THE Food & Drug Administration has regularly been working with feed industry stakeholders on the latest rule rolled out under the Food Safety Modernization Act (FSMA) and has a cooperative mindset in establishing new safety standards.
The expansive animal feed proposed rule includes both current good manufacturing practices (cGMPs) and hazard analysis and risk-based preventive controls for food for animals. Except for those in the medicated feed segment, many of the requirements will be completely new for the industry and will require extensive education.
Dr. Dan McChesney, director of the Office of Surveillance & Compliance at FDA's Center for Veterinary Medicine, said FDA remains open-minded on the issues of concern to stakeholders and is committed to thorough stakeholder engagement.
Richard Sellers, senior vice president of legislative and regulatory affairs at the American Feed Industry Assn. (AFIA), noted that the industry has identified gems, pitfalls and traps through this regular dialogue with FDA.
A hidden gem has been the recognition of the industry's cGMP programs such as the Safe Feed/Safe Food certification. However, along with that is a hidden pitfall within the rule that assumes that the industry is familiar with cGMPs and can adopt them quickly.
National Grain & Feed Assn. (NGFA) vice president of feed services Dave Fairfield discussed the impact of the "hazard" definition of compliance obligations of the rule. He said the question is: If a firm conducts a hazard analysis and finds that something is reasonably likely to occur, does that hazard become subject to the full scope of preventative control requirements? The crux of the issue is whether the proposed rule offers adequate consideration of the control of hazards through prerequisite programs.
McChesney said FDA's hope is that the proposed rule will help move the industry to a new paradigm of thinking — one that changes from responding to recalls to instead putting mechanisms in place to prevent contamination from entering the system or detect it before product ships.
The new question will be, "How do I put controls in place to ensure that I don't manufacture product with contamination in it," he explained in a webinar last Wednesday in which 1,100 feed industry representatives participated.
McChesney said a key issue is whether pet food and the feed rules should be broken out in the final rule.
How Congress wrote the rule does not provide many options on the preventative control powers, but certain GMPs that are appropriate for pet food may not be needed for the majority of the feed industry, so an option may be to establish a baseline set of GMPs to cover both pet food and food animal production but that apply more stringently to pet food, he suggested.
One major request from AFIA and NGFA has been for FDA to consider a one-year phase-in for GMPs, followed by phasing in the preventative control measures, especially since most have never been required to use GMPs.
McChesney said the agency is "truly open to those comments and the rationale behind" the idea. He added that extending the timeline and separating the two is "not an unreasonable request."
FDA has provided only 14 weeks for stakeholders to comment on the expansive rule; the industry requested a 30-day extension of the comment period, until March 31, 2014, but for now, the comment period closes Feb. 26, 2014. McChesney said he doesn't think an extension will be possible because of court orders, and it would limit the ability to provide an interim rule to codify new language.
Fairfield said, at a minimum, the industry needs to encourage FDA to provide — either through a re-proposal or interim final rule — the ability to comment on many of the items not codified in the proposed rule.
Editor's Note: A replay of the three-hour webinar hosted by AFIA, NGFA and Feedstuffs is available, upon registering, at tinyurl.com/khctgj3.