FDA Withdraws Guidance for Industry on Enforcement Approach to Human Food with Chlorpyrifos Residues
Constituent Update
What's New
February 5, 2024
The U.S. Food and Drug Administration is withdrawing a 2022 guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry, following a decision by the U.S. Court of Appeals for the Eighth Circuit to vacate, or void, an Environmental Protection Agency (EPA) final rule that revoked all tolerances for the pesticide chemical chlorpyrifos. A mandate to finalize the court’s judgment was issued on December 28, 2023, reinstating all tolerances for chlorpyrifos residues. The guidance was intended to explain the FDA’s enforcement policy for foods containing chlorpyrifos residues after the tolerances expired according to the EPA final rule, which is now void.
EPA is amending its regulations to reflect the current legal status of the chlorpyrifos tolerances.
Original Constituent Update
February 9, 2022
Today the U.S. Food and Drug Administration released a guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry. The guidance is intended to help food producers and processors who handle foods that may contain residues of the pesticide chemical chlorpyrifos. The Environmental Protection Agency (EPA) published a final rule on August 30, 2021, revoking all tolerances for chlorpyrifos; these tolerances are set to expire on February 28, 2022.
This guidance is based on the channels of trade provision of the Federal Food, Drug, and Cosmetic Act and follows the policies explained in the FDA’s 2005 Guidance titled “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for Industry: Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.”
Under the channels of trade provision, after the EPA tolerances expire, a food that contains chlorpyrifos residues is not deemed unsafe solely based on the presence of the residue as long as the chlorpyrifos was applied lawfully and before the tolerance expired, and the residue does not exceed the level permitted by the tolerance that was in place at the time of the application.
The FDA is responsible for enforcing the EPA pesticide tolerances for domestic and imported foods, with the exception of meat, poultry, Siluriformes fish and fish products (catfish), and certain egg products that are regulated by the U.S. Department of Agriculture (USDA).
The FDA’s approach has two phases and applies to both raw agricultural commodities and processed foods.
- Stage 1: The Agency intends to exercise enforcement discretion by not requesting showing documentation for residues complying with previous tolerances for a time period ranging from approximately 6 to 24 months, depending on the specific commodity. This is based on our estimate of how long raw agricultural commodities would remain on the market (e.g., time for growing and postharvest storage, distribution, and sale).
- Stage 2: The Agency will accept showing documentation that demonstrates that chlorpyrifos was applied before February 28, 2022. If the responsible party does not provide appropriate documentation, the food may be subject to regulatory action.
The EPA final rule also revokes tolerances applicable to animal foods. Enforcement of residues in animal foods will be addressed by the FDA’s Center for Veterinary Medicine. Any matter involving USDA regulated foods would be handled by the USDA.
The FDA has a public docket to receive comments on this guidance. You may submit electronic comments or written comments at any time.
Public comments can be submitted electronically to https://www.regulations.gov/ using Docket ID: FDA-2016-D-4484. Written comments can be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.