Public meeting hosted by FDA to answer questions, take part in dialogue surrounding proposed rule
The American Feed Industry Association (AFIA) on November 21 was among the industry groups attending the Food Safety Modernization Act (FSMA) public meeting to provide industry feedback on the proposed rule to establish current good manufacturing practice and hazard analysis and risk-based preventive controls for animal food.
The meeting, held in College Park, Md., was the first of three nationwide to be hosted by the U.S. Food and Drug Administration (FDA) to answer questions and take part in dialogue surrounding the proposed animal food rule.
Richard Sellers, AFIA senior vice president of legislative and regulatory affairs, provided “accolades and concerns” on behalf of AFIA, stating the organization’s and industry’s main worry is the court mandated comment period. “This industry has never seen the magnitude of such rulemaking with such a major impact on all of the feed industry,” said Sellers. “We are expected to review, answer questions and provide comments in just over four months. In fact, except for medicated feed, this industry has never seen good manufacturing practices regulations, and the FDA is proposing to implement those, as well as hazard analysis and risk-based preventive controls in a very short time frame. We think the FDA and the industry will have their hands quite full in the next decade implementing these rules.”
The FDA has filed an appeal in attempt to gain an extension for the comment submission time frame, but AFIA believes an extension is unlikely based on previous appeal attempts in similar scenarios. Sellers said AFIA hopes the FDA prevails on appeal of this unrealistic comment timeline. “Please note, the FDA took almost two years to draft the rules, held a back and forth with the office of management and budget for some 11 months and now expects the feed industry to review them and provide comments in some 14 weeks,” he said.
A separate concern Sellers gave at the meeting are the similarities between the proposed animal feed rule and the human food rule. He said although the FSMA language divides the two, there are too many references and requirements that lead AFIA to think the FDA does not understand the congressional intent to separate human and animal food requirements.
“We hope you will hear from Congress during this rulemaking, as some of the provisions in the proposed rules have requirements with little or no benefit from this overzealous approach to impose human food requirements on the animal feed industry,” said Sellers. “We hope the FDA will reign in its approach and publish a final rule that recognizes the clear food/feed risks and goals for human food products and animal food products and establishments and how these differ. At some point, it makes sense to separate human and animal food in the Food, Drug and Cosmetic Act. We have begun talking with our attorneys about these changes.”
Sellers said the proposed rule will be difficult for feed mills nationwide to implement, especially given the short time frame of one to three years based on business size to do so. ”What does concern us is the likelihood that a majority of the feed mills, not the majority of the feed tonnage, will have much difficulty in understanding, crafting programs and fully implementing these rules,” said Sellers. “In my 85 presentations across the U.S. in the past three years about this law, facilities in the heartland that are small to medium operations have the most difficulty understanding these concepts. One, two and three years may not be sufficient time to fully implement the final rules, but we’ll be back to the FDA with data and rationale if we need additional time.”
AFIA proposes the FDA use a phase-in on continued good manufacturing practices (cGMP) for one year and then add preventive control rules on a two- to four-year phase-in pose final rule publication allowing for better compliance.
In his comments Sellers said he applauds the FDA for drafting a “fairly well-constructed set of rules,” and that AFIA “believes these rules provide a clear guidepost for compliance that can coalesce the feed industry around a basic feed safety standard.”
The FDA will host two additional FSMA public meetings – one in Chicago, Ill., on November 25, and the second in Sacramento, Calif., on December 6.