Fifteen Years of Development Faces Fresh Scrutiny (Image Credits: Unsplash)
The U.S. Food and Drug Administration recently outlined steps to support compliance with its long-awaited Food Traceability Rule, prompting sharp rebukes from food safety advocates who view the plans as prolonged procrastination.[1][2]
Fifteen Years of Development Faces Fresh Scrutiny
Congress directed the FDA in 2011 through the Food Safety Modernization Act to establish enhanced traceability requirements for certain foods. The resulting rule targets high-risk items prone to contamination outbreaks, mandating records for critical supply chain events like packing, shipping, and receiving.[3]
Entities that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List must capture key data elements and assign traceability lot codes. This system aims to accelerate outbreak investigations by enabling quicker identification of contaminated products.[3]
Despite extensive public hearings, pilots, and drafts over the years, implementation has lagged. Industry groups cited burdensome paperwork and reliance on outdated records, often unable to provide details during recalls.[1]
FDA Unveils Guidance, Exemptions, and Engagement Plans
On February 19, 2026, the FDA released a detailed questions-and-answers guidance document to clarify rule applicability. It covers topics such as exemptions for farms, restaurants, and intracompany transfers, along with specifics on activities like produce culling and pallet breaking.[2]
The agency also finalized an exemption for Grade A cottage cheese listed under the Interstate Milk Shippers program, citing robust existing oversight through the Pasteurized Milk Ordinance. Facilities must still track immediate sources and recipients for these products.[2]
To address congressional mandates, the FDA partnered with the Partnership for Food Traceability for quarterly listening sessions. The first, for members only, occurs on March 6, 2026, followed by a public forum. These discussions will explore lot-level tracking challenges and solutions.[2]
- Questions-and-answers guidance on rule scope and recordkeeping.
- Exemption for certain cottage cheese products.
- Quarterly stakeholder sessions starting March 2026.
- Focus on assisting farms, retailers, and warehouses.
Compliance Timeline Extended Amid Industry Pushback
The original deadline of January 20, 2026, gave way to a 30-month extension until July 20, 2028, following a congressional appropriations act. This shift responded to concerns over supply chain coordination and preparation gaps.[4][3]
Proponents argue the delay allows time to build tools and refine processes. Critics, however, contend that repeated consultations delay protections against recurring outbreaks.[1]
Records must remain accessible within 24 hours of FDA requests, often in spreadsheet format during emergencies, underscoring the rule’s emphasis on rapid response.[3]
Safety Leaders Demand End to ‘Endless Meetings’
Food safety figures expressed frustration with the FDA’s approach. Sandra Eskin, CEO of STOP Foodborne Illness and former USDA official, acknowledged the value of guidance but urged against reopening the regulation.
“The decision to delay it was unfortunate but if retailers and small entities subject to the rule were challenged to comply with it, hopefully FDA can address these challenges in the extra time,” Eskin stated.[1]
Frank Yiannas, ex-FDA deputy commissioner, dismissed further sessions as redundant. “It’s been 15 years since Congress asked FDA to implement a food traceability rule. At some point, we need less talk, less endless meetings, and more action,” he said. Yiannas emphasized the need to resolve unsolved illnesses and prevent repeats.[1]
Key Takeaways:
- The rule targets traceability for high-risk foods to speed outbreak responses.
- Compliance now set for July 2028 after extensions.
- New FDA resources include guidance and exemptions, but advocates seek faster progress.
As foodborne threats persist, the balance between preparation and urgency defines the path forward. The FDA’s commitments offer tools, yet pressure mounts for decisive enforcement. What steps should regulators prioritize next? Share your views in the comments.
