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Statement on measuring the progress being made through implementing the FDA Food Safety Modernization Act

For Immediate Release:

Statement From:

Statement Author

Leadership Role

Acting
Commissioner of Food and Drugs – Food and Drug Administration

Norman E. “Ned” Sharpless
MD

Leadership Role

Deputy Commissioner for Food Policy and Response – Food and Drug Administration

Frank Yiannas

After a series of large-scale food safety problems almost a decade ago, Congress passed the U.S. Food and Drug Administration Food Safety Modernization Act, or FSMA, to shift our food safety system from one that focused primarily on responding to problems to a system that prevents them from happening in the first place. It was the most significant change to the food safety framework in decades and was an important step that gave the FDA new authorities to help fulfill our obligation to protect consumers. And now, as we embark on a New Era of Smarter Food Safety, we know further enhancing compliance with the foundational FSMA requirements will be critical to our success.

As the seven foundational rules of FSMA reach their compliance dates over the next several years, it’s important to begin to track their impact on the food safety system. To help us measure progress and continue to refine our implementation, the FDA has established a dashboard where we will publish metrics relating to implementation of the law.

The new Food Safety Dashboard launched today is part of FDA-TRACK, which is one tool the FDA uses to monitor certain FDA programs through key performance measures and projects, and regularly updates to ensure transparency to the public.

While we expect that it will take several years to establish trends in the data, the initial data show that since 2016, the majority of companies inspected are in compliance with the new requirements of the preventive control rules. Additional FDA data also show that overall, industry has improved the time it takes to move from identifying a recall event to initiating a voluntary recall, from an average of four days in 2016 to approximately two days in 2019. In fact, comparing the FSMA data with our recall data shows the bigger picture, demonstrating the effectiveness of preventive measures as food recalls once again have reached a five-year low.

At this point we cannot definitively say these are meaningful trends representative of the entire food industry. However, this is an encouraging start as industry, the FDA and our regulatory partners work together to improve food safety and protect consumers.

The new dashboard introduces metrics for food safety outcomes, associated measures and initial data for certain aspects of FSMA. Over time, the Food Safety Dashboard will be populated with additional data to show more FSMA outcomes and, we hope, an overall reduction in foodborne illnesses attributable to FDA-regulated food products. The initial metrics are tracking outcomes in the areas of inspections and recalls for three FSMA rules. They include:

  • Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls rules for both human food and food for animals (preventive controls rules). The first compliance dates for these rules occurred in September 2016
  • Imported food safety, including data relevant to the Foreign Supplier Verification Program (FSVP) rule. The first compliance date for importers subject to FSVP occurred in May 2017.

The data released today only provide a snapshot of both domestic and foreign industry compliance with these regulations.

Many factors will influence these data over time, especially in the early phases of implementation. For instance, some of the rules feature staggered compliance dates based on size of business to allow smaller businesses more time to comply. The data will ultimately help the agency identify trends in food safety, continue to improve our risk-based food safety framework, and modernize the agency’s food safety approaches in a way that will help prepare us for a New Era of Smarter Food Safety.

Publishing these metrics today is part of our commitment to greater transparency and accountability for all stakeholders responsible for improving the safety of the food supply. We plan to update the data for these three FSMA rules quarterly, with our goal being to ultimately publish metrics for all seven rules.

We know that we can’t stop every outbreak of foodborne illness; however, reducing the incidence of illness and death attributed to contaminated food is a shared goal of growers, manufacturers, packers, suppliers, importers and regulators alike. This goal can be realized through the successful implementation of FSMA and modernizing our approaches to food safety from farm to fork.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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