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In 2010, the Food Safety Modernization Act (FSMA) was signed into law, initiating a shift in the US food safety landscape. FSMA spurred an array of regulations intended to reduce contamination, mitigate foodborne illness, and make it easier to halt and track foodborne illness or chemical contamination. The National Sustainable Agriculture Coalition (NSAC) engaged heavily in this rulemaking process in support of scale-appropriate regulation, guidelines for diversified farm and food operations, and further training resources to make sure that smaller food businesses, farms, and those using sustainable agriculture practices would not be disproportionately burdened by these new requirements. 

In the decade and a half since FSMA became the law of the land, the Food and Drug Administration has finalized some of the required regulations; however, many of these new regulations have been mired by delays. Some of these delays have been necessary, prompted by significant stakeholder engagement and proper timelines, a function of the participatory rulemaking process. Other delays, however, have been driven by rescinded and reproposed rules. For example, the Agricultural Water Standard was found to be overly cumbersome for many types of farm and food businesses, while not proving a meaningful reduction in foodborne illness, and was not finalized as part of the initial Produce Safety Rule. It was only recently finalized, and the plan for enforcement was initiated in 2023, with compliance dates for the smallest farms into 2027. 

With the implementation of these rules staggered over time, farmers and food businesses have found themselves in an increasingly complicated regulatory environment that often only utilizes exemption as the main way to ensure scale-appropriate regulations. This blog post examines some of FSMA’s overlapping requirements, as well as the remaining FSMA regulations that have still not been finalized. While this Government Accountability Office (GAO) report covers all of FSMA, this post covers only those portions of greatest concern to small, diversified farms and food businesses. 

Those statutory requirements contained within FSMA of greatest concern to sustainable agriculture practitioners, and focused on in this blog post, are :

• Section 103: Hazard analysis and risk-based preventive controls
•  Section 105: Standards for produce safety 
• Section 204: Enhancing tracking and tracing of food and recordkeeping 

As these rules derived from this statue have come to overlay each other, and often have different exemptions depending on product, size of organization, and legal structure of the entity (non-profit, farm, packer, retail food) it has become increasingly complex to navigate, especially for those diversified, small to medium sized farms that are key in the development of more sustainable agriculture across the US. These rules have also caused and continue to cause a variety of financial burdens for farms that are smaller and more diversified. Much of this work has been done without the Food and Drug Administration (FDA) being able to showcase reduced foodborne illness attributable to the rules themselves as well.  

Until this moment, a midmortem of the rollout of the entirety of FSMA (though there have been reviews of subsets of the law) has not been conducted by a government entity, only partially by outside stakeholders. 

This recent GAO report provides an overview of what parts of FSMA are completed, partially completed, and not completed, as well as offers more general recommendations.  Most of the requirements identified in FSMA (41 out of 46) have been completed, showing clear FDA progress towards full implementation, though the report also notes many of the stakeholders felt the delay in doing so resulted in confused and unclear incentives for investments in food safety technologies. 

The report makes a variety of recommendations for FDA going forward, across all of the statutes of FSMA. 3 of the 7 recommendations are most relevant to a sustainable food safety audience:

GAO: The Commissioner of FDA should ensure that the Human Foods Program establishes milestones and timelines for updating the agency’s good agricultural practices for fruits and vegetables and publishes them as required by FSMA’s section 105. (Recommendation 5) 

• NSAC’s perspective: If the FDA is to approach reevaluating the Good Agricultural Practices, it should do so in coordination with the Agricultural Marketing Service (AMS) and the National Institute of Food and Agriculture (NIFA) at the US Department of Agriculture (USDA), pre- and post the development, given their historic and current involvement with farmers and food safety practitioners.

The FDA Commissioner should ensure that the Human Foods Program develops a plan with milestones and timelines for establishing a product tracing system to enhance FDA’s existing foodborne outbreak response processes, and that it establishes the system as required by FSMA’s section 204. (Recommendation 6)

• NSAC’s perspective: While NSAC supports the finalization of the Food Traceability Rule, referred to here, there is still work to be done to provide adequate resources and training to small farms and food businesses. 

The Commissioner of FDA should ensure the Human Foods Program and the Center for Veterinary Medicine develop and implement a performance management process to assess the results of FDA’s rules and their contribution to the prevention of foodborne illness. This process should include setting goals to identify results to achieve, collecting information to measure performance, and using that information to assess results and inform decisions for each rule. (Recommendation 7)

• NSAC’s perspective: While some attempts have been made to track the overall impact of FSMA, further data is needed on almost all of the rules that directly connect specific interventions within rules to food safety outcomes. Any further tweaking of the rules into the future will require further documentation to showcase the potential food safety outcomes in the context of other forms of analysis, such as costs to producers.

NSAC has been deeply involved in both formal and informal processes to shape these statutes and rules, and is glad to see FDA has made progress towards the finalization of all the rules.  The development of the performance management data analysis should have come on consequentially with the rules. This GAO report is a welcome and more comprehensive addition to the different analyses of FSMA over the years. 

However, there have been mitigating factors for the food research, investigation, and enforcement section of the FDA, including a lack of funding commensurate with its responsibilities and a complete reorganization into the Human Food Program. Developing methods to analyze both the efforts already made and the remaining rules yet to be fully implemented will improve transparency for farmers and food businesses. It will bring clarity to many on how their efforts and investments have contributed to a safer food system.

It may also help create further rationale for increases in food safety training funding or more precise targeting of food safety programs. Programs such as the Food Safety Outreach Program at USDA or some of the objectives of the Cooperative Agreement Program for State Implementation at FDA provide portions of this funding and have experienced declining real funding over time. If the FDA invests further in the proposed management system, it may reveal further instances where funding for training might best be allocated and help close the gap between the goals of FSMA and the reality, in an equitable way for all farms and food businesses. 

The post GAO Reports on the Mixed Success of Food Safety Rules appeared first on National Sustainable Agriculture Coalition.