# Presentation: 678087

## Risk Assessments in RCRA

## Risk Assessments in RCRA

- Goal: To relate the most important aspects of risk assessment in a pragmatic fashion for consideration as you advance risk management decisions
- The following discussion is designed to inform you of some basics w/r/t risk assessment, but primarily help you focus on:
- A better appreciation for the uncertainty which undermines risk-based decision making
- The most important considerations w/r/t risk management
- The most common flaws in PRP risk assessments which you can watch out for

## Brief Background on Utility of Risk Assessments in RCRA

- Baseline Risk Assessments
- “What If” scenario - future land use in the absence of any ICs
- Uncontrolled land use - conservative potential land use - usually residential

**Notes:**
Forms the basis and need for ICs, often

## Brief Background on Utility of Risk Assessments in RCRA

- Site-Specific Risk Assessments
- Depending on requirements of your program, these can help you get to the point with less effort and money, but don’t assess full spectrum - assess most likely exposures
- Pragmatism/Realism - still, focus is on RME condition

## Components of a Risk Assessment

- Data Collection/Evaluation
- Acquire reliable chemical release and exposure data to support quantitative assessment - on-site and background.
- Data quality objectives - Reporting Limits
- Unfiltered water samples
- Seasonal variability - low flow conditions, high potential for volatilization to indoor air during winter, esp. in NE or during frozen conditions
- No composite samples
- Purposive, Random Sampling – Combination

**Notes:**
Data quality objectives w/r/t screening criteria - ensure reporting limits are stringent enough to note potential exceedance, if present.

Seasonal variability - low flow conditions in streams during summer based on low occurrence of precipitation or depressed groundwater, low potential for volatilization during spring (precipitation drives downward migration), high potential for volatilization to indoor air during winter, esp. in NE or during frozen conditions.

Purposive sampling - helps characterize the site w/r/t chemical release
Random sampling - helps support statistically viable data sets for use in characterizing potential exposure
Out of necessity, we rely on a combination - recognizing limitations and conservative bias (b/c of targeting impacted areas and variability which is brought into combined dataset).

## Components of a Risk Assessment

- Exposure Assessment (refines your first cut at a CSM)
- Types and magnitudes of exposures from COPCs
- Characterize Physical Setting
- Characterize Potential Exposed Populations
- Identification of Exposure Pathways (Exposure points and exposure routes)

**Notes:**
Estimate the types and magnitudes of exposures from COPCs present at or migrating from a site.

Characterize Physical Setting (climate, meteorology, geologic setting, vegetation, soil type, hydrology, presence of surface water)

## Components of a Risk Assessment

- Exposure Assessment (cont’d)
- Complete and Potentially Complete Exposure Pathways
- e.g., Groundwater
- Reasonable Maximum Exposure v.s Central Tendency
- 95UCL as EPC for both
- Use of Max and Mean if data sets are small, not statistically viable
- Acute vs. Chronic Risks - Hotspots?

**Notes:**
Complete and Potentially Complete Exposure Pathways
e.g., Groundwater - Drinking water source?  Now - or in future?  Tricky for long-term exposure - dynamic medium.  Look at center of plume - or max detects?  Aquifer classification?

Reasonable Maximum Exposure vs. Central Tendency
95UCL as EPC for both
Use of Max and Mean if data sets are small, not statistically viable.

Acute vs. Chronic Risks- 
Very elevated?
Hotspots near discrete work stations?  Localized land use activities?  

## Components of a Risk Assessment

- Toxicity Assessment - RfDs, RfCs, CSFs and URs - continuous exposure versus adjustment for time, intake rate and body weights
- Risk per ug/m3 or risk per ug/L versus mg COPC/kg BW/day
- Hazard Identification - Nature and strength of the evidence of causation

**Notes:**
Hazard Identification - Determining whether an agent can cause an increase in the incidence of a given adverse health effect.  Nature and strength of the evidence of causation.

## Components of a Risk Assessment

- Toxicity Assessment (cont’d)
- Dose-Response Evaluation - Relationship between dose and health effects
- Cancer - assumption of no threshold
- Subchronic toxicity criteria for construction worker exposures - use of chronic OK - just more conservative

**Notes:**
Dose-Response Evaluation - Quantitatively evaluating the toxicity information and characterizing the relationship between dose and the incidence of adverse health effects in exposed population.

Cancer - assumption of no threshold - single exposure can lead to uncontrolled cellular proliferation
Your risk assessor will focus on the veracity of the info, consider it for background.

Subchronic toxicity criteria for construction worker exposures - if they use chronic- just more conservative (see HEAST)

## Components of a Risk Assessment

- Risk Characterization
- Quantify risks
- Qualitative assessment - very important
- Cancer risk cumulative
- Hazard can be segregated based on target organ system
- Administered vs. absorbed doses.  Can make adjustment for dermal exposure - but standard is to shy away from making absorption adjustment for other pathways

**Notes:**
Administered vs. absorbed doses.  Can make adjustment for dermal exposure - but standard is to shy away from making absorption adjustment for other pathways.  Can entertain argument for gastrointestinal absorption adjustments, but anything with greater than 50% absorption is assumed to be associated with 100%.  Needs to be accompanied by strong arguments.

## Components of a Risk Assessment

- Uncertainty Analysis
- Generally undervalued - but may be most important part of risk evaluation
- Provides basis for confidence in quantitative point estimates

## Consideration of the NCP Risk Range (Risk Management)

- Degree of uncertainty and conservatism inherent in the risk assessment
- Complexity of the COPC list - One COPC vs. Many w/ varied exposure pathways

## Important Considerations/Crucial Problem Areas

- Selecting Preeminent COPCs
- Selecting Representative or Maximally Exposed Populations for Management Basis
- Maintaining Common Sense Approach - Don’t Get Wrapped Up in Minutia

## Selection of Constituents of Potential Concern

- COPCs vs. COCs
- Screening Criteria (PRGs, RBCs, MCLs, SSLs, etc.)
- Treatment of Non-Detect Results
- Why Important - Public Record vs. Influence on Risk Management
- SQLs and PQLs vs. MDLs and IDLs
- Elevated SQLs Relative to Health-Based Screening Criteria

**Notes:**
Screening Criteria (PRGs, RBCs, MCLs, SSLs, etc.)
Dependent on Media, Pathway and Receptor Populations at Issue

## Selection of Constituents of Potential Concern

- Treatment of Non-Detect Results (cont’d)
- Development of Exposure Point Concentrations
- Zero
- One-half the SQL or MDL? - Impact of variability vs. RAGS, 1989
- Equal to the SQL or MDL? - Impact of variability vs. RAGS, 1989

## Selection of Constituents of Potential Concern

- Screening of Essential Human Nutrients (e.g., Fe, Mg, Ca, K, Na)
- Only if: Concentrations very low; toxic only at very high doses
- Frequency of Detection
- A common methodology employed by PRPs.
- Designed to focus time and money on likely drivers of risk and hazard.
- No longer supported

**Notes:**
Screening of Essential Human Nutrients (e.g., Fe, Mg, Ca, K, Na)
Only if: 
Present at very low concentrations (i.e., only slightly elevated above background)
Toxic only at very high doses (i.e., much higher than those which could reasonably be associated with the site). 

Was designed to help risk assessors focus time and money on the likely drivers of risk and hazard.
No longer supported with the advent and general widespread availability of health-based screening criteria.

## Selection of Constituents of Potential Concern

- Background
- Baseline Assessment of Risk
- Naturally Occurring Constituents
- Anthropogenic Constituents
- In some cases: A Hazardous Pollutant Associated with a Release is also a Background Constituent (e.g., Arsenic, PAHs)
- USEPA Generally Does Not Require Clean Up Below Naturally Occurring or Ubiquitous Anthropogenic Background

**Notes:**
USEPA Generally Does Not Clean up to Concentrations Below Naturally Occurring or Ubiquitous Anthropogenic Background, Based On: Cost Effectiveness, Technical Practicability, Potential for Recontamination

## Selection of Constituents of Potential Concern

- Background (cont’d)
- Background Screening History
- RAGS, 1989 Cautioned Against Screening w/r/t Background
- PRPs Were Allowed this Option
- Refined Guidances in 1997 and in 2002
- Baseline (Total) Risk, Site-Related Risk, Residual (Background) Risk
- Clean Up May/May Not Eliminate a Source Caused by Background

**Notes:**
History:
RAGS, 1989 Cautioned Against Screening COPCs Based on Background
Still, Many PRPs Were Allowed to Screen Based on Comparison to Background.
Refined Guidances Started Appearing in 1997 and in 2002 Several Definitive Guidances Were Generated.)

Even Though Clean Up May or May Not Eliminate a Source of Risks Caused by Background Levels

## Selection of Constituents of Potential Concern

- Consideration of Background in Risk Management
- Contribution of Background Risk May Refine COC Clean Up Levels
- Consideration of Background in Risk Communication
- Background Risk Levels Are Important to the Public

**Notes:**
Background Risk Levels Are Important to the Public
Can Impact Daily Activities
Can Put Site-Related Impacts in Perspective

## Selection of Constituents of Potential Concern

- Comparing Reference/Background Data to Site Release Area Data
- Distribution of the Data: Normal, Lognormal, Neither - Shapiro-Wilk
- Limitations Based on Small Sample Sizes
- Parametric Tests: Student’s t-Test - Difference between dataset means - 0.05
- Non-Parametric Tests: Wilcoxon Rank Sum - Population comparisons based on relative ranking
- Certain Limitations - Non-detect %, Judgmental Sampling, etc.

**Notes:**
Parametric Tests
Common: Student’s t-Test - Tests for a difference between discrete dataset means - 0.05

Non-Parametric Tests - No Assumptions About Dataset Distribution - Outliers, Non-detect Data
Common: Wilcoxon Rank Sum - Tests whether measurements from one population tend to be larger (or smaller) than those from another population based on relative ranking (in a single list).

## QA/QC Samples

- Blank Samples - Positive Results if > 10 X Detection in Blanks
- J-Coded Values - Treat as Detections

## Chemicals Lacking Promulgated Toxicity Criteria

- IRIS, PPRTVs, HEAST
- QSAR- Chemist
- Route to Route Extrapolations - Toxicologist
- Provisional Toxicity Criteria - NCEA
- Uncertainty Assessment Must Address Issues

**Notes:**
Integrated Risk Information System (IRIS), PPRTVs, HEAST

Quantitative/Structure-Activity Relationships - Chemist

Route to Route Extrapolations, Unless Contraindicated - Toxicologist

Uncertainty Assessment Must Address Attendant Issues to Greatest Extent Possible

## Screening Criteria - Consideration of Relevance

- PRGs, RBCs, SSLs, MCLs, etc.
- Comparison to:
- Maximum Detected Concentrations - Initial Screening
- Arithmetic Means - Pb - ALM, 2003
- Upper-Bound Estimate on the Mean - e.g., 95UCL

**Notes:**
Upper-Bound Estimate on the Mean - e.g., 95% Upper Confidence Limit on the Mean
Brief Background on Basis for 95UCL as the Exposure Point Concentration
Can Refine The COPC List

## Exposure Point Concentration (EPC) Development

## Reference List - Risk Assessment Guidance - Most Helpful

- General Background and Overview/ Understanding
*Risk Assessment Guidance for Superfund, Volume 1, Human Health Evaluation Manual (Part A)*, (EPA/540/1-89/002), December, 1989
*Memorandum: Role of the Baseline Risk Assessment in Superfund Remedy Selection Decisions*, April, 1991
*Land Use in the CERCLA Remedy Selection Process*, May, 1995

## Reference List - Risk Assessment Guidance - Most Helpful

- General Background and Overview/ Understanding (cont’d)
*Human Health Risk Assessment Protocol for Hazardous Waste Combustion Facilities*, April, 1998; errata, 1999
*Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites*, March, 2001

## Reference List - Risk Assessment Guidance - Most Helpful

- Data Usability
*Guidance for Data Usability in Risk Assessment*, April, 1992
- Exposure Point Concentrations
*Supplemental Guidance to RAGS: Calculating the Concentration Term*, June, 1992
*The Lognormal Distribution in Environmental Applications*, December, 1997

## Reference List - Risk Assessment Guidance - Most Helpful

- Exposure Point Concentrations (cont’d)
*Human Health Risk Assessment Protocol for Hazardous Waste Combustion Facilities*, April, 1998; errata, 1999
*Calculating Upper Confidence Limits for Exposure Point Concentrations at Hazardous Waste Sites*, December, 2002

## Reference List - Risk Assessment Guidance - Most Helpful

- Screening Criteria Development
*Soil Screening Guidance: Technical Background Document*, May, 1996
*Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites*, March, 2001

## Reference List - Risk Assessment Guidance - Most Helpful

- Selected Contaminant-Specific Guidance
- Lead
*Recommendations of the Technical Review Workgroup for Lead for an Interim Approach to Assessing Risks Associated with Adult Exposure to Lead in Soil*, January, 2003
- PAHs
*Provisional Guidance for Quantitative Risk *_***Assessment***_* of Polycyclic Aromatic Hydrocarbons*, July 1993

## Reference List - Risk Assessment Guidance - Most Helpful

- Selected Contaminant-Specific Guidance (cont’d)
- Dioxin - PCDD/PCDF
*Exposure and Human Health Reassessment of 2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD) and Related Compounds*, September, 2000
- Exposure Factors/Parameter Values
*Exposure Factors Handbook*, August, 1997
*Human Health Risk Assessment Protocol for Hazardous Waste Combustion Facilities*, April, 1998; errata, 1999

## Reference List - Risk Assessment Guidance - Most Helpful

- Exposure Factors/Parameter Values
*Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites*, March, 2001
*Child-Specific Exposure Factors Handbook*, September, 2002
*Risk Assessment Guidance for Superfund, Volume 1, Human Health Evaluation Manual (Part E): Supplemental Guidance for Dermal Risk Assessment*, July, 2004

## Reference List - Risk Assessment Guidance - Most Helpful

- Presentation and Format for Risk Assessments
*Risk Assessment Guidance for Superfund, Volume 1, Human Health Evaluation Manual (Part D): Standardized Planning, Reporting and Review of Superfund Risk Assessments*, December, 1997
- Sediments
*Contaminated Sediment Management Strategy*, April, 1998

## Reference List - Risk Assessment Guidance - Most Helpful

- Combustion Risk Assessment
*Human Health Risk Assessment Protocol for Hazardous Waste Combustion Facilities*, April, 1998; *errata*, 1999
*Risk Burn Guidance for Hazardous Waste Combustion Facilities*, July, 2001
- Radionuclides
*Soil Screening Guidance for Radionuclides*, October, 2000

## Reference List - Risk Assessment Guidance - Most Helpful

- Background
*Guidance for Characterizing Background Chemicals in Soil at Superfund Sites*, June, 2001
*Guidance for Comparing Background and Chemical Concentrations in Soil for CERCLA Sites*, September, 2002

## Reference List - Risk Assessment Guidance - Most Helpful

- Vapor Intrusion
*Draft Guidance for Evaluating the Vapor Intrusion to Indoor Air Pathway from Groundwater and Soils*, December, 2002
*User’s Guide for Evaluating Subsurface Vapor Intrusion into Buildings*, June, 2003

## Reference List - Risk Assessment Guidance - Most Helpful

- Toxicity Values Hierarchy
*Human Health Toxicity Values in Superfund Risk Assessments*; Memorandum, OSWER Directive 9285.7-53, December, 2003
- Dermal Exposure
*Risk Assessment Guidance for Superfund, Volume 1, Human Health Evaluation Manual (Part E): Supplemental Guidance for Dermal Risk Assessment*, July, 2004

## Risk Assessment vs. Risk Management

- Common Sense
- Consider Expressions of Risk and Hazard as Ranges
- NCP Relative Risk Range
- Every Step Is a Mini Cost-Benefit Decision/Analysis
- Inherent Conservatism in the Face of Uncertainty

## Risk Assessment vs. Risk Management

- Is a fairly well defined process - but significant room for improvement in Uncertainty Analysis - Pay attention to this section and ask questions regarding what your common sense tells you could be substantive impacts to Risk Management