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Guidance for Industry: Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues February 2022

Docket Number:
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

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.[2] On August 30, 2021, the Environmental Protection Agency (EPA) issued a final rule[3] to revoke all tolerances for chlorpyrifos residues in foods. That final rule set an expiration date for all chlorpyrifos tolerances of February 28, 2022.[4] 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for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations”[5] (the 2005 channels of trade guidance).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planned enforcement approach for foods containing residues of certain pesticide chemicals, for which tolerances have been revoked, suspended, or modified by EPA under the provisions of the FD&C Act, as amended by the Food Quality and Protection Act (Pub.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.[6] 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).[7]

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.

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Related Information

[1] This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug Administration.

[2] “We,” “us,” and “our” refer to FDA. “You” refers to the responsible person (e.g., grower, food processor, manufacturer, or importer) who is responsible for the food and submits such information to FDA.

[3] Chlorpyrifos; Tolerance Revocations. Final Rule. 86 FR 48315, August 30, 2021.

[4] FDA recognizes that EPA has authority to stay the final rule under section 408(g)(1) of the FD&C Act, 21 U.S.C. 346a(g)(1). For the purposes of this guidance, FDA presumes that the tolerances will expire on February 28, 2022, which was the date set in the final rule, and that February 27, 2022, is the last lawful application date.

[5] See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-channels-trade-policy-commodities-residues-pesticide-chemicals-which-tolerances

[6] Questions regarding USDA-regulated products can be sent to USDA through askFSIS (https://www.fsis.usda.gov/contact-us/askfsis). When submitting a question about the potential application of the channels of trade provision on USDA-regulated products, complete the web form and select Residue Case Information as the Inquiry Type.

[7] Questions to CVM can be sent to [email protected].

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-4484.

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