GENETICALLY MODIFIED WHEAT 2018

Incident Report

© Her Majesty the Queen in Right of Canada(Canadian Food Inspection Agency), 2018.CFIA P0951-18ISBN: 978-0-660-26780-7Catalogue No.: A104-141/2018E-PDFAussi disponible en français.Request other formats online or call 1-800-442-2342.If you use a teletypewriter (TTY), call 1-800-465-7735. Alternative format are available on demand.

EXECUTIVE SUMMARY TheCanadianFoodInspectionAgency(CFIA)wasnotifiedonJanuary31,2018,aboutafew

wheatplantsfoundonanaccessroadinsouthernAlbertathatsurvivedasprayingtreatmentforweeds.

TheCFIA’stestsconfirmedthatthewheatfoundisgeneticallymodifiedtobeherbicidetolerant.Geneticallymodified(GM)wheatisnotauthorizedtobegrowncommerciallyinanycountry.

Sincebeingnotified,theCFIAworkeddiligentlywithfederalandprovincialpartnersandotherstakeholderstodeterminetheoriginandextentoftheGMwheatplantstogetasmuchcomplete,accurate,andcredibleinformationaboutthisdiscoveryaspossible.Basedonextensivescientifictesting,thereisnoevidencethatthisGMwheatispresentanywhereotherthantheisolatedsitewhereitwasdiscovered.

Thereisalsonoevidencethatthiswheathasenteredthefoodoranimalfeedsystem,norisitpresentanywhereelseintheenvironment.

HealthCanadaandtheCFIAhaveperformedriskassessmentsofthisfinding,andhaveconcludedthatitdoesnotposeafoodsafety,animalfeed,orenvironmentalrisk.

ThewheatplantsfoundinAlbertaarenotamatchforanywheatauthorizedforsaleorforcommercialproductioninCanada.

TheCFIAhasdevelopedatesttodetectthisspecificGMwheat,whichcanbemadeavailabletotradingpartnerstotestwheatimports,iftheychoose.

TheCFIA,otherfederalandprovincialpartners,andindustryrepresentativeswereunabletospecificallyidentifythesourceoftheGMwheat.Multi-yearmonitoringwillbeconductedandmitigationmeasureswillbeadoptedatthesitetoverifythattheGMwheatdoesnotpersistinthearea.

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Incident Report2

DETECTION AND RESPONSE TO AN ISOLATED CASE OF NON-AUTHORIZED GENETICALLY MODIFIED WHEAT IN CANADA TheGovernmentofCanadahasastrongandrigorousregulatorysystemforGMcropsandthefoodsandanimalfeedsmadefromthem.Asatrustedscience-basedregulator,theCFIAiscommittedtobeingtransparentandaccountable.Thismeansreportingregulatorynon-compliancesofinteresttothepublic,industryandtradingpartners,evenwhenthereisnohealthorsafetyrisk.

ThisreportprovidesasummaryofactionstakenbytheCFIAandourfederalandprovincialpartnersinresponsetothefindingofasmallnumberofherbicidetolerantGMwheatplantsonanaccessroadinsouthernAlberta.

BACKGROUNDTheGovernmentofCanada’spriorityistoprotectCanada’senvironment,animalfeedandfoodsystemsbyusingarigorousscientificapproachinassessingsafetyandmanagingrisk.InCanada,HealthCanadaandtheCFIAaremandatedtoregulateproductsofbiotechnology,suchasGMcrops.TheCFIAisresponsibleforregulatingthereleaseofGMcropsintotheenvironmentundertheSeeds ActandSeeds Regulations.TheCFIAisalsoresponsibleforoverseeingthemanufacturing,saleandimportoflivestockfeedsincludingnovelfeedsundertheFeeds ActandtheFeeds Regulations.

HealthCanadaisresponsibleforassessingthesafetyofnovelfoodsforhumanconsumptioninCanadaundertheFood and Drugs ActandFood and Drugs Regulations.

GMwheatisnotauthorizedinanycountryforcommercialproduction,asnocompanyhassoughtcommercialization.However,herbicidetolerantGMcropsincludingcanola,cornandsoybeanshavebeenauthorizedinCanadaformorethan20years.AssessmentsbyHealthCanadaandtheCFIAhaveshownthattheseGMcropsareassafeastheirnon-genetically

Herbicide-tolerant GM crops including canola, corn and soybeans have been authorized in Canada for more than 20 years

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modifiedequivalentsanddonotposearisktohumanhealth,thehealthofanimalsortheenvironment.TheCFIA’swebsitehasacompletelistofcropsthathavebeenauthorizedandfoodsafetydecisionscanalsobefoundonHealthCanada’swebsite.

ConfinedresearchfieldtrialsforGMwheathavebeenconductedsincethe1990sinwheat-growingregionsofCanada.TrialshavealsobeenconductedaroundtheworldincountriesincludingtheUnitedKingdom,UnitedStatesandAustralia.ThesetrialsallowinformationtobegatheredonthesafetyandsuitabilityofthenewGMlinesforcommercialuse,whichsupportseconomicactivityandinnovationinCanada’sagriculturalsector.TheCFIAhasstrictandrigorousconditionsforthesetrialstoallowproductdeveloperstotesttheirnewGMvarietiesinthefield,underconditionsofconfinement.

AlltrialsareinspectedbytheCFIAtoconfirmcompliancewiththeseconditions.TherehavebeennocasesofanyexperimentalplantmaterialfromthesetrialspersistingintheCanadianenvironment.NoneofthewheattrialshaveoccurredatornearthelocationwheretheGMwheatplantswerefound,andthereisnoevidencedirectlylinkingthecurrentGMwheatfindingwiththesepreviouslyauthorizedtrials.TheinformationonconfinedresearchfieldtrialsismadepublicandcanbefoundontheCFIAwebsite.

TherehavebeenincidentsofunauthorizedGMwheatreleasesinotherjurisdictions.TheUnitedStatesreportedthreeseparateincidentsofunauthorizedGMwheatreleaseswhichoccurredinOregonin2013,inMontanain2014,andinWashingtonin2016.TheseincidentsinvolvedGMwheatlinesthataregeneticallydifferentfromthe

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GMwheatfoundinAlberta.ThereisnoevidencelinkingCanada’sGMwheatfindingtopreviousUnitedStatescases.SimilartoCanada’sfinding,GMwheatcasesintheUnitedStateswereisolatedincidents,andGMwheatdidnotentercommerce.

CFIA ACTIVITIES

Discovery and notificationDuringthe2017growingseason,aherbicideapplicationcontractorinsouthernAlbertareportedwheatplantsthatsurvivedaglyphosateherbicidetreatment(Roundup)tolocalauthorities.TheProvinceofAlbertacollectedsamplesfortesting,andconfirmedinlateJanuaryof2018thatthewheatwasherbicidetolerant.

OnJanuary31,2018,theCFIAwasnotifiedbytheGovernmentofAlbertathatafewherbicidetolerantwheatplantswerefoundinsouthernAlberta.TheCFIA,incollaborationwithfederalandprovincialpartners,immediatelyundertookcomprehensive,risk-basedstepstodeterminetheoriginandpotentialextentofthesewheatplants.

Confirmation that the herbicide tolerant wheat is genetically modifiedOnFebruary12,2018,theCFIA’sOttawaGenotyping/BotanyLaboratoryreceivedsamplesofthewheatseedfromAlberta.TheCFIAconductedseveralDNA-based

analyses,includingpolymerasechainreaction(PCR)amplificationsofvariouscommonGMDNAsequences.Thisconfirmedthatthewheatwasgeneticallymodified,sinceitcontainedpiecesofDNAthatareknowntobeusedinGMplantsandthatdonotoccurnaturallyinwheat.

Inadditiontoconclusivelyshowingthatthewheatwasgeneticallymodified,thisworkhelpedtoexcludecertainGMwheatlinesfromconsiderationasbeingthesourceoftheGMwheatinAlberta.TheCFIAmaintainsadatabaseofallGMcropsthathadbeenpreviouslyplantedinconfinedresearchfieldtrialsinCanada.BydeterminingwhichspecificpiecesofengineeredDNAwerepresentorabsentintheGMwheat,theCFIAwasabletonarrowdownthelistofpossibleGMwheatlinesforfurthertesting.

Identification of the genetically modified wheat DNA sequenceAsaresultofthisanalysis,theCFIAwasabletofocusonashortlistofthreepossibilitiesbelongingtotwodifferentcompanies.OnFebruary22,2018,theCFIAcontactedbothofthesecompanies,whohadfield-testedGMwheatlinesinpasttrials,toobtainmethodsandmaterialsfordetectingtheirrespectiveGMwheatlines.ObtainingthesematerialsandmethodswasimportanttoallowtheCFIAtoidentifytheGMwheat.

OnMarch13,2018,theCFIAwasabletoeliminateonecompany’swheatlineasthepotentialsourceoftheGMwheat.IncollaborationwithMonsanto,thesecondcompany,theCFIAwasabletoconclusively

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determinethattheAlbertaGMwheatisnotageneticmatchtopreviousunapprovedGMwheatreleasesintheUnitedStates.

Throughfurthercollaboration,onApril8,2018,theCFIAconfirmedthattheAlbertawheatsamplewasamatchforaMonsantoGMwheatline(MON71200),whichwasusedinmultipleconfinedresearchfieldtrialsinthelate1990sandearly2000sinbothCanadaandtheUnited

States.Thephysicallocationsoftheconfinedresearchfieldtrialswereapproximately300kilometresormoreawayfromwheretheGMwheatplantswerefoundinAlberta.Giventhepassageoftimeandlargedistancesinvolved,thereisnoevidencethatwouldexplainhoworifthecurrentGMwheatfindingislinkedwithaprevioustrial.

The GM wheat found in Alberta is not a genetic match to previous unapproved GM wheat releases in the United States

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Background variety identification: providing assurance that Canada’s seed and grain is free from GM wheatAtthesametimethattheCFIAwasworkingtoidentifytheinsertedGMDNAsequence,theCFIAwaslookingattherestofthewheat’sDNAtolearnmoreaboutitsidentity,usingatechniqueknownasDNAfingerprinting.DNAfingerprintingfunctionslikeabarcode,andallowsalivingthingtobeidentifiedbytheuniquepatternswithinitsDNA.TheCFIAmaintainsadatabaseofhundredsofDNAfingerprintsthatallowsustorecognizewheatvarietiesbythepatternsintheirDNA.TheCanadianGrainCommission(CGC)maintainsasimilardatabase.

BoththeCGCandtheCFIAusedDNAfromtheAlbertaGMwheattobuildafingerprintandcompareittothefingerprintsalreadystoredinthesedatabases.OnMarch23,2018,theCFIA,incollaborationwiththeCGC,confirmedthattheGMwheatplantsfoundinAlbertawerenotamatchforanycurrentlyregisteredwheatseedvarietyinCanada.TheGMwheathasauniqueDNAfingerprintthatdoesnotmatchanyoftheapproximately450wheatvarietiesonfilewiththeCFIAandtheCGC.Thismeansthat,aswheatmustberegisteredpriortosaleorimportintoCanada,farmerswhopurchaseregisteredseedvarietiescanrestassuredthatthesevarietiesarefreefromGMwheat.

TheDNAfingerprintwasalsocheckedagainstCanada’sgrainexports.TheCGCsamplesandmonitorsallbulkwheatexportshipmentsforqualityassurancepurposes.Partofthisroutinemonitoringincludesverifyingthevarietiesofwheatthatarepresentinashipmentusing

The CFIA maintains adatabase of hundredsofDNAfingerprints thatallows us to recognizeapproximately

The GM wheat plantsfoundinAlbertawerenotamatchforanycurrentlyregistered wheat seedvarietyinCanada.

DNA FINGERPRINTING

450wheat varieties by thepatternsintheirDNA.

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DNAfingerprinting.Overthelastthreecropyears,nearly170,000individualkernelsofgrainfrommorethan1,500exportshipmentshavebeenanalyzed.Throughareviewofthedata,nomatchesforthistypeofGMwheathaveeverbeenfoundbytheCGC.TheCFIAwillcontinuetoworkincollaborationwiththeCGCtomonitorCanadiangraintomakesureitdoesnotcontainanyvarietiesthatdonotconformtowhatshouldbeinbulkexportshipments.

TofurtherverifythatCanadiangraindoesnotcontainanyGMwheat,theCFIAandtheCGCcollaborativelyundertooktestingofcompositewheatsamplesfromtheprairieregion.OnApril9,2018,theCGCsentfivecompositewheatsamplesfromitsHarvestSampleProgramtotheCFIAforfurtheranalysis.ThesecompositesamplesarerepresentativeofwesternCanadianwheatclasses,andincludedatotalof1692individualsamples.BoththeCFIAandCGCindependentlytestedthesesamplesforGMwheat.OnApril26,2018,theCFIAconfirmedthatnoGMwheatwasdetected.ThisresultwasindependentlyconfirmedbytheCGC.

Detection method for GM wheat

OnApril6,2018,CFIAfinalizedthedevelopmentandvalidationofa2-stagePCR-basedmethodtoconclusivelydetecttheGMwheat.ThismethodissensitiveenoughtodetectoneGMwheatkernelin1,000.

TheCFIAalsosequencedtheGMwheat’sDNAtolearnmoreaboutitsidentityandtobeginthedevelopmentofasecond,moreefficient1-stagePCRtesttodetectthisGMwheat.ByperformingDNAsequencing,theCFIAwasabletofindwheretheengineeredDNAfragmentwasinsertedintothewheat’sDNA.ThisknowledgeformedthebasisfordevelopingaPCR-based

testthatselectivelyamplifiestheDNAsequenceatthejunctionbetweenthenaturalwheatgenomeandtheinsertedengineeredDNA.Inthisway,thetestcanbeperformedinasinglestagethatishighlyselectivefordetectingthepresenceoftheinsertedDNAinthisGMwheat.

Testing seed and grain from the surrounding area for GM wheat

Havingidentifiedtheunknownwheat’sgeneticmodificationanddevelopedatesttodetectit,theCFIAcontinuedtosystematicallyexploreleadstodeterminethesourceandthepotential

170,000

WERE ANALYZEDEXPORT SHIPMENTS

NO MATCHES

KERNELS OF GRAIN FROM

1,500

WERE FOUND

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extentoftheunauthorizedGMwheatplantsontheaccessroadwheretheywerediscovered,andatthefarmoperationthatownsthisland.

OnApril20,2018,theCFIAhelditsfirstinaseriesofmeetingswiththelandownertodiscussthehistoryofthelandneartheaccessroad,thecroprotationsonallfieldstheyfarm,theagriculturalpracticesonthefarm,aswellasthelocationandcontentsofanymaterialsinstorage.TheCFIAconductedsignificantonsitesamplingandtestingofallwheatstoredonthefarmandgrainthathadwheatpresent.Theseinspectionactivitiesextendedtotheentirefarmingoperationincludingninefieldscoveringapproximately1500acresoffarmedland.AllsamplingactivitiesofseedandgrainwerecompletedbasedonCFIA’sseedsamplingprotocolthatalignswithInternationalSeedTestingAssociation(ISTA)seedsamplingprocedures.

TheCFIAwasnotabletoidentifyanythingrelatedtothemanagementpracticesofthefarmthatcouldbelinkedtoGMwheat.Thelandownerownsanddoesnotshareseedingandharvestequipment.Theequipmentiscleanedinthefieldoryardandnotoffsite.Allfertilizerandherbicidetreatmentsaredonebythelandownerusingtypicalapplicationapproaches.Thisfarmingoperationplantscanola,wheat,andbarley.AllseedsamplestestednegativefortheGMwheat.Noseedwaseversoldbythelandowners.Therehavebeennoconfinedresearchfieldtrialsonthesite,orconsultantsorcropscoutswhohavevisitedthefarm.Allleadswerethoroughlyexplored.

Duringthissametimeperiod,theCFIAalsointerviewedtheleaseholderswhousetheaccessroad.TheCFIAwasnotabletoidentifyanythinglinkingthemanagementoftheroadwaytotheGMwheat.Theleaseholderconfirmedthattherehasbeennoconstructionworkdoneontheroadinthelastfiveyears.Alongtheaccessroad,therehasbeennogroundcoverseedingoftheroadditchesandnostrawmatswereused.Maintenancerecordsfortheaccessroadindicatethatwheatplantswerefirstidentifiedin2017asaweedtobecontrolledalongtheroad.

OnMay1,2018,CFIAtestresultsforthefarmingoperation’sseedandstoredgrainwereallconfirmedtobenegativefor

GRAINCANADIAN

1,692 INDIVIDUAL

SAMPLES WERE TESTED

NO GM WHEATWAS FOUND

The CFIA will continue to monitor over the next 3 years

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GMwheat.ThisfindingindicatesthatGMwheatwasnotpresentinthefarm’s2017harvestedcrops.

OnMay8,2018,assoonasthefieldsweredryenough,theCFIAconductedadditionalsamplingandtestinginthefieldalongtheperimeterofthediscoverysite.TheobjectivewastodeterminewhethertheremainsofanyotherGMwheatplantsfromthepreviousseasonwerepresentnearthesiteoftheoriginalfinding.CFIAinspectorswalkedasearchpatternonbothsidesoftheaccessroad.Theaccessroadis500metreslong,andthesearchpatternextended60metresintothefieldfromeachsideoftheaccessroad.Thismeansthatinspectorssearcheda60,000squaremetrearea,collectingallwheatplantremains.Atotalof284wheatheadswerefoundandcollectedatvariousdistancesfromtheaccessroadandweresubmittedfortesting.OnMay23,thesesampleswereconfirmedtobenegativeforthepresenceofGMwheat,withtheexceptionof4wheatheads,whichtestedpositiveforthespecificGMwheatevent(MON71200).ThesefourGMwheatheadswerelocatedwithina0-15metrezonefromtheaccessroad.Thiswasnotsurprising,givenitsproximitytotheoriginalfindalongtheaccessroad.ThisindicatesthattheGMwheatispresentonlyinahighlylocalizedarea.

TheCFIAisundertakingmulti-yearmonitoringandthelandownerisadoptingmitigationmeasuresonthefieldsurroundingtheaccessroadtoverifythattheGMwheatdoesnotpersistinthearea.Thesemeasuresincluderegularlymonitoringthesite,destroyinganywheatthatmaygerminateduringthegrowingseasonandplacingrestrictionsonthecropsthatcanbegrownatthislocation.Thefieldmonitoringwillcontinuethroughouttheentiregrowingseason,i.e.followingsnowmeltuntilfirstfrost,forthethreegrowingseasons(2018-2020)followingdetection.TheCFIAwilladjusttheresponseandmitigationmeasuresasrequiredbasedonanypotentialnewfindings.

Completion of Risk Assessments

OnMay9,2018,riskassessmentsexaminingpotentialimplicationsoftheunauthorizedGMwheattofood,animalfeed,andtheenvironmentwerecompletedbyHealthCanadaandtheCFIA.TheseriskassessmentsdeterminedthattheherbicidetolerantGMwheatdoesnotposearisktopublichealth,thehealthofanimalsortheenvironment.GMcropswiththisherbicidetolerancetraithavebeenauthorizedinCanadaforover20yearsandtherehavebeennohumanhealthconcernsidentifiedrelatedtothesecrops.

FIELDS9 1,500

60,000INSPECTORSSEARCHED A

AND COLLECTED 284 WHEAT HEADS

M2

THIS COVERED APPROXIMATELY

OF FARMED LANDACRES

WERE SAMPLED AND TESTED

AREA

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CONCLUSIONSAftercomprehensivetesting,analysisandevaluation,theCFIAandotherfederalandprovincialpartners,canconfirmthatnoGMwheathasenteredthefoodorfeedsystem,norisitpresentanywhereelseintheenvironment.Furthermore,thisGMwheatisnotamatchforanywheatauthorizedforsaleorforcommercialproductioninCanada,demonstratingthatCanadianwheatseedisfreefromGMwheat.Resultsfromseedandgrainsamplescollectedfromthefarmoperationwereallnegative,meaningnopresenceoftheGMwheatwasfound.Thecompositegrainsamplescontainingwheatfromthediscoverysite’sgeographicregiontestednegativeforthepresenceofGMwheat.StakeholderinterviewsandongoingfieldmonitoringtodatepointtoahighlylocalizedpresenceofGMwheatalongtheaccessroad.

HealthCanada’sfoodsafetyriskassessmentandtheCFIA’sanimalfeedandenvironmentalriskassessmentsdemonstratethattheGMwheatdoesnotposeafoodsafetyrisktothepublic,ananimalfeedorenvironmentalrisk.

TheCFIAincooperationwithotherfederal,provincial,andindustrypartnerswasabletoidentifytheGMwheatanddeterminethelimitedscopeofitspresence,butwasunabletospecificallyidentifythesourceoftheGMwheat.Allevidence-basedlinesofinquirywerepursuedandhavenotresultedinanyfurtheravenuestobeexplored.Goingforward,theCFIAwillfocusonmonitoringthesiteandwillverifythatallGMwheatthatmaygerminateisdestroyed.

TheCFIAisconfidentintheresultsoftheextensivetesting,butavalidatedtestcouldbesharedwithtradingpartnersshouldtheyrequestit.

VISIT WWW.INSPECTION.GC.CA/WHEATDETECTION TO LEARN MORE