Enacting FSMA through FITs and FOTs

Facing court-imposed deadlines to finalize seven major food safety regulations within the next two years, FDA will adopt a carrot-and-stick strategy to obtain industry compliance with the Food Safety Modernization Act (FSMA). For example, FDA will create “incentives” for companies to comply with FSMA’s preventive control rules for food and feed facilities by reducing inspections of firms having a record of “good behavior” and targeting high-risk firms with “enhanced” surveillance and inspections, according to the agency’s latest strategic plan for implementing FSMA.

When preventive control problems do arise, FDA will first seek voluntary corrections at the facility level. If that fails, the agency will next use its enhanced administrative powers, such as detention and mandatory recalls, and only afterwards seek court-ordered injunctions, seizures, or criminal prosecutions. Overall, FDA hopes to encourage industry compliance through education and technical assistance by partnering with other federal, state, and local agencies. For instance, FDA will partner with USDA and private auditors when it comes to on-farm inspections related to produce safety standards. Internationally, FDA will partner with foreign governments and accredited third-party auditors to assess imported food.

In May, FDA published its “Operational Strategy for Implementing the FDA FSMA.” As mandated by a federal court-ordered consent decree, FDA must finalize and publish rules for preventive controls for human and animal foods by Aug. 30, 2015 and publish final rules for produce safety, the Foreign Supplier Verification Program, and accreditation of third-part auditors by Oct. 31, 2015. The sanitary transport of food and feed rule must be finalized by March 31, 2016 and the intentional adulteration final rule by May 31, 2016.

These rules “intersect and cover an incredibly diverse spectrum of people and companies located all over the world,” says Roberta F. Wagner and Joanne Givens, co-chairs of the FSMA Operations Team Steering Committee and, respectively, deputy director for regulatory affairs at FDA’s Center for Food Safety and Applied Nutrition and an acting regional food and drug director in FDA’s Office of Regulatory Affairs. “Our team is talking with those most affected by the proposed rules—including farmers, importers, industry representatives, and state officials—for their feedback on the most reasonable and practical ways to carry out our preventive and enforcement activities,” Wagner and Givens state in a May 8, 2014 FDA blog posting. State regulatory partners will play an increasingly active role in industry oversight once the agency moves into post-final rule implementation in late 2015 and early 2016, Wagner adds.

This state-level collaboration will be critical, “especially when it comes to the new and unique challenge of implementing the produce safety rule,” explains Michael R. Taylor, deputy FDA commissioner for foods and veterinary medicine. “We aspire to rely heavily on state agriculture departments and other state and tribal departments with on-farm food safety responsibility, taking advantage of their food safety commitment, their knowledge of local conditions and practices, and their local presence to deliver training, technical assistance, and compliance oversight,” Taylor writes in a May 2, 2014 FDA blog posting coauthored by Howard Sklamberg, deputy FDA commissioner for global regulatory operations and policy. “But we have to work closely with our state partners to convert this aspiration to reality. That work includes finding the funding they will need to play an expanded role on produce safety and other areas of FSMA implementation.”

Funding Problems

“Good luck with getting more funding for the states; that’s probably not going to happen,” says David Acheson, MD, CEO, The Acheson Group and a former FDA associate commissioner for foods. “States are already doing inspections on behalf of FDA and any expansion of this will depend on more resources. The states are in at least as much budget trouble if not more so than FDA in that regard,” Dr. Acheson tells Food Quality & Safety magazine.