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    Literature and Other Resources on Impact Assessment for Synthetic Biology

    Websites and Online Introductions

    Synthetic Biology

    Synthetic Biology,” by Michele S. Garfinkel, Drew Endy, Gerald Epstein, and Robert M. Friedman

    The Synthetic Biology Project at the Woodrow Wilson International Center for Scholars

    CBA

    Cost-Benefit Default Principles” (pdf), by Cass R. Sunstein, Coase-Sandor Working Paper Series in Law and Economics, 2000

    Cost-Benefit Analysis for Development: A Practical Guide (pdf), by the Asian Development Bank, 2013

    Technology Policy,” at the Mercatus Center, George Mason University

    Precaution

    The Precautionary Principle: Decision-Making under Uncertainty” (pdf), European Commission

    The Precautionary Principle” (pdf), Peter Saunders

    Why the Precautionary Principle Matters,” Andrew Stirling

    Selected Annotated Bibliography

    On synthetic biology

    Presidential Commission for the Study of Bioethical Issues, New Directions: The Ethics of Synthetic Biology and Other Emerging Technologies (Washington, DC: PCSBI, 2010), — develops a set of overarching principles to guide policy, proposing “prudent vigilance” as a guiding ideal that reflects a moderate version of precaution.

    National Academies of Sciences, Engineering, and Medicine, Committee on Gene Drives Research in Non-Human Organisms: Recommendations for Responsible Conduct, Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values (Washington, D.C.: National Academies Press, 2016) —  discusses gene drive technology in detail, recommends against use of gene drives as currently understood, and proposes a set of steps for proceeding with research and moving toward eventual possible use.

    E. Kaebnick et al., “Precaution and Governance of Emerging Technologies,” Science 354 (2016): 710-11 — a commentary on the National Academies’ report Gene Drives on the Horizon, arguing that a moderate form of precaution is necessary for—and consistent with—responsible science; the authors are some of the members of and staff for the committee that wrote the report.

    International Risk Governance Council, Guidelines for the Appropriate Risk Governance of Synthetic Biology (Geneva, Switzerland: IRGC, 2010) — recommends measures for moving forward with research and use of synthetic biology.

    “Synthetic Future: Can We Create What We Want Out of Synthetic Biology,” ed. G. E. Kaebnick, M. K. Gusmano, and T. H. Murray, Hastings Center Report 44, no. 6 (2014): S1-S48  — a set of essays on the range of ethical issues raised by synthetic biology; a lead article sets questions about costs and benefits alongside ideals of justice and the human relationship to nature and strategies for public deliberation practices that might aim for a policy consensus, and accompanying commentaries offer contrasting views.

    D. Caruso, Synthetic Biology: An Overview and Recommendations for Anticipating and Addressing Emerging Risks, http://scienceprogress.org/2008/11/synthetic-biology/ — a more cautious set of recom­mendations for synthetic biology.

    J. B. Tucker and R. A. Zilinskas, “The Promise and Perils of Synthetic Biology,” The New Atlantis 12 (2006): 25-45 — an early statement of the governance challenge of synthetic biology.

    Friends of the Earth, International Center for Technology Assessment, and ETC Group, The Principles for the Oversight of Synthetic Biology (Washington, D.C.: Friends of the Earth, 2012), WEBSITE — a statement from a group of activist organizations, arguing that the use of synthetic biology should be severely constrained by the precautionary principle.

    On cost-benefit analysis and precaution

    The selections here are roughly ordered from those that defend cost-benefit analysis and a more permissive approach to technology regulation toward those that attempt to develop and defend the idea of precaution

    A. Wildavsky, Searching for Safety (Piscataway, NJ: Transaction Publishers, 1988) — a scathing critique of precaution, arguing that precaution is internally inconsistent and leads to paralysis in policy-making.

    C. Sunstein, Laws of Fear: Beyond the Precautionary Principle (Cambridge, UK: Cambridge University Press, 2005) — argues that the precautionary principle reflects inappropriate cognitive biases and that CBA is a corrective to these biases

    Jonathan B. Wiener has written a series of penetrating analyses of the different forms precaution has taken in U.S., European, and international policy documents:

    • with M. D. Rodgers, “Comparing Precaution in the United States and Europe,” Journal of Risk Research 5, no. 4 (2002): 317-49;
    • “The Regulation of Technology and the Technology of Regulation,” Technology in Society 26 (2004) 483-500 .
    • “Precaution in a Multi-risk World,” in Human and Ecological Risk Assessment: Theory and Practice, ed. D. J. Paustenbach (Hoboken, NJ: John Wiley, 2007);
    • “The Tragedy of the Uncommons: On the Politics of Apocalypse,” Global Policy 7, suppl. 1 (2006): 67-80.
    • “Precautionary Principle,” in Principles of Environmental Law, ed. L. Krämer and E. Orlando, part of the Encyclopedia of Environmental Law, ed. M. (Geneva, Switzerland: IUCN and Edward Elgar, 2017).

    L. Heinzerling and F. Ackerman, “Pricing the Priceless: Cost Benefit Analysis of Environmental Protection,” Washington, DC: Georgetown Environmental Law and Policy Institute and Georgetown University Law Center, 2002. — a clear formulation of common objections to cost-benefit analysis. also published in a law review.

    D. Stone, Policy Paradox: The Art of Political Reason, 3rd ed. (New York: W. W. Norton and Company, 2011 — an influential discussion of the challenges in capturing the public’s values adequately in the mechanisms of policy analysis.

    A. Sinden, “Formality and Informality in Cost-Benefit Analysis,” Utah Law Review no. 1 (2015): 93-172 — argues that CBA comes in more and less formal versions and that less-formal versions are often mistaken for formal versions, leading to an inappropriate reliance on CBA to guide policy

    Following are several key European and international policy documents endorsing versions of precaution:

    • United Nations, Rio Declaration on Environment and Development, Report of the United Nations Conference on Environment and Development, Rio de Janeiro, Brazil, June 3-14, 1992.
    • Commission of the European Communities, Treaty on European Union, Masstricht, February 7, 1992; https://europa.eu/european-union/sites/europaeu/files/docs/body/treaty_on_european_union_en.pdf.
    • European Commission, “Communication from the Commission on the Precautionary Principle,” COM(2000)1, Brussels, February 2, 2000.

    These essays examine the structure of the “precautionary principle” and attempt to develop strategies for defending a typically limited version of the precautionary principle:

    • E. C. Parke and M. Bedau, “The Precautionary Principle and Its Critics,” in The Ethics of Protocells: Moral and Social Implications of Creating Life in the Laboratory (Cambridge, MA.: MIT Press, 2009), 69-87;
    • S. Gardiner, “A Core Precautionary Principle,” The Journal of Political Philosophy 14, no. 1 (2006): 33-60.
    • M. Ahtensuu, “The Precautionary Principle in the Risk Management of Modern Biotechnology,” Science Studies 1 (2004): 57-65.
    • D. B. Resnik, “The Precautionary Principle and Medical Decision Making,” Journal of Medicine & Philosophy 29, no. 3 (2004): 281-99.
    • M. Saner, “An Ethical Analysis of the Precautionary Principle,” International Journal of Biotechnology 4, no. 1 (2002): 81-95.

    The following essays by Andrew Stirling defend a strong version of precaution while rejecting the idea that precaution should be construed as a decision rule:

    • “Risk, Precaution and Science: Towards a More Constructive Policy Debate,” EMBO Reports 8, no. 4 (2007): 309-315.
    • “Keep It Complex,” Nature 468 (2010): 1029-1031, at 1030.

    Anticipatory governance:

    1. H. Guston and D. Sarewicz, “Real-Time Technology Assessment,” Technology in Society 24 (2002): 93-109.

    Additional Reading

    (listed alphabetically)

    On synthetic biology

    A. Balmer and P. Martin, Synthetic Biology: Social and Ethical Challenges (Nottingham, U.K.: Institute for Science and Society, 2008).

    M. K. Cho et al. and the Ethics of Genomics Group, “Ethical Considerations in Synthesizing a Minimal Genome,” Science 286 (1999): 2087-90.

    ETC Group, Extreme Genetic Engineering: An Introduction to Synthetic Biology (Ottawa, Ontario: ETC Group, 2007).

    M. S. Garfinkel et al., Synthetic Genomics: Options for Governance (J. Craig Venter Institute, Center for Strategic and International Studies, and Massachusetts Institute of Technology, 2007).

    D. M. Kahan, D. Braman, and G. M. Mandel, “Risk and Culture: Is Synthetic Biology Different?” Yale Law School, Public Law Working Paper No. 190, 2009, http:// dx.doi.org/10.2139/ssrn.1347165.

    J. Kuzma and T. Tanji, “Unpackaging Synthetic Biology: Identification of Oversight Policy Problems and Options,” Regulation & Governance 4 (2010): 92-112.

    G. N. Mandel, D. Braman, and D. M. Kahan, “Cultural Cognition and Synthetic Biology Risk Perceptions: A Preliminary Analysis,” Yale Law & Economics Research 364 (2008), http://dx.doi. org/10.2139/ssrn.1264804.

    E. Parens, J. Johnston, and J. Moses, Ethical Issues in Synthetic Biology: An Overview of the Debates (Washington, D.C.: Woodrow Wilson International Center for Scholars, 2009).

    E. Pauwels, “Review of Quantitative and Qualitative Studies on U.S. Public Perceptions of Synthetic Biology,” Systems and Synthetic Biology 3, nos. 1-4 (2009): 37-46.

    Rathenau Instituut, Constructing Life: The World of Synthetic Biology (The Hague, The Netherlands: Rathenau Instituut, 2007).

    The Royal Academy of Engineering, Synthetic Biology: Scope, Applications and Implications (London: Royal Academy of Engineering, 2009).

    M. Schmidt, ed., Synthetic Biology: The Technoscience and Its Societal Consequences, (Dordrecht, Neth.: Springer Academic Publishing, 2009).

    M. Specter, “A Life of Its Own: Where Will Synthetic Biology Lead Us?,” The New Yorker, September 28, 2009, 56-65.

    On cost-benefit assessment and precaution

    S. Clarke, “New Technologies, Common Sense and the Paradoxical Precautionary Principle,” Evaluating New Technologies: The International Library of Ethics, Law and Technology 3 (2009): 159-73.

    D. H. Cole, “Reconciling Cost-Benefit Analysis with the Precautionary Principle,” Regulatory Review, March 5, 2012.

    R. Cooney, “The Precautionary Principle in Biodiversity Conservation and Natural Resource Management,” International Union for the Conservation of Nature, 2004
    D. Dobansky, “Scientific Uncertainty and the Precautionary Principle,” Environment: Science and Policy for Sustainable Development 33, no. 7 (1991): 4-44.

    D. Driesen, “Cost-Benefit Analysis and the Precautionary Principle: Can They Be Reconciled?,” Michigan State Law Review 771 (2013): 771-826.

    A. M. Finkel, “The Cost of Nothing Trumps the Value of Everything: The Failure of Regulatory Economics to Keep Pace with Improvemnts in Quantitative Risk Analysis,” Michigan Law Review 4, no. 1 (2014): 91-156.

    A. M. Finkel, “Solution-Focused Risk Assessment: A Proposal for the Fusion of Environmental Analysis and Action,” Human and Ecological Risk Assessment 17, no. 4 (2011): 754-87.

    R. W. Hahn and C. R. Sunstein, “The Precautionary Principle as a Basis for Decision Making,” The Economists’ Voice 2, no. 2 (2007): 1-9.

    K. K. Jensen, “The Moral Foundation of the Precautionary Principle,” Journal of Agricultural and Environmental Ethics 15, no. 1 (2002): 39-55.

    S. Kelman, “Cost-Benefit Analysis: An Ethical Critique.” by Steven Kelman, from AEI Journal on Government and Society Regulation (January/FebrUary 1981): 33-40.

    D. A. Kysar, Regulating from Nowhere: Environmental Law and the Search for Objectivity (New Haven, CT: Yale University Press, 2010).

    D. A. Kysar, “It Might Have Been: Risk, Precaution, and Opportunity Costs,” Cornell Law School Legal Studies Research Paper Series 50, 2006.

    D. MacLean, “Ethics, Reasons and Risk Analysis,” in The Ethics of Technological Risk, ed. L. Asveld and S. Roeser (Oxford: Earthscan, 2009), 115-27.

    D. MacLean, “The Ethics of Cost-Benefit Analysis: Incommensurable, Incompatible, and Incomparable Values,” in Democracy, Social Values, and Public Policy, ed. M. M. Carrow, R. P. Churchill, and J. J. Cores (Westport, CT: Praeger, 1998), 107-122.

    G. N. Mandel and T. Gathii, “Cost-Benefit Analysis versus the Precautionary Principle: Beyond Cass Sunstein’s Laws of Fear,” University of Illinois Law Review 5 (2006): 1037-1080.

    Nuffield Council on Bioethics, Biofuels: Ethical Issues (London: Nuffield Council on Bioethics, 2011).

    R. Powell, “What’s the Harm?: An Evolutionary Theoretical Critique of the Precautionary Principle,” Kennedy Institute of Ethics Journal 20, no. 2 (2010): 181-206.

    P. Sandin, “Dimensions of the Precautionary Principle,” Human and Ecological Risk Assessment 5, no. 5 (2012): 889-907.

    C. R. Sunstein, Risk and Reason: Safety, Law, and the Environment (Cambridge: Cambridge University Press, 2002).

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