The Food Safety Modernization Act (“FSMA”) was passed into law early in 2011, and will affect several areas within the alcohol beverage industry. The FSMA is meant to implement a prevention-based model for food safety, and places new requirements on the FDA, food facilities, and importers. Most new guidelines and requirements under the FSMA will not go into effect until at least the middle of 2012, but given the comprehensive nature of the Act, those affected will likely want to begin preparing for the changes in the near future.
The FSMA and related FDA laws include alcohol in the definition of “food,” and the Act applies to “Food Facilities.” A Food Facility includes any “factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food,” not including restaurants and other retail food establishments. Accordingly, many in the alcohol industry stand to be affected by the FSMA, including wineries, breweries, distilled spirits plants, and alcohol beverage distributors, importers, warehouses, and wholesalers.
The first major requirement placed on Food Facilities is a requirement to implement written preventative control plans, including: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise. The final rule implementing this requirement is due 18 months after enactment of the FSMA, which falls in July 2012. Wineries should also be aware that the FDA must implement new mandatory produce standards by early 2013.
Food importers also have new responsibilities under the FSMA. Most notably, importers will have a responsibility to verify that their foreign suppliers have adequate food safety controls in place. The final regulation detailing this provision is due in January 2012. The Act also establishes a program by which third parties can become accredited to certify that foreign foods comply with U.S. food safety standards. This system will be established by early 2013. Other provisions that may affect importers include: a) establishment of a voluntary qualified importer program, which will enable expedited review and entry of foods by those importers; and b) increased FDA authority to deny entry of imported food.
Other key provisions of the FSMA include: increased frequency of inspections of high risk facilities; new standards imposed on FDA for food-testing laboratories; the FDA will have more authority to make mandatory recalls, detain products, and revoke registrations; a model for improved product tracing capabilities; additional record-keeping requirements for high risk foods; and, a plan to strengthen partnerships between FDA and state and foreign agencies.
Look for specific guidelines late this year or early in 2012.
Alcohol.law Digest is published for general informational purposes only and is not intended as legal advice. Copyright © 2010-2011 · All Rights Reserved ·
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