The proposed rule focuses on manufacturers of animal food or feed, and according to information on the FDA website does not apply to farms that manufacture food for their own animals or other food facilities not required to register under section 415 of the Federal Food Drug and Cosmetics Act.
Under the proposed rule for preventive controls for food for animals, facilities manufacturing, processing, packing, and holding animal food, both domestically and abroad, would be required to put into place procedures to minimize or prevent hazards reasonably likely to occur, as well as to follow new current good manufacturing practices (CGMPs).
“Historically, we have put most of our efforts into responding to safety issues involving animal food as they arise,” writes Daniel McChesney, Ph.D., director of the Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine in an FDA Voice column. “And while regulations have been crafted to address such threats as the brain-wasting bovine spongiform encephalopathy, this regulation moves towards a comprehensive, risk-based regulatory framework to keep all animal foods safe.”
McChesney also cites the massive 2007 recalls of pet food due to melamine contamination in ingredients from China, a 2012 salmonella outbreak tied to dry dog and cat food from a South Carolina facility and the issue of dioxin contamination in some animal feeds.
The proposed rule for preventive controls for food for animals will publish in the Federal Register on October 29, 2013. Comments on this proposed rule are due by 120 days from the publication date. Based on the proposal, the requirements would become effective 60 days after the final rule is published in the Federal Register. Recognizing that small and very small businesses may need more time to comply with the requirements, FDA is proposing tiered compliance dates based on facility size.
The FDA will hold three public meetings on the Proposed Rule for Preventive Controls for Animal Food Facilities. The first meeting will be held on November 21, 2013 at the FDA Center for Food Safety and Applied Nutrition in College Park, MD. The second meeting will be on November 25, 2013 at the Ralph H. Metcalfe Federal Building in Chicago. The third meeting will be held on December 6 at the John E. Moss Federal Building in Sacramento, CA.