1Pet Spot-On Mitigation PlanMarch 17, 20102Risk Management•Agency concluded, based on the analysis,that mitigation is necessary to preventunreasonable adverse effects•Regulatory Action Plan – EPA will pursuethe following:•Product-specific, immediate further restrictions•Tighter regulation•Public outreach campaign3Risk Management:Further Restrictions•Address dosing concerns•Pursuing label and/or packaging changes thatwould result in more narrow pet weight rangesper vial size4Risk Management:Further Restrictions•Address concerns about cat exposure to dogproducts•Pursuing label changes that prohibit the use of thesame brand names for both dog and cat products•Determining appropriate, clear labels statements toaddress concerns with cat exposure to dog products•as a result of direct application or•as a result of interactions between dogs and cats afterapplication of dog products5Risk Management:Further Restrictions•Address concerns about label clarity•Address product specific concerns•Pursuing further label restrictions•Pursuing other changes, as needed, based onindividual product assessments (DERs)6Risk Management:Further Restrictions•Address uncertainties about inertingredients•Pursuing disallowing alternate formulations•Determining whether additional information oncertain inerts is needed and, if so, obtainingthat information•When inerts with suspected toxic effects areidentified, EPA will not allow the use of thesechemicals in pet products7Risk Management:Tighter Regulation•Pursue standardized adverse eventreporting•Standard format•Standard content•Analysis of the information•Will allow EPA to efficiently continue postmarket surveillance of these products8Risk Management:Tighter Regulation•Pursue standardized sales reporting•Will allow EPA to accurately comparenumbers of incidents between products9Risk Management:Tighter Regulation•Revise Data Requirements - taking steps tobring data requirements in line with FDA’srequirements for similar products•Will allow EPA to be consistent with FDA, includingpre-market clinical trials•Will allow EPA to more thoroughly assess the safetyof these products prior to registration•Will allow effective post-market surveillance10Risk Management:FDA and EPA RequirementsCurrent EPA RequirementsCurrent FDA RequirementsPre-MarketAnimalSafety StudyGuideline No: 870.7200Title: Companion Animal SafetyNumber of Animals: 6 per sex per doseLevel of Concern: 5XOther: Harmonized withprevious FDA/CVMGuidance #33Guideline No: 185 (VICH GL43)Title: Target Animal Safety for VeterinaryPharmaceutical ProductsNumber of Animals: 4 per sex per doseLevel of Concern: 5XOther: International harmonizationPre-MarketClinical TrialsNoneGuideline No: 85 (VICH GL9)Title: Good Clinical PracticeNumber of Animals~200 (where 1/2 are positivecontrol). Represents populationsof actualpetsrather than only test beagles. Informs labeling andcontributes to the overall approvaldecision.Post-MarketSurveillanceAggregate summary reporting of summarynumbers of adverse effects under FIFRASection 6(a)(2).Generally only used to triggera more detailed review.Ten veterinarians and other professional staffevaluate detailedadverse events, particularly fornew products. Findings may result in changes toproduct, label, insert, andcommunication with vetsand the public.11Risk Management:Tighter Regulation•Conditional Registrations•Future pet spot-on registrations (newproducts) and amendments to existingregistrations will contain appropriateconditions and time limitations•Will allow EPA to conduct appropriate postmarket surveillance12Risk Management:Potential Implementation Mechanisms•Anticipated further restrictions•Will be meeting with individual registrants to discussindividual products and product lines•Considering preparing a guidance document•Tighter regulation•Will be discussing with Canada’s PMRA•Will be discussing with FDA’s CVM•Will be obtaining public input•May require changes to rules and guidelines or otherregulatory process13Public Outreach Campaign•The Agency is taking steps to initiate a multiprong communication campaign•inform the public and other interested parties of theresults of the investigation•steps the public can take to ensure safe use of petflea and tick products14Next Steps•Public Comment on Implementation ofMitigation Plan•FR Notice•Docket:EPA–HQ–OPP–2010–0229•www.regulations.gov•60-day public comment period15Contact information•For all other inquiries:•Kimberly Nesci, Registration Division, Office ofPesticide Programs•pets@epa.gov•Web page•http://www.epa.gov/pesticides/health/petproductseval.html