More understanding needed on FSMA

The newly released Food Safety Modernization Act regulations were the main focus for attendees who gathered for a joint meeting of the Pet Food Institute and National Grain and Feed Assn. in Columbus, Ohio Sept. 29-Oct. 1.

Dave Fairfield, NGFA vice president of feed services, said the Food and Drug Administration is working on issuing some needed guidance to provide additional thinking on requirements under the animal feed rule on good manufacturing practices and preventative controls. Also speaking at the event was Dan McChesney, director of FDA’s Center for Veterinary Medicine Office of Surveillance and Compliance and Scott MacIntire, director of FDA’s division of enforcement and office of enforcement and import operations.

McChesney noted inspectors will be called to focus more on public health and less on the cop side. MacIntire added FSMA focuses more on a systems-based inspections, rather than observation focused. Noncompliance is viewed in the context of the firm’s food safety system, public health risk and impact and identification of system failures.

“We’re trying to change the culture in FDA so when we actually come and knock on your day and say we’re here to help you, we really mean it,” MacIntire said. He said they’re working to train their inspectors to provide an opportunity to mentor during an inspection and work together with facilities on looking for ways to control hazards and mitigate risk if its warranted.

Fairfield said FDA has provided flexibility in the rule, which is appreciated, but that has also drawn some areas where potentially a brighter line may be warranted through additional guidance.

For instance, Fairfield said that under the proposed rule feed mills producing livestock and poultry feed believed they would be unlikely to have significant hazards which would require preventive controls. However, under the new final requirements, Fairfield said the threshold is blurry on when a good manufacturing practice used to address a hazard becomes a preventive control, which requires additional documentation and management activities to demonstrate the control is working.

The final rule requires covered facilities to establish and implement an animal feed safety system that includes an analysis of hazards and implementation of risk-based preventive controls. The rule requires a “preventive controls qualified individual” to develop and implement the plan.

Fairfield said his interpretation of the rule said that qualified individual could be qualified by either job experience or by completing training at least equivalent to that provided by the standardized curriculum currently under development with the Food Safety Preventive Controls Alliance (FSPCA) which would take about 20 hours to complete..

During his speaking with attendees, McChesney said training would be required and downplayed that it could be an either or situation. In further questioning, McChesney said if facilities have an adequate food safety plan that appears to be adequate, it may not be as important how that person was trained. If there are holes in the food safety plan, that may require additional requirements for training.

Fairfield said Kansas State University recently was awarded a contract from FDA to help facilitate the development of the FSPCA curriculum training. The goal is to make a user-friendly training program for those in the animal feed industry to better understand the requirements required under the current good manufacturing practices and preventive controls.