The FDA’s decision in March to delay the implementation of a new traceability guideline should give countless food companies the time they need to put these new requirements in place. But companies must still ensure everyone is on board and adopt a policy of collaboration if they want to ensure they meet their obligations on traceability.
“This is a cross-functional effort. You need input and effort from a diverse set of stakeholders, and each stakeholder should be aware of what needs to be done, why it must be done, and how it's going to get done,” Sara Bratagar, Food Traceability and Food Safety Scientist at the IFT’s Global Food Traceability Center (GFTC), said this week.
Speaking in a webinar hosted by Food Safety Magazine on Tuesday, Bratagar discussed how companies can prepare to implement FSMA 204D and why they must look at themselves in terms of the wider food supply chain.
“It’s really important to think about what the supply chain or the larger food system needs for end-to-end traceability and how you fit into that and how you can fill the gaps within your own responsibilities in the system.”
Entitled “FSMA 204: How to Achieve Traceability and Transparency Along Your Supply Chain,” the webinar featured a panel of industry experts including Bratagar, Joe Buckley, Director of Food Safety and Quality Assurance at Sysco Corporation, and Takashi Nakamura, Vice President of Corporate R&D and Food Safety at Del Monte Fresh Produce Company.
The webinar examined how companies can implement the traceability requirements of Food Safety Modernization Act 204D (FSMA 204D). In March, the U.S. Food and Drug Administration (FDA) announced that it is delaying the compliance date for the rule by 30 months.
The FDA said that the extension gives companies “the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements.”
The FSMA 204D guidelines state that every company in the U.S. that manufactures or holds food products on the FDA’s Food Traceability List must carry out the recordkeeping requirements detailed in Section 204D of the FDA Food Safety Modernization Act (FSMA).
This means companies must keep records of Key Data Elements and Critical Tracking Events, and be able to provide the information to the FDA within 24 hours, if requested.
The food traceability list covers a wide range of foods, including:
The FDA defines traceability as “the ability to follow the movement of a food product and its ingredients through all steps in the [food] supply chain, both backward and forward. Traceability involves documenting and linking the production, processing, and distribution chain of food products and ingredients.”
During Tuesday’s webinar, Joe Buckley said it is imperative that companies should make the most of the 30-month extension.
“FSMA 204 takes time and a great deal of energy to understand and prepare to meet the requirements. Those out there that may have gotten a little bit of a later start in preparation, I encourage you to take advantage of the 30-month extension and do not underestimate the time it can take to prepare.”
Buckley said it is very important for companies to build the right team to implement FSMA 204D.
“Having a cross-functional team that understands its functions, deliverables is vital to the success of the project. Another key to success is having executive sponsors who can support key decisions and ensure that they understand business impacts across your organization.”
Takashi Nakamura said a variety of teams are needed for FSMA 204D to work.
“It's operations, it's sales, it's finance, it's procurement, and there are so many different elements that go across all these different functions. So it is not just one department that is to look at addressing.”
He added “there's just so many different nuances of this that you can't put yourself in just one bucket and silo yourself and think I'm done.”
Panelists also discussed why traceability is so crucial.
“Better traceability and better master data are just good for business in so many ways. Organizations, large and small, have so many items to manage. Managing those items is so much more difficult if the data lacks accuracy and standardization,” Buckley said.
For Bratagar, the business benefits were also clear.
“On the commercial benefit side, it can be used to substantiate claims that differentiate products, reduce the cost of recalls and litigation, improve supply chain efficiency, reduce supply chain risk, and help comply with regulatory requirements that allow for access into new markets or just continued access in the markets you're already in.”
The 30-month delay for implementation was met with a mix of praise and concern in the food industry.
The National Grocers Association said in a statement that the delay will provide “much-needed relief” for independent grocers who are finding difficulty with implementation.
“Disproportionately impacting smaller grocers, the traceability rule’s original timeline was nearly impossible to meet across the vast and dynamic food system. It quickly added exorbitant costs and operational complexity, threatening grocers’ ability to serve their communities effectively,” the NGA said.
FMI - The Food Industry Association said, “more time is needed for compliance with the overly complex rule to ensure it does not unnecessarily increase food costs and burden the food supply chain.”
The FMI referred to the traceability rule as “the most complex FDA regulation our industry has ever faced.”
Some watchdog groups criticized the delay. In a statement, Brian Ronholm, Director of Food Safety at Consumer Reports, saids the decision to delay “is extremely disappointing and puts consumers at risk of getting sick from unsafe food because a small segment of the industry pushed for delay, despite having 15 years to prepare.”
If you missed this week's webinar, you can still view it on-demand until April 15, 2026 by registering here.