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LEGAL ALERT

EDITOR'S NOTE


The U.S. Food and Drug Administration (FDA) has released updated revisions to the introduction and first appendix of its draft guidance, “Hazard analysis and risk-based preventive controls for human food.” The draft revisions follow an extensive period of feedback from industry seeking greater substantiation for the identification of potential food hazards. In its announcement for the draft guidance revisions, FDA has encouraged stakeholders to submit comments within 120 days of its publication.


The revised introduction to the guidance has greatly increased in size from 9 pages to 70. Changes include greater details and instructions regarding relevant uses for the guidance, as well as an expanded set of definitions and a wide-ranging index of links to related resources and policies on individual hazards.


Appendix 1 of the draft guidance, a set of tables listing potential hazards relevant to individual food groups, no longer includes tables listing potential process-related biological, chemical, or physical hazards. FDA has justified the removal of these tables on the grounds that such hazards are generally facility-specific. This appendix has been otherwise revised to provide additional instructions and information regarding its development and appropriate use. Of particular note, the revised appendix 1 states directly that a potential hazard identified in its tables does not require a preventive control under some circumstances, including a list of examples.


The tables found in appendix 1 have been heavily expanded with new food categories and additional details; most tables include footnotes with further information qualifying or explaining the identification of potential hazards in association with specific food categories. Of particular interest to the herbal products community, the Herbs and Spices groups are now listed at tables 1O and 2O, on pages 74 and 95 of the document, respectively. 

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food

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 16 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.


Download the Draft Guidance


Read more...

The American Herbal Products Association (AHPA) distributes dietary supplement regulation and enforcement news as Legal Alerts. The information presented in Legal Alerts represents the views and opinions of the original authors of the content and does not necessarily represent the views or opinions of AHPA. Distribution of dietary supplement regulation and enforcement news as a Legal Alert does not constitute AHPA endorsement of the content or legal advice. Please direct any questions about Legal Alerts to communications@ahpa.org.

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