Small Entity Compliance Guide: What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food November 2016

SMALL ENTITY COMPLIANCE GUIDE

• Docket Number: FDA-2011-N-0920
• Issued by: Human Foods Program

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.

Download the Guidance

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Related Information

• Preventive Controls for Human Food Final Rule
• Food Safety Modernization Act (FSMA)

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Individual Chapter Downloads

• Chapter 1: Introduction
• Chapter 2: Who Must Comply with the Rule
• Chapter 3: Key Terms Used in Part 117
• Chapter 4:  Who is Exempt from the Requirements for Hazard Analysis and Risk-Based Preventive Controls or Subject to Modified Requirements?
• Chapter 5: What Foods are Covered by this Regulation?
• Chapter 6: When do I have to Comply with the Rule?
• Chapter 7: Hazard Analysis
• Chapter 8: Preventive Controls
• Chapter 9: Risk-Based Supply-Chain Program for Manufacturing/Processing Facilities
• Chapter 10: Education and Training
• Chapter 11: Information for Qualified Facilities
• Chapter 12: What On-Farm Low-Risk Activities by Small or Very Small Businesses are Exempt from Hazard Analysis and Preventive Controls?
• Chapter 13: Updated and Clarified Current Good Manufacturing Practice (CGMP)
• Chapter 14: Holding and Distribution of Human Food By-Products for Use as Animal Food
• Chapter 15: Definitions

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Submit Comments Online

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-2011-N-0920.