Pesticide regulation Delaney clause

Until 1994 the EPA regulated pesticides proposed for use on food crops under certain sections of the Food, Drug, and Cosmetics Act. Carcinogenic pesticides were subject to the Delaney clause, and were thus prohibited. The use of a non-carcinogenic pesticide was allowed if its manufacturer provided data sufficient to establish an RfD, and information on expected food residue levels sufficient to document that the RfD would not be exceeded when people consumed food containing residues of the pesticide. The tool for determining compliance with this criterion is called a tolerance, and it is expressed as the maximum amount of a pesticide that can be present in a given amount of food, if the RfD is not to be exceeded. 

Finally it should be noted that prior to the FQPA in 1996, the Delaney clause prohibited the establishment of tolerances or maximum allowable levels for food additives if it has been shown to induce cancer in human or animal. This is an important change in regulations because pesticide residues were considered as food additives. Because of the FQPA, pesticide residues are no longer regarded as food additives, and there is no prohibition against setting tolerances for carcinogens. 

The regulation of carcinogenic pesticides on foods depends upon how EPA interprets and applies FIFRA, FFDCA Sections 408 and 409, and especially the Delaney clause in the FFDCA. Pesticide registrations are granted or denied under the FIFRA risk-benefit standard. However, food use pesticides cannot be registered, unless a tolerance or an exemption from a tolerance for the RAC was also granted under Section 408 of the FFDCA. 

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