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Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals
KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
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2011 (English)In: Environmental Pollution, ISSN 0269-7491, E-ISSN 1873-6424, Vol. 159, no 10, 2487-2492 p.Article in journal (Refereed) Published
Abstract [en]

Ecotoxicity data with high reliability and relevance are needed to guarantee the scientific quality of environmental risk assessments of pharmaceuticals. The main advantages of a more structured approach to data evaluation include increased transparency and predictability of the risk assessment process, and the possibility to use non-standard data. In this collaboration, between the research project MistraPharma and the German Federal Environment Agency, a new set of reporting and evaluation criteria is presented and discussed. The new criteria are based on the approaches in the literature and the OECD reporting requirements, and have been further developed to include both reliability and relevance of test data. Intended users are risk assessors and researchers performing ecotoxicological experiments, but the criteria can also be used for education purposes and in the peer-review process for scientific papers. This approach intends to bridge the gap between the regulator and the scientist's needs and way of work.

Place, publisher, year, edition, pages
2011. Vol. 159, no 10, 2487-2492 p.
Keyword [en]
Reliability, Relevance, Data evaluation, Data reporting, Non-standard data/studies/tests
National Category
URN: urn:nbn:se:kth:diva-47992DOI: 10.1016/j.envpol.2011.06.023ISI: 000295493100036ScopusID: 2-s2.0-80052305439OAI: diva2:456870
QC 20111116Available from: 2011-11-16 Created: 2011-11-15 Last updated: 2012-11-19Bibliographically approved
In thesis
1. From Science to Policy: Improving environmental risk assessment andmanagement of chemicals
Open this publication in new window or tab >>From Science to Policy: Improving environmental risk assessment andmanagement of chemicals
2012 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

A complex process like risk assessment and the subsequent risk management decision makingshould be regularly evaluated, in order to assess the need to improve its workings. In this thesisthree related matters are addressed: evaluation of environmental risk management strategies,evaluation of environmental risk assessments, and how ecotoxicity data from the open scientificliterature can be used in a systematic way in regulatory risk assessments. It has resulted in thefollowing: a publically available database with ecotoxicity data for pharmaceuticals (Paper I); anevaluation and review of the Swedish Environmental Classification and Information System forpharmaceuticals (Papers II and III); a comparison of current reliability evaluation methods and areliability evaluation of ecotoxicity data (Paper IV); and an improved reliability and relevancereporting and evaluation scheme (Paper V).There are three overall conclusions from this thesis:(1) Ecotoxicity data from the open scientific literature is not used to the extent it could be inregulatory risk assessment of chemicals. Major reasons for this are that regulators prefer standarddata and that research studies in the open scientific literature can be reported in a way that affectstheir reliability and the user-friendliness. To enable the use of available data more efficiently actionsmust be taken by researchers, editors, and regulators. A more structured reliability and relevanceevaluation is needed to reach the goal of transparent, robust and predictable risk assessments.(2) A risk assessment is the result of the selected data and the selected methods used in theprocess. Therefore a transparent procedure, with clear justifications of choices made, is necessaryto enable external review. The risk assessments conducted within the Swedish EnvironmentalClassification and Information System for pharmaceuticals vary in their transparency and choice ofmethod. This could come to affect the credibility of the system since risk assessments are notalways consistent and guidelines are not always followed.(3) The Swedish Environmental Classification and Information System for pharmaceuticalscontribute, in its current form, to data availability and transparency but not to risk reduction. Thesystem has contributed to the general discussion about pharmaceuticals’ effect on the environmentand made data publicly available. However, to be an effective risk reduction tool this is not sufficient.

Place, publisher, year, edition, pages
Stockholm: KTH Royal Institute of Technology, 2012. 43 p.
Theses in Risk and Safety from the Division of Philosophy at the Royal Institute of Technology, ISSN 1654-627X ; 8
environmental risk assessment, chemicals, pharmaceuticals, transparency, predictability, accuracy, consistency, voluntary initiatives, ecotoxicity data, reliability evaluation, relevance evaluation, non-standard test data, CSR, risk management.
National Category
Environmental Sciences
urn:nbn:se:kth:diva-105225 (URN)978-91-7501-507-1 (ISBN)
Public defence
2012-12-07, E3, Osquars Backe 14, KTH, Stockholm, 10:00 (English)
MistraPharmaFormas - Evaluation of the Swedish Environmental Classification and Information System for Pharmaceutcals.
FormasMistra - The Swedish Foundation for Strategic Environmental Research

QC 20121119

Available from: 2012-11-19 Created: 2012-11-19 Last updated: 2012-11-19Bibliographically approved

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