September 30, 2019
The U.S. Food and Drug Administration (FDA) has established a Food Safety Dashboard designed to track the impact of the seven foundational rules of the FDA Food Safety Modernization Act (FSMA), measure their progress, and help us continue to refine our implementation. The dashboard is available as part of the FDA-TRACK program, the FDA's agency-wide performance management system.
As we embark on a New Era of Smarter Food Safety, continuing the successful implementation of FSMA will support the FDA’s goal of reducing the incidence of illness and death attributable to preventable contamination of FDA-regulated human and animal food products. Today the FDA is announcing the availability of the initial metrics that begin to track outcomes for three FSMA rules in the areas of inspections and recalls:
- “Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls” rules for both human food and food for animals (preventive controls rules).
- Imported food safety, including data relevant to the “Foreign Supplier Verification Program” (FSVP) rule.
Over time, the Food Safety Dashboard will be populated with additional data to show more FSMA outcomes.
All FDA-regulated products imported into the U.S. are required to meet the same laws and regulations as domestic food. The current data on inspections provide a snapshot into both domestic and foreign industry compliance with these regulations. We are also measuring the effectiveness of oversight of foreign suppliers by U.S. importers. This will be tracked through the classification of FSVP inspections.
We recognize that the prevention-oriented system that FSMA created is not failproof. With this in mind, we are also tracking the speed of response to problems when they do arise. One of the metrics we are beginning to track on the dashboard is how quickly a firm issues public notification for a Class 1 recall – the most urgent type of recall -- for human and animal food. The dashboard will be updated periodically with metrics for Days from Recall Initiation to Firm Press Release to the Public.
Many factors will influence the interpretation of the data, especially in the early phases of FSMA implementation. For example:
- The preventive controls and FSVP rules featured staggered compliance dates based on business size to allow smaller businesses more time to comply;
- FDA does not inspect the same firms on a quarterly or annual basis, so these inspection results do not represent a consistent cohort of firms;
- The FDA’s approach to implementing the FSMA rules has been to “educate before and while we regulate.” The FDA conducts interactive inspections that emphasize education and help bring industry into compliance, while focusing enforcement actions on food safety problems that pose a threat to public health.
Taking into account these factors, considering the changing sizes of businesses subject to these regulations as these regulations become effective, and the changing regulatory approach from educational to more regulatory, the agency expects that it will take several years to establish meaningful trends to evaluate progress toward achieving the performance goals presented on the dashboard.
Additional performance measures and data will be released for other FSMA rules in the future.