The U.S. Food and Drug Administration has released the proposed rule on preventive controls that 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. The FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly. 

Key points of the Proposed Rule 
The rule proposes each covered facility to prepare and implement a written food safety plan, which would include the following:

  • Hazard analysis 
  • Risk-based preventive control
  • Monitoring procedures
  • Corrective actions, verification and record keeping

The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points systems.

Implementation of the rule

FDA is proposing that the requirements be effective one year after a final rule is published in the Federal Register. The agency is proposing to allow two years for small businesses and three years for very small businesses to comply with the rule. 

Comments on the proposed rule are due 120 days after the rule is published in the Federal Register. FDA will hold public meetings to explain the proposal and to provide additional opportunity for input.
FDA also released for public comment another proposed rule in response to the 2011 Food Safety Modernization Act. In addition to the preventative controls for human food, FDA released the proposed rule on standards for the safe production and harvesting of produce. FDA said that its proposed rule on importer foreign supplier verification will be issued soon.