ARLINGTON, VIRGINIA, U.S. — The American Feed Industry Association (AFIA) said on Sept. 19 that the U.S. Food and Drug Administration has incorporated many of the recommended changes into its four re-proposed rules pertaining to the Food and Safety Modernization Act (FSMA).
The reissued rules are: 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. AFIA previously submitted comments on five major sets of FSMA-related proposed rules during the last 10 months.
"The American Feed Industry Association is pleased the Food and Drug Administration has issued a revised proposal for these complex rules," said AFIA President and Chief Executive Officer Joel G. Newman. "This re-proposal will allow stakeholders to review these rules one last time before the final rule is issued."
While AFIA believes it is reasonable for FDA to re-propose these rules based on complexity alone, the association is concerned with the re-proposal's financial impact.
"The additional cost, with very limited added benefit, continues to be a major concern for AFIA. FDA seriously underestimated the cost of the proposed rule and the additions within this re-proposal have the potential to drive that cost up even further," said Richard Sellers, AFIA senior vice-president of legislative and regulatory affairs. "AFIA is committed to advocate for a final rule that is appropriate for the low risk that animal food presents. The cost-benefit ratio is nearly 20-to-1 and federal laws require the costs to reasonably approximate the benefit."
With input from membership, AFIA will yet again review the rules, develop comments and submit to FDA. AFIA staff also intends to work alongside its animal food coalition partners in hopes of the development of consistent comments on the FDA proposals as needed. The comment period to review all four rules is 75 days after publication in the Federal Register, which will take place next week.
AFIA plans to request an extension to the comment period as all the rules were released simultaneously versus in succession.