William Smith Fsis Asst Admin Office Of Program Evaluation Enforcement And Review

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

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William Smith Fsis Asst Admin Office Of Program Evaluation Enforcement And Review

  1. 1. Traceability – Stage 2y g William C. Smith, FSIS, Assistant Administrator Office of Program Evaluation,Office of Program Evaluation, Enforcement and Review
  2. 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 2
  3. 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 3
  4. 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 4
  5. 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 5
  6. 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 6
  7. 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 7
  8. 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 8
  9. 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 9

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