AntimicrobialUseSiteIndexUnitedStatesEnvironmentalProtectionAgencyOfficeofChemicalSafetyandPollutionPreventionOfficeofPesticideProgramsAntimicrobialsDivisionJuly14,20151UseSiteIndex– OverviewofWebinar•Background•Introduction•FoodUseDescriptionFlowChart•UseSiteIndexInstructions•SummaryandConcludingRemarks•Questions2Background:AntimicrobialUseSiteIndex(USI)•“FinalRuleforDataRequirementsforAntimicrobialPesticides”waspublishedonMay8,2013•FinalRulecodified12antimicrobialusepatternsthatwerepresentedinAppendixBtothe2008ProposedRule•USIupdatesinformationinAppendixBofthe2008proposedrule•Twelvemajorusepatternshavenotchanged,butthereanumberofnotabledifferences3Background:AntimicrobialUSIAppendix Bof2008ProposedRule July2015Antimicrobial UseSiteIndexAlist ofgeneralusepatternsandspecificusesites Includes guidanceonhowtodeterminedatarequirementsMany usesitesdesignatedas“indoor”IndoorandoutdoorarenolongerdescriptorsSome majorusepatternshadnofoodusedesignationsforspecificusesitesWithingeneralusepatterncategories,specificusesitesarealsoorganizedaccordingtoapplicablefoodusedesignationsLimited guidanceontherelationshipbetweenfoodusecategoriesandpresenceorabsenceofresidueswithregardtorequirementsfordietaryexposureassessment,tolerance,andtoleranceexemptionFood usedescriptionflowchartincludesinformationontherelationshipbetweenfoodusecategoriesandpresenceorabsenceofresidueswithregardtorequirementsfordietaryexposureassessment,tolerance,andtoleranceexemptionNodescriptionsofkeyterms Keytermsaredescribed4Introduction:AntimicrobialUseSiteIndexWhatdoestheUSIdo?•Providesguidancetohelpidentifydatanecessarytoregisterantimicrobialpesticideproducts•Compilesspecificusesitescategorizedintotwelvegeneralusepatterncategories•Designatesspecificusesitesinto“fooduse”categories,includingdirectfood,indirectfood,andnonfooduses5Introduction:KeyComponentsofUseSiteIndex•Generalusepatterncategories•Specificusesites•Foodusecategories6Introduction:KeyComponentsofUseSiteIndex•Generalusepatterncategoriesserveaslinkstotablesofdatarequirementsforenvironmentalfate,nontarget organisms,andnontarget plants•Specificusesitesareassociatedwithgeneralusepatterncategories•Foodusecategoriesarespecificallyapplicabletotoxicologyandresiduechemistrydatarequirements712MajorUsePatterns12MajorUsePatterns81. AgriculturalPremises&Equipment2. FoodHandling/StorageEstablishments,PremisesandEquipment3. Commercial,InstitutionalandIndustrialPremisesandEquipment4. ResidentialandPublicAccessPremises5. MedicalPremisesandEquipment6. HumanDrinkingWaterSystems7. MaterialsPreservatives8. IndustrialProcessesandWaterSystems9. AntifoulingCoatingsandBallastWaterTreatments10. WoodPreservatives11. SwimmingPoolsandSpas12. AquaticAreasIntroduction:SpecificUseSitesofUSI•USIservesasacompilationofspecificusesitescommonlylistedonantimicrobialproductlabels•Specificusesitesidentifywhereanantimicrobialpesticideistobeused•Specificusesitesarelistedwithingeneralusepatternsandcategorizedbyfooduse•Examplesofspecificusesitesandassociatedgeneralusepatterns9SpecificUseSite GeneralUsePatternMetalworking Fluids MaterialsPreservatives(7)Commercial/IndustrialCoolingWater(Once‐Through) Industrial ProcessesandWaterSystems(8)Fruit andVegetableRinses FoodHandling/Storage Establishments,PremisesandEquipment(2)OrnamentalPonds/Aquaria Aquatic Areas(12)Boat/ShipHull/Bottom AntifoulingCoatingsandBallastWaterTreatments(9)Introduction:RequestforPublicComment•TheUSIisalivingdocumentthatwillbeupdatedperiodically•USIwaspostedinthedocketonJuly1,2015fora30‐daycommentperiod•EPAplanstoreviewcomments,updateasneeded,andpostarevisedversionoftheUSIbyFebruary1,2016•TheAgencyisespeciallyinterestedinreceivingcommentsregarding•Simplifications•Missinginformation•Redundancies•Errors•Moreconsistentlabelterminology•TheUSIcanbeaccessedfromthewebsite,www.regulations.gov.ThedocketnumberisEPA‐HQ‐OPP‐2015‐030210FoodUseDescriptionFlowChart11DescriptionsofDirectFood,IndirectFood,andNonfoodUses•Designationisdeterminedbytheusepattern(howthepesticideisapplied)•Notdependentonwhetherresiduesareexpectedorpresentin/onfoodfollowingapplication(althoughsuchresiduesgenerallyarenotexpectedwithnonfooduses)•Presenceofresiduesdetermineswhetherornotatoleranceorexemptionfromtherequirementofatolerance(toleranceexemption)isrequiredbasedonthedefinitionofpesticidechemicalresidueperFFDCAsection201(q)12DirectFoodUses•Whenanantimicrobialpesticideisintendedtobedirectlyappliedtofoodorappliedtoamaterialorarticleforthepurposesoftreatingfood•Examplesinclude:fruitandvegetablewashes/rinses,foggingofpoultryareas,andeggwashingtreatments•ThesetypesofusearegenerallysubjecttoFFDCAclearances13IndirectFoodUses•Applicationoftheantimicrobialpesticideinoronamaterialorarticlethatcomesintocontactwithfoodandmayresultinresiduesinoronfood,buttheuseisnotintendedforpesticidaltreatmentoffood•Asaresultofcontactwithasurfaceand/ormaterialthathasbeentreatedand/orimpregnatedwithanantimicrobialpesticide,thereisapotentialforresiduesinoronfood•Examplesinclude:sanitizationoffood‐contactdishes,utensils,food‐processingequipment,andcountertops;disinfectionoffood‐useareas;andimpregnationofcuttingboards,conveyorbelts,orfoodcontainersand/orpackagingforapesticidalpurposeotherthantreatingfood•ThesetypesofusesmaybesubjecttoFFDCAclearances14NonfoodUses•Theantimicrobialpesticideisnotexpectedtocomeintocontact(directlyorindirectly)withfoodasaresultofitsintendeduse•Reasonablecertaintyofnoresiduesinoronfood•Examplesinclude:fueltanks,humanfootwear,ornonfoodareas(e.g.,underthesink)ofeatingestablishments•ThesetypesofusesaregenerallynotsubjecttoanFFDCAclearance•Nodietaryexposureassessmentisconducted15FFDCAClearances•Whentheuseofapesticidecreatesareasonableexpectationofresiduesonfood,appropriateFFDCAclearancesneedtobeinplaceorthefoodwillbeconsideredadulteratedandsubjecttoseizure•TheappropriateFFDCAclearanceisdeterminedbyapplyingthedefinitionof“pesticidechemicalresidue”underFFDCAsection201(q)•Ifthesubstancebeingappliedandforwhichthereisareasonableexpectationofresiduesinoronfoodisapesticidechemical,atoleranceortoleranceexemptionisrequiredunderFFDCA408•Ifthesubstancebeingappliedandforwhichthereisareasonableexpectationofresiduesinoronfoodisnot apesticidechemical,FDAmayneedtoissueafoodadditiveregulationorfoodcontactnotificationunderFFDCA409•NonfoodusesdonotrequireFFDCAclearancessincethereisnoreasonableexpectationofresiduesin/onfood16FIFRASafetyFinding•EvenifanantimicrobialpesticideisnotsubjecttoEPA’sreviewundertheFFDCAsection408(becauseitdoesnotmeetthestatutorydefinitionof“pesticidechemical”under201(q)),EPAstillmustevaluatehumandietaryrisktoensurethattheuseofthepesticideonfoodwillbesafe17FoodUseDescriptionFlowChart•AssumesthatadeterminationunderFFDCAsection201(q)hasbeenmadeandthatanyoftheresiduesin/onfoodwouldmeetthedefinitionofpesticidechemicalresidues(PCRs)•EPAwouldthenhavejurisdictionunderFFDCAsection408todetermineifatoleranceorexemptionfromtherequirementofatoleranceisneeded•FlowchartisnotdesignedtodelineatejurisdictionunderFFDCAbetweenEPAandFDA18FoodUseDescriptionFlowChartDirect FoodUseIndirectFood UseNonfoodUseAre residues expectedin/on food for this use?Are residues expectedin/on food for this use?No residues expectedin/on food for this useNoYesIs the use strictly residential?YesNoDietary exposure assessmentconducted for safety finding(FIFRA)A tolerance or exemption from therequirement of a tolerance is neededNo tolerance or exemption from therequirement of a tolerance is neededRegistrant mustprovide rationaleand/ordemonstrate thatthere is noreasonableexpectation ofresidues in/onfood**Examples of rationale include but are not limited to:Data and/or rationale used to support FDA food additive regulation or FCNTheoretical high-end calculations/modeling demonstrating thatthere is noreasonable expectation of residues in/on foodJustification of residue removal via a potable water rinseLabel restrictions limiting exposure to foodJustification based on product chemistry and/or environmental fatecharacteristics (i.e., volatility, solubility)Residue dataNo dietary exposure assessment is requiredFoodUseDescriptionFlowChartDirect FoodUseIndirectFood UseNonfoodUseAre residues expectedin/on food for this use?Are residues expectedin/on food for this use?No residues expectedin/on food for this useNoYesIs the use strictly residential?YesNoDietary exposure assessmentconducted for safety finding(FIFRA)A tolerance or exemption from therequirement of a tolerance is neededNo tolerance or exemption from therequirement of a tolerance is neededRegistrant mustprovide rationaleand/ordemonstrate thatthere is noreasonableexpectation ofresidues in/onfood**Examples of rationale include but are not limited to:Data and/or rationale used to support FDA food additive regulation or FCNTheoretical high-end calculations/modeling demonstrating thatthere is noreasonable expectation of residues in/on foodJustification of residue removal via a potable water rinseLabel restrictions limiting exposure to foodJustification based on product chemistry and/or environmental fatecharacteristics (i.e., volatility, solubility)Residue dataNo dietary exposure assessment is required12345FoodUseDescriptionFlowChartNonfoodUse•Noresiduesareexpectedin/onfood•Nodietaryexposureassessmentisneeded•Notoleranceorexemptionisneeded21FoodUseDescriptionFlowChartDirectandIndirectFoodUses– ResiduesExpected•Ifresiduesareexpectedbuttheusesarestrictlyresidential:•Dietaryexposureassessmentconductedtomakeasafetyfinding(FIFRA)•Notoleranceorexemptionisneeded22•Ifresiduesareexpectedbuttheusesarenotstrictlyresidential:•Dietaryexposureassessmentconductedtomakeasafetyfinding•Atoleranceorexemptionisneeded23FoodUseDescriptionFlowChartDirectandIndirectFoodUses– ResiduesExpectedFoodUseDescriptionFlowChartDirectandIndirectFoodUses– NoResiduesExpected2425ADDecisionProcessResiduesarenotexpectedResiduesare expectedUseSiteIndexInstructions26USESITEINDEXGUIDANCEFORPROPOSEDLABELS•ADPesticidelabelsneedtoincludeclearuseinstructionsconcerningwhetherthepesticideproductisintendedtocomeintocontactwithfood,eitherdirectlyorindirectly.•Thereare12generalusepatternssubdividedintothefollowingcategories:‐Directfooduses‐Indirectfooduses‐Nonfooduses27HowtoUseTheUseSiteIndextoDetermineDataRequirementsIdentifytheapplicablegeneralusepatterncategoriesandwhichspecificusepatternsaremostsimilartoeachproposedusepatternthatappearsonthelabel.Example:CompanyXhasanewdisinfectantcontaininganewactiveingredientthatwillbeusedinDairyfarms(notforuseinmilkingstalls,milkingparlors,or milkhouses),veterinaryclinics,hospitals,andhomesonfloors,walls,tables,handling/restrainingequipment,shoebaths,cages,bathtubs,toilets,sinks,counters,andappliances.Fortheseuses,whatarethegeneralusepatterncategoriesbasedontheUSI?Whatarethespecificusepatterns?28WhataretheGeneralandSpecificUsePatterns?GeneralUsePattern#1:SpecificUsePatterns:Dairy Farms‐floors,walls,tables,andrestraining/handlingequipment,andshoebathsGeneralUsePattern#4:ResidentialandPublicAccessPremisesSpecificUsePatterns:Homes‐floors,walls,tables,toilets,sinks,counters,andappliancesGeneralUsePatterns#5:MedicalPremisesandEquipmentSpecificUsePatterns:VeterinaryClinics‐floors,walls,tables,cages,andcountersHospitals‐floors,walls,tables,toilets,sinks,andcounters29UseSiteIndexInstructionsBasedontheidentifiedspecificusepattern,determineiftheuseisconsideredtobedirectfood,indirectfood,ornonfood.30DirectFoodUseIndirectFoodUseNonfoodDairy Farms(fromgeneralusepattern#1):IndirectFood:Nositesbecauselabelindicatednotforuseinmilkingstalls,milkingparlors,ormilkhouses.Nonfood– floors,walls,tables,restraining/handling equipmentandshoebathsHomes(fromgeneralusepattern#4):IndirectFood:tables,counters andappliancesNonfood:floors,walls,toiletsandsinksHospitals/VeterinaryClinics(fromgeneralusepattern#5):Nonfood‐floors,walls,tables,cages,toilets,sinksandcounters31Howwouldyoucharacterizethefoodusecategoryforthespecificusepatternsfromtheexample?FoodUseDescriptionFlowChartDirect FoodUseIndirectFood UseNonfoodUseAre residues expectedin/on food for this use?Are residues expectedin/on food for this use?No residues expectedin/on food for this useNoYesIs the use strictly residential?YesNoDietary exposure assessmentconducted for safety finding(FIFRA)A tolerance or exemption from therequirement of a tolerance is neededNo tolerance or exemption from therequirement of a tolerance is neededRegistrant mustprovide rationaleand/ordemonstrate thatthere is noreasonableexpectation ofresidues in/onfood**Examples of rationale include but are not limited to:Data and/or rationale used to support FDA food additive regulation or FCNTheoretical high-end calculations/modeling demonstrating thatthere is noreasonable expectation of residues in/on foodJustification of residue removal via a potable water rinseLabel restrictions limiting exposure to foodJustification based on product chemistry and/or environmental fatecharacteristics (i.e., volatility, solubility)Residue dataNo dietary exposure assessment is required541UseSiteIndexInstructionsOncetheproposedusehasbeendetermined with1ofthe12generalusepatterns,aswellastheappropriatefoodusecategory,consulttheantimicrobialdatarequirementstablesin40CFR158W.(FoodusecategoriesonlyapplytoToxandResiduechemistrydatarequirementtables)33DataRequirementsTable34Guideline Number Column: These are not data requirements.Data Requirement ColumnUse Pattern ColumnsGuideline No. Data requirementFood Uses Nonfood usesIndirect fooduses (>200 ppb)Indirect food uses(≤200 ppb)Swimming pools, aquaticareas, wood preservatives,metal working fluidsAll othernonfood usesAcute Testing870.11 Acute oral toxicity—rat R RRR870.12 Acute dermal toxicity R RRR870.13 Acute inhalation toxicity—rat R RRR870.24 Primary eye irritation—rabbit R RRR870.25 Primary dermal irritation R RRR870.26 Dermal sensitization R RRR870.26 Acute neurotoxicity—ratRCRRCRSubchronic Testing870.31 90-Day oral toxicity—rodentR R R CR870.315 90-Day oral toxicity—nonrodentRCR R CR870.32 21/28-Day dermal toxicity CR CR CR CR870.325 90-Day dermal toxicity CR CR CR CR870.3465 90-Day inhalation toxicity—rat CR CR CR CR870.62 90-Day neurotoxicity—ratRCR R CRChronic Testing870.41 Chronic oral toxicity—rodentRCR R CR870.42Carcinogenicity—two rodent species—rat and mouse preferredRCR R CRDevelopmental Toxicity andReproduction870.37Prenatal developmental toxicity—rat andrabbit preferredRRRR870.38 Reproduction and fertility effectsRRRR870.63 Developmental neurotoxicity CR CR CR CRMutagenicity870.51 Reverse mutation assayRRRR870.5300870.5375In vitromammalian gene mutation R R R R870.5385870.5395In vivocytogenetics R R R RSpecial Testing870.7485 Metabolism and pharmacokineticsRCR R CR870.72 Companion animal safetyCR CR CR CRGuideline No.Data requirementFoodUsesNonfoodusesIndirect food uses(>200 ppb)Indirect food uses(≤200 ppb)Swimming pools,aquatic areas, woodpreservatives, metalworking fluidsAll other nonfood usesSubchronic Testing870.31 90-Day oral toxicity—rodent RRR CR870.315 90-Day oral toxicity—nonrodentRCR R CR870.32 21/28-Day dermal toxicity CR CR CR CR870.325 90-Day dermal toxicity CR CR CR CR870.3465 90-Day inhalation toxicity—rat CR CR CR CR870.62 90-Day neurotoxicity—ratRCR R CRChronic Testing870.41 Chronic oral toxicity—rodentRCR R CR870.42Carcinogenicity—two rodent species—rat and mouse preferredRCR R CRDevelopmental Toxicity andReproduction870.37Prenatal developmental toxicity—rat andrabbit preferredRRRR870.38 Reproduction and fertility effectsRRRR870.63 Developmental neurotoxicity CR CR CR CRMutagenicity870.51 Reverse mutation assayRRRR870.5300870.5375In vitromammalian gene mutation R R R R870.5385870.5395In vivocytogenetics R R R RSpecial TestingGuideline No.Data requirementFoodUsesNonfoodusesIndirect food uses(>200 ppb)Indirect food uses(≤200 ppb)Swimming pools,aquatic areas, woodpreservatives, metalworking fluidsAll other nonfood usesSummary37TheAntimicrobialUSI•Providesguidanceintendedtohelpregistrantsidentifydatarequiredtoregistertheirantimicrobialpesticideproducts•Explainshowtouseinformationaboutgeneralantimicrobialpesticideusepatterns,specificusesites,andfooduseclassificationstodeterminedatarequirements•Designatesspecificusesitesinto“fooduse”categories,includingdirectfood,indirectfood,andnonfoodusesSummary•TheUSIisalivingdocumentthatwillbeupdatedperiodically•USIwaspostedinthedocketonJuly1,2015fora30‐daycommentperiod•EPAplanstoreviewcomments,updateasneeded,andpostarevisedversionoftheUSIbyFebruary1,2016•TheAgencyisespeciallyinterestedinreceivingcommentsregarding•Simplifications•Missinginformation•Redundancies•Errors•Moreconsistentlabelterminology•TheUSIcanbeaccessedfromthewebsite,www.regulations.gov.ThedocketnumberisEPA‐HQ‐OPP‐2015‐030238Contact Information•EPACONTACTSTerriaNorthern,northern.terria@epa.gov,703347‐0265DonWilbur,wilbur.don@epa.gov,703347‐8894PatJennings,jennings.pat@epa.gov,703308‐8569StevenWeiss,Weiss.steven@epa.gov,703308‐829339QUESTIONANDANSWERSESSION40CONCLUDINGREMARKS•Thanksforattendingtoday’swebinarontheantimicrobialusesiteindex.•FortheAgencytoconsideryourcommentsontheUSI,pleasesubmitthemtothedocketbyJuly31,2015.Againthedocketcanbeaccessedatwww.regulations.gov.ThedocketnumberisEPA‐HQ‐OPP‐2015‐030241