IU SPEA in Central London SYLLABUS Program Title: Managing Hazards in Europe and the United States Faculty: Professor John D. Graham (IU) and Professor Ragnar Lofstedt (King’s) Location: Department of Geography, King’s College London Dates: June 29, 2009 – July 24, 2009 Credits: Six (two three-credit courses) Program Overview The purpose of this six-credit offering is to examine how hazards are managed through a mixture of lectures, case studies, and classroom discussions. The program is offered in an educational context that invites comparison of how the United States and Europe cope with known or potential hazards to human health, safety and the environment. The intellectual style of the course will be interdisciplinary, with significant reliance on disciplinary contributions from environmental science, public health, public management, non-profit management, policy analysis, political science, economics and law. This is not a technical course in the methods of risk assessment or risk-benefit analysis. It is a management course. However, some of the lectures and case material will have significant scientific and quantitative content. Precourse reading requirements include some background on the European Union and some background on risk analysis. There are no course prerequisites. Undergraduate SPEA students may obtain credit toward their majors. MPA and MSES students in SPEA can also earn credit for the course if, in addition to fully participating in the course, they prepare (solo or in pairs) a research paper comparing how the USA and the UK manage a particular hazard. Schedule of the Class The course will meet each day during the week from June 29, 2009 to July 24, 2009. The morning session, primarily lecture, will run from 10:00 AM to 11:30 AM. The afternoon session, primarily seminar discussion, will run from 2:00 to 3:30 PM. The formal course sessions will be supplemented by some course-relevant excursions in London, including at least one formal dinner with a speech by a UK public official or a panel discussion by UK public servants. Expectations of Students A grade will be awarded for each three credit hour course. For the two classes (six credit hours) for undergraduate student, grades will be comprised of three in-class exams (60%), role-playing in one of the case studies (20%), essay on an approved topic of the student’s choice (10%), and class participation (10%). Grades for MPA and MSES studies will be determined 50% by the research paper, with the remainder divided proportionately across exams, role-playing, and class participation. 1 Reading Assignments Prior to Arrival in London J.McCormick. 2001. Environmental Policy in the European Union. Basingstoke: Palgrave, p.1-151 Richard Wilson and Edmund A.C. Crouch, Risk-Benefit Analysis, Harvard University Press, Cambridge, MA, 2001. SESSION 1 How Hazards are Identified and Assessed Leader: Professor Graham Topics: terminology; definitions of hazard and risk; probability versus outcome; types of hazards; measures of risk; uncertainty and variability; low probability, high-consequence events; damage assessments; comparing hazards; an example of a hazard that differs in the USA and the UK. John D. Graham and Lorenz Rhomberg, “How Risks are Identified and Assessed,” ANNALS (AAPSS), 545, May 1995, 15-24. SESSION 2: Prescription Drugs: Case Studies of Hazard Identification and Risk Assessment Topic: how hazards from prescription drugs are identified in medicine, and how they influence treatment protocols. Leader: Professor Graham Evridiki Hatziandreu, Constance Williams, John D. Graham, “Estrogen Therapy for Menopause,” in Risk vs Risk: Tradeoffs in Protecting Health and the Environment, Harvard Press, Cambridge, MA, 1995, pp. 42-52; Miriam E. Adams, Howard Chang, Howard S. Frazier, “Clozapine Therapy for Schizophrenia,” in Risk Vs. Risk, 53-71. (two short cases on prescription drugs to be read before the students arrive in London or the Sunday evening prior to the first day of class). SESSION 3: Setting Priorities among Hazards Topic: If limited resources preclude management of all hazards, how should priorities be set? The analytic solutions of experts may differ from what happens in the political process. Leader: Professor Graham M. Granger Morgan , Baruch Fischhoff, Lester Lave and Paul Fischbeck, “A Proposal for Ranking Risk within Federal Agencies: Tools for Setting Government Priorities,” in Comparing Environmental Risks (ed., J. Clarence Davies), Resources for the Future, Washington, DC, 1996, 111-147. John D. Graham, Laura C. Green, and Marc J. Roberts, “Setting Regulatory Priorities: Chemicals and Cancer Risk,” In Search of Safety: Chemicals and Cancer Risk, Harvard Press, Cambridge, MA, 1988, pp. 8-37. 2 SESSION 4: Competing Management Frameworks Topic: The classic frameworks for managing risks: zero risk, insignificant risk, lowest feasible risk, and the efficient level of risk. Leader: Professor Graham John D. Graham, Laura C. Green, and Marc J. Roberts, “The Problem of Setting Standards,” 80-114. SESSION 5: When Solving One Hazard Creates Another Topic: History suggests that solving one hazard often leads to another. How can one predict these “countervailing” hazards, and how might one assess and minimize them. Professor Graham John D. Graham and Jonathan B. Wiener, “Confronting Risk Tradeoffs,” Risk Versus Risk: Tradeoffs in Protecting Health and the Environment, Harvard Press, Cambridge, MA, 1995, 1-41. SESSION 6: Weighing Risk and Benefit: Who Decides Topics: When determining the optimal balance between risk and benefit, the locus of decision making varies from complete individual choice to complete control by a regulatory body, as well as many hybrid models between these extremes. How regulatory trends in the US and the EU are diverging. Leader: Professor Graham John D. Graham, “The Risk-Benefit Balance in the United States: Who Decides?” Health Affairs, 26(3), May/June 2007, 625-635. R.Lofstedt and D. Vogel. 2001. The changing character of regulation: A comparison of Europe and the United States. Risk Analysis, vol.21, p.399-406. SESSION 7: Public Perception of Risk Topics: the psychometric perspective on risk perception; attributes of hazards that provoke public concern; public acceptance of risks; accidents as signals; heuristics that influence risk perception; technological stigma; social cascades; alarmism and apathy; an example of how the same risk is perceived differently in the US and the EU. Leader: Professor Lofestdt Paul Slovic, “Perception of Risk,” Science, April 17, 1987, 280-285. D. Kahneman and A. Tversky. 1974. Judgment under uncertainty: Heuristics and biases. Science, vol.185, p. 11241131. 3 SESSION 8: Risk Communication I Topic: How the field of risk communication evolved from risk perception research. Leader: Professor Lofstedt B. Fischhoff. Risk perception and communication unplugged:Twenty years of process. Risk Analysis, vol.15, p.137145. SESSION 9: Risk Communication II Topic: why fears of some hazards are amplified and others suppressed; how predictable biases in personal risk perception can be overcome with communication; the future of risk communication. Leader: Professor Lofstedt Reading: R. Kasperson, O. Renn, and P. Slovic et al. 1988. The social amplification of risk: A conceptual framework. Risk Analysis, vol.8, p.177-187. N.D. Weinstein. 1989. Optimistic biases about personal risks. Science, vol.246, p.1232-1233. SESSION 10: What Managers Should Do When Experts and the Public Disagree Topic: How the nature of a hazard should influence how it is managed; how different technical and perceptual contexts inform the selection of management strategies; the difference between “pure” democracy and “deliberative” democracy in risk management. Leader: Professor Lofstedt Klinke and O. Renn. 2002. A new approach to risk evaluation and management: Risk-based, precaution based and discourse based strategies. Risk Analysis, vol.22, p.1071-1094 Cass R. Sunstein, Risk and Reason: Safety, Law, and the Environment, Cambridge University Press, New York, 2002, 28-77. SESSION 11: Exam SESSION 12: Regulating Risks in the USA: The Institutional Framework Topic: How the statutory, administrative and legal setup in the United States influence the way hazards are managed. Leader: Professor Graham Cass Sunstein, Risk and Reason: Safety, Law, and the Environment, 191-250. 4 SESSION 13: Regulating Risks in Europe: The Institutional Framework Topic: How the design of the European Union, and the governance of the member states, influence the way hazards are managed. How regulatory trends in the USA and Europe are diverging. Leader: Professor Lofstedt Reading: R.E.Lofstedt. 2004. The swing of the regulatory pendulum in Europe: From precautionary principle to (regulatory) impact analysis. Journal of Risk and Uncertainity, vol.28, p.237-260. SESSION 14: Safety Belt Use, Adults and Children Topic: How the USA and Europe have differed in their handling of a pervasive human problem: the failure of motorists to wear safety systems when traveling. Leader: John D. Graham B.J. Campbell and Frances A. Campbell, “Injury Reduction and Belt Use Associated with Occupant Restraint Laws,” in Preventing Automobile Injury: New Findings from Evaluation Research, Auburn House, Dover, MA, 1988, 24-50. Maria Segui-Gomez, Roberta Glass, John D. Graham, “Where Children Sit in Motor Vehicles: A Comparison of Selected European and American Cities,” Injury Prevention, 4, 1998, 98-102. SESSION 15: Discussion: Is a law compelling use of safety belts an appropriate use of governmental authority over citizen behavior? John D. Graham, Auto Safety: Assessing America’s Performance, Praeger, 1989, 16-36, 60-87. SESSION 16: Automobile Airbags in the USA and Europe Topic: Why the penetration of airbag technology was faster in the USA than Europe; how the adverse effects of airbags were identified, perceived and managed. Leader: John D. Graham John D. Graham, “Technological Danger Without Stigma; The Case of Automobile Airbags,” in Risk, Media, and Stigma: Understanding Public Challenges to Modern Science and Technology (eds, James Flynn, Paul Slovic, Howard Kunreuther), Earthscan, London, 2001, 241-255. SESSION 17: Discussion Question: If airbags protect adults but pose a hazard to children, how should the hazard be managed? Leader: Professor Graham John D. Graham, Sue J. Goldie, Maria Segui-Gomez, Kimberly M. Thompson, Toben Nelson, Roberta Glass, Ashley Simpson, Leo G. Woerner, “Reducing Risks to Children in Vehicles with Passenger Airbags,” Pediatrics (electronic edition), 1998, 2(1), 1998, url: http//www.pediatrics.org/cgi/content/full/102/1/e3. 5 SESSIONS 18: Genetically Modified Organisms (GMOs) I Topic: An Introduction to European and US policies toward genetically modified organisms. Leader: Professor Lofstedt G. Gaskell, N. Allum and W. Wagner et al. 2004. GM foods and the misperception of risk perception. Risk Analysis, vol.24, p.185-194. S. Jasanoff. 2000. Between risk and precaution: Reassessing the future of GM crops. Journal of Risk Research, vol.3, p.277-282 L. Levidow, S. Carr and D. Wield. 2000. Genetically modfied crops in the European Union: Regulatory conflicts as precautionary opportunities. Journal of Risk Research, vol.3, p.189-208. Session 19. GMOs II Discussion question: Why do public perceptions differ with regard to the acceptability of genetically modified organisms in Europe and the United States? Leader: Professor Lofstedt R. Lofstedt, B. Fischhoff and I. Fischhoff. 2002. Precautionary principles: General definitions and specific applications to genetically modified organisms. Journal of Policy Analysis and Management, vol.21, p.381-407. Add decision from World Trade Organization on genetically modified seeds and their use in European agriculture. SESSION 20: Cell Phones and Cell Towers. Topic: The ongoing European and US debate regarding public and stakeholder perceptions toward cell phones and cell towers. What has stimulated the controversy and how it might be resolved. Leader: Professor Lofstedt A. Burgess. 2004. Cellular phones, public fears and a culture of precaution. Cambridge: Cambridge University Press. SESSION 21: Exam SESSION 22. Cell phones and cell towers II Discussion question: Why are the publics more concerned about risks associated with cell towers than cell phones? Leader Professor Lofstedt 6 SESSION 23: Use of QT Biomarkers in Medicine I Topic: “Biomarkers” used by the pharmaceutical industry to help define sub-categories of patients at risks; implications for risk assessment and communication. Leader: Dr. Bouder R. Shah, ‘Drugs, QT interval prolongation and ICH E14: the need to get it right’. Drug Safety , 2005, 28: 115-125 F. Bouder, ‘Regulating risks resulting from the lengthening of the QT interval: a regulatory tennis game across the Atlantic’, Journal of Risk Research, 2007, 10(3): 385-412 SESSION 24. Biomarker Qt II Discussion Question: When European and US regulator introduce a new method to regulate health risks, what key lessons of risk assessments should they apply? Leader: Dr. Bouder SESSION 25: Air Quality Near Industrial Plants Leader: Professor Graham Jennifer Kassalow Hartwell and John D. Graham, “Fewer Fumes from Coke Plants.” The Greening of Industry, Harvard Press, 1997, 137-168. SESSION 26: Discussion Question: If risk regulations may place domestic industry at competitive risk in global competition, who should the risk be managed? Leader: Professor Graham Case Study on Coke production, Harvard Center for Risk Analysis. SESSION 27: Aspartame I Topic: The session provides an introduction to the 2005 scare stipulating that aspartame (an artificial sweetener) could cause cancer in laboratory animals and therefore should be banned. The scare ended following the European Food Safety Authority conducting an independent analysis of the data which showed that the link could not be proved. Leader: Professor Lofstedt R.E.Lofstedt. 2008. Risk communication, media amplification and the aspartame scare. Risk Management, vol.10, p.257-284. 7 Session 28: Aspartame ll Leader: Professor Lofstedt Discussion question: What is it easier to “amplify” in the media some food safety issues than others? SESSION 29: Arsenic in Drinking Water Leader: Professor Graham Cass Sunstein, Risk and Reason, 153-190. SESSION 30: Discussion Question: Should health-based water quality standards be the same in all parts of the United States (or the world), regardless of the wealth and income of the communities who pay the water bills? SESSION 31: Exam SESSION 32: Agricultural Pesticides I Topic: Exploring risk governance variety: the case of pesticide residues in the EU. Variety in risk governance is often commented upon, but how can it be explained? Leader: Dr. Rothstein Readings: Hood, C., Rothstein, H. and Baldwin, R. 2001. Government of Risk, Oxford, OUP. Ch’s. 1, 2, 4 and 8. Rothstein, H., Irwin, A., Yearley, S. and Mc. Carthy, E. 1999. Regulatory Science, Europeanisation and the Control of Agrochemicals. Science, Technology and Human Values, 27 (2): 241-264. SESSION 33: Agricultural Pesticides II Topic: In the EU, pesticide residues in food are subject to health based limits but pesticide residues in water are subject to vanishingly small levels. Can this difference be justified or is it a case of regulatory incoherence? What are the consequences of such variation? Leader: Dr. Rothstein SESSION 34: The VIOXX Story I Topic: The introduction of Cox 2s and the 2004 Merck recall of Vioxx (a Cox-2 product), following a clinical trial that showed that Vioxx was linked to increased cardiovascular adverse events. Who drove the story and what was the response of industry and the regulators? Leader: Professor Lofstedt Reading: R.E.Lofstedt. 2007. The impact of Cox-2 issue on perceptions of the pharmaceutical industry: Content analysis and communication implications. Journal of Health Communication, vol.12, p.471-491. 8 Session 35. The VIOXX Story II Discussion question: Why has public trust in large pharmaceutical companies and the medical regulators been damaged? Do you think this distrust is justified and what steps, if any, could be taken to rebuild it? Leader: Professor Lofstedt SESSION 36: Climate Change I: The Road to Kyoto Topic: The scientific, political and legal foundations of the Kyoto Protocol aimed at combating climate change. Leader: Dr. Bouder Michael Grubb, Christiaan Vrolijk, The Kyoto Protocol: A Guide and Assessment, The Royal Institute of International Affairs, Earthscan, 1999, 3-60. SESSION 37: Climate Change II: The Kyoto Treaty Topic: How the Kyoto Protocol was Negotiated and the Final Provisions Leader: Dr. Bouder Michael Grugg et al, 1999, 61-152. SESSION 38: Climate Change III: Is Kyoto Working? Topic: The flaws in Kyoto and paths to solutions. Leader: Professor Graham Readings: Richard B. Stewart, Jonathan B. Wiener, Reconstructing Climate Policy: Beyond Kyoto, AEI Press, Washington, DC, 2003. SESSION 39: Climate Change IV: The Link to Sustainability Topic: How climate change fuels the sustainability agenda at a global, national and community level. Leader: Dr. Bouder OECD, "Emerging risks in the 21st century, an agenda for action" OECD , Paris, 2003. OECD, "Governance for Sustainable Development, five OECD case studies", OECD, Paris, 2002. 9 Session 40: Precaution in the USA and Europe Topic: What does systematic research show about whether Americans or Europeans are more precautionary. How have controversies about hazards strained US-EU relations, and is there a pathway toward more cooperation. Leaders: Professors Graham and Lofstedt R.E. Lofstedt. 2007. The platea-ing of the European better regulation agenda: An analysis of activities carried out by the Barroso Commission. Journal of Risk Research, vol. 10, 423-447. J. Wiener and M. Rogers. 2002. Comparing precaution in the US and Europe. Journal of Risk Research, vol.5, 317349. 10