COBTA recommends regulatory discretion; prohibition remains
Posted July 1, 2004
Treating flea and tick infestations in minor species such as pet reptiles, pocket pets, rabbits, ferrets, pet birds, camelids, and captive wildlife can create a conundrum for veterinarians because no Environmental Protection Agency-registered pesticides are labeled for use in these species, and off-label use of pesticides is strictly prohibited by the EPA.
The situation is currently at the center of correspondence between the AVMA Council on Biologic and Therapeutic Agents and the EPA. With cooperation from the EPA, COBTA recently launched a campaign to educate veterinarians about their responsibilities under the EPA-administered Federal Insecticide, Fungicide, and Rodenticide Act. This article, the second in a four-part series about veterinarians' responsibilities under FIFRA, examines the EPA restriction on off-label use.
Discussions between the EPA and COBTA have focused on the agency's 25-year-old policy on veterinary use of pesticides. The policy was published in the Nov. 1, 1979, issue of the Federal Register. COBTA recently reviewed the policy and found it to be sound, with one caveat: Off-label use of pesticides is forbidden.
"...Veterinarians, like all other persons, must use all pesticides including those not classified for restricted use, consistently with their registered labeling. As authorized by section 2(ee) of FIFRA, this includes use against a pest not specified on the labeling as long as the animal or site treated is so specified, unless use against that pest is expressly forbidden by the Administration of the EPA," according the EPA policy.
Jack Neylan, chief of the agriculture branch of the EPA Office of Enforcement and Compliance Assurance, explained that the reason for the EPA restricting off-label use of pesticides is that the agency has determined the safety of a product only for the specified species.
The EPA's registration process allows the agency to examine the ingredients of a pesticide; the site or crop on which it is to be used; the amount, frequency, and timing of its use; and its storage. Using this information, the agency evaluates the pesticide to ensure that it will not have unreasonable adverse effects on humans, the environment, the target species, and nontarget species. The EPA forbids the use of pesticides on species that they have not been registered for, because agency cannot ensure their safety and efficacy.
The agency does allow some latitude for the use of pesticides against pests they are not specifically registered for, as long as they are used on an animal or site they are labeled for, and unless that particular use is forbidden.
The COBTA readily recognizes the value of using a product per label when it is clinically effective. While COBTA supports on-label use of pesticides, it recognizes that it may be difficult for veterinarians to comply with the law and fulfill their professional duties to rid numerous species of pests such as fleas, ticks, mites, lice, flies, and mosquitoes.
"Many registered products are labeled for major species such as dogs, cats, horses, pigs, cattle, and poultry," according to COBTA. "But pesticide registrants understandably cannot develop products for small markets that include a wide variety of minor species... .This leaves veterinarians without pesticides to adequately treat such animals."
According to COBTA, animals for which no products are registered also need relief from the pain and suffering caused by pests, and some pests for which no labeled products exist can be vectors of diseases that can harm animal or human populations.
To resolve this problem, COBTA has recommended that the EPA extend regulatory discretion to licensed veterinarians who use their professional judgment, within a veterinarian-client-patient relationship, to use EPA-registered pesticides in an off-label manner to ensure animal and human health when no EPA-registered pesticide is clinically effective as labeled.
Though the agency has not yet officially responded to the recommendation, Neylan said he thought the agency would be amenable to discussing off-label use, because veterinarians are a professional group.
COBTA cautions veterinarians that federal regulations stipulate that they, like all other persons, must use all pesticides consistent with their registered labeling.