FDA's Food Traceability Rule
and Its Effect on Specialty Food
BY RON TANNER
I
n September 2020, FDA published the last of
its proposed Food Safety & Modernization Act
rules. Called "Requirements for Additional
Traceability Records for Certain Foods," the
proposed rule immensely alters the traceability
system for high-risk foods.
At a virtual public hearing in October 2020,
Frank Yiannas, FDA's deputy commissioner for
food policy & response, said, "The Traceability Rule
will strengthen food protection for generations
to come. It is the pillar of the New Era of Modern
Food Safety Initiative," adding "our Achilles heel
has been a lack of traceability."
Specialty Foods on High-Risk List
FDA has been working since 2014 to identify foods
that are "high risk." Those that made the Food
Traceability List (FTL) include "cheeses (other than
hard cheese), shell eggs, nut butters, cucumbers,
fresh herbs, leafy greens, melons, peppers, sprouts,
tropical tree fruits, fresh cut fruits and vegetables,
fin fish (including smoked), crustaceans, mollusks,
and ready-to-eat deli salads."
Products that contain these foods as
ingredients are also impacted by the traceability
rule. In other words, if your specialty food contains
mango, eggs, shrimp, and so on, you are required
to implement the traceability system.
Those who manufacture, process, pack, or
hold foods on the FTL are required to establish
and maintain records containing Key Data
Elements (KDEs) associated with different Critical
Tracking Events (CTEs). Each would be assigned a
Traceability Lot Code.
FDA defines CTEs as:
• Growing: First step in the supply chain.
• Receiving: A food is received by a customer
at a defined location after transport. The
First Receiver at this location is responsible
for maintaining certain KDEs.
• Creating: Making or producing of a food on
the FTL using only ingredients that are not
on the FTL.
• Transforming: Changing a food on the
FTL, its package, or its label by combining
ingredients or processing.
• Shipping: Food being transported from one
location to another.
KDEs must be recorded at all of these steps, except
Growing. The KDEs would vary depending on the
CTE that is being performed. The records required
at each CTE would need to contain and link the
traceability lot code of the food to the relevant KDEs.
These records must be provided to FDA no
later than 24 hours after a request. If the request is
due to an outbreak, recall, or other threat to public
health, the records must be provided in a digital
sortable spreadsheet.
This ambitious system would require extensive
record-keeping transformation and upgrades,
especially for small and very small manufacturers,
importers, and distributors.
More than 5,000
comments were
submitted, from food
trade associations,
grower organizations,
and consumer
interest groups.
52 SPECIALTY FOOD SPECIALTYFOOD.COM
SPECIALTY FOOD
MAKER
