Developing a Vision for Developing a Vision for Enhanced Foodborne ‐ Illness Source Attribution Information The Role of Product Tracing: t d today and tomorrow d t Caitlin Hickey Caitlin Hickey Jennifer McEntire Jennifer McEntire Institute of Food Technologists Leavitt Partners
O Overview i Role of Product Tracing in Outbreak R l f P d t T i i O tb k Investigations IFT IFT – FDA Product Tracing Pilots FDA Product Tracing Pilots
Outbreak Investigation Outb ea est gat o • People get ill from something they ate • Go to doctor? Go to doctor? • Doctor collects samples? • Reported to public health? • Samples further distinguished (molecular techniques) • Outbreak recognized Outbreak recognized • Go back to people and ask what they ate • Try to find common product • Try to find common source of the product – convergence • This is the regulatory traceback g y 3
Traceability is not recall Product Tracing Recall Conducted by regulators: y g Conducted by industry: y y balance making quick protect public health and decisions with building a protect their firm and bottom regulatory case line Implicated product not Specific product(s) known- known – reliance on epi Objective: identify points of j y p Objective: remove product j p convergence in supply chain from the marketplace to rule in/out suspects Relies on good g Relies on good g recordkeeping by industry recordkeeping by industry 5
F From the last meeting highlights: th l t ti hi hli ht “The scoping meetings are intended to provide a platform for bringing together government and platform for bringing together government and industry representatives in the early stages of a foodborne illness outbreak investigation to share information and collaboratively develop a more information and collaboratively develop a more detailed analysis of the outbreak. The goals of these meetings are to provide CDC with critical g p information about food production and distribution ….”
I T Is Traceback Solely “After the Fact”? b k S l l “Aft th F t”? Today: No T d N • Root cause analysis can help prevent future issues In the future: No In the future: No • Can supply chain visibility help rule in/out certain products/brands? p • Instant, accurate knowledge of supply chains can help inform epi
T Tracebacks Today b k T d Often can’t find point of convergence Oft ’t fi d i t f • Many reasons, to be studied by pilots Without convergence may not “definitively” know Without convergence, may not definitively know the food = unsolved case = unsolved case = no food attribution
Pilot Requirements q • Task issued to IFT Sept 6, 2011; final report due June 6 due June 6 • Objective • more rapidly and effectively trace back product = greater likelihood of tying an outbreak to food • 2 Pilots: Produce and Processed food • Collaboration platform C ll b ti l tf • Cost/benefit evaluation 9
K Key Questions Q ti What data are really needed to trace products? Wh t d t ll d d t t d t ? How can we ensure accuracy? How can we GET it quickly? H GET it i kl ? How can we ANALYZE it quickly?
Solicit Stakeholder input Products collaboration platform use of Products, collaboration platform, use of existing systems, initiatives, cost data sources Baseline study- What is the process what makes it Baseline study What is the process, what makes it difficult/easier, where are the hang-ups Qualitative- discussions with traceback investigators Quantitative- evaluation of previous investigations Solicit participants Conduct tests Evaluate results and cost 11
T Testing Data ti D t Transfe Lot/Batch r Event Trading /Serial Unit of Order Order Numbe Transfer CTE Description Date Time Location Partner Item Number Quantity Measure Number Type r Type Accepting a shipment from Receiving g another facility y x x x x x x x x x x x x Changing the identity (such as a new item identifier , description, new item identifier description GTIN or batch identity) or characteristics (types of packaging, Transformatio configuration of contents, etc) of n a product Items input into a transformation T1 T1 process x x x x x x x x x x Items output from a T2 transformation process x x x x x x x x x Releasing product from one Releasing product from one Shipping facility to another x x x x x x x x x x x x
Evaluate results based on Evaluate results based on Speed to convergence/resolution Mapping speed of analysis to practices (current state) Mapping speed of analysis to practices (current state) Assessing speed of analysis when industry uses a template Evaluation of collaboration platforms Speed Accuracy A 13
After Report Completion p p • FDA report to Congress- early July • IFT intends to publish report report • FDA must have 3 public meetings public meetings • Rulemaking process 14
Questions? CHickey@ift.org http://www.ift.org/traceability To Stay Current Subscribe to Leavitt Partners Newsletter. Text your email to: 801 ‐ 891 ‐ 3451
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