Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

Open for public comment until Jan. 21, 2027. Comment on Regulations.gov

What it does

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(FDA, the Agency, or we) is announcing the availability of one additional draft chapter of a multichapter draft guidance for industry titled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under FDA's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 This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration's summary, as published in the Federal Register.

What it would change

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 117

What happens next and when

Submit either electronic or written comments on the draft guidance by January 21, 2027 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2016-D-2343 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register