How is this traceability rule different?
You may already have a traceability program because of food safety certifications or your own
business practices. The data you keep is likely tailored to your business needs, but your supply chain
partners might currently have difficulty linking their food
data back to your farm or food business.
That’s because traditional traceability requires food
businesses to track only “one step up, one step back,” which
essentially answers the questions: where did this food come
from and where is it going? The new traceability rule
expands on that regime in a few ways:
- The rule applies to farms and food businesses. There are a variety of exemptions, for example, for direct-to-consumer sales, but farms and food hubs in general are subject to the rule.
- But, this rule only applies to certain foods considered “high-risk.” These foods are listed on the Food Traceability List (FTL); see below.
- It adds speed to the equation. In the event of an investigation, all data must be handed over to the FDA within 24 hours. Most food businesses would need to do this in an electronic sortable spreadsheet format.
- Specific, standardized data is required to ensure consistency across the supply chain. Food businesses must create, maintain, and pass forward traceability lot codes (TLCs), which follow the food throughout the entire food chain (until a new TLC is assigned or the product is sold). On top of that, harvest, cooling, shipping, receiving, and transformation data must be kept and shared when needed. See below for more on these required data points!
Does this rule require me to keep digital records?
The rule does not require digital recordkeeping. However, there are requirements that strongly incentivize the use of digital records. Those requirements:
- Requested data must be submitted to the FDA within 24 hours. Most businesses will also have to have an electronic, sortable spreadsheet available within this time frame.
- There are many complex data points that have to be kept under the rule, making pen and paper increasingly impractical.
- Traceability Lot Codes (TLCs) must be linked across handlers.
What data tracking does the rule require?
When must this data be collected?
This data must be collected at each CTE. CTEs include:
- Harvest
- Cooling
- Initial Packing
- Shipping
- Receiving
- Transformation
What fresh produce is subject to this rule?
Please note that this is an abridged version of the FTL. Soft cheeses, some seafood, shell eggs, and nut butters are also included on the longer list.
Who is exempt from this rule?
Remember, foods that are not on the Food Traceability List (FTL) aren’t subject to the rule. In addition, some businesses or types of sales are exempt from the rule even if the food they sell is on the FTL. We’ve included exemptions below that apply to produce farms and their supply chain partners. Exemptions relating to shell eggs and seafood are not included here. All exemptions can be found in the rule here..
Key Resources
- FDA’s Exemptions Quiz/Interactive Flow Chart
- Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation
- FDA Supply Chain Example: Produce
- FDA’s Food Traceability Rule At-A-Glance Factsheet
- Additional Traceability Records for Certain Foods (Rule 204 text)
This is a beginner’s guide. For more detailed information, please refer to Farm Commons’ guide “Preparing for 2028: Traceability rule” or the Key Resources linked above.
