Docket Number:
FDA-2011-N-0920
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition

The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF) rule creates new requirements for the production of human food by registered food facilities, and revises previous requirements. This guide was developed to inform domestic and foreign food facilities about the PCHF regulation and how to comply with it. It contains important information that may affect your firm.

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. Law 104-121). The intent of this guide is to inform domestic and foreign food facilities about the PCHF regulation and enable them to better understand the requirements of the rule. The rule is binding and has the full force and effect of law.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendation, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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All written comments should be identified with this document's docket number: FDA-2011-N-0920.