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Project Information

Project Information


Incorporating 21st Century Science into Risk-Based Evaluations


Project Scope:

A ad hoc committee under the auspices of the National Research Council (NRC) will provide recommendations on integrating new scientific approaches into risk-based evaluations.  Specifically, the committee will first consider the scientific advances that have occurred following the publication of the NRC reports Toxicity Testing in the 21st Century: A Vision and a Strategy and Exposure Science in the 21st Century: A Vision and a Strategy.  Given the various ongoing lines of investigation and new data streams that have emerged, the committee will then propose how best to integrate and use the emerging results in evaluating chemical risk and identify how traditional human-health risk assessment can incorporate the new science.   It will consider whether a new paradigm is needed for data validation (or acceptance), how to integrate the divergent data streams, how uncertainty might need to be characterized (or how characterization of uncertainty might need to change), and how best to communicate the new approaches so that they are understandable to various stakeholders.  It will focus its recommendations on pragmatic solutions and provide case studies that illustrate its recommendations.  Finally, the committee will identify barriers or obstacles to advancing and integrating the various types of science, and ultimately transforming risk assessment.

Status: Completed

PIN: DELS-BEST-14-04

Project Duration (months): 24 month(s)

RSO: Mantus, Ellen

Topic(s):

Environment and Environmental Studies



Geographic Focus:

Committee Membership

Committee Post Date: 03/03/2015

Jonathan M. Samet - (Chair)
University of Southern California

Jonathan M. Samet is a pulmonary physician and epidemiologist. He is Distinguished Professor and Flora L. Thornton Chair for the Department of Preventive Medicine at the Keck School of Medicine at the University of Southern California (USC) and director of the USC Institute for Global Health. Dr. Samet’s research has focused on the health risks of inhaled pollutants. He has served on numerous committees concerned with public health: the U.S. Environmental Protection Agency Science Advisory Board; committees of the National Research Council (NRC), including chairing the Biological Effects of Ionizing Radiation VI Committee, the Committee on Research Priorities for Airborne Particulate Matter, the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, the Committee to Review the IRIS Process, and the Board on Environmental Studies and Toxicology; and committees of the Institute of Medicine. He is a member of the Institute of Medicine. Dr. Samet received his MD from the University of Rochester, School of Medicine and Dentistry.
Melvin E. Andersen
The Hamner Institutes for Health Sciences

Melvin E. Andersen is Distinguished Research Fellow at ScitoVation. His research career has focused on developing biologically based dose-response models and applying them to human health risk assessments for many environmental chemicals. Before joining ScitoVation in 2016, he held positions at the Hamner Institutes for Health Sciences, the Chemical Industry Institute of Toxicology, Colorado State University, the U.S. Environmental Protection Agency, and the Department of Defense with both the Navy and the Air Force. He has served on several National Research Council Committees, including the Committee on Toxicity Testing and Assessment of Environmental Agents. Dr. Andersen is a fellow of the Academy of Toxicological Sciences and a diplomat of both the American Board of Toxicology and the American Board of Industrial Hygiene. He earned a PhD in biochemistry and molecular biology from Cornell University.
Jon A. Arnot
Arnot Research & Consulting, Inc.

Jon A. Arnot is an adjunct professor in the Department of Physical and Environmental Science and in the Department of Pharmacology and Toxicology at the University of Toronto and president of ARC Arnot Research & Consulting Inc. He has 15 years of research experience in the development, application, and evaluation of methods and models to assess the exposure, hazard, and risk of organic chemicals to humans and the environment. His research has focused on the application of high-throughput screening methods for prioritizing chemicals for risk assessment. He is the principal investigator or co-investigator of various international projects including collaborations in the United States, Europe, and Canada. He was the recipient of the James M. McKim III Innovative Student Research Award (2008) from the International QSAR Foundation to Reduce Animal Testing and the Society of Environmental Toxicology and Chemistry (SETAC) Best Student Paper Award (2009). Dr. Arnot earned his PhD in environmental and life sciences from Trent University.
Estaban Burchard
University of California, San Francisco

Estaban Burchard is Professor of Medicine and Biopharmaceutical Sciences at the University of California, San Francisco (UCSF). His research interests center on identifying genetic, social, and environmental risk factors for asthma in ethnically diverse populations. Dr. Burchard has created the largest gene-environment study of asthma in minority children in the United States. Dr. Burchard directs the UCSF Center for Genes, Environment & Health. Dr. Burchard received his MD from Stanford University School of Medicine and his clinical training from Harvard’s Brigham and Women’s Hospital and UCSF. He also completed epidemiology training at Harvard and UC Berkley Schools of Public Health.
George P. Daston
Procter & Gamble Company

George Daston is the Victor Mills Society Research Fellow at the Procter & Gamble Company. He has published over 100 articles and book chapters and edited five books in toxicology and risk assessment. His current research efforts are in the areas of toxicogenomics and mechanistic toxicology, particularly in addressing how findings in these fields can improve risk assessment of chemicals and the development of non-animal alternatives. Dr. Daston has served as President of the Teratology Society, as Councilor and Treasurer-Elect of the Society of Toxicology, and on the U.S. EPA Science Advisory Board, the Board of Scientific Counselors of the National Toxicology Program, the National Research Council’s Board of Environmental Studies and Toxicology, and the National Children’s Study Advisory Committee. He is Editor-in-Chief of Birth Defects Research: Developmental and Reproductive Toxicology. With scientists at the U.S. Humane Society, Dr. Daston manages the AltTox website, which is devoted to the exchange of scientific information leading to the development of in vitro replacements for toxicity assessments. Dr. Daston has been awarded the Josef Warkany Lectureship and the Distinguished Service Award by the Teratology Society, the George H. Scott Award by the Toxicology Forum, and the Society of Toxicology’s Best Paper of the Year Award, and is an elected Fellow of AAAS. Dr. Daston is an adjunct Professor of Pediatrics at University of Cincinnati. Dr. Daston earned his PhD in developmental biology from the University of Miami.
David B. Dunson
Duke University

David B. Dunson is Arts and Sciences Distinguished Professor in the Department of Statistical Science at Duke University. His research interests include Bayesian statistics, complex hierarchical and latent variable modeling, and nonparametric statistical modeling. His ongoing methodologic research focuses on nonparametric Bayes, latent variable methods, big data, scalable Bayesian inferences, functional and object data, and dimensionality reduction. He is a member of the International Society for Bayesian Analysis, the Institute of Mathematical Statistics, the American Statistical Association, and the International Biometrics Society. Dr. Dunson received his PhD in biostatistics from Emory University.
Nigel Greene
Pfizer Inc.

Nigel Greene is the Director of Predictive Compound ADME and Safety at AstraZeneca and specializes in the application of computational and in vitro approaches to assess compound liabilities. His specific duties include establishing and managing a group of PhD-level scientists that profile chemicals for off-target pharmacology. His group uses computational modeling and analysis of chemical properties and in vitro assay profiles to help to predict the safety profile of chemicals in early discovery programs and to aid in chemical series and compound selection before in vivo studies are conducted. Dr. Greene’s other activities include mining internal and public databases of gene expression data to explore biological mechanisms of toxicity and developing new in vitro assays for safety profiling on the basis of findings from the mining exercises. He recently served as a member of the National Research Council Committee on the Design and Evaluation of Safer Chemical Substitutions. Dr. Greene received his PhD in organometallic chemistry from the University of Leeds.
Heather B. Patisaul
North Carolina State University

Heather B. Patisaul is Associate Professor in the Department of Biology at North Carolina State University. Her research examines the steroid-dependent mechanisms through which sexually dimorphic behaviors and brain circuits arise. She also explores the mechanisms by which sexually dimorphic systems and behaviors can be disrupted by environmental estrogens. Her laboratory is interested in the mechanisms by which exposure to environmental estrogens can advance puberty and impair fertility in females. Dr. Patisaul served on the World Health Organization expert panel that assessed the risks of bisphenol A in 2010 and recently served on the National Research Council Committee to Review EPA's Draft Paper, State of the Science on Nonmonotonic Dose Response. Dr. Patisaul received her PhD in population biology, ecology, and evolution from Emory University.
Kristi Pullen Fedinick
Natural Resources Defense Council

Kristi Pullen is a Staff Scientist with the Natural Resources Defense Council (NRDC) health program. Her multidisciplinary training spans nearly 20 years and includes work in molecular biology, biochemistry, structural biology, computational biology, and population health. Dr. Pullen’s work at NRDC has focused on the application of high-throughput technologies in predictive toxicology and chemical risk assessment. Before joining the health and environment team, she served as the sole scientist for the Environmental Law and Policy Center, where she worked on air quality, drinking water quality, science communications, and environmental justice projects. Dr. Pullen received a PhD in molecular and cell biology from the University of California, Berkeley.
Beate R. Ritz
University of California, Los Angeles School of Public Health

Beate R. Ritz is Professor and Chair of the Department of Epidemiology at the University of California, Los Angeles, (UCLA) Fielding School of Public Health. Her research focuses on the health effects of occupational and environmental toxins, such as pesticides, ionizing radiation, and air pollution, on chronic diseases, including neurodegenerative and neurodevelopmental disorders, cancers, adverse birth outcomes, and asthma. In her research, she uses geographic information system (GIS) modeling of environmental exposures, including pesticide use and traffic-related air pollution in California, and investigates links between genetic susceptibility factors and environmental exposures in populations. Dr. Ritz is a member of the Center for Occupational and Environmental Health and the Southern California Environmental Health Science Center and co-directed the NIEHS-funded UCLA Center for Gene-Environment Studies of Parkinson's disease. Dr. Ritz received her MD and a PhD in Medical Sociology from the University of Hamburg, Germany and a MPH and PhD in Epidemiology from UCLA.
Ivan Rusyn
Texas A&M University

Ivan Rusyn is a Professor in the Department of Veterinary Integrative Biosciences in the College of Veterinary Medicine and Biomedical Sciences at Texas A&M University. Before joining TAMU, Dr. Rusyn was professor of Environmental Sciences and Engineering at the University of North Carolina at Chapel Hill. Dr. Rusyn's laboratory has an active research portfolio with a focus on the mechanisms of action of environmental toxicants, the genetic determinants of the susceptibility to toxicant-induced injury, and computational toxicology. His studies on health effects of environmental agents resulted in over 150 peer-reviewed publications. He has served on several National Research Council committees and is currently a member of the Committee on Emerging Science for Environmental Health Decisions and the Committee on Toxicology. Dr. Rusyn received his MD from Ukrainian State Medical University in Kiev and his PhD in toxicology from the University of North Carolina-Chapel Hill.
Robert L. Tanguay
Oregon State University

Robert L. Tanguay is Distinguished Professor of Molecular Toxicology in the Department of Environmental and Molecular Toxicology at Oregon State University. His research interests are varied and include exploiting the advantages of the zebra fish (Danio rerio) model to improve human and environmental health; evaluating biological interactions and responses to environmental chemicals, pharmaceuticals and nanoparticles using rapid throughput approaches; and understanding the mechanisms underlying the toxicity of chemicals, such as 2,3,7,8-tetrachlorodibenzo-p-dioxin, PAHs, ethanol, pharmaceuticals, and pesticides. Dr. Tanguay is involved with Oregon State’s Superfund Research Program as the project leader for an investigation into PAH-induced developmental toxicity, as a co-investigator on work involving biological response indicator devices, and as a research coordinator within the program. He received his PhD in biochemistry from the University of California-Riverside.
Justin G. Teeguarden
Pacific Northwest National Laboratory

Justin G. Teeguarden is a Senior Scientist in Biological Monitoring and Modeling at Pacific Northwest National Laboratory. His current research involves developing an integrated systems-biology-directed research program in particulate matter on respiratory health. He works with the U.S. Environmental Protection Agency (EPA) and private companies to develop and apply physiologically based pharmacokinetic models and other dosimetry approaches to support risk assessments. He served as chair and president elect for the Dose-Response Specialty Section of the Society of Risk Analysis and as a member of the EPA STAR grant review panel (Computational Toxicology). In 2003, Dr. Teeguarden received an award from the Risk Assessment Specialty Section of the Society of Toxicology for the Best Published Manuscript Advancing the Science of Risk Assessment. Dr. Teeguarden served on the National Research Council Committee on Human and Environmental Exposure Science in the 21st Century. He received his PhD in toxicology from the University of Wisconsin, Madison.
James M. Tiedje
Michigan State University

James M. Tiedje is the University Distinguished Professor of Microbiology and Molecular Genetics, and of Plant, Soil and Microbial Sciences, and is Director of the Center for Microbial Ecology at Michigan State University. His research focuses on ecology, physiology, and genetics underlying important microbial processes in nature, including biodegradation of pollutants. He has made notable contributions using genomics and metagenomics to understand ecological functions, speciation, and niche adaptation. He has served as editor-in-chief of Applied and Environmental Microbiology and as editor of Microbial and Molecular Biology Reviews. He has over 500 refereed papers, including seven in Science and Nature. He shared the 1992 Finley Prize of UNESCO for research contributions in microbiology of international significance, is a fellow of the American Association for the Advancement of Science, the American Academy Microbiology, and the Soil Science Society of America, and is a member of the U.S. National Academy of Sciences. He was president of the American Society for Microbiology in 2004-2005. He received his PhD from Cornell University.
Paolo Vineis
Imperial College London

Paolo Vineis is Professor and Chair of Environmental Epidemiology at Imperial College London, School of Public Health. He is a leading researcher in the field of molecular epidemiology and his latest research focuses on examining biomarkers of disease risk, complex exposures, and intermediate biomarkers from omic platforms in large epidemiological studies. He also studies the effect of climate change on non-communicable diseases. Dr. Vineis is coordinating the European Commission funded Exposomics Project and is a principal investigator or co-investigator of numerous international projects. He has more than 700 publications including in Nature, Nature Genetics, Lancet, and Lancet Oncology. Additionally, he is a member of various international scientific and ethics committees and vice-chair of the Ethics Committee at the International Agency for Research on Cancer. Dr. Vineis received his MD from the University of Torino, Italy.
Michelle A. Williams
Harvard School of Public Health

Michelle Williams is Stephen B. Kay Family Professor of Public Health and Chair of the Department of Epidemiology at the Harvard School of Public Health. Her research interests lie principally in the field of reproductive and perinatal epidemiology where she focuses on integrating epidemiological, biological, and molecular approaches into rigorously designed clinical epidemiology research projects. Her overarching goal has been, and continues to be, to use biological and molecular biomarkers as objective measures of exposure and as validated pre-clinical proximal determinants (such as oxidative stress, systemic inflammation, and endothelial dysfunction) of discrete outcomes of clinical, public, and global health importance. She is the principal investigator of three large projects funded by the National Institutes of Health and previously served on the National Research Council Committee on Evaluation of Children's Health: Measures of Risks, Protective and Promotional Factors for Assessing Child Health in the Community. Dr. Williams received her ScD in epidemiology from Harvard University.
Fred Wright
North Carolina State University

Fred Wright is Professor of Statistics and Biological Sciences and Director of the Bioinformatics Research Center North Carolina State University. He is an internationally known statistical geneticist who has wide-ranging research interests, including genomics, bioinformatics, toxicogenomics, and the statistical principles underlying high-dimensional data analysis. Dr. Wright has been principal investigator of numerous grants, with activities ranging from development of new methods of gene mapping to expression-quantitative trait mapping for multiple tissues. He was principal investigator of an EPA-funded STAR Center to apply genomics principles to long-standing problems in toxicology. He is an elected fellow of the American Statistical Association and the Delta Omega Honor Society for Public Health. Dr. Wright received his PhD in statistics from the University of Chicago.
Lauren Zeise
Office of Environmental Health Hazard Assessment California Environmental Protection Agency

Lauren Zeise is Deputy Director for Scientific Affairs for the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA). Dr. Zeise oversees the department’s scientific activities, which include the development of risk assessments, hazard evaluations, toxicity reviews, cumulative impact analyses, frameworks and methods for assessing toxicity and cumulative impact, and the department’s activities in the California Environmental Contaminant Biomonitoring Program. Dr. Zeise was the 2008 recipient of the Society of Risk Analysis Outstanding Practitioners Award. She has served on advisory boards and committees of the Environmental Protection Agency, the Office of Technology Assessment, the World Health Organization, and the National Institute of Environmental Health Sciences. Dr. Zeise has served on numerous National Research Council (NRC) and Institute of Medicine committees, including the NRC Committee on Toxicity Testing and Assessment of Environmental Agents and the NRC Committee on Improving Risk Analysis Approaches Used by the U.S. Environmental Protection Agency. Dr. Zeise received a PhD from Harvard University.

Committee Membership Roster Comments

Effective January 2015, the committee membership changed with the passing of Edward Carney on January 12, 2015.

Events



Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Ivory Clarke
Contact Email:  iclarke@nas.edu
Contact Phone:  (202) 334-1942

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Melvin Andersen
Jon Arnot (via teleconference)
George Daston
David Dunson (via teleconference)
Nigel Greene
Heather Patisaul
Kristi Pullen
Ivan Rusyn (via teleconference)
Robert Tanguay
Justin Teeguarden
James Tiedje Paolo Vineis
Fred Wright
and Lauren Zeise

The following topics were discussed in the closed sessions:

1) Draft report and suggested revisions.
2) Committee findings and recommendations.
3) Report review process and timeline for completion.


The following materials (written documents) were made available to the committee in the closed sessions:

None

Date of posting of Closed Session Summary:
May 27, 2016
Publication(s) resulting from the event:

-


Location:

Arnold and Mabel Beckman Center
100 Academy Way, Irvine, CA 92617
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Ivory Clarke
Contact Email:  iclarke@nas.edu
Contact Phone:  (202) 334-1942

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Melvin Andersen
Jon Arnot
Esteban Burchard
George Daston (via teleconference)
David Dunson (via teleconference)
Nigel Greene
Heather Patisaul
Kristi Pullen
Beate Ritz
Ivan Rusyn (via teleconference)
Robert Tanguay
Justin Teeguarden
Paolo Vineis
Fred Wright
and Lauren Zeise

The following topics were discussed in the closed sessions:

1) Draft report materials and report organization.
2) Committee assignments and deadlines.
3) Schedule and agenda for final meeting.


The following materials (written documents) were made available to the committee in the closed sessions:

29. E-mail and two attachments from Thomas Knudsen,Developmental Systems Biologist, National Center for Computational Toxicology, US EPA/ORD, sent to Ellen Mantus. Received January 7, 2016.
a. EPAORD. 2015. Virtual Tissues Models: Predicting How Chemicals Impact Human Development Fact Sheet
b. Knudsen, T. 2014. International Innovation from Research Media

30. Judson, et al. 2015. Integrated Model of Chemical Perturbations of a Biological Pathway Using 18 In Vitro High Throughput Screening Assays for the Estrogen Receptor. Submitted via e-mail to Ellen Mantus from Richard Judson. Received January 26, 2016.

31. Browne et al. 2015. S2 ER Super Matrix, data from Browne et al. Submitted via e-mail to Ellen Mantus from Richard Judson. Received January 26, 2016.

32. Kleinstreuer et al. 2015. A Curated Database of Rodent Uterotrophiv Bioactivity. Submitted via e-mail to Ellen Mantus from Patience Brown with four additional attachments. Received January 26, 2016.
a. Suppl. File 1_NICEATM_UTDB_EHP
b. Suppl. File 2_NICEATM_GL-UTDB_EHP
c. Suppl._Material_Figure_S1_DiscChems_Study Design Radar Plots_EHP
d. ER Model Bioactivity_suppl. datav3


Date of posting of Closed Session Summary:
February 24, 2016
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Ivory Clarke
Contact Email:  iclarke@nas.edu
Contact Phone:  (202) 334-1942

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Jon Arnot
Esteban Burchard
George Daston
Nigel Greene
Heather Patisaul
Kristi Pullen
Beate Ritz
Ivan Rusyn
Robert Tanguay
Justin Teeguarden
Paolo Vineis
Fred Wright
and Lauren Zeise

The following topics were discussed in the closed sessions:

1) Draft report materials and report organization.
2) Committee assignments and deadlines.
3) Schedule and agenda for future meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

1. Bahadori, T. 2015. From Data to Decision: 21st Century Understanding of Exposures. Presentation distributed to the committee on December 14, 2015.

2. Lambert, J. 2015. Transforming Human Health Assessment of Environmental Chemicals through Practical Application of Alternative Data. Presentation distributed to the committee on December 14, 2015.


Date of posting of Closed Session Summary:
December 22, 2015
Publication(s) resulting from the event:

-


Location:

J. Erik Jonsson Woods Hole Center
314 Quissett Ave.
Woods Hole, Massachusetts
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Ivory Clarke
Contact Email:  iclarke@nas.edu
Contact Phone:  (202) 334-1942

Agenda
This meeting is closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Melvin Andersen
Jon Arnot
Esteban Burchard (via teleconference)
George Daston
David Dunson
Nigel Greene
Heather Patisaul (via teleconference)
Kristi Pullen
Beate Ritz
Ivan Rusyn
Robert Tanguay
Justin Teeguarden
James Tiedje (via teleconference)
Paolo Vineis
Michelle Williams
Fred Wright
and Lauren Zeise

The following topics were discussed in the closed sessions:

1) Draft report materials and report organization.
2) Committee assignments and deadlines.
3) Schedule and agenda for future meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

None

Date of posting of Closed Session Summary:
September 29, 2015
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Ivory Clarke
Contact Email:  iclarke@nas.edu
Contact Phone:  (202) 334-1942

Agenda
The open session meeting will be held on the morning of Thursday, June 4th, 2015.

If you would like to register to attend the meeting, please contact Ivory Clarke at iclarke@nas.edu with the following:

First and Last Name
Position, Organization
Phone Number
E-mail Address


Note: To receive future updates regarding the committee please join the mailing list at the following link: http://dels.nas.edu/Study-In-Progress/Incorporating-21st-Century-Science-into-Risk/DELS-BEST-14-04?bname=best


Open Session Agenda*
8:50 Purpose of Open Session and Introduction of Committee Members
Jonathan Samet
Chair, Committee on Incorporating 21st Century Science into Risk-Based Evaluations
Professor and Flora L. Thornton Chair, Department of Preventive Medicine
Keck School of Medicine, University of Southern California

9:00 Exposure Research Supported by NIEHS (~20 mins. presentation & 20 mins. discussion)
David Balshaw
Branch Chief
Exposure, Response, and Technology Branch
National Institute of Environmental Health Sciences

9:40 Level of Confidence Needed for FDA Decision-making
Michael Landa
Director, Retired
Center for Food Safety and Applied Nutrition
US Food and Drug Administration


10:20 Precision Medicine as a Parallel Example of Using High-density Data and Integrating Various Types of Evidence
Chirag Patel
Research Associate
Center for Biomedical Informatics at Countway
Harvard Medical School

11:00 Validation of Next-generation Toxicity Approaches
Warren Casey
Director
National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods
National Institute of Environmental Health Sciences

11:40 Open Microphone – Comments from the Audience


12:00 END PUBLIC SESSION

*Agenda subject to change
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Melvin Andersen
Jon Arnot
George Daston
David Dunson
Nigel Greene
Heather Patisaul
Kristi Pullen
Beate Ritz
Ivan Rusyn
Robert Tanguay
Justin Teeguarden
James Tiedje
Paolo Vineis
Michelle Williams
Fred Wright
and Lauren Zeise

The following topics were discussed in the closed sessions:

1) Information presented during the open session.
2) Draft report materials and report organization.
3) Committee assignments.
4) Schedule and agenda for future meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

1. Food and Drug Administration. 2014. Toxicological Principles for the Safety Assessment of Food Ingredients; Public Meeting on Updates and Safety and Risk Assessment Considerations (Docket No. FDA-2014-N-1497). Federal Register 79(210):64603-64604.

2. Osterman, R. 2014. Food Safety Requirements: Applicable Legal Principles. Presentation at the Food Advisory Committee Risk assessments and susceptible life stages and populations, on December 16, 2014.

3. Mega, J. et al. 2014. Population and Personalized Medicine in the Modern Era. JAMA 312(19):1969-1970.

4. Ioannidis, J. et al. 2009. Researching Genetic Versus Nongenetic Determinants of Disease: A Comparison and Proposed Unification. Sci. Transl. Med. 1(7): 1-8.

5. Patel, C. and Ioannidis, J. 2014. Studying the Elusive Environment in Large Scale. JAMA 311(21):2173-2174.

6. Casey, W. 2015. A New Path Forward: The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). Journal of the American Association for Laboratory Animal Science. 54(2): 170-172.

7. Joint Research Center. 2014. EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches (2013- April 2014) (Report EUR 26702 EN). Luxembourg: Publications Office of the European Union.

8. Patlewicz, G. 2015. Building scientific confidences in the development and evaluation of read-across. Regulatory Toxicology and Pharmacology 72: 117-133. Submitted to the committee by Tina Bahadori on May 28, 2015.

9. Balshaw, D. 2015. NIEHS: Transforming Exposure Science. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on June 4, 2015, in Washington, DC.

10. Patel, C. 2015. Integrating clinical, environmental, and genomic data streams for precision medicine. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on June 4, 2015, in Washington, DC.

11. Casey, W. 2015. Validation of Next-Generation Alternative (Non-Animal) Toxicity Approaches. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on June 4, 2015, in Washington, DC.

12. Becker, R. 2015. Developing Scientific Confidence in 21C Risk Assessment Approaches. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on June 4, 2015, in Washington, DC.

13. Patlewicz, G. et al. 2015. Proposing a scientific confidence framework to help support the application of adverse outcome pathways for regulatory purposes. Regulatory Toxicology and Pharmacology 71: 463-477. Submitted to the committee by Richard Becker on June 4, 2015.



Date of posting of Closed Session Summary:
June 16, 2015
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Ivory Clarke
Contact Email:  iclarke@nas.edu
Contact Phone:  (202) 334-1942

Agenda
To attend in person or via WebEx* please send a registration e-mail to Ivory Clarke (iclarke@nas.edu)
The e-mail should include: First and Last Name, Job Title, Organization, and attendance preference.

*WebEx information will be sent to those who contact Ivory Clarke


SECOND MEETING OF THE COMMITTEE ON INCORPORATING 21ST CENTURY
SCIENCE INTO RISK-BASED EVALUATIONS

Open Session: April 2, 2015
National Academies Keck Center, Room 208
500 Fifth Street, NW
Washington, DC 20001
PH: 202-334-3643 / FAX 202-334-2752

AGENDA*


9:00 Purpose of Open Session and Introduction of Committee Members
Jonathan Samet
Chair, Committee on Incorporating 21st Century Science into
Risk-Based Evaluations
Professor and Flora L. Thornton Chair, Department of Preventive Medicine
Keck School of Medicine, University of Southern California

9:15 Risk-Based Decision-Making at the U.S. Environmental Protection Agency
James Jones
Assistant Administrator
Office of Chemical Safety and Pollution Prevention
U.S. Environmental Protection Agency

10:15 ToxCast Program at the U.S. Environmental Protection Agency
Rusty Thomas
Director
National Center for Computational Toxicology
U.S. Environmental Protection Agency

11:15 Risk-Based Decision-Making at the U.S. Food and Drug Administration
Suzanne Fitzpatrick
Senior Advisor for Toxicology
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration

12:15 Open Microphone – Comments from the Audience

12:45 END PUBLIC SESSION

* Agenda subject to change

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Melvin Andersen
Jon Arnot
Esteban Burchard
George Daston
David Dunson
Nigel Greene
Heather Patisaul
Kristi Pullen
Beate Ritz
Ivan Rusyn
Robert Tanguay
Justin Teeguraden
James Tiedje (via teleconference)
Paolo Vineis
Michelle Williams
Fred Wright
and Lauren Zeise

The following topics were discussed in the closed sessions:

1) Bias and conflict-of-interest disclosure discussion for new members.
2) Information presented during the open session.
3) Committee’s task, possible report structure, and committee assignments.
4) Potential speakers for next open session.
5) Schedule and agenda for future meetings.


The following materials (written documents) were made available to the committee in the closed sessions:

Thomas, R. 2015. Evolution of the CompTox program at EPA: From primitive beginnings to sophisticated application. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on April 2, 2015, in Washington, DC.

Fitzpatrick, S. 2014. Risk Assessment at FDA. Presentation to the Committee on Incorporating 21st Century Science into Risk-Based Evaluations, on April 2, 2015, in Washington, DC.


Date of posting of Closed Session Summary:
April 10, 2015
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


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:  Ivory Clarke
Contact Email:  iclarke@nas.edu
Contact Phone:  202-334-1942

Agenda
Agenda Subject to Change.
To attend in person or via WebEx* please send a registration e-mail to Ivory Clarke (iclarke@nas.edu)
The e-mail should include: First and Last Name, Job Title, Organization, and attendance preference.

*WebEx information will be sent to those who contact Ivory Clarke

FIRST MEETING OF THE COMMITTEE ON INCORPORATING 21ST CENTURY
SCIENCE INTO RISK-BASED EVALUATIONS

Open Session: January 26, 2015
National Academies Keck Center, Room 105
500 Fifth Street, NW
Washington, DC 20001
PH: 202-334-1479



AGENDA


1:00 Purpose of Open Session and Introduction of Committee Members
Jonathan Samet
Chair, Committee on Incorporating 21st Century Science into Risk-Based Evaluations
Professor and Flora L. Thornton Chair, Department of Preventive Medicine
Keck School of Medicine, University of Southern California

1:15 21st Century Science at EPA and EPA Perspective on New NRC Study
Robert Kavlock
Deputy Assistant Administrator and Interim Science Advisor
Office of Research and Development
U.S. Environmental Protection Agency

2:00 21st Century Science at NIEHS and NIEHS Perspective on New NRC Study
Linda Birnbaum
Director
National Institute of Environmental Health Sciences and National Toxicology Program
National Institutes of Health

2:45 21st Century Science at FDA and FDA Perspective on New NRC Study
David White
Chief Science Officer and Research Director
Office of Foods and Veterinary Medicine
Office of the Commissioner
U.S. Food and Drug Administration

3:15 BREAK

3:30 21st Century Science at NCATS and NCATS Perspective on New NRC Study
David Gerhold
Group Leader, Genomic Toxicology
National Center for Advancing Translational Sciences
National Institutes of Health

4:15 Progress on the Vision Described in the NRC Report Toxicity Testing in the 21st Century
Daniel Krewski
NSERC Chair in Risk Science
Professor and Director
McLaughlin Centre for Population Health Risk Assessment
University of Ottawa

5:00 Open Discussion with Speakers and Committee

5:30 Open Microphone – Comments from the Audience

5:45 END PUBLIC SESSION

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Jonathan Samet (chair)
Melvin Andersen
Esteban Burchard
David Dunson
Nigel Greene
Heather Patisaul (via teleconference)
Kristi Pullen
Beate Ritz
Ivan Rusyn
Robert Tanguay
Justin Teeguraden
James Tiedje
Paolo Vineis
Michelle Williams
Fred Wright
and Lauren Zeise

The following topics were discussed in the closed sessions:

1) Standard NRC discussion of policies, procedures, bias, and conflict of interest.
2) Committee’s statement of task and its approach to its task.
3) Information presented during the open session.
4) Draft report outline, project schedule, and agendas for future meetings.


The following materials (written documents) were made available to the committee in the closed sessions:


1. Krewksi et al. 2014. A Framework for the Next Generation of Risk Science.

2. Kavlock, Robert. 2015. 21st Century Science at EPA and EPA Perspective on new NRC Study. Presentation to the Committee on Incorporating 21st Century Science into Risk Based Evaluations, on January 26, 2015, in Washington, DC.

3. Birnbaum, L. 2015. 21st Century Science at NIEHS and Perspectives on New NRC Study. Presentation to the Committee on Incorporating 21st Century Science into Risk Based Evaluations, on January 26, 2015, in Washington, DC.

4. White, D. 2015. 21st Century Science at FDA and FDA Perspective on New NRC Study. Presentation to the Committee on Incorporating 21st Century Science into Risk Based Evaluations, on January 26, 2015, in Washington, DC.

5. Austin, C. 2015. 21st Century Science at NCATS and NCATS Perspective on New NRC Study. Presentation to the Committee on Incorporating 21st Century Science into Risk Based Evaluations, on January 26, 2015, in Washington, DC.

6. Krewski, D. 2015. Progress on the Vision Described in the NRC Report Toxicity Testing in the 21st Century. Presentation to the Committee on Incorporating 21st Century Science into Risk Based Evaluations, on January 26, 2015, in Washington, DC.



Date of posting of Closed Session Summary:
February 06, 2015
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office