Closing the Gap between Academic Research and Regulatory Risk Assessment of Chemicals
Marlene Ågerstrand, Department of Applied Environmental Sciences, Stockholm University, Mary Sorensen, ENVIRON International Corporation, José Tarazona, European Chemicals Agency, Christina Rudén, Department of Applied Environmental Science
There is a need for regulators and researchers to meet and discuss how they can collaborate in order to improve the current risk assessment process. SETAC provides an important platform for such discussions and therefore we decided to organize the workshop “Closing the gap between academic research and regulatory risk assessment of chemicals” at the May SETAC Europe meeting in Glasgow. There was a high level of interest in taking part in these discussions, as shown by the fact that 176 participants pre-registered for the workshop. The workshop was sponsored by SETAC's Global Ecological Risk Assessment Advisory Group (ERA AG). The workshop was recorded and is available for viewing on the ERA AG website.
Conclusions from the Workshop
There is a need for a more structured reporting of ecotoxicity studies for publication in the peer-reviewed literature. This is important for two reasons: To ensure that academic data are of high quality, and to ensure that the data can be used outside academia. Structured reporting of ecotoxicity studies would contribute to that reliability, and thereby to reproducibility, and would ensure that criteria are met, making the studies qualified for use in regulatory risk assessment of chemicals. Structured criteria can also assist when evaluating ecotoxicity studies.
Through their editorial policies, scientific journals can play a key role in ensuring the reliability of published data. Regulatory bodies can facilitate that process by identifying issues that are critical to the regulatory verification of academic research.
There is a need to continue to discuss and question the relevance of the current risk assessment approach, and to update it according to the available tools and scientific knowledge. Are we, with the methods and knowledge that we currently use, protecting what we are aiming to protect?
It is important to continue arranging meetings between regulators and researchers in order to learn from each other and communicate our different needs.
The workshop comprised a mix of ten platform presentations and two panel discussions. Speakers represented academia, regulatory agencies, consulting firms and industry, and included editors of scientific journals.
European Chemicals Agency, Finland
"The REACH experience: current situation and options for improvement"
University of Nebraska, Lincoln, USA
"Why is incorporating better science into risk assessment so hard?"
UK Environmental Agency, UK
"Variability in environmental quality standards: what are the causes?"
Swiss Centre for Applied Ecotoxicology, Switzerland
"Towards Klimisch 2.0? - More transparency and quality in risk assessment"
ENVIRON International Corporation, USA, Editor at Integrated Environmental Assessment and Management
"Integrated Environmental Assessment and Management. Developing and using sound science in regulatory & industry decision-making."
University of Applied Sciences Darmstadt, Society for Institutional Analysis, Germany
"Input of Academic Ecotoxicity Studies to the REACH-Mechanisms"
University of Michigan, USA, Editor at
Environmental Toxicology and Chemistry
"Environmental triggers based on stressor importance and realistic exposures"
WCA Environment, UK
"Objective use of data from the scientific literature for risk assessment: nanosilver as a case study"
Messagewright, UK; Editor at Health and Environment
"Evidence-based medicine: a source of novel techniques for advancing the consistency of chemical risk assessment?"
AstraZeneca UK Ltd, Brixham Environmental Laboratory, UK
"Maximising scientific and stakeholder confidence in non-standard data: lessons learned from other disciplines"
Past and Present Activities and Publications
Examples of activities and publications regarding this issue:
- Reliability and relevance evaluation and reporting criteria have been developed as tools for researchers, editors, reviewers, risk assessors, and regulators. All information is presented at the webpage: www.scirap.org.
- Criteria for pharmaceuticals: collaboration between Stockholm University, and the German Environmental Protection Agency (UBA).
- Criteria for chemicals in general, including a ring test with over 60 risk assessors from North America, Europe and Asia: collaboration between Stockholm University, RIVM, and The Swiss Centre for Applied Ecotoxicology. MS in prep.
- Criteria for nanoparticles: collaboration between Stockholm University and the Danish Technical University. MS in prep.
- Criteria for endocrine disrupting chemicals: collaboration between Stockholm University and the Karolinska Institutet. MS in prep.
- The workshop ”Utilization of ecotoxicological research in society—bridging the gap between scientists and stakeholders” was held in March 2012 in Gothenburg, Sweden. The workshop aimed to improve the understanding between these scientists and promote improved utilization of ecotoxicological research in society.
- During the 6th SETAC World Congress in Berlin in May 2012, researchers, representatives from ECHA and the pharmaceutical industry, and risk assessors from consulting firms and national authorities met to discuss a ring test of the reliabilityand relevance evaluation method developed for chemicals in general, and to discuss the need for a more actions, such as workshops.
- Several regulatory bodies have published recommendations in this field. For example, the ECHA Practical Guide “How to report robust study summaries” was updated in November 2012. The guide indicates the key elements regarding the “material and methods” and “results and discussion” sections to be considered for the use of different studies in the regulatory context, and is applicable to both guideline and non-guideline studies.
- A session was held at the EUROTOX conference in Stockholm June 2012 regarding environmental risk assessment of pharmaceuticals: ”Pharmaceuticals in the environment: occurrence, effects on wildlife, and how to reduce the levels ." One of the things discussed was the editor's role in in publishing data that can be used in risk assessments. A follow-up session, “Closing the gap between academic research and regulatory risk assessment of chemicals", will be held at the EUROTOX meeting in Interlaken in September 2013. A session is also planned for EUROTOX 2014 in Edinburgh.
- Preliminary efforts are being made to determine if a SETAC Technical Workshop on the topic should be held in 2014.
- Ågerstrand M, Sorensen M, Tarazona J, Rudén C. 2013. Report from the workshop “Closing the gap between academic research and regulatory risk assessment of chemicals”
- Ågerstrand M, Küster A, Bachmann J, Breitholtz M, Ebert I, Rechenberg B, Rudén C. 2011. Reporting and evaluation criteria as means towards transarent use of ecotoxicity data for environmental risk assessment of pharmaceuticals. Environmental Pollution 159: 2487-2492.
- Ågerstrand M, Breitholtz M, Rudén C. 2011. Comparison of four different methods for reliability evaluation of ecotoxicity data—A case study of non-standard test data used in environmental risk assessments of pharmaceutical substances. Environmental Sciences Europe 23:17.
- Eriksson K M. 2012. Report from the workshop ”Utilization of ecotoxicological research in society—bridging the gap between scientists and stakeholders”
For more information about the workshop and future activities, please contact Marlene Ågerstrand.
Authors’ contact information: email@example.com
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