With the passage of the Food Safety Modernization Act (FSMA), FDA has been tasked to cultivate approximately 50 new rules, guidance documents, reports and studies – all of which all must be implemented within very specific timeframes.
In turn, 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 preventative controls and new import standards and expectations. Although many of these topics (along with additional anticipated developments still lurking just over the horizon) will be discussed in greater detail in our next issue, we wanted to provide a quick primer of both where we’ve been and how much further we still need to go.
Notably, FDA’s implementation of the FSMA first started gaining real momentum three months after passage (in March 2011), when 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 each of their foreign suppliers are following the same standards that are and will be expected of food processors here in the U.S.
It became clear from the meeting, however, that setting such standards, and then ensuring compliance, will create significant challenges. The amount of food that is imported into the United States has been steadily and rapidly increasing for years. This is especially true with 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 which are taken for granted here in the United States.
Nevertheless, the FDA has announced that it will expect those U.S. food companies who chose to import, process or sell foreign products to ensure not only the safety of the products themselves, but to also 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 FDA.
In the weeks following the March 2011 import safety meeting, FDA then began focusing additional effort on widening it regulatory powers here at home. On May 5, 2011, FDA issued a new rule allowing it to administratively detain foods which the agency has reason to believe may be adulterated or misbranded. The new rule went into effect on July 2, 2011.
Effective the following day, on July 3, 2011, the FDA then gave itself additional authority, which allows the agency to suspend the registration of regulated U.S. food facilities. This new power gives FDA the ability to suspend (or threaten to suspend) the registration of any regulated food facility if the facility is producing food which, 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 as well. With the assistance of the Department of Health and Human Services (HHS), 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 FDA report that they will be partnering with the Department of Homeland Security and the U.S. Customs and Border Patrol to implement multi-phase strategies and technologies to counter existing and emerging smuggling threats. The threat of smuggled food, of course, extends all the way from consumer safety to national security and terrorism.
And, as many of you know, the FDA was also accepting public comment – through last August – on the docket for “Preventive Controls for Registered Human Food and Animal Food/Feed Facilities.” According to FDA, the comments received will be used by the agency to help shape the new regulations which will mandate that all regulated food facilities implement written food safety plans no later than July 2012. While many industry groups have taken advantage of the opportunity to share their perspectives with FDA, substantial uncertainty continues to exist with regard to not only what the new standards will specifically say, but how they will be uniformly and fairly enforced across the vast array of differing food processing operations across the country.
In this regard, despite the agency’ 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 effectively prepare for the new anticipated regulatory changes until FDA actually publishes the new requirements.
Additionally, in the absence of any clear direction yet from FDA regarding what, specifically, the new regulations with say, many small and medium-sized 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 that the investments which will be required to ensure compliance could ultimately impact their ability to compete and potentially lead to financial collapse.
Indeed, Kathy Means, Vice President of Government Relations and Public Affairs at the Produce Manufacturer’s Association, recently echoed such fears, warning that while “[e]very 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 FDA from industry and key stakeholders will lead to practical standards which all companies can both efficiently and effectively implement to improve their food safety programs.
In spite of the progress already made by 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, FDA will need significant additional funding to properly, uniformly and fairly enforce those standards. Already, FDA has expressed frustration over the contrast between Congressional expectations and the limited funding which may ultimately be allocated. The agriculture appropriations bill recently passed by the House of Representatives, for instance, would decrease funding to the FDA next year by $87 million.
With that said, the FDA, seems to recognize the breadth of changes it faces, and now has more than two dozen separate working groups focused on implementing the FSMA. And, at the end of the day, we remain confident that FDA is doing all it can, and trying to do it well.
As with any piece of monumental legislation, especially one which directly affects every consumer in our nation, 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 we are driven by FDA further down this new regulatory path, we simply hope the continuing journey remains as smooth and bump-free as possible.