Toxicology Excellence for Risk Assessment (TERA)

2300 Montana Avenue, Suite 409, Cincinnati OH 45211
Phone: 513-542-7475
Fax: 513-542-7487

Email:
TERA@TERA.org

2004 VCCEP Peer Consultation Core Panel
 


Core panel members are experts with sufficiently broad areas of expertise to qualify them for service on most or all of the VCCEP panels.  Core panel members add continuity to the peer consultation program and will be asked to commit to serve on panels for one year.

A brief biography is provided below for each of the 2004 panel members.

John Balbus
M.D., M.P.H. 
Environmental Defense

R. Jeffrey Lewis (resigned)
Ph.D. Epidemiology
ExxonMobil Biomedical Sciences, Inc.

George P. Daston
Ph.D. Developmental Biology and Teratology
The Procter & Gamble Company  

Jennifer Seed
Ph.D. Developmental and Cellular Biology
U.S. EPA, Risk Assessment Division

Michael L. Dourson
Ph.D. Toxicology
Toxicology Excellence for Risk Assessment 
(Panel Chair)

Kimberly M. Thompson
Sc.D. Environmental Health
Harvard University  

Elaine A. Hubal
Ph.D. Chemical Engineering
U.S. EPA, National Exposure Research Laboratory  

Chad Sandusky
Ph.D. Pharmacology
Physicians Committee for Responsible Medicine 

Sam Kacew
Ph.D. Pharmacology
University of Ottawa  

 



Dr. John Balbus

Dr. John Balbus is currently the Director of the Environmental Health Program for Environmental Defense, where he is working on projects related to antibiotic resistance, health impacts of urban sprawl and transportation policy, and chemical testing and right-to-know.  Prior to his current position, he served as the founding Director of the Center for Risk Science and Public Health, as well as an Associate Professor at the George Washington University Medical Center .  Dr. Balbus’ research activities at the Center for Risk Science and Public Health included addressing susceptibility in risk assessment and risk management, children’s susceptibility to waterborne contaminants, and health impacts of climate change.  Dr. Balbus was a founding co-director of the Mid-Atlantic Center for Children’s Health and the Environment, one of 11 Pediatric Environmental Health Specialty Units funded by the USEPA and ATSDR.

Dr. Balbus received his M.D. from the University of Pennsylvania , an M.P.H. from the Johns Hopkins School of Hygiene and Public Health, and an A.B. in Biochemistry from Harvard University .  He completed residencies in internal medicine at Pennsylvania Hospital and in occupational and environmental medicine at Johns Hopkins School of Hygiene and Public Health.  Dr. Balbus has also held a variety of additional academic appointments that include: Assistant Professor of Medicine at George Washington University Medical Center , Clinical Fellow in Medicine at John Hopkins School of Medicine, Assistant Professor in Medicine at Uniformed Services University of the Health Sciences, and Clinical Instructor in Medicine at the University of Pennsylvania School of Medicine.

Dr. Balbus is currently certified by the American Board of Internal Medicine, and the American Board of Preventive Medicine, specialty in Occupational Medicine. 

In addition to Dr. Balbus’s extensive professional and academic career, he has published numerous articles relating to a variety of topics in risk assessment, public health, and environmental health.  

Back to Table

 

Dr. George Daston

Dr. George Daston is a Research Fellow for the Procter & Gamble Company where he has worked since 1985.  He has worked the past 21 years in the field of developmental toxicology and risk assessment, particularly in the area of children’s risk assessment. 

Dr. Daston is also an adjunct professor in the Department of Pediatrics and Developmental Biology Program at the University of Cincinnati and Children's Hospital Research Foundation, and lectures in courses on teratology, developmental biology, toxicology, and risk assessment. 

Dr. Daston received his Ph.D. in Developmental Biology and Teratology and a B.S. in Biology from the University of Miami .  Prior to joining the Procter & Gamble Company, Dr. Daston worked for the U.S. EPA’s Health Effects Research Laboratory as a National Research Council Research Associate and as an assistant professor for the Department of Biological Sciences at the University of Wisconsin .

His research interests include teratogenic mechanisms, in vitro methodologies, and risk assessment.  His most recent research includes toxicant-nutrient (especially zinc) and maternal-embryonal interactions in developmental toxicity, the role of pattern formation genes in abnormal development, genomic approaches to endocrine disrupter screening, and improvements in risk assessment methodology for non-cancer endpoints. 

Dr. Daston's activities in professional societies include serving as Chair of the Reproductive and Developmental Effects Subcommittee of the American Industrial Health Council, Chair of the Developmental and Reproductive Toxicology Technical Committee of ILSI-Health Effects Sciences Institute;  President of the Society of Toxicology's Reproductive and Developmental Toxicology Specialty Section, President of the Teratology Society, member of the National Academy of Sciences Board on Environmental Studies and Toxicology, and member of EPA's Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC). 

Dr. Daston has recently served on the organizing committees for an ILSI/EPA/AIHC workshops on benchmark dose methodology and human variability in toxic response; an EPA workshop on endocrine-mediated toxicity; and as co-chair of an AIHC/EPA workshop on Leydig cell tumors, an ILSI/EPA workshop on interpreting reproductive toxicity endpoints, and a NIEHS workshop on the state of validation of the FETAX assay for teratogen screening. 

Dr. Daston is an Associate Editor of Toxicological Sciences, Editor-in-Chief of Birth Defects Research Part B: Developmental and Reproductive Toxicology, on the Editorial Board of Human and Ecological Risk Assessment and Reproductive Toxicology, and an ad hoc reviewer for Teratology, Journal of Nutrition and other journals.  He has published over 90 peer-reviewed articles, reviews and book chapters, and has edited three books.

Back to Table

 

Dr. Michael Dourson

Dr. Michael Dourson directs Toxicology Excellence for Risk Assessment (TERA), a nonprofit corporation dedicated to the best use of toxicity data for estimating risk assessment values.  TERA's projects include the development of complex risk assessments, such as soluble nickel salts; research into improvements of risk methods, such as differential sensitivity of children and adults to chemical toxicity, organizing peer review and consultation meetings for risk assessment topics and documents; and education and outreach on risk assessment values through lectures and data bases, including the International Toxicity Estimates for Risk (ITER).

Before founding TERA in 1996, Dr. Dourson held leadership roles in the U.S. Environmental Protection Agency for fifteen years; as chair of EPA's Reference Dose (RfD) Work Group, charter member of the EPA's Risk Assessment Forum and chief of the group that helped create the Integrated Risk Information System (IRIS) in 1986.

Dr. Dourson received his Ph.D. in Toxicology from the University of Cincinnati and a B.A. in biology from Wittenberg University . 

Dr. Dourson’s research interests include investigating methods to extrapolate toxicity data garnered on experimental animals or healthy adults to the appropriate sensitive human population.  Topic such as adversity of effect, and characterization of risk are also of interest.

Dr. Dourson has served on numerous expert panels, such as EPA’s peer review panels for IRIS assessments and its Risk Assessment Forum, TERA’s International Toxicity Estimates for Risk (ITER) independent peer reviews and consultations, FDA’s Science Board Subcommittee on Toxicology, the NSF’s Health Advisory Board, and SOT’s harmonization of cancer and non-cancer risk assessment. 

Dr. Dourson has also organized over 16 symposia for 9 different organizations on a variety of topics, including: effective risk communication; chromium; information resources for toxicology and environmental health; risk assessment of essential trace elements; risk characterization; EPA’s IRIS; role of toxicology in tomorrow’s risk assessment practice; techniques for quantifying uncertainty in risk assessment; statistical and dose response models in risk assessment; workshop on benchmark dose methodology; basics of risk assessment; improvements in quantitative noncancer risk assessment; and neurotoxicity risk assessment. 

Dr. Dourson is a Diplomate of the American Board of Toxicology and served on its Board as President, Vice President and Treasurer.  He is currently Secretary for the Society for Risk Analysis.  He has also served as president of the Dose-Response Specialty Group of the Society for Risk Analysis, of the Society of Toxicology's Specialty Section on Risk Assessment and of the Ohio Chapter of the Society for Risk Analysis. He is currently on the editorial board of three journals.  Dr Dourson has published more than 70 papers on risk assessment methods, has co-authored over 100 government risk assessment documents, and has made over 90 invited presentations. 

Back to Table

 

Dr. Elaine Hubal 

Dr. Elaine Hubal is a chemical engineer for the U.S. EPA’s National Exposure Research Laboratory working in that lab’s human exposure research program studying children’s residential exposures to environmental contaminants.  Her research is on reducing uncertainty in risk assessment with a specific focus on children’s exposure.  She is developing exposure factor data to reduce reliance on default parameters in risk assessment.  She previously worked as a chemical engineer for the Research Triangle Institute, and Camp Dresser and McKee.  She also served as a Predoctoral Fellow at the Chemical Industry Institute of Toxicology.

Dr. Hubal received her Ph.D. and M.S. in Chemical Engineering from North Carolina State University and a S.B. in Chemical Engineering from Massachusetts Institute of Technology.

Dr. Hubal has served on a variety workgroups, panels, and committees.  She currently serves as a member of the Interagency Dosimetry Working Group, EPA’s Risk Assessment Forum Children’s Exposure Technical Panel, the American Chemistry Council’s Human Exposure Assessment Technical Implementation Panel, and the Study Design Working Group for the National Children’s Study.  She was an invited participant to the NERL Dermal Exposure Workshop, Outdoor Residential Task Force Workshop, ILSI Aggregate Exposure Assessment Model Evaluation and Refinement Workshop, the Chemical Manufacturer’s Association’s Exposure Workshop, and the EPA/ACC Technical Workshop for the Voluntary Children’s Chemical Evaluation Program (VCCEP).

Dr. Hubal’s current research interest is designing studies to evaluate dermal exposure assessment approaches and collect exposure factor data in support of the Food Quality Protection Act.  She has worked on the development of a modeling platform to predict contaminant fate and transport of environmental pollutants to perform exposure assessments in support of the Hazardous Waste Identification Rule, developed and worked with a variety of computational models to describe the simultaneous mass transport and reaction of inhaled gases in the airway lining, and conducted research in the area of industrial pollution prevention by developing a framework to evaluate the environmental impact of pollution prevention activities which directly relates to the energy requirements to process air, water, and solid waste emissions.

Dr. Hubal has published in the areas of children’s exposure and human health risk modeling.   

Back to Table

   
 
Dr. Sam Kacew

Dr. Sam Kacew is a professor in the Department of Cellular and Molecular Medicine, Faculty of Medicine, as well as a scientist of the Institute of Population Health at the University of Ottawa .  His responsibilities include teaching medical students and graduate students the techniques required to write and publish peer-review papers.  His current research involves the effects of chemical contaminants in breast milk on infants, the role of confounding factors in toxicity testing, as well as the basis for differences in responsiveness to chemicals between infants and adults.

Dr. Kacew received his Ph.D. in Pharmacology from the University of Ottawa .  He served as a Postdoctoral Fellow for the Medical Research Council of Canada at the University of Montreal .  Dr. Kacew was certified in 1994 as a Fellow of Academy of Toxicological Sciences.  He has received numerous awards, including several achievement, recognition, public communications and travel awards from the Society of Toxicology (SOT), the United States-China Foundation, and the National Science Council of the Republic of China.

Dr. Kacew has served on dozens of expert panels and committees, including as a member of the National Advisory Committee on Environmental Contaminants and the Implications for Child Health, and as a member of the National Academy of Sciences of the USA , Committee on Toxicology.  He has also served as a chairman for a variety of symposiums, panels, and committees including the SOT Annual Meeting’s General Toxicology Session, the Federation of American Societies for Experimental Biology Annual Meeting, an Assessment Panel for the Canadian Council on Animal Care, a SOT Symposium on Use of Moderate Dietary Restriction in Safety Assessment, and a SOT Symposium on the Role of Diet and Obesity in Endocrine Disruption. 

He has presented hundreds of invited lectures for a variety of federal and state government agencies, colleges and universities, private companies, and international organizations.  He was an invited participant to the American Society for Pharmacology and Experimental Therapeutics Meeting, the Federation of American Societies for Experimental Biology Annual Meeting, the International Life Sciences Institute, the Chalk River Nuclear Labs, Turkey Society of Biochemistry and the Korea Society of Toxicology.

Dr. Kacew is on a number of grant committees and has served as an external referee for grants and fellowships for a wide variety of organizations and government agencies.  He is currently the Editor-in-Chief the Journal of Toxicology and Environmental Health, an Associate Editor for Toxicology and Applied Pharmacology, an assistant editor for TOMES (Micromedex, Inc.), as well as a member of the editorial board of a number of other journals.  Dr. Kacew has over 140 publications in peer-reviewed journals and books in the area of toxicology, risk assessment, and children’s health.  He has also served as an editor for a number of books on toxicology and children.  

Back to Table

 

Dr. R. Jeffrey Lewis

Dr. Lewis resigned from the VCCEP core on February 18, 2004 due to the potential for a perceived conflict of interest with chemicals anticipated to be discussed in 2004.

Dr. R. Jeffrey Lewis has been a Scientific Associate with ExxonMobil Biomedical Sciences, Inc. since 1990.  He is responsible for designing and conducting epidemiological studies of ExxonMobil employees, and advising the Corporation regarding environmental health issues.  He also interacts with regulatory agencies regarding 1,3-butadiene, ethylene, and propylene scientific issues, participates in scientific trade association activities, and manages and plans research budgets and programs.  Dr. Lewis is also an Adjunct Assistant Professor of Occupational Health at the University of Texas , School of Public Health . 

Dr. Lewis received his Ph.D. and a M.S. in Epidemiology from the University of Texas , School of Public Health ’s Health Science Center .  He earned an M.B.A. from Rutgers University .

Dr. Lewis has over 15 years experience in designing, conducting, analyzing, and publishing epidemiology studies.  He currently serves as the Chair for the Endocrine Group of the Children’s Health Coordinating Group, the American Chemistry Council’s Epidemiology Work Group, and the International Institute of Synthetic Rubber Producer’s Epidemiology Subcommittee.  He is also currently a member on the International Institute of Synthetic Rubber Producer’s Environmental Health Committee.  He has served as a member on the European Center for Ecotoxicology and Toxicology of Chemical’s Propylene Task Force, as well as a organizing and editorial/publication committee member for an international symposium on 1,3-Butadiene, Isoprene, and Chloropene Health Effects in 2000.

Dr. Lewis is a current member of the American College of Epidemiology, the Society for Epidemiological Research, and the American Association for the Advancement of Science.  He has a variety of publications in the area of toxicology and human health assessment.  

Back to Table

 

Dr. Jennifer Seed

Dr. Jennifer Seed is a Branch Chief with the Office of Pollution Prevention and Toxics, Risk Assessment Division, Existing Chemicals Assessment Branch of the U.S. EPA. 

She provides supervision and leadership to a staff of scientists with expertise in toxicology, epidemiology, biostatistics, and ecotoxicology.  This branch is responsible for developing human health hazard and risk assessments, toxicology and ecotoxicology test guidelines in support of OECD harmonization efforts and alternatives to animal testing through ICCVAM activities.  Dr. Seed serves on a number of EPA committees and workgroups in these areas. 

Dr. Seed also worked as a biologist for the Health and Environmental Review Division, where she conducted human health hazard and risk assessments of environmental chemicals regulated under the TSCA.  She developed and reviewed Agency risk assessment guidelines for reproductive toxicity and testing guidelines for assessing developmental neurotoxicity for OPPT and OPP, as well as developing and teaching courses on developmental neurotoxicity for U.S. EPA and other agencies.  She helped develop OPPT’s children’s health strategy

In addition to her work at EPA, Dr. Seed also served as a senior scientist for ILSI Risk Science Institute where she developed and managed teams of scientists from academia, industry, and government charged with resolving issues in toxicology and risk assessment.  From 1996 to 1997 she worked as a private consultant on toxicology and risk assessment projects

Dr. Seed received her Ph.D. in Developmental and Cellular Biology and a B.A. in Anthropology (minor in Biology) from the University of Washington .  She served as a Postdoctoral Fellow with the Department of Biochemistry, University of Washington .

Dr. Seed has served on a variety of committees, panels, and workgroups.  She currently serves on the U.S. EPA’s Risk Assessment Forum, as well as the RfD/RfC technical Panel that is responsible for reviewing the methods used by the agency in developing RfD/RfCs to ensure that children and other susceptible subpopulations are adequately protected and on the FQPA 10x workgroup that is developing the implementation policy of the FQPA 10x factor to ensure adequate protection of children’s health.  Dr. Seed served as a member of the U.S. EPA’s Reference Dose Workgroup and co-chaired the Reproductive and Developmental Toxicity Harmonization Workgroup, as well as served as the Chair of the international OECD team to develop a guidance document for reproductive toxicity and as an OPPT representative for the ORD/OPPTS Toxics/Pesticides Research Coordination Team.  She has also served on the ILSI steering committee for behavioral developmental toxicity project, scientific advisor for the ILSI Residue Technical Committee, co-chaired the ILSI working group on skeletal variations and children’s health risk assessment, SOT steering committee for a workshop on harmonization of risk assessment for cancer and noncancer endpoints, OECD’s working group for developmental neurotoxicity guidelines, and EPA’s Technical Panel on Framework for Human Health Risk Assessment.

Dr. Seed has published in the area of developmental and reproductive toxicity and human health risk assessment, and has contributed to a number of EPA test guidelines and other documents.

Back to Table

 
Dr. Chad Sandusky

Dr. Chad Sandusky is currently Director of Research and senior toxicology advisor to the Physicians Committee for Responsible Medicine (PCRM), a non-profit organization that promotes nonanimal experimental methods in medical and scientific research.  For PCRM, Dr. Sandusky coordinates the review and preparation of comments on the EPA’s High Production Volume Challenge Program (HPV) and Voluntary Children’s Chemical Evaluation Program (VCCEP) chemical assessments. As such he stresses the weight-of- evidence approach in these assessments and also the development of exposure scenarios as key to the success of these programs.  He is actively engaged in identifying methods which use alternatives to animal testing to meet the needs of the safety assessments, including tests undergoing validation at the European Center for Alternative Methods (ECVAM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).

Dr. Sandusky was the past Manager of Toxicology and Risk Assessment at ENVIRON and has extensive experience at both the EPA and ENVIRON in pesticide toxicology as well as exposure and risk assessments.  For example, he evaluated the toxicology of pesticides and extrapolated these effects in risk assessments; directed the dietary exposure and risk assessments for agrichemicals and other potentially toxic residues in foods using the TAS Dietary exposure software;  served as toxicology team leader and senior author of numerous EPA documents, including Registrations Standards and Position Documents; and since the passage of the FQPA in August 1996, coordinated the review and assessment of numerous agrichemicals to address the full range of new requirements, including: assessing aggregate exposure from multiple pathways (e.g., drinking water and residential use), cumulative exposure from multiple pathways from chemicals with a common mode of action, accounting for potential sensitivity to infants and children, and assessing the potential for endocrine disruption.

Dr. Sandusky has extensive international experience including the coordination and submission of dossiers for the EU Reauthorization process under EU 91/414 and presentation of the results to member states.  Dr. Sandusky also represented the Institute of Food Technology at the Codex Committee for Pesticide Residues (CCPR) in The Hague for several years.  Dr. Sandusky has also coordinated preparation and reviews of dossiers for chemicals approved as GRAS through the GRAS – self-affirmation process as well as directed the preparation and submission of Food Contact Notifications (FCNs) to the FDA.

Dr. Sandusky received his Ph.D. in Pharmacology from the Emory University .  He served as a Postdoctoral Fellow at the Georgetown University Schools of Medicine and Dentistry, Washington , D.C.   He is currently a member of the Society of Toxicology, and was previously affiliated with such organizations as the International Society of Exposure Analysis and the Society of Environmental Toxicology and Chemistry.

Back to Table

 

Dr. Kimberly M. Thompson

Dr. Kimberly M. Thompson is Assistant Professor of Risk Analysis and Decision Science in the Department of Health Policy and Management at the Harvard School of Public Health.  She is the Director of the Kid Risk Project that seeks to improve the lives of children by using analytical methods to characterize children's risks and strategies to reduce those risks.  Dr. Thompson directs a professional education course on Probabilistic Risk Analysis: Assessment, Management, and Communication, and she seeks to effectively integrate technological, social, political, legal, and economic issues into risk analyses that inform public policy and improve decision making.  Her research interests focus on the issues related to developing and applying quantitative methods for risk assessment and risk management, and consideration of the public policy implications associated with including uncertainty and variability in risk characterization. 

Over the last decade, for both private and public clients Dr. Thompson has consulted on computer applications, projects concerning environmental quality, fate and transport of toxic chemicals in the environment, analysis of remedial alternatives at landfills and abandoned sites, efforts to characterize uncertainty and variability in risks, and development of white papers for the EPA on topics related to children’s risks.  Dr. Thompson’s most recent consulting includes work with the MIT Lincoln Laboratory as part of an integration team studying the development of a national health surveillance and biodefense system, and her recent book Overkill focuses on microbiological risks in what she calls this “Age of Risk Management.”

Dr. Thompson received a Sc.D. in Environmental Health from Harvard University ’s School of Public Health .  She received a M.S. and B.S. in Chemical Engineering from the Massachusetts Institute of Technology.  Dr. Thompson has served on several National Academy of Sciences committees and subcommittees and a number of other expert review panels.  She has been an invited presenter at a variety of workshops, conferences, and annual meetings, such as the Boston Mayor’s Symposium on Youth Development, the Congressional Research Services’ Children’s Environmental Risks:  Federal Activities in Perspective Symposium on Risk Assessment and Risk Communication, and a NIH/NIEHS Workshop on the Role of Human Exposure Assessment in the Prevention of Environmental Disease.  She also served as the chair of the Exposure Assessment Specialty Group of the Society for Risk Analysis.

Dr. Thompson has written over 30 peer-reviewed journal publications in the areas of human health modeling, probabilistic risk assessment, children’s health and risk communication.  She has also reviewed manuscripts for over a dozen journals, including the Journal of Toxicology and Environmental Health, Risk Analysis, Health Policy, and the Journal of the American Medical Association.

Back to Table

 

                                 © 2009 Toxicology Excellence for Risk Assessment