What does a 30-month extension to FSMA 204 mean?
Opinion by Angela Nardone, COO at Share-ify
In 2010, I attended a food safety workshop by the International Fresh Produce Association, where Dr. Bob Whittaker presented a post-mortem on the 2006 Spinach Outbreak. At that time, I was newly engaged and planning for a family, and the tragic story of a 2-year-old dying after eating contaminated spinach deeply affected me. This event inspired me to create a platform dedicated to food safety, quality assurance, and compliance, as I believe in the power of systems to enhance food safety.
That event ultimately led me to create a platform dedicated to food safety, quality assurance and compliance. I truly believe in the important and value of systems to help improve food safety.
In around 2008, the produce industry (in the aftermath of the Spinach Outbreak of 2006) decided to create an industry-based initiative called the “Produce Traceability Initiative” (“PTI”). I happened to be involved in the early stages. PTI was born out of the industry’s interest to do better. It aligned grocery retailers, foodservice organizations, importers, wholesalers, growers, packers, and shippers to a common labeling standard for traceability. Our company was a member of the Technology Committee where I sat with peer technology companies as we talked through issues. IFPA, CPMA, GS1, and others joined together to help support and promote this industry initiative. This was years before the Food Safety Modernization Act came into existence in 2011.
Recently, I looked back at a slide deck I had from 2009 that provided the industry’s timelines for compliance.
Q1 2009
Step 1: Brand owners must obtain their GS1-issued Company Prefix.
Step 2: Brand Owners must assign 14-digit GTINs to all case configurations.
Q3 2009
Step 3: Brand Owners must provide and maintain their GTINs (and corresponding data) to their buyers.
Q3 2010
Step 4. Those packing the product are responsible for providing human-readable information on each case (GTIN and LOT #).
Step 5. Those packing the product are responsible for encoding the GTIN and the Lot # in a GS1-128 barcode and human readable.
2011
Step 6: Each handler of the CASE must read and store the GTIN and associated Lot # for INBOUND cases.
2012
Step 7: Each handler of the CASE must read and store the GTIN and associated Lot # for OUTBOUND cases.
Ultimately, these timelines were pushed out even more as each party worked out their issues and asked for more time to handle the above.
Today, if asked (and if people are honest), the industry would share that about 50-60% of the produce industry adheres to PTI. I would estimate, that of the largest players, compliance is closer to 85-90%. Those that have not adopted PTI standards for their produce operations are often smaller organizations that may lack an IT infrastructure or someone on their team that can assist them with data standards. For an industry initiative (that was not a federal, legal requirement) this was a successful outcome.
With The Food Traceability Rule (FTR) commonly known as FSMA 204, there was a completely different rollout.
One complication was that FSMA 204 applied to more than one industry. Therefore, to gain alignment meant thinking through more issues and more processes. In addition, while the produce industry took years to align and also to adopt GS1 standards, other industries did not have that advantage.
In November 2022, the Final Rule was shared. It took between 4-6 months for the industry associations nationwide to begin to digest everything and to start and organize committees that could help their industry implement the rule. It then took another year for the committees to finish their work (and go through the iterative process of editing and finalizing). From there, the trade publications and trade associations started to speak in publicly with details to educate those that had no idea FSMA 204 was coming. That got us to around Fall 2024. The General Election was November 2024 and now a new administration begins in January 2025.
In the discussions that our company has had with no less than hundreds of companies from Summer 2024 to today, it is clear that the industry seemed to be watching a tennis match and trying to figure out where the ball was in the game. Unless you were watching from the early days when the Draft Rule was discussed and later finalized, all of this might be hard to follow.
In the last 45 days, our company attended an industry conference where we met with manufacturers, wholesalers, and distributors in the United States that are selling items in every category on the Food Traceability List. These were more regional players that may have sales in the $100M-$500M range and likely selling products to local restaurants, schools, and similar. Out of the 30 or so companies we met, about 5 had no idea what FSMA 204 was. Of the remaining 25, about half knew about it but did not know enough to truly assist their company in a rollout. The remaining companies were actively looking for solutions and had varying levels of competency in the law.
I have seen more than a few organizations making decisions in haste to try and meet requirements for FSMA 204 in what most technology companies would call a “half baked” solution. But with limited time, some companies could only do so much.
On another front, about 30 days ago, I visited a warehouse where a company that sold many items on the FTL list was giving me a walk through of a facility. The clear challenge in this setting was receiving. As I met individuals on the team, I met people with 20 years of experience and people with less than 5 years of experience. As I observed what they were doing and what tools they used, it was clear that for this facility to receive Key Data Elements (“KDE’s”) for each FTL item, the company would need to make some comprehensive changes to business processes, systems, and education & training.
This is all doable.
In the above scenario, change would be good. There would be clear supply chain benefits to them in additional to compliance with the law. But with the time remaining before January 20, 2026, that would be a tall order.
Share-ify’s CEO, Ernesto Nardone, was a project manager for IBM early in his career. In the early 2000’s he was tasked with a software implementation across IBM’s 200,000+ employee users. We discussed how to successfully initiate change across a massive multi-national organization. “You cannot take risks that the business can go down when putting in a change to an enterprise system.” So, how do you change software on 200,000 employee users successfully?
His immediate response was, “Planning. And then lots of testing.” He continued with, “And then you add contingency time and resources to the plan. At least 15%, if not more.”
I am sure I have met more than a couple people that prayed for the January 20, 2026 timeline to be extended. It is understandable. But human nature is human. The tendency will lean towards people deferring this out to “another budget” or “another quarter” or “right after we get this other project done.”
The most common issue holding many people back from adoption was “Is this going to be canceled as a requirement by the new administration?” With mandates like DOGE cutting staff and bureaucracy, would this be seen as just another unnecessary regulation?
At the end of the day, FSMA 204 is about shortening the time it takes for outbreak investigations. FDA has told industry it needs more information to be able to work faster. Shortening outbreak investigations means less people could be impacted in a foodborne illness outbreak. That translates to saving lives.
The produce industry demonstrated incredible leadership when it created PTI without the sharp stick of a federally mandated deadline. If we as the food industry are now given this 2.5 year extension, we shouldn’t use it to stop and catch up later. We should use it to continue at a more steady pace to properly test systems and processes and get everyone working together better.
My hope is that the industry will be prudent with this time.