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FDA releases proposed rule on preventive controls for human food

The US 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. FDA would evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly.

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

FDA proposes that the requirements be effective one year after a final rule is published in the Federal Register. The agency proposes 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. A similar proposed rule that would apply to animal feed and petfood is expected soon.

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