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Project Information

Project Information


Scoping Plan to Assess the Hazards of Organohalogen Flame Retardants


Project Scope:

At the request of the Consumer Product Safety Commission (CPSC), an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) will develop a scientifically based scoping plan to assess additive, nonpolymeric organohalogen flame retardants (OFRs) as a class for potential chronic health hazards under the Federal Hazardous Substances Act (FHSA), including cancer, birth defects, and gene mutations.  In developing the plan, the NASEM committee will complete the following tasks:  

  1. Survey available hazard data for OFRs and identify data needed (what exists and where there are data gaps) for a Chronic Hazard Advisory Panel (CHAP) to conduct a class-level hazard assessment.[1]

  2. Identify one or more approaches to scientifically assess the potential for treating OFRs as a single class for purposes of hazard assessment.

  3. Provide a plan, based on information gained from tasks (1) and (2) above, that will contain recommendations on how to most efficiently and effectively conduct research needed to evaluate OFRs under the FHSA, including timeline and cost estimates for obtaining scientific information and for executing the plan. The plan will focus on evaluation of OFR toxicity.

The product of the committee’s work will be a brief consensus report. The report will include methods to conduct any needed research to evaluate toxicity of OFRs as a class.  NASEM will develop the plan, taking into account that the plan, when executed, will provide a hazard assessment of OFRs as a class that will be used by a CHAP, along with data on exposure and human health effects, to complete a quantitative risk assessment.  To that end, CPSC needs the hazard assessment plan as envisioned by NASEM, when executed, to be able to be readily integrated with a separate quantitative exposure assessment to complete a human health risk assessment.  The ultimate CPSC goal is to assess the risk to human health posed by exposure to any OFR from the four categories of consumer products.



[1] Although some scientific review will be required, the goal is to produce a plan, with costs, for a subsequent committee or panel to do the risk assessment of OFRs as a class.

Status: Current

PIN: DELS-BEST-18-02

Project Duration (months): 12 month(s)

RSO: Mantus, Ellen

Topic(s):

Environment and Environmental Studies



Geographic Focus:

Committee Membership

Committee Post Date: 06/14/2018

David C. Dorman - (Chair)
David C. Dorman (chair) is a professor of toxicology in the Department of Molecular Biosciences of North Carolina State University. The primary objective of his research is to provide a refined understanding of chemically induced neurotoxicity in laboratory animals that will lead to improved assessment of potential neurotoxicity in humans. Dr. Dorman's research interests include neurotoxicology, nasal toxicology, pharmacokinetics, and cognition and olfactory in military working dogs. He has served as a member or chair of several National Academies committees, including two Committees on Emergency and Continuous Exposure Guidance Levels for Selected Submarine Contaminants, the Committee to Evaluate Potential Health Risks from Recurrent Lead Exposure to DOD Firing Range Personnel, the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde, the Committee to Review the IRIS Process, and the Committee on Endocrine-Related Low-Dose Toxicity. He received his DVM from Colorado State University. He completed a combined PhD and residency program in toxicology at the University of Illinois at Urbana-Champaign and is a diplomate of the American Board of Veterinary Toxicology and the American Board of Toxicology.
Hugh A. Barton
Hugh A. Barton is an associate research fellow with Pfizer, Inc. He specializes in the use of physiologically based pharmacokinetic and mechanistic pharmacodynamic modeling to address low-dose, interspecies, and inter-route extrapolations in estimating risks. Dr. Barton is a past president of the Biological Modeling Specialty Section and the Risk Assessment Specialty Section of the Society of Toxicology. He was a member of the National Academies Committee on Inorganic Arsenic. Dr. Barton received his PhD in toxicology from the Massachusetts Institute of Technology.
Karen Blackburn
Karen Blackburn is a Victor Mills Society Research Fellow at The Procter and Gamble Co. Her primary area of expertise is risk assessment to support safe human exposures to environmental contaminants and consumer products with an emphasis on development of novel approaches. Before working at Procter & Gamble, Dr. Blackburn was a toxicologist at the US Environmental Protection Agency. She received a PhD in physiology and biophysics from the University of Cincinnati.
John R. Bucher
John Bucher is a senior scientist in the National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS). He has held multiple leadership positions within NIEHS and most recently retired as the NTP Associate Director. His specific research interests include characterization of the toxic and carcinogenic potential of various chemicals, mixtures, and physical agents and issues related to improving research and analysis tools and assays for those purposes. Additional activities include guidance for the development and application of systematic review procedures to the field of environmental health sciences. Dr. Bucher is a fellow of the Collegium Ramazzini and a recipient of the Doerenkamp-Zbinden Foundation Award for Animal Protection in Science, along with numerous NIH awards. He recieved a PhD in pharmacology from the University of Iowa and is a diplomate of the American Board of Toxicology.
Julie L. Daniels
Julie L. Daniels is a professor in the departments of epidemiology and maternal and child health at the University of North Carolina at Chapel Hill. Her research focuses on prenatal environmental and nutritional exposures that might affect children’s growth, neurodevelopment, and overall health. She has created a platform for studying early life exposure to brominated and organophosphate flame retardants, persistent organic pollutants, and long-chain fatty acids as they relate to children's health in the Pregnancy, Infection & Nutrition Kids Study. Dr. Daniels is an associate editor for Environmental Health Perspectives and a member of the Autism Research Program Panel of the Department of Defense and US Army Medical Research and Material Command. She received her PhD in epidemiology from University of North Carolina, Chapel Hill.
Jennifer L. Freeman
Jennifer L. Freeman is an associate professor in the School of Health Sciences at Purdue University. Her research interests are to define the underlying genetic and epigenetic mechanisms of toxicity of environmental stressors with a current focus on pesticides, metals, radiation, and emerging contaminants. Her studies are investigating the developmental origin of health and disease pathogenesis with a specific focus on neurological disorders, reproductive dysfunction, cardiovascular function, and cancer with a goal of understanding the role of exposure to the environmental stressors in these adverse health outcomes. She received a PhD in environmental toxicology and molecular cytogenetics from the University of Illinois at Urbana-Champaign.
Kamel Mansouri
Kamel Mansouri is lead computational chemist at Integrated Laboratory Systems. Previously, he was an investigator at ScitoVation. In 2013, he joined the National Center for Computational Toxicology at the US Environmental Protection Agency as an ORISE Post-Doctoral Fellow. He has worked on several projects involving QSAR modeling, cheminformatics, and data-mining, and has collaborated and led projects in the QSAR field with renowned international scientists. Dr. Mansouri obtained an engineering degree in analytical chemistry from the University of Tunis, Tunisia, an MS degree in cheminformatics from the University of Strasbourg, France, and a PhD in computational chemistry from the University of Milano Bicocca, Italy.
Carmen Messerlain
Carmen Messerlian is a research scientist at the Harvard T.H. Chan School of Public Health. Her research is focused on understanding the impact of environmental chemicals on fertility, pregnancy, and human development. She is currently working on the Environment and Reproductive Health Study, an ongoing prospective preconception cohort established to evaluate environmental and dietary determinants of fertility among couples attending the Massachusetts General Hospital Fertility Center in Boston. She is investigating the effects of phthalates and other emerging chemicals and their mixtures on ovarian reserve, time to pregnancy, pregnancy loss, preterm birth, birthweight, and child development outcomes. Her goal is to understand how exposure to environmental chemicals in the preconception and prenatal periods influences a couple’s ability to achieve conception, maintain pregnancy, and delivery health offspring. Before her research career, she worked on maternal-child public health strategies for municipal, provincial, and global health programs. Dr. Messerlian received her PhD in epidemiology from McGill University.
David M. Reif
David M. Reif is an Associate Professor of Biological Sciences at North Carolina State University and resident member of the Bioinformatics Research Center. His research focuses on the complex interactions between human health and the environment through the integrated analysis of high-dimensional data from diverse sources, including epidemiological studies of human health, high-throughput screening of environmental chemicals, and model organism data. Dr. Reif was previously a Principal Investigator with the US Environmental Protection Agency’s National Center for Computational Toxicology, where he led several statistical and bioinformatical efforts with federal, academic, and industry partners. He served on the National Academies Committee on Predictive-Toxicology Approaches for Military Assessments of Acute Exposures. Dr. Reif received his PhD in Human Genetics and MS in Statistics from Vanderbilt University and his BS in Biology from the College of William and Mary, where he was a Monroe Scholar.
Gina M. Solomon
Gina M. Solomon is a principal investigator at the Public Health Institute in Oakland, California, and a Clinical Professor of Medicine at the University of California, San Francisco. She served as the Deputy Secretary for Science and Health at the California Environmental Protection Agency from 2012-2017. Dr. Solomon’s work has spanned a wide array of areas, including children’s environmental health, reproductive toxicity, cumulative impacts, and the use of novel data streams to screen chemicals for toxicity. Her work has also focused on exposure science for air pollutants, pesticides, mold, and metals in soil, and on the health effects of climate change. She was involved in the aftermath of Hurricane Katrina, the Gulf oil spill, and the Chevron Richmond explosion and fire, and she successfully spearheaded regulations to improve refinery safety in California. Dr. Solomon has served on multiple boards and committees of the National Academies, the EPA Science Advisory Board, and the National Toxicology Program’s Board of Scientific Counselors. She also serves on the EPA Board of Scientific Counselors Chemical Safety for Sustainability subcommittee. Dr. Solomon received her MD from Yale and completed her MPH and her residency and fellowship training in internal medicine and occupational and environmental medicine at Harvard.
Chihae Yang
Chihae Yang is the chief scientific officer of Altamira LLC and managing director and CEO of Molecular Networks GMbH. She is also a visiting professor in the Department of Chemical and Biological Engineering at the Ohio State University. Her research interests are in molecular informatics, computational modeling and simulation, and developing chemoinformatics software. Dr. Yang was an ORISE Fellow at the US Food and Drug Administration , where she was involved in the design and implementation of the Chemical Risk Estimation and Evaluation System. She is a former board member of the American Society of Cellular and Computational Toxicology. She received her PhD in chemistry from the Ohio State University.

Disclosure of Conflicts of Interest

Committee members who have relevant knowledge and expertise were sought from academe, industry, consulting firms, and public interest organizations. The committee was formed in accordance with the National Academies policies concerning conflict of interest and bias to ensure a balanced and objective review. No member is an active employee with or consultant for an industry that produces or uses OFRs or their alternatives. An effort was made to achieve diversity in terms of age, sex, geographic distribution, and other factors.

Events



Location:

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

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:  Jessica Wolfman
Contact Email:  jwolfman@nas.edu
Contact Phone:  -

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

Publication(s) resulting from the event:

-


Location:

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

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:  Jessica Wolfman
Contact Email:  jwolfman@nas.edu
Contact Phone:  -

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:

David Dorman (chair)
Hugh Barton
Karen Blackburn
John Bucher
Julie Daniels
Jennifer Freeman
Kamel Mansouri
Carmen Messerlian
David Reif
Gina Solomon
Chihae Yang (via teleconference)

The following topics were discussed in the closed sessions:

1) Report structure and draft materials.
2) Committee assignments and deadlines.
3) Project schedule, the report review process, and the final meeting agenda.

Date of posting of Closed Session Summary:
November 19, 2018
Publication(s) resulting from the event:

-

Event Type :  
TeleConference

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:  -
Contact Email:  -
Contact Phone:  -

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:

David Dorman
Karen Robinson
Gina Solomon
John Bucher
Jennifer Freeman
Hugh Barton

The following topics were discussed in the closed sessions:

Case examples discussed.

Date of posting of Closed Session Summary:
October 24, 2018
Publication(s) resulting from the event:

-


Location:

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

Description :   

OPEN SESSION AGENDA

9:00 Purpose of Open Session and Introduction of Committee Members
David Dorman; Chair, Committee to Develop a Scoping Plan to Assess the Hazards of OFRs
Professor, North Carolina State University

9:15 Hazard Assessment at the Consumer Product Safety Commission
Kristina Hatlelid
Directorate for Health Sciences
U.S. Consumer Product Safety Commission

10:00 Discussion – CPSC and Committee

11:00 Open Microphone – Opportunity for Public Comment

11:30 END OF OPEN SESSION


Registration for Online 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:  Jessica Wolfman
Contact Email:  -
Contact Phone:  -

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

Closed Session Summary Posted After the Event

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

David Dorman
Hugh Barton
John Bucher
Julie Daniels
Jennifer Freeman
Kamel Mansouri
Carmen Messerlian
David Reif
Gina Solomon
Chihae Yang

The following topics were discussed in the closed sessions:

(1) Committee’s statement of task and its approach to its task; (2) information presented during the open session; (3) report outline and organization; (4) committee assignments, project schedule, and agendas for future meetings.

Date of posting of Closed Session Summary:
September 28, 2018
Publication(s) resulting from the event:

-


Location:

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

Description :   

Tentative time is 10:00 AM EDT - 12:30 PM EDT. Discussion between committee and sponsor, opportunity for public comment. 


Registration for Online 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:  Jessica Wolfman
Contact Email:  jwolfman@nas.edu
Contact Phone:  -

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

Closed Session Summary Posted After the Event

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

David Dorman
Hugh Barton
Karen Blackburn
John Bucher
Julie Daniels
Jennifer Freeman
Kamel Mansouri
Carmen Messerlian
David Reif
Gina Solomon
Chihae Yang

The following topics were discussed in the closed sessions:

Scope of project and statement of task discussed. Discussed information shared in open session. Developed preliminary report outline. Determined needs for upcoming conference calls, and discussed needs for next in-person meeting. Conducted composition and balance discussion.

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

N/A

Date of posting of Closed Session Summary:
August 10, 2018
Publication(s) resulting from the event:

-

Publications

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

No data present.