In last month’s FSMA Perspective, I focused on FDA’s release of its proposed rule on Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. I would like to follow up here with issues raised November 21 at a public meeting in College Park, MD — the first of three FDA meetings on the animal feed proposal. The agency held a second session in Chicago, IL, Nov. 25, and has scheduled a third for Sacramento, CA, on December 6.
These meetings are extremely helpful for two-way communication between the agency and stakeholders. The regulated industry learns the agency’s thinking about the proposed rule and FDA staff hears the specific concerns of the stakeholders. I know the agency values these “listening” sessions highly. The first meeting featured public comment and Q&A sessions with senior FDA officials, including: Linda Tollefson, Associate Commissioner in the Office of Foods and Veterinary Medicine; Dan McChesney, director of the Office of Surveillance and Compliance in the Center for Veterinary Medicine (CVM); Kim Young, deputy director of the Division of Compliance in CVM; Eric Nelson, director of the Division of Compliance in CVM; and Jenny Scott, senior advisor in the Office of Food Safety in FDA”s Center for Food safety and Applied Nutrition (CFSAN).
Representatives of the American Feed Industry Association (AFIA) turned out in strength for the first meeting and argued that FDA is proposing to apply tougher preventive controls to animal feed producers than are justified by a risk-based approach. The industry group believes the agency is being overzealous in applying the same rigorous controls to animal feed as it plans for pet foods and for human foods. Instead, the feed industry would like the agency to modify the proposed rule to recognize differences between animal feed and pet food production facilities. The group argues that lawmakers kept animal food separate from human food in FSMA and that the agency needs to do the same. In addition, it wants FDA to apply the same approach to the Federal Food Drug and Cosmetic Act and to separate animal food and human food.
As a former CVM director who is now a consultant to the industry, I can see both sides of this picture. Cleary, there are significant differences between feed mills and pet food processing facilities and these should be taken into account in a final rule. But that does not mean animal feed facilities should get a pass from compliance with FSMA’s preventive approach.
The preventive controls provisions of the proposed rule, would apply to domestic and imported animal food, including pet food, animal feed, and raw materials and ingredients. 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 establish CGMPs that specifically address animal food. This will be a burden for the feed industry, which will have to comply with CGMP requirements for the first time.
The clock is ticking down toward the court-ordered deadline of June 30, 2015 for publishing this and four other FSMA final rules. So this does not leave much room for additional rounds of comment beyond the current comment deadline of February 26, 2014. For this reason — as I have suggested here before — now is the time for the regulated industry to play an active role in this rulemaking process.