FSMA Takes Shape

In less than 12 months from now, the U.S. Food and Drug Administration (FDA) will begin requiring regulated food companies to demonstrate that they have adopted and implemented written food safety plans, with defined preventive controls designed to reduce or prevent food safety hazards.

Under the FDA Food Safety Modernization Act (FSMA), the FDA is required to enact governing regulations in advance of July 2012, and has promised in the coming months to publish industry guidance materials to help food companies achieve compliance.

In the June-July issue of Food Quality (“We’re Happy to Comply—But How?” pg. 48), we detailed the new requirements and highlighted the many challenges the FDA will face as it works to:

• Develop the promised guidance materials;
• Publish the new preventive control rules; and
• Position itself to objectively and fairly enforce the new requirements.

Although it has been more than six months since the FSMA was signed into law, the FDA concedes it still has much to do.

According to the FDA, the development of the industry guidance materials—regarded by most as the “first step” in this process—is still in its infancy. Michael Taylor, FDA deputy commissioner for foods, recently acknowledged the reasons for this delay, as well as the momentous challenge that lies ahead:

Congress is now saying make preventive controls … the norm across the whole diverse processing industry. … And so (the FDA’s) got questions that we’ve got to grapple with in order to do that well, starting with the most basic question of how do we create a regulatory framework that really is applicable and adaptable across an incredible diversity of processing operations, types of commodities, types of processes, scale of operations? We’ve got to address how we have a framework that works across that incredible diversity.

It would appear the FDA recognizes the massive challenge associated with creating a set (or sets) of rules that can be reasonably followed by industry and easily enforced by the FDA. Indeed, following Taylor’s remarks, and in an effort to achieve that goal, the FDA issued a formal notice asking for public comment to help the agency define what, exactly, the new guidelines and requirements should look like.

What is the agency’s current thinking? According to the most recent notice, the FDA is most interested in learning about what companies are already doing. In particular, the FDA has asked industry to comment on the specific preventive controls they are following, in order to better identify and address the existing hazards associated with the vast expanse of regulated food products and processes.

In turn, the FDA plans—at least theoretically—to use this information to “inform the development of the industry guidance materials.” As described in the notice, the FDA intends “to leverage the best practices for hazards and controls identified by the food industry for specific foods and processes,” then develop a series of guidance materials aimed at broad product categories.

At the most basic level, the agency’s plans for now appear to involve surveying what food companies are doing, identifying the best practices being followed, and then making those the standard. In addition, we are told, the guidance materials will likely be directed toward specific product categories, as opposed to processing facilities.

So, what is the industry saying? Comments have been as diverse as the industry itself. On one end of the spectrum, some have asked the FDA simply to state clearly and explicitly what elements a written food safety plan should include. These commenters are looking for specific benchmarks, background resources, and the specific standards that will be deemed by the FDA to be “acceptable.” This, some argue, would make compliance—and, by extension, enforcement—more manageable.