EHH500d – Spring 2002 Harvard School of Public Health RISK ASSESSMENT EHH500d – Spring 2002 Landmark Center Room 414A 2.5 credits Instructors: Jonathan I. Levy, Sc.D. Assistant Professor of Environmental Health and Risk Assessment Landmark Center Room 404K (617) 384-8808; jilevy@hsph.harvard.edu John S. Evans, Sc.D. Senior Lecturer in Environmental Health Center for Risk Analysis Room 211 (617) 432-1259; jevans@hsph.harvard.edu Teaching Assistant: Glenn Rice Center for Risk Analysis Room L-215 (617) 432-4348; grice@hsph.harvard.edu Framework of Course: The field of risk assessment involves techniques for estimating the risks to humans or ecosystems from chemicals, radiation, technology, or any other factors that can influence health and well-being. Although risk assessment can cover a number of domains, in keeping with our placement at a School of Public Health, we focus exclusively on human health in this course, largely from chemical exposures. However, many of the techniques and concepts we will discuss can be applied in other areas. This course has been placed in the “D” period because it fundamentally involves the integration of knowledge across numerous disciplines, many of which you have learned about during the course of the year. Epidemiology and toxicology are used to understand the health risks for a given level of exposure. Exposure can be estimated through field measurements or mathematical models of pollutant fate and transport, and can sometimes include information about human physiology to better understand the actual dose delivered to an organ. These and other pieces 1 EHH500d – Spring 2002 of information are combined mathematically with a careful consideration of the relevant uncertainties to arrive at estimates of risk useful for decision making. In this course, we aim to explore all of the major components of risk assessment, learning how to make the critical calculations but also exploring the underlying assumptions and considering the implications for policy and public health. To the extent possible, we hope to make this class discussion-oriented, drawing on the collective expertise of everyone in the classroom. This course assumes some background knowledge, including basic calculus and statistics and some familiarity with fate and transport modeling. There will be opportunities to review or catch up on these concepts through TA sessions or one-on-one meetings with the instructors. Course Grading: Class Participation Homework Final Examination 20% 40% 40% Required Book (available at the COOP): Daniel M. Kammen and David M. Hassenzahl. Should We Risk It? Exploring Environmental, Health, and Technological Problem Solving. Princeton University Press: Princeton, NJ, 2001. (referred to as “SWRI” in the syllabus) 2 EHH500d – Spring 2002 Tuesday, April 2: Introduction and Perspectives on Risk Assessment (Levy) General topics: - Group exercise: Defining risk assessment - Overview of course and logistics - Discussion of perspectives on risk assessment, implications for course Thursday, April 4: Overview of Risk Assessment (Evans) General topics: - The four elements of a risk assessment - Differences between cancer and non-cancer risk assessment - Contrasting risk assessment and risk management Readings: - SWRI, Ch. 1 (p. 1-16) - Ruckelshaus W. “Risk, Science and Democracy”. Issues in Science and Technology 1: 1938 (1983). Homework for 4/9: SWRI Problem 2-A Friday, April 5: Optional computer lab on Excel basics Tuesday, April 9: Basic Models for Risk Assessment (Levy) General topics: - Strengths and limitations of stock-flow, simple dose-response models - Applications and extensions Readings: - SWRI Ch. 2 - Masters GM. “Mass and Energy Transfer”, Ch. 1 in Introduction to Environmental Engineering and Science. Englewood Cliffs, NJ: Prentice Hall, 1997 (p. 1-14). Homework for 4/11: SWRI Problem 2-F, calculation exercise 3 EHH500d – Spring 2002 Thursday, April 11: Statistics, Uncertainty, and Variability (Levy) General topics: - Differentiating between uncertainty and variability - Overview of core statistical concepts - Monte Carlo Analysis (theory and practice) Readings: - SWRI Ch. 3-4 Homework for 4/16: SWRI 4-D Friday, April 12: Optional computer lab on Analytica Tuesday, April 16: Exposure Assessment (Levy) General topics: - Concentration vs. exposure vs. dose - Different approaches to estimating exposure - Implications of variability - Case study assignments Readings: - US EPA. Guidelines for Exposure Assessment. EPA/600Z-92/001. National Center for Environmental Assessment: Washington, DC, 1992 (p. 16-49, 124-135). Homework for 4/18: Reflecting on the Gaussian plume model (handout) Thursday, April 18: Models for Exposure Assessment (Levy) General topics: - Extensions from the Gaussian plume model - Different types of exposure models Readings: - McKone TE, Ryan PB. Human exposures to chemicals through food chains: An uncertainty analysis. Environ Sci Technol 23: 1154-1163 (1989). - Hoek G, Fischer P, van den Brandt P, Goldbohm S, Brunekreef B. Estimation of long-term average exposure to outdoor air pollution for a cohort study on mortality. J Exp Anal Environ Epidemiol 11: 459-469 (2001). - US EPA. Mercury Study Report to Congress. Volume I: Executive Summary. EPA-452/R97-003. Office of Air Quality Planning and Standards (p. O-1-O-4, p. 2-2) Homework for 4/23: Combining information across studies (handout) 4 EHH500d – Spring 2002 Tuesday, April 23: Epidemiology and Risk Assessment (Levy) General topics: - Review of core epidemiological concepts - Roadblocks for use in risk assessment - bias, confounding, extrapolation, causality - Methods for combining evidence Readings: - Hertz-Picciotto I. Epidemiology and quantitative risk assessment: a bridge from science to policy. Am J Public Health 85(4): 484-491 (1995). - Wartenberg D, Simon R. Comment: Integrating epidemiologic data into risk assessment. Am J Public Health 85(4): 491-493 (1995). - Hill AB. The environment and disease: Association or causation? Proc Royal Soc Med 295300. (1965). Homework for 4/25: SWRI 5-A Thursday, April 25: Cancer Risk Assessment (Evans) General topics: - Sources of evidence used (epidemiology, toxicology, mutagenicity tests, structure-activity analysis) - Characteristics of rodent bioassay - Animal-human extrapolations Readings: - Masters GM. “Risk Assessment”, Ch. 4 in Introduction to Environmental Engineering and Science. Englewood Cliffs, NJ: Prentice Hall, 1997 (p. 117-162). - Optional: Teuschler LK, Groten JP, Hertzberg RC, Mumtaz MM, Rice G. Environmental chemical mixtures risk assessment: Current approaches and emerging ideas. Comments on Toxicology 7: 453-493 (2001). Homework for 4/30: SWRI 5-D Tuesday, April 30: Models for Cancer Risk Assessment (Evans) General topics: - One-hit and multistage models - Methods to estimate parameters of dose-response models Readings: - SWRI Ch. 5, p. 166-198 - Anderson EL et al. Quantitative approaches in use to assess cancer risk. Risk Analysis 3: 277-295 (1983). 5 EHH500d – Spring 2002 Thursday, May 2: Models for Non-Cancer Risk Assessment (Evans) General topics: - Consideration of threshold assumption - Definition of reference dose and reference concentration - No observed adverse effects level vs. benchmark dose approach Readings: - Dourson ML, Stara JF. Regulatory history and experimental support of uncertainty (safety) factors. Reg Tox Pharm 3: 224-238 (1983). - Barnes DG, Daston GP, Evans JS, Jarabek AM, Kavlock RJ, Kimmel CA, Park C, Spitzer HL. Benchmark dose workshop: Criteria for use of a benchmark dose to estimate a reference dose. Reg Tox Pharm 21: 296-306 (1995). Tuesday, May 7: Case Study: Health Effects of Power Plants (Levy, Evans) Homework: Calculating the value of research (handout) Thursday, May 9: Basics of Decision Theory (Evans) General topics: - Decision trees - Value of information Readings: - SWRI Ch. 9 Tuesday, May 14: Risk Perception and Risk Management (Levy) General topics: - Influence of problem framing - Implications for policy decisions Readin77gs: - SWRI, Ch. 10 - Wilson R, Crouch EAC. “Perception of Risks”, Ch. 4 in Risk-Benefit Analysis. Harvard University Press, 2001 (p. 99-133). - O’Brien M. “How Does Risk Assessment Actually Work?”, Ch. 2 in Making Better Environmental Decisions. MIT Press: Cambridge, MA, 2000. Thursday, May 16: Course Wrap-Up: A Case Study of Mercury (Levy, Evans, Rice) Tuesday, May 21: Q&A Thursday, May 23: FINAL EXAM 6 EHH500d – Spring 2002 NAME ____________________________________________________________ (Write how you wish to be addressed.) Degree Program ____________________________________________________ Dept. (and School if not HSPH) _______________________________________ Email _____________________________________________________________ Phone _____________________________________________________________ Background Coursework Calculus (# of semesters): Physics/Chemistry/Properties of Environmental Contaminants: Computer Experience (Spreadsheet, Basic Programming, Stat Packages): Biostatistics/Epidemiology: Other relevant courses: What do you hope to get out of this class? ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ ________________________________________________________________________________ 7