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Proposed RuleSignificant2013-001252013-01-16

Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) 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. FDA also is proposing to revise certain definitions in FDA's 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." FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system.

Action & Dates

Action
Proposed rule.
Dates
Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15, 2013, (see the "Paperwork Reduction Act of 1995" section of this document).

CFR References

Topics

Administrative practice and procedureBeveragesCosmeticsDrugsExportsFishFood additivesFood grades and standardsFood labelingFood packagingFoodsFruit juicesImportsInfants and childrenLabelingLaboratoriesNutritionPackaging and containersPrescription drugsRadiation protectionReporting and recordkeeping requirementsSeafoodSigns and symbolsVegetable juicesWarehouses

Public Comment

Comments Close
2013-05-16

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 [Docket No. FDA-2011-N-0920] RIN 0910-AG36 AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to amend its regulation for Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food (CGMPs) 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. FDA also is proposing to revise certain definitions in FDA's 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.” FDA is taking this action as part of its announced initiative to revisit the CGMPs since they were last revised in 1986 and to implement new statutory provisions in the FD&C Act. The proposed rule is intended to build a food safety system for the future that makes modern, science-, and risk-based preventive controls the norm across all sectors of the food system. DATES: Submit either electronic or written comments on the proposed rule by May 16, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 15,

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Related Documents

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Full Document

Citation: 78 FR 3646