2016-20176: The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
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The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.
The agency’s own summary, as published.
What this changes
Amends 15 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 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
- 21 CFR 112 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- 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
- 21 CFR 507 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
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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