May 25, 2020

EPA Requests Comments on Ad Hoc Panelists for FIFRA SAP Meeting on Proposed Guidelines for Efficacy Testing of Certain Flea and Tick Products

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was seeking comments on the experts who are candidates to serve as ad hocpanelists for the review of EPA’s Draft Product Performance Test Guidelines OCSPP 810.3300:  Treatments Topically Applied to Pets to Control Certain Invertebrate Ectoparasitic Pests.  The candidate list is available on EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) website.  Comments on the candidates are due by May 18, 2019, to the Designated Federal Official (DFO) Dr. Sue Shallal (shallal.suhair@epa.gov).  EPA is requesting these comments prior to the FIFRA SAP public in-person meeting scheduled for June 11-14, 2019, from 9:00 a.m. to 5:00 p.m. (EDT) which will review EPA’s proposed guidelines referenced above and the supplemental document Sample Size for Pet Product Studies.  84 Fed. Reg. 15214.  The charge questions to the panel are available here(Charge Questions). 

EPA’s Federal Register notice announcing the meeting states that the meeting will be augmented with additional experts to provide independent scientific advice on the proposed guidelines.  Preceding the in-person meeting, there will be a public half-day preparatory virtual meeting to consider the scope and clarity of the draft charge questions for this peer review.  The in-person meeting on June 11-14, 2019, will be held at the EPA Conference Center, Lobby Level, One Potomac Yard (South Building), 2777 South Crystal Drive in Arlington, Virginia.  The meeting will also be available via webcast.

EPA’s original Product Performance Test Guidelines, OPPTS 810.3300, Treatments to Control Pests of Humans and Pets were published in March 1998.  EPA’s Charge Questions state that “to increase clarity and consistency in efficacy testing and to include current scientific standards, the agency is revising this product performance guideline.”  Further, the proposed guidelines apply to products “in any topically applied formulation, such as a spray, spot-on, collar, shampoo, or dust, if intended to be directly applied to pets for a pesticidal purpose such as to kill, repel, or control ticks, fleas, mosquitoes, and biting flies”; do not apply “to those products exempt from FIFRA Registration under 40 CFR 152.25, products applied to humans or livestock, or product performance testing described in other agency guidelines”; and, in addition to guidance for testing efficacy against fleas, ticks, mosquitoes, and biting flies, the proposed guideline “also includes testing methods for evaluating efficacy under simulated environmental conditions.”

EPA believes the current Draft Guidelines represent the state of the science with regard to efficacy testing for these products; but is still seeking advice and recommendations from the FIFRA SAP on scientific issues related to the Draft Guidelines.  EPA states that it is committed to reducing the use of animals in testing but at this time no reliable non-animal alternatives are available to avoid the use of animals for efficacy testing of fleas, ticks, mosquitoes, and biting flies.  EPA is soliciting comment from the FIFRA SAP on approaches that may, in the future, support the replacement or reduction of animal use in efficacy testing of ectoparasitic pests on pets.

Information on attending the meeting in person and via webcast can be found on the FIFRA SAP website.  EPA is requesting that written comments on the documents undergoing peer review be submitted to Docket No. EPA-HQ-OPP-2019-0161 by May 17, 2019, to provide the FIFRA SAP the time necessary to consider and review the written comments.

©2020 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

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Margaret Graham, Environmental Science and Policy Paralegal, Bergeson Campbell Law firm
Paralegal

Margaret R. Graham (Maggie), a paralegal with Bergeson & Campbell, P.C. (B&C®), holds a Masters degree in Environmental Science and Policy, and has over a decade of paralegal experience, including eight years focused in federal regulatory law.  Her understanding of environmental policy and the administrative and legislative process involved in regulatory compliance makes her an invaluable resource to B&C staff and clients, who rely on her research, project management, and writing and editing skills to complete efficiently briefs, pleadings, and other documents.

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