ORLANDO, Fla. — Section 204 of the Food Safety Modernization Act was a major focus of GS1 US's annual conference, held in early June.
In one session, Jeffrey Cree, director of supply chain data ops and standards for ADUSA Procurement, an Ahold Delhaize USA company, and Andrew Kennedy, principal traceability adviser for New Era Partners, walked attendees through a 19-month plan Cree deployed to help the company prepare for compliance.
One piece of advice is not to panic, Cree said, adding that he was overwhelmed when he realized how far-reaching the regulation would be for his company.
“Panic a little, but then calm down,” he said, assuring the audience, “We're going to get there.”
Cree and ADUSA Procurement worked with New Era Partners to deploy its “Learn, Plan, Do, Review” strategy to prepare the global retailer for FSMA 204 implementation. Kennedy said it's important to remember that FMSA 204 implementation is a project, and like implementing any other project, it is a process.
“If you don't understand where you are today, it's hard to plan out where you're going to go next,” Kennedy said. “We really encourage people to spend the majority of their time right now in learning and planning and really understand where you're at and how to implement this going forward. We always say measure twice and cut once.”
Learn
FSMA 204 is a complex rule, and Cree said the first step in implementation was to understand the rule's implications for the business. He created internal guides to introduce FSMA 204 to the executive team.
“You've got a 60-second elevator pitch to let your executive team know what this is and what your approach is going to be,” he said.
Next, Cree said ADUSA Procurement identified the change of physical location as a key trigger for critical tracking events, or CTEs. The team mapped the physical flow paths of products within the network.
“It was eye-opening, even to me sitting in the supply chain. There are some ways that product gets into our [distribution centers], into our stores that I wasn't aware of,” he said.
The next step, Cree said, was to identify gaps in information collected or missing information. Then he looked at the teams impacted by the regulations. Cree and the team created a physical inventory flow to look at the number of steps in the ways physical inventory gets moved within the company — from reclamation to hub-and-spoke to direct-to-store delivery — and then identified the CTE in each of those modes.
(Photo: dizain, Adobe-Stock)
Plan
“Like any other project, we want our business requirements to be our anchor,” Cree said. “Getting the requirements all documented and down on paper is our first major step.”
Cree said ADUSA Procurement has identified 208 high-level requirements within the organization as part of FSMA 204 implementation, but it plans to go down to a lower level in the future.
And, given the scope of requirements and the impact FSMA 204 has on many portions of the business, Cree said the business needed to have a steering committee with work streams. Cree said leadership wanted to keep the work streams focused on business units or processes such as master data management, distribution and transportation operations.
While ADUSA Procurement still uses UPC values and not GTINs in its ERP system. Cree said supplier partners must help identify which products are in the scope of FSMA 204.
“We're going to have a lot of vendor outreach,” he said. “We need to reach out to any supplier that has a human edible product and ensure that their catalog is being reviewed and updated.”
Do
Cree said he and the team discussed FSMA 204 plans with supplier partners as part of the vendor outreach, asking if case labels will change or if the supplier plans to change its operating plan.
“Communicating with suppliers is extremely important,” he said. “This is all a partnership.”
ADUSA Procurement plans to issue initial supplier communication in July. Requirements include GTINs and GLN packaging hierarchy. Cree said FSMA 204 will be a catalyst to bring GTINs into the network. He said that supplier requirements need to factor in different levels of technical competencies.
“We need to consider solutions for supplier partners who have different technological experiences and resources available to them,” he said. “It's a spectrum, so we need to make sure we have more than one solution.”
Then, Cree said, it's important to conduct a beta test built into the project plan for FSMA 204 implementation. Looking at 2026 compliance, he said, means the company will look to 2025 for beta testing.
“When can we have everything ready to go so that we can really test this without strict validation rules?” he said. “We're not going to reject any product, but let's make sure all the pipes are connected and flowing seamlessly.”
Review
Once the FSMA 204 implementation goes from planning to compliance, Cree said a critical step is a continual review. Creating a FSMA 204 implementation plan is not a set-and-forget process. The team will need to monitor internal compliance and supplier compliance.
“We need to constantly validate that these systems are working, that our traceability operating plan is functional, and we need to monitor compliance,” he said. “Monitoring compliance is going to require a comparison of the physical events to the digital events, so we need to ensure that we build a proper audit program into this solution.”
He also said it's important to build in a third-party audit of a traceability program to ensure its effectiveness.
Challenges
When asked what challenges Cree experienced in preparing for FSMA 204, he mentioned the operational costs that FSMA 204 could bring in the strictest interpretation of the rule.
“This could require our selectors in a DC to have to stop and physically scan the product as they are selecting it and shipping it out,” he said. “If we multiply that out by the number of selection events that occur on a FSMA-impacted product, it's a significant cost that would inevitably pass down to the consumer.”
He said his company is looking at ways to improve the callback and traceback procedure while minimizing the cost to the consumer.
Another concern, Cree said, is when product is on display.
“What happens when we have loose product in a store?” he said. “We're sending it back to a reclamation center. What about a return to one of our DSD suppliers? What does that look like? I've lost the association to a TLC at that point. How can we comply?”
Kennedy, too, said another challenge is that often the lot code is not unique from different suppliers and the labels aren't always readable.
“If you're as a retailer, you're trying to receive a product and identify the traceability lot code,” he said. “With that traceability lot code, you want to link it to the traceability lot source or reference. If it's not unique, that means two different plants can ship in the exact same product with the exact same lot code but from two different sources.”
He said traceability lot codes need to be unique by facility and not just by date code.
Another challenge, Kennedy said, is if a facility receives a nonconformant product without a traceability lot code from a vendor.
“What I encourage people to do is treat it like any other food safety program. You have a corrective action program that is intended for any product that you receive that's nonconformant to your specifications,” he said. “Identify the issue, record it and then, depending on the type of product in the type of resolution parameters you have, you could reach out to the supplier to get the lot code.
“You could have a methodology for assigning a lot code based on your corrective action and log it and record it, so if the FDA ever does inspect your records, you could say, ‘Look, we had a nonconformant product,” he continued. “We recorded it with a follow-up from our quality folks to get that lot code and tie it to the number we use to track through our facility. You can come up with workarounds that can be resolved later but don't impact the product flowing through your facility.”
Resources
Kennedy mentioned that New Era Partners created scorecards to track key data elements, or KDEs, to understand what suppliers are conformant or nonconformant within a supply chain. There's also templates for gap analysis and even a recipe to help retailers track ingredients from multiple suppliers in something like a grab-and-go salad.
Kennedy also encouraged attendees to get started with FSMA 204 compliance, especially for those businesses using the “Learn, Plan, Do, Review” phases.
“It takes a while to do the learning and the planning, and you don't want to rush those steps,” he said.
Cree encouraged attendees to leverage resources from New Era Partners, GS1 US, the International Fresh Produce Association and more.
“Let your business requirements document really guide you,” he said. “Let that be your anchor and help provide guidance through your internal project.”