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Project Information

Project Information


Peer Review of the NTP Monograph on Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects


Project Scope:

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will review the National Toxicology Program (NTP) Monograph on Systematic Review of Fluoride Exposure and Neurodevelopmental and Cognitive Health Effects.  The committee will provide an overall critique of the draft monograph and address the following questions:

  • Has the systematic review protocol been followed and modifications appropriately documented and justified?
  • Does the monograph accurately reflect the scientific literature?
  • Are the findings documented in a consistent, transparent, and credible way?
  • Are the report's key messages and graphics clear and appropriate?  Specifically, do they reflect supporting evidence and communicate effectively?
  • Are the data and analyses handled in a competent manner?  Are statistical methods applied appropriately?
  • What other significant improvements, if any, might be made in the document?
  • Does the scientific evidence in the NTP Monograph support NTP's hazard category conclusions for fluoride in children and adults?







Status: Current

PIN: DELS-BEST-19-01

Project Duration (months): 12 month(s)

RSO: Mantus, Ellen

Topic(s):

Environment and Environmental Studies
Health and Medicine



Geographic Focus:

Committee Membership

Committee Post Date: 10/04/2019

David A. Savitz - (Chair)
David A. Savitz (chair) is professor of epidemiology and Associate Dean for Research at the Brown University School of Public Health, with joint appointments in obstetrics and gynecology and pediatrics at the Alpert Medical School. He was also vice president of research at the university from 2013-2017. His epidemiological research has addressed a wide array of important public health issues, including environmental hazards in the workplace and community, reproductive health outcomes, and environmental influences on cancer. He has worked extensively on health effects of nonionizing radiation, pesticides, drinking water treatment byproducts, and perfluorinated compounds. Before joining Brown University, Dr. Savitz held appointments as the Charles W. Bluhdorn Professor of Community and Preventive Medicine at Mount Sinai School of Medicine and a professor at the University of North Carolina School of Public Health. He was president of the Society for Epidemiologic Research and the Society for Pediatric and Perinatal Epidemiologic Research and was a North American Regional Councilor for the International Epidemiological Association. Dr. Savitz was elected to the National Academy of Medicine in 2007. Dr. Savitz received his MS in preventive medicine from the Ohio State University and his PhD in epidemiology from the University of Pittsburgh Graduate School of Public Health.
Germaine M. Buck Louis
Germaine M. Buck Louis is dean of the College of Health and Human Services at George Mason University. Her research has addressed a mixture of environmental exposures, including endocrine disruptors, stress, diet, and physical activity in relation to a spectrum of reproductive outcomes in men and women. She was an early pioneer in the application of the exposome research paradigm for understanding environmental influences on human fecundity and fertility impairments. Before joining the university, Dr. Louis was the director for the Division of Intramural Population Health Research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health, where she led population health scientists in designing research aimed at enhancing the health and well-being of fetuses, pregnant women, children, and young adults. She has served the National Academies, Pan American Health Organization, U.S. Environmental Protection Agency, and World Health Organization in various roles. She is a former president of the Society of Pediatric and Perinatal Epidemiologic Research and of the Society for Epidemiologic Research and has served on the boards for the American College of Epidemiology and the International Society for Environmental Epidemiology. Dr. Louis received her PhD in epidemiology from the State University of New York at Buffalo.
Kevin Crofton
Kevin Crofton is principal and consultant at R3 Fellows, LLC. Previously, he worked for more than 30 years as a developmental neurotoxicologist at the Environmental Protection Agency in the National Center for Computational Toxicology in the Office of Research and Development where he served as Deputy Director. Dr. Crofton also served as an adjunct associate professor at North Carolina State University and University of North Carolina. His research interests include developmental neurotoxicity with an emphasis on understanding the consequences of endocrine disruption on neurodevelopment. He received the U.S. Environmental Protection Agency’s Distinguished Career Service Award. He served as a councilor for the International Neurotoxicology Association and the President for the Neurotoxicology Section at the Society for Toxicology. Dr. Crofton received an MS in toxicology from Miami University and his PhD in toxicology from the University of North Carolina at Chapel Hill.
Akhgar Ghassabian
Akhgar Ghassabian is an investigator and assistant professor in Departments of Pediatrics, Population Health, and Environmental Medicine at the New York University (NYU) School of Medicine. Her research interests focus on identifying environmental exposures that contribute to the etiology of developmental disabilities in childhood. Before joining NYU, Dr. Ghassabian was the intramural research training award fellow at the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. During her doctoral and postdoctoral training, Dr. Ghassabian was involved in birth cohort studies in Europe and in the United States. She was a collaborator on European epidemiological consortia examining the effect of nutrition and air pollution on children’s neurodevelopment. Dr. Ghassabian was the recipient of the Rubicon Award from the Netherlands Organization for Scientific Research in 2014 and the Robin/Guze Young Investigator Award from the American Psychopathological Association in 2019. She obtained her MD from Tehran University of Medical Sciences and a PhD in epidemiology at Erasmus University Rotterdam, the Netherlands.
Judith B. Klotz
Judith B. Klotz is an affiliate faculty member in the Department of Occupational and Environmental Health at the Dornsife School of Public Health, Drexel University, and an adjunct associate professor in the Department of Epidemiology at the Rutgers School of Public Health. She is member of the Health Effects Committee of the New Jersey Drinking Water Quality Institute and of the Public Health standing committee of the Science Advisory Board, both advisory groups of the New Jersey Department of Environmental Protection. Dr. Klotz has served on several National Academies Committees, including the Subcommittee on Fluoride in Drinking Water and the Committee on the Review of the Styrene Assessment in the National Toxicology Program 12th Report on Carcinogens. She received her MS in genetics from the University of Michigan and her DrPH in environmental health sciences from Columbia University.
Juleen Lam
Juleen Lam is an assistant professor in the Department of Health Sciences at the California State University, East Bay. She is also an affiliate researcher in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California at San Francisco, School of Medicine. Her research interests are in environmental epidemiology, evaluation of population exposures to environmental contaminants, assessment and communication of environmental risks, and reproductive and developmental health. She specializes in analysis of environmental health data and development and application of risk assessment methods. Of particular note, Dr. Lam has been involved in the development of systematic review methods for environmental health data and has been a pivotal role in implementing, publishing, and disseminating these approaches in academic and government settings. She is a member of the US Environmental Protection Agency Board of Scientific Counselors Chemical Safety for Sustainability Subcommittee. She is currently serving on the National Academies Committee to Review DOD’s Approach to Deriving an Occupational Exposure Limit for TCE. She received her MS in environmental engineering management from George Washington University and her MHS in biostatistics and PhD in environmental health policy from the Johns Hopkins University Bloomberg School of Public Health.
Pamela J. Lein
Pamela J. Lein is a professor of neurotoxicology in the Department of Molecular Biosciences at the University of California, Davis, School of Veterinary Medicine. Her research interests are in how environmental stressors interact with genetic susceptibilities to influence the risk and severity of neurodevelopmental disorders and neurodegeneration. Because altered patterns of connectivity are associated with neurological deficits, her research focuses on investigating how environmental contaminants, chemical convulsants, and inflammation perturb neuronal connectivity as determined using biochemical, morphogenic, and electrophysiological end points. Her group is also developing biomarkers of organophosphate neurotoxicity and testing novel therapeutic approaches for protecting against the neurodegenerative effects associated with neurotoxic proconvulsants. Dr. Lein was a member of the National Academies Committee to Review Report on Long-Term Health Effects on Army Test Subjects. She received her MS in environmental health from East Tennessee State University and her PhD in pharmacology and toxicology from the State University of New York at Buffalo.
Michael L. Pennell
Michael L. Pennell is associate professor in the Division of Biostatistics in the College of Public Health at The Ohio State University. His research interests are in nonparametric Bayes, first hitting time models for survival analysis; design and analysis of Group Randomized Trials; joint modeling outcomes of different scales; statistical methods in toxicological risk assessment; and statistical applications in biomedical research, including cancer control, pathology, and veterinary medicine. Dr. Pennell has served as an ad hoc member of US Environmental Protection Agency (EPA) Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel, the EPA Science Advisory Board on trichloroethylene and Libby Amphibole Asbestos, and the Chemical Safety Advisory Subcommittee for 1-bromopropane. He currently serves on the National Academies Committee to Evaluate the IRIS Protocol for Inorganic Arsenic. He received his MS and PhD in biostatistics from the University of North Carolina at Chapel Hill.
Craig Steinmaus
Craig Steinmaus is an associate adjunct professor of epidemiology at the University of California Berkeley (UCB). He is also a public health medical officer III at the California Environmental Protection Agency (CalEPA) and is the UCB director of the Arsenic Health Effects Research Group. He is a board-certified physician with over 12 years of patient-care experience. His epidemiologic research has involved studies of drinking water contaminants with a focus on early-life exposure and other factors conferring susceptibility. He also teaches graduate courses on epidemiology, causal inference, and systematic review at UCB and at the University of California San Francisco. Dr. Steinmaus has served on several study sections of the National Institutes of Health and Centers for Disease Control and Prevention and is currently a full member of the Cancer, Heart, and Sleep Epidemiology, A study section. His work at the CalEPA Water Toxicology section has involved systematic reviews and risk assessments of drinking water agents, including nitrate, arsenic, copper, perchlorate, fluoride, chromium, and trihalomethanes. He received his MD at the University of California, Davis School of Medicine, and his MPH in environmental health sciences from the University of California, Berkeley.
Charles V. Vorhees
Charles V. Vorhees is a professor at the University of Cincinnati’s College of Medicine. He is co-director of the Animal Behavior Core and program director of the Teratology Training Program. He is on the graduate faculty of the Graduate Programs in Neuroscience and Molecular and Developmental Biology. His research interests focus on brain development and behavior. He was a founding member of the Neurobehavioral Teratology Society in 1977 and was elected president in 1984-85 and 2012-13. Dr. Vorhees has served on multiple scientific advisory committees for the US Food and Drug Administration, US Environmental Protection Agency, and National Institutes of Health. He was on the National Academies Subcommittee on Reproductive and Developmental Toxicants. Dr. Vorhees obtained his MA and PhD in neurobiology from Vanderbilt University.
Kimberly Yolton
Kimberly Yolton is a Professor at Cincinnati Children’s Hospital Medical Center (CCHMC) and the University of Cincinnati College of Medicine, and Director of Research in the Department of General and Community Pediatrics. She is a developmental psychologist and epidemiologist with over 25 years of experience studying the impact of prenatal and early life exposures on neurobehavior from infancy through childhood and directs the longitudinal Health Outcomes and Measures of the Environment (HOME) Study. She was formerly the director of a follow-up clinic serving high-risk infants and young children and has extensive experience with infants and children who were prenatally exposed to substances of abuse, who were born prematurely or at low birth weight, or who come from disadvantaged home environments. She was involved in the initial development of the NICU Network Neurobehavioral Scale (NNNS), a specialized neurobehavioral assessment tool used with healthy and high-risk newborns, and conducts frequent trainings on the proper administration, scoring, and interpretation of the instrument for research and clinical purposes. She has been affiliated with the NIH-funded Neonatal Research Network for over 25 years at two different sites, as an examiner, Gold Standard reviewer for intelligence testing, follow-up principal investigator, and steering committee member. She frequently collaborates with investigators regarding neurobehavioral assessment and staff training strategies to acquire the most appropriate outcome measures with the highest standards of reliability and validity. She earned her PhD in child development and developmental psychology from The Ohio State University and completed a 3-year NRSA fellowship in Pediatric Environmental Health at CCHMC.

Committee Membership Roster Comments

Please note that there has been a change in the committee membership with the appointment of Dr. Yolton, effective October 4, 2019.

Events



Location:

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

Description :   

The open session meeting will take place in the Keck building on November 6th from 10:00 AM to 12:30 PM. If you would like to attend virtually or in person, please contact Sarah Harper at sharper@nas.edu for instructions. 

To obtain materials shared with the committee, please contact paro@nas.edu. 


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:  Sarah Harper
Contact Email:  SHarper@nas.edu
Contact Phone:  (202) 334-3353

Supporting File(s)
NTP Monograph

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:

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

David Savitz (chair)
Kevin Crofton
Akhgar Ghassabian
Judith Klotz
Juleen Lam
Pamela Lein
Germaine Buck Louis
Michael Pennell
Craig Steinmaus
Charles Vorhees
and Kimberly Yolton

The following topics were discussed in the closed sessions:

The following topics were discussed in the closed sessions:

1) Information presented in the open session.
2) Committee’s evaluation of the NTP monograph and key literature.
3) Draft report outline and material to include in the committee’s report.
2) Committee assignment, deadlines, and report review process.

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

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

No materials were distributed during the closed sessions.

Date of posting of Closed Session Summary:
November 13, 2019
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:  Sarah Harper
Contact Email:  SHarper@nas.edu
Contact Phone:  (202) 334-3353

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 A. Savitz
Akhgar Ghassabian
Judith B. Klotz
Juleen Lam
Germaine M. Buck Louis
Michael L. Pennell
Craig Steinmaus
Charles V. Vorhees
Kimberly Yolton

The following topics were discussed in the closed sessions:

1) Completed balance and committee composition conversation.
2) Reviewed committee assignments and agenda for in person meeting.
3) HAWC Presentation.

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

N/A

Date of posting of Closed Session Summary:
October 01, 2019
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:  Sarah Harper
Contact Email:  SHarper@nas.edu
Contact Phone:  (202) 334-3353

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 A. Savitz
Kevin Crofton
Akhgar Ghassabian
Juleen Lam
Pamela J. Lein
Germaine M. Buck Louis
Michael L. Pennell
Craig Steinmaus
Charles V. Vorhees

The following topics were discussed in the closed sessions:

1) Conducted balance of committee composition conversation.
2) Reviewed statement of task.

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

N/A

Date of posting of Closed Session Summary:
September 17, 2019
Publication(s) resulting from the event:

-

Publications

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

No data present.