Risk Assessment as a Risk Management Tool

1. Risk Assessment as a Risk Management Tool Bernard D. Goldstein, MD University of Pittsburgh Graduate School of Public Health

2. Objectives of this Lecture • The student will: • better understand the tools available to risk managers, particularly the role of risk assessment • better understand the determinants of environmental policy • become knowledgeable about the roles of the various governmental and non-governmental organizations involved in managing environmental risk

3. The Three Approaches to Achieving A Policy Goal • Reward • Punish • Educate

4. What Are the Components of Risk Assessment? • Hazard identification • Dose-response evaluation • Human exposure evaluation • Risk characterization

5. Uses of Risk Assessment for Management Decision Making • Federal (US and others) Regulations: • Environmental standards (air, water, hazardous waste, etc.) • Food safety (chemical contaminants, additives, pathogens) • Manufacturing and production (pharmaceuticals, pesticides, etc.) • International Trade /WTO SPS Agreement: • Food products (Safety Assessment and Acceptable Daily Intake [ADI]) • Animals and animal products • Plants and plant products

6. Risk Management Selection of an appropriate course of action using • Risk assessment • Statutory and legal requirements • Economic effects • Social considerations • Informed judgments

7. Politics Press Public Perception Bureaucratic Imperatives Law Economics Science Ethics Driving Forces in Risk Management

8. Alphabet Soup • State or local environmental/health agencies • Non-Governmental organizations (NGO) • Federal agencies • Environmental Protection Agency (EPA) • Interior, Agriculture, CPSC • Health and Human Services (HHS) • Food and Drug Administration (FDA) • Natl Institute for Environmental Hlth Sci (NIEHS) • Centers for Disease Control (CDC) • Center for Environmental Health (CEH) • Agy for Toxic Substances and Disease Registry (ATSDR) • Natl Institute Occup Safety and Health (NIOSH)

11. Reasons to Protect Ecosystems • Protect human health through maintaining the purity of the food and water supply • Protect species related to human activities • Protect the planet • It is the right thing to do ethically and morally

12. No one would rather hunt woodcock in October than I, but since learning of the sky dance I find myself calling one or two birds enough. I must be sure that, come April, there be no dearth of dancers in the sunset sky. Aldo Leopold A Sand Country Almanac, 1966

13. Competing Goals in Managing Access to America’s Natural Assets • Maximize access so that all Americans can appreciate and obtain personal benefit from the beauties of our natural heritage • Minimize access so as to preserve for future generations the pristine nature of our natural heritage

14. When I grow up, I want to be a business mogul, live in a villa in the suburbs, wear a suit by Pierre Cardin, and drive a Mercedes-Benz 600 to work in Beijing. Chinese 5th Grader, quoted in World Press Review, November, 1997

15. FORTUNATE GENERATION: BORN AFTER THE ADVENT OF ANTIBIOTICS, GONE BEFORE THE OIL RUNS OUT

16. Definition of Sustainable Development “…to meet the needs of the present without compromising the ability of future generations to meet their own needs.” The World Commission on Environment and Development (The Brundtland Commission), Our Commission Future (Oxford: Oxford University Press, 1987), p. 43

17. Decision-Making Cultures, Nature Myths, and Response Strategies SUSTAINABLE DEVELOPMENT PREVENTIVE ADAPTIVE • Nature is robust • Morally wrong to curtail development • Nature is robust within limits • Morally imperative to preserve choice • Nature is fragile • Morally wrong to abuse nature

18. Risk Management Example Pesticide X Exposure assessment • Chemical is rapidly destroyed by sunlight • Production process is totally enclosed • Minimal residues remain on food • Extensive skin contact during mixing and application

19. So What Do We Do About It? FIFRA mandate is to control “Unreasonable Adverse Effect” “. . . taking into account the economic, social, and environmental costs and benefits.” FIFRA Sec. 3 (c) (5) (c) FIFRA Sec. 2 (bb)

20. Other Statutes SDWA calls for establishment of “maximum contaminant levels” at which “no known or anticipated adverse effects” occur and which allow an “adequate margin of safety.” SDWA Sec. 1412 (b) 1 (B)

21. Non Risk Analysis • Crop yields not significantly affected • Minimal increase in pesticide production costs • No substantial use of alternative, more toxic, pesticides

22. Risk Management Decision Formulation Restriction • Deny use as a liquid and permit use in granular form Application Restrictions • Prohibit entry to field immediately following treatment • Require interval between last treatment and harvest

23. Pollution Control Standards • Performance standards • Emission standards • Ambient Standards • Environmental Indicators • Health Standards

24. Second Order Issues in Pesticide Use • No till agriculture and pesticide/herbicide use • Replacement of persistent agents by acutely toxic compounds • Ecological impacts through altered land use patterns

25. Legal vs Public Health Approaches to Anticipating Risk • Legal Approach to Anticipating Risk: • Assume complete compliance • Hold sinners responsible • Public Health Approach to Anticipating Risk: • Assume incomplete compliance • Hold public health officials responsible

26. Alternatives to Command and Control • Common Sense Initiative • Project Excel • Environmental Indicators • Education

27. The Banning of Chlorine Criteria derived from the attempted ban on asbestos: • Is there a reasonable similarity in the potential for adverse consequences of all of the members of the chemical class? • Are there replacements available for the societal benefits, including value to human and ecological health, provided by this class of compounds? • Are we reasonably certain that the replacement compounds or activities are not more harmful than a focused approach to the problem.

28. Environmental Justice Indisputable Facts • There are more environmental hazards in disadvantaged communities • There are more individuals with poor health in disadvantaged communities • Individuals with poor health tend to be more susceptible to environmental pollutants

29. Environmental JusticeKey Factors • Problem is real but extent is unknown • Need for better indicators of environmental health • Local context must be understood • Citizen involvement is central to resolution • Jobs and the environment, not jobs vs the environment. • Restoration of Brownfields

30. Seven Ploys to “Manage” Inconvenient Scientific Findings • Ask for more research • Ask for more review • Obfuscate • Control the communication of science • Set the wrong target • Set up a strawperson • Attack the integrity of the scientist

32. Framework is Conducted: • In collaboration with stakeholders. • Usingiterationsif new information is developed that changes the need for or nature of risk management.

33. Framework for Risk Management • Define the problems and put it into context. • Analyze the risks associated with the problem in context. • Examine the options for addressing the risks. • Make decisions about which options to implement. • Take actions to implement the decisions. • Conduct the evaluation of the action’s results.

34. THE ONLY CERTAIN PREDICTION FOR THE NEXT DECADE IS THAT THERE WILL BE AT LEAST ONE MAJOR ENVIRONMENTAL PROBLEM THAT NO ONE NOW PREDICTS.