The Food Safety Modernization Act (FSMA) has continued to evolve over the past 12 months and there could be big changes for one of FSMA’s key components, food traceability, if the proposed legislation succeeds.
The Food Traceability Enhancement ACT (H.R. 7563), introduced to Congress by Representatives Scott Franklin (R-Florida), Sanford Bishop (D-Georgia), and Jimmy Panetta (D-California), strives “to strengthen compliance with the FDA Food Traceability Rule, to enhance the FDA foodborne illness outbreak investigation process, and for other purposes” and has gained co-sponsors from both sides of the aisle including Indiana, Kansas, Louisiana, Michigan, North Carolina, and Virginia.
Food Safety Magazine says the legislation could delay FSMA 204 compliance dates (less than 20 months away) and ease retailer recordkeeping requirements.
Food Safety Magazine: Compliance Date Would be Pushed Back from 2026 Deadline
Food Safety Magazine reports that, if passed, the legislation would delay the compliance date of the Food Traceability Final Rule which fulfills Section 204 of the FSMA. The current compliance date for all persons subject to recordkeeping requirements is Jan. 20, 2026.
“If passed, the bill would ease recordkeeping and traceability lot code (TLC) requirements for restaurants, retail food establishments, and warehouses by removing the requirement to maintain TLC information and provide such information to supply chain partners or to the Secretary of the U.S. Department of Health and Human Services (the Secretary),” reported Food Safety Magazine. “Additionally, the legislation would mandate the Secretary to execute at least nine pilot projects to measure the efficacy of foodborne illness outbreak investigations conducted without TLC information and identify and evaluate low-cost food traceability technologies.”
The publication says that the pilot projects would need to be representative of diverse retail establishments and commodities and that the projects would need to be conducted within 18 months of the enactment of the legislation.
“At present, the compliance date for FSMA 204 is January 1, 2026. However, if passed, the Food Traceability Enhancement Act would delay the compliance date to no earlier than two years after the completion of the pilot projects,” says Food Safety Magazine. “Finally, the legislation would require that the Secretary submit a report to Congress within 90 days of the Food Traceability Enhancement Act’s passage. The report would identify existing barriers that prevent FDA from sharing with the food retail sector important information about foodborne illness investigations, such as early warning signals, reported illnesses, and suspected vehicles of illness.”
Food Traceability Proposed Changes Has Industry Support
The Packer publication reported that the bill aimed at addressing FDA Food Traceability Rule challenges has industry support.
FMI, The Food Industry Association, says that the legislation would make targeted improvements to the rule that are necessary for more feasible industry compliance while continuing to enhance food safety.
“There is nothing more important to FMI members and the food industry than the safety of the food we make available to our customers and preventing the spread of foodborne illness. Because of their position in the supply chain, our food retail and wholesale members are often the first points of contact in outbreak investigations and serve as central resources in identifying potentially contaminated products that have entered the food supply so that they may be swiftly removed from the marketplace,” said FMI President and CEO Leslie G. Sarasin in a statement.
The statement continued: “While we support the Food Safety Modernization Act, passed by Congress in 2011 with FMI’s support, the Food Traceability Rule implementing Section 204 of the law is overly complex and must be fixed, as the implementation of the requirements set forth by FDA go well beyond that which Congress directed and are so burdensome as to not be achievable given currently available technology and other resources. The current rule will demand tremendous investments of time and resources across the entire food industry for recordkeeping, data management, and systems changes, without necessarily improving the timeliness of food safety investigations or preventing tainted products from entering the supply chain.
The FMI says that the legislation resolves key challenges in implementing the rule in a way that enhances food safety without unnecessary burdens and costs throughout the food supply chain.
The statement concluded: “Achieving a workable system across the entire supply chain to collect and maintain all data required under the rule by the January 2026 compliance date is simply not feasible. Action from Congress is needed to ensure FDA first conducts pilot projects with industry to determine how best to improve the rule such that industry compliance is achievable to allow continued assurance that food safety and prevention of foodborne illness can remain our top priority.”
FSMA Passage was Prompted by Foodborne Diseases
Food traceability is in the spotlight because foodborne diseases, which can wreak economic havoc on the U.S. food industry, and sicken the American population, prompted the FSMA passage.
“The FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system,” explained the FDA.
Economic losses to growers, processors, shippers, and retailers also factored into the new protections.
“The FSMA was adopted in part as a response to the large numbers of people becoming sick from foodborne diseases and the heavy economic losses,” said the National Conference of State Legislators.
The FDA estimates that largely preventable public health foodborne diseases result each year in the U.S. in:
- 48 million people (1 in 6) are getting sick.
- 128,000 people were hospitalized.
- 3,000 people die each year.
The FSMA 9 Major rules and related programs include:
- Agricultural Water
- Accredited Third-Party Certification
- Food Traceability
- Foreign Supplier Verification Programs (FSVP)
- Laboratory Accreditation for Analyses of Foods (LAAF)
- Mitigation Strategies to Protect Food Against Intentional Adulteration
- Preventive Controls for Human Food
- Preventive Controls for Animal Food
- Produce Safety
- Sanitary Transportation of Human and Animal Food
- Voluntary Qualified Importer Program (VQIP)
More: Latest News and Updates on FSMA
Other items of note from the FSMA in the past 12 months include:
- The FDA published a final rule in May 2024 that revises certain pre-harvest agricultural water provisions for covered produce (other than sprouts) in Subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule. Specifically, this rule replaces the previous pre-harvest water microbial quality criteria and testing requirements for covered produce (other than sprouts) with requirements for systems-based, pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes.
- The FDA published draft guidance for industry: hazard analysis and risk-based preventive controls for human food in January 2024. This guidance is intended to help you comply with the following specific PCHF requirements established in subparts C and G of part 117:
- A written food safety plan (FSP).
- Hazard analysis.
- Preventive controls.
- Monitoring.
- Corrective actions.
- Verification.
- Associated records.
- The FDA published a final guidance in Sept. 2023 (and a separate new draft guidance) replacing the original 2017 draft guidance for “standards for the growing, harvesting, packing, and holding of sprouts for human consumption. The 2023 Final Guidance updates and finalizes the following sections of the original 2017 draft guidance:
- Agricultural Water in Sprout Operations
- Seeds for Sprouting
- Environmental Monitoring
- Recordkeeping
- The 2023 Draft Guidance re-issues certain sections of the original 2017 draft guidance and issues one new section for sprout operations as revised draft guidance. The following updated and new sections in the revised draft guidance are now available for comment:
- Equipment, Tools, and Buildings
- Sampling and Testing of Spent Sprout Irrigation Water (or In-Process Sprouts)
- Personnel Qualifications, Training, and Hygienic Practices
Once finalized, the sections in the 2023 Draft Guidance will be incorporated into the 2023 Final Guidance creating one complete final guidance document.
