Risk Assessment Guidance

EPA Guidance

In order to conduct respectable risk assessments, based on sound science, that can respond to the needs of our nation, EPA has developed guidance, 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:

On this page:

Human Health
Ecological
Citizen Guides

EPA Human Health Guidance

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
Cumulative Risk Assessment Lessons Learned: A Review of Case Studies and Issue Papers	2015	Case Studies, Human Health
Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation	2014	Guidance Document, Toxicokinetic, Toxicodynamic
Framework for Human Health Risk Assessment to Inform Decision Making	2014	Framework, Human Health
Probabilistic Risk Assessment White Paper	2014	Case Studies, Human Health
Guideline for Microbial Risk Assessment: Pathogenic Microorganisms with Focus on Food and Water	2012	Guidance Document, Human Health, Pathogens
Scientific and Ethical Approaches to Observational Exposure Studies (SEAOES)	2008	Guidance Document, Exposure
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	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
EPA Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health	2000	Methodology, Human Health, Water Quality
Guidelines for Neurotoxicity Risk Assessment	1998	Guidance Document, Neurotoxicity, Human Health
Guiding Principles for Monte Carlo Analysis	1997	Guidance Document, Human Health
Guidelines for Reproductive Toxicity Risk Assessment	1996	Guidance Document, Reproductive Toxicity, Human Health
Guidelines for Human Exposure Assessment	2019	Guidance Document, Human Health, Exposure
Guidelines for Developmental Toxicity Risk Assessment	1991	Guidance Document, Human Health, Developmental Toxicity
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
A Framework for Assessing Health Risk of Environmental Exposures to Children	2006	Children, Human Health
A Review of the Reference Dose and Reference Concentration Processes	2002	Guidance Document, Human Health, RFD, RFC
Alpha2u-Globulin: Association with Chemically Induced Renal Toxicity and Neoplasia in the Male Rat	1991	Human Health, Risk Assessment, Toxicity
A Summary of General Assessment Factors for Evaluating the Quality of Scientific and Technical Information	2003	Summary Report, Human Health, Exposure Factors
Assessment of Thyroid Follicular Cell Tumors	1998	Assessment, Human Health
Benchmark Dose Technical Guidance	2012	Technical Guidance, BMDS, Modeling, Assessments
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	Technical Guidance, Cumulative Risk
Criteria for Evaluating Blood Lead Data Quality and Use	1995	Region 8, Lead
Cumulative Health Risk Assessment of Multiple Chemicals, Exposures, and Effects: A Resource Document	2008	Cumulative Risk
Guidance on Cumulative Risk Assessment: Planning & Scoping (Part 1)	1997	Cumulative Risk
Dioxin Toxicity Equivalency Factors (TEFs) for Human Health	2010	Human Health, Dioxin, 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, Soil
Evaluating and Identifying Contaminants of Concern for Human Health	1994	Region 8
Exploration of Aging and Toxic Response	2001	Human Health, Aging
Exploration of Perinatal Pharmacokinetic Issues	2001	Human Health, Children
Exposure Factors Handbook	2011	Human Health, Exposure Factors, children
Framework for Cumulative Risk Assessment	2003	Human Health, Cumulative Risk
Framework for Metals Risk Assessment	2007	Metals
Handbook for Non-Cancer Health Effects Valuation	2000	Human Health, Cancer
Model Site Conceptual Model for RI/FS Baseline Risk Assessments of Human Health	1995	Region 8, Human Health
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, Methods
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
Recommended Use of Body Weight 3/4 as the Default Method in Derivation of the Oral Reference Dose	2011	Human Health, RFD
Research Plan for Endocrine Disruptors	1998	Human Health, 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, Arsenic, Lead, Blood
Sampling Manual for IEUBK Model (1996)	1996	Region 8, Lead, Modeling
Scientific and Ethical Approaches for Observational Exposure Studies	2009	Approaches, Exposure Studies
Standard Operating Procedure: In Vitro Bioacessibility (IVBA) Procedure for Arsenic	2012	Region 8
Summary Report for the Workshop on Issues Associated with Dermal Exposure and Uptake	2000	Human Health, Dermal
Summary Report for the Workshop on the Relationship Between Exposure Duration and Toxicity	1999	Exposure Duration, 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

EPA Ecological Guidance

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, Technical Report, Endpoints, Ecological, GEAE
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	Risk Assessment, 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, Dioxin, Soil
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
Guidance Document on the Development, Evaluation and Application of Environmental Models	2009	Guidance Document, Models
EPA Scientific Integrity Policy	2012	Policies
EPA's Strategic Plan for Evaluating the Toxicity of Chemicals	2009	Chemicals, Strategic Planning
Estimating Site-Specific Exposure to Contaminants in Indoor Dust	1995	Region 8, Soil, Dust
Calculating Preliminary Remediation Goals		Region 8, Superfund
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 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, Modeling, Human Health
Peer Review Handbook - 4th Edition	2015	Peer Review
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
Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses	1985	Water Quality Criteria, Aquatic Organisms, Ambient Water
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
Scientific and Ethical Approaches to Observational Exposure Studies (SEAOES)	2008	Exposure Guidelines
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
Regional Ecological Risk Assessment Supplemental Guidance	2015	Region 4, Ecological
Issue Paper for PCB Characterization at Regional Superfund and RCRA Sites	2013	Region 4, Risk Characterization
Regional Background Soil Arsenic Concentrations Table (XLS) (2.5MB)	1999	Region 8, Arsenic, Soil
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, Human Health, Ecological
Stressor Identification Guidance Document	2000	Stressors, SI, Ecological, CADDIS
Viewpoints on Bioavailability for Wildlife	1998	Region 8, Ecological, Wildlife
Watershed Ecological Risk Assessment		Watershed, Ecological
Wildlife Exposure Factors Handbook	1992	Wildlife, Ecological
Radiation Protection Document Library		Radiation Protection, Ecological
Regional Removal Management Levels (RMLs) User's Guide	2015	Region, Superfund, Guidance, RMLs
Regional Human Health Risk Assessment Supplemental Guidance	2014	Region 4, Human Health, Guidance
An in vitro method for estimation of arsenic relative bioavailability in soil regional guidance document	2013	Region 8, Arsenic, Soil
Background Soil Arsenic Concentrations Table for Regions (XLS) (2.5MB)	1999	Region 8, Arsenic, Soil Concentrations
Measurement of Arsenic Relative Bioavailability in Swine - Regional Guidance Document	2013	Region 8, Arsenic, Measurement
Validation of an In Vitro Bioaccessibility Test Method for Estimation of Bioavailability of Arsenic from Soil and Sediment Guidance Document	2012	Region 8, Arsenic, Soil, Sediment, Guidance Document
Report of the Workshop on Selecting Input Distributions for Probabilistic Assessments	1999	Human Health
Standard Operating Procedures for Residential Pesticide Exposure Assessment	2012	Chemicals
Test Method Collections	2008	Test Methods
Integrating Ecological Assessment and Decision-Making	2010	Ecological
Contingencies for Regional Evaluation and Response for Various Levels of Dioxins Measured in Denver's Front Range Reference Surface Soils (Figure 3)	1999	Region 8, Dioxin, Soils
Final Test Guidelines for Pesticides and Toxic Substances	Various	Test Guidelines, Pesticides, Toxics

EPA Citizen Guidance

EPA has also produced a few handy citizen guides listed in the table below.

	Title	EPA Number	Year
1	A Citizen's Guide to Drycleaner Cleanup	EPA 542/F-11/013	2011
2	A Citizen's Guide to Phytoremediation	EPA 542/F-12/016	2012
3	A Citizen's Guide to Radon: The Guide to Protecting Yourself and Your Family from Radon	EPA402/K-12/002	2016
4	A Citizen's Guide to Reducing Toxic Risks	EPA 909/B-02/002	2002
5	Air Pollution and Health Risk	EPA 450/3-90/022	1991
6	EPA Assessment of Risk from Radon in Homes	EPA/402/R-03/003	2003
7	Evaluating Exposures to Toxic Air Pollutants: A Citizen's Guide	EPA 450/3-90/023	1991
8	RCRA: Reducing Risk from Waste	EPA 530/K-97/004	1997
9	Resources on Waste for Your Home and Community	EPA 530/B-98/005	1998
10	Risk Assessment for Toxic Air Pollutants: A Citizen's Guide	EPA 450/3-90/024	1991
11	A Citizen's Guide to Vertical Engineered Barriers	EPA 542/F-12/022	2012
12	A Citizen's Guide to Excavation of Contaminated Soil	EPA 542/F-12/007	2012
13	A Citizen's Guide to Vapor Intrusion Mitigation	EPA 542/F-12/021	2012
14	A Citizen's Guide to in Situ Chemical Oxidation	EPA 542/F-12/011	2012
15	Child Health Champion Resource Guide	EPA 100/B-98/004	1999
16	Pollinator Risk Assessment Guidance	(multiple)	2018
17	Procedures to Facilitate Risk Assessment	CIO 2150-P-14.2	2023
18	Resources for Citizen Involvement in Source Water Protection	(multiple)	2002