Significant Risk Is Not the Antonym of De Minimis Risk

  • Daniel ByrdIII
  • Lester Lave
Part of the Contemporary Issues in Risk Analysis book series (CIRA, volume 2)


Recent events have led to an increased interest in a “significant risk” policy for the regulation of exposures to toxic chemicals. In 1980 the Occupational Safety and Health Administration (OSHA) promulgated a rule in which the standard for any carcinogen was to be lowered to the extent technologically and economically feasible.1 In a 1980 decision, the Supreme Court vacated a rule that established a standard for exposure to benzene, based on a statutory interpretation, although the Court did not overturn OSHA’s entire cancer policy.2 An agency had to make a finding that a risk was significant before it could consider regulating it, and the finding had to be part of the record.


Environmental Protection Agency Significant Risk Ethylene Oxide Maleic Anhydride Federal Register 
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  1. 1.
    Occupational Safety and Health Administration, Identification, Classification and Regulation of Potential Carcinogens. Federal Register 45: 5001–5296 (1980).Google Scholar
  2. 2.
    Industrial Union Department v. American Petroleum Institute; 448 U.S.C. 607 (1980).Google Scholar
  3. 3.
    American Textile Manufacturers Institute, Inc., et al. v. Donovan, Secretary of Labor, et al. 452 U.S.C. 490 (1981).Google Scholar
  4. 4.
    D. Kessler, Food Safety: Revising the Statute. Science 223: 1034–1040 (1984).CrossRefGoogle Scholar
  5. 5.
    Food and Drug Adiministration Policy for Regulating Carcinogenic Chemicals in Food and Color Additives (Proposed) Federal Register 47: 14464 (1982).Google Scholar
  6. 6.
    Environmental Protection Agency, Federal Register 49: 18, 130 (1984).Google Scholar
  7. 7.
    Nuclear Regulatory Commission, Safety Goals for Nuclear Power Plants: A Discussion Paper (NUREG 0880; February, 1982 ); Revision I: Safety Goals for Nuclear Power Plants (May, 1983 ).Google Scholar
  8. 8.
    Statutes using significant risk: a. Uranium Mill Tailings Radiation Control Act of 1978, 2, 42 U.S.C. 7901 (1982). b. Toxic Substances Control Act, 2, 15 U.S.C. 2601 (1982). c. Naturel Gas Policy Act of 1978, 2, 15 U.S.C. 3301 (1982). d. Solid Waste Disposal Act Amendments of 1980, 1, 42 U.S.C. 6901 (1982). e. Intervention on the High Seas Act, 2, 33 U.S.C. 1471 (1982). f. Deepwater Port Act of 1974, 2, 33 U.S.C. 1501 (1982).Google Scholar
  9. 9.
    Regulations using significant risk: a. Drug Programs, 28: CFR 550 (6/29/79; DOJ). b. Domestic Quarantine Notices, 7: CFR 301 (12/16/67; Animal and Plant Health Inspection Service, USDA). c. Domestic Licensing of Production and Utilization Facilities, 10: CFR 50 (1/19/56, 3/3/75) (NRC). d. Procedures for Compliance with the National Environmental Policy Act, 12: CFR 408 (8/30/79) (CEQ). e. Assessing the Environmental Effects Abroad of EPA Actions, 40: CFR 6.1001 (1/14/81) (EPA). f. Pilot Rules (DOT), 33: CFR (4/15/82) (CGD). g. General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, 21: CFR 81 (3/22/77) (FDA). h. Investigational Device Exemptions (FDA), 21: CFR 812 (1/18/80) (FDA). i. Banned Devices, 21: CFR 895 (5/18/79) (FDA). j. Administrative Functions, Practices, and Procedures, 21: CFR 1316 (4/24/71; 9/24/73) (FDA). k. Geological and Geophysical Explorations on the Outer Continental Shelf, 30: CFR 251 (1/25/80). 1. National Interim Primary Drinking Water Regulations, 40: CFR 141 (12/24/76) (EPA). m. General Statements of Policy or Interpretations (CPSC), 16: CFR 1009 (11/1/76). n. Substantial Product Hazard Reports (CPSC), 16: CFR 1115 (8/7/78). o. Regulation of Products Subject to Other Acts Under The Consumer Product Safety Act (CPSC), 16: CFR 1145 (9/1/77). p. Ban of Artificial Emberizing Materials (Ash and Embers) Containing Respirable Free-Form Asbestos (CPSC), 16: CFR 1305 (12/15/77). q. Environmental Quality, 14: CFR 1216 (1/4/79; NASA). r. Protection of Human Subjects (HHS), 45: CFR 46 (3/13/75). s. General Provisions (DOT), 46: CFR 161 (7/10/74). t. Vessel Traffic Management, 33: CFR 161 (7/10/74; DOT). u. Navigational Safety Regulations (DOT), 33: CFR 164 (1/31/77). v. Facilities Engineering, Natural Resources-Land Forest and Wildlife Management (USA), 32: CFR 642 (03/28/77). w. Environmental Protection and Enhancement (USA), 32: CFR 650 (12/29/77). x. Reporting of Defects and Noncompliance (NRC), 10: CFR 21 (06/6/77). y. Patent Licensing Regulations (DOE), 10: CFR 781 (11/4/80).Google Scholar
  10. 10.
    The Occupational Safety and Health Act of 1970, Pub. L. 91–596, December 29, 1970, 84 Stat. 1590.Google Scholar
  11. 11.
    The Clean Air Act Amendments of 1977, Pub. L. 95–95, August 7, 1977, 91 Stat. 685.Google Scholar
  12. 12.
    Ethyl Corp, V. EPA; 541 F.2d 1, 26 ( D.C. Cir., 1976 ).Google Scholar
  13. 13.
    Secretary of Labor, Mine Safety and Health Administration (MSHA) v. Cement Control Division, National Gypsum Co. FMSHRC (Federal Mine Safety and Health Review Commission) Docket No. VINC 79–154-PM, April 7, 1981.Google Scholar
  14. 14.
    U.S. Department of Health, Education and Welfare, U.S. Decennial Life Tables for 1969–1971. DHEW Publication No. (HRA) 75–150; National Center for Health Statistics; Rockville, Md. (1975).Google Scholar
  15. 15.
    B. L. Cohen and I. S. Lee, A Catalogue of Risks, Health Physics 36: 707–722 (1979).CrossRefGoogle Scholar
  16. 16.
    A. S. Whittemore, Quantitative Theories of Oncogenesis. Advances in Cancer Research 27: 55–88 (1978).CrossRefGoogle Scholar
  17. 17.
    J. C. Rock, The NIOSH Action Level-A Closer Look. Chapter 29 in: Chemical Hazards in the Workplace, G. Choudhary (Ed.), ACS Symposium Series 149; Washington, D.C. (1981).Google Scholar
  18. 18.
    National Research Council; Committee on the Biological Effects of Ionizing Radiation, The Effects on Populations of Exposure to Low Levels of Ionizing Radiation. National Academy Press; Washington, DC (1980).Google Scholar
  19. 19.
    P. Milvy, A General Guideline for Management of Risk from Carcinogens. Risk Analysis 6: 69–79 (1986).CrossRefGoogle Scholar
  20. 20.
    Occupational Safety and Health Administration, Occupational Exposure to Inorganic Arsenic: Supplemental Statement of Reasons for Final Rule. Federal Register 48: 1864 (1983).Google Scholar
  21. 21.
    Occupational Safety and Health Administration, Occupational Exposure to Ethylene Dibromide; Notice of Proposed Rulemaking. Federal Register 48: 45956–46003 (1983).Google Scholar
  22. 22.
    Occupational Safety and Health Administration, Occupational Exposure to Ethylene Oxide; Final Standard, Federal Register 49: 25734–25809 (1984).Google Scholar
  23. 23.
    Occupational Safety and Health Administration, Occupational Exposure to Asbestos; Proposed Rule and Notice of Hearing. Federal Register 49: 14116–14145 (1984).Google Scholar
  24. 24.
    Environmental Protection Agency, National Emissions Standards for Hazardous Air Pollutants; Addition of Coke Oven Emissions to List of Hazardous Air Pollutants. Federal Register 49: 36560–36564 (1984).Google Scholar
  25. 25.
    Environmental Protection Agency, 4,4’-Methylenedianiline; Initiation of Regulatory Action. Federal Register 48: 42898–42900 (1983).Google Scholar
  26. 26.
    Environmental Protection Agency, Toxic Substances; 1,3-Butadiene; Initiation of Regulatory Action. Federal Register 49: 20524–20528 (1984).Google Scholar
  27. 27.
    Environmental Protection Agency, National Emission Standards for Hazardous Air Pollutants; Background Information Document (Integrated Risk Assessment) Final Rules for Radionuclides. Office of Radiation Programs; October 22, 1984; EPA 520/1–84–022–2.Google Scholar
  28. 28.
    Environmental Protection Agency, National Emission Standards for Hazardous Air Pollutants; Proposed Standards for Benzene Emissions from Coke By-product Recovery Plants; Proposed Rule and Notice of Public Hearing. Federal Register 49: 23522–23555 (1984).Google Scholar
  29. 29.
    Environmental Protection Agency, National Emission Standards for Hazardous Air Pollutants; Benzene Equipment Leaks (Fugitive Emission Sources); Final Rule. Federal Register 49: 23498–23520 (1984).Google Scholar
  30. 30.
    Environmental Protection Agency, National Emissions Standards for Hazardous Air Pollutants; Proposed Standards for Inorganic Arsenic. Federal Register 48: 33112–33180 (1983).Google Scholar
  31. 31.
    Environmental Protection Agency, Formaldehyde: Determination of Significant Risk; Advance Notice of Rulemaking and Notice. Federal Register 49: 21870–21897 (1984).Google Scholar
  32. 32.
    Occupational Safety and Health Administration, Coke Oven Emissions, 29: CFR 1910.1029 (10/22/76; 1/18/77; 5/23/80).Google Scholar
  33. 33.
    Environmental Protection Agency, Benzene Emissions from Maleic Anhydride Plants, Ethylbenzene Styrene Plants, and Benzene Storage Vessels; Proposed Withdrawal of Proposed Standards. Federal Register 49: 8386–8391 (1984).Google Scholar
  34. 34.
    Environmental Protection Agency, National Emission Standards for Hazardous Air Pollutants; Vinyl Chloride. Federal Register 50: 1182–1201 (1985).Google Scholar
  35. 35.
    P. Slovic, B. Fischhoff and S. Lichtenstein, Behavioral Decision Theory Perspectives on Risk and Safety. Acta Psychologica 56: 183–203 (1984).CrossRefGoogle Scholar
  36. 36.
    D. Litai, A Risk Comparison Methodology for the Assessment of Acceptable Risk. Ph.D. Thesis; Massachusetts Institute of Technology; Cambridge, Mass. (1980).Google Scholar
  37. 37.
    R. L. Keeney, Ethics, Decision Analysis, and Public Risk. Risk Analysis 4: 117–129 (1984).CrossRefGoogle Scholar
  38. 38.
    U. S. National Highway Transportation Safety Administration, Highway Needs Study: 1981 Update of 1976 Report to Congress, U.S. Department of Transportation, Washington, D.C., DOT-HS-806–283, (1981).Google Scholar
  39. 39.
    Nuclear Regulatory Commission, 10: CFR 50,Appendix I, (1977).Google Scholar
  40. 40.
    P. F. Deisler, A Methodology for Reducing Industrially Related Cancer Risk. In: Reducing the Carcinogenic Risks in Industry, Paul F. Deisler, Jr. (Ed.), Marcel Dekker, Inc.; New York (1984).Google Scholar

Copyright information

© Plenum Press, New York 1987

Authors and Affiliations

  • Daniel ByrdIII
    • 1
  • Lester Lave
    • 2
  1. 1.Halogenated Solvents Industry AllianceUSA
  2. 2.Graduate School of Industrial AdministrationCarnegie-Mellon UniversityPittsburghUSA

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