Editor's Note
The U.S. Food and Drug Administration (FDA) released a guidance for industry today to address foods containing residues of the pesticide chlorpyrifos. The U.S. Environmental Protection Agency had issued a final rule last year that will cause all existing food tolerances for the substance to expire on February 28, 2022. FDA issued today’s guidance to describe their intended approach to enforcement on products containing chlorpyrifos residues that may still be in production or on the market after February 28. This document expands on and heavily references an earlier “channels of trade” guidance that outlines FDA’s general approach to enforcement regarding pesticides with revoked tolerances.
 
The new guidance provides details of a multi-stage phased chlorpyrifos enforcement policy under which specific commodities will need to meet different standards of proof at different times to show that any detected chlorpyrifos residues are permitted. The end of this planned chlorpyrifos “showing period” is August 28, 2026, but FDA will continue to accept evidence justifying enforcement discretion after this date. The guidance also addresses a number of other procedural questions regarding the channels of trade policy and chlorpyrifos.
 
The full guidance document is available at this address.
Document outlines enforcement discretion approach
This guidance document represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance document at the phone number listed on the title page.

The purpose of this guidance document is to assist firms in the food production and processing industries that handle foods that may contain residues of the pesticide chemical chlorpyrifos. On August 30, 2021, the Environmental Protection Agency (EPA) issued a final rule to revoke all tolerances for chlorpyrifos residues in foods. That final rule set an expiration date for all chlorpyrifos tolerances of February 28, 2022. This guidance explains our planned enforcement policy on foods containing chlorpyrifos residues after the tolerances expire. This guidance also will help you understand the types of showing (documentation) under the channels of trade provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that we recommend, and provides relevant showing dates.

This guidance document follows the policies explained in our guidance document entitled “Guidance for Industry: 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 2005 channels of trade guidance). The 2005 channels of trade guidance explained our general policies on our planned enforcement approach for foods containing residues of certain pesticide chemicals, for which tolerances have been revoked, suspended, or modified by EPA under the provisions of the FD&C Act, as amended by the Food Quality and Protection Act (Pub. L. 140-170) (1996). In the 2005 channels of trade guidance, we stated our intention to issue further Level 2 guidance for specific pesticide chemicals that are to be the subject of an EPA tolerance revocation, suspension, or modification.

This guidance document does not apply to food regulated by the United States Department of Agriculture (USDA) under the Poultry Products Inspection Act, the Federal Meat Inspection Act, and the Egg Products Inspection Act. Any matter that might arise involving the potential application of the channels of trade provision to these USDA-regulated foods would be handled by USDA. This guidance document also does not apply to animal food regulated by FDA. Any matter that might arise involving the potential application of the channels of trade provision to animal food would be handled by FDA’s Center for Veterinary Medicine (CVM).

The contents of this guidance document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This guidance document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance documents means that something is suggested or recommended, but not required.
2022 Annual Fund Sponsors: