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Waste and Cleanup Risk Assessment

Human Health: Toxicity (Hazard Identification and Dose Response)

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Chemical Accident Prevention

Federal Facilities Restoration and Reuse

Underground Storage Tanks

Resource and Conservation Recovery Act

Superfund

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. For lead risk assessment documents, please visit this webpage

  3. Handbook for Implementing the Supplemental Cancer Guidance at Waste and Cleanup Sites
    This online handbook contains information and resources for use in applying EPA's Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens (Supplemental Guidance) to cancer risk assessments at waste and cleanup sites.

  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, 1.19MB, 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 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. 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.
  13. 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.
  14. Proposed Guidelines for Carcinogen Risk Assessment Federal Register 61(79):17960-18011 (1996).
  15. Provisional Guidance for Quantitative Risk Assessment of Polycyclic Aromatic Hydrocarbons, US EPA, 1993 (PDF) (26 pp, 5.8MB, About PDF) EPA/600/R-93/089 (July, 1993).
  16. Radiation Risk Assessment Guidance (PDF) (37 pp, 1MB, 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).
  17. 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 ).
  18. 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.
  19. 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
  20. Science Policy Council Handbook: Risk Characterization (PDF) (189 pp, 8.9MB, About PDF) Prepared by the Office of Science Policy, Office of Research and Development, Washington, DC. 2000, EPA 100-B-00-002
  21. 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.
  22. Hazard Assessment (HA) for Munitions and Explosives of Concern (MEC)

  23. Interim TCE Value withdrawal memo, January 15,2009 (PDF) (2 pp, 328K, About PDF)
    The Office of Solid Waste and Emergency Response has withdrawn the January 15, 2009, guidance entitled "Interim Recommended Trichloroethylene (TCE) Toxicity Values to Assess Human Health Risk and Recommendations for the Vapor Intrusion Pathway Analysis."

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EPA Links

  1. 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.
  2. EPA National Center for Environmental Assessment, Guide to Current Literature on Exposure Factors
    Web site summarizing sources of latest information on exposure factors.
  3. 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.
  4. 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.
  5. Federal Drinking Water Standards
    Drinking Water Regulations and Health Advisories
  6. 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.
  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. 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 ).

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