What does the FDA Traceability Rule mean for the Seafood Industry?

If you intend to ship your seafood product to the US in 2026, you will probably need to record and store traceability data for your product.

Just last month, the FDA released its much anticipated “Requirements for Additional Traceability Records for Certain Foods,” often called Section 204, as part of the FDA’s Food Safety Modernization Act (FSMA), a law signed into law back in 2011. 

The purpose of the act is: 

Businesses that manufacture, process, store, or pack food need to keep traceability records, and the business has to share this with the FDA in a reasonable time frame (~24 hours).

Why does the FDA have a Traceability Rule? 

Part of the Food and Drug Administration’s mandate is to protect public health against food-borne illnesses (Biological, chemical, toxins, or allergens). 

Don’t mix this rationale with the mandate from the National Oceanic & Atmospheric Administration (NOAA), whose traceability rules (e.g. SIMP) focus on reducing the occurrence of Ilegal, Unreported, and Unsustainable (IUU) fishing practices.  

The reasoning around enforcement of this rule is to “ allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.” So, if a hazard is found, it will be easier to find the source and reduce the number of people who get sick. 

Does this affect Canadian Businesses?

Yes, if you export your products for consumption in the US, your products fall under this rule, and you must keep traceability records if your food is on their Food Traceability List. 

What foods are included in this rule? 

This is where the Food Traceability List (FTL) comes in. The FDA scored each broad food group on metrics, like frequency and severity of illness, to determine what foods should be on the list and which ones were left off. 

For our Canadian Companies, the relevant food groups on the list include: 

• Finfish: Examples include, but are not limited to, tuna, mackerel, amberjack, jack, swordfish, yellowtail, cod, haddock, salmon, and trout.

• Crustaceans: Includes shrimp, crab, and lobster.

• Molluscan shellfish, bivalves: Examples include, but are not limited to, oysters, clams, and mussels. Does not include scallop adductor muscle.

Where does Traceability need to start? 

For the seafood industry, the FDA states that Traceability starts with the “First Land-Based Receiver.” We read this as the first financial transaction of goods on land, so this would generally be the buyer on the wharf or the first processing plant. 

It’s important to note that fishing vessels are largely exempt from this rule, so traceability records are generally not needed, even if processing happens on the vessel. Of course, NOAA and DFO already require fishing data from some vessels, but that’s outside the scope of the FDA’s rule. 

The first land-based receiver would have to record information like species, harvest location, and harvest date ranges. They also have to apply lot codes to the product they receive. 

Why is Traceability needed by so many bodies, and what can we do about it? 

There is a lot of overlap of traceability data requirements between different organizations: US Government (NOAA & FDA), Canadian Government (DFO, CFIA), and Certification Bodies (MSC, BRC, SQF). They all have their own mandates and scope that require traceability information.  

Standardization of this data will make it easier to record and share this data with everyone. That is why Mabel Systems was the first Seafood Traceability service provider to offer GDST-capable traceability software.

When does this take effect?

The traceability rule takes effect on January 20, 2026.   

What does all of these mean?

Well, we now have a date for the end of Simple Volumetric Inventory Management for the seafood industry. If you intend to ship your product to the US in 2026, you will need to store item-level traceability data for your product. This won’t be a big change for some products that already have these requirements (oysters, mussels, etc.), but will be a big change for others, like the lobster industry. 

There are still a few years to unpack how these rules will be implemented and enforced, so stay tuned. The FDA is also planning outreach and training opportunities before the rule is enforced.  

Please feel free to reach out to me if you have questions about the FDA’s Traceability Rule or Seafood Traceability in general. 

Gavin 

gavin@mabelsystems.com  

Links: 

FDA’s Food Traceability List: 

https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list

FDA’s Final Traceability Rule:
https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods

Sorry for all the acronyms.   

FDA = US Food and Drug Administration 

NOAA = National Oceanic & Atmospheric Administration

CFIA = Canadian Food Inspection Agency

DFO = Canadian Department of Fisheries and Oceans 

FSMA = Food Safety Modernization Act (US) 

FTL = Food Traceability List (US FDA)

SIMP = Seafood Import Monitoring Program (US NOAA)

IUU = Illegal, Unreported and Unregulated Fishing 

MSC = Marine Stewardship Council

BRC = British Retail Consortium Certification 

SQF = Safe Quality Food Certification 

GDST = Global Dialogue on Seafood Traceability Standard