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Pet Spot-On Mitigatio

March 17, 2010
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Risk Manageme

• Agency concluded, based on th

that mitigation is necessary to punreasonable adverse effects

• Regulatory Action Plan – EPA w

the following:

• Product-specific, immediate furth• Tighter regulation• Public outreach campaign
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Risk Managemen

Further Restrictions

• Address dosing concerns

• Pursuing label and/or packaging 

would result in more narrow pet wper vial size
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Risk Managemen

Further Restrictions

• Address concerns about cat exposu

products

• Pursuing label changes that prohibit th

same brand names for both dog and ca

• Determining appropriate, clear labels s

address concerns with cat exposure to 

• as a result of direct application or • as a result of interactions between dogs an

application of dog products
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Risk Managemen

Further Restrictions

• Address concerns about label c• Address product specific conce

• Pursuing further label restrictions • Pursuing other changes, as need

individual product assessments (
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Risk Managemen

Further Restrictions

• Address uncertainties about ine

ingredients 

• Pursuing disallowing alternate for• Determining whether additional in

certain inerts is needed and, if sothat information

• When inerts with suspected toxic 

identified, EPA will not allow the uchemicals in pet products
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Risk Managemen

Tighter Regulation

• Pursue standardized adverse e

reporting 

• Standard format• Standard content• Analysis of the information • Will allow EPA to efficiently contin

market surveillance of these prod
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Risk Managemen

Tighter Regulation

• Pursue standardized sales repo

• Will allow EPA to accurately com

numbers of incidents between pro
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Risk Managemen

Tighter Regulation

• Revise Data Requirements - taking 

bring data requirements in line with requirements for similar products

• Will allow EPA to be consistent with FD

pre-market clinical trials

• Will allow EPA to more thoroughly ass

of these products prior to registration

• Will allow effective post-market surveil
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Risk Managemen

FDA and EPA Requirem

Current EPA Requirements Curren

Pre-Market Animal Safety Study

Guideline No: 870.7200

Title: Companion Animal SafetyNumber of Animals: 6 per sex per dose

Level of Concern: 5X

Other: Harmonized with previous FDA/CVM 

Guidance #33 

Guideline No: 1

Title: Target An

Pharmaceutical 

Number of Anim

Level of Concern

Other: Internatio

Pre-Market Clinical Trials

None Guideline No: 85 

Title: Good Clin

Number of Anim

control). Repres

rather than only contributes to th

Post-Market Surveillance

Aggregate summary reporting of summary numbers of adverse effects under FIFRA Section 6(a)(2). Generally only used to trigger a more detailed review. 

Ten veterinarianevaluate detailed 

new products. Fproduct, label, in

and the public.
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Risk Managemen

Tighter Regulation

• Conditional Registrations

• Future pet spot-on registrations (

products) and amendments to exregistrations will contain appropriconditions and time limitations

• Will allow EPA to conduct approp

market surveillance
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Risk Managemen

Potential Implementation Mec

• Anticipated further restrictions

• Will be meeting with individual registra

individual products and product lines

• Considering preparing a guidance docu

• Tighter regulation

• Will be discussing with Canada’s PMR• Will be discussing with FDA’s CVM• Will be obtaining public input• May require changes to rules and guid

regulatory process
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Public Outreach Cam

• The Agency is taking steps to init

prong communication campaign

• inform the public and other intereste

results of the investigation

• steps the public can take to ensure 

flea and tick products
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Next Steps

• Public Comment on Implementa

Mitigation Plan

• FR Notice 

• Docket: EPA–HQ–OPP–2010–0

• www.regulations.gov

• 60-day public comment period
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Contact informatio

• For all other inquiries:

• Kimberly Nesci, Registration Divis

Pesticide Programs

• pets@epa.gov

• Web page

• http://www.epa.gov/pesticides

productseval.html