June 5, 2020

Fact Sheet on FSMA Rule for Preventive Controls

FDA-logoThe FDA has released a fact sheet on the Food Safety Modernization Act (FSMA) proposed rule for preventive controls for human food. The public can now comment on this rule. The rule would apply fo domestic and foreign firms that “manufacture, process, pack, or hold human food.”

Under the new rule, these firms must have written plans that identify hazards that could affect the food or product, specify the steps that will be put in place to prevent or minimize those hazards, identify monitoring procedures and record monitoring results, and specify what actions will be taken to correct problems that arise. The first compliance date is one year after the final rule is published in the Federal REgister. Small business have two years to comply, while very small businesses have three years.

The rule has two features: new provisions that require hazard analysis and risk-based preventive controls, and a revision of the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 110. You can see all of the details of the proposed rule at the FDA site.

Depending on the type of food produce, the type of facility or operation, and its size, some firms may be exempt from the Hazard Analysis and Risk Based Preventive Control Requirements. Most facilities must comply with CGMP rules, except for activities with the definition of “farm” and grain elevators and warehouses that store raw commodities intended for further distribution or processing.

The FDA will publish a guidance document within six months of publication of the final rule that details the requirements in “plain language” to help businesses comply. The FDA is also developing a core training curriculum for small and mid-size businesses.

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