|What veterinarians need to know |
Veterinarians who open spot-on flea-and-tick product packages to dispense single applications to clients must label those repackaged products in accordance with Environmental Protection Agency requirements.
Veterinarians prescribing, dispensing, repackaging, applying, or otherwise using pesticide products are subject to the regulations of the Federal Insecticide, Fungicide, and Rodenticide Act, which is administered by the EPA. The agency published a notice in the Nov. 1, 1979, issue of the Federal Register outlining how FIFRA applies to veterinarians.
To remind veterinarians of their responsibilities under FIFRA, the AVMA Council on Biologic and Therapeutic Agents and its staff are working cooperatively with the EPA to educate veterinarians about this topic. This article, the first in a four-part series outlining those responsibilities, will focus on the rules veterinarians must follow when repackaging any pesticide.
The rules regarding repackaging apply to any veterinarian who prescribes or otherwise dispenses a pesticide in a new container, or a container that the veterinarian has altered by changing the package or its labeling, after receipt of the product.
According to the EPA, labeling on pesticide products has been specially designed to ensure that the product is used properly, and to provide information to physicians in case of a human poisoning. Since 1996, the Environmental Protection Agency has been working to make the labels on pesticides as familiar and easy to use as the nutrition labels on packaged food. After gathering input from consumers and stakeholders, the EPA developed standardized labels that provide directions for use, storage, and disposal; safety information; product ingredients; and information about the manufacturer and product registration.
"The agency puts a lot of effort into making sure the label is as useful and as easy to read as possible," said Jack Neylan, chief of the agriculture branch of the EPA Office of Enforcement and Compliance Assurance.
Manufacturers are required to include those labels on pesticide packaging. When veterinarians repackage the products, however, there is potential for this important consumer information to be lost. According to the EPA, the agency recognizes the benefits of allowing veterinarians the discretion to repackage pesticide products to meet their clients' individual needs, but also wants to ensure that consumers receive adequate product information. To reconcile those competing demands, the EPA has established, as a matter of policy, rules veterinarians must follow when repackaging pesticides.
First and foremost, the agency requires that veterinarians prescribe and dispense repackaged pesticide products only for an EPA-registered use. According to the agency, pesticide registration is the process through which EPA examines 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 storage and disposal practices.
On the basis of that information, the EPA evaluates the pesticide to ensure that it will not have unreasonable adverse effects on humans, the environment, the target species, and nontarget species. Furthermore, the product must not be a restricted-use pesticide. The veterinarian also must label the repackaged product with the following information:
- The common or trade name(s) and percentage(s) of the active ingredient(s)
- The EPA product registration number
- Use directions for the use prescribed
- The name and address of the veterinarian
- An antidote statement
- Directions for disposal of the pesticide and the packaging
- Human safety precautionary statements, including but not limited to "for application to animals only," "keep out of reach of children," and "in case of accident, contact local physician immediately"
If there is sufficient space on the package, all of that information must be physically attached to the package. If there is not adequate space, items (a) through (d) must be physically attached, and item (g) should be affixed to the container by wire, plastic, or similar means. The information in (e) and (f) may be supplied to the client in the form of supplemental labeling, which may consist of the original labeling of the pesticide as received by the veterinarian.
Additionally, the container dispensed to the client must be child-resistant, unless the veterinarian has determined that there is no reasonable possibility that the package will come within the reach of children. The pesticide must be prescribed and dispensed to the client on a case-by-case basis for treatment of a specific problem as part of the veterinarian's normal practice. Veterinarians are also encouraged to discuss the directions on the label with the client when they dispense the product. Any veterinarian who repackages and dispenses pesticides and who does not satisfy those conditions may be penalized under FIFRA.
The COBTA recently reviewed the published requirements and found them to be satisfactory, with one caveat. Veterinarians may find off-label use necessary to treat minor species, such as pet reptiles, pet rodents, rabbits, ferrets, birds, captive wildlife, and other animals for which no registered product exists. COBTA has recommended that the EPA extend regulatory discretion to veterinarians who use their professional judgment, within a veterinarian-client-patient relationship, to use pesticide products in an off-label manner to ensure animal and human health, when no registered product exists. Currently, the EPA doesn't permit any off-label use of pesticides.
Neylan 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. Given that veterinarians are a professional group, however, Neylan said he thought the agency would be amenable to discussing the issue.
COBTA cautions veterinarians that federal regulations stipulate that they, like all other persons, must use all pesticides consistent with their registered labeling.
The next article in the series will examine the EPA's requirements for using products as labeled.