FSMA Takes Shape

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.

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: www.regulations.gov/#! 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.