Presentation regarding Produce Traceability as presented to FDA & FSIS on December 9 & 10, 2009 in Washington, D.C.

1. Traceability – Stage 2y g
William C. Smith, FSIS,
Assistant Administrator
Office of Program Evaluation,Office of Program Evaluation,
Enforcement and Review

2. FSIS A th it
It is essential in the public interest that the health
FSIS Authority
It is essential in the public interest that the health
and welfare of consumers be protected by
assuring that products distributed are safe andg p
not adulterated
Statutes require firms to keep and make available
full and correct transactional business records
Regulations specify businesses and types of
records required e g bills of sale bills of ladingrecords required, e.g., bills of sale, bills of lading,
receiving and shipping papers
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3. FSIS I ti ti
Collect trace back/forward information
FSIS Investigation
Collect trace back/forward information
Identify source of production
Determine distribution of suspect productp p
Locate or detain the product in commerce
Collect product samples for lab analysis
Coordinate throughout investigation
FSIS program areas (OPEER, OFO, OPHS)
Health partners (FDA CDC State Local)Health partners (FDA, CDC, State, Local)
Industry
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4. I t f R d
FSIS relies heavily on industry records, including
Importance of Records
FSIS relies heavily on industry records, including
retail records, to trace back products in
foodborne illness & other food safety incidents
Essential to quickly and effectively determine
source product
R d d if it d t d di tiRecords need uniformity and standardization,
with common data and consistency throughout
the distribution chain to enable rapid and properthe distribution chain, to enable rapid and proper
identity and linkage of products and source
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5. K R d El t
Product information (establishment or store)
Key Records Elements
( )
Date and time product was produced
Exact name and type of product
Q fQuantity of product
Sell-by or Use-by date and/or production code
of each lot of productof each lot of product
Other information used to identify product
Source (supplier) informationSource (supplier) information
Establishment # and lot specific coding for
each source material used
Cleaning/sanitizing, including date and time
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6. I ti ti Ch llInvestigation Challenges
Time it takes to review multiple records to find
relevant product-specific information
Increased time to indentify productIncreased time to indentify product
Inability to trace to the source
Inability to identify and remove all potentiallyInability to identify and remove all potentially
adulterated products in commerce
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7. R t I ti tiRecent Investigations
Impeded by inadequate records
In 2007–2008, FSIS-OPHS investigated 16
cases of foodborne illness implicating rawcases of foodborne illness implicating raw
ground beef products manufactured at retail
Of the 16, only 9 retail operations keptOf the 16, only 9 retail operations kept
production logs sufficient for trace back
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8. S E t dSuccesses Encountered
Adequate recordkeeping system allowed rapid
linking of specific lots to contaminated product
Limited public health impact due to rapid tracingLimited public health impact due to rapid tracing
to identify and remove contaminated product
Provided accurate information to consumersProvided accurate information to consumers
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9. L L d
Emphasized importance of efficient and effective
Lessons Learned
Emphasized importance of efficient and effective
product tracing systems and key elements
needed on all records
Need to work with FDA, CDC, State, and Local
partners to obtain and share information quickly
Work with manufacturers, distributors, retailers,
importers, and restaurants to efficiently and
effectively identify product remove it fromeffectively identify product, remove it from
commerce, and prevent further distribution
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