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Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food June 2021

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

The purpose of this document is to provide guidance for FDA staff on aflatoxins in human food. We revised this document to update the format and to include revisions for clarity, references to other aflatoxin Compliance Policy Guides (CPGs), and a reference to the Memorandum of Understanding between the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) and FDA. The contents of this 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 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 means that something is suggested or recommended, but not required.

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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-2021-D-0242.

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