Food

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food

Contains Nonbinding Recommendations
Draft — Not for Implementation

Please Note: This guidance is being distributed for comment purposes only.

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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-2016-D-2343.

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

In 21 Code of Federal Regulations (CFR) part 117 (part 117), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.” We published the final rule establishing part 117 in the Federal Register of September 17, 2015 (80 FR 55908). Part 117 establishes requirements for current good manufacturing practice for human food (CGMPs), for hazard analysis and risk-based preventive controls for human food (PCHF), and related requirements.

The PCHF requirements implement the provisions of the FDA Food Safety Modernization Act (FSMA), established in section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g). Part 117 includes several complete or partial exemptions from the PCHF requirements. See 21 CFR 117.5 for a list and description of these exemptions.

This document is directed to those persons (you) who are subject to the PCHF requirements of part 117. Establishing risk-based preventive controls enables you to apply a proactive and systematic approach to your food safety program through the establishment of preventive controls designed to protect your food, and the consumer, from biological, chemical (including radiological), and physical hazards. Risk-based preventive controls will not give you a "zero-risk” system for manufacturing, processing, packing, and holding food; rather, risk-based preventive controls are designed to minimize the risk of known or reasonably foreseeable food safety hazards that may cause illness or injury if they are present in the products you produce.

This guidance is intended to help you comply with the following specific PCHF requirements established in subparts C and G of part 117:

  • A written food safety plan (FSP);
  • Hazard analysis;
  • Preventive controls; 
  • Monitoring; 
  • Corrective actions; 
  • Verification; and
  • Associated records.

This guidance is not directed to persons who are exempt under 21 CFR 117.5. However, such persons may find some of the principles and recommendations in this guidance helpful in manufacturing, processing, packing, and holding human food.

We intend this draft guidance to include the 15 chapters listed in the Table of Contents. We will announce the availability of each draft chapter for public comment as the chapter becomes available, rather than delaying release of individual draft chapters until all the draft chapters are available. Those chapters that you see listed in the Table of Contents as “coming soon” are not yet available.

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

Individual Chapter Downloads

This draft guidance, when finalized, will represent 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 FDA’s Technical Assistance Network by submitting a form.

 

Page Last Updated: 08/30/2017
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