FDA has released for public comment its proposed rule on preventive controls for human food that focuses on preventing problems that can cause foodborne illness. The proposed rule on standards for the safe production and harvesting of produce is being published at the same time. These are two of the proposed rules that are key to the preventive food safety approach established by the 2011 FDA Food Safety Modernization Act (FSMA).

The proposed rule on preventive controls applies to many domestic and foreign firms that manufacture, process, pack or hold human food. The rule proposes 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.

Regulatory Impact Analysis

• Analysis of Economic Impacts – Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (PDF - 1.4MB)
• Docket: FDA-2011-N-0920
• Federal Register: 78 FR 3646, 1/16/2013