The Food and Drug Administration hosted a public meeting in Chicago on October 20, 2015 to discuss the recently released final rules on preventive controls for human and animal food, along with plans for the next phase of FSMA implementation. This was a substantive meeting and I encourage you to view the six slide presentations on FDA’s FSMA website.
The first phase of FSMA implementation – the release of final FSMA regulations and related guidance and policies – is moving swiftly forward. FDA released final rules on preventive controls for human and animal foods on September 17 and the agency is now developing numerous guidance documents.
FDA was under a court-imposed October 31, 2015 deadline for releasing three additional final rules – on produce, foreign supplier verification and accreditation of third-party auditors (These are not yet available as I prepare this article). Under the consent decree, FDA must issue final rules on sanitary transportation and on intentional adulteration by May 31, 2016.
The second FSMA implementation phase focuses on “gaining and maintaining industry compliance,” with the final rules and identifying metrics for measuring success. The third phase involves actually using those measuring tools and making any needed adjustments.
Many elements of the complex rules will require further explanation and guidance. In the October 20 meeting, Dan McChesney, director of the Office of Surveillance and Compliance in FDA’s Center for Veterinary Medicine, presented an overview of the animal food final rule and explained, for example, that feed mills may or may not be required to comply.
Mills that are not part of a farm and are required to register as a food facility are subject to the new rule. Examples include an independent feed mill, a feed mill that makes food for contract farms, an on-farm feed mill that makes food for animals under different management than the farm, he said.
Feed mills that are part of a farm are exempt from registering as a food facility and are not subject to the new rule, he explained. For the feed mill to be considered part of the farm, the raising of animals and the feed mill must be under the same management in one general location, and animal food made at the mill must only be fed to animals under the farm’s management, he said.
The agency is currently working on several guidance documents relating to the animal food rule, including guidance on current good manufacturing practices, on human food by-products for use as animal food, and on hazard analysis and preventive controls. It is also developing a compliance guide for small or very small businesses. Under the rule, a very small business is defined as one with an average of less than $2.5 million in annual sales of animal food, plus the market value of animal food held without sale. A small business is defined as one with fewer than 500 full-time equivalent employees.
Provided the three final rules on produce, foreign supplier verification and accreditation of third-party auditors are available, I will offer my perspective on those in the next EAS-e-News issue.