Food and Drug Administration: Current Good Manufacturing Processes and Hazard Analysis and Risk-Based Preventative Controls for Human Food

On January 4, 2013, the Food and Drug Administration (FDA) released for public comment its proposed rule on preventive controls established by the 2011 FDA Food Safety Modernization Act (FSMA); this rule focuses on preventing problems that can cause foodborne illness.  The proposed rule on preventive controls applies to many domestic and foreign firms that manufacture, process, pack or hold human food. The rule proposes that firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly. FDA is proposing that the requirements be effective one year after a final rule is published in the Federal Register. Recognizing that smaller businesses may need more time to comply with the requirements, FDA is proposing to allow two years for small businesses and three years for very small businesses to comply.

The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. Activities within the definition of "farm" would not be subject to the proposed rule, and the proposed rule would clarify those activities. 

The comment deadline is May 16, 2013.

  • Advocacy contact: Linwood Rayford at 202-205-6533
  • Submit comments electronically by Federal eRulemaking Portal
  • Submit written submissions in the following ways: FAX: 301-827-6870 or Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Friday, January 4, 2013