IndustryScienceFeedstheWorld CropLifeAmerica(CLA)1wouldliketoofferthefollowingdescriptiontoinformyouoftherigorous requirementstosupportpesticideproductregistrations.Specifically,wewouldliketohighlightthe requirementsfortheconductofregulatorystudiesandthelevelofscrutinytowhichthesestudiesare subjectedbyregulatoryagenciesaroundtheworld.Additionally,wewouldliketoreassertthehigh degreeofconfidenceinthesubstantialtoxicologicaldatabaseforherbicides. Withinagrowingnumberofarticles(bothpeerreviewedandselfpublished)theauthorsinferthat researchconductedbyindustryinsupportofherbicideproductregistrationsisunreliableandinfluenced byeconomicinterests.Inessence,theauthorsdirectlyassertthatcompaniesuseflawedscienceto defendtheirproductswithonlyminimalgovernmentalscrutiny.Thisreflectsamisconceptionthatsome researchersoutsideofindustryhaveaboutindustryfundedresearch. First,itshouldbenotedthatproductsafetydatagenerationcanbegenerallydividedintotwocategories (1)thosefollowingtheGoodLaboratoryPractices(GLP)requirementsand(2)thosenotfollowingGLP requirements.ResearcherswilloftenchoosetoavoidGLPrequirementsduringearlystagesofresearch orforcomplexinvestigativeresearch;GLPrequirementsareburdensome,costlyandtimeconsuming.

ng. However,itiswidelyrecognizedthatGLPrequirementsprovideastandardizedmethodtoensurethe traceabilityandintegrityoftheresearchdata.Withregardstodatagenerationonherbicides,most regulatoryagenciesrequiretheproductregistrantstogenerateproductsafetydataaccordingtoGLP guidelines. Undervariousgovernmentregulations(includingtheUnitedStatesFederalInsecticide,Fungicide,and RodenticideAct(FIFRA),theUnitedStatesFederalFood,Drug,andCosmeticAct(FFDCA),theEuropean UnionCouncilDirective91/414/EEC(currentlyundergoingrevision),andJapansAgriculturalChemicals RegulationLaw),pesticideproductdevelopersandmanufacturersarerequiredtosubmitanextensive datapackagethatcoversmanyspecifiedscientificdisciplinesasdefinedbyharmonizedtestguidelines (seewww.epa.gov/ocspp/pubs/frs/home/guidelin.htmand www.oecd.org/document/40/0,3343,en_2649_34377_37051368_1_1_1_1,00.html).Morethan200 differentstudiesaredefinedtoensuretheproductsafetycharacteristicsofapesticideareappropriately testedandscrutinizedtocoverthevarietyofpotentialusesforpesticideproducts.Ofthistotal, approximately50testsaddressawidearrayoftoxicologicaleffectsrelevanttohumanhealth(including teratogenicityandmutagenicity)andanother50testsaddresstoxicologicaleffectsrelevanttothe environment.
CLA is the not-for-profit trade organization representing the nations developers, manufacturers, formulators and distributors of plant science solutions for agriculture and pest management in the U.S. Our member companies produce, sell and distribute virtually all the crop protection technology products used by American farmers. CLA is focused on helping feed a hungry world and advancing agriculture.
1

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 Regulatorytoxicologystudiesidentifypotentialhazards,doseresponserelationships,noobserved adverseeffectlevels,andadditionalendpointsforuseinriskassessment.Thenoobservedadverse effectlevels(NOAELs)thatarederiveddirectlyfromtoxicologicalstudies,maybemodifiedbyan uncertaintyfactororsafetyfactor(whichisoftenatenfoldfactorforeachuncertainty)todetermine theReferenceDose.TheReferenceDoseisthelevelofexposureanindividualcouldbeexposedtoona dailybasisforalifetimewithminimalprobabilityofexperiencinganyadverseeffect.Oncethe ReferenceDosehasbeenestablished,itiscomparedtotheexpectedexposure.Iftheexpectedexposure islessthantheReferenceDose,theexposureisconsideredsafe.Anotherapproachistodividethe NOAELbytheexposurevalueanddeterminethemarginsofexposure. AllofthesestudiesarerequiredtobeconductedpursuanttoapprovedprotocolsandaccordingtoGLP Standards(EPAregulationsunder40CFRPart160;OrganizationforEconomicCooperationand Development(OECD)PrinciplesofGoodLaboratoryPractice;EuropeanDirective2004/10/EC;Good LaboratoryPracticeStandardsforToxicologystudiesonAgriculturalChemicalsinJapan).Formorethan threedecades,GLPStandardshaverequireddetailedwrittentestingprotocols,welldocumentedand characterizedtestsubstances,trainedpersonnel,calibratedequipment,anindependentquality assuranceunit,andmanyotherprovisionstorigorouslydocumentandensurequalityandtraceabilityof studiesforpesticideregistration.EachdatapointwithinaGLPstudycanbetracked,audited,and validated;andallrawdataandpreservedtissues,blocksandslidesarearchivedforaminimumof10 years(or,inmostcases,forthelifetimeofaproduct).Regulatoryagenciesworldwideconductregular auditsoftestingfacilitiestoverifycomplianceandtoenforceGLPStandards.FailuretocomplywithGLP Standardscanincurdelay,denial,orrevocationofproductregistration,aswellasheftycivilfinesand evencriminalpenaltiesfortheregistrant. Studyreportssubmittedtoregulatoryagenciesprovideresultspresentedinasummarizedformatas wellasallindividualanimaldata.AftercompliancewithGLPStandardsisverified,scientistsinthe regulatoryagenciesconductarigorouspeerreviewoftheindustryresearchsubmittedtoaddress pesticideregulatoryrequirements.Thistypicallyinvolvesathoroughreviewofmethods,results,and conclusions;reanalysisofrepresentativedataanddetailedtestingofalternatehypothesesor conclusions;andcomparisonwithotherrelevantstudies,includinganyfromtheopenliterature.Much oftheinformationfromtheregulatorsreviews,includingtheregulatorsconclusionsabouttheresults andscientificvalidityofthestudy,anditsacceptabilityforriskassessment,aremadeavailabletothe public. Thereisanextensiveandsubstantialtoxicologicaldatabaseforcropprotectionproducts.Multiplehigh qualitytoxicologicalstudiesandexpertreviewpanelsconsistentlyagreethatregisteredherbicidesdo notcauseadversehumanhealtheffects(includingbirthdefects,cancerandobesity).TheGLPstudiesor "industryfundedstudies"havebeenexhaustivelyreviewedbymultiplegovernmentscientific regulators,oftencomprisedofacademicexpertscientistsandallofwhichhavestronglysupportedthe conclusionsputforthinthosestudies.Registeredherbicidesdonotcauseadversereproductiveeffects inadultanimalsorbirthdefectsinoffspringoftheseadultsexposed,evenatveryhighdoses.These conclusionsarebasedonmultiplestudiesinlaboratoryanimalsthathavebeenconductedtoexamine thepotentialformultigenerationalandteratogeniceffects.Thesestudieshavebeenrepeatedby differentcompaniesatdifferentlaboratoriesacrosstheglobe,withconsistentresults.
RepresentingthePesticideIndustry
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 Herbicidesandothercropprotectionproductsareuniquetoolswithinthemodernagriculturaltoolbox thatcanhelpfeedtheworld.TheUnitedNationspredictsworldpopulationwillexceed9billionbymid centuryandhascalledfora100percentincreaseinworldfoodproductionby20502.Thisdoubledfood requirementmustcomefromvirtuallythesamelandareathatiscurrentlyinagriculturalproduction today.Therefore,theneedforinnovationthroughnewtechnologiesisessentialforthefutureof citizens,communitiesandnaturalresources.Thesetechnologiescanbesafelybroughttofarmers throughcontinuedinvestmentinresearchandsciencebasedregulatorysystems.Thesignificantroleof industryinscientificresearchandprovidingGLPdatatoregulatoryauthoritiesaroundtheworldshould beendorsedasindustryhelpstofeedtheworld.

United Nations. 2007. World Population Prospects: The 2006 Revision. U.N. Population Division, NY

RepresentingthePesticideIndustry
115615thSt.N.W.,Suite400Washington,D.C.20005202.296.1585phone202.463.0474faxwww.croplifeamerica.org