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Waste and Cleanup Risk Assessment

RCRA Risk Assessment: Human Health: Toxicity (Hazard Identification and Dose Response)

RCRA Human Health
Risk Topics:

Planning and Scoping

Acute Hazards

Toxicity (Hazard Identification and Dose Response)

Risk Characterization

RCRA Additional Risk Assessment Topics:

Risk Management

Risk Communication

Miscellaneous

View resources related to this topic from other Waste and Cleanup Risk Assessment Programs:
(note - programs not linked do not have content for this topic)

Chemical Accident Prevention

Federal Facilities Restoration and Reuse

Underground Storage Tanks

Resource and Conservation Recovery Act

Superfund

Additional RCRA Information:

Corrective Action

Vapor Intrusion

Combustion

Hazardous Waste Identification

Industrial Waste

Dose-Response Assessment is the process of quantitatively evaluating the toxicity of a given chemical agent as a function of human exposure to that chemical agent. The relationship between the dose of the contaminant administered or received and the incidence of adverse health effects in the exposed population forms the basis for the quantitative dose-response relationship. From these relationships, toxicity values (e.g., reference doses and slope factors) are derived that can be used to estimate the incidence or potential for adverse effects in an exposed population.

Hazard Identification is the process of determining whether exposure to a chemical agent can cause an increase in the incidence of a particular adverse health effect (e.g., cancer, birth defects) and whether the adverse health effect is likely to occur in humans. The process examines the available scientific data for a given chemical (or group of chemicals) and develops a weight of evidence to characterize the link between the negative effects and the chemical agent.

Documents | EPA Links

Documents

  1. Benchmark Dose Technical Support Document External Review Draft (PDF) (96 pp, 812K,  About PDF), NCEA-F-0000, October 2000. Risk Assessment Forum, Washington, DC
    The purpose of this document is to provide guidance for the Agency and the outside community on the application of the benchmark dose approach to determining the point of departure (POD) for linear or nonlinear extrapolation of health effects data.
  2. Guidance Manual for the Integrated Exposure Uptake Biokinetic Model for Lead in Children (PDF) (28 pp, 292K,  About PDF (February 1994) NTIS #PB93-963510, OSWER #9285.7-15-1.
    Table of Contents and Glossary (PDF) (28 pp, 292K,  About PDF)
    Chapter 1 (PDF) (29 pp, 232K,  About PDF)
    Chapter 2 (PDF) (50 pp, 1MB,  About PDF)
    Chapter 3 (PDF) (13 pp, 336K,  About PDF)
    Chapter 4 (PDF) (67 pp, 580K,  About PDF)
    Chapter 5 (PDF) (32 pp, 252K,  About PDF)
    Chapter 6 (PDF) (11 pp, 96K,  About PDF)
    Appendix A (PDF) (16 pp, 452K,  About PDF)
    Appendix B (PDF) (5 pp, 40K,  About PDF)

  3. Guidelines for Carcinogen Risk Assessment Federal Register 51(185):33992-34003 (1986).
    This is the first revision of the 1976 Interim Procedures and Guidelines for Health Risk Assessments of Suspected Carcinogens (U.S. EPA, 1976; Albert et al., 1977).
  4. Guidelines for Carcinogen Risk Assessment (PDF) (211 pp, 1MB,  About PDF) Review Draft, NCEA-F-0644 (July 1999). Risk Assessment Forum, Washington, DC
    These guidelines revise and replace United States Environmental Protection Agency (EPA) Guidelines for Carcinogen Risk Assessment published in 51 FR 33992, September 24, 1986.
  5. Guidelines for Developmental Toxicity Risk Assessment (PDF) (83 pp, 192K,  About PDF) Federal Register 56(234):63798-63826 (1991).
    These guidelines outline principles and methods for evaluating data from animal and human studies, exposure data, and other information to characterize risk to human development, growth, survival, and function because of exposure prior to conception, prenatally, or to infants and children.
  6. Guidelines for the Health Risk Assessment of Chemical Mixtures (PDF) (38 pp, 300K,  About PDF) 1986, Federal Register 51(185):34014-34025.
    The guidelines are intended to guide Agency analysis of information relating to health effects data on chemical mixtures in line with the policies and procedures established in the statues administered by the EPA.
  7. Supplementary Guidance for Conducting Health Risk Assessment of Chemical Mixtures (PDF) EPA630-R-00-002 (August, 2001) (209pp, 1MB,  About PDF)
    This document is a supplement to the EPA Guidelines for the Health Risk Assessment of Chemical Mixtures of 1986. The 1986 Guidelines represent the Agency's science policy and are a procedural guide for evaluating data on the health risks from exposures to chemical mixtures.
  8. Guidelines for Mutagenicity Risk Assessment (PDF) (23 pp, 256K,  About PDF) Federal Register 51(185):34006-34012 (1986)
    The Guidelines for Mutagenicity Risk Assessment (hereafter . Guidelines . ) are intended to guide Agency analysis of mutagenicity data in line with the policies and procedures established in the statutes administered by EPA.
  9. Guidelines for Neurotoxicity Risk Assessment (PDF) (89 pp, 184K,  About PDF) Federal Register 63(93):26926-26954 (1998)
    These Guidelines are intended to guide Agency evaluation of agents that are suspected to cause neurotoxicity, in line with the policies and procedures established in the statutes administered by the Agency.
  10. Guidelines for Reproductive Toxicity Risk Assessment (PDF) (143 pp, 324K,  About PDF) Federal Register 61(212):56274-56322 (1996)
    This notice describes the scientific basis for concern about exposure to agents that cause reproductive toxicity, outlines the general process for assessing potential risk to humans from exposure to environmental agents, and addresses Science Advisory Board and public comments on the 1994 Proposed Guidelines for Reproductive Toxicity Risk Assessment.
  11. Health Effects Assessment Summary Tables (HEAST), FY'97 Update. U. S. Environmental Protection Agency, Office of Solid Waste and Emergency Response, 1997 EPA/540-F-97-036 (July, 1997).
    The document provides the latest information and guidance on using radionuclide slope factors from the Health Effects Assessment Summary Tables (HEAST) - Radionuclides Table (formerly Table 4).
  12. Integrated Exposure Uptake Biokinetic Model for Lead in Children (IEUBK)
    The Integrated Exposure Uptake Biokinetic Model for Lead in Children (IEUBK) attempts to predict blood-lead concentrations (PbBs) for children exposed to lead in their environment. The model allows the user to input relevant absorption parameters (e.g., the fraction of lead absorbed from water) as well as intake and exposure rates.
  13. Interim Policy for Particle Size and Limit Concentration Issues in Inhalation Toxicity: Notice of Availability (1994)
    EPA has made available to all interested parties, an Interim Policy for Particle Size and Limit Concentration Issues in Inhalation Toxicity Studies which deals with several of the most controversial issues encountered in inhalation toxicity studies.
  14. Methods for Derivation of Inhalation Reference Concentrations and Application of Inhalation Dosimetry 1994, EPA/600/8-90/066F
    This document describes the U.S. Environmental Protection Agency (EPA) methodology for estimation of inhalation reference concentrations (RfCs) (earlier terminology was "inhalation reference dose" or RfDi") as benchmark estimates of the quantitative dose-response assessment of chronic noncancer toxicity for individual inhaled chemicals.
  15. Proposed Guidelines for Carcinogen Risk Assessment Federal Register 61(79):17960-18011 (1996).
  16. Provisional Guidance for Quantitative Risk Assessment of Polycyclic Aromatic Hydrocarbons, US EPA, 1993 EPA/600/R-93/C89 (July, 1993).
    The Office of Health and Environmental Assessment (OHEA) recently completed an extensive document entitled "Drinking Water Criteria Document (DWCD) for Polycyclick Aromatic Hydrocarbons (PAHs)."
  17. Radiation Risk Assessment Guidance (PDF) (23 pp, 2MB,  About PDF)
    This chapter provides supplemental baseline risk assessment guidance for use at sites contaminated with radioactive substances that are included on the National Priorities List (NPL).
  18. Radionuclide Table Slope Factors (Table 4 of HEAST (PDF) (72 pp, 1.4MB, About PDF)
    As of April 16, 2001, this page has the current and correct Radionuclide Table (formerly HEAST Slope Factors - Table 4 ).
  19. Recommendations of the Technical Review Workgroup for Lead for an Approach to Assessing Risks Associated with Adult Exposures to Lead in Soils
    This report describes a methodology for assessing risks associated with non-residential adult exposures to lead in soil.
  20. Risk Assessment Guidance for Superfund, Volume I
    Part A (1989)
    Part B (1991)
    Part C (1991)
    Part D (1998)
    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.
  21. Science Policy Council Handbook: Peer Review (PDF) (185 pp, 3.5MB,  About PDF)Second Edition. Prepared by the Office of Science Policy, Office of Research and Development, Washington, DC. 2000, EPA 100-B-00-001
  22. Science Policy Council Handbook: Risk Characterization (PDF) (189 pp, 9MB,  About PDF) Prepared by the Office of Science Policy, Office of Research and Development, Washington, DC. 2000, EPA 100-B-00-002
  23. Technical Support Document for the Integrated Exposure Uptake Biokinetic Model for Lead in Children (December 1994) (PDF) (115 pp, 928K,  About PDF) NTIS #PB94-963505, OSWER #9285.7-22.
    The Technical Support Document describes in detail the basis for the parameters and equations that are used in the Integrated Exposure Uptake Biokinetic Model for Lead in Children, version 0.99d. It is a supplement to the Guidance Manual that was published in February, 1994, and is available from the National Technical Information Service as document PB93-963510.
  24. Use of IRIS Values in Superfund Risk Assessment (PDF) ( 3 pp, 213K,  About PDF) 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.
  25. Use of the Benchmark Dose Approach in Health Risk Assessment EPA/630/R-94/007 (1995)
    The U.S. Environmental Protection Agency (EPA) frequently calculates a reference dose (RfD) or reference concentration (RfC), which is used along with other scientific information in setting standards for noncancer human health effects.
  26. Validation Strategy for The Integrated Exposure Uptake Biokinetic Model for Lead in Children (December, 1994) on this page." (PDF) (30 pp, 232K,  About PDF)
    This document describes the considerations and methods for characterizing the confidence to place in output from the Integrated Exposure Uptake Biokinetic (IEUBK) Model for Lead in Children, version 0.99d.

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EPA Links


  1. Clarification to the 1994 Revised Interim Soil Lead Guidance for CERCLA Sites and RCRA Corrective Action Facilities OSWER Directive 9200.4-27, EPA/540/F-98/030 PB98-963244, OSWER Directive # 9200.4-27P.
    This document provides an approach for determining protective levels of lead in soil, including recommended screening levels, how to develop preliminary remediation goals, and a description of a clean-up plan for CERCLA (Superfund) and RCRA sites with multiple sources of lead.
  2. EPA Integrated Risk Information System (IRIS)
    IRIS is a database of human health effects that may result from exposure to various substances found in the environment.
  3. EPA National Center for Environmental Assessment, Guide to Current Literature on Exposure Factors
    Web site summarizing sources of latest information on exposure factors.
  4. EPA Region 3: Hazardous Waste Cleanup Division
    HSCD is responsible for all cleanup activity in Region III at sites contaminated by hazardous waste, including oil spills. Document contains links to Superfund Sites and Superfund Program Information.
  5. EPA Region 9 PRGs
    Preliminary Remediation Goals (PRGs) are tools for evaluating and cleaning up contaminated sites. The PRGs contained in the Region 9 PRG Table in this document are generic; they are calculated without site specific information. However, they may be re-calculated using site specific data.
  6. EPA Technical Review Workgroup for Lead (TRW)
    These Web pages are designed to provide readily-accessible information about the EPA's Technical Review Workgroup for Lead (TRW), the Integrated Exposure Uptake Biokinetic Model for Lead in Children (IEUBK), and the Adult Lead Methodology.
  7. Federal Drinking Water Standards
    Drinking Water Regulations and Health Advisories
  8. Johnson and Ettinger Model for Subsurface Vapor Intrusion into Buildings, 1991
    Concerns have been raised about the potential for subsurface contamination in either soil or ground water adversely impacting indoor air quality. In September 1998, EPA developed a series of models for estimating indoor air concentrations and associated health risks from subsurface vapor intrusion into buildings.
  9. 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.
  10. Radionuclide Table Slope Factors (Table 4 of HEAST)
    As of April 16, 2001, this page has the current and correct Radionuclide Table (formerly HEAST Slope Factors - Table 4 ).
  11. Recommendations of the Technical Review Workgroup for Lead for an Approach to Assessing Risks Associated with Adult Exposures to Lead in Soils.
    This report describes a methodology for assessing risks associated with non-residential adult exposures to lead in soil.

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