Special pesticide formulations - August 15, 2004

The Environmental Protection Agency allows veterinarians to mix special pesticide formulations to meet unique case-specific needs, as long as they meet labeling and other safety requirements.

Veterinary use, production, and dispensation of pesticides are regulated by the Environmental Protection Agency under the authority of the Federal Insecticide, Fungicide and Rodenticide Act. To ensure that veterinarians are aware of their responsibilities under FIFRA, the AVMA Council on Biologic and Therapeutic Agents is working with the EPA to educate veterinarians on this topic. This story is the fourth in a four-part series outlining veterinarians' responsibilities under FIFRA, and will focus on special pesticide formulations.

Normally, individuals who produce or blend pesticides are required to register their products and establishments with the EPA, to keep records of special formulations and their use, and to meet all EPA labeling and repackaging requirements. Recognizing the benefits of allowing veterinarians to produce special formulations of pesticides when needed, the EPA has exempted them from those regulations. There are limitations, and they are outlined in a policy published in the Nov. 1, 1979, issue of the Federal Register, which explains how FIFRA applies to veterinarians.

The AVMA Council on Biologic and Therapeutic Agents has reviewed, and supports, the EPA's policy on special pesticide formulations.

Veterinarians who produce a special blend solely for their own use, or use by persons in their presence and under their immediate supervision (e.g., employees), are exempt by regulation from the EPA's producer regulations. Veterinarians producing special pesticide formulations must, however, comply with the labeling directions of any pesticides they use. Additionally, the EPA recommends that veterinarians adequately label special blends to promote safe use, storage, and disposal by veterinarians and their employees.

The veterinarian also must label the special formulation with the following information:

1. The common or trade name(s) and percentage(s) of the active ingredient(s)
2. The EPA product registration number
3. Use directions for the use prescribed
4. The name and address of the veterinarian
5. An antidote statement
6. Directions for disposal of the pesticide and the packaging
7. 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.

On the other hand, veterinarians who wish to dispense special pesticides mixtures are legally subject to all registration, labeling, and packaging requirements imposed on producers. However, EPA recognizes (by policy) that benefits may be obtained by allowing veterinarians to formulate products to meet unusual needs. Thus, veterinarians who dispense these special blends will not be subject to the requirements if they meet the following conditions. These formulations must be:

• made from EPA-registered pesticides
• administered by certified persons, if they contain restricted-use pesticide
• mixed and dispensed in accordance with recognized clinical practices, not for experimentation
• prescribed solely for application on the affected animal, following the directions on the label of the registered pesticide, and the mix must not be expressly prohibited on the label
• prescribed and dispensed to individual clients on a case-by-case basis to solve a specific pest problem
• labeled as described above
• dispensed in childproof packaging, unless there is no reasonable possibility that the package will come within reach of children

Certain pesticides that are highly toxic must always be packaged in a childproof container, and the EPA recommends that veterinarians err on the side of caution and use childproof packaging when in doubt.

Additionally, the EPA encourages veterinarians to discuss with their client the directions and safety information on the formulation's label.