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Risk Assessment

Risk Assessment Guidelines

In order to conduct respectable risk assessments, based on sound science, that can to respond to the needs of our nation, EPA has developed guidelines, handbooks, framework and general standard operating procedures.

In some cases, these resources are broad enough to be relevant across all statutes that EPA administers while in other cases, they are more applicable to specific EPA programs or regions. They are divided under human health related and ecological or environmentally related.

State (and regional) specific documents can also be found from the where you live page or by sorting from the tables below:

EPA Guidelines

Title Year Description
Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation 2014 This guidance outlines approaches for developing factors for inter- and intraspecies extrapolation based on data describing toxicokinetic and/or toxicodynamic properties of a particular agent.
Guideline for Microbial Risk Assessment: Pathogenic Microorganisms with Focus on Food and Water 2012 This document provides guidance on conducting risk assessments on potentially pathogenic microorganisms in water and food.
Guidance Document on the Development, Evaluation and Application of Environmental Models 2009  
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 on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants (Final) 2006 A document intended to provide guidance to EPA scientists on selecting age groups to consider when assessing childhood exposure and potential dose to environmental contaminants.
Guidelines for Carcinogen Risk Assessment 2005 These updated guidelines provide a framework to EPA scientists for assessing possible cancer risks from exposures to pollutants or other agents in the environment.
Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens 2005 The Cancer Guidelines explicitly call for consideration of possible sensitive subpopulations and/or lifestages (such as childhood). The consideration of childhood risks in the final Cancer Guidelines has been augmented by this document.
Guidance on Cumulative Risk Assessment of Pesticides with a Common Mechanism of Action 2002  
Guidelines for Neurotoxicity Risk Assessment 1998 This document guides EPA scientists in evaluating environmental contaminants that may pose neurotoxic risks.
Guiding Principles for Monte Carlo Analysis 1997 This document sets out a policy for use of probabilistic analysis in risk assessment and preliminary guidance on using probabilistic analysis.
Guidelines for Reproductive Toxicity Risk Assessment 1996 This document discusses exposure to agents that cause reproductive toxicity and describe the principles and procedures to be followed in conducting risk assessments for reproductive toxicity.
Guidelines for Exposure Assessment 1992 This document describes the general concepts of exposure assessment including definitions and associated units and planning and conducting an exposure assessment.
Guidelines for Developmental Toxicity Risk Assessment 1991 Guidelines for assessing the risks for developmental toxicity from exposure to environmental agents.
Guidelines for Mutagenicity Risk Assessment 1986 These guidelines advise Agency experts review information on each agent under consideration and use the most scientifically appropriate interpretation to assess risk.
Guidelines for the Health Risk Assessment of Chemical Mixtures 1986 These guidelines evaluate data on the health risks from exposures to chemical mixtures.

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Other EPA Resources

The following tables includes handbooks, framework documents, standard operating procedures (SOPs), and other related materials developed by EPA for human health risk assessments:

Title Year Keywords
A Framework for Assessing Health Risk of Environmental Exposures to Children 2006 Children
A Review of the Reference Dose and Reference Concentration Processes 2002 Reference
A Summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information 2003  
Alpha2u-Globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat 1991 Toxicity
Assessment Factors for Evaluating the Quality of Scientific and Technical Information 2003 Factors
Assessment of Thyroid Follicular Cell Tumors 1998  
Benchmark Dose Technical Guidance 2012 BMDS
Calculating Preliminary Remediation Goals   Region 8
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
Considerations for Developing a Dosimetry-Based Cumulative Risk Assessment Approach for Mixtures of Environmental Contaminants 2009 Cumulative Risk
Contingencies for EPA Region 8's Evaluation and Response for Various Levels of Dioxins Measured in Denver's Front Range Reference Surface Soils (Figure 3) 1999 Region 8
Criteria for Evaluating Blood Lead Data Quality and Use 1995 Region 8
Criteria Pollutant and Air Toxic Pollutant Risk Assessment 2008 Air Toxics
Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document 2008 Cumulative Risk
Cumulative Risk Planning & Scoping Guidance 1997 Cumulative Risk
Denver Front Range Study of Dioxins and Surface Soil Summary Report 2002 Region 8
Dioxin Toxicity Equivalency Factors (TEFs) for Human Health 2010 TEF

EPA Positive Matrix Factorization 1.1 (EPA PMF 1.1)

  PMF
EPA Scientific Integrity Policies 2012 Policies
EPA's Strategic Plan for Evaluating the Toxicity of Chemicals 2009 Chemicals
Estimating Site-Specific Exposure to Contaminants in Indoor Dust 1995 Region 8
Evaluating and Identifying Contaminants of Concern for Human Health 1994 Region 8
Exploration of Aging and Toxic Response 2001 Aging
Exploration of Perinatal Pharmacokinetic Issues 2001 Children
Exposure Factors Handbook 2011 Exposure
Framework for Cumulative Risk Assessment 2003 Cumulative Risk
Framework for Human Health Risk Assessment to Inform Decision Making 2014 Risk Management
Framework for Metals Risk Assessment 2007 Metals
Handbook for Non-Cancer Health Effects Valuation 2000 Cancer
Harmonized Test Guidelines 2015 Tests
Human Health Risk Assessment Colloquium Summary Report 2012 Human Health
Interim Genomics Policy 2002 Genomics
Interim Position on Environmental Endocrine Disruption 1997 Endocrine

Libby Asbestos: Human Health Risk Assessment

2014 Region 8
Model Site Conceptual Model for RI/FS Baseline Risk Assessments of Human and Ecological Health 1995 Region 8
Model Statement of Work for RI/FS Baseline Risk Assessments of Human Health 1994 Region 8
Nanotechnology White Paper 2007 Nanotechnology
PCBs: Cancer Dose-Response Assessment 1996 Cancer
Peer Review Handbook - 3rd Edition 2006 Peer Review
Pesticide: Science Policy Issues & Guidance Documents   Chemicals
Pesticides: Assessing Human Health Risk   Chemicals
Pesticides: Cumulative Assessment of Risk   Chemicals
Policy on Evaluating Risk to Children 1995 Children
Probabilistic Methods to Enhance the Role of Risk Analysis in Decision-Making (External Review Draft) 2009 Risk Management
Probablistic Analysis in Risk Assessment 1997 Monte Carlo
Provisional Guidance for Quantitative Risk Assessment of Polycyclic Aromatic Hydrocarbons 1993 Chemicals
Radiation Risk Assessment   Radiation
Recommended Use of Body Weight 3/4 as the Default Method in Derivation of the Oral Reference Dose 2011  
Regional Removal Management Levels (RMLs) User's Guide 2015 RMLs
Region 4 Human Health Risk Assessment Supplemental Guidance 2014 Region 4
Region 8: An in vitro method for estimation of arsenic relative bioavailability in soil 2013 Region 8
Region 8: Background Soil Arsenic Concentrations (XLS) (2.5MB) 1999 Region 8
Region 8: Measurement of Arsenic Relative Bioavailability in Swine 2013 Region 8
Region 8: Validation of an In Vitro Bioaccessibility Test Method for Estimation of Bioavailability of Arsenic from Soil and Sediment 2012 Region 8
Report of the Workshop on Selecting Input Distributions for Probabilistic Assessments 1999  
Risk Characterization Handbook 2000 Risk Communication
Sample Analysis and Quality Assurance Plan for Urinary Arsenic and Blood Lead Among Residents of VBI70 Neighborhoods 2002 Region 8
Sampling Manual for IEUBK Model (1996) 1996 Region 8
Scientific and Ethical Approaches for Observational Exposure Studies 2009  
Standard Operating Procedure: In Vitro Bioacessibility (IVBA) Procedure for Arsenic 2012 Region 8
Standard Operating Procedures for Residential Pesticide Exposure Assessment 2012 Chemicals
Summary Report for the Workshop on Issues Associated with Dermal Exposure and Uptake 2000  
Summary Report for the Workshop on the Relationship Between Exposure Duration and Toxicity 1999 Toxicity
Summary Report of the Technical Workshop on Issues Associated with Considering Developmental Changes in Behavior and Anatomy When Assessing Exposure to Children 2001 Children
Test Method Collections 2008 Tests

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EPA Guidelines

Title Year Description
Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation 2014 This guidance outlines approaches for developing factors for inter- and intraspecies extrapolation based on data describing toxicokinetic and/or toxicodynamic properties of a particular agent.
Ecological Risk Assessment and Risk Management Principles for Superfund Sites, (Issuance of Final Guidance)& 1999 This guidance is intended to help Superfund project managers make ecological assessment decisions that are consistent across the United States and are transparent to the public.
Guidelines for Ecological Risk Assessment 1998 These Agency-wide guidelines are provided to improve the quality and consistency of EPA's ecological risk assessments.

Other EPA Resources

The following tables includes handbooks, framework documents, standard operating procedures (SOPs), and other related materials developed by EPA for ecological risk assessments:

Title Year Keyword
Assessment Factors for Evaluating the Quality of Scientific and Technical Information 2003 Factors
Considerations for Developing a Dosimetry-Based Cumulative Risk Assessment Approach for Mixtures of Environmental Contaminants 2009 Cumulative Risk
Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document 2008 Cumulative Risk
Cumulative risk assessment lessons learned: A review of case studies and issue papers 2015 Cumulative Risk
Cumulative Risk Planning & Scoping Guidance 1997 Cumulative Risk
Denver Front Range Study of Dioxins and Surface Soil Summary Report 2002 Region 8
Dioxin Toxicity Equivalency Factors (TEFs) for Human Health 2010 Dioxin
EPA Scientific Integrity Policies 2012 Policies
EPA's Strategic Plan for Evaluating the Toxicity of Chemicals 2009 Tocicity
Estimating Radiogenic Cancer Risks 1994 Cancer Risks
Framework for Application of the Toxicity Equivalence Methodology for Polychlorinated Dioxins, Furans and Biphenyls in Ecological Risk Assessment 2008 Dioxin
Framework for Cumulative Risk Assessment 2003 Cumulative Risk
Framework for Developing Suspended and Bedded Sediment (SABS) Water Quality Criteria 2006 Sediment
Framework for Ecological Risk Assessment 1992 Ecological
Framework for Metals Risk Assessment 2007 Metals
Framework for the Economic Assessment of Ecological Benefits 2002 Economic
Generic Ecological Assessment Endpoints (GEAE) for Ecological Risk Assessment 2004 Endpoints
Guidance Document on the Development, Evaluation and Application of Environmental Models 2009 Models
Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation (External Review Draft) 2011 Interspecies
Guidance for Assessing Chemical Contaminant Data for Use In Fish Advisories - Volume 2: Risk Assessment and Fish Consumption Limits - Third Edition 2000 Fish
Integrating Ecological Assessment and Decision-Making 2010 Risk Management
Model Site Conceptual Model for RI/FS Baseline Risk Assessments of Human and Ecological Health 1995 Region 8
Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs 2004 Pestices
Peer Review Handbook - 3rd Edition 2006 Peer Review
Pesticide: Science Policy Issues & Guidance Documents   Chemicals
Pesticides: Ecological Risk Assessments   Pesticides
Probabilistic Methods to Enhance the Role of Risk Analysis in Decision-Making (External Review Draft) 2009 Risk Management
Probablistic Analysis in Risk Assessment 1997 Monte Carlo
Regional Removal Management Levels (RMLs) User's Guide 2015 RMLs
Region 4 Ecological Risk Assessment Supplemental Guidance 2015 Region 4
Region 4 Issue Paper for PCB Characterization at Region 4 Superfund and RCRA Sites 2013 Region 4
Region 8: Background Soil Arsenic Concentrations (XLS) (2.5MB) 1999 Region 8
Report on Population-level Ecological Risk Assessment Workshop 2009 Population-Levels

Risk Assessment Guidance for Superfund

  Superfund
Risk Characterization Handbook 2000 Risk Characterization
Standard Operating Procedures for Residential Pesticide Exposure Assessment 2012 Pesticides
Stressor Identification Guidance Document 2000 Stressors
Test Method Collections 2008 Methods
Viewpoints on Bioavailability for Wildlife 1998 Region 8
Watershed Ecological Risk Assessment   Watershed
Wildlife Exposure Factors Handbook 1992 Wildlife

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EPA has also produced a few handy citizen guides, including:

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