News
News
Topical Scientific Workshop - New Approach Methodologies in Regulatory Science
19-20 April 2016 | Helsinki, Finland
Topical scientific workshops of the European Chemicals Agency (ECHA) aim to foster discussion among academia, regulators, industry and other stakeholders on the possible regulatory impacts of the latest scientific developments. An anticipated outcome of these workshops is the emergence of new or improved approaches which may be applied to the implementation of the REACH, CLP and biocides regulations.
Video reportage
- Day 1 – part 1
Introduction, Theme 1: Definitive hazard assessment: improvement of read-across - Day 1 – part 2
Theme 1: Definitive hazard assessment: improvement of read-across (cont.) - Day 1 – part 3
Panel discussion: Role of NAM in definitive hazard assessment (read-across) - Day 2 – part 1
Break-out session reports - Day 2 – part 2
Theme 2: Screening and priority setting - Day 2 – part 3
Theme 3: Prospects for regulatory science
Aim of the workshop
The Topical Scientific Workshop on New Approach Methodologies in Regulatory Science explored the potential regulatory benefits arising from fundamental change in scientific thinking.
Complex toxicological apical endpoints cannot be predicted by a single non-standard test. Instead, it is necessary to combine multiple lines of evidence (including ‘-omics' and high-throughput screening methods) to predict the hazardous property with tools to facilitate this integration of evidence.
Two motivating drivers for the workshop were:
- A better understanding of the underlying biology behind how chemicals cause adverse effects to human health; and
- New tools and techniques that provide a huge amount of data to be used in solving regulatory issues.
The workshop drew inspiration from the EU research programme SEURAT-1 and the US Tox21 initiative, and also took into account general progress from the scientific field.
Format and themes
The discussions were held in plenary and break-out sessions and were complemented by a poster exhibition. In addition to the keynote presentations, a selection of case studies were presented in the plenary and discussed in-depth in the break-out sessions.
The central theme was a rational combination of data from new-approach methods on an individual substance to make an overall fit-for-purpose prediction for it. The idea was to discuss issues framed from the regulatory perspective with scientists who are experts in the field. Combining the expertise of scientists, regulators and industry professionals helped to address the biggest challenges and work out practical solutions.
The three specific themesstrong> of the workshop were:
- Definite hazard assessment, particularly read-across
- Screening and priority setting
- Prospects for regulatory science
First day
- Theme 1: Definitive hazard assessment: improvement of read-across
This theme covered the short-term achievable aim of using new-approach evidence to improve the quality of read-across and chemical categories by presenting case studies that demonstrated the usefulness of different types of new approach methodologies data in read-across and their added value. The plenary presentations served as a basis for the break-out group discussions in the afternoon of the first day.
Other objectives of this theme were to gain experience on how new approach methodologies can be used by registrants; to take a reality check of how read-across works on high quality risk assessment cases supported by mechanistic evidence; and especially to identify further development needs.
Second day
- Theme 2: Screening and priority setting
- Theme 3: Prospects for regulatory science
These themes covered other means of assessing substances and using new-approach methods for screening/priority setting. This led to discussions about how to make the most effective use of this new kind of evidence when not restricted to the current regulatory approach (i.e. ‘new paradigm' considerations).
Examples of theme-related cases were presented by the regulatory agencies from the USA, Canada and Australia. These examples were followed by presentations on other aspects of application of new approach methodologies data in regulatory science. The focus of the afternoon was on regulatory needs for experimental assays design, reporting of new approach methodology generated data for regulatory use as well as on the availability and use of existing frameworks on weight of evidence, mode of action, adverse outcome pathway for incorporation of new approach methodologies data into regulatory hazard assessment.
Programme
Proceedings
Participants
Reference documents
- Read-Across for 90-Day Rat Oral Repeated-Dose Toxicity for Selected Perfluoroalkyl Acids
Case study, Assessment, Annex - Read-Across for 90-Day Rat Oral Repeated-Dose Toxicity for Selected β-Olefinic Alcohols
Case study, Assessment, Annex
- Metabolomics as read-across tool: a case study with phenoxy herbicides
Case study, Assessment
Presentations
- EU Research and innovation in support to chemical safety, Dr Christian Desaintes, Scientific Officer, European Commission, DG Research & Innovation, Belgium, Presentation [PDF]
Theme 1: Definitive hazard assessment: improvement of read-across
- Setting the scene
Critical aspects in the assessment of read-across adaptations: the role of supporting evidence, Dr Norbert Fedtke, ECHA, Finland, Abstract [PDF], Presentation [PDF] - Case study from SEURAT-1
Read-Across for 90-Day Rat Oral Repeated-Dose Toxicity for Selected Perfluoroalkyl Acids: A Case Study, Professor Terry Schultz, University of Tennessee, USA, Abstract [PDF], Presentation [PDF] - Case study from SEURAT-1
Read-Across for 90-Day Rat Oral Repeated-Dose Toxicity for Selected β-Olefinic Alcohols: A Case Study, Professor Mark Cronin, Liverpool John Moores University, United Kingdom, Abstract [PDF], Presentation [PDF] - Case studies from BASF
Metabolomics as read-across tool: a case study with phenoxy herbicides, Dr Bennard van Ravenzwaay, BASF, Germany, Abstract [PDF], Presentation [PDF]
1. Case study from SEURAT-1
Perfluorinated alkyl acids: direct acting toxicant category supported by ToxCast evidence
| Chair: Dr Watze de Wolf, Chairman of Member State Committee, ECHA, Finland Presenter: Ms Sharon Stuard, Procter & Gamble, United States of America Rapporteur: Dr Norbert Fedtke, ECHA, Finland Abstract, Presentation, Report |
2. Case study from SEURAT-1
β-Unsaturated alcohols: indirect acting toxicant category supported by SEURAT-1 data
| Chair: Dr Derek Knight, Senior Scientific Advisor, ECHA, Finland Presenter: Dr Andrea Richarz, European Commission, Joint Research Centre, Italy Rapporteur: Dr Elisabet Berggren, European Commission, Joint Research Centre, Italy Abstract, Presentation, Report |
3. Case study from BASF
Read-across with metabolomics for phenoxy herbicides
| Chair: Dr Tomasz Sobański, Scientific Committee Chair, ECHA, Finland Presenter: Dr Bennard van Ravenzwaay, BASF, Germany Rapporteur: Dr Karel de Raat, advisor to ECHA, The Netherlands Abstract, Presentation, Report |
Reports from break-out sessions
Rapporteurs of the break-out sessions
Theme 2: Screening and priority setting
- The NICNAS IMAP Program, Dr Kerry Nugent, National Industrial Chemicals Notification and Assessment Scheme, Australia, Abstract [PDF], Presentation [PDF]
- Application of computational and high-throughput in vitro screening for prioritization, Dr Richard Judson, Endocrine Disruptor Screening Program, United States Environmental Protection Agency, USA, Abstract [PDF], Presentation [PDF]
- Chemicals Management Plan, Dr Christine Norman, Health Canada, Canada, Abstract [PDF], Presentation [PDF]
- A Common Screening Approach for REACH and CLP Processes, Dr Panagiotis Karamertzanis, ECHA, Finland, Abstract [PDF], Presentation [PDF]
Theme 3: Prospects for regulatory science
- Moving Towards Version 2.0 of Toxicity Testing in the 21st Century and Application to Regulatory Decision-Making, Dr Rusty Thomas, United States Environmental Protection Agency, USA, Abstract [PDF], Presentation [PDF]
- How to overcome limitations of new approach methodologies in the context of regulatory science, Dr Romualdo Benigni, Istituto Superiore di Sanità, Italy, Abstract [PDF], Presentation [PDF]
- Analysing Data: Towards a framework for transcriptomics and other Big Data analysis for regulatory application, Dr Timothy W Gant, Public Health England, United Kingdom, Abstract [PDF], Presentation [PDF]
- Using new approach methodologies in regulatory science: tools and methods for integration of evidence, Dr George Fotakis, ECHA, Finland, Abstract [PDF], Presentation [PDF]
Poster abstracts
| Theme 1: Definitive hazard assessment: improvement of read-across | |||
|---|---|---|---|
| Number | Organisation / Country | Submitter | Title / Authors / Poster |
| 1 |
European Chemicals Agency, Finland |
Dr Niklas ANDERSSON |
The read-across assessment framework under REACH
Niklas Andersson, David R. Bell, Ingo Bichlmaier, George Cartlidge, Karel De Raat, Norbert Fedtke, Anneli Kojo, Agnes Kovari, Tatiana Netzeva, Eric Stilgenbauer European Chemicals Agency, Helsinki, Finland
Poster [PDF] |
| 2 |
European Commission, Joint Research Centre, Italy |
Dr Elisabet BERGGREN |
SEURAT-1 Proof-of-Concept: The ab Initio safety assessment case study for daily exposure to an active ingredient in a body-lotion Elisabet Berggren(1), Gladys Ouedraogo (2), Alicia Paini(1), Andrea Richarz(1), Andrew White(3) and Catherine Mahony(4) Poster [PDF] |
| 3 |
Ideaconsult Ltd, Bulgaria |
Dr Nina JELIAZKOVA |
Linking LRI AMBIT Chemoinformatic system with the IUCLID Substance database to Support Read-across of Substance endpoint data and Category formation N. Jeliazkova 1 , V. Koch 2, Q. Li 2, U. Jensch 2, J. Schneider-Reigl 2, R. Kreilingb 2, I. Georgiev 1, B. Hubesch 3 1 Ideaconsult Ltd.,4, Angel Kanchev Str., 1000 Sofia, Bulgaria |
| 4 |
Eupoc GmbH, Germany |
Dr Uwe KÖNIG |
Exploring Uncertainty in Exposure Thresholds to help Downstream Companies in Acquisition, Analysis and Evaluation of Exposure Data to Implement adequate Activities in their Daily Work Dr. Uwe König(1), Dr. Malte-Matthias Zimmer(1), Prof. Dr. Göran Kauermann(2) 1. Eupoc GmbH, Memmingen, Germany |
| 5 |
United States Environmental Protection Agency, USA |
Dr Jason C. LAMBERT |
Adverse Outcome Pathway ‘footprinting': an integrated read-across approach to the assessment of mixtures Jason C. Lambert |
| 6 |
CAAT-Europe, University of Konstanz, Germany |
Dr Thomas HARTUNG |
REACH-across - making the publicly available safety data for 9,801 substances registered under REACH (2008-2014) a resource for read-across Thomas Luechtefeld1, Alexandra Maertens1, Daniel Russo2, Hao Zhu2,3, Costanza Rovida4 and Thomas Hartung1,4 1. Center for Alternatives to Animal Testing (CAAT), Johns Hopkins Bloomberg School of Public Health, Environmental Health Sciences, Baltimore, USA |
| 7 | Lhasa Limited, UK | Dr Donna S. MACMILLAN |
Predicting skin sensitisation using a decision tree integrated testing strategy with an in silico model and in chemico/in vitro assays Donna S. Macmillan, Steven J. Canipa, Martyn L. Chilton, Richard V. Williams and Christopher G. Barber Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK Poster [PDF] |
| 8 |
European Chemicals Agency, Finland |
Dr Gesine MÜLLER |
Predicting hazardous properties of substances from related substances - some case reports Gesine Muller, Jonas Nygren, Silvia Lapenna, Ari Karjalainen, Fabrice Broeckaert, Chiara Perazzolo, Linda Spjuth, Alexis Nathanail, Ricardo Simoes European Chemicals Agency, Helsinki, Finland Poster [PDF] |
| 9 |
European Commission, Joint Research Centre, Italy |
Dr Andrea RICHARZ |
Essential Aspects of Read-Across for Repeated-Dose Toxicity Predictions Andrea-N Richarz, European Commission Joint Research Centre, IHCP, Ispra, Italy Poster [PDF] |
| 10 |
European Commission, Joint Research Centre, Italy |
Dr Andrea RICHARZ |
SEURAT-1 Proof-of-Concept Read-Across Case Study for Repeated-Dose Toxicity Andrea-N Richarz, European Commission Joint Research Centre, IHCP, Ispra, Italy Poster [PDF] |
| 11 |
CAAT Europe, Germany |
Dr Costanza ROVIDA |
Practical needs to implement advanced strategies for a proper justification of the read across/category approach Costanza Rovida, CAAT Europe Poster [PDF] |
| 12 |
The University of Tennessee, USA |
Dr Terry W. SCHULZ |
Read-Across for 90-Day Oral Repeated-Dose Toxicity for Low or No Toxicity Substances: The Importance of Toxicokinetic Similarity Terry W. Schultz1, Steven P Bradbury2 and Mark T.D.Cronin3 1The University of Tennessee, Knoxville TN, USA Poster [PDF] |
| 13 |
Escola Superior de Tecnologia da Saúde de Lisboa – IPL, Portugal |
Dr Susana VIEGAS |
How to deal with uncertainties regarding the occupational exposure to antineoplastic mixtures – Additive effect should always be considered? C. Ladeira1,2,3, S. Viegas1,3, A. Costa-Veiga1 1 – Environment and Health Research Group, Escola Superior de Tecnologia da Saúde de Lisboa – IPL, Portugal. Poster [PDF] |
| 14 |
Novartis Institutes for Biomedical Research, Switzerland |
Dr Gian C. WINKLER |
In Silico and Read-Across Mutagenicity and Carcinogenicity Assessment to Close Data Gaps for the Pharmaceutical Intermediate Trans-1,4-dibromobut-2-ene Gian C. Winkler, Novartis Institutes for Biomedical Research, Preclinical Safety, Basel, Switzerland Poster [PDF] |
| Theme 2: Screening and priority setting | |||
| Poster number |
Organisation / Country | Submitter | Title / Authors / Poster |
| 15 | American Chemistry Council, USA | Dr R.A. BECKER |
Integrating the threshold of toxicological concern (TTC) with high throughput exposure assessment for risk-based screening of several thousand commodity chemicals R.A. Becker1, J. Wambaugh2, G. Patlewicz2, S. Felter3, T.W. Simon4 Poster [PDF] |
| 16 | North Carolina State University, USA | Dr David M. REIF |
Leveraging the power of high-dimensional data for integrated screening and prioritization decisions
David M. Reif
Bioinformatics Research Center, Department of Biological Sciences, North Carolina State University, Raleigh, NC, USA |
| 17 | XCellR8 Ltd, UK | Dr Carol TREASURE | Adaptation of Human Cell Based Safety Tests to Animal Product Free Conditions
Dr Carol Treasure, XCellR8 Ltd |
| 18 | University of Birmingham, UK | Dr Mark R. VIANT |
Metabolomics: a tool for mechanistic toxicology Mark R. Viant
(1) Environmental Metabolomics Research Laboratory, (2) Phenome Centre - Birmingham, (3) NERC Biomolecular Analysis Facility - Birmingham; all at School of Biosciences, University of Birmingham, Birmingham, B15 2TT, U.K. |
| 19 | Technical University of Denmark (DTU), Denmark | Dr Eva B. WEDEBYE |
New free Danish online (Q)SAR predictions database with >600,000 substances Eva B. Wedebye, Marianne Dybdahl, Trine K. Reffstrup, Sine A. Rosenberg, Nikolai G. Nikolov
Technical University of Denmark (DTU) National Food Institute Moerkhoej Bygade 19, 2860 Soeborg, Denmark Poster [PDF]
|
| Theme 3: Prospects for regulatory science | |||
| Poster number |
Organisation / Country | Submitter | Title / Authors / Poster |
| 20 | US National Institute of Environmental Health Sciences, USA | Dr Warren CASEY |
Developing a US National Strategy and Roadmap for the Replacement of Animal-Based Toxicity Testing
Warren Casey, PhD, DABT
Director, ICCVAM US National Institute of Environmental Health Sciences |
| 21 | ScitoVation, Research Triangle Park, USA | Dr Rebecca A. CLEWELL |
Using 21st Century tools to identify point of departure for safety assessment of genotoxic compounds
Rebecca A. Clewell (1), Bin Sun (1), Salil Pendse (1), Patrick D. McMullen (1), Yeyejide Adeleye (2), Paul L. Carmichael (2), Melvin E. Andersen (1)
(1) ScitoVation, Research Triangle Park, NC USA
(2) Unilever, SEAC, Colworth, Bedforshire UK |
| 22 |
University of Birmingham, UK
|
Dr John COLBOURNE |
PhyloToxicology: exploiting evolutionary concepts to improve toxicity testing
John Colbourne, Mark Viant
School of Biosciences, University of Birmingham |
| 23 | Parker Doe Partnership LLP, UK | Dr John DOE |
Removing Blockers to the Acceptance of New Methodology in Regulatory Science
Dr John Doe Parker Doe Partnership LLP, Cheshire, UK
Poster [PDF]
|
| 24 |
Parker Doe Partnership LLP, UK
|
Dr John DOE |
A 21st Century Roadmap for Human Health Risk Assessment
1 Imperial College London, London, UK
2 Parker Doe Partnership LLP, Cheshire, UK 3 University of Milan, Milan, ITALY 4 Pastoor Science Communications, LLC, Greensboro, NC, USA 5 ILSI Health and Environmental Sciences Institute, Washington, DC, USA Poster [PDF]
|
| 25 |
Douglas Connect GmbH, Switzerland
|
Dr Barry HARDY |
Integration into risk assessment of open source human omics data from in vitro studies
Lucian Farcal, Thomas Exner, Barry Hardy
Douglas Connect GmbH, Switzerland Poster [PDF]
|
| 26 |
Humane Society International, Belgium
|
Dr Jarlath HYNES |
Integrated Approaches to Testing and Assessment (IATA) can facilitate acceptance and regulatory use of non-animal methods
Jarlath Hynes, Kate Willett
Humane Society International |
| 27 |
Health Board, Estonia
|
Dr Kaja ILMARINEN |
The scientific background for identification of selected substances
Kaja Ilmarinen, Health Board,
Department of Chemical Safety Merike Nugin, Health Board, Department of Chemical Safety Riina Aav, Tallinn University of Technology
Dzmitry Kananovich, Tallinn University of Technology Sandra Kaabel, Tallinn University of Technology
Maria Fomitšenko, Tallinn University of Technology Arvo Mere, Tallinn University of Technology<
Poster [PDF]
|
| 28 |
Laboratory of Mathematical Chemistry, Bourgas "Prof. As. Zlatarov" University, Bulgaria
|
Dr O. MEKENYAN |
QSAR Toolbox as read-across/category building platform suitable for combining in-vivo experimental results with mechanistic data and expert knowledge
O. Mekenyan1, S. Dimitrov1, T. Pavlov1, C. Kuseva1, T. Sobanski2, D. Hirmann2,T. Netzeva2, A. Gissi2, A. Martin Aparicio2
1Laboratory of Mathematical Chemistry, Bourgas "Prof. As. Zlatarov" University "Yakimov" St. #1, 8010 Bourgas, Bulgaria 2Computational Assessment and Dissimination Unit European Chemicals Agency, Helsinki, Finland Poster [PDF]
|
| 29 |
US Army Engineer Research and Development Center, USA
|
Dr Edward PERKINS |
Driving Risk Decisions Through Information Integration and Visualization Using Systems Biology, Ontologies and the AOPXplorer
Edward Perkins, Natalia Garcia-Reyero, Kurt Gust, Mitchell Wilbanks, Natalie Barker, and Lyle Burgoon
US Army Engineer Research and Development Center, Vicksburg, MS, USA |
| 30 |
3Rs Management and Consulting, Denmark
|
Dr Erwin L ROGGEN |
Potency ranking of skin sensitizers using the Reconstituted Human Epidermis (RhE) IL-18 test and the Genomic Allergen Rapid Detection (GARD) test
Erwin L Roggen,3Rs Management and Consulting
Els Adriaens, Adriaens Consulting Eric Andres, Oroxcell Fanny Boisleve, Yves Rocher Sun-A Cho, Amorepacific
Emanuela Corsini, University of Milan George DeGeorge, MB Research Laboratories Horst W Fuchs, CellSystems Pierre-Jacques Ferret, Pierre-Fabre
Sue Gibbs, Vrije Universiteit Medical Center Patrick Hayden, MatTek Cooperation Henrik Johansson, SenzaGen Dagmar Lehmeier, Eurofins
Silvia Letasiova, MatTek IVSL Jean-Philippe Therrien, Stiefel Poster [PDF]
|
| 31 |
ECEAE/CrueltyFreeInternational, UK
|
Dr Katy TAYLOR |
The need to ADAPT to new methodologies
Taylor, K.
ECEAE/CrueltyFreeInternational Poster [PDF]
|
| 32 |
EBTC at the Johns Hopkins Bloomberg School of Public Health, USA
|
Dr Katya TSAIOUN |
Evidence-Based Toxicology – the missing link between the advancements of science and the confidence of regulatory decisions
Katya Tsaioun
EBTC at the Johns Hopkins Bloomberg School of Public Health |
Scientific and local organising committee members
Scientific committee members
The international Scientific Committee is chaired by Dr Tomasz Sobanski from ECHA. The committee members are:
- Dr Tara Barton-Maclaren, Health Canada, Canada
- Dr Sonja Beken, European Medicines Agency, United Kingdom
- Dr Elisabet Berggren, Joint Research Centre, European Commission, Italy
- Professor Ian Cotgreave, Swetox, Sweden
- Professor Mark Cronin, Liverpool John Moores University, United Kingdom
- Dr Joop De Knecht, National Institute for Public Health and the Environment, The Netherlands
- Dr Karel De Raat, Advisor to ECHA, The Netherlands
- Dr Jean-Lou Dorne, European Food Safety Authority, Italy
- Dr Matthias Herzler, Federal Institute for Risk Assessment, Germany
- Dr Derek Knight, ECHA, Finland
- Dr Catherine Mahony, Procter & Gamble, United Kingdom
- Dr Tatiana Netzeva, ECHA, Finland
- Dr Christine Norman, Health Canada, Canada
- Dr Kerry Nugent, National Industrial Chemicals Notification and Assessment Scheme, Australia
- Dr Magda Sachana, Organisation for Economic Cooperation and Development, France
- Professor Terry Schultz, University of Tennessee, Knoxville, USA
- Professor Michael Schwarz, Tübingen University, Germany
- Dr Rusty Thomas, US Environmental Protection Agency, USA
- Dr Bennard van Ravenzwaay, BASF, Germany
Local organising committee members, ECHA
- Dr Anja Klauk
- Dr Derek Knight
- Dr Tomasz Sobanski
- Dr Kaihsu Tai (chair)
Contact email
For specific questions, contact: scientificevents (at) echa.europa.eu