Attachment I: Meeting with Registrants on Spot-On Flea and Tick Pesticide Products

US Environmental Protection Agency
Office of Pesticide Programs

Meeting Summary - Meeting with
Registrants of Spot-On Flea and Tick
Pesticide Products
May 5, 2009

Meeting 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
companies (see also attached sign-in
sheet):
-

Summit Vet Pharm
Central Life Sciences
Hartz Mountain Corporation
MGK
TSG
Exponent
Fort Dodge Animal Health
Bayer Animal Health
Sergeant’s PetCare
Merial Limited
AHI
Pillsbury Law
Intervet

Representatives from FDA’s Center for
Veterinary Medicine:
- John Baker
- Angela Clark
Representatives from Health Canada:
-

Representatives from EPA:
Office of Pesticide Programs:
- Byron Backus, RD
- Kate Bouve, ITRMD
- Julie Chao, RD
- Venus Eagle, RD
- Kit Farwell, HED
- Calvin Furlow, ITRMD
- Claire Gesalman, FEAD
- Masih Hashim, RD
- John Hebert, RD
- Samantha Hulkower, RD
- Meredith Laws, RD
- Tina Levine, HED
- Mary Manibusan, HED
- Autumn Metzger, RD
- Oscar Morales, ITRMD
- Kimberly Nesci, RD
- Anne Overstreet, SRRD
- Lois Rossi, RD
- Norman Spurling, ITRMD
Office of General Counsel:
- Michele Knorr

Cheryl Chaffey
Peter Chen
Marion Law
Brenda Linke

1

Meeting 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.

2

Schedule/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)

3