Meeting the Requirements of FSMA in 2016

The food industry and government regulators alike will face significant challenges in meeting requirements of the Food Safety Modernization Act (FSMA), which begin taking effect in 2016. In 2015, FDA published final regulations for five of the seven major FSMA rules, establishing deadlines for food companies to embrace new manufacturing processes and requirements for testing, monitoring, recordkeeping, and reporting—all designed to ensure that safety is built into every link of the food chain, from raw materials, to transportation, to storage.

“Most companies want to do the right thing; many are doing it now,” said Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine, following the multi-state outbreak of Listeria monocytogenes tied to Blue Bell Creameries ice cream in early 2015. “Ultimately, the only way we will achieve the goals that we are focused on—the goals that consumers expect us to achieve and that industry wants us to reach—is if we have a system in which industry is systematically, every day, putting in place the measures that we know are effective in preventing contamination.”

Missing court-imposed deadlines by several days, the FDA in 2015 published long-awaited final regulations for the preventive controls for human food, preventive controls for animal food, the produce safety rule, the Foreign Supplier Verification Program, and third-party certification of auditors for foreign suppliers. FDA must publish final rules for the sanitary transportation of food and for countering intentional adulteration in the first half of 2016.

“Will food companies understand what they need to do to be in compliance with all these rules, and will FDA inspectors be properly trained on how to enforce them?” asks David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods. “I am hearing these questions a lot. For FDA, doing so will require money and resources, and we know the agency doesn’t have what’s needed,” he tells Food Quality & Safety magazine.

Plan for Preventive Controls

Things will not be easy for industry, either. The first FSMA deadline comes September 2016, when large companies (having 500 or more full-time equivalent employees) must comply with the preventive controls rules for human food. Small companies (fewer than 500 employees) will have until September 2017, and very small businesses (less than $1 million in average annual sales), until September 2018. Large companies dealing with animal food also have until September 2016 to implement the current Good Manufacturing Practices (cGMP) requirements of that rule. In addition, FDA intends to implement “as soon as possible” the third-party auditor certification program for U.S. importing companies, regardless of size. That final rule was published in November 2015. The other FSMA rules have staggered deadlines, but companies will generally have between one and three years following publication to comply, depending on their number of employees or average annual sales volume.

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Among the five published regulations, the two preventive controls and the produce safety rules will impact most food companies most directly. Generally speaking, FDA-registered food facilities must establish and maintain food safety systems that include a Hazard Analysis and Risk-Based Preventive Controls (HARPC) plan, similar in many ways to Hazard Analysis and Critical Control Points, or HACCP, plans for juice and seafood. To verify the controls are effective, companies must monitor, test, take corrective actions, verify, and document the outcomes. Manufacturing and processing facilities must also maintain risk-based supply chain programs for raw materials and ingredients and provide cGMP education and training to their relevant employees.

FDA plans to work with public and private partners to develop and deliver training curricula. These will become standardized yet remain flexible. FDA will rely on existing alliances to develop training programs for domestic and foreign businesses. USDA is also providing grants to establish regional centers for food safety and training for small- and medium-sized farms and for fresh fruit and vegetable wholesalers. “One size doesn’t fit all. The most important goal that the FDA expects of any training program is the outcome—that it advances knowledge among the food industry to meet FSMA requirements,” the agency says.