US Environmental Protection Agency
Office of Pesticide Programs
Meeting Summary - Meeting with
Registrants of Spot-On Flea and Tick
Pesticide Products
May 5, 2009
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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:
- Cheryl Chaffey
Peter Chen
Marion Law
Brenda Linke
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
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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.
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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)
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Agenda
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
I. Introductions & Opening Remarks
II. Background
III. Short-Term Actions
a. April^1 Advisory Statement
b. Canada's Registrant Meeting
IV. Mid- to Long-Term Actions
a. Analysis of the Incident Data
b. Domestic Animal Safety Studies
V. Next Steps
a. Information Needs (see back)
b. Mitigation Options
c. Schedule
VI. Open Discussion
VII. Meeting Summary
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Data & Information Needs
ซ Market Share
Incidents per dose sold
* Incident per package sold (number of doses per package)
ป Additional information on incidents received to date
Product name
- Registration # (very important)
Lot # if available
- Formulation (Basic, Alternate #1, etc...) if available
- Active ingredient(s)
Weight range for product
Date on which incident occurred.
State in which the incident occurred.
Registrant case #
Species: Dog, Cat. Other (specify)
Breed: (needs to be standardized)
Age: months or years
Sex: M, F, neutered
Weight: pounds
- Route of Exposure: Dermal, Oral, Other Animal, Inhalation, Other
- Body System: Neurological, Dermatological, GI, Respiratory, Ocular,
Other
Signs noted with separate column for each sign, using standard
terminology: (to be provided later)
Treated by Veterinarian: yes or no
Treatment provided:
EPA Severity Code: Death. Major, Moderate, Minor
- Certainty Index: (criteria to be provided later)
Outcome: (died, recovered, still treated, unknown)
Time to Onset: hours, days
- Duration of signs: < Ihr, 1-4 hr, 4-8 hr, 8-24 hr, 1-3 days, > 3 days
Any known precondition?
Was the product applied according to the label?
Was this the first time using this product?
How frequently was the product applied?
Was the pet being treated with other medications or other pesticides?
Spreadsheet cell with text narrative of incident.
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EPA Meeting With
Registrants of
Spot-On Flea and Tick
Products
May 5, 2009
May 5, 2009
Introductions
Purpose of the meeting is
to discuss the pet incidents that we're seeing,
ซ to discuss ongoing Agency actions and
additional information needs, and
to discuss a path forward
EPA is committed to working with
registrants and stakeholders to best
determine how to address this issue
May 5, 2009
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Background
Historical concerns about pet
incidents
Increase in number of incidents
between 2007 and 2008
Coordination with Canada; similar
trend
Spot-on products appear to
contribute the most
April 16, 2009, Advisory Statement
Short-Term Actions
Response to April 16, 2009, advisory
statement
Questions from the public
Removal & reposting of a list
Questions and Answers
May 5, 2009
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Short-Term Actions
Communications with Canada
Observed PMRA's meeting with
Canadian registrants
ฎ Report from PMRA on the meeting with
Canadian registrants
Will continue to coordinate with PMRA
May 5, 2009
Mid- to Long-Term Actions
Analysis of the spot-on products
Establishment of a DVM team
Review of incident data
Review of domestic animal safety data
Review of additional information
supporting the registration of these
products and active ingredients
May 5, 2009
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Mid- to Long-Term Actions
Domestic Animal Safety Studies
Considering whether these studies are
sufficient
Considering FDA's Center for Veterinary
Medicine's testing guidelines
ซ Reviewing domestic animal safety
studies in house for these products
May 5, 2009
Next Steps
Information Needs
Mitigation Options
Schedule
May 5, 2009
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Next Steps - Information Needs
Market Share
Incidents per dose sold
Incidents per package sold (doses
per package)
Additional information on individual
incidents
May 5, 2009
Next Steps - Mitigation Options
Action to reduce the numbers of
incidents that we're seeing
i The analysis of spot-on products will
inform that decision
i Sound science
i Options may include data
requirements, revisions to labeling,
cancellation
May 5, 2009
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Next Steps - Tentative Schedule
Obtain additional information by
July 2009
Complete our internal analysis by
October 2009
Initiate meetings to discuss
mitigation by October 2009
May 5, 2009
Open Discussion
Questions/Comments
May 5, 2009
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Meeting Summary
Points of Contact
Kimberly Nesci, nesci.kimberly@epa.gov
703-308-8059
John Hebert, hebert.john@epa.gov
703-308-8059
Marion Johnson, iohnson.marion@epa.gov
703-305-6788
May 5, 2009
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Spot-On Registrants - Information request
CHALEFD, COBBR, Cunningham, Dr. Karen,
Timothy. Dotson, Kari.Blaho-Owens, Doug Spilker, Bruce
Martin, RRosenwasser, LHemsarth, kellie.dixon, Rick
U-^KO-I wซ^i ปซ Tinsworth, patricia.sheehy, JConti, WANGB, jazkatz, ne/ae/oAAo M AA DM
N6SC. to. KHoskins/Doug Spi|keri ,kchaJvez, 05/26/2009 04.44 PM
Timothy. Dotson, jmcfadden, jedecto, janice.davis,
warren. lehrenbaum, sspaulding, dave.carlson, jhall,
bruce.martin.b, donaid. schwartz, sveluvolu
"Baker, John D" , Marion Law, Magy Bateh, Cheryl
Chaffey, Brenda Linke, Dana Bruce, Anne Overstreet, Autumn Metzger, Byron
P . Backus, Claire Gesalman, Clayton Myers, Deborah McCall, George Herndon,
John Hebert, Kit Farwell, Lots Rossi, Marion Johnson, Marty Monell, Mary
Manibusan, Meredith Laws, Michele Knorr, Norman Spurting, Oscar Morales,
Richard Gebken, Samantha Hulkower, Tina Levtne, Venus Eagle
Dear Registrants,
At our May 5, 2009, meeting with the registrants, we discussed how best to evaluate
and characterize the increase in adverse incidents being reported to EPA under F1FRA
section 6(a)(2). Below please find some guidance on how to provide the information on
the enhanced reporting discussed at our meeting.
Please send the information to me at the following address:
Kimberly Nesci
Product Manager 11
Mail Code 7505P
1200 Pennsylvania Avenue, NW
Washington, DC 20460
or via email at nesci.kimberly@epa.gov.
Please note that we will be updating the website to provide meeting minutes from the
Agency's May 5, 2009, meeting and the Agency's workplan for addressing animal
incidents. I will send you all a link when that information is posted. In addition, I know
that some of you were interested in obtaining the numbers that we presented during the
meeting. They are as follows (please note that they have been rounded):
2007:
Death - 560
Major-610
Minor/Moderate/Unspecified - 21000
Moderate-1600
Minor-5100
Unspecified -140
2008:
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Death - 640
Major - 740
Minor/Moderate/Unspecified - 8500
Moderate - 6700
Minor-27,000
Unspecified-130
If you have any questions, please contact me at 703-308-8059 or via email.
Thank you and best regards,
Kimberly Nesci
Kimberly Nesci, Product Manager 11
Insecticide Branch
Registration Division (7505P)
Office of Pesticide Programs
(703) 308-8059
Enhanced Reporting
Submission of the following enhanced incident data will help to better characterize the incident
data which EPA receives in regard to the types of incidents, severity, circumstances of use, and
possible sensitive populations. We want to distinguish misuse from proper use, but still want
data on misuse in order to know the circumstances and consequences of misuse. It's not
necessary to report information calls.
Listed below is the information we'd like in spreadsheet form. Registrants may submit their own
database which contains information similar to that requested below. If the data are contained in
a proprietary software program then it should be converted to spreadsheet form. We are not
asking you to conduct any new evaluation of the information that you have that is the basis of
your reports under FIFRA section 6(a)(2) and the implementing regulations at 40 CFR Part 159.
To assist the Agency in this process, we request that you be consistent, use standard terminology,
and have the same person enter the data as much as possible. Standard terminology of clinical
signs are used by companies providing adverse event management and regulatory reporting, by
NIOSH SENSOR, and other sources.
If standardized terms have not already been used, we suggest the following key terms:
Neurological (salivation, tremor, seizure, depression, excited/aggressive, ataxia, hiding, weak,
paralysis, vocalizing), Dermal (skin irritation, pruritus, ulcer, hair loss, staining).
Gastrointestinal (diarrhea, vomiting), Ocular (conjunctivitis, miosis, mydriasis, blinking, tearing).
The following is a list of information that would be helpful for EPA to better characterize these
incidents:
EPA Registration # (very important).
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Product name (brand name)
Lot# (if available)
Formulation (Basic, Alternate #1, etc...) if available
Where purchased: internet, store, veterinarian
Active Ingredient(s)
Weight range for product
Date on which incident occurred. (mm/dd/YYYY)
State in which the incident occurred, (standard 2 letter abbreviation)
Registrant case #
Species: Dog, Cat, Other (specify)
Breed: (as reported by pet owner)
Age: months or years
Sex: M, F, or neutered
Weight: pounds
Route of Exposure: Dermal, Oral, Other Animal, Inhalation, Other
How applied: base of skull, between shoulder blades, along back
Body System: neurological, dermatological, GI, respiratory, ocular, other
Major signs noted with separate column for each sign, using standard terminology
Time to Onset: (hours, days)
Duration of signs: < Ihr, 1-4 hr, 4-8 hr, 8-24 hr, 1-3 days, > 3 days
Treated by veterinarian: yes or no
Treatment provided: (name treatment)
First time product used: yes or no
Misuse: dog product on cats, overdose, too frequent dosing, other (describe)
Treated with other pesticide or drug: (name product)
Any known precondition
EPA Severity Code: Death, Major, Moderate, Minor.
Certainty Index: definite, probable, possible, unlikely
Outcome: died, recovered, still treated, unknown
Spreadsheet cell with text narrative of incident.
CERTAINTY INDEX
Definite
Confirmed by laboratory diagnosis (e.g. cholinesterase inhibition; or high concentrations of
pesticide detected; etc).
At least one specific clinical sign consistent with toxicity from chemical.
Exposure pathway and timing consistent with toxicity from chemical.
No other cause of toxicity identified.
Probable
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At least one specific clinical sign consistent with toxicity from chemical.
Exposure pathway and timing consistent with toxicity from chemical.
No other cause of toxicity identified.
Possible
Clinical sign(s) generally consistent with toxicity from chemical.
Exposure pathway and timing generally consistent but may be uncertainty.
Other health problems could be responsible for part of the clinical signs.
History may be incomplete.
Unlikely
Clinical signs generally inconsistent with toxicity from the chemical.
Or exposure pathway and/or timing are inconsistent.
Or another health condition is more likely the cause.
Or very incomplete history.
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