FDA unveiled its proposed rule on Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals on October 25 after more than a year and half of waiting for the proposal to emerge from the White House Office of Management and Budget.
This proposed rule is of particular interest to me — as a veterinarian and a former director of FDA’s Center for Veterinary Medicine –and I think it has the potential to make a significant impact on animal health and to improve the safety of the human food supply.
The rule represents the biggest regulatory change the animal feed industry has seen in decades, with many companies becoming subject to new Current Good Manufacturing Practice (CGMP) requirements as well as hazard analysis and preventive controls for the first time. However, there will be added costs for companies required to comply with the new CGMPs and to develop preventive controls. With some exceptions, the proposed rule would apply to facilities that manufacture, process, pack, or hold animal food and are required to register as a food facility. So this will include a large number of companies.
Each facility would be required to have a written food safety plan, including a hazard analysis for each type of animal food manufactured, processed, packed, or held at the facility. The plan would also require preventive controls, monitoring procedures, corrective actions, verification activities and recordkeeping — all terms that are familiar to those of you who have worked with Hazard Analysis and Critical Control Point (HACCP) systems, although the term HACCP is not used in the proposed rule.
The animal food rule will complement FDA’s separate proposed rules on imported foods and on the accreditation of third party auditors for foreign food facilities.
I am often asked if I think the agency will be able to meet its new court-ordered deadline of June 30, 2015 for publishing all five FSMA-related final rules. Because of the complexity of the animal feed proposal and of the other four rules, and because some of the necessary elements are beyond FDA’s control, I believe the agency will find it a major challenge to achieve the deadline. It is always a challenge to develop a new rule that must be properly supported by science and that must address the concerns of all stakeholders. So it would be unfortunate to have to rush through any of the necessary steps in the process.
The proposed animal foods rule, formally released in the October 29 Federal Register, is open for comment through February 26, 2014 and FDA has also scheduled several public meetings, one in College Park, MD on November 21, another in Chicago, IL, on November 25, and a third in Sacramento, CA, on December 6. I would encourage companies in the animal food industry to play an active role in this process because FDA is open to constructive comment on the proposal.