Scientific Issues Associated with EPA’sProposed Cancellation & Denial of CertainRodenticide ProductsGoals and Objectives of theNovember 29 – December 1FIFRA Scientific Advisory Panel ReviewSteven Bradbury, Ph.D.Director, Office of Pesticide ProgramsBackground•FIFRA (the Federal Insecticide, Fungicide andRodenticide Act) requires EPA to determinewhether the uses of a pesticide generally present“unreasonable adverse effects on theenvironment.”EPA l i h i id•EPAstatutes also require that pesticidesregistered prior to 1984 be re-evaluated by 2008to ensure continued use of these pesticides meetthe statutory standards of human health andenvironmental protection.2FIFRA Risk/Benefit Paradigm•To obtain or maintain a registration for a pesticideToobtainormaintainaregistrationforapesticideunder FIFRA, a registrant must demonstrate thatthe pesticide satisfies the statutory standard forregistration. That standard requires, among otherthings, that the pesticide performs its intendedfunction without causing unreasonable adversefunctionwithoutcausingunreasonableadverseeffects on the environment.•FIFRA defines an unreasonable adverse effect onth i t bl i k tthe environmentas any unreasonable riskto manor the environment, taking into account theeconomic, social, and environmental costs andbenefits of the use of the pesticide...3Notice of Intent to Cancel (NOIC) ProcessUnder FIFRA section 6(b), the Agency may issue aNotice of Intent to Cancel the registration of apesticide product whenever it appears either that:(1) A pesticide or its labeling or other materialrequired to be submitted does not comply withrequiredtobesubmitteddoesnotcomplywithFIFRA, or(2) When used in accordance with widespread andcommonly recognized practice, the pesticidegenerally causes unreasonable adverse effectson the environment.ontheenvironment.4FIFRA Requirements for a NOIC•EPA is required to send the draft NOIC to USDAEPAisrequiredtosendthedraftNOICtoUSDAfor comment on the impact of the decision on theagricultural economy.•When a public health use is affected, EPA isrequired to send the draft NOIC to HHS forcomment on benefits or use.•EPA is required to request the FIFRA SAP tocomment on the scientific bases of the humanhealth and environmental assessmentsunderlying the action proposed in a draft NOIC.•EPA must evaluate and publish responses toUSDA HHS andSAP reviews as part of theUSDA,HHS,andSAPreviewsaspartoftheAgency’s deliberations.5The Current NOIC•EPA’s regulatory conclusions:•20 rodenticide products should be cancelled.4 d ti id li ti f d t•4rodenticide applicationsfor productregistration should be denied.EPA id dth d ft NOIC th A ’•EPAprovidedthedraftNOIC,theAgency’sbenefits analyses, and associated backgrounddocuments to USDA and HHS.•USDA and HHS reviews are progressingconcurrentlywith theSAP review and its report.S6FIFRA Requirements for a NOICWhil th SAP i h d t t i tifiWhiletheSAPis chargedto commenton scientificissues associated with the rodenticide riskassessments, there are certain topics that the SAPi th d t idi ths notchargedto providing commenton wenreviewing a NOIC:•The impact of the draft NOIC on the agriculturaleconomy and public health uses, i.e., therodenticides benefits analyses.•EPA’regulatoryconclusions:sregulatory•Should these 20 products be cancelled.•Should the 4 product registration applicationsb d idedenied.7SAP Review: Goals and ObjectivesConsistent with SAP reviews concerning draftNOICs:EPAis not asking advice on whether theisnotaskingadviceonwhetherthescientific bases of the rodenticides riskassessments, the incident analyses, and theregulatorydecisioncould benefit from thecouldbenefitfromthedevelopment of new scientific methodologiesor additional data.8SAP Review: Goals and ObjectivesSAPReview:GoalsandObjectivesReview:ObjectivesEPA is requestingthe SAPprovideg pcomments on whether the Agency hasreasonably assessed the nature andmagnitude of risks to public health and theenvironment posed by the use of certainrodenticide productsgiven currentlyrodenticideproducts,givencurrentlyavailable information and accepted scientificmethods.9SAP Review: Background to Charge Questionsg•EPA has identified scientific issues most criticalto itsdecision to cancel and deny registrationsdecisiontocancelanddenyregistrationsthat do not conform to the Risk MitigationDecision for Ten Rodenticides.•The issues primarily concern topics that have notbeenpreviouslyaddressed bythe SAP.y y10SAP Review: Background to Charge QuestionsEPA i i il tii f th•EPAis primarily requesting a revew ofthescientific elements that relate to EPA’sconclusions that the 20 rodenticide productscause unreasonable adverse effectscauseunreasonableadverseeffects.•The general methodologies used to assessrodenticide ecological risks and to analyzeyhuman and pet incidents have been the subject ofseveral previous SAP reviews.11SAP Review: Background to Charge Questionsg•To provide adequate scientific peer review, SAPresponses to EPA’s charge questions are required.•While EPA’s charge questions must be addressed,the SAP is not precluded from commenting onadditional scientific aspects of the rodenticide riskassessments and incident analyses associated withthe draft NOIC.•Any additional scientific issues that the SAP mayAnyadditionalscientificissuesthattheSAPmaywish to address could be those raised by the publicor by individual SAP members.12Overview of Agenda•Review of the regulatory history andthe processReviewoftheregulatoryhistoryandtheprocessEPA followed in preparing the draft NOIC.•Presentations from scientists in OPP’PresentationsfromscientistsinOPP sEnvironmental Fate and Effects and HealthEffects Divisions concerning the ecological riskassessments and incident analyses for non-assessmentsandincidentanalysesfornontarget wildlife, human, and pets.•Apresentation on rodenticide efficacy.y•Public Comment.•Chargesto the PaneltothePanel.13