FDA Proposes New Regulations for Manufacturing, Processing, Packing and Holding Animal Food

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On October 29, 2013, the FDA proposed a new rule, pursuant to the 2011 Food Safety Modernization Act (FSMA), to regulate the manufacturing, processing, packing or holding of animal food. The proposed rule is intended to prevent food-borne illness in animal food that can harm both animals and humans. The proposed rule comes on the heels of a number of high-profile cases of contaminated animal food. For example, in 2007, 2010, and 2012, salmonella outbreaks in pet food sickened people that handled the contaminated food. Additionally, for the past six years, the FDA has been investigating the exact cause of approximately 600 dog deaths, believed to be linked to jerky treats imported from China.

Although the FSMA already covers facilities manufacturing and handling animal food, this is the first time that the FDA is proposing preventative controls specific to animal food in such a comprehensive manner. The rule focuses on two areas. First, the proposed rule seeks to create new current good manufacturing practices (CGMPs) that address issues relevant to preventing contamination of animal food. Like CGMPs for human food, the regulations focus on all areas of production, including adequate sanitation principles for ingredients and finished animal food, good hygiene for personnel, proper cleaning and maintenance of plant and grounds, and pest control. Second, the proposed rule would require facilities to implement a food safety system that includes a written food safety plan, a hazard analysis, preventative controls for hazards that are reasonably likely to occur, continued monitoring, a corrective action plan, verification of the food safety system, and required record keeping. The proposed rule would further require that a "qualified individual" oversee the preparation and monitoring of the food safety system. The proposed rule would also establish the minimum requirements for the "qualified individual."

Like other provisions of the FSMA, the proposed rule contains a number of exemptions for small businesses, manufacturers subject to the low-acid canned food requirements, and farms that manufacture or hold food for consumption by their own animals. Some of these exempted facilities will be subject to the new regulations, but with a delayed timeline for implementation.

The FDA is accepting comments on the proposed rule until February 26, 2014, and the final rule may be subject to change based on these comments. Reinhart will continue to monitor this proposed rule and the implementation of other provisions of the Food Safety Modernization Act.

For more information about the proposed rule, how it could affect your company, or how we can help you comment to or comply with the proposed rule, please contact your Reinhart attorney or a member of Reinhart's Product Liability Team.


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