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Science and Engineering Ethics

, Volume 23, Issue 2, pp 489–508 | Cite as

Risk, Uncertainty and Precaution in Science: The Threshold of the Toxicological Concern Approach in Food Toxicology

  • Karim Bschir
Original Paper

Abstract

Environmental risk assessment is often affected by severe uncertainty. The frequently invoked precautionary principle helps to guide risk assessment and decision-making in the face of scientific uncertainty. In many contexts, however, uncertainties play a role not only in the application of scientific models but also in their development. Building on recent literature in the philosophy of science, this paper argues that precaution should be exercised at the stage when tools for risk assessment are developed as well as when they are used to inform decision-making. The relevance and consequences of this claim are discussed in the context of the threshold of the toxicological concern approach in food toxicology. I conclude that the approach does not meet the standards of an epistemic version of the precautionary principle.

Keywords

Uncertainty Threshold of toxicological concern Environmental decision-making Precautionary principle Tuxedo Fallacy 

Notes

Acknowledgments

I would like to thank the Food Packaging Forum in Zurich, Switzerland for giving me the opportunity to present an earlier version of this article at a TTC workshop in 2013. I would also like to thank the participants of the workshop for a lively and inspiring discussion. Large parts of this article were composed during a Visiting Fellowship at the Center for Philosophy of Science at the University of Pittsburgh in 2014. I would like to thank everybody at the Center, and in particular the director John Norton, for having created a truly inspiring and supportive work environment. My fellow Fellows Joshua Alexander, Bill Bechtel, Ingo Brigandt, Sara Green, Nicholas Jones, Raphael Scholl and Maria Serban all contributed in their own ways to a truly special intellectual experience. Four anonymous reviewers provided highly useful comments. The financial support of Society in Science—the Branco Weiss Fellowship is kindly acknowledged.

References

  1. Brueschweiler, B. J. (2014). The TTC approach in practice and its impact on risk assessment and risk management in food safety: A regulatory toxicologist’s perspective. CHIMIA International Journal for Chemistry, 68(10), 710–715.CrossRefGoogle Scholar
  2. Canady, R., Lane, R., Paoli, G., Wilson, M., Bialk, H., Hermansky, S., et al. (2013). Determining the applicability of threshold of toxicological concern approaches to substances found in foods. Critical Reviews in Food Science and Nutrition, 53(12), 1239–1249.CrossRefGoogle Scholar
  3. Commission of the European Communities. (2000). Communication from the commission on the precautionary principle.http://eur-lex.europa.eu/legal-content/EN/TXT/uri=celex:52000DC0001. Accessed 30 June 2015.
  4. Cramer, G. M., Ford, R. A., & Hall, R. L. (1978). Estimation of toxic hazard: A decision tree approach. Food and Cosmetics Toxicology, 16(3), 255–276.CrossRefGoogle Scholar
  5. Crane, M., & Newman, M. C. (2000). What level of effect is a no observed effect? Environmental Toxicology and Chemistry, 19(2), 516–519.CrossRefGoogle Scholar
  6. Dewhurst, I., & Renwick, A. G. (2013). Evaluation of the threshold of toxicological concern (TTC): Challenges and approaches. Regulatory Toxicology and Pharmacology, 65(1), 168–177.CrossRefGoogle Scholar
  7. Douglas, H. (2000). Inductive risk and values in science. Philosophy of Science, 67(4), 559–579.CrossRefGoogle Scholar
  8. Douglas, H. (2008). Science, hormesis and regulation. Human & Experimental Toxicology, 27(8), 603–607.CrossRefGoogle Scholar
  9. Douglas, H. (2009). Science, policy, and the value-free ideal. Pittsburgh: University of Pittsburgh Press.Google Scholar
  10. EU Scientific Commitee on Food. (2002). Opinion of the Scientific Committee on Food on Bisphenol A. http://www.ec.europa.eu/food/fs/sc/scf/out128_en.pdf. Accessed 30 June 2015.
  11. EU Scientific Committee on Consumer Safety (SCCS), EU Scientific Committee on Health and Environmental Risks (SCHER), and EU Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). (2012). Joint opinion on the use of the Threshold of Toxicological Concern (TTC) approach for human safety assessment of chemical substances with focus on cosmetics and consumer products. www.ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_0. Accessed 30 June 2015.
  12. European Food Safety Agency (EFSA). (2012a). FAQ on the threshold of toxicological concern. www.efsa.europa.eu/de/faqs/faqttc.htm. Accessed 30 June 2015.
  13. European Food Safety Agency (EFSA). (2012b). Scientific opinion on the evaluation of the toxicological relevance of pesticide metabolites for dietary risk assessment. EFSA Journal, 10(7), 2799.CrossRefGoogle Scholar
  14. European Food Safety Agency (EFSA). (2015). Scientific opinion on the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs. EFSA Journal, 13(1), 3978.CrossRefGoogle Scholar
  15. European Food Safety Agency (EFSA) and World Health Organization (WHO). (2015). Threshold of toxicological concern approach: Conclusions and recommendations of the EFSA/WHO expert workshop (draft for consultation). www.efsa.europa.eu/de/consultations/call/150212.pdf. Accessed June 30 2015.
  16. Grandjean, P., & Landrigan, P. J. (2006). Developmental neurotoxicity of industrial chemicals. Lancet, 368(9553), 2167–2178.CrossRefGoogle Scholar
  17. Grandjean, P., & Landrigan, P. J. (2014). Neurobehavioural effects of developmental toxicity. Lancet Neurology, 13(3), 330–338.CrossRefGoogle Scholar
  18. Hansson, S. O. (2005). Seven myths of risk. Risk Management, 7(2), 7–17.CrossRefGoogle Scholar
  19. Hansson, S. O. (2009). From the casino to the jungle. Synthese, 168(3), 423–432.CrossRefGoogle Scholar
  20. Keynes, J. M. (1937). The general theory of employment. The Quarterly Journal of Economics, 51(2), 209–223.CrossRefGoogle Scholar
  21. Knight, F. H. (1921). Risk, uncertainty and profit. Boston: Boughton Mifflin Company.Google Scholar
  22. Knutti, R., & Sedláček, J. (2012). Robustness and uncertainties in the new CMIP5 climate model projections. Nature Climate Change, 3(4), 369–373.CrossRefGoogle Scholar
  23. Kroes, R., Kleiner, J., & Renwick, A. (2005). The threshold of toxicological concern concept in risk assessment. Toxicological Sciences, 86(2), 226–230.CrossRefGoogle Scholar
  24. Kroes, R., Renwick, A. G., Cheeseman, M., Kleiner, J., Mangelsdorf, I., Piersma, A., et al. (2004). Structure-based thresholds of toxicological concern (TTC): Guidance for application to substances present at low levels in the diet. Food and Chemical Toxicology, 42(1), 65–83.CrossRefGoogle Scholar
  25. Macon, M. B., Villanueva, L. R., Tatum-Gibbs, K., Zehr, R. D., Strynar, M. J., Stanko, J. P., et al. (2011). Prenatal perfluorooctanoic acid exposure in CD-1 mice: Low-dose developmental effects and internal dosimetry. Toxicological Sciences, 122(1), 134–145.CrossRefGoogle Scholar
  26. Manová, E., von Goetz, N., & Hungerbuehler, K. (2015). Aggregate consumer exposure to UV filter ethylhexyl methoxycinnamate via personal care products. Environment International, 74(2015), 249–257.CrossRefGoogle Scholar
  27. Martin, O., Scholze, M., & Kortenkamp, A. (2013). Dispelling urban myths about default uncertainty factors in chemical risk assessment: Sufficient protection against mixture effects? Environmental Health, 12(1), 53–74.CrossRefGoogle Scholar
  28. Munro, I., Ford, R., Kennepohl, E., & Sprenger, J. (1996). Correlation of structural class with no-observed-effect levels: A proposal for establishing a threshold of concern. Food and Chemical Toxicology, 34(9), 829–867.CrossRefGoogle Scholar
  29. Munro, I., Kennepohl, E., & Kroes, R. (1999). A procedure for the safety evaluation of flavouring substances. Food and Chemical Toxicology, 37(2–3), 207–232.CrossRefGoogle Scholar
  30. Newbold, R. R., Jefferson, W. N., & Padilla-Banks, E. (2009). Prenatal exposure to bisphenol A at environmentally relevant doses adversely affects the murine female reproductive tract later in life. Environmental Health Perspectives, 117(6), 879–885.CrossRefGoogle Scholar
  31. Peterson, M. (2006). The precautionary principle is incoherent. Risk Analysis, 26(3), 595–601.CrossRefGoogle Scholar
  32. Peterson, M. (2007). Should the precautionary principle guide our actions or our beliefs? Journal of Medical Ethics, 33(1), 5–10.CrossRefGoogle Scholar
  33. Renwick, A. G. (2000). The use of safety or uncertainty factors in the setting of acute reference doses. Food Additives and Contaminants, 17(7), 627–635.CrossRefGoogle Scholar
  34. Richiardi, L., Bellocco, R., Adami, H.-O., Torrång, A., Barlow, L., Hakulinen, T., et al. (2004). Testicular cancer incidence in eight northern European countries: Secular and recent trends. Cancer Epidemiology, Biomarkers & Prevention, 13(12), 2157–2166.Google Scholar
  35. Richter, C. A., Birnbaum, L. S., Farabollini, F., Newbold, R. R., Rubin, B. S., Talsness, C. E., et al. (2007). In vivo effects of bisphenol A in laboratory rodent studies. Reproductive Toxicology, 24(2), 199–224.CrossRefGoogle Scholar
  36. Shibamoto, T., & Bjeldanes, L. F. (2009). Introduction to food toxicology (2nd ed.). San Diego: Elsevier Academic Press.Google Scholar
  37. Shrader-Frechette, K. (2010). Conceptual analysis and special-interest science: Toxicology and the case of Edward Calabrese. Synthese, 177(3), 449–469.CrossRefGoogle Scholar
  38. Sprenger, J. (2012). Environmental risk analysis: Robustness is essential for precaution. Philosophy of Science, 79(5), 881–892.CrossRefGoogle Scholar
  39. Steel, D. (2011). Extrapolation, uncertainty factors, and the precautionary principle. Studies in History and Philosophy of Science Part C, 42(3), 356–364.CrossRefGoogle Scholar
  40. Steel, D. (2015). Philosophy and the precautionary principle. Cambridge: Cambridge University Press.Google Scholar
  41. Tebaldi, C., & Knutti, R. (2007). The use of the multi-model ensemble in probabilistic climate projections. Philosophical Transactions Series A, Mathematical, Physical, and Engineering Sciences, 365(1857), 2053–2075.CrossRefGoogle Scholar
  42. The Science and Environmental Health Network. (1998). Wingspread conference on the precautionary principle. www.sehn.org/wing.html. Accessed June 30 2015.
  43. Vandenberg, L. N., Colborn, T., Hayes, T. B., Heindel, J. J., Jacobs, D. R., Lee, D.-H., et al. (2012). Hormones and endocrine-disrupting chemicals: Low-dose effects and nonmonotonic dose responses. Endocrine Reviews, 33(3), 378–455.CrossRefGoogle Scholar
  44. Vandenberg, L. N., Hauser, R., Marcus, M., Olea, N., & Welshons, W. V. (2007). Human exposure to bisphenol A (BPA). Reproductive Toxicology, 24(2), 139–77.CrossRefGoogle Scholar
  45. Welshons, W. V., Nagel, S. C., & vom Saal, F. S. (2006). Large effects from small exposures. Endocrine mechanisms mediating effects of bisphenol A at levels of human exposure. Endocrinology, 147(6 Suppl), 56–69.CrossRefGoogle Scholar
  46. World Health Organization (WHO). (2012). State of the science of endocrine disrupting chemicals. www.who.int/ceh/publications/endocrine/en. Accessed June 30 2015.

Copyright information

© Springer Science+Business Media Dordrecht 2016

Authors and Affiliations

  1. 1.Department of Humanities, Social and Political SciencesSwiss Federal Institute of TechnologyZurichSwitzerland

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