For Release May 20, 2016

EPA has developed a draft standard template to be used by registrants submitting information on incidents involving spot-on pet products to ensure the submission of data in a consistent format using consistent terminology. Some animals have been known to have adverse reactions to these chemicals, including local irritation or other effects. The standardized template will allow the Agency to review incidents more efficiently and, if concerns are raised, give us the necessary information on which to act.

Although registrants have been submitting the incident data required under FIFRA section 6 (a)(2), including the more detailed reports required in 2010, those data submissions lack consistent terminology and a common format, making it difficult and labor intensive to use the data for regulatory purposes. EPA has developed a new template and common terminology that we wish to pilot.

EPA is seeking nine registrants of pet spot-on products to test the new template for a 1 year period. Registrants interested in participating in the pilot should contact Julie Breeden-Alemi, DVM, (Breeden-Alemi.Julie@epa.gov) using the key phrase “Pilot Spot-on Participant” in the subject line. EPA held a webinar on June 7, 2016, for registrants interested in the pilot to learn how to use the template. 

EPA wants to ensure that the enhanced information collected satisfies public as well as regulatory needs without disclosing confidential business information. EPA is, therefore, also seeking feedback from the public on the template itself. To submit comments on the template contact Dr. Breeden-Alemi (Breeden-Alemi.Julie@epa.gov) using the key phrase “Pilot Spot-on Comment” in the subject line.