IT has been nearly five months since the Food & Drug Administration proposed an overhaul of food safety rules for the animal feed industry under the Food Safety Modernization Act (FSMA).
Despite attempts to further extend the comment period for the rule, FDA will officially close the comment period March 31.
In a March 19 letter, FDA officially denied a joint request from the American Feed Industry Assn. (AFIA), National Grain & Feed Assn. (NGFA), National Renderers Assn. and Pet Food Institute to extend the comment period for the Current Good Manufacturing Practice & Hazard Analysis & Risk-Based Preventative Controls for Food for Animals.
The animal feed rule was proposed in late October, and FDA provided an initial comment period extension of 33 days, until March 31.
The human food rule, in contrast, provided 11 months for comment versus the animal feed rule's five months.
Court-imposed deadlines have limited FDA somewhat in how long it can accept comments and still have ample time to review and evaluate any final changes.
In a letter to the groups from Bernadette Dunham, director of FDA's Center for Veterinary Medicine, FDA said it felt that the total period of 153 days "has provided ample opportunity for stakeholders to comment on the proposed rule."
FDA did say it would allow for additional time to comment on the rule pertaining to intentional adulteration and the accompanying draft qualitative risk assessment, and it will soon announce a 90-day extension of the comment period for both documents until June 30.
FDA also is extending the comment period on the designation of high-risk foods for tracing until May 22, which provides an additional 45 days for comment, the agency said.
The rule-making comment periods provide an opportunity for interested parties to have their voices heard. Leading industry groups have developed their own extensive comments on the animal feed rule. Many industry groups have encouraged members to submit their own comments in addition to the groups' comments.
Richard Sellers, AFIA senior vice president of legislative and regulatory affairs, said he has informed AFIA staff and members to make sure any comments provided to FDA are justified.
"Our comments reflect that if we disagree with something, we need to tell the rationale of the industry practicality of that aspect or explain the science behind it," he said.
Dave Fairfield, NGFA vice president of feed services, said NGFA has sent out a complete draft statement to its members for final revisions and suggestions. The 100-plus-page document highlights some of the key concerns, with a major tenet of NGFA's comments focused on how FDA's current good manufacturing practices requirements for animal feed and pet food should differ significantly from those established for human food.
Sellers added that many of the provisions look similar to hazard analysis and critical control points (HACCP), but this is not supposed to be a HACCP law, and NGFA's comments will explain why that isn't necessary. Its comments also will focus on why the preventative controls should not mandate HACCP.
Many industry members have called on FDA to re-propose the animal food rule for a second time after the agency reviews the comments received in response to the March 31 deadline.
Sellers noted that AFIA does not predict that FDA will move forward with a re-proposal of the entire rule as there is simply not enough time given the court-mandated timeline.
Fairfield said by announcing that the comment period for the proposed feed rule would not be extended, FDA reiterated its previous statement from December that it intends to issue "significant" changes to key provisions of the proposed rule for public comment later this year.
"We anticipate that these 'significant' changes will include proposed requirements associated with domestic supplier approval and verification, product testing, environmental monitoring and review of complaint files," Fairfield said. "FDA introduced its interest in these areas within its proposed rule but did not offer proposed codified language."
Bob Ehart, senior policy and science adviser at the National Association of State Departments of Agriculture, said FDA has been talking about releasing the codified language this summer and providing 60-90 days for review.
That would take it into fall and still provide the expected six to eight months to finalize the rule by the court-imposed deadline of Aug. 30, 2015, he explained.
The court agreement also allows FDA to come back and ask for additional time if the parties can agree that FDA is working in good faith on nearing completion.