2016-01092: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Correction
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The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for "farms." The final rule published with some editorial and inadvertent errors. This document corrects those errors.
The agency’s own summary, as published.
What this changes
Amends 12 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
- 21 CFR 1 General Enforcement Regulations
- 21 CFR 11 Electronic Records; Electronic Signatures
- 21 CFR 16 Regulatory Hearing Before the Food and Drug Administration
- 21 CFR 106 Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
- 21 CFR 110 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
- 21 CFR 114 Acidified Foods
- 21 CFR 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
- 21 CFR 120 Hazard Analysis and Critical Control Point (HACCP) Systems
- 21 CFR 123 Fish and Fishery Products
- 21 CFR 129 Processing and Bottling of Bottled Drinking Water
- 21 CFR 179 Irradiation in the Production, Processing and Handling of Food
- 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
Rulemaking docket
We haven’t pulled this rulemaking’s full docket yet. View docket FDA-2011-N-0920 on Regulations.gov →
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