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Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

The Food and Drug Administration published this proposed rule in the Federal Register on October 23, 2026. Comments are due by January 21, 2027.

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What the agency says

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of one additional draft chapter of a multichapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's regulation titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." The newly available draft chapter is titled "Chapter 12: Control of Chemical Hazards." This draft guidance is not final nor is it in effect at this time.

Key facts

Document number
2026-21669
Type
Proposed rule
Action
Notification of availability
Agency
Health and Human Services Department; Food and Drug Administration
Published
October 23, 2026
Comments due
January 21, 2027
Dates
Submit either electronic or written comments on the draft guidance by January 21, 2027 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Docket
Docket No. FDA-2016-D-2343
Code of Federal Regulations
21 CFR 117
Pages
2

The document on federalregister.gov PDF Comment on regulations.gov

Other documents from the Food and Drug Administration

Everything from the Food and Drug Administration · Published in October 2026

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.