Historically, the agencies have determined oversight for products topically administered to animals to treat fleas and ticks on the basis of whether the chemical is systemically absorbed into the bloodstream (FDA oversight) or remains on the skin (EPA oversight). This arrangement originated with a 1971 memorandum of understanding between the two agencies.
The agencies now understand that many of these topical products are absorbed into the animal’s bloodstream, according to the white paper. That knowledge, along with an agreement by the two agencies that the FDA is better equipped to evaluate and monitor products topically administered to animals, is the basis for the proposed transference of product oversight from the EPA OSCPP to FDA CVM.
“The agencies’ current approach to determining whether EPA or FDA is the appropriate regulator of products incorporating these technologies does not effectively accommodate scientific advancement,” the white paper’s summary states. “Further, scientific advancements and improved scientific understanding have highlighted the importance of increased clarity for regulated entities, robust animal safety evaluations of certain products, and applying consistent regulatory standards to similar types of products.
“An updated approach clarifying oversight over new and existing products would promote the efficient use of each agency’s expertise, improve regulatory clarity, and better protect human, animal, and environmental health.”
As for the genetically engineered pest animals, the EPA states a new approach can “provide the agencies with more flexibility to update and align their regulatory oversight of relevant products consistent with each agency’s mission and expertise.”
While no specific proposal is offered, the EPA notes that it “may need resources to expand its existing biotechnology program for products to control populations of pest animals and clarify the program’s approach to meet the needs of this growing industry.”
The EPA invited comments on the white paper and held a virtual public meeting on March 22.
During the meeting, Bill Jordan, a representative of the Environmental Protection Network, questioned whether the FDA has the regulatory authority to evaluate the environmental risks potentially posed by pesticides for animals.
EPA and FDA officials attending the meeting did not directly address the speaker’s questions. Instead, they spoke about the proposal and the need to revamp the current regulatory system.
Several AVMA staff members also attended the meeting and multiple AVMA entities are studying the proposal.
A version of this article appears in the June 2023 print issue of JAVMA.