After 15 Years, FSMA Requirements Still Not Complete

Although the Food Safety Modernization Act (FSMA) was enacted in 2011, for which the FDA has issued nine rules, the agency has not yet completed all requirements of the Act.

A GAO report, released in early January, found that FDA had completed 41 of the 46 requirements. The requirements that were incomplete, along with current status and GAO recommendations, include:

1. Guidance on hazard analysis and preventive controls for human food.
   • FDA Status: Draft chapters of the required guidance issued between August 2016 and January 2024, but not all chapters have been issued and none finalized. Officials said they continue to work on the guidance but do not have a timeframe for finalizing it.
   • GAO’s Recommendation: Establish timeframes for finalizing and issuing guidance for hazard analysis and preventive controls for human food.
2. Guidance to protect against the intentional adulteration, or tampering, of food.
   • FDA Status: Draft of the required guidance issued in March 2019 but has not finalized it. Officials said they are updating the guidance but do not have a timeframe for finalizing it.
   • GAO’s Recommendation: Establish a timeframe for finalizing and issuing guidance to protect against the intentional adulteration of food.
3. Report on the progress of implementing a national food emergency response laboratory network.
   • FDA Status: Required reports published through 2019 but not in 2021 or 2023 and planned to issue the next report in 2025. However, officials could not provide details or documentation.
   • GAO’s Recommendation: Establish milestones and timelines for publishing a report on the implementation of a national food emergency response laboratory network.
4. Publication of updated good agricultural practices (GAPs) for fruits and vegetables.
   • FDA Status: Although the current GAPs are more than 25 years old, FDA has not begun work on the update and does not have a timeframe for beginning the work. The agency stated that in implementing FSMA, it prioritized finalizing guidance for the Produce Safety rule above updating its GAPs.
   • GAO’s Recommendation: Establish milestones and timelines for publishing updates of the agency’s good agricultural practices for fruits and vegetables.
5. Establishment of a system (for FSMA 204) to improve the agency’s capacity to track and trace domestic or imported food.
   • FDA Status: System development began in 2024 and stated that it expects to have it complete by July 2028. Although FDA had stated in March 2025 that development was expected to be completed by January 2026 (the initial extended compliance date), in extending the compliance date to July 2028, FDA now expects completion of a system, along with testing, by then.
   • GAO’s Recommendation: Develop a milestone/timeline plan for, and establishes, a FSMA 204 product tracing system to enhance its foodborne outbreak response processes.

The agency’s reorganization and “competing priorities” were given as reasons for the requirements not being fully completed. But, while the agency’s response to GAO included a completion date for food traceability, it did not provide specific timeframes for completing the other requirements.

Additionally, while FDA has conducted some assessment of the rules, this was focused primarily on industry compliance. The agency stated that it had not developed a performance management process to guide its assessment, because it had prioritized implementing the rules over assessing the results. To further this, GAO recommended that FDA’s Human Foods Program work with the Center for Veterinary Medicine to develop and implement a performance management process to assess the results of FDA rules and their contribution to the prevention of foodborne illness.

With a new report issued by USDA showing the annual cost of foodborne illness in the US to be estimated at $79 billion, it’s critical that the food industry has all the guidance on the FSMA rules possible, particularly that which was required by the Act. Additionally, effectively assessing the results of the rules can enable updates and improvements to ensure the best possible outcomes.

However, the 2025 reduction of FDA’s workforce, resources, and scientific expertise of its advisory panels has certainly put the agency behind the eight ball, particularly as it attempts to adapt to the continuing ideology changes of the current Administration. Thus, we don’t see a high likelihood of FDA completing all the requirements in any imminent timeframe, despite the GAO recommendations.  

Of all the observations, it is the Traceability Rule that we feel is the most important. Yes, the others are good to have, but their absence is not really having much impact on public health. Lack of traceability continues to plague the FDA when it comes to understanding complex supply chains and, thus, puts the public at risk. While the current rule, which is pushed out to 2028, may be seen by some as the ultimate solution, the challenges to industry, especially at the retail and restaurant level, will likely diminish its overall impact on public health. So moving forward with incremental but workable traceability requirements is perhaps something GAO could have thought about.