September/October 2024 - 6

AUDITING & REGULATIONS
Accelerated
FSMA 204 compliance may be
coming faster than suppliers,
producers anticipate
BY MELINDA WALDROP
CONTRIBUTING EDITOR
A
new U.S. Food and Drug Administration (FDA) rule
requiring additional traceability records for certain
foods goes into effect in January 2026, but the
deadline for compliance may become a reality even sooner.
The FDA's Food Traceability Final Rule establishes
recordkeeping requirements beyond existing regulations
and will implement Section 204(d) of the Food Safety
Modernization Act (commonly known as FSMA 204) for
persons who manufacture, process, pack or hold foods
included on the Food Traceability List (FTL). Records
containing Key Data Elements (KDEs) associated with
Critical Tracking Events (CTEs) must be maintained and
quickly providable to the FDA.
The goal is faster identification and removal of
potentially contaminated food from the market.
At least one retail giant has already taken steps to
beef up its traceability measures well before the FDA
deadline, and a company working to streamline the
compliance process expects more to follow.
GAME-CHANGING MEMO
On Dec. 1, The Kroger Co. sent a memo to its suppliers
that sent ripples throughout the grocery supply chain.
The memo notified suppliers that Kroger intended to
collect and record traceability information for all food
products entering its facilities - not just those on the
FTL - by June 30, 2025.
" By taking these steps, Kroger believes we are taking
the appropriate actions to ensure both our companies
will satisfy the FDA's Final Rule requirements, " the
memo, addressed to " Valued Supplier, " stated.
That decision " changes everything, " according to Randy
Fields. Fields is chair and CEO of ReposiTrak, a global
food traceability and regulatory compliance network
which connects food supply chain companies and
wholesalers through an inventory management platform.
Network members can exchange KDEs for each CTE in
their supply chains.
" (The memo) says two things that I think have galvanized
the industry. Kroger has said all food is now going to be
traced. That's No. 1, " Fields said. " So for example, if you
DEADLINE
had a retail store with 60,000 SKUs, before the Kroger
announcement, maybe five to seven thousand of those
SKUs were covered by rule 204. That's a lot, but it's not
everything. Now, with the Kroger announcement, all
60,000 are going to be tracked and traced.
" The other is: sooner. Kroger said you have to be
compliant with us by June of 2025. ... Now, people will not
accept shipments that don't have the traceability records
with them. It's not going to be like, 'Hey, I'd appreciate it
if you would do traceability with me.' It's going to be as
simple as: no label, no traceability, no ship. "
Fields told Produce Processing that the ReposiTrak
Traceability Network (RTN) currently includes almost
1,400 supplier facilities that are in some stage of joining
the network, with another 3,000 to 4,000 expected to join
by this June.
" It's bigger than we guessed, " Fields said. " We always
thought people would end up, by default, doing everything,
(because) it's easier to do everything than a few things.
How do you know, when you have 100 cases of produce
hitting the store, which of those cases are (covered by)
204? But what we didn't expect was that people would do
it sooner than what the government requires. "
Fields predicted other retail behemoths would follow
Kroger's lead within a few months, partially to seize a
strategic marketing advantage.
A 'GARGANTUAN' ADJUSTMENT
Achieving FSMA 204 compliance is a complicated
process, Fields said - a reality ReposiTrak has realized
as it tracks thousands of SKUs over dozens of distribution
centers and stores.
" We have a better view of what the actual real-life
problems are in doing it, and they are myriad, " Fields
said. " Here's an example: 30% of all the cases of product
that go from a supplier to a wholesaler or retailer have no
label. That has to get fixed. "
Fields has also encountered confusion among produce
suppliers who weren't concerned with enhanced
traceability requirements
because their products,
such as onions, aren't
on the FTL. FTL is
available at fda.gov/
food/food-safetymodernization-act-fsma/
food-traceability-list
" You're
not on that list,
(but) you're on the Kroger
list, " Fields said. " It's a
6 | SEPTEMBER/OCTOBER 2024
http://www.fda.gov/
September/October 2024

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