Preambles to 21 CFR Part 110

Preambles are the notes that FDA publishes when it announces a proposed or final rule. They respond to comments submitted by industry and the public, and often reveal the intent and FDA's interpretation of the regulation. All preamble files are in PDF format, and require Adobe Acrobat Reader to view.

16 January 2013 (78 FR 3798)
The Food and Drug Administration 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.

6 November 2001 (66 FR 56035)
Changes the reg to reflect a new address for the Center For Food Safety and Applied Nutrition.

19 September 2000 (65 FR 56468)
Removed the requirement that raw materials and other ingredients susceptible to contamination with aflatoxins, other natural toxins, pests, undesirable microorganisms, or other extraneous material, comply with FDA guidelines.

19 June 1986 (51 FR 22475)
The primary purpose of the revision is to establish new, updated, or more detailed provisions for the food industry to help ensure a safe and sanitary food supply.

8 June 1979 (44 FR 33238)
Proposed to revise and update requirements for plant personnel; plant design and construction; sanitary operations, facilities, and controls; equipment and utensils; regulating and recording controls; processing operations; and coding and record keeping.

26 April 1969 (34 FR 6877)
Final regulations

20 December 1968 (33 FR 19023)
Reg proposal of regulations based on comments

15 December 1967 (32 FR 17980)
Original proposed regulations