A Cause of Action for Regulatory Negligence? The ... .1-23.pdf · since review of GM crop...

ACauseofActionforRegulatoryNegligence? 1(2009)6:1&2UOLTJ1

Copyright2009©byThomasMoran,NolaMRiesandDavidCastle.* TheauthorsacknowledgefundingsupportfromAFMNet,theNetworkofCentresofExcellenceforAdvancedFoods&

Materials.ThomasMoran,BA,JD,iswithBullHousser&TupperinVancouver.NolaM.Ries,MPA,LLM,isAssistantProfessor,FacultyofLaw,UniversityofVictoriaandResearchAssociate,HealthLawInstitute,UniversityofAlberta.DavidCastle,PhD,isCanadaResearchChairinScienceandSocietyandAssociateProfessor,UniversityofOttawa.TheauthorsthankStuartSmyth,PhD,CollegeofBiotechnology,UniversityofSaskatchewan,forhelpfulcommentsonadraftofthispaper.ThispaperreflectsthestateoflawasofSpring2008.

This paper considers wheTher, under canadian law, a government regulatory agency could be found liable for “negligent regulation” of genetically modified (GM) crops. The paper begins with an overview of the Canadian framework for GM crop regulation and notes criticisms about the adequacy of this framework. The state of Canadian law regarding regulatory liability is then analysed. The authors conclude that litigants who wish to assert a claim of regulatory negligence face significant legal barriers, particularly since review of GM crop applications involves weighing complex scientific data and determining tolerable levels of risk, matters that would likely be non-justiciable in a negligence claim. Current jurisprudence, however, leaves open some unresolved bases of liability. The paper closes with a brief overview of recommendations to improve the Canadian regulatory framework for GM crops, focusing particularly on enhancing transparency in the decision-making process.

dans ce TexTe, on examine dans quelle mesure un organisme de réglementation gouvernemental pourrait, en vertu du droit canadien, être tenu responsable d’une « réglementation négligente » des cultures transgéniques. Cet article débute par une vue d’ensemble du cadre canadien pour la réglementation des cultures d’espèces génétiquement modifiées et note l’existence de critiques à propos de la justesse de ce cadre. On analyse ensuite l’état du droit canadien au chapitre de la responsabilité réglementaire. Les auteurs concluent que les parties désireuses de déposer une plainte pour négligence réglementaire rencontrent des obstacles juridiques importants, en particulier dans la mesure où l’examen des demandes relativement à des cultures transgéniques comprend l’évaluation de données scientifiques complexes et la détermination des niveaux tolérables de risque, des questions probablement non justiciables dans le cadre d’une poursuite pour négligence. La jurisprudence actuelle laisse cependant ouverts certains arguments non résolus de la responsabilité. Le texte se termine par un bref aperçu des recommandations visant à améliorer le cadre réglementaire du Canada pour ce qui est des cultures transgéniques, en rappelant en particulier l’importance d’une transparence accrue dans le processus décisionnel.

A Cause of Action for Regulatory Negligence? The Regulatory Framework for Genetically Modified Crops in

Canada and the Potential for Regulator Liability

ThomasMoran,NolaMRies,andDavidCastle*

2 university of ottawalaw & technology journal www.uoltj.ca

3 1.INTRODUCTION

5 2.THECANADIANREGULATORYFRAMEWORKFORGMCROPS

3.CRITICISMSOFTHECANADIANREGULATORYFRAMEWORK

11 4.OVERVIEWOFRECENTGMCROPLAWSUITSAGAINSTREGULATORS

14 5.ACAUSEOFACTIONFORREGULATORYNEGLIGENCEINCANADA?

16 5.1. To Whom is a Duty Owed?

18 5.2. Failure to Act in Compliance with the Governing Statute

18 5.3. Failure to Regulate in a Particular Manner

20 6.TRANSPARENCYINREGULATION

22 7.CONCLUSION


A Cause of Action for Regulatory Negligence? The Regulatory Framework for Genetically Modified Crops in

Canada and the Potential for Regulator Liability

ThomasMoran,NolaMRies,andDavidCastle

(2009)6:1&2UOLTJ1

1. INTRODUCTION

Genetically modified (Gm) crops remainasourceofheateddebateinCanadaandaround theworld.Muchof thedisagreementstems fromdivergentviewsaboutthebenefitsandrisksofGMcrops, includingenvironmentalandhumanhealth concerns. In Canada, government officials and agencies have longstressed the safety of GM products and the economic and social benefitsassociatedwiththeirdevelopmentandcommercialization.In1998,forexample,theCanadianMinisterofAgricultureandAgri-FoodtoutedCanada’semergenceasaworldleaderinagriculturalbiotechnologyandemphasizedthebenefitsofCanadian efforts in this area: “Biotechnology is a valuable resource in ourongoing commitment to provide safe, healthy foods in an environmentallysustainable manner [. . . and] also offers the Canadian agriculture and foodindustriesnewopportunitiesforeconomicprosperity.”1Morerecently,afederalreportonbiotechnologyinCanadastated:

The growth of the biotechnology industry requires world-class business and

regulatoryregimesthatnurtureinnovationandbuildpublictrustandconfidence.

Industry Canada supports such a competitive business climate [... and it ...]

participatesininitiativestopromotethecreationofoptimalconditionstoattract

andretainbiotechnologycompanieswhilealsoprotectingthepublicinterest.2

OpponentsofGMcrops,ontheotherhand,havecautionedaboutthepotentialforadversehealthandenvironmentalimpactsandraisedconcernsaboutundue

1. GovernmentofCanada,“FederalGovernmentReleasesNewBiotechnologyStrategy,”NewsRelease,8014-e(6August1998),<http://biotech.gc.ca/archives/engdoc/bh00228e.html>.

2. GovernmentofCanada,Biotechnology Transforming Society: Creating an Innovative Economy and a Higher Quality of Life—Report on Biotechnology, 1998-2003(Ottawa,GovernmentofCanada,2003),<http://www.biostrategy.gc.ca/CMFiles/11865_CAN_BIO_REP_Ev949SFJ-922004-3421.pdf>atp.58.


industryinfluenceongovernmentpolicyrelatingtoGMproducts.3Oneofthecentrallegalquestionsassociatedwiththisdebateconcerns

responsibility forharms related toGMcropapprovalandproduction.Organiccropproducers inCanada, inparticular,haveexpressedseriousconcernaboutthepotentialadverseimpactofGMplantcontamination.4Canadianjurisdictionshave not enacted statutory compensation regimes5 for harms associated withGM crops, so “liability flowing from GM activities must be assessed throughthecommon lawof torts.”6Scholarly literaturehasexplored liability issues forproducersandfirmsthatproduceGMcrops7and,indeed,GMcropmanufacturersandproducershavefacedlitigation,suchasintheStarlinkmaize8andGMrice(LRICE601)9contaminationsintheUS.

Bycontrast,issuesofregulatorresponsibilityandliabilityforapprovalofGMcropshavereceived littleattention.ThispaperfocusesspecificallyonGMcropregulationinCanadaandontheparticularissueofwhetheragovernmentregulatoryagencycouldbefoundliablefor“negligentregulation”ofGMcrops.CommonlawjurisdictionssuchasCanadahavelongabandonedtheconceptofCrown immunity,with the result that theactionsofpublicofficialsandprivatecitizensaresubjectgenerallytothesamerulesoftortiousliability.10Thecommonlawrecognizes,however,thattheoftendistantrelationshipbetweenaregulatorandspecificindividualsorgroupsstrainsthenotionofaprivatelawdutyofcareand that governments must have room to maneuver when making regulatorydecisionswithoutthespectreofnegligenceclaims.

3. Fordiscussion,seee.g.BradleyMandrusiak,“PlayingwithFire:ThePrematureReleaseofGeneticallyEngineeredPlantsintotheCanadianEnvironment,”(2000)9Journal of Environmental Law and Practice 259–280(summarizingenvironmentalandhumanhealthconcernsassociatedwiththereleaseofGMplants)andRobertFService,“Agbiotech:AGrowingThreatDownontheFarm,”(2007)316:5828Science1114–1117(discussingconcernswiththeemergenceofherbicide-resistantweeds).

4. Seee.g.SaskatchewanOrganicDirectorate’sOrganicAgricultureProtectionFund,<http://www.saskorganic.com/oapf/index.html>.Thisorganizationsupportedan(ultimatelyunsuccessful)attempttolaunchaclassactionlawsuitagainstMonsantoonbehalfoforganicfarmersinSaskatchewan:Hoffman v Monsanto Canada Inc.,2007SKCA47,<http://www.canlii.org/en/sk/skca/doc/2007/2007skca47/2007skca47.pdf>,2007:283Dominion Law Reports, 4th ser.190(dismissaloftheclasscertificationapplication;leavetoappealtotheSupremeCourtofCanadarefused:<http://www.canlii.org/en/ca/scc-l/doc/2007/2007canlii55334/2007canlii55334.pdf>).

5. Foracomprehensivereviewofliabilityandcompensationschemesininternationaljurisdictions,seeBernhardAKoch,Liability and Compensation Schemes for Damage Resulting from the Presence of Genetically Modified Organisms in Non-GM Crops(EuropeanCentreofTortandInsuranceLawandResearchUnitforEuropeanTortLaw,AustrianAcademyofSciences,2007),<http://ec.europa.eu/agriculture/analysis/external/liability_gmo/full_text_en.pdf>.

6. LaraKhouryandStuartSmyth,“ReasonableForeseeabilityandLiabilityinRelationtoGeneticallyModifiedOrganisms,”(2007)27:3Bulletin of Science, Technology and Society215–232atp.222.

7. Seee.g.KhouryandSmyth,“ReasonableForeseeability,”supranote6;JaneMatthewsGlenn,“Footloose:CivilResponsibilityforGMOGeneWanderinginCanada,”(2004)43:3Washburn Law Journal547–573,<http://www.washburnlaw.edu/wlj/43-3/articles/glenn-jane.pdf>;NeilCraik,KeithCulver,andNormanSiebrasse,“GeneticallyModifiedCropsandNuisance:ExploringtheRoleofPrecautioninPrivateLaw,”(2007)27:3Bulletin of Science, Technology and Society 202–214;Koch,Liability and Compensation Schemes, supranote5.

8. ForadiscussionofinternationalcustomarylawandUSobligationsaswellasgeneralliabilityissuesposedbytheStarlinkincident,seeGurdialSinghNijar,“LiabilityandRedressforGMOHarm:TheStarlinkCaseStudy,”ThirdWorldNetworkBiosafetyInformationService,(8December2000),<http://www.twnside.org.sg/title/service9.htm>.ForfurtherreviewoftheUSregulatoryfailuresinvolvedintheStarlinkcontamination,seeFriendsoftheEarthInternational,GMO Contamination Around the World,2ded.(2001),<http://www.foei.org/en/publications/pdfs/contamination2eng.pdf>.

9. ForadiscussionofGMricecontamination,seeHeidiLedford,“OutofBounds,”(2007)445:7124Nature132–133;RickWeiss,“FirmBlamesFarmers,‘ActofGod’forRiceContamination,” The Washington Post,A5(22November2006),<http://www.washingtonpost.com/wp-dyn/content/article/2006/11/21/AR2006112101265.html>;KerriWalsh,“USDADeclaresBayerCropScience’sRiceSafe,”(2006)168:41Chemical Week 34.

10. Foracomprehensiveanalysisofhowthelawofgovernmentliabilityhasdeveloped,seeKarenHorsmanandJGarethMorley,Government Liability: Law and Practice (CartwrightLawGroup,2006),andPeterWHoggandPatrickJMonahan,Liability of the Crown,3ded.(Carswell,2000).


This paper begins with an overview of the Canadian framework forGM crop regulation and a discussion of criticisms about the adequacy of thisframework.TohighlightrecentlitigationoverGMcropapprovals,claimsagainstregulators in other jurisdictions are summarized. The paper then turns to ananalysisofthestateofCanadianlawregardingregulatoryliability.TheleadingcaseofAnns v Merton London Borough Council11 ispresented,followedbyananalysis of how Canadian courts have applied the Anns analysis to claims ofregulatory negligence. Indeed, Canadian courts continue to grapple with the“ongoingproblemofdeterminingwhenapublicauthoritycanbeheldliableinnegligence.”12Thelegalrequirementthattherelationshipbetweengovernmentregulator and plaintiff be of sufficient proximity to establish a duty of care,and the juridical distinction between government policies and operationalactivities,createanumbrellaofCrownimmunityfromnegligenceclaims.Currentjurisprudence, however, leaves open some unresolved bases of liability. Afterassessingpotentialregulator liability issuesassociatedwithCanadianGMcropregulation,weconcludewithabriefoverviewofrecommendationstoimprovetheCanadianregulatoryframeworkforGMcrops,focusingparticularlyonenhancingtransparencyinthedecision-makingprocess.

*2. THE CANADIAN REGULATORY FRAMEWORK FOR GENETICALLY

MODIFIED CROPS

the canadian food inspection aGency (cfia), established under the Canadian Food Inspection Agency Act13(CFIA Act),hasprimaryresponsibilityforregulationofGMcrops.ResponsiblefortheadministrationandenforcementoftheSeeds Act,14 CFIA is responsible for the assessment and regulation of all plants andcrops,includingproductsderivedfrombiotechnology.CFIAisalsoresponsibleforevaluatingnewfertilizers,livestockfeeds,andveterinarybiologics,includingthoseproductsdevelopedusingbiotechnology,pursuanttotheFertilizers Act,15 the Feeds Act16 and the Health of Animals Act.17 The federal Minister ofAgriculture and Agri-Food maintains responsibility for the overall direction ofCFIA.18

OtherfederaldepartmentscarryoutfunctionsrelatedtoGMproducts.Health Canada is responsible under the Food and Drugs Act (FDA) and

11. Anns v Merton London Borough Council(UKHL,1977),<http://www.bailii.org/uk/cases/UKHL/1977/4.html>,1977:2All England Law Reports 118,1978Law Reports, Appeal Cases, 3d ser. 728[Anns].

12. Holland v Saskatchewan (Minister of Agriculture, Food & Rural Revitalization)2007SKCA18,<http://www.canlii.org/en/sk/skca/doc/2007/2007skca18/2007skca18.pdf>,2007:281Dominion Law Reports,4th ser.349,atpara.1;appealtoSCCallowedinpart,2008SCC42.

13. Canadian Food Inspection Agency Act,1997Statutesof Canadach.6,<http://laws.justice.gc.ca/en/showtdm/cs/C-16.5>[CFIAAct].

14. Seeds Act,(1985)Revised Statutes of Canadach.S-8,<http://laws.justice.gc.ca/en/showtdm/cs/S-8>.15. Fertilizers Act,(1985) Revised Statutes of Canadach.F-10,<http://laws.justice.gc.ca/en/showtdm/cs/F-10>.16. Feeds Act,(1985) Revised Statutes of Canadach.F-9,<http://laws.justice.gc.ca/en/showtdm/cs/F-9>.17. Health of Animals Act,1990Statutes of Canadach.21,<http://laws.justice.gc.ca/en/showtdm/cs/H-3.3>.18. SeeCFIAAct,supranote13,s.4(1).


associatedregulations19forconductingsafetyassessmentsforallnewfoodsanddrugs,includingproductsdevelopedusingbiotechnology.EnvironmentCanadahasresponsibilityundertheCanadian Environmental Protection Act (CEPA)forregulatingproductsforusesnotaddressedunderotherfederallaws.

The regulatory regimeunder theSeeds Act andSeeds Regulations isproduct–based,ratherthanprocess–based,meaningthattraitnoveltyinaplanttriggersregulatoryreview,regardlessoftheprocessbywhichthetraitwascreated(through conventional breeding, recombinant DNA technology or anotherprocess).PartVoftheSeeds Regulations definesa“noveltrait”asfollows:

“noveltrait”,inrespectofseed,meansacharacteristicoftheseedthat

(a) hasbeen intentionally selected, createdor introduced intoadistinct,stable population of cultivated seed of the same species through aspecificgeneticchange,and

(b)based on valid scientific rationale, is not substantially equivalent, intermsof its specificuseandsafetyboth for theenvironmentand forhumanhealth, toanycharacteristicofadistinct, stablepopulationofcultivated seed of the same species in Canada, having regard toweediness potential, gene flow, plant pest potential, impact on non-targetorganismsandimpactonbiodiversity.20

In assessing a plant with a novel trait, the regulations require considerationof “all relevantmatters, including […] thepotential impactonand risk to theenvironment,includingthepotentialimpactonandrisktohumanhealth,posedby the proposed release”21 of a seed, including a seed with novel traits. Theenvironmental and human health risks associated with release (ranging fromminimal to unacceptable risk) must be assessed, which requires evaluation ofscientific data and specialized knowledge. The regulations give authority toreject,approveandimposeconditionsonthereleaseofseeds.

*3. CRITICISMS OF THE CANADIAN REGULATORY FRAMEWORK

one of the most debated aspects of the canadianregulatoryframeworkconcernstheuseof“substantialequivalence”asthedecisionthresholdintheassessment

19. Food and Drugs Act, (1985)Revised Statutes of Canadach.F-27,<http://laws.justice.gc.ca/en/showtdm/cs/F-27>.In1999,theFood and Drug Regulations,(1987)Consolidated Regulations of Canadach.870,<http://laws.justice.gc.ca/en/showtdm/cr/C.R.C.-c.870>,undertheActwereamendedtoincludeDivision28(27October1999)133:22Canada Gazette—Part II948,<http://canadagazette.gc.ca/partII/1999/19991027/html/sor392-e.html>,whichaddressesnovelfoods.

20. Seeds Regulations,(19December1996)131:1Canada Gazette—Part II,s.107(1).21. Regulations Amending the Seeds Regulations,(15August2001)135:17Canada Gazette—Part II274,

s.111(1),<http://canadagazette.gc.ca/partII/2001/20010815/html/sor274-e.html>.


processforagriculturalGMproducts.22Asnotedabove,Canadaoperatesonaproduct-based model of GM regulation such that the regulatory safetyevaluations focuson thecharacteristicsof theendproduct rather thanon theprocesses used to develop the novel plant or food. The assessment involvesdeterminationoftheextenttowhichanovelplantis“substantiallyequivalent”toitsconventionalcounterpartexceptfordefineddifferences,andtheanalysisthen focuses on these defined differences.23 Both CFIA and Health Canadaoperate within this decision-making framework, each using the substantialequivalencestandardforevaluatingnewproductsderivedfrombiotechnology.

The clarity of CFIA’s application of substantial equivalence in theregulationofagriculturalbiotechnologyhasbeenafocusofcriticism.Acentralconcernrelatestothefactthat,whenaGMcropproposedforcommercializationisdeemedsubstantiallyequivalenttoanon-GMvariety,inpracticethisdesignationeffectively“pre-emptsanyrequirement[...]toassessfurtherthenewvarietyforunanticipatedcharacteristics.”24The2001ExpertPanelon theFutureofFoodBiotechnologyinCanadalistedproperconceptualandpracticalimplementationofsubstantialequivalenceasthemostcriticalelementinthecurrentregulatoryapprovalprocessinCanada,notingthatwhenanovelplantorfoodisjudgedtobesubstantiallyequivalenttoonepresentintheCanadiandiet,“passageofthisstepinthedecisiontreespellssuccessforitsapproval.”25

While the substantial equivalence analysis factors heavily into thedetermination process, questions have been raised about ambiguities in itsinterpretationandapplication.The2001ExpertPanelidentifiedtwoalternativeanddistinctinterpretationsof“substantialequivalence”inrelationtoregulationofGMproducts.Underthemoreprecautionary“safetystandard”interpretation,a GM organism is “substantially equivalent” if rigorous scientific analysisestablishesthattheorganismposesnomorehealthorenvironmentalrisksthanitsconventionalcounterpart,despiteallchangesresultingfromtheintroductionof novel genes. By contrast, under the less restrictive “decision threshold”interpretation,aGMorganism(GMO)

is“substantiallyequivalent”if,onthebasisofreasoninganalogoustothatused

in the assessment of varieties derived through conventional breeding, it is

assumedthatnochangeshavebeen introduced into theorganismother than

thosedirectlyattributabletothenovelgene.Ifthelatteraredemonstratedtobe

22. ForcriticismsofthesubstantialequivalenceprincipleanditsapplicationinGMcropregulationinCanada,seeRoyalSocietyofCanada,Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, ExpertPanelReportontheFutureofFoodBiotechnology(TheRoyalSocietyofCanada,2001),<http://www.rsc.ca//files/publications/expert_panels/foodbiotechnology/GMreportEN.pdf>;AlexanderSingh,“ProceedwithPrecaution:TheStatutory,Legal,andConsumerInfluenceofGeneticallyModifiedFoodsinCanada,”(2005)4Canadian Journal of Law and Technology 181–193,<http://etc.dal.ca/cjlt/vol4_no3/pdfarticles/singh.pdf>;PeterAndrée,“AnAnalysisofEffortstoImproveGeneticallyModifiedFoodRegulationinCanada,”(2006)33:5Science and Public Policy377–389,<http://etc.dal.ca/cjlt/vol4_no3/pdfarticles/singh.pdf>.

23. JaneMatthewsGlenn,“GeneticallyModifiedCropsinCanada:RightsandWrongs,”(2003)12Journal of Environmental Law and Practice281–310atp.307;DPate,Genetically Modified Feeds for Livestock(December2000).

24. RoyalSocietyofCanada,Elements of Precaution, supranote22atp.180.25. RoyalSocietyofCanada,Elements of Precaution, supranote22atp.180.SeealsoCanadianBiotechnology

AdvisoryCommittee[CBAC],Improving the Regulation of Genetically Modified Foods and Other Novel Foods in Canada(CanadianBiotechnologyAdvisoryCommittee,2002),<http://cbac-cccb.ca/epic/site/cbac-cccb.nsf/en/ah00186e.html>.


harmless,theGMorganismispredictedtohavenogreateradverseimpactsupon

healthorenvironmentthanitstraditionalcounterpart.26

ThePanelaffirmedthescientificvalidityoftheformer“safetystandard”interpretationofsubstantialequivalence,whileexpressing“gravereservations”about use of the latter “decision threshold” interpretation.27 Its report noteshow substantial equivalence is commonly used in practice by governmentregulatory agencies under the “decision threshold” interpretation, whilepublic statements by these same agencies defending substantial equivalence“oftenplayupon its inherent ambiguity”by suggesting the“safety standard”interpretation.28IninterviewswiththePanel,CFIArepresentativesclaimedthatsubstantial equivalence “is used more as a guiding principle than as an endpoint (decision threshold).”29 After reviewing the Canadian regulatory schemeand conducting interviews with agency representatives, however, the PanelconcludedthattheCanadianregulatorymodelisconsistentwiththelatter,lessrestrictiveinterpretationofsubstantialequivalenceas“decisionthreshold.”30Thisconclusionmeansthat,inpractice,CFIAdesignationsofsubstantialequivalenceareoftenbasedon“unsubstantiatedassumptionsabouttheequivalenceoftheorganisms,byanalogywithconventionalbreeding,”31ratherthanonafullandrigorousanalysisofallofthecharacteristicsoftheGMorganisminquestion.32

Inadditiontoconcernsaboutapplicationofthesubstantialequivalencestandard,theCanadianregulatoryframeworkhasbeencriticizedforinadequateconsideration of potential socio-economic impacts related to GM cropproduction.33IncontrasttoCanada’sGMcroppolicy,theEuropeanUnion(EU)regulatoryapproachincludessocio-economicandethicalissuesintheevaluationprocessandreliesontheprecautionaryprincipleasthedecisionthresholdduringthe evaluative process.34 Opponents, however, characterize the precautionaryprincipleasbeingbasedonunfoundedfearsandsuggestthatitoperatesasan

26. RoyalSocietyofCanada,Elements of Precaution, supranote22atp.182.ThePanelnotedthatreviewofCFIAregulationofGMplants“demonstrateshowinitialfindingsof‘familiarity’and‘substantialequivalence’areusedtoexemptnewplantsfromthethirdstep,whichisthefullenvironmentalsafetyassessment.”

27. RoyalSocietyofCanada,Elements of Precaution, supranote22at p.183.28. RoyalSocietyofCanada,Elements of Precaution, supranote22at p.182.29. RoyalSocietyofCanada,Elements of Precaution, supranote22at pp.36–37.30. RoyalSocietyofCanada,Elements of Precaution, supranote22at p.182.31. RoyalSocietyofCanada,Elements of Precaution, supranote22atp.182(emphasisinoriginal).32. ForfurtherdiscussionoftheuseofsubstantialequivalenceinCanada,seee.g.PeterAndrée,“The

BiopoliticsofGeneticallyModifiedOrganismsinCanada,”(2002)37:3Journal of Canadian Studies162–191;Singh,“ProceedwithPrecaution,”supra note22;Andrée,“AnalysisofEfforts,”supranote22.

33. Forexample,theheadsoftenconcernedorganizationswrotetothefederalMinisterofAgriculturerequestingthattheregulatorysystembeadaptedtoincludeacost-benefitanalysisthatincorporatesissuessuchasmarketimpactsandfarmerrevenueintotheapprovalprocess,althoughthefederalgovernmenthasnotactedonthissuggestion.SeeGlenn,“Footloose,”supra note7atp.569,footnote81.

34. SeeEuropean Community Regulation No. 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(EU),O.J.L.31/1,Article7,<http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:031:0001:0024:EN:PDF>(ontheprecautionaryprinciple).


uncertain,unscientifichindranceontechnologicalandeconomicdevelopment.35

CriticismoverCFIA’sscientificassessmentprocedure isheightenedbyalackoftransparencyabouttheevaluationandapprovalprocess,asneitherthescientificcommunitynorthepubliccanreviewpertinentdetailsoftheinformationconsideredduringregulatoryassessment.FollowingtheapprovalofanewGMplant for unconfined release into the environment, CFIA makes informationabouttheapprovalavailableonitswebsite,explainingtheconclusionsreachedandprovidingthegeneralbasisofthedecision.36Arguablythemostimportantinformation,at least fromapublic intereststandpoint, isnot revealed:neitherthestudiesonwhichtheassessmentisbasednortheirresultsareincludedintheDecisionDocument.Thepubliccanonlyreviewthegeneralconclusionsoftheregulatoryapprovalandexamine relevant statutesand regulations tosee thatcompaniesare, infact,requiredtosubmitextensive informationandstatisticaldata.Yet,astheExpertPanelnoted,whiletheseregulationsareextensiveintheirrequiredinformation,thereisnowayforthepublictoknow“theextenttowhichthese information requirements are actually met during the approval process,orofassessingthedegreetowhichtheapprovalsarefoundedonscientificallyrigorousinformation.”37

The narrow scope of the information disclosed in CFIA’s DecisionDocumentshighlightstheagency’songoingstruggletobalancethepublicinterestinaccesstoregulatoryinformationagainstthebusinessinterestsofcompanies.Asaresult,“[c]urrentregulatorypracticeinCanadaprotectstheconfidentialityof[…]test[ing]datasubmitted”bytheapplicant,since“[d]ataidentifiedby[these]companiesasConfidentialBusinessInformation(CBI)isprotectedunderfederalaccesstoinformationlaws.”CBImaterialscanonlybereleased“withapprovaloftheowneroftheproprietaryinformation.”38

CFIAdealswithGMcropapplicantsonacase-by-casebasisandcouldinsist on greater information disclosure, but this response is often difficult ina regulatory environment where the government seeks to promote industryresearchanddevelopmentasapolicypriority.AsoneAgricultureCanadaofficialsuggested, theobjectiveof regulatory agencieswith regard tobiotechnologyis to implement regulations to ensure “the products can be used withoutadverselyaffectinghumanandanimalhealth,andtheenvironment[,butare]not[…]sorestrictiveortime-consumingtofulfillthatindustrylosesitscompetitive

35. Seee.g.JohnHodgson,“ScientistsCryFoulasEuropePlaysPoliticswithGMCrops,”(2008)26:2Nature Biotechnology139–140atp.139(discussingarecommendationtotheEuropeanCommission(EC)fromitsscientificadvisorybodytoapprovetwoGMmaizevarieties;theEChasstalledonadecision,citingnewpapersthatquestionlong-termenvironmentalsafety;theEuropeanFederationofBiotechnologychargestheECis“cherry-pick[ing]publicationsclaimingpossibledangers.”);RichardJMahoney,“OpportunityforAgriculturalBiotechnology,”(2000)288Science615;HenryMillerandGregoryConko,“Replyto‘PrecautionaryPrinciple,’”LettertotheEditor,(2000)18:7Nature Biotechnology 697;FlorianWeighardt,“EuropeanGMOLabelingThresholdsImpracticalandUnscientific,”(2006)24:1Nature Biotechnology23–25.

36. CanadianFoodInspectionAgency,Decision Documents— Determination of Environmental and Livestock Feed Safety,<http://www.inspection.gc.ca/english/plaveg/bio/dde.shtml>.

37. RoyalSocietyofCanada,Elements of Precaution, supranote22atp.214.ThePanelconcludedafteritsreviews,includingdiscussionswithCFIArepresentatives,thatalthoughthebiotechnologycompanyapplicantsweresometimesaskedtoprovidenewdata,nomethodexistedforindependentreviewofeitherthequalityofthescientificdataorthevalidityoftheexperimentaldesignused.Itsreportnotedthatliteraturereviewsappearedtocompriseasignificantportionofthedecision-makingprocess.

38. SeeRoyalSocietyofCanada,Elements of Precaution, supra note22 at p.212.


advantageandseeksmarketsoutsidethecountry.”39Yetsincethecrucialstagesofregulatorydecision–makingareconcealed

frompublicview—withthe largerscientificcommunityunableeventoconfirmorchallenge thevalidityof thedataonwhich theassessmentsarebased—nomechanism exists for objective verification of claims about a particular GMproduct under the current regulatory structure. Independent and objectivescientific verification constitutes a foundational part of the scientific method,which is characterized by full and open access to clinical methodologies andtrialresults(asexemplifiedintheacademicpeerreviewprocess).InoneknownreviewofdatathatCFIAusedtoassesstheinvasivenessofMonsanto’sRoundupReadyCanola,thereviewerconcludedthatthedatawasscientificallyinadequatefor either a rational regulatory decision-making process or a peer-reviewedpublication.40TheExpertPanelontheFutureofFoodBiotechnologyagreedwiththisconclusion.41

An overarching regulatory issue related to these important concernsabouttransparencyandtheuseofscientificdatawithinCanadianpolicyinvolvesthe perception of undue industry influence and the appearance of potentialconflicts of interest arising from the organizational structure and operationalpracticesofCFIA.ThegoaloftheAgencyisbothtoregulatethesafetyofproductsderivedfrombiotechnologyandtopromoteandfacilitatethedevelopmentofaninternationallycompetitivebiotechnologyindustry.42AgricultureandAgri-FoodCanada (AAFC) invests approximately $60 million in biotechnology researchand development each year, which includes collaborating with biotechnologycompanies in executing field tests of GM crops under investment matchinginitiatives,whileat the same timeAAFCstands toearnbetweenoneand tenpercentroyaltiesonMonsanto’sRoundupReadywheatifitisapproved.43CriticshavequestionedasysteminwhichCFIA,theregulatorybodythatdealswiththeevaluationandapprovalofGMcrops, isundertheaegisofAAFC,thefederaldepartment that is investeddirectly in thepromotionalandcommercializationaspectsofGMcropdevelopment. Theperceptionof conflicting interests andundueinfluenceongovernmentpolicyseemsinherentinthecurrentoperationalstructure:

If the same government agency that is charged with theresponsibility to protect the public health and environmentalsafetyfromrisksposedbytechnologiesalso ischargedwiththepromotionofthatsametechnology,andifitssafetyassessmentsare, by official policy, balanced against the economic interests

39. JeanHollebone,“AnOverviewoftheCanadianFederalandAgriculturalRegulatoryFrameworksforBiotechnology,” CARC Workshop on Biotechnology Regulation (Ottawa,5-6December1988),citedinElisabethAbergelandKatherineBarrett,“PuttingtheCartBeforetheHorse:AReviewofBiotechnologyPolicyinCanada,”(2002)37:3Journal of Canadian Studies135–161atp.141.

40. KatherineJ.Barrett,Canadian Agricultural Biotechnology: Risk Assessment and the Precautionary Principle (PhDDissertation,UniversityofBritishColumbia,1999)[unpublished],<http://www.collectionscanada.gc.ca/obj/s4/f2/dsk1/tape2/PQDD_0018/NQ48601.pdf>.

41. RoyalSocietyofCanada,Elements of Precaution, supranote22atp.215.42. CanadianFoodInspectionAgency,“AgencyOverview,”<http://www.inspection.gc.ca/english/agen/broch/

broche.shtml>.CFIAstatesthatitstrivestoimplementa“fairandeffectivefood,animalandplantregulatoryregimethatsupportscompetitivedomesticandinternationalmarkets.”

43. JasonWarick,“LiningUpAgainstGMWheat,”Saskatoon Star Phoenix(9August2003),availableatSaskatchewan Organic Directorate’s website,<http://www.saskorganic.com/oapf/snn-09aug03.html>.


of the industries that develop them, this represents, from thepointofviewofboththepublicandthe industrialstakeholders,asignificantconflictofinterest.Eachstakeholderisplacedinthepositionofhavingtoask,withrespecttoeachregulatorydecision,whetheritsowninterestshavebeenundulycompromisedbytheinterestsoftheother.44

Concerns about lack of transparency in the regulatory process,applicationofthesubstantialequivalenceconcept,andthetreatmentofscientificdata during safety assessments have been central to policy discussions andreformrecommendations.45Issuesaroundtheperceptionofconflictinginterestsorundueindustryinfluenceongovernmentpolicygototheheartoftheintegrityof the regulatory system in Canada. Such concerns are intimately connectedwith the public’s confidence in government regulation, as well as the desirefor environmental, health and safety evaluation procedures and governmentoversightpracticestokeeppacewithtechnologicaldevelopmentsintherapidlyexpandingbiotechnologysector.

*4. OVERVIEW OF RECENT GM CROP LAWSUITS AGAINSTREGULATORS

to date, canadian federal reGulators have not beensuedinnegligencefortheirGM crop approval decisions, though such action was briefly threatened inSaskatchewan.46 Legal challenges have arisen in other jurisdictions, primarilyallegingthatregulatoryagenciesfailedtocomplywithstatutoryenvironmentalassessment requirements in their GM crop approval decisions. While theseclaimsarenotdirectlyanalogoustoaprivatelawclaimofnegligence,theydoillustrate scenarios where GM crop opponents sought legal recourse againstregulatorydecisions,andsimilarcircumstancesinCanadacouldinstigateclaimsofregulatorynegligence.

IntheUnitedStates,therewereseveralsuccessfullegalactionsagainsttheUSDepartmentofAgriculture (USDA) in2006and2007,eachconcerningregulatoryapprovalsthattookplacewithoutadequatecompletionofthelegallymandatedenvironmentalassessments.InthreesuitsledbytheCenterforFoodSafety (CFS), federal judges found that the USDA had either inadequatelyperformed,ornotconductedatall,theenvironmentalevaluationsthatmustbe

44. RoyalSocietyofCanada,Elements of Precaution, supranote22atp.212.45. Seee.g.RoyalSocietyofCanada,Elements of Precaution, supranote22; CBAC,Improving the Regulation,

supra note25;AnneClark,“RegulationofGeneticallyModifiedCropsinCanada:Science-Basedor…?”(PaperpresentedtotheSafe FoodConference,SaltSpringIsland,BritishColumbia,August2003)[unpublished];Andrée,“AnalysisofEfforts,”supra note22.

46. Ina2001newsarticleintheWestern Producer regardingthethen-pendingSaskatchewanOrganicDirectoratelawsuitagainstMonsantoCanadaInc., reporterSeanPrattsummarizedcommentsfromDaleAdolphe,presidentoftheCanolaCouncilofCanada,that“growersandcreatorsofGMcanolahavedonenothingillegalbecausetheproductshavepassedfood,feed,environmentalandsafetyregulationsandhavemadeitthroughthevarietyregistrationsystem.”PrattquotesAdolpheasstating:“Iftheclassactionshouldbetargetedatanybody,itwouldbetargetedattheregulatorysystemsthatallowedthat.”Prattalsostatesthat“SaskatchewanOrganicDirectorateofficialssaidthefederalgovernmentandotherpartiesmaybeincludedinlegalaction,butthemaintargetwillbeMonsanto.”SeeSeanPratt,“ProposedGMLawsuitMayStirMajorWaves,”Western Producer (18October2001),availableat<http://www.mindfully.org/GE/GE3/Lawsuit-Major-Waves.htm>.


conductedprior to testingorcommercialization.47 InGeertson Seed Farms, et al. v Johanns,48acaseconcerningtheUSDA’sapprovalofMonsanto’s“RoundUpReady”GMalfalfaforcommercialsale,aFederalCourtfoundthattheUSDAhad violated environmental protection regulations pursuant to the National Environmental Policy Act(NEPA)byapprovingaGMcropforcommercializationwithoutcompletingaproperEnvironmentalImpactStatement(EIS).NotingtheUSDA’sfailuretoaddressvariousenvironmentalrisks, includingtheriskofGMcropcontaminationandpotentiallytheeventualdestructionoforganicalfalfaintheregion,49JudgeBreyeroftheFederalDistrictCourtoftheNorthernDistrictofCaliforniahaltedtheGMalfalfaproductionbygrantingapermanentinjunction.TheCourt’srulingrequirestheUSDAtoconductafullEIScontainingathoroughevaluationoftheenvironmentalrisksinvolvedbeforecommercializationofGMalfalfacanresume.50

Duringthesamemonth,JudgeKennedyoftheFederalDistrictCourtoftheDistrictofColumbiaalsofoundthattheUSDAactedunlawfullyinapprovingfield trials of GM Creeping Bentgrass and Kentucky Bluegrass.51 The USDAbypassedenvironmentalreviewduringtheapprovalprocessbyclaimingthatthetrialswere“categoricallyexcluded” from the federally requiredenvironmentalriskassessments.JudgeKennedyruledthattheUSDAhadwrongfullyexemptedGMBentgrassfromtheNEPA’senvironmentalreviewrequirements,notingthatthereis“substantialevidencethatthefieldtestsmayhavehadthepotentialtoaffectsignificantlythequalityofthehumanenvironment.”52TheCourtorderedtheUSDAtohaltapprovalofallnewfieldtrialsuntilfullenvironmentalreviewsarecompletedforeachspecifictrial.53ThisdecisionhassignificantimplicationsintheUnitedStatessincetheUSDAhadcommonlyusedthe“categoricalexclusion”argumenttoavoidenvironmentalassessmentsforfieldtrialsinrecentyears.54

Severalmonthsbeforethesetwolandmarkjudgments,JudgeSeabrightoftheFederalDistrictCourtfortheDistrictofHawaiiruledtheUSDAviolatedtheEndangered Species Act(ESA)byapprovingfieldtrialsofbiopharmaceuticalGM corn and sugarcane without considering the potential impact onendangeredspecies.TheUSDA’sfailuretocompleteafullenvironmentalsafetyassessmentalsoviolatedtheNEPA.55Thiscasemarkedthefirstfederalrulingonbiopharmaceuticalcrops,andtheCourtmadeclearthattheseGMcropsmustbetestedinamannerthatcomplieswiththeenvironmentalandspeciesprotectionlawsintheNEPAandESA.

LegalactionoverGMcropregulationhasalsobeendirectedattheUS

47. SeeCenterforFoodSafety,Gaining Ground in the Courts: The Center for Food Safety’s Recent Victories in the Battle over Genetically Engineered Crops,(CenterforFoodSafety,2007),<http://www.centerforfoodsafety.org/pubs/USDA%20Violates%20Env’l%20Laws%20on%20GE%20Crops_FINAL.pdf>.

48. Geertson Seed Farms v Johanns (USACANDistCt,2007).<http://www.cand.uscourts.gov/cand/judges.nsf/ba8bc702282ba44588256d480060b732/05528e50cbd9a1c78825728200027954/$FILE/6-1075%20Geertson.pdf>,Case3:06-cv-01075-CRBDocument83,Filed02/12/2007.

49. Geertson Seed Farms, supra note48atpp.8,13.50. Geertson Seed Farms, supra note48atp.19.51. International Center for Technology Assessment v Johanns.(USADCDistCt,2007),<https://ecf.dcd.

uscourts.gov/cgi-bin/show_public_doc?2003cv0020-94>,473Federal Supplement 2d ser.9.52. International Center for Technology Assessment, supra note51atp.32.53. International Center for Technology Assessment, supra note51atpp.33–34.54. CenterforFoodSafety,“GainingGroundintheCourts,” supranote47atp.2.55. Center for Food Safety v Johanns (USAHIDistCt,2006),availableattheCFSwebsite,<http://www.

centerforfoodsafety.org/pubs/ORDER%208-10-06.pdf>,451Federal Supplement,2d ser.1165.


EnvironmentalProtectionAgency(EPA).In1999,GreenpeaceledacoalitionofenvironmentalistsandotheractivistsinfilingalawsuitagainsttheEPAtoforcetheagencytoreverseitsapprovalofBt(Bacillus thuringiensis)transgeniccrops.56The plaintiffs alleged that the agency violated federal law when several Bt-producingplantswereapprovedforcommercialsale.TheyarguedtherewasahighlikelihoodthattheBtproductscouldcauseenvironmentalharm,includingthe potential development of resistance to Bt insecticides. In the openingsessionoforalhearings,JudgeLouisOberdorderoftheFederalDistrictCourtofWashington,DC,statedthathewould“hold[theEPA’s]feettothefire”ontheissueofBtcrops.57Aftersuccessfullyopposingapreliminaryapplicationforsummarydismissaloftheclaim,theplaintiffs laterwithdrewthe lawsuit inJuly2000, vowing to continue the challenge against EPA’s Bt crop policy. JosephMendelson,anattorneyforCFS,oneoftheco-plaintiffs,explainedthatthesuitwaswithdrawninpartbecauseseveraloftheBtcropswereupforimmediatere-considerationbytheEPA,meaningsomeelementsofthelawsuitweresettobe“mootedout.”58

InIndonesia,regulatoryapprovalofBtcropsforcommercializationalsoresultedinacontentiousbutultimatelyunsuccessfullawsuitagainsttheIndonesiangovernment, again followingaGMcrop regulatoryapprovalprocess thatwasheavily influenced by industry interests. A coalition of 72 non-governmentalorganizations (NGOs) filed legal action against a Ministry of AgricultureDecreeallowing the commercialproductionofMonsanto’sBt cotton inSouthSulawesi.59Theplaintiffscontendedthatnoneoftheprerequisitebiosafetytestsweremadepublicorindependentlyreviewed,thatfarmerswerenotinformedofallpotentialrisksandeffects,andthatgovernmentofficialshadrejectedoutrighttherecommendationforanindependentriskassessment.Fromtheoutsetofthetrial, the Indonesian subsidiary of Monsanto worked to influence its outcome,appealingforandwinningtherighttobeaddedasadefendanttodisputetheclaim. While the suit against the government was ultimately unsuccessful, theextenttowhichMonsantohadinfluencedIndonesia’sregulatoryapprovalofBtcottonbecameclearseveralyears later: inJanuary2005,Monsanto(USA)wasfined USA$1.5 million for bribing Indonesian government officials to avoid adecreerequiringanenvironmentalriskassessmentforBtcotton.60

56. Greenpeace International, et al. v Browner(USADCDistCt,1999),DocumentNo.99-cv-389(LFO).57. See“GreenpeaceWinsFirstRoundinEPALawsuittoBanBtCrops,”(GreenpeaceInternational,19January

2000),availableatOrganicConsumersAssociation’swebsite,<http://www.organicconsumers.org/ge/grnpeacesuit.cfm>.

58. QuotedinJeffreyLFox,“WithdrawnGreenpeaceBtSuitEntersSpinCycle,”(2000)18:9Nature Biotechnology 920atp.920.

59. “RedesigningNature:KeepingBtCottonoutofIndonesia,”(2001)31The Ecologist17.60. Seee.g.“MonsantoFined$1.5mforbribery,”BBC News (7January2005)<http://news.bbc.co.uk/2/hi/

business/4153635.stm>;“FormerexecutiveofMonsantofinedforbribingIndonesianofficial,”The International Herald Tribune(8March2007)F14,<http://www.iht.com/articles/2007/03/07/yourmoney/monsanto.php?pass=true>.


*5. A CAUSE OF ACTION FOR REGULATORY NEGLIGENCE IN CANADA?

this paper has so far discussed the canadian Gm cropregulatoryframeworkandsummarizedconcernsexpressedaboutsomeaspectsoftheGMcropregulationprocess,especiallyconcernsaboutthewayinwhichplantswithnoveltraitsareassessed, industry influence over decisions and inadequate opportunities forregulators toconsiderbroader socio-economic impacts.Examplesof litigationagainst regulators in other jurisdictions illustrate situations where critics havesoughtlegalrecoursefordeficienciesintheGMOregulatoryreviewprocess.Thequestion,now,iswhetheracauseofactionforregulatorynegligenceisviableinCanadaforregulatordecisionsaboutapprovalapplicationsforGMcrops.Thefollowing section discusses the current state of Canadian law regardinggovernmentliabilityfornegligence,summarizesrecentcasesinvolvingclaimsofregulatory negligence, and identifies several unresolved questions that mayleaveopenthedoorforfutureclaimsofliabilityagainstregulatoryauthorities.

GovernmentbodiesinCanadamayfaceliabilityinnegligenceifaplaintiffcansatisfythetwo-steptestfirstsetoutintheUKHouseofLordsdecisioninAnns v Merton London Borough Councilandsubsequentlyappliedby theSupremeCourtofCanada:

Firstonehastoaskwhether,asbetweentheallegedwrongdoerandtheperson

who has suffered damage there is a sufficient relationship of proximity or

neighbourhood such that, in the reasonable contemplation of the former,

carelessnessonhispartmaybelikelytocausedamagetothelatter—inwhich

caseaprimafaciedutyofcarearises.Secondly,ifthefirstquestionisanswered

affirmatively, it is necessary to consider whether there are any considerations

whichoughttonegative,ortoreduceorlimitthescopeofthedutyortheclass

ofpersontowhomitisowedorthedamagestowhichabreachofitmaygive

rise[...].61

TheSupremeCourtofCanadahasinstructedthat:

AtthefirststageoftheAnnstest,twoquestionsarise: (1)wastheharmthat

occurredthereasonablyforeseeableconsequenceofthedefendant’sact?and(2)

aretherereasons,notwithstandingtheproximitybetweenthepartiesestablished

inthefirstpartofthistest,thattortliabilityshouldnotberecognizedhere?62

Inaclaimof regulatorynegligence, then, theanalysismust focusfirston the relationship between the government and the plaintiff and whetherthe latter’sharm isa foreseeable resultof thegovernment’sallegednegligentconduct. A government regulator is often not in a relationship of sufficient

61. Anns, supra note11atpp.751–752(citedtoAppeal Cases).FortheSupremeCourtofCanadadiscussionandapplicationofAnns,seee.g.Kamloops (City) v Nielsen(CANSC,1984),<http://scc.lexum.umontreal.ca/en/1984/1984rcs2-2/1984rcs2-2.pdf>,1984:2Supreme Court Reports 2;Just v British Columbia(CANSC,1989),<http://scc.lexum.umontreal.ca/en/1989/1989rcs2-1228/1989rcs2-1228.pdf>,1984:2Supreme Court Reports 2[Just];Cooper v Hobart,2001SCC79,<http://scc.lexum.umontreal.caen/2001/2001scc79/2001scc79.pdf>,2001:3Supreme Court Reports537[Cooper].

62. Cooper,supra note61atpara.30.


proximitytoaspecificclassofpersonstogiverisetoaprivatelawdutyofcare,typicallybecause regulation is aimedat thebroadpublic interest, rather thaninterestsofparticularindividualsorgroups.Ithasbeennotedthat“incasesofanallegedregulatoryfailure,theconceptofproximityhasawkwardapplicationbecausethe‘relationship’betweenthepartiesisoneentirelybasedinstatute.”63It is important, therefore, to consider carefully the languageof thegoverningstatutetodetermineifthelegislativetextobligestheregulatortoregulateintheinterestsofaspecificgroup.Insuchacase,membersofthatgroupmayhaveastrongerclaimthattheregulatormustperformitsfunctionsinawaythatdoesnotcauseforeseeableharmtomembersofthatspecificgroup.

The second stage of the Anns test examines “whether there areresidual policy considerations outside the relationship of the parties that maynegativetheimpositionofadutyofcare.”64Theseconsiderationsfocusontheundesirable consequences of imposing Crown liability, including the “spectreof unlimited liability to an unlimited class.”65 An important issue at this stageiswhetherthe impugnedgovernmentactivityconstitutesanexerciseofpolicyauthority or the operational implementation of policy. The Supreme Court ofCanadahasconfirmedonnumerousoccasionsthatthegovernmentisprotectedfromnegligenceliabilityforitspolicydecisions,butisliablefornegligenceinitsoperationalactivities.66Drawingthedistinctionbetweenpolicyandoperationalactivity isnotstraightforward;asHorsmanandMorleyobserve,“[t]hedividinglinebetweenpolicyandoperationsislessthanprecise.Theinherentambiguityoftheseconceptshasresultedindecidedcasesthataredifficulttorationalize,which inturnmakesoutcomesdifficult topredict.”67Nonetheless,establishingthe line between policy and operations is important to account for the factthat governments engage in “decision-making of a generality and complexitythataCourtcannotbeexpectedtoevaluate, letalonereplicate.”68 Ingeneralterms, the following types of activities have been held to constitute activitiesthatareimmunefromnegligenceliability:prioritysettingdecisionsthatrequiregovernments to balance limited resources and competing social and politicalinterests;69 legislative or quasi-judicial decisions;70 and decisions made underdiscretionarypowersconferredbystatute.71

Innegligenceclaimsagainststatutoryregulators,CanadiancourtshavetendedtofocusonthefirststepintheAnns analysistoscrutinizewhetheradutyofcareexistsbetweentheregulatorandtheplaintiff.Wheretheallegeddutydoesnotfallintoapreviouslyacceptedproximaterelationshipgivingrisetoaprivatelawduty,72thedutymaybefoundfromthelanguageofthestatute;“[i]nnovelregulatorycontexts,adutyofcarewillbefoundonlyifthegoverningstatutory

63. HorsmanandMorley,Government Liability, supranote10atpp.5–6.64. Cooper,supra note61atpara.30.65. Cooper,supra note61at para.37.66. Seee.g.Cooper,supra note61atpara.38;Just, supra note61.67. HorsmanandMorley,Government Liabilitysupra note10atpp5–27.68. HoggandMonahan,Liability of the Crown, supra note10atp.164.69. Seee.g.Just, supra note61.70. Seee.g.Wellbridge Holdings Ltd. v Winnipeg (City)(CANSC,1971),<http://scc.lexum.umontreal.ca/

en/1970/1971rcs0-957/1971rcs0-957.pdf>,1971Supreme Court Reports 957.71. Seee.g.Home Office v Dorset Yacht Co.1970UKHL2,<http://www.bailii.org/uk/cases/UKHL/1970/2.html>,

1970:2All England Reports294.72. Foradiscussionofcategoriesofsituationsgivingrisetoajudiciallyrecognizeddutyofcare,seee.g.

HorsmanandMorley,Government Liability supranote10atpara.5.30.40.


schemeimpliesaspecialprivatedutytosomesubsetofthecommunity.”73Asnotedearlier,amajorhurdleformostpotentialplaintiffsisthatmanyregulatoryfunctionsarepremisedonabroadpublic interest, rather than the interestsofaclearlydefinedgroup.The rationale for focusingon thisfirst step inAnns isexplainedasfollows:

The relationship between the government and the governed is not one of

individualproximity.Any,perhapsmost,governmentactionsarelikelytocause

harmtosomemembersof thepublic.That iswhygovernment isnotaneasy

matter.Ofcourse,thegovernmentowesadutytothepublicbutitisadutyowed

tothepubliccollectivelyandnotindividually.Theremedyforthosewhothinkthat

dutyhasnotbeenfulfilledisatthepollsandnotbeforetheCourts.74

In considering a cause of action in negligence against GM cropregulators, thechallenge is toapplyexistingcommon lawprinciples toCFIA’sregulatoryactsasmandatedundertheSeeds Actandregulations.If,forexample,organicproducerssoughttosueregulatorsfornegligenceintheirapprovalofanewGMcropvariety,couldtheypassbothstagesoftheAnns analysis?Couldthey establish a relationship of sufficient proximity that they could advance acredibleclaimthattheregulatoryauthorityowesthemaprivatelawdutyofcaretopreventforeseeableharm?Wouldacauseofactionariseinnegligenceiftheregulator failedtoact incompliancewith itsgoverningstatute? Is themannerofregulation—forexample,byapplicationofa“substantialequivalence”test—legallyactionable?Thefollowingsectionsaddressthesequestions.

5.1. To Whom is a Duty Owed?

TheSeeds ActandregulationsdonotstipulatethatCFIAmustregulateintheinterestofagriculturalproducersbroadly,orspecifictypesofproducers.Rather,theSeeds Actprohibitscertainactivities(e.g.sellingseedsinCanadathathavenotbeenregisteredinaccordancewiththestatute75),authorizesCFIA’spresidenttodesignateinspectorsandanalyststocarryoutstatutoryfunctions,76setsoutoffences and penalties for contraventions,77 and confers broad, regulation-makingpowerontheGovernorinCouncil.78

73. HorsmanandMorley,Government Liability, supranote10atpara.5.30.30.74. A.O. Farms Inc. v Canada(CANFedCt,2000),<http://decisions.fct-cf.gc.ca/en/2000/t-1620-

95_929/t-1620-95.html>,28Administrative Law Reports,3d ser.315,atpara.11.75. Seeds Act, supranote14ats.3.76. CFIAAct, supranote13ats.13(3).Section6oftheSeeds Act, supranote14,setsoutpowersofinspectors

asfollows:

6.(1)Aninspectormayatanyreasonabletime

(a)enteranyplaceinwhichtheinspectorbelievesonreasonablegroundsthereisanyseedtowhich thisActapplies;

(b)openanypackagefoundinthatplacethattheinspectorbelievesonreasonablegroundscontains anysuchseed;

(c)examinetheseedandtakesamplesthereof;and

(d)requireanypersontoproduceforinspectionorforthepurposeofobtainingcopiesorextractsany books,shippingbills,billsofladingorotherdocumentsorpaperswithrespecttothe administrationofthisActortheregulations.

77. Seeds Act, supranote14ats.9.78. Seeds Act, supranote14ats.4.


ThepreambleoftheCFIAActstatesgeneralprinciplesregardingCFIA’sfunctions.Itstatesthattheestablishmentofthefederal“foodinspectionagencywillcontributetoconsumerprotectionandfacilitateamoreuniformandconsistentapproachtosafetyandqualitystandardsandrisk-basedinspectionsystems.”79Thepreambleisalsoexplicitthat“theGovernmentofCanadawishestopromotetradeandcommerce.”80ThesestatementsarerelevanttoallCFIA’sfunctionsandmaybeofminimalassistanceinsubstantiatingaclaimthattheregulatorowesadutyofcaretospecificagriculturalproducergroupsinitsGMcropregulatoryactivities.Indeed,assessingwhetherparticularregulatorydecisionsprotectconsumersandpromotetradeandcommercerequiresassessmentoftheregulator’sriskanalysis.Asdiscussedinmoredetailbelow,riskanalysesoften involvepolicydimensionsthatarenotamenabletoreviewinaprivatelawnegligenceaction.

Aregulatorybodythatisobligedbystatutetoprotecttheinterestsofadefinedgroupismorelikelytooweaprivatelawdutyofcaretomembersofthatgroupthanaregulatorwithabroadmandatetoregulateinthepublicinterest.81A question that remains unresolved in Canadian jurisprudence is whether aregulator’srepresentationsmayestablishadutyofcaretoaspecificgroupwhenthelanguageofthestatuteisaimedbroadlyatthepublic.

Sauer v Canada (Attorney General)82 concerns a claim for negligentregulationoftheCanadiancattleindustry.Followingthe2003discoveryofbovinespongiform encephalopathy (BSE or “mad cow” disease) in a cow in Alberta,theplaintiff,anOntariocattlefarmer,initiatedclassactionlitigationagainstthefederalgovernmentandacompanythatmanufacturedcattlefeedallegedtobethesourceoftheBSEcontamination.In1990,thefederalgovernmentenactedaregulationundertheFeeds Act83permittingthecontinuingadditionofruminantremainsincattlefeed.InApril1996,theWorldHealthOrganizationadvocateda ban on such ruminant remains in feed.84 Eighteen months later, the federalgovernmentbroughtintoeffectafeedbanundertheHealth of Animals Act.85

InSauer, theplaintiffallegedthegovernmentwasnegligentinits1990and1997regulatoryactivitiesbypermittingruminantmaterialsinfeedandthenbyfailingtoactquicklyenoughtoenactafeedban.Inanapplicationtodismisstheclaim,thefederalgovernmentargued“therecanbenorelationshipofsufficientproximity between commercial cattle farmers in Canada when Canada makeslegislativedecisions.”86Theplaintiffcounteredthisargumentbyciting“themanypublic representations by Canada that it regulates the content of cattle feedtoprotectcommercial […] farmers,”87 rather than regulating inabroadpublicinterest. The Court refused to dismiss the claim on a preliminary basis88 so itremainsunclearinCanadianlawwhenaregulatormay,ineffect,imposeadutyofcareonitselfbyitsrepresentationstoparticulargroups.

79. CFIAAct,supra note13atpreamble.80. CFIAAct,supra note13atpreamble.81. HorsmanandMorley,Government Liability, supranote10atpara.5.30.30.82. Sauer v Canada (Attorney General) et al.,2007ONCA454,<http://www.ontariocourts.on.ca/decisions/2007/

june/2007ONCA0454.pdf>,2007:225Ontario Appeal Cases143.83. Feeds Act,supranote16;Feeds Regulations(8January1990)124:3Canada Gazette—Part II73atss.5.1.6,5.1.7.84. Sauer, supranote82atpara.20.85. Health of Animals Act,supranote17;Regulations Amending the Health of Animals Regulations,(25July

1997)131:16Canada Gazette—Part II362ats.164.86. Sauer, supranote82atpara.61.87. Sauer, supranote82atpara.62.88. LeavetoappealtoSupremeCourtofCanadadismissed,2008CanLII36470(SCC).


5.2. Failure to Act in Compliance with the Governing Statute

What of situations where a plaintiff alleges the regulator failed to act incompliancewithitsgoverningstatute?TheearliersummaryofGMcroplitigationin the United States and other countries illustrated a common complaint thatthe regulatory authority failed to follow steps required under environmentalprotection statutes. An analogous claim in Canada might contend that theregulator failed to follow steps as required under the Seeds Act in making adecisionaboutreleaseofaGMcrop.Thiscircumstancemaygiverisetojudicialreviewonadministrativelawgrounds(atopicoutsidethescopeofthispaper),butdoesa successful judicial reviewactionexpose the regulator to liability innegligence? The answer here is generally no. In the recent case of Holland v Saskatchewan (Minister of Agriculture, Food and Rural Revitalization),89 an elkfarmerrefusedtoparticipateinagovernmentdiseasesurveillanceprogramand,asaconsequence,theMinistryofAgricultureassignedhisherdtheloweststatus.Aftersuccessful judicial reviewregardingvalidityof theherdstatuscertificate,thefarmersuedtheMinisterfornegligence.HearguedthattheMinister’sactofexceedinghislegalauthorityinissuingtheherdstatuscertificateamountedtonegligence.TheMinister’sapplicationtodismisstheclaimwasrejectedatfirstinstancebutacceptedonappeal.RichardsJA, for theSaskatchewanCourtofAppeal,articulatedconcernswiththefarmer’sclaim:

The respondent’s claim, if recognized in law, would put regulators and other

publicauthoritiesinthepositionwhere,notwithstandingbothcarefuleffortsto

determine the limitsof theirauthorityandearnestattempts tooperatewithin

thoselimits,theywouldnonethelessbeexposedtoprivatelawliabilityifacourt

subsequentlytookadifferentviewofthescopeoftheirpowers.90

Ultimately,theCourtrejectedtheclaimthatabreachofstatutoryduty—thatmaybeactionableonpubliclawgrounds—shouldgiverisetoliabilityinnegligence.91

5.3. Failure to Regulate in a Particular Manner

Opponents or proponents of GM crop technology may advocate a specificregulatoryregime.SomecriticsoftheCanadianregulatoryevaluationofanovelplantbasedon“substantialequivalence”arguethatregulationshouldbemore

89. Holland, supra note12.90. Holland, supra note12 atpara.41.SeealsoA.O. Farms Inc., supra note74atpara.8 wheretheCourt

states:“Thedecisiontolegislateandthedecisionhowtolegislateare,inmyview,inseparable.”91. Thisprincipleisapplicableinotherjurisdictions.Forexample,anAustraliananalysisofpotentialregulator

liabilityforGMcropapprovalsstates:

Awrongfuladministrativedecisionisincapable,byitself,ofsupportingaclaimfordamages.ThereforeifapersonsuffersdamagebyreasononlyoftheRegulatorissuingalicencetoapersonincircumstanceswherethatpersonshouldnothavebeenissuedwithalicence(forexample,[…]becausetheRegulatorusesincorrectinformationabouttheproposedGMOactivity)thatpersoncannot,withoutmore,obtainanydamagesforanyoftheconsequencesoftheperson’swrongfuldecision.

See:LeeMcIntosh,“LiabilityforEnvironmentalDamageCausedbytheReleaseofGeneticallyModifiedOrganisms,”For Whose Benefit?—Evaluating Genetically Modified Organisms in Western Australia from a Different Perspective,PaperpresentedtotheAustraliaConversationPolicyConference,10October2002,<http://www.edowa.org.au/archives/5A_gmo_liability.pdf>,atp.10.


explicitlyprecautionaryandrequireahigherstandardofsafetyevidence.92Cana government face negligence liability for regulating in a specific manner, forexample,byestablishing in lawa testof substantialequivalence rather thanadifferentstandardagainstwhichtoassessthenoveltyofaplant?Previouscasesdemonstratestrongjudicialreluctancetoacceptclaimsofregulatorynegligencebased on a choice to regulate in a specific manner. This activity is generallyviewedasthesine qua nonofpolicymakingwheregovernmentisimmunefromprivatelawduties.

Attis v Canada (Minister of Health)93 concerned the safety of breastimplants approved for sale in Canada and the allegation that Health Canadawas negligent in its regulatory activities under the Food and Drugs Act andMedical Devices Regulations.TheplaintiffsclaimedthatthefederalgovernmenthadaprivatelawdutytoenactaregulatoryprohibitionagainstbreastimplantsmanufacturedbyDowCorningInc.TheCourt,however,rejectedtheargumentthatastatutoryregimethatprimarilyestablishesrulesfordevicemanufacturersanddistributors“canbeexpandedbyimplicationtoincludeaprivatelawdutyofcareowedbythegovernmenttotheconsumersorusersofthedevices.”94TheCourtfurtheremphasizedthat“[a]nallegationthattherewasa‘dutytoprohibit’isakintoanallegationthatthereisadutytogoverninacertainway.[…]Thatisamanifestpolicydecisionanditiswell-settledthat,assuch,itisimmunefromcivilliability.”95

Governancechoices,however,mustbedistinguishedfromtheexerciseofspecificregulatorypowersthatmay, insomelimitedcases,beactionableinnegligence.InanothermedicaldevicesclaimagainstHealthCanada,96anOntarioCourtruledthatthedefendant’sfailuretoenforceregulationsitknewwerebeingbreached,maygiverisetoaprivatelawdutyofcaretoaspecificgroupofplaintiffswhoexperiencedforeseeableharmarisingfromthegovernment’sconduct.

AnimportantfeatureofGMOregulationisthatdecision-makingcentresonthescientificevaluationofriskofharmanddiscontentoftenstemsfromtheviewthat the regulatoryprocessdoesnot takeadequateaccountofpotentialharms.This typeof claim tends to impugn thepolicy frameworkwithinwhichdecisionsaremadeand,therefore,runsafoulofthejurisprudential limitagainstnegligenceliabilityforpolicychoices.Indeed,ithasbeennotedthat“assessing[risk] acceptability is not apurely technocraticexercisebut involvesapoliticaldeterminationinthatregulatorsmustmakepolicychoicesthataccountforthelevelofrisktoleranceassociatedwithpotentialharmtothenaturalenvironmentandhumanhealth.”97Additionally,Glennarguesthataregulatoryagency’sfailuretoincludesocio-economicissues(suchasmarketimpact)orethicalconsiderationsin the evaluation process, and issues relating to reliance on the “substantial

92. Seee.g.PeterAndrée,“AnAnalysisofEffortstoImproveGMFoodRegulationinCanada,”(2006)33:5Science and Public Policy377.Theauthorargues,atp.386,thattheevidencehereviews“showsthattheGovernmentofCanadaisnotpreparedtoacceptthedegreeofprecautionaryscrutinyofGMOscalledforbytheRSC[RoyalSocietyofCanada]Panel.”

93. Attis v Canada (Minister of Health)(ONSupCt,2007),<http://www.canlii.org/en/on/onsc/doc/2007/2007canlii15231/2007canlii15231.pdf>,46Carswell’s Practice Cases6th ser.129,appealdismissed2008ONCA660.

94. Attis, supranote93atpara.17.95. Attis, supranote93atpara.42.96. Taylor v Canada (Minister of Health)(ONSupCt,2007),<http://www.canlii.org/en/on/onsc/doc/2007/2007ca

nlii36645/2007canlii36645.pdf>,285Dominion Law Reports, 4th ser. 296,leavetoappealdenied,(2007)289Dominion Law Reports,4th ser.567.

97. Craik,Culver,andSiebrasse,“GeneticallyModifiedCropsandNuisance,”supra note7atp.205.


equivalence” test,would likelybemattersof “policy” forwhich the regulatorwouldnotbeliable.98

Thepreviousdiscussion indicatesthatacauseofactionfor regulatorynegligenceintheGMcropreviewprocessislikelyquitenarrow.Glennproposesthat issues pertaining to the assessment process itself, including “perceivedconflictbetweenCFIA’sregulatoryandpromotionalrolesforbiotechnology,thepossibilityofundueindustryinfluenceandlackoftransparency–mightwellbeheldtobeoperationalandhencejusticiable.”99Yetthesematterswouldonlybejusticiable in a private law context where a relationship of sufficient proximityexistedbetweentheregulatorandtheplaintiff.Government’slegislativedecisionsabouthow to assign statutory responsibilities and reporting relationships—forexample, as between the Minister of Agriculture and Agri-Food Canada andCFIA—aredecisionsthatwouldbeoutsidethescopeofanegligenceclaim.Inits assessmentsofGMcropapplications,CFIAcould likelyescapenegligenceliability for acting outside the bounds of its statutory authority or failing totake account of environmental and health factors as prescribed in the Seeds Regulations,thoughthesefailuresmaywellgiverisetoadministrativelawclaims.Asafinalpointregardingregulatorliability,itisimportanttonotethatregulatorsmustactingoodfaithintheirpolicydecisionsandfailuretodosomayexposethem to liability. In the Supreme Court of Canada decision in Brown v British Columbia,CoryJremarked:

Itwill alwaysbeopen toaplaintiff toattempt toestablish,onabalanceof

probabilities,thatthepolicydecisionwasnotbona fideorwassoirrationalor

unreasonableastoconstituteanimproperexerciseofgovernmentaldiscretion.

This is not a new concept. It has long been recognized that government

decisionsmaybeattackedinthoserelativelyrareinstanceswherethepolicy

decisionisshowntohavebeenmadeinbadfaithorincircumstanceswhereit

issopatentlyunreasonablethatitexceedsgovernmentaldiscretion.100

*6. TRANSPARENCY IN REGULATION

in the context of Gm crop reGulation and litiGation, Canadian legal scholarshavearguedthat“democraticlegitimacyisbetterpromotedthroughincreasedregulatory transparency than through judicial empowerment.”101 Moreover,greatertransparencyinregulatorydecisionsmayhelpavoidlitigation;thosewhodisagreewitharegulatoryoutcomemaybelesslitigiousifthedecision-makingprocesswastransparentinevaluationcriteriaandconsistentwithclearlystatedprocesses. This final section addresses concerns about the current degree of

98. Glenn,“GeneticallyModifiedCrops,”supra note23atp.307.99. Glenn,“GeneticallyModifiedCrops,”supranote23atp.307.Fordiscussionofanegligencecauseof

actionagainstregulatorsintheAustraliancontext,seeMcIntosh,“LiabilityforEnvironmentalDamage,”supranote91atp.10,whoconcludes“itisunlikelythattheRegulatorwouldbeliableatcommonlawforanyenvironmentaldamagewhichresultsfromanactivitywhichtheRegulatorauthorised.”

100. Brown v British Columbia(CANSC,1994),<http://scc.lexum.umontreal.ca/en/1994/1994rcs1-420/1994rcs1-420.pdf>,1994:1Supreme Court Reports420atp.435.

101. Craik,Culver,andSiebrasse,“GeneticallyModifiedCropsandNuisance,”supra note7atp.204.


transparencyinregulationofGMcropsinCanadaandbrieflysuggestswaysinwhichtransparencycouldbeenhanced.

LackoftransparencyhasrepeatedlybeenidentifiedasaproblemintheCanadianGMcropregulatorysystem.Inits2001report,theRoyalSocietyPanelemphasizedthat

thelackoftransparencyinthecurrentapprovalprocess,leadingasitdoesto

aninabilitytoevaluatethescientificrigoroftheassessmentprocess,seriously

compromisestheconfidencethatsocietycanplace inthecurrentregulatory

frameworkusedtoassesspotentialriskstohuman,animalandenvironmental

safetyposedbyGMOs.102

Ina2002report,theCanadianBiotechnologyAdvisoryCommitteeidentified

significantshortfallsinthewaythegovernmentcommunicateswithandinvolves

thepublicintheregulatoryprocessforGMfoods.Thefederalgovernmenthas

notprovidedclear informationabouthowtheseproductsare regulatedand

decisions[are]made,therolesofthevariousregulatorybodies,andthedata

thatareconsideredduringthesafetyassessmentprocess.103

In a 2004 report on CFIA’s regulatory activities regarding plants with noveltraits, the Auditor General of Canada “found that the Agency did not havecompletedocumentaryevidenceand,therefore,wasnottransparentabouthowitwasevaluating the long-termeffectson theenvironmentbeforeauthorizingunconfinedreleaseofplantswithnoveltraits.”104TheAuditorGeneralcautionedthatits“findingsprovideanearlywarningsignalthatsomeimportantaspectsoftheAgency’sprocessesforregulatingplantswithnoveltraitsneedstrengthening[,particularlysince]thenextgenerationofplantswithnoveltraitscouldposenewandmorecomplexenvironmentalrisks[…].”105

While concerns have been expressed about industry influence onregulators, lack of clear assessment guidelines in the regulatory process is ofconsiderable concern for proponents seeking GM crop approvals. A recentreviewofGMcropregulationinCanadaobservesthatthe

useofcase-by-caseassessments[byCFIA]hasresultedinasituationinwhich

there is no identifiable regulatory template for seed developers to follow.

[…] This has created a scenario in which no seed developer submitting an

applicationpackage for regulatoryapprovalof anewPNT [plantwithnovel

trait]knowswhatorhowmuchscientificdataarerequired.106

102. RoyalSocietyofCanada,Elements of Precaution,supra note22atp.215.103. CBAC,Improving the Regulation, supra note25atpp.30–31.104. OfficeoftheAuditorGeneralofCanada,Report of the Auditor General of Canada to the House of

Commons, Chapter 4: Canadian Food Inspection Agency—Regulation of Plants with Novel Traits(MinisterofPublicWorksandGovernmentServicesCanada,2004),<http://www.oag-bvg.gc.ca/internet/docs/20040304ce.pdf>atpara.4.6.

105. OfficeoftheAuditorGeneralofCanada,Report, supra note104atpara.4.94.106. StuartSmythandAlanMcHughen,“RegulatingInnovativeCropTechnologiesinCanada:TheCaseof

RegulatingGeneticallyModifiedCrops,”(2008)6:3Plant Biotechnology Journal213–225,atp.219.


Theseconcerns indicateaneedforgreatertransparencyandclarity intheregulatoryprocess,incorporationofabroaderrangeofpublicperspectivesand opinions in the policy dialogue, and an improved method of evaluatingconcernsanduncertaintiesaboutthepotentiallong-termecologicalandhealthrisksassociatedwiththeuseandproductionofGMcrops.Absentmajorpublicopposition to GM crops, however, it has been suggested that “Canadianregulators[…]havehadfewerincentives[…]tocorrectthedemocraticlimitationsofweaktransparencyandlimitedopportunitiesforinjectionofpublicvaluesandconcernsintoplantbiotechnologyregulation.”107

Someotherjurisdictions,suchastheUK,108haveestablishedindependent,expertbodieswiththespecificresponsibilitytoreviewapplicationsforreleaseofGMcropsandgiveadvicetogovernment.TheCanadianBiotechnologyAdvisoryCommittee recommended that there should be “effective independence ofregulatoryfunctionsforGMfoodsandothernovelfoodsunencumberedbyothergovernmentfunctionsandresponsibilities, including,butnotlimitedto,policy,economicdevelopment,negotiationofinternationalpolicyandtraderules,andtradepromotion.”109ThecurrentregulatorysysteminCanadahasbeendescribedasasuccess“astheadoptionratesofGMcanola,cornandsoybeanshasbeenveryhigh,therebyprovidingbenefitstoCanadianproducerswithnodocumenteddamage to health or the environment.”110 Yet even those who hold this viewexpressconcern thatexisting regulationsare ill-suited toaddress thegrowing“scientificcapabilitytodetectanincreasingnumberofpotentialriskfactors”111ofGMOs.ThecapacitytoproducestacksofscientificdatacomparingGMOstoconventionalcounterpartsisonlyusefulifregulatorshaveadequateframeworksforevaluatingthisevidenceandassessingtherisksandbenefitsofnovelproducts.Evaluation frameworksought tobeclearlycommunicatedtoseeddevelopers,producersandotherstakeholders,withtransparencyaroundevaluationcriteria,standardsagainstwhichevidenceisassessedandtheadequacyofevidenceforspecificapplicationsforGMOrelease.

*7. CONCLUSION

despite onGoinG controversy over Gm cropapprovalandcommercialization inCanada,thosewhomightwishtoassertaclaimofregulatorynegligenceagainstCFIA face significant legal barriers. The application of the Anns test limitsnegligenceliabilityofgovernmentauthoritiestosituationswherearelationshipofsufficientproximityexistsbetweengovernmentandtheplaintiff(s);aregulatorisnotliableinnegligenceifthenatureofitsrelationshipwiththeaggrievedpartyis too remote to give rise to a private law duty of care. Further, policy

107. SarahHartleyandGraceSkogstad,“RegulatingGeneticallyModifiedCropsandFoodsinCanadaandtheUnitedKingdom:DemocratizingRiskRegulation,”(2005)48:3Canadian Public Administration305–327,atpp.323–324.

108. FormoreinformationontheUKAdvisoryCommitteeonReleasestotheEnvironment,see<http://www.defra.gov.uk/Environment/acre/index.htm>.

109. CBAC,Improving Regulation, supra note25atrecommendation1.1.110. SmythandMcHughen,“RegulatingInnovativeCropTechnologies,”supra note106atp.224.111. SmythandMcHughen,“RegulatingInnovativeCropTechnologies,”supra note106atp.224.


considerations restrict theextensionofprivate lawobligations togovernmentactorsatbothstagesoftheAnns analysis.SincereviewofGMcropapplicationsinvolves weighing complex scientific data and determining tolerable levels ofrisk, many aspects of Canadian GM crop regulation would likely be non-justiciableinanegligenceclaim.

Courtsarereluctanttoimposelegalresponsibilitywhereaccountabilityforregulatoryandpolicydecisionsmoreappropriatelyrestsoutsidethejudicialsystem.Consequently,thoseoutsidethejudicialsystem—namely,thelegislators,policy-makers and regulators that create and work within legal and policyframeworks for assessing GMOs—have responsibility for transparency andaccountability.GMcroplitigationinotherjurisdictionsdemonstratesshortcomingsthathaveoccurredinregulatoryprocessesandrecoursetolegalactiontoensureadequate environmental and other assessments before commercialization ofcrops with novel traits. To date, Canadian litigation involving agricultural andhealthregulatorshasnotinvolveddisputesoverGMcropsandcourtshavenotadjudicatedaclaimof regulatorynegligence in that context.Ambiguitiesandshortcomings inGMOregulationhave,however,been identified inother fora,suchas reportsby theRoyalSocietyExpertPanelandtheAuditorGeneralofCanada. These criticisms warrant attention to maintain public, producer andindustryconfidenceinthesystem,particularlyasgeneticmodificationsofgreaterscientific,socio-economicandethicalcomplexityareintroducedintocropplants.

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