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Food traceability rule remains a proposal more than a decade after being mandated

By on November 8, 2022 0

After years of development and still not final, the FDA’s proposed rule on food traceability has been made public and shows that some parts will be voluntary for industry.

The rule is part of congressional mandates in the Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011.

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Formally named “Requirements for Additional Traceability Records for Certain Foods,” the rule, if enacted, would apply to people who “manufacture, process, package, or preserve foods that the (FDA) has designated for inclusion in the food traceability list”.

In its advisory on the proposed rule, the Food and Drug Administration stated that “the proposed requirements would help the FDA quickly and effectively identify recipients of these foods in order to prevent or mitigate outbreaks of foodborne illnesses and address credible threats of serious adverse health consequences or death”.

A key element of the proposed traceability rule is the “Food Traceability List” (FTL), which will specify which foods will be covered by the prose rule. Only certain foods would be bound by the proposed rule.

“While the proposed requirements would only apply to foods listed on the FTL, they were designed to be appropriate for all FDA-regulated food products. The FDA would encourage voluntary adoption of these practices nationwide. industry,” according to the FDA’s announcement of the proposed rule.

“At the heart of this proposal is a requirement for those who manufacture, process, package or store food on the Food Traceability List (FTL) to establish and maintain records containing key data elements (KDEs) associated with different critical tracking events (CTE). ).”

Main features of the traceability rule

1. Critical tracking events

The proposed rule identifies growing, receiving, transforming, creating, and shipping as CTEs for which KDE-containing records would be required. KDE requirements vary depending on the CTE being run. Records required at each ETC should contain and link the food lot traceability code to the relevant KDEs.

The main areas for critical tracking events are:

  • Growth — For products like fruits and vegetables, cultivation is usually the first step in the supply chain. In addition to the general key crop data elements, sprout growers would be required to establish and maintain additional key growth data elements that are sprout specific. The FSMA gives special treatment to germs because of the greater danger they represent.
  • Receive — is an event in a food supply chain in which food is received by a customer, other than a consumer, at a defined location after being transported by truck, ship or other means to from another defined location. In addition to the general key data elements for receipt, “first recipients” should establish and maintain additional key data elements.
  • Creation — is the manufacture or production of foods on the food traceability list, for example by manufacturing or processing, using only ingredients that are not on the food traceability list. Creation does not include the origin or processing of food.
  • Transformation – is an event in the supply chain of a food which involves the modification of a food on the food traceability list, its packaging and/or its label – concerning the traceability lot code or the identifier of traceability product – such as combining ingredients or transforming a food such as cutting, cooking, mixing, repackaging or repackaging. Processing does not include the initial packaging of a single ingredient food or the creation of a food.
  • Shipping is an event in a food supply chain in which some food is arranged for transport by truck or ship or other means from one defined location to another defined location on a different farm , a first recipient or a subsequent recipient.
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2. Traceability Program Records

In addition to requiring records of key data elements, as noted above, the proposed rule would require anyone subject to the rule to establish and maintain records of the traceability program. These records are intended to help regulators understand an entity’s traceability program and include:

  • A description of relevant reference records: A company’s key data elements can be kept in various types of reference records, such as bills of lading, purchase orders, or production logs. A company’s traceability program records should include a description of the reference records on which the company maintains the required key data elements. This description would explain where on the master record traceability information appears and, if applicable, a description of how master records for different food tracing events are linked.
  • Foods on the food traceability list that are shipped: The proposed rule would require anyone shipping foods on the traceability food list to keep a list of the listed foods they are shipping, including the traceability product identifier and the traceability product description for each food. This list would be part of a company’s traceability program records.
  • How traceability lot codes are assigned The proposed rule would require traceability lot codes to be established at the origin, processing or creation of a food on the food traceability list. The traceability lot code allows food to be uniquely identified throughout the supply chain. As part of a company’s traceability program records, companies would be required to describe how they establish and assign traceability lot codes. Because of the crucial role traceability lot codes play in the proposed rule, it is important for regulators to know how a company created and assigned these codes so they can better understand the scope of the records they are reviewing.
  • Understand data in required records The proposed rule would require a company’s traceability program records to include any other information necessary to understand the data contained in its traceability records, such as internal or external coding systems or classification schemes, glossaries and abbreviations. . This will help regulators understand the terminology, methods and systems a company uses in its traceability operations.

3. Additional requirements

The proposed rule would also require that:

  • Records are retained as original paper records, electronic records, or true copies; they must all be legible and stored to avoid deterioration or loss.
  • Traceability records are provided to FDA as soon as possible but no later than 24 hours after request.
  • A sortable electronic spreadsheet containing relevant traceability information must be provided to FDA within 24 hours of a request if needed to assist FDA during an outbreak, recall, or other public health threat .

To view frequently asked questions about the proposed food traceability rule, click here.

For a discussion of exemptions to the rule, click here.