On Friday, January 4, 2013, FDA announced the pre-publication of two long-awaited proposed rules implementing parts of the Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011. The two proposed rules, entitled Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, are scheduled to appear in the Federal Register on January 16, 2013 and are open for public comment for the next 120 days. (Pre-publication versions of the proposed rules are available here and here.) Written or electronic comments may be submitted to FDA until May 16, 2013.
The first proposed rule, Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, would require food manufacturers to develop a written plan for preventing foodborne illness. The rule would apply whether food is produced at a foreign- or domestic-based facility, and also would require companies to have plans for monitoring and correcting any problems that arise. FDA is proposing that many food manufacturers be in compliance with the new preventive controls rules within one year after the final rules are published in the Federal Register, but small and very small businesses would be given additional time, though what constitutes small and very small businesses has not yet been defined.
The second proposed rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, contemplates enforceable safety standards for the production and harvesting of produce on farms. This rule proposes science- and risk-based standards for the safe production and harvesting of fruits and vegetables. FDA is proposing that larger farms be in compliance with most of the produce safety requirements 26 months after the final rule is published in the Federal Register. Small and very small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality.
The proposed rules are quite lengthy, 680 pages (cGMP Standards) and 547 pages (Produce Standards), which may partly explain the delay in their issuance. As a result, we would expect that the review of comments and subsequent publication of a final rule may take another year or more. Moreover, FDA has announced that additional proposed rules on importer verification and accreditation will follow soon. As a result, we expect that industry and trade associations will be active in reviewing and commenting on these proposed rules in the near future.
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