This month, FDA finalized two rules on current Good Manufacturing Practices ("cGMP") and preventive control requirements, see here and here, under the Food and Safety Modernization Act ("FSMA"). These rules cover human and animal food facilities and aim to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. Requirements for both rules are quite similar, requiring owners, operators, or agents of food facilities to implement written preventive control plans that identify and evaluate known or reasonably foreseeable hazards in the food, including biological, chemical, physical, and radiological hazards. The rules require that such food safety plans must include a hazard analysis, preventive controls, monitoring, corrective action and verification procedures, and recordkeeping. The FDA has stated it has evaluated the comments received from the public, allowing for more flexibility in some of the rules' requirements. For example, the "farms" definition has been extended to narrow the kinds of facilities covered by the rules, and the responsibilities under the supply-chain program have been reduced by, among other things, not requiring facilities where hazards are identified and controlled by a subsequent entity in the distribution chain to implement preventive controls. Additionally, FDA provides industry with staggered implementation based on business size, cGMP requirements, and preventive control requirements. Implementation will occur over a number of years, beginning on September 17, 2016.
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