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New Approaches to Developmental Toxicity Risk Assessment at the U.S. Environmental Protection Agency

  • Robert J. Kavlock
  • Carole A. Kimmel

Abstract

The United States Environmental Protection Agency (US EPA) is charged under a variety of statutes, including the Federal Insecticide, Fungicide and Rodenticide Act, the Toxic Substances Control Act, the Clean Air Act, and the Clean Water Act, with evaluating the potential health risks of chemicals present in the human environment. In considering the implementation of these laws, it is important to note that the situations to be evaluated range from workers occupationally exposed during the manufacture of industrial chemicals or during the preparation and application of pesticides, to widespread, but low level, exposure of large segments of the general population through the food, water or air. Such situations are in direct contrast to the health risks associated with pharmaceutical agents, where the exposure is direct and controlled and the benefits accrue to the exposed individual.

Keywords

Risk Assessment Developmental Toxicity Lower Confidence Limit Quantitative Risk Assessment Risk Assessment Process 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  1. Allen BC, Van Landingham C, Howe R, Kavlock RJ, Kimmel CA, Faustman EF (1992) Dose-response modeling for developmental toxicity. The Toxicologist 12(1): 300.Google Scholar
  2. Barnes D, Dourson M (1988) Reference dose (RfD): Description and use in health risk assessment. Regulatory Toxicol Pharmacol 8: 471–486.CrossRefGoogle Scholar
  3. Crump KS (1984) A new method for determining allowable daily intakes. Fund Appl Toxicol 4: 854–871.CrossRefGoogle Scholar
  4. Daston GP, Rogers JM, Versteg DJ, Sabourin TD, Baines D, Marsh SS (1991) Interspecies comparisons of A/D ratios are not constant across species. Fund Appl Toxicol 17: (in press).Google Scholar
  5. FDA (1966) Guidelines for reproduction and teratology studies of drugs. Bureau of Drugs, Rockville, MD.Google Scholar
  6. Gaylor DW (1989) Quantitative risk analysis for quantal reproductive outcomes. Environ Hlth Perspect 79: 243–246.CrossRefGoogle Scholar
  7. Kimmel GL, Kimmel CA, Francis EZ, eds (1988) Evaluation of Maternal and Developmental Toxicity. Teratogen Carcinogen Mutagen 7: 203–338.Google Scholar
  8. Kimmel CA, Wellington DG, Farland W, Ross P, Manson JM, Chernoff N, Young JF, Selevan SG, Kaplan N, Chen C, Chitlik LD, Siegel-Scott C, Valaoras G, Wells S (1989) Overview of a Workshop on Quantitative Models for Developmental Toxicity Risk Assessment. Environ Hlth Perspect 79: 209–215.Google Scholar
  9. Kimmel CA (1990) Quantitative approaches to human risk assessment for non-cancer health effects. Neurotoxicol 11: 189–198.Google Scholar
  10. Kodell RL, Howe RB, Chen JJ, Gaylor DW (1991) Mathematical modelling of reproductive and developmental toxicity effects for quantitative risk assessment. Risk Analysis 11: in press.Google Scholar
  11. Kupper LL, Portier C, Hogan MD, Yamamoto E (1986) The impact of litter effects on dose-response modelling in teratology. Biometrics 42: 85–98.PubMedCrossRefGoogle Scholar
  12. NRC (1983) Risk Assessment in the Federal Government: managing the process. Committee on the Institutional Means for Assessment of Risks to Public Health. Commission on Life Sciences, National Research Council. Washington D.C., National Academy Press, pp 17-83.Google Scholar
  13. Rai K, van Ryzin J (1985) A dose-response model for teratological experiments involving quantal response. Biometrics 41: 1–9.PubMedCrossRefGoogle Scholar
  14. Setzer RW, Rogers JM (1992) Assessing developmental hazard: The reliability of the A/D ratio. Teratology, in pressGoogle Scholar
  15. Smith MK, Randall JL, Read EJ, Stober JA (1989) Teratogenic activity of trichloroacetic acid in the rat. Teratology 40: 445–451.PubMedCrossRefGoogle Scholar
  16. US EPA (1982) Pesticide Assessment Guidelines, Subdivision F. Hazard evaluation: human and domestic animals. EPA-540/9-82-025.Google Scholar
  17. US EPA (1985) Toxic Substances Control Act Test Guidelines; Final rules. Fed Reg 50: 39426-39428 and 39433-39434.Google Scholar
  18. US EPA (1986) Guidelines for the Health Assessment of Suspect Developmental Toxicants. Fed Reg 51: 34028-34040.Google Scholar
  19. US EPA (1989) Proposed Amendments to the Guidelines for the Health Assessment of Suspect Developmental Toxicants; Request for Comments; Notice. Fed Reg 54: 9386–9403.Google Scholar
  20. US EPA (1991) Guidelines for developmental toxicity risk assessment; Notice. Fed Reg 56: 63798–63826.Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1992

Authors and Affiliations

  • Robert J. Kavlock
  • Carole A. Kimmel

There are no affiliations available

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