Undermining food safety: The threat of legislative rollbacks on FSMA 204

— OPINION —

In the landscape of food safety, the 2011 Food Safety Modernization Act (FSMA) represents a monumental shift towards preventing contamination rather than merely responding to it. A new element of FSMA is the Food Traceability Final Rule (FSMA 204), which is designed to enhance the ability to track and trace food through the supply chain, with a compliance date of January 2026. 

Food traceability is not a new concept; it has been a fundamental aspect of food safety practices globally. The ability to trace food items through the entire supply chain — from farm to table—allows for rapid identification and containment of foodborne illness outbreaks. FSMA 204 is a critical part of this framework, and its successful implementation is paramount for public health.

However, recent legislative efforts threaten to undermine these advancements, potentially compromising the safety of our food supply. The Safe Food Coalition, comprising key food industry stakeholders and consumer protection organizations, has sounded the alarm over two bills in Congress aimed at weakening FSMA 204. These bills, if passed, would significantly dilute the FDA’s ability to trace and manage foodborne illness outbreaks.

House Resolution (HR) 7563 – “The Food Traceability Enhancement Act” proposes to ease recordkeeping and traceability lot code (TLC) requirements for restaurants, retail food establishments, and warehouses. It removes the mandate to maintain and provide TLC information to supply chain partners or the Secretary of Health and Human Services.  Further, this bill mandates at least nine pilot projects to measure the efficacy of foodborne illness outbreak investigations conducted without TLC information and to identify low-cost food traceability technologies.

The Fiscal Year (FY) 2025 Agriculture Appropriations Bill seeks to delay the FDA’s 2026 implementation date by requiring additional traceability pilots, including one that mandates solving outbreaks without lot code information. This bill provides no new funding for these pilots and effectively maintains funding at FY 2024 levels.

The Safe Food Coalition argues that the Food Traceability Final Rule aligns with best industry practices. As the 2026 compliance date approaches, many companies have made significant progress in tracking and recording data for food traceability, demonstrating the feasibility of compliance. Exempting lot code information, as proposed, would “effectively gut” the rule, allowing retailers to discard critical information that is essential for tracing and solving foodborne illness outbreaks.

Historical Lessons 

The current legislative efforts are reminiscent of past attempts to delay or weaken food safety regulations. Two notable examples illustrate the dangers of such actions:

Leafy Greens and FSMA water standards

In September 2107, the FDA decided to delay the implementation of the FSMA’s agricultural water standards (originally set to roll out between 2018 and 2022) to address stakeholder concerns regarding the feasibility and practicality of the standards. delayed the implementation of FSMA agricultural water standards.  

The delay in implementing these standards had dire public health consequences, as subsequent outbreaks highlighted the critical need for these standards. 

Between 2016 and 2024, numerous multi-state outbreaks (mostly E.coli O157, but also Cyclospora and Listeria) have been investigated each year.  The CDC identified hundreds of illnesses and hospitalizations, and at least five fatalities. These outbreaks included recalls of romaine lettuce and spinach, as well as several packaged salad products (Dole, Fresh Express).  Many notable outbreaks came with CDC and FDA warnings to avoid all romaine lettuce from the Yuma growing region or from areas in California, or recommendations that consumers avoid all romaine lettuce temporarily.

In its May 21, 2020 Report on their Investigation into Fall 2019 Outbreaks of Illnesses Tied to Romaine Lettuce, the FDA focused not on their delay, but stated that their “ability to determine the source of contaminated foods that may have caused the illnesses has lagged, due in part to the lack of modernized food traceability capabilities.”

The USDA’s “Safe Handling” labels

In 1994, in response to the landmark 1993 E.coli outbreak, the USDA not only declared E.coli O157:H7 an illegal adulterant in meat and poultry under the USDA’s regulatory authority and initiated a “zero tolerance” policy for the pathogen, but also took another controversial step by requiring meat manufacturers to affix all packages of not-ready-to-eat meat and poultry at retail a label outlining safe-handling instructions. The goal was to ensure that the public understood not only how to handle raw meat and poultry products safely, but also how to properly cook it.

The USDA’s intention for mandating their food safe handling instruction labels on all packages of raw meat, and poultry products was to inform consumers how to protect themselves. The meat industry took a position against this mandate as the labels may result in shoppers’ knowledge that problems may exist. This warning indicated that more detailed information can be put out in a simple, precise way that would not require different labels for many products.

Concerns over consumer’s awareness about their meat’s safety was evident some 20 years earlier when the APHA sued the USDA on the grounds that their mark of inspection was misleading in APHA vs. Butz (1974). Claiming that consumers were not aware that the USDA’s stamp of approval on a piece of mead did not actually mean that they tested it for bacteria that posed a risk to public health, the APHA argued that the USDA should require that meat carry a warning label with handling and cooking instructions to protect the consumer from foodborne pathogens. The court decided in favor of the USDA and denied a rehearing in 1975.

In May of 1993 the government changed its position when it agreed to require the food safe handling labels as part of its settlement of a lawsuit filed in Washington, DC’s US District Court by Jeremy Rifkin from the consumer coalition “Beyond Beef.” Rifkin criticized the USDA on how the information on the labels was insufficient, thus creating a weak message. His group even demanded that “cook thoroughly” be replaced with more explicit instructions.

On Oct. 14, 1993, one day before the initial rule of the labeling was to take effect, the National American Wholesale Grocers Association convinced a Texas federal judge to issue an injunction to delay the labeling because “unlabeled meat was not a significant health threat, and that the tainted meat outbreak in January was isolated to the Pacific Northwest.” Only two weeks later, the Texas State Department of Health issued a statewide warning similar to the one contained in the USDA’s intended food safe handling labels because of the deaths of two 3-year-old Texas boys from E. coli.

Despite industry opposition, the labels were eventually implemented as of July 6, 1994, (a delay of three months from the USDA’s initially intended date), helping to educate consumers about proper food handling and cooking techniques. However, delays and compromises in the labeling process meant that critical information was not immediately available to the public, potentially exposing consumers to foodborne illnesses.

Conclusion

FSMA 204 represents years of progress in enhancing food safety standards. Many companies have already invested in systems to comply with these requirements, recognizing the critical role of traceability in protecting public health. The current legislative proposals to ease traceability requirements and delay the implementation of the Food Traceability Final Rule pose significant risks to public health. Without stringent traceability requirements, the FDA’s ability to quickly identify and contain foodborne illness outbreaks will be severely compromised. Rolling back these regulations would not only negate these efforts but also place consumers at greater risk of foodborne illnesses.

Delaying or weakening regulations can have serious public health implications. The proposed legislative changes to the Food Traceability Final Rule undermine the very foundation of food safety that the FSMA aims to strengthen. The American consumer gains no stronger food safety protections as a result of these delays. Recognizing that 3,000 American consumers die every year due to failures in food safety underscores the importance of robust food safety regulations. 

Congress must uphold the integrity of the Food Traceability Final Rule, ensuring that the FDA has the tools needed to protect consumers from foodborne illnesses. The safety of our food supply depends on a courageous commitment to rigorous standards and prompt action in the face of threats. For the sake of public health, efforts to weaken the safeguards that keep our food safe must be resisted.

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