Managing Potentially Toxic Substances in Canada - A State of the Debate Report

7/31/2019 Managing Potentially Toxic Substances in Canada- A State of the Debate Report

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M anaging Potent ially

Toxic Substances in

Canada

A St a te of the D ebate Report from

the Nat ional Round Table on the

Env ironm ent and the Econom y


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M a n d a t eM a n d a t e

The Nat ional Round Table on the

Env ironm ent and the Econom y (N RT EE)w as created to play the role of catalyst in

identifying, explaining and promoting, in

all sectors o f Canad ian society and in all

regions o f Canada, princip les a nd

pra ct ices o f susta inable developm ent .

Specifically, the a gency id entifies issues

tha t have both en v ironm enta l andeconom ic im plications, explores these

imp licat ions, and at t emp ts to identify

act io ns that w ill bala nce econom ic

pro sp erity w ith env iro nm en tal

preservat io n.

i


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At th e heart o f the N RTEEs work is acomm itment to improve the quality of econom icand environmental policy development byproviding decision m akers with the inform ationthey need to m ake reasoned choices on a

sustainable future for C anada. The agency seeks tocarry out its mandate by:

advising decision makers and opinion leaderson t he best way to integrate environ m ental andecon om ic considerations into decision m aking;

actively seeking inpu t from stakeholders with avested interest in any particular issue andproviding a neutral meeting ground where theycan work to resolve issues and overcome

barr iers to sustainable developm ent; analysing environmental and economic facts to

identify changes that will enhancesustainability in Canada; and

using the products of research, analysis andnation al con sultation to com e to a con clusionon the state of the debate on the environm entand the economy.

The N RTEEs state of the debate repor ts

synt hesize the results of stakeholder consultationson potential opportunities for sustainabledevelopm ent. They sum m arize the extent ofconsensus and reason s for disagreemen t, reviewthe consequences of action or inaction, andrecommend steps specific stakeholders can take topro m ote sustainability.

Mandate H ea l t h , t h e En v i ro n m en t a n d t h e E co n o m y


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M e m b e r s h i pM e m b e r s h i p

The NRTEE is com posed of a Chair an d

up to 24 dist inguished Canad ians. Theseindivid uals are appointed by the Prime

M inist er as op inion leaders represent ing

a variet y of regions and sect ors of

Cana dia n society including business,

labour, academia , envi ronmenta l

orga niza t ions, and First Nat ions.

Mem bers of the N RT EE m ee t as a ro undtable four t im es a yea r to re v iew and

d iscuss the ongo ing w ork of the agency,

se t p riorit ies, and init ia te new act iv it ies.


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ChairD r. Stuart SmithChairmanENSYN Techno logies Inc.Etobicoke, On tario

Vice-ChairLise LachapellePresident & CEOCanadian Pulp & Paper AssociationMontreal, Quebec

Vice-ChairElizabeth MayExecutive Directo rSierra Club of CanadaOttawa,Ontario

Paul G. AntleVice-PresidentThermal OperationsM-I Drilling FluidsSt. Johns, Newfoundland

Jean BlangerOttawa,Ontario

Lise Brouss eauLa Prairie, Quebec

Patrick CarsonNobleton,Ontario

Do uglas B . DeaconOwn er, Trailside Caf and AdventuresCharlottetown , Prince Edward Island

Terry D uguidChairmanManitoba Clean Environment CommissionWinnipeg, Manitoba

Sam H amad, P.Eng.Vice-President, Indu stryRoche Ltd., Consulting Group

Sainte-Foy, Qu ebecMichael HarcourtSenio r AssociateSustainable Developm ent Research InstituteUniversity of British Colum biaVancouver, British Colum bia

Raymo nd E. IvanyPresidentNova Scotia Com mu nity CollegeHalifax, Nova Scotia

William H. Johnston eMoo se Jaw, Saskatchewan

Cindy Kenny-GildayYellowknife, Nor thwest Territories

Emery P. LeBlancPresidentAlcan Prim ary Metal GroupExecutive Vice-PresidentAlcan Alum inium Lim itedMontreal, Quebec

Patricia M cCunn-Miller

Managing Director

Environ men t an d Regulatory AffairsPanCanadian Petroleum LimitedCalgary, Alberta

Ken O gilvieExecutive Directo rPollution Probe FoundationToronto, Ontario

Jose ph O NeillHanwell, New Bru nswick

Florence RobartPointe-du- Chne, New Brunswick

Angus RossScarborough, Ont ario

Irene SoVice-President & Associate Por tfolio Man agerRBC Do m inion SecuritiesToronto, Ontario

Joh n W iebePresident & CEOGLOBE Foundation of Canadaand President & CEOAsia Pacific Foun dation o f CanadaVancouver, British Colum bia

Judy G. WilliamsPartnerMacKenzie Fujisawa Brewer StevensonVancouver, British Colum bia

Executive Director & CEOD avid J. McGuinty

Membership H ea l t h , t h e En v i ro n m en t a n d t h e E co n o m y

M embers of the N at ional Round Table on the Environment

and the Economy


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D r. Stuart Smith (Co-Chair)Chair, NRTEEChairmanENSYN Techno logies Inc.

Elizabeth May (Co-Chair)Vice-Ch air, NRTEEExecutive Directo rSierra Club of Canada

Patrick CarsonNRTEE MemberNobleton,Ontario

Ken Ogilvie

NRTEE MemberExecutive Directo rPollution Probe Foundation

Sam H amadNRTEE MemberVice-President, Indu stryRoche Ltd., Consulting Group

Jean BlangerNRTEE MemberOttawa,Ontario

D ouglas DeaconNRTEE Member

Own er, Trailside Caf and Adventures

Dr. Do nna MerglerDirector, CINBIOSEUniversit du Qu bec Mont ral

Dr. Will iam RossActing DirectorBureau of Biostatistics and Co m puter ApplicationsHealth Canada

Rod RaphaelDirector GeneralEnvironmental Health DirectorateHealth Protection BranchHealth Canada

Dr. D avid McKeownMedical Officer of HealthRegion of Peel

Claude-Andr LachanceDirector, Govern m ent AffairsDow Chemical

Dr. Alan AbelsohnCollege of Family Physicians

D r. Sheila ForsythForsyth Consulting Essentials

D iane Carroll

Director GeneralStrategic Direction and Policy Coordinat ionEnvironment Canada

Task ForceH ea l t h , t h e En v i ro n m en t a n d t h e Eco n o m y

Program on Health, Environment and the Economy

Task Force


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Foreword

1 . In tro d u ct io n .............................................................................................................................................1How the work was carried out .....................................................................................................3Com missioner docum ents reduced resources ....................................................................3Four real-life case studies ................................................................................................................4How the current regulatory system works ............................................................................4Stakeholders express clear concerns ..........................................................................................5Integrating health and environmental issues .......................................................................6Need for greater capacity to create and m anage scientific inform ation ..............7

Tran sparency in d ecision m aking ...............................................................................................8In con clusion ........................................................................................................................................10

2 . Final Recom mendat ions ............................................................................................................11

3 . Ap pe nd ix 1 ..............................................................................................................................................17A. Lindane Case Study ..................................................................................................................19B. Reducing Sulphur in Gasoline and Diesel Fuel Case Study ..............................33C. Methylcyclopen tadienyl Man ganese Tricarbon yl (M MT ) Case Stud y .......51D. Revalor-H Case Study .............................................................................................................69

4 . Ap pe nd ix 2 ..............................................................................................................................................83NRTEEs Health, Environ m ent and th e Econ om y WorkshopParticipants List

ContentsH ea l t h , t h e En v i ro n m en t a n d t h e Eco n o m y

Table of Contents


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Foreword

The Nation al Rou nd Table on t he Environm ent an d th e Econom y (NRTEE) established its program

on Health, Environm ent an d th e Econom y to investigate how governm ent assesses chem ical

substances and h ow it makes decisions about th eir use. The program included the exam ination of

four case studies, and con sultation with stakeholders.

As Chair of the NRTEE, I am p leased to introdu ce this report, which p resents 11 recom m endations

aimed at im proving the decision m aking that pro tects Canad ians from dangerou s chem icals in air,

water, soil and food.

Stuart L. Smith, M.D.

Chair, NRTEE


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I n t r o d u c t i o nI n t r o d u c t i o n

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Introduction

Cana dia ns are increasingly concerned

about the hea lt h im pact s of chem ica l

subst ances in the env iro nm ent . Yet they

st ill w ant the econom ic b enefi t s of new

chem ica ls, m ateria ls and m ed icines.


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In 1998, the National Roun d Table on theEnvironm ent and the Econom y (NRTEE) began amultistakeholder process to investigate howgovernment assesses chemical substances and howit makes decisions about th eir use. This report

docum ents the results of that work, presenting 11recom m endations aimed at imp roving thedecision-m aking pro cesses designed to prot ectCanadians from health impacts that could resultfrom contact with d angerous chem icals in air,water, soil and food.

A key finding of the report, based on strongstakeholder input, is that m any problems in thedecision-m aking process stem from reducedgovernment capacity to assess substances.

Com poun ding the im pacts of funding cuts areadvances in scientific un derstandin g of howsubstances in the environm ent affect hum anhealth. These developm ents often point to theneed for more comp lexand h ence m oreresource-intensiveassessm ent procedu res.

For example, while cancer has historically been th efocus of assessment s, recent research suggests thatsignificant, no n- cancer health impacts can arisefrom lon g-term , low-level exposure to a m ix of

substances. Govern m ents are therefore tr ying todeterm ine whether the current scope of theirresearch and regulatory activities is appropriate.

This repor t also h ighlights the n eed to increasepu blic con fidence in the regulatory p rocess byencouraging greater government openness andpu blic involvemen t.

How the work was carried outTo study govern m ent decision-m aking pro cesses,

the NRTEE created a Task Force on Health,Environm ent and the Econom y that includedm embers of the NRTEE and a variety of expertsand stakeholders. The work p roceeded as follows:

First, the Task Force con du cted four case studiesinto how the government made decisions withrespect to four chem ical substances. It thenanalysed these studies.

Second, the Task Force shared the results of thecase-study analysis at a stakeholder workshop heldin January 2000. The participants, who weredrawn from across Canada, were urged to be frankabou t their d ifferences.

Third, the Task Force examined the experiences ofother jurisdictions.

Finally , the Task Force and all NRTEE mem bersdebated and approved specific recommendationsfor change in the way governm ent m akesdecisions abou t p otentially hazardous substan cesand their use.

Commissioner documents reduced resourcesA few weeks after the NRTEE decided to focus ongovernm ent decision m aking, the Com missionerof the Environm ent and Sustainable Developm ent(the Environment Commissioner) released hisannual report. Part of it reviewed an audit of theway govern m ent han dles toxic sub stances andconcluded that there was a growing gap b etweenthe demands placed on [federal] departments toprovide scientific inform ation on toxic substan cesand their ability to m eet existing obligation s andrespond to emerging issues.1

The Com m ission er also no ted that reassessmentof existing sub stances falling und er the CanadianEnvironm ental Protection A ctand the Pest ControlProducts Actlagged far behind their m and atedschedu le. Within existing bu dgets, he said,departm ents are stru ggling to m eet legislatedresponsibilities, policy comm itm ents andinternational treaty obligations and, in m anycases, are failing to do so.2

Between 1994 and 1998, four science-baseddepartm entsEnvironment Canada, Fisheriesand O ceans Canada, Health Canada and NaturalResources Canada reduced th eir personn el by 17percent.3 The n egative repercussion s of these cutswere clearly expressed by scient ists interviewed b ythe Commissioner,4 as well as by stakeholder sconsulted by the NRTEE in th e mo nth s before andafter the Commissioners report was released.

IntroductionH ea l t h , t h e En v i ro n m en t a n d t h e Eco n o m y


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Introduction H ea l t h , t h e En v i ro n m en t a n d t h e E co n o m y

Four real-life case studiesAs m ention ed, the N RTEE Task Force used a case-study approach to examine decision-makingpro cesses sur rou nd ing substance assessment andm anagem ent. This approach enabled the Task

Force to focus on real-life situation s rather thantheoretical frameworks.

Recognizing that it is difficult for four case studiesto cover the full spectrum of decision-m akingpro cesses, the Task Force took care to cho oserepresentative sub stances that would providebroad insights into h ow governm ent t ypicallym akes decisions abou t po tentially hazardoussubstances.

Lindane. Registered in Canad a 60 years ago, thispesticide has been identified as a persistentorganic pollutant (POP) and found in significantlevels in n or thern peoples. This case studyexam ined th e regulator y respon ses to theidentification of lind ane as a POP an d to th e U.S.policy of preventing the im portation from Can adaof canola seed treated with lindan e.

The case study also looked at the stakeholderissues surrou nd ing the negotiation of Canadas

international position on the use of lindan e. Itrevealed h ow stakeholders both out side and insidegovernm ent ( part icularly Abor iginal group s) werefrustrated at being unable to obtain the risk andhealth assessment d ata used to determ inelind anes safety. (Because of its propr ietary nature,this information was exempted from publicrelease un der th eAccess to In form at ion Act.)

Sulphur in gasoline. This case study exploredhow new regulations for sulphur levels in gasolinewere developed th rough th e use of an expert paneland extensive stakeholder participation. While thispro cess did no t run comp letely smoo thly, itdemon strated that third-p arty inpu t cancontribute to concrete policies where the science iscomp lex and con troversial. This case stud yillustrated a decision- m aking pro cess thatattempted to ensure its own transparency andaccess to r elevant data.

M M T. The MMT case study com pared theAmerican and Canadian procedures used todeterm ine the management of this octane-enhancing fuel additive. Part of the case studyfocused o n the Can adian govern m ents decision to

use trade legislation to cont rol the use of MM T.The study docum ents how this decision was m adewithout th e use of a clear-cut process and withoutinform ing stakeholders about h ow the decisionwas made or how information was used.

Revalor-H . This case study investigated th eappro val process for the Revalor-H beef growthpro m oter, as well as comm un ication issues linkedto th e veterinary dr ugs approvals process. It alsoexam ined th e dispu te between th e Euro pean

Union and Canada over six other beef growthprom oters used by the beef industry in Nor thAm erica. The approval of veterinary dru gs such asRevalor-H is regulated by a well-defined process,but on ce again o utsiders fou nd it difficult to getbasic inform ation on the status of the drugs underreview. The inform ation u sed for the assessmentwas practically inaccessible to those outside thedecision- m aking p rocess.

How the current regulatory system w orksNine p ieces of federal legislation apply to t oxicsubstances in Canad a. New and existingsubstances are pr imar ily regulated by th eCanadian Environmental Protection Act(CEPA),th e Food an d D rugs Act(FDA), the Pest ControlProducts Act(PCPA), theH az ard ou s Products A ct,th e Ferti lizers Act, t he Fisheries Actand the Feeds Act.

Enacted in 1988, revised in 1999, and adm inisteredjoin tly by Environm en t Canad a and Healt hCanad a, CEPA deals with toxic substan ces notregulated un der any oth er piece of federallegislation . The appro ach the governm ent usesun der the current version of CEPA sets out twotracks for the man agem ent of toxic substances:

virtual elimination from the environment oftoxic substances that r esult from hu m anactivity and that are p ersistent and bio-accumulative;


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be based on greater scientific capacity ingovernm ent so as to provide balanced, credibleinput to policy- and decision-makingprocesses.

Participants pointed to several key areas forchange based on the case stud ies and discussion :

1. integration of health and environmental issues;

2. capacity for creating, processing and m anagingscientific inform ation;

3. transparency of decision making.

Starting from these areas of convergence, theNRTEE identified specific recomm endation s to

improve health and environmental decision-m aking processes. These recomm endation s are setout at the end of this report.

Integrating health and environmental issuesOn the basis of the four case studies, workshoppar ticipan ts identified a consistent an d seriouslack of integration of health and environm entalissues in policy making.

The studies showed how the policies of on e

departm ent could contradict the findings ofanot her, as seemed to be the case for M MT.Another case study demonstrated how one branchof governm ent could identify potential dangers ofa persistent organic pollutant like lindane yet failto tr igger an im m ediate response by theresponsible regulatory agency.

The Environment Commissioners 1999 report(referred to abo ve) h ad also d etected tensionswithin various governm ent departm ents and warned

of a silo effectthat is, departm ents and agenciesviewing issues from their perspective alone.

In contrast to Canada, the United States has am ore centr alized system . The U.S. Environm entalProtection Agency (EPA), for exam ple, ism andated to act as a watchdog for bo th th eenvironm ent and hum an health. The U.S. systemembraces independent institutions such as the

National Academy of Sciences, the highly regardedAtlan ta Toxic Substan ces Disease Registr y, asuperfund to clean up environm ental disastersand programs to evaluate the impact ofenvironm ental factors on childrens health.

Addressing horizontal issuesThe silo effect n oted in the Environm entCommissioners report makes it difficult forgovernm ent to address issues that cu t acrossdisciplinary bo un daries and departm entalm andates. Environm ent ministers from the G7countries, plus Russia, signed a Declara tion onChildrens Environm ental H ealth in May 1997. Thedeclaration acknowledged the n eed to consider thespecial physiological and social needs of children

in ord er to pro tect them from hazards such as airpollution, lead exposure, un safe drinking waterand tobacco smoke.

Health Can ada and Environment Canada havesince investigated their risk-assessment/m anagem ent plans and pinpointed areas needingattention. Better collaboration amon g federaldepart m ents on childrens environm ental healthwas the topic of a recent interdepartmentalm eeting in O ttawa. However, a lack of resources

has hind ered pro gress on the childrens environ -mental health agenda across the departmentspart icipating in the interdepar tm ental initiative.As a result, efforts to better address the un iquevulnerabilities of children to environm entalhazards (e.g., substance assessm ent an dmanagement) may require additional resourcesbefore significant p rogress is realized.

Harmonizing assessmentsThe need for more scientific capacity was a

recurr ing them e raised by the four case studiesand t he workshop participants. Participantspoin ted to d elays in con du cting regularreassessmen ts of substan ces on CEPAs Dom esticSubstances List and pesticides already registeredunder the PCPA.

On e solution t o th e assessment backlog is forCanada to do m ore harmo nizing with other


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countries. The Organization for Econom icCooperation and Developm ent (O ECD) isun dertaking several joint efforts to foster th em utual acceptance of data related to th eassessm ent of chemicals. For example, all OECD

m ember countr ies, including Canada, have agreedto accept safety data developed in oth er m emb ercoun tries to supp or t th e risk assessm ent p rocess.As well, there is a series of OECD initiativesdealing with registration, no tification, cooperativeassessment s, and assessment and classification ofbest practices addressing new and existingchemicals and pesticides. These efforts willdeterm ine the extent to which count ries willaccept other nationsassessment information and,poten tially, their regulatory decisions. With regard

to th e assessm ents of veterinar y drugs such asRevalor-H , the Office intern ational desepizooties (OIE) is also initiating adru g harm onization process.

While these harm on ization initiativeswill no t rem ove a coun tr ys author ityto app rove or reject a substance, it ishoped that increased efficiencies willreduce costs for businesses andgovernments.

Canad a is working with th e U.S. EPAto assess high-volume chemicals.Another Canada-U.S. initiative, theFour Corn ers pilot p roject, willexperiment with increased datasharing between both countries to speed upevaluation of new substances. CEPA99 alsoincludes provisions that requ ire Canada tocooperate with oth er OECD coun tries to exchan geinform ation o n p roh ibited or severely restrictedsubstances, or to re-examin e any substance that anOECD country decides to prohibit forenvironmental or health reasons.

Despite these comm endable efforts ofgovernm ents to work together, stakeholdersstressed that worthwhile progress still depends onadequate governm ent fun ding.

For exam ple, concerns were raised th at whileCEPA99 will permit joint work with o therju risdict ions, no resou rces h ave yet been allocated .Moreover, although t he OECD is developing apro tocol to assess endo crine disru pters, this

imp or tant work will on ly advance if stablepro gram fun ding is provided to allow long-termresearch strategies to be developed and expert staffto be retained. A lack of funding could preventCanad a from including the resulting data fromthese harm on ization in itiatives in its nation aldecision m aking.

Need for greater capacity to create and

manage scientific informat ionThe second an d p erhaps most strongly supported

them e to emerge from t he four case stud ies wasgovernments reduced ability togenerate an d m anage scientific datathat support policy development.There is a clear need to increaseresearch capacity out side governm entand knowledge management insidegovernment.

Ou r governm ent is routinely asked tom ake decisions that m ust weigh pu blichealth, environm ental and comm ercialinterests. Science plays a cru cial role inthese decisions but on e that isincreasingly difficult becau se ofbudget constraints, rising pu blic

expectations, globalization, increasing comp lexityof science and n ew techno logies.

Need for increased researchStakeholders expressed significant suppo rt for th e

creation of greater capacity to con du ctenvironm ental health research. The prevailingview suggested th at research on health an denvironm ent be coordinated th rough th e newCanadian Institutes of Health Research (CIHR).Ties to m ajor Nort h American academic centreswould allow for greater collaboration in com plexand expensive fields of research. Multidisciplinar yand cross-disciplinary r epresentation was also

Science play s a crucial rolein t hese decisions but one

that is increasingly difficult

because of budget

constraints, rising public

expectations, globalization,increasing complex ity of

science and new

technologies.


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considered essential, given th e breadth o f theissues.

Re-evaluating existing substancesThe case stud ies illustrated the lack of policymechanisms for revisiting existing substanceswhen new inform ation emerges. This was evidentin th e lindan e case study, which featured asubstance registered decades ago and recentlyidentified as a p ersistent organic po llutan t.

The Environment Commissioners 1999 reportnoted that the Pest Management RegulatoryAgency (PMRA) had no t allocated any fund s for asystem atic re-evaluation of existing pesticides atthe tim e of the study. The report also noted that

the U.S. program spends 25 percent more on re-evaluating pesticides than on registering n ewones.5 Although the PMRA has since received anaddition al $7 m illion allocated over two years, thatwill no t r aise its bud get to comp arable U.S. levels.

New information should require reconsiderationof earlier d ecisions about approvals, standards orthr esholds. CEPA99 addresses the issue of newdata, m aking registran ts responsible forsubm itting significant new data on substances

already in u se. These new data cou ld then tr igger areassessm ent. This clause, however, pertain s on lyto information from bu siness propon ents and n otto that from all sources.

Handling scientific uncertaintyThe M MT an d sulphu r in gasoline cases werecharacterized by scientific issues that were hotlydisputed by the petroleum and au tom otiveindustries. In the sulphur case, the policyimplications of the current state of the science

were assessed by a group that all majorstakeholders foun d credible; this assessment wasthen u sed in developin g new regulations. TheMM T decision-m aking process, in contrast, hadno equivalent m echanism for addr essingcontent ious issues.

The case studies pointed to the n eed to increasethe ability of governm ent to call on o utside help

in reviewing data from diverse sources.Stakeholders agreed that third-party input couldbe effective in m oving the d ebate forward wh enthere is scient ific uncertain ty. Th e Royal Society ofCanad a and th e U.S. National Academy of

Sciences sometimes receive funding for conveningpan el processes that op erate independ ently fromthe funding agency. The panels are made up ofm ultidisciplinar y experts, which increases thelikelihood of reaching imp artial decisions. Otherresources cou ld in clud e u niversities, bu sinessesand non -governm ental organizations. Expertpan els represent an accepted m eans of resolvingconflict in interp reting data.

It was also suggested th at on e way to hand le

inadequate information or scientific uncertaintywould be to grant condition al appro val on ly whenthe benefits to society are potentially great andany concerns minor. This type of conditionalappro val is som etimes given to th e experim entalor controlled use of new drugs.

Con ditions for such approval would include:

early re-review;

limi ted applica tion;

special care in the use and disposition of theproduct.

Transparency in decision makingThe th ird them e identified by workshopparticipants was governments lack oftran sparencyin p articular, its failure tocomm un icate clearly, candidly and regularly, tostakeholders and the pu blic, the governm ents

standard s and p rocedures for d eciding whichsubstances to appr ove, reject or m anage (as in thecase of the regulation of a pollutant).

The four case studies documented how somerepresentatives of both industry andenvironm ental group s were un able to accessneeded information or were frustrated in theirattemp ts. In several instances, they were left in th e


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dark about the process; they were unsure aboutwhat was being assessed, when the assessmentwould take place, or who would participate. Often,it was difficult to gain access to data on substances.

Stakeholders considered th e on goingdissem ination of clear and concise inform ation anessent ial first step in increasing transparen cy. Basicinform ation on all substance appr ovalsshould be rou tinely availablen ot justwhen requested.

More information is becomingavailable. Part of the 1999amendments to CEPA included aprovision for an Environmental

Registr y. The recent ly laun chedRegistr y acts as a sou rce of pu blicinform ation on activities und er CEPA.As well as providing up-to -date copies of curren tCEPA instru m ents, the Registr y will also help thepublic to m onitor p roposed regulations andorders and public consultations.

Other important initiatives include HealthCan adas recently completed H ealt h Can ad aDecision M ak in g Fram ework for Iden tify in g,

Assessing and M an aging R isks to H um an H ealth .This framework incorporates requirements forengaging th e pu blic at every stage of decisionm aking from the identification of the issuethrou gh to assessment, public intervention andfollow-up m onitoring activities. Also, the m andateof Health Can adas new Office of Consum erAffairs and Public Involvement is to increase thedepar tm ents capacity to engage the pu blic on aran ge of health issues, including those related toenvironmental hazards.

The N RTEE believes that all departm ents andagencies sho uld follow established p rocesses whendeciding whether to approve the use of newchemical substan ces and wheth er to rem ove orrestrict the u se of existing chem ical substances.The public should have easy access to informationon the stages of the process, on what substancesare cur rently under review, and o n what stage a

part icular sub stance has reached in t he assessmentprocess.

Examples of successful communicationA review of existing process com m un ication to olssuggested th at govern m ents are pro gressing in thisarea. For exam ple:

The Ontar io Environmental Bill of Rights oversees an electron icdatabasethe Environm entalRegistrythat anyone can access viathe Internet. Certain m inistries mu stinclude p ropo sals on t his Web site forenvironmentally significantinstrum ents such as perm its and

licences. However, some u sers havefound the information un clear,incomplete or h ard to find.

The Canadian Council of Ministers of theEnvironm ent ( CCM E) boasts a progressiveexample of pub lic com mu nication in itsCanad a-wide Stand ards pro cess. The publiccan find a com plete tim etable for thedevelopm ent of these standards on the CCMEWeb site, which includes dates for each step

and stages where pu blic inp ut is invited. Allsubstances un der r eview are listed an d ageneric temp late for the standard d evelopm entprocess is available. Interested par ties can evenregister to receive e-m ail no tice of newdevelopments.

The federal Regulatory Process ManagementStandards (RPM S) p rovide the basis for ageneric temp late that cou ld enable m oreconsistency within and across departm ents and

agencies. Created as a regulator y reform tooland imp lemented in the m id-1990s, the RPMSuse a stand ardized pro cess to describe the keysteps in form ulating regulations that all federalregulatory departm ents follow whendeveloping regulations.

The Canadian Centre for ManagementDevelopm ent is considering pu tting all process

Stakeholders considered theongoing disseminat ion of

clear and concise information

an essential fir st step in

increasing tran sparency.


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F i n a l R e c o m m e n d a t i o n sF i n a l R e c o m m e n d a t i o n s

22

Final RecommendationsTh e NRT EEs program on H ealth,

Env ironm ent and the Econom y add ressed

the fu ll ra nge of governm enta l act iv it ies

tha t involv e decision m aking linked to

the assessm ent and m anagem ent of

subst ances.


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Final RecommendationsH ea l t h , t h e En v i ro n m en t a n d t h e Eco n o m y

Final RecommendationsNote on the recomm endations: The N RTEEsprogram on H ealth, Environment and theEcon om y addressed th e full ran ge ofgovernmental activities that involve decision

making linked to the assessment and managementof substances. In several cases, the ideas presentedin th ese recom m endation s are already beingimplemented, in whole or in part, in somegovernm ent departm ents and agencies. They arenot, however, being implemented across theboard ; the NRTEE believes that th ere rem ainimpor tant gaps that should be add ressed.

1A.The NRTEE recomm ends the creation of a

fed eral gover nm en t-w id e H ea lt h and

Env ir on m en t Sci en t ific A dv isory Com m it teeto sup por t CEPA, the PCPA and ot he r p ieces

of legi sla t io n tha t bea r on the m anagem en t of

subst ances. T hi s co m m it tee, w hi ch w ould

com prise representat iv es from Env ir onm en t

Canada and Health Canada, would:

report annually on the federal governmentscurren t capacity to carr y out legislatedactivities;

provide a research agenda to fulfil thelegislated m and ate m ore effectively;

continuously review existing scientificinform ation to identify emerging issuesrelevant to Canadas system for theman agement of substances;

propose new research relevant to theCanadian situation;

provide a coordinated response on thosesubstances falling u nd er th e jurisdiction ofseveral pieces of legislation.

The com m ittee would report to bo th theMinister of Health and the Minister of theEnvironment.

1B.The N RTEE propo ses that the Privy Cou ncil

Office convene a m eeting of deput y m inisters

tw ice a yea r to fa ci li ta te hi gh-level

com m it m en t to the collabora t io n of fed era l

d ep artm en ts o n he alt h and en v ir onm en tal

issues.

2. T he N RT EE recom m en d s t ha t the gover nm en t

p ro v id e $4 0 m il li on over a p er io d of three

yea rs to fund a st ra teg ic resea rch in it iat iv e on

he alt h and en v ir on m en t w it hin the ex is t ing

Canad ian Institutes of Health Research. The

research init ia t iv e w ould :

fund and link health and environmentresearch within the CIHRs 13 institutes;

create links with other jurisdictions such asthe U.S. National Institute of Environm entalHealth, the U.S. National Academy ofSciences, provincial depart m ents andacademic centres;

nurture the development of a mult i-disciplinary and cross-disciplinary sciencebase.

The research cond ucted by the Institutes m ighttouch on occupational health, but th is wouldnot be a primary focus of its man date.

3. Be ca use the N RT EE bel ie ves tha t the Royal

Societys independ ent exp ert pa nels can

p ro v id e unbiased adv ice to augm en t d ecis io n

m aki ng, it recom m en ds t ha t the se bod ie s p la y

an adv isory ro le to gover nm en t . T he use of

expert pa nels would be based on the following

condit io ns:

The decision to create a new panel shouldbe based on criteria such as high cost

impacts of the propo sed po licy and h ighdegrees of scientific un certaint y.

The panels should include mu lti-disciplinaryand cross-disciplinary repr esentation .

The panels should focus on assessing thecurr ent state of scientific knowledge.


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H ea l t h , t h e En v i ro n m en t a n d t h e E co n o m yFinal Recommendations

Controversial scientific issues should bereferred to t he expert pan el in a tim elyman ner to better inform decision m akers.

4. In ord er to add ress the grow in g cha llen ges a nd

com p lexit ie s t ha t gover nm en t now fa ces w he n

regu la t ing subst ances, the N RT EE

recom m en d s d ra st ica lly increa sing

gover nm en t sci en t if ic ca paci ty to:

better judge the scientific material itreceives, better perform or cont ract for itsown scientific work where n ecessary, andtake into accoun t com plex issues, such asthose associated with taking childrenshealth into account during substance

assessment and regulation ; ensure timely reassessments of substances

according to CEPA and the PCPA;

provide better access to data and processesrelating to the decision-making processes inquestion.

5. T he N RT EE recom m en d s t ha t the subst ance

appro val pro cesses b e ex p anded to a llow

cond it ion s t o be at tached to the appro val of a

subst ance w he n a hi gh degree of uncer tainty is

present . Such an app ro val w ou ld be p ossible

on ly w he n the ben efi ts t o societ y are

pot en t ia lly grea t and the doubts, w hi le

insufficient to deny those benefits, are

imp ortant enough to require:

ear ly review;

limi ted applica tion;

special measures of care in the use anddisposition of the produ ct.

A con ditional appr oval wou ld require a secon dreview when additional data became available,or after a certain am oun t of time had elapsed,whichever cam e earlier.

6. The NRTEE recomm ends that systematic

reassessm en ts o f ex is t ing subst ances take in to

considerat io n new sci en t ific fin d ings from a ll

legitim ate sources. New d ata a re defined as

d ata from legi t im ate sources t ha t m ay

influence an existing substances status.

7. The NRTEE recomm ends increasing the

gover nm en ts ca paci t y to coord in ate w ith

othe r countrie s t he task of reassessing e xis t ing

su bst ances, su ch as t ho se fa ll in g u nder CEPA

and the PCPA, and to jo in t ly p la n and share

sci en t ific d a ta and assessm en ts. Cou nt rie s

w ould follow a joint scientific protocol to

leverage research program s and find ings

effectively. W hile the assessm ents w ould b e

shared , the fina l p olicy d ecis io n w ould rem ainw ith each national governm ent.

8 . The NRTEE recomm ends that the federal

gover nm en t im m ed iately in crea se

interdepartmental action on the commitment

Canada m ade at the May 1997 G8 Summ it to

consider the sensi t iv it ies, vuln erabili t ie s a nd

exposure patt erns of children in all areas of

environmental health and policy.

9. The N RTEE recom m en ds t ha t the governm en tm ake rea d ily av ailable clea r i nfor m atio n abou t

the status of any substance i t is ev alu at in g. The

gove rn m en t sho uld com m unica te:

a list of substances undergoing assessments;

what step a particular substance has reachedwithin t he pr ocess;

when and how the public can comm ent onthe review and how th is inpu t will be used;

where the public can obtain additionalinform ation, including scientific data andthe rationale for the decision, at the end o fthe process;

a t the end of the evaluat ion, a summary of the scientific data and the ration ale for thedecision, including all references.


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Case StudiesH ea l t h , t h e En v i ro n m en t a n d t h e Eco n o m y

Public inp ut wou ld be sought at th e last stageof the process, when appropriate.

To the extent p ossible, the governm ent shou lddevelop comm on description s for th e stages ofan evaluation to avoid confusion an d increasepublic un derstanding. Also, the Inform ationComm issioner of Canada shou ld review theefforts of depar tm ents and agencies to sharethis information in a clear and timely mannerwith the public, and should comp el action ifnecessary.

10.The NRTEE recomm ends that the government

increase public access to health a nd

environmental information. The first category

of in form at ion tha t shou ld , w he re ver p ossible ,be m ade m ore p ublicly accessi ble is t he d a ta

subm it ted to gover nm en t d ep art m en ts a nd

agencies by thi rd p art ies su ch as i nd ust ry. T he

gover nm en t shou ld :

comm unicate to the public whether thistype of information m ay be accessed an dwhom to contact to obtain information th atcan be released;

clarify the conditions under which therelease of health an d environmentalinform ation m ay affect the comp etitiveposition of a company (e.g., trade secrets);

transfer third-party inform ation betweengovernment departments and agencieswhen appropr iate. In this situation,depart m ents and agencies would h ave toidentify key depar tm ental repr esentativeswho, acting as inform ation bro kers, would

be respon sible for d issem inating third -par tyinform ation directly to relevant staff withinother departments/agencies needing thatinformation;

develop departm ent- and agency-specificguidelines for com pliance with Access toInform ation legislation th at encour age aninterpretation of the statutes that is mo reconsistent with the pr inciple of openn ess;

revise key legislation (CEPA, FDA, PCPA) toensure p ublic access to h ealth andenvironm ental data, subject on ly tolegitim ate pr opr ietary interests;

allow the distribution of third-partyinformation if the inform ation is outdatedor if a chan ge m akes the need for restrictingdistribution to the public irrelevant;

request that the Department of Justiceprovide the Inform ation Com m issioner ofCanad a with a man date to evaluate the needfor more open guidelines on interpretingtheAccess to In form at ion Act.

A second category of information isinformation th at is not exempted fromdistribution un der theAccess to In form at ion Actbu t which is no t easily accessible. Inform ationfalling into this category includes assessmentsof substances on the Do m estic Substan ces List,mostly because the data are difficult tointerpret. The NRTEE recom mend s that thegovernm ent p rovide prop er resources to d eliverinformation in the sim plest and m ostintegrated way possible.

11.The NRTEE recomm ends that Ca nada

investigate ha rm onizing its b urden-of-proof

cr it er ia for subst ances w it h those in the

United States.


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H ea l t h , t h e En v i ro n m en t a n d t h e E co n o m yFinal Recommendations

Endnotes

1 Comm issioner of the Environment andSustainable Developm ent, 1999 repor t,Chapter 3, Section 3.49, http://www.oag-

bvg.gc.ca/domino/reports.nsf/html/c903ce.html

2 Commissioner, Chapter 3, Section 3.63.




6 In novat ion s and Good Practices in Single-W indow Service (Ottawa: Canadian Centre for

Managem ent Development, March 1999).

7 Health Minister Allan Rock OutlinesAmend m ents to Pest Cont rol Produ cts ActBefore Environm ent Co m m ittee,Environm ental Dim ensions, February 25, 2000,p . 10.


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Case Studies H ea l t h , t h e En v i ro n m en t a n d t h e E co n o m y

1 9 3 8 Lind a n e i s r eg i ste re d a s a b r oa d -sp e ctr um in se cti ci d e i n Ca n a d a (g a m m a iso m er o f HCH) .

19 70 s/ 8 0s HC H show s up in the environment, which leads to a ban on technical HCH 2 in ma ny countr ies.

1 9 7 2 M a n ufa c tu re r v o lu nta r il y d i sc o nti nu es p r o d uc ti o n o f te ch ni ca l HCH in Ca n a d a a n d th e Un ite d Sta te s.

1 9 7 6 Pr o d uc ts c o nta in in g te ch n ic a l HCH a r e b a n n ed a n d no lo n g er a c ce p ta b le fo r r eg i str a ti o n i n Ca n a d a .

19 78 The U.S. EPA requests manufac tu re rs o f p roduc ts con ta in ing techn ica l HCH to d iscon tinue reg istra tion o f the irproducts or to replace it with l indane.

1 9 8 3 Lind a n e is r e-e va lua te d i n th e Un ite d Sta te s, a n d ma n y p ro d u cts a r e r estr ic te d .19 91 Long-range Transboundary A i r Po l lu tion W orking Group on Stra teg ies rece ives a sc ien ti fi c ra tiona le f o r a

PO Ps protocol. N orthern Contamina nts Progra m (N CP) beg ins research.3

1 9 9 1 Esta b l ish m en t o f th e A r cti c M o n i to r in g a n d A sse ssm e nt Pr o g ra m m e (AM AP), a n e ig ht-n a ti o n p ro g r a m toresearch PO P conta mina nts.

1 9 9 4 Th e LRTAP Ex ec uti ve Bo d y str ik es a n Ad H o c Pr ep a r a to r y W o r k in g G r o u p o n PO Ps th a t i n 1 9 9 5 d r a fts acomp osite neg ot iat ing text: a do cument to restrict , ban or p hase out uses of 1 5 named PO Ps. Thir ty co untr iesare under the chair of a C ana dia n public servant at the Depa rtment of India n and N orthern Affairs (DIA N D),now known as Indian and N or thern Af fa irs Ca nada .

1 9 9 5 Th e Pe sti ci d e M a n a g e m en t Re g ula to r y Ag e n cy i s c re a te d i n Ap ri l, c o mb in in g e x p er ti se fr o m En vi ro n me ntCa nada , Ag r icul ture Ca nada , Health Cana da, a nd N atural Resources Ca nada .

1 9 9 5 A n Environment Ca nad a study in the St. Law rence valley, Q uebec, show s mob ile volat i l izat ion is occurr ingand l indane is moving aw ay f rom the area o f appl icat ion.

19 97 The chemica l company Gusta f son sends a lette r to the EPA asking fo r cla r if ica tion on impor ted trea ted seed.

1 9 9 7 Fo r ma l LRTAP n eg o ti a ti o ns b e g in a t th e Un ite d N a ti o ns i n G e n ev a i n Ja n ua r y.

1 9 9 7 Th e N o rth ern Co nta mi na nts Pro g ra m i ssue s a re po rt, Ca nad ian A rctic C ontamina nts A ssessment Repo rt ,highlig ht ing the persistent contaminants that ha ve been found in the A rctic, including various PO Ps. The reportis the culminat ion o f six yea rs of scient ific research a nd more than 1 0 0 studies.

19 97 An in te rna tiona l study under the Arc tic Mon i to r ing Assessment Programme finds robust levels o f be ta isomersof HC H, fo l lowed by a lphas and very smal l amounts of ga mma in the blood o f the Cana dian A rcticpopulat ion.

1 9 9 7 The EPA determines that it is i l legal to impo rt l indane-treated seed, raising grave concerns amo ng cano lagrowers in Canad a.

19 98 In M arch, the EPA ind ica tes tha t i t w i l l be i llega l to impor t non-reg iste red trea ted seed in to the Uni ted Sta tes.

19 98 The LRTAP PO Ps convention is signed in June. Lindane is a severely restr icted p roduc t, w i th some app l ica tionsa l lowed.

1 9 9 8 G lo ba l neg otia tio ns o n PO Ps co mm ence und er UN EP.

1 9 9 8 In N o ve mb e r, th e v olu nta r y re mo va l o f li nd a n e i s a n no un ce d b y th e C an o la C o u nc il o f C a n a d a. A s o fDecember 31 , 1 99 9, companies wi l l stop imp or t ing a nd ma nufactur ing l indane. Comp anies can cont inue tosell and farmers to use l indane unt i l July 1, 2001.

1 9 9 8 The N orthern Co ntaminants Progra m beg ins second pha se (N CP-II) to ad dress immedi ate health and safetyneeds.

1 9 9 9 Th e PM RA a g r ee s to re vi ew l in d a ne re p la c em en ts o n a p ri o ri ty b a si s.

1 9 9 9 A n alterna tive fo r li nd a ne is a p pro ved in July.

econom ic issue pu t lindane un der scrutiny. TheU.S. EPA clarified its policy on im po rt ing seedstreated with pesticides that were n ot registeredfor use on seeds in the United States. Thepolicy indicated that it would be illegal to

import Canadian canola seed treated withlind ane into the United States, since treatment

with lindan e was not a registered Americanuse. This prom pted im m ediate concern amon gCanad ian canola growers, and discussionsbegan amon g the PMRA, U.S. EPA, CanolaCoun cil of Canada and Canadian Canola

Growers Association and registrants t oimplement a volun tary withdr awal of lindan e.

Figure 1. Chronology


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Issues of Process Surrounding LindaneA num ber of issues have com e to light throu ghdiscussion s with various stakeholders on t he u seof lindane in Canada:

La ck of Tra nspa rency The Black Box

Syndrome. Stakeholders from both inside andout side governm ent expressed frustration at a)being unable to obtain t he risk and healthassessment data u sed b y the PM RA todeterm ine the safety of lindan e, and b) notknowing th e basis for decisions on prod uctregistration. This inform ation is un availabledue to a stipulation in the Access to In form at ionAct that prohibits the provision of informationreceived in confidence to ot her par ties.

Stakeholder Consultation Prior toInternational N egotiations. In the first set ofintern ational negotiations there appears tohave been insufficient consultation withstakeholders who would be affected by thenegotiations. For examp le, nor thernAbor iginals were surpr ised to find out thatCanada had opposed the inclusion of lindan ein the LRTAP agreem ent on POPs, since theyhad seen no indication of this prior to the

negotiations. The m ore recent UN EPnegotiations have been more successful inconsulting stakeholders (althou gh lindan e isno t on UN EPs list).

Formulating Canadas InternationalN egotiating Position. A number ofstakeholders were not clear on how Canadasinternational negotiating position for theLRTAP agreement had been established. There

was concern that Canadas initial negotiationpositions were formulated by senior-levelbureaucrats with little input from Cabinet orthe elected governm ent, and th erefore had littleaccoun tability. A form al process forestablishing in ternation al negotiating positions

was not app arent to all stakeholders.

Domestic Regulations SupersedeInternational Regulations. It is a matter ofpolicy that Canad a will no t r atify anyinternational agreem ents if they contradictdom estic regulation s, since intern ational policyshould n ot dr ive dom estic measures.

Success w ith Voluntar y Initia tives.Whenthere were major concerns about the economic

consequences of using lind ane as a canola seedtreatment, the PMRA acted quickly andefficiently, in close con sultation with t heaffected u ser groups, to find a solution. In th iscase, a prop osal for registrants to volunt arilywithdr aw lindan e and a qu icker approvalsprocess for alternatives to lindane have wonkudos. Should th e voluntary withdrawalappr oach work, it will result in th e nearelimination of lindan e use in Canada.

Burden of Proof. In ord er to instigate a specialreview or reassessment of a product, therem ust be evidence of risk from a product, eventho ugh in t his case the r isk assessment is quiteold. The burden of proof lies on the PMRA toprove this risk is un acceptable (based onscience), rather than on the registrant to provethat t he pro du ct is safe.

1 9 9 9 In M a r ch , th e PM RA a n n ou nc es a s p ec ia l re view o f p est c o ntr o l p r o d uc ts c o nta in in g l in d a n e. Ta r g et d a te fo rcompletion is December 20 00 .

19 9 9 Al l new products, registration renew als and amended registrations that are granted in 19 9 9 wi l l expire andbe renewed annual ly unti l December 31 .

1 9 9 9 Lin d a ne i s n o min a te d i n Ja n ua r y fo r co n sid e ra ti o n a s a c a n d id a te su b sta n ce fo r d ev elop m e nt o f a N o r thA merican Regiona l A ction Plan (N A RA P) through the Commi ssion for Environmental Co-operat ion (CEC).

19 99 Substance se lec tion is car ried ou t by the Commission fo r Env ironmenta l Co-opera tion task fo rce cur ren tlyreviewing l indane.

1 9 9 9 U N EP g lo ba l neg otia tio ns a re co ntinuing .


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The Uses of LindaneLind ane is an or ganochlorine insecticide andfum igant t hat h as been used on a wide range ofsoil-dwelling and plant-eating insects.4 Lind ane isnot prod uced or manufactured in Canada. It is

registered for use in Canada as a broad- spectruminsecticide and acaracide. Curr ently, there are 44registered prod ucts in Canad a. Trade nam es forlindan e are Prem iere Plus, Vitavax RS Flowable,Vitavax RS Dynaseal, Cloak, and Foun dation .Inquinosa and Rhone-Poulenc are two European-based producers of lindan e.5

Lindane was first registered for use in Canada in1938. Over the life of lindan e, 504 lindan e-containin g prod ucts have been registered.

Currently, 29 lindane-containing comm ercialpro du cts are registered. Lind anes prim ary use inCanada is to treat canola seed for flea beetles.6 It isalso used against ectoparasites (scabies and headlice) on animals and hu m ans. At this tim e, HealthCan adas on -line d atabase lists seven differen tprodu cts for th erapeutic use (sham poo andlotions) that contain 1 percent lindane.7

The Chemistry of Lindane and HCHLindane is a derivative ofhexachlorocyclohexane(HCH ), also known as benzene hexachloride

(BHC) .

Benzene hexachloride and hexachlorocyclohexaneare com m on nam es for the sam e chemical m ostcomm only referred to as HCH . The more form alnam e is 1,2,3,4,5,6-hexachlorocyclohexane. H CHhas a num ber of isomers, of which alpha, beta,delta, gam m a and epsilon are stable, and areusually the isomers found in environmental

samples.Techn ical HCH is a nam e given t o on em anifestation of a pesticide containing at least fiveisom ers (appr oximately 6070 percent alpha-HCH , 512 percent beta-HCH , 1015 percentgamm a-HCH, 610 percent delta-HCH and 34percent epsilon-H CH) .

Lind ane is also a pesticide p rodu ced b y using thecomp ound H CH, and is composed of 99.5 percentgamm a-HCH isomer. It is the gamm a-HCHisom er, or lindane, that has the most potentinsecticidal properties.

Production and UseGlobal use of lind ane is estim ated to be 720,000ton nes, with Can ada being the sixth largest globaluser of lindane (gamm a-HCH). Additionally, it isestimated that 55,000 tonnes of technical HCHare used worldwide.8

Lind ane has been listed as one of the dirt y dozenpesticides by the Pesticide Action N etwork Nor thAmerica (PANNA). It is bann ed from use in 28

coun tries, severely restricted in 18 an dde-registered in on e. The use of techn ical HCH isbanned in 52 coun tries, restricted in 8 andde-registered in 10.9

Large amou nts of technical HCH continue to beused in In dia, m ostly for cotton p rotection andmalaria control.10 The United Nations EconomicCom m ission for Europe (UN ECE) also reportsthat technical HCH is still widely used in Asia andthe countries of the former Soviet Union. It is also

suspected th ere are stockpiles of lind ane invarious African an d Asian coun tries and in Russia.

Health and Environmental Impacts of LindaneThe major sources of lindan e in th e atmosphereare fugitive dust par ticles from wind erosion ofcontam inated soil, and volatilization from t reatedagricultural soil and from plant foliage sprayedwith lindan e. Lindane is rem oved from th e

The dirt y dozen are 18 pesticides group edtogether because of their closely relatedchemical structu res: Aldicarb (Tem ik);Camph echlor (Toxaphene); Chlordane;Heptachlor; Chlordimeform; DBCP; DDT; theDrins (Aldrin, Dieldrin, Endrin); EDB;

HCH /BHC; lindane; Paraquat; Parathion;Methyl Parathion; Pentachloroph enol; and2,4,5-T.


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The U.S. EPA regulates lindane as group C, apossible hu m an carcinogen, while theInternational Agency for Research on Cancerclassifies lind ane as possibly carcinogen ic tohumans.17

There have been mixed results with respect tothe end ocrine effects in aqu atic organism s andm am m als, with estrogenic effects foun d insome studies bu t not in o thers. The EPA willlikely be examin ing lind ane un der th e FoodQu ality Protection Actin order to determinewhether it is a potential endocrin e disru pter.

Lindane exposure has been shown to haveadverse effects on the im m un e system o f fish,

including imm un osuppression, at sublethalconcentrations of lindan e (10 or 15 ppm) .18

Economic I ssues Surrounding LindaneAs lindane is an older product, one of its keybenefits is its low cost while being especially effectiveas a seed treatment d ue to its persistent natu re. Theprim e concern of canola farm ers is the potentialcost o f effective alternatives to lind ane. Farmers arealso concerned that if lindan e is banned withoutsufficient alternatives, the produ ction of canola m ay

become uneconom ic or un feasible. Farmers arelimited as to the types of crops that they can rotateprofitably, and canola is one of the more profitablecrops available for farming. In addition, comp aniesthat make and sell lindane would likely experienceecono m ic consequences if the substance were to bede-registered.

Alternat ives t o LindaneThere are several pesticide alternatives to lindane

as a seed treatm ent, in addition to non -pesticidepossibilities. On e new pesticide, Gaucho, is alreadyregistered in the United States, although it is mor eexpensive than lind ane. It was recently approved( July 1998) by the PM RA for u se in C anada,althou gh it is un known what pr ice it willcomm and on the Canadian market. Otheraltern atives cur rently un der r eview by the PM RAare Premiere 2 and Helix.19

Accordin g to th e World Wildlife Fun d, when fleabeetle pop ulations are not expected to b e high,there are some non-chemical alternatives availablethat m ay provide adequate pest contro l. Theseinclude early planting, planting larger seeds, using

no-till or direct dr illing of seed, and increasing theseeding rate. Beetle damage can also b edim inished by leaving a trap strip of volun teercanola near o verwinter ing sites and cu ltivating theremainder of the field. The trap strip is destroyedbefore beetles can move into seedlings.20 However,according to the Canola Coun cil of Canada, non -chemical alternatives for controlling flea beetlesare not feasible at this tim e. Op tions that h avebeen looked at include parasite predators andbiological m eans, and com pan ies are curren tly

looking at d evelopin g resistant varieties of canola.

Alternatives to u sing lindan e lotion as a treatm entfor scabies and head lice includ e comb ing and theuse of tea tree oil. In addition, the syntheticpyrethroid perm ethrin (5 percent cream) can beused. Perm ethrin is mu ch less toxic than lindaneand less easily absorbed thro ugh the skin,although it is more costly.

Account of the Policy Dev elopment,Decision-M ak ing and Implement at ion ProcessThe following section outlines the issues andpro cess that led u p to the special review onlindan e being conducted by the PMRA, and th eproposed volun tary withdr awal of lindan e byregistrants.

Contamination in the ArcticIn th e 1980s, studies on PO Ps in th e CanadianArctic found unexpectedly high levels

un associated with local sources. Furth er researchin 1990 found levels of five to six POPs thatexceeded Can adian health guidelines for eatingflesh (p rim arily fish). This research laun ched theNorth ern Contam inants Program, a six-yearprogram coordinated and led by Indian andNorth ern Affairs Canada ( then kn own as theDepartm ent of Indian Affairs and North ernDevelopm ent) in part nership with several federal


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participants, including representatives of industryand governm ent. The nor thern Aboriginal peoplesdid n ot consider th is sufficient: they were un easypar ticipating as one interest amon g many.Moreover, they were acutely aware of their

Abor iginal and treaty rights and th e fiduciaryobligations of the Crown toward them, whichplaced significant consultative bur dens up on thefederal governm ent before it could en gage inintern ational negotiations that m ight affect theirrights. At no stage were no rth ern Aboriginalpeoples invited to assist the federal government indeveloping its form al negotiating p osition .28

The n ort hern Abor iginal peop les were alsoexpecting Canada to include all POPs on the

negotiation list, because of the recent scientificstudies that h ad shown th at the levels of PO Ps inno rth ern peop les were well in excess of the levelof concern defined by Health Canada. After thefirst negotiation session , in which Canada did notsupport m aking lindan e part of the LRTAPpro tocol, the Abor iginal peop les coalition (InuitCircum polar Conference, Inu it Tapirisat ofCanada, Dene Nation, Mtis Nation N WT andthe Cou ncil of Yukon First Nation s) felt thatCanada had done an about-face, and was

concerned that the econom ic impact of includinglind ane was taking precedence over th e pu blichealth issues. There was also concern th atCanad as position was the result of agreem entsbetween federal pu blic servants rath er th anCabinet-approved instructions.29

The perspective of the Canadian negotiators,however, was that at the out set of the officialnegotiations (an d d espite there having beendiscussions on lindane during preparations for thenegotiations), lindan e was not am ong thesubstances that had been collectively agreed uponby coun tries for th e initial list. It was on e of a fewsubstances still being debated and coun trieshad n ot yet agreed that lindan e was a PO P thatrequired in ternation al action u nd er the LRTAPprotocol.30

In addition, Canada could no t agree to anoutr ight international ban on lindan e, since such amove was seen as conflicting with therequirem ents of our own legislation ( which wouldrequire lind ane to be de-registered thro ugh a

special review and scient ific risk assessm ent thatdemon strated substantial evidence of major h ealthimpacts occurring because of the concentr ationsof lindane in the environm ent).31 The existingregistered status of lind ane would prevent Canad afrom r atifying the protocol.

The n egotiation team considered th e way forwardto be a ban on techn ical HCH and restrictions onthe use of lindan e, as well as a man datoryreassessment of lindan e, which would p rovide a

more extensive scientific basis for further actionon lindane as needed.32 The rationale behind thisappro ach was that a pro cess to register and de-register prod ucts had already been established inCanada to protect the environm ent, the health ofCanadians, and the econom ic interests ofcomp anies developing an d selling pesticides. IfCanad a were to o verr ide this pr ocess by agreeingto a ban on lind ane at the internation al level, itwould circumvent th e established n ationalpro cess, thereby setting a pr ecedent for substances

of future concern.

By the second LRTAP negot iating session(O ctober 1997), a form al process was in p lace toensure more thorough stakeholdercomm un ication: for example, extensive time wasavailable to prepare interdepartmental input,briefing materials and processes werestandard ized, individuals were designated assubject leads on all negotiating topics, and asenior-level steering comm ittee providedguidance. In addition, the Departm ent of ForeignAffairs and Intern ational Trade joinedEnvironment Canada to co-chair the process andco-head the delegation. The Departm ent ofForeign Affairs and International Trade was seenas a natur al lead for intern ational negotiation s, aneu tral part y with respect to Canadian chem icalsm anagement issues, and a critical player in


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ensuring consistency with Canadas otherintern ational obligations.33

Concerned about the Canadian position, theAbor iginal peop les coalition u sed t he Inu itCircum polar Con ferences con sultative status tothe UN Econ om ic and Social Cou ncil to send anobserver to t he session. They believed that C anadawas taking a m ore conservative position t hanvirtually any other nation, which seemed at oddswith Can adas earlier successful attem pts topersuade LRTAP coun tries to n egotiate a PO Psprotocol.34 Later th at year, the Inu it Circum polarCon ference form ally asked th e PM RA for copiesof the risk assessment and suppo rting dataform ing the basis of Canadas regime for lindan e.

The PM RA, however, was un able to provide thisinformation, due to the confidentiality provisionsunder theAccess to In form at ion Act.

In the Octob er 1997 negotiations, the Abor iginalpeoples tabled a paper that, if adopted, wouldpar tially grou nd the LRTAP POPs pr otocol inArctic, Abor iginal and pub lic health con cern s. Insubsequent meetings, some of the preambu larlanguage was accepted. In addition, Canada nowaccepted that lindan e could b e included in t he

pro tocol as a restricted substance, but in sisted,along with oth er coun tries such as the Un itedKingdom , that all current uses of the pesticide beallowed to contin ue.35

The LRTAP n egotiations wrapp ed up in th esumm er of 1998, and the resulting conventioncovered 16 substan ces, with a pro vision for ad dingsubstances. The agreement was signed in 1998 by34 coun tries. Under the agreement, technicalH CH is restricted to u se as an interm ediate in

chemical manu factur ing and lind ane is restrictedto six uses, thr ee of which are registered inCanada. These are:

1. seed treatment;

2. soil applications directly followed byincorpo ration into t he top soil surface layer;

3. public health and veterinary topical insecticide.

The cond ition stated in th e proto col is that allrestricted u ses of Lindan e shall be reassessedun der th e Protocol no later than two years afterentr y into force. The pro tocol does no t enter intoforce until 16 coun tries have ratified th e pro tocol.

This is estimated t o take between two an d two an da half years, so entr y into force would occur in2000 and the reassessment two years later, that is,in 2002.36

Altho ugh this required reassessm ent of lind anedid n ot d rive the special review process, it hasbeen a critical factor in making the special reviewof lindan e a high priority in th e PMRA.37

Global Negotiations UNEP

In Februar y 1997, the Governing Council of theUnited Nations Environm ent Program m e decidedto initiate im m ediate intern ational action toprotect hum an health and th e environmentthrough measures which will reduce and/oreliminate . . . the emission and discharges of 12listed POPs.38 Just as the LRTAP negotiation s werewrapping up, the UN began global negotiationson POPs (July 1998). These were driven by arecom mend ation from the International Forumon Chem ical Safety.

UNEP Governing Council Decision DocumentGC 19/13C outlines the negotiating m and ate forthe POPs Intergovernmental NegotiatingCom m ittee. Negotiation s are still on going.Lind ane is not in clud ed in t he initial list ofsubstances, as out lined in th e Governin g Coun cilDecision Docum ent, althou gh provisions arebeing worked on for ad ding oth er substances inthe future.39 In contr ast, in th e earlier negotiations

that led to the 1998 protocol on PO Ps under theLRTAP, negotiators determ ined the sub stancesincluded in th e original agreemen t.40

There is no direct conn ection between the LRTAPand UN EP POPs negotiations. However, somestakeholders have commented that the UNEPprocess is an im pro vemen t over its LRTAPpredecessor. These imp rovem ents include mu chm ore comp rehensive con sultation and discussion


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with key stakeholders, such as the InuitCircum polar Conference, and t he inclusion ofrepresentatives of Abor iginal peoples, indu stryand environmental groups directly on theCanadian delegation.41 On e farmer expressed

strong supp ort for the fabulous job thatEnvironm ent Canada has done in condu cting aproper consultation on the issues of POPsinternational negotiations.42 In addition, havinggone thro ugh th e LRTAP POPs process, thenegotiators have some n otification of thepositions that som e stakeholders may take in th eUNEP POPs negotiations.43 Despite theseimp rovements, there is still frustration th atCanada is only slowly defining its position on keyissues.44

EPA Ruling on Imported Treated Canola SeedIn Septem ber 1997, the chemical com panyGustafson asked the EPA to clarify its position ontreated seed being imported into the UnitedStates. The EPA determ ined th at it would be illegalto im por t seeds treated with p esticides that wereno t registered for that specific purp ose into theUnited States. Lind ane-treated can ola seed fellun der th is policy (even th ough lind ane is

registered for oth er seed treatm ent u ses in t heUnited States).45 Then, in the spring of 1998, ashipm ent to th e United States of canola seedtreated with lindan e was stopped. Canadiancanola growers, the Canola Coun cil of Canada, aswell as canola farm ers in Nor th Dakota werealarmed at a po tential scenar io in which theUnited States cou ld stop an y treated seed u sed forplanting being moved south of the border. Inaddition , if lind ane residues were detected in seedfor crushing of m eal or oil, the United States

could stop the movem ent of these products.

For Can adian farm ers this was a serious issue.One canola farmer explained that any crop mayhave 50 to 100 pests, and each on e cou ld reducethe yield, depending on the severity of theinfestation, by up to 100 percent. Therefore,farmers need a selection of tools to deal withdifferent pests, and to redu ce the risk of resistance

developing. The loss of lind ane could be critical tothe control of pests, and could determine whethergrowing canola was viable or no t.46

In respon se, the Canola Coun cil of Canada lookedat what was happ ening worldwide with lindan eand determined that alternative products wereneeded. The Coun cil met with the registrantcompanies, growers and the PMRA, and thegrowers propo sed to have registran ts volun tarilywithdr aw cano la from the registration label aslong as alternative seed treatments were availablefor flea beetle control.

The PMRA played an important role in thepro posed volun tary withdrawal. Since growers

needed alternatives quickly, the P MRA47

worked inclose collabor ation with stakeholders and set u pthe opp ortu nity for priority review of alternativepro du cts by send ing the m essage out toregistrants. Three po tential alternatives werereceived, one of which was no t reviewable (i.e.,did n ot h ave a comp lete package according tostandards), which resulted in two potentialalternatives for review.

The farming comm un ity was consulted t hrough

their association s about th e propo sed withd rawalof lindan e. A prime concern initially was thepotential loss of the U.S. market for their prod uct.However, there was also concern abo ut losing avery effective tool for pest control on canola andother, minor crops, with the p ossibility of noalternatives being available.

While the app roval time for n ew active ingredientsis usually 18 mo nth s, the app roval pro cess forlind ane alternatives was speeded u p. To find n ew

seed treatm ents that are viable in bo th coun tries,the PMRA worked with th e EPA, the Cano laCoun cil of Canada and its U.S. counterparts tojoin tly evaluate n ew com pounds. Th ey a lso m ad ea comm itment to com plete the joint review andregister approved alternatives by 2000.48 Onepesticide alternative, Gaucho, was registered inJuly 1999. It is considered safer from anenvironm ental and h ealth p erspective and will be


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available for the 2000 growin g season. Ho wever,its cost is un known , which is a con cern togrowers.49

The volunt ary withdr awal comes into effect onDecember 31, 1999, at which po int chemicalcompanies will no longer impor t or m anufacturelind ane. They can, however, continue to selllindan e to farmers, who can use the produ ct untilJuly 1, 2001. The U.S. Food and Dr ugAdm inistration h as agreed n ot to take anyregulatory or t rade action against canola seedscomin g across the U.S. bord er as a com m odity,du e to the volun tary action being taken byCanadian companies and growers.50

End ocrin e D isrupter sAlthough several Canadians thought that the FoodQ uality Protection A ctwas the trigger for the U.S.imp ort action on canola seed, Anne Lindsay,Director o f the Field an d External Affairs Divisionof the Pesticides Office of the U.S. EPA, statedun equivocally that it was no t. The new FoodQ uality Protection A ctestablishes an endo crinedisrup ter screening and testing program over afour-year period and will then report back toCon gress. It will cover all indu strial chem icals and

pesticides (over 90,000), of which lindan e m ay beon e since most PO Ps are included on the list.51

Special Review by the PM RABy signing the LRTAP proto col, Canada m ade acomm itment to restrict the uses of lindan e and tocondu ct a reassessm ent ( special review) o f allremaining uses. On March 15, 1999, the PMRAno tified registran ts and ot her interested par tiesthat p est contro l produ cts con taining the active

ingredient lindan e would be subject to th is specialreview52 un der Section 19 of the Pest Contro lProducts Regulations. In th e notice, it stated thatthe decision to review was influenced by theongoing national and international scrutiny thatlindan e is receiving as a result of its persistence,potential for long-range transport and widespreadoccurrence in th e environm ent.53

The first step of this review is to obt ain new datafrom the registrants on the chemistry ofingredients. The PMRA has also written to ot hergovernm ent d epartments and provinces for anyinformation th ey m ay have, in addition to

working closely with th e United States on th isissue, since the EPA is also reassessing lind ane.The PM RA is also cognizant of the stud ies invarious European coun tries. After the inform ationis gathered, lind ane will un dergo a r isk assessmentreview to determ ine whether the r isks (e.g.,dietary exposure, worker exposur e) are stillacceptable based on n ewer standard s. Based on therisk assessment , the registration p erm its m ay bechanged to allow for new, fewer, different, or n operm itted application s for lindan e. Person nel at

the PM RA state that they are trying to be asfocused and as efficient as possible in coming to adecision, while following th e Pest Control ProductsAct.54


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Lindane Endnotes

1 Registrants are those companies that sell,man ufacture, and/or reformulate produ cts thatfall un der th e Pest Con trol Products Act.

2 Technical HCH is a pesticide with m ixedisomers of HCH. Lindane, on the other hand, iscomposed m ostly of the gamm a-HCH isom er.

3 Fenge, Terry. POPs in the Arctic: TurningScience in to Policy.N ort hern Perspectives.Volume 25, Num ber 2, Winter 1998.

4 Extension Toxicology Network.http://pmep.cce.cornell.edu/profiles/extoxnet/

haloxyfop-methylparathion/Lindane-ext.htm.5 Meakin, Stephanie. Technical Advisor for

Canadian Arctic Indigenous Peoples againstPOPs. Research notes.

6 Buth, Joanne. Vice-President, Canola Council ofCanada. Personal interview. August 23, 1999.

7 Health Canada.http://www.hc-sc.gc.ca/hpb/drugs-dpd.

8 Indian and Northern Affairs Canada. CanadianArctic C on tam in an ts Assessm en t Report. 1997.

9 Pesticide Action Network North America.Dem iseof the Dirty Dozen . 1998.http://www.ig.capc.org/panna/campaigns.DD.html.

10 Biegel, Wolfgang (ed.).Lindan e: Answers t oIm portan t Q uestion s. Centre Internationaldtudes du Lindan e (CIEL). Bru ssels. 3rdEdition. 1995.

11 Indian and North ern Affairs Canada. CanadianArctic C on tam in an ts Assessm en t Report.

12 Nom ination Dossier for Lindane. Subm ission bythe United States to th e Working Grou p for th eSoun d Managem ent of Chemicals (SMOC) forconsideration as a candidate for developm ent ofa Nor th Am erican Regional Action P lan.Janu ary 15, 1999.

13 Furgal, Chris M., and Keith, Robbie.Contam inant s Assessment Report: Overviewand Sum m ary.N ort hern Perspectives. Volum e25, Num ber 2, Winter 1998.

14 Meakin, Stephanie. Research notes.

15 Furgal, Chris M., and Keith, Robbie.N orth ernPerspectives.

16 Arctic Mon itoring and Assessm entProgramme.A M A P A ssessm en t Report : ArcticPollution Issues. Oslo. 1998.

17 Nom ination D ossier for Lindane.

18 Dun ier et al. Effect of lindan e exposure on

rainbow trout immunity. Ecotoxicol Env ironSafety. Num ber 30, 1995: 25968.

19 Buth, Joanne. Personal interview.

20 World Wildlife Fund Canada. Personalcomm unication. October 6, 1999.

21 Furgal, Chris M., and Keith, Robbie.N orth ernPerspectives.

22 Stone, David. Director of Northern Science

Contam inants Research, Indian and North ernAffairs Canad a. Person al interview. August 21,1999.

23 Fenge, Terry. Director of Research, InuitCircum polar Conference. Person al interview.July 27, 1999.

24 Gilman, Andy. Director, Bureau of SustainableDevelopm ent, Health Protection Branch,Health Canada. Person al interview. August 3,

1999. (All statem ents made by Dr. Gilm anreflect his personal un derstanding of thelind ane issue at th at tim e.)

25 The UN ECEs mem bership includ es westernand southern European countries, Canada, theUnited States, Russia and ot her easternEuropean states. It has assum ed a key role infacilitating a nu mb er of environm entalagreements.


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control equipment, as well as the perform anceof emerging techn ologies to be used in the nextgeneration of low-em ission vehicles.

Over view of t he Decision-M aking Process

Establishing lim its for sulphur in gasoline anddiesel fuel is on e aspect of a larger program forclean air that has involved many federal,provincial and municipal actions and a broadconsultative effort . The first docu m ented evidenceof a concerted effort to address sulphur in fuelappears in a report completed by TransportCanada and Environm ent Canada entitled A Planto Iden tify an d A ssess Em ission Redu ction

Opportun ities from Transportation, Industrial

Engines and M otor Fuels, released in May 1989.

Since that tim e, two significant form al processeshave been convened to consider the cont rol ofsulphu r levels in gasoline. The first m ajor effortwas undertaken by the Canadian Council ofMinisters of the Environm ent (CCME), referredto in t his report as the CCME Process. Thesecond effort was led by Environm ent Can ada at

the direction of the CCME, and will be referred toas the Sulph ur Panel Process. Environ m entCanad a used th e Sulphu r Pan el Process results,summ arized in the Final Report of the Governm entWorking Group on Sulphur in Gasoline and Diesel

Fuel4

to establish the Sulphu r in GasolineRegulations,5 which lim it sulphur in gasoline to anaverage of 30 ppm with a never-to- be-exceededlimit of 80 ppm to be implemented by 2005. TheRegulation s also includ e an interim requirem entof a 150 ppm average from m id-2002 toDecem ber 2004.

ChronologyThe policy process to address sulphur levels inCanad ian gasoline and diesel is well docum ented.

The m ajor m ileston es in Figure 1 have beenhighlighted in bo ldface for ease of reference. Moredetailed description s of these milestones areprovided in the following text. The remainin gmilestones listed in Figure 1 are not directly tiedto effort s to regulate sulph ur and are provided forcontext.

Figure 1. Chronology

19 88 The federa l government in troduces new ligh t- and heavy-du ty veh ic le em issions standards under the M o t o r Vehicle Safety Act, which take effect September 1, 1987, and December 1, 1988, respect ively. At the t ime,these standards are considered some of the tightest in the world.

1 9 8 9 In M ay, Transport Ca nad a and Environment Ca nad a release A Plan to Identify and A ssess EmissionReductio n O pp ortunities from Transpo rtation, Industrial Engines and M otor Fuels.

19 94 The U.S. Env ironmenta l Pro tec tion Agency (EPA) regu la tes on-road d iese l su lphur levels to 50 0 pp m. InCa nad a, ref iners sign a M emorand um of Understand ing to start voluntar i ly introducing d iesel fuel withsulphur levels of no more than 500 ppm.

19 95 The U.S. EPA re leases the Federa l Reformula ted Ga so l ine Program ta rge ting U.S. reg ions tha t a re out o fcompl iance with N at ional Amb ient A ir Q ual i ty Standa rds.

1 9 9 5 Th e C a na d ia n Co un ci l o f M i n iste rs o f th e En vi ro nm e nt e nd o rse s th e Final Report of the Task Force on Cleaner

Vehicles and Fuels(CCM E Process).

1 9 9 6 Envi ronm ent Ca na da , a cting on recom m e nda t ions o f the CCM E, form s e x pe r t pa ne ls a nd a stee ring com m i tte e

that includes representatives of key partners: provinces, Health Canada, the Canadian Petroleum Products

Institute and others (Sulphur Panel Process).

1 9 9 7 Envi ronm ent Ca na da prom ulga tes the D iese l Fue l Re gula tions in Fe brua ry a nd the Be nze ne in Ga s ol ine

Regulations in N ovemb er as per the CCM E direction.

1 9 9 7 The Gov ernm ent W ork ing Group conve nes to consider the e x per t pa ne l re por ts, to form ula te options a nd

recommend ations, an d to conduct the b roa der stakeho lder consultation pro cess (Sulphur Pa nel Process).

1 9 9 7 Th e CCM Es Ve hi cl e/ Fu el s Co m p a ti b i li ty Ta sk G r o up r elea se s i ts r ep o r t i n Ju ly.

1 9 9 8 Th e fi na l re p or t a nd r eco m m en d a tio n s o f th e G ov er nm e nt W o rk in g G ro up a r e re le a se d in Ju ly.


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1 9 9 8 Th e Su lp hu r in G a so lin e Re gu la tio ns a r e p ub lish ed in th e Canada Gazette , Part I, and submissions are received

from a broad range of stakeholders in O ctober.

1 9 9 9 Th e Su lp hu r in G a so lin e Re gu la tio ns a r e p ub lish ed in th e Canada Gazette , Part I I , on June 23 .

19 99 The U.S. EPA announces i ts in ten tion to regu la te lower su lphur leve ls in conjunc tion w i t h Tie r II veh ic leemission standards, ef fect ive 2004.

19 99 The U.S. EPA in troduces the Vo lun ta ry N at iona l Low -Emission Veh ic le (N LEV) p rogram to the northeaste rnstates; introduction to the remainder of the United States is scheduled for 2000.

20 04 Tie r II veh icle standards wi l l beg in imp lementa t ion in the

Documents

Managing Potentially Toxic Substances in Canada - A State of the Debate Report