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From: Food Quality & Safety magazine, Aug/Sept 2011

FSMA Takes Shape

Public comments begin to refine FDA guidance materials

by Shawn Stevens

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.

Others disagree. Given the vast range of food products and processing facilities, many have urged the FDA to reject any approach that is too restrictive. The Grocery Manufacturers Association (GMA), for instance, states that the new rules and regulations developed by the agency “should be goal oriented, (since) multiple approaches can result in the same level of food safety.” Ultimately, the GMA believes preventive controls “should be tailored to each situation, each plant design, and the many factors based upon individual plants.”

Many of the GMA’s comments were echoed by others. Some industry associations urged the FDA to allow food companies to modify and improve food safety programs and controls “as they see fit,” based upon the unique conditions within a food facility and food products being produced. Others agreed that the FDA guidance materials, as well as the regulations that follow, should in the end be practical, cost effective, and flexible enough to allow innovation.

Given the additional challenges the FDA faces with respect to hiring enough qualified inspectors to determine compliance in each individual processing facility, however, the FDA was also urged (if it adopts such an approach) to consider a mechanism for industry to appeal any FDA decision where there is a disagreement regarding the adequacy of a written food safety plan.

In addition to providing general perspective on how broad or restrictive the new rules should be, many stakeholders offered additional wide-ranging suggestions. Some have requested that the FDA mandate pathogen testing for certain food products and ingredients. Others urged the FDA to go further, suggesting that the agency should also require environmental sampling, while at the same time making test results available for FDA inspection. Others encouraged the use of video-monitoring programs, enhanced worker safety programs (which they claim will enhance food safety), and new interventions. Some even suggested that the FDA require food companies to electronically submit written food safety plans, once implemented, to the agency.


The FDA welcomes industry comment through Aug. 22. If you haven’t already, you can submit written comments by mail to: The Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Alternatively, you can check on the status of the FDA’s rule-making efforts, as well as submit your comments, on the FDA’s website:!documentDetail;D=FDA-2011-N-0238-0001.

While some of these proposals would likely have some value in certain limited segments of the industry, it is unlikely that it would be reasonable—or even feasible—to adopt them industry-wide. Most agree that, when it comes to food safety, one size does not fit all.

So where do you stand? The FDA welcomes industry comment through Aug. 22. If you haven’t already, you can submit written comments by mail to: The Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Alternatively, you can check on the status of the FDA’s rule-making efforts, as well as submit your comments, on the FDA’s website:! documentDetail;D=FDA-2011-N-0238-0001.

We anticipate that the FDA will issue guidance materials and proposed rules this fall. That said, the agency is asking for your help on how best to accomplish its goals. Many important issues remain undecided and will likely be influenced by your continued input. According to Taylor: “This is your opportunity to share your thoughts on the implementation of preventive controls. We don’t have any of these regulations fully developed yet, so we have the opportunity to take your comments to heart.”

We will watch to see whether the resulting FDA rules are extremely prescriptive, extraordinarily broad, or somewhere in between. In the meantime, it’s a safe bet that your comments are truly being heard.

Stevens, an attorney at Gass Weber Mullins LLC in Milwaukee, Wis., counsels food industry clients nationally on food safety regulatory and liability issues. He can be reached at or (414) 224-7784.



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