IT took the Food & Drug Administration almost two years to draft its animal feed rules called for under the Food Safety Modernization Act (FSMA), which was held back and forth within the Office of Management & Budget for some 11 months, and now, the industry is expected to review the expansive rule and provide comments in approximately 14 weeks.
The tight timeline is one of the most concerning to those in the feed industry for a rule that would require new practices for a majority of the nation's feed mills, according to Richard Sellers, senior vice president for regulatory and legislative affairs at the American Feed Industry Assn. (AFIA). Industry members are seeking an extension until at least March 31, 2014, but for now, the comment period closes Feb. 26, 2014.
FDA began its public vetting process at the end of November with two of three public meetings, with the first being held Nov. 21 in College Park, Md., and the second Nov. 25 in Chicago, Ill. A third is scheduled for Dec. 6 in Sacramento, Cal.
Industry members and leaders from major feed trade groups, including AFIA and the National Grain & Feed Assn. (NGFA), both had members and key staff on site for the meetings.
Dan McChesney, director of FDA's Center for Veterinary Medicine Office of Surveillance & Compliance, acts as the senior leader of the animal feed proposal and has been in regular contact with feed industry leaders on developing the rule.
Opening up the meeting, he noted that many members in attendance would be those ultimately charged with operationalizing the new rules in their facilities. He added that it will be important, during the comment process and on through implementation, for those affected to look at the proposal compared to what is currently in place to see how the new rules fit into current practices rather than starting from scratch.
McChesney said the proposal outlines about 60 key questions on which FDA hopes to gain specific comments. During the meetings, he touched on a half-dozen that rise to the top of the list.
One of the major ones focuses on the differences between the human and animal food safety rules. McChesney said he recognizes that what's appropriate in a human food plant may not be so in the animal feed industry, and even within the industry, there are differences that need to be accounted for depending on whether it is a pet food or bulk feed manufacturer.
In a public statement at the Maryland meeting, Sellers explained that although the FSMA language divides the human and animal food proposed rules, there are too many references and requirements that lead AFIA to think that FDA does not understand the congressional intent to separate the two.
Another area in which McChesney called for additional comments pertains to the definition of "hazard" in the proposed rule.
Dave Fairfield, vice president of feed services for NGFA, said there is "significant concern" among the industry that the proposed definition would essentially cause any hazard to become subject to the rigorous management oversight that is associated with a "critical control point" within a formal hazard analysis and critical control point plan.
"We believe that the proposed definition does not appropriately consider the effect that prerequisite programs have in controlling hazards," Fairfield said. "The bottom line is that we believe the required controls and management oversight for hazards should be commensurate with the level of severity associated with the hazard. All hazards should not have to be managed in the same way."
Overall, Sellers said, the rule stands as a "clear guidepost for compliance that can coalesce the feed industry around a basic feed safety standard."
He explained that although a majority of feed producers understand the concept of good manufacturing practices (GMPs), preventative controls are a new thing, so it would work better for the industry to roll out GMPs the first year and then phase in preventative controls over one, two or three years, depending on the size of the facility.
Gail DeGreeff, previous chair of the AFIA Feed Regulatory Committee who attended the Maryland meeting, noted that although the rules are unprecedented, "it's probably past due" for the feed industry to take some action to make the regulated feed system more proactive.
However, it will be important for "FDA to still be flexible and understand how diverse the feed industry is," she said.