ACTIVITY: EFFECT-BASED TOOLS/METHODS

for WG Chemicals as part of the Water Framework Directive CIS Work Programme (2016-2018)endorsed by the Water Directors

“Effect-based assays; links between chemical and ecological status; mixtures. Possible follow-up of estrogen-screening project. Exchange of information on innovative techniques, approaches and potential application in WFD context”

TERMS of REFERENCE

Introduction

In the aquatic environment[1] thousands of chemical substances are dischargeddaily, from point and diffuse sources,and among these substances a large number could have adverse effects on aquatic ecosystems and/or human health. It would be highly challenging to perform a chemical analysis of all these substances; furthermore, to estimate the risk of effects related to the large number of substances that are present and detected in the environment (including pollutants of emerging concern, metabolites and transformation products), it would be necessary to develop a very large number of assessment criteria and Environmental Quality Standards (EQS).

There is an increasing awareness that chemicals never occur as individual compounds in the environment but as components of very complexmixtures, reflecting the approximately 100,000 chemicals in daily use together with huge numbers of environmental transformation products3Assessment criteria for chemicals are generally developed substance-by-substance, based on laboratory studies, and usually do not consider the consequences of simultaneous exposure to multiple chemicals occurring in the environment. Exposure to chemical mixtures cangiverise to cumulative effects, even if individual chemicals are present at or below their EQS levels(Raquel Carvalho et al. 2015). Numerous specifically-acting chemicals such as pesticides, biocides and pharmaceuticals with similar modes of action (MoA) have been or are on the market and replace each other in application patterns. Specifically-acting chemicals can be grouped according to their MoA and addressed by cost-efficient effect-based tools/assays (e.g. in vitro assays).

In the2010-2012 Work Programmeof the Common Implementation Strategy for the Water Framework Directive (WFD), the subgroup on Chemical Monitoring and Emerging Pollutants (CMEP) under the WG “Chemical Aspects” received a mandatefor the elaboration of a technical report on effect-based tools. The activity was chaired by Sweden and co-chaired by Italy and progressively involved several Member States, JRC, associated States and stakeholders in an EU-wide drafting group (47 Experts). The resulting technical report (Wernersson et al. 2014)identified effect-based tools (e.g. bioassays, biomarkers) and new ecological indicators with the potential to be used to support the different monitoring programmes (surveillance, operational and investigative) of the WFD. Use could also be made of such tools in the context of the Marine Strategy Framework Directive (MSFD) (forDescriptor 8 – D8, descriptor 9 –D9), and the technical report includes a specific chapter on the marine environment.

The report identifies several objectives for the use of effect-based tools/assaysin a WFD context:

As screening tools in the framework of the pressures and impacts assessment to aid in theprioritisation of water bodies, to establish early warning systems, to take the effects of chemical mixtures or chemicals that are not analysed into account, to provide additional support in water and sediment quality assessment.
On-going project in the context of the watch list[2]
In the context of WG Chemicals'work and as a follow-up to the Science-to-Policy Interface activity (Kase et al. 2012) an internationalvoluntary project was approved which aims to verify and apply some of the concepts included in the technical report. The project is ongoing ( and is evaluating the use of effect-based tools/assays (invitro bioassays) for the detection of the estrogenic substances, 17α-ethinylestradiol (EE2) and 17β-estradiol (E2), which are included in the WFD “Watch List”.This project investigates approaches to screening environmental samples (Hecker and Hollert 2011) for the presence and quantity of oestrogenic activityusing effect-based tools/assays, before applying more demanding and expensive chemical analytical methods to monitor these substances.In vitro bioassays, among the different possible applications, are able to detect oestrogenic activity of environmental mixtures in a cost-effective way.
The objectives of the above estrogen monitoring project are the following:
Promoting reliable screening methods for the monitoring of chemicals in wastewater and surface waters; harmonising monitoring strategies across Europe as well as data interpretation methods, includingthe testing and definition of trigger values; implementing cost-effective and reliable effect-basedtools/assays in regulatory monitoring.
General Objective of the Task
The task is a follow-up of the CMEP work.Its main objective is to examine and further document the possible implementation of effect-based tools/assays for monitoring and assessment in the WFD context, bearing in mind their possible application under the MSFD. The results of the estrogen monitoring project will support the achievement of some of the specific objectives.
Specific Objectives (the final list will be decided on the basis of the human resources available)
1.Identification of chemical modes of action (MoAs) (e.g. estrogenicity, Ah receptor binding, acetylcholinesterase inhibition, anti-cholinergic activity, photosynthetic inhibition, mutagenicity, immunotoxicity), considered to be of relevance in or via the aquatic environment.
2. Perform an inventory of MoAs (if known) for currently regulated and/or monitored compounds (in particular priority and other WFD Annex X substances, watch-list substances, and river basin specific pollutants identified to be of concern).
3. Based on 1 and 2, selection and prioritisation of effect-based assays/methods (in vivo and in vitro) available on the market for the detection of the relevant MoA, in the different matrices of the aquatic environment.
4. Selection and prioritisation of available effect-based assays/methods (in vitro and in vivo) for the evaluation of complex mixtures occurring in the differenttypes of aquatic environments (e.g. freshwaters, coastal waters), and aiming at being able to identify water bodies at elevated risk (i.e. support the WFD assessment of pressures and impacts).
5. Development, where possible, of in vivo and in vitro effect-based trigger values, signalling a risk to or via the aquatic environment (including risks to human health from chronic exposure via consumption of drinking water or fishery products). With the aim of making effect-based methods/assaysapplicable in WFD chemical monitoring and assessment.
6. Evaluation of methods that can be used to link chemical pollution with the biological quality elements used to assess ecological status (to be decided if this objective can be achieved considering a period of 2 years).
7. Identification of a list of effect-based tools/bioassays to be considered forMSFD application according to D8 criterion8.2.1 (of Decision 2010/477/EU) and/or considered within the WFD.
8. Identify ways to harmonise the WFD and MSFD assessments in this context (cf 7).
9. Assess the availability and suitability of investigative approaches for identifying the underlying causes contributing to the overall risks, to facilitate measures to appropriate sources of emissions.
10. Assess the practical feasibility of implementing at EU-scale the above proposals.
Deliverables
  • Science/Policy documentation regarding the possible the application of effect-based tools for monitoring and assessment of aquatic surface water-bodies in the context of the WFD and MSFD.
  • Report on the results of the International Estrogen Monitoring Project.
Workplan
The activity of the Drafting Group will start in July 2016 and will continue through 2017 and 2018, with the aim of providing a final report at the end of 2018.The form and status of the final report under the WFD Common Implementation Strategywill be discussed with the Working Group Chemicals/ the SCGbased on findings/developments. Relevant MSFD groups will be closely associated.
The ways of working will includeteleconferences, email exchanges, creation of specific on-line folders/boxes (e.g. dropboxes). At least 1 meeting per year will be organised depending on the amount of work. In view of the innovative scientific aspects, the drafting group, including the EU Commission,will consider whether to involve additional experts for some specific issues.In addition to the meetings mentioned above, aWorkshopwill be organized in 2017.Some laboratory or field testing by volunteer States could be considered in 2018.
Drafting GroupMembers(interest/availability at time of drafting these ToR)
Sweden, Italy, Switzerland, DG JRC (Activity Chairs)
Germany, France, UK, Norman, Concawe, DG ENV (Contributors)

References

Hecker Markus and Hollert Henner (2011): Endocrine disruptor screening: regulatory perspectives and needs. Environmental Sciences Europe 2011. 23:15. Environmental Sciences Europe 2011, 23:15 doi:10.1186/2190-4715-23-15. Online at:

Carvalho R et al. Mixtures of Chemical Pollutants at European Legislation Safety Concentrations: How Safe are They? Toxicological Science. 2014. doi: 10.1093/toxsci/kfu118.

Kase Robert, Clayton Helen, Martini Frederique (2012): Science-Policy Interface (SPI) activity on prioritisation of research needs, knowledge availability and dissemination for the Working Group E (Chemical Aspects) 2010-2012. Open available at CIRCABC at:

Wernersson Ann-Sofie; Carere Mario, et al. (2015): The European technical report on aquatic effect-based monitoring tools under the water framework directive. Environmental Sciences Europe, 2015; 27 (1) DOI: 10.1186/s12302-015-0039-4.

Press release at:

Aquatic environment includes surface water, groundwater, inland water, transitional waters, coastal waters, artificial waters, heavily modified waters in regard to directive 2000/60/EC. Environment covers water column, biota and sediment. The effects to be considered are those on the aquatic environment and on human health via the aquatic environment.

[2]The watch list is a new mechanism designed to provide the Commission with targeted high-quality monitoring information on the concentration of substances in the aquatic environment, with a focus on emerging pollutants and substances for which available monitoring data are of insufficient quality, for the purpose of risk assessment. The first watch list is set out in the.Commission Implementing Decision (EU) 2015/495 of 20 March 2015 establishing a watch list of substances for Union-wide monitoring in the field of water policy pursuant to Directive 2008/105/EC of the European Parliament and of the Council (notified under document C(2015) 1756) Text with EEA relevance