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Guide to FDA’s Proposed Food Traceability Rule: What Has Changed in 2021?

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Although prevention is the gold standard in food safety practices, most pathogens aren’t entirely preventable and outbreaks are still inevitable. When a foodborne pathogen sickens consumers, a fast response can literally save lives. During E. Coli outbreaks in romaine lettuce between 2018 and 2021, there wasn’t sufficient accessible electronic data to allow a quick discovery of the source. Although the 2011 Food Safety Modernization Act (FSMA) required some traceability recordkeeping, the rules weren’t stringent and allowed for paper and other manual methods of sharing records. 

As part of its response to recent outbreaks, the Food and Drug Administration (FDA) proposed a new traceability rule that will require entities throughout the food supply chain to maintain electronic shareable data that links certain foods all the way from the field where they were grown to the end consumer. The FSMA Proposed Rule for Food Traceability was originally announced in September 2020, underwent changes in early 2021, and is still under evaluation.

FDA’s Proposed Food Traceability Rule 

The new rule would require data to be collected for each critical tracking event (CTE) the product passes through. CTEs are defined as any step where data needs to be collected in order to maintain traceability of the product. They are specific to each product depending on the steps it goes through. Typical examples of CTEs include growing, receiving, and shipping. At each CTE, the data points that need to be collected are referred to as key data elements (KDE). Growing coordinates, cooling and receiving dates and times, and location identifiers for each CTE are common KDEs. You can explore other CTEs and KDEs in FDA’s illustrative guide.

FDA’s new rule aims for every product on its list to be traceable back to the source so the industry can respond quickly and in a targeted way to outbreaks and contaminations. Under the new rule, entities would be required to maintain full records for at least 2 years and be able to provide them in a sortable electronic spreadsheet to the FDA within 24 hours of a data request. This would empower FDA to act quickly during an outbreak or public hazard and apply a targeted recall for specific products produced in a certain area. They will have an enhanced ability to remove the correct foods from the market, meaning that consumers will be protected sooner. 

And there’s another positive implication for the food industry, too: When FDA lacks sufficient traceability data they end up either imposing an extremely broad recall or distributors and consumers are forced to avoid a large category of food. With field-level tracking and highly targeted recalls, the overall industry will be less impacted by outbreaks they aren’t related to.

Central to the rule is the list of affected foods, called the Food Traceability List (FTL), which FDA established by assessing the relative risk involved in the production and handling of each food. This is the entire FTL as it currently stands:

  • Cheeses, other than hard cheeses
  • Shell eggs
  • Nut butter
  • Cucumbers (fresh)
  • Herbs (fresh)
  • Leafy greens (fresh), including fresh-cut leafy greens
  • Melons (fresh) Peppers (fresh)
  • Sprouts (fresh)
  • Tomatoes (fresh)
  • Tropical tree fruits (fresh)
  • Fruits and Vegetables (fresh-cut)
  • Finfish, including smoked finfish
  • Crustaceans
  • Mollusks, bivalves
  • Ready-to-eat deli salads

There are also exceptions to the rule, such as small growers selling directly to consumers, nonprofit food establishments like food banks, and foods that go through a kill step or high levels of processing.

2021 Updates to the Rule

Earlier this year, updates were released to the proposed rule. Accompanying the changes, FDA released an explanation of what had changed and why. The main adjustments were clarifying language around the list of affected foods. Updates to the food list include clarifying which types of cheese are impacted and adding “fresh” to some foods to limit the scope of what products are included.

In addition, FDA released a list of frequently asked questions to provide more clarification around the rule. The FAQs can be accessed on the Proposed Traceability Rule webpage. Overall the rule remained largely unchanged from its first iteration aside from more explanation and clarification.What Comes Next?

Once the rule is put in place, it will take 2 years for the new requirements to go into effect. This gives food safety teams plenty of time to choose software platforms, create new SOPs around data collection, and run self-audits and recall drills using their new traceability data. After the 2 year period, the rule will be in full effect for every food on the list for all companies who hold foods during a CTE.

The last open comment period ended in March 2021 and all online comments are still viewable. FDA has stated it will be taking those comments into consideration, but hasn’t provided a recent update. Although it is uncertain when the FSMA Proposed Rule for Food Traceability will be passed, 2022 is a common estimate meaning full compliance would start being required in 2024.

How to Start Preparing

Even though it’s unknown when the new rule will pass, food safety teams can start now to plan their own timeline based on how many of their crops are included in the FTL. This will determine how extensive their implementation will be and how much of their operation will be affected. 

Companies can get a head start on evaluating traceability documentation methods now, even if they aren’t ready to put one in place. That way, they can be aware of their different digital options and get buy-in across their organization. 

Some software platforms that gather and share traceability data also fill other business needs, like documenting food safety compliance and quality assurance. By integrating multiple digital solutions into one product, operations can benefit from a streamlined adoption across their entire organization. HeavyConnect Inspector is a mobile-based platform that allows food producers and processors to easily maintain traceability records that can be shared seamlessly across the supply chain while also documenting their compliance with all relevant food safety and quality standards. 

Impact of the New Rule

As technology becomes more integrated throughout the food supply chain, traceability recordkeeping will be easier and less burdensome for individual companies. Even more importantly, as various software recordkeeping platforms can integrate with one another, unified data can flow through the supply chain between partners. Although adoption will be challenging, companies who start moving towards traceability models now will be well positioned to meet the new traceability rule when it passes and help move the market towards quicker responses to recalls.


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