BUSINESS AND REGULATORY NEWS

http://biotech.nature.com • APRIL 2002 • VOLUME 20 • nature biotechnology 323

tis, for instance, would be a pharmaceuticalclaim,” he says, and would push the prod-uct under pharmaceutical regulation. “Onthe other hand,” Eggers says, “a claim that aproduct was ‘good for joints’ is acceptablein a food—as long as the claim is not mis-leading.”

To substantiate a claim, manufacturerswill have to produce evidence of their prod-uct’s benefits that is strong enough to with-stand legal challenges from competitors. Theabsence of uniform European regulationscomplicates this picture and, in somerespects, there are direct parallels with theabsence of European rules on advertisingstandards: challenges could be made atnational or local levels, says Eggers, and theoutcome of any given judgement wouldapply only in the territory in which it wasmade. “London might say ‘no’ while Berlinsays ‘yes.’” There is also the additional com-plication, he says, that claims that are toostrongly supported by medical evidencemight also come under threat. A competitorcould argue that a product is so effective thatit should, in fact, fall under pharmaceuticallegislation, with all the burdens that entails.

The other difficulty in Europe, unlike inthe US, is that regulators cannot tell manu-facturers in advance whether any nutraceuti-cal claim will be acceptable. In the US, theFood and Drug Administration (FDA;Rockville, MD) allows a set of “reduced riskof disease” definitions, which at least givesnutraceutical manufacturers a target to aimat. In Europe, the only guidance for foodclaims come from the EU regulation on novelfoods and novel food ingredients, becauseapprovals given under that legislation applyto the label as well as to the product itself.However, Eggers believes that the onerous

In a strongly worded report released in lateFebruary, the members of a committee of the

National Research Council of the US NationalAcademy of Sciences (NAS; Washington, DC)urge the US Department of Agriculture(USDA; Washington, DC) to toughen reviewsof transgenic plants, defer to other federalagencies in cases where environmental assess-ments would be more rigorous, conduct post-market ecological surveillance, and take othersteps to augment scientific inputs into trans-genic plant reviews and to make that processmore transparent to the public.

These along with a series of other findingsand recommendations in the NAS report,

Environmental Effects of Transgenic Plants: TheScope and Adequacy of Regulation, are directedspecifically to officials of the USDA Animaland Plant Health Inspection Service (APHIS).This agency regulates transgenic plants—ini-tially, by reviewing applications fromresearchers and companies seeking to field-test new plant varieties and, subsequently, byapproving petitions to deregulate such plantsand thereby allow their large-scale cultivationand commercialization.

“Our report provides a detailed road mapfor the federal government to follow as itreinforces its assessment of environmentalrisks,” says entomologist Frederic Gould of

North Carolina State University (Raleigh,NC), chair of the NAS committee, whose 11other members also come from US universi-ties. In his preface to the report, Gouldacknowledges the controversial character ofagricultural biotechnology and refers topainstaking efforts by committee membersto reach consensus before issuing their find-ings and recommendations. In doing so, thecommittee also took into account commentsfrom “scientists working on novel planttraits, individuals with special expertise inregulation of transgenic plants, and mem-bers of public interest groups,” as well asresponses to a letter from the committee that“probed for unique perspectives on potentialenvironmental impacts….”

Referring to past APHIS performance onsuch matters, Gould and other committeemembers say that the agency’s treatment oftwo issues—namely, assessments of trans-genic plants engineered to produce pesticideseither for their capacity to harm non-targetorganisms or for the capacity of pests todevelop immunity to the engineered pesti-cides—has been “generally superficial.” Thus,the committee recommends that APHISeither “increase the rigor” of such analyses or“completely defer” to the US EnvironmentalProtection Agency (EPA; Washington DC),which shares in the responsibility for assess-ing these risks.

In recommending to APHIS that its officialsconduct more rigorous risk analyses, the newreport addresses two issues of general impor-tance to this agency (and implicitly other fed-eral agencies that regulate biotechnologyproducts)—one focused on “essential techni-cal information” that is needed for conductingsuch reviews and the other serving “as evi-dence to [members of] the public that thedecision-making agencies are deserving oftheir trust,” Gould points out. Expressingthese concerns apparently aims in part atsquaring this report with earlier NAS studieson transgenic organisms and related topics,including a landmark 1987 report from theacademy stating that the environmental risksassociated with such organisms are “the samein kind” as risks from unmodified organismsor those modified by conventional means.

Another one of those earlier NAS reports“points out that information about theprocess used to produce a genetically modi-fied organism is important in understandingthe characteristics of the end product,” Gouldnotes. Thus, he and other committee mem-bers take care to reinforce those earlier find-ings while also encouraging regulatory agen-cies “to maintain some degree of sensitivity toshifts in cultural values and implicit under-standings that frame the public’s expecta-tions…. Maintaining public confidence in theregulatory system almost certainly requires a

administrative burden and the requirementsfor extended human safety testing will meanthat most manufacturers will avoid exposingtheir products as “novel foods.”

Those involved in establishing the FoodSafety Authority in Dublin, Ireland and theEuropean Food Safety agency (location indispute) have not shown any great interest increating a European single market innutraceuticals. Part of their reluctance maystem from widely differing national attitudesto food regulation within Europe. WhereasScandinavian countries, Germany, andAustria want the onus to be on consumerprotection, countries such as the UK aremore willing to allow valid claims and letconsumers decide for themselves. Eggersbelieves that resolution of nutraceutical reg-ulations in Europe will have to await theconclusion of discussions taking place at aglobal level, under the aegis of the CodexAlimentarius.

John Hodgson, Cambridge, UK

National academy panel urges USDA totoughen reviews of transgenic plants

Werner Badziong believes that the claimsnutraceutical manufacturers establish for theirproducts will allow food manufacturers topromote new product lines containing thoseingredients.

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nature biotechnology • VOLUME 20 • APRIL 2002 • http://biotech.nature.com

BUSINESS AND REGULATORY NEWS

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focus on transgenic crops in addition to anyneed based solely on scientific grounds.”

Whether regulatory officials will imple-ment recommendations calling for height-ened sensitivity remains to be seen, particu-larly when they arrive during a period ofderegulatory fervor. Noting that the NASreport was commissioned in January 2000and that several specific issues it raises are“already addressed,” APHIS official BobbyAcord says that the agency will “thoroughlyreview the report and study its recommenda-tions,” “is currently assessing options formonitoring already commercialized trans-genic plant products,” and also is “consideringwhether it may be appropriate in someinstances for research agencies to gather addi-

The European Union could be facinganother chaotic season involving dis-

putes over the adventitious presence of GMseeds in batches of conventional seeds to besown. While the European Commissionwaits for member states to agree on revi-sions to the seed directives setting clearrules on the matter, European countries arefree to adopt their own approaches toimported seed lots, creating havoc forexporters, seed companies, and farmers.

The EU depends heavily on seedimports—70,000 tons of corn (21% of itsneeds), 15,000 tons of soy (68%), 4,000 tonsof oilseed rape (20%), and 7,000 tons ofcotton (58%) were imported in 2000.Having acknowledged that absolute segre-gation of types of seed is technically impos-sible, the EC is looking to revise currentseed marketing directives, which wereestablished before GM content became acommercial issue.

The Commission has been trying todetermine acceptable levels of GM seeds inbatches of conventional seed since thespring of 2000, when many European coun-tries discovered small amounts of GM seedsin conventional cotton, oilseed rape, andsoybean seeds imported from the US andCanada. The resulting environmentalprotests, seed destruction, and re-exporta-tion or exclusion of seeds from food useprompted most European countries to agreeto an “Interim Action” proposed by the EUScientific Committee on Plants to accept a0.5% threshold and try to coordinate moni-toring and testing of seed batches until theseed directives could be modified.

The EC recently revised this level, takinginto account possible sources of mixing,such as cross-pollination, volunteers (crops

that persist without deliberate cultivation),harvesting, transport, and storage—some ofwhich differ according to the crop. Forexample, in the case of maize, volunteersrarely cause a major problem and control ofcross-pollination is more important; and forvegetative crops, such as potato, volunteersare likely to be the major source of trans-genes in food-chain materials. As a result,the EC has set a 0.3% tolerance for swederape and cotton, 0.5% for tomato, beet,chicory, maize, and potato, and 0.7% for soy;batches containing higher percentages ofGM seed must be labeled as exceeding thethreshold. (These figures have been calculat-ed exactly to meet the 1% threshold estab-lished for food and food ingredients underRegulation 49/2000, to ensure that the finalproducts derived from the harvest will notrequire labeling.)

The EU Standing Committee onAgricultural, Horticultural and ForestrySeeds and Plants (comprising agriculturalrepresentatives of EU member states) dis-

cussed these proposals on February 28. Oneof the biggest concerns is the fate of seedbatches exceeding these thresholds. Severalcountries say it is not enough to simplylabel them as containing GM seed. Theywant an upper threshold set, above whichseeds cannot be sold commercially. Theproblem lies with crops like corn, beet, andcotton that have no precise varietal purityrequirements for commercialization. In thecase of soy, for example, a seed batch mustcomprise at least 99% of a specific varietyin order to be certified; thus if the GM con-tent exceeds 0.7%, then the batch must belabeled (according to adventitious presencerules), but if the GM content exceeds 1%,the batch cannot be sold (according to vari-ety rules). A corn batch containing 10%GM seeds, however, must be labeled asexceeding the 0.5% GM threshold, butcould nonetheless be sold.

Until EU countries reach agreement, theyare left to apply the Interim Action at theirdiscretion. Germany, for instance, has reject-ed it, and tolerance levels for GM seeds nowdiffer from state to state, whereas France hasstarted a self-control system involving anagreement between all links in the chain to“minimize” mixing. Some countries eveninsist on a zero tolerance policy. Austria, forexample, passed a law in January 2002 set-ting a threshold of 0.1% (effectively zero, asit is the limit of current detection methods),and apparently relies on self-certificationfrom seed producers. Although it could bepossible for a country as small as Austria tofind enough GM-free seeds for its needs, it isimpossible for larger countries.

A case in point is Italy, which insists on anunworkable zero tolerance policy despite theimplications for its farming and food indus-tries. In 2001, then Italian agricultural min-ister Alfonso Pecoraro Scanio raised the zerotolerance flag, prompting environmentalcampaigns against imported conventionalcorn and soybeans (Nat. Biotechnol. 19, 603,2001). On December 28, 2001, Italy’s newagricultural minister Gianni Alemanno,before setting an official threshold, commis-sioned the National Agency for SelectedSeeds (overseen by the ministry of agricul-ture) to assess the availability of GM-freeseeds on the market. The survey found thatseed producers were able to declare as GM-free only 14% of corn and 6% of soybeanseeds sold in Italy—not enough for Italianfarmers’ needs. (“GM-free” was not clearlydefined in this study.) Despite these findings,Alemanno has verbally confirmed the zerotolerance threshold but has not actually set itby decree. As a result, monitoring and testingof seed lots is not standardized. The situa-tion is further complicated by the August2000 decree of the Italian government ban-

tional environmental information throughnon-regulatory means.”

Similar iffiness is reflected in commentsfrom the Biotechnology IndustryOrganization (BIO; Washington, DC). “BIOsupports the overall tone and tenor of the NASdocument,” says Michael Phillips, executivedirector for food and agriculture at BIO. But,he adds,“We might not be 100% in agreementon some… recommendations.” He also pointsout that, during more than a decade, APHIShas reviewed and granted more than 30,000field permits “without a single incidence ofinjury to human health or the environment,”calling this a “very good regulatory systemwith an excellent track record.”

Jeffrey L. Fox, Washington, DC

European Union in disarray over GM seeds

While the EC waits for member states to agreeon revisions to the seed directives, Europeancountries are free to adopt their own approachesto imported seeds containing traces of GMOs.

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