1. RISK ASSESSMENTS AND BUSINESS CONTINUITY FOR THE EGG INDUSTRY Sasidhar Malladi, Center for Animal Health and Food Safety, University of Minnesota April 17 th 2013

2. Overview 1) Business continuity planning for a Highly Pathogenic Avian Influenza (HPAI) outbreak Background SES Plan Proactive Risk Assessments 2) Salmonella Enteritidis risk assessments Background Recent studies and ongoing work Opportunities for risk assessment

3. Background: Market Continuity Impact of HPAI Outbreak Emergency response in the event of a HPAI outbreak Control Area established Quarantine and movement control Market continuity consequences: table egg sector Just in time supply chain: holding capacity limited to 48-72 hours Poultry dense area: potential impact on food security e.g., Mexico H7N3 outbreak

4. Background: Control Area HPAI Scenario

5. SES Plan Purpose Provide science and risk based guidelines supporting movement permitting decisions Promote food security and animal health Ensure continuity of markets and egg supply Facilitate rapid permitting decisions Foster government, industry, consumer confidence

6. State Animal Health Officials UEP, AEB, Production Veterinarians Egg Sector Working Group USDA-APHIS-VS NCAHEM CEAH UMN-CAHFS ISU-CFSPH Public-Private-Academic Partnership

8. Proactive Risk Assessments Definition Proactive = completed prior to an outbreak Risk Assessment = A science based process that both quantifies and qualifies risk Whats their role? Provides decision making guidance to those responding (i.e. regulatory & industry)

9. Proactive Risk Assessments Risk of HPAI spread via movement of various egg industry products from Infected but Undetected flocks in a Control Area Preventive measures evaluated: Federal programs and regulations (AMS, FSIS, NPIP) Routine biosecurity and C&D practices Product specific biosecurity measures (during outbreak) Active surveillance protocols (during outbreak) Holding time (during outbreak)

10. Proactive Risk Assessment Process RA specific working groups Industry representatives Industry practices and data Input on outbreak measures and field experiences USDA APHIS and State Animal Health Officials Regulatory perspective Technical expertise Academic institutions Technical expertise Outreach and facilitating workgroup Review process: industry workgroup; USDA-APHIS- CEAH; risk managers and stakeholders

11. Proactive Risk Assessment: Quantitative Models Simulation model outcomes Time to detect HPAI Clinical signs Active surveillance Likelihood of moving contaminated egg industry products from an infected flock before detection Methods Stochastic simulation model of within flock HPAI spread Simulation models of detection via RRT-PCR testing given testing of daily mortality

13. Proactive Risk Assessment: Washed and Sanitized Shell Eggs Washed and sanitizedin a 100–200 parts per million (ppm) chlorine solution Outbreak Measures Diagnostic testing from sick/dead birds from each house Daily mortality within normal range Truck and driver biosecurity C&D of egg handling materials Two day hold after production before moving eggs to market

14. Example Timeline for Washed and Sanitized Shell Eggs

15. Quantitative Results for Movement of Shell Eggs Predicted number of HPAI H5N1 contaminated eggs moved per house before detection among 75000 eggs for different hold times Surveillance and Movement Option 1 Day hold2 Day hold3 Day hold Baseline scenario: 2 birds /6 hours 6.5 (0-19)0.80 (0-2)0.10 (0-0) Alternate Scenario 0.5 birds/6 hours 3.4 (0-14)1.6 (0-6)0.75 (0-3)

16. Washed and Sanitized Shell Eggs Risk Assessment Results The risk associated with the shell surface of eggs that are washed and sanitized as specified in 7CFR56.76 is negligible. The overall risk of moving washed and sanitized shell eggs into, within, and outside of a Control Area during an HPAI outbreak is, negligible if there are no poultry on the destination premises low if there are poultry on the destination premises

17. Proactive Risk Assessments Supporting SES Plan Commodity Risk Posed to Other Poultry Pasteurized Liquid EggsNegligible Non-Pasteurized Liquid EggsNegligible Washed and Sanitized Shell Egg (no poultry on destination premises) Negligible Washed and Sanitized Shell Egg (poultry on destination premises) Low Nest-Run (unwashed) EggsLow Egg-Type Hatching EggsLow Egg-Type Day-Old ChicksLow Egg Shells, Inedible Egg ProductLow Manure and MaterialsIn progress

18. SES Plan Summary Permit Table (Selected portions)

19. SES Plan Benefits Ensures a continuous supply of fresh egg products Enhances market continuity within and between States during an HPAI outbreak Facilitates early detection of avian influenza in egg production flocks and reduces HPAI spread from an index outbreak to other egg production flocks Supports the USDA APHIS HPAI Response Plan: The Red Book Beneficial working relationships between Stakeholders

20. Salmonella Enteritidis(SE) Risk Assessments: Background Previous public health risk assessments Farm to fork approach Lesser emphasis on on-farm risk factors 1998 FSIS Risk Assessment Predicted 2.3 million contaminated eggs and mean 661,633 SE illnesses per year from eggs and egg products Risk factors evaluated: molting, storage temperature, handling, cooking and pooling in preparation of eggs

21. SE Risk Assessments: Background 2005 FSIS Risk Assessment Update Predicted approximately 15 million contaminated eggs and 131,122 SE illnesses per year from eggs and egg products Detailed modeling of location of SE in egg, temperature, yolk membrane breakdown, growth and pasteurization scenarios USDA NAHMS Layers 1999 study Rodent index, age, molting, access of pests to feed, visitor biosecurity Potential factors: C&D practices, manure handling

22. SE Risk Assessments: Recent Studies on Attribution Attribution: the proportion of SE illnesses due to the consumption of eggs and egg products FDA final rule Outbreak Surveillance1985-2002 Mean 66% of SE illness (53% to 79%) attributable to eggs Recent CDC update Painter et al., 2013 Outbreak Data from 1998 to 2010 35.2 to 61.8 % of SE illnesses attributable to eggs 68% of SE outbreaks attributable to eggs

23. SE Risk Assessments: Ongoing Studies Upcoming NAHMS layers 2013 survey Update prevalence estimates Vaccination practices SE testing practices Greater detail on practices such as manure handling and end of production C&D Risk assessment relevance Update parameters related to risk factors Improve modeling of the impact of farm management practices on SE prevalence.

24. SE Risk Assessment Opportunities: Between Premises Spread Transmission risk with different types of movements Egg handling materials Nest run eggs, inedible eggs Surplus hens and pullets to backfill a layer house Risk assessment and simulation models Estimate likelihood of spread per movement based on predicted within flock prevalence Impact of C&D and movement specific biosecurity practices Epidemiological studies help in validation

25. SE Risk Assessment Opportunities: Within Premises Spread and Prevalence Improved estimation of the impact of various risk factors Fly and insect control End of production C&D Vaccination Manure handling Risk Assessment Quantitative simulation models of within flock salmonella prevalence Models may help quantify interaction between various risk factors Risk assessment approaches can help identify efficient and effective strategies to maintain continuity of market and improve food safety

26. Resources U.S. Secure Egg Supply Plan www.secureeggsupply.com FAD-PReP Secure website: fadprep.lmi.org UMN-CAHFS and NCFPD www.cahfs.umn.edu www.ncfpd.umn.edu ISU www.cfsph.iastate.edu Interagency RA www.fsis.usda.gov/Science/risk_assessments/index.asp