Food

Guidance for Industry: What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide

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How to Comment
You may submit either electronic or written comments regarding this guidance beginning on November 1, 2016.

Submit Written Comments
Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852

Submit Comments Online
Submit electronic comments on http://www.regulations.gov to docket folder FDA-2011-N-0920.

Questions?
For questions regarding this document contact FDA’s Technical Assistance Network by submitting the inquiry form.

Contains Nonbinding Recommendations

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.

 

This guidance represents the Food and Drug Administration’s (FDA or Agency) current thinking on this topic. It does not establish any rights for any person and does not bind 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 using the contact information on the title page.

 

Page Last Updated: 11/02/2016
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