The New Millennium: Values, Perceptions of Risk and the Key Roles of Science and Technology

1. The New Millennium: Values, Perceptions of Risk and the Key Roles of Science and Technology Ionizing Radiation Science and Protection In the 21st Century Gilbert S. Omenn, MD, PhD Executive Vice President for Medical Affairs and CEO, University of Michigan Health System National Council on Radiation Protection and Measurements April 5-6, 2000 Arlington, Virginia

2. AMERICAN VALUES FOR THIS MILLENNIUM Sustainable development: Robust economy, environmental protection, inter-dependent world Freedom of speech, freedom of religion, freedom from want, freedom from fear (FDR, 1941) Transparency of decision-making in an internet- informed or misinformed, more empowered populace High expectations and benefits and tolerance for risks from science and technology

3. SOURCES OF IONIZING RADIATION EXPOSURES • Nature background; radon progeny • Medical Diagnostic and Therapeutic Uses • Industrial Radionuclides • Radioactive Liquid and Solid Wastes • Nuclear Power Plant Operations / Emissions Risk • Decommissioning of Nuclear Reactors

4. “I know no safe depository of the ultimate powers of society but the people themselves; if we think them not enlightened enough to exercise their control with a wholesome discretion, the remedy is not to take it away from them, but to inform their discretion.” - Thomas Jefferson

5. NOT OBSERVABLE Unknown to those exposed Effect delayed New risk Risks unknown to science OBSERVABLE Known to those exposed Effect immediate Old risk Risks known to science RISK PERCEPTION

6. CONTROLLABLE Not dread Not catastrophic Not fatal Equitable Low risk to future generations Easily reduced Risk decreasing Voluntary UNCONTROLLABLE Dread Global catastrophic Consequences fatal Not equitable High risk to future generations Not easily reduced Risk increasing Involuntary

7. FRAMEWORK FOR REGULATORY DECISION-MAKING Epidemiology Hazard Identification Lifetime rodent bioassays Short-term, in vitro tests Structure / activity Potency (dose/response) Risk Characterization Exposure analysis Variation in susceptibility Information Risk Reduction Substitution Regulation / Prohibition

8. Objectives of Risk Assessment 1.Balance risks and benefits Drugs Pesticides 2. Set target levels of risk Food contaminants Water Pollutants 3. Set priorities for program activities Regulatory agencies Manufacturers Environmental/Consumer organizations 4. Estimate residual risks and extent of risk Reduction after steps are taken to reduce risks

10. Cancers Mutations Birth Defects Reproductive Toxicity Immunological Toxicity Neurobehavioral Toxicity Organ-Specific Effects Endocrine Modulation/Disruption Ecosystem Effects BIOLOGICAL END-POINTS

11. Major Toxic Chemical Laws EPA: Air pollutants Clean Air Act 1970, 1977, 1990 Water Pollutants Fed WP Control Act 1972, 1977 Safe Drinking Water Safe DW Act 1974 Pesticides FIFRA 1972 Ocean Dumping Marine Protection Act Toxic Chemicals TSCA 1976 Hazardous Wastes RCRA 1976 Hazardous Waste Cleanup CERCLA (Sperfund) 1980, 1986 CEQ: Envvlt Impacts NEPA OSHA: Workplace OSH Act FDA: Foods, Drugs, Cosmetics FDC Acts CPSC: Dangerous Consumer Products CPS Act DOT: Transport of Haz Materials THM Act

12. MANDATE • Uses and limitation of risk assessment in decision-making • Appropriate exposure scenarios • Uncertainty and risk communication • Risk management policy issues • Consistency across agencies

14. EXPOSURE • Sources • Pathways • Environmental transformations • Routes of entry • Time course of exposures • Concept of total exposure • Need for translation from ambient levels to target tissue effective dose • New methods for tissue burdens and dosimetry

15. MIXTURES Test real world mixtures diesel exhaust urban smog actual effluents pesticide combinations workplaces Assume additivity of risks as default; use mechanisms, if known Pay attention to radiation and microbial exposures/risks

16. PUTTING ENVIRONMENTAL RISKS INTO CONTEXT • Multi-Source • Multi-Media • Multi-Chemical / Multi-Agent • Multi-Risk

17. CONTEXT Multi-Source Multi-Media Multi-Agent Multi-Risk Public Health Status/Trends Ecological Health Social & Cultural Environmental Justice Considerations

18. Reducing risk by orders of magnitude is not equivalent to linear reductions Risk Commission, Final Report, 1997

19. RISK COMMISSION RECOMMENDATION (1997 REPORT, p. 82) A concerted effort should be made to evaluate and relate the methods, assumptions, mechanisms, and standards for radiation risks to those for chemicals to clarify and enhance the comparability of risk management decisions, especially when both types of hazards are present.

20. LACK OF COLLABORATION ON CHEMICAL AND RADIATION HAZARDS • Different models of carcinogenesis • Different regulatory laws and agencies • Different disciplines and scientific meetings • Smaller margin of exposure tolerated for IR • Despite common waste streams and co-existing contamination

21. POLICY AND PUBLIC INTEREST IN COMPARISONS OF RISK Discrepancy between levels of risk considered negligible for radiation exposures and for chemical exposures WorkersGeneral PopulationComments Chemicals 10-3 10-6 Single chemicals Radiation 50 mSV/yr 1mSV/yr Integrated Dose 10-1 / 10-2 Ratio of 50 vs 300+ Importance of interactions of radiation and chemicals, of radiation and infectious disease risks.

22. BEIR VII - Phase 1 Letter---21 January, 1998 • Continued reliance on epidemiological studies • Lots of laboratory studies • OPPORTUNITY FOR REALLY BIG BREAKTHROUGH - Patterns of gene expression on microarray and protein expression in proteomics readouts that reflect carcinogenesis: key to resolving long-festering questions about risks of low-level exposures

23. OUR GENETIC FUTURE “Mapping the human genetic terrain may rank with the great expeditions of Lewis and Clark, Sir Edmund Hillary, and the Apollo Program.” --Francis Collins, Director National Human Genome Research Institute, 1999