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Project Information

Project Information


Workshops to Support Development of EPA's IRIS Toxicological Reviews


Project Scope:

An ad hoc committee will organize up to two workshops on topics pertinent to the development of draft toxicological reviews by the U.S. Environmental Protection Agency's Integrated Risk Information System (IRIS) program.  The workshops will be designed to assist EPA with increasing quality, transparency, and confidence in its assessments by addressing scientific issues related to systematic review, hazard identification, and dose-response analysis.  Topics could include the following:

  • approaches to planning and performing evidence identification,
  • methods for evaluating individual studies and bodies of evidence,
  • approaches to synthesizing and integrating evidence to reach hazard conclusions,
  • development and application of specialized tools for systematic review,
  • considerations in study selection for developing toxicity values, and
  • research on quantitative analyses for evidence integration and dose-response analyses.

Status: Current

PIN: DELS-BEST-18-03

RSO: Martel, Susan

Topic(s):

Environment and Environmental Studies
Health and Medicine



Geographic Focus:

Committee Membership


Ivan Rusyn - (Chair)
Ivan Rusyn is a Professor in the Department of Veterinary Integrative Biosciences of the College of Veterinary Medicine and Biomedical Sciences of Texas A&M University. He is also chair of the Interdisciplinary Faculty of Toxicology at the university. His laboratory has an active research portfolio with a focus on the mechanisms of action of environmental toxicants, the genetic determinants of susceptibility to toxicant-induced injury, and computational toxicology. His studies on health effects of environmental agents have resulted in over 200 peer-reviewed publications. He is currently on the Board of Scientific Councilors of the National Institute of Environmental Health Sciences and is a member of the Research Committee of the Health Effects Institute. He has served on several committees of the National Academies, including the Committee on Incorporating 21st Century Science into Risk-Based Evaluations and the Committee on the Design and Evaluation of Safer Chemical Substitutions. Most recently, he chaired the Committee to Review Report on Long-Term Health Effects on Army Test Subjects. Dr. Rusyn received his MD from Ukrainian State Medical University in Kiev and his PhD in toxicology from the University of North Carolina at Chapel Hill.
Richard A. Corley
Richard A. Corley (retired) was a laboratory fellow at the Pacific Northwest National Laboratory operated by Battelle for the US Department of Energy. He specializes in the development of physiologically based pharmacokinetic models, real-time breath analysis, dermal and inhalation bioavailability, and the development of three-dimensional computational fluid-dynamic models of the respiratory system. He has published numerous peer-reviewed papers on oral, dermal, and inhalation toxicology; on modes of action of a variety of industrial and consumer chemicals; and on pharmacokinetic modeling and its applications in human health risk assessment. Dr. Corley has served on several National Academies committees, including the Committee to Assess the Health Implications of Perchlorate Ingestion, the Standing Committee on Risk Analysis Issues and Reviews, the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, the Committee to Review EPA's Draft State of the Science Paper on Nonmonotonic Dose Response, and the Committeee to Review Advances Made to the IRIS Process. He received his PhD in environmental toxicology from the University of Illinois at Urbana-Champaign.
Ana Navas-Acien
Ana Navas-Acien is a Professor of environmental health sciences at Columbia University and director of the Columbia University Superfund Research Program. She is a physician-epidemiologist with a specialty in preventive medicine and public health. Her research interests are in cardiovascular and metabolic effects related to chronic exposure to arsenic and other metals in drinking water and food. She is involved in prospective cohort studies of arsenic exposure and metabolism in American Indian communities and in multi-ethnic urban adults. Other research interests include tobacco control research and the contribution of emerging tobacco products, including e-cigarettes to metal exposure and health effects. Her work for the National Academies of Sciences, Engineering, and Medicine includes past service on the Committee on Inorganic Arsenic and Committee on the Review of Health Effects of Electronic Nicotine Delivery Systems, among other committees. Dr. Navas-Acien received her MD from the University of Granada School of Medicine in Spain, her MPH from the National School of Health in Madrid, and her PhD in epidemiology from the Johns Hopkins University Bloomberg School of Public Health.
Andrew A. Rooney
Andrew A. Rooney is the Acting Director of the Office of Health Assessment and Translation (OHAT) in the National Toxicology Program at the National Institute of Environmental Health Sciences (NIEHS). He has been developing risk assessment methods and guidance throughout his professional career and is a principal author of the 2012 World Health Organization/International Programme on Chemical Safety Guidance for Immunotoxicity Risk Assessment for Chemicals. Most recently, Dr. Rooney has been working on emerging issues in toxicology and environmental health, including methods to address study quality in terms of risk of bias for human, animal, and mechanistic studies and adaptation of systematic review methods for addressing environmental health questions. He led the team that developed the OHAT approach to systematic review. Dr. Rooney was a member of the National Academies Committee Endocrine-Related Low Dose Toxicity. He has an MS and a PhD in zoology from the University of Florida.
Holger J. Schunemann
Holger J. Schunemann is Chair of the Department of Health Research Methods, Evidence, and Impact and professor of clinical epidemiology and medicine at McMaster University. He also leads the McMaster GRADE Centre and Cochrane Canada. His research interests are in guideline development, systematic reviews, evidence synthesis, health related quality of life, pulmonary function and respiratory disease epidemiology and knowledge translation. His work also focuses on practical application of science by researchers and clinicians through co-inventing tools like GRADEpro guideline development tool. Dr. Schunemann received his MD from the Medical School of Hanover in Germany, and his MSc in epidemiology and PhD in epidemiology and community medicine from the University at Buffalo, State University of New York.
Peter S. Thorne
Peter S. Thorne is Professor and Head of the Department of Occupational and Environmental Health at the University of Iowa College of Public Health. He is associate director and co-founder of the Interdisciplinary Graduate Program in Human Toxicology. He also directs the NIH-funded Environmental Health Sciences Research Center. His research interests are in environmental risk factors for asthma, inflammatory lung diseases, endotoxin- and glucan-induced immunomodulation, and novel methods for exposure assessment and modeling. He is internationally recognized for his discoveries in the exacerbation of asthma associated with domestic and occupational exposures to bioaerosols. He was a co-investigator on a large study of exposure and health outcomes in Persian Gulf War veterans. He is a former chair of the U.S. Environmental Protection Agency’s Science Advisory Board. Dr. Thorne is currently a member of the National Academies Board on Environmental Studies and Toxicology and the Committee on Toxicology. He received his BS in chemical engineering, MS in biomedical engineering and PhD in toxicology from the University of Wisconsin-Madison and completed a postdoctoral fellowship in immunotoxicology at the University of Pittsburgh.
Katya Tsaioun
Katya Tsaioun is the Director of Evidence-based Toxicology Collaboration at Johns Hopkins Bloomberg School of Public Health, where she leads international multi-stakeholder efforts to establish evidence-based methodologies and practices in translational research to inform regulatory decisions. The focus of her career has been on the translation of scientific innovations into policies and technologies enabling improvements in public health. She spent two decades in the pharmaceutical industry leading translational drug-discovery teams, subsequently founding her company, Apredica, which became a leader in commercializing innovative in vitro ADME and toxicity technologies. After a successful acquisition of Apredica by Cyprotex, PLC (now Evotec), she then served as CSO and Board member in the merged company. Dr. Tsaioun is serving on advisory boards of companies, non-profits, and on scientific review committees at the NIH and private foundations. She earned her PhD in human nutrition science from Tufts University Friedman School of Nutrition Science and Policy and completed post-doctoral training in neurochemistry at Harvard Medical School.
Joyce S. Tsuji
Joyce S. Tsuji is a Principal Scientist at Exponent, where she is involved in assessing health risks associated with substances in the environment, foods, consumer and personal care products, and medical devices in the United States and internationally for industry, trade associations, the federal government, state agencies, municipalities, and private citizens. Her work has also involved environmental exposure studies and community programs involving health education and biomonitoring for populations potentially exposed to chemicals in the environment, including soil, water, and food-chain exposures. Dr. Tsuji is a board-certified toxicologist and a fellow of the Academy of Toxicological Sciences. She has served on expert committees for EPA, the US Army, and the state of Washington. She is a former member of the National Academies Board on Environmental Studies and Toxicology and has served on a number of National Academies committees. Dr. Tsuji received her PhD focused in environmental physiology from the Department of Zoology at the University of Washington.

Events


Event Type :  
Workshop

Description :   

The National Academies of Sciences, Engineering, and Medicine will hold a workshop on evidence integration, which is a summary step of the systematic review in human health assessments conducted by the US Environmental Protection Agency. The overall aim of this workshop is to explore strategies for addressing challenges that arise during evidence integration. Through presentations, discussions, and poster sessions, workshop participants will address topics such as:

  • Best Practices in Evidence Integration
  • Approaches for Using Mechanistic Data to Integrate Evidence from Animal and Human Studies
  • Case Studies of Systematic Review-Enabled Evidence Integration, and
  • Practical Approaches to Expedited Evidence Integration




If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Tamara Dawson
Contact Email:  tdawson@nas.edu
Contact Phone:  (202) 334-2776

Agenda
-
Supporting File(s)
-
Is it a Closed Session Event?
Some sessions are open and some sessions are closed

Publication(s) resulting from the event:

-


Location:

National Academy of Sciences Building
2101 Constitution Ave NW, Washington, DC 20418
Event Type :  
Workshop

Description :   

The objective of the workshop is to explore relevant strategies and tools that are being developed and used across the systematic review and risk assessment communities to assist the US Environmental Protection Agency with developing guidance on performing systematic reviews of mechanistic data to support the chemical assessments in its Integrated Risk Information System program.  A poster session will accompany the workshop that will have examples demonstrating the application of systematic review approaches to mechanistic data.

 

Invited experts and speakers from academia, industry, and government agencies will convene for this two-day public workshop on:

  • Approaches and tools to search and screen the literature for mechanistic data,
  • Approaches to evaluating the validity of mechanistic studies,
  • Methods for assimilating and using mechanistic information to support evidence synthesis and integration, and
  • Practical experience with implementing systematic reviews of mechanistic evidence into human health assessments.




If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Tamara Dawson
Contact Email:  tdawson@nas.edu
Contact Phone:  -

Supporting File(s)
-
Is it a Closed Session Event?
No

Publication(s) resulting from the event:

-

Publications

Publications

No data present.