# US Environmental Protection Agency Office of Pesticide Programs Meeting Summary - Meeting with Registrants of Spot-On Flea and Tick Pesticide Products May 5 , 200 9Meeting Summary Meeting with Registrants of Spot-On Flea and Tick Pesticide Products May 5, 2009, 1:00 pm to 3:00 pm Room 1206, One Potomac Yard 2777 S. Crystal Drive Arlington, VA 22202 Attendees:

Representatives from the following Representatives from EPA: companies (see also attached sign-in sheet): Office of Pesticide Programs:

- Byron Backus, RD

- Summit Vet Pharm - Kate Bouve, ITRMD

- Central Life Sciences - Julie Chao, RD

- Hartz Mountain Corporation - Venus Eagle, RD

- MGK - Kit Farwell, HED

- TSG - Calvin Furlow, ITRMD

- Exponent - Claire Gesalman, FEAD

- Fort Dodge Animal Health - Masih Hashim, RD

- Bayer Animal Health - John Hebert, RD

- Sergeant’s PetCare - Samantha Hulkower, RD

- Merial Limited - Meredith Laws, RD

- AHI - Tina Levine, HED

- Pillsbury Law - Mary Manibusan, HED

- Intervet - Autumn Metzger, RD

- Oscar Morales, ITRMD Representatives from FDA’s Center for - Kimberly Nesci, RD Veterinary Medicine: - Anne Overstreet, SRRD - Lois Rossi, RD

- John Baker - Norman Spurling, ITRMD

- Angela Clark

- Office of General Counsel: Representatives from Health Canada: - Michele Knorr

- Cheryl Chaffey

- Peter Chen

- Marion Law

- Brenda Linke 1Meeting Summary: The above-listed representatives from industry, EPA, FDA, and Health Canada met on May 5, 2009, to discuss reported adverse effects on pets associated with flea and tick products, ongoing agency actions related to the reported incidents, additional information needs, and a path forward for addressing the issue of pet incidents (see also attached slides). The Agency presented historical information about pet incidents and discussed its April 16, 2009, advisory statement. The Agency discussed its ongoing communications with Health Canada, its intent to analyze the spot-on products and incidents seen more thoroughly, and its intent to consider whether the domestic animal safety studies currently required in the process of registering pet products are sufficient to protect the health of pets. The Agency discussed what types of additional information would be helpful to EPA in further evaluating these products, including the following: • information on market share; • numbers of incidents per doses or packages sold; and • additional information on each specific incident. The Agency also discussed mitigation options and noted that mitigation options may include data requirements, revisions to labeling, or cancellation. A question and answer session followed. Questions and Answers: During the question and answer session, registrants asked questions about the additional information that would be helpful to EPA and the numbers of incidents being seen. During the meeting, the Agency committed to providing the registrants with further details concerning the additional information and numbers of incidents that have been reported to the Agency. This information was provided to the registrants in the form of an email message (see attachments). The registrants also had questions about the use of statistics in the analysis of incident numbers. The Agency responded that we will be looking at information on individual incidents and not simply at total incident numbers. Registrants asked whether the Agency’s analysis of incidents will be subject to a public process. The Agency responded that its analysis will be released publicly. Registrants commented that the overall effect of the message sent in the Agency’s April 16, 2009, advisory and associated Web site has been dramatically negative. The Agency acknowledged the comment and committed to posting a complete list of all registered spot-on products, which EPA did on May 6, 2009. 2Schedule/Next Steps: The tentative schedule for the Agency’s evaluation of these products was presented as well. The Agency has plans to complete its analysis of risk this fall, after which appropriate mitigation measures will be discussed. The Agency will also continue to update its Web page with additional information as it becomes available. Attachments: May 5, 2009, Agenda (2 pages) May 5, 2009, Slides (7 pages) Sign-In Sheet (3 pages) Follow-Up email to participants (4 pages)

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