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TraceabilityIn early November, the FDA released a new FSMA Proposed Rule for Food Traceability. The rule establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold certain high-risk foods.

For the most part, bakers will not be affected, because the foods on the Food Traceability List (FTL) are not common bakery ingredients. However, there are some exceptions, like nut butters, that bakery manufacturers need to be aware of. Note that the new rule applies not just to the foods themselves, but also to any foods that contain them as ingredients

The rule requires anyone who handles these foods to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs). The five CTEs are growing, receiving, transforming, creating, and shipping. At each CTE, data must be collected and linked to the relevant KDE so that traceability can be established across the entire supply chain.

The rule also requires processors to establish and maintain traceability program records to help regulators understand their traceability program.

There are some exemptions — for example, produce that receives commercial processing that adequately reduces the presence of microorganisms is exempt. And if there’s a kill step in the process, then records don’t need to be maintained for the subsequent shipping of the food.

Here are the examples the FDA gives for peanut butter in the agency’s “Creation and Transformation” presentation:

Peanut butter is an example of a food that is created.

  • Peanut butter is a food on the Food Traceability List (FTL) that is made from peanuts and additional ingredients that may include salt, sweeteners, and/or emulsifiers.
  • Since the individual ingredients of peanut butter do not appear on the FTL, peanut butter is considered a created food for the purposes of traceability.

Peanut butter sandwich crackers are an example of a food that is transformed.

  • Peanut butter sandwich crackers are a product made from a food on the FTL.
  • Peanut butter is added between baked crackers and packaged without further processing and is considered a transformed food for the purposes of traceability. 

Peanut butter cookies are an example of a food that is transformed, however…

  • If the cookies are made with peanut butter and a kill step is applied, recordkeeping requirements would not apply to that person’s subsequent shipping of the food, provided that the person maintained a record of application of the kill step.
  • And for any persons who receive a food on the Food Traceability List that has been subjected to a kill step, recordkeeping requirements would not apply to that person’s receipt or subsequent transformation and/or shipping of the food.

The FDA provides extensive resources to help food manufacturers understand the rule and its implications for their processes. We recommend you review these carefully — better safe than sorry!

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5661 W 120th Street
Alsip, IL 60803



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