  |
|
 |
|
FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search  | ||
Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides (CPG 7120.29)
BACKGROUND:
The Environmental Protection Agency (EPA) is responsible, under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), for registering uses of pesticides in the United States. If the pesticide is to be approved for use in crop or animal production, EPA may establish tolerances under the Federal Food, Drug, and Cosmetic Act (the Act) for residues of that pesticide in foods which might be contaminated from such use. These tolerances are established at the same time the pesticide use is registered.
FIFRA also authorizes EPA to cancel registered uses of pesticides when such pesticides are causing unreasonable adverse effects on humans or the environment. EPA has exercised this authority for a number of pesticides such as DDT, aldrin, dieldrin, chlordane, and heptachlor. However, when these pesticide uses were cancelled, EPA did not revoke the residue tolerances which had been established when the pesticide was registered. In fact, there is no statutory requirement that such tolerances be revoked.
Most of the pesticides which have thus far been cancelled are chlorinated hydrocarbons. Because these types of pesticides may persist in the environment for many years following their use and potentially contaminate the food of humans and other animals, there is a need to limit the amount of their residues in food even though the pesticides are not being used. However, residues in food resulting from environmental contamination would not usually be expected to be as high as those resulting from purposeful use of the pesticide. Therefore, EPA, the Food and Drug Administration (FDA), and the USDA's Food Safety and Inspection Service (FSIS) agreed to institute new regulatory limits for residues of a pesticide when the pesticide uses are cancelled.
An interagency policy published in the Federal Register of September 29, 1982, 47 FR 42956, describes procedures which will be followed when the registration of a pesticide is cancelled. Thus, the affected pesticide's residue tolerances will routinely be revoked and replaced, if necessary, with action levels.
POLICY:
EPA will determine the appropriate action level using the same criteria as required under section 406 of the Act to establish tolerances for poisonous and deleterious substances in food. Therefore, the action level should limit residues to the extent necessary to protect the public health, while taking into account the extent to which the residues in food cannot be avoided by good manufacturing practices and other ways a consumer might be affected by the same or other substances. In most cases, a notice proposing the establishment of an action level will be published simultaneously with the EPA Notice of Intent to cancel the pesticide.
EPA will recommend the appropriate action levels to FDA, and the action levels will actually be established and enforced by FDA, except for those applying to FSIS monitoring of pesticide residues in meat and poultry. The action levels will be reviewed periodically by EPA for possible revision.
Issued: 2/1/83
Revised: 2/1/89