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Are We Almost There?
FDA has steadily met FSMA milestones nearly a year after passage
by Shawn Stevens
With the passage of the FDA Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) has been tasked to create approximately 50 rules, guidance documents, reports, and studies—all of which all must be implemented within very specific time frames.
While many of the new provisions have yet to be implemented, numerous milestones—despite popular belief—have already been met. These milestones have also, at least in part, touched upon many of the most significant changes under the new law, including increased agency authority, new requirements for preventive controls, and new import standards and expectations. Although many of these topics, along with additional anticipated developments lurking over the horizon, will be discussed in greater detail in our next issue, we wanted to provide a quick primer to explore where we’ve been and how much farther we need to go.
Notably, implementation of the FSMA first started gaining real momentum in March, three months after its passage, when the FDA hosted a public meeting focused on the legislation’s new import safety requirements. The meeting attracted more than 500 attendees and, although many topics were discussed, the debate focused mainly on four key import safety provisions:
- Accredited third-party certification;
- Import certifications of food;
- The voluntary qualified importer program; and
- The foreign supplier verification program.
In essence, these new initiatives will require food product importers to ensure that their foreign suppliers are following the same standards expected of food processors in the U.S.
However, setting such standards, then ensuring compliance, will create significant challenges. The amount of food imported into the United States has been steadily and rapidly increasing for years. This is especially true of high-risk foods like fruits, vegetables, and seafood. In turn, much of the food imported annually originates from countries (and economies) without the resources or infrastructure to develop and implement the robust food safety programs taken for granted in the United States.
Nevertheless, the FDA has announced that it will expect those U.S. food companies that choose to import, process, or sell foreign products not only to ensure the safety of the products themselves, but also to ensure that their foreign suppliers are complying with each of the regulatory requirements under the FSMA. These requirements, for instance, will mandate that each foreign supplier implement a written food safety plan that satisfies the requirements of the FDA.
In the weeks following the March import safety meeting, the FDA began focusing additional effort on widening its regulatory powers here at home. On May 5, the FDA issued a new rule allowing it to administratively detain foods the agency has reason to believe may be adulterated or misbranded. The new rule went into effect July 2. Effective the following day, the FDA gave itself additional authority allowing the agency to suspend the registration of regulated U.S. food facilities. This new power gives the FDA the ability to suspend—or threaten to suspend—the registration of any regulated food facility producing food that, in the judgment of the agency, presents a reasonable probability of causing serious adverse health consequences or death.
Since July, the agency has been moving forward on other fronts. With the assistance of the U.S. Department of Health and Human Services (HHS), the FDA has also begun to develop and implement a joint-anti smuggling strategy to identify and prevent smuggled foods from reaching the United States. HHS and the FDA report that they will be partnering with the U.S. Department of Homeland Security and U.S. Customs and Border Protection to implement multiphase strategies and technologies to counter existing and emerging smuggling threats. The threat of smuggled food extends all the way from consumer safety to national security and terrorism.
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@example.com or (414) 224-7784.