The FSMA Journey Continues | What’s Ahead for Food Traceability

By Manex Consultant, Michael Guerini Ph.D.

An increasingly globalized supply chain and evolving regulations are making food traceability a priority for food and packaging manufacturers. Businesses in the food sector must trace materials across different production stages to demonstrate that products meet safety and quality standards.

On November 7, the U.S. Food and Drug Administration (FDA) announced its final ruling for Rule 204, the Traceability Rule.

The rule focuses on additional recordkeeping requirements for businesses that manufacture, process, pack, and/or hold foods that are listed on the Food Traceability List (FTL). In creating this list of key products that will require enhanced traceability, the FDA used a Risk Ranking Model, which scored hazardous potential relating to the frequency of outbreaks, severity of illnesses, and other related factors.

processed food in containers

What foods are affected by FSMA Rule 204?

Foods that are in the cross hairs of this rule are currently on the FTL and include:

  • Cheeses other than hard cheese
  • Crustaceans
  • Cucumbers
  • Finfish
  • Fresh herbs
  • Fresh-cut fruits and vegetables
  • Leafy greens
  • Melons
  • Mollusks
  • Nut butters
  • Peppers
  • Ready-to-eat deli salads
  • Shell eggs from domesticated hens
  • Sprouts
  • Tomatoes
  • Tropical tree fruit

Food Traceability Rule 204 will have a far-reaching impact.

Any facility that holds, packs, manufactures, or processes one or more foods on the FTL must keep records of any Key Data Elements (KDEs) resulting from Critical Tracking Events (CTEs). While only those who deal with foods on the list are mandated, the FDA is encouraging others to adopt the same traceability processes.

A facility must create KDEs for each of these CTEs:

  • Growing
  • Receiving, including first receiver
  • Creating
  • Transformation
  • Shipping

With the goal of making foods safer, the proposed rule requires a detailed account of food origins and movements throughout production, processing, and shipping, even as these foods are transformed into other food products, or as other foods are added to them. You read that correctly – even if these items are an ingredient in your products – you will need to maintain enhanced traceability records for these items.

From the publishing of Rule 204 in November 2022, organizations will have two years to come into compliance. However, the longer a company waits, the more challenging it will be to be fully compliant by 2025.

Not sure what food traceability and Rule 204 means for you? We suggest these five steps to help you on this journey.

  1. Watch for updates from FDA on the final rule and if you are having trouble deciphering the information – reach out and ask for help.
  2. Challenge your current system of traceability. Do not make it easy – really challenge your team to see if they can take the finished product back to the sources of all ingredients and for any on the above list – can you get it to the boat/field/farm of origin.
  3. Review opportunities to start digitizing your information or enhance your current system of traceability.
  4. For those that have foods on the list – begin building your system to track KDEs that come from CTEs.
  5. Take the time to optimize your current systems. Over the years as food manufacturers step up to meet customer requests, audit standards and regulatory requirements, we often capture more and more information – consider an assessment of your program to see if you are gathering the correct type and amount of information.

For more information or assistance, contact Manex directly at 925-807-5100 and

About the Author

Michael Guerini, Ph.D., is a food safety consultant with Manex and has more than 10 years of experience in food safety, specializing in Food & Drug Administration (FDA) and U.S. Department of Agriculture (USDA) audit protocols, biologics and remediation. He is proficient in microbiology, food safety, auditing, audit preparation and quality assurance; and skilled in developing production plant standard operating procedures (SOP), sanitation standard operating procedures (SSOP), hazard analysis and critical control points (HACCP) and Food Safety Modernization Act (FSMA) plans.