FDA Finalizes FSMA Rules for Preventive Controls

Sept. 25, 2015
At long last, the FDA finalized the first two of seven major rules required by Congress under the Food Safety Modernization Act.

At long last, the Food and Drug Administration finalized on Sept. 10 the first two of seven major rules required by Congress under the Food Safety Modernization Act. More than a week after being submitted to the Federal Register, the rules for preventive controls for human food and animal feed have been finalized.

FDA's new Hazard Analysis/Preventive Controls rule closely follows the proposals previously issued by the agency but contains additional flexibility on some key issues such as recordkeeping requirements. The food industry welcomes the rules, and is urging Congress to specifically provide adequate funds to implement them.

The Current Good Manufacturing Practice Hazard Analysis and Risk Based Preventive Controls for Human Food final rule includes the following key requirements:

∙Covered facilities must establish and implement a food-safety system with a written food-safety plan that includes hazard analysis, preventive controls and the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification).

∙The "farm" definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm. Such farms that conduct produce activities will also have to comply with the Produce Safety Rule (to be finalized at the end of October).

∙A more flexible supply chain program, with separate compliance dates.

∙Update and clarification to CGMPs.

The FDA says the rules constitute the first step in strengthening the prevention of foodborne illnesses, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities.

The rules will ensure that food companies are taking action and working with the FDA to prevent hazards to consumers during food manufacture, rather than waiting to act until a disease outbreak has occurred. They also require human and animal food manufacturing plants to develop and implement written food safety plans that indicate the possible problems that may risk food product safety and outline steps plant management would take to prevent or minimize the likelihood of the problems occurring.

Thus, food companies will be accountable for monitoring plant production processes, identifying any potential hazards that may occur in the products and preventing the hazards. Under the rules, the FDA will be able to assess the systems and their outcomes to prevent problems, will better be able to respond when food safety problems occur, and will better protect the safety of manufactured food.

Once all seven of the FSMA rules are finalized in 2016, they will work together to systematically strengthen the food safety system and better protect public health says Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. Taylor said there were some refinements and tweaks made to the preventive controls rules in response to public comments, but there are no significant departures from what’s been published before.

The human food rule modernizes existing current good manufacturing practices (CGMPs) for manufacturing, processing, packing or holding human food, which were last updated in 1986. The rule also clarifies the definition of "farm," which is key to whether an entity has to register as a food facility and become subject to the new requirements for hazard analysis and risk-based preventive controls.

The flexibility built into the final rules is meant to ensure food safety “across the great diversity of the food system,” Taylor adds. Very small businesses have three years to comply with the rules; small businesses have two years and the rest have one year.
The agency conducted three webinars about the two finalized rules and will hold a public meeting in Chicago on Oct. 20. The next three rules for produce safety, foreign supplier verification program and third-party accreditation must be finalized by Oct. 31.

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