WHAT IS RISK? Definition: probability of harm or loss Risk = Hazard x Exposure Risk can be voluntary or involuntary Interpretation of risk differs for
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1 BASELINE RISK ASSESSMENT OVERVIEW Dawn A. Ioven Senior Toxicologist U.S. EPA Region III
2 WHAT IS RISK? Definition: probability of harm or loss Risk = Hazard x Exposure Risk can be voluntary or involuntary Interpretation of risk differs for each of us Predictive risk assessment (U.S. EPA) vs. health study (ATSDR, Health Department)
3 PURPOSE OF BASELINE RISK ASSESSMENT Characterize current and potential future risks to human health and the environment Determine the need for remedial action Aid stakeholders in understanding potential site-related risks Satisfy Federal regulations requiring the assessment of risk at Superfund sites
4
5 BASELINE RISK ASSESSMENT PROCESS Hazard Identification Exposure Assessment Toxicity Assessment Risk Characterization Uncertainty Analysis
6 HAZARD IDENTIFICATION Gather and analyze relevant site data Identify Chemicals of Potential Concern (CoPCs) CoPCs are chemicals that may contribute significantly to site-related risks Determined by comparison to generic risk-based screening levels or regulatory criteria Identification process also considers essentiality, frequency of detection, and background conditions
7 EXPOSURE ASSESSMENT Analyze contaminant releases Identify potentially-exposed exposed populations (current and future) Identify potential exposure pathways Estimate exposure point concentrations for CoPCs Estimate contaminant intakes for CoPCs (dose or exposure concentration)
8 EXPOSURE ASSESSMENT (cont.) Common Land-Use Scenarios Residential Occupational Commercial / Industrial Construction Recreational Other Agricultural Trespassing Maintenance (Landscaping)
9 EXPOSURE ASSESSMENT (cont.) Common Exposure Pathways Surface soil Subsurface soil Ground water Air Surface water Sediment
10 EXPOSURE ASSESSMENT (cont.) Common Exposure Routes Ingestion Soil Ground water Surface water Sediment Dermal contact Soil Ground water (bathing) Surface water Sediment Inhalation Soil (outdoor vapors, airborne particulate, vapor intrusion) Ground water (showering, vapor intrusion) Air
11 EXPOSURE ASSESSMENT (cont.) Generic Dose Equation - Ingestion Dose = (C x CR x EF x ED) / (BW x AT) where: C = contaminant concentration, media-dependentdependent CR = contact rate, media-dependentdependent EF (days/yr) = exposure frequency ED (yrs) = exposure duration BW (kg) = body weight AT (days) = averaging time Generic Dose Equation - Inhalation Exposure Concentration = (CA x ET x EF x ED x CF) / AT where: CA (ug/m 3 ) = contaminant concentration in air ET (hrs/day) = exposure time EF (days/yr) = exposure frequency ED (yrs) = exposure duration CF (1 day/24 hrs) = conversion factor AT (days) = averaging time
12 TOXICITY ASSESSMENT Collect qualitative and quantitative toxicity information for CoPCs Determine appropriate toxicity values for CoPCs to estimate risks Reference Dose (RfD) Inhalation Reference Concentration (RfC) Carcinogenic Slope Factor (CSF) Inhalation Unit Risk (IUR)
13 RISK CHARACTERIZATION Combine Exposure Assessment with Toxicity Assessment to describe potential for adverse health effects
14 Cancer Risks RISK CHARACTERIZATION (cont.) Risk = CSF x Dose where: CSF (mg/kg/day) - 1 = Carcinogenic Slope Factor Risk = IUR x EC where: IUR (ug/m 3 ) - 1 = Inhalation Unit Risk, chemical-specific EC (ug/m 3 ) = exposure concentration Non-Cancer Risks HQ = Dose / RfD where: HQ (unitless) = Hazard Quotient RfD (mg/kg/day) = Reference Dose HQ = EC / (RfC x 1000 ug/mg) where: HQ (unitless) = Hazard Quotient EC (ug/m 3 ) = exposure concentration RfC (mg/m 3 ) = Reference Concentration, chemical-specific
15 RISK CHARACTERIZATION Unacceptable Risk (cont.) Excess cancer risk greater than 1E-04 probability of developing cancer from defined exposure is greater than 1 in 10,000 For non-cancer impacts, sum of HQs for similar target organs is greater than 1 safe dose is exceeded
16 UNCERTAINTY ANALYSIS Describe assumptions and significant unknowns associated with risk assessment process Quantitative measure of variability and sensitivity of each input parameter can be performed via Monte Carlo Analysis
17 NATIONAL RESEARCH COUNCIL RISK ASSESSMENT PARADIGM Risk Assessment Dose-Response Assessment Hazard Identification Exposure Assessment Risk Characterization Statutory and Legal Considerations Public Health Considerations Control Options Economic Factors Regulatory Decisions Social Factors National Research Council, 1983 Risk Management
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