FDA Shifts Focus to Prevention with Publication of Proposed Food Safety Rules

On January 4th, the U.S. Food and Drug Administration (FDA) published two long-awaited proposed food safety rules aimed at preventing foodborne illness. The proposed rules implement the 2011 Food Safety Modernization Act (FSMA) and are available for public comment over the next four months. The rules have wide-ranging effects on a diverse group of industries, including every link in the global food supply chain.

Preventive Controls for Human Food -

The first rule would require domestic and foreign food facilities to develop a formal plan for preventing their products from causing foodborne illness. These plans, which are subject to FDA audit, must identify hazards, specify the steps implemented to minimize or prevent those hazards, identify monitoring procedures and record monitoring results, and specify what actions will be taken to correct problems that arise.

Importantly, the preventive controls are both “risk-based” and “flexible.” This means that the rule would require controls only where necessary to prevent hazards to public health. Accordingly, the rule would exempt certain facilities from requirements or modify requirements for certain low-risk activities. For example, farms are exempted from this first rule. (The proposed rule would also clarify the definition of “farm” for purposes of exemption from food facility registration, particularly with respect to farms that also engage in food processing activities.) In addition, certain manufacturing operations that are already subject to, and compliant with, specific good manufacturing (GMP) or hazard analysis and critical control point (HACCP) regulations would be exempt from some provisions of the proposed rule, including manufacturers of dietary supplements, acidified and low-acid canned foods, juice products, and seafood.

If and when finalized, most businesses would only have one year to comply with the rule.

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