The National Grain and Feed Association (NGFA) during a recent public meeting urged the U.S. Food and Drug Administration (FDA) to make significant changes to its proposed rule that would establish for animal feed and pet food new requirements for current good manufacturing practices (CGMPs) and hazard analysis and risk-based preventive controls.
The FDA conducted the public meeting to receive stakeholder feedback on four major reproposed rules associated with its implementation of the Food Safety Modernization Act (FSMA). The four reproposed rules address produce safety, CGMPS and preventive controls for human food, CGMPs and preventive controls for animal feed and pet food, and foreign supplier verification programs.
The FDA issued the reproposed animal feed rule on Sept. 29 to provide the agency's current thinking on requirements after its review of comments received in response to its original proposal issued in 2013. The NGFA submitted extensive comments on the 2013 proposal, and strongly recommended that FDA make major changes and re-propose the rule for additional stakeholder comment given the very significant nature of the regulations, and the extent of changes recommended by the NGFA and other stakeholders.
During the public meeting, Max Fisher, NGFA director of economics and government relations, commended FDA for re-proposing the rule and allowing additional comment. But Fisher said the NGFA remains concerned that "many of the proposed CGMP provisions continue to mirror those established for human food, and do not reflect the realities associated with feeding animals, nor are they necessary to assure the safety of feed products."
In prior statements to FDA, the NGFA has urged the agency to develop final requirements that are practical, achievable and serve to benefit the safety of animal feed and pet food. In doing so, the NGFA has cautioned that adding unnecessary regulatory burdens and costs would undermine the industry's ability to serve the animal agriculture industry and divert finite resources away from effective practices that already are assuring a safe and abundant supply of feed and pet food.
"The NGFA requests that FDA carefully consider the economic impact of its proposed requirements and weigh the extensive costs against anticipated benefits, which the agency has yet to quantify," stated Fisher, while commenting on the costs associated with the proposed rule. The NGFA's economic analysis of FDA's original proposal indicated the requirements would cost animal feed and pet food facilities over $500 million annually - approximately four times more than estimated by FDA.
In addition, Fisher's comments addressed the need to develop a common, baseline understanding between industry and regulatory officials pertaining to regulatory compliance obligations after the rule's requirements become final.
To do so, Fisher expressed NGFA's belief that the Food Safety Preventive Controls Alliance - consisting of members from FDA and state regulatory agencies, industry, academia and scientific organizations - provides the best forum to develop and convey necessary technical information to industry and regulatory officials for compliance purposes. The NGFA actively has served as an Alliance member since its inception in 2011, and David Fairfield, vice president of feed services, currently is chairman of the Alliance's animal feed-related activities.
The NGFA's Biofuels and Co-Products Committee, Feed Legislative and Regulatory Affairs Committee and Feed Manufacturing and Technology Committee are assisting in developing NGFA's comments on the reproposed rule, which are due by Dec. 15.