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FDA Proposes Two FSMA Regulations

On January 4, 2013, FDA proposed the two new regulations implementing the FDA Food Safety Modernization Act (“FSMA”) that are aimed at preventing foodborne illness.

The first proposed rule, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative Controls for Human Food,” would revise FDA’s CGMP regulations.  It would require foreign and domestic food facilities that make food sold in the U.S., with some exceptions, to create and maintain a food safety plan, perform a hazard analysis, and undertake preventative controls for the mitigation of such hazards.  Additionally, food facilities would be required to monitor their preventative controls to verify that they are effective, and if not, they must take corrective action.  As with other CGMP regulations, records documenting actions taken must be maintained.   The proposed preventative controls rule would not apply to those involved in the manufacturing, processing, packaging or holding of dietary supplements if they comply with the dietary supplement CGMPs and the requirement for serious adverse event reporting.

The second proposed rule, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of raw produce for human consumption in light of microbiological hazards.  For example, it creates standards for worker training, health and hygiene.  The standards would not apply produce that is scarcely eaten raw or to produce for personal or on-farm consumption.  There are also several exemptions contained in the proposed rule, such as an exemption for farms that have an average annual value of food sold during the previous three-year period of $25,000 or less.

Both rules are available for public comment for 120 days after the rules’ publication.  Comments are due by May 13, 2013. After the final preventative controls rule is published, food manufacturers will have up to a year to comply.  Large farms will have to comply with most of the requirements of the final standards rule within 26 months of it being published.  Small farms and manufacturers will have more time to comply with the final rules.

Proposed rules implementing other sections of the FSMA are expected to be published soon, including a rule on importer responsibilities.

With FDA’s budget in limbo, as previously reported on our blog, it is unclear whether FDA will have the resources necessary to fully implement the FSMA.

Whether evaluating a concept, performing regulatory due diligence, maintaining or prosecuting regulatory filings, or contesting adverse litigation, Emord & Associates provides exceptional counsel for all your litigation and regulatory needs.

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