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.
Keywords
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsNotes
- 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).
References
Breitholtz M., Eriksson J., Green N., Rudén C. (2006) ‘Testing and Risk Assessment of Persistent and Bioaccumulating Chemical Substances – improvements within REACH?’ Human and Ecological Risk Assessment 12(4):782–805.
Burton G.A., Chapman P.M., Smith E.P. (2002) Weight-of-evidence approaches for assessing ecosystem impairment. Human and Ecological Risk Assessment 8:1657–1673.
Council Directive (EEC) 67/548 of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. Official Journal 196: 1–5.
ECHA (2008) Comments on Document CA/56/2008. Review of REACH Annex XIII. European Chemicals Agency. Helsinki, Finland December 12 2008 http://chemicalwatch.com/downloads/ECHA%20paper%20on%20Annex%20XIII.pdf. Accessed April 21, 2009.
European Commission (2001) European Union Risk Assessment ReportDiphenyl ether, Pentabromo derivative CAS No: 32536-52-0EINECS No: 251-087-9 1st Priority List Volume: 5.
European Commission (2002) European Union Risk Assessment ReportDiphenyl ether, Decabromo derivative CAS No: 32536-52-0EINECS No: 251-087-9 1st Priority List Volume: 17.
European Commission (2003a) Technical guidance document in support of commission directive 93/67/EEC on risk assessment for new notified substances and commission regulation (EC) No 1488/94 on risk assessment for exiting substances. Luxembourg.
European Commission (2003b) European Union Risk Assessment ReportDiphenyl ether, Octabromo derivative CAS No: 32536-52-0EINECS No: 251-087-9 1st Priority List Volume: 16.
European Commission (2004) Update of the risk assessment of bis(pentabromophenyl) ether (decabromodiphenyl ether) CAS Number: 1163-19-5 EINECS Number: 214-604-9 Final Environmental Draft of May 2004.
Green N., Bergman Å. (2005) Chemical reactivity as a tool for estimating persistance. Environmental Science and Technology 39: 480A–486A.
Long E.R., Chapman P.M. (1985) A sediment quality triad: measures of sediment contamination, toxicity, and infaunal community composition in Puget Sound. Marine Pollution Bulletin 16:405–415.
Peterman, R.M., M’Gonigle, M. (1992) Statistical power analysis and the precautionary principle. Marine Pollution Bulletin 24(5): 231–234.
Reineke, N. (2008) REACH must allow use of ‘real world’ PBT evidence. Guest column. Chemical Watch European Business Briefing.http://www.chemicalwatch.com/. Accessed April 21, 2009.
Renn O. (2008) Risk Governance: Coping with Uncertainty in a Complex World. London: Earthscan.
Suter G.W., Efroymson R.A., Sample B.E., Jones D.S. (eds) (2000) Ecological Risk Assessment for Contaminated Site. Boca Raton, FL: Lewis Publishers.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2010 Springer Science+Business Media B.V.
About this chapter
Cite this chapter
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
Download citation
DOI: https://doi.org/10.1007/978-90-481-9428-5_10
Published:
Publisher Name: Springer, Dordrecht
Print ISBN: 978-90-481-9427-8
Online ISBN: 978-90-481-9428-5
eBook Packages: Earth and Environmental ScienceEarth and Environmental Science (R0)