Risk Management

Risk Management is a distinctly different process from risk assessment. Risk assessment establishes whether a risk is present and, if so, the range or magnitude of that risk. In the risk management process, the results of the risk assessment are integrated with other considerations, such as economic or legal concerns, to reach decisions regarding the need for and practicability of implementing various risk reduction activities. Risk managers also use risk assessment results as a basis for communicating risks to interested parties and the general public.

Documents

1. Key Principles of Superfund Remedy Selection
2. Clarification of the Role of ARARs in Establishing Preliminary Remedial Goals under CERCLA (PDF) (4 pp, 411 K) August 22, 1997
   This memorandum clarifies the relationship between the two key remedy selection mandates of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA).
3. Response Actions at Sites with Contamination Inside Buildings (August 1993) (PDF) (6 pp, 104 K)
   Addresses the use of the CERCLA authority to conduct response actions within buildings that are contaminated. Includes a flow-chart that designates the sequence of steps to take when addressing indoor contamination scenarios. Headquarters consultation requirements are defined. OSWER 9360.3-12
4. The following link contains information on addressing asbestos at Superfund sites
5. Headquarters Consultation for Dioxin Sites (PDF) (2 pp, 31 K) OSWER Directive 9200.4-19, December 13, 1996
   This document requests that CERCLA regional offices consult with EPA Headquarters on sites where remediation goals are to be developed for dioxin in soil.
6. Approach for Addressing Dioxin in Soil and CERCLA and RCRA Sites (PDF) (6 pp, 43 K) OSWER Directive 9200.4-26, April 13, 1998
   The purpose of this document is to recommend preliminary remediation goals (PRGs), or starting points for cleaning up dioxin in soil.
7. EPA FAQ's about the Update to the ATSDR Policy Guideline for Dioxin and Dioxin-Like Compounds in Residential Soil (PDF) (6 pp, 39 K)
8. Lead at Superfund Sites: Risk Assessment
9. Assessment Guidance for Perchlorate
10. EPA Radiation Risk Assessment Guidance for Superfund sites
11. National Recommended Ambient Water Quality Criteria
    The criteria in this document (for 158 pollutants) provide guidance for states and tribes authorized to establish water quality standards under the Clean Water Act to protect human health and aquatic life.
12. The Role of Natural Resource Trustees in the Superfund Process, March 1992, Eco Update
    This EcoUpdate bulletin is intended to help project managers to work with Natural Resource Trustees, explaining the responsibilities and authorities of those trustees and those of the Remedial Project Managers and On-Scene Coordinators with respect to those trustees.
13. Ecological Risk Assessment and Risk Management Principles for Superfund Sites, (Issuance of Final Guidance), October 7, 1999
    Guidance intended to help Superfund project managers to make ecological assessment decisions that are consistent across the United States and are transparent to the public.
14. Eco Update Bulletin Series
    Eco Update is a bulletin series on ecological risk assessment of Superfund sites. These bulletins serve as supplements to "Ecological Risk Assessment Guidance: Process for Designing and Conducting Ecological Risk Assessments - Interim Final (EPA 540-R-97-006)"
15. Role of Screening Level Risk Assessment and Refining COCs (Chemicals or Contaminants of Concern) in Baseline Ecological Risk Assessment 2001
    This EcoUpdate bulletin describes the process and purpose of the screening level ecological risk assessment, which is the first steps in a ecological risk assessment at a site, and how the list of COCs can be refined to include only those contaminants that may pose a risk.
16. Preliminary Remediation Goals for Ecological Endpoints (PDF) Exit (41 pp, 139 K)
    Eco Update, (Guidance document dated August 31, 2000.) Preliminary Remediation Goals are upper concentration limits of specific chemicals that are expected to be protective of human health or the environment and are useful in risk assessment and decision making at Superfund sites.

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EPA Links

1. Region 5 Ecology Technical Center Ecological Risk Assessment
   Overview of ecological risk assessment process in Superfund, regional case studies, toxicity profiles, and regional contacts.

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Risk Communication

Risk Communication comprises the formal and informal processes of communication among various parties who are potentially at risk from or are otherwise interested in the site. Throughout the risk assessment process, EPA will keep the public informed on issues concerning the site and provide guidance on how it will receive and respond to input from the affected community. Advisory groups are one example of the tools EPA may employ to communicate risk information including Biological Technical Assistance Groups or "BTAGs." In addition, the Agency will notify and communicate with the Natural Resource Trustees who have jurisdiction at the site regarding known or potential adverse effects on ecological receptors.

Documents

1. Risk Assessment Guidance for Superfund, Volume I
   Part A (1989)
   Part B (1991)
   Part C (1991)
   Part D (2001)
   Part E (2004)
   Part F (2009)
   Supplement to Part A: Community Involvement in Superfund Risk Assessments (1999)
   The purpose of this guidance document is to provide the site team--risk assessor, remedial project manager (RPM), and community involvement coordinator--with information to improve community involvement in the Superfund risk assessment process.
2. Presenters' Manual for: Superfund Risk and Assessment and How You Can Help
   EPA developed the 40-minute videotape "Superfund Risk Assessment and How You Can Help" to help explain in plain terms the Superfund human health risk assessment process and how communities can be involved.
3. Superfund Today: Focus on Risk Assessment: Involving the Community What is Human Health Risk Assessment?
4. Superfund Community Involvement Tools and Resources
   A basic overview of the risk assessment process in Superfund.
5. A Community Guide to Superfund Risk Assessment, Spanish Version, (December, 1999)
   EVALUACIÓN DE LOS RIESGOS DEL SUPERFUND: De Qué Se Trata La Evaluación De Los Rriesgos Y Cómo Nos Puede Ayudar.
6. Asbestos
7. Dioxin
8. Lead
9. Assessment Guidance for Perchlorate
10. EPA Radiation Risk Assessment Guidance for Superfund sites
11. Ecological Assessment of Superfund Sites: An Overview, (December 1991)
    This EcoUpdate bulletin describes the components of the ecological risk assessment process and how they fit into the Remedial Investigation/Feasibility Study process.
12. Ecological Risk Assessment and Risk Management Principles for Superfund Sites, Issuance of Final Guidance, (October 7, 1999)
    Guidance intended to help Superfund project managers to make ecological assessment decisions that are consistent across the United States and are transparent to the public.
13. Role of BTAGs in Ecological Assessment (PDF) (4 pp, 364 K) Eco Update (September, 1991)
    This EcoUpdate bulletin describes the responsibilities and activities of the Biological Technical Assistance Group: a group of scientists established to aid remedial project managers.
14. Role of Screening Level ERAs and Refining Contaminants of Concern in Baseline Ecological Risk Assessments
    This EcoUpdate bulletin describes the process and purpose of the screening level ecological risk assessment, which is the first steps in a ecological risk assessment at a site, and how the list of COCs can be refined to include only those contaminants that may pose a risk.
15. The Role of Natural Resource Trustees in the Superfund Process, Eco Update (March, 1992)
    This EcoUpdate bulletin is intended to help project managers to work with Natural Resource Trustees, explaining the responsibilities and authorities of those trustees and those of the Remedial Project Managers and On-Scene Coordinators with respect to those trustees.

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Miscellaneous

These are documents and links that provide general or other information related to risk assessment, but that does not readily fit into other topic categories:

• Human Health Planning and Scoping
• Human Health Exposure
• Human Health Toxicity
• Human Health Risk Characterization and Risk Management
• Human Health Risk
• Ecological Risk
• External Links

Human Health Planning and Scoping

1. (Revised) Policy on Performance of Risk Assessments During RI/FSs Conducted by PRPs
   As part of the recently announced administrative reforms to the Superfund program, the Administrator stated that EPA would reaffirm its commitment to "allow PRP's to conduct risk assessments under proper circumstances as part of the overall site study (RI/FS)." This memorandum announces EPA's revised policy on allowing PRP's to conduct the risk assessment portion of the RI/FS.
2. Guidelines for Characterizing Background Chemicals in Soil at Superfund Sites, September 2002
   This document provides guidance to the U.S. Environmental Protection Agency Regions concerning how the Agency intends to exercise its discretion in implementing one aspect of the CERCLA remedy selection process. The guidance is designed to implement national policy on these issues.
3. Response Actions at Sites with Contamination Inside Buildings (August 1993) (PDF) (6pp, 104 K)
   Addresses the use of the CERCLA authority to conduct response actions within buildings that are contaminated. Includes a flow-chart that designates the sequence of steps to take when addressing indoor contamination scenarios. Headquarters consultation requirements are defined. OSWER 9360.3-12
4. The EPA Office of Pollution Prevention and Toxics has developed software in its Estimation Program Interface ("EPI") which provides physical and chemical properties on contaminants.
5. Analytical Methods
   The following EPA Forum on Environmental Measurements link provides information on the collection and analysis of environmental samples.
6. Guidance for Data Useability in Risk Assessment (Part A), April 1992
   Guidance for Data Useability in Risk Assessment, Part A, is designed to provide data users with a nationally consistent basis for making decisions about the minimum quality and quantity of environmental analytical data that are sufficient to support Superfund risk assessment decisions, regardless of which parties conduct the investigation. Part B of this guidance addresses radioanalytical issues.
7. Guidance for Data Useability in Risk Assessment (Part B), May 1992
   This document is the second part of the two-part Guidance for Data Useability in Risk Assessment. Part B provides supplemental guidance to Part A on planning and assessing radioanalytical data needs for the baseline human health risk assessment conducted as part of the remedial investigation process at sites containing radioactive substances. Part B is not a stand alone document and at all times should be used in conjunction with Part A.
8. Guidance for Data Usability in Risk Assessment: Quick Reference Fact Sheet, September 1990
   Bibliography of entries from categories of EPA documents.
9. Soil Screening Guidance July 1996, December 2002
   The Soil Screening Guidance (SSG) presents a framework for developing risk-based, soil screening levels (SSLs) for protection of human health
10. EPA's Envirofacts Database
    Provides access to several EPA databases to provide you with information about environmental activities that may affect air, water, and land anywhere in the United States.
11. Greenbook Pesticide Labels and MSDS, EPA's Pesticide Program, PPIS Data, Biopesticides, and RED Pesticide Summaries
    EPA pesticide news stories, summaries, and featured sites.
12. US EPA Laws and Regulations
    Links to various laws, and regulations.
13. Supplemental Guidance to RAGS: Calculating the Concentration Term (PDF) Exit(8pp, 67 K)

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Human Health Exposure

1. Role of the Baseline Risk Assessment in Superfund Remedy Selection, April 22, 1991
   This memo describes the process and purpose of the baseline risk assessment (the latter steps) in terms of remedy selection.
2. Risk Assessment Guidance for Superfund, Volume I - Human Health Evaluation Manual
   Part A: Baseline Risk Assessment (1989)
   Supplement to Part A: Community Involvement in Superfund Risk Assessments (1999)
   The purpose of this guidance document is to provide the site team--risk assessor, remedial project manager (RPM), and community involvement coordinator--with information to improve community involvement in the Superfund risk assessment process
   Part B: Development of Risk-based Preliminary Remediation Goals (1991)
   Part C: Risk Evaluation of Remedial Alternatives (1991)
   Part D: Standardized Planning, Reporting and Review of Superfund Risk Assessments (2001)
   Part E: Supplemental Guidance for Dermal Risk Assessment (2004)
   Part F: Supplemental Guidance for Inhalation Risk Assessment (2009)
3. Standard Default Exposure Factors for Superfund sites
4. NCEA Exposure Factors Program - Sometimes NCEA calls this their Exposure Factors Handbook, and sometimes their Exposure Factors Program. Let's use what I found on their website link as the descriptive text: Exposure Factors Handbook.
5. EPA Superfund's "Process for Conducting Probabilistic Risk Assessment, RAGS Volume III, Part A, December 2001, EPA 540-R-02-002
6. Additional Information from EPA's Center for Public Health and Environmental Assessment (CPHEA) on Probabilistic Risk Assessment
7. New Policy on Evaluating Health Risks to Children
   From Administrator Carole Browner to: Assistant Administrators, General Counsel, Inspector General, Associate Administrators and Regional Administrators. October 20, 1995.
8. The EPA Center for Public Health and Environmental Assessment's 2008 Child-Specific Exposure Factors Handbook
9. Summary Report of a Peer Involvement Workshop on the Development of an Exposure Factors Handbook for the Aging, February 2007
10. The EPA/OSWER Office of Solid Waste (OSW) has developed an approach for conducting multi-pathway, site-specific human health risk assessments on hazardous waste combustion facilities. The technical approach presented in the combustion guidance may be useful when combustion risk is assessed on a Superfund site.
11. Vapor Intrusion Guidance
    OSWER Draft Guidance for Evaluating the Vapor Intrusion to Indoor Air Pathway from Groundwater and Soils (Subsurface Vapor Intrusion Guidance). Provides current technical and policy recommendations on determining if the vapor intrusion pathway poses an unacceptable risk to human health at cleanup sites.
12. The following link contains information on addressing asbestos at Superfund sites
13. For lead risk assessment documents, please visit this webpage.
14. Bioavailability is the amount of a contaminant that is absorbed into the body following skin contact, ingestion, or inhalation. Relative bioavailability is how much of a contaminant is absorbed by humans from soil as compared to how much of that contaminant is absorbed from food or water. This Web site describes how EPA is incorporating relative bioavailability information for human exposures at Superfund sites exposed to soil contaminants via the oral pathway.
15. Hazard Assessment (HA) for Munitions and Explosives of Concern (MEC)
16. EPA Radiation Risk Assessment Guidance for Superfund sites

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Human Health Toxicity

1. OSWER Toxicity Value Heirarchy - Human Health Toxicity Values in Superfund Risk Assessments.
2. IRIS Database - EPA's Integrated Risk Information System (IRIS) of human health toxicity assessments.
3. Use of IRIS Values in Superfund Risk Assessment - OSWER Directive 9285.7-16, December 21, 1993
   This memorandum clarifies the policy stated at section 7.4.1 of the December 1988 Risk Assessment Guidance for Superfund (Volume I) Human Health Evaluation Manual (Part A) (RAGS) on the use of Integrated Risk Information System (IRIS) values in performing health risk assessments.
4. Cancer Guidelines
   EPA's Guidelines for Carcinogen Risk Assessment are intended to aid scientists in assessing the possible cancer risks caused by exposure to pollutants in the environment. Released in March 2005, the revised Cancer Guidelines integrate recent advances in scientists' understanding of the processes involved in the development of cancer.

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Human Health Risk Characterization and Risk Management

1. EPA's 1992 Guidance on Risk Characterization
2. EPA Risk Characterization Program 
3. Risk Characterization Memo - Implementing the Administrator's Risk Characterization Memorandum
4. Clarification of the Role of ARARs in Establishing Preliminary Remedial Goals under CERCLA August 22, 1997
   This memorandum clarifies the relationship between the two key remedy selection mandates of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA).
5. Current Drinking Water Standards
   List of regulated contaminants with links for more details.
6. National Recommended Ambient Water Quality Criteria
   The criteria in this document (for 158 pollutants) provide guidance for states and tribes authorized to establish water quality standards under the Clean Water Act to protect human health and aquatic life.
7. Headquarters Consultation for Dioxin Sites (PDF) (2 pp, 31 K) - OSWER Directive 9200.4-19, December 13, 1996
   This document requests that CERCLA regional offices consult with EPA Headquarters on sites where remediation goals are to be developed for dioxin in soil.
8. Approach for Addressing Dioxin in Soil and CERCLA and RCRA Sites (PDF) (6 pp, 43 K) - OSWER Directive 9200.4-26, April 13, 1998
   The purpose of this document is to recommend preliminary remediation goals (PRGs), or starting points for cleaning up dioxin in soil.
9. EPA FAQ's about the Update to the ATSDR Policy Guideline for Dioxin and Dioxin-Like Compounds in Residential Soil

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Human Health Risk

1. Superfund Community Involvement Tools and Resources
2. Presenters' Manual for: Superfund Risk and Assessment and How You Can Help
   EPA developed the 40-minute videotape "Superfund Risk Assessment and How You Can Help" to help explain in plain terms the Superfund human health risk assessment process and how communities can be involved.

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Ecological Risk

1. Ecological Risk Assessment Guidance for Superfund: Process for Designing and Conducting Ecological Risk Assessments - Interim Final,  June 1997, EPA 540-R-97-006
   This document provides guidance on how to design and conduct consistent and technically defensible ecological risk assessments for the Superfund program. Although this guidance addresses ecological risk, it is presented on a human health page as part of a collection of all of EPA's Risk Assessment Guidance (RAGS). This guidance replaced RAGS Volume II.
2. US EPA Region 5 Ecology Technical Center Ecological Risk Assessment
   Overview of ecological risk assessment process in Superfund, regional case studies, toxicity profiles, and regional contacts.

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External Links

1. Risk assessors completing risk assessments on Superfund sites may find the following Environmental Council of States (ECOS) paper: Identification and Selection of Toxicity Values/Criteria for CERCLA and Hazardous Waste Site Risk Assessments in the Absence of IRIS Values (DOC) Exit, useful in evaluating and selecting human health toxicity values for use in risk assessments. Both EPA/OSWER and EPA/ORD scientists and risk assessors, as well as Department of Defense and California Environmental Protection Agency scientists and risk assessors, participated in the writing of this paper. These parties find the paper an its seven preferences on evaluating toxicity values useful.
2. The U.S. Agency for Toxic Substances and Disease Registry (ATSDR)
   ATSDR developes chronic, intermediate, and acute minimal risk levels (MRLs) for some contaminants, which are considered a Tier 3 source in the OSWER hierarchy of human health toxcity values.
3. The California Environmental Protection Agency (Cal EPA)/Office of Environmental Health Hazard Assessment Exit
   The California Environmental Protection Agency (Cal EPA)/Office of Environmental Health Hazard Assessment derives human health toxicity values, which the EPA Superfund Program sometimes uses, such as when EPA has not derived a needed toxicity value. Cal EPA toxicity assessments and values can be obtained from this Cal EPA database.
4. The World Health Organization/International Programme Exit
   The World Health Organization/International Programme on Chemical Safety's (IPCS) Concise International Chemical Assessment Documents may also be considered a Tier 3 source, when no Tier 1 (IRIS) or Tier 2 (Provisional Peer Reviewed Toxicity Values) values are available.
5. The 2005 World Health Organization Re-evaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-like Compounds Exit
   In 1998 and again in 2005 the World Health Organization/International Programme on Chemical Safety (WHO/IPCS) evaluted the relative cancer potentcy of chlorinated dioxins, chlorinated dibenzofurans and some polychlorinated biphenyls (PCBs) and derived toxicity equivalency factors (TEFs) which can be used in conjunction with cancer toxicity values from other sources to evaluate the cancer risk of these contaminants. The EPA Superfund Program supports the use of the current (2005) TEFs from the WHO/IPCS, which are presented in this document.

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