FDA issues guidance document on insecticide chlorpyrifos residues in food

U.S – The U.S. Food and Drug Administration (FDA) has released a guidance document to help food producers and processors who handle foods that may contain residues of the pesticide chemical chlorpyrifos.

Chlorpyrifos is a broad-spectrum organophosphate insecticide, widely used in food crop agriculture to control foliage and soil-borne insect pests. It has been found to inhibit an enzyme, which leads to neurotoxicity, and has also been associated with potential neurological effects in children.

The document is titled ‘Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry.’

The Environmental Protection Agency (EPA) published a final rule on August 30, 2021, revoking all tolerances for chlorpyrifos. These tolerances are however 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for Industry: Channels of Trade Policy for Commodities with Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.”

According to 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.

In the first stage, the agency intends to exercise enforcement discretion by not requesting display of 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),” says FDA.

However, during the second stage, it will permit presentation of documentation that demonstrates that chlorpyrifos was applied before February 28, 2022. Failure to present appropriate documentation by the responsible party may subject the food to regulatory action.

EPA move in line with court order

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 move by EPA was in compliance with a court order in response to the 2007 petition filed by Pesticide Action Network North America and Natural Resources Defense Council.

The petition requested that EPA revoke all chlorpyrifos tolerances, or the maximum allowed residue levels in food, because those tolerances were not safe, in part due to the potential for neurodevelopmental effects in children.

Under the previous Administration, EPA denied the petition in 2017 and denied the subsequent objections in 2019. These denials were challenged in the Ninth Circuit Court of Appeals in 2019 by a coalition of farmworker, health, environmental, and other groups. 

In April 2021, the Court found that “…EPA had abdicated its statutory duty under the Federal Food, Drug and Cosmetic Act…” to “conclude, to the statutorily required standard of reasonable certainty, that the present tolerances caused no harm.”

In its decision, the Court ordered EPA to grant the petition, issue a final rule in which the agency either modifies the chlorpyrifos tolerances with a supporting safety determination or revokes the tolerances, and modify or cancel food-use registrations of chlorpyrifos.

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