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MEETING SUMMARY 

Meeting with Registrants: 

EPA Evaluation of Pet Spot-on Products 

Analysis and Mitigation Plan 

March 17, 2010, 9:30 am to 11:00 am 

Room N-4830, One Potomac Yard 

2777 S. Crystal Drive 

Arlington, VA 22202 

Meeting Attendees (see also attached signin sheet): 

- Summit Vet Pharm, LLC 

- Central Life Sciences 

- Consumer Specialty Products 

Association 

- The Hartz Mountain Corporation 

- Technology Sciences Group Inc. 

- Exponent, Inc. 

- Bayer Healthcare LLC, Animal 

Health Division 

- Sergeant’s Pet Care Products, Inc. 

- SafetyCall International 

- Merial Limited 

- Animal Health Institute 

- Pillsbury Winthrom Shaw Pittman 

LLP 

- Pfizer Inc. 

- The Accord Group 

Via Telephone 

- Canada’s Pest Management 

Regulatory Agency 

Representatives from EPA: 

Office of Pesticide Programs 

- Julie Chao, RD 

- Venus Eagle, RD 

- Kit Farwell, HED 

- Claire Geselman, FEAD 

- Samantha Hulkower, RD 

- Meredith Laws, RD 

- Rosanna Louie, RD 

- Mary Manibusan, HED 

- Autumn Metzger, RD 

- Kimberly Nesci, RD 

- Lois Rossi, RD 

- Kevin Sweeney, RD 

Office of General Counsel 

- Michele Knorr 

- Erin Koch 
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Meeting Summary

The above-listed representatives from industry, EPA, and Canada’s Pest Management 

Regulatory Authority (PMRA) met on March 17, 2010, to discuss the Agency’s analysis of the 

enhanced adverse incident pet reports, the Agency’s conclusions, and a mitigation action plan 

needed to minimize adverse effects to pets. 

The Agency presented background information about the increase in the number of reported 

adverse incidents seen between 2007 and 2008 associated with the use of spot-on dog and cat 

products to control fleas and ticks. As part of that summary, the Agency described the 

information received from the registrants of pet spot-on pet products after holding a meeting on 

May 5, 2009. EPA explained that that information was analyzed by EPA’s expert internal 

veterinarian team and the resulting Technical Review Document was peer reviewed by the Food 

and Drug Administration’s (USFDA) Center for Veterinary Medicine (CVM) and Canada’s Pest 

Management Regulatory Authority (PMRA). 

The Agency shared the following regarding the analysis of the enhanced incident reporting: 

- The Agency explained that its objective in its analysis was to describe the nature of the 

incidents, and to identify susceptible subpopulations or other trends associated with the 

use of the spot-on products; 

- The Agency described the types of detailed information received in the enhanced incident 

reports; 

- The Agency described additional sources of data and methods to analyze and corroborate 

the received enhanced incident reports, including toxicological studies and literature by 

expert veterinarians; 

- The Agency described its review process, including the methods used to standardize the 

incident data in order to compare and evaluate the data; and, 

- The Agency shared its key findings from the analysis, as follows: 

o Most incidents were minor, but unfortunately there were some pet deaths and 

“major incidents” reported. The Agency learned that the most commonly affected 

organ systems were dermal, gastrointestinal, and nervous. 

o Dog Findings 

 small breed dogs were affected more than larger breeds for some products 

 the amount of product in a single dose needed to vary more for small to 

large dogs – that is, how much the dog weighs matters a lot in deciding 

how much of a product should be used. 

o Cat Findings 

 misuse or accidental exposure of cats to dog products was an important 

problem; cats can be harmed by dog products; and 

 label warnings against use of dog products on other animals, especially 

cats, are not working well enough and this appears to be a global concern. 

o Safety Testing: The team also found that the data we now require to determine the 

safety of these products for pets do not accurately predict the toxicity seen in the 

incidents that took place. 

The Agency concluded that, based on its peer-reviewed analysis, mitigation is necessary to 

prevent adverse effects to pets. The Agency then presented a regulatory action plan that is being 
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pursued that will include immediate further restrictions on products, tighter regulations, and a 

public outreach campaign. Specifically, the Agency is pursuing the following actions: 

• Further Restrictions on Products 

o Dosing. To address concerns about dosing, the Agency is pursuing requiring label 

and/or packaging changes that would result in more narrow pet weight ranges per 

vial size. This means there will be more categories for the weights of pets so that 

small, medium, and large dogs get the right amount of product. Pet owners should 

always be aware of the weight of their pet and purchase and use the correct 

product for their pet’s weight. 

o Improve labeling to avoid confusion between dog and cat products. Because 

there were problems reported with cats exposed to dog products, the Agency 

needs to address this problem and is pursuing the following actions: 

 Label changes that prohibit the use of the same brand names on cat and 

dog products; and 

 Requiring appropriate, clear label statements to address concerns with cat 

exposure to dog products as a result of direct application or interactions 

between cats and dogs in multi-pet households after the application of dog 

products. 

o Make labels more understandable. To improve label clarity, EPA will pursue 

changes such as larger fonts and pictograms. 

o Make other label changes as needed. EPA will meet with companies 

individually to review their products and discuss additional changes to labels or 

ingredients that the Agency feels are needed. These actions may include anything 

from adding a more complete list of potential side effects to product labels to 

canceling products. 

o Inert Ingredients. To address uncertainties about the “inert” (non-active) 

ingredients in these products and how they might contribute to toxicity, EPA will 

be pursuing the following actions: 

 No longer allow the interchangeable use of inert ingredients in these 

formulations; 

 Determine whether additional information is needed and, if so, require that 

information to evaluate certain inert ingredients; and 

 Disallow inerts that have suspected toxic effects when and if these are 

identified. 

• Tighter Regulation 

o Standardized reporting. To be able to monitor these products better, EPA is 

pursuing more standardized reporting on adverse effects and sales. This will allow 

the Agency to more effectively review incidents, and if concerns are raised, give 

EPA information to act. 

o Pre-market clinical trials and post-market surveillance. The Agency is taking 

steps to bring data requirements in line with FDA’s requirements for similar 

products. This will allow EPA to be more consistent with how FDA regulates 

similar animal drugs, which includes pre-market clinical trials and a formal postmarket surveillance program, and will allow the Agency to more thoroughly 

assess the safety of the products. 
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o Grant conditional registrations for new products. Future pet spot-on 

registrations and amendments to new registrations will be restricted by 

appropriate conditions and time-limitations to allow EPA to continue to ensure 

the safety of these products after they are available to the public. 

After the Agency presented their findings and the regulatory action plan, there was a question 

and answer session. 

Questions and Answers:

Registrants asked many questions about the process by which the Agency is releasing the 

information, the analysis conducted, and the mitigation plan being pursued. The summary below 

describes the types of questions asked and the Agency’s responses, but is not a transcript. The 

meeting was not recorded therefore a transcript is not available. 

1. The registrants had logistical questions about the schedule for the release of the findings 

and the rationale for the rigorous schedule. The registrant had questions about the 

timing for making the Agency’s reviews and decisions available to the public.

The Agency described the following process: the data evaluation records (DERs) are 

being made available for each registrant immediately after the 9:30 am briefing and that 

the total set of DERs is being posted for public access at 2:00 pm along with the 

Technical Review Document and the Agency’s mitigation plan. The Agency explained 

that it was criticized for the May 2009 meeting with the registrants and, as such, it is 

releasing to the public as soon as possible after the registrant meeting the same 

information provided to the registrants to help eliminate doubts that the public may have 

about the impartiality of the Agency decisions. 

2. Registrants asked questions about how the information from the enhanced incident 

reporting was analyzed.

The Agency stated that its analysis, which includes a description of the methods, will be 

available at the end of this meeting and will be made available to the public at about 2:00 

pm. The Agency noted that the Technical Review Document was peer reviewed by 

PMRA and US FDA’s CVM. The Agency stated that the data evaluation records 

(DERs) for each individual product describe/summarize the enhanced incident data after 

the Agency standardized the format of the information to more appropriately compare 

similar incidents. With the standardized incident information, the team was able to 

determine for each product the relative ratios of the number and severity of each type of 

incident. 

3. Registrants asked questions about the factors EPA considered in its decision to impose 

additional restrictions on products. 

The Agency responded that the Agency’s expert veterinary team concluded from its 

intensive analyses of the enhanced reporting information that mitigation measures are 

necessary to avoid preventable adverse effects to pets. The Agency explained that the 

factors considered are described in detail in the DERs and the Technical Review 
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Document. The Agency stated that there are a number of mitigation measures that the 

Agency is pursuing in order to minimize future adverse incidents to pets. The Agency 

stated that it feels these incidents are avoidable. 

4. Registrants had questions about the mitigation measures the Agency seeks to implement 

immediately, including what are the additional reporting requirements and new labeling 

requirements for the spot-on products.

The Agency responded that further, product-specific discussions will need to take place 

in order to finalize details of the mitigation measures. Some of the immediate 

requirements can include disallowing alternate formulations, requiring the submission of 

additional information for inert ingredients if there are suspected potential toxic effects, 

time-limited conditional registrations of new products, and product labeling clarity 

improvements. 

5. Registrants had questions about the effectiveness of label changes, considering that 

current warnings are being disregarded by consumers. 

As stated above, the Agency responded that that further, product-specific discussions will 

need to take place in order to finalize details of the mitigation measures. The Agency 

wishes to continue discussions about the incident report findings that indicate that, in 

some cases, current warnings are not working. A possibility that registrants may wish to 

consider is the availability of market-research information on consumer products. 

Companies with that data may have information to better inform labeling decisions. EPA 

also believes that consumer education about both proper use and potential side effects is 

crucial. 

6. Registrants asked about additional requirements that the Agency anticipates needing 

from the registrants in the future that would require long-term collaboration. 

The Agency responded that as part of the move to become more similar with FDA 

requirements for similar topical animal drugs, EPA is looking into additional detailed 

reporting requirements; clinical trials similar to FDA’s clinical trials; and a formalized 

post-market surveillance process. The interim, the Agency will pursue enhanced adverse 

event reporting to allow EPA to efficiently continue post-market surveillance and 

analysis of any incidents associated with the use of these products. 

7. Registrant had questions about how the Agency’s plan compares to the FDA’s current 

regulatory processes. Registrants also asked questions about how EPA intends to 

streamline regulations between the two Agencies and whether changes to guidelines will 

be subject to rulemaking. 

With regards to the questions about how the Agency’s plan compares to FDA 

requirements, the Agency stated that it is looking into streamlining current regulations 

and requirements with those of FDA in order to address the information gaps in the 

information we currently obtain. The Agency explained that it will follow usual, public 

procedures in order to revise its guidelines. 
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8. Registrants had questions on the Agency’s plans for public outreach and publicity of the 

issue to consumers.

The Agency responded that to maintain transparency to all stakeholders, including the 

public, EPA has taken steps to keep all interested parties informed as the information and 

reviews become available. The Agency stated that it recognizes the importance of these 

flea and tick products and the importance of their availability to a wide range of 

consumers, but also the importance for consumers to have full understanding of the 

proper use and potential impacts of these products. In addition to the press 

announcements and the release of the Agency’s Technical Review Document and Data 

Evaluation Records, part of the public outreach campaign is to inform the public of steps 

they can take to ensure safe use of pet flea and tick products. The Agency stated that 

although specific details have not been finalized, some examples could include label 

clarity improvements, information bulletins and videos, and additional product 

information made available at the stores where these products are purchased. Based on 

the current product labeling and the Agency’s analysis of the incident reporting, it 

appears that consumers are not aware of the full spectrum of potential toxicity to pets, 

such as the possible different effects seen between a dog and cat. 

9 The registrants had logistical questions about the timing of implementing these 

mitigation measures, to ensure a level-playing field for all companies. 

The Agency acknowledged that the implementation of these mitigation measures will 

begin as soon as possible, and will be addressed on a case-by-case basis depending on the 

characteristics of the product in question. In addition, the Agency acknowledged that a 

proposed (new) product application may be handled differently than an amendment to an 

existing product and that individual company meetings are needed. The Agency also 

acknowledged that there are other influencing factors that may need to be considered as 

part of these decisions, such as how a specific product is market to targeted consumer 

groups. 

10. The registrants had logistical question about clinical trials for pesticide products; e.g., 

how unregistered product can be distributed and whether EPA will accept clinical trials 

conducted for submission to the European Union.

The Agency responded that there are many questions to address and consider when 

changing any regulation and that additional discussions and public comment will be 

needed in the future to address these questions. The extensive collaboration with FDA 

and the resulting mitigation proposals are unprecedented. By taking the time and effort 

to make these changes and consider public input as well as input from external experts, 

the overall credibility and safety of these products will be enhanced. 

With regards to clinical trials conducted for the EU, the Agency is open to the possibility 

of considering these trials and willing to discuss this further. 

11. The registrants had questions about the Agency’s plan to better distinguish between cat 

and dog products (including changes in brand names or other means); specifically, 

whether we were going to require that distinction in cases where a formulated dog 

product could be safely used on cats. 
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The Agency explained that the rationale behind distinguishing between cat and dog 

products is because the average consumer may not know the differences between active 

ingredients and the Agency would like the message that consumers should never use dog 

products on cats to be more universal. Consumers are typically not aware of the full 

spectrum of potential toxicity to a pet and curent label warnings do not appear to be 

adequate. In addition, part of the issue is dosing in that, even if an active ingredient could 

be safely used on cats, generally the dose for cats would be very different than the dose 

for dogs. The Agency also reiterated that this would be addressed on a case-by-case 

basis.