FDA releases two proposed rules under the Food Safety Modernization Act

The U.S. Food and Drug Administration (FDA) has released for public comment a proposed rule to establish science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. The proposed rule for preventive controls for human food is being published at the same time. These are two of the proposed rules that are key to the preventive food safety approach established by FDA’s 2011 Food Safety Modernization Act (FSMA). FDA will soon issue its proposed rule on foreign supplier verification. Future proposed rules will address preventive controls for animal food, and accreditation of third-party auditors for imported food.

The Preventive Controls for Human Food Rule would require food companies—whether they manufacture, process, pack or store food—to put in place better controls to minimize and reduce the risk of contamination. The rule proposes each covered facility to prepare and implement a written food safety plan to identify potential hazards, similar to Hazard Analysis and Critical Control Points (HACCP) systems that are required by FDA for juice and seafood. View the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Proposed Rule.

The Produce Safety Rule would require farms that grow, harvest, pack or hold fruits and vegetables to establish and follow science-based standards for the safe growing, harvesting, packing, and holding of produce in its raw or natural (unprocessed) state. FDA proposes to set standards associated with identified routes of microbial contamination of produce, including: (1) agricultural water, (2) biological soil amendments of animal origin, (3) health and hygiene, (4) animals in the growing area, and (5) equipment, tools and buildings. The proposed produce rule provides growers flexibility in their approach to on-farm food safety, so that food safety practices taken by farmers can be appropriate for the scale of production and type of agricultural practices being used. View the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Proposed Rule.

FDA is proposing that the requirements be effective 60 days after a final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, compliance dates would be phased in based on business size. Comments on the proposed rules are due within 120 days of their publication in the Federal Register.


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