Challenges in Food Supply Chain Management and FDA Regulatory Science Focus
Addressing the shortcomings of the food supply chain like insufficient traceability protocols and pressure to produce, this article highlights the importance of FDA's management in identifying and managing foodborne disease outbreaks. It discusses the FDA's CORE team's efforts, data management difficulties, and the focus areas of FDA regulatory science, emphasizing public health preparedness and data-driven approaches to food safety.
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Presentation Transcript
FoodWarn A.I. America s Got Regulatory Science Talent Competition 2023 Justin Jablonski, Dan Farchione CENTER forMEDICAL TECHNOLOGY & INNOVATION
Shortcomings of the Food Supply Chain Insufficient Traceability Protocols Pressure to Produce Lack of Communication Creates blind spots and unnecessary risks Decreases the quality and safety of food products Leads to food waste and mishandling 1. 2. HBR.org Lin et al., IOPScience, 2019 CENTER forMEDICAL TECHNOLOGY & INNOVATION
How Does the FDA Manage? FDA can track reports via1 CAERS Reportable Food Registry Safety Reporting Portal PulseNet FDA CORE team investigates outbreaks2 1. 2. FDA 2022 FARS Report FDA About the CORE Network CENTER forMEDICAL TECHNOLOGY & INNOVATION
Is This Sufficient? The FDA s CORE team reports identification of 959 outbreaks since 20111 However, the CDC estimates an average of 800 foodborne disease outbreaks yearly2 1. 2. FDA About the CORE Network CDC Surveillance Summaries CENTER forMEDICAL TECHNOLOGY & INNOVATION
Data Management Difficulties Addressing outbreaks requires: Confirmation of the Food Source Tracing of the Contaminated Food Identification of the Outbreak Must obtain and correlate distribution reports to identify spread of contamination Must confirm and correlate reports to localize outbreak Must contact consumers, distributors, and food manufacturers to identify possible sources of the outbreak 1. FDA 2022 CAERS Excel CENTER forMEDICAL TECHNOLOGY & INNOVATION
FDA Regulatory Science Focus Areas Public Health Preparedness and Response: FDA faces unique challenges in the oversight of human and animal food safety . This oversight involves continuous surveillance of the human and animal food supply for ongoing and emerging threats Unleashing the Power of Data: FDA is working to improve ways to identify new safety signals with increased precision in decreased time. Some of the approaches being evaluated for feasibility rely on incorporating [AI, RWE, surveillance] 1. FDA 2022 FARS Report CENTER forMEDICAL TECHNOLOGY & INNOVATION
FoodWarn AI: The Solution An AI developed to identify and predict outbreaks in our food supply 4 3 2 1 Input of Unstructured Data Implementation of Deep Learning Algorithm AI Analysis of Data Output of Prediction Can come in the form of: Training the AI to recognize certain patterns, keywords, etc. from unstructured data Creation of an iterative process that is then used on actual datasets Results that can be used as preventative or reactive measures Videos News articles Social media posts CENTER forMEDICAL TECHNOLOGY & INNOVATION
What FoodWarn Brings 1 2 3 Faster analysis and correlation of: Reports PulseNet data Distribution information Ability to contact distributors, manufacturers, and customers: Faster More Predictive modeling Distribution patterns Contamination patterns CENTER forMEDICAL TECHNOLOGY & INNOVATION
References 1. 2. Lin, Xiaowen et al (2019) Environ. Res. Lett. 14 084011 Konar, Megan (2019). We Mapped How Food Gets from Farms to Your Home. The Conversation, Accessed Feb. 2023 Bateman, Alexis, and Leonardo Bonanni (2019). What Supply Chain Transparency Really Means. Harvard Business Review, Accessed Feb. 2023 FDA (2022). Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) 2022 Report. FDA.gov, Accessed Feb. 2023 FDA (2022). About the CORE Network. FDA.gov, Accessed Feb. 2023 Dewey-Mattia et. al. (2018). Surveillance for Foodborne Disease Outbreaks United States, 2009 2015. CDC.gov/Morbidity and Mortality Weekly Report, Accessed Feb. 2023 FDA (2022). CFSAN Adverse Event Reporting System (CAERS). FDA.gov, Accessed Feb. 2023 3. 4. 5. 6. 7. CENTER forMEDICAL TECHNOLOGY & INNOVATION
