Health and Human Services Department Docket FDA-2016-D-2343 Proposed Rule

2024-01911: Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

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Summary

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food." This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food." We revised the draft Introduction and draft Appendix 1: Known or Reasonably Foreseeable Hazards ("Potential Hazards") to address comments submitted on drafts that we made available in 2016. This draft guidance is not final nor is it in effect at this time.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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