Abstract
In this chapter relatively recent European Commission risk assessment reports for three potential PBT/vPvB chemicals are used as examples to illustrate scientific uncertainty in the risk assessment process, and how science and policy interact when such uncertainty is handled. The studied risk assessment reports are for pentabromodiphenylether (Penta), octabromodiphenylether (Octa), and decabromodiphenylether (Deca) and the analyses focus on the scientific basis for assessing the risk of potential PBT and vPvB properties as described in these documents. The purpose of this effort is to contribute to a discussion aiming at clarifying the nature of science-policy interactions, and improving the transparency of the risk assessment process.
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Notes
- 1.
The human health risk characterization is typically carried out by comparing the No-Observed-Adverse-Effect-Level (NOAEL) to the human exposure level. The ratio is called Margin of Safety. If human exposure is estimated to exceed the NOAEL, the substance is considered to be ‘of concern’. If the exposure estimate is less than the NOAEL, the appropriate ‘margin of safety’ is assessed case-by-case (European Commission 2003a).
- 2.
The environmental risk characterization is typically carried out by comparing the predicted no effect concentration (PNEC) to the predicted environmental concentration (PEC). A PEC/PNEC ratio above 1 indicates that the substance poses a potential risk to the environment (European Commission 2003a).
- 3.
This traditional scientific focus on purely minimising false positives has been criticized as being inadequate for applied sciences such as toxicology since costs of false negatives (i.e. concluding that a hazardous chemical is safe) are larger than in non-applied sciences. For applied sciences it has been argued that it is scientifically justifiable to shift the burden of proof somewhat towards reducing false negatives (i.e. adopting a more precautionary approach) (Peterman and M’Gonigle 1992).
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Rudén, C., Gilek, M. (2010). Scientific Uncertainty and Science-Policy Interactions in the Risk Assessment of Hazardous Chemicals. In: Eriksson, J., Gilek, M., Rudén, C. (eds) Regulating Chemical Risks. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-9428-5_10
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