KANSAS CITY, MO — Ever-present threats to food security have food manufacturers under a regulatory microscope, the intensity of which is only expected to increase. The compliance date for the last of the series of FSMA regulations — often referred to as FSMA Rule 204 or the Food Traceability Rule — is Jan. 20, 2026. While that may seem a long way off, food safety regulation experts advise commercial bakers to start preparing now.
The primary goal of FSMA Rule 204 is to speed up the identification and removal of contaminated food from the supply chain. The rule requires companies that manufacture, process, pack or hold foods included in the FDA’s Food Traceability List (FTL) to keep additional records beyond current regulations. The data must be stored for 24 months and made available to the FDA within 24 hours upon request.
“The FDA’s final rule imposes three key recordkeeping requirements for these facilities,” explained Rasma Zvaners, VP of government relations for the American Bakers Association. “They must maintain records containing Key Data Elements (KDEs) for Critical Tracking Events (CTEs), assign Traceability Lot Codes (TLCs) to FTL foods, and develop and maintain a food traceability plan.”
Although nut butters and shell eggs are on the FTL, most bakers will likely not be responsible for maintaining full-scale traceability records because of one key factor: the kill step.
“One thing to think about when looking at the Food Traceability List is that whatever is on the list must be in the form that’s stated,” said Ben Miller, executive VP of regulatory and scientific affairs for The Acheson Group, a full-service global food safety consulting company. “For example, leafy greens have to be fresh. So, if a food on the list goes through a validated kill step, as in the baking process, then it no longer needs to be traced.”
“The FDA requires a written agreement stating that either the receiver or a subsequent entity in the supply chain other than a retail food establishment or restaurant will apply a kill step.” — Rasma Zvaners | VP of government relations | American Bakers Association
However, bakers aren’t completely off the documentation hook. They still need to keep track of FTL foods they receive and provide proof they will apply the kill step.
“The FDA requires a written agreement stating that either the receiver or a subsequent entity in the supply chain other than a retail food establishment or restaurant will apply a kill step,” Zvaners said.
Bakers who add an FTL food to a product after the validated kill step — such as garnishing a dessert with fresh herbs, certain fresh or fresh-cut fruit, or a peanut butter glaze — must maintain traceability records, assign TLCs for those specific products and share that information with its downstream supply chain, including distributors.
The good news is that because of the documentation required under existing food safety regulations, the majority of bakers are likely already doing at least some of this recordkeeping.
“Baking operations have pretty good ‘internal traceability’ processes, with the ability to link incoming ingredients to the outgoing product,” Miller said. “The biggest change is going to be on the shipping side because they’re going to have to maintain specific key data elements, one of which is going to be that traceability lot code. They have to make sure they pass information forward to their supply chain and distribution customers.”
This story has been adapted from the AUGUST | Q3 2024 issue of Commercial Baking. Read the full story in the digital edition here.
