Webinars and Downloads

SOT Risk Assessment Specialty Section (RASS)
with the
International Society of Exposure Science (ISES)

Jointly Sponsored Webinar


(See Below for Instructions on Webinar Access)

Epidemiology and Risk Assessment—Bridging the Gap

Judy S. LaKind, PhD
President, LaKind Associates, LLC
Past President, International Society of Exposure Science
Adjunct Associate Professor, Dept. of Epidemiology and Public Health
University of Maryland School of Medicine

Carol J. Burns, PhD
Burns Epidemiology Consulting, LLC
Sanford, MI


For decades, global regulators have used animal data as the basis for establishing guidelines to protect human health. Recently, the US EPA and others have begun rely more heavily on results from non-occupational epidemiology studies for risk and weight-of-evidence (WOE) assessment. Studies that are well-conducted with transparent and full reporting and that are sufficiently concordant with previous research can provide valuable information on the scale of risk related to a defined level of exposure. However, the quality, transparency and concordance of these epidemiology studies differ vastly from the robust in vivo guideline studies that must follow Good Laboratory Practices and these differences can adversely impact the ability to draw causal inferences from a given body of literature. In addition, when considering strength of evidence across studies, epidemiology studies often utilize inconsistent methods that preclude inter-study comparisons. In general, public health decision-making requires multiple studies as its foundation in order for those decisions to be rigorous, and the data from these studies must be sufficiently robust, transparent and concordant for their results to be used in decision-making.

Significant efforts have been made to develop checklists and guidelines designed to improve scientific research with humans. Workshops and manuscripts have addressed the issue of improving the quality and concordance of environmental epidemiology data prior to or during its use in risk and WOE assessment and other efforts are underway (e.g., ROBINS-E, Risk of Bias in Non-Randomized Studies – Exposure). However, the disciplines of risk assessment and epidemiology generally utilize different models, language and skill sets, and at present there is no instrument or guidance for bridging the gap between the disciplines.

The webinar will describe key needs in risk assessment for using epidemiology studies as the basis for decision-making. Ultimately these needs will be integrated into a visual guide for both disciplines that can be used in study design and review. The guide will be a communication tool to advance understanding of the needs of risk assessors with the activities of epidemiologists. It will be designed to include only highest-level key risk assessor considerations. It is not intended to supplant current best practices for environmental epidemiology or existing instruments but rather to highlight key elements of a useful study.

Webinar Presentation

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Upcoming Webinars

2018–2019 RASS Webinar Series

March N/A (Annual Meeting)

● April 10, 2019
Information-based Causal Modeling (IBCM): Applications in Clinical and Environmental Epidemiology

Sharon-Lise T. Normand, PhD
Professor of Health Care Policy
Harvard Medical School
Professor, Dept. of Biostatistics
Harvard T.H. Chan School of Public Health
Director, FDA Medical Device Epidemiology Network Methodology Center
Anthony Cox, PhD
President, Cox Associates
NextHealth Technologies (CSO)

● May 8, 2019
Co-sponsored with the SOT MixSS
EuroMix: An assessment of mixture toxicity using in vitro analyses of liver steatosis to develop an adverse outcome pathway

Prof. Dr. Alfonso Lampen
Head of the Department of Food Safety
German Federal Institute for Risk Assessment
Berlin, Germany

Past Webinars

Webinar January 9, 2019: Use of Chemometrics and Multivariate Statistical Analysis to Determine Toxic Constituents Within Various Crude Oils PDF Icon

Temporal Trends of Cumulative Risks from Six Phthalates in Biomonitoring Data PDF Icon

Webinar December 12, 2018: In Vitro to in Vivo Extrapolation (IVIVE) to Support New Approach Methodologies (NAMs)-based Safety Assessment: A Tiered Approach with a Focus on the Consideration of Kinetics and Metabolism PDF Icon

Webinar November 14, 2018: A Mechanistic Approach for Source-to-Outcome Risk Assessment Across Human Health and Ecological Endpoints Using the Aggregate Exposure Pathway (AEP) and Adverse Outcome Pathway (AOP) Frameworks PDF Icon

Webinar October 10, 2018: U.S. EPA Strategic Plan to Promote the Development and Implementation of Alternative Test Methods PDF Icon

Webinar September 12, 2018: The Key Characteristics Approach to Evaluating Mechanistic Data in Hazard Identification and Risk Assessment PDF Icon

Webinar May 9, 2018: Overview of an Uncertainty Analysis Tool to Increase Transparency and Communication of Uncertainty in Chemical Risk Assessment PDF Icon

Webinar April 11, 2018: Use of the "Exposome" in the Convergence of Toxicology and Epidemiology: A Primer on—Omic Technologies for Achieving Health Impact PDF Icon

Webinar February 14, 2018: Exposure Assessment for Chemical and Non-chemical Exposures for Urban Epidemiology

Webinar January 10, 2018: Assessing the Health Impact of Diverse Mixtures in the Environment

Webinar December 13, 2017: A Liver-centric Multiscale Modeling Framework for Xenobiotics

Webinar November 8, 2017: Systematic Review: Concept and Tool Development with Application to Assessment Processes of the National Toxicology Program (NTP) and the Integrated Risk Information System (IRIS)

Systematic Review Methods to Support Transparency and Consistency in Environmental Health Decision Making

Webinar October 11, 2017: A Source to Outcome Approach for Inhalation Risk Assessment

Webinar September 13, 2017: Mixing Hazardous Agents in a Mouse Model: Noise with Lead and Cadmium

Complex Mixtures of Anti-Androgens at Concentrations below Individual Chemical Effect Levels Produce Reproductive Tract Malformations in the Male Rat

Webinar May 10, 2017: Putting Exposure Back in Risk Assessment (Or: The Dose Makes the Poison)

Webinar April 12, 2017: Crowdsourcing Scientific Perspectives with SciPinion™: Hexavalent Chromium as a Case Study

Webinar February 8, 2017: How Can Mechanistic Data from Systems Approaches Improve our Understanding of Carcinogenic Risk for Mixtures?

Webinar January 11, 2017: German Environmental Survey and Environmental Specimen Bank and the Use of Human Biomonitoring Data for Risk Assessment

Webinar December 14, 2016: Aggregate Exposure Pathway (AEP): An Organizational Approach for Advancing Exposure Science Research and Applications

Webinar November 9, 2016: Improving Causal Inference in Cumulative Risk Assessment Using Directed Acyclic Graphs

Webinar October 12, 2016: Overview of TSCA Reform and Introduction to Key Provisions in the New
Lautenberg Law

Webinar September 14, 2016: Incorporating Non-Chemical Stressors into Cumulative Risk Assessment (CRA)

Webinar May 11, 2016: Unconventional Gas and Oil Drilling Is Associated with Increased Hospital Utilization Rates

Webinar April 13, 2016: Studying Biology to Understand Risk: Dosimetry Models and Quantitative Adverse Outcome Pathways

Webinar February 10, 2016: Characterization of Murine Hepatocarcinogenesis Induced by the Nitrification Inhibitor Nitrapyrin: Mode of Action, Human Relevance Framework and Risk Assessment Implications

Webinar January 13, 2016: Health Effects of Mixtures: Comparing Approaches in Epidemiology and Toxicology (with a discussion of the July 2015 NIEHS Workshop entitled “Statistical Approaches for Assessing Health Effects of Environmental Chemical Mixtures in Epidemiology Studies”)

Webinar December 9, 2015: Highly fluorinated chemicals: A Legal and Technical Challenge

Webinar November 18, 2015: Framework for Human Health Risk Assessment of Noncancer Effects Resulting from Short-Duration and Intermittent Exposures to Chemicals

Webinar October 14, 2015: The Integration of LNT and Hormesis for Cancer Risk Assessment Optimizes Public Health Protection

Webinar September 9, 2015: Mechanisms of Action for Arsenic in Cardiovascular Toxicity and Implications for Risk Assessment

Webinar June 10, 2015: Quantitative Evidence Integration to Facilitate the Use of Tox21 Data for Rapid Risk Screening

Webinar April 8, 2015: Adverse Outcome Pathways

Webinar February 11, 2015: CHAMACOS: Lessons from the Fields

Webinar January 14, 2015: Systematic Reviews, Risk of Bias and Evidence Evaluation for Characterization of Environmental Chemicals

Instruments for Assessing Risk of Bias and Other Methodological Criteria of Published Animal Studies: A Systematic Review

Webinar December 10, 2014: Improving Reproducibility in Toxicology

Webinar November 12, 2014: Introduction to Decision Analysis and Value of Information Analysis for Toxicology and Environmental Science

Webinar October 8, 2014: Every Breath You Take: Exposure Science and the Virtual Respiratory System

Webinar September 10, 2014: Toxicology for Breast Cancer Prevention

Webinar June 11, 2014: Environmental Decisions in the Face of Uncertainty

Webinar May 14, 2014: Cancer Clusters in the USA: What Do the Last Twenty Years of State and Federal Investigations Tell Us?

Webinar January 8, 2014: Environment-wide Association Studies (EWAS) to Connect Multiple Personal Exposures to Health

Webinar December 11, 2013: Providing the Missing Link: the Exposure Ontology (ExO) , High Throughput Human Exposure Forecasts for Environmental Chemical Risk

Webinar November 13, 2013: Approaches to Dose-response Analysis for Compounds with Endogenous Production: Two Case Studies Critical Issues for Formaldehyde Cancer Risk Assessment (Swenberg Presentation and Starr Presentation ) and Derivation of Methanol RfD and RfC—Accounting for Background Blood Levels

Webinar September 11, 2013: International Experience in Addressing Combined Exposures: Increasing the Efficiency of Assessment

Webinar May 8, 2013: Cumulative Risk Assessment: Approaches and Case Study

Webinar May 8, 2013: Evidence for the Existence of Nonmonotonic Dose-Response: Does It or Doesn’t It?

Are Nonmonotonic Dose Response Curves (NMDRCs) Common after Estrogen or Androgen Signaling Pathway Disruption: Fact or Falderal?

Webinar April 10, 2013: Interface of Health Effects Caused by the CardioMetabolic Syndrome and Exposures to Air Pollutant Mixtures

Webinar February 13, 2013: Roundtable Panel Discussion: Should Journals Require the Release of Supporting Data As a Condition for Publication?

Webinar January 9, 2013: Mode of Action Research, Multispecies Pharmokinetic Modeling, and Risk Assessment for the Carcinogenesis of Hexavalent Chromium in the Small Intestine

Webinar December 12, 2012: Deming and Statistical Strategies to Make Observational Studies More Reliable

Webinar October 10, 2012: Alternative Methods for the Evaluation of Bioavailability of Arsenic in Mining Soils

Webinar September 12, 2012: A More Efficient and Effective Testing and Assessment Paradigm for Chemical Risk Management

Webinar June 13, 2012: Identification and Characterization of Adverse Effects in 21st Century Toxicology and Risk Assessment

Webinar April 25, 2012: Introduction to the New WHO/IPCS Guidelines for Immunotoxicity Risk Assessment for Chemicals

Immunotoxicity Risk Assessment

Webinar February 8, 2012: Challenges in the Application Of Quantitative Approaches in Risk Assessment: A Case Study with Di-(2-Ethylhexyl)Phthalate

Webinar January 11, 2012: Comprehensive Environmental Assessment of Nanomaterials:
A Meta-Assessment Approach

Webinar December 14, 2011: Studies with Diesel Exhaust Particulate: Implications for the Potential Human Health Hazards of Nanoparticles

Webinar November 9, 2011: Risk from Multiple Chemicals in Polluted Communities

Webinar October 12, 2011: Estimating the Economic Value of Improved Information for Health Risk Assessment

Webinar June 8, 2011: Linear Low-Dose Extrapolation for Noncancer Health Effects Is the Exception, Not the Rule

Webinar May 11, 2011: The Maximum Cumulative Ratio (MCR): A Tool That Uses Both Exposure and Toxicity Data to Determine When Cumulative Assessments Are Most Necessary

Webinar April 13, 2011: OSTP Scientific Integrity Guidance Memo—December 17, 2010

Webinar February 9, 2011: Development of a Quantitative Model Incorporating Key Events in a Hepatotoxic MOA to Predict Tumor Incidence

Webinar January 12, 2011: NexGen Risk Assessment Framework

Teleconference December 8, 2010: Selected Silver Book Highlights and Update on Related Activities

Teleconference November 10, 2010: The Use of PBPK Modeling to Reduce Uncertainty in Risk Assessment: Example of Manganese

Teleconference October 13, 2010: An Integrated Evaluation Strategy for Making Regulatory Decisions: Moving from Data Requirements to Knowledge Requirements

Teleconference September 8, 2010: Improving Prognostic Science for Risk Assessment: Developing Better Biomarkers for Key Clinical Diseases PDF

Teleconference June 30, 2010: Developments and Good Practice in Mode of Action/Human Relevance Anaylsis

Teleconference June 9, 2010: Analyzing Genomic Dose-Response Information to Inform Key Events in a Mode of Action for Carcinogenicity: An Example with Arsenic

Teleconference May 12, 2010: Opportunities for Progress in the Applications of Mechanistic Information in Risk Assessment

Rescheduled Teleconference February 10 presented on April 14, 2010: Key Events Dose-Response Analysis. Part 2: Application to Nutrients, Pathogenic Microorganisms, and Food Allergens

Teleconference January 13, 2010: Key Events Dose-Response Analysis. Part 1: Conceptual Framework and Application to Chemicals

Teleconference December 9, 2009: Biomonitoring Equivalents: Derivation Guidelines and Lessons Learned

Teleconference June 10, 2009: Models in Environmental Regulatory Decision-Making—Report of the Committee on Models in the Regulatory Decision Process

Teleconference May 13, 2009: Science and Decisions: Advancing Risk Assessment—Joseph Rodricks and Jonathan Levy

Teleconference April 8, 2009: Approaches for Evaluating the Relevance of Multiroute Exposures in Establishing Guideline Values for Drinking Water Contaminants—Kannan Krishnan and Richard Carrier

Teleconference March 11, 2009: Hormesis: What It Means for Toxicology, the Environment, and Public Health

Getting the Dose-Response Wrong: Why Hormesis Became Marginalized and the Threshold Model Accepted

The Road to Linearity: Why Linearity at Low-Doses Became the Basis for Carcinogen Risk Assessment

Teleconference February 11, 2009: Predicting Pharmacokinetics in Humans: The Bottom-Up Approach

Teleconference January 14, 2009: State of the Science Workshop: Low Dose-Response Extrapolation for Environmental Health Risk Assessment

Teleconference November 12, 2008: Pb NAAQS Human Health Risk Assessment—Overview of Design and Implementation

Teleconference October 8, 2008: Betraying Paracelsus, Ignoring Newton: A Flaw in the Nanotoxicology Paradigm

Teleconference September 10, 2008: Mutagenic MOA Carcinogens: How Hign Is the Burden of Proof?

Teleconference June 11, 2008: The Hamner Institutes Programs Related to Implementing Recommendations from “Toxicity Testing in the 21st Century: A Vision and a Strategy”

Teleconference May 14, 2008: Incorporating Gene-Environment Information into Kinetic Models: Lessons Learned and Future Challenges

Design and Dose Selection for Chronic Rodent Studies

Integration of Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Arsenic to Inform the Risk Assessment Process

Toxicity Testing in the 21st Centry—Mel Andersen and Dan Krewski

Updated Principles for Risk Analysis—Nancy Beck

Integrating Life Stage Susceptibility into Immuntoxicity and Microbial Risk Assessment—Robert W. Luebke

The Unc Atmospheric Simulation Chamber Toxicology System–Effects of Chemical Transformations in Complex Mixtures—Harvey Jeffries, Kenneth G. Sexton, Seth Ebersviller, Kim de Bruijne, Erin Potts, Liz Naess —32 mb, 2–5 minutes to download)

Model Averaging: Beyond Model Uncertainty in Risk Analysis—Matthew W. Wheeler

Developing Tumor-Associated Somatic Mutations As Biomarkers of Cancer Risk—Barbara Parsons

Benchmark Dose Evaluations for Acute Inhalation Exposures to Human Toxicants—G.V. Alexeeff, K. K. Deng, R. L. Broadwin, A. G. Salmon

Framework for Inorganic Metals Risk Assessment—Anne Fairbrother, Randy Wentsel, Bill Wood, Keith Sappington, and Pam Noyes Office of Research and Development

The Application of Genomic Dose-Response Data in Risk Assessment—Harvey Clewell and Rusty Thomas CIIT Centers for Health Research

Use of Developmental Neurotoxicity Data in Risk Assessment at EPA: Current Status and Future Efforts—Kathleen Raffaele and William Mundy

A Biologically-Based Model for Low-Dose Extrapolation of Cancer Risk from Ionizing Radiation—Doug Crawford-Brown

Dosimetry Can Change Mechanistic Models: The Challenge of Scrutinizing the Source before Gathering and Analyzing the Data—Owen R. Moss

Dose-Response Modeling for EPA’s Organophosphate Cumulative Risk Assessment: Combining Information from Several Datasets to Estimate Relative Potency Factors—R. Woodrow Setzer

Dose-Response Modeling: Past, Present, and FutureRory B. Conolly

Intentional Human Dosing Studies for EPA: SOT Briefing

Dose-Response Modeling: Past, Present, and Future II—Rory B. Conolly and Rusty Thomas

HESI Project Committee on Dose-Dependent Transitions in Mechanisms of Toxicity Teleconference: Part 1 of 3

HESI Project Committee on Dose-Dependent Transitions in Mechanisms of Toxicity Teleconference: Part 2 of 3

HESI Project Committee on Dose-Dependent Transitions in Mechanisms of Toxicity Teleconference: Part 3 of 3

Identifying Research Needs for Risk Assessment of US Food Supply Security—Bruce Hope

RASS Annual Business Meeting and Reception

RASS Reception HESI Panel

RASS Panel Discussion Questions

Assessing the Real Risk in Complex Diseases—Michael N. Liebman