Are We Almost There?

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.