
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
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)
|
