Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability

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 This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule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 This draft guidance is not final nor is it in effect at this time.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.