A STRAW MAN PROPOSAL FOR A QUANTITATIVE DEFINITION OF THE RfD

REFERENCES

• Lehman A.J., Fitzhugh O.G. 100-Fold Margin of Safety. Assoc. Food Drug Off. U.S. Q. Bull. 1954; 18: 33–35
   Google Scholar
• Baird S.J.S., Cohen J.T., Graham J.D., Shlyakhter A.I., Evans J.S. Noncancer Risk Assessment: A Probabilistic Alternative to Current Practice. Hum. Ecol. Risk Assess. 1996; 2: 78–99
   Web of Science ®Google Scholar
• Hattis D. The Conception of Variability in Risk Analyses—Developments Since 1980. Presented at “Risk and Governance, An International Symposium,” June 21–25, 2000, Airlee Conference Center, Warranton, Virginia. Proceedings to be published in Risk Analysis and Society in the 21st Century: An Interdisciplinary Characterization of the Field, McDaniels., Small Eds.; in press
   Google Scholar
• Swartout J.C., Price P.S., Dourson M.L., Carlson-Lynch H.L., Keenan R.E. A Probabilistic Framework for the Reference Dose (Probabilistic RfD). Risk Analysis 1998; 18: 271–282
   PubMed Web of Science ®Google Scholar
• Hattis D. Strategies for Assessing Human Variability in Susceptibility, and Using Variability to Infer Human Risks. Human Variability in Response to Chemical Exposure: Measures, Modeling, and Risk Assessment, D.A. Neumann, C.A. Kimmel. CRC Press, Boca Raton, FL 1998; 27–57
   Google Scholar
• Hattis D., Banati P., Goble R. Distributions of Individual Susceptibility Among Humans for Toxic Effects–For What Fraction of Which Kinds of Chemicals and Effects Does the Traditional 10-Fold Factor Provide how much Protection? Annals of the New York Academy of Sciences. 1999; 895: 286–316
   Google Scholar
• Evans J.S., Rhomberg L.R., Williams P.L., Wilson A.M., Baird S.J.S. Reproductive and Developmental Risk from Ethylene Oxide: A Probabilistic Characterization of Possible Regulatory Thresholds. Risk Analysis 2001; 21: 697–717
   PubMed Web of Science ®Google Scholar
• Hattis D., Anderson E. What should be the Implications of Uncertainty, Variability, and Inherent ‘Biases’/‘Conservatism' for Risk Management Decision Making?. Risk Analysis 1999; 19: 95–107
   Web of Science ®Google Scholar
• Hattis D. Human Interindividual Variability in Susceptibility to Toxic Effects- from Annoying Detail to a Central Determinant of Risk. Toxicology 1996; 111: 5–14
   PubMed Web of Science ®Google Scholar
• Hattis D., Minkowitz W.S. Risk Evaluation: Criteria Arising from Legal Traditions and Experience with Quantitative Risk Assessment in the United States. Environ. Toxicol. Pharmacol. 1996; 2: 103–109
   PubMed Web of Science ®Google Scholar
• Brown H., Goble R.L. The Role of Scientists in Risk Assessment, Risk: Issues in Health and Safety. 1990; I: 283–311
   Google Scholar
• Hattis D., Burmaster D.E. Assessment of Variability and Uncertainty Distributions for Practical Risk Analyses. Risk Anal. 1994; 14: 713–730
   Web of Science ®Google Scholar
• Hattis D., Baird S., Goble R. A Straw Man Proposal for a Quantitative Definition of the RfD, in Final Technical Report, U.S. Environmental Protection Agency STAR grant #R825360, “Human Variability in Parameters Potentially Related to Susceptibility for Noncancer Risks,” Paper presented 4/24/01 at the U.S. EPA/DoD Symposium on Issues and Applications in Toxicology And Risk Assessment, Fairborn, Ohio, Available on the Web at http://www2.clarku.edu/faculty/dhattis
   Google Scholar
• Evans J.S., Baird S.J.S. Accounting for Missing data in Noncancer Risk Assessment. Human and Ecological Risk Assessment 1998; 4: 291–317
   Web of Science ®Google Scholar
• Price P.S., Swartout J.C., Schmidt C., Keenan R.E. Characterizing Inter-Species Uncertainty Using Data from Studies of Anti-Neoplastic Agents in Animals and Humans, Human and Ecological Risk Assessment (2002) in Preparation Paper and Data Available on Request from P. S. Price—[email protected]
   Google Scholar
• Hattis D., Banati P., Goble R., Burmaster D. Human Interindividual Variability in Parameters Related to Health Risks. Risk Anal. 1999; 19: 705–720
   Web of Science ®Google Scholar
• Faustman E.M., Allen B.C., Kavlock R.J., Kimmel C.A. Dose-Response Assessment for Developmental Toxicity. I. Characterization of Database and Determination of No Observed Adverse Effect Levels. Fundam. Appl. Toxicol. 1994; 23: 478–486
   PubMedGoogle Scholar
• Allen B.C., Kavlock R.J., Kimmel C.A., Faustman E.F. Dose-Response Assessments for Developmental Toxicity, II. Comparison of Generic Benchmark Dose Estimates with NOAELs. Fundam. Appl. Toxicol. 1994; 23: 487–495
   PubMedGoogle Scholar
• Allen B.C., Kavlock R.J., Kimmel C.A., Faustman E.F. Dose-Response Assessments for Developmental Toxicity, III. Statistical Models. Fundam. Appl. Toxicol. 1994; 23: 496–509
   PubMedGoogle Scholar
• Weil C.S. Statistics vs. Safety Factors and Scientific Judgment in the Evaluation of Safety for Man. Toxicol. Appl. Pharmacol. 1972; 21: 454–463
   PubMed Web of Science ®Google Scholar
• Finney D.J. Probit Analysis, 3rd Ed. Cambridge University Press, London 1971
   Google Scholar
• ten Berge W.F., Zwart A., Appema M. Concentration–Time Mortality Response Relationship of Irritant and Systemically Acting Vapors and Gases. J. Haz. Materials 1986; 13: 301–309
   Web of Science ®Google Scholar
• Weil C.S., McCollister D. Relationship Between Short and Long-Term Feeding Studies in Designing an Effective Toxicity Test. Agriculture and Food Chemistry 1963; 11: 486–491
   Web of Science ®Google Scholar
• Nessel C.S., Lewis S.C., Stauber K.L., Adgate J.L. Subchronic to Chronic Exposure Extrapolation: Toxicologic Evidence for a Reduced Uncertainty Factor. Human and Ecological Risk Assessment 1995; 1: 516–526
   Google Scholar
• Watanabe K., Bois F.Y., Zeise L. Interspecies Extrapolation: A Reexamination of Acute Toxicity Data. Risk Anal. 1992; 12: 301–310
   PubMed Web of Science ®Google Scholar
• Travis C.C., White R.K. Interspecific Scaling of Toxicity Data. Risk Anal. 1988; 8: 119–125
   PubMed Web of Science ®Google Scholar
• Mordenti J. Man Versus Beast: Pharmacokinetic Scaling in Mammals. J. Pharmaceut. Sci. 1986; 75: 1028–1040
   PubMed Web of Science ®Google Scholar
• Travis D.C., White R.K., Ward R.C. Interspecies Extrapolation of Pharmacokinetics. J. Theor. Biol. 1990; 142: 285–304
   PubMed Web of Science ®Google Scholar
• Ad Hoc Working Group on Risk Assessment, Federal Coordinating Council for Science, Engineering and Technology (FCCSET). Draft Report: A Cross-Species Scaling Factor for Carcinogen Risk Assessment Based on Equivalence of mg/kg3/4/Day. Federal Register 57 (1992) 24152–24173, June 5
   Google Scholar
• Registry of Toxic Effects of Chemical Substances (1980 edition, volume 1) U. S. Department of Health and Human Services DHHS (NIOSH). Publication No. 81–116. Government Printing Office, Washington, D.C., 20402, February, 1982
   Google Scholar
• Hattis D., Russ A., Goble R., Banati P., Chu M. Human Interindividual Variability in Susceptibility to Airborne Particles. Risk Anal. 2001; 21: 585–599
   PubMed Web of Science ®Google Scholar
• Ginsberg G., Hattis D., Sonawane B., Russ A., Banati P., Kozlak M., Smolenski S., Goble R. Evaluation of Child/Adult Pharmacokinetic Differences from a Database Derived from the Therapeutic Drug Literature. Toxicol. Sci. 2002; 66: 185–200
   PubMed Web of Science ®Google Scholar
• Hattis D., Russ A., Banati P., Kozlak M., Goble R., Ginsberg G. Development of a Comparative Child/Adult Pharmacokinetic Database Based upon the Therapeutic Drug Literature. Report by Clark University and the Connecticut Department of Public Health to the U.S. Environmental Protection Agency under Cooperative Agreement #827195-0, (October 2000)
   Google Scholar