October 16, 2014 | Richard Sellers

FDA Slowly Proposes FSMA Rules

AFIA stands ready to review and provide industry comment

Richard Sellers, senior vice president of legislative and regulatory affairs.

In the last six months, the American Feed Industry Association has vigorously reviewed and submitted comments on five major proposed regulations and notices that affect the animal food industry. FSMA is the largest regulation to affect the animal food industry since the 1950s. AFIA’s members have bonded together forming working groups helping to provide industry feedback in comments submitted by the organization to the U.S. Food and Drug Administration — and there is still more ahead of us!
At the time of press, AFIA is anxiously awaiting the release of the second round of proposed rules. Four of the FSMA rules will be re-proposed: Produce Safety Regulation; Foreign Supplier Verification Program; Current Good Manufacturing and Hazard Analysis and Risk-based Preventive Controls for Human Food; and Current Good Manufacturing Practices and Hazard Analysis and Risk-based Preventive Controls for Food for Animals. Although the industry is pleased with the opportunity to review the rules once again, the re-proposal is likely to raise costs due to the expected addition of some portions of the proposed rules. It will also provide a much shorter comment period than the previous ones due to a court-ordered timeline mandating final rule publication by the end of August 2015.
Congress specified the rules were to be promulgated; it also created a provision that allows the agency to “exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man.” AFIA asked OMB to consider promulgating Current Good Manufacturing Practices rules first, performing an analysis to determine the real benefits and promulgate preventive control rules if merited by a retrospective analysis of the CGMP rules costs and benefits. 
The industry will have an expected 60 to 75 days to comment. Agency officials have said the entire rules will be published, not just the changed parts, providing the public the opportunity to comment on the entire rule once again along with FDA’s additions. 
However, the industry is already preparing for the implementation of the new rules. To assist with the transition, AFIA has begun hosting FSMA regional training sessions. The organization rolled out phase I this summer; phase II and phase III will follow in 2015. Phase I addresses the overall FSMA statute, focusing on the preventive controls, basic CGMPs and ways to address hazard analysis. Phase II will address CGMPs in more depth and specifics on hazard analysis. Phase III will take place after FDA publishes the final rule and will address preventive controls. 
AFIA continues to utilize its working groups yet again as the re-proposal will require more discussion and comments to determine the impact, practicality and enforceability of each rule. AFIA will continue its basic FSMA training programs and develop “qualified individual” training once the Food Safety Preventive Controls Alliance releases the animal food framework for training. Given the breadth and depth of this law, AFIA believes a 10-year process is needed to train FDA/state investigators/auditors to bring the industry into full compliance.


Richard Sellers is the senior vice president of legislative and regulatory affairs at the American Feed Industry Association. For more information on the Food Safety Modernization Act, contact him at (703) 558-3569 or rsellers@afia.org. 

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