Are We Almost There?

The FDA accepted public comment through August on the docket for “Preventive Controls for Registered Human Food and Animal Food/Feed Facilities.” According to the agency, the comments received will be used to help shape the new regulations mandating that all regulated food facilities implement written food safety plans no later than July. While many industry groups have taken advantage of the opportunity to share their perspectives with the FDA, substantial uncertainty continues to exist with regard not only to what the new standards will specifically say, but also to how they will be uniformly and fairly enforced across the vast array of food processing operations nationwide.

In this regard, despite the agency’s progress on many fronts, virtually all regulated food companies continue to wonder what is going to be asked of them and when. Although we have talked generally in previous articles about approaching deadlines and anticipated expectations, it will remain difficult for any food company to prepare effectively for the new anticipated regulatory changes until the FDA publishes the new requirements.

Additionally, in the absence of any clear direction from the FDA regarding what, specifically, the new regulations will say, many small and medium companies remain worried about their long-term survival. Given the unprecedented increase in new FDA regulation triggered under the FSMA, many small businesses (some already struggling as a result of the lethargic economy) are fearful the investments that will be required to ensure compliance could affect their ability to compete and potentially lead to financial collapse.

Indeed, Kathy Means, vice president of government relations and public affairs at the Produce Marketing Association, recently echoed such fears, warning that while “every business must have a food safety plan, these plans should be adaptable and not burdensome to small businesses.” After all, Means concluded, “the reality is that pathogens simply do not respect the size or type of an operation.”

Thus, we remain hopeful that the public comments already received by the FDA from industry and key stakeholders will lead to practical standards that all companies can efficiently and effectively implement to improve their food safety programs.

In spite of the progress made by the FDA, the implementation of effective regulations—whatever their form—remains a significant challenge. In addition to the difficulties associated with developing a single set of clear and effective standards, the FDA will need significant additional funding to properly, uniformly, and fairly enforce those standards.

The FDA has expressed frustration about the contrast between congressional expectations and the limited funding that might be allocated. The agriculture appropriations bill recently passed by the House of Representatives, for instance, would decrease funding to the FDA by $87 million next year.

The FDA seems to recognize the breadth of changes it faces, however, and now has more than two dozen working groups focused on implementing the FSMA. At the end of the day, we remain confident that the FDA is doing all it can—and trying to do it well.

As with any piece of monumental legislation, especially one that directly affects every consumer in our nation, the FDA has wisely solicited assistance directly from the food industry in a sincere effort to make the coming changes workable for all.

In the meantime, as the FDA drives us farther down this new regulatory path, we hope the continuing journey remains as smooth as possible.

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 [email protected] or (414) 224-7784.