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Round 3-6b: Standardize Risk Assessments




Reform Description
This initiative will improve current national Superfund risk assessment guidance by updating and expanding parts of the 1989 Risk Assessment Guidance for Superfund (see Documents below). EPA developed this reform to:
  • Improve current Risk Assessment Guidance for Superfund (RAGS) to ensure quality, consistency, and reliability; and
  • Ensure greater community involvement in designing risk assessments by providing for stakeholder input.
For related information, see the closely associated reform on Community Participation in Designing Risk Assessments (Reform 3-5a).

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Reform Status
During 2002, EPA planned to issue final guidance documents for background chemicals in soil at Superfund sites, problemistic risk assessment, and non-residential soil screening guidance.

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Results
Throughout 1996, EPA met with various stakeholders to solicit ideas and help prioritize the focus areas for the Risk Assessment Guidance for Superfund (RAGS) reforms. This outreach effort culminated in two large stakeholder forums convened by the International City/County Managers Association (ICMA) on October 29-31, 1996, in San Francisco, California, and on November 6-8, 1996, in Washington, D.C.

At the forums, stakeholders identified key areas for improvement and offered suggestions to improve RAGS. The stakeholders also had the opportunity to dialogue with EPA and other interested groups on a variety of Superfund issues. ICMA prepared meeting proceedings, which were mailed to the forum participants.

Based on input from both the stakeholders and the Agency's own risk assessors and managers, EPA identified four key issues to address:
  • Community Involvement in Superfund Risk Assessments;
  • Use of Background in Risk Assessments;
  • Non-residential Land Uses incorporated into soil screening guidance; and
  • Probabilistic Risk Assessment.
In March 1997, EPA created workgroups with both Headquarters and the Regional representatives to address these issues, and to prepare a risk assessment reference document. After completion of the first draft of the reference document in September 1997, the document was circulated within EPA for comments. In January 1998, a revised draft was provided for review to over 200 representatives of community groups, State and local governments, and industry.

In March 1998, the Agency revisited the key issues with stakeholders at the third ICMA/EPA RAGS Reform Stakeholder Forum in Atlanta, Georgia. EPA also solicited comments from the participants on a draft of the reference document, and continued to make revisions based on feedback received. After the March conference, EPA discussed the draft at a number of EPA technical and community involvement meetings, and with other stakeholders, such as ASTSWMO.

In addition to the four key areas identified in 1996, EPA risk assessors began a new effort to develop an educational videotape on risk assessment and the role of citizens. Participants of the March 1998 meeting in Atlanta provided input on the early planning stages for the video and gave advice on the format and content. Draft versions of the video were played for EPA staff and various stakeholders attending EPA meetings to help refine the focus of the tape.

In 1999, EPA (1) issued the final risk assessment reference document, (2) produced a video that discusses risk assessments and opportunities for public involvement, and (3) prepared a hand-out on community participation. The reference document was finalized and released in March 1999, as a supplement to the 1989 Risk Assessment Guidance for Superfund (see Documents below). EPA developed a citizen brochure to accompany the guidance in April 1999. The video was finalized in September 1999 and includes examples from communities living near Superfund sites. EPA plans to pilot the video in the Regions during FY 2000.

EPA has completed internal and external reviews of the guidance documents pertaining to characterization of background chemicals in soil, probabilistic risk assessment, and supplemental soil screening guidance for non-residential land uses. All three are expected to become final in 2002. See the Documents for more information.

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Stakeholder Comments
Generally, stakeholders thought the discussion forums were a useful first step in initiating dialogue about this initiative. They especially liked the breakout sessions where they could talk in small groups about Superfund risk assessment issues.

At the forum in Washington, D.C., an attendee from a non-profit organization commented that:

"I was impressed that people from very diverse perspectives [and] affiliations could come together in small groups and leave behind their preconceived notions and positions to constructively discuss problems and reach solutions."

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Documents

Title: Radiation Risk Assessment: Updates and Tools [Training Course] New
Date: July 29, 2003
Document #: N/A
Synopsis: The focus of this training is EPA's new radiation risk assessment tools which can facilitate better decision making for accelerated cleanups.

Title: Distribution of OSWER Radionuclide ARAR Dose Compliance [Transmittal Memo] New
Date: July 28, 2003
Document #: OSWER No. 9355.0-86A
Synopsis: N/A

Title: Draft Guidance for Evaluating the Vapor Intrusion to Indoor Air Pathway from Groundwater and Soils
Date: November 2002
Document #: N/A
Synopsis: This document also known as the Subsurface Vapor Intrusion Guidance, provides current technical and policy recommendations on the determining if the vapor intrusion pathway poses an unacceptable risk to human health at cleanup sites. This draft guidance is intended to aid in evaluating the potential for human exposure from this pathway, given the state-of-the- science at this time, although EPA continues to explore this area for further improvements.

Title: Distribution of Memorandum of Understanding between EPA and the Nuclear Regulatory Commission [Transmittal Memo]
Date: October 9, 2002
Document #: OSWER No. 9295.8-06a
Synopsis: This transmittal note includes guidance to the EPA Regions to facilitate Regional compliance with the Memorandum of Understanding Between the Environmental Protection Agency and the Nuclear Regulatory Commission: Consultation and Finality on Decommissioning and Decontamination of Contaminated Sites," signed on September 9, 2002 and October 9, 2002. It also clarifies that the MOU does not affect CERCLA actions that do not involve NRC (e.g., the MOU does not establish cleanup levels for CERCLA sites).

Title: Memorandum of Understanding Between the Environmental Protection Agency and the Nuclear Regulatory Commission: Consultation and Finality on Decommissioning and Decontamination of Contaminated Sites
Date: Signed by EPA on September 2002 and NCR on October 9, 2002
Document #: OSWER 9295.8-06, NTIS PB2003 100246
Synopsis: This document was developed by EPA and the Nuclear Regulatory Commission (NRC) to identify the interactions of the two agencies for only the decommissioning and decontamination of NRC-licensed sites and the ways in which those responsibilities will be implemented. EPA believes that implementation of the MOU between the two agencies will ensure that future confusion about dual regulation does not occur regarding the cleanup and reuse of NRC-licensed sites.

Title: Guidance for Characterizing Background Chemicals in Soil at Superfund Sites
Date: September 2002
Document #: EPA 540-R-01-003
Synopsis: This guidance provides a framework for developing risk-based, soil screening levels (SSLs) for the protection of human health. The framework presents an approach to site evaluation and screening level development, including detailed models and generic SSLs to be used where site conditions warrant a simple methodology for developing site-specific screening levels.
Contacts: Jane Michaud (703) 603-8847

Title: Distribution of OSWER of Common Radionuclides Found at Superfund Sites Booklet for General Public [Transmittal Memo]
Date: August 2002
Document #: OSWER No. 9200.1-34b
Synopsis: The purpose of this memorandum is to transmit the final booklet entitled "Common Radionuclides Found at Superfund Sites." The booklet explains how a person can be exposed to radionuclides; how radionuclides can affect human health, as well as how they enter and leave the body; what levels of exposure result in harmful effects; and the recommendations made by the federal government, to protect human health from radionuclides.

Title: Common Radionuclides Found at Superfund Sites
Date: July 2002
Document #: OSWER No. 9200.1-34 NTIS PB2001 963303
Synopsis: This booklet provides information to help the general public understand more about the various radionuclides that are commonly found at Superfund sites across the nation. It explains how a person can be exposed to radionuclides; how radionuclides can affect human health, as well as how they enter and leave the body; what levels of exposure result in harmful effects; and the recommendations made by the federal government, to protect human health from radionuclides.

Title: Simulating Radionuclide Fate and Transport in the Unsaturated Zone: Evaluation and Sensitivity Analyzes of Select Computer Models
Date: July 2002
Document #: EPA/600/R-02/082
Synopsis: This report provides a detailed technical analysis of five unsaturated zone fate transport models for radionuclides. This report supports the information provided in Part 3- Unsaturated Zone Models for Radionuclides Fate and Transport of the Soil Guidance for Radionuclides: Technical Background Document on Determining the general applicability of the models to subsurface conditions, and an assessment of each model's potential applicability to the soil screening process.

Title: Radionuclide Preliminary Remediation Goals (PRGs) for Superfund
Date: N/A
Document #: N/A
Synopsis: This electronic calculator provides information about establishment of PRGs for radionuclides at CERCLA sites with radioactive contamination. It provides standardized exposure parameters and equations that should be used for calculating radionuclide PRGs for residential, commercial/industrial, and agricultural land use exposures, tap water and fish ingestion exposures, and migration of radionuclides through the unsaturated zone.

Title: Proposed Asbestos Cancer Risk Assessment Methodology
Date: N/A
Document #: N/A
Synopsis: This draft report provides a basis for completing a state-of-the-art-protocol to assess potential human-health risks associated with exposure to asbestos. This protocol is intended specifically for use in performing risk assessments at Superfund sites, although it may be applicable to a broad range of situations.

Title: Distribution of OSWER of Radionuclide Preliminary Remediation Goals (PRGs) for Superfund Electronic Calculator [Transmittal Memo]
Date: February 7, 2002
Document #: OSWER 9355.01-83A, NTIS PB2002 963301
Synopsis: The purpose of this memorandum is to transmit the final booklet entitled "Common Radionuclides Found at Superfund Sites." The booklet explains how a person can be exposed to radionuclides; how radionuclides can affect human health, as well as how they enter and leave the body; what levels of exposure result in harmful effects; and the recommendations made by the federal government, to protect human health from radionuclides.

Title: Risk Assessment Guidance for Superfund (RAGS): Volume III - Part A, Process for Conducting Probabilistic Risk Assessment.
Date: December 2001
Document #: OSWER 9285.7-45
Synopsis: This guidance builds upon the basic concepts of risk assessment outlined in "RAGS Volume I" by providing policies and guiding principles on the application of probabilistic risk assessment (PRA) methods to human health and ecological risk assessment
Contacts: Steve Chang, (703) 603-9017

Title: Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites (Final Draft)
Date: March 2001
Document #: OSWER 9355.4-24
Synopsis: Companion guidance to the 1996 Soil Screening Guidance; includes non-residential land use scenarios and pathways for soil screening level development and incorporates new modeling data. The revised model and supporting information is available on the User's Guide For the Johnson and Ettinger (1991) Model for Subsurface Vapor Intrusion Into Buildings (REVISED). (PDF 98 pages, 682KB)
Contacts: David A. Bennett (703) 603-8759, and Jane Dinan (404) 562-8491.

Title: Risk Assessment Guidance for Superfund, Volume 1, Human Health Evaluation Manual (Supplement to Part A): Community Involvement in Superfund Risk Assessments
Date: March 1999
Document #: EPA 540-R-98-042, OSWER 9285.7-01
Synopsis: Experience has shown that communities can provide useful information about site history, the ways people may come into contact with the site, and health concerns. This document provides: guidance for EPA staff on ways to involve the community in the risk assessment process; case examples; tips for risk assessors and RPMs; and key questions to ask people. (This guidance does not replace or supercede any existing community involvement requirements under the NCP.)
Contacts: Jane Michaud (703) 603-8847

Title: Superfund Today: Focus on Revisions to Superfund's Risk Assessment Guidance
Date: February 1999
Document #: EPA 540-F-98-055, OSWER 9285.7-26J-P, NTIS PB99-963302
Synopsis: This issue of "Superfund Today" updates EPA's progress with the risk assessment reforms.
Contacts: Jane Michaud (703) 603-8847

Title: Superfund Today: Focus on Revisions to Superfund's Risk Assessment Guidance
Date: October 1997
Document #: EPA 540-F-97-013
Synopsis: This issue of "Superfund Today" discusses EPA's commitment to conduct reasonable and consistent Superfund risk assessments and involve stakeholders in the decision-making process.
Contacts: Jane Michaud (703) 603-8847

Title: Risk Assessment Guidance for Superfund, Volume 1, Human Health Evaluation Manual (Part A, Interim Final)
Date: December 1989
Document #: EPA 540-1-89-002, OSWER 9285.7-01a, NTIS PB90-155581CDH
Synopsis: RAGS Part A provides guidance on the human health evaluation activities that are conducted during the baseline risk assessment.
Contacts: Jane Michaud (703) 603-8847

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