In 2011, U.S. President Barack Obama signed the Food Safety Modernization Act (FSMA) into law in a bid to bolster the country’s defense against foodborne illnesses.
On 20 January 2026, new rules linked to FSMA Section 204 will come into effect, and the seafood industry – from the top to the bottom of the supply chain – will need to be ready for it, according to trade experts.
During a presentation at the 2024 Seafood Expo Global – which ran from 23 to 25 April in Barcelona, Spain – Domenic Veneziano, a U.S. Food and Drug Administration (FDA) regulatory and strategic consultant who was also the director of import operations within the administration, said the driving force behind FSMA’s creation was a spate of recalls in 2007.
That year has been dubbed “the year of the recall” by Consumer Reports Magazine, with incidents ranging from Gold Star Sausage Company recalling 15,000 pounds of sausage due to listeria contamination to Conagra Foods recalling 325 million pounds of peanut butter due to salmonella contamination.
When enforcing the recalls, FDA staff were forced to investigate every link in the supply chain. That took a lot of time and led to the creation of a more streamlined system under FSMA, Veneziano said.
“That’s one of the major reasons why FSMA, specifically the traceability provisions, came into play back in 2011,” he said.
One part of FSMA that is particularly relevant to the seafood industry is the FDA final rule on Requirements for Additional Traceability Records for Certain Foods. The rule, which enforces Section 204 of FSMA, adds a new set of recordkeeping requirements above and beyond existing regulations for any company that manufactures or holds foods included on the FDA’s lengthy Food Traceability List. Those new requirements will, as of Tuesday, 20 January 2026, come into full effect.
Once Section 204 kicks in, companies will need to maintain extensive records with key data elements (KDEs) associated with what the FDA calls critical tracking events (CTEs). Companies will then need to be able to provide the FDA with information on both KDEs and CTEs within “24 hours or within some reasonable time to which the FDA has agreed,” according to the administration.
Trace Register President Heath England said that as of 20 January 2026, any company not meeting those traceability requirements will face problems.
“It’s important to understand this is already law,” England said. “They’ve simply said, ‘We’re not going to enforce it until 20 January 2026.’ There are some people running around going, ‘Well, the law will get repealed, or something will change.’ There is a very slim chance that that enforcement date might get moved – but I certainly wouldn’t count on it because they’ve given us a lot of time.”
According to England, a lot of seafood companies haven't fully grasped what enforcement of FSMA Section 204 means.
“I’ve spoken with a lot of producers in other countries over the past several months, and they will say things like, ‘Well, I’m just going to let my broker take care of that,’” he said. “That’s not the way this works. There is information that you as a manufacturer or you as a producer must generate and keep if you wish to do business in the U.S. with items on the food traceability list, which comprise the vast majority of seafood.”
Almost all fresh, frozen, and previously frozen finfish products fall under the new requirements, per the traceability List. That includes histamine-producing species like tuna, mahi, mackerel, amberjack, jack, swordfish, and yellowtail; species potentially contaminated with ciguatoxin like grouper, barracuda, and snapper; and species not associated with either histamines or ciguatoxin like cod, haddock, Alaska pollock, salmon, tilapia, and trout.
The only finfish species specifically not under the requirements are siluriformes fish like catfish – which underwent a shift in jurisdictional authority from the FDA to the U.S. Department of Agriculture’s Food Safety and Inspection Service in 2018.
Other species covered under the new rules include smoked finfish, all crustaceans, and almost all molluscan shellfish including oysters, clams, and mussels. There is only one small exception to FSMA 204 for some shellfish: raw bivalve molluscan shellfish that are “covered by the requirements of the National Shellfish Sanitation Program; subject to the requirements of 21 CFR part 123, subpart C, and 21 CFR 1240.60; or covered by a final equivalence determination by FDA for raw bivalve molluscan shellfish.”
“If you don’t understand FSMA and you’re not gearing up to get ready for it, you need to,” England said.
There are a few parts of the legislation that England labeled as essential and that seafood companies need to keep in mind.
“It’s possession-based – not ownership-based. Wherever that physical product is going, those are the people who have to keep these records,” England said. “The key provision to this … is to be able to get quickly back to the source of the problem.”
The way the FDA is aiming to achieve this level of traceability is through a traceability lot code (TLC) that, theoretically, will be able to give the FDA information that links directly back to the source of any product.
A key problem facing seafood companies is that new parts of the supply chain will need to keep some of those records – like third-party cold-storage providers.
However, some services and systems have already been gearing up for changes to FSMA. The Global Dialogue on Seafood Traceability (GDST), which released its first traceability standards at the 2020 Seafood Expo North America, has created what it has dubbed the FSMA 204 pathway, which can help seafood companies meet Section 204 standards.
The pathway contains a set of guidelines that can help seafood companies achieve interoperable traceability throughout their supply chains.
“The FSMA 204 pathway is a fit-for-purpose pathway whereby if you’re compliant with GDST requirements, you can use that same data to comply [with FSMA 204],” GDST Executive Director Greg Brown said.
Brown added that, conversely, companies can use the same investments they make for FSMA compliance to work toward GDST standards.
“Using the same investment that I’m making into FSMA, companies can exemplify sustainability and supply chain transparency, as well as identify provenance and anti-IUU [illegal, unreported, and unregulated fishing] credentials,” he said.
Elsewhere, England’s company, Trace Register, joined forces in April 2024 with ReposiTrak to advance FSMA 204 compliance with retailers, wholesalers, and seafood suppliers.
“Trace Register is already collecting the FDA-required KDEs from seafood suppliers,” England said in a release during the announcement. “Now, through interoperability with ReposiTrak, that specific data set can be sent to their retailer and wholesaler customers without the need to log in to one more portal or system.”
Other companies like Deloitte have released guidelines on how to capitalize on the FSMA 204 requirements to increase value.
Complying with FSMA will be just one benefit of increased traceability standards, England said. When U.S. President Joe Biden recently signed an executive order strengthening bans on Russian seafood, companies that already had full-chain traceability systems were able to adapt much more quickly.
“We had a lot of our customers calling us and going, ‘Does this affect me?’ The answer was, ‘Well, let’s just take a second and look at your system and see because we have full chain traceability,’” England said. “If you have a good system in place and you have those digital records, you can very quickly and easily identify what may be or is not at risk.”
