The U.S. Food and Drug Administration issued a proposed rule Oct. 25 under the FDA Food Safety Modernization Act (FSMA) aimed at improving the safety of food for animals. FSMA represents the most significant reform to feed regulation in several decades, and has been anticipated by those in the industry.
“This proposed rule on animal food complements proposed rules published in January 2013 for produce safety and facilities that manufacture food for humans to set modern, prevention-based standards for food safety,” said deputy commissioner for foods and veterinary medicine Michael R. Taylor. “They also work in concert with standards proposed in July 2013 to help ensure that imported foods are as safe as those produced domestically.”
FDA estimates the proposed rule has a one-time compliance cost to industry estimated at $100.74 million, and discounting the one-time cost over 10 years at a 7% discount rate and adding the annual costs results in a total an annualized compliance cost estimate of $128.75 million.
The proposed rule would require makers of animal feed and pet food to be sold in the U.S. to develop a formal plan and put into place procedures to prevent foodborne illness. Facilities producing animal food would be required to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures and record monitoring results, and specify what actions would be taken to correct problems that arise.
The proposed rule would also require animal food facilities to, for the first time, follow proposed current good manufacturing practices (CGMP) that address areas such as sanitation. Although the proposed rule is similar to the earlier proposed human food CGMPs, it isn't identical including excluding such practices that don't pertain to animal food, such as allergen cross-contact.
The rule does not apply to farms that manufacture food for their own animals.
National Grain and Feed Assn. President Randy Gordon said, "It will be vitally important that FDA's regulations provide the flexibility necessary for companies to continue to effectively address feed safety, as well as provide the necessary education and training of its inspectors and the regulated industry. All indications are that the agency shares those views, and we'll be eager to work with FDA in implementing this truly fundamental change in its approach to food and feed safety."
American Feed Industry Assn. president and chief executive officer Joel G. Newman said FSMA will help ensure the continuation of the highest standards of safety throughout the entire food system. "AFIA will be working with FDA, feed industry partners and our members over the coming months and years to guarantee a smooth implementation of FSMA."
Richard Sellers, AFIA vice president of feed regulation and nutrition, added the organization will begin implementing its plan to analyze the preventive control rules jointly with the Foreign Supplier Verification and the Accreditation of Third Party Auditors rules already released. "We have asked the agency to extend the deadline for comments to match the preventive control rules deadline.” (Which is open until Nov. 26).
FDA has posted a link to the proposed rules, which will be published in the Federal Register on Oct. 29. Comments will be due 120 days after the official publication in the Federal Register.
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, 2013 at the John E. Moss Federal Building in Sacramento, CA. For more information, visit www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247568.htm.
AFIA, NGFA and Feedstuffs are jointly planning a webinar on the proposed rule in November. Check www.Feedstuffs.com for additional details.