Search for:

FDA Food Safety Modernization Act Proposed Rule to Advance Traceability of Foods

Key Takeaways

On September 23, 2020, the Food and Drug Administration (FDA, the Agency) released its proposal to establish additional recordkeeping requirements for those that manufacture, process, pack, or hold foods on the Food Traceability List by collecting Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). If finalized, this rule has the potential to impact a significant number of organizations in the food supply industry and implementation can be costly. The rule also offers opportunity for players in the digital technology sector to develop and offer novel software platforms to assist industry execute more digital traceability systems.

Entities are advised to assess current food traceability programs, as the new traceability requirements will require substantial changes to many existing programs. Also, entities are advised to determine whether they may be subject to the rule to the extent new offerings or services may require compliance with these proposed requirements. Those subject to the rule should consider conducting a supply chain audit and develop a work plan to update their recordkeeping program in the near future. Proper preparation, clear understanding of the requirements and effective implementation will be monumental in meeting the proposed compliance timeline.

In more detail

The proposed requirements to impose additional record keeping requirements are intended to help the Agency rapidly and effectively identify recipients of contaminated food product to prevent or mitigate foodborne illness outbreaks and address credible threats of serious public health consequences resulting from foods being adulterated or misbranded. Section 204 of the FDA Food Safety Modernization Act (FSMA) requires the FDA to designate foods for which additional recordkeeping requirements are appropriate and necessary to protect public health, and to establish those recordkeeping requirements. “While the proposed requirements would only apply to those foods on the Food Traceability List (FTL), they were designed to be suitable for all FDA-regulated food products,” the Agency said. The Agency plans to endorse “voluntary adoption of these practices industry-wide.”

This proposed rule will allow the Agency to trace food product movement through the supply chain, thereby increasing the speed and precision at which the food causing the illness is identified, removed from the market and strategies to curb future contamination are developed.

Currently, many food traceability programs focus on procedures for internal use to help ensure the safety of the entity’s products and the security of their supply chains; complying with the one-up, one-back recordkeeping requirements. However, it has become readily apparent a more robust supply chain system linking incoming and outgoing product throughout the supply chain would be more efficient and impactful from a public health perspective. Consistent data and information collection, harmonized food tracing terminology, electronic records (encouraged) and uniform methodology to connect records could bridge the gap to decrease the spread of contamination and prevent future outbreaks.

Thus, the FDA has determined requiring entities to create and maintain KDE linked to specific CTEs in a listed food’s supply chain, including the growing, receiving, transforming, creating, and shipping of listed foods, would aid in product tracing during an investigation of a foodborne illness outbreak or recall. This type of sweeping regulatory oversight has been contemplated for years and the Agency’s advancement of this proposed rule is a pioneering development in end-to-end food traceability across the industry.

Key Points of the Proposed Rule

Determination of foods on the Food Traceability List:

FDA developed a risk-ranking model with consult to external expert panels. Using the risk-ranking model, FDA tentatively identified foods for the Food Traceability List for which additional traceability records will be required.  The term “Food Traceability List” (FTL) refers not only to the foods specifically listed, but also to any foods that contain listed foods as ingredients.

Who is Subject to the Proposed Rule:

Persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List are subject to the proposed rule. Foreign and domestic suppliers manufacturing, processing, packing or holding foods on the FTL and marketed in the US will be subject to the proposed rule. Further, those subject to the rule will expect entities involved or tangential to their supply chain to provide information and/or implement policies to assist the regulated entities to maintain compliance with the regulatory requirements.

Key Features of the Proposed Rule:

  • Critical Tracking Events (CTEs)

Pursuant to the proposed rule, the CTEs, which require records containing KDEs, are growing, receiving, transforming, creating, and shipping. The required KDEs would vary depending on the CTE. The CTE records would need to contain and link the traceability lot code of the food to the relevant KDEs.

  • Traceability Program Records

The proposed rule also requires persons who manufacture, process, pack or hold foods on the FTL to establish and maintain traceability program records.

  • Additional Requirements
    • Maintenance of records as either original paper records, electronic records, or true copies; they all must be legible and stored to prevent deterioration or loss.
    • Provision of traceability records to FDA as soon as possible, but no later than 24 hours after a request is made.
    • Provision of an electronic sortable spreadsheet containing relevant traceability information to FDA within 24 hours of a request when necessary to assist FDA during an outbreak, recall or other threat to public health.

Exemptions and Modified Requirements:

The proposed rule provides for exemptions for certain types of foods and certain persons who manufacture, process, pack or hold foods on the Food Traceability List, including the following:

  • Exemption for Certain Types of Small Originators
  • Exemption for Farms That Sell Directly to Consumers
  • Exemption for Foods that Receive Certain Types of Processing
  • Exemption for Produce that is Rarely Consumed Raw
  • Partial Exemption for Commingled RACs (raw agricultural commodities)
  • Co-proposal for Small Retail Food Establishments
  • Partial Exemption for Retail Food Establishments
  • Partial Exemption for Farm-to-School and Farm-to-Institution Programs
  • Partial Exemption for Food from Fishing Vessels
  • Exemption for Transporters
  • Exemption for Nonprofit Food Establishments
  • Exemption for Personal Consumption
  • Exemption for Persons who Hold Food for Individual Consumers
  • Special Requirements for Foods Subjected to a Kill Step


  • Compliance Dates

The FDA proposes that any final rule on additional traceability recordkeeping requirements for foods on the FTL would become effective 60 days after it is published in the Federal Register.  The proposed compliance date for all persons subject to the recordkeeping requirements would be 2 years after the effective date of the final regulation.

  • Enforcement

Section 301(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits the violation of any recordkeeping requirement under section 204 of FSMA. Furthermore, an article of food is subject to refusal of admission under section 801(a)(4) of the FD&C Act if there is noncompliance with the recordkeeping requirements under section 204 of FSMA.

Proposed rule available for comment

The proposed rule and draft Food Traceability List are available for public comment until 21 January 2021.

The proposed rule can be accessed here.


Khelin Aiken practices in the area of US Food and Drug Administration regulatory and compliance law. She leverages her deep understanding of the US Food Drug & Cosmetic Act, US Public Health Service Act and their implementing regulations along with her prior experience at the US Food and Drug Administration (FDA) to help clients develop and achieve their strategic business objectives. Khelin previously served as regulatory counsel at the FDA in the Center for Drug Evaluation and Research, in both the Office of Regulatory Policy and in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff.