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Hongliu Ding, MD, PhD, MPH FDA Commissioner’s Fellow

Quantitative Microbial Risk Assessment Approach for Evaluation of Risk Management Options for Sprouts. Hongliu Ding, MD, PhD, MPH FDA Commissioner’s Fellow. Salmonella Outbreak linked to Jimmy John’s Alfalfa Sprouts.

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Hongliu Ding, MD, PhD, MPH FDA Commissioner’s Fellow

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  1. Quantitative Microbial Risk Assessment Approach for Evaluation of Risk Management Options for Sprouts Hongliu Ding, MD, PhD, MPH FDA Commissioner’s Fellow

  2. Salmonella Outbreak linked to Jimmy John’s Alfalfa Sprouts • From November 1, 2010, through February 9, 2011, 140 infected individuals were reported from 26 states and the District of Columbia. • Tiny Greens Alfalfa Sprouts or Spicy Sprouts at Jimmy John’s restaurant outlets were linked to the outbreak. From CDC investigation update

  3. Taormina et al, Emerg infect dis 1999

  4. Guidelines • FDA guidance for industry: reducing microbial food safety hazards for sprouted seeds. 1999 • FDA guidance for industry: sampling and microbial testing of spent irrigation water during sprout production. 1999. • Microbiological safety evaluations and recommendations on sprouted seeds. National Advisory Committee on Microbiological Criteria for Foods. Int J Food Microbiol. 1999;52(3):123-153.

  5. Montville and Schaffner. J of Food Prot 2004

  6. Disinfection Efficacy of 20,000 ppm chlorine Montville and Schaffner. J of Food Prot 2004

  7. Limitations of previous reviews • Only summarized efficacy of chemical disinfection treatment • Limited number of publications • Weight of different studies • Confounding factors (type of sprouts, pathogens et al)

  8. Updated review • Searched Pubmed to date • Identified 52 publications • Extracted data obtained under optimal study conditions • Data analysis adjusted for confounding factors • Evaluated all types of seed disinfection treatments

  9. Summary of findings • 20,000 ppm chlorine can achieve approximately 3 log cfu/g of pathogen reduction • As the current gold standard, 20,000 ppm chlorine appears not to be the most effective seed disinfection treatment • Physical treatments, especially high pressure, could be promising • None of the seed disinfection treatments guarantees achievement of the target 5 log cfu/g of pathogen reduction • Seed disinfection emphasized, but spent water testing largely ignored!

  10. What can we do next? • More studies to test the superiority of physical disinfection treatments • Sampling and testing • Other alternative risk management strategies • Quantitative microbial risk assessment (QMRA)

  11. QMRA in food safety • Salmonella Enteritidis in Eggs, USDA (1998) • FDA • Draft Risk Assessment on the Human Health Impact of Fluoroquinolone Resistant Campylobacter Associated with the Consumption of Chicken (2000) • Draft Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods (2001) • Draft Risk Assessment on the Public Health Impact of Vibrio parahaemolyticus in Raw Molluscan Shellfish (2001) • Listeria in RTE Foods Risk Assessment (2003) • Vibrio in Raw Oysters Risk Assessment (2005) • Highly Pathogenic Avian Influenza in Poultry and Eggs (2010)

  12. CCP: Critical Control Point Seeds from farm (Initial pathogen load) Sampling and testing (seeds) Contaminated (discard) Sprout producers Disinfection treatment (CCP) Sampling and testing (seeds) Germination (CCP) Sampling and testing (spent irrigation water) Final rinsing (CCP) Sampling and testing (spent wash water and sprouts) Packaging (CCP) Sampling and testing (sprouts) Storage Sampling and testing (sprouts) Consumers (Pathogen associated illness?)

  13. How to do? • Risk identification at each step of sprout supply chain • Dose-response assessment • Develop quantitative risk assessment models (Monte Carlo Simulation) • Quantify risk reduction that can be achieved from a microbial sampling and testing program • Quantify the overall risk reduction that can be achieved through a combination of mitigation steps including the microbial sampling and testing plan applied at various sprout supply chain steps

  14. Challenge • Establish a feasible and scientifically sound sampling and testing program • When to do? (at least at each CCP) • What to do? (seed, sprouts, spent water) • How to do? (risk analysis algorithm) • Where to start? (QMRA of spent water testing)

  15. Hypothetical result of prioritized risk management analysis in sprouts

  16. Ask for data • Testing data at farm • Testing data at packaging • Testing data at storage • Other available data (disinfection et al)

  17. Acknowledgements • FDA Commissioner’s Fellowship Program • IFSH • Dr. Tong-Jen Fu • Dr. Mary Lou Tortorello

  18. Questions? Thank You!

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