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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

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

Title Year Keywords
Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation 2014 Guidance Document, Toxicokinetic, Toxicodynamic
Guideline for Microbial Risk Assessment: Pathogenic Microorganisms with Focus on Food and Water 2012 Guidance Document, Pathogens
Guidance Document on the Development, Evaluation and Application of Environmental Models 2009 Guidance Document, Models
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
Guidance on Selecting Age Groups for Monitoring and Assessing Childhood Exposures to Environmental Contaminants (Final) 2006 Guidance Document, Age Group Selection
Guidelines for Carcinogen Risk Assessment 2005 Guidance Document, Cancer
Supplemental Guidance for Assessing Susceptibility from Early-Life Exposure to Carcinogens 2005 Guidance Document, Cancer
Guidance on Cumulative Risk Assessment of Pesticides with a Common Mechanism of Toxicity 2002 Guidance Document, Pesticides
Guidelines for Neurotoxicity Risk Assessment 1998 Guidance Document, Neurotoxicity
Guiding Principles for Monte Carlo Analysis 1997 Guidance Document
Guidelines for Reproductive Toxicity Risk Assessment 1996 Guidance Document, Reproductive Toxicity
Guidelines for Exposure Assessment 1992 Guidance Document, Exposure
Guidelines for Developmental Toxicity Risk Assessment 1991 Guidance Document, Developmental Toxicity
Guidelines for Mutagenicity Risk Assessment 1986 Guidance Document, Chemical Mixtures
Guidelines for the Health Risk Assessment of Chemical Mixtures 1986 Guidance Document, Children
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
Alpha2u-Globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat 1991 Toxicity
A Summary of General 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
Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document 2008 Cumulative Risk
Guidance on Cumulative Risk Assessment: Part 1. Planning & Scoping 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 (PMF) 5.0 Fundamentals and User Guide   PMF
EPA Scientific Integrity Policy 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   Tests
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 - 4th Edition 2015 Peer Review
Standard operating procedures for residential pesticide exposure assessment 2012 Pesticides, Residential
Revised methods for worker risk assessment 2014 Pesticides, Worker
Indirect Dietary Residential Exposure Assessment Model (IDREAM) Implementation 2015 Pesticides, Exposure
Available information on assessing exposure from pesticides in food—A User’s Guide 2007 Pesticides, Food
Framework for assessing non-occupational, non-dietary (residential) exposure to pesticides 1998 Pesticides, Non-dietary
General principles for performing aggregate exposure and risk assessments 2001 Pesticides, Aggregate
Determination of the appropriate FQPA safety factor(s) in tolerance assessment 2002 Pesticides, Safety, Tolerance
Choosing a percentile of acute dietary exposure as a threshold of regulatory concern 2000 Pesticides, Regulatory
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
Advances in genetic toxicology and integration of in vivo testing into standard repeat dose studies   Pesticides, Toxicology
Use of the local lymph node assay and reduced dose protocol for LLNA in assessing pesticide products 2011 Pesticides, Assessment
Process for establishing and implementing alternative approaches to traditional in vivo acute toxicity studies 2014 Pesticides, Vivo Acute Toxicity
Acute oral toxicity up-and-down procedure 2002 Pesticides, Oral
Developing a tiered framework for extrapolation modeling 2014 Pesticides, Extrapolation
Alternate testing framework for classification of eye irritation potential of EPA-regulated pesticide products 2015 Pesticides, Classification
Guidance for thyroid assays in pregnant animals, fetuses and post-natal animals, and adult animals 2005 Pesticides, Thyroid
Part 158 toxicology data requirements: guidance for neurotoxicity battery, subchronic inhalation, subchronic dermal and immunotoxicity studies 2013 Pesticides, Neurotoxicity
Occupational pesticide handler exposure data 2015 Pesticides, Handler
Occupational pesticide post-application exposure data   Pesticides, Post-Application
Guidance for identifying pesticide chemicals and other substances that have a common mechanism of toxicity 1999 Pesticides, Toxicity
Guidance on cumulative risk assessment of pesticide chemicals that have a common mechanism of toxicity 2002 Pesticides, Toxicity
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
The use of data on cholinesterase inhibition for risk assessments of organophosphorous and carbamate pesticides 2000 Pesticides, Inhibition
Policy on Evaluating Risk to Children 1995 Children
Potential Implications of Genomics for Regulatory and Risk Assessment Applications at EPA 2004 Genomics
Probabilistic Methods to Enhance the Role of Risk Analysis in Decision-Making (External Review Draft) 2009 Risk Management
Probabilistic Analysis in Risk Assessment 1997 RAF
Provisional Guidance for Quantitative Risk Assessment of Polycyclic Aromatic Hydrocarbons 1993 Chemicals
Radiation Protection Document Library   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  
Research Plan for Endocrine Disruptors 1998 Endocrine
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

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

Title Year Keywords
Generic Ecological Assessment Endpoints (GEAE) for Ecological Risk Assessment (2nd Edition) and Technical Background Paper 2016 Guidance Document, Endpoints
Ecological Risk Assessment and Risk Management Principles for Superfund Sites, (Issuance of Final Guidance) 1999 Guidance Document, Superfund
Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation 2014 Guidance Document, Toxicokinetic, Toxicodynamic
Guiding Principles for Monte Carlo Analysis 1997 Guidance Document
Guidelines for Ecological Risk Assessment 1998 Guidance Document
A Summary of General 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
Denver Front Range Study of Dioxins and Surface Soil Summary Report 2002 Region 8
Documents for Recommended Toxicity Equivalency Factors (TEFs) for Human Health Risk Assessments of Dioxin and Dioxin-Like Compounds 2010 Dioxin
Ecological Risk Assessment for Pesticides: Technical Overview 2015 Pestices
EPA Scientific Integrity Policy 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
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
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 2014 Interspecies
Guidance for Assessing Chemical Contaminant Data for Use In Fish Advisories - Volume 2: Risk Assessment and Fish Consumption Limits - Third Edition 2000 Fish
Guidance on Cumulative Risk Assessment: Part 1. Planning & Scoping 1997 Cumulative Risk
Integrating Ecological Assessment and Decision-Making at EPA: A Path Forward - Results of a Colloquium in Response to Science Advisory Board and National Research Council Recommendations 2010 Risk Management
Model Site Conceptual Model for RI/FS Baseline Risk Assessments of Human and Ecological Health 1995 Region 8
Peer Review Handbook - 4th Edition 2015 Peer Review
Standard operating procedures for residential pesticide exposure assessment 2012 Pesticides, Residential
Revised methods for worker risk assessment 2014 Pesticides, Worker
Indirect Dietary Residential Exposure Assessment Model (IDREAM) Implementation 2015 Pesticides, Exposure
Available information on assessing exposure from pesticides in food—A User’s Guide 2007 Pesticides, Food
Framework for assessing non-occupational, non-dietary (residential) exposure to pesticides 1998 Pesticides, Non-dietary
General principles for performing aggregate exposure and risk assessments 2001 Pesticides, Aggregate
Determination of the appropriate FQPA safety factor(s) in tolerance assessment 2002 Pesticides, Safety, Tolerance
Choosing a percentile of acute dietary exposure as a threshold of regulatory concern 2000 Pesticides, Regulatory
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
Advances in genetic toxicology and integration of in vivo testing into standard repeat dose studies   Pesticides, Toxicology
Use of the local lymph node assay and reduced dose protocol for LLNA in assessing pesticide products 2011 Pesticides, Assessment
Process for establishing and implementing alternative approaches to traditional in vivo acute toxicity studies 2014 Pesticides, Vivo Acute Toxicity
Acute oral toxicity up-and-down procedure 2002 Pesticides, Oral
Developing a tiered framework for extrapolation modeling 2014 Pesticides, Extrapolation
Alternate testing framework for classification of eye irritation potential of EPA-regulated pesticide products 2015 Pesticides, Classification
Guidance for thyroid assays in pregnant animals, fetuses and post-natal animals, and adult animals 2005 Pesticides, Thyroid
Part 158 toxicology data requirements: guidance for neurotoxicity battery, subchronic inhalation, subchronic dermal and immunotoxicity studies 2013 Pesticides, Neurotoxicity
Occupational pesticide handler exposure data 2015 Pesticides, Handler
Occupational pesticide post-application exposure data   Pesticides, Post-Application
Guidance for identifying pesticide chemicals and other substances that have a common mechanism of toxicity 1999 Pesticides, Toxicity
Guidance on cumulative risk assessment of pesticide chemicals that have a common mechanism of toxicity 2002 Pesticides, Toxicity
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
The use of data on cholinesterase inhibition for risk assessments of organophosphorous and carbamate pesticides 2000 Pesticides, Inhibition
Probabilistic Methods to Enhance the Role of Risk Analysis in Decision-Making (External Review Draft) 2009 Risk Management
Policy for Use of Probabilistic Analysis in Risk Assessment at EPA 1997 Probabilistic Analysis
Radiation Protection Document Library   Radiation
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 (RAGS) Part A   Superfund
Risk Assessment Guidance for Superfund (RAGS) Part B   Superfund
Risk Assessment Guidance for Superfund (RAGS) Part C   Superfund
Risk Assessment Guidance for Superfund (RAGS) Part D   Superfund
Risk Assessment Guidance for Superfund (RAGS) Part E   Superfund
Risk Assessment Guidance for Superfund (RAGS) Part F   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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