How well does science support the QMRA process An overview

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How well does science support the QMRA process An overview Jeff Soller State-of-the-Science Symposium: Fecal Source Identification and Associated Risk Assessment Tools Southern California Coastal Water Research Project Authority November 29, 2012

Why QMRA for Recreational Waters QMRA provides a scientifically accepted framework considering alternative water quality criteria QMRA can complement epidemiology studies to understand illness risks in recreational waters QMRA is specifically called out as option for site specific criteria in final 2012 RWQC

What is QMRA? QMRA a formal, scientific process, analogous to chemical risk assessment of estimating human health risks due to exposures to selected infectious pathogens Problem Formulation: Identify goals, regulatory and policy context, and develop conceptual models Analysis: Document and evaluate exposure and health effects data Risk Characterization: Compile information and data and put results into context

Federal and International Organizations have a long history of using QMRA EPA has used risk assessment extensively for decades to establish human health criteria for a wide range of pollutants in water and other media QMRA has been applied to evaluate and manage pathogen risks for numerous scenarios - food, biosolids, drinking water, recycled water, and recreational waters. QMRA specifically has been used to inform policy making for drinking water and biosolids in the U.S. and by U.S. and international governmental agencies to protect public health from exposure to microbial pollutants in food and water

Considerations for Framing a QMRA Which pathogen(s) (hazard identification)? How many pathogens are individuals or populations exposed to (exposure assessment) and from what scenarios (hazardous events)? What are the adverse health effects of interest? What is the relation between exposure and health effects (doseresponse evaluation)? How does variability (temporal, spatial, inherent) and/or uncertainty impact Our understanding or interpretation of risk Monitoring needs Do properties that are unique to microorganisms or infectious diseases such as person-person transmission and/or immunity need to be accounted for? What methods are appropriate / needed to characterize risk?

QMRA considerations Pathogen specific (compared to epi studies) Works best when comparing relative risk of two or more scenarios Exposure can be difficult to characterize Dose-response relationships are based on limited data Numerical simulation studies, need to be anchored to observable data to be widely accepted Have not been extensively applied for risk management of recreational waters

What is the linkage between QMRA epidemiological studies for recreational waters Recreational water epidemiology studies indicate Rates of some adverse health effects are generally higher in swimmers than non-swimmers FIB can predict GI illness, and in some cases AFRI Most epidemiology studies have focused on humanimpacted waters (primarily POTW effluent) Notable exceptions - Southern CA, South FL, New Zealand Recreational water risks in waters impacted by sources other than those studied are not well understood Even in human impacted waters, the primary etiologic agents are not well understood

The etiologic agents are the intersection of QMRA and recreational water epidemiology studies To estimate illness via QMRA, we need to understand Exposure Relationship between exposure and infection Relationship between infection and illness

Representative Exposure Data: Volume of Water Ingested During Recreation Source: Dufour et al. 2006

Pathogen Classes of Public Health Concern Viruses Rotavirus Poliovirus Echovirus Adenovirus Hepatitis A Coxsackie virus Parasites Cryptosporidium Giardia Bacteria Salmonella Shigella E. coli O157 Vibrio cholera Campylobacter jejuni

Reference Pathogens for Recreational Water QMRA In the US, there are 38.6M illnesses annually from known pathogens. 24.8M illnesses are non-foodborne This set of eight reference pathogens accounts for >97% of nonfoodborne illness from known pathogens in US. Norovirus Rotavirus Adenovirus Cryptosporidium spp. Giardia lamblia Campylobacter spp. Salmonella E. coli O157:H7

Representative Data: Dose-Response Relationships 1 Prob of Infection 0.8 0.6 0.4 0.2 0 1.10 4 1. 10 3 0.01 0.1 1 10 100 1. 10 3 1. 10 4 1. 10 5 1. 10 6 Cryptosporidium Rotavirus Salmonella Echovirus 12 Dose

Examples of Using QMRA to understand recreational water risks Which etiological agent(s) cause illness during epidemiological studies Adding context for when epidemiological studies indicate equivocal results Relative risks from non-human sources Mixed sources mixed human (treated / untreated) human / non-human sources

Case Study: NEEAR Great Lakes Studies Illness rate /1000 swimmers Health Based Approach Infection Rate / 1000 swimmers Estimated mean concentration (organisms/l) Illness Rate / 1000 swimmers POTW Effluent Based Approach Infection Rate / 1000 swimmers Estimated mean concentration (organisms/l) Pathgoen All 30.6 Unknown NA 30.6 Unknown NA Rotavirus 4.8 13.6 0.7 0.3 0.7 0.04 276.9 32.3 Norovirus 1 17.1 28.6 2.1 29.7 49.5 3.8 Adenovirus 4.8 9.5 0.7 0.3 0.5 0.04 Cryptosporidium 0.3 0.7 0.2 0.2 0.5 0.15 Giardia 2.2 4.9 7.6 0.01 0.03 0.05 Camplyobacter 0.6 24.6 1.0 0.1 3.8 0.4 E. coli O157:H7 0.01 0.05 0.2 0.001 0.01 0.01 Salmonella 0.09 0.44 122 0.0003 0.001 0.4 1. Genome copies per liter 2. First row is based on assumption of dose dependent illness given infection, second row is based on fixed proportion of illnesses regardless of dose. Both rows are based on data presented in Teunis et al 2008

Case Study: Relative Risks from Various Animal Sources ENT E. coli

Relative Contribution of Reference Pathogens for Risks from Various Animal Sources ENT E. coli Probabilty of Illness 10 0 Campylobacter Salmonella Giardia spp. 10-1 Cryptosporidium spp. Norovirus E Coli O157 10-2 10-3 10-4 Probabilty of Illness 10 0 10-1 10-2 10-3 10-4 10-5 10-5 10-6 Gull Cattle Pigs Poultry Raw Sewage Secon. Effluent 10-6 Gull Cattle Pigs Poultry Raw Sewage Secon. Effluent

Case Study: Mixed Sources of Contamination Purpose: Evaluate how the source of fecal contamination can influence the potential for adverse human health effects from recreational activities Approach: Examine various scenarios of mixed fecal sources and estimate the probability of GI illness as the proportion of FIB from the fecal sources varies Human source mixed with a non-pathogenic (environmental) source Pig source mixed with a non-pathogenic source Human source mixed with pig source Human source mixed with chicken source

1 0.1 0.03 Probability of Illness 0.01 0.001 0.0001 0.01 0.005 0.003 0.00001 0.000001 0.0 0.2 0.4 0.6 0.8 1.0 Proportion of 35 cfu/100ml ENT from humans Numerically higher, but equivalently protective, sitespecific water quality standards could be developed for recreational waters that are impacted by low levels of human fecal contamination

Final Thoughts We have a solid framework to consider recreational water risks via QMRA Some of the next challenges to consider relate to how to determine relative contributions of important sources These tools could prove to be very useful allocating resources to waters that can have greatest public health benefit