ScientificIssuesAssociatedwith EPA’se t c ssues ssoc ated t sProposed Cancellation & Denial ofCertain RodenticideProductsSc e t c ssues ssoc ated t sProposed Cancellation & Denial ofCertain RodenticideProductsta ode t c de oductsRegulatory BackgroundRusty Wasem, M.S.Chemical Review ManagerOffice of Pesticide ProgramsOfficeofPesticideProgramsCommensal Use Rodenticide ActiveIngredients• 1stGeneration Anticoagulants• warfarin (and its sodium salt)first registered 1950 (and 1954)•diphacinone (and its sodium salt)first registered 1960 (and 1962)diphacinone(anditssodiumsalt)firstregistered1960(and1962)• chlorophacinonefirst registered 1971• 2ndGeneration Anticoagulants(AKA Long Acting Anticoagulant Rodenticides or Super Warfarins)(AKALongActingAnticoagulantRodenticidesorSuperWarfarins)• brodifacoumfirst registered 1979• bromadiolonefirst registered 1980• difethialonefirst registered 1995• difenacoumfirst registered 2007• Non-Anticoagulants(AKA Acute Rodenticides)(AKAAcuteRodenticides)• zinc phosphidefirst registered 1947• Homeowner uses are limited tobelow ground applications for moles, voles, & pocketgophers•bromethalinfirst registered 1984firstregistered1984• cholecalciferol (Vit-D3)first registered 1984• Currently no homeowner products2Active Ingredients & Products Subject tothis NOIC• Products Proposed for Cancelation Contain:• Bromethalin• Brodifacoum• Difethialone• Warfarin• Products Proposed for Denial Contain• BromethalinB dif•roacoum• Product Currently Registered Products for ResidentialConsumer Market Contain:• Bromethalin• Diphacinone•Chlorophacinone3Pre-1998• 1982 – Registration Standards for Warfarin & ZincPhosphide• 1983 - Pesticide Registration Notice (PR Notice) 83-5• Product labels were to require the statement:“baits mustbe placed inlocations not accessible to children pets wildlife and domestic animals orlocationsnotaccessibletochildren,pets,wildlife,anddomesticanimals,orin tamper-proof bait boxes”•1991-Warfarin Reregistration Eligibility Decision (RED)WarfarinReregistrationEligibilityDecision(RED)• Product labels were to require the use of tamper-resistant baitstations wherever bait placements would be within the reach ofchildren, pets, domestic animals, or non-target wildlifechildren,pets,domesticanimals,ornontargetwildlife• 1994 - PR Notice 94-7• “Tamper-Proof”replaced by“Tamper-Resistant”bait stationreplacedbyResistantbaitstation• Commensal rodents41998 Rodenticide Cluster RED &Zinc Phosphide RED•The 1998 REDs only assessed the brodifacoum,bromethalin, bromadiolone chlorophacinone,di h i (& it di lt) d i h hiddiphacinone(&its sodium salt), andzinc phosphide•Identical mitigation measures were required for rodenticide products,containing warfarin (& its sodium salt), difethialone, andcholecalciferol (vit D3)cholecalciferol(vit.D-•Mitigation Measures:•Non-ag baits must incorporate indicator dyes and bittering agents•Products formulated as tracking powders to remain restricted useproducts (RUP)•All products labeled for field uses, except those limited to manualunderground baiting were to be reclassified as RUPundergroundbaitingweretobereclassifiedasRUP•Organize a stakeholder FACA group to advise Agencyon rodenticide exposure reduction.•Further evaluation of ecological risk was needed.51999-2004•1999-2001-Rodenticide Stakeholder Workgroup•Formed in 1999 under federally chartered Pesticide ProgramDi l C i (PPDC)DialogueCommittee(PPDC)•Recommendations:•Use of bittering agent should be voluntary•Rescind the indicator dye requirement•Recommendations adopted in November 2001C f•2001-2004omparative Ecological Assessmentfor 9Rodenticides•2004-West Harlem Environmental Action (WEACT) &Natural Resources Defense Council (NRDC) vs. EPA•Challenged Agency’s decision on bitteringagent and indicatorg y ggdye2007Proposed Mitigation Decision• Commensal uses only• Mitigation Highlights:•Homeowner products must be soldHomeownerproductsmustbesoldwith tamper resistant bait station andcould only contain solid block baitscouldonlycontainsolidblockbaits• 2ndgeneration anticoagulants wouldbe classified restricted use productsbeclassifiedrestricteduseproducts(RUP)• Extensive comments received72008 Risk Mitigation Decision forTen Rodenticides(RMD)• The Agency’s final reregistration eligibilityd i i f d ti iddecisionfor rodenticides• Commensal uses onlyfor:• brodifacoum, bromadiolone, bromethalin,chlorophacinone, cholecalciferol, difenacoum,difethialone diphacinone (and its sodium salt)difethialone,diphacinone(anditssodiumsalt),warfarin (and its sodium salt), and zinc phosphideLi it d i t f i l•Limitedimpacton professionalusers8RMD Mitigation–Children & Pets• Risks Identified:• Accidental child exposureSince199312k15k cases(children <6 years) peryear•,-15kcases(children<6years)perreported• Rarely do reported exposures result in symptoms• Accidental pet exposureOftlt i td th d i ifi t•en resun pedeathandsignificantexpense• Mitigation Required:• Bait Stations• Required for outdoor, above ground use.• Tamper resistant bait stations required if children, pets, nontarget mammals, or birds may access the bait.• Homeowner/retail products must be sold with a bait station;and• Product Packaging Size Requirements• Homeowner/retail products may notcontain more than 1 lb ofbait.F l ti R i t•FormulationRequirements• Pellets and meal baits prohibited for all “residential consumer”products.9RMD Mitigation-Ecological• Risk Identified:• Primary and secondary poisonings of non-target speciesd• Well documented presence of 2ngeneration (gen.)anticoagulants in livers of raptors, foxes, wild cats, deer•MitigationRequired:• Reduce availability of 2ndgen. anticoagulants tohomeowners•Prohibitsale of 2ndgen products in retailstores•Prohibitsaleof2ndgen.productsinretailstores• Packaging size requirements for 2ndgen. products8 lbs for agriculture products/ 16 lbs for professionals (PCOs)• Bait Stations• Required for all outdoor, above ground uses10RMD Implementation Timeline•June 2008 : Publish RMDNo comment period•Nocommentperiod• Requested registrants voluntarily adopt RMD mitigationthrough product changes, cancellation of non-conformingd t d i t ti f f i d tproducts, andregistration ofnew conforming products•3 Years After RMD Publication (June 4, 2011)• Last day for registrants to release into commerce a productnot complying with the risk mitigation decision• Existingstocks of non-compliantproducts released forpshipment by the registrant onor before this date can be solduntil stocks are exhausted11Schedule of Presentations• Rodenticide Product Efficacy• Dr. William Jacobs• Rodenticide Toxicity Overview• Dr. Ray Kent• Human Incident Analysis• Shanna Recore• Pet Incident Analysis• Sarah Winfield• Ecological Risk Introduction & OverviewD Ed d Od ki h•Dr.EdwardOdenkirchen• Primary Exposure & Risk Characterization• Dr. Christine Hartless•Secondary Exposure & Risk CharacterizationSecondaryExposure&RiskCharacterization• Elizabeth Riley, M.S.• Wildlife Incident Analysis•Justin Housenger M SJustinHousenger,M.S.• Ecological Risk Conclusion• Dr. Edward Odenkirchen12Thank You!ThankYou!•Rusty WasemRustyWasem•wasem.russell@epa.gov(703) 3056979•(703)305-13