– OPINION –
In the food safety landscape, the Food Safety Modernization Act (FSMA) of 2011 represents a monumental shift toward preventing contamination rather than merely responding to it. A new element of the FSMA is the Food Traceability Final Rule (FSMA 204), which is designed to increase the ability to track and trace food throughout the supply chain, with a compliance date of January 2026.
Food traceability is not a new concept; it is a fundamental aspect of food safety practices worldwide. The ability to trace food products throughout the supply chain – from farm to fork – enables rapid identification and control of foodborne illness. FSMA 204 is a critical part of this framework and its successful implementation is critical to public health.
However, recent legislative efforts threaten to undermine this progress, potentially jeopardizing the security of our food supply. The Safe Food Coalition, made up of key food industry stakeholders and consumer protection organizations, has sounded the alarm in Congress on two bills aimed at weakening FSMA 204. If passed, these bills would compromise the FDA’s ability to detect outbreaks detection and control of foodborne diseases.
House of Representatives Resolution (HR) 7563 – “The Food Traceability Enhancement Act” proposes relaxing record keeping and lot code traceability (TLC) requirements for restaurants, 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 directs at least nine pilot projects to measure the effectiveness of foodborne disease outbreak investigations conducted without TLC information and to identify low-cost food traceability technologies.
The Fiscal Year (FY) 2025 Agriculture Appropriations Act is seeking to delay the FDA’s 2026 implementation date by requiring additional traceability pilots, including one that would require resolving outbreaks without lot code information. This bill does not provide new funding for these pilots and effectively maintains funding at FY 2024 levels.
The Safe Food Coalition states that the Food Traceability Final Rule aligns with industry best practices. As the 2026 compliance date approaches, many companies have made significant progress in tracking and recording food traceability data, demonstrating the feasibility of compliance. Exempting lot code information as proposed would “effectively” undermine the rule, allowing retailers to throw out critical information essential to detecting and resolving foodborne illness.
Historical lessons
Current legislative efforts are reminiscent of previous attempts to delay or weaken food safety regulations. Two notable examples illustrate the dangers of such actions:
Leafy vegetables and FSMA water standards
In September 2107, the FDA decided to delay implementation of FSMA’s agricultural water standards (which were originally scheduled to be implemented between 2018 and 2022) to address stakeholder concerns about the standards’ feasibility and usefulness. delayed the implementation of FSMA agricultural water standards.
The delay in implementing these standards had serious public health consequences as subsequent outbreaks underscored the critical need for these standards.
Numerous outbreaks in multiple states (mainly E.coli O157, but also Cyclospora and Listeria) were investigated annually between 2016 and 2024. The CDC identified hundreds of illnesses and hospitalizations, and at least five fatalities. These outbreaks include recalls of romaine lettuce and spinach, as well as several packaged salad products (Dole, Fresh Express). Many notable outbreaks have been accompanied by warnings from the CDC and FDA to avoid all romaine lettuce from the Yuma growing region or areas in California, or with recommendations that consumers should temporarily avoid all romaine lettuce.
On May 21, 2020 Report In their investigation into the fall 2019 disease outbreaks linked to Romaine Lettuce, the FDA did not focus on their delay, but stated that their “ability to determine the source of contaminated food that may have caused the diseases , has lagged, in part due to the lack of modernized food traceability capabilities.”
The USDA ‘Safe Handling’ labels
In 1994, in response to the milestone 1993 E.coli outbreak, the USDA not only declared E.coli O157:H7 is an illegal adulterant in meat and poultry under the USDA regulatory authority and initiated a “zero tolerance” policy for the pathogen, but also took another controversial step by requiring meat producers to remove all packaging containing non-food meat and poultry in retail stores a label with instructions for safe handling. The goal was to ensure that the public understood not only how to safely handle raw meat and poultry products, but also how to prepare them properly.
The USDA’s intent in requiring their food-safe handling instruction labels on all packaging of raw meat and poultry products was to educate consumers on how to protect themselves. The meat industry has taken a stand against this mandate because the labels can help shoppers know problems may exist. This alert indicated that more detailed information can be distributed in a simple, accurate way that does not require different labels for many products.
Concerns about consumer awareness of the safety of their meat became apparent some twenty years earlier when the APHA sued the USDA on the grounds that their label was misleading APHA vs. Butz (1974). The APHA alleged that consumers were unaware 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 public health risk. The APHA argued that the USDA should require meat to carry a warning label stating usage and cooking instructions to protect consumers from foodborne pathogens. The court ruled in favor of the USDA and denied a rehearing in 1975.
In May 1993, the government changed its position when it agreed to require food-safe processing labels as part of the settlement of a lawsuit brought by Jeremy Rifkin of the consumer coalition “Beyond Beef” in the U.S. District Court in Washington, DC. Rifkin criticized the USDA for providing insufficient information on labels, creating a weak message. His group even demanded that “thorough cooking” be replaced with more explicit instructions.
On October 14, 1993, one day before the original labeling rule was to take effect, the National American Wholesale Grocers Association convinced a federal judge in Texas to issue an order delaying labeling because “unlabeled meat does not posed a significant threat to health’. , and that the contaminated meat outbreak was isolated to the Pacific Northwest in January.” Just two weeks later, the Texas State Department of Health issued a statewide warning, similar to those on the USDA Food Safe Handling labels, over 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 three-month delay from the USDA’s initial target date), educating consumers on proper food handling and cooking techniques. However, delays and compromises in the labeling process meant that crucial information was not immediately available to the public, potentially exposing consumers to foodborne illness.
Conclusion
FSMA 204 represents years of progress in improving food safety standards. Many companies have already invested in systems to meet these requirements, recognizing the crucial role of traceability in protecting public health. Current legislative proposals to relax traceability requirements and delay implementation of the Food Traceability Final Rule pose significant public health risks. Without strict traceability requirements, the FDA’s ability to quickly identify and control outbreaks of foodborne illness will be seriously compromised. Rolling back these regulations would not only negate these efforts, but also put consumers at greater risk of foodborne illness.
Delaying or weakening regulations can have serious consequences for public health. The proposed legislative changes to the Final Rule for food traceability undermine the basis of food safety that the FSMA wants to strengthen. American consumers will not receive stronger food safety protections as a result of these delays. The recognition that 3,000 American consumers die each year due to food safety deficiencies underscores the importance of robust food safety regulations.
Congress must uphold the integrity of the Food Traceability Final Rule and ensure that the FDA has the tools necessary to protect consumers from foodborne illness. The security of our food supply depends on a courageous commitment to high standards and swift action when threats arise. In the interest of public health, attempts to weaken the safeguards that keep our food safe must be resisted.
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