Food Business News - October 13, 2020 - 20

FOOD AND DRUG ADMINISTRATION

WASHINGTON

FDA seeks enhanced traceability
for 'high risk' foods

T

he US Food and Drug Administration
on Sept. 21 announced a proposed
rule to establish additional traceability recordkeeping requirements for certain
foods. The FDA also published the same
day a draft food traceability list (FTL), which
enumerated the specific foods to be subject
to the proposed requirements.
The FDA said the proposed rule,
"Requirements for Additional Traceability
Records for Certain Foods," is a component
in the FDA's New Era for Smarter Food
Safety and would implement the section
of the FDA Food Safety Modernization Act
of 2010 (FSMA) that mandated the agency
require more extensive product tracing
records for foods the agency determined to
be at "high risk" for contamination.
The Acheson Group noted the FTL
foods were determined through FDA's
development of a risk-ranking model.
"Data was collected to populate the
model for chemical and microbiological
hazards associated with specific foods,
and the draft risk-ranking model and data
were reviewed by independent external experts," Acheson said. "From this, FDA proposed 16 FTL foods, with the rule mandating additional traceability requirements
for both the listed food and any food that
contains a listed food as an ingredient."
Foods on the draft FTL include
sprouts, shell eggs, tomatoes, nut butter,
tropical tree fruits, cucumbers, fresh-cut
fruits and vegetables, fresh herbs, finfish,
leafy greens, crustaceans, melons, mollusks, peppers and ready-to-eat salads.
The FDA said the proposal, if finalized, would standardize the data elements
and information firms must establish and
maintain, and the information they would
20

Food Business News

need to send to the next entity in the supply chain to facilitate rapid and accurate
traceability.
"While limited to only certain foods
(those on the FTL), this proposal lays the
foundation for a standardized approach to
traceability recordkeeping, paving the way
for the industry to adopt, harmonize and
leverage more digital traceability systems
in the future," the FDA said.
The FDA said existing regulations
require much of the food industry to
establish and maintain records to identify
the immediate previous sources and the
immediate subsequent recipients of foods.
"These requirements form a baseline
for traceability recordkeeping, but they provide limited information to effectively and
rapidly link shipments of food through each
point in the supply chain," the FDA said.
"This - and the fact that recordkeeping
systems can be largely paper-based and lack
a universal lexicon throughout industry -
can make it difficult to trace a product to its
original source when necessary."
The FDA said the improved traceability, as envisaged by the proposed rule,
would allow the agency to more quickly
identify the source of a contaminated
product, reduce the scope of product
recalls, and conduct more timely rootcause investigations to learn more about
how contamination occurred in order to
prevent future outbreaks.   
The FDA said at the heart of the
proposal is a requirement for those
who manufacture, process, pack or
hold a food on the FTL to establish and
maintain records associated with specific
critical tracking events (CTEs), which the
FDA said comprised growing, receiving,

transforming, creating and shipping.
For each CTE, entities would be
required to establish and maintain records
containing key data elements (KDEs).
Examples of KDEs include the traceability
lot code, the date the product was received,
the date the product was shipped, and a
product description.
The FDA emphasized the traceability
lot code is an important KDE throughout
the supply chain intended to establish critical linkages to help to facilitate traceback
and trace-forward investigations during
investigations and recalls.
Those subject to the rule also would
be required to create and maintain records
related to their internal traceability
program, which would help regulators
better understand a firm's recordkeeping
practices and traceability operations.
The proposed rule would require records to be maintained as either electronic,
original paper records or true copies. In addition, the proposal stated that in the event
of a foodborne illness outbreak, a product
recall or other threat to public health, the
FDA could require firms submit, within 24
hours, an electronic sortable spreadsheet
containing relevant traceability information for specific foods and date ranges.
The proposed rule has several exemptions, including that the additional
traceability records would not be required
after a kill-step (a process that minimizes
pathogens in a food) is applied to a food,
but documentation of the kill-step application would have to be established and
maintained. FBN
Jay Sjerven
jsjerven@sosland.com
October 13, 2020



Food Business News - October 13, 2020

Table of Contents for the Digital Edition of Food Business News - October 13, 2020

Food Business News - October 13, 2020 - 1
Food Business News - October 13, 2020 - 1
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