The Risk Assessment Information System

EPA Human Health Risk Assessment Guidance

EPA Human Health Related Guidance

We searched the world wide web for the best available pdf copy of every document listed below and have stored it on the RAIS server. Additionally, we have created a single searchable document for each source, if multiple pdfs were provided. Although every effort has been made to obtain the best available electronic copies directly from their sources, RAIS makes no claims as to the validity, current status, or latest version of each document.

Federal Guidance

Dermal Exposure Assessment: Principles and Application. Interim Report. EPA/600/8-91/011B. Office of Research and Development, Washington, D.C. 1992.

Exposure Factors Handbook. EPA/600/8- 89/043. Office of Health and Environmental Assessment, Washington, D.C. May 1989 (March 1990).

Exposure Factors Handbook. EPA/600/8- 89/043. Office of Health and Environmental Assessment, Washington, D.C. August 1996.

Exposure Factors Handbook. EPA/600/P-95/002Fa. Office of Research and Development, U.S. Environmental Protection Agency, Washington, D.C. 1997.

Exposure Factors Handbook: 2011 Edition. EPA/600/R-090/052F. Office of Health and Environmental Assessment, Washington, D.C. September 2011.

Guidance for Conducting Remedial Investigations and Feasibility Studies Under CERCLA. Interim Final. OSWER Directive 9355.3-01. EPA/540/G-89/004. Office of Emergency and Remedial Response. U.S. Environmental Protection Agency, Washington, D.C. October 1988.

Guidance for Data Useability in Risk Assessment (Part A). EPA/540/R-92/003 U.S. Environmental Protection Agency Office of Research and Development, U.S. Environmental Protection Agency, Washington, D.C. December 1991.

Guidance for Data Useability in Risk Assessment (Part B). Publication 9285.7-09B, PB92-963362. U.S. Environmental Protection Agency Office of Emergency and Remedial Response, U.S. Environmental Protection Agency, Washington, D.C. May 1992.

Guidelines for Exposure Assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, 600Z-92/001, 1992.

Health Effects Assessment Summary Tables. Annual FY-1997. EPA-540-R-97. Office of Solid Waste and Emergency Response, U.S. Environmental Protection Agency. July.

Integrated Risk Information System (IRIS). Environmental Criteria and Assessment Office. Cincinnati, OH. 1996 (or latest version).

Risk Assessment Guidance for Superfund: Volume I - Human Health Evaluation Manual. (Part A) EPA/540/1-89/002. Office of Emergency and Remedial Response, U.S. Environmental Protection Agency, Washington, D.C. 1989.

Risk Assessment Guidance for Superfund: Volume I - Human Health Evaluation Manual (Part B, Development of Risk-based Preliminary Remediation Goals). OSWER Directive 9285.7-01B.Office of Emergency and Remedial Response, U.S. Environmental Protection Agency, Washington, D.C. 1991.

Risk Assessment Guidance for Superfund: Volume I - Human Health Evaluation Manual (Part C, Risk Evaluation of Remedial Alternatives). OSWER Directive 9285.7-01C. Office of Emergency and Remedial Response, U.S. Environmental Protection Agency, Washington, D.C. 1991.

Risk Assessment Guidance for Superfund: Volume I - Human Health Evaluation Manual (Part D, Standardized Planning, Reporting, and Review of Superfund Risk Assessments) (Final). Publication 9285.7-47. Office of Emergency and Remedial Response, U.S. Environmental Protection Agency, Washington, D.C. December 2001. [Excel Tables have been incorporated into the PDF file. To view the Excel files, open the PDF file in Adobe and not in a web browser. A navigation pane will be on the left that contains the embedded XLS files.]

Risk Assessment Guidance for Superfund: Volume I - Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal Risk Assessment (Final) . OSWER Directive 9285.7-02EP.OOffice of Superfund Remediation and Technology Innovation, U.S. Environmental Protection Agency, Washington, D.C. July 2004.

Risk Assessment Guidance for Superfund: Volume I - Human Health Evaluation Manual (Part F, Supplemental Guidance for Inhalation Risk Assessment (Final) . OSWER Directive 9285.7-82. Office of Superfund Remediation and Technology Innovation, U.S. Environmental Protection Agency, Washington, D.C. January 2009. Cover memo.

Risk Assessment Guidance for Superfund Volume I: Human Health Evaluation Manual Supplemental Guidance Standard Default Exposure Factors. OSWER Directive 9285.6-03. Office of Emergency and Remedial Response. Toxics Integration Branch. 1991.

Role of Background in the CERCLA Cleanup Program, U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response, Office of Emergency and Remedial Response, April 26, 2002 OSWER 9285.6-07P.

Soil Screening Guidance: User's Guide. U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response, July 1996. Publication 9355.4-23.

Soil Screening Guidance: Technical Background Document. U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response, May 1996. EPA/540/R95/128.

Soil Screening Guidance for Radionuclides: User's Guide. U.S. Environmental Protection Agency, Office of Radiation and Indoor Air, Office of Solid Waste and Emergency Response, October 2000. Publication 9355.4-16A, EPA/540-R-00-007, PB2000 963307.

Soil Screening Guidance for Radionuclides: Technical Background Document. U.S. Environmental Protection Agency, Office of Radiation and Indoor Air, Office of Solid Waste and Emergency Response, October 2000. Publication 9355.4-16, EPA/540-R-00-006, PB2000 963306.

Superfund Exposure Assessment Manual. EPA/540/1-88/001 OSWER directive 9285.5-1. U.S. Environmental Protection Agency Office of Remedial Response, U.S. Environmental Protection Agency, Washington, D.C. 1988.

Supplemental Guidance for Developing Soil Screening Levels for Superfund Sites. U.S. Environmental Protection Agency, Office of Solid Waste and Emergency Response, December 2002. Directive 9355.4-24.

Supplemental Guidance to RAGS: Calculating the Concentration Term. Publication Number Publication 9285.7-08I. Office of Solid Waste and Emergency Response. May 1992.

Water Quality Assessment: A Screening Procedure for Toxic and Conventional Pollutants in Surface and Ground Water-Part I (Revised-1985). U.S. Environmental Protection Agency, Environmental Research Laboratory, Athens, GA 30613. EPA/600/6-85/002a. September 1985 revised.

91 document links taken from the EPA Risk Assessment Guidance webpage

Title Date Keywords
Guidelines for Mutagenicity Risk Assessment 1986 Guidance Document, Human Health, Chemical Mixtures
Guidelines for the Health Risk Assessment of Chemical Mixtures 1986 Guidance Document, Human Health, Children
Risk Assessment Guidance for Superfund (RAGS) Part A 1989 Superfund
Alpha2u-Globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat 1991 Human Health, Risk Assessment, Toxicity
Guidelines for Developmental Toxicity Risk Assessment 1991 Guidance Document, Human Health, Developmental Toxicity
Risk Assessment Guidance for Superfund (RAGS) Part B 1991 Superfund
Risk Assessment Guidance for Superfund (RAGS) Part C 1991 Superfund
Provisional Guidance for Quantitative Risk Assessment of Polycyclic Aromatic Hydrocarbons 1993 Chemicals
Evaluating and Identifying Contaminants of Concern for Human Health 1994 Region 8
Model Statement of Work for RI/FS Baseline Risk Assessments of Human Health 1994 Region 8
Criteria for Evaluating Blood Lead Data Quality and Use 1995 Region 8, Lead
Estimating Site-Specific Exposure to Contaminants in Indoor Dust 1995 Region 8, Soil
Model Site Conceptual Model for RI/FS Baseline Risk Assessments of Human Health 1995 Region 8, Human Health
Policy on Evaluating Risk to Children 1995 Children
Guidelines for Reproductive Toxicity Risk Assessment 1996 Guidance Document, Reproductive Toxicity, Human Health
PCBs: Cancer Dose-Response Assessment 1996 Cancer
Sampling Manual for IEUBK Model (1996) 1996 Region 8, Lead, Modeling
Guidance on Cumulative Risk Assessment: Planning & Scoping (Part 1) 1997 Cumulative Risk
Guiding Principles for Monte Carlo Analysis 1997 Guidance Document, Human Health
Probabilistic Analysis in Risk Assessment 1997 RAF

Assessment of Thyroid Follicular Cell Tumors

1998 Assessment, Human Health

Framework for assessing non-occupational, non-dietary (residential) exposure to pesticides.

1998 Pesticides, Non-dietary

Guidelines for Neurotoxicity Risk Assessment

1998 Guidance Document, Neurotoxicity, Human Health

Research Plan for Endocrine Disruptors

1998 Human Health, Endocrine

Guidance for identifying pesticide chemicals and other substances that have a common mechanism of toxicity

1999 Pesticides, Toxicity

Summary Report for the Workshop on the Relationship Between Exposure Duration and Toxicity

1999 Exposure Duration, Toxicity

Report of the Workshop on Selecting Input Distributions for Probabilistic Assessments

1999 Human Health

Choosing a percentile of acute dietary exposure as a threshold of regulatory concern

2000 Pesticides, Regulatory

Handbook for Non-Cancer Health Effects Valuation

2000 Human Health, Cancer

Risk Characterization Handbook

2000 Risk Communication

Summary Report for the Workshop on Issues Associated with Dermal Exposure and Uptake

2000 Human Health, Dermal

The use of data on cholinesterase inhibition for risk assessments of organophosphorous and carbamate pesticides

2000 Pesticides, Inhibition

Exploration of Aging and Toxic Response

2001 Human Health, Aging

Exploration of Perinatal Pharmacokinetic Issues

2001 Human Health, Children

General principles for performing aggregate exposure and risk assessments

2001 Pesticides, Aggregate

Summary Report of the Technical Workshop on Issues Associated with Considering Developmental Changes in Behavior and Anatomy When Assessing Exposure to Children

2001 Children

Risk Assessment Guidance for Superfund (RAGS) Part D

2001 Superfund

A Review of the Reference Dose and Reference Concentration Processes

2002 Guidance Document, Human Health, RFD, RFC

Acute oral toxicity up-and-down procedure

2002 Pesticides, Oral

Consideration of the FQPA safety factor and other uncertainty factors in cumulative risk assessment of chemicals sharing a common mechanism of toxicity

2002 Pesticides, Safety, Assessment

Determination of the appropriate FQPA safety factor(s) in tolerance assessment

2002 Pesticides, Safety, Tolerance

Guidance on cumulative risk assessment of pesticide chemicals that have a common mechanism of toxicity

2002 Pesticides, Toxicity

Guidance on Cumulative Risk Assessment of Pesticides with a Common Mechanism of Toxicity

2002 Guidance Document, Pesticides

Sample Analysis and Quality Assurance Plan for Urinary Arsenic and Blood Lead Among Residents of VBI70 Neighborhoods

2002 Region 8, Arsenic, Lead, Blood

A Summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information

2003 Summary Report, Human Health, Exposure Factors

Framework for Cumulative Risk Assessment

2003 Human Health, Cumulative Risk

Potential Implications of Genomics for Regulatory and Risk Assessment Applications at EPA

2004 Genomics

Risk Assessment Guidance for Superfund (RAGS) Part E

2004 Superfund

Guidance for thyroid assays in pregnant animals, fetuses and post-natal animals, and adult animals

2005 Pesticides, Thyroid

Guidelines for Carcinogen Risk Assessment

2005 Guidance Document, Cancer

Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens

2005 Guidance Document, Cancer

A Framework for Assessing Health Risk of Environmental Exposures to Children

2006 Children, Human Health

Guidance on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants

2006 Guidance Document, Age Group Selection

Guide to Considering Children's Health When Developing EPA Actions: Implementing Executive Order 13045 and EPA's Policy on Evaluating Health Risks to Children

2006 Guidance Document, Children

Available information on assessing exposure from pesticides in food - A User's Guide

2007 Pesticides, Food

Framework for Metals Risk Assessment

2007 Metals

Nanotechnology White Paper

2007 Nanotechnology

Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document

2008 Cumulative Risk

Considerations for Developing a Dosimetry-Based Cumulative Risk Assessment Approach for Mixtures of Environmental Contaminants

2009 Technical Guidance, Cumulative Risk

EPA's Strategic Plan for Evaluating the Toxicity of Chemicals

2009 Chemicals

Probabilistic Methods to Enhance the Role of Risk Analysis in Decision-Making (External Review Draft)

2009 Risk Management

Scientific and Ethical Approaches for Observational Exposure Studies

2009 Approaches, Exposure Studies

Risk Assessment Guidance for Superfund (RAGS) Part F

2009 Superfund

Dioxin Toxicity Equivalency Factors (TEFs) for Human Health

2010 Human Health, Dioxin, TEF

Exposure Factors Handbook

2011 Human Health, Exposure Factors, children

Recommended Use of Body Weight 3/4 as the Default Method in Derivation of the Oral Reference Dose

2011 Human Health, RFD

Use of the local lymph node assay and reduced dose protocol for LLNA in assessing pesticide products

2011 Pesticides, Assessment

Benchmark Dose Technical Guidance

2012 Technical Guidance, BMDS, Modeling, Assessments

EPA Scientific Integrity Policy

2012 Policies

Guidance for considering and using open literature studies to support human health risk assessment

2012 Pesticides, Literature Studies

Guidance for waiving or bridging of mammalian acute toxicity tests for pesticides and pesticide products

2012 Pesticides, Toxicity Tests

Guideline for Microbial Risk Assessment: Pathogenic Microorganisms with Focus on Food and Water

2012 Guidance Document, Human Health, Pathogens

Standard Operating Procedure: In Vitro Bioacessibility (IVBA) Procedure for Arsenic

2012 Region 8

Standard operating procedures for residential pesticide exposure assessment

2012 Pesticides, Residential

Conflicts of Interest Review Process for Contractor-Managed Peer Reviews of EPA Highly Influential Scientific Assessment (HISA) and Influential Scientific Information (ISI) Documents

2013 Peer Review

Part 58 toxicology data requirements: guidance for neurotoxicity battery, subchronic inhalation, subchronic dermal and immunotoxicity studies

2013 Pesticides, Neurotoxicity

Developing a tiered framework for extrapolation modeling

2014 Pesticides, Extrapolation

EPA Positive Matrix Factorization (PMF) 5.0 Fundamentals and User Guide

2014 PMF

Framework for Human Health Risk Assessment to Inform Decision Making

2014 Framework, Human Health

Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation

2014 Guidance Document, Toxicokinetic, Toxicodynamic

Probabilistic Risk Assessment White Paper

2014 Case Studies, Human Health

Process for establishing and implementing alternative approaches to traditional in vivo acute toxicity studies

2014 Pesticides, Vivo Acute Toxicity

Revised Methods for Worker Risk Assessment

2014 Pesticides, Worker, Methods

Alternate testing framework for classification of eye irritation potential of EPA-regulated pesticide products

2015 Pesticides, Classification

Cumulative Risk Assessment Lessons Learned: A Review of Case Studies and Issue Papers

2015 Case Studies, Human Health

Indirect Dietary Residential Exposure Assessment Model (IDREAM) Implementation

2015 Pesticides, Exposure

Occupational pesticide handler exposure data

2015 Pesticides, Handler

Peer Review Handbook - 4th Edition

2015 Peer Review

Guidelines for Human Exposure Assessment

2019 Guidance Document, Human Health, Exposure

Advances in genetic toxicology and integration of in vivo testing into standard repeat dose studies

various Pesticides, Toxicology

Occupational pesticide post-application exposure data

various Pesticides, Post-Application


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