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Laws & Regulations

Summary of the Federal Food, Drug, and Cosmetic Act

21 U.S.C. §301 et seq. (2002)

Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes EPA to set tolerances, or maximum residue limits, for pesticide residues on foods. In the absence of a tolerance for a pesticide residue, a food containing such a residue is subject to seizure by the government. Once a tolerance is established, the residue level in the tolerance is the trigger for enforcement actions. That is, if residues are found above that level, the commodity will be subject to seizure.

In setting tolerances, EPA must make a finding that the tolerance is "safe." Safe is defined as meaning that there is a "reasonable certainty that no harm will result from aggregate exposure to the pesticide residue." To make the safety finding, EPA considers, among other things: the toxicity of the pesticide and its break-down products, aggregate exposure to the pesticide in foods and from other sources of exposure, and any special risks posed to infants and children. Some pesticides are exempted from the requirement to have a tolerance. EPA may grant exemptions in cases where the pesticide residues do not pose a dietary risk under reasonably foreseeable circumstances.

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The Office of Pesticide Programs (OPP) regulates the use of all pesticides in the United States and establishes maximum levels for pesticide residues in food, thereby safeguarding the nation's food supply. OPP implements key parts of the FFDCA.