On October 25, the Food and Drug Administration ("FDA") released a proposed rule aimed at increasing the safety of food for animals. The proposed rule, "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals," would serve to ensure the safety of animal food for both animals consuming the food and for humans handling the food.  If passed, the rule would establish Current Good Manufacturing Practices (CGMPs) specifically designed to address the manufacturing, packing, processing, and holding of animal food, which would protect such products from potential contamination.  In addition, the proposed rule would establish preventive controls and hazard analysis for animal food, as required by section 103 of the Food Safety Modernization Act ("FSMA"), signed into law by President Obama in January 2011.

New CGMPs for animal food

The proposed rule includes similar, but not identical, CGMP safety requirements as the CGMPs that apply to human food.  The similar areas include:  (1) facility sanitation, maintenance, and operations; (2) processes and controls; (3) warehousing and distribution; (4) personnel hygiene practices and training; and (5) equipment and utensil design, maintenance, and use.

Hazard analysis and preventive controls

In general, the proposed rule would require every person in charge of a facility required to register as a food facility with the FDA pursuant to section 415 of the Federal Food Drug and Cosmetic Act ("FD&C Act") to comply with the hazard analysis and preventive controls set forth in the proposed rule.  The rule would not apply to farms that manufacture their own animal food or facilities not required to register by the FD&C Act.

Specifically, the proposed rule requires food facilities to implement a written food safety plan.  The FDA would require the written food safety plan to:

  • Identify foreseeable hazards;
  • Establish preventive controls that would address animal food processing, preventing contamination, or animal food sanitation programs;
  • Establish a recall plan for animal food if foreseeable hazards occur;
  • Institute monitoring procedures to track the effectiveness of the preventive controls;
  • Identify corrective actions to be used if preventive controls are not properly implemented; and
  • Establish verification activities to ensure that the required preventive controls have been successfully implemented and effective.

The FDA will hold three public meetings regarding the proposed rule.  These meetings will take place in College Park, MD on November 21, in Chicago, IL on November 25; and in Sacramento, CA on December 6.  The comment period for the proposed rule will remain open until February 26, 2014.

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