Understanding Pesticide Regulation: New Pesticide Registration

http://edis.ifas.ufl.edu/ ( Publisher's URL )
MISSING IMAGE

Material Information

Title:
Understanding Pesticide Regulation: New Pesticide Registration
Physical Description:
Fact sheet
Creator:
Nesheim, O. Norman
Publisher:
un
Place of Publication:
Gainesville, Fla.
Publication Date:

Notes

Acquisition:
Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Melanie Mercer.
Publication Status:
Published
General Note:
"Publication date: October 1993. Revised: September 1993."
General Note:
"PI-14"

Record Information

Source Institution:
University of Florida Institutional Repository
Holding Location:
University of Florida
Rights Management:
All rights reserved by the submitter.
System ID:
IR00004587:00001


This item is only available as the following downloads:


Full Text

PAGE 1

FactSheetPI-14 October1993UnderstandingPesticideRegulation: NewPesticideRegistration1 O.NormanNesheim2Pesticideregistrationisapre-marketreviewand licensingprogramforallpesticidesmarketedinthe U.S.,whetherofdomesticorforeignproduction.The U.S.EnvironmentalProtectionAgency(EPA) annuallyreviewsapproximately15,000registration submissionsofvariouskinds.Mostofthese submissionsarefornewformulationscontaining activeingredientswhicharealreadyregistered,new usesofexistingproductsorvariousotherlabel amendmentstoexistingproducts.Onlyabout15new chemicals(newactiveingredients)areregisteredeach year.RISKASSESSMENTUndertheFederalInsecticide,Fungicide,and RodenticideAct(FIFRA),allpesticidesdistributed orsoldtoanypersonintheUnitedStatesmustbe registeredwiththeU.S.EPA.TheEPAis responsibleforregisteringnewpesticidestoensure that,whenusedaccordingtolabeldirections,theywill notpresentunreasonableriskstohumanhealthorthe environment.FIFRArequirestheEPAtotakeinto accounteconomic,social,andenvironmentalcosts andbenefitsinmakingdecisions.TheEPAbases registrationdecisionsfornewpesticidesonits evaluationoftestdataprovidedbyregistration applicants.Applicantsforpesticideregistration obtainthesedatafromteststhatarespecifiedbythe EPA.Thetestsmustbeperformedaccordingto specifiedprotocols.Requiredstudiesincludetesting toshowwhetherapesticidehasthepotentialtocause adverseeffectsinhumans,fish,wildlife,and endangeredspecies.Potentialhumanrisksinclude acute(short-term)reactionssuchastoxicpoisoning andskinandeyeirritation,aswellaspossiblechronic (long-term)effectssuchascancer,birthdefects,or reproductivesystemdisorders.Dataon environmentalfatearealsorequiredsothatEPAcan determine,forexample,ifapesticideposesathreat toground-orsurfacewater,agriculturalworkers, endangeredspecies,etc.PRODUCTCLASSIFICATIONEPAmayclassifyapesticideproductfor restricteduseifitscharacteristicswarrantspecial handling.Restrictedusepesticidesmaybeusedonly byorunderthesupervisionofcertifiedapplicators trainedtohandlethesechemicals.Restricteduse classificationmustbeshownonlabels.During registrationreviewtheEPAmayalsorequirechanges inproposedlabelingandusepatterns.TOLERANCESIfapesticideisbeingconsideredforuseona foodorfeedcrop,theapplicantmustpetitionEPA foratoleranceandsubmitappropriatedatasoEPA candefineasafeandrealistictolerancelevel. Tolerancesaremaximumpermissibleresiduelevels forrawagriculturalproductsandprocessedfoods. 1.ThisdocumentisFactSheetPI-14,aseriesofthePesticideInformationOffice,FloridaCooperativeExtensionService,InstituteofFoodand AgriculturalSciences,UniversityofFlorida.Publicationdate:October1993.Revised:September1993. 2.O.NormanNesheim,pesticideinformationcoordinator,FoodScienceandHumanNutritionDepartment,CooperativeExtensionService, InstituteofFoodandAgriculturalSciences,UniversityofFlorida,GainesvilleFL32611. TheInstituteofFoodandAgriculturalSciencesisanequalopportunity/affirmativeactionemployerauthorizedtoprovideresearch,educational informationandotherservicesonlytoindividualsandinstitutionsthatfunctionwithoutregardtorace,color,sex,age,handicap,ornational origin.Forinformationonobtainingotherextensionpublications,contactyourcountyCooperativeExtensionServiceoffice. FloridaCooperativeExtensionService/InstituteofFoodandAgriculturalSciences/UniversityofFlorida/JohnT.Woeste,Dean

PAGE 2

NewPesticideRegistration Page2TheyareestablishedbyEPAundertheFederalFood, Drug,andCosmeticAct(FFDCA).Tolerancesfor agriculturalcommoditiesareenforcedbyFDA;those formeatandpoultryproductsbytheUSDA.REGISTRATIONPROCESSTheregistrationprocessusuallybeginswithan experimentalusepermit(EUP)issuedbytheEPAto permitpre-marketfieldtesting.Subsequently,the manufacturersubmitsanapplicationforfederal registrationtoEPAforreview.Thisapplicationmust includeappropriatehealthandsafetydata,andEPA mayrequirefurthertestingtoclarifyspecifichealthor environmentalquestionsthatmayariseduring registrationreview. Amanufacturermayspendfivetosevenyears researchinganddevelopinganewactiveingredient beforearegistrationpackageisevensubmittedto EPAforconsideration.Oncetheregistrationpackage issubmittedtoEPAitmaytakeuptothreeyearsor moreforEPAtoreviewthedatacontainedinthe packageandtoapproveordenytheregistration. Registrationofanewformulationcontainingan activeingredientalreadyregisteredoranewusefor acurrentlyregisteredactiveingredientusuallytakes lesstime.Inventing,testing,evaluating,andmoving anewactiveingredientthroughtheregistration requirementsmaytakeamanufacturersevento10 yearsandcost$40-60milliondollarsbeforeanysales occur.SPECIALREGISTRATIONSFIFRApermitsEPAtoissueaconditional registrationforapesticide,ifEPAfindsthattheuse oftheproductwillnotsignificantlyincreasethelevel ofriskposedbysimilarproductsalreadyonthe market.Theconditionimposedontheregistrationis satisfactorycompletion(usuallywithinaspecified time)ofspecificstudiesrequiredforfullregistration. UnderspecialcircumstancesEPAmayalsogrant conditionalregistrationsforproductscontainingactive ingredientsnotpreviouslyregisteredwithEPAifthe conditionaluseoftheproductwillbeinthepublic interest,andwillnotpresentanunreasonablerisk. EPAalsoevaluatesseveralothertypesofspecial registrationsubmissionsmandatedbyFIFRA. ExperimentalusepermitsunderSection5ofFIFRA allowlarge-scaleexperimentationinordertodevelop datafornewproductsornewusesofexistingones. ThroughSection18ofFIFRA,EPAmaytemporarily authorizestateorfederalagenciestocombatcertain pest-relatedemergencieswithpesticideusesnot permittedbyexistingfederalregistrations.Section 24(c)authorizesstatestoregisterapesticidefora "speciallocalneed".Suchregistrations,whenissued, areeffectiveimmediately,butEPAhasauthorityto disallowthemwithin90daysafterbeingissued. Speciallocalneedregistrationsbecomefederal registrationsforuseinspecifiedstates.STATEENFORCEMENTFIFRAgivesstatesprimaryenforcement responsibilityforpesticideuseviolations,subjectto EPAoversight.Pesticideapplicatorcertification programsarealsoconductedbythestates.In Florida,enforcementresponsibilitiesarehandledby theDepartmentAgricultureandConsumerServices (FDACS).FDACSisthedesignatedStateLead Agencyfortheenforcementofstateandfederal pesticideregulations.Throughamemorandumof agreementwithFDACS,theInstituteofFoodand AgriculturalSciencesattheUniversityofFloridahas trainingandtestingresponsibilitiesfortheapplicator certificationprogram.