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“Small Entity” Traceability Guide Just as Applicable to Large Entities

Although FDA titled its new Traceability Rule publication: “Small Entity Compliance Guide,” we see no real reason it singles out small entities, as the guidance appears to apply to anyone who is required to comply. Consisting of more than 50 Q&As (labeled A to YY), the guide provides a general overview of the rule, required traceability plan, and recordkeeping. However, we see gaps in the agency’s guidance on some of the more technical aspects of implementation, that will continue to elicit questions and cause challenges for the industry.

The first four questions/responses of the guide focus primarily on the who, what, and when of rule compliance, including an 8-page table detailing full and partial exemptions. Following that is a very brief section on the Traceability Plan, then detailed discussion (5 ½ pages) of records that are to be kept on Critical Tracking Events (CTEs) for various foods on the Food Traceability List (FTL). The guide only slightly mentions the FTL, referring instead to another publication for detailing of the foods on the list.

Although a separate FDA Traceability Rule page notes that those required to comply must “maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs),” the guide mentions KDEs only three times, primarily in its definitions (e.g., “Information associated with a CTE for which a record must be maintained and/or provided”). Questions H-Q essentially restate the KDE requirements from the rule, with no additional context provided by use of example scenarios.  Question Q addresses Transformation CTEs, and it would have been nice to see the agency provide some clear examples of how they view compliant recordkeeping when combining previously assigned traceability lot codes into a new traceability lot code, or if a change in an FTL input should trigger a new transformation assigned traceability lot code. This level of clarity will help the industry comply and help ensure investigators have access to high fidelity data during traceback and outbreak investigations. 

One area for which the guide does provide information that could be of greatest benefit to smaller entities is its Q&As on waivers. The primary reason FDA would consider waiving requirement(s) of the rule would be for economic hardship due to an entity’s unique circumstances. Consideration for waiving requirements could be initiated by FDA itself, by an entity’s request, or by a citizen petition for a type of entity, however it would only be considered if it did not impair the traceability in an outbreak or other critical event and if it would not be “contrary to the public interest.”

Altogether, we see the guide as providing some good general information about the rule that can provide a basis of general understanding for the industry. However, it does not go into the level of detail of the questions that are being asked by those trying to determine how to be compliant. We are hearing (and helping companies answer) questions such as: How do I sufficiently document that I comply with the descriptions required by the food safety plan? How do I create a systemized approach to identify the CTEs and KDEs? When do I keep an existing lot code vs. creating a new one? What records do I use to document and support my plan?

Any mention of the Traceability Plan brings up numerous questions, in and of itself. This is primarily because what may seem simple on the surface gets complex when you start to map it out; and because you have to rely on others in the supply chain to do their part to ensure accuracy on your part. Because of this, and because of the fluid nature of the supply chain, we would recommend that everyone in the industry develop a Traceability Plan even if you are exempt. There are two reasons for this:

  • The plan is required for any FTL food, so if you ever handle an FTL food, you will need to have one in place. Therefore, creating your plan while you have time to do so will be much less stressful than having to have one at the eleventh hour.
  • Some customers will require that you have a Traceability Plan in order to do business with them and will not honor exemptions. With the number of suppliers with whom they deal, large companies won’t want to, or have the mechanisms or time, to track and maintain information on exemptions across their supply chain. So, again, putting a plan in place, regardless of an exempt status, will be smart business.

On TAG’s team is an expert who was involved in the development of many of the founding principles of what became the Traceability Rule, so we have the experience and expertise to help you determine what products are subject to the rule, develop your CTEs and KDEs, write your plan, and ensure you comply.

To help companies get started, we are offering an initial assessment, to include a Zoom call and initial written assessment at a discounted rate, during which we will help you determine what CTEs and KDEs apply to you.  For more information, or to schedule your assessment, give us a call or email [email protected] with the subject line: Traceability Rule Assessment.


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