FDA Operations Team Prepares to Implement Food Safety Laws

By: Roberta Wagner and Joann Givens

Since President Barack Obama signed the FDA Food Safety Modernization Act (FSMA) into law—giving FDA new power to oversee food safety using controls that prevent, rather than react, to hazards—we have been developing an operational strategy to help prevent unsafe foods from ever being distributed.

Roberta Wagner

Roberta Wagner, Co-Chair of FDA’s FSMA Operations Team Steering Committee and Deputy Director for Regulatory Affairs at FDA’s Center for Food Safety and Nutrition.

FDA has proposed seven FSMA-mandated rules that, when final, will establish the comprehensive framework of modern, prevention-oriented standards mandated by FSMA, covering the production and transportation of human and animal foods, whether produced in the U.S. or overseas.

As co-chairs of the FSMA operations team, our job is to facilitate implementation of the food law. And we’re not waiting until the proposed rules are finalized to build the infrastructure that will be needed to support their requirements. Foodborne disease currently affects 1 in 6 Americans each year, and we can’t waste any time.

Many of FSMA’s proposed rules intersect and cover an incredibly diverse spectrum of people and companies located all over the world. Our strategy must be workable for all while protecting our food safety goals. Our team is talking to 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.

We’re thinking about how we can encourage industry compliance with the new rules, and how we can measure this compliance. For example, we’re considering the role of information technology (IT) and how it can be used in reporting activities that will eventually measure compliance with the law.

Joann Givens

Joann Givens, Co-Chair of FDA’s FSMA Operations Team Steering Committee and Acting Regional Food and Drug Director (Central Region) in the Office of Regulatory Affairs.

Our operations team has created three workgroups tasked with implementing a multiyear strategy for compliance. Each group includes at least one state government representative. They focus on:

  • Preventive controls, considering issues such as the need to develop a trained workforce that can complete consistent, high quality inspections.
  • Produce safety and the development of performance measures.
  • Import controls and the need for goals and timelines for each phase of the two proposed rules designed to strengthen FDA oversight of foods imported into the U.S.

As co-chairs, we meet routinely with these workgroups and stay current on their progress and recommendations. We share what we learn from workgroup brainstorming sessions with Michael R. Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and work with him to fine-tune operational strategies. And we meet with other federal agencies, such as the U.S. Department of Agriculture (USDA), to see what lessons can be learned from their operations.

The final timing of FSMA depends on when the rules are set, and when industry compliance dates are determined. But we’re getting the people and systems we’ll need in place now so that we’re ready to act when rules go into effect.

Our ultimate public health goal is a safer food supply and a reduction in food-related illnesses. As the proposed rules move through this period in which the public provides input, we hope that all stakeholders will continue to submit comments. Please engage with us and stay tuned for updates.

Roberta Wagner is Co-Chair of FDA’s FSMA Operations Team Steering Committee and Deputy Director for Regulatory Affairs at FDA’s Center for Food Safety and Nutrition.

Joann Givens is Co-Chair of FDA’s FSMA Operations Team Steering Committee and Acting Regional Food and Drug Director (Central Region) in the Office of Regulatory Affairs.

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