’sanexpandedbasisforviewingthesefoodsasdangerous–andenhancedreasontoregardtheenterprisethat’sproducingthemasoneofthemostrecklessinhistory.

CHAPTERELEVEN

OverlookedLessonsfromComputerScience

TheInescapableRisksofAlteringComplexInformationSystems

DNAiscommonlycomparedtocomputersoftware,andit’sroutinelydescribedastheprogramofinstructionsthatdrivestheprocessesoflife.1Further,thealterationsthatbioengineerseffectinDNAareoftenlikenedtotheprogrammingrefinementsimplementedbysoftwareengineers.Forinstance,PamelaRonald,oneofthemostprominentbiotechboosters,haswritten:“Overthelast20years,plantbreedinghasentered‘thedigitalageofbiology.’Justassoftwareengineerstinkerwithcomputercodestoimprovemachineperformance,scientistsandbreedersarealteringthe‘DNAsoftwaresystem’ofplantstocreatenewgeneticallyengineeredcropvarieties....” 2

However,suchanalogiesareinapt–andfartoosimplistic.Notonlydotheymisrepresenthowexquisitelyintricatetheinformationsystemswithinlivingorganismsactuallyare,theymisrepresenttheroleofDNAwithinthem.3Moreover,reputablesoftwareengineerswouldneverrevisecomputerprogramsinthewaybiotechniciansaltergenomes;and,besidesactingwithfargreaterinsight,theyexercisemuchgreatercaution.Aswe’llultimatelysee,whenthefundamentalfactsareexamined,andthelessonsofsoftwareengineeringarecarefullyconsidered,it’sclearthatreprogramminglife’sinformationsystemsthroughrecombinantDNAtechnologyisaninherentlyhigh-riskprocessthatcannotbepracticedinconformitywiththeessentialsafetystandardsofsoftwareengineering–oranyotherbranchofengineering.

TheBasicFeaturesofHuman-DerivedSoftwareToday,computeruseiswidespreadandmostpeoplearefamiliarwithseveralofthebasictermsandconcepts.Theyknowthathardwarecomprisesthepartsofthesystemthatareconcreteandphysical,whilethesoftwareisacomponentthat’sabstractandessentiallyimmaterial.Theyknowthattheformerisformedfrommatterandthatthelatterisapatternofinformation–thattheonecanbegraspedbythehandandtheotherprimarilybythemind.Butjustasthemajorityofcomputerownersdon’tknowtheintricaciesofthegadgetsandcircuitswithintheirunit’smotherboard,they’reonlysuperficiallyawareofwhatsoftwareisandhowitgetsdeveloped.Andwithoutthisknowledge,it’sdifficulttofullyappreciatethedramaticdifferencesbetweengeneticengineeringandsoftwareengineering.

Instructionsvs.Data

Therearetwobasiccategoriesofsoftware:instructionsanddata.Thefirstprescribesactions,thesecondisactedupon.Forinstance,asetofencodedrulesformakingnumericalcomputationsareinstructions;theinformationrepresentingthenumbersthatgetcomputedisthedata.Awordprocessingprogramisalsoasystemofinstructions,whilethedocumentfilesitprocessesaredata.

Generally,thetermprogramreferstoasetofinstructions;andsuchprogramsareexecutable.Butthatdoesn’tmeanprogramsnevercontaindata.Forinstance,thespellcheckerinawordprocessorisasub-setofinstructionsthatincludesadictionaryofwordsagainstwhichtheprocesseddatacanbecompared.Sothatdictionaryservesasdata.4

Inmostcontemporarycomputers,instructionsanddataarebothstoredinthecomputer’smemory–but

usuallyinseparateregions.However,althoughtheytendtobestoredseparately,they’rebothstoredinthesameencodedform.Theinformationineachisrepresentedviamerelytwodigits:zeroesandones(0’sand1’s).Thus,thecodeisbinary,becauseitutilizesonlytwosymbolicunits.

DistinctLevelsofCode

Yet,althoughasetofprogrammedinstructionsisfedintothecomputerasapatternof0’sand1’s,theprogramneverstartsoutthatway.Thebinarypatternisthefinalphaseoftheprogrammingprocess,andtheinformationitconveyswasmanifestedindifferentmodesatearlierstages.Intheearliest,theprogramexistsasideaswithinthemindoftheprogrammer.Thisisthemostabstractphaseoftheprogram–andalsothemostimportant,sinceit’satthislevelthatthesystemgetscreatedandcoordinated.Theprogrammerthenexpressestheprograminaspecializedlanguage,calledaprogramminglanguage.Throughsuchalanguage,thespecificinstructionscanbesetforthandtheirinterconnectionsworkedout.Manydifferentprogramminglanguageshavebeendeveloped;andthetrendistowardincreasingtheirabstraction–whichentailsdiminishingtheconcretecorrespondencebetweenthelanguageandtheelectricaloperationsthroughwhichitwillbeapplied.Suchabstractionisvaluedbecausethegreateritis,themorepowerfullyandefficientlythelanguagecanbeemployed.5Forinstance,asthelanguagebecomesmoreabstract,eachofitsstatementscanrepresentalargernumberofindividualinstructions.

Moreover,althoughprogramminglanguagesarenotcomposedwith0’sand1’s,theyconsistofcodes.Theygenerateanintricatearrayofsymbolicstatementslayingoutthelogicalstructuresofthevariousinstructionsandestablishingtheirwebofinterrelations.Accordingly,suchanarrayiscalledtheprogram’ssourcecode.However,whilethiscodecanbereadbyhumanswhoarefamiliarwiththeparticularlanguageemployed,itcannotbereadbycomputers.Soitmustbetranslatedintoaformatsuitableforthesemachines.

Thetranslationiscarriedoutbyanotherprogramcalledacompiler.Itcompilestheencodedinstructionsofthehigherlevelintoacodethatthemachinecanreadandexecute.Thisisthemachinecode,andit’sthelevelatwhichtheinstructionsareexpressedin0’sand1’s.Eachoftheseinstructionsisdirectlyexecutedbythecomputertoperformadiscreteoperation.Soatthislevelthere’saclosecorrespondencebetweentheelementsofthesoftwareandtheactionsofthehardware.

It’simportanttonotethatwhilemostprogramsarenotinitiallyexpressedinmachinecode,itispossibletodoso.Andprogrammershavesometimestakenthisdirectroutebecauseitcanmaximizetheefficientuseofcomputerresources.However,becauseworkingatthislevelisadifficultanderror-proneprocess,it’sonlyfeasiblewhentheprogramisverysmall.

EnhancedReliabilityThroughReducedInteractivity

Oneofthebiggestproblemsforsoftwareengineershasbeenthepropensityoftheirprogramstogenerateunintendedeffects,apropensitythatincreaseswiththeprogram’ssizeandcomplexity.Mostoftheseeffectsarisewhendifferentpartsoftheprograminteractwithoneanotherinunanticipatedways.

Soprogrammershaveendeavoredtoisolatemodulesofcodedinstructionsthataredesignedtofunctionincoordinationandinsulatethemfromtheinstructionswithwhichtheyarenotsupposedtointeract.They’veincreasinglyaimedtodevelopsegmentedprogramsinwhichtheunitsself-interactbutminimallyaffectoneanother–andthenonlyinatightlycontrolledmanner.6Theoverallgoalistodevelopasystemthat’saslinearaspossible:whereeachcommandordiscreteseriesofcommandswillyieldaspecific,predictableoutcomewithoutalsoinducingresultsthatareunpredicted.7

Acommonwayofdepictingthetypesofprogramsthataredesired,aswellasthosethatarenot,isthroughanalogiestopasta.Softwareengineersgenerallywanttoavoidprogramsthatarestructuredlikeamoundofspaghetti,inwhichthevariousstrandsaresoentangledthatnotonlyisitdifficulttofollowthecourseofanyoneofthem,butpullingononeaffectsseveralothers.Thus,theydisdainfullyrefertoprogramsinwhichthelogicalflowiscomplicatedandtheelementsareextensivelyinterconnectedasspaghetticode.Whatmanyinsteadaimtocreateareprogramspatternedlikeaservingofravioli–programsinwhichtheconstituentsofthevariousmodulesareessentiallyasindependentfromoneanotherasthecheeseandvegetablesenclosedwithinseparatepacketsofpasta.8However,theystillhavetokeepthemodulessufficientlyinterconnectedtofunctionasanintegratedwhole–acapacitywithwhichnoplateofraviolihaseverbeenendowed,nomatterhowstickythesauce.

HowtheSoftwareofLifeDramaticallyDiffersfromHuman-DerivedSoftware

HighComplexity,LowComprehensibility

Aswe’veseen,human-fashionedsoftwarecangrowverycomplex,andasitscomplexitygrows,sodoesthetendencyforunintendedinteractionsbetweenitscomponents.However,despitetheseunpredictableevents,suchhighlycomplexsystemsarestillhighlycomprehensible.Programmerscanclearlydiscernwhatthecomponentsareandcancomprehendalmostalltherulesthroughwhichtheyoperate.There’sawrittenrecorddetailingalltheelementsandhowthey’reintendedtofunctiontogether;andit’spreciselyknownwhereinthecomputertheprogramisstoredandhowitscommandsaretransferredtothehardware.

Buteventhemostcomplexhuman-madesystemseemssimplecomparedtonature’ssoftware.Andthecomplexityofthisnaturallyformedsystemissogreatthatevensomeofitsbasiccontourscan’tbeclearlydetermined.Wedonotknowwhatallthecomponentsare,nordowefullyunderstandhowthey’rearrayed.AlthoughDNAiscommonlyregardedasthelocusofacell’sinformationsystem,theevidenceindicatesthatthesystemisnotfullylocalizedwithinthatmolecule–andthatsomeofitsmostimportantpartsresideelsewhere.Further,notonlyaremanyofthecomponentsoutsidethegenome,therulesthroughwhichallthecomponentsinteractaretoalargedegreeoutsideourunderstanding.

Evidenceofadispersedprogramwasalreadystrongbythelastdecadeofthe20thcentury,anditssignificancewasexaminedinaninfluentialarticlepublishedinNatureBiotechnologyin1997byRichardStrohman,aprofessorofmolecularandcellbiologyattheUniversityofCalifornia,Berkeley.Init,Strohmanexplainedthatalthoughmainstreammolecularbiologyhadformorethanfortyyearsportrayedgenesasthe“ultimate”agentscontrollinglife’sprocesses,exertingtheircontrolbyissuingthekeycommandswithinthecellularprogram,thisportrayalwashighlyinaccurate.9Hepointedoutthat“therealsecretsoflife”cannotbefoundatthelevelofthegeneticagentsbutinsteadatthelevelof“therulesandconstraintsthatorganizegeneticagentsintofunctionalarrays.” 10Andhenotedthatnotonlyisthis

levelof“genemanagement”ahigherlevelthantheoneatwhichgeneexpressionoccurs,itisnotconfinedwithintheDNAbutis“coextensivewiththecellitself.” 11Moreover,heemphasizedthatthedynamicsoperatingatthislevelaredifferentthanthoseattheloweroneandthattheinteractionsarefarmorecomplex–totheextentofbeingultimately“transcalculational,”which,ashenoted,is“amathematicaltermformindboggling.” 12

Inasubsequentpaper,heelaboratedonthesethemes,emphasizingtheimportanceofthefactorsthatarenotdeterminedbyDNAsequences(termedepigeneticfactors)–andourdeficientunderstandingofhowtheyoperate.Henotedthat“manybiologists,worldwide,haveknownfordecadesthatgeneticsaloneisnotsufficienttoexplainlife’scomplexoutcomes,andthatanotherkindofinformationmanagementsystemmustbepresent....”Hecontinued:“Thissecondinformationalsystemiscoextensivewiththecellitself[and]consistsofmanyinterconnectedsignalingpathways....”Andheemphasized:“Thekeyconcepthereisthatdynamic/epigeneticnetworkshavealifeoftheirown:theyhavenetworkrulesnotspecifiedbyDNA,andwedonotunderstandtheserules.” 13

EvelynFoxKeller,aprofessorofthehistoryandphilosophyofscienceattheMassachusettsInstituteofTechnology,isanotherexpertwhohasrepeatedlypointedoutthatthecell’sinformationalprogramextendswellbeyondthegene–andfarbeyondourcomprehension.Inherbook,TheCenturyoftheGene,shequotesastatementmadebythepresidentoftheNationalAcademyofSciencesin1998that“[w]ealwaysunderestimatethecomplexityoflife,evenofthesimplestprocesses;”andsheshowshowasubstantialamountofsuchunderestimationhasoccurredbyoverestimatingtheroleofgenes.LikeStrohman,sheemphasizesthatanorganism’sdevelopmentandcoherentfunctioningareprimarilycoordinatednotbythegenesthemselvesbutby“thecomplexregulatorymechanismsthat,intheirinteractions,determinewhenandwhereaparticulargenewillbeexpressed.” 14

However,thepatternoftheseinteractionsisdifficulttoapprehend,especiallysincethesystemisnotfixed,butfluid.AsKellerpointsout,incontrasttothesequenceofthegenome,whichislargely“static,”thisregulatorysystemis“dynamic.” 15Moreover,sheequatesthisdynamicsystemwith“thedevelopmentalprogram;”andsheassertsthat“...anunderstandingofitsdynamicsneedstobesoughtatleastasmuchintheinteractionsofitsmanycomponentsasinthestructureorbehaviorofthecomponentsthemselves.”Shecontinues:“...theprogramconsistsof,andlivesin,theinteractivecomplexmadeupofgenomicstructuresandthevastnetworkofcellularmachineryinwhichthosestructuresareembedded.” 16Shethenremarks:“Itmayevenbethatthisprogramisirreducible–inthesense,thatis,thatnothinglesscomplexthantheorganismitselfisabletodothejob.” 17Accordingly,shenotesthat,insteadofbeingboundbythegenome,theprogramisessentially“everywhere.” 18

NonlinearityandAmbiguousAgency

Thus,intheanalysesofbothStrohmanandKeller,abiologicalinformationsystemisspreadthroughouttheorganism,andthissubstantiallyobstructsitscomprehensibility.Suchdispersionsharplycontrastswiththewell-definedcontoursofhuman-shapedprograms,thestructuresofwhicharefarbetterunderstood.Further,ourcapacitytocomprehendthesenaturalsystemsisfurtherconstrainedbythefactthat,besidesbeingnonlocalized,they’renonlinear.19Insuchcomplexes,distinctactionsinducesystem-wideeffectsinasignificantlyunpredictablefashion.Thisalsocontrastswiththehuman-madesystems,whicharesubstantiallylinearbecausethey’redesignedsothatdiscreteoperationsyielddiscrete,predictableresults.

Further,asStrohmanpointedout,oneofthebigcognitivecomplicationsposedbylife’ssoftwareistheelusivenessofitsrules.Notonlyareweunabletofathomhowtheyinteractasanetwork,wehavelittleunderstandingofwhatthevariousrulesactuallyare;andit’sdifficulttodiscernhowanyofthemisembodiedwithin(anddistributedamong)thecell’smultifariouscomponents.

Compoundingtheconundrums,thedistinctionbetweeninstructionsanddataissignificantlyblurred.Inhuman-madesystems,thereareusuallyclearboundariesbetweenthetwo,andit’seasytodifferentiatethepartsoftheprogramthatareactiveagentsfromthepassiveparcelstheymanipulate.Wecandistinguishbetweenthatwhichcommandsandthatwhichiscommanded.20Incontrast,nature’ssoftwareisnotmerelyambiguous,butenigmatic.AsStrohmanandKellerhavenoted,notonlyhasitbeenwrongtoviewgenesastheultimateagents,whateveragencytheydoexertislimited,andthey’reoftentheelementsthatareactedupon.

Moreover,someexpertssaytheydon’texerciseagencyatall.ThetheoreticalbiologistMichaelConradpointsoutthatDNAdoesnotprescribebehaviorasdotheinstructionsinacomputerprogram,notingthatwhileinthelatterprograms,“eachunit...reactstodefinedoutputsofotherunits”inasequentialmanner,thecomponentsofabio-basedinformationsysteminteractinsuchaholisticandnon-sequentialfashionthateachisessentiallyrespondingto“globalproperties”oftheentiresystem.21

Accordingly,hesaysthatsuchasystem“cannotbeprogrammedlikeanordinarycomputer.” 22Andheemphasizesthat,contrarytocommonopinion,discretecommandfunctionsarenotlocalizedwithinDNA.Asheexplains,DNAdoesnotprovideprescriptionsforspecificcellularbehaviorsbutrathercontainssymbolicdescriptionsofthe“primarystructure”ofmanyofthecell’simportantmolecules.23

Fromthisperspective,besidestheirincapacitytoprescribedistinctbehaviors,thesectionsofDNAreferredtoasgenesdonotevendictatetheproductionofparticularproteins.Rather,theyserveasrepositoriesofinformationthatareusedbythecellinproducingproteinsaccordingtoneedsthatareregistered,expressed,andrespondedtothroughtheoperationsofthesystemasawhole.Andtheseoperationsaresocomplexlycoordinatedthatdiscreteoutcomescannotbereliablypredicted.

Conrad’sconclusionswerepublishedin1972,andoverthefollowingfourdecades,thegroundsforthemhavegrownincreasinglycompelling.Anabundanceofevidencehasamassednotonlyconfirmingthesoundnessofhisanalysis,butrevealingthatthecomplexityofbioinformationsystemsisfargreaterthanwasthenknown–andthattheirdynamicsareevenmoreglobal.Forinstance,in2003BBCnewsreportedthatateamofscientistswhotrackedmorethan20,000interactionsbetween7,000ofthegenesinthefruitflydiscovered“ahiddenlevel”oforganizationbetween“apparentlydisconnectedproteins,”andhencealsobetweenthegenesthatexpressthem.24

Theprofoundextentofthecomplexityandholisticcoordinationthatcharacterizescellularlifecanbeglimpsedbyconsideringthemechanicsofhowgenesareexpressed,whichalsodemonstratesthepassivityoftherolethattheyplay.

AsdiscussedinChapter4,thesequentialinformationwithinagenebecomesexpressedasaparticularproteinthroughamulti-stageprocess.Inthefirstphase,aspecializedenzymetranscribestheinformation

intoastrandofanother(butrelated)typeofnucleicacidcalledribonucleicacid,orRNA.ThisRNAservesasamessenger,anditconveystheinformationtoanintricatestructurecalledaribosomethattranslatesitintoachainofaminoacidsthatsubsequentlyfoldsintoaprotein.Butinplantsandanimals,beforetheRNAtravelstotheribosome,itmustbeedited.AndtheeditingisdonebyasetofenzymesthatremovethesectionsofDNAthatdonotcodeforaminoacids(theintrons).However,that’softennottheendoftheeditorialprocess.Agroupofotherenzymesfrequentlyintervenestorearrangetheinformationsoastocodeforadifferentproteinthanwouldhavederivedfromtheinitialsequence.Andinmanyinstances,therangeofalternativeproteinsissubstantial.Somegenescangiverisetodozensofdifferenttypes;andthemechanicsbywhichtheenzymesdeterminewhichproteinisgoingtobeproducedisneitherprescribedbythegenewhoseassociatedRNAtheyreconfigurenoreveninfluencedbyit.Further,althoughtheseenzymesareproteinsthatarecodedbyothergenes,thosegenesdonotdirectthedetailsthroughwhichtheenzymesoperateeither.Manyadditionalfactorscomeintoplay;andalthoughsomeofthemderivefromyetothergenes,thosegenesalsolackthecapacitytoprescribethecomplexwaysinwhichtheirproductsinteractwithothergenesandwiththesubstancestheyproduce.

Further,notonlyisthefullprocessofgeneexpressiondependentonanumberoffactorsoutsidethegene,mostgenescan’tevengettheprocessstartedinanautonomousmanner.Atranscribingenzymewillonlyattachtoagene’spromoterregionwhenthatpromoterisinareceptivemode,whereasthedefaultconditionformostpromotersistobeunreceptive.25Andapromoterinitsclosed-downdefaultstateonlybecomesreceptivethroughtheagencyofspecificmoleculesthatareusuallyindependentofitsassociatedgene.Mostofthesemoleculesareregulatoryproteinsproducedbyother(oftendistantlylocated)genesthatarenotinfluencedbythegenestheirexpressedproteinsregulate.

Theinterplaybetweensuchregulatoryproteinsandapromoter’sactivationsitescanbeastounding.Considerthecaseofthepromoterattachedtoagene(dubbedEndo16)thatencodesamulti-functionproteincriticalforthedevelopmentoftheseaurchinembryo.Theexpressionofthisgeneiscontrolledby14proteinsthatbindtoitspromoterinamannerthatenablestranscribingenzymestoconvertitsinformationintoRNAattheappropriatetimesandrates.Further,notonlyarethebindingsitesforthesetranscription-enablingproteinshighlyspecific,therearefarmoreofthemthanproteins:atleast50.Moreover,20ofthemaretailoredtobindjustoneoftheproteins.26Accordingtoresearcherswhoextensivelystudiedthispromoter,thesevarioussitesformsevenclusters,eachofwhichfunctionsasaregulatorymodule.Theyreportthatduringtheearlystagesofdevelopment,themoduleclosesttotheareawherethegene’stranscriptionbeginsservesas“acentralprocessor”thatintegratestheoutputoftheothersixandcausestranscriptionoftheadjacentgenetoeitherstartorceaseasrequiredtomaintaintheembryo’spropergrowth.27Then,atalaterdevelopmentalphase,themodulenextdownthelinetakesoverasthecentralprocessor.28

InacommentaryinSciencethataccompaniedaresearchstudyonthisremarkablepromoter,theevolutionarybiologistGregoryWraydescribeditasa“geneticcomputer.”Hestated:“The‘program’thatrunsthistinycomputerisdirectlyencodedinDNAasregulatoryelements;itsinputsaresinglemoleculeswhosecompositionvariesintimeandamongvariouscellsoftheembryo,anditsoutputisapreciseleveloftranscription.” 29

Yet,asEvelynFoxKellerpointsout,there’s“tension”betweenthisconceptionofthingsandthemolecularrealities–andit’sastretchtoregardtheprogramas“‘directlyencodedintheDNA.’” 30Assheexplains,thewidely“scattered”DNAsequencesthatgiverisetotheregulatoryproteinsthataffectthepromoter’soutputmerelycodefortheiraminoacidsequences;andthesesequencesdonotinthemselvesfullydeterminethestructuralfeaturesoftheproteinsthatgovernthe“dynamics”oftheirinteractionwiththepromoter’sbindingsites.SheadditionallynotesthatbecausemessengerRNAcanbesplicedandrevisedbyenzymesindependentoftheDNAfromwhichit’sderived,eventheaminoacidsequencesof

theregulatoryproteins“cannotbefullypredicted”fromthesequenceoftheassociatedDNA.31Ofcourse,thesituationisfurthercomplicatedbythefactthatthegenesencodingthe14regulatory

proteinsdonotcontainanyinstructionsforwhenandatwhatratetheythemselvesaretobeexpressed–andthatthefactorsinfluencingthesevariablesareinturninfluencedbytheproductsofadditionalfarflunggenes,whichareinturninfluencedbyanothersetofgenes,andsoon.Obviously,thiswebofrelationsnecessarilyextendsthroughouttheentirecellandincludesepigeneticfactorsaswell–whichconfirmsConrad’sassertionthatgenesareultimatelyregulatednotbyindividualinputs,butby“globalproperties”ofthesystem.

Moreover,eventhoughourunderstandingofEndo16’sregulatoryprogramissubstantiallycircumscribed,it’sprodigiouscomparedtoourknowledgeoftheprogramsassociatedwithmostotherpromoters.AsWraynotedinhiscommentary,“Inspiteofconsiderableinvestigationofthefunctionofanimalpromoters,generalprincipleshaveremainedfrustratinglyelusive.Thereislittlelogicapparentintheorganizationofregulatoryelements....Itthereforecomesasasurprisetodiscoverapromoterthatoperatesinalogicalmanner.” 32Infurtheremphasizingtheinscrutabilityofmostpromoters,hedescribedtheiroperationsas“seeminglyhaphazard.” 33

Buttheword“seemingly,”aswellastheword“apparent”thatshortlyprecededit,shouldbedoublyunderscored.That’sbecausetheoperationsofpromotersmustbehighlylogical.Otherwise,theelegantlyintegratedorganismsthataboundinourworldcouldnotexist.Therefore,theactuallackisonthelevelofhumanunderstanding,andtheextenttowhichtheseoperationsappearaslogicallydeficientisameasureofhowinadequatelywegrasptheintricaciesoftheirdynamics.Further,althoughourunderstandinghassignificantlyadvancedsince1998,whenWray’swordswerewritten,it’sstillquiterudimentary–especiallycomparedtoourknowledgeofhuman-madeinformationsystems.Andthedeficiencyisnotlimitedtoanimalpromoters.Ourknowledgeofplantpromotershasalsoremainedmeager.34

So,comparedtoourknowledgeof,andabilitytomanage,eventhemostimmenseandcomplexhuman-madecomputerprograms,ourcapacitytocomprehendandcontroltheprogramscoordinatingtheprocessesoflivingorganismsisminiscule.

AnUnparalledLevelofParallelProcessing

Theprofoundcomplexityofcellularinformationsystemscanbemorefullyappreciatedinlightofthefacttheyperformaprofounddegreeofparallelprocessing.

Thesimplestformofcomputerprocessingisnotparallelbutserial.Inserialprocessing,instructionsareexecutedsequentiallyandoneatatime.Butinparallelprocessing,distinctoperationsoccursimultaneously.Consequently,parallelprogramsaremoredifficulttowritebecausemultiplesubtasksneedtobecoordinated.Hence,they’realsomorepronetoproblems.

Ofthese,themostcommonarecausedwhenseparatesubtasksdonotactivateinpropersequence,affectingthesystem’soutputinunintendedways.35They’recalledraceconditions,becauseit’sasifonesubtaskhasracedaheadoftheothertocapturesystemresourcesbeforeitshouldhave.

Inordertoensurethatsubtasksincomplexparallelprogramsremainsynchronizedandaccessresourcesinthepropersequence,theprogrammersmustcreatebarrierstoblockasynchronousbehavior.Andthisbecomesmorechallengingthemoreintricatelyinterconnectedthesystembecomes.Accordingly,eventhemostadeptprogrammerscouldnotcreatesystemsthatevenvaguelyapproximatethedegreeofinterconnectionandharmonizationdisplayedbycellularsystems.Andeveniftheycouldsuccessfullycreatebarriersasneeded,theywouldstillfaceotherbasiclimits.Foronething,iftheparallelizationwithinahuman-madesystemincreasestoogreatly,thesubtasksmustspendsomuchtimecommunicatingwithoneanotherthatperformanceisnotacceleratedbutretarded.Incontrast,cellularsystemssustainintricatecommunicationbetweencomponentswhileachievingastoundingratesofoperation–and

avoidingtheraceconditionsthatbedevilthecomplexprogramsmadebyman.

Mind-Madevs.MindBoggling

Thus,inlightofwhatwe’veconsideredsofar,theclaimthatbioengineershaveadequateunderstandingofthecellularsoftwarethey’rerestructuringisatbestnaïve–asisthenotionthathumanscouldfullycomprehendsuchsystemsbythoroughlystudyingtheirconstituentDNA.

Aswe’veseen,DNAdoesnotserveasinstructionsbutasdata;andthedataoccupiesaconcretelevelcorrespondingtomachinecode,notthemoreabstractplaneofsourcecode.Thecorrelativeofthesystem’ssourcecodewouldbeasetofprinciplesandrulesthatdescribesitsarchitectureandgovernsitsoperations;andsuchacodeisapparentlynotinscribedwithinthephysicalconfinesoftheorganism.Althoughit’sobviousthatthesystem’scomponentsareintricatelycoordinatedandhighlyorganized,therulesthroughwhichthiscoordinationandorganizationoccursarenotphysicallyexpressedlikethesourcecodeofacomputerprogram,andit’sunlikelythattheyevencouldbe.Whiletheremustbesomeorganizingprinciples,it’sdoubtfulthatthehumanmindcouldevengraspanybutthemostgeneral;andthedegreeofgeneralitywouldbetoogreattoaffordadetaileddescriptionofthedynamics.

Accordingly,whilecomputerprogramsarecreationsofthehumanmind,andarethereforewell-comprehendedbyit,theinformationprogramsthatunderlielifenotonlydidn’tderivefromthatmind,theintricaciesoftheirorganizingprinciplesandoperationaldynamicssovastlyoutstripitscognitivecapacitiesthattheyboggleit.

TheStarkContrastsBetweenGeneticEngineeringandSoftwareEngineering:GlaringGapsinVision,Precision,andPrecautionBecausegeneticengineersknowsomuchlessabouthowtheprogramstheyalteractuallyoperatethandosoftwareengineers,andbecausetheassociatedrisksaresohigh,onecouldreasonablyexpectthemtoexercisenotmerelythesamedegreeofcautionasdothelatter,butsubstantiallymore.Andthisexpectationisevenmorejustifiedinlightofthefactthattheiroperationsarefarlessprecisethanthoseofsoftwareengineers.Aspreviouschaptershaveexplained,theycannotcontrolwhereintheDNAstrandtheinsertedgenesendup,norcantheyconfigurethemtoactinharmonywiththemyriaddoingsofthetargetcell.Instead,theseintrusivegeneticsequencesoperateoutsidethecell’sintricateregulatorysysteminanexceptionallyunruly,andpotentiallydisruptive,manner.

Yet,althoughcomparedtosoftwareengineers,theirvisioniscriticallyrestrictedandtheiractsinexact,thebioengineershaveoperatedwithfarlessprecaution–whichisobviousfromsurveyingtheprotocolsofthatotherprofession.

AFundamentalFacetofSoftwareDevelopment:TestingtheProgram

Despitethefactthatsoftwareengineersknowsomuchmoreabouttheprogramsthey’vefashionedthanbioengineersknowaboutcellularinformationsystems,andalthoughtheirprogramshavebeenincreasinglydesignedtoreduceunintendedeffects,thepotentialforsuchproblemshasnotbeeneliminated;andtheystillarisealltoofrequently.Therefore,testingisacrucialpartofthedevelopmentprocess.Andbecauseit’ssoimportant,it’susuallyputinthehandsofpeoplewhohadnothingtodowiththeprogram’screation–andwhothereforearenotpredisposedtoseeitsreliabilityconfirmed.Infact,thoseinthetestingdivisionarepredisposedtofindproblems,becausethat’stheirjob;andtheyattempttodosobysubjectingtheprogramtoextensiveandintensivetrials.

MaintainingandRevisingtheProgram

However,evenafterseveralroundsofrobusttesting,manyproblemscanstillgoundetected;andsoftwareisoftenreleasedwithbugsthatareonlydiscoveredasit’semployedinalargerangeofconditions.Asthisoccurs,programmershavetomakerevisions.

Further,maintainingaprogramcomprisesmorethancorrectingerrors;andthemajorityofthemaintenancecostsareincurredbecausetheprogrammustregularlyevolvetoadapttochangingconditions.36Thepressuretoevolveissostrongthatthetotalmaintenanceexpensetypicallyconsumestwo-thirdsofthelife-cyclecostofasuccessfulprogram.37Andthisexpenseissobigbecauserevisingsoftwareisabigprocess.

Anytimeaprogramisrevised,whetherincorrectingerrorsoradjustingtonewcircumstances,theveryprocessofmakingthechangecoulditselfdisturbthesysteminsomeunexpectedmodeandcreateanotherproblemelsewhere.Intheearlydaysofcomputing,whenaprogram’spartstendedtobehighlyinterconnected,thesystemsweresosusceptibletounwantedinteractionsthatmakingevenasmallrevisiontoonesectionusuallycausedadisruptionelsewhere.Consequently,asaprogram’serrorswerecorrected,thetotalnumbertendedtostayconstant,becausefixingoneusuallyentailedcreatinganotheratadifferentlocation.

Butasprogrammerslearnedtoinsulatethevariouscomponentsfromoneanotherandreducethepotentialforunwantedeffects,theprocessoferrorcorrectionbegantoyieldanetbenefit.However,althoughprogrammerscouldreducethepotentialforproblems,theycouldnoteliminateit.That’sbecause,aspreviouslydiscussed,thecomponentsofanylarge,complexinformationsystem,evenwhendesignedtointerrelatemorelikeraviolithanspaghetti,canstillinteractinwaysthattheirdevelopersnotonlyneverintended,butcouldnotevenforesee.

Consequently,afteranyrevision,evenasmallonethat’scarefullyplannedandpreciselyexecuted,theentiresystemneedstobethoroughlyre-tested.Thispost-revisionscrutinyiscalledregressiontesting;anditordinarilyentailsnotonlyalargeportionoftheteststhatwererunpriortotheprogram’sfirstrelease,butasetofnewonesspecificallydesignedtogaugetheeffectsofthenovelcodethatwasadded.

ImposingStifferStandardsonLife-CriticalSystems

Despitetherigoroftheabove-describedtestingprocedures,softwaredevelopershaverecognizedthatifaprogram’smalfunctionwouldposeasubstantialdegreeofrisktohumanlife,itrequiresaleveloftestingthat’sevenmorerigorous.Accordingly,theyroutinelysubjecttheselife-criticalprogramstostrictertesting,bothbeforerelease,andafteranyrevisionsaresubsequentlymade.Inthesetests,theprogramisputthroughasmanypermutationsaspossibletomakesurethatitwillperformsafelyunderthewidestrangeofconditions,eventhosethatwouldseldomarise.

Notonlyhassuchtestingbecomestandardindustrypractice,it’smandatedbyregulators.IntheUnitedStates,theFederalAviationAdministrationinsistsonitinthecaseofairplaneguidancesystems,andtheFDArequiresitinthecaseofthesoftwaregoverningmedicaldevicessuchasX-raymachines,radiationtherapyequipment,andpacemakers.38Andthenewinternationalstandardforlife-criticalmedicaldeviceslikewiseestablishesthisstricterleveloftesting.39

Further,it’simportanttonotethatevenwithoutgovernmentmandates,thesoftwareindustrywouldberoutinelysubjectingitshigh-riskproductstothoroughtesting,becausethat’sstandardpracticeevenforsoftwarethatisnotlife-critical;andalthoughsuchprogramsaren’tregulated,theirdevelopersordinarilydon’treleasethemuntilthey’vebeencarefullytested.Thus,themaindifferencebetweenthetwocategoriesofsoftwareisnotthatthehigherriskprogramsaretested,butthatthey’retestedmorestrictly;andgovernmentregulationdidnotimpeltheimplementationofanewpracticebutinsteadensuredthatacommonpracticewouldbepracticedinauniformlyrigorousmanner–commensuratewiththerelated

levelofrisk.

HowBioengineersFallDeplorablyShortinRegardtoTesting

Instrikingcontrasttosoftwaredevelopment,thoroughtestingforunexpectedproblemsisnotaroutinefeatureofgeneticengineering–eventhoughthepotentialforunintendedeffectsisfargreaterwhennature’sinformationprogramsarebeingaltered.AlthoughthedevelopersofGEcropsusuallyperformnutritionalstudiestomakesurethatlivestockfedonthemwillsufficientlygrowforcommercialneeds,suchstudiesdon’tassesssafety,andthey’renotdesignedtoscreenforsymptomsoftoxicity.Sotheanimalsthatarestoutenoughtomarketmayyetharborarangeofundetected,feed-inducedinfirmitiesthatcouldalsodevelopinthehumanswhoconsumethecrops.

Moreover,it’sunlikelythatactualsafetytestingwouldhappenatallifitweren’trequired;andwhenitisrequired,it’swoefullyinadequate.Eveninthenationsthatmandatesometoxicologicaltesting,thestipulatedstudieslastnomorethan90days,whichisn’tlongenoughtodetectthemanytypesofproblemsthatdevelopoveranextendedtime–aswasdemonstratedbytheSéralinistudydiscussedinChapter10.Worse,theEuropeanUniondidn’tgetaroundtomakingeventhoseinadequatetestsmandatoryuntil2013.AndintheUnitedStates,amanufacturercandumpalimitlessnumberofGEcropsonthemarketwithoutperformingaspeckoftesting.40

Thedisparityinhowsoftwareengineeringandgeneticengineeringareregulatedissovastit’sastounding.Whendealingwithlife-criticalhuman-madesoftware,regulatorsthroughouttheworldarehighlysensitivetothepotentialforunintendedconsequences,andtheywon’tacceptargumentsthatnewprogramsaresubstantiallyequivalenttopriorones,nomatterhowwell-groundedandreasonablethoseargumentsmightseem.Instead,theyrequirethatthesafetyofeachnewprogrambeestablishedthroughrigoroustesting.41Moreover,theirrejectionofthesubstantialequivalencedoctrineisthoroughgoing;andwhenaprogramthathasbeenrigorouslytestedandapprovedformarketislaterrevised,regulatorswon’tacceptassertionsthatthenewversionisessentiallythesameastheold–nomatterhowsmall,well-planned,andpreciselyexecutedthealteration,andnomatterhowwell-insulatedthesystemagainstadverseintercoursebetweenitscomponents.Rather,evenwhenaminusculechangeiseffectedbyexpertswithfullknowledgeofthesystem’sarchitectureanddesignedinteractions,theyrequirethattheprogrambetreatedasanewentityandthatitssafetybeconfirmedthroughanotherstringentroundoftesting.

Butwhenfacedwithradicalalterationstothemostcomplexandintricatelyinterconnectedinformationsystemsonearth,madeinahaphazardmannerbypeoplewhodon’tunderstandthesystem’srulesandcontoursandcanbarelybegintofathomthefulleffectsoftheirinterventions,regulatorshaveforyearsallowedtheresultantfood-yieldingorganismstobemarketedaslongasasuperficialcasecanbemadethatthey’resubstantiallysimilartotheirconventionalcounterparts–despiteextensiveevidencethatsuchradicaltamperingcanrenderthefoodtoxic.AndintheUnitedStates,suchequivalenceisautomaticallypresumed,withnorequirementforeventhemostsuperficialofefforts.42

Further,intheUStheparadoxismoreglaringbecausethesameadministrativeagencyisinvolvedinbothsituations.SowhiletheFDArigorouslyregulatesthesoftwarethatdriveslife-criticalmedicaldevices,requiringthateventhemostminorandwell-managedrevisionsbesubjectedtoextensivetesting,itdrasticallyshiftsitsstandardswhendealingwithGEfoods.Inthatcase,itpresumesthattheunprecedentedrestructuringoftheinformationprogramsdirectingthedevelopmentandfunctionoflivingorganismsbythosewholackcapacitytocontrolwherethenewchunksofcodewedgeorhowtheyimpactthesystemisnonethelesssoinnocuousthatitneednotberegulatedatall–despitethefactsuchrestructuringcouldcausefarmoreextensivedamagetohumanlifethanamalperformingpacemakeroranerrantX-raymachine.43

Additionally,notonlyisthereahugediscrepancyinthewayregulatorstreatthetwoclassesof

informationmanipulation,there’samajordifferenceinthediligencedisplayedbythosewhodothemanipulating.

Ontheonehand,softwareengineershaveexercisedanadmirablelevelofself-regulationandhaveroutinelysubjectedevenlow-risksoftwaretocarefultestingwithoutanygovernmentmandatetodoso.What’smore,theydidn’tresistgovernmenteffortstoregulatetheirhigh-risksoftware–andhadevenrecognizedandbeguntoaddresstheneedforstricterscrutinyofsuchprogramswellbeforetheregulationswereimposed.

Ontheotherhand,thebehaviorofbioengineershasbeennotmerelyunadmirable,butreprehensible.Aspreviouschaptershavedocumented,besidesfailingtoresponsiblytesttheircreations,theyhave,fromtheearliesteraofgeneticengineering,forcefullyresistedregulationanddeterreditwithdubiousandevendeviousmeans.Andalthough,despitetheirdeceptions,somemeagerregulationswerefinallyinstitutedinmanycountries,manufacturershaveoftenevadedtheimposedobligationsbyconductingshoddyresearch,obfuscatingadversedata,andinaccuratelyreportingtheirfindings.Further,eveninthecaseswhereamanufacturerhasnotonlyobeyedtherequirementsbutexceededthem,theleveloftestinghasstillnotreachedthestandardthat’svoluntarilyupheldbysoftwaredeveloperswhentestingprogramsthataren’tclosetolife-critical–andfallsfarbeneaththeoneemployedforthosethatare.

Theenormityofthegapbetweenthelevelsoftestingperformedonlife-criticalsoftwareandGEfoodscanbebetterappreciatedbyrecognizinghowvastlyrevampedthebiotechindustry’scurrentsystemwouldhavetobeinordertoapproximatetherigorwithwhichthesafetyoflife-criticalsoftwareisstandardlyestablished.Attheleast,thistransformationwouldentailimplementingtheminimumsetofproceduresprescribedbyJohnFaganandMichaelAntoniouthatwasdescribedinChapter10.Andsuchahugetransformationisunlikelytooccur.

Yet,evenifitdid,thetestingofGEfoodswouldstilllackthereliabilityofsoftwaretestingunlessanothermajorreformwereadopted.Thepeopledoingthetestingwouldhavetobeinsulatedfrompressurestoreturnrosyresults–andbeevendevoidofthedesiretodoso.Otherwise,thetestingcouldnotachieveparitywiththeproceduresgoverningsoftware.Aswe’veseen,althoughtheindividualstestingsoftwareareusuallyemployedbythecorporationsthatdevelopit,theirjobistofindasmanyflawsastheycanandnottooverlookanythingsuspicious.Incontrast,thecorporatedevelopersofGEfoodshaverepeatedlydemonstratedthattheirprimaryconcernisnotsafetybutprofit;andthey’veroutinelyendeavoredtorelaxtherigoroftestinginordertocutcostsandacceleratetheadvancetowardcommercialization.Inconsequence,becausethosewhotestGEfoodsareeitheremployeesofthemanufacturersorhiredbythem,they’relikelytoreflectthecorporatebiastowardfavorablefindingsthatcanhastentheproduct’srelease–justastheemployeesofsoftwarefirmsreflecttheiremployers’desiretodetectallproblemspriortorelease,eventhoughthepaceofcommercializationistherebyretarded.

Ofcourse,it’snotknownwhetherthisattitudinaldiscrepancyisduetoadifferenceinrectitudeorinsteadtothefactthatprogrammingdefectsarefarmorediscoverableafterreleasethanaremostharmfulchangestofoodbecause,unlikethelatter,theyusuallycausepalpableproblemsthatareclearlylinkedtotheproduct.44However,inlightoftherepeateddelinquenciesofsomeofthemajorGEfoodmanufacturers,it’sdoubtfulthediscrepancysolelystemsfromthefactthatflawedfoodcanbemoreeasilypassedoffthanflawedsoftware.Butinanyevent,thedisparitydoesexist;andwhateverthereason,thebehaviorofsoftwarecompanieshasineffectbeenfarmoreresponsiblethanthatoftheGEfoodindustry.

Further,althoughGEproponentsforcefullycontestthechargethatindustry-controlledtestingislessreliablethantestingthat’sindependentlyconducted,it’snotonlyconsistentwithcommonsense,buthasbeenconfirmedbyscientificassessment.Asubstantialbodyofresearchhasshownthat,forarangeofvariousproducts,testsconductedbytheproducts’manufacturers,orbyresearchersintheirpay,tendtobebiasedandaresignificantlylesslikelytodetectproblemsthanarethoseperformedfreeoftheirinfluence.45ThisbiashasalsobeendetectedinthecaseofGEfoodsandwasdocumentedinapublished

reviewoftheresearchontheseproducts.46Consideringthedisparitieswe’vesofardiscussed,it’snotsurprisingthat,besidesinsistingthat

testingberigorous,softwaredevelopershavedevotedamuchlargerportionoftheirbudgettoitandtoothermeasuresthatenhancethesafetyandreliabilityoftheirproducts.Thus,testingtypicallyaccountsforover20%ofaprogram’sdevelopmentcosts;andaccordingtoastandardtextbook,thetotalamountspentonpre-andpost-releasetesting,incombinationwiththeothermeasuresthatmaintaintheprogram’sperformance,consumesaround70%ofthetotalexpenditure.47Incontrast,amuchsmallerfractionofthedevelopmentalbudgetforaGEcropisconsignedforsafetytesting.

Thus,overall,thetest-relateddifferentialisenormous,becausenotonlyaretheteststhebiotechindustrydoesperformunreliablyconducted,they’renotthekindsthataremostneeded.NoneofthevariousproceduresprescribedbyFaganandAntoniouhasyetbeenimplemented;andnoneislikelytobewithoutanarduousstruggle.Andtheprospectsforasystemoftrulyindependenttestingarejustasdim.Therefore,thedisparityinresponsibilityshownbybioengineersandsoftwareengineerswillmostprobablypersist.

Moreover,asstarkasthisdisparityappearswhenthegapintestingisassessed,it’sevenstarkerwhenwealsogaugethevarianceinthewaythetwogroupshaverespondedtoproblems.

DiscrepancyintheResponsetoAdverseIncidents:Responsibilityvs.Recklessness

Althoughthemajorityofsoftwarefailureshavecausedonlyminortomoderateannoyances,anumberhaveentailedseriousconsequences,includingsomefull-blowncatastrophes.Andexamininghowtheyarose,andhowthedevelopersandregulatorsresponded,ishighlyinstructive.

OneofthestrangestmishapsoccurredinthestateofNewYorkafterAT&Ttriedtoimproveasoftwareprogramthatmanagestelecommunicationswithinalargenetworkof4ESSswitchingsystems.Inmid-December1989,thecompanyinstalledthenewsoftwareintheprocessorsofall114oftheseunitswiththegoalofspeedinguptheflowofinformationbetweenthem.However,inrevisingtheoldprogram,theprogrammershadinadvertentlyomittedafewlinesofitscode.

Severalweekslater,onJanuary15,1990,acrisiseruptedwhenoneoftheswitchesshutdownandrebooted–andthensentamessagetoneighboringswitchessignalingthatitwasagainfunctional.Althoughthisinitialcrashapparentlywasnotcausedbytheglitchinthenewsoftware,theensuingproblemswere.Whentheformerprogramwasrunning,thistypeofrecoverymessagewasproperlysentandprocessed,butduetotheabsenceofthoseexcludedlinesofcode,the‘improved’softwarebotchedtheprocedure.AccordingtoAT&T’sdirectoroftechnologydevelopment,themessage“confusedthesoftware”inthereceivingswitchesbecauseit“didn’tmakeanysense.” 48Hecontinuedthat,ineffect,thefirstswitchtoldthem,“MyCCS7processorisinsane,”whichinducedthemtoshutthemselvesdownsotheywouldn’tspreadtheproblem.Ironically,insteadofconstrainingtheproblem,thispreventivemeasureactuallyextendedit,becausewhenthoseunitsrebootedandattemptedtosignaltheirneighborsthatallwaswell,theneighborswereinturnconfused,whereupontheyshutdown,rebooted,andthentransmittedthesamedisruptivemessagetotheirneighbors.Theeffectquicklyrippled,andsoonall114switcheswerecrashingandrebootingeverysixseconds,withtheresultthatforninehours,anestimated60thousandcustomershadnolongdistancetelephoneservice–amajorpredicamentinanerawhenmobilephoneswererare.

Sixyearsafterthecrashofthephonesystem,anothersoftware-induceddisasteroccurredthatwasnotonlymuchmoredramatic,butduetoacontrastingcause.ChroniclingtheincidentintheNewYorkTimesMagazineinDecember1996,ahalfyearafterithappened,JamesGleickencapsulateditasfollows:

IttooktheEuropeanSpaceAgency10yearsand$7billiontoproduceAriane5,agiantrocket

capableofhurlingapairofthree-tonsatellitesintoorbitwitheachlaunchandintendedtogiveEuropeoverwhelmingsupremacyinthecommercialspacebusiness.

AllittooktoexplodethatrocketlessthanaminuteintoitsmaidenvoyagelastJune,scatteringfieryrubbleacrossthemangroveswampsofFrenchGuiana,wasasmallcomputerprogramtryingtostuffa64-bitnumberintoa16-bitspace.49

Thiserrorwastheresultofasimple,butstupendousblunder.Asubsystemofthesoftwareprogramthathadbeendesignedforanearlierversionoftherocket,theAriane4,hadbeenreusedinAriane5;andthatsectionofsoftware,whichhadworkedadmirablyintheoldermissile,didnotmeshwiththephysicalfeaturesofitssuccessor.That’sbecausetheAriane4wasaslowerrocket,andallthevelocity-relatednumbersitgeneratedcouldbesuccessfullyhandledbytheprogram.ButthemorepowerfulandspeedierAriane5producedanumberthatwastoobigforthatprogramtoprocess,causingtheguidancesystemtoshutdown–whichtriggeredaseriesofmalfunctionsculminatinginthemission’sexplosiveend.

Commentingonthecalamity,inwhicharocketandcargoworth500milliondollarshadbeenobliteratedamere39secondsafterlaunch,theheadoftheprojectremarked,“Verytinydetailscanhaveterribleconsequences....That’snotsurprising,especiallyinacomplexsoftwaresystemsuchasthisis.” 50Underscoringthedegreeofcomplexity,Gleickobserved:“Softwarebuiltupoveryearsfrommillionsoflinesofcode,branchingandunfoldingandintertwining,comestobehavemorelikeanorganismthanamachine.”

It’snoteworthythatinthephonesystemcrash,thehardwarewasnotalteredandthekeychangewastheaccidentaldeletionofasmidgenofcodefromapriorprogram,whiletherocketexplodedbecausethehardwarehadchangedwhileanincompatiblesegmentofpriorcodecontinuedtobeemployed.Anditwasnotthesolecatastrophecausedbyanerroneousassumptionthatasegmentofsoftwarewhichbehavedbeautifullyinonephysicalsettingwouldcontinuetodosoinanotherthatwascomparableinmostrespects.Asimilarmisconceptioninducedaseriesofmedicalaccidentsthatnotonlywroughtextensivesuffering,butdeath.

Thatmistakeoccurredwhenthemanufacturerofaradiationtherapydevicedevelopedanewmodel(theTherac-25)thatimprovedonthepreviousone(theTherac-20).However,theimprovementswereprimarilyonthelevelofthehardware,andalotoftheoldersoftwarewasretainedwithoutrevision–onthebeliefthatbecauseithadalongandreliablerecord,itwouldstillworksafelywithinthenewmachines.Butthisbeliefwasunwarranted.AlthoughtheTherac-25’sdidoperatesmoothlymostofthetime,therewereraresetsofcircumstancesthatcausedsomesegmentsofoldersoftwaretomisperform,whichinturncausedthemachinerytoseriouslymalfunction.AndthiswouldnothavehappenedintheTherac-20’s,becausetheywerecapableofsafelyhandlingsuchsoftwareslip-ups.

Thus,whilethenewmachinesweremoreversatileandeconomicalthanthepreviousmodels,becausetheycouldn’taccommodatethequirksintheoldsoftwaretheycontained,theyweresignificantlylesssafe.Asaresult,atleastsixpeopleweresubjectedtomassiveoverdosesofradiation,causingthemseverepainandinjury–andultimatelykillingsomeofthem.

Althoughtherehavebeenmanyothersoftware-createdcatastrophes,theabovethreeareamongtheworst;andit’silluminatingtoconsidertheirimplicationsforgeneticengineering.Foronething,virtuallyallGEfood-yieldingorganismshaveoneormorepiecesofsoftwarethatderivefromonephysicalsystembutarebeingemployedinanother.Andinmostcases,there’satleastonegeneproducingaproteinwithinaforeignenvironmentthatmaynotprocessitproperly.Asdiscussedinearlierchapters,insuchsituationsthere’sariskthattheproteincouldbemisfolded–ordangerouslyalteredthroughtheadditionofauxiliarymolecules.Further,whereastheAriane5andtheTherac-25werequitesimilartothemodelstheyreplaced,andyetwerestillperilouslyincompatiblewithsomeofthesoftwarethosesystemsutilized,therearemajordifferencesbetweentheorganismsinvolvedinmostDNAtransfers.Accordingly,there’s

goodreasontosuspectincreasedriskofharmfulincongruitybetweenhardwareandsoftware.Moreover,notonlyaremostbioengineeredcropsvulnerabletothesamekindofproblemthatdowned

theArianeandplaguedtheTherac,they’realsoopentothetypeoftroublethatcrashedAT&T’sphonesystem.That’sbecause,besidestheirpotentialhardware/softwaremismatch,theirsoftwareisalteredinawaythataccidentallydeletessomeinformation,andscramblessomeother.

ButthedifferencesintherisksposedbyGEfoodsandthoseentailedbythefailedphonesystem,theill-fatedrocket,andthemisfiringradiationmachinedon’tstopthere.Forinstance,onlyoneofthosethree(theTherac)significantlyendangeredhumanlife,andeventhenthenumberofindividualsdirectlyexposedwasminisculecomparedtothetensofmillionsofpeopleworld-widewhoareingestingingredientsfromoneoranotherbioengineeredfoodeveryday.Therefore,eachofthesefoodsposesamuchbiggerriskthandidanyofthoseentities,becauseeachhasthepotentialtocausealotmoreaggregateharm.51

There’salsoabigdiscrepancyinthewaytheexpertcommunityandgovernmentshaverespondedtothesoftware-relatedcalamitiesandthewaythey’vereactedtoproblemsassociatedwithbioengineering.Inthephonesystemcrash,AT&Tpromptlydeterminedthattheerrorwasinthesoftwareandmadethenecessaryfix.WhentheAriane5exploded,apanelofinquiryconvenedtwoweekslater,performedathoroughinvestigation,identifiedthesourceoftheproblem,andpublicizeditsfindings.AndalthoughittooklongertodeterminewhyseveralTherac5’shadmalfunctioned,adeterminationwaseventuallymade.Further,innoneofthesecasesdidthesoftwareindustryandprogrammingprofessionalsarisetodefendtheimageofsoftwarebydeclaringitcouldnothavebeenatfault–nordidtheyspreaddisinformation,trytothwarttheinvestigation,orimpugnthecompetenceortheintegrityoftheinvestigators.Nordidgovernmentregulatorsattempttoprotecttheinvolvedindustriesbysuppressingevidenceorissuingmisleadingstatements.Onthecontrary,pursuanttoitsauthoritytosupervisemedicaldevices,theFDAexercisedcommendablediligenceintheTheraccase;andeventhoughthemanufacturerapparentlytriedtoobfuscatethefacts,theagencydidnotaidtheeffortbutinsteadendeavoredtoachieveclarification.52Further,theTheracincidentmotivatedtheagencytostrengthentheregulationsgoverningmedicaldevicesandthesoftwarethatdrivesthem.53

Atleastasimportant,softwareengineershaveearnestlyattemptedtolearnfromtheirmistakes.Notonlyhavetheyrefrainedfromportrayingtheirproceduresasessentiallyerror-free,they’veopenlyacknowledgedtheirvariouserrors,systematicallyanalyzedthem,andsteadilyimprovedtheirmethods.Andtoaugmentthereliabilityoftheirprograms,they’veroutinelysubjectedthemtorigoroustesting.Consequently,softwareengineeringisasounderandsafertechnologytodaythanitwastwentyyearsago.

Incontrast,astheprecedingchaptershavedemonstrated,thepractitionersandproponentsofgeneticengineeringhavestubbornlymaintainedthattheirtechnologyisprecise,reliable,andsafe;andthey’vebeenaversetoevenacknowledgeitsfailuresletalonetolearnfromthem.Further,they’veevadedrobusttestingandinsteadhavebasedtheirclaimsofsafetyonobstinatelyheld,albeitthoroughlydiscredited,beliefs.Consequently,althoughsoftwareengineershaveprogressivelyrecognizedthecomplexityoftheartificialsystemstheycreate–andrealizedthatinkeyrespectsthey’remoreakintoorganismsthanmachines,bioengineershavegrosslydiscountedthecomplexityofthelivingsystemstheyalterandhavetreatedintricateorganismslikesimplemechanicalsystems.Andthey’vepersistedinthepracticedespiteitsdissonancewithanever-growingmassofevidence.

Moreover,(asChapters6and10havedocumented)majorgovernmentalregulatoryauthoritieshavebeenequallyunwillingtofacethefacts;andasdisquietingdatahasmounted,they’vedecreasedtheirdiligenceandoftenloweredthestandardsfortesting.Thistrendissopersistentthat,notwithstandingindependentreassessmentsofseveralindustry-conductedfeedingstudiesthathavediscoveredpreviouslyundisclosedevidenceofharm–andsolidoriginalresearchthathasproducedalarmingresults,in2012

theEuropeanCommission’schiefscientificadvisorproclaimedthat“theprecautionaryprincipleisnolongerrelevantwithGMOfoodsorcrops”–whichisanartfulwayofsayingthatroutinepre-markettestingisnolongerneeded.54

DrawingtheCrucialContrast:PreciseProgrammingvs.HaphazardHackingAstheprecedingsectionshaveshown,althoughsoftwareengineersandgeneticengineersbothmanipulatecomplexinformationsystems,thelatterpossessmuchlessrelevantknowledge,exercisefarlesscaution,andarefarlesswillingtolearnfrom(orevenacknowledge)theirfailures.Butthedifferencesrunmuchdeeperthanthis–sodeepthat,notwithstandingthefrequentanalogiesbetweenbioengineeringandcomputerprogramming,thetwoare,atbasis,notonlydisparate,buttoalargeextentopposite.

Toappreciatethis,wefirstneedtobeclearaboutwhatthetwosetsofprofessionalsdo–anddonotdo.Andthefirstfacttonoteisthatbioengineersarenotengagedintheprimaryactivityofsoftwareengineers,norcouldtheyevenattempttobe.Thatactivitycomprisesthedesignandcreationofcomplexinformationprograms;andthebioengineerswhodevelopnewvarietiesofedibleplantsandanimalsareutterlyincapableofdesigningandcreatingtheinformationsystemsofthehigherorganismtheydealwith–systemsthatcruciallycontributetothegenerationoflivingcells,guidetheirdevelopmentintocomplexorganisms,andenablethoseorganismstoconductamultitudeoffinelytunedandintricatelycoordinatedoperationsthroughwhichtheysustaintheirlivesandsuccessfullyinteractwithimmenselyvariegatedenvironments.Instead,theymerelymakealterationstothosesystems:systemsthatwerenot(andcouldnothavebeen)createdbyhumans.

Aswe’veseen,softwareengineersalsomakealterationstopreviouslydevelopedprograms,andit’sanimportantpartofprogramming.Buttherearemajordifferencesbetweenthosealterationsandtheoneseffectedbybiotechniciansoncellularsoftware;andtheybelongtodistinctandcontrastingcategories.

Thechangesmadetocomputerprogramsbythepeoplewho’vedevelopedthemarerevisions.They’recarefullyplannedimprovementsthatenhancetheprogram’sefficiencyandeffectiveness,enablingittobetteraccomplishwhatitwasdesignedtodo.Andtheyservethisconstructivepurposebecausethey’reconceivedandexecutedbyindividualswithcomprehensiveknowledgeofhowtheprogramisstructuredandhowitscomponentsaredesignedtointeract.Accordingly,they’reperformedwithprecisionandprudence;andwhenoldcodeisedited,ornewsectionsareadded,it’sinamannercalculatedtomeshwiththesystemandminimizetheriskofdisturbingitinundesirableways.

Inmarkedcontrast,bioengineersarevastlyignorantofthestructureanddynamicsofthecomplexsystemstheyalter.Theyhavevirtuallynounderstandingofthesourcecode,andeventheircomprehensionofthemachinecode(thesequenceofnucleotidebasesintheDNAmolecule)isseriouslyconstricted.55Consequently,theydon’tknowhowaninsertedcassetteofnewcodewillimpacttheentiresystem;andeveniftheycouldascertainthespecificlocationatwhichitwouldbeleastlikelytocausebroaderdisruptions,they’dbeincapableofputtingitthere.Instead,theirinsertionsaremadeinarandommanner.

Ineffect,thebioengineersareaddinganewfunctiontoaprogrambyactingonthelevelofthemachinecodewithscantunderstandingofhowtheprogramisputtogetherandhowtheiralterationswillaffectit–whichisafarcryfromhowprogrammersmakerevisions.Notonlydothelatterpossessabundantlygreaterknowledgeandactwithfarmoreadroitnessandcare,theydon’toperateatthelevelofthemachinecode.Workingatthatlevelischallengingandproblem-prone;andaprofessionalwhodesignedthesourcecodewouldnotevenbeabletorecognizetheprogramonthebasisofthemachinecode,letalonereviseitfromthereinacompetentmanner.Sobesidescreatingprogramsatthelevelofthesourcecode,softwareengineersrevisethemfromthatlevelaswell.

Moreover,thedoingsofbioengineersarefurtherdistancedfromwhatcouldcountasrevisingaprogrambythefactthattheydon’timproveperformancebutimpedeit.AsChapters4and9haveexplained,theyforcetheorganismtodivertenergyandassetsfromessentialfunctionstodriveprocesses

thatprovideitnobenefitandimposeanetdetriment.Andtheprocessestheyimposebehaveinanunregulatedmannerthatcaninducedisruptionthroughoutthesystem.

Hence,itwouldbehighlyillegitimatetolikensuchactionstotherevisionofacomputerprogram.Butitwouldbeappropriatetogroupthemwithanotherclassofalterations–oneswhich,likethoseofthebioengineers,areconductedbypeoplewhodon’tunderstandthesourcecode,whoactlargelyonthelevelofthemachinecode,andwhoseinsertionsimpairtheprogram’sperformance.56Thesearethealterationsmadebyhackers;andinanyopen-eyedassessment,themanipulationsofthebioengineersarefarmoreakintohackingprogramsthantorevisingthem.

Thiskinshipisespeciallystrikinginlightofthefactthatinbothhackingandbioengineering,theinsertedsegmentsofcodeactlikeavirus.Notonlydotheygainentrybybreachingtheprogram’sdefensesagainstforeignincursions,onceinside,theyoperateindependentlyof,andinimicalto,theaimsoftheinvadedsystem–whilecommandeeringitsresourcesinordertodoso.57AsanarticleinScienceNewsobserved,“Computervirusesgottheirnamefrom...‘anobviousbutdeepbiologicalanalogy.’” 58Andmanybiologistshaverecognizedthattheanalogyholdsforthealieninsertsofgeneticengineeringaswell.Forinstance,PatrickBrown,aprofessorofplantscienceattheUniversityofCalifornia,Davis,hasstated:“Indeed,itcanbearguedthatgenetransferviarDNAtechniquesresemblestheprocessofviralinfectionfarmorecloselythanitresemblestraditionalbreeding.” 59

However,despitethefactthatbothbioengineeringandhackingdegradetheintegrityoftheinvadedsystemandcancompromiseitssafefunction,bioengineeringisultimatelylesspredictable.Althoughhackersaimtoimpairthesysteminsomeway,theycangenerallyimposetheimpairmentspreciselyandcanusuallyengendertheresultsthatareintendedwithoutproducingthosethatarenot.60Incontrast,bioengineerscanneithercontrolhowtheirinsertionsinteractwiththesystemnorregularlyinduceeventheintendedoutcomes;andtheyhavevirtuallynocapacitytorestrict,orpredict,theunintendedones.

Thus,althoughproponentsofbioengineeringportraythealterationsiteffectsaspreciselyperformed,scientificallyinformedenhancementsofgeneticprograms,inreality,they’retantamounttothehackingofasoftwaresystem–andinanabnormallyhaphazardfashion.

AdditionalFactorsthatAreNotMerelyAstounding,butInsurmountablyConfoundingSoit’sclearthatsoftwareengineersoperatefarmoresafelythandobioengineers;anditshouldalsobeobviousthatevenifthelatterearnestlyendeavoredtoactmoreresponsiblyandtomatchtheperformanceoftheprogrammers,theycouldnotcomeclosetosucceeding.

GrapplingWiththeUltimateSpaghettiCode

Moreover,theywouldstillfallsubstantiallyshorteveniftheyhaddesignedthebioinformationsystemsandpossessedexplicitlywrittencopiesofthesourcecode.That’sbecausethesystemsaresointricatelyintertwinedthat,fromtheperspectiveofsoftwareengineering,theyresembleextremeinstancesofwildlytangledspaghetticode.Forinstance,onaNationalPublicRadioprogramdiscussingthesimilaritiesofDNAandsoftware,acomputerscientistattheUniversityofCaliforniareferredtoDNAas“theworstkindofspaghetticodeyoucouldimagine.”Andhestatedthathewouldhavegivenanystudentwritingsuchunrulycodeabadgrade.Tohelpthelistenersunderstandwhy,theprogram’smoderatorexplainedthatwithsuchacode,“eventhepersonwhowroteitcan’tunderstandit.” 61

Accordingly,biotechnicianswhohadbysomemiracledesignedanorganism’sinformationsystemcouldnotlateralteritinmannerremotelyapproximatingthecompetenceandprudencedisplayedbysoftwareengineerswhenrevisinglife-criticalprograms–andtheriskofinducingaccidental,andpotentiallyharmfuldisruptionswouldbeunacceptablyhigh.Therefore,thefactthat,inreality,theyhaveonlyscantunderstandingofthesystemtostartwithrenderstheirmanipulationsimmeasurablymore

reckless.Thisunsettlingtruthismoresolidlydrivenhomebytakingadeeperlookathowdeepisthedeficiency

oftheirknowledge,andhowdauntingarethedifferencesbetweenalteringDNAandrevisingacomputerprogram.

DisruptingaFinely-TunedRegulatoryNetwork

Aswe’veseen,genesdonotregulatethemselves;andtheattachedpromotersthatcontroltheircapacitytoexpressaremodulatedbyproteinsproducedbyothergenes,whicharelikewiseregulatedbyothergenes,whichareinturncontrolledbyothers–withtheultimateresultthatregulationoccursthroughthecellularsystemasawhole.Therefore,whenadiscretegeneisinsertedintoanorganismofadifferentspecies,itarrivesstrippedofthecomplexsetoffeaturesthatregulatehowitexpresses.Accordingly,asChapter4explained,suchtransferredgenesgenerallywon’texpressintheirnewsurroundingsbecausetheirpromotersdon’treceivethespecificinputthatenablesexpressiontobegin–whichhasforcedbioengineerstoremovethosepromotersandreplacethemwithonesfromvirusesthatwillcontinuallydrivethegene’sexpressionwithouttheneedforexternalinput.Infact,evenwhentheorganismisgivenextracopiesofitsowngenes,thenativepromotersareoftenreplacedbyalways-onpromotersbecausetheinnateonescan’tinduceahighenoughlevelofexpressiontosatisfythebiotechnicians’aims.Asaresult,notonlydothegenesendowedwiththesehigh-poweredpromotersfunctiondifferentlythanwhenpossessedoftheirown,theyoperateoutsidethecell’sregulatorysystem,which,asChapters4and9havediscussed,candisruptthingsindiverseways.

Forinstance,theincessantanduncontrolledproductionofproteins(whetheralienornative)createspotentialfortwotypesofproblemsagainstwhichsoftwareengineersmustbeconstantlyonguard.Intheprogrammingcontext,theseproblemsarecalledraceconditionsandbufferoverflow.Aspreviouslynoted,theformeroccurwhendistinctoperationscompeteforsystemresourcesinadestabilizingmanner;andthey’vebeenattherootofmanymalfunctionsandsomeoftheworstdisasters(includingatleastoneoftheTherac-25catastrophesandtheworld’ssecondbiggestpowerblackout).62

IntheGMOcontext,suchdestabilizingcompetitioncanariseasahyper-expressedforeignproteindrawssoheavilyonthecells’chemicalresourcesthatsomeoftheirownproteinscan’tbesynthesizedasnecessary.Thus,whenasunflowergenewasinsertedinrice,theover-expressionofitssulfur-richproteinsodepletedtheplants’sulfurreservesthatproductionofnativesulfur-containingproteinsslackened.63Consequently,althoughthebioengineershadintendedtoboosttherice’ssulfurcontent,therewasnonetgain–andapparentlynoadvanceappreciationonthepartofthetechniciansthathyper-consumptionofsulfurbyoneprocesswouldproportionatelyimpedeothersthatalsorequiredit.Moreover,thereseemstohavebeenlittleappreciationwithinthebiotechcommunitythatit’sriskytoplacesuchextremedemandsononeormoreresourcesbecauseitcancreateimbalancesthatturntheplanttoxicinnonobviousways.

Intheotherriskyscenario,thedisruptiondoesn’tstemfromdesynchronouscompetitionforthesystem’sresourcesbutfromtheoverwhelmingofitsbufferingmechanisms.Withinasoftwareprogram,abuffermaintainsbalancebetweentheinfluxofdataandtheprocessingofthedata,adjustingthewayit’sreceivedandarrangedsothecapacityoftheprocessorcomponentswon’tbeovertaxed.Butifanoverrunoccurs,andthosecomponentscannotkeepup,thesystemcouldcrashorotherwisemalfunction.

WithinaGMO,asimilarsituationcanoccurthroughacell’sinabilitytoaccommodatetheeffectsofforeigngenes,eveniftheyaren’thyper-expressed.PhilipRegalhaspointedoutthat“...theoryandevidencehavesuggestedthatthehost’sbufferingorcontrolsystemswilloftenbeineffectiveforthosetransgenesthatcanexpresswell.”Heexplainsthatbecausetheforeigngenescouldinduce“unusualconditions”thatcannotbemodulatedbythebufferingmechanisms,“...newfactorsmaybeaddedtothehost’sbiochemicalmilieuandcausequantitativeorqualitativechangesintheoutputofexisting

biochemicalpathways.” 64Additionally,evenanativesubstancecanoverburdencellularcontrolsifit’sexcessivelyexpressed.

AswesawinChapter3inthecaseofL-tryptophan,thehyper-productionofoneoftheaminoacidstheorganismordinarilymakespushedthebufferingmechanismsbeyondtheirlimitsandledtotheformationofatleastoneunusualtoxin.

However,althoughbothsoftwareengineersandbioengineersfacesignificantriskofraceconditionsandbufferoverloads,therisksarenotevenlyapportioned.Softwareengineerscancontroltheircreations,andtheyassiduouslystrivetodesignprogramsthatminimizetherisks.Ontheotherhand,bioengineershavelittlecontroloverthewaytheirinsertionsimpactlivingsystems,andthealterationstheyeffectinevitablyinduceconditionsthatsignificantlyfosterbothtypesofproblem.Consequently,therisksinherentintheiroperationsareofmuchgreatermagnitudethanthoseordinarilyassociatedwithcomputerprogramming.

MultipleCodes,MultipliedRisks

Whensoftwareengineersdevelopsourcecode,eachlinehasonlyonemeaning.Accordingly,whenthatparticularlineisconvertedintoasegmentofbinarymachinecode(the0’sand1’s),ittoohasbutonemeaning.Therefore,eventhoughtheprogrammerscannotalwayspreciselypredicthowvarioussectionsofcodewillinteractastheprogramperformsdiverseoperations,theycanbeconfidentthatwhatthemachinecodespecificallycodesforwillremainconstant–andthatitdoesnotcontainadditional,unknownmeaningsembeddedwithinitthatmightbeaccidentallyactivatedinsurprisingways.

Butthingsaremuchmorecomplicatedintherealmofcellularsoftware;and,incontrasttotheinformationsequencesinhuman-madesystems,thoseincellularonescanhavemorethanasinglesignification.Thus,adiscretesectionofDNAcanbereadbythetranscribingenzymesinalternateways,withsomeofitsnucleotidesinvolvedinthegenerationofoneparticularsequenceofRNAatsometimesandanothersequenceatothers–resultingintheproductionofdifferentproteins.65

Moreover,evenostensiblynon-codingsegmentsofDNAcancontainprotein-codingsequences;andsuchasequencecanescapetherecognitionofregulatorsformanyyears–evenifit’spresentinmostoftheGEfoodsonthemarketandposesasubstantialrisk(aswe’veseeninChapter6,inthecaseoftheviralgenesegmentembeddedwithinthepromoterfromthecauliflowermosaicvirus).

Obviously,thefactthatDNAcontainsoverlappingcodingsequencessubstantiallydiminishesthepredictabilityofbioengineering;andthisisthecaseevenwhenonlyasinglecodeisinvolved.Butothercodesexistaswell,whichshrinksthepredictabilityfarmoredrastically–especiallysincenoneofthemwasevendiscovereduntilmorethanadecadeafterthefirstGEfoodswerecreated,andnoneisstillnomorethansketchilyunderstood.

Althoughforseveraldecadesbiologistswerefocusedonthethree-lettercodethroughwhichaminoacidsarespecifiedandproteinsareultimatelyassembled–andactedasifthegenomeharborednoothers–asDNAwasstudiedmorethoroughly,itbecameincreasinglyclearthattheirvisionwastooconstricted.ThroughthewritingsofthinkerslikeRichardStrohman,therealizationgrewthatahugeportionofcellularactivitycouldnotbeorganizedthroughtheaminoacidcodealone–asdidtherecognitionthatthebasicfeaturesofthiscodeenableotherstobeembeddedwithinit.Butsubstantialtimewasrequiredbeforeanywerediscovered.

Amajorbreakthroughoccurredin2006,whenagroupofscientistsreportedtheyhaddetectedacode“superimposed”ontheaminoacidcodethattosomedegreeregulateshowtheinformationinthatbasiccodeisexpressed.66ThisnewcodeappearstospecifyhowthetinyspoolsofproteinaroundwhichDNAislooped(thenucleosomes)areplaced–whichinturninfluenceshowgenesbecomeaccessibletothegeneexpressionmachinery.

Soonafterthisnucleosomecodewasuncovered,severalotherscametolight;andbytheendof2013,atleastsevenadditional“regulatorycodes”hadbeendiscerned–anddiscussedinapaperpublishedinScienceinDecemberofthatyeartitled,“TheHiddenCodesthatShapeProteinEvolution.” 67Further,thepaperreportingthemostrecentdiscoveryappearedinthatsameissueofScience.68Itelucidatedhowthesitesthatbindtranscriptionfactors,whichstimulategeneexpression,arespecifiedwithinthehumangenome.Theauthors’researchrevealedthatapproximately15%ofthecodonsinhumanDNAare“dual-usecodons”that“simultaneouslyspecify”bothaminoacidsandtranscriptionfactorrecognitionsites.Andtheydubbedthesedoubledutycodons“duons.”

Inannouncingthisdiscovery,theUniversityofWashington(withwhichseveraloftheresearcherswereaffiliated)emphasizedhowitoverturnedacceptedwisdom:“Sincethegeneticcodewasdecipheredinthe1960s,scientistshaveassumedthatitwasusedexclusivelytowriteinformationaboutproteins.UWscientistswerestunnedtodiscoverthatgenomesusethegeneticcodetowritetwoseparatelanguages.Onedescribeshowproteinsaremade,andtheotherinstructsthecellonhowgenesarecontrolled.Onelanguageiswrittenontopoftheother,whichiswhythesecondlanguageremainedhiddenforsolong.” 69

Ofcourse,therevolutionarynatureofthisdiscoverywasoverstated,sincepreviousresearchhadalreadyshownthatregulatorycodesareembeddedwithintheaminoacidcode–whichprovidesinsightintohowlongitcantakeforboundarybreakingknowledgetotransformthethinkingofthelifesciencecommunity.70AnditsrelevancefortheGEfoodventureapparentlyhasyettosinkin,despite(orperhapsbecauseof)thefactthat,initself,itinvalidatesthebasicparadigmonwhichtheventurehasbeenbased.AsthemoleculargeneticistRicardaSteinbrecherhasnoted,thefactthatregulatorysequencesdonotfallexclusivelyoutsidetheaminoacidcodingsequences,ashadpreviouslybeenbelieved,butinsteadarealsowovenwithinthem“meansthatanychangesintroducedthroughgeneticengineeringcanpotentiallyresultinanalteredregulationofanygenesaffected–andpossiblytoamuchhigherdegreethanpreviouslyacknowledged.”Andshepointedoutthatanygenecouldbeaffectedbecause“thetransformationproceduresthemselvesgiverisetoamultitudeofmutations...thatcanoccuranywhereinthegenomeoftheplant,notjustwhereanewsequenceisinsertedorwithinthegenethatisbeinginserted.” 71

SoalthoughthebioengineeringventureisbasedonthepremisethatadiscretesequenceofDNAhasbutonemeaning–andthatthemeaningisconservedwhenthesequenceisrandomlytransplantedwithintheDNAofanotherspecies–inreality,themeaningcanberadicallyrevisedthroughsuchanoperation.Thatsequencemayhavehadmultiplemeaningswithinitsnativecontext,andthosemeaningscanbeskewedwithinaforeigncontextbecausetheytoalargeextentdependonhowtheinformationinsidethesequenceinteractswithinformationarrayedoutsideitsconfines.Moreover,theinsertedsequencecandisruptinformationnetworkswithinthetargetorganismandjumblethemeaningsofseveralofitsnativeDNAsequencesaswell.

Further,becauseseveralregulatorycodescouldcohabitasinglesegmentofDNA,andbecausethatsegmentcouldalsoharboroverlappingaminoacidcodingsequences,somecodonsmayplaymorethantworoles–andmightservenotmerelyasduonsbutastrions,quintons,orsomethingevenmoremultifaceted.Thiscouldleadtogreaterdisruptioniftheywereforcedintoanovelsetofinterconnections(eitherbybeinginsertedwithinanewsetorbythealterationoftheirnativesetthroughtheinsertionofanovelsequencewithinit).

What’smore,evenifbioengineerspossessedcompleteknowledgeofhowtheregulatorycodesarestructuredandwherealltheoverlappingaminoacidcodingsequencesarelocated,theircomprehensionwouldstillbepunycomparedtothatofprogrammersbecauseitwouldonlyembracethesystem’smachinecode–andfailtoencompassitssourcecode:theprinciplesandrulesthroughwhichitsvarioussub-codesandmyriadothercomponentsoperateasaharmoniousandfinelytunedwhole.

ACompellingConclusion:GeneticEngineeringisIncurably,andUnacceptably,RiskyThus,whenthepracticereferredtoasbioengineeringisconsideredasatechniquetoaltercomplexinformationsystems–andcarefullycomparedwithsoftwareengineering–notonlyisitshowntobeinherentlyhigh-risk,buttobeincapableofconformingtoeventheminimalstandardsofriskmanagement.Andsostarkareitsdeficiencies,andsoextremeitsinnateunpredictability,itdoesn’tdeservetobeclassedasaformofengineering–andinsteadofbeingtermed“bioengineering”shouldactuallybecalled“biohacking.”

Further,theignoranceofitspractitionersregardingthesystemstheyrestructureisnotonlyvastbutinevitable,afactunderscoredbytheassertionoftheexecutivevicepresidentofapioneeringbiotechnologycorporationthatbecausethegenomeisso“enormouslycomplex...theonlythingwecansayaboutitwithcertaintyishowmuchmorewehavelefttolearn.” 72Andtherealityofjust“howmuch”continuestobedrivenhomebyastringofstartlingdiscoveriesthatwecanreasonablyassumewillbeanongoingphenomenon.

Forinstance,inMarch2014,IndianaUniversityannouncedthatateamofitsscientistshadparticipatedinresearchthatexaminedtheoperationsofthefruitflygenome“ingreaterdetailthaneverbeforepossible”andidentified“thousandsofnewgenes,transcriptsandproteins.”Accordingtothisreport,theresultsrevealthatthefly’sgenome“isfarmorecomplexthanpreviouslysuspectedandsuggeststhatthesamewillbetrueofthegenomesofotherhigherorganisms.”Further,ofthe1,468newlydiscoveredgenes,536werefoundwithinzonesthatwerepreviouslyregardedtobegene-free.Moreover,whenthefliesweresubjectedtovariousstresses,changeswereinducedintheexpressionlevelsofthousandsofgenes;andfour“wereexpressedaltogetherdifferently.”Thisisespeciallyrelevantforbioengineering,since,aswe’veseen,thatprocessimposesmultiplestressesonthecellsittransfigures.

Theseastoundingresultsareevenmoredramaticinviewofthefactthatthefruitflygenomeisoneofthemostthoroughlystudiedandcomprehensivelyunderstoodofallgenomes,andyetsomuchbasicinformationaboutitwasstillunknownpriortoMarchof2014–andsomuchmorestillliesbeyondthecurrentscopeofhumanknowledge.Further,becausebiotechniciansknowsomuchlessaboutthegenomestheyalterthandidbiologistsaboutthefruitflygenomeevenpriortotherevelationsof2014,itaccentuatesthemeagernessoftheirknowledge,andthehigh-risknatureoftheirgenomicincursions.

SoftwareEngineersAreShockedbythePracticesofGeneticEngineersSodeepisthedissonancebetweenbioengineeringandsoftwareengineeringthatwhenthosewhopracticethelatterlearnwhatthosewhopursuetheformerareactuallydoing,they’reusuallyaghast.WhenIstartedtoinvestigatethetechnology,Iwantedtodiscoverhowitstackedupagainstsoftwareengineering,soIbeganquestioningcomputerprofessionals.Overtheensuingyears,I’vetalkedwithmany;andoncethey’reapprisedofthebasicfacts,theyinvariablyreactwithastonishment–usuallyaccompaniedbyasubstantialdoseofindignation.Oneastoundedprogrammerexclaimed,“That’sliketakingasnippetofcodefromtheprograminatoasterovenandsplicingitintoanairplaneguidancesystem–andyetassumingthatnothingwillbedisturbed.”

OneofthemostpowerfulandperceptivecommentsonthedefectsofbioengineeringwhenassessedintermsofinformationtechnologywaswrittenbytheAustraliansoftwareengineerandinformationsecurityexpertStephenWilsoninJanuary2011.73

Hebeganbystating:“Asasoftwareengineer,yearsagoIdevelopedadeepuneaseaboutgeneticengineeringandgeneticallymodifiedorganisms(GMOs).ThesoftwareexperiencesuggeststomethatGMproductscannotbeverifiablegiventhestateofourknowledgeabouthowgeneswork.”Hecontinued:“Genesareveryfrequentlycomparedwithcomputersoftware.Iurgethatthecomparisonbeexaminedmoreclosely,sothatlessonscanbedrawnfromthelongstanding‘SoftwareCrisis’.”

Hethenobserved:

Itisclearthateachgenomeisanimmenselyintricateensembleofinterconnectedbiochemicalshortstories.Weknowthatgenesinteractwitheachother,turningeachotheronandoff,andmoresubtlyinfluencinghoweachisexpressed.Insoftwareparlance,geneticcodesareexecutedinamassivelyparallelmanner.

Ifgenomesarelikeprogramsthenlet’sremembertheyhavebeenwrittenachinglyslowlyovereons,tosuitthecircumstancesofaspecies.Genomesarerevisedinarealworldlaboratoryoverbillionsofiterationsandtestcases,toalevelofconfidencethatsoftwareengineerscan’tevendreamof....Tinkeringwithisolatedpartsofthismachinery,asifitweremerelysomesortofwikiwitharticlesopentoanyonetoedit,couldhaveconsequencesweareutterlyunabletopredict.

Hethenleveledhismostpotentcritique–theforceofwhichisamplifiedbythefactthathemayhavebeenmisledintobelievingthatbioengineeredfoodshavebeensubjectedtorigoroussafetytesting(ashavesomanyotheralertandintelligentindividuals).HenonethelessdemonstratedtheutterunsoundnessoftheGEfoodventurebypointingoutthatinthecaseofcomplexlife-criticalsoftware,eventhemostrigorouslyconductedsafetytestingisnotsufficient.Ashestatedit:

Insoftwareengineering,itisreceivedwisdomthatmostbugsresultfromimprudentchangesmadetoexistingprograms.Furthermore,editingonepartofaprogramcanhaveunpredictableandunboundedimpactsonanyotherpartofthecode....Somissioncriticalsoftware(liketheimplantabledefibrillatorcodeIusedtoworkon)isalwaysverifiedbyacombinationofmethods,includingunittesting,systemtesting,designreviewandpainstakingcodeinspection.Becausemostproblemscomefromhumanerror,softwareexcellencedemandsformaldesignanddevelopmentprocesses,andhighlevelprogramminglanguages,toprecludesubtleerrorsthatnoamountoftestingcouldeverhopetofind.

Howmanyofthesesoftwarequalitymechanismsareavailabletogeneticengineers?Codeinspectionismootwhenwedon’tevenknowhowgenesnormallyinteractwithoneanother;howcanwepossiblytellbyinspectionifanartificialgenewillinterferewiththe‘legacy’code?

Andthosecommentswerewrittenbeforeextensiveresearchhadrevealed,totheshockofmanybiologists,thatmuch,ifnotmost,oftheimmenseregionswithinDNApreviouslyregardedas“junk”areactuallyfunctionalpartsofthegenome.Afterthatrevelation,heremarkedthatit“reinforces”histhesisabouttheultimateuntestabilityoftheproductsofbioengineeringandincreasesthegenome’s“combinatorialcomplexityenormously.” 74Hethenadded,“Ifgenesareswitchedonandoffbybitsofcodespreadacrossthegenome,thenIdon’tknowhowgeneticengineersareabletopredicttheeffectsofgenesplicing.” 75

Moreover,theGEventureisevenmoredevastatinglydiscreditedbyrealizingthatevenifbiotechniciansdidpossessthecomprehensiveunderstandingofcellularinformationsystemsthattheysosorelylack,theextraordinaryinterconnectednessofthecomponents,whichrendersDNAthemostmindbogglingspaghetticodeonearth,wouldstillpreventthemfromoperatingwithanadequatedegreeofprecisionorprecaution.

TheinformationtechnologyspecialistRobertoVerzolahasexpressedthisideaquiteforcefully:

Letusconsidergenesasiftheyaresubroutinesofacomplexpieceofsoftware.Aplantlikecornwouldthenhavetensofthousandsofthesesubroutines,combinedinaveryunstructuredprograminwhicheachsubroutineinteractswithhundreds,perhapsthousands,ofothersubroutinesina

kindofverytightly-couplednon-modularspaghetticodethatIT[informationtechnology]expertswouldconsiderimpossibletomodifyandtomaintain....

Inareal-worldcomputerprogramwithfulldocumentationandunderstandingoftheinstructionsetandthefunctionsofeverysubroutine,makingevenminorchangesinatightlycoupledprogramwillinallprobabilityintroduceside-effects(”bugs”)whichcanmanifestimmediatelyoronlyundercertainconditions,andwhichcanleadtoamajorsystemcrashortosubtlechangesinthebehavioroftheprogram....

Andthatisforaprogramthatiscompletelyunderstood.Howmuchmoreforatightlycoupledgeneticsystemwhichconsistsofthousandsofsubroutinesandtheirinteractionswhicharenotevenunderstood?

GeneticEngineeringisByFartheMostHigh-RiskFormofFoodDevelopmentChapter9demonstratedthat,whenrisksarerationallyassessed,bioengineeringtopsallothermethodsforproducingnewvarietiesofplantsinthepotentialforcausingharm.AndChapter10showedthatsubstantialtest-basedevidencelendssupporttothisassessment.Nowthischapterhasshownthatthehigh-risknatureofbioengineeringislikewiseconfirmedfromthestandpointofcomputerscience–andtoadecisivedegree.

Toappreciatehowdecisively,it’sinstructivetogaugehowgreatlybioengineeringdiffersfromradiationbreedingwhenbothareexaminedfromtheperspectiveofsoftwareengineering.AswesawinChapter9,apanelestablishedbytheNationalAcademyofSciencesarguedthatmodificationviaradiationisevenmorepronetocauseunintendeddisruptionsthanisbioengineering.Butwealsosawthat,whenthepanels’variouscontentionsarelogicallyarranged,theyactuallyentailthatthelatteristhemostdisruptive.Andwhenweanalyzethetwoprocessesinlightofcomputerscience,bioengineering’sstatusasthemostrisk-ladentechniqueisclearlyconfirmed.ThisanalysisappearsinAppendixD.

TheIronyoftheDNA/SoftwareAnalogy:AlthoughGEAdvocatesUseIttoStrengthenTheirCase,It’sActuallytheStrongestArgumentAgainstItAspreviouschaptershaveshown,thehistoryofgeneticengineeringispepperedwithironies;andnowwe’repositionedtosavoroneofthebiggest.Whereasproponentsofthispracticelikenittosoftwareengineeringsoitwillseemmoremanageableandacceptable,asystematiccomparisonrevealsthatit’sradicallyreckless.Andsoftwareprofessionalswho’veexaminedthecontrastsurgethatbiologistsandregulatorsdosoaswellinordertolearntheimportantlessonsthatsoftwareengineeringcanteach.

But,unfortunately,therehasbeenlittleprogressinthisdirection.Instead,thecomparisonsremainsurprisinglysuperficial.ConsiderthecaseofRichardDawkins,oneofthemostprominentandprolificlifescientistsofrecenttimes.Ina2003articleinTheLondonTimeslambastingthosewhoprotestgeneticengineering,hedeclaredthat“geneticshasbecomeabranchofinformationtechnology.” 76Inexpandingonthistheme,hestated:

Thegeneticcodeistrulydigital,inexactlythesamesenseascomputercodes.Thisisnotsomevagueanalogy,itistheliteraltruth.Moreover,unlikecomputercodes,thegeneticcodeisuniversal....Theconsequencesareamazing.Itmeansthatasoftwaresubroutine(that’sexactlywhatageneis)canbecarriedoverintoanotherspecies....Inthesameway,aNASAprogrammerwhowantsaneatsquare-rootroutineforhisrocketguidancesystemmightimportonefromafinancialspreadsheet.Asquarerootisasquarerootisasquareroot.Aprogramtocomputeitwillserveaswellinaspacerocketasinafinancialprojection.

However,aswe’veseen,inrealitythingsarenotsosimple;andeventransferringasegmentofcode

fromonerocketintotheprogramofanewerversionofthesamerocketcausedadisastrousmalfunction.AndalthoughDawkins’discussiondoeseventuallyrecognizethatthenewcontextinwhichasubroutineisplacedcanmakeadifference,hedoesn’tgodeeplyenough.Thus,whileheacknowledgesthatatransferredgene“mightnotworkunlessproperlytweaked...tomesh”withthegenesofthetargetorganism,heindicatesthatsuchtweakingcanbedone–butfailstonotethatenablingthenewgenetosufficientlymeshsothatitsproteinwillbeexpressedisnotthesameasharmonizingitseffectswiththerestofthesystem.And,aswe’veseen,creatingalimitedmeshcancauseamess.

Nonetheless,Dawkinsultimatelyagreesthatit’sjustifiedtomake“arationalpleaforrigoroussafetytesting.”Andhestatesthat“noreputablescientistwouldopposesuchaplea”–apparentlyunawarethatthisassertioneffectivelyimpugnstheintegrityofmanyhigh-placedmembersofthescientificestablishment.Moreover,heseemsoblivioustothefactthatinorderforthetestingofGEfoodstocomeanywhereclosetothelevelofrigorwithwhichlife-criticalsoftwareisscrutinized,thecurrentsystemwouldhavetoundergoamassiverevampingthatwouldbestronglyresistedbymostoftheostensiblyreputablescientistswhosupporttheproducts–andthatcouldnotbefinanciallybornebytheirmanufacturers.

AndtheironyisenhancedbecausenotonlydidDawkinspropoundananalogythatactuallyundercutshisclaims,atthetimehepropoundedit,hewasProfessorforthePublicUnderstandingofScienceatOxfordUniversity,aspecialpositionendowedbyasoftwaredeveloperwhohadmadeafortuneduringtheyearsheledakeygroupatMicrosoft.77Thus,abiologistrepresentingoneoftheworld’stopuniversitiesintheendeavortofosterpublicunderstandingofsciencewasinadvertentlymisleadingthepublicabouttherelationbetweencomputerscienceandgeneticengineering–anddoingitfromaplatformcreatedbyfundsderivedfromcomputerscience.

TheUltra-IronyoftheDNA/SoftwareAnalogy:EventheWorld’sMostFamousSoftwareDeveloperHasNotYetGraspedItsImplicationsButtheironiesdon’tstopthere.NotonlyhasmoneyearnedbyaMicrosoftexecutivefundedascientistwho’screatedconfusionabouthowsoftwareengineeringbearsonbioengineering,themanwhoco-foundedthecompany,servedasitschiefsoftwarearchitect,andfordecadeswasitsCEOhashimselffailedtoappreciatehowthelessonsofsoftwareengineeringdiscredittheGEfoodventure–andhasdevotedasubstantialpartofhisvastsoftware-generatedfortunetowardfosteringitsgrowth.

Ofcourse,BillGatesishighlyastute,andhe’swellawarethattheinformationsystemsoflivingcellsdifferfromhuman-madesoftwareinimportantways.Andinhisbook,TheRoadAhead,whenhelikensDNAtoacomputerprogram,heacknowledgesthatit’s“far,farmoreadvancedthananysoftwarewehaveevercreated.” 78Butontheroadhe’sactuallytraveling,thisrealityhasapparentlyslippedfromsight.Insteadofloomingalongthewayasaregularlypostedcaution,itseemstohaverecededbeyondtherangeofevenperipheralvision.Consequently,hehaspressedaheadtoexpandtheGEfoodventure,promotingtheradicalalterationofearth’smostintricatesoftwareabsenteventhekindofqualitycontrolsemployedindevelopingMicrosoft’swordprocessingprogram,letalonethestrictsafeguardsmandatedforlife-criticalsystems.

Accordingly,althoughhe’smotivatedbyaltruisticpurposes,hiseffortsarenonethelessmisguided.Afterall,doesitultimatelybenefitanyAfricannationtodevelopnewvarietiesofcropsthat,althoughtheymaybesalt-orheat-tolerant,mightalsobeintolerablydiseasedealing?Fromtheperspectiveofsoftwareengineering,thislatterriskcannotbediscountedandshouldbetakenintoseriousaccount,especiallysincetheadverseeffectsmightnotmanifestformanyyears.Infact,aswe’veseen,fromsuchaperspective,oneshouldnotevenattempttoapplyrecombinantDNAtechnologyincropproductionunlessthereareabsolutelynootherreasonablealternatives,which,asChapter14willdiscuss,isdefinitelynotthecase.

It’sadditionallyironicthat,likeDawkins,Gatesholdsviewsabouttestingthataren’tattunedwiththerealitiesofsoftwaredevelopment.Thus,althoughhesaysthatrigoroustestingshouldbeconductedonGEfoods,heappearstothinkeitherthatit’sregularlybeingdoneorthatitreadilycanbe–unmindfuloftheimmensereformationthatwouldberequiredtoachieveevenpartialparitybetweenthesafetytestingoftheseproductsandthetestingroutinelyappliedtolife-criticalsoftware.79

Sometimes,whenIreadanotherreportabouttheGatesFoundation’sgrantingofmanymillionstoaprojectthataimstoimprovenutritioninAfricabyinsertinggenesintooneoranotherspeciesofplant,Iwonderifhewouldhavestillviewedthegrantapplicationfavorablyhaditexplicitlyframedthingswithinasoftwarerevisioncontext.Wouldhehavemaintainedhisconfidenceinthesoundnessoftheprojectiftheapplicationhadstatedthatthemoneywouldbeemployedtohackintotheplant’sintricateinformationsystem;haphazardlyinsertachunkofcodecobbledtogetherwithpiecesofDNAfromanunrelatedplant,afewbacteria,andavirus;andthenreleasetheresultantcropintothefoodsupplyofnumerousnationsonthebasisofsomesimpletestingthatdoesn’tcomeclosetomeetingMicrosoft’sstandardsforanewversionofWindowsletalonetheminimalrequirementsforcertifyingthesafetyoflife-criticalsoftware?

So,fromthestandpointofcomputerscience,theGEfoodventureisirreparablyrisky,toanintolerabledegree,becausethere’svirtuallynowaytoaltertheprogramsoflivingorganismswithsufficientforesighttoavoidharmfulunintendedeffects–andscantpracticalpossibilityofsuccessfullyscreeningforthem.Further,fromsuchaperspective,evenifeverytestsofarperformedonGEfoodshadfailedtoobserveanyadverseoutcomes,theirsafetywouldstillnothavebeendemonstratedbecausetheteststhathavebeenemployedaredeplorablyincapableofdoingso.

Accordingly,onewellmaywonderhow,despitetheircrucialimportance,thelessonsofcomputersciencecouldhavebeensoconsistentlyignoredbythosewhopromotetheGEfoodventure–evenbyonewhoformanyyearsledtheworld’slargestsoftwaredevelopmentcompany.

Aswe’llsee,thisongoingoversightcorrelateswiththelife-sciencecommunity’schronicembraceofafewfundamentalassumptionsaboutthenatureoflivingorganismsthatwereneversubstantiatedandhaveforyearsbeenthoroughlydiscredited.Andit’sthroughsuchessentiallyfaith-basedbiasthathighlyintelligentmenandwomenhavebeenblindedtothemanifestrisksoftamperingwiththesoftwareoflife–andbeguiledintobelievingthattheseexquisitelyintegratedsystemscanberadicallyalteredwithfarlesscautionthanisemployedwhenmakingevenminorrefinementstoahuman-madecomputerprogram.

CHAPTERTWELVE

UNFOUNDEDFOUNDATIONALASSUMPTIONS

TheFlawedBeliefsthatUndergirdAgriculturalBioengineering

ThefirsttenchaptersdevelopedacomprehensiveandthoroughlydocumentedcasedemonstratingtheunsoundnessoftheGEfoodventure.Theyclearedupmanymisconceptionsandestablishedmanyimportantpoints,includingthefollowingfive:

ThecommercializationofgeneticallyengineeredfoodswasenabledbythefraudulentbehavioroftheUSFoodandDrugAdministration(FDA),couldnothavehappenedwithoutit,andcontinuestobereliantonit.

TheFDAusheredthesenovelproductsontothemarketinviolationofexplicitmandatesoffederalfoodsafetylaw,andtheyarestillillegallyonthemarket.

TheFDA’sfalsehoodshavebeenabundantlysupplementedwithfalsehoodsdisseminatedbyeminentscientistsandscientificinstitutions,andtheentireGEfoodventurehasbeenchronicallyandcruciallydependentonthisdisinformation.

ThesafetyofGEfoodshasneverbeenestablishedinascientificallyreliablemanner,andsubstantialresearchhascastdoubtupontheirsafety.

Thesefoodsentailunacceptablerisks.

AndthebookcouldhaveeasilyendedwiththeendofChapter10.ButitcontinuedwithChapter11inordertoshowthatbesidesbeingunsoundfromthestandpointof

biologicalscience,theGEfoodventureisadditionallyunsoundfromthestandpointofcomputerscience–therebyprovidingafullerunderstandingofjusthowriskyandrecklessitreallyis.

Theaimofthischapteristomorefullyprobetheideationalfoundationsofthisenterpriseandtodiscerntheassumptionsthatinitiallyinspiredfaithinitssoundness–andthatcontinuetosustainthefaithdespitethedearthofsolidsupportingevidenceandtheaccumulationofconsiderableevidencetothecontrary.

Aswe’veseenintheprecedingchapter,thebiotechproponents’seeminglyunshakeablefaithintheGEfoodventurehasevendeludedthemintoassumingthatthelargelyuncontrollablealterationsitimposesupongenomesaresomehowequivalenttothepreciserevisionsthatareappliedtocomputersoftware.Further,theyhavefailedtorecognizethateventhesepreciserevisionsentailinevitablerisksofunintendedconsequences–andsothey’veutterlyfailedtoappreciatehowmuchgreateraretherisksofimposingimprecisealterationsoninformationsystemsoflivingorganismsthatarefarmorecomplexandfarlesswell-comprehendedthananyhuman-madeinformationsystem.

Moreover,astheotherchaptersclearlyrevealed,theadvocatesofGEfoodshavenotonlyoverlookedthelessonsofcomputerscience,they’vedisregardedtheaggregateimplicationsofnumerousbiologicalfacts–andevensomeofthefactsthemselves.

Withoutthesecrucialandcontinuingoversights,confidenceinthesafetyoftheGEfoodventurecouldnothavebeenmaintainedevenbyitsownadvocates,anditalmostsurelywouldhavewithered.However,itwasthroughtheinitialoverconfidencethattheseoversightsactuallyoccurred.Thus,theoverconfidencecausedtheoversights,whichinturnsustainedtheoverconfidence.

Thisoverridingoverconfidencewasrootedinafewnotionsthat,althoughtheyprovidedtheiradherentsaseeminglyscientificbasisforbeliefinthesafetyofgeneticengineering,haveneverbeenempiricallyverifiedandhaveincreasinglyclashedwiththegrowingstockofevidence–buthavenonethelessbeentreatedassolidscientificfacts.

Yet,ittooktimeforthisunderminingevidencetoaccumulate,andwhenrecombinantDNAtechnologyemergedintheearly1970’s,knowledgeofthestructureanddynamicsofbio-informationsystemswasstillquitesparse–whichfacilitatedtheformationofsignificantlyoversimplified,andinaccurate,conceptionsaboutthem.Theseerroneousideaswereanessentialaspectofthegeneticengineeringventure,anditwastoalargeextentgroundedonthem.

SomeKeyPresumptionsonWhichtheBioengineeringVentureWasBasedAsChapter9pointedout,thesafetyofgeneticengineeringwaspremisedonthepresumptionthatthegenomeisasimplelinearsysteminwhichtheactionofasinglegenewillnotsignificantlyimpacttheothersandwon’tdisrupttheirnormalfunction.Thiswasemphasizedinthe2001reportoftheRoyalSocietyofCanadaandhasbeenrecognizedbymanyotherexperts.1Forinstance,ina2007NewYorkTimesarticle,theveterantechnologyreporterDeniseCarusoobserved:“Thepresumptionthatgenesoperateindependentlyhasbeeninstitutionalizedsince1976,whenthefirstbiotechcompanywasfounded.Infact,itistheeconomicandregulatoryfoundationonwhichtheentirebiotechnologyindustryisbuilt.” 2

GiorgioBernardi,abiologistattheUniversityofRomeIIIwhospecializesinthestudyofgenomeevolution,haspointedoutthatwithinsuchaconceptualframework,thegenome’scapacityissignificantlylimitedbecauseit“isonlyendowedwithadditiveandnotwithcooperativeproperties.” 3Inotherwords,thegenesareviewedassignificantlyautonomousagentsthataddtothewholewithoutactingholisticallybecausetheydon’texpresstheirproteinsinacloselycoordinatedmanner.

However,thiswasnottheonlyfoundationalpresumption,anditwaslinkedwithsomeothersofthesameilk.Oneofthemostimportantwasthenotionthatgenesaren’tarrangedinanorganizedmannerandthatthesequenceinwhichtheyoccurisessentiallyunimportant.4Fromsuchaviewpoint,agenewouldfunctionjustassatisfactorilyifitwererelocatedtoadifferentchromosomeorcameinfrontofaneighboringgeneinsteadofafterit.Bernardireferstothisperspectiveasa“bean-bagviewofthegenome”becauseitregardsthegenesas“randomlydistributed.” 5

Together,thesetwopresumptionssupportedthebeliefthatachunkofrecombinantDNAcouldbeputintoaplant’sgenomewithoutinducingdisturbance–becauseifthebehaviorofthenativegeneswaslargelyuncoordinatedandtheirarrangementwasirrelevant,therewouldbenoimportantpatternsthatcouldbeperturbedbysuchinsertions.Accordingly,theyengenderedconfidenceintheprecisionofgeneticengineering,becausetheyimpliedthattheoutcomeofageneinsertionwouldbeexactlywhatthebioengineersexpected.Theybolsteredthebeliefthatthetargetorganismwouldcontinuetofunctionjustasbeforeandthatchangewouldbelimitedtothenewtraitendowedbytheinsertedgene–whichwouldtidilymanifestwithoutalteringanyoftheorganism’sotherqualities.

DespiteBeingWrong,thePresumptionsMaintainedTheirForceThesepresumptions,whichprovidedanideologicalfoundationforthebioengineeringventureandundergirdedamassiveendeavortotransformagriculture,turnedouttobewrong.Aswe’veseeninpreviouschapters,abundantevidencehasdiscreditedthenotionthatgenesactindependentlyfromoneanother–andhasinsteaddemonstratedthattheiractionsarehighlycoordinated.Commentingonthis

evidence,GiorgioBernardihaswrittenthatthegenomemustnowbeviewedasan“integratedensemble.” 6Likewise,inherpreviouslymentionedNewYorkTimesarticle,DeniseCarusoemphasizedthefactthat“genesappeartooperateinacomplexnetwork.”Andshenotedtheseriousimplicationsofthisfactforthebioengineeringventure,stating:“Evidenceofanetworkedgenomeshattersthescientificbasisforvirtuallyeveryofficialriskassessmentoftoday’scommercialbiotechproducts,fromgeneticallyengineeredcropstopharmaceuticals.”

Overwhelmingevidencehasalsounderminedthetenetthatgenesarerandomlyarranged;andby2004anarticlepublishedinNatureReviewsGeneticscouldassertthatthistenetwas“nolongertenable.” 7

Moreover,besidesbeingdiscredited,thesepresumptionsshareanotherignoblefeature:theysurviveddiscreditationandoutlivedtheirplausiblelegitimacy.Despitetheaccumulationofunderminingevidence,biotechproponentsstubbornlyclungtothemanyway;andtheyexertedinfluencelongbeyondthepointtheyrightfullyshouldhave.

Forinstance,inhistestimonytoNewZealand’sRoyalCommissionin2001,themoleculargeneticistMichaelAntonioustatedthatagriculturalbioengineeringwas“basedontheunderstandingofgeneticswehad15yearsago,aboutgenesbeingisolatedlittleunitsthatworkindependentlyofeachother.”Andhepointedoutthatduringtheensuingyears,sufficientevidencehadamassedtorefutethatviewanddemonstratethatgenesactually“workasanintegratedwholeoffamilies.” 8

However,thescientistswhopromoteGEfoodsremainedlargelyunfazedbythisevidence,afactdrivenhometoAntoniouwhenin2003hewasselectedtorepresentnongovernmentalorganizationsontheUK’sGMReviewPanel.Althoughhisargumentsforenhancedprecautionwerebasedonextensivestudiesdemonstratingthatgenesarecoordinated,mostofthe11otherscientistsonthepanel,whowerebiotechproponents,dismissedthesestudiesandevenarguedthatitmakesnodifferencehowgenesarearranged.9

TheveryfactthatGEfoodsarestillbeingmarketedanddeveloped,andthattheirproponentscontinuetoclaimtheirsafetyhasbeenscientificallycertified,atteststotheunwarrantedstayingpowerofthepresumptions,becausehadtheybeenfullyrelinquished,confidenceinGEfoodscouldnothavebeensustained.

Thus,theGEfoodventurewasgroundedonthebeliefthat,attheirdeepestlevel,biologicalorganismsdonotdisplaytheorderlyarrangementandcoordinationofpartsthat’scommonlydenotedbytheterm“organic.” 10Althoughitsfoundersandearlyadherentsrecognizedthatontheexpressedleveloforgansandtissues,anorganismdisplaysprofoundinterrelatedness,andthatthenon-chromosomalcomponentsofthecellsalsodisplayit,theybelievedthesituationwasquitedifferentwithinthechromosomes,attheleveloftheDNA.Andtheyregardedthislevelasdistinctlydisjointed.Therefore,theybelievedthatthelayersoforganicwholenesswithinanorganismareunderlainbyadimensionthat’ssignificantlynon-holistic–becausetheyregardedthecomplexinformationsystemonwhichthecoordinationexistingattheotherlevelsdependsasanassemblageofunitsthataresubstantiallyuncoordinated.

Further,eventhoughtheventure’sadvocatesmayhavetakennoteofthecontraryevidencethatsteadilyamassedovertheyears,andeventhoughitmayhavecoloredtheirthinkingaboutspecificaspectsofbiology,totheextenttheycontinuedtosupporttheventureandtoassertitssoundness,theywereendorsinganendeavorthatstillreliedonpresumptionsthatthisevidencehadrefuted–whichwasnotthefirsttimeintelligentpeoplehavecompartmentalizedtheirthinkingtoinsulateconflictingideas.

Andsuchdisregard,denial,oravoidanceinregardtotheevidencewasessentialformaintainingfaithintheventure,becauseitspredictabilityandsafetyhavealwaysreliedonthegenomebeinglargelydisjointed;andthemorethegenomeinsteadappearstofunctionasatightlycoordinatedsystem,themore

potentiallydisruptiveandunpredictablearetheinterventionsofthebioengineers.

TheVenture’sFallbackBelief:NaturalBreedingasaMoreRandomandUnrulyProcessthanBioengineeringTheGEfoodventure’sendurancedespitethediscreditationoftwoofitskeypresumptionsandthesteadyproductionofadverseexperimentalevidencehasbeenenablednotonlybyresorttodisregardanddenial,butbyrelianceonafallbackbelief:abeliefthat’sinsomewaysdeeperandmorebasicthaneitherofthepresumptionswe’vepreviouslyexamined.It’sthebeliefthat,regardlessofspecificdatathatmaybemarshaledbythosewhoexpressconcerns,thebiologicalprocessesunderlyingnaturalreproductionaremorerandomandunpredictablethanthemechanicsofgeneticengineering–andthatthelatterthereforemustbemoretrustworthy.

Althoughmanyoftheventure’sproponentsarelikelytocontestthisstatement,it’ssupportedbytheirownrepeatedassertions.Atypicalinstanceappearsinthe2000reportoftheInstituteofFoodTechnologiststhat’scritiquedinAppendixB.Thatdocumentdeclares:“GiventhemorepreciseandpredictablenatureofgeneticchangeaccomplishedthroughrDNAtechniquesascomparedtotherandomgeneticchangesobservedinconventionalbreeding,suchunintendedeffectswouldbeconsideredlesslikelyinfoodsderivedfromrDNAbiotechnology.” 11SuchallegationsarewidelymadeonbehalfofGEfoodsbytheirscientist-advocates,andtheyserveastheultimaterejoinderwheneveranexpertmountsasubstantialchallengetothetechnology’ssafety.

Astrikingexampleofsucharejoinder,whichatteststhecentralityofthebeliefinnature’sunruliness,wasevokedbyawarningabouttherisksofGEfoodsthatappearedasacommentinNatureBiotechnologyin2002.TheauthorwasDavidSchubert,who,aspreviouslymentioned,isacellbiologistattheSalkInstituteforBiologicalStudies.Henotedtherewasmountingevidencethattheinsertionofevenasinglegeneintoacell’sDNAinvariablyalterstheexpressionpatternofgenesthroughoutthecell;andheexplainedwhyotherdisconcertingfactslikewisecastdoubtonthesoundnessofagriculturalbioengineering–andentailtheconclusionthatit“isnotasafeoption.” 12

Inresponse,18biologistsatrespecteduniversitiesandinstitutespublishedaletterinthatjournalcriticizingSchubertanddefendingthesafetyofGEfoods.Andthewaytheydidsoisquiterevealing.Facedwithaseriouschallengewrittenbyaprofessorandlaboratorydirectoratoneoftheworld’smostprestigiousscientificinstitutes,theirresponseplacedprimaryemphasisonwhattheydescribedasthe“realissue”:Dr.Schubert’sfailuretoproperlyconsider“thegeneticrealities.”Andthemainrealityheallegedlyfailedtorecognizeisthatthenaturalmethodofplantbreedingisinherentlymorerandomthanbioengineering.Astheyputit:“WedonottakeissuewithSchubert’sbasiccontentionthatunintendedgeneticandmetaboliceventscantakeplace.Therealityisthat‘unintentionalconsequences’aremuchmorelikelytooccurinnaturethaninbiotechnologybecausenaturereliesontheunintentionalconsequencesofblindrandomgeneticmutationandrearrangementtoproduceadaptivephenotypicresults,whereasGMtechnologyemploysprecise,specific,andrationallydesignedgeneticmodificationtowardaspecificengineeringgoal.” 13[Emphasisadded]

ThisletterthusrevealshowstronglytheGEfoodventurereliesonthepresumptionthatthenaturalprocessesdrivingbiologicaldevelopmentareintrinsicallymoredisorderlyandrisk-bearingthanthegeneticinterventionsinstigatedbythehumanmind.Anditconfirmsthatthisbeliefformstheideologicalbedrockonwhichtheventurerests.

Butthisbeliefisatoddswiththefacts,arealitysubstantiatedbythefailedattemptofthe2004NASreporttoupholdeventhemoremodestnotionthatbioengineeringandnaturalbreedingposethesamerisks.AsChapter9described,whenthepanelthatproducedthereportrankedthevariousmodesofplantbreedingintermsoftheirpropensitytoproduceunintendedeffects,itwascompelledtoacknowledgethatbioengineeringhasfargreaterpropensitythandoespollen-basedsexualreproduction–andisfarless

predictable.Yet,itnonethelessinsistedthatthisdisparityinperturbationalpotentialdoesnotentailadifferenceinrisks.However,asthechapterdemonstrated,ifthedisruptivepotentialisdifferentbuttherisksarestillthesame,thentheaverageunpredictedeffectofnaturalbreedinghastobemuchmoredangerousthantheaverageunplannedalterationcausedbygeneticengineering–whichisapatentlyridiculousoutcome.

Thus,there’snorationalwaytoreconcilethefactthatnaturalbreedingislessdisruptiveandmorepredictablethanbioengineeringwiththeclaimthatitposesequalorgreaterrisk,whichiswhytheadmissioninthe2004reportisararity–andwhybiotechproponentsalmostalwaysignoreordenythatfactandinsteadassertthatnaturalbreedingismoredisorderlyandunpredictable.

MisrepresentingtheDegreeoftheRandomnessMoreover,notonlydobiotechproponentsroutinelyimputesubstantialrandomnesstothedynamicswithinlivingorganisms,theyoverstatetheamountandmischaracterizetheprocessesthatpurportedlydisplayit.Accordingtotheirversionofreality,naturalplantbreedingisfraughtwithunrulyforcesthatcanwreakhavocwithintheplantsuponwhichunsuspectinghumansfeed;andpeopleshouldfeelrelievedthatthesemenacescannowbeminimizedthroughbioengineering.Previouschaptershaveprovidedseveralspecificexamplesofsuchmisrepresentation,oneofthemorestrikingofwhichisChapter9’sexaminationofhowtheNASreportof2004triedtomakepeoplejumpyaboutthemobileelementsthatarecommonlycalled“jumpinggenes”byportrayingthemasmorerandomlymobile,andmorethreatening,thantheyactuallyare.Anditpointedoutthatinreality,thereportgotitbackwardsbecause,althoughtheseentitiesdonotposeappreciableriskswithinnaturalpollen-basedbreeding,theydowhenbioengineeringisemployedbecausethatprocesstendstostirthemupandgetthemjumping.

Anevenmoreegregiouscaseofoverstatingtherandomnessinnaturalprocessesrelativetogeneticengineering–andstatingthingsbackwardsregardingtherisks–istheroutineattemptofbiotechadvocatestoportraysexualreproductionasadisturbinglyrandomandmessyphenomenon.Forinstance,intheirlettercritiquingSchubert,those18lifescientistsdidnotstopatcallinggeneticmutationa“random”phenomenon,theysaidthesameaboutnatural“geneticrearrangement.” 14Andthemostfrequentandimportantformofsuchrearrangementisanessentialphaseinthereproductiveprocessinplantsandanimalsthatprovidesalargepartofthegeneticdiversityrequiredforaspeciestoremainrobust.Likegeneticengineering,itinvolvestherecombinationofDNA;butunlikethatartificialtechnique,itdoessoinamannerthatdoesn’tdisruptorimbalancetheorganism.

Thisnaturalformofrecombinationoccursduringtheformationofgametes(thespermandeggcells).ItincludesastepcalledcrossoverinwhichtwopartnerchromosomesbreakatcorrespondingpointsandthenexchangecomplementarysectionsofDNA;andeverytimeagameteisproduced,everysetofpairedchromosomesengagesinit.Inthisway,allthechromosomesendupwithgenesfrombothparentsinsteadoffromonlyone.However,allthegenesarepreserved,asisthesequenceinwhichthey’repositioned.Theonlychangesareintherelationshipsbetweenalleles.AswasdiscussedinChapters2and4,allelesarealternativeversionsofagene,andwhenchromosomesrecombine,allelesthatwereformerlyonseparatechromosomescanoccupythesameone,andanarrayofnewassemblagescanarisewhiletheintegrityofthegenomestaysintact.Sothisnaturalrecombinationaugmentsdiversitywhilemaintainingstability.Andwithoutit,exceptfortheoccasionalfavorablemutation,thecompositionofchromosomeswouldstaythesamefromgenerationtogeneration,andgeneticdiversitywouldgrowatfartoosluggishapace.

Moreover,notonlydoesnaturalrecombinationpreservetheorderofthegenes,it’spredictableinhowitcutsDNA.Inpreparationforcrossover,enzymescleavetheDNAatspecificsites;andthesesitesarenotrandomlylocated.Sotheentireprocessdisplaysahighdegreeoforderliness,and,inthewordsofPhilRegal,“isamazinglyorganized.”

Further,thestepsofreproductionthatfollowitarealsohighlyordered.Consequently,whenaspermandeggunitetoformthecellfromwhichaneworganismdevelops,eachcontributesthesamenumberofchromosomes,eachchromosomeismatchedwithasimilarpartner,andthetotalnumberofchromosomesismaintained.

However,althoughsexualreproductionis,fromstarttofinish,anexquisitelywell-coordinatedandcoherentprocess,fromwhattheGEproponentssay,youwouldneverknowit.Instead,youwouldthinkitwasfarfromorderly;andthetwoexamplesalreadycitedarenotintheleastatypical.Forinstance,anarticlepublishedin2012bysixscientistswhoadvocateGEfoodscontraststheallegedlyprecisemodificationsmadethroughbioengineeringwiththe“randomgeneticmodificationsthatoccurinconventionalbreeding.” 15Andthe2004reportbytheNationalAcademyofSciences(NAS)triestomakethecontrastmorevivid.Itasserts:“Geneticengineeringmethodsareconsideredbysometobemoreprecisethanconventionalbreedingmethodsbecauseonlyknownandpreciselycharacterizedgenesaretransferred.Incontrast,conventionalbreedinginvolvestransferringthousandsofunknowngeneswithunknownfunctionalongwiththedesiredgenes.” 16

Butbesidesbeinginaccurate,theargumentsabouttherandomnessandunpredictabilityofnaturalbreedingaredeceptive,becausetheyshiftthefocusawayfromtheissueofwhethertheplantissafetoeatandplaceitonanunrelatedone–whilepretendingthatitisthekeysafety-relatedquestion.Thismisleadingtacticfixatesonthepredictabilityoftheplant’sspecificagronomictraits;anditportraystraditionalbreedingaslesspredictablethanbioengineeringbecauseundesiredattributesareoftentransferredalongwiththeonethatisdesired.However,thosewhoemploythisploydon’tacknowledgethat(asChapter9hasshown)ifbothparentsaresafetoeat,theunwantedtraitshardlyeverposerisktohumanhealth.Rather,they’reundesirableforreasonsirrelevanttorisk(suchasaestheticappearanceorseedsize),andbreedersmustthenperformback-crossingtoeliminatethemwhileretainingthetraittheywant.However,althoughtheinclusionofunwantedtraitsentailsmorework,itdoesnotincreaseattendantrisks.Therefore,whilebreederscan’tfullypredictwhattraitswillappear,theycanconfidentlypredictthattheresultingplantwillbesafetoeat.17

Thus,thepro-GEportrayalofnatureisshamefullymisleading.Althoughitdescribesthesexualreproductionoffood-yieldingplantsasamessyandriskyaffairthatinvolvesthetransferof“thousandsofunknowngeneswithunknownfunction,”weactuallyknowquitealotaboutthosegenes.Andwhatweknowisfarmoreimportantthanwhatwedon’tknow.Weknowthatthey’reallwherethey’resupposedtobe,andthatthey’rearrangedinanorderlyfashion.Andweknowthatduringtheessentialprocessinwhichsomeofthemaretradedbetweenpartneredchromosomesinordertopromotethediversitythatstrengthensthespecies,theirorderlyarrangementismarvelouslymaintained.Mostimportant,weknowthattheirfunctionsmeshtoformanexquisitelyefficientsystemthatgeneratesandsustainsaplantthatregularlyprovidesuswholesomefood.

Thissharplycontrastswithgeneticengineering.Althoughthegenethat’stransferredviathistechnologyisknown,notonlyisitimpossibletopredictallitsunintendedeffects,there’snosoundbasisforassumingthey’llbesafe.Infact,asseveralpreviouschaptershavedemonstrated,there’sgoodreasontopresumetheyposesignificantrisk.

Therefore,whenthetwoprocessesarefairlycompared,it’sbioengineeringthatismorerandomandrisky.Theinsertedcassettesarehaphazardlywedgedintothecell’sDNA,theycreateunpredictabledisruptionsatthesiteofinsertion,theoverallprocessinduceshundredsofmutationsthroughouttheDNAmolecule,theactivityoftheinsertedcassettescancreatemultipleimbalances,andtheresultantplantcannotbedeemedsafewithoutundergoingabatteryofrigorousteststhathasyettobeappliedtoanyengineeredcrop.18

Nonetheless,despiteitsgrossinaccuracy,theGEproponents’depictionofnaturalprocessesas

disorderlyanduntrustworthyhas,throughpersistentrepetitionbyscientistswhoshouldknowbetter,beenadoptedbythemediaandingrainedingeneralawareness.Thus,indiscussingtheconclusionsoftheNAS’s2004report,TheNewYorkTimescontrastedbioengineeringandnaturalbreedinginthesamemisleadingmannerashadthereport.Apparently,neitherthereporternoreditorscriticallyassessedthereport’sversionofrealityorconsideredwhetheremployingitslanguagewouldconveyafalseimpression.Instead,theytoldtheirreadersthat“[g]eneticengineeringinvolvesthetransferofaspecificgenefromoneorganismtoanother”butthat“[c]ross-breeding,bycontrast,involvesthemixingofthousandsofgenes,mostunknown.” 19

ADubiousDistinction:Ag-BiotechistheFirstEssentiallyFaith-BasedTechnologyManyscientistshavepointedoutthatscienceitselfrequiresfaithinsomebasicideas,andeverytechnologyrequiresittoo.Butinthesefields,faithdoesnotfunctiontosubstantiatetheories;andinthecaseoftechnology,itdoesnotserveastheprimarybasisforconfidenceinthesafetyofproductsandprocedures.Instead,safetyisinitiallyassessedviatesting,andthereafterit’scontinuouslygaugedthroughreal-worldperformance.Ifthebuildingsconstructedthroughaparticulartechniquearegenerallystableovertime,thetechniqueisconsideredsafe;andifthereareinsteadasignificantnumberoffailures,it’sdeemedtoorisky.Andinmostfieldsofengineering,althoughsomedefectsmaygoundetectedduringtesting,theywilleventuallymanifestinanobviousmanner.Bridgescollapse,airplanescrash,softwaremalfunctions.So,flawedtechniqueswilleventuallybeexposed.

Butagriculturalbioengineeringisdifferent.Aspreviouschaptershavedemonstrated,notonlyhasthescopeofthetestingneverbeenadequate,20adverseresultshavebeenroutinelyignored.Moreover,aftertheproductshavebeenbroughttomarket,there’sbeennoreliablewaytomonitortheirperformance.Althoughacutetoxicityhasbeenessentiallyruledoutinmostcases(exceptthetoxictryptophansupplementthatcausedanEMSepidemicin1989),duetothelackofpropermonitoring,it’sbeenimpossibletodeterminewhetheranyGEfoodsarecreatinglong-termhealthproblems.And,aswe’veseen,althoughbiotechproponentscommonlyclaimthatthelackofobservedcalamitiesservesasproofofsafety,significantdamagemightbeoccurringthatevenepidemiologicaltestingcouldn’tdetect;andintheutterabsenceofmeaningfulmonitoring,aGEfoodcouldbecausingcanceratagreaterratethancigarettesyetstillappearbenign.

Consequently,becauseGEfoodshavenotbeendemonstratedsafeviatestingnorshowntobesafethroughexperience,theirsafetyissolelyamatterofbelief.Theconvictionthatthey’resafeisnotbasedonreliableclinicalorpracticalevidencebutinsteadisfedbyfaiththatnaturalbreedingprocessesaremoreunpredictableandriskythanproducingfoodsthroughgeneticengineering.Andthisfaithisfoundedonerroneousassumptions.

TheproponentsofGEfoodshaveunwarrantedlypresupposedthatalthoughthestructuresoflivingorganismsareelegantlycoordinatedatmostlevels,thiscoordinationdoesnotprevailattheirdeepestdimension–andthattheirseminalcomponentsarearandomassemblageofpartiallyattunedparts.Accordingly,theyregardtheinformationsystemsthatundergirdlivingbeingsaslesssoundlyconstructed,lesscomprehensivelycoordinated,andhencelesssusceptibletodisruptionthroughalterationthanarethesystemsofsoftwareproducedbythehumanmind.Andtheythereforepresumethatthesupposedlywell-managedinterventionswroughtbygeneticengineeringwillbelargelyinnocuous.Atthesametime,theywronglypresumethattheoperationsofnaturalbreedingaremorehaphazardthanthoseofbioengineering,andhencemoredangerous.

Thus,agriculturalbioengineeringstandsapartfromallothertechnologiesbecauseit’stheonlyonethatissocruciallyreliantonfaith.Andeveniftherewereanothertechnologyinwhichfaithplaysascriticalarole,ag-biotechwouldstillbeuniquebecauseit’stheonlyonebasedonbeliefinthedisorderlynatureofsomevitalbiologicalprocesses–andtheonlyoneforwhichsuchabeliefservesasthebasis

fordecisionsaboutpredictabilityandsafety.

So,notwithstandingitsclaimtobebasedonsolidscienceandhardevidence,theGEfoodventureisultimatelygroundedonfaith;and,fromanobjectivestandpoint,thefaithismisplacedbecauseitssuppositionsarefalse.

Yet,eventhoughthesepresumptionshavebeendiscredited,andeventhoughadversetestresultshaverepeatedlyemerged,thisvastenterprisehasmanagedtocontinue.And,aspreviouschaptershaveamplydemonstrated,itscontinuationhasbeencruciallydependentonincessantdisinformationanddeception.

Asweshallsee,whenthemassoffalsehoodandfraudthathassustainedtheventureisassessedagainstthebackdropofhistory,itsmagnitudeisclearlyunprecedented–anditstandsasauniquephenomenonintheannalsofscience.

CHAPTERTHIRTEEN

THEDEVOLUTIONOFSCIENTISTSINTOSPINDOCTORS

GeneticEngineering’sMostMalignantMutation

“Thescientist...mustconformtothefacts.Thesanctionoftruthisanexactboundarywhichencloseshim.”

JacobBronowski,ScienceandHumanValues1

Inhisinfluentialbook,ScienceandHumanValues,therenownedscientistJacobBronowskiemphasizestheneedforscientiststomaintainarigorousrelationshipwiththefacts,andhestatesit’sessentialthattheycultivate“thehabitoftruth.” 2Moreover,hehighlightstheimportanceofthispracticebytitlingthemiddlesectionofthebook“TheHabitofTruth.” 3

However,despitethenecessityofthishabitfortheproperpracticeofscience,sincetheadventofgeneticengineeringithassosteadilyandsubstantiallyerodedwithinthelifesciencecommunitythatmanymembershaveinsteadgrownhabituatedtotwistingthetruthinordertopromotethatcontroversialtechnology–andtheirpenchantforfalsepronouncementhasbecomequitepronounced.

BlurringtheBoundarybetweenScientistsandSpinSpecialistsAsthepreviouschaptershavedocumented,thescientist-proponentsofgeneticengineeringhavenotmerelyfailedtoadheretothefactsasassiduouslyasscientistsaresupposedto,inseveralrespects,theyhaven’tevenmaintainedhigherstandardsoftruthfulnessthanpeopleengagedinpolitics.Andwe’veseenthatassciencebecamemorepoliticizedinregardtogeneticengineering,andasitsscientist-promotersstrovetoaugmenttheirinfluenceoverthepoliticalprocess,themedia,andpublicopinion,theyincreasinglyadoptedthetechniquesofspinspecialistsadvancingpoliticalcampaigns.

Thetransformationofdoctorsofscienceintospindoctorsbeganatleastasearlyas1977,whenGEproponentsmountedamajorefforttoquellthegrowingconcernsabouttherisksofgeneticengineering.AswesawinChapter1,thehistorianSusanWright,inchroniclingthisendeavor,documentedseveralexamplesoftheproponents’propensitytospinthefactsinamisrepresentativemanner.ThistendencytowardspinhasalsobeennotedbyDianaB.Dutton,aSeniorResearchAssociateoftheStanfordSchoolofMedicine,whoobservedthatastheproponentsstrainedtoprojectapositiveimageoftheirtechnology,“[e]venaccumulatingevidencethattherewere,indeed,riskswasinterpretedinapositivelight.” 4

AsChapter1recounted,thisendeavorsoonevolvedintoanenormouspoliticallobbyingcampaigntoquashproposedlegislationthatwouldhaveregulatedgeneticengineering.Exemplifyingthezealwithwhichscientiststookuptheirnewlobbyistrole,NortonZinder,aneminentmicrobiologistatRockefellerUniversityandamemberoftheNationalAcademyofSciences,“urgedhiscolleaguesto‘lobbylikecrazy’withtheCongressmenfromtheirstates.” 5

Duttonreportsthatasthiscampaigngainedstrength,thenumerousscientistswhodidhaveconcerns“begantoseetheburdenofproofconcerningrisksshiftfromtheproponents’camptotheirown.” 6Accordingly,manysignedastatementforcefullycritiquingthe“‘misrepresentationandexaggerationofrecentdatapurportingtoshowthesafetyofrecombinantDNAresearch’”andallegingthatthescientist-

proponentsofgeneticengineeringwereusingscientificdatafortheirownpoliticalpurposes.7Butbecausethereweresomanyprestigiousscientistsandscientificinstitutionsengagedinthe“full-blownlobbyingeffort,” 8includingtheAmericanSocietyforMicrobiology,theNationalAcademyofSciences,andmajoruniversities,itsforcecouldnotbebluntedbythescientistswhoprotesteditsexcesses.9

However,inachievingvictory,andblockingregulatorylegislation,thescientistsincurredsubstantialcosts,themostseriousofwhichwerenotfinancial.AsDuttonobserves,“Scientistshadwontheirpoliticalbattle,butintheprocesslostsomeoftheirinnocence.” 10What’smore,theylostsomeoftheirintegrityaswell.AndthesignificanceofthislosswasnotlostonNortonZinder,themicrobiologistwhohadexhortedhiscolleaguesto“lobbylikecrazy.”Duttonreportsthatinreflectingonhisownlobbyingefforts,heconfidedtoPaulBerg,“‘I’vebeenbusysolongcalculatingtheresultsofmoves–didIpushtoosoon?toolate?weretherightpeoplecontacted?...howfarcanIstretchthe‘truth’withoutlying?–thatImayhavelostallperspective.’” 11

Regrettably,inordertokeeptheGEventurerolling,thekindsofexcessesdisplayedduringthatlobbyingcampaignhadtocontinue,andastheenterpriseexpandedintofoodproduction,toomanyofitsscientist-promotersdefinitelydidlosetheirperspective–andstretchedthetruthbeyondtheboundsofmerespinintotherealmofclear-cutfalsehood.

Aswe’veseen,duetotheirtruth-twisting,theburdenofproofnotonlyshiftedasapracticalmatter,butwaseventuallyinstitutedasaformalgovernmentalpolicy–startingwithintheUSNationalInstitutesofHealthandeventuallyspreadingthroughoutthefederalexecutivebranchanditsregulatoryagencies.AndthisshiftwasevenimplementedbytheFoodandDrugAdministration,despitethefactthatinordertorelievethemanufacturersofGEfoodsfromtheobligationofestablishingtheirproducts’safety,thisagencyhadtoperpetrateamajorfraudandalsoviolateoneofthenations’mostimportantandlong-standingconsumerprotectionlaws.

Aspreviouschaptershavedemonstrated,withoutthisshiftintheburdenofproof,whichscientistsinducedbysheddingtheirburdenoftruth,theGEfoodventurecouldnothaveprogressedandnoneofitsproductswouldhavebeencommercialized.Moreover,asthechaptershavealsodemonstrated,notonlywouldenforcingthelaw(andkeepingtheburdenproperlyimposed)haveblockedthemarketingofGEfoods,themaintenanceofintegritywithinthescientificestablishmentwouldindependentlyhavedoneso,becauseifscientistshadhonestlydescribedthefactsaboutthesenovelfoods,andacknowledgedtheirdeepdifferenceswithnaturallyproducedones,thepublicwouldneverhaveacceptedthem.

RecognizingtheCentralityoftheScientists’Duplicity

TheKeyDeceptionsHaveComefromtheScientificEstablishment,NottheBiotechIndustry

Thus,thedeceptionsofthemainstreamscientificestablishmenthavenotmerelyplayedacrucialroleinenablingtheadvanceofagriculturalbioengineering,butthekeyrole,andthehistoryoftheenterprisecannotbeproperlycomprehendedwithoutrecognizingit.Accordingly,thisgroupofindividualsandinstitutionsmustultimatelybeheldresponsibleforalloftheenterprise’sdelinquenciesandassociatedproblems–whichwouldnothaveariseniftheyhadspokenhonestly.

ThisassertionwillprobablycomeasasurprisetomostpeoplewithconcernsaboutGEfoods,becausetheytendtofocusonthetransgressionsofMonsantoandtheothermulti-nationalcorporationsthatsellthemandportraytheseentitiesassolelyresponsiblefortheproblemstheirproductspose.Butindoingso,theyoverlooktherealitythatthesecorporationscouldnothavecommercializedanyGEfoodsifthescientificestablishment(andespeciallythemolecularbiologists)hadnotpreparedthewaybysystematicallydeludingthegovernmentandthepublicaboutthebasicfacts.Andhadthisdeceptionnotbeenachieved,andwidespreadconcernsnotbeensubstantiallymollified,it’sdoubtfulsuchprofit-

seekingentitieswouldhaveinvestedthevastsumsrequiredtodevelopGEfoodsinthefirstplace.12Further,it’simportanttorealizethattheendeavortoavoidregulationofgeneticengineeringpre-dated

themodernbiotechnologyindustry.WhenmorethanahundredbiologistsconvenedatAsilomarinFebruary1975inanefforttomaintaincontroloverhowtheirresearchwithrecombinantDNAtechnologywouldbesupervised,andtodetertheinvolvementofoutsideregulatoryagencies,nocompaniesemployingthattechnologyevenexisted.Andwhenthefirstoneeventuallyappeared,itwasfoundedbyascientistwhowasoneofthetechnology’sinventors(andco-foundednotbyabigcorporationbutbyaloneventurecapitalist).13Moreover,mostoftheearlybiotechcompanieswerelikewiselaunchedbymolecularbiologistsandventurecapitalists,andmajorchemicalcompanieslikeMonsantoandDuPontdidnotsignificantlyenterthepictureuntilmuchlater.Thus,whenthefirstpoliticallobbyingcampaignwasmountedbyGEproponentsin1977,whateverbiotechindustryexistedwasnotonlysmall,butessentiallyanextensionofthescientificresearchcommunity–notanarmofthemajorcorporationsthatpurveypesticides.Norwasityetinvolvedintheproductionofbioengineeredplantsbutwasinsteadfocusedonthetechnology’smedicalapplications.Moreover,thatinitiallobbyingendeavorwasprimarilyconductedbyuniversityscientists,universities,andotherscientificinstitutions.14

Furthermore,evenafterbioengineeringhadexpandedtoagriculture,theGEfoodventurehadkickedintohighgear,andMonsantoandothermulti-nationalshadbecomeheavilyengaged,thescientificestablishmentcontinuedtoplaythechiefroleindispensingthedisinformationonwhichtheventure’ssurvivaldepended.

Thescientists’pivotalpositionwasduetotheirperceivedauthority.Becausethepublictrustsscientistsatuniversitiesandnon-profitinstitutesmuchmorethanprivatecorporations,thelattertrytogetpotentiallycontroversialproductsendorsedbyscientistswhoareostensiblyindependentfromthem.Butinthecaseofgeneticengineering,scientiststooktheinitiativebeforetherewasarelatedindustry,andtheystillneedednoproddingaftertheindustryhaddeveloped.Further,theirinfluenceinregardtothistechnologyhasbeenexceptionallystrong.ResearchhasshownthattheAmericanpublicregardsuniversityscientists,alongwiththefederalregulatoryagencies,asthemostreliablesourcesofinformationonGEfoods;15anditwasthroughthemisrepresentationsspreadbysuchscientiststhattheFDAwasenabledtodistortthefactsaswell,becauseiftheyhadupheldthetruth,theagencycouldnothavegottenawaywithtwistingit.Afterall,ifthemajorityofuniversity-basedbiologistshadforthrightlyacknowledgedthebigdifferencesbetweengeneticengineeringandtraditionalbreeding,andhadnotobfuscatedanddistortedbasicfacts,theFDAcouldnothaveissuedclaimsabouttheessentialsimilaritybetweenthetwo.AndiftheyhadspokenasfranklyandresponsiblyaboutrisksandtheneedtotestforthemasdidtheexpertpaneloftheRoyalSocietyofCanadaandthescientist-plaintiffsintheAllianceforBio-Integritylawsuit,theagencycouldnothaveplausiblyassertedthatGEfoodsaregenerallyrecognizedassafewithinthecommunityofexperts.

Moreover,whenmakingpublicpronouncements,thescientist-proponentsofbiotechhavetendedtobeevenmorebiasedthanindustryrepresentatives.Forinstance,ResearchersattheCenterforBiotechnologyPolicyandEthicsatTexasA&MUniversityanalyzed132newspaperarticlesrelatingtobioengineeringpublishedintheUSduring1991and1992andfoundthatthebulkofquotedinformationcamefromindustryanduniversitysources–andthattheuniversityscientistsgenerallypresentedamoreone-sidedpicturethandidtheindustry.Whileindustryrepresentativeswereaslikelytocommentonpotentialdangersofbiotechnologyaswereitscritics,academicscientistsmademuchlessmentionofthemandoverwhelminglyarguedfortheprojectedbenefits.16

TheAMAasaClinicalCaseofChronicIrresponsibility

OneofthemostremarkableexamplesofunabashedandbiasedpromotionofGEfoodsbyamajor

memberofthescientificestablishmenthasbeenprovidedbytheAmericanMedicalAssociation(AMA).AswesawinChapter9,thisorganizationhasbeenattheforefrontofthepromotionalendeavor,declaringina1990policystatementonagriculturalbiotechnologyitsintent“toendorseorimplementprogramsthatwillconvincethepublicandgovernmentofficialsthatgeneticmanipulationisnotinherentlyhazardous....” 17AndthispronouncementabouttheinherentsafetyofagriculturalbiotechnologywasreleasedtwoyearsbeforetheFDAissueditsownpolicystatementonthistechnology’sproductsandlongbeforeanygenuinesafetytestinghadevenbeenconducted.Further,besidesannouncingacommitmenttobelittletherisksofagriculturalbioengineering,theAMA’sstatementpledged“toactivelyparticipateinthedevelopmentofnationalprogramstoeducatethepublicaboutthebenefits....”

Thisblatantpromotionalpolicystandsinstarkcontrasttotheearlierstanceofthemedicalcommunityinregardtotobacco.Duringthe1950’s,althoughasubstantialpercentageofAmericandoctorssmoked,theywerebarredbytheirethicalcodefromappearingincigaretteadvertisements.Sotobaccocompanieshadtopayactorstoposeasdoctorsintheiradsinordertoprojecttheimpressiontheircigaretteswereendorsedbythisesteemedclassofhealthprofessionals.ButwhenGEfoodsweredevelopedafewdecadeslater,theAMAitselfunreservedlychampionedthem–andevenencouragedindividualmemberstoendorsethemasagentsofitsofficialpolicy.Further,itspromotionalendeavorhasbeenunstintinglymaintainedsince1990;andalthoughitssuccessivepronouncementsaboutGEfoodswereimbuedwithanauthoritativeaura,severalhavebeensignificantlymisleading.18

TheNationalAcademyofSciences:AnotherExampleofProtractedIrresponsibility

Aspriorchaptershaverevealed,thecaseoftheAMAisfarfromunique,andmanyotherrespectedscientificinstitutionshavelikewisesulliedthemselvesinordertopromotethebioengineeringventure.OnewhosemisbehaviorhasbeenasdeplorableasithasbeeneffectualistheUSNationalAcademyofSciences(NAS).AndChapters1,2,4,9and10havesolidlydocumentedthefollowingdelinquencies.

In1977,thisesteemedorganizationnotonlyabettedthedisseminationofdisinformationabouttherisksofgeneticengineering,itincreasedthedegreeofdistortion.

Moreover,itfailedtoconductaproperexaminationoftherisksofreleasingGMOsbecausethemolecularbiologistswhoinfluenceditsagendawereconcernedtheywouldlosecontroloftheissue.

AndwhenPhilRegalfinallyconvincedtheEnvironmentalProtectionAgencytosponsoraworkshopatwhichameaningfulexaminationcouldbeconducted,theAcademytriedtocommandeerandcrippleit.

Then,in1987,theAcademyreleasedareportthatminimizedtheenvironmentalrisksofGMOsbymishandlingscientificissues–areportoneoftheauthorsprivatelyadmittedwasessentiallypoliticalratherthanscientific.

Althoughthemid-sectionofitsnextreportonthetopic(in1989)didcontainscience-basedacknowledgementsofrisk,theNASstaffaffixedopeningandclosingchapterswithunwarrantedclaimsaboutsafetythatenabledthedocumenttobepassedoffasanaffirmationthattherewasnocauseforconcern.

In1997and2004,theAcademypublishedinfluentialbooksthatdownplayedtherisksofgeneticengineering–butcontainedsignificantinaccuracies.

In2004,theorganizationissuedareportonGEfoodsthat,althoughithashadamajorimpact,issubstantiallyillogicalandseriouslymisleading.Notonlydoesitdisregardormisrepresentseveralimportantfacts,itsargumentsareinkeyrespectsincoherentandevenself-contradictory.

HowScientistsHaveDeliberatelyThwartedLabeling

ThedeceptionsofthescientificestablishmenthaveevenplayedanessentialpartinblockingattemptstoachievethelabelingofGEfoodsinAmericathatwouldhaveadverselyaffectedtheirmarketing.Thisbecameespeciallyclearin2012duringtheintensepublicdebateinconnectionwithaballotinitiativeinCaliforniathatwouldhaverequiredthelabelingofGEfoodswithinitsborders.Thatcontroversyattractedsubstantialmediaattention,andeminentscientistseagerlyfedreportersstatementsthatsupportedthesafetyofGEfoods.Butnotonlyweremanyofthemcouchedinmisleadinglanguage,fartoomanywereflagrantfalsehoods.

Someofthemostinfluentialoftheseweredispensedbyascientistwhowieldedconsiderableauthority:BobGoldberg,aprofessorintheDepartmentofMolecular,Cell,andDevelopmentalBiologyattheUniversityofCaliforniaLosAngeles(UCLA)whoisalsoamemberoftheNationalAcademyofSciences.Forinstance,indefendingthesafetyofGEfoods,heassertedtoaLosAngelesTimesreporter,“Whenyouputageneintoaplant...itbehavesexactlylikeanyothergene.” 19Butthisboldstatement,soprominentlyfeaturedinanarticleinCalifornia’slargestnewspaper,isfalse.Asdiscussedinpreviouschapters,mostinsertedgeneswon’tevenfunctionunlessthey’reartificiallyboostedbyalienpromoters,andthepowerfulpromotersfromvirusesthatareusuallyemployedradicallyalterthegenes’behaviorandcausethemtoactverydifferentlythantheothergenesinthetargetplant.20Moreover,we’veseenthereareotherrespectsinwhichtheinsertedgenesdon’talwaysbehave“exactly”likethenativegeneseither–andthatthevariouswaysinwhichtheirbehaviordiffersentailsunusualriskstothehealthoftheconsumer.21

ButGoldbergwouldnotdesist,andhefreelydeliveredotherquotablebutgrosslyerroneouspronouncementsaswell.Thus,anarticleintheSanFranciscoChroniclecontainedhisdeclaration:“Bioengineeredcropsarethesafestcropsintheworld....We’vebeentestingthemfor40years.They’reliketheModelTFord.” 22Butthisclaimaboutthe40-yearspanoftestingisastoundinginlightofthefactthatin1972,40yearspriortothedateofhisstatement,thefirstgeneticallyengineeredbacteriahadnotevenbeencreated.23Moreover,notonlywerenoGMO’sinexistencewhenheallegedthattestingonGEcropshadbegun,bioengineersweren’tabletoproduceevenonefunctionalGEplantuntil1982;andthestudiesontheFlavrSavr™tomatointheearly1990’s(discussedinChapter10)probablymarkedthefirsttimeaGEcrophadundergoneanymeaningfulsafetytesting.Sohisclaimaboutthedurationoftestingexceededrealitybyaround20years.

Nevertheless,thisfalseclaimcommandedalotofattention,especiallybecausethesectioninwhichitappearedwasintroducedbythebold-typeheading:40yearsoftests.Further,hisclaimthatGEcropsarethesafestcropsintheworldentailsthatthoseproducedthroughsexualreproductionaresomehowriskier,ahighlydubiouspropositionforwhichthere’snosupportingevidence–andwhichiscontraryeventothe2004reportbytheNAS.24

ButGoldberg’sstoreofbogusstatementswasnotexhausted.WhenaskedaboutthestudiesthathavereportednegativeeffectsofGEfoods,hedismissedthemasneverhavingbeenpeerreviewed.25However,aswesawinChapters6and10,severalhaveundergonepeerreview.SoGoldbergeitherhadkepthimselfinsulatedfromanyevidencethatcouldshakehiscertitudeorhewaslying–orperhapshadhimselfbeendeceivedbyliesthatwerecirculatedbyotherGEproponents.Inanycase,whetherhewascarelesslyspeakingfromignoranceorshamefullyattemptingtodeceive,hisfalsehoodsmustsurelyhavemisledalargenumberofpeople,mostofwhomwereprobablyunawarethathehadco-foundedanagriculturalbiotechnologycorporationandstoodtoprofithandsomelyfrompublicacceptanceofGEfoods.26

Yet,althoughthemisrepresentationsbyGoldbergandotherindividualscientistsnodoubtdissuaded

manyvotersfromcastingtheirballotsinfavorofthelabelinginitiative,afargreaterdissuasiveeffectwasgeneratedbytheunexpectedinterventionofamajorscientificorganization.Formanyweeks,commercialentitieslikeMonsanto,DuPont,andtheothermanufacturersofGEfoods–joinedbymajorcorporationslikePepsiCoandGeneralMills,whoseproductscontainingredientsderivedfromthem–hadbeenpumpingtensofmillionsofdollarsintoamammothadvertisingcampaigntodefeatthelabelinginitiative.Thismassivecorporateoppositioncameasnosurprise.Norwasitsurprisingthattheadsthesecorporationsfundedcontainedseveraldistortionsandwerehighlydeceptive.Butitwassurprisingwhen,onOctober20th,theAmericanAssociationfortheAdvancementofScience(AAAS),oneoftheworld’smostesteemedscientificbodiesandthepublisheroftheprestigiousjournalScience,decidedtoenterthefrayandofficiallylenditsweighttotheanti-labelingcampaign.Onthatdate,afewweeksbeforevoterswenttothepolls,theassociation’sBoardofDirectorsissuedastatementthatpurportedtodemonstratewhymandatorylabelingofGEfoodsisnotonlyunnecessarybutunwise.Anditendedwiththeassertionthatsuchameasure“canonlyservetomisleadandfalselyalarmconsumers.” 27

Butwhatwastrulymisleadingwasthestatementitself,which,liketheadvertisementsofthebigcommercialcorporations,containedseveralfalseallegations.

Itsmaincontentionswere:

1. That“everyrespectedorganization”thathasexaminedtheevidencehasdeterminedGEfoodstobe“noriskier”thanconventionalones.

2. Thatthesedeterminationsarebackedbysolidscientificevidence.

3. ThatinordertoreceiveregulatoryapprovalintheUnitedStates,eachnewGEcrop“mustbesubjectedtorigorousanalysisandtesting.”

Andit’samazingtheseassertionswereissuedundertheauspicesoftheAAAS,becauseeachisclearlyuntrue.Chapter9hasdemonstratedtheinvalidityofthefirst,Chapter10hasdonethesameforthesecond(revealinghowthestudiesthatwerecitedtosupportitfallfarshortofdoingso),andChapter5hasestablishedtheflagrantfalsenessofthethird.

Regrettably,whilemanysavvyCalifornianswerewaryoftheadvertisementsthrownatthembyMonsantoanditscohorts,theynaturallypresumedthatthewidely-publicizedassertionsofsucharenownedscientificorganizationwereaccurate.Andit’salmostcertainthattheseapparentlyauthoritativeyeterroneousassertions,incombinationwiththoseissuedbyBobGoldbergandotherscientist-proponentsofGEfoods,providedthemarginofvictorytotheforcesthatopposedlabeling–especiallysincethemarginwassoslim.

TheDisinformationIsEvenMoreDominantToday

Thus,thescientistspromotingtheGEfoodventurehavebeenmuchbetteratskillfullymanipulatingperceptionsthanatsafelymanipulatinggenomes,andtheperceptionsthey’veinculcatedaretoalargedegreefalse.Indeed,iftheclaritythatscientistsaresupposedtofacilitatehadinsteadbeenfostered,theventurecouldnothavesurvived.

Butnotonlyhasitsurvived,throughtheongoingdisseminationofseeminglyscience-baseddisinformation,it’sbeensteadilygainingthesupportofrespectedjournalsandjournalists.Forexample,anarticlepostedinApril2014onTheNewYorker’sonlineblogobservedthat“there’sbeenashifttowardG.M.O.samongeditorialboardsandsciencewriters”tosuchanextentthatMichaelPollan,afamousauthor,Berkeleyprofessor,andprominentcriticofGEfoods,hasconfided,“Ifeelprettylonelyamongmyscience-writingcolleaguesinbeingcriticalofthistechnology,atthispoint.” 28

Moreover,evenhiscriticismisnowsubstantiallylimited.Hetoldthereporterthatalthoughhe’s

concernedthatthetechnology’scurrentapplicationsareharmingtheenvironmentandentrenchingundesirablefarmingpractices,he’snotsignificantlyconcernedabouttheeffectsofitsproductsonhumanhealth.Andthe700studentsinthecoursehewasteachingonhowtocreateamorehealthfulandsustainablefoodsystemdidn’tseemconcernedaboutpotentialhealthrisksofGEfoodseither.Accordingtothejournalist,theywereprimarilybotheredbywhattheyperceivedasgrowingcorporatecontrolofthefoodsupply.

ThefactthatneithertheprofessornorthestudentsinacourseonsustainableagricultureatUCBerkeleyintheSpringof2014regardedGEfoodsasriskiertoeatthannaturallyproducedones,andinsteadbelievedtheycanbesafelyemployedinglobalagricultureaslongasthespecificcropsandmethodsarealignedwithproperprinciples,revealshowthoroughlythedeceptionsoftheirscientist-supportershavesucceeded.

FlawedThinkingHasAccompaniedtheFalseTalking

Further,notonlyarethesescientist-promotersunabletoconsistentlytalkstraightaboutGEfoods,theycan’talwaysthinkstraightaboutthemeither.Thisdebilityiswell-exemplifiedwithinthereportsreleasedbytheNationalAcademyofSciences.AswesawinChapter9,noneofitsfirstfourreportsonGEcropsproperlyemployedtheconceptofrisk,andeachblurredthedistinctionbetweenrisksandhazards.Further,Chapter4revealedthat,inattemptingtoasserttheequivalenceofgeneticengineeringandtraditionalbreeding,the1989reportservedupanabsurdstatement;andChapter9showedthatwhenthe2004reporttriedtodemonstratetheparityoftheirrisks,itbecamelogicallydysfunctional.

AnincisiveassessmentoftheextenttowhichtheargumentsoftheproponentsarebothdeceptiveandrationallydefectiveisprovidedbyGuyCookinhisbook,GeneticallyModifiedLanguage,whichhebeganresearchingwhenheheldtheChairofAppliedLinguisticsattheUniversityofReadingintheUK.Intheintroduction,hesaysthebookdemonstratesthatmanyoftheargumentsforgeneticengineering“...exemplifydisturbingtrendsinthepublicuseofcontemporaryEnglishbypowerfulindividualsandorganizations,inwhichlanguage,whilepurportingtoberational,honest,informative,democraticandclear,isinfactnoneofthesethings,but,onthecontrary,oftenillogical,obscure,patronizingandone-sided,populatedwithfalseanalogies,misleadingmetaphors,andimpenetrableambiguities.” 29

TheMostImmediateDamageHasBeentoScienceBesidesenablingtheimpositionofgreatpotentialharmonconsumersandtheenvironment,thedelinquenciesofthescientificestablishmenthaveinflictedconcreteharmonscience–andtheharmhasbeenmajor.What’smore,thisdamagehasbeeninflictedinthenameofprotectingscience.StartinginChapter1,we’veseenhowthescientist-promotersofthegeneticengineeringventurehaveroutinelybrandedanyoppositiontoitasanattackonscienceitself–andhowinmountingtheirdefense,they’veincreasinglyemployeddeceptivepracticesthatareforeigntoscienceandinjurioustoitsspirit.AsPatrickBrown,aprofessorofplantsciencesattheUniversityofCalifornia,Davis,hasobserved:“TodatemanyinthescientificcommunityhavebeenunwillingtorationallyconsidertheconcernssurroundingthecurrentGMOsandhavewronglyconsideredthatadefenseofGMOsisaprerequisitetoprotectthescienceofplantbiotechnology.Nothingcouldbefurtherfromthetruth....” 30

Butinsteadoffacingthetruthaboutthewrong-headednessoftryingtoprotectsciencebyprotectingtheimageofGEcrops,theirscientist-proponentshavesignificantlyeffacedthetruthabouthowthesecropsarecreated,howtheydifferfromtraditionallybredcrops,andhowextensiveevidencehascastdoubtontheirsafety.Andinstrivingtomanage(andcensor)theflowofinformationtothepublic,they’vesuppressedthefreeflowofideaswithinthescientificcommunity,whichisthelife-bloodofscientificprogress.

StiflingFreeDiscussion,InculcatingFear

Chapter10hasdocumentedhowexpertswho’vedaredtopublishresearchshowingproblemswithGEfoodhavesufferedviciousandunjustattacksthathavedisgracedthemanddiscreditedtheirresearch.Further,therepressiveclimatewithinthescientificcommunityhasbeensointensethatitsmembershavenotonlybeeninhibitedfromperformingresearchthatcouldcastdoubtonGEfoods,butevenfromaccuratelydescribinginconvenientfacts.Incommentingonthisdeplorablephenomenon,PhilipRegalhasnoted:“Traditionally,scientistsregardedintellectualhonestyaspartofcollegiality,andtherewasaccountabilityifonewascaughttellinglies.Accordingly,liarswereblackballed.Butsincetheriseofgeneticengineering,thesituationinmolecularbiologyhastoasignificantdegreebecomeinverted,and,whenitcomestothattechnology,onegetsblackballedfortellingthetruth.”

ThissuppressionbeganwellbeforetheadventofanyGEcrops,whenthemolecularbiologyestablishmentstrovetodeterregulationduringthe1970’s.DianaDuttonreportshow,eventhen,“...dissidentscientistshadtoendureincreasinglyovertprofessionalostracism”andweresubjectedtoharshcriticism.Andshenotesthat,inawidelyquotedinterview,JamesWatsonreferredtothosewhoexpressedconcernsas“‘kooks,shits,andincompetents.’”Accordingly,shestates:“Itwasespeciallydifficultforyoungerfacultymemberswithouttenuretowithstandhostilityandintimidationfromseniorcolleagues,andmanywithdrewfromthecontroversy,fearingfortheircareers.” 31

Further,becausethescientificestablishmentintensifieditsdefenseofbioengineeringafterGEfoodsarrived,hasstubbornlyinsistedthatthey’resafe,andhasharshlydenigratedopposingviewpoints,scientistswhodohavereservationsarereluctanttoexpressthem.Andthere’sabundantevidencethatthosewhoareboldenoughtovoicedoubtsareroutinelycensuredbysuperiors,deniedtenureatuniversities,refusedchoiceemploymentintheprivatesector,orotherwisedegradedinthescientificcommunity.

Forinstance,whenAnnClark,ascientistattheUniversityofGuelphinCanada,publiclycriticizedthedeficientsafetytestingforGEfoods,adverseconsequencescameswiftly.“Withintwohoursofthepressconferencereleasingthereport,mydeanhadcalledmeunethical,”Clarksaid.“Itbecamequiteugly,becausethenationalmediapickeditup,andpeoplewhoseviewsaren’tparalleltominehaveused[thedean’sremarks]extensively.” 32BecauseClarkhadtenure,shecontinuedtospeakoutwithoutfearoflosingherjob.Butshesayshertreatmenthasdeterredothers:“Therearen’tmanyacademicswhowillsaysomethingiftheyknowtheiradministrators–thepeoplewhositinjudgmentontheirperformance–aregoingtopubliclylambastethem.” 33

Similarly,agriculturaleconomistJohnIkerd’srefusaltogetonthebiotechbandwagonbroughthimproblemsattheUniversityofMissouri.“Youbecomelabeledasnotateamplayer,asnotoneofthetrustedmembersofthefaculty,”hesays.“Youarenotoncommitteesyouusedtobeon,you’renotinvolvedintheleadershipofthedepartment,andyoudon’tgetwrite-upsintheuniversitypublications.Youhavetodecidebeforeyouspeakoutthatyoudon’tcareabouttheserepercussions.It’slikebeingawhistleblower.” 34

AndatleastoneAmericanuniversityhastriedtopurgeitsranksofscientistswhowon’tespousetheofficialpositiononGEfoods.Forinstance,in2001OregonStateUniversitysentalettertoitsbiosciencefacultyinformingthemthatiftheydidn’tsupportgeneticengineering,theydidnotbelongthere.35Interestingly,itwassignedbyaformerpresidentoftheinstitution,perhapsbecausethepresidingpresident,whowasanecologist,couldn’tbringhimselftoputtinghissignatureonsuchadocument.

Besidesitschillingeffectonthefacultywhoremained,theletterdroveatleastoneprofessoraway:ElaineIngham,thesoilscientistwhohadperformedsuchavaluableserviceinhelpingtodiscovertheseriousriskposedbythebioengineeredKlebsiellaplanticolabacteriathatwasdiscussedinChapter7–andwhodissuadedtheEPAfromapprovingtheirrelease.Inghamhadalreadysufferedascoldingfrom

herdepartmentheadafterspeakingabouttherisksofthatbioengineeredbacterialstrainataninternationalconference,andwhenshereadtheominousletter,sherealizedthatbecauseshewasnotpreparedtostaysilentaboutwhatsheperceivedtobethepotentialproblemsofgeneticengineering,herlifeattheuniversitywouldbecomeevenmoreunpleasant.Soshedecidedtoresignandstartherownresearchinstitutewhereshecouldfreelyfunctionasascientist.

Duetothevariouspressures,numerousexpertsprofessthesafetyofGEfoodsinpublicyetprivatelyconfessconcerns,asPhilRegalnotedinthedeclarationhesubmittedtothecourtintheAllianceforBio-Integritylawsuit.36Hisobservationwasbasedonextensiveparticipationonexpertpanelsandinscientificconferences;andit’sconfirmedbyastudythatfoundsignificantrepressionofopinionamongCornellUniversityagriculturalandnutrition-sciencefacultyandextensionstaff.Although63%hadreservationsaboutthesafetyofGEcrops,theysaidtheyfeltuncomfortableaboutexpressingtheirviews,incontrasttotheminoritywhowerestrongbackersofbiotech.37Notonlyissuchsuppressionablightonthescientificspirit,itsustainstheillusionthatGEfoodsarefarmoresupportedwithinthesocietyofscientiststhanisactuallythecase.

Thus,it’sasadfactthatduringthebioengineeringera,theethicalstandardsofthescientificestablishmenthavebeensosubstantiallypervertedthat(a)speakingdeceptivelyaboutGEfoodshasbecometheexpectednorm,(b)speakingtruthfullyonthattopicisnotmerelydiscouragedbutpunished,and(c)thosewhoattempttoupholdthetraditionalethicsofsciencebyopenlycommunicatingthefactsarebrandedasunethicalbyscientistswhowieldauthority.

AWidespreadFailuretoCriticallyAssessthePromotionalClaims

Further,notonlyhavealargenumberoflifescientistsbeeninhibitedfromforthrightlycommunicatingfactsaboutGEfoodsduetofearofreprisals,alargenumberhavefailedtoseriouslyassessthefactsatallandhaveinsteadunthinkinglyrepeatedthestandardclaimspropagatedbytheestablishment.PhilRegalhascommentedontheprevalenceofthispracticeandnotedhowstrikinglyitmanifestedwhenscientistsroutinelyrepeatedthe“partyline”inregardtotheEMSepidemicinducedbyabioengineeredfoodsupplement(discussedinChapter3)–andunequivocallyassertedthatthebioengineeringhadinnowaycausedthecatastrophe.Asheobserved:

Universityscientistswhohadnotstudiedthedocumentationitselfbeganparrotingtheargumentsthatthepublicrelationspersonsfortheindustryhaddeveloped.Asthoughanyproofwasnecessary,itbecamecrystalclearthatideaswithinthecommunityofmolecularbiologistswerelargelybeinggeneratedandspreadfromthetopdown.Thiswasclearbecauseopinionsthatwerebeingstatedwithauthoritywerenotbeingbasedonstudiesoftheactualfactsbytheindividualscientistswhowerespeakingas‘scientific’authorities,butonlyonwhatwasbeingsaidbythosewhowereinpositionsofpower.Itwasclearthatgossiphadbecomeasgoodasscientificevidenceintheprofession,evenonmatterswherehumanlivescouldbeatstake.

Inreflectingonthepersistenceofthisbehavior,Regalhasstated:“Ofcourse,becauseit’sintheself-interestofmanymolecularbiologiststotrusttheirleaders,Icannotassumethatthey’veallbeenlying.Butarguingthatyouknowsomethingtobetruewhenyouhavenotstudiedit,andinsteadparrotingthepartyline,iscertainlyaformofintellectualdishonestyevenifitisnotoutrightlying.”Nonetheless,althoughhe’sbeingfairinrefrainingfromcondemningallthescientistswho’veroutinelyrepeateddubiousclaimsasliars,it’sobviousthatfartoomanyhavebeensocarelessintheclaimstheymake,andsointenttoconcealunfavorablefacts,thattheirstatementscanbejustlyjudgedfraudulent.

Moreover,manyscientistswhohavenotactivelydisseminatedthepromotionalclaimsthemselveshaveyetbeenbadlymisledbythem.AsthemolecularbiologistDavidSchubert(oftheSalkInstitute)has

noted:

Ihavespokenwithmanymolecularandevenplantbiologistswhoarenotdirectlyinvolvedinproducinggeneticallyengineeredfoods,andit’sclearthatmosthavebeenmisledaboutthebasicfacts.Forinstance,theyassumethesefoodshaveundergonerigoroussafetytesting(asinthecaseofdrugs)andaresurprisedtolearnthattheyhaven’t.Noraretheyawarethattheinsertionsoftherecombinantcassettesarenotprecisebutrandom.Andtheydon’tunderstandthepotentialeffectsontheplants’secondarymetabolismthatcouldgenerateharmfulsubstances.Instead,duetothedisinformationdispensedbythelifescientistswhopracticeandpromoteagriculturalbioengineering,theyhavetheimpressionthattherearenounusualrisksandthateverythingisundercontrol.Inmostcases,afterI’veexplainedthekeyfacts,theychangetheirposition.38

ManyScientistsHaveBeenDeliberatelyLying

ButSchuberthasalsopointedoutthattoomanyofthescientistswho’vebeenmakingthestatementsthathavemisledtheircolleagueshavenotbeeninnocentlymistakenthemselves.Inhiswords,“SomeplantbiologistsaremakingstatementsaboutGEfoodsthattheyalmostcertainlyknowarenottrue.” 39Andthisbookhaspresentedextensiveevidencethatsupportsthisobservation.Thus,whilesomebiotechproponentsdismissscientistswhocritiqueGEfoodsas“outliers,”it’sclearthatasubstantialnumberofthosewhochampionthemareoutrightliars.40

ScientificStandardsHaveBeenEroded

AstheintegrityofscientistshassteadilyerodedintheendeavortopromoteGEfoods,sohaveseveralofthestandards,inadditiontotruthfulness,thatscientistsaresupposedtouphold.Forinstance,asChapter6hasdescribed,regulators(andthescientificcommunity)haveallowedthemanufacturersofGEfoodstore-writebasicrulesonhowexperimentsshouldbeconducted,permittingthemtodilutestatisticallysignificantdifferencesbetweenGEcropsandtheirparentalvarietygrownunderthesameconditionsbyinsteadcomparingtheformerwithawiderangeofvarietiesgrownundersubstantiallydifferentconditions.

Further,asthatchapterandChapter10havedocumented,inseveralinstancesregulatorsliketheEuropeanFoodSafetyAuthority(EFSA)haveignoredstatisticallysignificantdifferencesbetweenanimalsfedGEfoodsandthecontrolanimalsthatatethenon-alteredcounterpartsbyupholdingthemanufacturers’claimsthatthedifferencesarenot“biologicallymeaningful.”Moreover,theEFSArepeatedlydismissedsuchsignificantdifferencesasnotbiologicallyrelevantwithoutprovidingclearcriteriaforwhatcountsasrelevant.Andwhen,inresponsetorepeatedcriticismbyindependentscientists,itfinallyattemptedtofurnishadefinition,theresultwasmarkedlydeficient.41AsthescientistsJohnFaganandMichaelAntoniouhavenoted,theEFSA’sattempt“failstogivearigorousscientificorlegaldefinitionofwhatmakesastatisticallysignificantfinding‘biologicallyrelevant’ornot.”Theypointoutthatitinstead“allowsindustrytocometoitsownconclusiononwhetherchangesfoundinanexperimentare‘important’,‘meaningful’,or‘mayhaveconsequencesforhumanhealth.’”Andtheynotethatbecause“[t]hesearevagueconceptsforwhichnomeasurableorobjectivelyverifiableendpointsaredefined...theyareamatterofopinion,notscience.” 42

And,asChapter10hasshown,thescientist-proponentsofGEfoodshavebeeninconsistentinthewaythey’verelaxedscientificprotocols,doingsoinabiasedmannerthat’screatedadoublestandardunderwhichanystudyreportingproblemswiththeseproductsissubjectedtofarstricterrequirementsthanthosepurportingnottofindany.Throughsuchaduplicitoussetup,rigorousstudiespublishedinpeer-reviewedjournalsarepilloriedorevenforcedintoretractionifthey’vedetectedilleffectswhileshoddy

onesthatcouldn’tqualifyforpublicationinsuchjournalshavebeentreatedasauthoritativeaslongastheyclaimreassuringresults.

ThisgrossdegradationofscientificstandardsisanimportantpartoftheGEfoodfraud,becauseproponentshavecreatedtheillusionthatsciencehasbeenassiduouslyupheldwhen,inreality,ithasbeensystematicallysubvertedinordertomaketheproductsofbioengineeringappearsafe.

TheVeryNatureofScienceHasBeenMisunderstoodandMisrepresented

Notonlyhavemanyscientist-proponentsofGEfoodsmisrepresentedscientificfactsandsubvertedscientificstandards,they’vemisrepresentedtheverynatureofscienceitself.Anditseemsthatasignificantnumberhavedonesobecausetheythemselveshavegrownconfusedaboutwhatitisandisn’t.Thus,asseveralobservershavepointedout,manyproponentstendtoerroneouslyequatethetechnologyofgeneticengineeringwithscienceandtreatanycriticismofthetechnologyasanattackonscience.

Butinreality,thetechnologyofagriculturalbioengineeringisnotinitselfsciencebutmerelyanattempttoapplysciencetoachievepracticalresults,andthesafetyofitsproductsisnotautomaticallyassured.Rather,theirsafetymustbeassessedinascientificmanner.Onewayisthroughthetheoreticalapproach,whichinvolvesapplyingourbestbiologicalknowledgeandmakinganearnestevaluationofrisks.Theotherisbyperformingscientificallyrigoroustestsoneachproduct.

Aswe’veseen,whenthetheoreticalapproachhasbeenemployedbyscientistswhoweresincerelyendeavoringtoconsideralltherelevantevidenceandrenderanobjectiveassessment(aswasthecasewiththeexpertsontheFDA’sbiotechnologytaskforceandthoseontheRoyalSocietyofCanada’sexpertpanel),geneticengineeringhasbeenrecognizedasdeeplydifferentthanconventionalbreeding,andthefoodsitproduceshavebeendeemedtoentailgreaterriskthanthoseproducedviatraditionalmeans.Ontheotherhand,whenscientistswhoapparentlywantedtoupholdtheimageofGEfoodshaveperformedriskassessments(asinthecaseofthosethatproducedthe2004NASreportdiscussedinChapter9),theytendtoignorealotofevidenceandemployalotoflooselogic,eventothepointofalteringtheconceptofrisk.AndonlyinthiswayhavetheybeenabletoconcludethatGEfoodsarenotinherentlyriskierthanconventionallyproducedones.

Additionally,asChapter12demonstrated,thebeliefinthesafetyofGEfoodsisultimatelygroundedonasetofassumptionsthathavebeenthoroughlydiscredited,whichrenderstheventurethatproducesthembereftofanysoundtheoreticalsupport.

Moreover,aswe’veseeninChapters6and10,theventuredoesnothaveasoundempiricalfoundationeither,andwhenactualtestshavebeenperformed,they’veyieldedacropofdisturbingdata.Further,ifthedataareexaminedinanhonestandscientificallyrigorousmanner,there’sampleevidencetosupporttheviewthatnoGEfoodhasyetbeenprovensafe,thatthesafetyofseveralisinseriousdoubt,andthatnoneofthemshouldbeonthemarket.

Nonetheless,despitethelackofsolidtheoreticalortest-basedsupport,thescientist-proponentsofGEfoodshavepersistentlyproclaimedthattheseproductsaresafe.Andindoingso,they’vegonebeyondfalselyconflatingthetechnologyofgeneticengineeringwithscienceandhavealsomistakentheirownunsubstantiatedopinionsforscience.Therefore,theirclaimsareultimatelybasedontheirownpurportedauthority;andChapter9hasfurnishedaprimeexample,demonstratinghowtheargumentsofthepanelthatproducedthe2004NASreportessentiallyboileddowntotheassertion,“GEfoodsaresafebecausewesaytheyare.”

SuchparadingofunfoundedopinionintheguiseofsolidsciencehasbeenaconstantfeatureoftheGEfoodventure–andoneofitsdeepestandmostenduringdeceptions.AsPhilRegalhasnoted,althoughthescientist-supportersofGEfoodshavebeenunabletoprovideadequatescientificbackupfortheirclaims,theyneverthelesspresentthemasscience-based–thus“tryingtowavetheflagofsciencewithoutastafftosupportit.”

PuttingThingsinPerspective:TheBiggestFraudintheHistoryofScienceToproperlygaugethesizeandseverityoftheaggregatefraudthathasenabledtheadvanceandsurvivaloftheGEfoodventure,weneedtoviewitwithinthecontextofhistoryandassessitagainstmajorscience-relatedfraudsthathavealreadyhappened.Aswe’llsee,althoughsomeoftheearlierfraudshavebeenbothsizableandharmful,theonethat’sbeenperpetratedonbehalfofGEfoodssurpassesthemall.

TheNotoriousPiltdownHoaxisDwarfedbytheGEFoodFraud

InDecember1912,thescientificcommunitywaselectrifiedbytheunveilingofaseeminglymomentousdiscovery.AtthePiltdownquarryinSussex,England,fossilremainshadbeenunearthedoverseveralyearsthat,whencombined,appearedtoformaskullthatexhibitedbothhumanandpre-humanfeatures.Thebrowwasdistinctlyhumanwhilethejawbonewasfarmoreprimitiveandape-like.Intheeyesofmany,the“missinglink”intheevolutionarychainfromapestoHomosapienshadfinallybeenfoundandtheDarwiniantheoryofhumandescentconfirmed.However,althoughnumerousexpertsregardedthespecimensastheauthenticremainsofanearlyhominid,manyhaddoubts.Foronething,whenthejawwasdiscovered,itwasnotattachedtotheskull,soitcouldhavecomefromadifferentanimal.

In1953theissuewasdecisivelysettled.Sophisticatedanalysisrevealedthattheboneswerenotsufficientlyancientbuthadbeendoctoredtolookso.Andthejawboneappearedape-likebecauseitinfacthadbelongedtoanape.What’sstillunresolvedistheidentityofthepersonorpersonswhodoctoredthefossilsandplantedtheminthequarry,althoughit’sevidentthatatleastoneindividualwithscientificexpertisemusthavebeeninvolved.43

ThePiltdownforgeryisoneofthegreatestfraudsinflictedonscience.Itpurportedtoconfirmoneofthemostrevolutionaryandvehementlycontestedscientifictheoriesofthemodernera;itdupedalargenumberofpeople,includingmanyexperts;andtheconfusioncontinuedfordecades.Yet,comparedtothatfraud,thedeceptionthatunderliesthegeneticengineeringofourfoodisfarbigger–andfarmoreinsidious.Biggerintermsofthenumberofscientistsperpetratingit,biggerintermsofthenumberofpeoplemisled,andbiggerintermsofthedamagetoscienceandthepotentialharmtosocietyandthenaturalenvironment.

TheUK’sMadCowDiseaseDeceptionDoesn’tComeCloseEither

Further,althoughtherehavebeenfraudsthat,unliketheoneatPiltdown,didinvolveriskstopublichealth,they’renotonaparwiththeGEfood-relatedfraudeither.OneofthebiggestofthesedeceptionsinvolvedtheUKgovernment’sattemptstodispelfearsabout“madcow”disease(BSE).AsdocumentedinareportbyresearchersattheUniversityofSussex,officialskeptinsistinginpublicthatBritishbeefwascompletelysafewhentheyknewthisclaimwasunjustified.Inthewordsofthereport:“Policy-makerswererepeatedlytold,bothbythescientificexpertsonwhomtheyclaimedtorely,andbythewiderscientificcommunity,thatitwasimpossibletobecertainthatconsumingmeat,milkanddairyproductsfromanimalswithBSEposednorisk.” 44Nonetheless,governmentofficialscontinuedtoclaimsolidgroundsforcertainty,aswhentheAgriculturalMinisterdeclaredtotheHouseofCommonstherewas“...clearscientificevidencethatBritishbeefisperfectlysafe.” 45

WhilethereareparallelsbetweenthedeceptionsonbehalfofBSEandthosethatenabledGEfoods,therearemajordifferences;andthefraudinthelattercaseisoffargreatermagnitude.MostofthedeceitaboutBSEwasperpetratedbytheUKgovernment,andonlyafewothergovernmentsalsoemployeddeceptiontoclouditsrisks.Incontrast,manygovernmentalbodiesaroundtheglobehaveengagedinsignificantmisrepresentationregardingGEfoods,andthey’vedonesooveralongerperiodoftime.

Moreover,whileitappearsthatthemajorityofthescientificcommunityacknowledgedthepotentialrisksofBSEandemphasizedthelackofscientificcertainty,inthecaseofGEfoods,themajorityofscientistshavefailedtobeforthrightabouttherisksanduncertaintiesandalargenumberhaveinsteaddealtinsystematicduplicity.Thus,whileinthecaseofBSE,thefraudulentbehaviorofgovernmentofficialswasnotabettedbythebulkofthescientificestablishment,inthecaseofGEfoods,ithasbeen.

TheWorstScientificFraudoftheStalinistEraWasFarLessEgregious

EvenanenormousfraudthatwasabettedbytheStalinistSovietgovernmentandseriouslydamagedscienceandagricultureintheUSSRfordecadespalesincomparisontotheGEfoodfraud.ThisuglyepisodewasduetotheendeavorsofthebiologistandagronomistTrofimLysenko,whopromotedtheoriesforboostingagriculturalproductionthatwereattractivetotheCommunistpartybossesbutmisalignedwithreality.Andbecausehewasbackedbyatotalitarianstate,hewasabletoimposehisideasinathoroughandrepressivemannerforatleast30years.However,whenscientistsfinallyhadsufficientfreedomtospeakoutagainsthim,itsparkedanofficialinvestigationthatproduceda“devastating”reportaccusinghimofmisrepresentingfactsanddeliberatelyfalsifyingdata.46Thefindingsindicatedthatthemethodshepropoundedwereunsoundandwerecausingsignificantlosses.47

Yet,despitethedurationofLysenko’sinfluenceandtheextentofitsharmfuleffects,theaggregatefraudthathasaccompaniedandenabledagriculturalbioengineeringisinmostrespectsofgreatermagnitudethanthefraudthathewrought.Hewasthemainscientistdrivingit,andalthoughthemajorityoftheotherscientistswerecowedintosilencebyfearoftheSovietregime,onlyaminoritybecameardentpromotersofhisviews.Forinstance,merelyfouroutofthethirty-fivegeneticistsintheAcademyofSciences’InstituteofGeneticsbecameLysenkoiteswhenLysenkobecamethedirectorin1940.48Thus,hisagendagainedthesupportofthegovernment,notbecauseitwaspushedbyalargenumberofscientistsorallegedtorepresentascientificconsensus,butbecauseitwasappealingonbotheconomicandideologicalgrounds–andbecausethegovernmenthadthepowertoignoreandmanipulatescientificopinion.49Incontrast,alargesegmentofthescientificcommunityhasbeenavidlyengagedintwistingthetruthonbehalfofgeneticengineering,andthebiotechagendahasgainedgovernmentsupportthroughtheintensiveeffortsofthescientificestablishment.Further,whereasLysenko’sfraudwasfacilitatedbyonlyasinglegovernment,whichwasrigidlytotalitarian,theGEfoodfraudhasbeenactivelyabettedbyseveralgovernmentsinsocietiesthataresupposedtobeopenanddemocratic.AndalthoughtheSovietgovernmentsupportedLysenko,itapparentlydidnotparticipateinthemisrepresentationofresearchashastheUSFoodandDrugAdministration,whichhasdisseminateddisinformationaboutGEfoodsjustasvigorouslyashavetheirscientistandindustrypromoters.

Moreover,althoughtherepressionsufferedbySovietscientistsduringtheLysenkoerawasinseveralcasesmoreseverethanthatinflictedonscientistswhosespeechorresearchhasbeendeemedthreateningtotheGEfoodventure,farmorescientistshavebeennegativelyimpactedinthelattercase;andtherepressionhasoccurredonaglobalratherthanregionalscale.Worse,theirmistreatmentisinimportantrespectsmoreegregiousbecauseithasoccurredinopensocietiesthataresupposedtoprotectandnurturefreedomofthoughtandspeech.

Inaddition,there’samajordiscrepancyinthedegreeofriskimposedonhumanandenvironmentalhealth.AccordingtotwoNewYorkTimesjournalistswhoanalyzedtheLysenkoepisodeintheirbookonscientificfrauds,BetrayersoftheTruth,althoughhisprojectsyieldednobenefits,ingeneraltheydidn’tcostverymuchnordidtheyproducesignificantharm.50Ontheotherhand,theGEfoodventurehasrequiredmassiveexpenditure,hasproducedextensiveenvironmentalharm(asdocumentedinChapter7),hasimposedexcessiverisksonhumanhealth,and(asfarasweknow,giventhelackofpropermonitoring)mayhaveactuallybeenharmingmillionsofconsumers.

Finally,notonlyhastheGEfoodfraudbeenperpetratedbymorescientistsinmorecountries,beenabettedbymoregovernments,imposedmoreextensiverepression,andentailedfargreaterrisk,itsinfluencehasalsolastedlonger.Lysenko’sinfluencewasdominantfor30years,andwassignificantfornomorethan35,51whilethescientist-proponentsofgeneticengineeringhavealreadysucceededinmisleadingthescientificcommunity,governments,andthemediaformorethan37.52

TheGEFoodDeceptionEncompassesAllPreviousFormsofFraud–andHasEvenIntroducedaNewOne

Further,althoughBetrayersoftheTruthpresentsacomprehensivestudyofscientificfrauds,noneoftheotherdelinquenciesitdescribescomesclosetothemagnitudeofthecumulativefraudthathasempoweredtheGEfoodventureeither.Foronething,mostofthemwerepulledoffbyasinglescientist.Andeventheworstdidn’timposerisksonhumanorenvironmentalhealthanywhereneartheenormityofthoseentailedbytheGE-relatedfraud.

What’smore,whilemostofthetransgressionsdiscussedinBetrayersoftheTruthexemplifyonlyoneofthetypesoffraudthatitdescribes,theGEfoodfraudencompassesallofthem–includingtheonetheauthorsclassifyasthemostserious(andrarest)form:inventinganexperiment“outofthinair.” 53AsChapter1pointedout,duringtheearlyeraofgeneticengineeringitsproponentsallayedpublicandCongressionalconcernsaboutitsrisksbyclaimingthatresearchhadproducedimportant“newevidence”demonstratingitssafety,despitethefactthatnosuchresearchhadbeenperformedandnosuchevidenceexisted.Andthatchapter,alongwithChapter4,alsorevealedthatduringthesameera,StanleyCohenhelpeddefeatCongressionalattemptstoregulategeneticengineeringbysogrosslymisrepresentinganexperimenthehadconductedthatpeopleweredupedintothinkingitwasperformedundernaturalconditionsandachievedresultsithadfallenfarshortofattaining.Thus,heineffectinventedafantasyexperiment,becausetheversionheinstilledinpeople’smindswasverydifferentfromtheonehe’dactuallycarriedout.AndthischapterhasshownhowBobGoldbergboastedaboutamulti-yearspanofsafetyteststhatwaspurefiction.54

Moreover,thepromotersofGEfoodshaveeffectedatypeoffraudthatBetrayersoftheTruthdoesn’tevendescribe.Theyhavenotonlyfabricatedresearchstudiesthatdon’texistbuthaveessentiallyexpungedrealonesthattheydon’tlike.Throughtheirfervidattacks,theyforcedretractionofSéralini’sandheapedsomuchderisiononPusztai’sthatthescientificcommunityandthemedialargelyignoreit,notonlyasifithadneverbeenpublishedinamajorpeer-reviewedjournal,butasifitneverevenhappened.Moreover,aswesawinChapter3,they’veevenmanagedtoeffectivelydisappearanentireepidemicthatwasassociatedwithaGEfoodsupplement,alongwiththepublishedresearchrelatedtoit.

EntirelyUnprecedentedandUniquelyUnsavory

Consequently,whenviewedinthecontextofhistory,theaggregatefraudthathasfosteredthegrowthofthebioengineeringventure,hasallowedittoavoidtheregulationitshouldhavereceived,hasenabledthefoodsitproducestobecommercialized,andhaskeptthosefoodsonthemarketdespitetheaccumulationofevidencethatshouldhaveforcefullydriventhemfromitisthebiggestandmostperniciouseverconnectedwithscience.ManymorescientistsandrespectedscientificinstitutionshaveinonewayoranotherabettedthespreadofmisinformationaboutGEfoodsthanhavebeeninvolvedinanyotherdeception,andhundreds(ifnotthousands)aroundtheworldhavebeencomplicit.Alsounprecedentedarethenumberofpeoplewho’vebeenfooledandthedegreetowhichthey’vebeendeluded.Hundredsofmillionsonallcontinentshavebeengivenadistortedpictureofkeybiologicalprocesses,falseaccountsoftheresearchandtesting,andmisleadingreportsaboutrisk.Inaddition,regulatorshaveoftenbeenmisledbythemisreportingofdata,andinseveralinstances,theregulatorsthemselveshavecolludedin

themisrepresentationoffacts.Noneoftheotherfraudssignificantlyjeopardizedtheintegrityofscience,nordidanyrelyon

misrepresentingbasicprocessesofbiology.55Further,thosethathaveposedsomethreattohealthhaveusuallyinvolvedasingledrugorfoodadditive.Incontrast,thepotentialnegativeimpactsoftheGEfooddeceptionarewide-ranginganddeeplyendangering.Onthedimensionofpublichealthalone,thisfraudhasalreadypermittedseveralfoodsofquestionablesafetytobebroadlymarketedandextensivelyconsumedthroughouttheUS,Canada,andseveralothernations;anditsultimategoalistosubstantiallytransformthegeneticcoreofvirtuallyeveryfood-yieldingorganism.

Thus,theevidencehasborneoutanassertioninitiallymadeinthisbook’sintroduction:thatthedelinquenciesofthescientificestablishmentinpromotingGEfoodshavenotonlybeenunsavorybutunprecedented.Andithasrevealedthatthecumulativefraudperpetratedtoenableandsustaintheircommercializationisbyfarthebiggest,mostbrazen,andmostdangerousinthehistoryofscience.

ThePsychologyThatDrivestheDeceptionWhathasmotivatedsomanyscientiststobetraythestandardstheyweretaughttohonorandengageinpersistentdeception?Obviously,asseveralchaptershavepointedout,manyhavebeenatleastpartlymotivatedbytheprospectoffinancialgain,eitherbecausetheyownequityinabiotechnologycompany,receivesubstantialincomefromconsultingforsuchcompanies,orreceivegenerousgrantstopursueresearchutilizingrecombinantDNAtechnology.ButmanyscientistswhopromotetheGEfoodventurehavenosuchconflictofinterest,andevenmostofthosewhostandtoprofitfromtheventureareprobablynotentirelydriventosupportitbythedesireforpersonalwealth.Therearedeeperfactorsatplay,andtheyhavealsobeenapowerfulforce.

For40yearslifescientistshavebeenimbuedwiththeideathatgeneticengineeringisnotonlyefficaciousandsafebutintegraltoappliedbiologyandessentialfortheprogressofsociety.Further,many–perhapsmost–havedevelopedthebeliefthatit’scrucialforfeedingtheburgeoningpopulationintheThirdWorldaswellasinstrumentalforprotectingtheenvironmentandenhancingthequalityoffoodwithintheindustrializednations.Theyalsobelieveitwillenableprofoundadvancesinmedicineandmanyfieldsofmanufacturing.Socertainaretheythatthebenefitsofthistechnologywillbeprofoundandtherisksnegligiblethatmanyfeelnotonlyjustifiedtoemployit,butdeeplyobligatedtodoso.Asonemicrobiologistdeclared,heandhiscolleagueshavea“moralandethicalresponsibility”topursuethepromiseofgeneticengineering.56AndseveralprominentBritishscientistshavearguedthatdevelopingGEcropsintheThirdWorldisa“moralimperative.” 57

Concomitantwiththisbeliefinthenecessityofgeneticengineeringisthefeltneedtovigorouslydefendit,andalargenumberoflifescientistshavecometoregardanycritiqueagainstaparticularapplicationofrDNAtechnologyasathreattoallitsotherapplicationsaswell.Accordingly,thebiosciencecommunitytendstobehaveasifpublicrejectionofgeneticengineeringinagriculturewillendangeritswidespreadacceptanceinotherareasandtoreacttocriticismofGEfoodsasifitwereanassaultonbiotechnologyasawhole–andtoasignificantextent,anattackonthelifesciencesascurrentlystructuredandpracticed.ItalsoincreasinglyregardsallconcernsaboutthesafetyofGEfoodsasbasedinignorance.ThisnotioncolorsaWorldBankreportonGEcropsthatsaysthosewhoare“technicallycompetent”havenoqualmsaboutsafetyandthatthepublicperceivesrisksonlybecauseitsmemberslacksuchcompetence.58

Withinthismindset,thingstendtobeviewedintheextreme,andanattitudehasarisenthatthebiosciencecommunityneedstocloseranksanddefenditselfagainstthepublic’signoranceandirrationalfearswhich,leftunchecked,couldimpedeifnotthwartthefulldevelopmentanddeploymentofbiotechnology.Forinstance,theeminentbotanistNormanBorlaugwarnedthatwhenitcomestonew

modesofagriculturesuchasbioengineering,“scienceandtechnologyareundergrowingattack”by“misinformedenvironmentalists”who“seemtobedoingeverythingtheycantostopscientificprogressinitstracks.” 59

Becausesomuchprogressisfelttobeinjeopardy,theconvictionhassteadilygrownthatpreservingthevastbenefitsofbiotechnologyfromtheravagesofirrationalityisofsuchimportancethatthosewithgenuineknowledgearejustifiedinresortingtowhatevertechniqueswillfavorablyswaypublicperceptions.Andasmanyscientistsprogressivelyindulgedintheprojectionofalluringimagesandtheobfuscationoffacts,theyeventuallycrossedthevagueboundarybetweenobfuscationandmisrepresentation–andseemtohavefeltlegitimizedindoingso.Ironically,thisendsjustifiesthemeansapproach,inwhichmisrepresentationintheserviceofscientificprogressisviewedasessentiallybenign,isreminiscentofthe“piousfrauds”throughwhichreligiousofficialssometimesmanipulatedinformationsoastobolsterfaithamongtheflock.

TheImportanceofAssigningCulpabilityWhatevertheunderlyingmotivations,themisleadingpronouncementsofthescientificcommunityhavealreadydonegreatharm–andimposedmuchgreaterpotentialharm.Moreover,it’simportanttorecognizethatmostofthesepronouncementshavebeengenuinelyfraudulentandthatthescientistswhohavemadethemareguiltyoffraud,evenwhentheyhavenottechnicallytoldlies.

Ourlegalsystemrecognizesthatfraudcanexistwithoutovertfalsehoodandthatitsdefiningfeatureisdeception.Asonecourtstated:“Actsconstitutingfraudareasbroadandasvariedasthehumanmindcaninvent.Deceptionanddeceitinanyformuniversallyconnotefraud.” 60Becausetheessenceofdeceptionistocauseafalseimpressioninthemindsofothers,onecanbeguiltyofitnotonlybyemployingmisleadingwords,butalsobywithholdingwords.Therefore,accordingtothelaw,failingtorevealpertinentfactsisaformoffraud,asistheattempttohinderothersfromgainingorunderstandingthem.

Sofromtheperspectiveofthelegalsystem,alargenumberofscientistshaveclearlyengagedinfraudulentbehaviorinordertopromotegeneticallyengineeredfoods.Whetherornottheyhaveintentionallylied,theyhavegeneratedwidespreadconfusion,andoftendelusion,aboutthefacts;andtheyarethereforeguiltyoffraud.61

ThemisrepresentationsthathavesurroundedGEfoodsarevaried,rangingfromblatantliesissuedbyFDAofficialstonuanceddistortionsdispensedbyuniversityprofessors.Butwhiletheformsvary,theyareallinsomesignificantwaydeceptive–andhaveallbeeneffective.Andtheindividualswhohavedispensedthemshouldbeheldaccountable.

Thus,theadventofgeneticengineeringhasindeedinducedaseriousattackonscience;buttheattackhascomefromwithin,ashundredsofscientistshavesystematicallysubvertedthestandardstheyweretrainedtoupholdinordertoupholdthatenterprise.Consequently,notonlyisagriculturalbioengineeringthesolefaith-basedtechnology,it’stheonlytechnologythat’sbeenchronicallyandcruciallyreliantonthepersistentdisseminationofdisinformation–withthescientificestablishmentthedisseminator-in-chief.Andifthatesteemedgroupofindividualsandinstitutionshadmaintaineditsintegrityandspokenhonestly,theventurecouldneverhavegainedtraction.

Furthermore,themyriaddistortions,deceptions,anddownrightliesissuedbyscientistsandscientificinstitutionsonbehalfofgeneticengineeringsinceitemergedinthe1970’sconstitutethemostcolossalandperniciousscientificfraudeverperpetrated;andbesidestheseriousdamagethey’vedonetotheintegrityofscience,they’veimposedunacceptablerisksonhumanandenvironmentalhealth.

Accordingly,inlightoftheenormityofthisfraud,thecomplicityofsomanygovernmentagenciesand

officials,andthemagnitudeoftherisksithasinflicted,majorremedialactionisrequiredwithinboththepublicandprivatesectors.Fortunately,sensiblesolutionsareavailable.

CHAPTERFOURTEEN

NewDirectionsandExpandedHorizons

AbandoningGeneticEngineeringandAdvancingtoSafe,Sustainable,andSensibleModesofFarming

FacingUptotheCriticalFactsTheinfluentialbioethicistGaryComstockhasarguedthatitisethicallyjustifiedtodevelopgeneticallyengineeredfoods“assumingweproceedresponsiblyandwithappropriatecaution.” 1ButtheprecedingchaptershavedemonstratedthattheGEfoodventurehasabjectlyfailedtomeetthiscriterionandhasinsteadroutinelyproceededinanirresponsibleandrecklessmanner.Aswe’veseen,ithasadvancednotbyhonoringtheprinciplesandprotocolsofsciencebutbyevadingthem,notbyfollowingthefoodsafetylawsbutbyviolatingthem,andnotbyopenlyandfairlycommunicatingthefactsbutbysystematicallycloudingandfrequentlydistortingthem.Further,we’veseenthatbecauseofthenatureofthegeneticengineeringprocess–andtheeconomicrealitiesinherentinapplyingittocommercialagriculture–theseabusesarenotavoidableaberrationsthatcanultimatelybeeliminatedfromtheenterprisebutratherareintrinsicfeaturesnecessaryforitssurvival.Andit’sbecomequiteclearthatifthecorporationsthatproducegeneticallyengineeredfoodsandthegovernmentagenciesthataresupposedtoregulatethemwereactuallytofollowsoundscience,toupholdthelaw,andtoconsistentlycommunicatethetruth,theentireventurewouldquicklycollapse.

Moreover,Chapter11hasdemonstratedthatfromtheperspectiveofcomputerscience,thetechniquereferredtoasbioengineeringisactuallybiohacking–andthatit’sinherentlyunsafebecause,duetothevastcomplexity,extremeinterconnectivity,andsubstantialinscrutabilityofbioinformationsystems,scientistsareincapableofalteringthemaccordingtothestandardsbywhichsoftwareengineersreviselife-criticalcomputerprogramsandcanonlyexerciseameremodicumofthecautionrequiredinthatfarmoremanageableenterprise.

TheGEFoodVenture’sDefining(andDebilitating)Attribute:EthicalUnsustainabilityConsequently,althoughtheproponentsoftheGEfoodventureconsistentlyclaimthatit’sessentialforestablishingsustainableagriculture,ithasinfactintroducedanewdimensionofunsustainability.Regardlessofthefarmingpracticesassociatedwiththecropsitproduces,theenterpriseisethicallyunsustainablebecauseitcannotcontinuewithoutconsistentevasionofsoundscientificpractices,violationofthelaw,andmisrepresentationofthefacts.Justconsiderwhatwouldhappenifalltheinformationinthisbookbecamewidelyknownandmostpeople(includingmostUS,Canadian,andEuropeanlegislatorsandothergovernmentofficials)learnedhowradicallygeneticengineeringdiffersfromtraditionalbreeding,howmethodicallytheriskshavebeenmisrepresented,howfrequentlythetestshavereturnedunsettlingresults,howroutinelytheprotocolsofsciencehavebeenviolated,howbadlythefoodsafetylawsoftheUnitedStateshavebeenbroken,andhowthoroughlytheythemselveshavebeendeceived.

It’sobviousthattheventurecouldnotsurvive.Andbynowitshouldbeobviousthatitdoesn’tdeserveto.

TheBiotechnicians’LackofNecessaryKnowledgeIsFarMoreEvidentTodaythanWhenEarlier

WarningsWereIssuedAnyonewhomaystillbeunconvincedabouttheunacceptabilityoftheGEfoodventureshouldagainconsiderhowdeeplydeficientistheknowledgeonwhichitrests.Forinstance,in2000PatrickBrown,aprofessorofplantscienceattheUniversityofCalifornia,Davis,wroteacautionaryarticleaboutagriculturalbioengineeringasserting:“Asscientistsitisourresponsibilitytorecognizethatwedonotyethavesufficientknowledgeoftheprocesstouseitsafely.” 2Asheexplained:“Wemustrecognizethatourknowledgeoftheprocessesthatregulategeneincorporationandexpressionareintheirinfancyandthatourcapacitytomanipulatetheplantgenomeiscrude....”Hethenpointedoutthatmostofwhatwedoknowindicatesthe“profoundmanner”inwhichthisartificialprocessdiffersfromtraditionaltechniques–andthatit’s“wellknowntocauseunexpectedmetabolicperturbations.”

Aswell-foundedasProfessorBrown’swarningswerein2000,they’reevenmorecompellingtodaybecause(asChapter11hasshown)startlingdiscoverieshaverevealedthatbioinformationsystemsarefarmorecomplex,andfarmorepoorlycomprehended,thanwasrecognizedwhenhewrote.Accordingly,wenowknowthatbiotechnicianshaveevenlesscapacitytosafelymanagethealterationstheyimposeuponthoseintricatesystemsthanheassumedtheypossess.ThisalsoentailsthatthesimilarprecautionsissuedbytheRoyalSocietyofCanadaayearafterDr.Brownissuedhisarelikewiseevenmorepertinenttodaythanwhenfirstwritten.

Underscoringhowvastistheongoingignoranceabouttheintricaciesofbiologicalsystems,andhowutterlyincapablebiotechniciansareofreconfiguringtheminapredictablysafemanner,scientistsstillhavenotlearnedhowtoalteroneofthemostrudimentaryofthesesystemswithoutunexpectedoutcomes.Thus,afterseveralyearsofattemptstocomputationallymodelavirusthat’s“oneofthesimplestandmostwell-studiedbiologicalsystems,”abiologistattheMassachusettsInstituteofTechnologywasstillunabletopredicthowmutationswouldaffectitsdevelopment,withhissimulationsregularlyfailingtomatchactualresults.3Incommentingonthisfailure,anarticleinHarvardMagazineobserved,“Evolutionmayhavebeenresponsibleforthediversityofbiologicalfunctions,buttoahumanscientist,thosefunctionscouldappearbyzantineandimpossibletocomprehend,letaloneengineer.” 4Consequently,inordertobetter“understandandmanipulate”thevirus,thebiologistandhisteamre-builtitinawaythatwasmuchsimpler.However,althoughthisrestructuringmadethenewversionoftheviruseasierforthemtoalterinapredictablemanner,itsubstantiallyimpairedtheentity’sintegrity,and“itsfitnesswasconsiderablyreduced.”

Thisincidentundercutstheideathatagriculturalbioengineeringcanbeperformedsafely.Virusesarenotevenlivingcells,andthevirusinvolvedwasoneofthesimplestamongeventhatclassofsimplesystems.Further,ithadbeenstudiedfor60years.5Yet,itsgenomewasstillnotcomprehendedwellenoughtomanipulateinapredictablefashion.Therefore,itwouldbeoutlandishtosupposethatbiotechnicianscouldartificiallyalterthefarmorecomplex,farlesswell-studiedgenomesofhigherorganismswithgreaterforesightandenhancedreliability–andfarmorerealistictoconcludethatthey’llprobablyneverbeableto.

AnotherCompellingRealityCheckIncaseyoustillshyawayfromtheideaofcompletelycurtailingGEfoods,askyourselfwhetheryouwouldbewillingtodailyflyonanairplanethat’sdependentonacomplexcomputer-runguidancesystemthathadbeenradicallyrevisedwithoutundergoingthesafetytestingnecessarytoensurethatevenminorrevisionstosuchsoftwareprogramshavenotdisruptedthemindangerousways.Further,evenifyou’dpersonallybewillingtotakethisgamble,wouldyouwanttosubjectyourchildrenorgrandchildrentosucharepetitiverisk?

Ofcourse,thiskindofsituationwouldnotariseinthecaseofacommercialairlinerbecausethe

federalregulatorswouldn’tallowthedeploymentofsuchanalteredbutimproperlytestedguidancesystem,andit’sonlybecausetheregulatorsthatshouldhavebeenapplyingparallelsafeguardstoGEfoodshavebeengrosslydelinquentthatthelatterproductsareonthemarketatall.Moreover,ifyouwouldn’twantyourlovedonessubjectedtotheriskofregularlyflyingonanairplanewitharadicallyrevisedbutdeficientlytestedguidancesystem,howcouldyoucountenancesubjectinghundredsofmillionsofpeopletotherisksofconsumingfood-yieldingorganismswhosecomplexinformationsystemshavealsobeenradicallyrevisedbutinadequatelytested?

ExposuretoGenuineFactsCanPromptDramaticTurnaroundsAscompellinglyasthesoftwareanalogycanfunctioninsolidifyingoppositiontoGEfoods,there’sampleevidencetodosowithoutbringingthatanalogyintoplayatall.AstrikingexampleofhowpowerfullyevenapartialsetofthepertinentfactscanreverseopinionsabouttheseproductsisprovidedbyDr.ThierryVrain,whowasformanyyearstheHeadofBiotechnologyatAgricultureCanada’sSummerlandResearchStation.Followingaresomeilluminatingremarkshemadein2014.

Iretired10yearsagoafteralongcareerasaresearchscientistforAgricultureCanada....Iwasthedesignatedscientistofmyinstitutetoaddresspublicgroupsandreassurethemthatgeneticallyengineeredcropsandfoodsweresafe....

Ihaveinthelast10yearschangedmyposition.IstartedpayingattentiontotheflowofpublishedstudiescomingfromEurope,somefromprestigiouslabsandpublishedinprestigiousscientificjournals,thatquestionedtheimpactandsafetyofengineeredfood.

Irefutetheclaimsofthebiotechnologycompaniesthattheirengineeredcropsyieldmore,thattheyrequirelesspesticideapplications,thattheyhavenoimpactontheenvironmentandofcoursethattheyaresafetoeat....

Thewholeparadigmofthegeneticengineeringtechnologyisbasedonamisunderstanding....Ithinkthereiscauseforalarmanditismydutytoeducatethepublic.OneargumentIhearrepeatedlyisthatnobodyhasbeensickordiedafterameal...ofGM

food.Nobodygetsillfromsmokingapackofcigaretteseither.Butitsureaddsup,andwedidnotknowthatinthe1950sbeforewestartedourwaveofepidemicsofcancer.Exceptthistimeitisnotaboutabitofsmoke,it’sthewholefoodsystemthatisofconcern.Thecorporateinterestmustbesubordinatedtothepublicinterest,andthepolicyofsubstantialequivalencemustbescrappedasitisclearlyuntrue.6

ConfidenceinGEFoodsIsSubstantiallyBasedonMisinformationAlthoughtherehavealsobeencasesinwhichindividualswhopreviouslyobjectedtoGEfoodshavereversedtheirposition,I’mnotawareofanyinwhichthereversalwas,likeDr.Vrain’s,basedonanaccurateunderstandingofthefacts.Instead,theshiftsseemtohavesignificantlystemmedfromconfusion.Forinstance,inanarticledescribingwhyhechangedhispositiononGEfoodsandhascometothinkthatit’slegitimatetodevelopthem,thebioethicistGaryComstockindicateshehastrustedthepronouncementsoftheirscientist-promoters–andhasnotrealizedtheyaresignificantlyinaccurate.7Healsoappearstobemistakenaboutthequalityofthetestingthat’sbeingconducted,becausehestipulatesthatthesafetyofGEfoodsmustbeassured“througharigorousandwell-fundedriskassessmentprocedure”–andevidentlybelievesthatGEcropshavebeensubjectedtoone.

Moreover,headditionallybaseshispositiononthebeliefthatit’slegitimatetopermitthepotentialbenefitsofGEfoodstooutweightheirharms,eventhough(asChapter9hasexplained)whenitcomestofoodsafety,USlawstrictlyforbidssuchapracticeanddemandsdemonstrationofareasonablecertaintythatnovelproductswillnotbeharmful.Butnotonlyisheunawareofthiscriticalfact,heseemsunaware

thatthetoutedbenefitshavebeenoverblownandthatseveralrigoroustestshavedetectedharmtolaboratoryanimals.Thus,hisrealignmentofattitudehasbeenundulyinfluencedbyerroneousideas.8

Furthermore,aswe’veseeninChapter13,itappearsthatmostscientistswhothemselvesdon’tactivelypromoteGEfoodsandyetbelievethey’resafe,have(likethebioethicistComstock)formedtheirbeliefsduetodisinformationdispensedbyscientistswhodopromotethem.Anditalsoappearsthatwhenprovidedaccurateinformationbyarespectedsource,theychangetheirminds.We’veadditionallyseen(inChapter11)thatBillGates’confidenceinGEfoodsissignificantlybasedonthemistakenbeliefthatthey’rebeingadequatelytested(orreadilycanbe),despitethefactthatfromtheperspectiveofsoftwareengineering,thetestinghasbeenludicrouslydeficient–andcouldnotvaguelyapproachtherigorwithwhichlife-criticalsoftwareistestedwithoutatremendousrevampingofthecurrentsystem.

GEFoodsAreUnacceptablyRiskyfromEverySignificantAngleofAnalysisAsrevealedinpreviouschapters,therisksofGEfoodshavebeenshowntobeunacceptablethrougheachofthreedistinctlinesofinvestigation:(1)agenuinelyscientific,biological-basedriskassessment,(2)anassessmentbasedontheprinciplesofcomputerscience,and(3)anassessmentoftheaggregateevidenceofadverseoutcomesthey’veinduced.Butthere’syetanotherangleofanalysisthroughwhichtheextraordinaryriskinessoftheseproductscanbedemonstrated:aformalstatisticalapproachbasedinprobabilitytheoryandthepropertiesofcomplexsystems.Suchananalysiswaspublishedin2014byateamoffiveexpertsinriskassessment,headedbyNassimN.Taleb,aDistinguishedProfessorofRiskEngineeringattheNewYorkUniversitySchoolofEngineeringandwidelyrenownedforhisbook,TheBlackSwan.

Theseexpertsasserttheimportanceofdistinguishingtwobasicformsofpotentialharm:(a)“localizednonspreadingimpacts”and(b)“propagatingimpactsresultinginirreversibleandwidespreaddamage.”Theystatethatthefirsttypeismorecommonandmoreeasilydealtwithbecauseitcanbecalculatedthroughpastdataandmanagedthroughcost-benefitanalysesandmitigationtechniques.Moreover,theypointoutthatevenwhenmiscalculationsaremadeinregardtosuchrisks,theresultantdamage“isbounded.” 9

Incontrast,theyemphasizethatthesecondtypeofpotentialharm,whichentailsthepossibilityofnonlocalizedirreversibledamage,requiresamuchmoreprecautionaryapproach.Theystatethatifanactivityposessucharisk,unlessthereis“scientificnear-certainty”aboutitssafety,itsproponentsmustbeartheburdenofprovingthatit’ssafebeforeimplementationispermitted.

Butthey’requiteconservativeinregardtothishighlyconservativeapproach,andtheythinkitshouldonlybeappliedinextraordinarycases.Thus,theydon’tevenconsiderittobewarrantedinmanyoperationsthatemploynuclearenergy,becausetheyviewthepotentialharmasessentiallylocalandnonsystemic–andthuscapableofbeingmanagedthroughconventionalriskassessmentandcostbenefitanalysis.

Yet,althoughinthecaseofnuclearenergytheseexpertscautionagainstextremecaution,andadviseagainstapplyingthestrictprecautionaryapproachasageneralrule,theycategoricallyprescribeitinthecaseofGEcrops.That’sbecausetheydeemtheattendantriskstobesystemic–andtoentailpotentialwidespreadharmtotheecosystemaswellastohumanhealth.Andtheyprovideextensiveanalysistobacktheirjudgmentup.

Moreover,theynotethelackofsoundanalysisorevidencetosupportthepermissiveapproachurgedbybiotechproponents.Astheyobserve:“Ratherthanrecognizingthelimitationsofcurrentunderstanding,poorlygroundedperspectivesaboutthepotentialdamagewithunjustifiedassumptionsarebeingmade.Limitedempiricalvalidationofbothessentialaspectsoftheconceptualframeworkaswellasspecificconclusionsarebeingusedbecausetestingisrecognizedtobedifficult.”

TheirconclusionaboutGEcropsisunequivocal:thatstrictprecautionshouldbeexertedtoavoidthe

riskof“considerableandirreversibleenvironmentalandhealthdamage”–which,intheirapproach,entailsthatnonewGEcropsshouldbeapprovedandallthosecurrentlyonthemarketshouldbewithdrawn.

AnInescapableConclusion:GEFoodsMustBePromptlyBannedThus,fromwhateverangleweconsidertherelevantevidence,it’sclearthattheGEfoodventurehasnotbeen,norcanbe,conductedresponsiblyorsafelyandthatitmustthereforebeterminatedasrapidlyaspossible.AndthenationthatcouldplaythekeyroleinhaltingitistheUnitedStates.AlthoughtheUShasbeenthechiefdriveroftheGEfoodventure,andalthoughtheventurecouldnothaveadvancedorevensurvivedwithoutthefraudoftheUSgovernment,becausethenation’sfoodsafetylawsareactuallyinimicaltothisventureascurrentlyconducted,itcouldbemostquicklyandthoroughlyarrestedthere.Andthesoonerthisfactbecomesmorewidelyrealized,thequickerthechangecanhappen.

TheFocusShouldExpandfromMereLabelingtoFullElimination

ThetimehascomeforAmericanconsumerswithconcernsaboutGEfoodstobroadentheirfocus.Insteadofexclusivelyendeavoringtogetthesefoodslabeled,theyshouldalsoconcentrateongettingthembanned.NotonlyaretheproductsillegallyontheUSmarket,it’sclearthattheprocessbywhichthey’reproducedisinherentlyhigh-riskandcouldneveradequatelyconformtotherequirementsofthefoodsafetylaws,thestandardsofscience,ortheprotocolsofinformationtechnology.

Althoughtherighttoknowwhat’sinourfoodisanimportantone,it’sunderlainbyonethatismorefundamentaland(inthecaseoftheUnitedStates)moreexplicitlygrantedbystatute:therightnottobeexposedtoinadequatelytestedgeneticallyengineeredfoodsinthefirstplace.Afterall,labelingistechnicallyappropriateforfoodsthatarelegitimatelyonthemarket,andifagroupoffoodsareinsteadbeingmarketedillegally,theproperremedyisnottolabelthembuttoremovethem.Infact,placingtheemphasisonlabelingimpliesthatthefoodsareonthemarketlegallyandobscurestherealitythatthey’reactuallybeingsoldinviolationofthelaw.

ThecampaignstoobtainlabelingthathavebeenundertakeninsomanystateswithintheUShaveperformedahighlyvaluablefunctionininformingcitizensaboutthepresenceofGMOsinmostofthefoodsthey’vebeenbuying,ineducatingthemaboutthedownsides,andinhighlightingthelackoffederalregulation.Butnowthatpeoplearegenerallymoreawareandbetterinformed,it’simportanttheyrecognizethekeyissueisnotthatGEfoodsareonthemarketwithoutlabelingbutthatthey’reonthemarketatall–andthatfederallawwouldhavekeptthemoffthemarketiftheFDAhadnotfraudulentlybrokenit.

Moreover,theissueoflabelingis,asbothapracticalandtechnicalmatter,ultimatelyintertwinedwiththequestionofwhethertheFDA’spresumptionthatthey’reGenerallyRecognizedasSafe(GRAS)isvalid.Asatechnicalmatter,thejudgeintheAllianceforBio-IntegritylawsuitlinkedthetwoissuesandruledthatiftheFDA’spresumptionislegitimate,itsdeterminationthatbioengineeringisnotamaterialfactthatmustbedisclosedthroughlabelingislikewiselegitimate.(ThishasbeendiscussedinChapter5.)Andasapracticalmatter,anylawthatastatepasses(eitherthroughdirectlegislativeactionorballotinitiative)thatrequireslabelingwillbechallengedincourt;andthestrongestdefensewillbetodemonstratethattheFDA’srebuttableGRASpresumptionnotonlyhasalwaysbeenillegitimatebuthasbeenrepeatedlyrebutted–andcannotthereforelegitimizetheagency’sfailuretorequirelabeling.Thus,althoughthecourtadjudicatingsuchalawsuitwouldnotbeempoweredtoorderGEfoodsoffthemarket(aswouldacourtadjudicatingadirectactionchallengingtheFDA’sGRASpresumption),thepresumption’sinvalidityprovidesgroundsforrulingthatstateshavealegitimaterighttorequirethatthesefoodsbelabeled.10

It’salsoimportanttobearinmindthateveniflabelingbecomesrequiredintheUnitedStates,it

wouldprobablynotcompletelycurtailtheGEfoodventure.WhileitmightdeterMonsantoandmajormultinationalcorporationsfromcontinuingtoproduceherbicideresistantandpest-resistantGEcrops,whichdon’tprovideconsumersanydirectbenefit,itmightnothinderthemfromdevelopingtheso-calledsecondgenerationofGEcropsdesignedtoprovidenutritionalenhancement(suchastheadditionofOmega3fattyacids)ortoeliminateundesirablefeatures(suchasanallergen).Manufacturerswouldwanttolabelsuchfoodsanyway,becausetheywouldneedtoinformconsumersofthepurportedbeneficialdifferencesbetweenthemandtheirconventionalcounterparts.

Further,it’sdoubtfulthatalabelingrequirementwouldstoptheBillandMelindaGatesFoundationorotherfoundationsandinstitutionsfromdevelopingGEcropstoassisttheThirdWorld.ThenarrativethatwouldpredominateisthatalthoughaffluentUSconsumershadbeendrivenbyirrationalfearstodemandlabelingforthemselves,theimpoverishedpeoplesofthedevelopingworldshouldnottherebybedeniedthebenefitsofGEcrops;andtherewouldnodoubtbeanincreasedeffortto“educate”thesepopulations,andtheworldatlarge,aboutthepurportedscience-basedsafetyoftheseproducts.Moreover,becausethelabelingcampaignshavefocusedontherighttoknowandhavelargelycededthescientifichighgroundtotheproponentsofGEfoods,they’vemadeiteasierforsuchamisleadingnarrativetoprevail.

Incontrast,byinsteadpressingforacompleteban,andfocusingontheillegitimacyoftheFDA’sGRASpresumption,thecoveredupwarningsofitsownscientists,andtheotherreasonsforregardingGEfoodsasunacceptablyrisky,thestandardfictionalnarrativewillbelesslikelytostand.Andit’simportantthatitdoesnot,andthattheprevailingnarrativebefact-based,nomatterhowunpleasantthosefactsbynowhavebecome.Thetruthhasbeentwistedforfartoolong,andtherecordmustfinallybesetstraight.

EffectingaBanCanBeAccomplishedQuiteSimply

a.There’sNoNeedtoPassaNewLaw,butMerelytoEnforceOnethat’sAlreadyontheBooks

Whereasachievinglabelingatthestatelevelrequiresnotonlythepassageofnewlawsbutthesuccessfuldefenseofthoselawsincourt,removingGEfoodsfromthemarketdoesnotrequireanyadditionallaworregulation.Thestatutethatshouldhaveforcedthemtobeadequatelytested(andthatwouldhaveeffectivelykeptthemoffthemarkethaditbeenhonored)waspassedin1958,andtheFDAregulationsthatgaveitadditionalstrengthhavealsobeenonthebooksformanyyears.Theonlynoveltythat’sneededisfortheFDAtostartenforcingthelawratherthantocontinuebreakingit.

Andthatchangecouldbeeasilyeffected.Itonlyrequiresonepersontotakethedefinitivestep,andthatpersonisthepresidentoftheUnitedStates,whoatthetimeofthiswritingisBarackObama.IfPresidentObamaweretolearn,eitherfromthisbookoranothersource,howbadlyheandhispredecessorshavebeenmisledaboutGEfoodsandhowflagrantlythelawhasbeenbrokenformorethantwentyyears,it’squitelikelyhewouldbemovedtotakeremedialaction.AndallhewouldneedtodoisissueanexecutiveordertothecommissioneroftheFDAinstructingherthattheagency(1)mustopenlyacknowledgethatitsrebuttableGRASpresumptionregardinggeneticallyengineeredfoodshasbeensolidlyrebuttedand(2)musttakestepstoremoveeachGEfoodfromthemarketuntilithasatminimumbeendemonstratedsafe(accordingtothereasonablecertaintyofnoharmstandard)throughrigorouslong-term,multi-generationaltoxicologicalfeedingtests.Suchanorderwouldbewellwithinthelawand,moreover,wouldhavetheforceoflaw.

AlthoughpresidentialexecutiveordersareoftencriticizedbymembersoftheopposingpartyinCongressonthegroundstheactionshouldhavefirstreceivedCongressionalapproval,andalthoughtheonesissuedbyPresidentObamahavetendedtoincursuchcriticism,therewouldbenoplausiblegroundsforsuchobjectionsinthecaseofanordertoreformFDApolicyonGEfoods.That’sbecausethepresidentwouldbecorrectingalongstandingderelictioninwhichtheexecutivebranchhassubvertedthewillofCongressbyviolatinganimportantlawthatCongresshadalreadypassed.Sosuchanexecutive

orderwouldnotbecircumventingCongressbutremedyinganillegalcircumventionofthatbody’swill.Thus,thepresidentwouldbeupholdingandimplementingtheexpressedintentionofthelegislativebranch,anactforwhichnoneofitsmemberscouldlegitimatelycriticizehim.

b.QuickRemovalIsAgriculturallyFeasibleToo

Butintermsofeconomicandagriculturalfeasibility,couldGEcropsberapidlyremovedfromthemarket?AccordingtotheagriculturaleconomistJohnIkerd,anemeritusprofessorwiththeUniversityofMissouri,itwouldbedifficulttodoitwithinoneyearduetothefacttherewouldn’tbeanadequatesupplyofnon-GEseedswithwhichtoplantthenextcropofcorn,soybeans,andcanola.Inhisview,thebancouldapplytoallnewGEvarieties,withexistingonesphasedoutoverperhapsasfewastwogrowingseasonstoallowforanorderlyadjustment.Hesays,“Althoughthesechangescouldn’tbemadeimmediately,theycouldstillbeachievedratherquickly.” 11

Ofcourse,themereannouncementbytheFDAthatGEfoodscouldnolongerbepresumedGRAS,thateachmustundergotheformalfoodadditivepetitionprocessandbedemonstratedsafeviarigoroussafetytesting,andthateachwouldbebanneduntilthishadhappenedwouldhaveapowerfuleffect.Andeveniftheagencyspecifiedthatthebanwouldbeimplementedoveratwoyearperiod,itwouldsubstantiallydepressconsumerdemandandcouldcreatesignificantcomplications.Butsuchconsiderationsshouldnotbepermittedtodelaytheannouncement,becauseotherwiseitwouldbecontinuallypostponed.

OnceweaccepttherealitythatGEfoodsareunacceptablyrisky,decisiveactionmustbetaken,withtheunderstandingthatit’sfarbettertoweatherwhatevershort-termeconomicdifficultiesmaybeentailedbypromptlybanningthemthantosufferthepotentiallong-termhealthandenvironmentaldamagethatcouldresultfrominaction.

InAdditiontothePresident,OtherKeyIndividualsCouldPlayaMajorRole

EvenifthepresidentoftheUSdidnottaketheinitiative,severalotherindividualsareinapositiontodoso.Forinstance,whatifBillorMelindaGatesweretoreadthisbook?Theyareastuteindividualswithadeepunderstandingofcomputerscience,andit’sdifficulttobelievetheywouldnotbeaffectedbythepresentationofevidenceandbytheanalysisdemonstratingtheunsoundnessofgeneticengineeringfromtheperspectiveofsoftwareengineering.IfMr.Gatesconcludedthathe’sbeensignificantlymisinformedaboutthefacts,decidedthatit’sunwiseforhisfoundationtocontinuetoinvestinthedevelopmentofGEcrops,andthenspokeoutaboutwhyhehadchangedhismind,theGEfoodventurewouldnosedive.

AnotherpersonwhocouldgenerateanequallyprofoundeffectisBillClinton,whohasbeenoneoftheGEfoodventure’sstrongestboosters.In2006hedeclared,“IdideverythingIcouldasPresidenttosupportthedevelopmentofbiotechnologyanditspracticalapplicationsinAmericanlife.” 12HealsoexpressedhisongoingsupportforGEcrops,butwiththeproviso,“IfanybodycouldgivemeanyevidencewhyIshouldn’tdoit,I’dbehappytochangemyposition.” 13AndI’dbehappyifsomeonecouldputthisbookinfrontofhim,whichwouldprovidesuchevidenceinabundance.Ifherealizedhowseriouslytheactualfactsclashwithwhathewasledtobelievebypeoplehehadgoodreasontotrust,andhow,underpressurefromhispredecessor’sadministration,theFDAhadviolatedthelawinordertoputGEfoodsonthemarket,it’slikelythathewouldnotonlychangehisposition,butfeelobligedtotrytomakeamendsfortheirresponsiblepolicyhehasforsolongmistakenlysupported.Andbecausehe’ssoskilledatcommunicatingideasandcontinuestowieldgreatinfluence,hecouldpulltherugoutfromundertheGEfoodventureifhewantedto.

Further,thereareseveralcurrentandformerheadsofstateinothernationswhocouldputthebrakesontheventure,especiallywhenarmedwiththepertinentfacts.

Butevenifittakesconsiderabletimebeforehighlyinfluentialindividualsspeakout,ascitizenslearn

thefactsandexerttheircollectiveinfluence,progresscanoccur.BecausetheGEfoodventureisgroundedondisinformation,it’sdeeplyvulnerable.So,inonewayoranother,itwillinevitablybestopped.

ThisIsNotanExtremePosition

Althoughmanymaybrandthisstanceanextremeposition,it’snot.Afterall,isitextremetoinsistthatthefoodsafetylawsbefollowed?Isitextremetodemandthathumansrefrainfromrewritingthemostcomplexandleastunderstoodinformationsystemsonearthunlesstheycandosowithatleastthesamedegreeofcarethat’sexercisedbythetechnicianswhoreviseman-madesystemsthatarefarsimplerandfarbettercomprehended?Isitextremetoaskthatmajordecisionsaboutthewholesomenessofourfoodandthefutureoffoodproductionbebasedonthebestscientificknowledgeandsolidempiricalevidenceratherthanondiscreditedpresumptionsanddeficienttesting?Isitextremetorejectthepronouncementsofscientistsandscientificinstitutionsthathavesoconsistentlydisplayeddishonestythatnoresponsiblejurywouldaccepttheirtestimony–eveninacasewherethestakesare,bycomparison,trifling?

Ofcoursenot.Inreality,it’squiteconservative.What’sextremeistheGEfoodventureitselfandtheclaimthatitsproductsareessentiallyasreliable

andsafeascropsproducedviatheprocessesofnature.What’sextremeisthenotionthatthisradicalventureshouldnotonlybecontinuedbutbeextendedintoorganicagriculture.What’sextremeistheideathatalthoughthisventurehasconsistentlydependedondeceptionandimposedextraordinaryrisks,becauseithasbecomesoentrenchedweshouldjustputupwithit.

CurtailingGEFoodsIsJustasMuchaConservativeCauseasaProgressiveOneAlthoughmanyproponentsoftheGEfoodventureportrayanyoppositiontoitastheproductofaleft-leaningagenda,andimplythatconservativesshouldasamatterofprinciplesupportit,thisisinaccurate.Inreality,notonlyistheventurecontrarytobasicprinciplessharedbyliberalsandconservativesalike,it’sespeciallyoffensivetosomethatarespecificallyupheldbythelatter.

Forinstance,FriedrichHayek,oneofthemostinfluentialconservativethinkersofthelasthundredyears,whosetheorieshavebeenlaudedbyfreemarketeconomistsandpoliticianslikeRonaldReaganandMargaretThatcher,emphasizedtheimportanceofrespectingcomplex,spontaneouslyorderedsystemsandtheinabilityofhumanintelligencetoimposepurportedlyrationalplansontosuchsystemswithoutinducingunintendedconsequences.Andalthoughthisthinkingisjustasapplicabletobioinformationsystemsastoeconomicsystems,toomanyconservativesfailtorealizethatthebioengineersaredoingpreciselywhatHayekobjectedtoandareattemptingtomanipulatecomplexnaturalsystemsinatop-down,interventionalmannerwithscantknowledgeoftheintricatedynamicsthroughwhichthesesystemsfunction.

Unfortunately,astheconservativecolumnistDavidBrookshasobserved,manyoftoday’sconservativeshavebecomesonarrowlyfocusedonreducinggovernmentregulationthattheytendtooverlookothertraditionalconservativeaims.14And,fromaHayek-inspiredperspective,itwouldseemthatpreservingtheintegrityofthebioinformationsystemsuponwhichhumanityreliesfornourishmentclearlyqualifiesasoneofthosegoals.Accordingly,itcouldbecogentlyarguedthatconservativesshouldnotbewillingtotoleratetheheavy-handedandradicalrestructuringofthesemostcomplexnaturallyformedsystemsonearthmerelybecausesomegovernmentalregulationwouldbeneededtopreventit.

Furthermore,thenumerousconservativeswhoaredevoutlyreligioushaveevendeeperreasonsforobjectingtosuchheavy-handedinterventions.

ThereAreAlsoStrongReligiously-BasedReasonsforRejectingtheGEFoodVentureAstheintroductiontothisbooknoted,theplaintiffsintheAllianceforBio-Integritylawsuitnotonly

includedninescientistsbutagroupofindividualsandorganizationsfromdiversereligioustraditionsthatobjectedtoGEfoodsonthebasisofreligiousprinciple.SevenoftheseplaintiffswereordainedChristianpriestsandministers(includingaRomanCatholic,anEpiscopalian,aLutheran,andaBaptist)andthreewererabbis(Orthodox,Conservative,andReform).Further,thepositionstakenbymostofthereligiously-motivatedplaintiffs(whetherChristian,Jewish,orHindu)werebasedintraditionaltheism,asystemofbeliefinwhichdivineintelligenceisviewedashavinginsomesignificantwaybeendirectlyandpurposivelyinvolvedinthedevelopmentofthevariousformsoflife.15Therefore,sincealargeproportionofhumankindalsoembracetraditionallytheisticbeliefs,it’simportanttoexaminesomebasicreasonswhypeoplewhoholdsuchbeliefscouldviewtheGEfoodventureasspirituallyoffensive.

Becausefromatraditionaltheisticperspectivethenaturalcross-breedingbarrierscanbeseenasbasicfeaturesofthedivineplan,thislogicallyengenderstheideathatlimitedhumanintelligenceshouldrefrainfromartificiallyalteringsuchanintricatesystem–especiallywhenitinvolvesreconfiguringthegeneticstructureofnumerousorganisms.

Moreover,suchanattitudeisnotexclusivelyreligious,andsomescientistshavedevelopeditbasedonentirelysecularconsiderations.AsChapter4noted,theNobelLaureatebiologistGeorgeWaldrepeatedlyunderscoredhowradicallygeneticengineeringdiffersfromallpreviousmethodsofmanipulatingnatureandhowominousarethealterationsitbringsabout.Hewarnedthatitpresents“problemsunprecedentednotonlyinthehistoryofscience,butoflifeontheEarth,”andheemphasizedthat“suchinterventionmustnotbeconfusedwithpreviousintrusionsuponthenaturalorderoflivingorganisms.” 16Consequently,hereferredtothisnewlevelofinterventionas“thebiggestbreakinnaturethathasoccurredinhumanhistory.” 17

Asimilaroutlookwasevidencedbyoneofthepioneersofmolecularbiology,ErwinChargaff,whomTheGuardiandescribedas“oneofthegiantsoftheworldofbiochemistry.” 18InexpressinghisconcernaboutthesunderingofnaturalboundariesthatrecombinantDNAtechnologyhadwrought,hestated:“Ihavethefeelingthatsciencehastransgressedabarrierthatshouldhaveremainedinviolate.” 19

Accordingly,iffromapurelysecularstandpointtheincursionsofgeneticengineeringcanberegardedasserioustransgressionsofthenaturalorder,there’sfarmorereasontoregardthemassuchfromatraditionallytheisticperspective.Thus,oneoftheplaintiffsintheAllianceforBio-Integritylawsuit,RabbiAlanGreen,statedinafilingwiththecourtthatheregardsthecross-breedingboundariesasdivinelysetbarriersthathumanityshouldnotsunder.Hethenasserted:“Ibelievethatgeneticengineeringgreatlyexceedsallothermethodsofcreatingnewvarietiesoffood-producingorganismsinitsdistortionanddisruptionofnaturalboundariesandstructures.”Andhedeclared:“Therefore,asamatterofreligiousprinciple,Ifeelobligedtoavoidconsumingtheproductsofthisradicaltechnology.” 20TheChristianclergywhowerehisco-plaintiffsexpressedsimilarpositions.Forinstance,inastatementtypicalofthoseenteredbythissetofindividuals,anEpiscopalianministersaidhebelievedthat“theforcibletransferofgeneticmaterialacrossnature’scross-breedingbarriersforthepurposeofredesigningfoodisadisruptionofthedivineplan.” 21

Further,evenshortofregardingthecross-breedingbarriersas“inviolate”boundariesandgeneticengineeringasadisruptionofthedivineplan,therearestillstrongreligiously-basedreasonsforrejectingtheventure.That’sbecauseanyreligiousindividualcouldlegitimatelyinsistthatlimitedhumanintelligenceshouldatminimumtreatthecross-breedingbarriersandthecomplexweboflifewithsubstantialrespectandexercisegreatcareinattemptingtoartificiallyaltersuchanintricatesystemaboutwhichsolittleisyetcomprehended.

Moreover,becauseeventhemorereverential,andstricter,attitudetowardthesenaturalboundariesdiscussedaboveislegitimatefromasecularaswellasareligiousstandpoint,it’sobviousthatthismoremoderateonemustbetoo.SuchanattitudehasbeenexpressedbytheAmericanpublicinterest

organizationConsumersUnion.Incontemplatingtheunprecedentedpowersofgeneticengineeringtoreconfigurefundamentalfacetsofnature,CUurgedpolicymakerstorecognizethistechnology“...representssomethingthatisfundamentallynewand,assuch,shouldbeapproachedwithcaution,careandsomehumility.” 22

AlthoughCU’spleaforhumilitywasbasedonseculargroundsandiswell-justifiedonsuchgrounds,it’sfarmorecompellingfromaperspectiveinwhichthestructuresoflivingorganismsandthebarriersbetweenthemareseenasfeaturesofadivinelyinstatedsystem;andthevirtualabsenceofhumilityfromthethinkingofthebioengineersandtheirgovernmentalpromotersisaglaringdefectthatrightlyunderminesconfidenceintheiractions.Furthermore,fromsuchaperspectivetheroutinelyrecklessapproachthathascharacterizedtheGEfoodventurecanjustlybeviewedasdisplayingnotmerelyalackofhumility,butahighdegreeofarrogance–andadisrespectforGod.

Inparticular,theistscouldregardthestarkdiscrepancybetweengeneticengineersandsoftwareengineersintermsoftheprecautionexercisedbyeachasaclearcaseofsuchdisrespect.AsChapter11pointedout,whensoftwareengineersmakeevenminor,well-plannedrevisionstolife-criticalinformationprogramsthattheythemselveshavedesigned,theyproceedunderthepresumptionthat,despitetheirbestefforts,unintendeddisruptionshaveprobablyoccurredthatcouldundulyendangerhumanlife.Theythereforefollowstrictproceduresandsubjecttherevisedprogramstorigorousroundsoftesting.Butwhenbioengineersmakeradicalrevisionstotheinformationprogramsoffood-yieldingorganismsthattheyhavenotcreated,thatarefarmorecomplexandinterconnectedthananyman-madesystem,andaboutwhichtheyhaveminimalcomprehension,theyandtheirsupportersnonethelesspresumeeitherthatnoharmfuldisruptionshaveoccurredatall(asinthecaseoftheFDA)orthatanywhichmayhavehappenedcanbedetectedbyteststhat,relativetothoseemployedinsoftwareengineering,aregrosslysuperficial.Accordingly,fromatraditionallytheisticperspective,theyfailtohonorthefactthatGodhasdesignedthesystemsthey’realtering,andfailtoappreciatethatHisintricatelyexquisitesoftwareshouldbetreatedwithatleastthesamedegreeofrespectasisaccordedthesoftwarefashionedbythelimitedhumanmind.

Moreover,fromsuchareligiousperspective,thedisrespectisamplifiedbythefactthatthelackofproperprecautionstemsfromoneoftheGEfoodventure’sfoundationalpresumptions:theerroneousnotion(discussedinChapter12)thattheprocessesofnaturalreproductionaremoredisorderlyandunpredictablethanthoseofhuman-conductedgeneticengineering–andarethereforeriskier.

It’salsonoteworthythattherearereligiouslybasedreasonsforrejectingGEfoodsthatdon’trelyonanytheisticbeliefs.Thus,oneoftheplaintiffsinthelawsuitwastheChancellorofaBuddhistuniversity,andalthoughBuddhismisclassifiedasanontheisticreligion,hestatedthathefeltreligiouslyobligedtoavoidGEfoodsbecauseheregardstheartificialgeneticrestructuringthatoccursthroughrecombinantDNAtechnologyascontrarytoBuddhistprinciples.

GEFoodsAreNotSufficientlyBeneficialtoOutweighTheirRisks–andTheyAreNotNeededtoSolvetheProblemsofAgricultureBecausetheadvocatesofagriculturalbioengineeringroutinelytoutitspurportedbenefitsandarguethattheymustbegivengreatweight,andbecausesomanyinfluentialpeoplehavebeenledtobelievethatGEcropscansolvemajorproblemsinthedevelopingworld,it’simportanttoexplainwhythisisnotthecase.

However,anydiscussionofpotentialbenefitsmustbeginbyre-emphasizingthefactthat,asatechnicalmatter,they’reirrelevant.AccordingtoUSfoodsafetylaw,theyshouldplaynoroleinassessingtherisks;sowithinthatkeynation,notonlyisitirrelevanttofactorthemin,it’sillegal.Moreover,asdiscussedearlierinthischapter,theprobability-basedriskanalysisperformedbyNassimTalebandhiscolleaguesalsodeterminedthatit’sillegitimatetoconsiderbenefits.Accordingtothese

experts,therisksofGEfoodsaresogreattheyfalloutsideoftheboundsofthosethatcanbeproperlyoffsetbypotentialbenefits,andtheymustinsteadbecontainedbytheproducts’strictprohibition.23

Butevenifitwerelegitimatetoconsiderpotentialbenefits,GEcropsdon’tpossessenoughtojustifytheiruse.Chapters7and9haveshownnotonlyhowthebenefitsofthosethatarecurrentlycommercializedhavebeenhighlyexaggerated,buthowthosecropshaveactuallybeencausingsignificantagriculturalandecologicalproblems.Andwhentheplausibleriskstothehealthofhumanconsumersarealsofactoredin,thebalancetiltssoheavilyagainsttheproductsthattheiruseisclearlyunwarranted.

Norcantheprojectedbenefitsofalong-promisednewgenerationofGEcrops,whicharesupposedtoprovidegenuineboonstoconsumersandtangiblebooststoproduction,outweightheriskseither.Foronething,therewouldstillbesubstantialrisktohumanhealth–evenincaseswherethedegreeofgeneticalterationissignificantlylessthaninthecurrentformsofGMOs.(ThispointismorefullyelaboratedinAppendixD.)Foranother,inmanycasesnaturallybredalternativeswouldbeavailablethatdon’tentailthedownsidesoftheirGEcounterparts.Forinstance,althoughbiotechproponentsrepeatedlytellusthatgeneticengineeringisnecessaryforproducingcropsthataredrought-tolerant,notonlycansuchcropsbeproducedviaconventionalbreeding,conventionalbreedinghasbeenmoresuccessfulindoingso.24That’sbecausedroughtresistanceisacomplexattributeandisnotbasedinasinglegene.Instead,itarisesfrommanygenesoperatinginacoordinatedmanner.Therefore,it’sverydifficultforbioengineerstoendowcropswiththistrait.

Duetothisdifficulty,geneticengineeringhasrarelyplayedapartincreatingdroughttoleranceintheGEcropsthatdisplayit.Instead,thiscapacitywasdevelopedthroughconventional,non-GEtechniquesandthedrought-tolerantplantwasthenbioengineeredtoadditionallyrenderitherbicide-orpest-resistant.25

Moreover,evenwhengeneticengineeringcanendowplantswithotherdesirabletraits,it’snobetteratitthanconventionalbreeding.AstwoexpertswiththeUnionofConcernedScientistshavenoted:“Geneticengineeringmightbeworththeextracostifclassicalbreedingwereunabletoimpartsuchdesirabletraitsasdrought-,flood-andpest-resistance,andfertilizerefficiency.Butincaseaftercase,classicalbreedingisdeliveringthegoods.” 26Comprehensivelistsofnon-GEcropsthatpossessbeneficialtraitssuchashighyield,droughtresistance,salttolerance,pestresistance,diseaseresistance,andnutritionalfortification(withoutposingtheinherentrisksofgeneticengineering)areprovidedatthefreeresource,GMOMythsandTruths(2ndEdition)onpages285and318–321,http://earthopensource.org/files/pdfs/GMO_Myths_and_Truths/GMO-Myths-and-Truths-edition2.pdf.

Thesimplefactisthatwedon’tneedGEcrops,arealitythat’sbeenrecognizedbynumerousindependentexpertswhohaveanalyzedtheextensiveevidence.Forexample,in2008theWorldBankandfourUnitedNationsagenciescompletedafour-yearstudyonthefutureoffarming:theInternationalAssessmentofAgriculturalKnowledge,ScienceandTechnologyforDevelopment(IAASTD).27Thismassivestudywasconductedbymorethan400expertsfrom80countries,and58governmentshaveendorsedit.Anditsassessmentofgeneticengineeringflewinthefaceofthepromotionalclaimsbyconcludingthatthistechnologyisnotessentialforsolvingtheproblemofhunger.What’smore,itnotedthatyieldsofGEcropswere“highlyvariable”andthatinsomecasestherehadbeen“yielddeclines.”Italsonotedthattherewerecontinuingconcernsaboutthesafetyofthecrops.

Tothefurtherconsternationofthetechnology’sproponents,thescientistsinchargeoftheIAASTDstudyhavenotmincedwordsaboutitsinabilitytodeliveronthepromisesthatthey’vebeenmakingaboutwhatitwilldo.Whentheproject’sdirector(BobWatson)wasaskedatapressconferencewhetherGEcropsweretheanswertoworldhunger,hereplied,“Thesimpleanswerisno.” 28Andwhentheco-chairofthestudy(HansHerren)wasinterviewed,heprovidedananswerthat,whilenotassimple,wasnolessexplicit:

[GMOs]haven’tactuallyprovenanythingyetintermsofincreasedyields,asfarasanyofthemajorfoodcropsareconcerned....Idon’treallyseeanyproperuseforGMOs,noworeveninthefuture.Ithinkthatthesolutionsforproblemswithagriculturalfoodsecuritylieelsewhere–notintheseedorGMOseedsinparticular....Thefactoflifeisthatrightnow,weproduceenoughfoodfor14billionpeople....Inthedevelopedcountriesinparticular,weproducemorefoodthanisrequired.Indevelopingcountries,weunder-produceandthat’snotbecauseweneedGMOs,that’sbecausethosecountrieshavebadagronomicpractices,farmersdon’thavetherightinformationonwhentoplantandhowtobestmanagetheirfarms.It’sanissueofmoreandbetterinformationtofarmersinthedevelopingcountries.” 29

Thus,asalegal,atheoretical,andapracticalmatter,it’sfutiletoassertthebenefitsofGEcrops;andit’snecessarytorecognizethatthey’reunnecessary.Moreover,notonlyarethesecropsunneeded,they’reimpedingprogressbecausethey’redivertingattentionandresourcesfromtheapproachesthatarenecessary.

TheParamountNeedIsforFullerDevelopmentofAgroecological/SustainableMethodsWhiletheIAASTDstudydidnotsupportgeneticengineering,itclearlyendorsedadifferentapproach.Itcalledforthedevelopmentof“agroecological”methodsofproduction(whichincludethosethatareclassified“organic”),methodsthatrequirefewerinputs,conserveresources,andpreservethesoil.Suchmethodscanbuildpestprotectionthroughnaturalmeansandalsoinducebothhardiercropsandgreatersoilfertilitywithoutrelianceonsyntheticadditives.

Moreover,althoughtheagroecologicalapproachemploysmanytraditional,time-honoredpractices,it’snotlimitedtothem.Forinstance,italsomakesuseofmoderntechniquessuchasMarkerAssistedSelection(MAS),whichenablesthedevelopmentofplantswithimportantcomplextraitsthatbioengineeringcannotproduce–butwithouttherisksthatitdoesengender.

Mostimportant,notonlyareagroecologicalmethodsbettersuitedtothedevelopingworldthanarethehigh-inputpracticesofindustrialagriculture,they’vebeenhighlysuccessfulatproducinghigheryields.Forinstance,arecentUNreportthatsurveyed114farmingprojectsin24Africancountriesdeterminedthatthroughtheadoptionoforganicornear-organicpractices,yieldsincreasedonaveragebyover100%.30FurtherevidencingthewidespreadsuccessesofsuchmethodsinAfrica,theUNSpecialRapporteurontheRighttoFoodhasreported:“Yieldswentup214%in44projectsin20countriesinsub-SaharanAfricausingagroecologicalfarmingtechniquesoveraperiodof3to10years....”Andhepointedoutthatthisaccomplishmentis“farmorethananyGMcrophaseverdone.” 31

Hehasalsostated:

Tofeed9billionpeoplein2050,weurgentlyneedtoadoptthemostefficientfarmingtechniquesavailable.Today’sscientificevidencedemonstratesthatagroecologicalmethodsoutperformtheuseofchemicalfertilizersinboostingfoodproductionwherethehungrylive–especiallyinunfavorableenvironments.Todate,agroecologicalprojectshaveshownanaveragecropyieldincreaseof80%in57developingcountries,withanaverageincreaseof116%forallAfricanprojects.Recentprojectsconductedin20Africancountriesdemonstratedadoublingofcropyieldsoveraperiodof3–10years.Conventionalfarmingreliesonexpensiveinputs,fuelsclimatechangeandisnotresilienttoclimaticshocks.Itsimplyisnotthebestchoiceanymoretoday.Agricultureshouldbefundamentallyredirectedtowardsmodesofproductionthataremoreenvironmentallysustainableandsociallyjust.” 32

Furthermore,agroecologicalmethodscanalsosucceedinindustrializednations.Long-termstudiesin

theUnitedStateshavedemonstratedthatwell-managedorganicfarmingsystemscanproduceyieldsthatarecomparabletoconventionalsystems.33,34Andsmallfarmsemployingagroecologicalpracticesareonbalancesubstantiallymoreproductivethanlargeindustrializedfarms.AsMiguelAltieri,aProfessorofAgroecologyatUniversityofCaliforniaatBerkeley,explains:“Alargefarmmayproducemorecornperhectarethanasmallfarminwhichthecornisgrownaspartofapolyculturethatalsoincludesbeans,squash,potatoes,andfodder.But,productivityintermsofharvestableproductsperunitareaofpolyculturesdevelopedbysmallholdersishigherthanunderasinglecropwiththesamelevelofmanagement.Yieldadvantagescanrangefrom20percentto60percent,becausepolyculturesreducelossesduetoweeds(byoccupyingspacethatweedsmightotherwiseoccupy),insects,anddiseases(becauseofthepresenceofmultiplespecies),andmakemoreefficientuseoftheavailableresourcesofwater,light,andnutrients.” 35

Butevenifagroecologycouldnotyieldaswellasindustrializedmonocultures,itwouldstillofferbetterbenefitsfortheindustrializednations.AstheUniversityofMissouriagriculturaleconomistJohnIkerdhaspointedout,becauseglobalfoodsecurity“doesnotdependoncontinuedincreasesinproductivityinindustrialagriculturalcountriessuchastheU.S.andCanada,”themostimportantgoalinthesecountriesshouldbe“toincreasethesustainabilityofagricultureratherthantoincreaseagriculturalyieldsorproductivity.” 36

Thus,it’sclearthatbesidesbeingunsustainable,conventionalagricultureisnotmaximallyproductive–andthatagroecologicalagriculturecanoutperformit,especiallyinthelessdevelopedregionsoftheworld.It’salsoclearthatgeneticengineeringisnottheanswer–andnotevenasoundoption,whateverthelevelofeconomicdevelopmentorsetofenvironmentalconditions.Thishigh-techbutlow-foresightapproachisthemostunsustainableformofagriculture,becausenotonlyisitinherentlyandunacceptablyriskyinregardtobothhumanandenvironmentalhealth(nomatterwhatgenesareemployedinthereconfigurations),itdependsonconsistentcontortionofthetruth–andcannotsurviveanaccurateairingofthefacts.

Nonetheless,ithasbeenfarmorelavishlyfundedoverthelast30yearsthantheagroecologicalmethodsthatcanoutperformitandoutlastit.Andthelopsidedemphasisongeneticengineeringhasrestrictedthemoresustainableandvaluableapproachesfromachievingasmuchastheycouldiftheywerebettersupported.

TheexperienceofaprofessorofsoilscienceattheUniversityofHawaiiisindicativeofthisrestriction.AfterI’dgivenalecturetherethat(amongotherthings)notedthegrossimbalanceinfundinganditsilleffects,heexpressedfullagreementwithwhatI’dsaid.Hetoldmethathehadsubmittedseveralgrantapplicationsforsustainableprojectsindevelopingnationsthathadbeenturneddownbecause,ashewasinformed,theydidn’tinvolvemolecularbioengineering.Hesaidthatthishadhappenedenoughtimesthathehadgivenuponwritingmoreproposalsbecausehedidnotwanttoemploythattechnology–anddidnotwanttowastemoreofhistime.

It’sTimetoDecisivelyMoveForwardWe’veseenhowamassofdisinformation,muchofitspreadbyeminentscientistswhoabusedtheirpositionsofauthority,haskeptmostpeopleconfusedabouttheproductsofgeneticengineeringfornearly40years.Andwe’veseenhowevenhighlyastuteindividualswithtraininginscienceorengineeringhavebeentakenin.

Butwe’vealsoobservedthat,whenthecloudofdisinformationissystematicallydispelled,theactualfactsbecomenotonlyclearbutcompelling.AndtheconclusiontheycompelisthatGEfoodsshouldneverhavebeencommercializedinthefirstplaceandmustbecurtailedasquicklyaspossible.Theywerenevergenerallyrecognizedassafewithinthescientificcommunity,therehasneverbeengenuineevidenceoftheirsafety,andsubstantialevidenceindicatesthatseveralaremostlikelyunsafe–andthat

theprocessthroughwhichthey’reallcreatedisinherentlyrisky.Further,theywereinitiallycommercializedthroughthefraudoftheUnitedStatesFoodandDrug

Administration(theFDA)andtheflagrantviolationofthatnation’sfoodsafetylaws,andtheircontinuedmarketingintheUScontinuestobeillegal.Yet,theUSgovernmentplaystheleadingroleinpromotingthemworld-wideandimpellingtheiruseinothernations.

However,thingscanbeturnedaroundquickly–evenmorequicklythanin1906,whenAmerica’sfoodindustryunderwentitsfirstdramaticreform.OnFebruary26thofthatyear,abooktitledTheJunglewaspublishedthatgraphicallyexposedtheunsanitaryandgruesomeconditionsinthenation’smeatpackingplants.Itsrevelationscreatedashockwave,andoneoftheindividualsmostshockedwasthePresident,TheodoreRoosevelt,whodeclaredthat“radicalactionmustbetaken.” 37SohedispatchedhisLaborCommissionerandasocialworkertoinvestigatetheChicagofactories,andhesubmittedtheirunsettlingreporttoCongressonJune4th.38Beforetheendofthemonth,duetothatreportandstrongpublicpressure,CongresshadpassedboththeMeatInspectionActandthePureFoodandDrugAct,thefirstfederalstatutestoprotectthepublicfromdangerouspracticesintherelatedindustries.

Now,morethanahundredyearslater,thetimeisripeforanotherdramaticfood-relatedreform;anditcanbeachievedmoresimply.PresidentObamadoesn’thavetoconvinceCongresstoact;hemerelyhastoordertheFDAtogetitsacttogether–andtostopviolatingthenation’scentralfoodsafetylawandstartapplyingittoGEfoods.AndthatsimplestepwouldquicklysendtheGEfoodventureintoadeathspiral.

Butevenifhedoesn’ttakethatstep,theventurecannotsurviveforlongbecauseitrestsonaperilouslyflimsyfoundation.Ithasalwaysbeensupportedbydistortionsoftruth–anditwilltopplewhenthedistortionsareexposedandexpunged.

Wedon’tneednewlaws,wedon’tneednewresearch,wejustneednewawareness.Allthat’srequiredisforafewkeypeople,orenoughpeopleingeneral,tolearnthebasicfacts.Andwhenthathappens,asitisboundto,itwillbringthefact-averseGEfoodventuretoanend.

AbandoningGEfoodswillnotbeasacrificebutaliberation.Itwillfreeusfromthedebilitatinginfluenceofdisinformationanddelusion.Itwillfreeusfromunacceptableriskstoourhealth,thehealthoffuturegenerations,andthehealthofourenvironment.Itwillfreeupimmenseresourcesandenablethemtoberedirectedtothedevelopmentofsafe,sustainable,andsensiblemodesoffarming.

Forfartoolongthegenesofthefood-yieldingorganismsonwhichwedependhavebeenalteredinradicalandriskyways,andforfartoolongthetruthaboutwhat’sbeenhappeninghasbeenbadlytwisted.

Thetimehascometosetthingsstraight.Thetimehascometorestoretheintegrityofgenomes,theintegrityofscience,andthesustainabilityofagriculture.Thetimehascometotranscendthemistakesofthepastandadvancetoabrighterandmorefruitfulfuture.

APPENDIXA

EXTENDEDEXAMINATIONOFTHEJUDGE’SDECISIONINALLIANCEFORBIO-INTEGRITYV.SHALALA

ThisAppendixprovidesadditionalanalysisoftheflawsinJudgeKollar-Kotelly’sopinionbyexaminingsomepriordecisionsoffederalcourtsthatarerelevanttotheissuesbutthatwerenotdiscussedinChapter5duetospacelimitations.Someofthesedecisionswerereliedonbythejudge,andsomewerereliedonbythePlaintiffsintheirwrittenarguments.

I.TheIllogicofAllowingFDAAdministratorstoDisregardtheInputofTheirScientificStaffJudgeKollar-KotellyruledthattheFDA’sadministratorscouldpresumethatGEfoodsaregenerallyrecognizedassafedespitethefactthattheirownexpertshadrepeatedlywarnedabouttheirunusualrisks.Shejustifiedherrulingbyarguingthatanagency’sinterpretationofitsownregulationsisnotinvalidatedbycontraryopinionsof“lower-level”officials;andsheciteda1986decisionoftheD.C.CircuitCourtofAppeals(thecourtthatreviewsdecisionsbythejudgesinherdistrict)tobackherup.1

Butthatcasedoesnotsupportherargument.ItinvolvedinterpretationofaNuclearRegulatoryCommission(NRC)regulationthatpreventednuclearpowerplantsfrombeinglicensedunlesstherewasafindingthatadequateprotectivemeasurescouldbetakenineventofanemergency.TheCircuitCourtupheldtheCommission’sdecisionthatthepotentialeffectsofearthquakesneednotbeconsidered,despitetheopinionsoftwoofitsstaffthattheyshould.

However,theissueinthatcasesubstantiallydifferedfromtheissueinoursuit,sinceitcenteredonwhetherthegenerallanguageofaregulationshouldbeinterpretedtopertaintoaspecifictypeofrisk–whichtoalargeextentisapolicydecision.Incontrast,theissueinourcasewasnotabouthowthelanguageofanagencyregulationshouldbeinterpretedbutaboutwhether,inlightofwell-establishedregulations,therewererationalgroundsonwhichanagencycouldmakeaparticularpresumption.Further,theopinionoftheagency’sscientificstaffwasahighlyrelevantfactorindeterminingwhethersuchgroundsexisted.ThequestionwaswhetherupperleveladministratorsmayrightfullypresumethatthereisanoverwhelmingconsensusamongscientiststhatGEfoodsaresafedespitetheobviousfactthatmostoftheirownexpertsdidnotregardthemtobe.Itwasnotaquestionofallowingoneopinionaboutinterpretingregulatorylanguagetoprevailoveranother.Itwasaquestionofallowingadministratorstodisregard(andcontradict)acrucialfactinmakingwhatwassupposedtobeafact-baseddetermination.2ByadoptingapresumptionthatGEfoodsaregenerallyrecognizedassafe,despitedirectknowledgethattheywerenot,theadministratorswereactinginanarbitraryandcapriciousmannerforbiddenbylaw.

II.IgnoringtheIssueofInconsistencyThere’sanothersignificantrespectinwhichtheactionoftheNRCdiscussedaboveisdistinguishablefromtheFDA’sactionsinadoptingits1992policy.Inthatearliercase,thecourtemphasizedthattheNRC’sdecisionwasnotinconsistentwithitspriorpractices.Incontrast,theFDA’sapplicationofitsGRAS-relatedregulationstoGEfoodsisclearlyinconsistentwithitspreviouslyestablishedinterpretationsandapplicationsofthem.

Inourwrittensubmissions,wenotedthatcourtsarewaryofagencyinconsistency.Wecalledthejudge’sattentiontoawarningtheD.C.CircuitCourthadissuedin1982that“sharpchangesofagencycourseconstitute‘dangersignals’towhichareviewingcourtmustbealert;”andwecitedthecourt’s

statementthatsuchchangesaregroundsfordenyingdeferencetotheagency’sactions.3Further,wedemonstratedthattheFDA’sinterpretationoftheGRASstandardsinregardtoGEfoodsconstitutesa“sharpchange”ofcourse,pointingoutseverallegalactionstheagencyhadpreviouslypursuedinwhichitsoughttobarunapprovedadditivesbyarguingforastrictinterpretationoftheGRASrequirements.4WealsonotedthechangeincoursewassoseverethatthedirectoroftheFDA’sBiologicalandOrganicChemistrySectionreprovedtheagencyforturningthepriorunderstandingofthetermfoodadditive“onitshead.” 5Moreover,oneFDAdocumentobservedthata“disadvantage”ofthetypeofpolicythattheagencyeventuallydidadoptwasthefactitwouldbe“AtoddswithemergingFDAlegalinterpretationsofwhatisrequiredtoachieveGRASstatus…” 6

WeadditionallydiscreditedthenotionthattheFDA’sactionsdeserveddeferencebycitingarulingoftheUSSupremeCourtthatjudgesshouldnotdefertoanagencywhenitsdecisionfailstoconsideranimportantaspectoftheproblem,orwhenitgivesanexplanationforitsdecisionthatrunscountertotheevidence.BecausetheFDAadministratorsfailedtoconsidertheunusualaspectsofGEfoods,andbecausetheirjustificationfortheirpolicyclashedwiththeevidence,thisrulingwasrightonpoint.7

Surprisingly,JudgeKollar-Kotellydidnotseefittomentionthiscase,orthecaseinwhichtheD.C.Circuithadwarnedaboutinconsistency,oranyofthecases(orotherevidence)demonstratingthattheFDA’s1992policywasatoddswithitspriorpractice.Instead,shechosetodisregardtheissueofinconsistencyaltogether.

III.MisplacedEmphasisonAgencyExpertiseRatherthanacknowledgingthatinconsistencydeservesnodeference,JudgeKollar-Kotellysoughttojustifyherexerciseofdeferencebystressingtheimportofagencyexpertise.Todoso,shecitedadecisionoftheD.C.CircuitCourtwhich,inupholdinganactionoftheEnvironmentalProtectionAgency(EPA),remarkedthat“therationalefordeferenceisparticularlystrong”whenanagency“isevaluatingscientificdatawithinitstechnicalexpertise.” 8

However,liketheNRCcase,thisoneprovidednosupportfordeferringtotheFDA’spresumptionaboutGEfoods.Foronething,asintheNRCcase,thecourtemphasizedthattheagencyhadactedconsistentlywithitspriorpractices.9Moreover,whiletheEPAhadapplieditsexpertiseinthoroughlyanalyzingthedata,theFDAstaffmemberswhopossessedthescientificexpertise(andevaluatedthetechnicalissues)hadarguedagainstthepresumptionofGRAS–anditwasadoptedinspiteoftheirinput.

Thus,fullerexaminationoftherelevantdecisionsoffederalcourtsmorefullydemonstratestheunsoundnessofJudgeKollar-Kotelly’sreasoning.

APPENDIXB

TWOREPORTSBYOTHERRESPECTEDORGANIZATIONSTHATMISREPRESENTTHERISKSOFGEFOODS

TheRoyalSocietyOnewidelycitedreportonthesafetyofGEfoodswasreleasedin2002bytheUK’sRoyalSociety.And,likeitscounterpartissuedbytheNationalAcademyofSciencesin2004,notonlydiditfailtoaddresstheargumentsofthe2001CanadianRoyalSocietyreport,itdidn’tevenacknowledgethem.Althoughitdidatleastmentionthatreport(incontrasttotheNAS’scompletedisregard),thenoticeittookwasminimal.Itmerelyremarkedthatthereporthadcriticizedregulatoryrelianceontheconceptofsubstantialequivalence.1Butitneglectedtodescribethecriticisms,andcertainlyneverrefutedthem.NordiditmentionanyoftheotherconcernstheCanadianexpertshadraised;anditavoideddiscussionofmanyoftheimportantissuestheyexamined.Forinstance,whileitdidnotetheroutineuseofviralpromotersinGEcrops,itgavenoindicationthattheyimpelhyperexpressionofthegenetowhichthey’reattached–noranyhintthattheCanadianexperts,alongwithmanyothers,haveregardedthisasrisky.2

Further,liketheNASreport,thatoftheRoyalSocietygrosslyoverstatedtherisksofconventionalbreeding.Forinstance,itallegedthatsuchbreedingmethodscouldgiveriseto“unknowntoxins,anti-nutrientsorallergens.” 3Butbecausethere’snoevidencethishaseverhappened,ithadtopropitsclaimwithinaptexamplesinvolvingthesamespecies(celeryandpotatoes)thatwerelateremployedbytheNASforthesamepurpose–examplesinwhichtoxinsthatwerealreadypresentbecameelevated,butinwhichnotasingle“unknown”toxinwasproduced.Moreover,notonlydidtheauthorsemploytheseinvalidexamplestobolstertheirfalseassertion,theyalsounfairlyusedthemtosuggestthattherisksofconventionalfoodsareonaparwiththoseproducedthroughrDNAtechnology,statingthatthispurportedevidence“raisesthequestion”ofwhetherbothsetsoffoodsshouldberequiredtomeetthesamesafetyassessmentcriteria.

But,inreality,themainquestionraisedbyacarefulreadingofthereportiswhetheritsauthorsweremorecommittedtopromotingGEfoodsthantoupholdingthestandardsofscience.Andinlightoftheadditional,andmoreegregious,derelictionsdocumentedinChapter10,it’sclearthatthecommitmenttothelatterhasindeedbeeneclipsedbytheformer.

TheInstituteofFoodTechnologistsRemarkably,othergroupshaveevenexceededtheexcessesoftheRoyalSociety.Considerthecaseofthe29,000-memberInstituteofFoodTechnologists(IFT),whichpublishedareportin2000because(initswords)itwas“eagertocontributetoameaningfuldialogueonscientificissuesandconsumerconcerns....” 4But,ashavemostothersuch“meaningful”contributions,itmangledthemeaningofrisk.5Itlikewisebaselesslyraisedthespecterofunknownandpotentiallyharmfulingredientsinfiltratingthemarketthroughconventionalbreeding.6Anditclaimedthatbecausebioengineeringis“morepreciseandpredictable,”thistrustytechnologyis“lesslikely”toinducesuchunintendedeffects.7Ofcourse,itwaseasierforthepanelthatwrotethefoodsafetysectiontomakesuchaclaimbecausetheydidn’tmentionseveralaspectsofbioengineeringthatsetitapartfromconventionalbreeding(andentailahigherriskofunintendedeffects),suchastheuseofviralpromoterstoover-expressgeneproducts–orthegenome-scramblingeffectsofcassetteinsertion.8Nordidtheynotethat,incontrasttomostconventionalcrops,

almostallofthoseproducedthroughbioengineeringaresubjectedtothemutativeprocessoftissueculture.

Moreover,theircasefortheharmlessnessofGEfoodstohumanhealthwassubstantiallyaugmentedbytheindiscriminateinclusionof,andrelianceon,statementsfromotherreportsthathadnothingtodowithfoodsafety.Thus,theyfeaturedseveralpronouncementsfromtheNASreportsof1987and1989,despitethefactthosedocumentsdealtonlywithenvironmentaleffectsoffieldtrialswithinthecontinentalUS.9Andtheygaveprominencetotheassertioninthe1989reportthat“...noconceptualdistinctionexistsbetweengeneticmodificationofplantsandmicroorganismsbyclassicalmethodsorbymolecularmethodsthatmodifyDNAandtransfergenes.”AsChapter4explained,thisassertionislogicallyabsurd.Nonetheless,theIFTpaneltreatedthisabsurdityasaverity–andproffereditassupportforthesafetyofGEfoods.

Thus,carefulscrutinyrevealsthat,likethe2004reportoftheNAS,thetwodiscussedabovearedeeplyflawed–andcontributetothemethodicalmisrepresentationofrisk.

NOTES

Introduction1TheFDAacknowledgesthatithasbeenoperatingunderapolicy“tofoster”theUSbiotechnologyindustry.See,e.g.,“Genetically

EngineeredFoods,”FDAConsumer(Jan.-Feb.,1993),14.2Keller,EvelynF.TheCenturyoftheGene.(Cambridge:HarvardUniversityPress,2002),142-43.3Ibid.143.4Ibid.144.5Ibid.148.

1.ThePoliticizationofScience1AmongtheHarvardprofessorswhoregardedMayrasthegreatest20thcenturybiologistwereE.O.WilsonandStephenJayGould.See

Meyer,A.,“OntheimportanceofbeingErnstMayr,”PLoSBiol3(5):e152(2005):0100.2Whenusedinthisway,theterm“gene-splicing”referstomanipulationsofbiotechnicians.Aswillbediscussedinsubsequentchapters,

althoughsegmentsofDNAarealsosplicedintoDNAmoleculesthroughnaturalprocesses,thedetailsoftheseprocessessignificantlydifferfromthoseofrecombinantDNAtechnology.

3Regalrecordedthesewordsinasetofrecollectionsabouthisendeavorstosetthegeneticengineeringventureonamorescientifictrack–recollectionsthathesenttomeforuseinthisbook.Thestatementsfromhimthatfollowinthisandotherchaptersarelargelydrawnfromtheserecollectionsandfrommyextensiveconversationsandemailcorrespondencewithhim.Accordingly,exceptforquotesexcerptedfromhispublishedarticles,Iwillnotprovidespecificreferencesforhisvariousstatements.

4CrichtoncompletedthefirstdraftofTheAndromedaStrainin1967.5Morrow,J.F.,Cohen,S.N.,Chang,A.C.Y.,Boyer,H.W.,Goodman,H.M.,Helling,R.B.,“ReplicationandtranscriptionofeukaryoticDNA

inEscherichiacoli,”ProceedingsoftheNationalAcademyofSciences71(1974):1743-47.Priortothataccomplishment,otherresearchershadlearnedhowtojointwopiecesofDNAtogether.TheinitialfusionwasachievedbyateaminPaulBerg’slabatStanfordUniversity;andBergsubsequentlyreceivedaNobelPrizeinrecognitionofthisandothergroundbreakingresearchinrecombinantDNAtechnology.Jackson,D.A.,Symons,R.H.,andBerg,P.,“BiochemicalmethodsforinsertingnewgeneticinformationintoDNAofSimianVirus40:CircularSV40DNAmoleculescontaininglambdaphagegenesandthegalactoseoperonofEscherichiacoli,”ProceedingsoftheNationalAcademyofSciences[PNAS]69(1972):2904.

6Asdiscussedinthepreviousnote,BerghadbeenabletocreatesomerecombinantDNAevenbeforescientistshaddiscoveredhowtoisolateindividualgenesfromonespecies,copythem,andthensplicethemintotheDNAofotherspecies.Buthistechniquewasrelativelycomplicatedandcouldnotbewidelyemployed.Thetumor-inducingvirusthatheplannedtoworkwithisreferredtoasSV40.

7Foradiscussionofthisincidentseetheprefacetothe2013paperbackeditionof:Pollack,R.,TheFaithofBiologyandtheBiologyofFaith(NewYork:ColumbiaUniversityPress,2013).

8Berg,P.,“AStanfordProfessor’sCareerinBiochemistry,SciencePolitics,andtheBiotechnologyIndustry,”anoralhistoryconductedin1997bySallySmithHughes,RegionalOralHistoryOffice,TheBancroftLibrary,UniversityofCalifornia,Berkeley(2000),92;http://texts.cdlib.org/view?docId=kt1c6001df&doc.view=entire_text.

9Ibid.,93.10Singer,MaxineandSoll,Dieter,“GuidelinesforDNAHybridMolecules,”Science181(September21,1973):1114.11Wright,Susan,MolecularPolitics:DevelopingAmericanandBritishPolicyforGeneticEngineering1972-1982(Chicago:

UniversityofChicagoPress,1994),136.12Ibid.13Berg,Pauletal.,“PotentialBiohazardsofRecombinantDNAMolecules,”Science185(July26,1974):303.14Ibid.15Barinaga,Marcia,“AsilomarRevisited:LessonsforToday?”Science28,no.5458(March3,2000):1584–85.16Watson,J.andTooze,J.,TheDNAStory(SanFrancisco:W.H.Freeman,1981),49.17Wright(1994),op.cit.note11,135.18Ibid.,26.19CitedinGoodell,Rae,“HowtoKillaControversy:TheCaseofRecombinantDNA”inScientistsandJournalists:ReportingScience

asNews,Friedman,S.M.,Dunwoody,S.andRogers,C.,eds.(NewYork:TheFreePress/Macmillan,1986),172.20Bennett,WilliamandGurin,Joel,“SciencethatFrightensScientists:ThedebateoverDNA,”TheAtlanticMonthly239(February,1977):

43-62.21Lewin,Roger,“TheAsilomarConference:WastheAsilomarConferenceaJustifiedResponsetotheAdventofRecombinantDNA

Technology,andShouldItServeasaModelforWhistle-BlowingintheFuture?”inBioscienceSociety;ReportofScheringWorkshop,Roy,D.J.etal.,eds.,(Chichester,NewYork:JohnWiley&Sons,1991),206.

22Ibid.23Wright,Susan,“MolecularBiologyorMolecularPolitics?TheProductionofScientificConsensusontheHazardsofRecombinantDNA

Technology,”SocialStudiesofScience16,no.4(Nov.1986):593-620,595.24Ibid.25Watson,JamesD.,“AnImaginaryMonster,”BulletinoftheAtomicScientists33(May1977):12.26WatsonexpressedhisregretinaspeechquotedinMcAuliffe,SharonandMcAuliffe,Kathleen,LifeForSale(NewYork:Coward,

McCann&Geoghegan,1981),176.27Kay,Lily,TheMolecularVisionofLife:Caltech,TheRockefellerFoundation,andtheRiseoftheNewBiology(NewYork:

OxfordUniversityPress,1993);PninaAbir-Am,“Thebiotheoreticalgathering,transdisciplinaryauthorityandtheincipientlegitimationofmolecularbiologyinthe1930s:newperspectivesonthehistoricalsociologyofscience,”HistSci25(1987):1-70.

28Weaver,Warren,SceneofChange:ALifetimeinAmericanScience,(NewYork:Scribner’s,1970),56.

29Ibid.,57.30Regal,Phil,“MetaphysicsinGeneticEngineering:CrypticPhilosophyandIdeologyinthe‘Science’ofRiskAssessment.”InCopingwith

DeliberateRelease:TheLimitsofRiskAssessment,VanDommelen,Ad,(ed.),InternationalCentreforHumanandPublicAffairs,Tilburg/BuenosAires(1996).

31Weaver,op.cit.note28,183.32Regal,“MetaphysicsinGeneticEngineering,”op.cit.note30.33Alibek,Ken,Biohazard:TheChillingTrueStoryoftheLargestCovertBiologicalWeaponsProgramintheWorld–Toldfrom

InsidebytheManwhoRanIt(NewYork:RandomHouse,1999),xi.34Chargaff,Erwin,“OntheDangersofGeneticMeddling,”Science192(1976),940.35Ibid.,938.36King,Jonathan,quotedinMcAuliffeandMcAuliffe,op.cit.note26,174;SeealsoBennettandGurin,op.cit.note20,56-57.37Wald,George,“TheCaseAgainstGeneticEngineering,”inTheRecombinantDNADebate,Jackson,D.andStich,S.,Eds.(Prentice-

Hall,1979),127-28.38Ibid.39Wald,George,speakingatapressconferenceinWashington,D.C.March1977.QuotedinKimbrell,A.,TheHumanBodyShop:The

EngineeringandMarketingofLife,(NewYork:HarperCollins,1994),159.AlthoughWald’sstatementthatgeneticengineeringisthe“biggestbreakinnature”occurredatapressconference,Ithinkit’sappropriatetoincludeitalongwithstatementshewroteinanearlierarticlebecausedoingsodoesnotinanywaymisrepresenthisthinking–andenablesittobeexpressedinacompactmanner.

40Wald,George,“TheCaseAgainstGeneticEngineering,”op.cit.note39.41Lewin,Roger,(1991),op.cit.note21,206.42Wright(1986),op.cit.note23,593.43Ibid.,601.44Ibid.,600.45Ibid.,600-01.46Ibid.,601.47Ibid.48Ibid.49Ibid.,602.50Thomas,Gavin;http://www.microbiologyonline.org.uk/ecoli.htm.51Wright(1986),op.cit.note23,603.52Ibid.,602,no.20.53Ibid.,604.54Ibid.55Ibid.,604-556Ibid.,605.57Ibid.,emphasisinoriginal.58Ibid.,606.Thefullquotethatappearsonp.45ofthetranscriptofthemeetingis:“Ithinkthatiswhatyouhavetodealwith.Itmaynot

meanathing,butthatisveryeasytodo.Itsmolecularpolitics,notmolecularbiologyandIthinkwehavetoconsiderboth,becausealotofscienceisatstake.”Inanemailtome(inanswertomyquestions)Wrightexplainedthatfromthepriordiscussion,itiscleartheword“that”referstotheproblemofconvincingthepublic.Accordingly,inherarticle,Wrightrendersthefirstsentenceas:“Ithink(theproblemofconvincingthepublic)iswhatyouhavetodealwith.”

59Ibid.60Ibid.,600.Inanemailtome,Wrightconfirmedthatthemediawerenotinvitedtoanyoftheconferencesoreveninformedofthem–and

sowerenotpresent.61Ibid.,607.62QuotedinWright(1986),op.cit.note23,607.63Ibid.,608.64Ibid.65QuotedinDutton,Barbara,WorsethantheDisease:PitfallsofMedicalProgress(NewYork:CambridgeUniversityPress,1992),

193.66Ibid.67Ibid.68Wright(1986),op.cit.note23,613.69Ibid.

70Ibid.71Wright(1994),op.cit.note11,275.TheAcademy’smisrepresentationappearedinareportissuedbyitsAssemblyofLifeSciences.72Ibid.,269.73Dutton,op.cit.note65,193.74Ibid.75Ibid.,193-94.76Wright(1994),op.cit.note11,269.77Ibid.,270.78Ibid.,271.79EdwardM.Kennedy,speechtotheAssociationofMedicalWriters,September27,1977,NewYork,quotedinWright(1994),272.80Wright(1994),op.cit.note11,272.81Ibid.,245.82Chang,ShingandCohen,StanleyN.,“InVivoSite-SpecificGeneticRecombinationPromotedbyEcoRIRestrictionEndonuclease,”

ProceedingsoftheNationalAcademyofSciences74(November1977):4811-15.ThefragmentsofmouseDNAwerenotintegratedwithinthecentralareaofthebacterialDNA(itschromosome)butwithinasmallringofDNAoutsideofit(calledaplasmid).ChromosomesandplasmidswillbediscussedinChapter4,whichwillalsomorethoroughlyexamineCohen’sexperimentandthedeceptiveclaimsthatweremadeaboutit.

83StanleyCohenquotedinWright(1994),op.cit.note11,272.84StanleyCohentoDonaldFredrickson,September6,1977,ORDAR,quotedinWright(1994),op.cit.note11,246.85Dutton,op.cit.note65,194.86Wright(1994),op.cit.note11,272.WrightsaysKennedyusedCohen’sclaimasan“escapehatch.”87RoyCurtisstoDonaldFredrickson,April12,1977,ORDAR8,quotedinWright(1994),op.cit.note11,244.Ilearnedoftheconflict

betweenthelettersthroughWright’sobservations.88Wright(1994),op.cit.note11,246.89Ibid.,291.90InlightoftheextensiveinformationI’veread,itseemsreasonabletoassumethatmostlegislators,includingKennedy,werenever

adequatelyinformedabouttheillegitimacyofCohen’sclaim.However,Ihaveseennoexplicitevidencetothateffect.Further,althoughseverallegislatorsweresentcopiesoftheCurtissletterinApril1977,itseemsthatwhenCohen’sclaimwasissuedsixmonthslater,theydidnotrealizethatitwasundercutbytheearlierdocument.Foronething,Cohen’sletterdidnotmentiontheunusualconditionsunderwhichtheresearchwasperformed;andthefactthathe’demployedthemwasnotwell-publicized.

91Wright(1986),op.cit.note23,609.92Ibid.,610.93TranscriptquotedinWright(1986),op.cit.note23,611.94Ibid.,612.95Ibid.96Ibid.97Ibid.98Ibid.,615andWright,op.cit.note11,(1994),513,n.56.Wrightobtainedthequoteinaninterviewsheconducted.99Wright(1994),256.100Wright(1986),op.cit.note23,614.101Ibid.102Ibid.,596,615103Wright(1994),op.cit.note11,351.104Newmark,Peter,“WHOLooksforBenefitsfromGeneticEngineering,”Nature272(20April1978):663-64,quotedinWright(1986),

op.cit.note23,614.105Wright(1994),op.cit.note11,366.106Wright,Susan,emailcommunication.107Ibid.108Wright(1994),op.cit.note11,64.ThemolecularbiologistwhoproposedadangerousexperimentwasSydneyBrenner,oftheUniversity

ofCambridge.109Wright(1994),op.cit.note11,250.110Ibid.,248-50.111Ibid.,249,463.

112RowequotedinWright(1994),op.cit.note11,372.113Thestudywaspublishedas:Israel,M.A.,Chan,H.W.,Hourihan,S.L.,Rowe,W.P.andMartin,M.A.,“Biologicalactivityofpolyoma

viralDNAinmiceandhamsters,”J.Virol29(1979):990–96.ThespecifictypeofpolyomavirusthatwasemployedisreferredtoasPY.It’sinthesameviralgroupasthetumor-producingSV40thatPaulBerghad,severalyearspreviously,intendedtoinsertwithinanE.coli-infectingvirus–whichrousedtheconcernofRobertPollackandultimatelyspurredthedevelopmentoftheprecautionarymeasuresthattheRowe-Martinexperimentwasintendedtorelax.

114Israel,MarkA.etal.,“InterruptingtheEarlyRegionofPolyomaVirusDNAEnhancesTumorigenicity,”ProceedingsoftheNationalAcademyofSciences76(August1979):3714.

115Wright(1994),op.cit.note11,373.Foradiscussionofthevariousresults,see368-74.116Ibid.,368.117Ibid.,366-67.118Ibid.,375-66.AtanRACmeetinginMay1979,JonathanKingofMITnotedthatanexperimentconfinedtoE.coli(suchasRowe-

Martin)couldnotconfirmthesafetyofrDNAresearchwithotherorganisms.119OnNovember10,2010,Iaccessedthefalseclaimat:

http://www.niaid.nih.gov/labsandresources/labs/aboutlabs/lmm/viralpathogenesisvaccinesection/Pages/martin.aspx.InJanuary2014,IdiscoveredthatthisURLisnolongerfunctionalandthatMartin’scurrentbiographicalinformationomitsthe

misrepresentationthatwaspresentin2010–andhadpresumablybeenpostedformanyyears.Infact,thecurrentpagedoesnotspecificallymentiontheRowe-Martinexperimentatall.ThenewURLis:http://www.niaid.nih.gov/LabsAndResources/labs/aboutlabs/lmm/viralPathogenesisVaccineSection/Pages/martin.aspx#niaid_inlineNav_Anchor.It’squiteplausiblethatthefalsehoodwasremovedasaresultofbeingexposedbyinformationIcirculateddescribingit.Asupporterofthe

bioengineeringventuremaywellhavereaditandalertedDr.Martinabouttheneedforrevision.120Wright(1986),op.cit.note23,616.

2.ExpansionoftheBiotechAgenda1BecausecommercializationofaGEfoodwasstillmorethanadecadeaway,attentionatthattimewasprimarilyfocusedonwhethera

gene-alteredcropcoulddamagetheenvironmentduringfieldtesting,notonwhetheritmighteventuallybringnewriskstothedinnertable.Foodsafetydidnotbecomeasalientissueuntilmuchlater–anditwillbediscussedinsubsequentchapters.

2InterviewwithArnoldFoudin,Ph.D.,DeputyDirector,BiotechnologyPermits,PPQ,APHIS,USDA,Washington,DC(October6,1997),citedinJones,MaryEllen,“PoliticallyCorrectedScience:TheEarlyNegotiationofU.S.AgriculturalBiotechnologyPolicy,”aDoctoralDissertationinScienceandTechnologyStudiesatVirginiaPolytechnicInstitute(1999),63.

3Ibid.,88.4InterviewwithDavidMacKenziecitedinJones,(1999),op.cit.note2,p.89,n.231.Theword“disbelief”isthetermthatJonesusesin

describinghisreactionasrelatedtoher.5Ibid.,101.6Ibid.7Ibid.,105-06.8Ibid.,108.9Ibid.10Berg,Pauletal.,“PotentialBiohazardsofRecombinantDNAMolecules,”Science185(July26,1974):303.11AttheApril22,1981meetingofanRACworkinggroup,concernwasraisedthatriskassessmentdatawasstilllimitedtoE.ColiK-12;

andIhaveseennoindicationthatbyDecemberofthatyearthesituationhadchanged.SeeMinutesofLarge-ScaleReviewWorkingGroupoftheRAC,April22,1981,inUSDepartmentofHealthandHumanServices,(1982);DocumentsRelatingto“NIHGuidelinesforResearchInvolvingRecombinantDNAMolecules,”November1980-August1982,OfficeofRecombinantDNAActivities,NIHPublicationNo.83-2604,78.

12Jones(1999),op.cit.note2,109.JonesreportsthatJonathanKing(ofMIT)andRuthHubbardandGeorgeWald(bothofHarvard)“reproached”Baltimore“...forconflictofinterest,accusinghimofpromotingthederegulationofanindustryinwhichhehadaconsiderableeconomicinterest.”Inreferencingtheirallegations(infootnote287),shecitesdocumentstheyfiledwiththeNIHin1982as:Documentsrelatingto“NIHGuidelinesforResearchInvolvingRecombinantDNAMolecules”November1980-August1982,OfficeofRecombinantDNAActivities,NIHPublicationNo.83-2604;Hubbard(p.717),JonathanKing(p.719),andGeorgeWald(p.701).ThesedocumentsarenolongeravailableontheNIHwebsite.Tomyknowledge,therewerenoallegationsthatPaulBerghadanyconflictofinterest;andtheevidenceindicatesthatheendeavoredto

avoidsuchconflicts–andtomaintainproperboundariesbetweenacademiaandindustry.13Jones,op.cit.note2,113.14Ibid.,113-14.Duetotheselacks,thedirectorofNIHdeferredactionpendingreceiptofmoreinformationaboutcontainment–

informationthatwasnotprovideduntilthefollowingyear.Eventually,theproposalwasgivenfinalapprovalonAugust7,1981.15Ibid.,146-47.16Ibid.17Ibid.,156.18AsnotedinChapter1,becausethevariousstatementsfromRegalinthisbookarelargelydrawnfromhiswrittenrecollectionsandfrom

myextensiveconversationsandemailcorrespondencewithhim,exceptforquotesexcerptedfromhispublishedarticles,Iwillnotprovidespecificreferencesforhisvariousstatements.

19ThegenericargumentsdidexcludeatleastoneclassofGMO:thosederivedfromorganismsknowntobepathogenic.20Regal,Philip,“ModelsofGeneticallyEngineeredOrganismsandTheirEcologicalImpact,”inEcologyofBiologicalInvasionsofNorth

AmericaandHawaii,Mooney,H.andJ.Drake.,eds.(NewYork:Springer-Verlag,1986),117.21CitedinIbid.,118.22Ibid.(emphasisinoriginal).23Becausethewrinkle-inducingalleleisrecessive,itdoesn’tgetexpressedinasmanypeasasdoestheallelethatconferssmoothness,

whichisdominant.Sothemajorityofpeasaresmooth.24Regalfurthernotestheillegitimacyoftheclaimthatgene-splicingisakintocrossingtwodistantlyrelated(yetinter-breedable)species–

aprocessthatgenerallyreducesthefitnessoftheresultantorganisms.Hepointsoutthatthisinfirmityresultsbecausetheoffspringofsexualreproductionreceiveonesetofchromosomesfromeachparent,andthatwhentheparentsaredistantlyrelated,thesesetsarenotco-adapted.Hecontraststhiswithgeneticengineering,whereafewforeigngenesareaddedtoastablegenomeinwhichthesetsofchromosomesareco-adapted.Moreover,Regalpointsoutanothersignificantrespectinwhichgeneticengineeringradicallydiffersfromtraditionalbreeding:itcanalter

partsofthegenomethatthelattercannottouch.Inhiswords:“TraditionalbreedingislimitedtorearrangingonlyafractionoftheDNAmolecule–thefractionthatvarieswithinapopulation.Yetmuchof

theDNAmoleculedoesnotvaryamongindividualsinapopulation.Forexample,dogshaveonlytwoeyes.Eventhougheyesareundergeneticcontrol,theydonotvaryinnumberandthuswecannotselectfordogswiththreeormoreeyes.ThispartoftheirDNAcodeis‘lockedup’invariouswaysbeyondthereachofnaturalorartificialselection.Mutagenesiscaninducerandomchangesinpartsofthecodethatare

lockedup,butmutagenesiscannotsystematicallyrewritethispartofthecodeinabiologicallycoherentway.WithrDNAtechniquesonecan,inprinciple,gointotheDNAcodebooksthatare‘lockedup’andrewritethem.”

25Raven’scurrentviewsonGMOsarediscussedinendnote8ofChapter14.26AmemberofReagan’sWhiteHousestaffrecounts:“WewantedittobeanAmericantechnology,”Jones(1999),op.cit.note2,231.27Forinstance,thiswastheviewofWarrenWeaverandMaxMason,twoofmolecularbiology’sprimepromoters.See:Schwartz,J.“The

SoulofSoullessConditions?Accountingforgeneticfundamentalism,”RadicalPhilosophy86(November/December1997):4.28TheNASwebsitedevotesmanypagestoitsbuilding;andoverseveralyears,themainpagehasdisplayedtheprominentheading:“The

NASBuilding...aTempleofScience.”(TheheadingwaspresentwhenIfirstvisitedthatwebpagein2007,andasofJanuary2014,it’sstillinuse.Further,it’sreasonabletopresumethatitwastherelongbeforeIfirstaccessedthepage.)http://www.nasonline.org/about-nas/visiting-nas/nas-building/

29EinsteinwaselectedaforeignassociateoftheAcademyin1922andbecameamemberin1942,twoyearsafterhebecameanaturalizedcitizen.

30Jones(1999),op.cit.note2,231.31Ibid.,227-28.32Ibid.,164.33Ibid.,69,217,239.34Ibid.,217.35Ibid.,ii.36Ibid.,330.37NationalAcademyofSciences,“IntroductionofRecombinantDNA-EngineeredOrganismsintotheEnvironment:KeyIssues”(1987):6.38Ibid.,22.39Ibid.,20.40Marchant,Gary,“ModifiedRulesforModifiedBugs,”HarvardJournalofLawandTechnology1(SpringandSummer,1988):165.41Krimsky,S.andR.Wrubel,AgriculturalBiotechnologyandtheEnvironment:Science,Policy,andSocialIssues(Champaign,IL:

UniversityofIllinoisPress,1996),219.42Dumanoski,“AcademyReportChallenged,”BostonGlobe,August24,1987,44(CitedinMarchant,G.,op.cit.note40,166.)43KrimskyandWrubel(1996),op.cit.note41,219.44Regalrelatesthatafterthetaskforcecarefullydraftedasetofregulations,thestate’sdepartmentofagriculture(whichwasboosting

biotech)managedtogaincontrolandfashionedsomanyloopholesthattheregulationswererenderedvirtuallymeaningless.45Reporters’Guide:GeneticEngineeringinAgriculture(Washington,D.C.:EnvironmentalMediaService,2000),29.46EcologicalSocietyofAmerica,“ThePlannedReleaseofGeneticallyEngineeredOrganisms:EcologicalConsiderationsand

Recommendations,”Ecology70,no.2(April1989).47http://www.ourdocuments.gov/doc.php?flash=true&doc=90&page=transcript48Ibid.

3.DisappearingaDisaster1JanetO’Brien,NationalEMSNetworkNewsletter,Fall1997.2StoryonHarrySchulte,WCPO-TV,11PMNews,Cincinnati,Ohio,February26,1998.3PersonalCommunicationfromBettyHoffingtoJeffreySmithasreportedinSmith,J.,SeedsofDeception:ExposingIndustryand

GovernmentLiesAbouttheSafetyoftheGeneticallyEngineeredFoodsYou’reEating(Fairfield,IA:Yes!Books,2003),107.4PersonalcommunicationfromGeraldGleich,M.D.5Thewebsiteofamedicaldoctorwhoisanauthorityontryptophanstatesthatthe2%figurecamefromtheNewEnglandJournalof

Medicine:http://craighudsonmd.com/tryptophan.html(accessed1-2-12).6Hertzman,P.etal.,“TheEosinophilia-MyalgiaSyndrome:TheLosAlamosConference,”JournalofRheumatology18,no.6(1991):

867-73.7TheCDC’sfinalestimate(whichwasmadealmosttwodecadesago)putthenumberofdeathsatbetween80and100.Thefigureof

1,500permanentdisabilitiesisfromWikipedia.8AlthoughthecausallinkbetweenShowaDenko’sLTandtheepidemichasbeenquestionedbysomeresearchers(e.g.,Shapiro,S.,

“EpidemiologicstudiesoftheassociationofL-tryptophanwiththeeosinophilia-myalgiasyndrome:acritique,”JRheumatolSuppl[Oct.1996]:44-59),thelinkhasbeenfirmlyestablishedbypublishedresearchconductednotonlyattheCenterforDiseaseControl(CDC),butattheMayoclinicandotherrespectedinstitutions.ThestrengthoftheconnectionisattestedbyCDCscientistswhohavewritten:“ThesestudiesconstituteoverwhelmingevidencethatthecauseoftheEMSepidemicwasingestionofL-tryptophanproducedbyShowaDenko,”(emphasisadded),TheLancet343(April23,1994):1037.

9Philen,R.M.etal.,“3-(Phenylamino)alanine—aLinkBetweenEosinophilia-MyalgiaSyndromeandToxicOilSyndrome?,”MayoClinicProceedings68(1993):197-200.

10Ibid.11Slutsker,L.etal.,JournaloftheAmericanMedicalAssociation264,no.2(July11,1990):213-17.12GarrettL.,“Geneticengineeringflawblamedfortoxicdeaths,”Newsday,August14,1990:C-1.13Roberts,Leslie,“L-tryptophanpuzzletakesnewtwist,”Science249(August31,1990):988.14Ibid.15Ibid.16Belongia,E.A.etal.,“AnInvestigationoftheCauseoftheEosinophilia-MyalgiaSyndromeAssociatedwithTryptophanUse,”New

EnglandJournalofMedicine323,no.6(August9,1990):357-65.17Scientistsalsosometimesreferredtoitas“PeakE.”Subsequenttotheinitialpublicationdiscussingitsstructure,amoreprecise

determinationwasmadebyagroupattheMayoClinic,Mayeno,A.N.,etal.,Characterizationof“peakE,”anovelaminoacidassociatedwitheosinophilia-myalgiasyndrome,Science21(December1990)250,no.4988:1707-08.

18Belongiaetal.,(1990),op.cit.note16.19Charles,Dan,LordsoftheHarvest:Biotech,BigMoney,andtheFutureofFood(Cambridge:Perseus,2002),224.20Raphals,P.,“Doesmedicalmysterythreatenbiotech?,”Science249,no.619(1990).21UnpublishedstudybytheFDAandShowaDenkoK.K.,citedinToyoda,M.etal.,“Formationofa3-(Phenylamino)alanineContaminant

inEMS-associatedL-Tryptophan,”Bioscience,Biotechnology,Biochemistry58(1994):1318.22Ibid.,1318-1320.23Belongiaetal.,(1990),op.cit.note16.24PhilenRM,Hill,RHJr,FlandersWD,etal.,“Tryptophancontaminantsassociatedwitheosinophilia-myalgiasyndrome.TheEosinophilia-

MyalgiaStudiesofOregon,NewYorkandNewMexico,”AmJEpidemiol138(1993):154-59;Hill,R.H.etal.,“ContaminantsinL-tryptophanAssociatedwithEosinophilia-MyalgiaSyndrome,”ArchivesofEnvironmentalContaminationandToxicology25(1993):134-42.

25Love,L.A.,Rader,J.I.,etal.,“PathologicalandImmunologicalEffectsofIngestingL-Tryptophanand1,1’-Ethylidenebis(L-Tryptophan)inLewisRats,”JournalofClinicalInvestigation91(March1993):804-

11.26Hill,R.H.etal.,“ContaminantsinL-tryptophanAssociatedwithEosinophilia-MyalgiaSyndrome,”ArchivesofEnvironmental

ContaminationandToxicology25(1993):134-42.27Ibid.28Ibid.29Loveetal.(1993),op.cit.note25,statedthattheresearchindicatesthatseveralfactorswereprobablyinvolved.Further,EBTmayhave

sometimesplayedasubordinaterole.Althoughitwasnotsignificantlyrelatedtoalot’sharmfulstatus,therewasapositiveassociation,whichsuggestsitmayhavesometimesactedincombinationwithotherfactorstofacilitatetheoccurrenceofEMS(eventhoughthediseasewasofteninducedinitsabsence).

30Yanofsky,C.,emailtoWilliamCrist,June2,1998.31Yanofsky,C.,quotedinRaphals,P.,“EMSdeaths:IsrecombinantDNAtechnologyinvolved?,”TheMedicalPost,November6,1990.

32Yanofsky,C.,emailtoWilliamCrist,June2,1998.33PersonalcommunicationfromGeraldGleich,M.D.toJeffreySmith,asreportedinSmith,J.,SeedsofDeception:ExposingIndustry

andGovernmentLiesAbouttheSafetyoftheGeneticallyEngineeredFoodsYou’reEating(Fairfield,IA:Yes!Books,2003),275.34EmailfromWilliamCrist.35EdwinM.Kilbourneetal.,“TryptophanProducedbyShowaDenkoandEpidemicEosinophilia-MyalgiaSyndrome,”Journalof

RheumatologySupplement23,no.46(October1996):81-92.36NationalEosinophilia-MyalgiaSyndromeNetwork,positionstatement,approvedquotebyGeraldJ.Gleich,M.D.,MayoClinicand

Foundation,May25,2000.37Mayeno,A.N.andGleich,G.J.,“Eosinophilia-myalgiasyndromeandtryptophanproduction:acautionarytale,”TrendsinBiotechnology

(TIBTECH)(September1994),Vol.12,pp.346-352.38EmailfromDennisMackinofJanuary31,2012.Mr.Mackinandotherplaintiffs’attorneyseventuallyreceivedthisinformation,which

includedthedatesonwhichthevariousstrainshadbeenused.Yearslater,BillCristobtainedachartlistingthestrainsanddatesfromMackin,andIreceivedacopyfromCrist.AlthoughthislatterdocumentwasnotthecopyofthefaxtheFDAhadsentinSeptember1990,itcontainedthecriticalinformation.

39Hill,RobertH.etal.,“ContaminantsinL-tryptophanAssociatedwithEosinophilia-MyalgiaSyndrome,”ArchivesofEnvironmentalContaminationandToxicology25(1993):134-42.(ThisstudyindicatesthatStrainIVwasmoretoxicthanIII.)

40EmailfromWilliamCrist.41“BitterPill,”DatelineNBC,NBCNews,August22,1995;NHKSpecialinJapan,“ProductLiabilityLitigationinAmerica,”August5,

1995.42TorigoememoofAug23,1988,Exhibit90inspecificlawsuitsagainstShowaDenko,3.43EmailfromAdrianGibbs,EmeritusProfessorofVirology,AustralianNationalUniversity,44Althoughthere’scurrentlyinsufficientbasisfordeterminingwhethertheviralproblemarosewithinStrainIIIorIV,theerratic

employmentofIVsuggeststhatitwastheaffectedstrain.45SDrecordsobtainedbyattorneysduringthelawsuitsindicatesuchashutdown;andPaulRheingold(anattorneywhorepresented

hundredsofvictims)confirmedinaphoneconversationinJanuary2012thatasignificantshutdowndidoccur.46WithinSDrecordsthatfollowTorigoememo,op.cit.,inwhatappearstobepartofExhibit90atofficialreferencenumber3337550885.47EmailfromWilliamCristthatincludedacopyoftheMaryanskiletter.48EmailsfromWilliamCristregardinginformationreceivedfromDonMorgan(ofCleary,Gottlieb,Hamilton&Steen)viaphoneandemails

ofMarch5andApril19,2001.AccordingtoMorgan’sMarch5email:“SDKinvitedFDAtosendsomeonetoJapantoreceivethebacteriaandlearnhowtocareforthemandrunjarfermentationscorrectly.FDAneverfolloweduponthisoffer,orexpressedanycriticismofSDK’sreluctancetosendlivebacteriabymail.”

49Cristconveyedthisinformationtomeviaemail.50Ibid.51Bains,William,BiotechnologyfromAtoZ(Oxford:OxfordUniversityPress,1993),10.Thisfalsestatementisrepeatedinthesecond

edition,publishedin1998.52ReportoftheRoyalCommissiononGeneticModification(NewZealand,2001),43.53Ibid.54Ibid.55TheRoyalCommission’sreportgavenospecificreferenceforanyassertionitmadeinthetryptophansection.Rather,itlistedallfifteen

sourcesfortheentiresectioninonelargereferencenote.Thesesourcesincludesubmissionstothecommissionbyinterestedpersonsaswellasseveraljournalarticlesandevenaspecialreportpreparedforthecommission.Butnoneoftheassertionsinthetryptophansectionwasspecificallylinkedwithanyofthesesources,norwereanypagenumbersprovidedtoindicatewhichpartsofthesesourcescontainedtherelevantinformation.Consequently,itisextremelydifficulttodiscoverfromwhichsourceeachassertionwassupposedlyderivedandtoascertainitsreliability.Moreover,asofthetimeofthiswriting,neitherthesubmissionsbyinterestedpersonsnorthespecialreportonwhichtheCommissionreliedareprovidedonthegovernmentsiteatwhichthereportcanbedownloaded–andit’snotclearforhowlong,ifever,theywerereadilyavailable.http://www.mfe.govt.nz/publications/hazards/report-royal-commission-genetic-modification.Ineffect,thisstrangewayofreportingreferenceshasessentiallybarredpeoplefromcheckingthesourcesfortheCommission’sassertions

aboutthetryptophanincident.56DouglasL.Archer,DeputyDirectorCenterforFoodSafetyandAppliedNutrition(CFSAN),FDA,TestimonybeforetheSubcommittee

onHumanResourcesandIntergovernmentalRelations,USHouseofRepresentatives,July18,1991.Asfortheagency’sknowledgethatthebacteriahadbeenengineered,JeffreySmithreportsthataformerFDAemployeewasastoundedwhenheinformedherthatArcherhadfailedtomentionthatfact,declaringthatbythen“everyoneintheagency”knewaboutthebioengineering,Smith,SeedsofDeception(citedinnote33),121.

57CitedinBeisler,Joshua,H.,“DietarySupplementsandTheirDiscontents:FDARegulationandtheDietarySupplementHealthandEducationActof1994,”RutgersLawJournal(Winter2000):531.Althoughthisparticularreportwasissuedin1993,afewyearsafterArcher’stestimony,itindicatesthattheagency’sdesiretoregulatesupplementshadcontinuedunabatedfordecades,andhadnotbeensatiatedbythebanimposedonLT.

58Ibid.Inthelawjournal,theentirepieceistermedanote,butthatdoesnotindicateitiseithershortorotherwiseminor.Lawjournalstypicallyreservethetermarticleforpiecesauthoredbyprofessors,judges,andpracticingattorneysandrefertothosewrittenbymembersoftheirstaff,whoarelawstudents,asnotes.Butnotesreceivethesameeditorialscrutinyasarticles,theyareoftenofsimilarlength,andthey’refrequentlycitedinjudicialopinionsandarticlesinotherjournals.BecauseMr.Beisler’spiecerunsfortypagesandiscarefullyreasonedandthoroughlyresearched,Idecidedtorefertoitasanarticleratherthananotetoavoidconveyingthefalseimpressionthatit’sashortstatementofopinionthat’salsoshortonsupportiveevidence.

59Manders,Dean,“TheFDABanofL-Tryptophan:Politics,ProfitsandProzac,”SocialPolicy,vol.26,no.2,Winter1995:http://www.ceri.com/trypto.htm(accessedFebruary16,2012).

60FDAPublicAffairsOffice,PressReleaseofMay18,1994.Theenzymewasintroducedin1990,andShowaDenkofirstmarketedGE-derivedLTin1984.

61StephenNaylor,personalcommunication.62“GeneticallyModifiedFoods,”AustraliaNewZealandFoodAuthority,November2001.(downloadedfromtheagency’swebsiteon

March3,2002.)Theagency’snamewaslaterchangedtoFoodStandardsAustralia/NewZealand.63Fedoroff,N.andBrown,N.M.,MendelintheKitchen:AScientistLooksatGeneticallyModifiedFoods(Washington,DC:Joseph

HenryPress,2004);Ronald,P.andAdamchak,R.,Tomorrow’sTable:OrganicFarming,Genetics,andtheFutureofFood(NewYork:OxfordUniversityPress,2008).

64Charles,LordsoftheHarvest,op.cit.note19,224.65Aldridge,Susan,TheThreadofLife:TheStoryofGenesandGeneticEngineering(Cambridge:CambridgeUniversityPress,1996),

185-86.66http://www.bastyrcenter.org/content/view/1828/(accessed1-24-12)67http://www.bastyrcenter.org/content/view/590/#top(accessed1-24-12)68Lambrecht,B.,DinnerattheNewGeneCafé:HowGeneticEngineeringIsChangingWhatWeEat,HowWeLive,andtheGlobal

PoliticsofFood(ThomasDunneBooks:St.Martin’s,2001);Hart,K.,EatingIntheDark:America’sExperimentWithGeneticallyEngineeredFood(Pantheon:RandomHouse,2002).

69Mann,L.R.B.,Straton,D.,andCrist,W.E.,“TheThalidomideofGenetic‘Engineering.’”http://www.gmfoodnews.com/trypto.html70TheFDArescindeditsbanonLTin2006.Ofcourse,ifthefatalbatchesofLThadnotbeenmarketedin1989,therewouldnothave

beenabaninthefirstplace,andnobarriersforanewengineeredlineofLTtoface.RegardingEurope,areportbytheBBCindicatedthatthetoxicLTwouldgainentrytheretoo.(SeedsofDeception[op.cit.note33above],p.275,n.20.)

71Schubert,David,JournalofMedicinalFood11(4)(December2008):601-0572Hill,R.H.,Caudill,S.P.,etal,“ContaminantsinL-TryptophanAssociatedwithEosinophiliaMyalgiaSyndrome,”Archivesof

EnvironmentalContaminationandToxicology25(1993):134-42.73Intechnicalterms,AAAis“anunsaturatedfattyacidconjugateoftryptophan,”emailfromStephenNaylor.74EmailfromStephenNaylor.75SothereisnoquestionastotheaccuracyofmyaccountofDr.Naylor’sresearch,heexecutedanotarizedaffidavitconfirmingthefacts

asconveyedinthischapter.It’sreproducedatwww.alteredgenestwistedtruth.com/stephen-naylor-affidavit/

4.Genes,Ingenuity,andDisingenuousness1Miller,Henry,I.,“HappyEarthDay,Mr.Rifkin,”WashingtonTimes,April22,1997.2Wald,George,“TheCaseAgainstGeneticEngineering,”inTheRecombinantDNADebate,Jackson,D.andS.Stich,eds.(Prentice-Hall,

1979),127-28.3Wald,George,speakingatapressconferenceinWashington,D.C.March1977;QuotedinKimbrell,A.,TheHumanBodyShop:The

EngineeringandMarketingofLife(NewYork:HarperCollins,1994),159.AlthoughWald’sstatementthatgeneticengineeringisthe“biggestbreakinnature”occurredatapressconference,Ithinkit’sappropriatetoincludeitalongwithstatementshewroteinanearlierarticlebecausedoingsodoesnotinanywaymisrepresenthisthinking–andenablesittobeexpressedinacompactmanner.

4Bains,William,BiotechnologyfromAtoZ(Oxford:OxfordUniversityPress,1993).TheintroductionwaswrittenbyG.KirkRaab,PresidentandCEOofGenentech,Inc.,vi-viii.

5Ibid.,224.6Forexample,in2004asociologistwhohasconductedmanysurveysofconsumerattitudesintheUSobservedthatalthoughtwo-thirdsof

therespondentsvoicesupportforGEfoods,theyknowverylittleabouttheissueandthattheminoritywhoopposethemtendtobemosteducatedaboutthefacts.“ChangeofHeartByThomasHoban,”September23,2004:http://www.lobbywatch.org/archive2.asp?arcid=4387(accessedAug.15,2012)

7CommunicationsProgrammesforEuropaBio,January1997;PreparedbyBurstonMarsteller,GovernmentandPublicAffairs:http://home.intekom.com/tm_info/geleak1.htm(accessedAug.15,2012).

8Miller,Henry,I.“HappyEarthDay,Mr.Rifkin,”WashingtonTimes,April22,1997.Insubsequentyears,Dr.Millerhascontinuedtosoundthe“seamlesscontinuum”theme.Seee.g.,Miller,H.I.,PointofView,Dec1,2007(27,no.21):http://www.genengnews.com/keywordsandtools/print/1/12239/(accessedAug.15,2012).

9May,SirRobert,BBCInterview,March9,2000.10Virusesareaninterestingcase.Theyarenotfullcells,andmostbiologistsdonotconsiderthemtobelivingorganismsintheirownright.

Theycannotreproduceontheirownandcanonlydosowhentheyhaveinvadedalivingcellofanotherspecies,commandeereditsgeneticapparatus,andre-directedittogeneratetheircomponents.

11Whileoverall,thereisstillanetlossofthecapacityofenergytoperformwork,thedissipationisfarmoregradualwithinlivingsystems,moreoftheenergycontributestotheformationoforganizedstructure,andthedegreeoforganizationismuchhigherthanintheprocessesthattypifynonlivingnature.

12Grace,Eric.,BiotechnologyUnzipped(Washington,DC:JosephHenryPress,1977),22.13Whilethematureredbloodcellsofmammalshaveshedtheirnucleus(andtheDNAwithinit),theydidpossessaDNA-packednucleus

intheirearlierstagesandsofunctionedasinformationprocessingmachinesastheydeveloped.14MostbacteriapossessonemainmoleculeofDNA(referredtoasachromosome)andseveralsmaller,auxiliarymolecules(called

plasmids).Thiswillsubsequentlybediscussedinmoredetail.15Gitt,W.,IntheBeginningWasInformation(GreenForest,AR:MasterBooks,2007),98.16Inplantsandanimals,mostgenescangeneratemultipleproteinsbecausethetranscriptionalmachinerycanarrangetheinformationthey

containinvariousways.17Sexchromosomesareanexception.Thesexchromosomeofthehumanmale(theYchromosome)doesnotcontainallthegenesinthe

femalechromosome(theXchromosome).18Althoughsomeplantsfertilizethemselves,theyusuallyalsosendsomeoftheirpollenoutwardtofertilizethefemalegametesofother

plantswhilesomeoftheirfemalegametesreceivepollenfromotherplants.Someplantsalsohavefourormoresetsofchromosomesinsteadoftwo.Buttheirgameteswillstillcontainonlyonehalfofthenumberpossessedbytheirparentalcells,soiftheplant’scellscontainfourdifferentsetsofchromosomes,itsgameteswillhaveonlytwo.

19http://link.springer.com/chapter/10.1007/978-94-011-5794-0_320Thomas,C.andNielsen,K.,“Mechanismsof,andBarriersto,HorizontalGeneTransferbetweenBacteria,”NatureReviews

Microbiology3(September2005):712.21Griffithsetal.,AnIntroductiontoGeneticAnalysis,SixthEdition(NewYork:W.H.Freeman,1996),424.22Ibid.23Notallrestrictionenzymesmakestaggeredcuts,butbiotechniciansareabletodrawonawidevarietyofthosethatdo.Further,they’ve

learnedhowtoaddstickyendstofragmentsthatarecutwithenzymesthatleavesheeredges.Butthisabilitycouldnothavedevelopedwithouttheapplicationoftheenzymesthatdomakestaggeredcuts.

24Althoughevidenceindicatesthatrestrictionenzymesprobablyhaveadditionalroles,andthattheyattimesmayhavefacilitatedtheintegrationofforeignDNAintobacterialgenomes,it’sclearthattheirprimaryfunctionistoinhibitsuchintegration.Forinstance,WernerArber,whoreceivedaNobelPrizefordiscoveringtheseenzymes,haspostulatedthattherearetwobasictypesofwhatheterms“evolutiongeneproducts.”Theseproductsacteithertogenerategeneticvariationortomodulateit“tolowlevelsthataretolerableforthelong-termmaintenanceofagivenstrainorspecies.”Heclassesrestrictionenzymesasmodulatorsbecausethey“seriouslyreduceboththechanceofDNAacquisitionandthesizeofaDNAsegmentthatmayeventuallybeacquiredbytherecipientcell.”Andhedoessoeventhoughhethinksthattheystimulate“occasionalDNAacquisitiontooccurinsmallsteps.”(Arber,W.,“MolecularEvolution:ComparisonsofNaturaland

EngineeredSystems,TheChallengesofSciences,ATributetoCarlosChagas,”PontificalAcademyofSciences,ScriptaVaria103[VaticanCity2002]):www.pas.va/content/dam/accademia/pdf/sv103/sv103-arber.pdf;Arber,W.,“GeneticVariationandMolecularEvolution,”EncyclopediaofMolecularCellBiologyandMolecularMedicine(2006).Incontrast,bioengineersemployrestrictionenzymesnotonlytoradicallyincreasetherateatwhichgenomesarealteredbyalienDNA,but

tovastlyexpandtherangeofspeciesthatcaninteract–tothepointwherenoneofthenaturalspeciesbarriersremainsintact.25OneexperimentdidfindthatwhenE.coliarewithinriverorspringwaterthatnaturallycontainsasufficientlevelofcalciumion,they

cantakeupplasmidDNAwithoutadditionalcalciumorabnormalshiftsintemperature(Baur,B.etal.,“GeneticTransformationinFreshWater:EscherichiacoliisAbletoDevelopNaturalCompetence,”AppliedandEnvironmentalMicrobiology62(Oct.1996):3673-78).Andincreasingevidencesuggeststhatmanyspeciesofbacteriathataren’tordinarilyabletotakeupexternalDNAcandosoundersomenaturallyoccurringconditions.Butsuchinstancesappeartoberelativelyrare.Inanycase,thefactremainsthatbiotechnicianshaveroutinelyresortedtounnaturalmeanstoinduceE.colitoreceiveexternalDNA.

26TheonlybacteriainwhichtheseparticularelementshavebeenfoundbelongtotheArchaebacteriakingdom,bacteriathatexistinextremeenvironments,suchasboilingwater.Thesebacteriaarerarelyusedincommercialapplicationsofbioengineering.

27Foragooddiscussionofreversetranscriptase,see:http://www.nature.com/scitable/topicpage/the-biotechnology-revolution-pcr-and-the-use-553.

28BiotechnologyfromAtoZ,FirstEdition,(citedinnote4),131.29Chang,ShingandCohen,StanleyN.,“InVivoSite-SpecificGeneticRecombinationPromotedbyEcoRIRestrictionEndonuclease,”

ProceedingsoftheNationalAcademyofSciences74(November1977):4811-15.30Althoughgenesaresometimesinsertedtoblocktheexpressionofanothergeneratherthantoexpressanyoftheirownproteins,thiswas

seldomtheaimofcommercialapplicationswhenCohen’sexperimentwasperformed;andeventoday,thepredominantgoalofcommercialbioengineeringistoproduceafunctionalproteinfromtheinsertedgene.

31Chang,A.C.Y.,Lansman,R.A.,Clayton,D.A.&Cohen,S.N.,“StudiesofMouseMitochondrialDNAinEscherichiacoli,”Cell6(1975):231-44,at241.ThisstudywasperformedtwoyearspriortotheoneonwhichCohenbasedhisinfluentialclaim.It’sdiscussedmorefullyinthefollowingnote.

32Actually,onecannotknowtowhatextent(ifany)mitochondrialproteinswereproducedinthe1977experimentconductedbyChangandCohenbecausetheirtechnicalreportmakesnomentionofthattopic.Butin1975CohenandthreeothercolleaguespublishedapaperthatdiddiscusstheproteinproductionthatwasobservedaftermousemitochondrialgeneswereinsertedintoE.coli.Andthedegreeofproductionwasdisappointing.ThosearetheresultsIreportedindescribingthe1977study.Intheabsenceofdatadirectlybearingonthelevelofproductioninthatstudy,Ithinkit’sreasonabletoassumethattheresultswerenobetterthaninthe1975experiment,becauseiftheauthorshaddeterminedthattheproductionwasmoreimpressive,theywouldhavemadethatfactknown.However,itappearsthatin1977,theydidn’teventrytomakesuchadetermination.Performingoneintheearlierexperimenthadbeenacomplicated,timeconsumingendeavor,sobecausetherewaslittlelikelihooditwouldrevealbetterresults,theyprobablydecideditwasn’tworththeeffort.Ofcourse,theresultsin1977mightevenhavebeenworse;butIdecidedtogiveCohenthebenefitofthedoubtbyreportingthe1975dataasiftheyappliedtothe1977experiment.OnemightwonderwhyCohenevenperformedthatexperimentifhehadalreadydiscoveredthattheproteinsencodedbythegenesof

mousemitochondriawillnotbeadequatelyproducedwithinE.coli.Thereason,itseems,wastoprovidethebasisforarguingthatbacteriacanintegrateplantandanimalgenesinanaturalmanner.The1975experimentfellshortofprovidingsuchaplatform.Inthatresearch,rDNAtechnologywasusedtosplicethemouseDNAintoplasmidsthatwereoutsidetheE.coli,andonlythereafterdidthefullyengineeredplasmidsenterthebacteria.Butinhissubsequentstudy,Cohenwantedtoshowthatthesplicingcouldoccurwithinthebacteria.HeaimedtodemonstratethatfragmentsofmouseDNAandfragmentsofplasmidDNAcouldbetakenupbythebacteriaandthenjoinedtogetherinsidethebacterium.However,aswe’veseen,hefailedtodemonstratethatthisprocesscanoccurthroughpurelynaturalmeansbecauseheinducedtheuptakethroughmeansthatwerehighlyunnatural.(Thesewerethesamemeanshe’demployedin1975inordertogetthefullyengineeredplasmidsintothebacteria.)Moreover,hecompoundedtheartificialitybycuttingboththeplasmidandmousemitochondrialDNAwiththesamerestrictionenzymetomakeiteasierforthemtofusetogetheraftertheyenteredthebacteria.

33QuotedinWright,Susan,MolecularPolitics:DevelopingAmericanandBritishPolicyforGeneticEngineering1972-1982(Chicago:UniversityofChicagoPress,1994),82.

34Itakura,K.etal.,“ExpressioninEscherichiacoliofachemicallysynthesizedgeneforthehormonesomatostatin,”Science198(4321)(Dec9,1977):1056-63.Whenhumaninsulinwasproducedfrombacteriathefollowingyear,thesamesetoftechniqueswasemployed(Crea,R.etal.,“ChemicalSynthesisofGenesforHumanInsulin,”PNAS75,no.12,5765-69).

35Fedoroff,N.andBrown,N.M.,MendelintheKitchen:AScientistLooksatGeneticallyModifiedFoods(Washington,DC:JosephHenryPress,2004),4-5.

36Oneotherspeciesofsoilbacteria,Agrobacteriumrhizogenes,isknowntohavecapacityforinducingplantstoexpresssomeofitsgenes.Theresultisamaladytermed“hairyrootdisease.”

37Ibid.,129.38Inrecentyears,biotechnicianshavefoundotherpromotersthataresuitedforsomeoftheirpurposes;andseveralGEplantshavebeen

developed(orareinthedevelopmentalpipeline)thatdonotrelyexclusivelyonthe35S,whilesomedon’tcontainitatall.Further,someofthesepromotersderivefromplantsaswellasviruses.Yet,aswillbediscussedinsubsequentchapters,inalmosteverycase,theinsertedgenesarestillimpelledtoexpressinunnaturalways;andtheregulatoryintegrityoftheengineeredorganismscontinuestobecompromised.

39Charles,Dan,LordsoftheHarvest:Biotech,BigMoney,andtheFutureofFood(Cambridge:Perseus,2002),75.40Ibid.,78.

41Dr.SherriBrown,quotedinMillingandBakingNews,August4,1997,ascitedinKneen,B.,Farmageddon:FoodandtheCultureofBiotechnology(BritishColumbia:NewSocietyPublishers,1999),26.

42Latham,J.R.etal.,“TheMutationalConsequencesofPlantTransformation,”JournalofBiomedicineandBiotechnologyArticleID:25376,(2006),1-7.

43Ibid.,3.44QuotedinReese,A.,GeneticallyModifiedFood:AShortGuidefortheConfused(London:PlutoPress,2006),46-47.45Srivastava,M.,Eidelman,O.&Pollard,H.B.,“PharmacogenomicsoftheCysticFibrosisTransmembraneConductanceRegulator

(CFTR)andtheCysticFibrosisDrugCPXUsingGenomeMicroarrayAnalysis,”Mol.Med.5(1999):753-67.Theresearchersassessedasampleof588genesandfoundsignificantchangesin5%ofthem.

46Schubert,D.,“AdifferentperspectiveonGMfood,”NatBiotechnol20(2002):969.47PersonalcommunicationfromDavidSchubert.48Seediscussionin:Clark,E.Ann,“ParliamentariansandTechnology:MeetingtheChallengesfortheNewMillennium,Workshopon

EnsuringFoodSafety,”uoguelph.ca,May9,2000:http://www.uoguelph.ca/plant/research/homepages/eclark/Hc.htm.SeealsoDocument#4at:http://biointegrity.org/24-fda-documents

49Ordinarily,onlyarelativelysmallnumberofanorganism’sgenesarecontinuouslyactive;andtheyaretheoneswhoseproductsareconstantlyrequired.It’sunnaturalforagenetobeexpressedduringtimeswhenthere’snoneedforitsproduct.

50Elmoreetal.,“Glyphosate-ResistantSoybeanCultivarYieldsComparedwithSisterLines,”AgronJ93(2001):408-12.51Wilson,A.,J.Latham,andR.Steinbrecher,“GenomeScrambling-MythorReality?Transformation-InducedMutationsinTransgenic

CropPlants,”TechnicalReport(October2004):1,http://www.econexus.info/taxonomy/term/12.52LordsoftheHarvest(citedinnote39),85.53Seee.g.,Kaeppleretal.,“Epigeneticaspectsofsomaclonalvariationinplants,”PlantMolecularBiology43(2000):179–88;181.54Althoughtissuecultureisusedinembryorescuetoo,becauseaseedisinvolved,theretendtobelessperturbationsthanwhengenetically

engineeredcellsarecultured.Chapter9providesfurtherdiscussionoftherisksoftissuecultureinproducingGEcrops.55Finnegan,H.andMcElroy,“Transgeneinactivation:plantsfightback!”Biotechnology,12(1994):883-88.56Hansen,Michael,“GeneticEngineeringisNotanExtensionofConventionalPlantBreeding,”ConsumerPolicyInstitute/Consumers

Union,Jan.2000,http://www.mindfully.org/GE/GE-Not-Ext-Michael-Hansen.htm.57Ibid.58Lambrecht,Bill,DinnerattheNewGeneCafé:HowGeneticEngineeringIsChangingWhatWeEat,HowWeLive,andthe

GlobalPoliticsofFood,(ThomasDunneBooks:St.Martin’sPress,NewYork,2001),ix.59Fox,M.W.,SuperpigsandWondercorn(NewYork:LyonsandBurford,1992),102and117;Commoner,Barry,“UnravelingtheDNA

Myth:Thespuriousfoundationofgeneticengineering,”Harper’s(February2002).60SuperpigsandWondercorn(citedabove),102.61Ibid.62Jabed,A.etal.,“TargetedmicroRNAexpressionindairycattledirectsproductionofβ-lactoglobulin-free,high-caseinmilk,”PNAS109,

no.42(2012):16811-16,http://www.pnas.org/content/109/42/16811.full.63Reddy,A.S.,Thomas,T.L.,“ModificationofPlantLipidComposition:ExpressionofaCyanobacterialD6–desaturaseGenein

TransgenicPlants,”NatureBiotechnology14(1996):639-42.64Inose,T.andMurata,K.,“EnhancedAccumulationofToxicCompoundinYeastCellsHavingHighGlycolyticActivity:ACaseStudyon

theSafetyofGeneticallyEngineeredYeast,”InternationalJournalofFoodScienceandTechnology30(1995):141-46.65“MakingCropsMakeMoreStarch,”BBSRCBusiness,UKBiotechnologyandBiologicalSciencesResearchCouncil,January1998,6-8.66Yamada,Ken,“GeneticVegomaticsSpliceandDiceWithWeirdResults,”WallStreetJournal18(April1992).67MendelintheKitchen,op.cit.note35,x;alsobackcover.68NinaFedoroffquotedathttp://sciblogs.co.nz/guestwork/2010/02/15/is-genetic-engineering-just-like-breeding/(accessedApril11,2012).69Withinrecentyears,evidencehasaccumulatedindicatingthat,althoughstillrarecomparedtopointmutations,largermutationsthatleadto

adaptivechangeoccurmorefrequentlythanbiologistshadrecognized.SeeShapiro,James,Evolution:AViewfromthe21stCentury(FTPress,2011).However,therearesignificantdifferencesbetweensuchnaturalchangesandthoseinducedbytheartificialmodesofbioengineering.

70Evenwhenbreedersintentionallyinducemutationswithradiationorchemicals,theselectedchangesareusuallysmallandcouldhaveoccurredthroughnaturalmeans.Noalienpromotersareintroduced,norareseveralotherhazardsimposedthatareinherenttorDNAtechnology.SuchpurposelyinducedmutationsaremorethoroughlydiscussedinChapter9andAppendixD.

71Dreifus,C.,“AConversationWithNinaV.Fedoroff,”NewYorkTimes,August19,2008.72Althoughshedoessaythat“agenefromabacteriumcan,withtheproperswitchesadded,workinaplantcell”,sheisevidentlyreferring

tothepromotersandterminatorsthatmustbeadded,nottothecodonsthatrequirerevision.Moreover,shegoesontomakeamisleadingstatementabouttheresultsofsuchcross-kingdomtransfers.Sheasserts:“Theplantcellwillmaketheverysameproteinfromthatgenethatthebacteriummade.”(MendelintheKitchen,op.cit.,note35,91.[emphasisadded])However,aswillbediscussedinChapter6,plantscanaddsugarchainstotheseproteinsthatareneveraddedbybacteria;andthesechangescouldrendertheproteintoxicorallergenic.

73AlthoughanexperimentthatcombineddifferentspeciesoftobaccoviagraftingresultedintransferofchloroplastDNAfromcellsinonesectionofthegraftedplanttocellsintheother,thisphenomenon,too,significantlydiffersfromwhatoccursingeneticengineering.(Stegemann,S.andBock,R.,“ExchangeofGeneticMaterialBetweenCellsinPlantTissueGrafts,”Science,vol.324,no.5927[May1,2009]:649-51.)Chloroplastsaresmallunitswithinplantcellsthatperformphotosynthesis,theprocessthroughwhichtheenergyinsunlightistransformed

intotheplant’sfood.Likemitochondria(thecell’spowerhouses),chloroplastspossesstheirowngenomes;andtheirgenomesaresubstantiallydifferentfromthosethatresideinthecellularnucleus.Inthisgraftingexperiment,noneofthenuclearDNAtransferredbetweenthegeneticallydistinctcells.Itallstayedathome.Nordidanyof

themitochondrialgenesrelocate.Theonlygenesthatmovedacrossthegraftjunctionwerethoseofchloroplasts.Andtheydidnotmovepiecemeal.AlargesectionofchloroplastDNA(perhapsallofit)movedasaunitandfunctionedasaunitinitsnewcellularlocation,performingessentiallythesameusefulfunctionasthecell’snativechloroplasts.Andthesegenesoperatedwithinchloroplasts,notwithinthenucleus.Thisphenomenoncontrastsstarklywithgeneticengineering,whereisolatedsegmentsofnuclearDNAfromonespeciesarewedgedintothenuclearDNAofanotherspecies–andthenactindependentlyoftheirneighborsinperformingunregulatedactivitiesthatarealientothehostcell.Further,fortransferofchloroplastDNAtooccurviagrafting,notonlymustthebiologicaldistancebetweenthespeciesbesmall(againin

contrasttoGE),somustthephysicaldistancebetweenthecellsthatareinvolved.Onlycellsincloseproximitytothesplicejunctionbetweenthetwopartsoftheplantareinvolvedinthetransfer.Thus,thephenomenonisrestrictedtoatinyfractionofthetotalcells,whereasinmostengineeredplants,allthecellscontainsomeDNAthatwastransferredfromanotherspecies.Moreover,asearchIperformeddidnotdetectanypublishedreportsofsuchtransfersoccurringingraftsinvolvingotherspecies,soit’s

possiblethephenomenonisrestrictedtotobaccoplants.74WhenIrefertogenesintheir“natural”state,I’mdenotinggeneswhoseinternalchemicalstructurehasnotbeendirectlyreconfiguredby

humanartificeinawaythatcouldneverotherwiseoccur.Accordingtothisdenotation,thegenesrestructuredviarecombinantDNAtechnologyareunnaturalwhereasmostofthosemutatedviaintentionalapplicationofionizingradiationarenot,becausethesametypesofradiation-inducedmutationscouldhaveoccurredvianaturalsourcesofradiation,withoutanyhumanintervention.Ofcourse,ifthedoseofradiationismuchgreaterthanwouldordinarilybereceivedabsenthumanintervention,thenunusualmutationsthatresultwouldbeconsideredunnatural.Further,eveninmostofthecaseswheretheindividualmutationsarenotdeemedunnatural,theoverallpatternofmutationswouldbe,becausetheentireseedwouldhavebeensubjectedtoanextraordinaryapplicationofradiation.Evenso,asChapter9andAppendixDdiscuss,theuseofradiationinplantbreedingsignificantlydiffersfromgeneticengineering–andentailsalowerlevelofrisk.

75MendelintheKitchen,op.cit.note35,127.Inherexactwords:“Itisasnatural–orasartificial–asanappletree.”AlthoughthespecificreferenceistotherecombinantDNAmolecule,itlogicallyextendstotheorganisminwhichthatmoleculefunctions.

76Ibid.77Evenwhenbranchesfromseveraldifferentspeciesaregraftedontothesamerootstock,thevariousfruitsremainonseparatebranches

inthematuretree,andtheirrespectivegenesdonotintermingle.Further,althoughitmaybepossibleforchloroplastDNAtomovebetweenthesectionsofagraftedtree(ascanoccuringraftedtobaccoplants,describedinnote73above),itappearsthatnosuchcaseshavebeenobserved.Moreover,evenifsuchtransfersdooccurintrees,theywouldn’t“combine”genesfromdifferentspecies.AccordingtotheAmericanHeritageDictionaryoftheEnglishLanguage(4thEdition),to“combine”is“tobringintoastateofunity,”to“merge,”“tojoin(twoormoresubstances)tomakeasinglesubstance.”But,althoughforeigngenesarejoinedtoformasinglemoleculeinbioengineering,whenchloroplastgenesmovetochloroplastsinaneighboringforeigncell,theydonotsuddenlyenterthenucleusandmergewithitsDNA.Andeventhough,overthelifetimeofthetree,it’spossiblethatafewforeignchloroplastgeneswouldmigratetothenucleusthatwouldhardlymakegraftingasignificantcombinerofforeigngenes.Thisisespeciallysoconsideringthatonlyaminisculefractionofthetree’scells(thosealongthesplicejunction)wouldevenbecandidatesforsuchcombination.Further,therewouldbenomigrationofforeigngenesintotheleavesorfruit.There’sanotherimportantpoint.WhenFedoroffwroteherbook,therewasnoevidencetosuggestgraftingmightenableeventhetrivial

levelofforeigngenetransferjustdiscussed.Herbookwaspublishedin2004,andtheexperimentshowingthetransferofchloroplastDNAingraftedtobaccoplantswasn’tpublisheduntil2009.Thus,atthetimeshemadeit,Fedoroff’sclaimthatgraftingcombinesforeigngeneswasnotevenremotelysupportedbytheknownevidence;anditconflictedwiththeprevailingscientificconsensus–whichindicatesherwillingnesstoignore(andevencontradict)thebestavailablebiologicalknowledgeinordertopromoteGEfoods.

78MendelintheKitchen,op.cit.note35,123-27.79Ibid.,127.80Foronething,thebacteriadon’tordinarilyattacktheregionwherethegametesform.Moreover,ifsomehowagametedidbecome

infectedandthensurvivedtoparticipateinforminganembryo,ifthebacterialtumor-inducinggeneswereactive,theembryowouldprobablybecometumorous–aswouldanycellsderivedfromit.Soit’shighlyunlikelythatamatureorganismwouldeveremergewithafunctionalgenefromA.tumefaciens.Further,althoughthere’sanotherspeciesofsoilbacteria,Agrobacteriumrhizogenes,thatalsoinsertssomeofitsgenesintoplants(inducing

amaladyknownas“hairyrootdisease”),andalthoughthere’sevidenceimplyingthatinthedistantpastittransferredfourofthesegenesintothegermlineofatobaccospecies,there’snoevidencethatanyoftheproteinstheycodeforisbeingexpressed(Aoki,S.andSyono,K.,“Horizontalgenetransferandmutation:NgrolgenesinthegenomeofNicotianaglauca,”PNAS96,no.23[Nov.9,1999]:13229–34).RecentresearchconfirmsthattransferofAgrobacteriagenestothegermlineofplantsisindeedextremelyrare.Inastudypublishedin

December2012todetermineifanyplantspeciesbesidestobaccocontainedsuchgenes,127werescreenedandnonewasfoundtocontainanygenesfromA.tumefaciens.Further,onlyoneofthemwasobservedtocontainsomeDNAfromA.rhizogenes–andthatDNAisapparentlynotbeingexpressed.(Matveeva,T.etal.,“HorizontalGeneTransferfromGenusAgrobacteriumtothePlantLinariainNature,”MolPlantMicrobeInteract25,no.12[December2012]:1542-51).

81AlthoughAgrobacteriahavebeenusedtocreatemorevarietiesofGEfoodthanthegenegun,becausethelatterhasbeenusedtocreatecommercializedGEcornandsoy,ithasproducedthegreatestvolumeofGEorganismsactuallyconsumed.

82ANZFAOccasionalPaperSeriesNo.1,GMfoodsandtheconsumer(June2000):28.Whentheguidewasreleased,theagencywascalledtheAustralia/NewZealandFoodAuthority(ANZFA).InJuly,2002,itwasrenamedFoodStandardsAustraliaNewZealand(FSANZ).

83OnFebruary15,2001ImetwithANZFA’schiefscientist,biotechnologymanager,andgeneralstandardsmanagerforalmosttwohoursandinformedthemaboutthefalsestatementregardingpromoters,aswellassomeothererrorsthedocumentcontained.Theyinvitedmetosubmitfurthercommentstothemattheirpersonalemailaddresses.OnJuly25,2001Isentthemformalcommentsmorefullyexplainingthesefalsehoods.Itisevidentthattheyreadmycomments,andIalsosentthemtoseveralotherofficialswithintheagency.Nonetheless,theagencycontinuedtodistributethedocumentinpamphletformformanymonthsafterbeinginformedoftheerrors;andas

ofSeptember12,2002,morethanayearlater,itwasstillofferingthedocumentonitswebsitefordownloadingwiththefalsestatementsintact.Thisindicatesaseverelackofintegrity,sincemakingcorrectionstothedigitalversionwouldhavebeenquitesimple.(Theuncorrecteddocumentmaywellhavebeenavailablelongthereafter,butIstoppedcheckingatthatpoint.Idon’tknowhowmanymoremonthsoryearselapsedbeforeitwasfinallyremoved.)

84NeitherthefirsteditionofBaines’book,publishedin1993,northesecondedition,publishedin1998,evenmentionedtheterm“promoter,”althoughtheydidindicatethataforeigngenewouldgenerallynotexpresswithinthehostcellwithoutbeinggivenasuitable“geneticcontext”(asinp.132ofthefirstedition).And,whilethethirdedition(in2004)doesenlargethisdiscussionbynotingthatan“appropriate”promotersequencemustbepartofthecontext,there’sstillnoindicationthat,inatransgenicplant,thepromoterisderivedfromavirus–orthatasaresult,theexpressionoftheforeigngeneiscompletelyderegulated.

85Ronald,P.andAdamchak,R.,Tomorrow’sTable:OrganicFarming,Genetics,andtheFutureofFood(NewYork:OxfordUniversityPress,2008),xiii.Thequotesfromthejournalsappearonthebook’sfrontandbackcover.

86Theindexhasnoentryfor“promoter”or“cauliflowermosaicvirus,”andinmyreadingofthebook,Ifoundnoreferencetoeitheroftheminthemaintext.Theonlyappearanceoftheword“promoter”thatIdiscoverediswithinthedefinitionof“transgene”intheglossaryatthebackofthebook.Accordingtothepertinentsentence,“Alongwiththegenesofinterest,maycontainpromoter,otherregulatory,andmarkergeneticmaterial.”(p.177)However,becausetheterm“promoter”has(asfarasIcouldascertain)notbeenpreviouslydefinedordiscussed(there’snotevenanentryforitintheglossary),mostreaderswouldnotevenknowwhatapromoteris.Andevenifsomeonedidalreadyunderstandapromoter’sgeneralroleingeneexpression,thissentenceimpliesthatthegene’snativepromoteristransferredalongwithit.There’snoindicationthatvirtuallyalltheforeigngenesinsertedincommercializedGEcropsareattachedtoapowerfulpromoterderivedfromaplantvirus.

87Theterms“particlebombardment,”“bioballistics,”and“genegun”arenotintheindexand,tomyknowledge,theydon’tappearintherestofthebookeither.

88FieldTestingGeneticallyModifiedOrganisms:FrameworkforDecisions,TheNationalAcademyofSciences(1989),14.89Antoniou,Michael,quotedinSmith,Jeffrey,GeneticRoulette(Fairfield,IA:Yes!Books,2007),8.90Thebizarrestatementappearsinthereport’sintroduction.AsChapter2noted,theintroductionwaswrittenbyNRCstaff,notbythe

universityscientistswhowrotemostoftherestofthereport.91Grace,Eric.,BiotechnologyUnzipped(Washington,DC:JosephHenryPress,1977),xiii.TheJosephHenryPressisanimprintofthe

NationalAcademiesPress.92Ibid.,xiii-xiv.93Ibid.,45.94Ibid.,29.95Ibid.,xv.WhileFedoroffwasnotonthereviewteamthatinteractedwithGrace,shewassentareviewcopysothatshecouldwritea

commentaboutthebook(emailfromEricGrace).96TheemailtohimwassentonMarch1,2012;herepliedonMarch5.97TheDr.OzShow,December7,2010:http://www.doctoroz.com/videos/genetically-modified-foods-pt-3.98MendelintheKitchen,op.cit.note35,xii.99Therewereonlytwootherspeakersthatmorning:aMonsantoofficialtorepresenttheviewsofthebiotechindustryandanexecutive

fromapublicinterestorganizationtorepresenttheviewpointofconsumers.100AllianceforBioIntegrity/ICTAPressConference,NationalPressClub,WashingtonD.C.,May27,1998.

5.IllegalEntry1Regal,Philip,“AreGeneticallyEngineeredFoodsSafe?AScientist’sQuestforBiosafety”:

http://www.iatp.org/files/Are_Genetically_Engineered_Foods_Safe_A_Scient.htm.2Ibid.3Lloyd,T.,“Monsanto’snewgambit:Fruitsandveggies,”HarvestPublicMedia,April8,2011:http://bit.ly/LQTNxp4Goodman,M.M.,“Newsourcesofgermplasm:Lines,transgenes,andbreeders.”Paperpresentedat:MemoriaCongressoNacionalde

Fitogenetica;2002;Univ.AutonimoAgr.AntonioNarro,Saltillo,Coah.,Mexico.5Millstoneetal.,“Beyond‘substantialequivalence,’”Nature(Oct.7,1999)estimatedthatacombinationofshortandmedium-termtests

wouldcostatleastanadditional$25million;andDr.Millstoneinformedmethatfulllong-termtestingwouldbesignificantlymoreexpensive–andthatifmultigenerationaltestingwereincluded,thecostwouldbeevenhigher.BecauseMajorGoodmanputthecostofdevelopingaGEcropataround$60million(absentanytoxicologicaltesting),adding$25milliontothecostwouldamounttoanincreaseofover40%(SeeGoodman,30).

6Regal,op.cit.,note1.7Forabasichistoryoftheregulationoffood,seehttp://www.fsis.usda.gov/Factsheets/Additives_in_Meat_&_Poultry_Products/index.asp

(accessedApril26,2012).8“ProfilesinToxicology,”ToxicologicalSciences70,(2002):159-60:http://toxsci.oxfordjournals.org/content/70/2/159.full.pdf;accessed

April26,2012.9S.Rep.2422,1958U.S.C.C.A.N.5301-2.1021U.S.C.§32111Althoughoneoftheprovisionsofthe1958reforms(theso-calledDelaneyAct)wasrepealedbyCongressin1996thatdidnotchange

thefundamentalsofthefoodadditiverequirements.12Document#4at:http://biointegrity.org/24-fda-documents13Ibid.Allthequotesinthisparagrapharefrom#4.14Ibid.15Document#5at:http://biointegrity.org/24-fda-documents16Document#2at:http://biointegrity.org/24-fda-documents17CommentsfromtheDivisionofFoodChemistryandTechnologyandtheDivisionofContaminantsChemistry,“PointstoConsiderfor

SafetyEvaluationofGeneticallyModifiedFoods.SupplementalInformation”(November1,1991).Document#6at:http://biointegrity.org/24-fda-documents

18Ibid.ThisstatementisinasectionthatisnotreproducedontheAllianceforBioIntegritywebsite.ItspagenumberintheFDAadministrativerecord(A.R.)forthelawsuitis18613,andthisisthewayitwasreferencedinthebriefsthatwerefiledwiththeCourt.

19Thestatementcitedisatpage18744oftheadministrativerecord.20Document#9at:http://biointegrity.org/24-fda-documents21Document#10at:http://biointegrity.org/24-fda-documents22Ibid.,atA.R.18990-91.23Document#7at:http://biointegrity.org/24-fda-documents24Document#1at:http://biointegrity.org/24-fda-documents25Eichenwaldetal.,“BiotechnologyFood:FromLabtoDebacle,”NewYorkTimes,January25,2001.Inthisarticle,executiveswho

directedMonsanto’spolicyduringthe1980’spurportedthattheyhadpushedformeaningfulregulationfrom1986untiltheearly1990’s,when“anewmanagementteam”tookover,decidedtoreversecourse,andconvincedtheWhiteHousethatitshouldscrapplansforsuchregulation.However,thisaccountissuspect.ItdoesnotsquarewithRegal’sobservationsoftherealitiesduringthelate1980’s,andit’salsodubiousinlightoftheindustry’spersistentanti-regulatoryeffortsduringthepreviousyears.Asearlierchaptershaveshown,theindustryhasconsistentlyendeavoredtoavoidregulationwhileprojectingtheillusionthatresponsibleregulationswereinplace.Accordingly,onecouldreasonablysurmisethattheMonsantoexecutivesinterviewedforthearticlewereattemptingtoshiftblameforthecompany’sunpopularpoliciestotheirsuccessors–andthatwhateverdifferencesexistedbetweentheiragendaandtheonepursuedintheearly90’swerenotaboutwhethermeaningfulregulationsshouldbeimplementedbutabouthowbesttocreatetheimpressionthattheyhadbeen.

26“WhatWouldYouDowithaFluorescentGreenPig?,”EcologyLawQuarterly201,no.34(2007):238.27Document#1at:http://biointegrity.org/24-fda-documents.Inhermemo,Dr.Kahlstatedthatthisforcedconclusion“isbecauseofthe

mandatetoregulatetheproduct,nottheprocess,”p.2.28Document#4at:http://biointegrity.org/24-fda-documents29Document#21at:http://biointegrity.org/24-fda-documents30Document#23at:http://biointegrity.org/24-fda-documents31Document#24at:http://biointegrity.org/24-fda-documents32Theletterheadonhisstationerysays:ExecutiveOfficeofthePresident

OfficeofManagementandBudget33“FromLabtoDebacle,”op.cit.note25.34“StatementofPolicy:FoodsDerivedFromNewPlantVarieties,”May29,1992,FederalRegister57,no.104,sec.VI.35Ibid.,22991.3621U.S.C.§321(s)37Thetextofthestatutestatesthatthesubstancemustbe“...generallyrecognized,amongexpertsqualifiedbyscientifictrainingand

experiencetoevaluateitssafety,ashavingbeenadequatelyshownthroughscientificprocedures...tobesafeundertheconditionsofitsintendeduse....,”21U.S.C.§321(s).

38Theagencydidnotextendthepresumptiontogenesthatareknowntoproduceatoxinoranallergen.Butmanufacturerswouldwanttoavoidsuchgenesanyway.

39Document#8at:http://biointegrity.org/24-fda-documents.4021CFRSec.170.30(b);21CFR170.3(i)4121CFRSec.170.30(b)42Document#1at:http://biointegrity.org/24-fda-documents43Document#19at:http://biointegrity.org/24-fda-documents.“FDARegulationofFoodProductsDerivedfromGenetically-AlteredPlants:

PointstoConsider.”Theauthorshipofthisdocumentisnotindicated,anditisalsoundated.However,itspagenumbersintheadministrativerecordsupportaninferencethatitwaswritteninJulyorAugustof1991.

44Ibid.,atA.R.18195.45Ibid.,atA.R.18196.46Maryanski,J.,“SafetyAssuranceofFoodsDerivedbyModernBiotechnologyintheUnitedStates,”July1996.InJanuary1999,theFDA

affirmedthatitstillwasnotconductingscientificreviews,stating:“FDAhasnotfounditnecessarytoconductcomprehensivescientificreviewsoffoodsderivedfrombioengineeredplants...consistentwithits1992policy”(ReportedinTheLancet353(May29,1999):1811.)ForadetaileddiscussionoftheunreliabilityoftheFDA’svoluntaryprogram,seeFreese,W.andD.Schubert,“SafetyTestingand

RegulationofGeneticallyEngineeredFoods,”BiotechnolGenetEngRev.21(2004):299-324.47LaceyDeclaration,AllianceforBioIntegrityvShalala.48RegalDeclaration,AllianceforBioIntegrityvShalala.http://alteredgenestwistedtruth.com/declaration-of-philip-regal/.49Defendants’OppositiontoPlaintiffs’CrossMotionforSummaryJudgment,1.50AllianceforBioIntegrityv.Shalala.,116F.Supp.2d166(D.D.C.2000)at172-73.51116F.Supp.2dat174,175.52Theexceptionisforfoodscontaininggeneticmaterialtransferredfromoneofthemostcommonlyallergenicspecies.Todate,itdoesnot

appearthatanysuchfoodhascometomarket.53IfthejudgehadruledthattheFDAhadviolatedtheAdministrativeProcedureActbynotholdingformalnoticeandcomment,orhad

violatedNEPAbynotperforminganenvironmentalassessment,itwouldalsohavemeantthattheFDA’spolicyhadbeenimplementedinviolationofthelaw.ButneitheroftheserulingswouldhavecastdoubtonthesafetyofGEfoodsforhumanconsumption

54116F.Supp.2dat177;Citing21C.F.R.Sec.170.30(a-b);62Fed.Reg.18940.55116F.Supp.2dat177;Citing62Fed.Reg.At18939.56116F.Supp.2dat17757UnitedStatesv.SevenCartons...Ferro-Lac,293F.Supp.660,664(S.D.Il.1968),modifiedonothergrounds,424F.2d136(7thCir.

1970).58StatementofPolicy:FoodsDerivedFromNewPlantVarieties,May29,1992,FederalRegister57,no.104at22991.59A.R.at11723-24.60A.R.at37744-45.61Document#8at:http://biointegrity.org/24-fda-documents62Document#1at:http://biointegrity.org/24-fda-documents63Ferro-Lac,293F.Supp.660(S.D.Il.1968).Citedinnote57.64Ibid.,at664.65Ibid.,at665.66WhilesomebiotechproponentsclaimthataproposedruletheFDAintroducedin1997independentlylegitimizesthepresenceofGEfoods

onthemarket,inactuality,itdoesnot.ThatproposalaimedtosimplifyproceduresthroughwhichmanufacturerscaninteractwiththeagencyinestablishingtheGRASstatusofadditives.(FederalRegister62(1997):18938-964)Butithasneverformallymovedbeyondthestageofa“proposed”rule.AlthoughtheFDAhasbeentreatingitasan“interimpolicy,”ithasnotbeenfinalizedandlackstheforceoflawthatofficiallyenactedrulespossess.So,despitewhatmanypeoplehavebeenledtobelieve,ithasnolegalauthorityoreffect.Accordingly,whentheAllianceforBioIntegritylawsuitwaslitigatedin1998-99,theFDAdidnottrytoasserttherelevanceofthatproposedrule,anditisnotmentionedinthecourt’sopinion.Moreover,thatproposedrulemakesnoattempttoalterthetwobasiccriteriathatmustbesatisfiedinorderforanadditivetovalidlypossess

GRASstatus(technicalevidenceofsafetyandgeneralrecognitionwithinthescientificcommunitythatsuchevidenceinfactexists.)And,as

theanalysisinthischapterhasdemonstrated,neitherofthosecriteriahaseverbeenmetbyanyGEfood.Soeveniftherulehadbeenfinalized,itwouldnothaverenderedGEfoodsGRAS.

6721U.S.C.§321(n)68116F.Supp.2dat179.69Defendants’OppositiontoPlaintiffs’CrossMotionforSummaryJudgment,pp.2&4.70“ProposedRules,”FederalRegister66,no.12(January18,2001):4709.71Ibid.,4710.72Ibid.73Ibid.74Ibid.,4710-11.75Ibid.,4711.76Temp.Envtl.L.&Tech.J.225(2000-2001):19.Althoughthispieceis17pagesinlength,inlawreviewparlance,it’sreferredtoasa

“note”andnotanarticle,becauselawreviewarticlesarenotauthoredbylawstudentsandaremuchlonger.ButI’mreferringtoitasanarticle,sincemostreaderswouldbemisledbytheterm“note”intothinkingthatthepieceismuchshorterthanitis.

77Ibid.,229-30.It’snoteworthythatalthoughtheauthoruncriticallyacceptedthejudge’serroneousrulingsregardingtheGRASissue,shecritiquedherhandlingofthelabelingissue.Thisindicatesthatheracquiescenceintheformerwasnotduetoexcessdeferencebuttodeepconfusion.

78E.g.,22Rev.Litig.669at681(2003);22BerkeleyTech,L.J.671at698(2007)(discussedatnote80).7934EcologyL.Q.201(2007)at2248022BerkeleyTech.,L.J.671at695.ThearticlestatedthatincontrasttotheEU,“[t]heU.S.policy...isthatGMOsshouldbepermitted

toflourishintheabsenceofprovenhazards.”Althoughthisstatementreferredtofoodsafetyaswellastheenvironment,therewasnotevenahintthatthepolicyviolatesexplicitmandatesofthelaw–andillegallyshiftstheburdenofprooftothosewhoquestionthesafetyofGEfoods.Thisarticlealsoimpliedthatwefailedtopresentevidenceofexpertconflict.Itssuperficial(andsomewhatmisleading)statementsaboutour

lawsuitappearonp.698inthemaintextandalsoinnote156.81Lambrecht,Bill,DinnerattheNewGeneCafé:HowGeneticEngineeringIsChangingWhatWeEat,HowWeLive,andthe

GlobalPoliticsofFood(ThomasDunneBooks:St.Martin’sPress,NewYork(2001),51.82Glickman,Dan,quotedinSimon,Stephanie,“BiotechSoybeansPlantSeedofaRiskyRevolution,”LosAngelesTimes,July1,2001.83Glickman,Dan,quotedathttp://eap.mcgill.ca/MagRack/RH/RH_E_97_02.htm(accessed6-14-12)84Glickman,Dan.March1999.Quotedat:http://www.ces.ncsu.edu/depts/foodsci/ext/pubs/biotech.html(accessed:7-17-12)85Pickett,M.,“AgOfficialDefendsRulesforBiotechCrops,”BillingsGazette,November23,2004.86Shacinda,S.,“U.S.NeedsGoodPlantoGiveAIDSFunds-healthChief,”Reuters,December1,2003.87Lambrecht,B.,“OutgoingSecretarySaysAgency’sTopPriorityisGeneticallyModifiedFood,”St.LouisPost-Dispatch,January25,

2001.88Clinton,Bill,ConferencecallwithfarmradiobroadcastersfromHermitage,Arkansas(asreportedbyReuters,November5,1999).89StatementofPolicy:FoodsDerivedFromNewPlantVarieties,May29,1992,FederalRegister57,no.104.Seethediscussionin

SectionV.90USDepartmentofHealthandHumanServices.PressRelease.May3,2000.91FDAquotedin:“HealthRisksofGeneticallyModifiedFoods,”TheLancet353,no.9167(May29,1999):1811.92Weise,E.,“FDATriestoRemoveGeneticLabelBeforeitSticks,”USAToday,October9,2002.93Cole,M.,“FDAObjectstoFoodLabelingInitiative,”CropChoiceNews,October9,2002,

http://www.cropchoice.com/leadstry6df6.html?recid=1028.94StatementofRobertE.Brackett,Ph.D.,Director,CenterforFoodSafetyandAppliedNutritionbeforetheSenateCommitteeon

Agriculture,NutritionandForestry,June14,2005:http://www.fda.gov/NewsEvents/Testimony/ucm112927.htm(accessed:7-17-12).95Leahy,Stephen,“CropTestingRulesMenaceFoodSupply,SayCritics,”IPSNewsAgency,November25,2004.96Ibid.97Philpott,Tom.Monsanto’smanTaylorreturnstoFDAinfood-czarrole,GRIST,July8,2009.Taylor’smostrecentreturntotheagency

wasnotmadedirectlyfromMonsanto.Afterservingasoneofthecorporation’svicepresidents,heworkedforafewotherorganizationspriortorejoiningtheFDA.

98http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/ucm196721.htm99PersonalcommunicationfromDr.MarionHealy,ANZFAOffices,Canberra,AU,February15,2001.

6.GlobalizationofRegulatoryIrregularity1Millstone,E.etal.,“Beyond‘substantialequivalence’,”Nature,October7,1999.2Ibid.3Ibid.4Clark,E.Ann,“FoodSafetyofGMCropsinCanada:toxicityandallergenicity,”GEAlert,2000.5Faust,Marjorie,“BiotechCropsfortheDairyandLivestockIndustries,”Proceedingsofthe2001CaliforniaAnimalNutrition

Conference,76-86.Althoughby2001,therehadbeentestsinwhichanimalswerefedthewholeGEfood,theywerenotthekindsofteststheFDAexpertshad

calledfor.EithertheyaimedtodiscoverwhethertheforeignDNAandtheresultantforeignproteinthatgetimplantedinthecropsarelaterfoundintheanimals,ortheyweredesignedasnutritionalfeedingstudies,whichgaugehowwelltheanimalsgrowbutdonotassesstoxicologicaleffectsinathoroughmanner.Chapter10discusseshowbiotechpromotershavemisrepresentedtherelevanceofsuchstudies.

6“ElementsofPrecaution:RecommendationsfortheRegulationofFoodBiotechnologyinCanada;AnExpertPanelReportontheFutureofFoodBiotechnologypreparedbyTheRoyalSocietyofCanadaattherequestofHealthCanadaCanadianFoodInspectionAgencyandEnvironmentCanada,”TheRoyalSocietyofCanada,January2001.

7Calamai,P.,“OttawaRapped,ExpertStudyConsideredMajorSetbackforBiotechIndustry,”TorontoStar,February5,2001.8“ElementsofPrecaution,”op.cit.note6.9Ibid.10“OttawaRapped,”op.cit.note7.11PersonalcommunicationfromLucySharratt,Coordinator,CanadianBiotechnologyActionNetwork,June28,2012.12Smith,Jeffrey,SeedsofDeception:ExposingIndustryandGovernmentLiesAbouttheSafetyoftheGeneticallyEngineered

FoodsYou’reEating(Fairfield,IA:Yes!Books,2003),7-9.13Ibid.,9.14Theorganization’snamewassubsequentlychangedtoFoodStandardsAustraliaNewZealand(FSANZ).15CommentstoANZFAaboutApplicationsA346,A362andA363fromtheFoodLegislationandRegulationAdvisoryGroup(FLRAG)of

thePublicHealthAssociationofAustralia(PHAA)onbehalfofthePHAA(October,2000).16GEproponentsmightarguethatchangesbetweentheGEplantandthecontrollinemightnotnecessarilybetheresultsofthegene

insertionbutofthesomaclonalvariationthatusuallyaccompaniesthegenerationofplantsviatissueculture.However,evenifthechangeswereduetotissueculture,thatprocessisanessentialpartofplantgeneticengineering.Therefore,unlessrigoroustestingeventuallydemonstratedthatthechangeswereharmless,itwouldbepropertoregardthemaspotentialrisksofthebioengineeringprocess.TissuecultureandsomaclonalvariationwillbemorethoroughlydiscussedinChapter9.

17CommentstoANZFAaboutApplicationsA372,A375,A378andA379fromtheFoodLegislationandRegulationAdvisoryGroup(FLRAG)ofthePublicHealthAssociationofAustralia(PHAA)onbehalfofthePHAA(April2001).

18PHAAReportof2000(emphasisinoriginal).19Millstoneetal.,op.cit.note1.20Ibid.21Kawata,Masaharu,“InspectionoftheSafetyAssessmentoftheRoundupTolerantGeneticallyModifiedSoybean:Monsanto’s

DangerousLogicasseenintheApplicationDocumentsubmittedtoJapan.”ThereportwasoriginallypublishedintheJapanesejournalTechnologyandHumanBeings,vol.11(Nov.2000):24-33.AsofNovember2014,itwasavailableat:http://www.mindfully.org/GE/GE2/Monsanto-Safety-Japan-Inspection.htm

22http://www.biosafety-info.net/article.php?aid=22(accessed:July5,2012).Althoughthedifferenceswerenotstatisticallysignificant,the8%mortalityratewasdoubletheusualrateintheUKbroilerchickenindustry.

23Ibid.24Ibid.25Lean,Geoffrey,“EuropeSplitOverSafetyofGMCorn,”TheIndependent,December21,2003.26Smith,Jeremy,“EULiftsBiotechBan,”Reuters,May19,2004.Seealso:http://www.gmo-safety.eu/archive/218.moratorium-ends.html

(accessed:June22,2012).27Ibid.28It’sprobablethatthecommissioner(DavidByrne)wasnotintentionallydeceivingthepublicbutbelievedwhathesaidbecausehehimself

hadbeendeceivedbypro-biotechforces.Infact,inlightofhispriorhistory,it’smostreasonabletoassumethatthiswasthecase.29Schubert,David,“ADifferentPerspectiveonGMFood,”NatureBiotechnology,vol.20,no.10,October2002,969.30Thetransferoftheproteinfrombeantopeaisdescribedin:Shade,R.E.etal.,“Transgenicpeaseedsexpressingthealpha-amylase

inhibitorofthecommonbeanareresistanttobruchidbeetles,”Biotechnology12(1994):793-796.Theresearchthatdiscoveredtheadverseeffectsoccurredseveralyearslaterandisdescribedin:Prescott,V.E.etal,“Transgenic

expressionofbeanalpha-amylaseinhibitorinpeasresultsinalteredstructureandimmunogenicity,”JournalofAgriculturalFoodChemistry

(2005)Nov16;53(23):9023-9030.31Thetestthat’scommonlyusedistheSDSgeltest.ThemoresensitivetestistheMALDI-TOFtest.32Commoner,Barry,“UnravelingtheDNAMyth:Thespuriousfoundationofgeneticengineering,”Harper’sMagazine,Feb2002.33However,MadCowDiseasehasnotresultedfromgeneticengineering;andalthoughitcanbeinducedbyfeedingcattlediseasedtissue

fromsheep(therebytransgressinganaturalboundarybycrossfeeding),thereisnoknownlinkbetweenit(oranyofitsrelateddiseases)andcrossbreeding.

34Hagan,N.etal.,“Theredistributionofproteinsulfurintransgenicriceexpressingageneforaforeign,sulfur-richprotein,”PlantJ.34(2003):1–11.ThisstudyismoreextensivelydiscussedinChapter9,note111.

35Gurian-Sherman,Doug,“HolesintheBiotechSafetyNet,”CenterforScienceinthePublicInterest(2003),14:cspinet.org/new/pdf/fda_report__final.pdf.Note:ThereportprovidescitationstothescientificstudiesthatsupportGurian-Sherman’sassertions.Foramajorreviewpublishedsincehisreport,see:Latham,J.,WilsonA.andSteinbrecher,R.,“TheMutationalConsequencesofPlantTransformation,”JournalofBiomedicineandBiotechnology,vol.2006,ArticleID25376,3.Chapter9discussesthemessinessoftheinsertionalprocessinmoredetail.

36Ibid.37ThefirstGEcrop(atomato)wascommercializedin1994.38Podevin,N.andduJardin,P.,“PossibleconsequencesoftheoverlapbetweentheCaMV35Spromoterregionsinplanttransformation

vectorsusedandtheviralgeneVIintransgenicplants,”GMCropsFood3(2012):296–300;doi:10.4161/gmcr.21406.39DeTapia,M.etal.,“Moleculardissectionofthecauliflowermosaicvirustranslationtransactivator,”EMBOJ12(1993):3305-14.40Takahashi,H.,Shimamato,K.,Ehara,Y.,“CauliflowermosaicvirusgeneVIcausesgrowthsuppression,developmentofnecroticspots

andexpressionofdefence-relatedgenesintransgenictobaccoplants,”MolGenGenet.216(1989):188–94.41Park,H.S.,Himmelbach,A.,Browning,K.S.,Hohn,T.,Ryabova,L.A.,“Aplantviral‘reinitiation’factorinteractswiththehost

translationalmachinery,”Cell.106(2001):723-33.42Haas,G.,Azevedo,J.,Moissiard,G.,Geldreich,A.,Himber,C.,Bureau,M.,etal.,“NuclearimportofCaMVP6isrequiredforinfection

andsuppressionoftheRNAsilencingfactorDRB4,”EMBOJ27(2008):2102-12.43http://www.independentsciencenews.org/commentaries/regulators-discover-a-hidden-viralgene-in-commercial-gmo-crops/44http://www.efsa.europa.eu/en/faqs/faqinsertedfragmentofviralgeneingmplants.htmhttp://archive.foodstandards.gov.au/consumerinformation/gmfoods/gmfactsheetsandpublications/gmfoodsandtheuseofdn5796.cfm45http://independentsciencenews.org/commentaries/gmo-regulators-hidden-viral-gene-vi-regulators-fail/46TheScienceandEnvironmentalHealthNetworkmadetheobservation.Quotedat:http://www.precaution.org/lib/pp_def.htm)47Thestatuteexemptsspecificclassesofsubstancesfrombeingdefinedas“additives,”suchaspesticidalchemicals,whichareregulated

undertheprovisionsofadifferentstatute.See:21U.S.C.§321(s).48CommunicationofApril30,1997onconsumerhealthandfoodsafety(COM(97)183final).49ResolutionofMarch10,1998ontheGreenPaper:GeneralPrinciplesofFoodLawintheEU.50ECCommunicationonthePrecautionaryPrinciple,Feb.2,2000,Reference11.51ECCommunicationonthePrecautionaryPrinciple,Feb.2,2000.52Kok,E.J.andKuiper,H.A..“Comparativesafetyassessmentforbiotechcrops,”TrendsinBiotechnology21(2003):439–44.53Hilbeck,A.,Meier,M.,Römbke,J.,Jänsch,S.,Teichmann,H.andTappeser,B.,“Environmentalriskassessmentofgeneticallymodified

plants-conceptsandcontroversies,”EnvironmentalSciencesEurope23,no.13(2011).54Dalli,John.,“GMOs:TowardaBetter,MoreInformedDecision-MakingProcess,”March17,2011.55Séralinietal.,“Geneticallymodifiedcropssafetyassessments:presentlimitsandpossibleimprovements,”EnvironmentalSciences

Europe,23,no.10(2011):http://www.enveurope.com/content/23/1/10/(accessedJuly12,2012).56Ibid.57Ibid.58Fleming,J.,“NoriskwithGMOfood,saysEUchiefscientificadvisor.”EurActiv.com,July24,2012:http://www.euractiv.com/innovation-

enterprise/commission-science-supremo-endor-news-514072(accessedAugust2,2012).59ThemeetingtookplaceintheANZFAofficesinCanberra.Isubsequentlyemailedtheparticipantsaletterthatsummarizedwhatthey

hadsaidandcritiquedtheirpolicy.IalsorequestedthattheyinformmeofanyfactualerrorsImighthavemadeinmyrecountingofthemeeting.Dr.Healy,thechiefscientist,sentanemailacknowledgingreceiptofmyletteranddidnotobjecttoanyofmystatementsaboutwhatshehadsaid.OnSeptember6,2001Isentheranemailstating:“WhenIsentmycomments,Iaskedthatyouinformmeofanyfactualmisstatementsyoumightfindinthem.Overamonthhaspassedandyouhavenotpointedoutanysuchmisstatements.Therefore,Iassumeyouassenttothecorrectnessofmystatementsoffact.”Copiesofmyinitialletterandmyfollow-upareavailableat:www.alteredgenestwistedtruth.com

60ANZFAOccasionalPaper,SeriesNo.1,GMfoodsandtheconsumer(June2000).Aspreviouslynoted,theagency’snamewassubsequentlychangedtoFoodStandardsAustraliaNewZealand(FSANZ).

61Thedegreetowhichtheagency’sofficialshaveevadedtheimplicationsofadverseevidence,misrepresentedthefacts,andpersistedinderelictpracticesisdrivenhomeinthetwolettersIemailedthemsubsequenttoourmeetingthatarereferredtoinnote59.

62Séralinietal.(2011),op.cit.note55.63Ibid;theauthorsstatethatitwasnecessarytoobtaincourtorders,buttheydon’tprovidethedetails.Someoftherelevantonesareas

follows.ThethreeGEplantsinvolvedwerevarietiesofmaize(corn)producedbyMonsanto:MON863,MON810andNK603.Atthetimeapprovalwasfirstsoughtfortheseplants,amanufacturerinitiatedtheprocessbyapplyingtotheappropriateregulatoryagencyinanEUmemberstate.BecauseMonsantoclaimedthattherawdatawasconfidential,theregulatoryagenciesthatpossessedthedatarefusedtoreleaseittothepublic,ortotheresearchers.Butthecourtsruledthatthepublichadarighttoseethedataandorderedtheregulatorstoreleaseit.

64QuotedinSmith,Jeffrey,“AnFDA-CreatedHealthCrisisCirclestheGlobe,”3:http://www.seedsofdeception.com/utility/showArticle/?objectID=1477

65“ElementsofPrecaution,”op.cit.note6,214.66“ThrowingCautiontotheWind:AreviewoftheEuropeanFoodSafetyAuthorityanditsworkongeneticallymodifiedfoodsandcrops,”

FriendsoftheEarthEurope(November2004):3.67Ibid.,13.68Ibid.69Ibid.70Ibid.,13&14.Thesetwopagesarethesourceforthevariousassertionsmadeintheparagraph.71Seralinietal.,“NewAnalysisofaRatFeedingStudywithaGeneticallyModifiedMaizeRevealsSignsofHepatorenalToxicity,”

ArchivesofEnvironmentalContaminationandToxicology52,no.4(May2007):596-602.72FriendsoftheEarthEuropeandGreenpeace,“HiddenUncertainties:WhattheEuropeanCommissiondoesn’twantustoknowabout

therisksofGMOs,”April2006.73Ibid.

7.ErosionofEnvironmentalProtection1Ingham,Elaine,“EcologicalBalanceandBiologicalIntegrity,”postedathttp://www.purefood.org/ge/klebsiella.cfm.2Doyle,J.D.etal.,“Effectsofgeneticallyengineeredmicroorganismsonmicrobialpopulationsandprocessesinnaturalenvironments;”in,

Neidleman,S.,Laskin,A.J.(eds.),AdvancesinAppliedMicrobiology,vol.40(AcademicPress,SanDiego,CA,1995),237-87;seealso,Shortetal.,“Effectsof2,4dichlorophenol,ametaboliteofageneticengineeredbacteriumand2,4dichlorophenoxyacetateonsomemicroorganism-mediatedecologicalprocessesinsoil,”Appl.Environ.Microbiol.57(1991):412-18.

3Jones,R.P.,“Biologicalprinciplesfortheeffectsofethanol,”EnzymeMicrobiol.Technol.11(1989):130-53.4Ingham,E.R.,Doyle,J.D.,andHendricks,C.W.,“EffectsofKlebsiellaplanticolaSDF20onsoilbiotaandwheatgrowthinsandysoil,”

AppliedSoilEcology11(1999):67-78.5Infact,whenMichaelHolmes,thegraduatestudentwhoinitiatedthestudy,continuedtheresearch,hediscoveredthatinsome

circumstancestheGEbacteriacouldout-competetheparentstrain.(ElaineIngham,theprofessorwhosupervisedandparticipatedintheoriginalresearch,informedmeofthisinapersonalconversation.ShesaidthatthesefindingsweredescribedinHolmes’doctoraldissertation,whichhasnotbeenpublished.)

6Ingham,E.,“EcologicalBalance,”op.cit.note1;Ingham,E.,LettertotheEditor:“EngineeredBacteriumCouldHaveSeriousImplicationsforHumanLifeonEarth,”AgribusinessExaminer,Issue119,June11,2001.

7Suzuki,D.andDressel,H.,FromNakedApetoSuperspecies:HumanityandtheGlobalEco-Crisis(Vancouver:GreystoneBooks,2004),121.

8Ingham,E.,quotedinLukeAnderson,GeneticEngineering,FoodandOurEnvironment(WhiteRiverJct.,VT:ChelseaGreen,1999),39-40.

9Ingham,E.,LettertotheEditor,op.cit.note6.10Ingham,“EcologicalBalance”op.cit.note1.11Inthiscontext,“regulators”referstothosewiththeauthorityandcapacitytosetpolicy.Itisnotmeanttoincludeallemployeesofthe

regulatoryagencies.From1983tothepresent,therehavebeenmanymembersoftheseinstitutionswhoendeavoredtopursueagenuinelyscience-basedandresponsiblepolicyonGMOs.However,theircollectiveinfluencehasbeeninsufficienttoshapeoutcomes.

12Anderson,Luke,op.cit.note8,40.13USGeneralAccountingOffice,Biotechnology:ManagingRisksofGeneticallyEngineeredOrganisms(GovernmentPrintingOffice

[GAO/RCED-88-27,WashingtonD.C.,1988,108pp.])14PEERWhitePaper,“GeneticGenie:ThePrematureCommercialReleaseofGeneticallyEngineeredBacteria,”September21,1995;re-

issued,January25,2000.15Roslin,Alex,“Germsgonewild,”GeorgiaStraight,July21,2005:http://www.ibiblio.org/london/SoilWiki/message-

archives/JoeCummins/msg00517.html16PEERWhitePaper,op.cit.note14,v.17Ibid.,reportingonthecommentsofSuzanneWuerthele.18PEERNewsRelease,Jan.26,2000.19Pollack,Andrew,“LaxinTestsofGene-AlteredCrops,”NewYorkTimes,January3,2006.20Brasher,Philip,“ReportBlastsOversightofFieldTests,”DesMoinesRegister,Dec.30,2005.21Weiss,Rick,“U.S.RiceSupplyContaminated,GeneticallyAlteredVarietyIsFoundinLong-GrainRice,”WashingtonPost,August19,

2006;Weiss,Rick,“FirmBlamesFarmers‘ActofGod’forRiceContamination,”WashingtonPost,November22,2006;A05.22Seeforexample,Doering,Christopher,“ProdiGenetospendmillionsonbio-corntainting,”ReutersNewsService,USA,December9,

2002.23Ibid.Thecorngotmixedwiththesoybeans,butitdidnotcross-pollinatethem(anoutcomethatisbiologicallybarred).24Smith,Jeffrey,InstituteforResponsibleTechnologyNewsletter,August2006.25PressRelease,CenterForFoodSafety,February6,2007:http://www.centerforfoodsafety.org/GTBC_DecisionPR_2_7_07.cfm26Séralini,G.E.etal.,“Geneticallymodifiedcropssafetyassessments:Presentlimitsandpossibleimprovements,”EnvironmentalSciences

Europe23(10)(2011);Freese,W.&Schubert,D.,“Safetytestingandregulationofgeneticallyengineeredfoods.BiotechnolGenetEng.(rev.2004):299-324.

27Castaldini,M.etal.,“ImpactofBtcornonrhizosphericandsoileubacterialcommunitiesandonbeneficialmycorrhizalsymbiosisinexperimentalmicrocosms,”ApplEnvironMicrobiol.71(11)(Nov.2005):6719-29;Zwahlen,C.etal.,“DegradationoftheCry1AbproteinwithintransgenicBacillusthuringiensiscorntissueinthefield,”MolEcol.12(3)(Mar2003):765-75.

28Ibid.29Cheeke,T.E.,Pace,B.A.,Rosenstiel,T.N.,Cruzan,M.B.,“Theinfluenceoffertilizerlevelandsporedensityonarbuscularmycorrhizal

colonizationoftransgenicBt11maize(Zeamays)inexperimentalmicrocosms,”FEMSMicrobiolEcol.75(2)(Feb.2011):304-12;Cheeke,T.E.,Rosenstiel,T.N.,Cruzan,M.B.,“EvidenceofreducedarbuscularmycorrhizalfungalcolonizationinmultiplelinesofBtmaize,”AmericanJournalofBotany.99(4)(2012):700–07.

30Tank,J.L.,Rosi-Marshall,E.J.,Royer,T.V.,etal.,“Occurrenceofmaizedetritusandatransgenicinsecticidalprotein(Cry1Ab)withinthestreamnetworkofanagriculturallandscape,”PNAS27(September2010).

31Rosi-Marshall,E.J.,Tank,J.L.,Royer,T.V.,etal.,“Toxinsintransgeniccropbyproductsmayaffectheadwaterstreamecosystems,”ProcNatlAcadSciUSA104(41)(Oct9,2007):16204-08.

32Bohn,T.,Traavik,T.,Primicerio,R.,“DemographicresponsesofDaphniamagnafedtransgenicBt-maize,”Ecotoxicology19(2)(February2010):419-30.

33Marvier,M.etal.“Ameta-analysisofeffectsofBtcottonandmaizeonnontargetinvertebrates,”Science316(5830)(June8,2007):1475-77;Losey,J.E.,Rayor,L.S.,Carter,M.E.,“Transgenicpollenharmsmonarchlarvae,”Nature399(6733)(May20,1999):214;Jesse,L.C.H.andObrycki,J.J.,“FielddepositionofBttransgeniccornpollen:Lethaleffectsonthemonarchbutterfly,”J.Oecologia125(2000):241–48;Lang,A.andVojtech,E.,“TheeffectsofpollenconsumptionoftransgenicBtmaizeonthecommonswallowtail,PapiliomachaonL.(Lepidoptera,Papilionidae),”BasicandAppliedEcology7(2006):296–306;Ramirez-Romeroetal.,“DoesCry1AbproteinaffectlearningperformancesofthehoneybeeApismelliferaL.(Hymenoptera,Apidae)?,”EcotoxicologyandEnvironmentalSafety70(2008):327–33.

34Lövei,G.L.,Arpaia,S.,“Theimpactoftransgenicplantsonnaturalenemies:Acriticalreviewoflaboratorystudies,”EntomologiaExperimentalisetApplicata114(January2005):1–14.Thispapersystematicallyreviewedthestudiesinpeer-reviewedjournalsthatexaminedhowBtcropsaffectinsectsthatpreyonplantpests.Theauthorsdeterminedthat57%oftheparametersmeasuredshowed“significantnegativeimpacts,”(p.7).Eventhoughtheauthorsnotedthatseveralstudieshadmethodologicalshortcomings,theyconcluded:“Nevertheless,theoverallskewtowardsnegativeimpacts...isasignalthatweoughttoconsiderseriously.Thenegativeimpactsaretoonumeroustojustexplainthem[sic]awayasnon-significantornon-relevant”(p.11).

35Mellon,M.,“Introduction,”NoworNever:SeriousNewPlanstoSaveaNaturalPestControl(UnionofConcernedScientists,1998),2.

36GassmannAJ,Petzold-MaxwellJL,KeweshanRS,DunbarMW.“Field-evolvedresistancetoBtmaizebyWesterncornrootworm.”PLoSONE.2011;6(7):e22629.

37Ibid;AssociatedPress,“Monsantosharessliponbug-resistantcornwoes,”August29,2011;GrayM.,“SevererootdamagetoBtcornconfirmedinnorthwesternIllinois,”AcesNews,August24,2011.

38Fagan,J.,Antoniou,M.C.,andRobinson,C.,GMOMythsandTruths:AnEvidence-BasedExaminationoftheClaimsMadefortheSafetyandEfficacyofGeneticallyModifiedCrops,2ndEdition,version1.0,(London:EarthOpenSource,2014),249.

39Freese,Bill,“GoingBackwards:Dow’s2,4-D-ResistantCropsandaMoreToxicFuture,”FoodSafetyReview(Spring2012),1:http://www.centerforfoodsafety.org/wp-content/uploads/2012/04/CFS_FSR_spring_2012.pdf

40Benbrook,C.M.,“ImpactsofgeneticallyengineeredcropsonpesticideuseintheUnitedStates:Thefirstthirteenyears,”TheOrganicCenter(November2009):http://www.organic-center.org/reportfiles/13Years20091126_FullReport.pdf

41Ibid.42Stanley,T.,“TheSuperweedInvasion,”NationalPublicRadio,October4,2010;NeumanandPollack,“FarmersCopewithRoundup-

ResistantWeeds,”NewYorkTimes,May3,2010:http://www.nytimes.com/2010/05/04/business/energy-environment/04weed.html?_r=0(accessed:7-15-12).

43NeumanandPollack(2010),op.cit.note42.44Benbrook(2009),op.cit.note40.45Breeze,V.G.andC.J.West“Effectsof2,4-Dbutylvaporonthegrowthofsixcropspecies,”Ann.Appl.Biol.111(1987):185-91.46AAPCO(1999&2005),“1999/2005PesticideDriftEnforcementSurvey,”AssociationofAmericanPesticideControlOfficials,survey

periods1996-1998and2002-2004,respectively.47Freese(2012),op.cit.note39,2.48Ibid.49Paganelli,A.,Gnazzo,V.,Acosta,H.,López,S.L.,Carrasco,A.E.,“Glyphosatebasedherbicidesproduceteratogeniceffectson

vertebratesbyimpairingretinoicacidsignaling,”ChemResToxicol.23(10)(2010):1586–95.50Gasnier,C.,Dumont,C.,Benachour,N.,Clair,E.,Chagnon,M.C.,Seralini,G.E.,“Glyphosatebasedherbicidesaretoxicandendocrine

disruptorsinhumancelllines,”Toxicology262(3)(August21,2009):184-91.51KremerRJ,Means,N.E.,Kim,S,“Glyphosateaffectssoybeanrootexudationandrhizospheremicroorganisms.”IntJofAnalytical

EnvironmentalChemistry85(15)(2005):1165–1174;SanogoS,YangXB,SchermH,“EffectsofherbicidesonFusariumsolanif.sp.glycinesanddevelopmentofsuddendeathsyndromeinglyphosate-tolerantsoybean.”Phytopathology90(1)(Jan2000):57-66.

52FoodStandardsAgency,Aboutmycotoxins,undated:http://www.food.gov.uk/safereating/chemsafe/mycotoxins/about/53Alm,H.etal.“InfluenceofFusarium-toxincontaminatedfeedoninitialqualityandmeioticcompetenceofgiltoocytes,”ReprodToxicol.

22(1)(July2006):44-50;Diaz-Llano,G.andSmith,T.K.,“EffectsoffeedinggrainsnaturallycontaminatedwithFusariummycotoxinswithandwithoutapolymericglucomannanmycotoxinadsorbentonreproductiveperformanceandserumchemistryofpregnantgilts,”JAnimSci.84(9)(September2006):2361-66.

54InSeptember2014theUSDepartmentofAgriculturederegulatedDow’s2,4-D-resistantsoybeansandcorn55Freese(2012),op.cit.note39,2.56PressRelease,CenterforFoodSafety,May3,2007:http://www.centerforfoodsafety.org/2007/05/03/federal-judge-orders-first-ever-halt-

to-planting-of-a-commercialized-genetically-altered-crop/

57Waltz,E.,“IndustryexhalesasUSDAokaysglyphosateresistantalfalfa,”NatureBiotechnology29(3)(March2011):179–81.58LeslieTW,BiddingerDJ,MullinCA,FleischerSJ.,“Carabidaepopulationdynamicsandtemporalpartitioning:Responsetocoupled

neonicotinoid-transgenictechnologiesinmaize.”EnvironEntomol.38(3)(Jun2009):935-943.59Tennekes,H.A.,“ThesignificanceoftheDruckrey-Kupfmullerequationforriskassessment--thetoxicityofneonicotinoidinsecticidesto

arthropodsisreinforcedbyexposuretime,”Toxicology276(1)(September30,2010):1-4.60Pettis,J.S.,Vanengelsdorp,D.,Johnson,J.,Dively,G.,“Pesticideexposureinhoneybeesresultsinincreasedlevelsofthegutpathogen

Nosema,”DieNaturwissenschaften99(2)(February2012):153-58;Krupke,C.H.,Hunt,G.J.,Eitzer,B.D.,Andino,G.,Given,K.,“Multipleroutesofpesticideexposureforhoneybeeslivingnearagriculturalfields,”PLoSONE7(1)(2012),e29268.

61Bindraban,P.S.,Franke,A.C.,Ferrar,D.O.,etal.,“GM-relatedsustainability:Agro-ecologicalimpacts,risksandopportunitiesofsoyproductioninArgentinaandBrazil,”PlantResearchInternational(Wageningen,theNetherlands,2009).

62NeumanandPollack(2010),op.cit.note42.

8.MalfunctionoftheAmericanMedia1Ican’trecollecthisnameorthenetworkheworkedfor.2AllianceforBioIntegrity/ICTAPressConference,NationalPressClub,WashingtonD.C.,May27,1998.3PressRelease,GroceryManufacturersofAmerica,May27,1998.4E.g.,“FDASuedOverGeneticallyAlteredFood,”OmahaWorld-Herald,May28,1998,at9.(ThestatementwasmadebyEricFlamm,

aseniorpolicyadviserattheFDA).5Krimsky,S.andWrubel,R.,AgriculturalBiotechnologyandtheEnvironment:Science,Policy,andSocialIssues(Champaign,IL:

UniversityofIllinoisPress,1996),163-64.6Ibid.7Torefertothesescientistsasnotamongthepro-biotechmainstreamisnottoimplythattheywereopposedtoallformsofgenetic

engineering.Manybelievedthatsomeofitsapplicationsmightprovetobesafeandbeneficial.However,theywerenotpartisanpromotersofthetechnologybutwerewillingtoprovideobjectivescrutinyandtocritiqueaspectsoftheenterprisethattheyperceivedtobeproblematic.

8Lewenstein,B.etal.,“HistoricalsurveyofmediacoverageofbiotechnologyintheUnitedStates,1970to1996.”PaperpresentedtoAEJMCAnnualMeeting,Baltimore,MD,August8,1998.

9Priest,S.H.,andTalbert,J.,“MassMediaandtheUltimateTechnologicalFix:NewspaperCoverageofBiotechnology,”SouthwesternMassCommunicationJournal10(1)(1994):76-85.

10SusannaPriestquotedin“TheOddCouple:BiotechnologyandtheMedia,”AgBiotechBuzz2(11)(December20,2002).11http://www.commondreams.org/news2002/0429-06.htm(accessed7-23-12)12Ibid.13Hencke,D.andEvans,R.,“HowUSputpressureonBlairoverGMfood,”TheGuardian,February28,2000.14Hankinson,S.E.etal.,“CirculatingConcentrationsofInsulin-LikeGrowthFactor1andRiskofBreastCancer,”Lancet,vol.351,no.

9113(1998):1393-96;Chan,J.etal.,“PlasmaInsulin-LikeGrowthFactor-1[IGF-1]andProstateCancerRisk:AProspectiveStudy,”Science279(January23,1998):563-66.

15Smith,Jeffrey,SeedsofDeception:ExposingIndustryandGovernmentLiesAbouttheSafetyoftheGeneticallyEngineeredFoodsYou’reEating(Fairfield,IA:Yes!Books,2003),188.

16“CantworeporterstakeonMurdochandwin?,”TheIndependent,London,Sept.14,1999.17Ibid.18QuotedinSeedsofDeception,op.cit.note15,189.19TheIndependent(1999),op.cit.note16.20PersonalcommunicationfromJaneAkre.21TheIndependent(1999),op.cit.note16.22QuotedinSeedsofDeception,op.cit.note15,190-92.23TheIndependent(1999),op.cit.note16.24Ibid.25Oddly,althoughWilsonalsosuedFoxforthesamereason,hisclaimwasnotsuccessful.26http://www.foxbghsuit.com/2D01-529.pdf27Atthatpoint,thedocumentshadnotyetbeenpostedtotheAllianceforBioIntegritywebsite.Aftertheywere,Inolongerneededtofax

themtointerestedindividuals.28Weiss,Rick,“BiotechFoodRaisesaCropofQuestions,”WashingtonPost,August15,1999.Althoughthearticledidnotethatsome

expertswereconcernedthatsomeoftheinsertedgenesmightbeallergenic,greaterspacewasdevotedtotheexpertswhostatedthatnounusualriskwasposed.Further,theriskoftoxicitywasneverevenmentioned.

29Eichenwaldetal.,“BiotechnologyFood:FromLabtoaDebacle,”NewYorkTimes,January25,2001.30Licthblau,E.andShane,S.,“VastF.D.A.EffortTrackedE-MailsofitsScientists,”NewYorkTimes,July15,2012.31Thatheadlinewasevenmoredramatic:“VastEffortbyF.D.A.SpiedonE-MailsofitsOwnScientists.”32Brody,Jane,“FacingBiotechFoodsWithouttheFearFactor,”NewYorkTimes,January11,2005.33Inaspecialreportmarkingthe40thanniversaryofWatergate,theWashingtonPostnotedhowtheWhiteHousehad“continuedto

denounce”itscoverageas“biasedandmisleading”andhadalsodispensed“unveiledthreatsandharassment”:http://www.washingtonpost.com/wp-srv/politics/special/watergate/part1.html

34LeonardDownie,Jr.,whowasthePost’sdeputymetroeditorduringthatperiodandhelpedsupervisetheWatergatecoverage,hasrecentlyrecountedthestrainthatheandhiscolleaguesendured:“Wewereignoredanddoubtedbytherestofthenewsmediaandmostofthecountry,andunderheavyfirefromtheNixonadministrationanditssupporters.Itwasatensetime...,withourcredibilityandournewspaper’sfutureontheline;”Downie,Leonard,Jr.,“FortyyearsafterWatergate,investigativejournalismisatrisk,”WashingtonPost,June7,2012:http://www.washingtonpost.com/opinions/forty-years-after-watergate-investigative-journalism-is-at-

risk/2012/06/07/gJQArTzlLV_story.html.35Seenote34.36WhilethePostandothermembersofthemediamayhavesometimesrefrainedfromrevealingquestionablegovernmentactionsin

mattersofforeignpolicy,intheinterestofnationalsecurity,I’mnotawareofanyotherinstancesinwhichithassuppressedfactsaboutgovernmentfraudonthedomesticfront–especiallyfraudthatcompromisespublicsafety.

37Apple,R.W.,“LessonsfromthePentagonPapers,”NewYorkTimes,June23,1996:http://www.nytimes.com/books/97/04/13/reviews/papers-lessons.html.

38Correll,JohnT.,“ThePentagonPapers,”AirForceMagazine,February2007.39Ibid.40Ibid.41Ibid.42Ibid.43Althoughthegovernmentultimatelydecidednottobringcriminalchargesagainstthenewspapers,itdidbringthemagainstEllsberg.

However,duetogrossirregularitiesinthebehavioroftheFBIandsomeothergovernmentemployeesinrelationtohiscase,thejudgeeventuallydeclaredamistrialanddismissedthechargesagainsthim.ButhewasneverformallyacquittedofviolatingtheEspionageAct,andhaditnotbeenforthegovernment’sbunglingofthecase,hewouldprobablyhavebeenconvicted(SeeCorrell’sarticle,citedabove).

44Downie,2012,op.cit.,n.34.DowniewasthePost’sexecutiveeditorfrom1991to2008.AlthoughIdon’tknowifhewasdirectlyinvolvedinthedecisiontoremovetherevelationsabouttheFDAfromWeiss’sarticle,it’sdifficulttobelievethattheeditorwithwhomWeisswasinteractingwouldhavemadesuchanimportantpolicydecisiononhisown–anditseemslikelythathewasactingwithinaneditorialframeworkthathadalreadybeenestablishedathigherlevelsofauthority.Thus,there’sgoodreasontoassumethatDowniehadinsomesignificantwaybeeninvolvedintheformulationandimplementationofapolicyrestrictingwhatwouldbewrittenabouttherisksofGEfoods.Afterall,heheldthesamepositionatthePostduringthefirst15yearsoftheGEfooderaashadBenBradleeduringtheWatergateera;andthosefamiliarwiththebook(ormovie),AllthePresident’sMen,knowhowactivelyengagedBradleewasinthesupervisionoftheWatergatereporting.Further,regardlessofthedegreetowhichDowniemayhavebeeninvolved,Ithinkit’shypocriticalforexecutivesatthePosttosustaintheir

chest-thumpingaboutthepaper’scourageousactionsregardingWatergatewhiletheyclingtotheircowardlypolicyaboutGEfoods.IfDownie,whoiscurrentlyaprofessorofjournalismatArizonaStateUniversity’sWalterCronkiteSchoolofJournalismandMassCommunication,andisalsoavicepresidentatlargeofthePost,issincerelycommittedto“accountabilityjournalism,”hewillopenlyassumeresponsibilityforwhateverrolehemayhaveplayedinthePost’sirresponsiblebehaviorinregardtoGEfoods–or,ifheplayednoroleatall,hewillidentifythosewhoshouldbeheldaccountable.Moreover,heshouldusehisinfluencetorescindtherestrictivepolicyandreplaceitwithonethatallowsfullreportingofthefacts.What’smore,Ithinkthathe(and/orothersatthePost)shouldstartmakingamendsbypublishingaseriesofarticlesthatcommunicatenotonlythefactsthatwereremovedfromWeiss’sreport,butmanyoftheotherkeyfactsthataredocumentedinthisbook–factsthattheAmericanpeoplehavearighttoknow.Onlythencantheirboastsaboutthepaper’sWatergatetriumphsbefreefromhypocrisy.

45NewYorkTimes,Co.v.UnitedStates,403U.S.713(1971).

9.MethodicalMisrepresentationofRisk1http://www.aaas.org/news/releases/2012/media/AAAS_GM_statement.pdf2http://www.who.int/foodsafety/publications/biotech/20questions/en/3“ElementsofPrecaution:RecommendationsfortheRegulationofFoodBiotechnologyinCanada;AnExpertPanelReportontheFuture

ofFoodBiotechnologypreparedbyTheRoyalSocietyofCanadaattherequestofHealthCanadaCanadianFoodInspectionAgencyandEnvironmentCanada,”TheRoyalSocietyofCanada,January2001.

4Calamai,P.,“OttawaRapped,ExpertStudyConsideredMajorSetbackforBiotechIndustry,”TorontoStar,February5,2001.5“Geneticallymodifiedfoodandhealth:Asecondinterimstatement,”BritishMedicalAssociationBoardofScienceandEducation,March,

2004.6Kmietowicz,Z.,“GMFoodsShouldBeSubmittedtoFurtherStudies,saysBMA,”BritishMedicalJournal328(7440)(March13,2004):

602.7PublicHealthAssociationofAustraliaLettertoGovernmentOfficials,November2,2000.8TheLancet353(May29,1999):1811.9Fedoroff,N.,andBrown,N.M.,MendelintheKitchen:AScientistLooksatGeneticallyModifiedFoods(Washington,DC:Joseph

HenryPress,2004),xii.10NationalResearchCouncilandInstituteofMedicineoftheNationalAcademies(NAS),“SafetyofGeneticallyEngineeredFoods:

ApproachestoAssessingUnintendedHealthEffects”(WashingtonD.C.:TheNationalAcademiesPress,2004).(Asthereport’stitleindicates,itwaspreparedbytwooftheNAS’sdivisions:theNationalResearchCouncilandtheInstituteofMedicine.)Itcanbereadonlineordownloadedat:http://www.nap.edu/openbook.php?record_id=10977&page=R1.

11“ElementsofPrecaution,”op.cit.note3,184.12Ibid.,185.13Ibid.,184.14Ibid.,22.15Ibid.,185.16Ibid.,186.17Ibid.,ix.18Ibid.,48.19Inpreviouspartsofthisbook,wherethediscussionofriskswasnottechnical,thetermshavealsosometimesbeenemployed

synonymously,accordingtocustomaryusage.20Forsimplicity,thisexampleassumesthateverybitefromavenomoussnakeinArizonaentailsthesamepotentialfordeathaseverybite

incurredinOhio.Underthisassumption,thedegreeofharmineachcase–thedeathofoneperson–isthesame,enablingthedifferenceinrisktobedeterminedmerelybyassessingthedifferentprobabilitiesofbeingbitten.However,inreality,somespeciesofvenomoussnakesaremoredeadlythanothers.Sotoaccuratelycalculatetheriskdifferential,wewouldneedtofactorinthedifferencebetweenthetoxicityoftheaveragevenomoussnakebiteinArizonaandtheaveragebiteincurredinOhio.ThiswouldrendertheArizonawalkevenriskier.

21AccordingtoarecentNewYorkTimesarticle,runwaycollisionsarethebiggestthreatinaviation.ItcontainedthefollowingquotefromthechairmanoftheNationalTransportationSafetyBoard:“Wherewearemostvulnerableatthismomentisontheground....Tome,thisisthemostdangerousaspectofflying,”Wald,M.“ForAirlines,RunwaysAretheDangerZone,”NYTimes,April25,2008.

22In2008,theNationalSafetyCouncilcompiledanodds-of-dyingtablecomparingtherisksofflyinganddriving.Theoddsofdyinginamotorvehiclewerecalculatedtobe1in98overalifetime.Incontrast,forairtravelthelifetimeoddswereonly1in7,178.http://traveltips.usatoday.com/air-travel-safercar-travel-1581.html.

23IntroductionofRecombinantDNA-EngineeredOrganismsintotheEnvironment:KeyIssues(NationalAcademyofSciences,1987),6.

24Ibid.,22.25FieldTestingGeneticallyModifiedOrganisms:FrameworkforDecisions(TheNationalAcademyofSciences,1989),14.26E.g.,40and43;althoughthereportdoescitethestandarddefinitionofrisk(p.41),andalthoughitattimesdoesspeakaboutthe

“magnitude”ofrisk,itsapproachisinconsistent;anditslanguageisloose.Soisitsreasoning.However,becausethe2004reportmakessimilarmistakesthatarealsomorevaried,andbecauseit’sthebroaderandmoreimportantofthetwo,I’llfocusonitandwillnotexpendspaceexaminingthedefectsofthe2000reportingreaterdepth.

27NAS2004Report,op.cit.note10,2.28Becausethe2004reportwasfocusedsolelyonhumanhealtheffects,the2000reportwasbroaderinrespectofissuesaddressed,sinceit

alsodealtwithenvironmentalones.ButitonlydealtwiththoseissuesinregardtoalimitedclassofGMOs,andsowasnarrowerinthatrespect;anditsconclusionsweren’ttechnicallyapplicabletoallengineeredfoodcrops.

29ThereleasewasissuedonJuly27,2004bytheNationalResearchCouncilandtheInstituteofMedicine,thedivisionsoftheNASthathadproducedthereport.Itwastitled:“CompositionofAlteredFoodProducts,NotMethodUsedtoCreateThem,ShouldBeBasisfor

FederalSafetyAssessment.”30NAS2004,op.cit.note10.Thisfindingisstatedonp.180(andalsoonp.9intheExecutiveSummary).Thereportstatesthat“thepolicy

toassessproductsbasedexclusivelyontheirmethodofbreedingisscientificallyunjustified.”SincethisstatementfollowsreferencetothefactthattheEUsubjectsGEfoodstoahigherlevelofassessmentthanotherfoods,it’sclearthatitintendstoconveytheideathatthispracticeisunjustifiedandthatGEfoods,asaclass,shouldnotbetreateddifferentlythanconventionalones.

31JenniferHillardquotedin:Pollack,A.,“PanelSeesNoUniqueRiskfromGeneticEngineering,”NewYorkTimes,July28,2004.32Document#1at:http://biointegrity.org/24-fda-documents33TheNAS1989reportstates(onp.2)thatthemaximwasa“fundamentalprinciple”ofthe1987report;anditnotesthatthisprinciple

wasthen“adopted”bythoseresponsibleforpreparingit(the1989report)and“reemphasized”inChapter2.34Ibid:InthePDFformat,thechartappearsonp.64andtheexplanatorytextonp.65.See:http://www.nap.edu/openbook.php?

record_id=10977&page=64;ThechartalsoappearsintheExecutiveSummaryonp.4.35Thecommitteespecifiedthatselectionfromahomogeneouspopulationhaslesspotentialforunintendedeffectsthanselectionfromone

thatisheterogeneous.36Ibid.,65.Inthechart,thecategorycomprisingbothradiationandchemical-basedprocessesisreferredtoas“mutationbreeding.”

However,Iprefernottousethisterm,sinceitimpliesthesearetheonlytechniquesthatinducemutations,eventhough(aswillbediscussed)tissueculture-basedbreedingalsogeneratesnewtraitsbyinducingmutations.Andgeneticengineeringcausesmutationsaswell.Therefore,insteadofemployingtheterm“mutationbreeding”torefertothetechniquesthatemployradiationandchemicals,I’llrefertothemjointlyas“radiationandchemical-basedbreeding.”

37AsChapterFourexplained,althoughanactualriflefiringa.22-calibrebulletwasinitiallyemployedinsuchtransfers,asthegunevolved,macroscopicbulletswerenolongerused,andthemicroscopicparticleswerepropelledbyablastofair.Butthedeviceprovidingtheblastisstillatypeofgun.Theprocessisoftenreferredtoasparticlebombardment,bioballistics,orbiolistics.The2004reportusesthelatterterm.

38NAS2004,op.cit.note10,63.39Forstylisticpurposes,I’msubstituting“dangerous”for“risky,”withtheintentthatitconveysthesametechnicalmeaning.Further,the

number10wasarbitrarilyselectedforthesakeofargument,notbecausebioengineeringhasbeendeterminedtoinducethatmanysideeffectsforeveryeffectinducedbypollen-basedbreeding.However,inthisregardthehypotheticalvaluemaybeonthelowside,becauseinthereport’scomparativechart,thebardepictingtheunintendedeffectsofbioballisticgenetransferbetweendistantlyrelatedspeciesisaround14timeslongerthanthebaradjoiningtheleastdisruptiveformofpollen-basedbreeding.

40NAS2004,op.cit.note10,63.41Ibid.42Ibid.43Nordowe“know”thatanyofthefoodscreatedthroughtissuecultureisactuallysafe.44Inthiscontext,thewords“provensafe”donotdenotethecertaintyinvolvedinamathematicalproof.Theydenotethestandardofproof

institutedbytheFDAforpurposesofevaluatingfood:ademonstrationthatthereis“reasonablecertainty”ofnoharm.It’salsoimportanttonotethattheNASreportdoesnotprimarilyattempttoestablishitsclaimaboutthesafetyofGEfoodsbycitingactual

safetytests.Instead,itreliesonthespeciousargumentsthatarecritiquedinthischapter’sanalysis.Moreover,asChapter6revealed(andasChapter10willmorefullyelucidate),severalofthetestsonGEfoodsraisereasonabledoubts.Thisresearchcannotbelightlydismissed,anditfurtherundercutsthecommittee’sclaimaboutwhatwepresentlyknow.

45Whilesometestshavebeenconductedonwholefoodsthatwereirradiatedforthepurposeofreducingmicrobes,safetytestinghasnotbeenperformedonfoodsgrownfromirradiatedseeds,whichpresentadifferentsetofhazards.

46NAS2004,op.cit.note10,27.47Ibid.,45.48Thecommitteeacknowledgedthelackofrecordsregardingradiation(onp.28oftheirreport);andtheyalsonotedthatithasnotbeen

feasibletotrackforeffectsofGEfoods,whileurgingtheFDAtoinstitutepracticesthatwouldfacilitateit.49Schubert,David,“PharmedFood:ConsumewithCaution,”TheEcologist,November2008.50Althoughtheevidencedoesn’tprovethatGEwasthecause,itstronglypointstothatconclusion;and,asChapter3explains,it’smore

likelythannotthattheprocesswastoblameforthetoxiccontamination–whichwouldbesufficienttoholdtheprocessliableinacourtoflaw.

51NAS2004,op.cit.note10,47.52Ronald,P.andAdamchak,R.,Tomorrow’sTable:OrganicFarming,Genetics,andtheFutureofFood(NewYork:OxfordUniversity

Press,2008),102.Althoughshedoesn’texplicitlycitethereportasthebasisforthisparticularassertion,herforegoingdiscussiondemonstratesthatthedocumentistheprimarysourceonwhichitrelies.Forinstance,onp.69shestatesthereportindicatesthattheGEcropscurrentlyonthemarket“aresafetoeat.”

53Whileitisnotinprincipleimpossiblethatshecouldknowtheyaresafe,giventhepresentstateoftheevidence,it’snotcurrentlypossible.54NAS2004,op.cit.note10,63.55NAS2004,opcit.note10,131-32.Althoughthecommittee’slanguagelacksprecision,theyappeartoincludeGEfoodsamongthosethat

neednotbeprovensafepriortomarketingandcanonlyberemovedifobviousproblemsemergelater.Andiftheyinfactwerenotconfused,theyshouldhaveavoidedconfusinglanguagethatimpartstheimpressiontheywereunawareofwhatthelawrequires.

Further,besidesacceptingthebasicsoftheFDA’shands-offpolicyinregardtoGEfoods,thecommitteealsodefendedthelaxregulatorypolicyinmostoftherestoftheworld,wheretheconceptofsubstantialequivalencereigns(Ibid.,129-30).Butindoingso,theyreliedonthetypeofsimplisticlinearmodelthattheCanadianexpertshaddiscredited.Theyindicatedthatputtingprimaryattentionontheproteintheinsertedgeneexpressesisasoundapproach,whilefailingtoacknowledgethat,eveniftheproteinissafetoconsume,itsunregulatedexpression(aswellastheinsertionprocessitself)coulddisruptcellularfunctionindeleteriousways.Thus,inexplaining(approvingly)howthesubstantialequivalenceapproachisappliedtoalmostalltheGEfoodsthenonthemarket(includingBtcornandRoundupReadysoybeans),thereportnotedthattheassessmentfocuses“primarilyontheintroducedtraitorgeneproduct”(Ibid.,130).But,astheirCanadiancounterpartshaddemonstrated,thepresumedsufficiencyofthisnarrowapproachisitselfbasedonapresumptionthat’ssignificantlyflawed:thepresumptionthatwhateverunintendedsideeffectsareinducedbythetransformationprocesswillbeadequatelydetectedbysuperficialcompositionalcomparisons.Andsuchconstrictedthinkingisbasedonthenotionthatattentionshouldmainlyrestontheproduct–andthattheprocesshasnosignificantbearingontheriskthattheproductwillharborharmfulsideeffectsthataredifficulttodiscover.Moreover,totheextenttheNASreportfaultedtheregulatorypolicyoftheEuropeanUnionandotherregionsembracingthesubstantial

equivalenceapproach,itwasnotforapplyingthisapproachtoGEfoods,butforrequiringthatitbeappliedtoallofthemwhileexemptingallconventionalproducts.Inrejectingthisaspectofthepolicy,thereportemphasizedthatit’s“scientificallyunjustified”tosetassessmentcriteriabasedexclusivelyonthemannerofproduction(Ibid.,180).

56Ibid.,29.Here’showthecommitteedescribedthewayGEplantsaredevelopedviatheuseofreconfiguredbacteria:“BysubstitutingtheDNAofinterestforthecrowngalldisease-causingDNA,scientistsderivednewstrainsofAgrobacteriumthatdeliverandstablyintegratespecificnewgeneticmaterialintothecellsoftargetplantspecies.Ifthetransformedcellthenisregeneratedintoawholefertileplant,allcellsintheprogenyalsocarryandmayexpresstheinsertedgenes.”

57Theterm“genomicshock”isusedinconnectionwithtissueculturebyseveralbiologists.Oneexampleis:Kaeppleretal.,“Epigeneticaspectsofsomaclonalvariationinplants,”PlantMolecularBiology43(2000):179–88;181.

58Whengeneticallyidenticalcellsgothroughtissueculture,theytendtomutateindifferentways.Thisdifferentialinmutationsisreferredtoassomaclonalvariation.TheNASreportgenerallyemploysthisterminreferringtotheprocessoftissueculture,andit’susedastheheadingoftherelevantsectiononpage26.BecauseIthinkit’ssimplerandmorestraightforwardtospeakoftissuecultureinstead,sinceitisthenameofthetechniquethroughwhichsomaclonalvariationoccurs,Idon’temploythelatterterm.

59NAS2004,op.cit.note10,27.60Ibid.,28-29.Ittooktwenty-sevenmorepagesbeforetheyfinallyacknowledgedthattissuecultureisanaspectofthebioengineering

process.IndescribingafewofthepotentialunintendedeffectsofGE,theysaid:“...spontaneousmutationmayoccurinthetissueculturephaseofthetransformationregenerationprocesses”(p.56).But,unlessonealreadyknewhowwidelythetechniqueisreliedoninproducingGEplants,thissentencewouldbeunlikelytoinducesuchunderstanding.Further,aswillbeseen,whenthecommitteesubsequentlypresentedachartdepictingdifferencesindisruptivepotentialbetweenthevariousmodesofplantbreeding,ittreatedtissuecultureasdistinctfrombioengineering.

61Althoughinthecaseofafewspecies,therearewaysinwhichisolatedcellscanberegeneratedwithoutresorttotissueculture,it’sthestandardmethodthroughwhichengineeredcellsaretransformedintomatureplants.

62Neelakandan,A.andWang,K.,“Recentprogressintheunderstandingoftissueculture-inducedgenomelevelchangesinplantsandpotentialapplications,”PlantCellRep31(2012):597-620;611.IemailedDr.Wang,thedirectoroftheCenterforPlantTransformationatIowaStateUniversity,inquiringifthestatementabout“highprobability”ofchangesreferrednotmerelytoregeneratedplantsbeforethey’vebeencrossed,buttothefinal,commercializedproductsaswell–eventhoughthetotalnumberofchangeswouldhavebeenreducedinthoseproductsviacrossing.Sheemailedtoconfirmthatthestatementappliedtothefinalproductstoo.

63It’slogicaltopresumethatallthebarsrepresentthepotentialforunintendedeffectstoremaininthefinalproductsoftherespectivemethods,becauseiftheyinsteadaremeanttopertaintoplantsthathavenotundergonecrossing,thentheycouldn’treflectdifferencesinthepotentialforunintendedeffectsthatremainaftercrossinghasoccurredandtheproductisreadyformarketing–thephaseatwhichthedifferencesaremostimportant.Andit’sreasonabletothinkthatsuchdifferencesexist,aswillbeexplainedshortly.

64Skirvinetal.,“Sourcesandfrequencyofsomaclonalvariation,”HortSci29(1994):1232-1237.65It’salsomorelikelythatthemoreintensiveculturingprocesseswouldgenerateahigherpercentageofdramaticmutations;butit’salso

likelythatmostofthesewouldnotremaininthefinalproduct,sincetheywouldeitherpreventplantdevelopmentorresultinobservable(andmorereadilyremovable)abnormalities.

66Asweshallsee,evenwithoutregisteringtheeffectsoftissueculture,thebarassociatedwiththatmodeofbioengineeringshouldbesubstantiallylongeranddarker.

67Itsbar,whenadjusted,wouldextend1.3centimetersbeyondtherightverticalaxisofthechart(thepointatwhichthebarforradiationends).Inthecontextofthechart,thisisasignificantdifference.Moreover,eveniftheGEbarsareadjustedbyaddingonlyone-fourththelengthofthetissueculturebar,theoneassociatedwiththemostdisruptivemodeislongerthanthatofradiation;andtheotherisalmostaslong.Note:Inordertotakemeasurements,Ifirstreproducedthechartthat’sinthePDFversionofthereportonan8.5x11inchpieceofpaper.I

thenusedarulertoascertainthelengthsofthebars.Itwasdifficulttobeprecisebecauseofthewaythegraytailsshadetowardtheends.SomeofthevaluesIobtainedare:tissueculture(SCV):5.6cm;bacterialtransferofrDNAbetweendistantlyrelatedspecies:9.0cm;biolistictransferofrDNAbetweendistantlyrelatedspecies:10.2cm;radiationbreeding:10.8cm.Otherpeoplemaygetslightlydifferentvalues;buttheoverallresultwillmostlikelybesimilar.Further,it’simportanttokeepinmindthatthelengthsofthebarsonlyreflectthecommittee’sroughestimates.

68Whilethisanalysisisilluminating,it’simportanttonotethatinneitherthecommittee’schartnortheadjustedversionsofitdotheratios

betweenthelengthsofthebarspreciselyreflectreality.Thecommittee’scalculationsarenotbasedonevidencethatenablesexactdeterminations;andtheavailabledatadon’tprovideabasisforanythingmorethanreasonableestimates–althoughtheestimatesthecommitteemadedidnotalwaysexpressthisattribute.

69RonaldandAdamchak,op.cit.note52,88.Ofcourse,instatingthatradiationisriskier,she’satoddswiththecommittees’claimthatthere’snocorrespondencebetweenplacementonthechartanddegreeofrisk.However,aswe’llseeinChapter14,whendiscussingrisks,RonaldnotonlycontradictstheNAS,sheevencontradictsherself.

70Atthecloseofasectionarguingthatgenesinsertedviabioengineeringarenotdrawnto“hotspots”intheDNAthatfostergeneticinstability,theystated:“Similarly,thereisnoevidencetosuggesttheCaMV35SpromoterinGEplantsisanymoreunstablethantheCaMV35SpromoterinordinaryplantsinfectedwithCaMV”(NAS2004,61).Thequestionofwhetherthe35Spromoterinsertedinplantsis,itself,geneticallyunstableisseparatefromtheotherissuesthatInoted.Althoughthere’sstillroomforscientificdebateaboutthisadditionalissue,becauseproperlypresentingitwouldaddasignificantamountoftexttoanalreadylongchapter,I’vedecidedtoforgoit.

71Hohn,T.andRothnie,H.,“Plantpararetroviruses:replicationandexpression,”CurrentOpinioninVirology3(2013):621–28.72NAS2004,op.cit.note10,60&62.73Ibid.,60.74E.g.,Fedoroff,MendelintheKitchen,op.cit.note9,103;whereit’sstatedthat“neithergenesnortransposonsnormallymove.”75E.g.,Wu,R.,Guo,W.L.,Wang,X.R.,Wang,X.L.,Zhuang,T.T.,Clarke,J.L.,Liu,B.,“Unintendedconsequenceofplanttransformation:

biolistictransformationcausedtranspositionalactivationofanendogenousretrotransposonTos17inrice,”ssp.japonicacv.,Matsumae,PlantCellRep28(2009):1043–51.

76MendelintheKitchen,op.cit.note9,105.77DavidSchubert,personalcommunication.Mutationbreedingviaradiationandchemicalsalsostirsuptransposons.But,aswillbe

discussed,there’sgoodreasontothinkbioengineeringentailsatleastasgreatatransposon-relatedrisk.78MendelintheKitchen,op.cit.note9,104-05.However,asthebookpointsout,widecrossesbetween“verydistantlyrelatedplants”

canactivatetransposons.79Asinseveralothersectionsofthereport,thecommittees’discussionisnotascoherentasonewouldexpect,andit’sdifficulttodiscern

thestructureoftheirargument.ButtheirwordsdocreatetheimpressionthattransposonmobilizationissomehowseparatefromtheGEprocess.Leavingasidetheissueofwhetherthisobfuscationwasdeliberate,itseemstheymayhavebeentryingtoadvancethefollowingargument:(a)Plantgenomescontainnumeroustransposons;(b)manyoftheassociatedinsertioneventseithercreated,orcouldhavecreated,

disruptions;(c)anydisruptionscausedbyinsertionsofrDNAwouldbenoriskierthanthoseassociatedwithtransposons;(d)therefore,suchinsertionspresentnocauseforconcern.Butsuchanargumentisflawed.Notonlydoesitdisregardthefactthatgeneticengineeringcaninducetransposonmovement(throughthree

distinctmodes)andtherebyimposeadditionaltransposon-relatedrisks,itmistakenlyequateswhateverrisksmaylingerfromancienttransposoninsertionswiththerisksentailedbypresent-dayinsertionsofrDNAcassettes.Scientistsrecognizethattransposonsandtheirmovementshaveplayedasignificantroleintheevolutionofplantsandhavecontributedtoimportantfeaturesthatarefoundincontemporaryvarieties.Andit’sknownthatovergreatexpansesofbiologicaltime,whilepositiveeffectsofthetranspositionaleventshavebeenconserved,mostdeleteriouseffectshavenotbeenmaintained.ButthesituationisotherwisewithrDNAinsertions.Insteadofalongprocessofscreeningbynaturalselection,thescreeningforharmfuleffectsinwhateverplantssurvivethetransformationprocessisperformedbyhumaninspection;and,asthe2001Canadianreportrepeatedlywarned,thecurrentmonitoringprocessisunabletodetectallthesubtlechangesthatcouldharmconsumerhealth.Moreover,evenifeffectsoftranspositionaleventsinthedistantpastremainthatdon’timpairthefunctionoftheplantbutdoimpairthe

healthofthosethatconsumethem,theinsertionaleffectsofbioengineeringaddtothisbaselineofrisktoamoresignificantdegreethandoespollen-basedbreeding–and,aswillbedemonstrated,moregreatlythandoallotherformsofbreedingaswell.

80ForsbachA.,Schubert,D.,Lechtenberg,B.,Gils,M.,Schmidt,R.,“Acomprehensivecharacterizationofsingle-copyT-DNAinsertionsintheArabidopsisthalianagenome,”PlantMolecularBiology52(1)(2003):161–76.Theresearchersselectedonlyplantsthatcontainedasingleinsertionsite.

81Latham,J.,Wilson,A.andSteinbrecher,R.,“TheMutationalConsequencesofPlantTransformation,”JournalofBiomedicineandBiotechnology,vol.2006,articleID25376,3.

82Ibid.(emphasisadded).Theynotedthatconclusionsaboutparticlebombardmenthadtobeprovisional,becauseveryfewofitsinsertioneventswerewell-studiedatthattime.

83NAS2004,66.84Regardinggeneloss,e.g.,Kaya,H.,Sato,S.,Tabata,S.,Kobayashi,Y.,Iwabuchi,M.,Araki,T.,“hosobatogetoge,asyndromecaused

byalargechromosomaldeletionassociatedwithaT-DNAinsertioninArabidopsis,”Plant&CellPhysiology41(9)(2000):1055–66.Re:deletion-relateddisruptionofgenefunction,seee.g.,Amedeo,P.,Habu,Y.,Afsar,K.,MittelstenScheid,O.,Paszkowski,J.,“DisruptionoftheplantgeneMOMreleasestranscriptionalsilencingofmethylatedgenes,”Nature405(6783)(2000):203–06.Re:potentialdisturbanceofnativegenesthroughtheinfluenceoftheinsertedDNA;E.g.,Hannon,G.J.,“RNAinterference,”Nature418(6894)(2002):244–51;Bartel,B.andBartel,D.P.,“MicroRNAs:attherootofplantdevelopment?”PlantPhysiology132(2)(2003):709–17.”

85Amedeoetal.,op.cit.note84;Ichikawa,T.,Nakazawa,M.,Kawashima,M.,etal.,“Sequencedatabaseof1172T-DNAinsertionsitesinArabidopsisactivationtagginglinesthatshowedphenotypesinT1generation,”ThePlantJournal36(3)(2003):421–29;Weigel,D.,Ahn,J.H.,Bl azquez,M.A.,etal.,“ActivationtagginginArabidopsis,”PlantPhysiology122(4)(2000):1003–13.

86Freese,W.andSchubert,D.,“Safetytestingandregulationofgeneticallyengineeredfoods,”BiotechnologyandGeneticEngineeringReviews21(2004):314(emphasisadded).

87Lathametal.,op.cit.note81,4.88Ibid.,3.89Ibid.,4.90Ibid.91Further,ifplantsarenotgrownfromseedbutarepropagatedclonally(asisusualwithpotatoandbanana),noneofthegenome-wide

mutationsareremoved,andthey’llbepresentineveryfuturecloneoftheoriginalGEplant.92Lathametal.,op.cit.note81,4.93Ibid.,5.AccordingtothemolecularbiologistAllisonWilson,whohasextensivelyexaminedthedatasubmittedtoregulators,althoughthe

standardSouthernanalysessubmittedinapplicationstotheUSDAareclaimedtodetectwhetheradditionalcopiesofallorpartsofthecassettehavebeendepositedindistantsites,theplants’developersdonotsubmitsequencedatafortheentiregenome.Therefore,subsequentwholegenomesequenceanalysiswilllikelyrevealtransgenicinsertsmissedbySouthernanalysis–aswasthecasewiththecommercializedtransgenicpapaya.Comparisonofthetransgenicgenomewiththegenomeoftheparentplantwouldalsobenecessarytodeterminethepresence(andextent)ofanyadditionalgenome-widedifferencesbetweenthetransgenicplantanditsparent(e.g.movementofnativetransposons,rearrangementsordeletionsofplantDNA)[personalcommunication].

94Lathametal.,op.cit.note81,5.95E.g.,Windels,P.etal.,“CharacterisationoftheRoundupReadysoybeaninsert,”EuropeanFoodResearchandTechnology213(2)

(200):107–12;Hernandez,M.etal.,“Aspecificreal-timequantitativePCRdetectionsystemforeventMON810inmaizeYieldGardbasedonthe3-transgeneintegrationsequence,”TransgenicResearch12(2)(2003):179–89.

96Wilson,A.etal.,“GenomeScrambling–MythorReality?Transformation-InducedMutationsinTransgenicCropPlants,”EcoNexusTechnicalReport(October2004).Thereportpresentedsuchscramblingasareality.

97Numerousstudiescitedinthereviewwerepublishedin2003orearlier,sothecommitteecouldhavetakenaccountofthem,sinceitsreportwasnotreleaseduntilthesummerof2004.Andalthoughtheydidrefertofourpapersmentionedinthatreview,noneoftheseweretheonesthatexamined(orevenexpresslydiscussed)deletionsandrearrangementsintheregionssurroundingtheinsertionsite.NordidanymentiontheinsertionofsuperfluousDNA.

98E.g.,Lathametal.,op.cit.note81;Freese,W.,Schubert,D.,“Safetytestingandregulationofgeneticallyengineeredfoods,”BiotechnologyandGeneticEngineeringReviews21(2004):299–324;Spok,A.etal.,“RiskAssessmentofGMO-ProductsintheEuropeanUnion,”Bundesministeriumf¨urGesundheitundFrauen,2004.

99NAS2004,27.100NAS2004;theirmaindiscussionrunsfromp.41throughp.45.Althoughtheyalsonotedthattomatoescouldcontainproblematiclevels

ofanaturallyoccurringtoxin,theyacknowledgedthiswasduetoenvironmentalfactorsratherthantothebreedingprocess.101Steiner,H.Y.etal.,“EvaluatingthePotentialforAdverseInteractionswithinGeneticallyEngineeredBreedingStacks,”Plant

Physiology,April2013,vol.161no.4:1588.102NAS2004,op.cit.note10,43.103Ibid.,56.104http://wildflowerfinder.org.uk/Flowers/P/Potato/Potato.htm;http://www.sigmaaldrich.com/catalog/product/sigma/d5649?

lang=en&region=US.Further,thefactthatdemissidineispresentinpotatoeswasreportedinthescientificliteratureasearlyas1981:Jadhav,S.J.,R.P.Sharma,D.K.Salunkhe,“Naturallyoccurringtoxicalkaloidsinfoods,”CritRevToxicol9(1981):21–104.

105Ibid.,43.106Steiner,H.Y.etal.,op.cit.note101,1588.It’snoteworthythattheseauthorsareproponentsofGEfoods,andoneisemployedby

PioneerHi-Bred,amajorbiotechcorporation.Yet,theyadmitthere’snoevidencethatconventionalbreedinghasproducednoveltoxins(orisevenlikelyto),despitetheNAScommittees’contentionthatthishasactuallyhappened–andthatitcouldwellbehappeninginseveralcasesofwhichwe’reunaware.Further,althoughmanypeopleareundertheimpressionthatthroughtheprocessofpollination,modernvarietiesofhybridizedwheathave

becomeendowedwithoneoranothernovelproteins,thereappearstobenosoundevidencethishasactuallyhappened.Instead,therelativeconcentrationsofnativeproteinshavechanged.See,e.g.,vandenBroeck,H.C.etal.,“Presenceofceliacdiseaseepitopesinmodernandoldhexaploidwheatvarieties:wheatbreedingmayhavecontributedtoincreasedprevalenceofceliacdisease,”TheorApplGenet(2010)121:1527–1539.DOI10.1007/s00122-010-1408-4.

107Schubert,David,quotedinSmith,Jeffrey,GeneticRoulette(Fairfield,IA:Yes!Books,2007),56.108Hagan,N.etal.,“Theredistributionofproteinsulfurintransgenicriceexpressingageneforaforeign,sulfur-richprotein,”PlantJ.34

(2003):1–11.Foradiscussion,seenote111.109AlthoughthestudyontheallergeniceffectsoftheproteinproducedbytheGEpeaswasnotpublisheduntilafterthecommitteehad

releaseditsreport,thestudyrevealingthattheforeigngeneexpressedinGEricemighthavebeenmisfoldedwaspublishedtheyearpriortothereport’srelease.Yet,thereportmakesnomentionofit.Moreover,thepotentialforaproteinsynthesizedwithinaforeignspeciestobeadverselyalteredviaeitheradd-onsormisfoldingwasrecognizedwellbeforethereportwaswritten.

110It’sclearthatseriousproblemscouldresultfromeitherclassofinsertions.Inregardtoadverseoutcomesinducedbyforeigngenes,PhilipRegalhaspointedoutthat“...theoryandevidencehavesuggestedthatthehost’sbufferingorcontrolsystemswilloftenbeineffective

forthosetransgenesthatcanexpresswell.”Heexplainsthatbecausetheforeigngenescouldinduce“unusualconditions”thatcannotbemodulatedbythebufferingmechanisms,“...newfactorsmaybeaddedtothehost’sbiochemicalmilieuandcausequantitativeorqualitativechangesintheoutputofexistingbiochemicalpathways.”Regal,P.,“ScientificPrinciplesforEcologicallyBasedRiskAssessmentofTransgenicOrganisms,”MolecularEcology3(1994):5-13(Thesentencescitedabovewerefromasectionrelevanttofoodsafetyaswellasecologicalsafety).Ontheotherhand,whentheinsertedgenecomesfromacloselyrelatedspecies,theorganism’scontrolsystemcouldbestressedintryingto

copewiththehyper-expressionofanativesubstance,resultingintheformationofunusualtoxins–ashappenedwithShowaDenko’stryptophan-producingbacteria.

111Forinstance,inanattempttoincreasethesulfurcontentofrice,atransgenicvarietywascreatedcontainingasunflowergenethatexpressesaproteinrichinsulfur.However,theamountofsulfurinthericedidnotincrease,apparentlybecausethehighdemandforsulfurimposedbytheover-expressionofthesunflowergenedrewheavilyupontheplants’sulfurpoolsanddecreasedtheproductionofsomeoftheirownsulfur-containingproteins.Further,therewereatleasttwoothertypesofchangethatwerenotdirectlyrelatedtothecompetitionforsulfurproductionbutwere

inducedbysomeothermechanics.Inone,theleveloftwonativeproteinssignificantlyincreased;andbecausetheychaperonethecorrectfoldingofproteins,andbecausetheirlevelstendtoincreaseinplantsinresponsetostressesthatimpairproperproteinformation,theresearchersregardedthisresultasawarningsign.Theystatedit“...raisesthepossibilitythatatleastsomeoftheSSA[theforeignprotein]ismisfolded.”Thesecondunusualoutcomethatwasnotdirectlyrelatedtothecompetitionforsulfurinvolvedafailuretoprocessanothernativeprotein

[glutelinB]inanormalmanner,whichledtoelevatedlevelsofitsunprocessedform.Althoughtheresearchersdidn’tdeterminewhetherthevariousalterationscouldexertnegativeimpactsonconsumerhealth,orwhether

otherpotentiallyhazardouschangeshadalsooccurred,aprocessthatcaninducesuchsignificantshiftsinthewayaplantoperatesclearlyhasthepotentialfordoingso.Hagan,N.etal.,“Theredistributionofproteinsulfurintransgenicriceexpressingageneforaforeign,sulfur-richprotein,”PlantJ.34(2003):1–11.Seealso,Islam,N.etal.,“Decreasedaccumulationofglutelintypesinricegrainsconstitutivelyexpressingasunflowerseedalbumingene,”Phytochemistry66(2005):2534–39.

112Nestle,Marion,“TheAMA’sStrangePositiononGMFoods”:http://www.theatlantic.com/health/archive/2012/06/the-amas-strange-position-on-gmfoods-test-but-dont-label/258968/Whileherallegationwasspecificallydirectedataparticular,andglaring,instanceofinconsistencybetweentwoofthereport’smainassertions,evenwhenthedocumentisself-consistent,itisnotconsistentwithgoodscience–aswillbedemonstrated.

113AmericanMedicalAssociation,PolicyStatementonBiotechnologyandtheAmericanAgriculturalIndustry,1990.114AmericanMedicalAssociation,Report2oftheCouncilonScienceandPublicHealth(A-12)(2012)2.115TheAMA’soppositiontolabelingisclearlystatedinthe2012report,whichwasheavilyreliedonbytheopponentsofaCaliforniaballot

initiativethatwouldhaverequiredlabeling.Theinitiativewasnarrowlydefeated.116AMA(1990),op.cit.note113.ThefirstGEwholefoodthatcametomarketwastheFlavrSavrtomato,introducedinMay1994.Itis

discussedinChapter10.117Document#1at:http://biointegrity.org/24-fda-documents118Inoneindicationofdeficientbenefits,theDesMoinesRegisterreportedthatstudiesofIowafarmersconductedfor1998and2000by

IowaStateUniversityeconomistDr.MichaelDuffyshowed:“Farmerswhoplantgeneticallymodifiedcornandsoybeansfarenobetterfinanciallythanthosewhogrowtraditionalcrops....”AnditnotedDuffy’sstatementthatseedcompaniesandchemicalcompanieshavereapedtheprimarybenefitsofbiotechnologysofar(Perkins,Jerry,“BiotechCropsFailtoReapMoreCash,”DesMoinesRegister,January13,2002).Dr.Duffyalsofoundthat,inbothyears,yieldsfortheGEsoybean(Monsanto’sRoundupReadyvariety)werelowerthanforthenon-GEbeans.

119TheyielddragoftheRoundupReadysoybeanwasconfirmedbyresearchersattheUniversityofNebraska.IncontrolledstudiescomparingRRsoywithnon-engineeredsisterlines,theyfoundconsistentyielddecreaseswiththeGEbeansof5%.Theyconcludedthatthestudy“demonstratesthata5%yieldsuppressionwasrelatedtothe[foreign]geneoritsinsertionprocess....”Andtheymadeitclearthatthereductionwasnotduetotheapplicationoftheherbicide,becausetheydeterminedthatithadexertednoeffectonyields(Elmoreetal.,“Glyphosate-ResistantSoybeanCultivarYieldsComparedwithSisterLines”,AgronJ93[2001]:408-12).TheotherproblemshavebeendiscussedinChapter7.

12021CFR170.3(I)121AmericanMedicalAssociation,PolicyStatementonBiotechnologyandtheAmericanAgriculturalIndustry,1990.

10.ACropofDisturbingData1Asitturnedout,thishypothesiswasincorrect;andthetranslationofthePGgenewasinhibitedviaadifferentmechanism.2Aswillbediscussedlaterinthischapter,thetomatoalsocontainedamarkergene;andthatgenehadabacterialorigin.3Martineau,Belinda,FirstFruit:TheCreationoftheFlavrSavr™TomatoandtheBirthofBiotechFoods,2001(McGraw-Hill:New

York),146.4CalgenealsoconductedacuteoraltoxicitytestsofeightotherlinesoftheFlavrSavrandfivecorrespondingcontrollines.(Martineau,

personalcommunication)5FirstFruit,op.cit.note3,150.Theterm“grosslesions”wasusedbyFDApathologistswhoreviewedthedata.Theyalsoreferredtothe

lesionsas“gastricerosions”(Document#14,p.1at:http://biointegrity.org/24-fda-documents).6Pusztai,A.,“CanScienceGiveUstheToolsforRecognizingPossibleHealthRisksofGMFood?,”NutritionandHealth16(2002):73-

84.7FirstFruit,op.cit.note3,152.8Document#14,p.2at:http://biointegrity.org/24-fda-documents.9Document#17,pp.2-3at:http://biointegrity.org/24-fda-documents.10Document#16at:http://biointegrity.org/24-fda-documents.11Document#15,p.3at:http://biointegrity.org/24-fda-documents.12FirstFruit,op.cit.note3,181.13AgencySummaryMemorandum,Re:ConsultationwithCalgene,Inc.,ConcerningFLAVRSAVR™Tomatoes,May17,1994,U.S.Food

andDrugAdministration.BecausetheCommissionerselectstheFACmembers,andbecauseKesslerhadhadalongtenure,it’sreasonabletoassumehehad

appointedasubstantialnumberofthestandingmembers.14FirstFruit,op.cit.note3,182.15Cony,A.,“FDAScientistsfindFlavrSavrSafe,”SacramentoBee,April6,1994.(TheFDA’sstatementwasreleasedseveraldays

beforethisarticlewaspublished;andthearticlereferredtoitasapastevent.)16FirstFruit,182.BelindaMartineau,theauthorofthebook,wasamemberoftheFlavrSavrdevelopmentteamandmadethis

observationfirst-hand.17Cony,A.,“FDAScientistsfindFlavrSavrSafe,”SacramentoBee,April6,1994;AscitedinFirstFruit,252,n.1.TheFDA’s

subsequentpublicreleasesregardingtheFlavrSavrcontinuedtofalselyassertthatitsscientistshaddeterminedthatthetomatowassafe,e.g.“FirstBiotechTomatoMarketed,”U.S.FoodandDrugAdministration,CenterforFoodSafetyandAppliedNutrition,FDAConsumer,September1994.

18FDAFoodAdvisoryCommitteeMeeting,April6-8,1994,Transcript:vol.2,153.19Ibid.,159-61.20Ibid.,162;167-68.21FirstFruit,op.cit.note3,186.Thewords“lovefest”wereinquotationmarksinMartineau’sreport.22FDAPublicAffairsOffice,HHSNews,May18,1994.23“BiotechnologyofFood,”U.S.FoodandDrugAdministration,CenterforFoodSafetyandAppliedNutrition,FDABackgrounder,May

18,1994.24“FDA’SPolicyforFoodsDevelopedbyBiotechnology,”U.S.FoodandDrugAdministration,CenterforFoodSafetyandApplied

Nutrition,CFSANHandout:1995.ThedocumentwasalsopublishedasachapterinAmericanChemicalSocietySymposiumSeriesno.605,1995.

25FirstFruit,146.Thispagediscussestheinitialconsensus,andthewordsinquotationmarksarefromMartineau’stakeonit.26Document#15,p.3at:http://biointegrity.org/24-fda-documents.27Ibid.,4.28Additionally,somesubstanceshavebeengrantedaspecificstatutoryexemptionfrommeetingthetestrequirements.29AccordingtotheFDA’sownregulations,foodsclaimedtobeGRAS“...requirethesamequantityandqualityofscientificevidenceas

isrequiredtoobtainapprovalofthesubstanceasafoodadditive.”(21CFRSec.170.30[b])30AgencySummaryMemorandumRe:ConsultationwithCalgene,Inc.,ConcerningFLAVRSAVR™Tomatoes,May17,1994,USFood

andDrugAdministration.31Pusztai,A.etal.,“Geneticallymodifiedfoods:potentialhumanhealtheffects,”inFoodSafety:ContaminantsandToxins,inD’Mello,

J.P.F.,ed.,ScottishAgriculturalCollege,Edinburgh,UK,April2003,351.32BelindaMartineau’sfilesattestthatthedeathsoccurredinadifferentlinethandidthelesions.33BecausetherelevantfileswerenotwithmeatthetimebutattheofficesoftheInternationalCenterforTechnologyAssessment(the

attorneysofrecordinourlawsuit)inWashington,D.C.,Iconveyedtherequesttothem;andtheysenthimtheinformation.

34Pusztai,A.etal.,(2003),op.cit.note31,351.35http://www.responsibletechnology.org/posts/throwing-biotech-lies-at-tomatoes-part-1-killer-tomatoes/36Pusztai,A.etal.(2003)op.cit.,note31,350.Althoughthequotedwordswerespecificallymadeindiscussingtheacutetoxicitystudy,

theyalsoappliedtothe28-daystudies,inwhichthevariationinstartingweightswasevengreater.37Ibid.,351.38Ibid.,351-52.39Althoughtheadministratorswereapparentlyabettedbyafewagencyscientists,theirscientificstandardsseemtohavebeensignificantly

lowerthanwerethoseoftheexpertswhowrotethecriticalmemos.Further,it’snotcleariftheyscrutinizedthedataascarefullyasdidthatsetofexperts.

40Whenthecassettealreadycontainsageneconferringresistancetoanherbicide,thatherbicidecanbeusedtokilloffthenon-transformedcells,eliminatingtheneedtoaddanantibioticresistancemarkergene.

41Althoughbiotechproponentshavetriedtodiscreditconcernsbyarguingthatkanamycinhaslargelyfallenintodisuseandisnolongermedicallysignificant,thefactsshowotherwise.Notonlyisitusedpriortoendoscopyofthecolonandrectum,it’susedtotreatocularinfections,andalsoinblunttraumaemergencytreatment.It’sadditionallyappliedinveterinarymedicine.Perhapsevenmoresignificant,theeffectivenessofotherantibioticscouldalsobecompromised.That’sduetoaphenomenoncalledcross

resistance,whereinbacteriathatbecomeresistanttoaparticularantibioticsubsequentlydevelopresistancetootherswithinitsfamily.Andkanamycinbelongstoanimportantfamily.Itsrelativesincludeantibioticsthataresubstantiallyreliedontoday.Soit’samatterofconcernthatthisfamilyhasdisplayedappreciablecrossresistance(Onaolapo,J.,Afr.J.MedSci23[1994]:215-9).Moreover,accordingtothemedicaldoctorJaanSuurkula,twoofkanamycin’scousinsareof“greatvalue”intreatingseriousinfectionsbecausetheyentailgentlersideeffectsthantheiralternatives.See:http://www.psrast.org/antibiot.htm.Therefore,it’sominousthatastrainofbioengineeredbacteriainwhichthekanamycinresistancemarkergenehadbeenusedwasfoundtobecrossresistanttothesetwovaluabledrugs(Smirnov,V.V.etal.,Antibiot-Khimiorec39(4)[Apr1994]:23-28).AsDr.Suurkulahasobserved,“itwouldbeanimportantdrawback”ifresistancetotheseantibioticsweretoincrease.

42FirstFruit,op.cit.note3,161.BelindaMartineauhasinformedmethatdespitethefactpeopleinboththeFDAandthebiotechindustryroutinelyclaimthatCalgenedecidedtosubmittheapplicationonitsownvolition,shewas(asshereportsinherbook)intheofficeofthecompany’sCEOwhenhereceivedacallfromanFDAofficial(whichsheheardviahisspeakerphone)informinghimthattheagencypreferredtohaveCalgene’srequestforanadvisoryopinionconvertedinto,andsubmittedas,aformalfoodadditivepetition.

43Document#11at:http://biointegrity.org/24-fda-documents44Document#12,p.6(atAR#013136)at:http://biointegrity.org/24-fda-documents45Ibid.(atAR#013130)46Document#13(atAR#013139)at:http://biointegrity.org/24-fda-documents47ThescientistwasNegaBeru.FACMeetingTranscript,op.cit.note18,vol.2,178.48Dr.Beru’sassertionthattheFDAhadconcludedthattheuseofthegeneissafeappearsonpage187oftheabovetranscript.49AsAppendixCexplains,althoughtheFDAdidexpresslyapprovethemarkergene,itrefrainedfromdoingsointhecaseofthetomato

itself.Andintheagency’slettertoCalgeneregardingthelatter,itcleverlychoseitswordstogivetheillusionthatanapprovalwasbeinggrantedwhile,inactuality,therewasnoexpressapprovalorcertificationofsafety.Butduetotheartfulillusion,Calgenedeclared,andthemediareported,thatformalapprovalhadbeenreceivedandsafetycertified.

50BelindaMartineau’sfilesindicatethatCalgenehaddecidedtomarketthatparticularline;andsheinformedmethat,asfarassheknows,it’stheonethatwascommercialized.

51UnitedStatesv.SevenCartons...Ferro-Lac,293F.Supp.660,664(S.D.Il.1968).ThatcaseisdiscussedinChapter5.Init,theFDAwaschallengingtheGRASstatusofanadditive,theexpertstestifiedonbehalfofitschallenge,andtheyassertedthattheywerenotawareofanystudiesinthestandardliteraturedemonstratingthesubstancewassafe.Obviously,theoutcomewouldalmostsurelyhavebeendifferentifthosescientistshadquestionablecredentialsandwerecounteringalargenumberofwell-qualifiedexpertswhoseopinionwasbasedonsolidevidenceofsafetypublishedinstandardpeer-reviewedjournals.Butifevenafewexpertscanshowthatawidely-heldopinionisnotbasedonsuchevidenceandinsteadrestsonassumptionsandhypothesesthatareopentoreasonabledoubt,thenthesubstancetheychallengecannotbelegitimatelydeemedGRAS.(Thisrulingwassubsequentlymodifiedonothergroundsbyanappellatecourt,424F.2d136(7thCir.1970)–groundsthatdidnotaffecttheholdingaboutthesufficiencyoftwoexperts.)

52Document#12,pp.5&7at:http://biointegrity.org/24-fda-documents53Ibid.,7.54Document#13,p.3at:http://biointegrity.org/24-fda-documents55Ibid.,2.56IaskedBelindaMartineau,whowasintimatelyinvolvedinCalgene’sendeavorsregardingthetomato,whetheranyadditionaldataabout

thespreadofresistancetogutflorahadbeensubmittedinresponsetotheconcernsoftheFDAexperts.Shegraciouslysearchedherfilesandreportedthatnonehad.(Theonlyadditionaldatathatwassubmittedwasunrelatedtothosespecificconcerns.)

5721CFR170.3(3)(I).58BecausethisfactwasmorethansufficienttonegateanyclaimthegenewasGRAS,itcertainlycouldnotbecircumventedmerelyby

convertingCalgene’ssubmissionintoafoodadditivepetition,inwhichthesamestandardofsafetyisineffect.Moreover,evenifCalgenehaddecidedtocommercializeaFlavrSavrlinethathadnotbeenlinkedwitheitherlesionsordeaths,thatline

wouldstillhaveenteredthemarketincontraventionofthelaw.Foronething,itwouldhavecontainedtheillegally-approvedmarkergene.Foranother,itssafetywouldstillhavebeensubjecttoreasonabledoubt.BecausetheFDAexpertshadidentifiedanunresolvedsafetyissue,ashadowwascastoneverylineoftheFlavrSavr.Anduntilthatissuewasresolved,theshadowwouldremain.Afterall,ifthelesions(orthedeaths)wereinsomewaycausedbyoneoranotheraspectofthebioengineering,therewouldbeapossibilitythatdeleteriouseffectscouldbeinducedbyotherlinesoftomatoalteredwiththesamecassette–andthattheseeffectsmightnotbeevidentunlessmorethoroughstudieswereconducted.

59FirstFruit,op.cit.note3,203,223.60Ibid.,221-22.61Ibid.,222.62Ibid.,221(fortheinformationthattherewasnopublicopposition).63AsAppendixCexplains,thisprofessionaboutsafetyhavingbeendemonstratedwentfarbeyondwhattheagencywaswillingtostatein

theactualletterithadsentCalgeneinregardtothetomato.64“ElementsofPrecaution:RecommendationsfortheRegulationofFoodBiotechnologyinCanada;AnExpertPanelReportontheFuture

ofFoodBiotechnology,”TheRoyalSocietyofCanada,January2001,48.65Pusztai,A.,SubmissiontotheNewZealandRoyalCommissiononGeneticModification(2001).66Pusztaihasstatedthat“ourtaskwastoestablishnoveltestingmethods,”Pusztai,A.,”ResponsestotheRoyalSociety’s(RS)six

referees’reviewsontheAuditandAlternativeReport,”(placedontheinternetbytheRowettResearchInstituteonFebruary16,1999).67Pusztai,A,TranscriptoftestimonytotheNewZealandRoyalCommissiononGeneticModification,February7,2001,3406.68Smith,Jeffrey,GeneticRoulette(Fairfield,IA:Yes!Books,2007),23.69Thedifferencescouldalsohavebeenduetovariableeffectsoftissueculture,aswillbediscussedsubsequently.70Pusztai,A.,SOAEFDflexibleFundProjectRO818:ReportofProjectCoordinatorondataproducedattheRowettResearchInstitute

(RRI):http://www.worldcat.org/title/soaefd-flexible-fund-project-ro-818-report-of-projectcoordinator-on-data-produced-at-the-rowett-research-institute-rri/oclc/041214388

71Pusztaitestimony,op.cit.note67,3430.72Ibid.73Ibid.74Ewen,S.W.B.andPusztai,A.,“EffectsofdietscontaininggeneticallymodifiedpotatoesexpressingGalanthusnivalislectinonratsmall

intestine,”TheLancet354(1999):1353-54.75However,notumorswereobserved.76EmailfromSusanBardocz,oneofthescientistsontheresearchteam(andPusztai’swife).77Smith,Jeffrey,SeedsofDeception:ExposingIndustryandGovernmentLiesAbouttheSafetyoftheGeneticallyEngineered

FoodsYou’reEating(Fairfield,IA:Yes!Books,2003),13.SmithbasedhisaccountofPusztai’sexperiencesandsubjectivereactionsonextensiveinterviews.Unlessotherwisespecified,thefollowingstatementsaboutPusztai’ssubjectiveoutlookarebasedonSmith’saccount,whichprovidesamuchmoredetailedanddramaticexpositionofeventsthanisprovidedinthischapter.

78GM-FREEMagazine,vol.1,no.3,August/September1999.79Transcriptfrom,“WorldinAction,”sentbyArpadPusztaitoJeffreySmith.QuotedbySmithinSeedsofDeception,op.cit.note77,15.80Ibid.,op.cit.note77,16.81Ibid.,18.82Rowell,A.,“Thesinistersackingoftheworld’sleadingGMexpert–andthetrailthatleadstoTonyBlairandtheWhiteHouse,”Daily

Mail,July7,2003.http://www.gmwatch.org/latest-listing/42-2003/430583Ibid.84Rowell,A.,Don’tWorry,It’sSafetoEat(London,UK:Earthscan,Ltd,2003).85https://royalsociety.org/86Upuntilthe1960’s,everyissueofitsjournalPhilosophicalTransactionsboreanoticethat“ItisanestablishedruleoftheRoyalSociety

...nevertogivetheiropinion,asaBody,uponanysubject.”87TheproactivenatureofthepolicywasacknowledgedinthePresident’sAddressinTheRoyalSocietyAnnualReview1998-99,which

declaredthat“Wehavecontributedearlyandproactivelytopublicdebateaboutgeneticallymodifiedplants.”88Flynn,L.andGillard,M.,“Pro-GMfoodscientist‘threatenededitor’,”TheGuardian,October31,1999.89JeffreySmithreported(intheHuffingtonPost)thatPusztaiinformedhimabouthavingofferedthedatatotheSocietyandbeingrefused:

http://www.huffingtonpost.com/jeffrey-smith/biotech-propaganda-cooks_b_675957.html90Inhisresponsetothereview(op.cit.note66)PusztaipointedoutthattheRoyalSocietybore“agreatdealoftheblame”becauseitgave

thereviewersinternaldocumentsthatwere“manifestlyinappropriateforpeer-review.”91ForPusztai’scommentaboutthelackofqualifications,see:http://gmwatch.org/index.php/news/archive/2006/1937-pusztai-replies-to-

fedoroff.92Ibid.

93Ibid.94Ibid.95Ibid.96Editorial:“Healthrisksofgeneticallymodifiedfoods,”TheLancet353(May29,1999):1811.TheeditorialsaidthatbyMay22,1999,the

Societyhadcompleteditsreview;butadocumentissuedbytheSocietyin2002statedthereportwaspublishedinJune.Apparently,theeditoroftheLancethadseenacopyofthereportpriortoformalpublication.

97Horton,R.,“GMFoodDebate,”TheLancet353,issue9191(November13,1999):1729.98TheGuardianstatedithad“establishedthattheRoyalSocietywasinvolvedintryingtopreventpublication.”Anditnotedthatthese

effortsbeganbeforetheSocietylearnedthattheLancetwasreviewingtheresearch.FlynnandGillard(1999),op.cit.note88.(Whilethisarticledidnotemploytheterm“unsavory,”itprovidedacomprehensive,andunflattering,reportontheSociety’sactionstodiscreditPusztaiandhisresearchthatclearlyrevealedtheirunsavorycharacter.)

99Ibid.100FlynnandGillard,op.cit.note88.101Ibid.102Ibid.AllwordsinquotationmarksinthisparagraphwereinquoteswithinTheGuardianarticle.103Bateson,P.,“Mavericksarenotalwaysright,”ScienceandPublicAffairs,June2002.Bateson’sallegationdistortsthetruthbyignoring

thefactthatfiveoutofthesixrefereesvotedforpublication.Instead,heimpartstheimpressionthatmorethanoneobjected(whichisfalse),andthatnoonewithstatisticalcompetencevotedforpublication(whichisalmostsurelyfalseaswell).

104RoyalSociety,“Geneticallymodifiedplantsforfooduseandhumanhealth–anupdate,”February2002,5.105ThereviewwaspublishedinJune1999,andtheLancetpaperwasnotpublisheduntilOctober15th.106RoyalSociety(2002),op.cit.note104,5.Thecrucialsentenceswere:“InJune1999,theRoyalSocietypublishedareport,Reviewof

dataonpossibletoxicityofGMpotatoes,inresponsetoclaimsmadebyDr.Pusztai(Ewen&Pusztai,1999).ThereportfoundthatDrPusztaihadproducednoconvincingevidenceofadverseeffectsfromGMpotatoesonthegrowthofratsortheirimmunefunction.”Thus,thefirstsentenceclearlyimpliesthatthereviewcenteredonthepaperauthoredbyPusztaiandStanleyEwenthatwaspublishedintheLancet,nottheincompletesummarythathadbeenpreparedforscientistsattheRowettInstitute(whichwastheonlysubmissiontheparticipantsinthe1999reportexamined).AnextensiveexaminationoftheRoyalSociety’smisbehaviorinregardtoPusztaiiscontainedin:RowellA.Don’tWorry,It’sSafetoEat.(London,UK:EarthscanLtd,2003).

107RoyalSociety,ReviewofdataonpossibletoxicityofGMpotatoes,June1999,1&2.108http://www.publications.parliament.uk/pa/ld200001/ldhansrd/vo010216/text/10216-02.htm(accessed:June2,2014).109Ibid.110Arthur,Charles,“Scientistsblamemediaandfraudforfallinpublictrust,”TheIndependent,January31,2003:

http://www.independent.co.uk/news/science/scientists-blame-media-and-fraud-for-fall-in-public-trust-609014.html111ReportoftheRoyalCommissiononGeneticModification(NewZealand,2001),209.112Forinstance,thereportallegesthatdifferencesdetectedinthefeedingstudieswereduetothefactthatrawpotatoeswereused–and

thatbecauseratsdon’tlikethem,theywerestarvingandthe110-daytrialhadtobeabandonedafter67days.Itthenasserted:“Starvationaffectsguthistology,andtheliningofthegutofcontrolratseatingunmodifiedpotatoeswasshowntobeabnormal.”Buttheseassertionsareerroneous.First,therewerefourmajorstudies,andonlyonewasdesignedtolast110days.Theotherswere

completedin10days,andeventhoughthelongeronethatusedrawpotatoesendedearlierthanplanned,itstillyieldedsignificantresults.(PusztaiWitnessBrief,p.3)Second,allfourtestsshowedsignificantdifferencesinseveralphysiologicalindicesbetweenratsfedGEpotatoesandthosefedonthenon-GEones.Inall,39statisticallysignificantdifferenceswerefound(byindependentmultivariatestatisticalanalysis),ofwhichnomorethanfivecouldhavebeentheresultofrandomerror.(PusztaiTestimony,transcriptofFebruary7,2001,p.3430.)Further,whatevernegativeeffectstherawpotatodiethadonthecontrolgroupwereofsignificantlylessmagnitudethantheeffectsobservedintheratseatingtheGEpotatoes,whichindicatesthatsomethinguniquetotheGEpotatoeswasalsoacausativefactor.Third,theratswerenot“starving.”Theywerecontinuingtoputonweight,butnotattheraterequiredbyUKgovernmentregulationsonanimalfeedingstudies.(Ibid.,pp.3435,3441.)Fourth,evenstarvationdoesnotproduceabnormalguthistology.Itmerelycontractsthegut.(PrivatecommunicationfromDr.Pusztai.)Fifth,trialswerealsoconductedusingboiledpotatoes.Onthisdiet,thelongerstudydidrunforafull110days.Asinthecaseoftherawpotatodiet,therewerestatisticallysignificantdifferencesbetweentheratseatingGEandnon-GEpotatoes.(EwenWitnessBrief;Pusztaitranscript,p.3442.)Moreover,thecommissionwasfullyinformedofthesefacts(exceptforthefourth)butnonethelessmisrepresentedthem.

113Fedoroff,N.andN.M.Brown,MendelintheKitchen:AScientistLooksatGeneticallyModifiedFoods(Washington,DC:JosephHenryPress,2004),181-83.

114Althoughthesubstanceofthischargewasmadeinherbook,theprecisewordingwasextractedfromanarticleshepostedonapro-GEwebsiteonFebruary25,2006,around18monthsafterherbookhadbeenpublished.See:http://www.agbioworld.org/biotech-info/articles/biotech-art/pusztai-potatoes.html.ThatarticlewasforthemostpartthesameasthesectiononPusztai’sresearchinherbook,exceptthatitelaboratedmorefullyinsome

placesandcontainedafewrevisions.115Inherwords:“Butoddlyenough,intheentirepoisonedratdebatenooneseemstohaveseenthecentralflawinPusztai’sexperiments:

theabsenceofappropriatecontrols,”MendelinKitchen,op.cit.note113,182.116RoyalSociety,ReviewofdataonpossibletoxicityofGMpotatoes,June1999.

117RoyalSocietyReport(2002),op.cit.note104,5.TherelevantsectiondiscussedtheSociety’s1999critiqueofPusztaiandthenstated:“ItconcludedthattheonlywaytoclarifyDrPusztai’sclaimswouldbetorefinehisexperimentaldesignandcarryoutfurtherstudiestotestclearlydefinedhypothesesfocusedonthespecificeffectsreportedbyhim.Suchstudies,ontheresultsoffeedingGMsweetpeppersandGMtomatoestorats,andGMsoyatomiceandrats,havenowbeencompletedandnoadverseeffectshavebeenfound(GassonandBurke,2001).”

118Althoughiteventuallydidgetreviewedandpublished,thatdidn’toccuruntilwellafteritwasreliedontorefutePusztai’sfindings.And,accordingtoDavidSchubert,thestudywasnonethelessdeficientinseveralrespects,andnotnearlyasstrongaswasPusztai’s.Thepaperwaspublishedas:ChenZ.etal.,“SafetyAssessmentforGeneticallyModifiedSweetPepperandTomato,”Toxicology188(2003):297-307.

119DavidSchubertpointedthisoutinanemailtome.120Pusztai,A.,LettertoRoyalSociety,February6,2002:http://ngin.tripod.com/300103f.htm121Ibid.122EmailfromDavidSchubert.123Gasson,M.andBurke,D.,“Scientificperspectivesonregulatingthesafetyofgeneticallymodifiedfoods,”NatureReviewsGenetics2

(2001):217-22.124RoyalSocietyReport(2002),op.cit.note104,209.125Intheirpaper,EwenandPusztaionlydiscussedintestinalabnormalities.Sotheonlyteststhatcouldcastseriousdoubtonthestudies

wouldhavetodemonstratethattheparticularlectininvolvedactuallycausestheproblemstheydetectedintherats.Butit’sextremelyunlikelythatsuchfindingscouldbelegitimatelyregistered,sinceseveralpublishedstudieshavedemonstratedthatthattypeoflectinisharmlesstomammalsatlevelshundredsoftimeshigherthanwasproducedwithintheGEpotatoes–andPusztai’sexperimentshowedthatthecontrolpotatoesthatwerespikedwiththelectinusedinhisstudiesdidnotinducetheproblemsthattheGEpotatoesdid.

126Burke,Derek,“GMcrops:timetocounterthescarestoriesandrelaxbarriers,”March27,2014:https://theconversation.com/gm-crops-time-tocounter-the-scare-stories-and-relax-barriers-24678(accessedMay2014).

127Burkespecifically(andfalsely)allegedthatPusztaimadetheclaimsin1998.Whileitistruethatin2002StanleyEwencautioned(inasubmissiontoacommitteeoftheScottishParliament)thatthe35SviralpromoterusedinmostGEfoodscouldincreasetheriskofstomachandcoloncancerbyover-stimulatingcellulargrowth,hedidnotclaimthatanyGEfoodshadcausedcancer.http://www.sundayherald.com/29821.

128Fedoroff’sarticlewaspostedFebruary25,2006at:http://www.agbioworld.org/biotech-info/articles/biotech-art/pusztai-potatoes.html.AsofMarch14,2006,PusztaihadnotreceivedareplyfromFedorofftohismessageinformingherofhererror,soheauthorizedhiscritiqueofherstatementstobepostedat:http://gmwatch.org/index.php/news/archive/2006/1937-pusztai-replies-to-fedoroffAsofAug.25,2013,Fedoroff’sarticlewasstillontheAgBioWorldsiteinitsoriginal,erroneousform.129AlthoughtheEMSepidemiccausedbythetoxictryptophansupplementbrokeoutduring1989,itextendedinto1990,andtheresearch

linkingittoShowaDenko’sgeneticallyengineeredbacteriadidn’toccuruntilthatyear.130Gab-Alla,A.A.etal.,“Morphologicalandbiochemicalchangesinmaleratsfedongeneticallymodifiedcorn”(Ajeeb,Y.G),JAmSci.8

(9)(2012):1117–23.131Gab-Alla,A.A.etal.,“Histopathologicalchangesinsomeorgansofmaleratsfedongeneticallymodifiedcorn”(Ajeeb,Y.G.),JAmSci.

8(10)(2012):684–96.132Finamore,A.,Rosell,M.,Britti,S.,etal.,“IntestinalandperipheralimmuneresponsetoMON810maizeingestioninweaningandold

mice,”JAgricFoodChem.56(2008):11533–39;doi:10.1021/jf802059w.133Krzyzowska,M.,Wincenciak,M.,Winnicka,A.,etal.,“Theeffectofmultigenerationaldietcontaininggeneticallymodifiedtriticaleon

immunesysteminmice,”PolJVetSci.13(2010):423-30.134Tudisco,R.,Lombardi,P.,Bovera,F.,etal.,“Geneticallymodifiedsoyabeaninrabbitfeeding:DetectionofDNAfragmentsand

evaluationofmetaboliceffectsbyenzymaticanalysis,”AnimSci.82(2006):193–99.doi:10.1079/ASC200530.135Malatesta,M.,Boraldi,F.,Annovi,G.,etal.,“Along-termstudyonfemalemicefedonageneticallymodifiedsoybean:effectsonliver

ageing,”HistochemCellBiol.130(2008):967–77.136Malatesta,M.,Caporaloni,C.,Gavaudan,S.,etal.,“Ultrastructuralmorphometricalandimmunocytochemicalanalysesofhepatocyte

nucleifrommicefedongeneticallymodifiedsoybean,”CellStructFunct.27(2002):173–80;Malatesta,M.,Caporaloni,C.,Rossi,L.,etal.,“Ultrastructuralanalysisofpancreaticacinarcellsfrommicefedongeneticallymodifiedsoybean,”JAnat.201(2002):409–15;Malatesta,M.,Biggiogera,M.,Manuali,E.,Rocchi,M.B.L.,Baldelli,B.,Gazzanelli,G.,“Finestructuralanalysesofpancreaticacinarcellnucleifrommicefedongeneticallymodifiedsoybean,”EurJHistochem.47(2003):385–388.

137Interviewindocumentaryfilm:Robin,M.M.,“TheWorldAccordingtoMonsanto[film],”2008.138Séralini,G.E.,Clair,E.,Mesnage,R.,etal.,[RETRACTED:]“LongtermtoxicityofaRoundupherbicideandaRoundup-tolerant

geneticallymodifiedmaize,”FoodChemToxicol.50(2012):4221-31.139Hammond,B.,Dudek,R.,Lemen,J.,Nemeth,M.,“Resultsofa13weeksafetyassurancestudywithratsfedgrainfromglyphosate

tolerantcorn,”FoodChemToxicol.42(2004):1003-14.doi:10.1016/j.fct.2004.02.013.140EuropeanFoodSafetyAuthority(EFSA);OpinionoftheScientificPanelonGeneticallyModifiedOrganismsonarequestfromthe

Commissionrelatedtothesafetyoffoodsandfoodingredientsderivedfromherbicide-tolerantgeneticallymodifiedmaizeNK603,forwhicharequestforplacingonthemarketwassubmittedunderArticle4oftheNovelFoodRegulation(EC)No258/97byMonsanto(QUESTIONNOEFSA-Q-2003-002):OpinionadoptedonNovember25,2003,EFSAJ.2003(9)(2003):1–14.

141DeVendomois,J.S.,F.Roullier,D.Cellier,G.E.Séralini,“AcomparisonoftheeffectsofthreeGMcornvarietiesonmammalianhealth,”IntJBiolSci.5(2009):706–26.

142Evenifthesubstancebeingtestedhasatendencytoinducetumorsatahigherthannormalrate,ifeachgroupofratscontainsonly10ofeachsex(aswasthecaseinSéralini’sstudy),notumorsmightbeobserved,whereasif50persexpergroupareused(asisordinarilydoneincancerstudies),thestudyhasamuchbetterchanceofdetectingsometumors.However,thatdoesn’tentailthatusingalowernumberofratssomehowinvalidatesanystatisticallysignificantincreaseintumorsthatisobserved.Aslongasasufficientnumberwasusedtoreliablyregistersuchdifferences(whichwasenabledbythenumberSéraliniemployed),thosedifferencesarevalid.

143Thus,PeterSaunders,emeritusprofessorofmathematicsatKing’sCollegeLondon,hasstatedthatthesmallernumberofrats“makestheresultsifanythingmoreconvincing,notless.”Heexplained:“Usingasmallernumberofratsactuallymadeitlesslikelytoobserveanyeffect.Thefactthataneffectwasobserveddespitethesmallnumberofanimalsmadetheresultallthemoreserious.”Saunders,P.,“ExcesscancersanddeathswithGMfeed:Thestatsstandup,”SciSoc.(2012).Availableat:http://www.i-sis.org.uk/Excess_cancers_and_deaths_from_GM_feed_stats_stand_up.php.

144Onlyoneintencontrolratsdevelopedatumor,andeventhenitoccurredlateintheirlives.145CommitteeonPublicationEthics(COPE),Retractionguidelines,2009.Availableat:

http://publicationethics.org/files/retraction%20guidelines.pdf146Hayes,A.W.,“ResponsetoLetterstotheEditors,”December2013.Availableat:http://www.elsevier.com/about/press-

releases/research-and-journals/food-and-chemical-toxicology-editor-in-chief,-a.-wallace-hayes,-publishes-response-to-letters-to-the-editors#sthash.tTW2LCGq.dpuf.

147Inhisresponsetotheretraction,Seralinipointedout:“Itshouldbenotedthattumorigenesisisnotsynonymouswithcancer.Tumorscanbeinsomecasesmorerapidlylethalthancancersbecausetheirsizecancausehemorrhagesandpossibleimpairmentsofvitalorgans,aswellassecretionoftoxins.”Séralini,G.E.etal.,“Conclusivenessoftoxicitydataanddoublestandards,FoodandChemicalToxicology”(2014),doi:http://dx.doi.org/10.1016/j.fct.2014.04.018

148OECDguidelineno.452forthetestingofchemicals:Chronictoxicitystudies:AdoptedSeptember7,2009.149Hestated:“Whilethenumberofanimalsusedmayhavebeensufficienttoreachconclusionsregardingoraltoxicity,itprovedinsufficient

forconclusionsrelatedtothecarcinogenicityofthetestsubstances.”HayesResponse(2013),op.cit.note146.150AsreportedintheNewYorkTimes:“Theeditorofthejournal,FoodandChemicalToxicology,saidinalettertothepaper’smainauthor

thatthestudy’sresults,whilenotincorrectorfraudulent,were‘inconclusive,andthereforedonotreachthethresholdofpublication.”Pollack,A.,“PaperTyingRatCancertoHerbicideisRetracted,”NewYorkTimes,November28,2013.Seraliniquotedthatletterashavingstatedthattherawdatawere“‘notincorrect’”.Séralinietal.,op.cit.note147.

151Schubert,D.,“Sciencestudycontroversyimpactsworldhealth,”U-TSanDiego:http://www.utsandiego.com/news/2014/jan/08/science-food-health/,publishedJanuary8,2014.

152Thewords“couldhavebeencaused”havebeenusedbecausetheresultsprovidedreasonablegroundsforthinkingthatthishadhappenedbutdidnotdecisivelydemonstrateit.

153TheresearchdemonstratesthatthelevelofherbicideresidueonmarketedRoundup-readyplantscaninducesubstantialdamagetoanimalsthateatthem,whichentailsthatallsuchplantsaredangerous;anditalsoindicatesthatharmfuleffectsmightbeinducedbytheexpressionofthegenethat’sinsertedtoconfertheRoundupresistance,whichcastsadditionaldoubtonthesafetyofalltheplantsthatcontainit.

154Pollack,A.,“PaperTyingRatCancertoHerbicideisRetracted,”NewYorkTimes,November28,2013.155EnvironmentalSciencesEurope(ESEU,2014,26:14).156Fagan,J.,Antoniou,M.C.,andRobinson,C.,GMOMythsandTruths:AnEvidence-BasedExaminationoftheClaimsMadeforthe

SafetyandEfficacyofGeneticallyModifiedCrops,2ndEdition,version1.0,(London:EarthOpenSource,2014),147.157It’sbecomesostandard,andsoobvious,thatit’sbeennotedbyseveralothercommentators.158StatementbytheAAASBoardofDirectorsOnLabelingofGeneticallyModifiedFoods,October20,2012:

http://www.aaas.org/sites/default/files/migrate/uploads/AAAS_GM_statement.pdf159EuropeanCommission,AdecadeofEU-fundedGMOresearch(2001–2010),2010.160http://earthopensource.org/index.php/3-health-hazards-of-gmfoods/3-2-myth-eu-research-shows-gmfoods-are-safe161EuropeanCommission,AdecadeofEU-fundedGMOresearch(2001–2010),2010.162Snell,C.,Aude,B.,Bergé,J.,etal.,“AssessmentofthehealthimpactofGMplantdietsinlong-termandmultigenerationalanimal

feedingtrials:Aliteraturereview,”FoodChemToxicol.50(2012):1134-48.163MythsandTruths,op.cit.note156,138,140,161.164Ibid.,162.165E.g.,Fares,N.H.,El-Sayed,A.K.,“Finestructuralchangesintheileumofmicefedondelta-endotoxin-treatedpotatoesandtransgenic

potatoes,”NatToxins6(6)(1998):219-33.166MythsandTruths,op.cit.note156,105.I’mindebtedtotheauthorsofthisdocumentforthisandthefollowinginsightsaboutthe

weaknessesoftheNicoliareview.167Ibid.168Ibid.,107-08.TheauthorsofthiscritiquepointoutthatNicoliaandcolleaguesdonotbasetheirconclusion“onempiricaldata,reasoned

scientificargument,orevenpeer-reviewedpapers”butonfournon-peer-reviewedopinionpieces“containinginaccuraciesandunsubstantiatedpersonalviews.”

169Ibid.,106.Althoughanotherlong-termstudyonaGEglyphosate-tolerantcrop(asoybean)hasbeendone,ClaireRobinsonhasnotedthatit’sdoubtfulthebeansweresprayedwithglyphosate–atleastnottoadegreeevenclosetotheamountthat’stypicallyappliedbyfarmers.That’sbecausetheherbicidewasdetectedatanextremelylowlevel:farlowerthanwhenbeansaresprayedinactualfarmingoperations.Sothetestwaslimitedtoassessingtheeffectsoftheinsertionaleventitself,anditwasill-designedtodosobecausethecontrolbeanwasnottheisogenicvariety.(SakamotoY.etal.,“A104-weekfeedingstudyofgeneticallymodifiedsoybeansinf344rats.”ShokuhinEiseigakuZasshi49(2008):272-282.(AnEnglishtranslationofthestudyisavailableat:net.gedal.fr/knowledgebase/docs/A593742.pdf)

170Ibid.,Section2.3.Forexample,themainreviewpaperalsofailedtodiscussamultigenerationalstudyinwhichratsthatconsumedGEBtmaizeoverthreegenerationsnotonlydisplayedalterationsinbloodchemistrybutsufferedliverandkidneydamage.(KilicA,AkayMT.,“AthreegenerationstudywithgeneticallymodifiedBtcorninrats:Biochemicalandhistopathologicalinvestigation,”FoodChemToxicol.46(2008):1164–70.doi:10.1016/j.fct.2007.11.016.)TheotherreviewpapersthatpurporttodemonstratethesafetyofGEfoodshavelikewisefailedduetomultipledeficiencies.Onethat’s

frequentlycitedisasurveyofthedataonlivestockthatwerefedGEcrops.(VanEenennaam,A.andYoung,A.E.,“Prevalenceofimpactsofgeneticallyengineeredfeedstuffsonlivestockpopulations.”JAnimSci,92(2014):4255-4278.)Butbesidesrelyingonuncontrolledstudiesofanimalswithdissimilardigestivesystemsthanhumanstotrytorefutetheadversefindingsofwell-controlledstudiesonstandardlaboratoryanimalsthataremuchbettermodelsforourphysiologies,thispapercontainsseveralotherseriousflawsthatundercutitsclaims,asisincisivelydemonstratedat:http://www.gmwatch.org/index.php/news/archive/2014/15717-junk-science-and-gmo-toxicityandhttp://www.gmwatch.org/index.php/news/archive/2014/15669Incontrast,aroundthesametimethatdefectivereviewappeared,anotherreviewwaspublishedinapeer-reviewedjournalprovidingfurther

confirmationthatthesafetyoftheGEcropsonthemarkethasnotbeenestablished.ItfocusedonthosecontainingatleastoneofthethreemostprevalentgenesusedincreatingGEplants,anditinvestigatedtheextenttowhichthesecropshadbeensubjectedtoreliabletestsemployingstandardlaboratoryanimalsandhistopathologicalstudyofthedigestivetract–afarmoresensitivetypeofstudythanthesuperficialinspectionsreliedonbytheVanEenennaamreview.Theresearchersdiscoveredthatalthoughtherewere47cropvarietieswithoneormoreofthesegenesthathadbeenapprovedbyregulatorsforanimalorhumanconsumption,only9(19%)hadbeentestedviasuchhistopathologicalstudy.Further,76%ofthosetestsweredoneafterthecrophadbeenapprovedformarketing,andhalfwerepublishedatleast9yearsafterapproval.Worse,theresearcherscouldnotfindasinglestudythatwasproperlyconductedorreported.ZdziarskiI.M.etal.,“GMcropsandthedigestivetract:Acriticalreview,”EnvironmentInternational73(2014):423-433.http://gmojudycarman.org/wp-content/uploads/2014/10/Zdziarski-et-al-14-GM-crops-and-rat-digestive-tract-review.pdf

171Forexample,duringthemeetingoftheFoodAdvisoryCommitteeinregardtotheFlavrSavrtomato,aparticipantaskedtheFDAtorespondtoachargethathadbeenmadebyRebeccaGoldburg(whorepresentedapublicinterestorganization)thatitspolicyonGEfoodshadillegitimatelyshiftedtheburdenofproof.Butinsteadofadmittingthisobvioustruth,thebiotechnologymanager,JamesMaryanski,engagedindenial.Heargued:“ThestandardsbywhichasubstancemustbedeterminedtobeGRASarebasedonthecasehistoryandthelaw,andsowedidnotchangethatstandardwhatsoever.”ButGoldburgwouldnotlethimgetawaywithit;andshepointedouthowtheFDAhad,inpracticaleffect,changedthestandard.FACtranscript,op.cit.note18,vol.3,138-41.

172Document#15,p.3at:http://biointegrity.org/24-fda-documents.173Ibid.174Ibid.175Parrott,W.,Chassy,B.M.,“Isthisstudybelievable?ExamplesfromanimalstudieswithGMfoods,”2009,8.Availableat:

http://agribiotech.info/more-details-on-specific-issues.176Ibid.,6.177Folta,K.,quotedinJohnson,N.,“Foodforbots:Distinguishingthenovelfromtheknee-jerkintheGMOdebate,”Grist,August22,2013:

http://grist.org/food/dodging-argument-bot-crossfire-to-revisit-some-gm-research-controversies/Further,it’sclearFoltawasarguingthattryingtodiscreditthebeliefthatGEfoodsareassafeasnaturallyproducedonesisonaparwith

tryingtodisprovethatgravityexists–andnotwithmerelyattemptingtoreplaceanacceptedtheoryaboutwhatgravityiswithanotherthat’sallegedtoexplainthephenomenonbetter.That’sbecauseofhowheillustratedhispointthat“pro-andanti-GMscience”havedifferentverificationalthresholds.Hestated:“Forexample:TotestthehypothesisthatgravitydoesnotexistonearthIneedsomeelaboratemechanisms,manyreplicates,tonsofmathandnewmodelsofthinkingthatchangeourunderstandingofbasicfundamentalsofnaturalscience.Totestthehypothesisthatgravityexists,Ihavetopushapenciloffofmydesk.Twoverydifferentevidencethresholds.”

17821CFRSec.170.30(b);21CFR170.3(I).WhileI’mawarethatit’simpossibletoproveafoodissafeasconclusivelyasonecanproveamathematicalpropositionistrue,I’memployingtheterms“prove”and“burdenofproof”asunderstoodwithinthecontextoffoodsafetyregulation.AndwithinthecontextofUSlaw,themanufacturerbearstheburdenofproof;andthestandardofproofisclearlydefined:ademonstrationthatthere’sa“reasonablecertainty”theproductwon’tbeharmfulunderitsintendedconditionsofuse.

179MythsandTruths,op.cit.note156,142-144.180Ibid.,143.181Ibid.182Antoniou,Michael,emailcommunication.183InUnitedStatesv.AnArticleofFood,etc.678F.2d735(5thCir.1982),thecourtupheldtheFDA’schargethatasubstancewasnot

GRASbasedonthetestimonyoffivedoctors.AndinUnitedStatesv.SevenCartons...Ferro-Lac,293F.Supp.660,664(S.D.Il.1968),thecourtdeniedGRASstatustoasubstancebasedontheaffidavitsoftwoscientistswhosaidthattheywerenotawareofanystudiesinthe

scientificliteratureshowingitwassafe.(Thisrulingwassubsequentlymodifiedonothergroundsbyanappellatecourt,424F.2d136(7thCir.1970)–groundsthatdidnotaffecttheholdingaboutthesufficiencyoftwoexperts.)

184http://www.ensser.org/increasing-public-information/no-scientificconsensus-on-gmo-safety/.Althoughsomeofthesignatoriesdonothavegraduatedegreesinoneofthedirectlyrelevantlifesciences,alargenumberdo;andtheirnumberismorethansufficienttodefeattheclaimthatconsensusaboutsafetyexistswithintheexpertcommunity.

185Schubert,D.,LettertotheLosAngelesTimes,October28,2012.186Thisstatementassumestherewon’tbeanyhasty,andsuccessful,attemptstoalterthelaws.

11.OverlookedLessonsfromComputerScience1Writingin2002,EvelynFoxKellerobserved:“Computermetaphorshavebeencommonplaceinbiologyforalmosthalfacentury,”Keller,

E.F.,MakingSenseofLife,HarvardUniversityPress,Cambridge,MA(paperbackedition,2003),247.2http://scienceblogs.com/tomorrowstable/2012/09/24/rachel-carsons-dream-of-a-science-based-agriculture-may-come-as-a-surprise-to-

those-who-believe-that-sustainability-and-technology-are-incompatible/3I’memployingtheword“misrepresent”merelytodenotethataninaccuraterepresentationhasbeenconveyed,nottoimplythatthe

inaccuracywaspartofanintentionalefforttomisleadpeople.Inregardtosoftware,IthinktheerroneousstatementsoftheGEproponentshavestemmedfromafailuretofullycomprehendthefacts,notfromadesiretoobfuscatethem.

4Thisexamplecomesfrom:http://en.wikipedia.org/wiki/Data_(computing)5http://en.wikipedia.org/wiki/Computer_programming6Aprevalentformofsuchprogrammingistermedobject-orienteddesign.7Althoughsomeprogramsarenotcommand-basedimperativecodesandinsteadspecifyoutcomeswithoutdictatingthediscretesteps

throughwhichthey’retobeattained(andarethuscalleddeclarativecodes),theprogrammersstillaimtoachievepredictableoutcomesthatfollowlinearlyfromtheinitialspecifications.

8Foronediscussionofraviolicode,see:http://www.techopedia.com/definition/26876/ravioli-code.Anotheralternative,inwhichtheprogramissomewhatlayered,iscalledlasagnacode.

9Strohman,Richard,“TheComingKuhnianRevolutioninBiology,”NatureBiotechnology15,March1997.10Ibid.,197.11Ibid.,199.12Ibid.,197.13Strohman,Richard,“BeyondGeneticDeterminism:TowardaNewParadigmofLife,”PressingTimes,Spring2002:

http://www.mindfully.org/GE/GE4/Beyond-Genetic-Determinism-Apr02.htm14Keller,E.F.,TheCenturyoftheGene(HarvardUniversityPress,Cambridge,MA,2000),100.15Ibid.16Ibid.,100-01.17Ibid.,101.18Ibid.,162,n.52.19Strohman,“TheComingKuhnianRevolution,”op.cit.note9,194.20Evenwhenonesegmentofcodesometimesactsasaninstructionandsometimesservesasdata,theroleit’splayingisclearinanygiven

instance.21Conrad,Michael,“TheImportanceofMolecularHierarchyinInformationProcessing,”inTowardsaTheoreticalBiology4:ESSAYS,

Waddington,C.H.,ed.(Chicago:Aldine-Atherton,Inc.,1972),222-28.Thequotedtextisonp.224.22Ibid.,225.23Ibid.,226.24Whitehouse,D.,“ScientistsHailNew‘MapofLife’”:http://news.bbc.co.uk/go/pr/fr/-/2/hi/science/nature/3223318.stm25Aminorityofthepromotersarealwaysinanopen,receptivestate.Theywillbediscussedabitlater.26Yuh,Chiou-HwaandDavidson,E.H.,“Modularcis-RegulatoryOrganizationofEndo16,”Development12(1996):1069-82.27Yuh,Chiou-Hwaetal.,“Genomiccis-RegulatoryLogic:ExperimentalandComputationalAnalysisofaSeaUrchinGene,”Science279

(1998):1896-1902.28Yuh,Chiou-Hwaetal.,“Cis-RegulatoryLogicintheEndo16Gene:SwitchingfromaSpecificationtoaDifferentiationModeofControl,”

Development128(2001):617-29.29Wray,G.A.,“PromoterLogic,”Science279(1998):1872.30Keller,MakingSenseofLife,op.cit.note1above,338-9,n.12.31Ibid.,339.32Wray,op.cit.note29,1871.33Ibid.,1872.34Infact,theknowledgeregardingplantpromotersmaybeevenmoredeficientthaninthecaseofanimalpromoters.Accordingto

molecularbiologistAllisonWilson,greaterresourceshavebeenexpendedonthestudyofthelatter.35https://www.owasp.org/index.php/Race_Conditions36Lehman,M.M.,“Program,Life-CyclesandtheLawsofSoftwareEvolution,”InProceedingsofIEEE68(9)(1980):1060-76;Lientz,

B.,E.Swanson.,SoftwareMaintenanceManagement(AddisonWesley,Reading,MA,1980).37Schach,R.,SoftwareEngineering,FourthEdition(McGraw-Hill,Boston,MA,1999),11.

3821CFRParts807,81439IEC6230440Thisstatementpertainstosafetytesting;anditdescribesthesituationaccordingtothestandpointoftheFDA.Iftheinsertedcassette

producesapesticidalprotein,thentheEPAhasauthoritytoregulateit,butithasrarelyrequiredmeaningfulsafetytestingofsuchsubstanceseither.See,e.g.,Marden,E.,“RiskandRegulation:U.S.RegulatoryPolicyonGeneticallyModifiedFoodandAgriculture,”44B.C.L.Rev.733.

41Forinstance,FDAregulationsstatethatinthecaseof“highriskdevicesthatposeasignificantriskofillnessorinjury”(ClassIIIdevices)safetyclaimsmustbesupportedby“thesubmissionofclinicaldata”(21CFRPart814).Extensivenon-clinicaldataisalsorequired.Incontrast,devicesthatentaillowerrisk(ClassII)cangainapprovalbyestablishingthatthey’resubstantiallyequivalentwithspecifictypesoflegallymarketeddevices(CFRPart807SubpartE).Andsomeoftheleastrisky(ClassI)don’tevenrequirepre-marketnotification:http://www.millerassociates.net/files/SW_Risk_Mgmt_Arch.gif.However,accordingtoTomMiller,whosecompany(MillerAssociates,Inc.)performsqualityassuranceforsoftwareusedinmedical

devices,the‘substantialequivalence’routedoesn’teliminatetheneedfortesting,andtosatisfyFDAstandards,thesoftwareinClassIIdevicesmustundergo“significanttesting,”albeitnotasstringentasforClassIII(emailcommunication).MarkRainbow,asoftwareengineerwhoworksforamedicaldevicecompany,concurs,statingthatwhensubstantialequivalenceisclaimed,“theFDAstillrequiresfulltestingofthedeviceoperationsandcompletereviewsofthedesignandananalysisofpotentialhazard”(emailcommunication).Further,theinternationalstandardforthetestingoflife-criticalsoftware,whichtheFDArecommendsbutdoesnotformallyrequire,iseven

stricterthanthestandardimposedbythelatter.AflowchartontheMillerAssociateswebsiteprovidesinsightintothethoroughnesswithwhichsoftwareisassessedandtestedinordertosatisfythisstandardenforcedintheEUnationsandothercountries–andprovidesaglaringcontrastbetweenthetoughnessthesenationsexhibitinthecaseoflife-criticalsoftwareandthelaxnesstheydisplaywhenitcomestoGEfoods:http://www.millerassociates.net/files/SW_Risk_Mgmt_Arch.gif.

42ThispresumptionismadebytheFDAinregardtothesafetyofGEcrops.TheagencysetsGEanimalsinadifferentcategory.43BecauseamuchgreaterpercentageofthepopulationconsumeaparticularvarietyofGEfoodthanrelyonaparticulartypeof

pacemakerorareexposedtoaspecifickindofX-raymachine,thatfoodcouldcausemuchmoreharmthaneither.44Asdiscussedinpreviouschapters,mostharmfulalterationstofooddon’tcauseimmediateproblemsbutdodamageincrementally;andso

themajorityofsuchchangesinGEfoodswouldlikelygounnoticedabsentepidemiologicaltesting,especiallyiftheycausecommonailmentssuchascancer.

45E.g.,Michaels,D.,DoubtisTheirProduct:HowIndustry’sAssaultonScienceThreatensYourHealth(OxfordUniversityPress,2008);Barnes,D.E.andBero,L.A.,“Whyreviewarticlesonthehealtheffectsofpassivesmokingreachdifferentconclusions,”JAMA279(1998):1566-70;Lexchin,J.,Bero,L.A.,Djulbegovic,B.,Clark,O.,“Pharmaceuticalindustrysponsorshipandresearchoutcomeandquality:systematicreview,”BrMedJ.326(2003):1167;doi:10.1136/bmj.326.7400.1167;Lexchin,J.,“Thosewhohavethegoldmaketheevidence:Howthepharmaceuticalindustrybiasestheoutcomesofclinicaltrialsofmedications,”SciEngEthics(2011);doi:10.1007/s11948-011-9265-3;Bekelman,J.E.,Li,Y.,Gross,C.P.,“Scopeandimpactoffinancialconflictsofinterestinbiomedicalresearch:asystematicreview,”JAMA289(2003):454-65.

46Diels,J.etal.,“Associationoffinancialorprofessionalconflictofinteresttoresearchoutcomesonhealthrisksornutritionalassessmentstudiesofgeneticallymodifiedproducts,”FoodPolicy36(2011):197–203.

47Schach,op.cit.note37.48LarrySeese,quotedinTheRisksDigest9(62),February26,1990.49Gleick,James,“ABugandaCrash,”NewYorkTimesMagazine,December1,1996.50QuotedinGleick,above.51AGEfoodwouldonlyposelessriskiftherewasscantlikelihoodthatitsassociatedhazardswouldmanifest–which,inlightofthe

analysisinChapter9,doesnotappeartobethecase.Theissueofriskwillbeexaminedmorethoroughlyasthechaptercontinues.52Leveson,N.,andTurner,C.,“AnInvestigationoftheTherac-25Accidents,”IEEEComputer26(7),July1993,18-41.Thisarticle

describesboththe“impressive”behavioroftheFDAandthelessthanimpressivebehaviorofthemanufacturer,includingstatementsfromFDAofficialscriticalofhowitwithheldevidence.

53PersonalcommunicationfromTomMiller,whosequalificationsaredescribedinnote41above.54Glover,Ann,“Interview”byEurActiv,July24,2012:http://www.euractiv.com/innovation-enterprise/chief-scientifc-adviser-policy-p-

interview-51407455Forinstance,there’sstilldebateabouthowmuchoftheDNAhasafunction,andeventhefunctionsofmanysectionsthatareknownto

befunctionalarenotwellunderstood.Andthegenomesofsomeoftheplantsthatareengineeredhavenotbeenfullysequenced.Moreimportantly,mostcommerciallinesarepoorlycharacterizedonthemolecularlevelandonlyonehasbeenfullysequenced:papaya.Further,eventhoughtheexaminationofthatGMOwasnotrigorousenoughtodetectunintendedmutations(becauseitwasnotcomparedtotheisogenicparentline),ityetrevealedthattheinsertionofnewDNAwasnotrestrictedtothesitefromwhichtheforeigngenefunctionedandthatmanysmallfragmentsofthatgenewerelodgedinotherlocations.

56Althoughhackerssometimesknowthesourcecodeoftheprogramthey’reinvading(asinthecaseofopensourcecode),theyusuallydon’t;andhackingisgenerallyperformedintheabsenceofsuchknowledge.

57Althoughhackersinsertseveraltypesofsequences,whichhavedistinctfunctions,eachalmostalwaysharmsthesoftwaresystemorinjurestheinterestsoftheuser.Accordingly,they’regenerallyreferredtoas“malware,”becausetheyservemaliciouspurposes.Andalthoughaspecificclassofmalwarearereferredtoas“viruses,”allmalwareexhibitssomebasicfeaturesofbiologicalviruses;andthosearethe

featuresdescribedinthemaintext.58Christensen,D.,“BeyondVirtualVaccinations,”ScienceNews,July31,1999(Thewordsthearticlequotedwerethoseofanexpertat

IBM,SteveR.White).59Brown,Patrick,“ThePromiseofPlantBiotechnology–theThreatofGeneticallyModifiedOrganisms,”July2000.Availableat:

http://www.campaignforrealfarming.org/2012/01/the-promise-of-plant-biotechnology-the-threat-of-genetically-modified-organisms/60Althoughtherehavebeenexceptions,suchastheunintendedconsequencesofthe“Morrisworm”releasedin1988.61“DNAasSoftware,”AllThingsConsidered,NationalPublicRadio,April25,2003:http://www.npr.org/templates/story/story.php?

storyId=124432562http://en.wikipedia.org/wiki/Northeast_blackout_of_200363Hagan,N.etal.,“Theredistributionofproteinsulfurintransgenicriceexpressingageneforaforeign,sulfur-richprotein,”PlantJ.34

(2003):1–11.64Regal,P.,“ScientificPrinciplesforEcologicallyBasedRiskAssessmentofTransgenicOrganisms,”MolecularEcology3(1994):5-13

(Thequotedsentencesarefromasectionrelevanttofoodsafetyaswellasecologicalsafety).65Thiscanoccurwhenthetranscriptionprocessstartsatdifferentlocations,withtheresultthatasinglebasecanbepartofonedistinct

three-basecodonononeoccasionandaconstituentofadifferentcodononanother,dependingonwherethetranscriptionofRNAbegins.Inconsequence,adiscretesegmentofDNAcanparticipateingeneratingdiversesegmentsofRNA.However,althoughasegmentofDNAcanbetranscribedviaalternate,overlappingreadingframes,theaminoacidcodeitselfisnonoverlapping,whichmeansthat(barringerrors)asinglereadingframeisalwaysdirectlytranscribedintothesameRNAsequence(whichcansubsequentlybealteredviaalternatesplicing).

66Segal,E.etal.,“AGenomicCodeforNucleosomePositioning,”Nature442(August17,2006):772-78.Theword“superimposed”wasemployedbythejournalistwhoreportedthediscoveryintheNewYorkTimes:Wade,N.,“ScientistsSayThey’veFoundaCodeBeyondGeneticsinDNA,”NewYorkTimes,July25,2006:http://www.nytimes.com/2006/07/25/science/25dna.html

67Weatheritt,R.andBabu,M.,“TheHiddenCodesthatShapeProteinEvolution,”Science13:342(6164)(December2013):1325-26.Theauthorsrefertothecodesas“regulatory.”

68Stergachis,A.etal.,“ExonicTranscriptionFactorBindingDirectsCodonChoiceandAffectsProteinEvolution,”Science342(6164)(December13,2013):1367-72.

69“ScientistsDiscoverDoubleMeaninginGeneticCode,”PressRelease,UniversityofWashingtonDecember12,2013:http://www.washington.edu/news/2013/12/12/scientists-discover-double-meaning-in-genetic-code/

70However,sincethestatementappearedinapressrelease,itmaymerelyreflectthedesireoftheuniversity’spublicrelationsdepartmenttohypetheimportanceofthediscovery.Inanyevent,theresilienceofingrainedpresumptionstonewevidenceisawell-recognizedphenomenonwithinthebiologicalsciences,especiallyasregardsthepresumptionsonwhichtheGEventurerelies.

71Emailtoagroupofconcernedscientists,December14,2013.72BarbaraA.Caulfield,executivevicepresidentofAffymetrix,Inc.,quotedinCaruso,D.,“AChallengetoGeneTherapy,aTougherLook

atBiotech,”NewYorkTimes,July1,2007.73Wilson,Stephen,“We’reNotReadyforGeneticEngineering,”January15,2011:http://lockstep.com.au/blog/2011/01/15/not-ready-for-gm74Ibid.UpdateofSeptember2012.75Ibid.ReplytoareadercommentonSeptember11,2012.76Dawkins,Richard,“WhyPrinceCharlesisSoWrong,”LondonTimes,January28,2003.77TheprofessorshipwasendowedbyCharlesSimonyi,whooversawthedevelopmentofMicrosoft’ssuiteofOfficeapplications.78Gates,Bill,TheRoadAhead,Penguin1996,228.AlthoughGateswasreferringspecificallytohumanDNA,it’sreasonabletopresume

thathewouldapplyhiscommenttotheDNAofotherorganisms;andit’sdoubtfulhethinkshumanshavecreatedsoftwaremoreadvancedthantheinformationsystemsofplantsandanimals.

79InhisspeechattheWorldFoodPrizeeventonOctober15,2009hestated:“Insomeofourgrants,weincludetransgenicapproachesbecausewebelievetheycanhelpaddressfarmers’challengesfasterandmoreefficientlythanconventionalbreedingalone.Ofcourse,thesetechnologiesmustbesubjecttorigorousscientificreviewtoensuretheyaresafeandeffective.”Andit’sevidenthebelievesthatadequatetestingisregularlyperformedorreadilycanbe.Otherwise,hewouldhaverefrainedfromputtingsomuchmoneyintodevelopingGEcrops–orattheleastpostponedituntilafterhehadfundedprojectstodevelopatestingregimebettersuitedtoatechnologythat’salteringtheworld’smostcomplexinformationsystems.Moreover,asthemaintextobserves,ifhecarefullyconsideredbioengineeringinlightofwhat’sknownaboutsoftwareengineering,hewouldnotfunditatallandwouldexclusivelyfostersounderformsoffoodproduction.

12.UnfoundedFoundationalAssumptions1“ElementsofPrecaution:RecommendationsfortheRegulationofFoodBiotechnologyinCanada,”TheRoyalSocietyofCanada(January

2001):184.2Caruso,Denise,“AChallengetoGeneTheory,aTougherLookatBiotech,”NewYorkTimes,July1,2007:

http://www.nytimes.com/2007/07/01/business/yourmoney/01frame.html?pagewanted=1&_r=2&ref=yourmoney&3Bernardi,Giorgio,“TheRoleofChanceinEvolution,”inScientificInsightsintotheEvolutionoftheUniverseandofLife,Pontifical

AcademyofSciences,Acta20(2009):233.www.pas.va/content/dam/accademia/pdf/acta20/acta20-bernardi.pdf4Hurst,Laurence,D.etal.,“TheEvolutionaryDynamicsofEukaryoticGeneOrder,”NatureReviewsGenetics,5(2004):299-310.This

paperstatedthat“geneorderhastypicallybeenassumedtoberandom.”Thisassumptionpertainedtoorganismswithcellularnucleibutnotbacteria,whichwereknowntocontainstructures(calledoperons)inwhichseveralgenesaregroupedtogetherunderthecontrolofasinglepromoter.

5Bernardi,op.cit.note3,233.6Ibid.7Hurst,op.cit.note4,308.8MichaelAntoniou,TestimonytoNewZealandRoyalCommissiononGeneticModification.9EmailfromMichaelAntoniou.TheUKGMScienceReviewPanelsatfortwosessions.Antoniouwasamemberofthesecondpanel.10Althoughtheword“organic”hasseveraldenotations,animportantonereferstoasystematicinterconnectionofpartssuggestiveofthe

structuredisplayedbylivingorganisms.11InstituteofFoodTechnologists,IFTExpertReportonBiotechnologyandFoods,2000,17.12Schubert,D.,“ADifferentPerspectiveonGMFood,”NatureBiotechnology20(October2002):969.13Beachy,R.etal.,LettertotheEditor,NatureBiotechnology20(December2002):1195.14Ibid.15Forinstance,anarticlepublishedin2012bysixscientistswhoadvocateGEfoodscontraststheallegedlyprecisemodificationsmade

throughbioengineeringwiththe“randomgeneticmodificationsthatoccurinconventionalbreeding.”Weber,Natalieetal.,“CropGenomePlasticityandItsRelevancetoFoodandFeedSafetyofGeneticallyEngineeredBreedingStacks,”PlantPhysiology160(December2012):1842.

16NationalResearchCouncilandInstituteofMedicineoftheNationalAcademies(NAS),“SafetyofGeneticallyEngineeredFoods:ApproachestoAssessingUnintendedHealthEffects”(WashingtonD.C.:TheNationalAcademiesPress,2004),46.

17Whensexualbreedingdoesintroducenewrisk,it’susuallybecauseawildandweedyrelativethatis,itself,notwholesomeforhumanshasbeencrossedwithadomesticatedvariety.Sothecasesrequiringcautionareordinarilyknown.Further,insuchcasestheharmfulsubstanceisusuallyatoxinoranti-nutritivefactorthatalreadyexistswithinthespecies,that’spresentinhigherconcentrationinthewildvarieties,andthatgetsexpressedinthehybridatgreaterlevelsthanisnormalforthecultivatedvarieties.Consequently,it’seasiertoscreenforsuchrisksbecausebreedersknowwhatsubstancetomonitor.

18AllofthesedefectshavebeenthoroughlydiscussedinChapter9.Moreover,(asalsodiscussedinthatchapter),mostengineeredplantsmustundergosubstantialbackcrossingtoo,and(asChapter5noted)theaverageGEcroptakeslongertodevelopthantraditionallybredonesand,forseveralreasons,entailsmuchhighercost.Consequently,there’snotrade-offbetweenincreasedriskandreducedcost.Instead,risksandcostsarebothincreased.

19Pollack,Andrew,“PanelSeesNoUniqueRiskFromGeneticEngineering,”NewYorkTimes,July28,2004.20Ofcourse,oneofthemainreasonsthatthetestinghasbeeninadequateistheunrealisticbeliefthatverylittledataisneededinorderto

demonstratethataGEfoodissubstantiallyequivalenttoit’snaturallyproducedcounterpart.Sofaithhasbeentoasignificantdegreeresponsibleforthedeficienttesting.

13.TheDevolutionofScientistsintoSpinDoctors1Bronowski,J.,ScienceandHumanValues,(NewYork:Harper&Rowe,1965),28.2Ibid.,46.3Ibid.,25.4Dutton,DianaB.,WorsethantheDisease:PitfallsofMedicalProgress(NewYork:CambridgeUniversityPress,1992),193.5Ibid.6Ibid.,194.7Ibid.,194-95.8Ibid.,195.9Ibid.,193.10Ibid.,195.11Ibid.12AsreportedinLordsoftheHarvest,MonsantospentatleastonebilliondollarsonresearchinvolvingGEplantsbeforeithadproduced

evenonethatwasmarketable.Charles,Dan,LordsoftheHarvest:Biotech,BigMoney,andtheFutureofFood(Cambridge:Perseus,2002),xv.

13WhenIspeakofmodernbiotechnologycorporations,I’mreferringtothosethatemployrDNAtechnology.Andthefirstoneofthese(Genentech)wasnotfoundeduntilApril,1976(bythebiochemistHerbertBoyerandtheventurecapitalistRobertSwanson).Further,ittookafewyearsbeforethatcompanyhaddispelledwidespreaddoubtsabouttheabilityofrDNAtechnologytoproducecommerciallyvaluableproducts,anditdidnotgopublicuntil1980,http://www.gene.com/media/company-information/chronology.Although,asChapter4noted,theCetuscorporation(whichhadbeenfoundedbyscientistsinBerkeley)waspitchingthepromiseofgeneticengineeringtoinvestorsin1975,itdidn’tstartemployingthattechnologyuntilwellafterGenentechgotgoing:http://en.wikipedia.org/wiki/Cetus_Corporation.

14AlthoughMonsantohadbegunresearchonhowtoproduceGEplantsinthelate1970’s,itdidnotactuallyproduceoneuntil1982,anditapparentlydidnotplayasignificantroleinthelobbyingeffortsmountedbythebiotechindustryduringthatdecade.Forinstance,inhercomprehensivestudyofthedevelopmentofUSbiotechnologypolicy,MaryEllenJonesdoesnotmentionanyinvolvementofMonsantountilthe1980’s;andherfirstcitationofaMonsantocommunicationtothegovernmentisaletteritsenttotheNIHsometimebetween1980and1982(Jones,MaryEllen,“PoliticallyCorrectedScience:TheEarlyNegotiationofU.S.AgriculturalBiotechnologyPolicy,”aDoctoralDissertationinScienceandTechnologyStudiesatVirginiaPolytechnicInstitute[1999],n.289,110).Further,theindexofSusanWright’sexhaustivehistoryofthedevelopmentofUSbiotechpolicybetween1972and1982providesonlyonementionofMonsanto:inconnectionwithanagreementitformedwiththeHarvardMedicalSchoolin1974tofundresearchinmedicallyrelatedareasofbiotech(Wright,Susan,MolecularPolitics:DevelopingAmericanandBritishPolicyforGeneticEngineering1972-1982[Chicago:UniversityofChicagoPress,1994]).

15Forinstance,a2003surveybyresearchersatNorthDakotaStateUniversityfoundconsumersrankeduniversityscientistsasthemosttrustworthysourceofinformationaboutGEfoods(alongwiththeUSDepartmentofAgriculture),regardingthemasfarmorereliablethanpublicinterestgroups,and,duetothetechnicalnatureoftheissue,eventheclergy.Wachenheim,C.J.andW.D.Lesch,“NorthDakotaShoppersPerceptionsofGeneticallyModifiedOrganismsandFood:ResultsofaWinter2003Survey,”DepartmentofAgribusinessandAppliedEconomics,NorthDakotaStateUniversity,Agribusiness&AppliedEconomicsReportNo.540,June2004,p.v.(ThisstudyspecificallyaskedforopinionsabouttheUSDAbutnottheFDA.OthershavefoundthatwhenpolledabouttheFDA,consumersplaceitinthetoptierofreliabilityaswell.)Priest,S.H.,andTalbert,J.,“MassMediaandtheUltimateTechnologicalFix:NewspaperCoverageofBiotechnology,”Southwestern

MassCommunicationJournal,10(1),(1994):76-85.16PriestandTalbert(1994),op.cit.note15.17AmericanMedicalAssociation,PolicyStatementonBiotechnologyandtheAmericanAgriculturalIndustry,1990.18Forexample,areportissuedin2012containsseveralmisleadingstatements.(AmericanMedicalAssociation,ReportoftheCouncilon

ScienceandPublicHealth,CSAPHReport2-A-12,2012.)Afewofthemfollow.Onp.2,thereportstates:“Bioengineeredfoodshavebeenconsumedforcloseto20years,andduringthattime,noovertconsequenceson

humanhealthhavebeenreportedand/orsubstantiatedinthepeer-reviewedliterature....However,asmallpotentialforadverseeventsexists.”Butitdoesn’tdocumentthatlastassertion,nordoesitexplainhowitsauthorsarrivedattheconclusionthatthepotentialis“small.”Nordoesitacknowledgethatmanyexpertsthinkthepotentialissignificant.Onp.4thereportdenigratesthePusztaistudy(thatwasexaminedinChapter10)bystatingthat“theexperimentaldesignofthisstudyis

widelyregardedasflawed,withsubsequentstudiesunabletoreproducethefindings.”ButChapter10hasdemonstratedwhyboththeseassertionsaredeceptive.Moreover,theAMAreportgoesontoimplythatwhateverdifferencesmayhavebeenfoundintheratsconsumingtheengineeredpotatoeswerelikelycausedbyconsumptionofthelectinsthatwereexpressedbythetransgene,despitethefactthat(asChapter10hasexplained)thepresenceofthelectinswascontrolledforandcannotexplainthedifferences.Lateronp.4,thereportclaimsthatsafetyassessmentsbasedontheconceptof“substantialequivalence”involve“athoroughcomparison”

betweentheGEcropanditsconventionallybredcounterpart–astatementatoddswiththeopinionofnumerousindependentexperts,includingthepanelthatproducedthe2001reportoftheRoyalSocietyofCanada.

19Mestel,Rosie,“Scientistsdefendsafetyofgeneticallymodifiedfoods,”LosAngelesTimes,October24,2012:

http://www.latimes.com/news/science/la-scigmo-foodsafety-20121025,0,5914417.story?page=220Althoughaminorityoftheplant’sgenesareattachedtopromotersthatinducethemtoexpressinacontinualmanner,thosepromoters

don’tordinarilycompelthelevelofexpressionthattheviralpromotersdo.Moreover,becausethosegenesareessentialtotheplant’sfunction,theirconstantexpressionisharmonizedwiththeoperationsoftheothergenes.Buttheincessantactivityofthealiengenesisnot.

21Forinstance,besidesforcingtheinsertedgenestohyper-expressinanunregulatedmanner,theviralpromotersthatareaffixedtothemcandirectlydisturbthefunctionofsomenativegenes.Moreover,(asChapter6discussed)there’sevidencethattheproteinsexpressedbytheinsertedgenescangainunintendedadd-onsorbecomemisfolded,eitherofwhichposeahealthrisk.

22Finz,Stacy,“BiotechfoodmeasureProp.37onballot,”SanFranciscoChronicle,August15,2012:http://www.sfgate.com/news/article/Biotech-foodmeasure-Prop-37-on-ballot-3788811.php

23ThefirstbacteriumendowedbyhumanswithrecombinantDNAwascreatedin1973,andthefirstGEplantwascreatedin1982(andwaspubliclyannouncedinJanuary1983):TimelineofPlantTissueCultureandSelectedMolecularBiologyEvents,UniversityofFloridaHorticulturalSciencesDepartment.

24IfhehadmerelyintendedtoconveytheideathatGEcropsarejustassafeasnaturallyproducedones,hecouldhavesaidsoinsteadofcallingthem“thesafestcrops.”

25Finz,op.cit.,note22.26https://www.mcdb.ucla.edu/Research/Goldberg/the_seed_institute/Biotech_exploit.pdf27StatementbytheAAASBoardofDirectorsOnLabelingofGeneticallyModifiedFoods,October20,2012:

http://www.aaas.org/sites/default/files/migrate/uploads/AAAS_GM_statement.pdf28http://www.newyorker.com/online/blogs/elements/2014/04/a-civildebate-over-genetically-modified-food.html29Cook,Guy,GeneticallyModifiedLanguage:TheDiscourseofArgumentsforGMCropsandFood,(London:Routledge,2004),2.30http://www.psrast.org/promplantbiot.htm31Dutton,op.cit.note4,195.32QuotedinCharman,K.,“BraveNewNature:SpinningScienceintoGold,”SierraClubMagazine,July/August2001:

http://www.sierraclub.org/sierra/200107/charman.asp33Ibid.34QuotedinIbid.35TheinformationinthisparagraphandtheonethatfollowswasdirectlycommunicatedtomebyElaineIngham.36PhilipJ.Regal,PhD:DeclarationsubmittedtotheUSDistrictCourt,AllianceforBioIntegrityv.Shalala,1998.37ReportedinCharman,K.,op.cit.note32.38EmailfromDavidSchubert.39Ibid.40OneprominentGEdefenderwhoreferstoscientistswithwhomhedisagreesas“outliers”isJonEntine.See:forbes.com

http://www.forbes.com/sites/jonentine/2014/08/14/got-soy-milk-not-consumer-reports-which-throws-science-under-the-bus-in-warning-about-gmo-soy/.

41EuropeanFoodSafetyAuthority(EFSA),“Scientificopinion:Statisticalsignificanceandbiologicalrelevance,”EFSAJ,9(2011):2372.

42Fagan,J.,Antoniou,M.C.,andRobinson,C.,GMOMythsandTruths:AnEvidence-BasedExaminationoftheClaimsMadefortheSafetyandEfficacyofGeneticallyModifiedCrops,2ndEdition,version1.0,(London:EarthOpenSource,2014),137.

43ForadiscussionofthePiltdownfraud,seeBroad,W.andWade,N.,BetrayersoftheTruth:FraudandDeceitintheHallsofScience(NewYork:SimonandSchuster,1982),119-22.

44vanZwanenberg,P.andMillstone,E.“‘MadCowDisease’1980’s–2000:Howreassurancesunderminedprecaution,“inLateLessonsfromEarlyWarnings:ThePrecautionaryPrinciple1896–2000(Luxembourg:EuropeanEnvironmentAgency,2001),161.

45Ibid.46BetrayersoftheTruth,op.cit.note43,191.47Ibid.48Ibid.,189.49Lysenko’sapproachpromisedtoboostyieldsmuchfasterthanalternatives,anditwasbasedontheideathatacquiredcharacteristicscan

bepassedontofuturegenerations,whichdovetailedwiththeMarxistbeliefthatalteringexternalsurroundingscaninduceprofoundinnerchange.

50BetrayersoftheTruth,op.cit.note43,190.51Ibid.,188,191.52AlthoughthefirstGEplantswerenotcreateduntiltheearly1980’s,thedeceptionsperpetratedinordertoadvancethegenetic

engineeringventureingeneralbeganatleastasearlyastheBethesdaConferencein1976andwereforcefullyemployedduringthesummerandfallof1977.AsdiscussedinChapter1,thesedeceptionssetthestageforthelaxregulationofGEfoodsandtheireasyentrytotheUSmarketbecausetheyquashedlegislativeattemptstoestablishsoundregulationofgeneticengineeringandshiftedtheburdenofprooffromthetechnology’sproponentstothosewhothoughtitshouldbesubjecttosuchregulation.

53BetrayersoftheTruth,20.54NinaFedoroffhasalsoallegedtheexistenceofteststhatapparentlyneverhappened.Onpage175ofMendelintheKitchen,shestates

thattheFlavrSavrtomato“wassubjectedto$2million-worthoftestingbytheFDAontopofthetestingdonebyCalgene.”However,Icouldn’tfindaspecificreferenceforthisstatementinthenotepages,andtheFDArecordsprovidenoindicationthatsuchtestingwasundertaken–andinsteadimparttheimpressionthatnonewas.Further,theagencydoesnotordinarilyconducttestsonnewadditivesbutinsteadreviewsthosesubmittedbythemanufacturers.Moreover,BelindaMartineau,whohadextensivefirst-handknowledgeabouttheinteractionbetweentheFDAandCalgene,informedmethattothebestofherunderstanding,theFDAhadnotconductedanytestsonthetomato.

55AlthoughLysenkopropoundedideasaboutinheritancethatwereunsubstantiatedanddubious,itseemsthatheearnestlybelievedthem;anditappearsthathedidnotintentionallymisrepresentwell-establishedbiologicalprocesses.Incontrast,scientist-proponentsofbioengineering(sometimeseveningovernmentagencies)havemisrepresentedfundamentalbiologicalfacts.Forinstance,they’veproffereddeceptivedescriptionsabouthowpromotersoperate,andsomehavedisseminatedmisleadingaccountsofwhatoccursintheprocessofgrafting.

56Khachatourians,GeorgeC.,UniversityofSaskatchewan,writingintheAgBiotechBulletin,February1998.57NuffieldCouncilonBioethics,Theuseofgeneticallymodifiedcropsindevelopingcountries,June2003.58BioengineeringofCrops,WorldBankPanelonTransgenicCrops,1997.59Borlaug,Norman,“FeedingaWorldofTenBillionPeople:TheMiracleAhead,”LectureatDeMontfortUniversity,Leicester,UK,May

6,1997.(IamnotimplyingthatDr.Borlaughasengagedinoradvocateddeception.Thepointisthathisconcernsaresharedbymanyotherscientistswhohavefeltmotivatedtoengageinit.)

60CentralConstr.Co.v.HomeIndemnityCo.,794P.2d595,598(Alaska1990).61Tobeinnocentoffraudinsuchcircumstances,notonlywouldascientisthavehadtolackintenttoconfusepeople,heorshewouldalso

havehadtobeunawarethatthestatementsissuedwereincorrect–or,eveniftechnicallycorrect,werelikelytobemisleading.Whiletheremayhavebeenmorethanafewscientistsinthiscategory,itseemstherehavebeenmanymorewhodonotfitwithinit.

14.NewDirectionsandExpandedHorizons1Comstock,Gary,“EthicsandGeneticallyModifiedFoods,”SCOPEGMFoodControversyForum(July1,2001).2Brown,Patrick,“ThePromiseofPlantBiotechnology–theThreatofGeneticallyModifiedOrganisms,”July2000.Availableat:

http://www.psrast.org/promplantbiot.htm.3Xue,K.,“SyntheticBiology’sNewMenagerie,”HarvardMagazine,September-October,2014.4Ibid.5Ibid.6“FormerPro-GMOScientistSpeaksOutOnTheRealDangersofGeneticallyEngineeredFood,”September24,2014:

http://earthweareone.com/former-pro-gmo-scientist-speaks-out-on-the-real-dangers-of-genetically-engineered-food/7Comstock,op.cit.note1.Heemphasizestheresponsibilityofscientiststoaccuratelycommunicatefactsandsays,“Ifscientistsare

dishonest,untruthful,fraudulent,orexcessivelyself-interested,thefreeflowofaccurateinformationsoessentialtosciencewillbethwarted.”Andheadds,“Thepubliclargelytrustsscientists,andscientistsmustinturnactasgoodstewardsofthistrust.”Accordingly,becauseheneverexpressesdoubtaboutthesoundnessoftheinformationthat’sbeendisseminatedbythescientist-promotersofGEfoods,heapparentlybelievesthatthey’vebeenhonoringtheirobligation–abeliefthat’ssorelymistaken.

8AnotherprominentindividualwhoapparentlyshiftedhispositiononGMOsatleastinpartduetomisapprehensionofthefactsisPeterRaven.AsnotedinChapter2,duringtheearly1980’shesharedtheconcernsofErnstMayrandPhilRegalabouttherisksposedbyenvironmentalreleasesofGMOs,andheassistedinplanningaworkshopatwhichtheseriskscouldbeexamined.However,heeventuallybecamesupportiveoftheGEfoodventure;and,asisthecasewithsomanyofitsscientist-supporters,hehasendorsedclaimsaboutitthatareinaccurate.Forinstance,in2009heparticipatedinastudygroupthatreleasedastatementdescribinggeneticengineeringasthenewestadditionto“alongandseamlesscontinuumofprogressivelymorepreciseandpredictabletechniques”ofplantbreeding.Andthestatementwentontomoregrosslyoverstatethedegreeofprecisionbyassertingthatthegeneticengineeringofaplantis“accompaniedbyapreciseanalysisofthegeneticandphenotypicoutcomes.”Amongitsotherinaccuracies,thestatementalsodeclaredthattheoperationsofgeneticengineering“affectonlyoneorafewgenes.”(Previouschaptershaveshownthatalltheseassertionsaremisalignedwithreality.)Thus,Raven’sassociationwithastatementcontainingsuchflawedassertionsimpliesthathiscurrentpositiononGEfoodsisnotfirmlybasedonthefacts.(Thestatementreferredtois:“TransgenicPlantsforFoodSecurityintheContextofDevelopment,”PASStudyWeek,VaticanCity,15-19May2009,pp.4,9.)

9Taleb,N.etal.,“ThePrecautionaryPrinciple(withApplicationtotheGeneticModificationofOrganisms),ExtremeRiskInitiative–NYUSchoolofEngineeringWorkingPaperSeries,September4,2014:http://nassimtaleb.org/2014/08/precautionary-principle-paper/#.VE2ocRb63mE

10Althoughotherlegalissueswouldberaisedaswell,suchaswhetherthemanufacturershavearightnottobecompelledtospeak,themostcompellingdefensewouldbetodemonstratethattheFDAhasnotmerelyfailedtopreemptthefield(becauseitspolicyisadmittedlyoneofinaction),butthatithasbeendeliberatelymisrepresentingthefactsandwillfullyviolatingafederalstatuteanditsownregulations–andthatthisdelegitimizesitsdeterminationthatGEfoodsdonotrequirelabeling.

11Emailcommunication.12RemarksofWilliamJeffersonClinton,ConferenceoftheBiotechnologyIndustryOrganization,Chicago,Illinois,April11,2006.13Ibid.14Brooks,David,“TheConservativeMind,”NewYorkTimes,September24,2012.15Thus,whenIspeakoftraditionaltheism,IamnotreferringtoabeliefsysteminwhichGodhascreatedthecosmosanditslawsbuthas

notdirectlyplannedforthedevelopmentoflifeandhasinsteadleftwhetherandhowlifewoulddevelopuptotheundirectedinteractionsofnaturallyoccurringphenomena.

16‘TheCaseAgainstGeneticEngineering’byGeorgeWald,inTheRecombinantDNADebate,JacksonandStich(eds.),127-28(reprintedinTheSciences,September/October1976issue).

17Wald,G.,quotedinKimbrell,A.,TheHumanBodyShop:TheEngineeringandMarketingofLife,HarperCollins(1994),159.18http://www.theguardian.com/news/2002/jul/02/guardianobituaries.obituaries19Chargaff,Edwin,HeracliteanFire:SketchesofaLifeBeforeNature,(NewYork:RockefellerUniversityPress,1978).20DeclarationofRabbiAlanGreen,AllianceforBioIntegrityv.Shalala.21AllianceforBioIntegrityv.Shalala,Plaintiffs’SecondAmendedComplaintforDeclaratoryandInjunctiveRelief,Paragraph36.22ConsumersUnion,CommentstoUSFoodandDrugAdministrationonStatementofPolicy:FoodsDerivedFromNewPlantVarieties,

August,1992,2.23Althoughtheseexpertsstatethatwhenthestrictprecautionaryprincipleisemployed,theproponentsofanactivityhavetheburdenof

provingit’ssafe,inthecaseofGMOs,it’sevidentfromtheirdiscussionthattheydonotthinksuchproofcouldbepracticallyaccomplished–especiallyasregardstheriskofirreversibleenvironmentalruin.That’sbecausetheystatethatGMOsshouldbepreemptivelyprohibitedbecausethereisnot“scientificnear-certainty”abouttheirsafety;soaccordingtotheirstandards,anyattemptedproofofsafetywouldneedtoachievesuchnear-certaintytosuffice.Consequently,forpracticalpurposes,theirpositionamountstofullprohibitionoftheseproducts.

24Fagan,J.,Antoniou,M.C.,andRobinson,C.,GMOMythsandTruths:AnEvidence-BasedExaminationoftheClaimsMadefortheSafetyandEfficacyofGeneticallyModifiedCrops,2ndEdition,version1.0,(London:EarthOpenSource,2014),Section5.12.

25Ibid.,284.26Mellon,M,andGurian-Sherman,D.,“Thecost-effectivewaytofeedtheworld,”TheBellinghamHerald,June20,2011.27InternationalAssessmentofAgriculturalKnowledge,ScienceandTechnologyforDevelopment(IAASTD),“Agricultureatacrossroads:

SynthesisreportoftheInternationalAssessmentofAgriculturalKnowledge,Science”and“TechnologyforDevelopment:ASynthesisoftheGlobalandSub-GlobalIAASTDReports”(Washington,DC,USA:IslandPress;2009).

28Lean,G.,“Exposed:ThegreatGMcropsmyth,”TheIndependent,April20,2008.29Sherman,M.,Q&A:HansHerrenon“SustainableAgricultureSolutions,”GMOInside,April9,2014:http://gmoinside.org/q-hans-

herren-sustainable-agriculture-solutions/30Hine,R.,Pretty,J.andTwarog,S.,“OrganicagricultureandfoodsecurityinAfrica,”NewYorkandGeneva:UNEP-UNCTAD

Capacity-BuildingTaskForceonTrade,EnvironmentandDevelopment(2008).Availableat:http://bit.ly/KBCgY031DeSchutter,Olivier,quotedinLeahy,S.,“Africa:Saveclimateanddoublefoodproductionwitheco-farming,”IPSNews,March8,2011:

http://allafrica.com/stories/201103090055.html32DeSchutter,Olivier,quotedin“Eco-farmingcandoublefoodproductionin10years,saysnewUNreport”(pressrelease)United

NationsHumanRightsCouncil,March8,2011:http://bit.ly/Lkfa9U33Drinkwater,L.E.,Wagoner,P.andSarrantonio,M.,“Legume-basedcroppingsystemshavereducedcarbonandnitrogenlosses,”Nature

396,1998,262–65.34RodaleInstitute,“TheFarmingSystemsTrials;Celebrating30years,”2012:http://rodaleinstitute.org/assets/FSTbooklet.pdf35Alteri,Miguel,“Agroecology,SmallFarms,andFoodSovereignty,”MonthlyReview,vol.61,issue3,July/August,2009.36Ikerd,John,“FamilyFarmsofNorthAmerica,”inDeepRoots,(Rome:TheFoodandAgricultureOrganizationoftheUnitedNations,

2014),30-32.37http://www.blackwellreference.com/public/tocnode?id=g9781405184649_yr2012_chunk_g9781405184649136138https://en.wikipedia.org/wiki/Pure_Food_and_Drug_Act

AppendixA1SanLuisObispoMothersforPeacev.U.S.NuclearRegulatoryComm’n,789F.2d26,33(D.C.Cir.1986).2Thecourtshavemadeitclearthat“generalrecognition”isamatteroffact.e.g.UnitedStatesv.4680Pails,725F.2d976,985(5thCir.

1984)3StateFarmMutualAutomobileInsuranceCo.v.Dept.ofTransp.,680F.2d206,220(D.C.Cir.1982).4AmongthecasescitedwereFerro-Lac(discussedinChapter5),NatickPaperboardCorp.v.Weinberger,525F.2d1103(1stCir.

1975)(packaging);U.S.v.ArticlesofFood...Pottery,370F.Supp.371(E.D.Mi.1974)(dinnerware).5Document#7at:http://biointegrity.org/24-fda-documents(A.R.at18960).6Document#19at:http://biointegrity.org/24-fda-documents(A.R.at18196).TheFDA’sdramaticshiftinpolicyisnotedinanarticleinthe

BostonCollegeLawReview.44B.C.L.Rev.7332002-2003at749.7SECv.CheneryCorp.,332U.S.194(1947)at196.8116F.2dat177citingInternationalFabricareInstitutev.U.S.E.P.A.,972F.2d384at389(D.C.Cir.1992).9972F.2d384at390,396,&398.

AppendixB1RoyalSociety,“Geneticallymodifiedplantsforfooduseandhumanhealth–anupdate,”(2002),6.2Ibid.,8.3Ibid.,6.4InstituteofFoodTechnologists,IFTExpertReportonBiotechnologyandFoods,2000.5Page21oftheabovereportstatesthattherisksofGEare“thesameinkind”asthoseoftraditionalbreeding.6Ibid.,15.7Ibid.,17.8Althoughalatersectiononthebenefitsofbioengineeringdidnotetheuseofviralpromoters,itignoredthefacttheyforcehyper

expressionofthegeneaffixedtothemandthusavoidedconfrontingtherelatedsafetyissues.9Ibid.,21.

ACKNOWLEDGEMENTS

I’mespeciallygratefulfortheassistanceofPhilipRegal,whocontributedtothisbookinsomanywaysandwhoseheroicendeavorstoalignthegeneticengineeringventurewithsoundsciencearesointerwovenwiththenarrative.MydeepgratitudealsoextendstoJaneGoodallforsoquicklyappreciatingtheimportanceofthisbookandcontributingsuchanexcellentforeword–andtoRandallTolpinrud,whobroughtittoJane’sattentionandhasassistedinseveralothersignificantways.SpecialthanksarealsoduetoStephenNaylorforenhancingChapter3bylettingmebethefirsttoreportontheimportant(butasyetunpublished)researchthatheandGeraldGleichconductedattheMayoClinic–andfordevotingsomuchtimetoensuretheaccuracyofmyaccount.

I’malsoveryappreciativefortheextensiveassistanceoftheexpertswho,inadditiontoDr.Regal,carefullyreviewedthechapters,mademanyvaluablecomments,andansweredmymanyquestions:DavidSchubert,AllisonWilson,BelindaMartineau,JosephCummins,JoanLevin,JackHeinemann,JohnIkerd,andRichardC.Jennings.AndmanythankstoSusanWright,whothoroughlyreviewedChapter1andanswerednumerousquestionsaboutdetailsofherresearchontheearlyhistoryofgeneticengineering.Anyflawsthatremainaremyresponsibility,nottheirs.

Moreover,myprofoundappreciationgoestoRobertKentforcheerfullyanddiligentlyperformingthecopyeditingandprovidinghelpfuleditorialsuggestions.Hiscontributionhasbeenexemplary.IamadditionallygratefulfortheassistancegivenbyWilliamCrist,CharlesYanofsky,MichaelAntoniou,JohnFagan,ClaireRobinson,MichaelAlbertsen,JonathanLatham,RalphBunker,SteveNolle,MarkRainbow,TomMiller,LarryWeisselberg,GeraldGleich,TaraCook-Littman,KenWalton,DavidFisher,KenRoseboro,BillFreese,Gilles-EricSéralini,SusanBardocz,JudyCarman,JeffreySmith,ElaineIngham,RobertMerritt,DennisMackin,MichaelHansen,PatriciaZambryski,PaulRheingold,SteveMcClaskey,AlexandreaBarogianis,SonjaGobec,RomyDas,ShaneZisman,KurtandBarbaraRauscher,LucySharratt,NoraMylett,GeorgeFoster–andanyoneelsewhoassistedbuthasinadvertentlybeenoverlooked.

Further,Iwanttoexpressdeepestgratitudetomydearwife,Kathryn,whohasalwayswhole-heartedlybelievedinthisbookandgivenit(andme)tendersupportinamultitudeofways.Shewasusuallythefirstpersontoreadandcommentonthechapters,andthroughhersensitiveawareness,thebookhasachievedgreaterclarityandreadability.

ABOUTTHEAUTHOR

StevenM.DrukerisapublicinterestattorneywhoinitiatedalawsuitagainsttheUSFoodandDrugAdministrationthatforcedittodivulgeitsfilesongeneticallyengineeredfoods.Thisrevealedthattheagencyhadcovereduptheextensivewarningsofitsownscientistsabouttheunusualrisksofthesefoods,liedaboutthefacts,andthenusheredtheseproductsontothemarketinviolationofexplicitmandatesoffederalfoodsafetylaw.Inorganizingthesuit,hefoundedtheAllianceforBio-Integrityandassembledanunprecedentedcoalitionofeminentscientistsandreligiousleaderstostandwithitasco-plaintiffs–thefirsttimescientistshadsuedafederaladministrativeagencyonthegroundsthatoneofitspoliciesisscientificallyunsound.

Heisaprominentcommentatorontherisksofgeneticallyengineered(GE)foodsandhasbeenafeaturedspeakeratsymposiaattheBritishHouseofCommonsandtheNationalCongressofBrazilandatpressconferencessponsoredbytheBrazilianMedicalAssociation,theSwedishConsumers’Association,andtheGreenPartymembersoftheEuropeanParliament.

HehasservedonthefoodsafetypanelsatconferencesconductedbytheNationalResearchCouncilandtheFDA;givenlecturesatnumerousuniversities(includingtheBiologicalLaboratoriesatHarvard,TelAvivUniversity,andtheUniversityofCopenhagen);andmetwithgovernmentofficialsworld-wide,includingtheUK’sEnvironmentalMinisterandtheheadsoffoodsafetyforFrance,Ireland,andAustralia.HealsoconferredattheWhiteHouseExecutiveOfficeswithaninteragencytaskforceofPresidentClinton’sCouncilonEnvironmentalQuality.

HisarticlesonGEfoodhaveappearedinseveralrespectedpublications,includingTheCongressionalQuarterlyResearcher,TheParliamentMagazine,andTheFinancialTimes.

Hehasextensiveacademicbackgroundinthehistoryandphilosophyofscienceandinhumandevelopmentandethics.Heco-authoredtheintroductoryandfinalchaptersofHigherStagesofHumanDevelopment,publishedbyOxfordUniversityPress,andwroteachapteronethicaldevelopmentforTranscendenceandMatureThoughtinAdulthood,publishedbyRowmanandLittlefield.

HemajoredinphilosophyattheUniversityofCalifornia,Berkeley,receivedaspecialawardfor“OutstandingAccomplishment”inthatfield,waselectedtoPhiBetaKappainhisjunioryear,andgraduatedwith“GreatDistinctioninGeneralScholarship.”HealsoreceivedhisJurisDoctorfromUCBerkeleyandwaselectedtoboththeCaliforniaLawReviewandtheOrderoftheCoif(thelegalhonorsociety).