ECETOC e-newsletter issue 28, Spring 2015

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EUROPEAN CENTRE FOR ECOTOXICOLOGY AND TOXICOLOGY OF CHEMICALS e-Newsletter Issue 28

Spring 2015

2015 Annual Technical Meeting explores opportunities to agree on Science Approaches in Risk Assessment

58 participants representing Member Companies, Academia and Regulatory Authorities gathered in Brussels for the ECETOC Annual Technical Meeting held on 3rd March 2015. Within the theme of “Opportunities to agree on Science Approaches in Risk Assessment “, speakers presented the Regulatory and ECETOC approaches to Ecosystem Services and Read Across in Risk Assessment. Karel de Raat of ECHA speaking on read-across under REACH

The morning session on Ecosystem Services began with an overview by Lorraine Maltby of the University of Sheffield. Jose Tarazona, Head of Pesticides Unit at EFSA, then presented the Regulatory Approach to Ecosystem Services. The ECETOC Approach was presented by Stuart Marshall of Unilever who introduced the work of the ongoing ECETOC Task Force on Chemical Risk Assessment – Ecosystem Services. The afternoon session on Read Across in Risk Assessment kicked-off with a presentation by Karel de Raat of ECHA on read-across under REACH. René Hunziker of Dow Europe then spoke on understanding ECETOC approaches to Read Across in Risk Assessment. He said that a crucial contribution by ECETOC in the context of read across is

In This

Issue

Front page • Report from the ECETOC ATM Page 2 Scientific Committee News Upcoming Events

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Page 3 Recent Events

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Page 4 Latest publications News from EUROECOTOX

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Ben van Ravenzwaay (Scientific Committee Chair) described the ECETOC consultative process

the framework put forward by the Nano task force that helps to categorise nano materials and makes recommendations on the relevant testing (see more details in “Latest Publications” on page 4). Kees van Leeuwen (KVR Watercycle Research Institute) looked at areas with opportunities to agree on read across in risk assessment, reviewing the past 10 years, the current status and the way forward. Wrapping up the meeting, Professor Jim Bridges of the University of Surrey provided an analysis and review of the Science Approaches presented during the day. Mamta Patel of Chemical Watch has written a deeper analysis of the meeting and its findings, available to Chemical Watch subscribers at: https://chemicalwatch.com/23054/ europe-needs-to-agree-on-how-to-doread-across

Jim Bridges (University of Surrey) wound up the meeting by reviewing the Science Approaches presented during the day

Scientific Committee News New ECETOC Transformational Programme: “Using Molecular Data Wisely” As part of the ECETOC Board decision to spend part of its resources on Thought Leadership, a new Transformational Programme has been established which will run for the next three to five years. The Programme: Using Molecular Data Wisely responds to a growing need to understand how to get the best value out of the increasing generation of large volumes of ‘omics’ data. Currently, there is no guidance on how to produce, store or interpret omics data in the regulatory context. Principles for a common path forward should be established so regulators can have confidence in using omics data for better decision-making and standard operating procedures based on best practice for each technology will ensure consistent application in laboratories. With this in mind, ECETOC has established a tripartite Transformational Programme: 1. Establish a set of principles for data production and storage in a standardised and GLP-like way in order to ensure similar paths and principles are adhered to across multiple laboratories 2. Establish a framework on how to analyse omics data, starting with transcriptomics. An Expert Meeting will take place in July 2015 to decide steps to develop the framework. 3. Develop weight of evidence to facilitate the incorporation into risk assessment of in vitro and in vivo omics hazard data developing using new methods and tools in a transparent and consistent way. Achieving our goals would set quality criteria to ensure data quality,

reproducibility and confidence in decision making. It could help facilitate regulatory acceptance of data from new technologies whilst protecting against interpretation of poor data, developed lacking the quality standards.

Newly-Established Task Forces Adverse Outcome Pathways (AOPs) focusing on endocrine active chemicals There are many global activities directed towards using the framework of adverse outcome pathways (AOPs) to understand and describe the biological pathway describing the key events linking the molecular initiating event, (initial chemical interaction between a chemical and cellular molecules), with adverse (eco/toxicological) outcomes. The ultimate desire is eventually to use measurement of the molecular initiating or key events, preferably in in vitro test systems, to predict adverse outcome at the whole animal or population level. This will enable high throughput assessment of chemicals and dramatically reduce animal use. The Task Force will examine how AOPs for endocrine active substances might be constructed and assess the data required to come to sound conclusions that might have regulatory applications. The Task Force, which first met on March 4th 2015, will produce a report providing guidance and a structured framework on how AOP methodology can be applied to provide a better understanding of how endocrine disruption can lead to an eco/ toxicological outcome. Freshwater ecotoxicity as an environmental impact category This Task Force is being established

to address freshwater ecotoxicity as an environmental impact category by establishing the scientific relevance of USEtox and developing guidance for its interpretation in the context of chemical impact assessment and selection of chemical-based products. A detailed work plan will be agreed at the first meeting that will be planned as soon as the Task Force has been set up. Exploring community-based environmental hazard assessments of mixtures based on mode-of-action based approaches There is an increasing awareness of the need to complement single substance assessments with the assessment of mixtures. Mode of action considerations have been proposed to derive environmental thresholds for substances with the same mode of action. This implies that for mixtures of substances which act according to the same mode of action, there is one threshold, i.e. a concentration below which no impact on the environment is expected. Finally, there is an acknowledged need to increase ecological realism of environmental assessments by considering communities rather than single species to represent whole communities. These three developments in the field of risk assessment in the aquatic environment are to be tied together in the work of the task force. Its objective is to draft a provisional ecological risk assessment approach based on a review of the current state of science in the areas of mode of action, mixtures and community assessment. Secondly, the knowledge gaps for actual implementation of the provisional assessment approach are to be identified.

Upcoming Events Emerging Issues: the use and safety assessment of small RNA molecules

29-30.Oct.15, Snowbird, Utah, USA

to the SETAC North America meeting in Salt Lake City, Utah as many of the scientists will attend that meeting too. Society is facing a variety of challenges in environmental risk assessment (ERA): growing concerns about the effects of multiple stressors (chemical and non-chemical); risks associated with exposure to complex mixtures; and demands to quantify local site-specific risks. At the same time, risk assessors are seeking to provide a more efficient framework on which to address these emerging problems and questions in a manner that reduces cost and the use of animals.

This ECETOC workshop will be held prior

The workgroup will assess the

24.Aug.15, Prague, Czech Republic

ECETOC-sponsored workshop at European Environmental Mutagenesis and Genomics Society (EEMGS) 44th Annual Meeting. For further information, visit http://eemgsmeeting2015.eu/ monday-24-august.htm

Defining the role of chemical activity in ERA: Practical guidance & advice

ECETOC e-Newsletter issue 28, Page 2

applicability of using chemical activity in the interpretation of effects data. Recent studies have demonstrated the utility of the concept with respect to acute baseline toxicity, consequently the emphasis of this workgroup will be on expanding the concept to chronic baseline toxicity and providing guidance regarding the handling of acute effects for non-narcotic chemicals. This Workshop was a recommendation of ECETOC Technical Report no. 120 and follows the work of Cefic LRI ECO16. 29-30 October, 2015 Participation is by invitation only.

Recent Events Annual ECETOC Environmental Progress Review

12-13 February 2015, Brussels, Belgium The 2015 environment progress review took place with a record turnout of 55 scientists from member companies, academia and regulatory authorities such as Cefas, the European Commission, ECHA, EFSA, OECD and UBA. This annual meeting sets out to inform and review the spectrum of ECETOC environmental activities: task forces, workshops and LRI projects. The first day consisted of a review of existing ECETOC and LRI projects. The second day focussed on identifying new ideas for ECETOC and LRI activities.

Workshop on the improvement of the OECD 306 screening test 17-18 February 2015, CEFAS laboratories, Lowestoft, UK

Recent ECETOC workshops recommended a series of modifications and enhancements to existing OECD biodegradation screening tests to deliver more robust methods for assessing persistence [1]. This reflects the high variability and poor reliability previously reported in OECD biodegradation screening tests such as the OECD 306 [2,3,4]. The Cefic-LRi funded Eco11 [5] investigated and validated these enhancements, producing a framework for selecting the most suitable inocula cell concentration method for improved enhanced activated sludge (c.f. OECD 301) and marine tests (c.f. OECD 306). The plan is that these improvements will lead to a ring test of an enhanced OECD 306 test. This workshop, aimed at labpractitioners and those with a specific interest in this area, introduced the concepts and hands-on lab-based training so that any facilities interested in participating in a ring test will have the knowledge to do so. ECETOC 2013. Assessing Environmental Persistence. Workshop Report No. 24. ECETOC 2003. Persistence of chemicals in the Environment. Workshop Report No. 90. [3] ECETOC 2007. Workshop on Biodegradation and Persistence. Workshop Report No. 10. [4] Goodhead et al., 2013. Standard inocula preparations reduce the bacterial diversity and reliability of regulatory biodegradation tests. Environmental Science and Pollution Research 21 (16); 9511-9521. [5] Cefic 2014. Cefic LRi Eco11 [1]

[2]

http://www.cefic-lri.org/projects.

ECETOC welcomes 2 new Board Members at Annual General Meeting 03 March 2015, Brussels, Belgium

At the 2015 Annual General Meeting, Dr Carole Langrand-Lerche (Head of Global Regulatory Toxicology at Bayer

Photo: Jose Tarazona, Head of Pesticides Unit at EFSA, speaking at the Annual ECETOC Environmental Progress Review on the scientific needs for improving environmental risk assessment of chemicals from the EFSA point of view. CropScience) and Lorraine Francourt (Dow Chemical - Lead Director, EH&S and Sustainability, Europe, Middle East and Africa, and Asia Pacific) were unanimously elected as new members of the ECETOC Board.

Annual Technical Meeting

03 March 2015, Brussels, Belgium (See front page article)

Basing chemicals management on the best science During a recent visit to ECHA, ECETOC Secretary General Dr Alan Poole described the activities ECETOC is engaged in and the common goals between ECHA and ECETOC to ensure the best scientific knowledge as a basis for decisionmaking. The video is available at https:// www.youtube.com/watch?v=3VSZ0xW5 47o&list=PL4FBDBAF95999655D

RSC second expert workshop on low-dose endocrine disrupter effects 09 April 2015, RSC, London

The purpose of this second expert workshop on low-dose endocrine disrupter effects was to build on the outputs of the previous workshop held on 4th June 2014 and to develop a practical research protocol to investigate low dose non-monotonic (LDNM) endocrine disrupter effects. The intention is that this protocol will then be used by several laboratories to produce reproducible results needed to fill the gaps in current knowledge and to inform regulatory policy. The first workshop (report available at http://rsc.li/ed-low-dose-effects ) was itself a follow-up to the ECETOC Expert Panel to Better Understand Endocrine Disrupter Low Doses Effects held on 2223 April 2013 – see ECETOC Workshop Report No. 27).

ECETOC e-Newsletter issue 28, Page 3

Expert Meeting: AOP/MOA of Reproductive Health Ontology

23-24 April 2015, Brussels, Belgium

There is no single source of information providing a comprehensive ontology of developmental toxicity linked to the molecular initiating events (MIEs) and adverse outcome pathways (AOPs) responsible for these effects. Yet there are burgeoning amounts of data increasingly available that inform us about molecular pathogenesis leading to human developmental toxicity. The time has come to organise the field of toxicology in a different way. Responding to this need, an ECETOC Expert Team made up of regulatory, academic and industry experts, met in Brussels this spring to progress its drafting of a state of science on building prenatal developmental toxicity ontology for publication in peer reviewed, open access literature. The document will first identify the challenges and approaches ― and then propose the necessary steps ― to build a prenatal mode of action (MOA) ontology framework. This work will be the basis from which to identify scientific research priorities (e.g. under Cefic LRI or Horizon 2020), and form the basis from which to plan a workshop next year. Such an ontology will help link molecular data to traditional toxicology; elucidate whether existing high throughput or high content approaches are sufficiently inclusive of MOA and serve as an organizing structure for constructing AOPs. Thus, contributing to the universe of integrated approaches to testing and assessment (IATA), increasing efficiency and helping to reduce animal testing, whilst providing the knowledge base for industrial and regulatory scientists to use in risk assessment and decision making.

Latest Publications Thresholds in chemical respiratory sensitisation A variety of chemicals are known to cause allergic sensitisation of the respiratory tract associated with allergic rhinitis and asthma. It is generally accepted that the development of sensitisation of the respiratory tract to chemicals is a threshold phenomenon. That is, a certain minimum level of exposure is required to induce sensitisation to a given allergen. This Task Force was set up to assess whether the corollary is true: that there will be levels of exposure below which sensitisation will fail to develop. The analyses by the Task Force have revealed that the acquisition of sensitisation of the respiratory tract to chemicals is dose-dependent and that thresholds do exist. However it is commonly difficult to define exactly what levels of exposure will be required for sensitisation to develop. It is clear that in some circumstances it may be possible to use occupational exposure data to derive levels of workplace exposure that are safe. However, the Task Force highlights the fact that there remains a need to develop improved methods for hazard characterisation. Cochrane SA, Arts JHE, Ehnes C, Hindle S, Hollnagel HM, Poole A, Suto H, Kimber I. Thresholds in Chemical Respiratory Sensitisation Toxicology 333:179-194 (Open Access) Doi 10.1016/j.tox.2015.04.010 The following shortcut can be used to download the article from the publisher’s website: http://bit.ly/ecetoc-art2015-cochrane-et-al

ECETOC publication presents concept for the grouping and safety assessment of nanomaterials The safety of nanomaterials can be ensured by undertaking animal testing only as a very last resort. This is the premise and promise of the

Decision-making framework for the grouping and testing of nanomaterials - DF4nanoGrouping. The ECETOC Nano Task Force has developed the DF4nanoGrouping based upon an earlier review of existing approaches for the grouping and testing of nanomaterials published in summer 2014. The output of the Nano Task Force continues to be impactful with Task Force members being asked to make presentations to many organisations including ECHA, OECD and JRC as well as several member states including the UK, Netherlands, Spain and Czech Republic. The ECETOC Nano Task Force Decision-making framework for the grouping and testing of nanomaterials – DF4nanoGrouping is published as an Open Access article in Regulatory Toxicology and Pharmacology. Arts J, Hadi M, Irfan MA, Keene AM, Kreiling R, Lyon D, Maier M, Michel K, Petry T, Sauer UG, Warheit D, Wiench K, Wohlleben W, Landsiedel R. 2015 A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping) Regulatory Toxicology and Pharmacology (In press – uncorrected proof - Open Access) The following shortcut can be used to download the article from the publisher’s website: http://bit.ly/ecetoc-art2015-arts-et-al

ECETOC workshop addresses aquatic toxicity using species sensitivity distribution Predicting the toxicity of chemicals to aquatic communities is an integral element in environmental risk assessment. It is therefore a major component in environmental protection strategies and in the process of managing the safe use and disposal of chemicals. ECETOC and the Environment Agency for England organised a three day workshop to discuss and review current statistical species sensitivity distribution (SSD) models, when and how they should be used in regulatory applications

and their ecological significance. A number of recommendations were made on how SSD methods could be further developed to improve the quality of decisions needed from both the prospective risk and retrospective impact assessment of chemicals. The document is published as ECETOC Workshop Report No.28: Estimating toxicity thresholds for aquatic ecological communities from sensitivity distributions. 11-13 February 2014. The report can be freely downloaded via http://bit.ly/ecetoc-wr28

ECETOC 2014 Annual Report Published in preparation for the March 2015 ECETOC Annual General Meeting and Annual Technical Meeting, the 2014 Annual Report can be downloaded from: http://bit.ly/ecetoc-2014ar

EUROECOTOX Newsletter no.7 The European Network for Alternative Testing Strategies in Ecotoxicology has published its 7th newsletter. The main feature is a report by Adam Lillicrap (NIVA) and Teresa Norberg-King (US EPA) on the Animal Alternatives Advisory Group (AAAG) meeting, held during the 2014 SETAC Europe annual meeting in Basel, to discuss progress in the state of the science within animal alternatives for environmental toxicity testing. The newsletter can be downloaded at http://bit.ly/euroecotox-enl-7 EUROECOTOX is a network, initiated within a coordination action funded by the EC FP7 Environment Programme (2010-2012) and continued with coordination by ECETOC.

Download the catalogue of ECETOC publications at http://bit.ly/ecetoc-catalogue ECETOC reports are freely available from the ECETOC website:www.ecetoc.org/publications Graphics in this newsletter are based on “The dancers” by anamontreal on Flickr: https://www.flickr.com/photos/30236331@ N06/5927216681 They are used under the CC BY-SA 2.0 licence - http://creativecommons.org/licenses/by/2.0/

EUROPEAN CENTRE FOR ECOTOXICOLOGY AND TOXICOLOGY OF CHEMICALS Avenue E. Van Nieuwenhuyse 2 Bte. 8, B-1160 Brussels, Belgium Tel: +32 2 675 3600 Fax: +32 2 675 3625 VAT: BE 0418344469 Visit www.ecetoc.org or e-mail [email protected] for more information about ECETOC and to download ECETOC reports free of charge ECETOC e-Newsletter issue 28, Page 4