Workshop Overview
Presentation by Ed Ohanian, U.S. Environmental Protection Agency (EPA). NRC findings and Current EPA Risk Assessment Forum Efforts
Presentation by
Adam Finkel, University of Pennsylvania Law School & NAS Panelist. Beyond
Misleading Underestimation of Carcinogenic Potency
Presentation by Peter Grevatt, Office
of Children's Health Protection (No Slides; presentation on issues
related to children's health)
Presentation by Craig Rowlands, The Dow Chemical Company. ILSI Risk21
Presentation by Doug Wolf, U.S. EPA National Health and Environmental Effects
Research Laboratory. Dose Response Approaches for Nuclear Receptor
Mediated Modes of Action Workshop Preliminary Report
Workshop Overview
Rita Schoeny, Environmental Protection Agency. Experience at EPA in Problem Formulation Relevant to both Ecological and Human Dose-Response Analysis
Bette Meek, University of Ottawa. Increasing Assessment & Management Efficiency - The Importance of "Fit for Purpose" MOA/ Human Relevance Analysis
James Swenberg, University of North Carolina. Endogenous and Background DNA Adducts as a Means of Understanding Mode of Action (MOA) in the Low End of the Dose Response Curve
Resha Putzrath, U.S. Navy. Low-Dose Linearity for Noncancer Risks and Dose Additivity for Mixtures
Case Studies
Case studies were presented at Workshops II & III. In some instances, studies presented at Workshop II were revised and the enhanced case studies were presented
at Workshop III. In such situations, the both the "initial" and the "revised" presentations are provided below.
Panel Discussion Questions
Lead – Dose-response relationship for effect on Children’s IQ
Carrington C.D.
Background/Endogenous Damage: Considerations for Dose-Response & Risk Assessment
Pottenger L.H., Bus J.S., with support from J.A. Swenberg
Comparison of Hattis strawman approach and BMDs/UFs for noncancer endpoints (carbonyl sulfide and tetrachlorobenzene)
Greco S.L., Hattis D.H., Lynch M.K.
Quantitative Assessment of Sensitivity and Variability in Humans: Modeling the Effects of Low Dose Exposure to Dietary Residues of Chlorpyrifos
Juberg D.R., Price P.
Risk Assessment of Exposure to Trihalomethane Drinking Water Disinfection By-Products. Use of Biomonitoring Equivalents and Biomonitoring Data from NHANES
Aylward L.L., Hays S.M., Kirman C.R., Becker RA
Risk-Risk Comparison: Comparative Risk for Use of Perchloroethylene (Perc) or N-propyl-bromide (NPB) in Dry Cleaning
Clewell H., Finkel A.
BBDR model for respiratory
tract carcinogenicity of inhaled formaldehyde
Allen B., Clewell H., Conolly R., Haney J., Kester J.
Inititial Case Study
Revised Case Study
Assessment of Low-Dose
Dose-Response Relationships (Non-linear or Linear) for Genotoxicity,
Focused on Induction of Mutations & Clastogenic Effects
Moore M., Pottenger L., Zeiger E., and Zhou T.
Initial Case Study
Revised Case Study
Implications of Linear Low-Dose Extrapolation
from Benchmark Dose for Noncancer Risk Assessment
Kroner O., Haber L.
Advisor: Dourson M.
Initial Case Study
Revised Case Study
Framework for
Evaluating Alternative Temporal Patterns of Exposure for Risk
Characterization
Maier A., Haber L., Haney J., Kaden
D.A., Carrier R., Craft E., and Hertzberg R.
Advisor: Dourson, M.
Initial Case Study
Revised Case Study
Review and application of data fusion methodologies for
toxicological dataset analysis to resolve data quality issues in
predictive toxicology and contaminated sites risk assessment.
Mohapatra A.K., Sadiq R., Zargar A., Islam S., Dyck R.
Initial Case Study
Revised Case Study
Use
of human data in cancer risk assessment of chemicals as illustrated
by the case of 1,3-Butadiene
Albertini R., Sielken Jr.
R.L.
Initial Case Study
Revised Case Study
The Quantitative Human
Health Risk Assessment for 1,3-Butadiene Based Upon Ovarian Effects
in Rodents
Kirman C.R., Grant R.L.
Initial Case Study
Revised Case Study
Apply AEGL
Methodology to Develop Acute Exposure Guideline Levels for
Ethylbenzene
Grant R., Erraguntla N., Hinz J., Camacho I.A.
Initial Case Study
Revised Case Study
Deriving Health-Protective
Values for Evaluation of Acute Inhalation Exposures for Chemicals
with Limited Toxicity Data Using a Tiered Screening Approach
Grant R.L., Phillips T., Ethridge S.
Initial Case Study
Consideration of Human Kinetic Variability
Lipscomb J.C., Teuschler L.K., Swartout J., Popken D., Cox T.,
Kedderis G.L.
Initial Case Study
Multiple modes of
action and risk assessment modeling
Hertzberg R.
Advisor: Dourson M.
Initial Case Study
Application of National
Research Council “Silverbook” Methodology for Dose Response
Assessment of 2,3,7,8-Tetrachlorodibenzo(p)dioxin.
Simon T., Stephens M., Yang Y., Manning R.O., Budinsky R.A. and
Rowlands J.C.
Intial Case Study
Revised Case Study
Estimate Risk Above
the RfD Using Uncertainty Factor Distributions
Spalt E., Kroner O.
Advisor: Dourson M.
Initial Case Study
Revised Case Study
Use of biomarkers in the
benchmark dose method
Gentry R., Van Landingham C., Hays S., Aylward L.
Initial Case Study
Revised Case Study
Sustainable Futures Screening
Becker E., Ranslow P.
Initial Case Study
Revised Case Study
Biologically-Informed
Empirical Dose Response Modeling: Using Linked Cause-Effect
Functions to Extend the Dose-Response Curve to Lower Doses (Titanium
dioxide - TiO2)
Allen B., Maier
A., Willis A., Haber L.T.
Initial Case Study
Ethanol Case Study –
Evaluating Human Dose-Response of Morbidity and Mortality from
Hepatic Disease: Are the Predicted Risks from Low-Dose Linear
Extrapolation to Environmentally Relevant Concentrations
Biologically Plausible?
Becker R., Hays
S.
Initial Case Study
Revised Case Study
Use of Categorical Regression – Risk
Above the RfD
Danzeisen R., Krewski D., Chambers A., Baker S., Hertzberg R.,
and Haber L.
Initial Case Study
Revised Case Study