Tools for Human Health Risk Assessment

Click on the bulleted items below to access guidance, policy, and technical tools for Superfund human health risk assessment. Both general tools and tools specific to the major steps of the risk assessment process are included, and most of the resources referenced can be downloaded.

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General Guidance/Policy
Planning, Scoping, Problem Formulation
Exposure Assessment
Hazard Identification and Dose-Response Assessment
Risk Characterization
Risk Management

General Guidance/Policy

Presenter's Manual For "Superfund Risk Assessment And How You Can Help", A 40-Minute Videotape (PDF) (77 pp, 772 kb, About PDF)
A Community Guide To Superfund Risk Assessment--What It's All About And How You Can Help
In Spanish: De qué se trata la evaluación de los riesgos y cómo nos puede ayudar
Risk Assessment Guidance for Superfund (RAGS): Volume I -- Human Health Evaluation Manual

Part A of RAGS describes how to conduct a site-specific baseline risk assessment. The information in Part A is necessary background for Part D. Part B provides guidance for calculating risk-based concentrations that may be used, along with applicable or relevant and appropriate requirements (ARARs) and other information, to develop preliminary remediation goals (PRGs) during project scoping. PRGs (and final remediation levels set in the Record of Decision) can be used throughout the analyses in Part C to assist in evaluating the human health risks of remedial alternatives. Part D complements the guidance provided in Parts A, B, and C and presents approaches to standardize risk assessment planning, reporting, and review. Part D guidance spans the CERCLA remedial process from project scoping to periodic review of the implemented remedial action. Part D guidance applies to all Superfund Risk Assessments starting after January 1, 1998.

RAGS Part A (1989)
Supplement to RAGS Part A: Community Involvement in Superfund Risk Assessments (1999)
RAGS Part B (1991)
RAGS Part C (1991)
RAGS Part D (2001)
RAGS Volume 3 Part A: Process for Conducting Probabilistic Risk Assessment
Soil Screening Guidance (1996)

EPA developed Soil Screening Guidance as a risk-based tool to expedite the evaluation of contaminated soils at sites addressed under Superfund. The guidance is intended to help determine whether on-site soil contamination exists at levels sufficient to warrant further evaluation of the risks these contaminants may pose. Use of the Soil Screening Guidance may significantly reduce the time it takes to complete soil investigations and cleanup actions at some sites, as well as improve the consistency of these actions across the nation.

Fact Sheet
User's Guide
Technical Background Document
Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites (2002) (PDF) (106 pp, 1.9MB, About PDF)
PRPs and Risk Assessment

EPA's 1996 Superfund administrative reforms allowed PRPs to conduct Superfund site risk assessments in appropriate cases as part of the overall remedial investigation/feasibility study (RI/FS). Allowing PRPs to perform risk assessments makes the cleanup process more efficient by decreasing the time needed for conducting the RI/FS study, improving communication between EPA and PRPs, giving PRPs a greater role in the decision-making process, and reducing EPA's oversight requirements.

On January 26, 1996, the Office of Solid Waste and Emergency Response (OSWER) issued Directive No. 9340.1-02 to announce EPA's new policy to allow PRPs to conduct the risk assessment at most sites where they are also performing the RI/FS. The Directive listed six criteria that the Regions are to consider when deciding whether or not to allow the PRP to perform the risk assessment. The new policy also removed the previous requirement for the Regions to consult with Headquarters before authorizing a PRP to conduct the risk assessment. Eight Regions have indicated that they are identifying sites where PRPs will be conducting the risk assessments.
New Policy on Performance of Risk Assessments During Remedial Investigation Feasibility Studies (RI/FS) Conducted by Potentially Responsible Parties (PRPs) (1993)
Supplemental Guidance on Performing Risk Assessments in Remedial Investigation/Feasibility Studies (RI/FS) conducted by Potentially Responsible Parties (PRPs)
Policy for Use of Probabilistic in Risk Assessment at the U.S. Environmental Protection Agency (1997)
Guiding Principles for Monte Carlo Analysis (1997)
Proposed Guidelines for Carcinogen Risk Assessment (1996)
Guidelines for Reproductive Toxicity Risk Assessment (1996)
Guidelines for Neurotoxicity Risk Assessment (1998)

Planning, Scoping, Problem Formulation

RAGS Part D, Chapter 2 (2001) (PDF) (4 pp, 21 kb, About PDF)

Chapter 2 of RAGS Part D describes the role risk assessors should play during the scoping phase of a Superfund project. This information should also guide the planning, scoping, and problem formulation phase of the risk assessment itself.
Soil Screening Guidance (1996)

EPA developed Soil Screening Guidance as a risk-based tool to expedite the evaluation of contaminated soils at sites addressed under Superfund. The guidance is intended to help determine whether on-site soil contamination exists at levels sufficient to warrant further evaluation of the risks these contaminants may pose. Use of the Soil Screening Guidance may significantly reduce the time it takes to complete soil investigations and cleanup actions at some sites, as well as improve the consistency of these actions across the nation.

Fact Sheet
User's Guide
Technical Background Document
Soil Screening Calculations
Johnson and Ettinger (1991) Model for Subsurface Vapor Intrusion into Buildings

Exposure Assessment

Risk Assessment Guidance for Superfund (RAGS) Part A (1989)
Soil Screening Guidance Technical Background Document (1996)
Soil Screening Calculations
Johnson and Ettinger Air Model
Exposure Factors Handbook (1997)
Data Quality Objectives

Sampling and analysis activities undertaken during the RI should provide adequate data to evaluate all appropriate exposure pathways. Therefore, risk assessors should be involved in the development of the data quality objectives for sampling and analysis and in selecting the types of sampling and analyses that will be done. The DQOs should address the qualitative and quantitative nature of the sampling data in terms of relative quality and intent for use, to ensure that the data collected will be appropriate for the intended objectives. DQOs are discussed under Section 2.2 of RAGS Part D (PDF) (4 pp, 21 kb, About PDF).
Data Useability in Risk Assessment

Data quality is an important component of the risk assessment and the evaluation of data quality should be documented. RAGS Part D includes Data Useability Worksheets (ZIP 7KB) to address this need. In addition, Section 3.1.1 of Risk Assessment Guidance for Superfund (RAGS) Part D (PDF 59KB, 30 pages) discusses standard tables, worksheets, and supporting information.

Guidance for Data Useability in Risk Assessment: Quick Reference Fact Sheet (1990)
Guidance for Data Useability in Risk Assessment (Part A) (1992)
Guidance for Data Useability in Risk Assessment (Part B) (1992)

Hazard Identification and Dose-Response Assessment

1,1-Dichloroethylene

Notice to Public (PDF) (1 page, 6 kb, About PDF)
Instructions to Peer Review (PDF) (3 pp, 9 kb, About PDF)
External Peer Review Draft (PDF) (57 pp, 123 kb, About PDF)
IRIS External Peer Review Draft (PDF) (25 pp, 58 kb, About PDF)
Integrated Risk Information System (IRIS)

Risk Characterization

Risk Management

Role of the Baseline Risk Assessment in Superfund Remedy Selection Decisions (1991)
EPA's Technology Innovation Office (TIO)

TIO's mission is to advance the use of new technologies for site characterization and remediation. This site provides information about innovative technologies, programs, organizations, publications, software, and other tools related to the characterization and cleanup of hazardous waste sites.

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