New FSMA Traceability Rule

In November of 2022 FDA released final rule on requirements for Traceability Records for Certain Foods.

This requirement is part of Food Safety Modernization Act (Section 204) and is to assure that manufacturing, processing or holding facilities of certain foods have sufficient records to track and recall products that might be harmful to the American Public.

The concept of the rule if that entities who manufacture, process, pack, or hold foods included on Food Traceability List (FTL), maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.

The list of products covered under this rule includes anything from cheese, through vegetables and herbs to fish and salads. Comprehensive list of covered foods could be found on FDA Website at –

In compiling that list FDA considered the frequency of foodborne illness outbreaks related to certain foods, severity of illness, process specifics and the likelihood of contamination.

The rule requires that firms handling covered products gather Key Data Elements records from Critical Tracking Events (CTEs). CTEs include harvesting, cooling, initial packing, first land-based receiver, receiving, shipping and transformation (processing / manufacturing).

Companies are required to establish Traceability Lot Codes to assure product is properly identified and the company can link that code to all records associated with their food.

The rule also requires a written Traceability Program that outlines procedures and responsibilities the companies use to maintain traceability records, collect traceability information, contact information in case of traceability related questions and site maps for farms.

Finally, there is a requirement for records, that covered sites must keep demonstrating their traceability system is complete and effective. If requested, electronic records related to traceability must be made available to the FDA within 24 hours. FDA will still aid during recall or outbreak events to minimize impact on the public.

Companies with 3rd party audits including GFSI (SQF, BRC and others) should be compliant with these requirements. 3rd party audit codes require similar type of documents however the requirements may not include electronic records. Audit codes may give you option for handwritten / hard copy records.

FDA is expected to conduct number of regulatory inspections to enforce compliance to that rule. Don’t wait to the last minute and develop an effective Traceability Program. At BD Food Safety Consultants, we offer consulting services to get your company ready for compliance to the new Traceability Rule. Contact us at for more information and to schedule an appointment.