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Pesticide News Story: FDA Publishes Final Channels of Trade Policy Guidance
For Release: May 31, 2005
The Food and Drug Administration published a final guidance document entitled “Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.” The purpose of the guidance is to present FDA's general policy on its planned enforcement approach for foods containing residues of certain pesticide chemicals in accordance with the “channels of trade” provision of the Food Quality Protection Act of 1996 (FQPA). This provision addresses how FDA will handle findings of pesticide residues in foods when the applicable pesticide registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been canceled and the applicable pesticide residue tolerance has been revoked by the Environmental Protection Agency (EPA) due to dietary risk considerations. The provision states that food containing a residue of such a pesticide shall not be deemed “adulterated” by virtue of the residue, if the residue is within the former tolerance, and the responsible party can demonstrate to FDA’s satisfaction that the residue is present as the result of an application of the pesticide to the crop at a time and in a manner which were lawful under FIFRA.
The guidance describes the types of documentation that FDA will consider acceptable to demonstrate that a food found to contain a residue of the pesticide chemical is entitled to the “safe harbor” granted by the “channels of trade” provision. This guidance will assist firms in understanding the types of showing that FDA may find satisfactory, in accordance with its planned enforcement approach. The final guidance document follows the publication of a draft guidance document on July 22, 2003 and a public comment period. FDA also previously published two chemical-specific “channels of trade” final guidance documents for foods containing residues of the pesticide chemicals methyl parathion and vinclozolin. The guidance is available at http://www.cfsan.fda.gov/~dms/pesguid2.html. 