Earlier this month the U.S. Food and Drug Administration released Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry, an advisory document for food producers/processors explaining how to handle foods that could be contaminated with chlorpyrifos residue.
On Aug. 30, 2021, the Environmental Protection Agency published its final rule on chlorpyrifos that revoked all tolerances. The tolerances will expire on Feb. 28.
The FDA document based on the Federal Food, Drug, and Cosmetic Act’s channel of trade provisions. Its policies are outlined in FDA’s Guidance from 2005, “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for Industry: Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.”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 channels of trade provision states that when EPA tolerances expire, food containing chlorpyrifos residue will not be deemed unsafe based solely detected residue if chlorpyrifos was lawfully applied before tolerance expiration. The residue level must not exceed that permitted by the tolerance in place when the application was made.
The FDA is the enforcer of EPA pesticide tolerances for domestic and imported foods other than meat, poultry, Siluriformes fish and fish products (catfish), and specific egg products which are regulated by the USDA.
Two phases will be used by the FDA, applying both to applies raw commodities and processed foods.
In Stage 1 the FDA “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).”
In Stage 2 the FDA “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.”
A public docket has been set up by the FDA for comments on the guidance. Comments may be submitted electronically or in writing 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.