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Meetings with Registrants of Pet Spot-on Products
In order to advance the EPA’s efforts to mitigate adverse effects from spot-on products used on pets, the Agency has been meeting with the producers, or registrants, of the products to discuss product-specific mitigation. The Agency announced its intention to hold product-specific mitigation meetings in our March 2010 public release and committed to providing the public with information on those meetings. We have prepared this update to the Web page to follow up on that commitment.
EPA prepared Data Evaluation Records (DERs) for products registered that represent the largest market share of the pet spot-on products. The DERs, which formed the basis of the analysis we conducted in 2009 and released in March 2010, are intended to better characterize incidents received in aggregate incident summaries submitted by the registrants to the Agency under FIFRA Section 6(a)(2) and are available at the following Web page: http://www.epa.gov/pesticides/health/petproductsders.html.
Since EPA’s report and mitigation plan were released for comment in March, the Agency has been in the process of reviewing the public comments. In addition, we have been closely reviewing the DERs, the public comments, and products’ labeling to determine what product-specific mitigation measures are needed for individual registered products. In doing so, we identified some common issues with the pet spot-on products and some common changes that need to be made to pet spot-on product labels.
The following information is available on this page:
- a generic mitigation table that the Agency has been providing to all of the pet spot-on registrants;
- a list of the product specific mitigation meetings that have been held;
- links to a document that contains the agenda and sign-in sheets for each of those meetings; and
- a summary of the meetings.
Registrant Meeting Dates:
| 27 April 2010 | Bayer HealthCare, Animal Health Division | Bayer Agenda and Sign-In Sheet |
| 11 May 2010 | The Hartz Mountain Corporation | Hartz Agenda and Sign-In Sheet |
| 1 June 2010 | Pfizer Animal Health | Pfizer Agenda and Sign-In Sheet |
| 17 June 2010 | Central Life Sciences | Central Life Sciences Agenda and Sign-In Sheet |
| 20 July 2010 | Merial Limited | Merial Agenda and Sign-In Sheet |
| 22 July 2010 | Sergeant’s Pet Care Products, Inc. & PetLogic LLC | Sergeant’s Agenda and Sign-In Sheet |
| 29 September 2010 | Summit Vetpharm | Summit Agenda and Sign-In Sheet |
As further meetings are held, we will update this page.
Meeting Summary:
The Agency met with representatives from the companies listed above for one to one-and-a-half hours to begin discussing product-specific mitigation measures for the registrants’ pet spot-on products. The objectives of the meetings for each of the companies were similar:
- to discuss registrants’ views and actions on EPA’s reviews of their products and the general mitigation proposal,
- to hear the registrants’ mitigation proposals and actions;
- to discuss EPA’s product-specific mitigation measures, and
- to discuss the next steps.
In each of these meetings, the registrant began by making a presentation on its analysis of its own product incidents, any label changes made to date or proposed, and other steps the registrant is taking to either reduce incidents or aid EPA’s review of these products and mitigation efforts.
The Agency then asked any questions it had on the registrant’s presentation. Next, the Agency and the registrant discussed the Agency’s own mitigation plan specific to the registrant and its spot-on registrations. Such mitigation plans included, but were not limited to:
- further increasing the number of weight ranges and having appropriate pictures of the weight ranges;
- repeating the word “dog” or “cat” throughout the instructions on the packaging;
- having species, age, and weight ranges clearly labeled on all packaging; and
- having specific cat warning on all dog products.
The product-specific mitigation plans follow the generic proposal provided below; however, each product was individually considered. Finally, the representatives and the Agency discussed the next steps in the mitigation process.
The meetings were productive and the registrants were receptive to the Agency’s mitigation proposals. Some registrants were proactive, beyond the Agency’s proposals, in their efforts to stem adverse incidents. One company for example, has begun listing all ingredients on its packaging, including inert ingredients. Many of the registrants are making significant changes to their registration, and the Agency commends their effort in addressing this significant problem.
In the registrants’ presentations, most spoke of their efforts to educate the public on how to safely use their products and on an expanded post-market surveillance system. Most importantly, all the registrants expressed their concerns about the incidents and their desire to work with the Agency in order to protect pets.
Generic Pet Spot-On Mitigation Plan:
EPA has developed a list of generic mitigation measures to reduce adverse incidents. Each registration will be reviewed on a case-by-case basis to determine whether these measures are appropriate/adequate for the product.
Below is a table that explains the Agency's generic pet spot-on mitigation plan. This plan includes label improvements that the Agency indentified as generally necessary across the pet spot-on products. This table will be used to guide label changes on a product-specific basis.
Generic Pet Spot-On Mitigation Table
| Purpose of Mitigation Action (from public Mitigation Plan) |
Mitigation Actions | |
|---|---|---|
| Cat Products | Dog Products | |
| To address dosing concerns | Companies should provide additional directions for use, especially on the largest product size, on what to do for very large animals.
Companies should consider lower weight limits as well. |
Companies should provide additional directions for use, especially on the largest product size, on what to do for very large animals.
Companies should consider lower weight limits. |
| To address concerns about cat exposure to dog products | Brand names: Companies should increase the size of the word “cat” to the same size as the brand name
Directions for use: Companies should repeat the word “cat” throughout the directions for use. Pictures: Companies should place large, clear pictures of the appropriate species on the front panel. Separate registrations: Split any registrations with cat & dog uses into two registrations. |
Brand names: Companies should increase the size of the word “dog” to the same size as the brand name
Directions for use: Companies should repeat the word “dog” throughout the directions for use. Pictures: Companies should place large, clear pictures of the appropriate species on the front panel. Separate registrations: Split any registrations with cat & dog uses into two registrations. |
To address concerns about cat exposure to dog products (Cat warning language) |
N/A | Cat Warning:
|
| To address concerns about label clarity | Brand Names: See Second Row
Other warnings: Companies should use the word “ONLY” when referring to cat size and age. In addition, this must appear on the front panel. Examples:
Weight/Age Restrictions: Ranges must appear on product vials. |
Brand Names: See Second Row
Other warnings: Companies should use the word “ONLY” when referring to dog size and age. In addition, this must appear on the front panel. Examples:
Weight/Age Restrictions: Ranges must appear on product vials. |
| To address product-specific concerns |
Side effects: Companies should list potential side effects in plain language on product label based on incidents most commonly seen. This must appear on the back panel, not only a package inserts, so consumers can make choices based on potential side effects.
If any commonly seen side effect would warrant veterinary care, registrants must provide instructions on what to do (e.g., in case of x, contact veterinarian immediately and report incident to company at 1-866-xxxx) Note: For consumer ease the Agency is considering standard terminology. |
|
| To address uncertainties about inert ingredients | The Agency is considering limiting products to one basic CSF as a condition of registration. | |
Standardized adverse event reporting |
Contact Information: Companies should add language to the phone number block providing a number to call “If your pet is experiencing an adverse event…” and instructing users to contact their veterinarian, when warranted.
Potential conditions of registration - The Agency is considering requiring that quarterly enhanced incident reports and an analysis of the incidents be submitted as a condition of registration. Enhanced reporting must include weight range of product used and weight of animal. |
|
Standardized sales reporting |
Potential conditions of registration - The Agency is considering requiring that quarterly sales information be submitted as a condition of registration. | |
To bring data requirements in line with FDA’s requirements for similar products (companion animal safety; premarket clinical trials; and post-market surveillance) |
Protocols. The Agency is requesting that future companion animal safety studies be discussed with the Agency prior to submission
Potential conditions of registration - The Agency is considering making pet spot-on registrations (new and existing products when approving amendments) time-limited to expire two years after the product is released for shipment. This could allow for post-market surveillance of the incidents for these products before the guidelines are revised to include pre-market clinical trials. |
|
Next Steps
The Agency will be continuing to communicate with the pet spot-on registrants as needed to further implement label changes and other actions described in the Agency's mitigation plan. This may include additional meetings and letters to the registrants. The Agency will continue to update this web page with any changes to the mitigation plan and notable accomplishments.