Food companies and farmers should be aware that they have approximately 4 months to provide their comments to the FDA regarding its proposed new food safety standards. On January 4, 2013, the FDA proposed two new regulations to implement the Food Safety Modernization Act passed by Congress in 2011: (1) preventive controls for human food and (2) produce safety. In addition, the FDA soon will publish additional regulations for public comment involving (a) verification of the foreign food supply, (b) third party certification for overseas food audits, and (c) preventive controls for animal food facilities.
Briefly, the FDA's first rule proposes that food companies selling products in the US (whether produced in a foreign or domestic facility) develop formal food safety plans (and maintain auditable records) to reduce the risks of contamination, as well as contingency plans once problems arise. The FDA's second rule proposes safety standards for the production and harvesting of produce, including the cleanliness of irrigation water, worker training and hygiene, and restricting animals from fields.
The goal of the regulations is to prevent foodborne illnesses before they cause harm. As a reaction to recent outbreaks of Salmonella, E.coli, and Listeria, the proposed framework broadens the authority of the FDA to regulate food on farms and shifts the FDA's focus on food safety to prevention as opposed to investigations after an outbreak occurs. The FDA estimates that one in six Americans falls ill as a result of a foodborne illness each year, resulting in 130,000 hospitalizations and 3,000 deaths. However, there are financial costs associated with the proposed regulations. The FDA estimates that these new regulations could cost large farms $30,000 per year and manufacturers up to $475 million annually.
Please note that public comments on the proposed rules are due by May 16, 2013.
and Dorinda Peacock
have extensive legal experience advising clients in the food industry. Lisa & Dorinda are eager to assist clients in understanding the intricacies of the proposed food safety regulations and in developing strategies for effectively communicating requested rule changes to the FDA. In addition, Womble Carlyle’s Federal and State Government Affairs attorneys are well-positioned to assist clients in lobbying-related efforts.
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