Print Page   |   Contact Us   |   Sign In
Site Search
Workshop: Glasgow
Group HomeGroup HomeGroup PagesDirectory & Features Join Group
Share |

 

Workshop

CLOSING THE GAP BETWEEN ACADEMIC RESEARCH AND REGULATORY RISK ASSESSMENT OF CHEMICALS

(see below for recorded sessions)

Sunday, 12 May 2013, 13:00-18:00

SETAC Europe, Glasgow, Scotland

Sponsor: Global Ecological Risk Assessment Advisory Group

WORKSHOP CHAIRS

   

Workshop Chair: Christina Rudén

Department of Applied Environmental Science

Stockholm University, Professor

Stockholm, Sweden

christina.ruden@itm.su.se

   

Workshop Co-Chair: Mary Sorensen

Chair of SETAC's Global Ecological Risk Assessment Advisory Group

ENVIRON International Corporation, Senior Science Advisor

Georgia, USA.

msorensen@environcorp.com

   

Workshop Co-Chair: José Tarazona

European Chemicals Agency (ECHA), Science Chair

Helsinki, Finland.

jose.tarazona@echa.europa.eu

WORKSHOP OVERVIEW

Ecotoxicity studies from the academic research are not used to the extent it could be in environmental risk assessment of chemicals. A possible reason for this could be guidance documents that recommend use of standard tests. Another possible reason could be that research studies are not reported in a structured way, which sometimes affects their reliability and user-friendliness. To close the gap actions must be taken. Researchers and editors need to report data in a way that enables use in regulatory risk assessment, and regulators must open up for use of that data. Speakers representing the academia, regulatory agencies, industry tripartite, and editors from scientific journals are participating in a workshop intended to start a discussion and encourage actions to close the gap between academic research and regulatory risk assessment of chemicals. The workshop is a mix of panel talks and panel discussions where audience participation will be encouraged.

Co-Organizer

 

Marlene Ågerstrand

Department of Applied Environmental Science

Stockholm University, Sweden

marlene.agerstrand@itm.su.se

SPEAKERS OVERVIEW

· José Tarazona, European Chemicals Agency (ECHA), Finland

· Valery Forbes, University of Nebraska, Lincoln, USA

· Paul Whitehouse, UK Environmental Agency

· Robert Kase, Swiss Centre for Applied Ecotoxicology

· Rick Wenning, ENVIRON International Corporation, Integrated Environmental Assessment and Management, USA

· Martin Führ, University of Applied Sciences Darmstadt, Society for Institutional Analysis (Sofia), Germany

· Allen Burton, University of Michigan, Environmental Toxicology & Chemistry, USA

· Peter Simpson, WCA Environment, UK

· Paul Whaley, Messagewright, Health and Environment, UK

· Jason Snape, AstraZeneca UK Ltd, Brixham Environmental Laboratory, UK

  

SPEAKERS DETAIL

 

José Tarazona

European Chemicals Agency (ECHA), Finland

Scientific Chair

jose.tarazona@echa.europa.eu

The REACH experience: Current Situation and Options for Improvement

Although ecotoxicity studies from academic and research institutions have been frequently used in the regulatory context, there are still some limiting issues. The experience from REACH and other regulatory processes identifies two main reasons: the use of non-standard methodologies/endpoints and the limitations in reporting methodological details and results. Both issues will be addressed, explaining the regulatory needs for allowing a proper evaluation of environmental studies and offering suggestions for closing the gap.

 

Valery Forbes

University of Nebraska, USA

Director, School of Biological Sciences

vforbes3@unl.edu

Why is Incorporating Better Science into Risk Assessment So Hard?

There is widespread recognition among academic, industry, and regulatory stakeholders that the approaches we use for chemical risk assessment today are far from ideal. Yet there is remarkable resistance to changing the status quo. Part of this is due to stakeholder concerns that modifications to current practice will result in risk assessments that are more (industry) or less (regulators) conservative than what we have today. Another issue contributing to inertia is academic disputes among scientists, that may be valid, but unhelpful for gaining consensus on the way to move forward. Progress will require that both of these issues – in addition to better quality control of data – are effectively addressed.

   

Paul Whitehouse

UK Environmental Agency

Research Manager

paul.whitehouse@environment-agency.gov.uk

Variability in Environmental Quality Standards: What are the Causes?

The Water Framework Directive (WFD) is a major piece of European legislation requiring Member States to take steps aims to achieve good surface and groundwater status. Delivering good chemical status relies heavily on Environmental Quality Standards (EQSs), including EQSs derived by each Member State for contaminants of national concern (‘Specific Pollutants’). Many of the Specific Pollutants are common to several Member States and assessors deriving EQSs have access to common technical guidance and similar sources of data. Despite this, variability between EQSs derived for the same substance by different Member States can arise. This presentation presents the results from an analysis of EQS variability and discusses the likely causes of the differences in the derived EQS values.

   

Robert Kase

Swiss Centre for Applied Ecotoxicology, Switzerland

Risk Assessor, SPI Research Correspondent

Robert.Kase@oekotoxzentrum.ch

Towards Klimisch 2.0? - More Transparency and Quality in Risk Assessment

There is a need for improvement of the criteria used for data evaluation within various legislations. We report results from a ringtest with 80 risk assessors from Europe, North America and Asia where the current evaluation criteria (Klimisch et al. 1997) have been compared with a new updated checklist method. A total of 8 aquatic ecotox studies (including different taxonomic groups, tested substance classes and quality levels) were evaluated. The results highlight the inconsistencies among assessors when using the current Klimisch evaluation for reliability and relevance assessment. We are now able to compare these findings directly with the results from the newly developed checklist approach, in order to increase the transparency and consistency of environmental risk assessments.

 

Rick Wenning

Editor-in-Chief: Integrated Environmental Assessment and Management

ENVIRON International Corporation, California, USA

Principal, Global Ecology and Sediment Management Practice Leader

rwenning@environcorp.com

Developing and Using Sound Science in Regulatory & Industry Decision-Making

The value of science and engineering is woefully diminished when government and industry decision-makers are unable to understand the significance and application of new discoveries and technologies. The mandate of peer-reviewed science publications with an actively engaged, cross-disciplined editorial board is to help scientists communicate clearly and confidently the value of their achievements. Science editors have a unique opportunity to improve the use of scientific information in decision-making, and promote constructive interactions between scientists and decision-makers. Editors and editorial boards are also capable of mobilizing the scientific community to inform solutions to environmental accidents, vexing regulatory issues, and difficult industry investment challenges. To be successful, researchers in academia and industry must satisfy two obligations - open and transparent communication of their work, and direct answers to the "so what” question.

 

Martin Führ

Professor, Public Law, Legal Theory, Comparative Law

Univ. of Applied Sciences Darmstadt, Society for Institutional Analysis, Germany

fuehr@sofia-darmstadt.de

Input of Academic Ecotoxicity Studies to the REACH-Mechanisms

Registrants are obliged to take into account and submit all "toxicological and ecotoxicological information that is relevant and available to the registrant” (Art. 12(1) REACH). The risk assessment hast to kept up to date and the registration dossier has to be updated "without undue delay” in cases where new risk knowledge relevant for the safety data sheet or the chemical safety report is available (Art. 14(7), 22(1)e REACH). These obligations could be underpinned by an additional institutional framework in the context of the REACH-mechanisms.

  

Allen Burton

Editor-in-Chief: Environmental Toxicology & Chemistry (EC&T)

Professor and Director, University of Michigan, USA

burtonal@umich.edu

Environmental Triggers Based on Stressor Importance and Realistic Exposures

Traditional aquatic ecosystem quality management approaches need a reality check. Human-dominated waterways are impacted by multiple stressors that cause impairments to varying degrees. Aquatic life impairments are most efficiently and effectively reduced (managed) by focusing on the most ecologically-important stressors first, on a site-specific basis. This requires experimentally-designed assessments where stressor linkages to effects are considered in the context of spatial and temporal distributions and stressor interactions.

   

Peter Simpson

WCA Environment Limited, UK

Principal Consultant

peter.simpson@wca-environment.com

Objective Use of Data from the Scientific Literature for Risk Assessment: Nanosilver as a Case Study

The EU REACH regulation requires that substances manufactured or imported into the EU market are registered with the European Chemicals Agency (ECHA). The level of information required in registrations is proportionate with the tonnage of material used, with greater information requirements associated with greater tonnages. Several silver substances have already been registered under REACH and industry is currently reviewing the scientific literature with a view to updating the current REACH registration to clarify the properties and risks associated with nanosilver; a material that has attracted significant scientific, media and regulatory attention over recent years. I will describe the approach adopted by industry for the objective identification, quality assessment, selection and treatment of data on the properties of nanosilver relevant to an environmental risk assessment from the large numbers of potentially relevant studies published in the scientific literature. Issues associated with nanomaterial characterisation, study design and study reporting will be discussed in terms of how they influenced data selection and regulatory gap analysis.

  

Paul Whaley

Editor: Health and Environment, UK

Scientific Advisor, Cancer Prevention and Education Society

Research Lead, Policy from Science Project

paul@messagewright.co.uk

Evidence-based Medicine: A Source of Novel Techniques for Advancing the Consistency of Chemical Risk Assessment?

BPA is arguably the poster-child of an increasingly fractured consensus on the safety of a growing number of chemicals in everyday use. While the European Food Safety Authority says BPA is safe at current levels, the French authorities have banned it, it has virtually disappeared from infant care products, and the Swedish authorities are even planning on restricting its use in thermal paper.

A number of drivers of inconsistency in risk assessment (RA) have been proposed, including a failure of academic research practices to produce data which meets the needs of regulators, and an uneven emphasis on hazard over risk in interpreting safety data, among others. Here, the view is presented that inconsistent practices in both the evaluation and presentation of data in chemical RA is a major contributing factor to controversies about chemical safety, undermining RA's aspirations to objectivity and usefulness. It is proposed that techniques from evidence based medicine can provide a novel toolkit for advancing the consistency of risk assessment; an example of one such tool, a risk of bias assessment, will be demonstrated.

  

Jason Snape

Principal Scientist and Research Manager

AstraZeneca UK Ltd, Brixham Environmental Laboratory, UK

Jason.Snape@astrazeneca.com

Maximising Scientific and Stakeholder Confidence in Non-standard Data:Lessons Learned from Other Disciplines

This presentation will describe some of the key challenges posed by the use of non-standard data in risk assessment together with some opportunities and mechanisms to increase confidence in how non-standard data is reported and presented. In doing so, examples will be drawn from other disciplines including the genomic based data standardisation efforts coordinated by the Functional Genomics Data Society (FGED) who work with other organizations to develop standards for biological research data quality, annotation and exchange. FGED also facilitate the creation and use of software tools that build on these standards and allow researchers to annotate and share their data easily to facilitate data integration and meta-analysis. This presentation will focus on some of the data standardisation and meta data capture systems developed by FGED and their success and wider utility.

  

BACKGROUND INFORMATION

Background – Activities

A meeting was held at SETAC in Berlin 2012 with representatives from ECHA, pharmaceutical industry, risk assessors at consultant firms and national authorities, and researchers. The main purpose of the meeting was to discuss the ring test (see below) but the need for a more actions, such as workshops, was also discussed.

A workshop was held at EUROTOX in Stockholm 2012 regarding pharmaceuticals in the environment. Some of the things discussed here was editors role in publishing data that can be used in risk assessments.

Collaborative Development of Evaluation and Reporting Methods

Collaboration among various entities has been occurring for a variety of topics:

- For chemicals in general: collaboration between Stockholm University (Sweden), UBA (Germany), RIVM (the Netherlands), and The Swiss Centre for Applied Ecotoxicology (Ecotox Centre).

- For nanoparticles: collaboration between Stockholm University and DTU (Denmark).

- For endocrine disrupting chemicals: collaboration between Stockholm University and Karolinska Institute (Sweden).

- Participants in this SETAC ERA AG Workshop from these organizations will discuss collaborative efforts.

· A ring test was conducted during 2012-2013 with over 80 participants representing academia, industry, consultants and governmental agencies. In this ringtest, 8 aquatic ecotoxicological studies (including different taxonomic groups, tested substance classes and quality levels) were evaluated. Robert Kase will discuss the results of the currently used Klimisch approach in comparison to an updated checklist approach.

Background – Scientific papers

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.

Overall the evaluation of non-standard tests resulted in a low number of studies with acceptable reliability. The nine selected studies were evaluated by four different methods which resulted in 36 evaluations. Only 15 (or 42%) of these evaluations resulted in acceptable reliability. Some argue that academic research is curiosity driven and therefore not suitable for risk assessment. However, there are no contradictions between producing curiosity driven innovative research and producing research of high reliability. In fact, the latter is a corner stone in the scientific work since it is closely connected to reproducibility. It is therefore notable that the overall reliability of the evaluated data is low. Whether this is due to the design and performance of the study or the reporting of it is not clear. A combination of the two is of cause also possible.

Ågerstrand M, Küster A, Bachmann J, Breitholtz M, Ebert I, Rechenberg B, Rudén C. 2011. Reporting and evaluation criteria as means towards transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals. Environmental Pollution 159 (10): 2487-2492.

A more structured reliability and relevance evaluation is needed to reach the goal of transparent, robust and predictable risk assessments. In this paper a new reliability and relevance evaluation method is presented. Intended users are risk assessors and researchers performing ecotoxicological experiments, to bridge the gap between the regulator and the scientist's needs and way of work. Furthermore, the criteria can be used for education purposes and in the peer-review process for scientific papers.

SCHEDULE

OPENING REMARKS (13:00)

Christina Rudén

Mary Sorensen

Marlene Ågerstrand

GROUP 1: SPEAKERS

1

José Tarazona

Regulator

2

Valerie Forbes

Academia

3

Paul Whitehouse

Regulator

4

Robert Kase

Academia

5

Rick Wenning

Editor/Industry

DISCUSSION                                                                                 

BREAK                                                                                              

GROUP 2: SPEAKERS

6

Martin Führ

Academia

7

Allen Burton

Editor/Academia

8

Peter Simpson

Industry

9

Paul Whaley

Editor/Regulator

10

Jason Snape

Industry

DISCUSSION                                                                                 

ADJOURN (18:00)

 

 

Group 1, Part 1 (recording)
Group 1, Part 2 (recording)
Group 2 (recording)

 

 


Sign In


Forgot your password?

Haven't joined yet?

SETAC News
Upcoming Events

10/14/2014 » 10/15/2014
SETAC Europe 10th Special Science Symposium

11/9/2014 » 11/13/2014
SETAC North America 35th Annual Meeting

 

© 2013 Society of Environmental Toxicology and Chemistry