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Articles

Mistrust of the black box: the public auditing of private models in the chemicals regulatory space

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Pages 41-69 | Received 03 Dec 2019, Accepted 14 Nov 2023, Published online: 06 Dec 2023

References

  • Adams, V. (2016) Metrics: What Counts in Global Health (Duke University Press).
  • Anderson, W. (2021) The model crisis, or how to have critical promiscuity in the time of Covid-19, Social Studies of Science, 51(2), pp. 167–188.
  • Beck, S. and Forsyth, T. (2015) Co-production and democratizing global environmental expertise: The IPCC and adaptation to climate change, in: S. Hilgartner, R. Hagendijk and C. A. Miller (Eds) Science and Democracy, pp. 113–132 (New York: Routledge).
  • Bois, F. Y., Zeise, L. and Tozer, T. N. (1990) Precision and sensitivity of pharmacokinetic models for cancer risk assessment: Tetrachloroethylene in mice, rats, and humans, Toxicology and Applied Pharmacology, 102(2), pp. 300–315.
  • Boullier, H., Demortain, D. and Zeeman, M. (2019) Inventing prediction for regulation: The development of (Quantitative) structure-activity relationships for the assessment of chemicals at the US Environmental Protection Agency, Science and Technology Studies, 32(4), pp. 137–57.
  • Breucker, P., Cointet, J., Hannud Abdo, A., Orsal, G., de Quatrebarbes, C., Duong, T., Martinez, C., Ospina Delgado, J. P., Medina Zuluaga, L. D., Gómez Peña, D. F., Sánchez Castaño, T. A., da Costa J., M., Laglil, H., Villard, L. and Barbier, M. (2016) CorTexT manager (version v2). Available at https://docs.cortext.net.
  • Brown, V. and Grossman, E. (2015) Why the United States leaves deadly chemicals on the market, In These Times.
  • Carpenter, D. (2010) Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton, NJ: Princeton University Press).
  • Christley, R. M., Mort, M., Wynne, B., Wastling, J. M., Heathwaite, A. L., Pickup, R. and Latham, S. M. (2013) ‘Wrong, but useful’: Negotiating uncertainty in infectious disease modelling, PLoS One, 8(10), pp. e76277.
  • Clark, L. H., Setzer, R. W. and Barton, H. A. (2004) Framework for evaluation of physiologically-based pharmacokinetic models for use in safety or risk assessment, Risk Analysis: An Official Publication of the Society for Risk Analysis, 24(6), pp. 1697–1717.
  • Clewell, H. J. (2015) Overview: Value of ADME/PK studies in safety assessment. Presented at the SOT-FDA Colloquia on Emerging Toxicological Science: Application of ADME/PK Studies to Improve Safety Assessments for Foods and Cosmetics.
  • Clewell, H. J. and Andersen, M. E. (1985) Risk assessment extrapolations and physiological modeling, Toxicology and Industrial Health, 1(4), pp. 111–134.
  • Clewell, H. J., MacNaughton, M. G. and Andersen, M. (1988) Toxicokinetics: An analytical tool for assessing chemical hazards to Man, Aviation, Space and Environmental Medicine, 59(11, Suppl.), pp. A125–A131.
  • Cordner, A. (2015) Strategic science translation and environmental controversies, Science, Technology & Human Values, 40(6), pp. 915–38.
  • Dedrick, R.L. and Bischoff, K.B. (1980) Species similarities in pharmacokinetics, Federation Proceedings, 39(1) pp. 54–59.
  • Demortain, D. (2013) Regulatory toxicology in controversy, Science, Technology & Human Values, 38(6), pp. 727–48.
  • Demortain, D. (2017) Expertise, regulatory science and the evaluation of technology and risk: Introduction to the special issue, Minerva, 55(3), pp. 139–59.
  • Demortain, D. (2023) Experts in the regulation of technology and tisk: An ecological perspective on regulatory science, in: G. Eyal and T. Medvetz (Eds) The Oxford Handbook of Expertise and Democratic Politics, pp. 282–313 (New York: Oxford University Press).
  • DeWoskin, R. S. (2007) PBPK models in risk assessment – a focus on chloroprene, Chemico-Biological Interactions, 166(1), pp. 352–359.
  • DeWoskin, R., Lipscomb, J., Thompson, C., Chiuh, W. and Schlosser, P. (2007) Pharmacokinetic/physiologically based pharmacokinetic models in integrated risk information system assessments, in:  J.C. Lipscomb and E. V. Ohanian (Eds) Toxicokinetics and Risk Assessment, pp. 301–48 (New York: Informa Healthcare).
  • Douglas, M. and Wildavsky, A. (1983) Risk and Culture: An Essay on the Selection of Technical and Environmental Dangers (University of California Press).
  • Dourson, M. L. and Stara, J. F. (1983) Regulatory history and experimental support of uncertainty (safety) factors, Regulatory Toxicology and Pharmacology, 3(3), pp. 224–238.
  • Dowling, D. (1999) Experimenting on theories, Science in Context, 12(2), pp. 261–273.
  • Downer, J. (2007) When the chick hits the fan: Representativeness and reproducibility in technological tests, Social Studies of Science, 37(1), pp. 7–26.
  • Edwards, P. N. (1999) Global climate science, uncertainty and politics: Data-laden models, model-filtered data, Science as Culture, 8(4), pp. 437–472.
  • Egmond, S. van, and Bal, R. (2011) Boundary configurations in science policy: Modeling practices in health care, Science, Technology & Human Values, 36(1), pp. 108–30.
  • EPA (1985a) Addendum to the Health Assessment Document for Dichloromethane (Methylene Chloride). Final Report. EPA/600/8-82/004FF, Washington, DC: Environmental Protection Agency.
  • EPA (1985b) Health Assessment Document for Dichloromethane (Methylene Chloride). Final Report. EPA/600/8-82/004F, Washington, DC: Environmental Protection Agency.
  • EPA (1986) Guidelines for Carcinogen Risk Assessment. No EPA/630/R-00/004, Washington, DC: Environmental Protection Agency.
  • EPA (1987) Technical Analysis of New Methods and Data Regarding Dichloromethane Hazard Assessments. No. EPA/600/8-87/029A, Washington, DC: Environmental Protection Agency.
  • EPA (1989) Biological Data for Pharmacokinetic Modeling and Risk Assessment. Report of a Workshop Convened by the U.S. Environmental Protection Agency and ILSI Risk Science Institute. No. EPA/600/3-90/019.
  • EPA (1992) Memorandum from F. Henry Habicht II, Deputy Administrator, to Assistant Administrators and Regional Administrators, Guidance on Risk Characterization for Risk Managers and Risk Assessors. US EPA.
  • Eyal, G. (2019) The Crisis of Expertise (Polity Press).
  • Federal Register (2006) Approaches for the Application of Physiologically Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment – Notice of Availability – Environmental Protection Agency, 71(184), pp. 55469–55470.
  • Finkel, A. M. (1990) Confronting Uncertainty in Risk Management: A Guide for Decision Makers a Report (Washington, DC: Resources for the Future).
  • Fisher, E., Pascual, P. and Wagner, W. (2010) Understanding environmental models in their legal and regulatory context, Journal of Environmental Law, 22(2), pp. 251-83.
  • Frederick, C. (1993) Limiting the uncertainty in risk assessment by the development of physiologically-based pharmacokinetic and pharmacodynamic models, Toxicology Letters, 68(1–2), pp. 159–175.
  • Gunter-Remy, U. (2007) Presentation at the International Workshop on the Development of Good Modelling Practice (GMP) for PBPK Models. Athens, Greece.
  • Hancher, L. and Moran, M. (1989) Organizing regulatory space, in: L. Hancher and M. Moran (Eds) Capitalism, Culture and Regulation, pp. 271–299 (Oxford: Clarendon Press).
  • Hastrup, K. and Skrydstrup, M. (2013) The Social Life of Climate Change Models: Anticipating Nature (Routledge).
  • Henry, E., Thomas, V., Aguiton, S. A., Déplaude, M.-O. and Jas, N. (2021) Introduction: Beyond the production of ignorance: The pervasiveness of industry influence through the tools of chemical regulation, Science, Technology, & Human Values, 46(5), pp. 911–924.
  • Heymann, M. and Dahan Dalmedico, A. (2019) Epistemology and politics in earth system modeling: Historical perspectives, Journal of Advances in Modeling Earth Systems, 11(5), pp. 1139–1152.
  • Jasanoff, S. (1987) Contested boundaries in policy-relevant science, Social Studies of Science, 17(2), pp. 195–230.
  • Jasanoff, S. (1990) The Fifth Branch: Science Advisers as Policymakers (Harvard University Press).
  • Kohn, M. C. (1995) Achieving credibility in risk assessment models, Toxicology Letters, 79(1–3), pp. 107–114.
  • Kieken, H. (2004) RAINS : Modéliser les pollutions atmosphériques pour la négociation internationale, Revue d’histoire des sciences. 57(2), pp. 377–406.
  • Kohn, M. (1997) The importance of anatomical realism for validation of physiological models of disposition of inhaled toxicants, Toxicology and Applied Pharmacology, 147(2), pp. 448–458.
  • Krimsky, S. (2004) Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research? (Lanham: Rowman & Littlefield).
  • Kutzman, R. S. and Conolly, R. B. (1998) Toxic Hazards Research Unit: Annual Report. No. AAMRL-TR-89-022 / NMRI-89-36). Harry G. Armstrong Aerospace Medical Research Laboratory, Human Systems Division and Air Force Systems Command Wright Patterson Air Force Base.
  • Lahsen, M. (2005) Seductive simulations? Uncertainty distribution around climate models, Social Studies of Science, 35(6), pp. 895–922.
  • Landström, C., Whatmore, S.J. and Lane, S.N. (2011) Virtual engineering: computer simulation modelling for flood risk management in england, Science & Technology Studies.
  • Levi-Faur, D. (2011) Regulation and regulatory governance, in: D. Levi-Faur (Ed) Handbook on the Politics of Regulation, pp. 3–24 (Cheltenham, Edward Elgar Publishing).
  • Loconto, A. and Rajão, R. (2020) Governing by models: Exploring the technopolitics of the (in)visilibities of land, Land Use Policy, 96, pp. 104241.
  • Loizou, G., Spendiff, M., Barton, H. A., Bessems, J., Bois, F. Y., d’Yvoire, M. B. and Schmitt, W. (2008) Development of good modelling practice for physiologically based pharmacokinetic models for use in risk assessment: The first steps, Regulatory Toxicology and Pharmacology, 50(3), pp. 400–411.
  • MacKenzie, D. (1998) The certainty trough, In: R. Williams, W. Faulkner and J. Fleck (Eds) Exploring Expertise: Issues and Perspectives, pp. 325–29 (London: Palgrave Macmillan UK).
  • Majone, G. (1984) Science and trans-science in standard setting, Science, Technology, & Human Values, 9(1), pp. 15–22.
  • McGoey, L. (2016) An Introduction to the Sociology of Ignorance: Essays on the Limits of Knowing (New York and London, Routledge).
  • McLanahan, E. D., El-Masri, H. A., Sweeney, L. M., Kopylev, L. Y., Clewell, H. J., Wambaugh, J. F. and Schlosser, P. M. (2012) Physiologically based pharmacokinetic model use in risk assessment – why being published is not enough, Toxicological Sciences, 126(1), pp. 5–15.
  • Michaels, D. (2006) Manufactured uncertainty: Protecting public health in the age of contested science and product defense, Annals of the New York Academy of Sciences, 1076(1), pp. 149–162.
  • Morgan, M. S. and Morrison, M. (1999) Models as Mediators: Perspectives on Natural and Social Science (Cambridge: Cambridge University Press).
  • NRC (1987) Drinking Water and Health, Volume 8 – Pharmacokinetics in Risk Assessment (Washington, DC: NRC).
  • NRC (1994) Science and Judgment in Risk Assessment (Washington, DC: National Academies Press).
  • NRC (1996) Understanding Risk: Informing Decisions in a Democratic Society (Washington, DC: National Academies Press).
  • NRC (2007) Models in Environmental Regulatory Decision Making (Washington, DC: National Academy of Sciences).
  • NRDC (2007) Petition to revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos. Filed 12 September 2007.
  • Oreskes, N. (1998) Evaluation (not validation) of quantitative models, Environmental Health Perspectives, 106(Suppl 6), pp. 1453–1460.
  • Pielke, R. A., Jr. (2003) The role of models in prediction for decision, in: C. Canham, J. Cole and W. Lauenroth (Eds) Models in Ecosystem Science, pp. 111–135 (Princeton: Princeton University Press).
  • Porter, T. M. (1995) Trust in Numbers: The Pursuit of Objectivity in Science and Public Life (Princeton: Princeton University Press).
  • Portier, C. J. and Kaplan, N. L. (1989) Variability of safe dose estimates when using complicated models of the carcinogenic process. A case study: Methylene chloride, Fundamental and Applied Toxicology: Official Journal of the Society of Toxicology, 13(3), pp. 533–544.
  • Ramsey, J. C. and Andersen, M. E. (1984) A physiologically based description of the inhalation pharmacokinetics of styrene in rats and humans, Toxicology and Applied Pharmacology, 73(1), pp. 159–175.
  • Rhodes, T., Lancaster, K. and Rosengarten, M. (2020) A model society: Maths, models and expertise in viral outbreaks, Critical Public Health, 30(3), pp. 253–256.
  • Rushefsky, M. E. (1986) Making Cancer Policy (Albany, NY: SUNY Press).
  • Schwarz, M. and Thompson, M. (1990) Divided We Stand: Redefining Politics, Technology and Social Choice (University of Pennsylvania Press).
  • Scoones, I. and Stirling, A. (2020) The Politics of Uncertainty: Challenges of Transformation (Routledge).
  • Siegler, E. (1996) Regulatory negotiations and other rulemaking processes: Strengths and weaknesses from an industry viewpoint, Duke Law Journal, 46(6), pp. 1429–44.
  • Sismondo, S. (1999) Models, simulations, and their objects, Science in Context, 12(02), pp. 247–60.
  • Sismondo, S. (2017) Hegemony of knowledge and pharmaceutical industry strategy, in: Philosophical Issues in Pharmaceutics, pp. 47–63 (Dordrecht: Springer).
  • Shackley, S. and Wynne, B. (1995) Global climate change: The mutual construction of an emergent science-policy domain, Science and Public Policy, 22(4), pp. 218–230.
  • Shackley, S. and Wynne, B. (1996) Representing uncertainty in global climate change science and policy: Boundary-ordering devices and authority, Science, Technology, & Human Values, 21(3), pp. 275–302.
  • Spear, R. C., Bois, F. Y., Woodruff, T., Auslander, D., Parker, J. and Selvin, S. (1991) Modeling benzene pharmacokinetics across three sets of animal data: Parametric sensitivity and risk implications, Risk Analysis, 11(4), pp. 641–654.
  • Sundberg, M. (2007) Parameterizations as boundary objects on the climate arena, Social Studies of Science, 37(3), pp. 473–488.
  • Taylor, P. (1989) Revising models and generating theory, Oikos, 54(1), pp. 121.
  • van der Sluijs, J., van Eijndhoven, J., Shackley, S. and Wynne, B. (1998) Anchoring devices in science for policy: The case of consensus around climate sensitivity, Social Studies of Science, 28(2), pp. 291–323.
  • van Egmond, S. and Zeiss, R. (2010) Modeling for policy: Science-based models as performative boundary objects for Dutch policy making, Science Studies, 23(1), pp. 58–78.
  • Vogel, S. (2008) From “The Dose Makes the Poison” to “The Timing Makes the Poison”: conceptualizing risk in the synthetic age, Environmental History, 13(4), pp. 667–73.
  • WHO/IPCS (2010) Characterization and Application of Physiologically Based Pharmacokinetic Models in Risk Assessment. IPCS Harmonization Project Document No. 9, Geneva: World Health Organization, International Programme on Chemical Safety.
  • Wilson, J. (1980) The politics of regulation, in: J.Q. Wilson (Ed) The Politics of Regulation, pp. 357–94 (New York: Basic Books).
  • Wynne, B. (1987) Uncertainty – technical and social, in: H. Brooks (Eds) Science for Public Policy, pp. 95–115 (Pergamon Press).

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