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

 

Video recordings

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

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

Participants

Reference documents

Case studies and assessments
SEURAT-1
BASF


Presentations

 

 

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]
19 April 2016: Break-out Sessions

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
20 April 2016: Plenary Sessions

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

 

Poster Presenters:  list of poster presenters
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)

(1) Joint Research Centre, European Commission
(2) L'Oreal
(3) Unilever SEAC
(4) Procter & Gamble

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
2 Clariant Produkte (Deutschland) GmbH, Am Unisyspark 1, 65843 Sulzbach, Germany
3 CEFIC, 4 Avenue E. Van Nieuwenhuyse, 1160, Brussels, Belgium

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
2. Department of Statistics, Ludwig-Maximilians-University Munich, 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
United States Environmental Protection Agency, Office of Research and Development, National Center for Environmental Assessment, Cincinnati, OH

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
2. The Rutgers Center for Computational & Integrative Biology Rutgers University at Camden, USa
3. Department of Chemistry Rutgers University at Camden, USA
4. 4CAAT-Europe, University of Konstanz, Germany

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
Mark TD Cronin, Liverpool John Moores University, Liverpool, United Kingdom
Terry W Schultz, The University of Tennessee, College of Veterinary Medicine, Knoxville, TN, USA

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
Elisabet Berggren, European Commission Joint Research Centre, IHCP, Ispra, Italy
Martina Klaric, Cosmetics Europe, Brussels, Belgium
Catherine Mahony, Procter & Gamble, Egham, UK

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
Monica Locatelli, REACH mastery

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
2Iowa State University, Ames, IA, USA;
3Liverpool John Moores University, Liverpool, UK

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.

2 - Grupo de Investigação em Genética e Metabolismo, Escola Superior de Tecnologia da Saúde de Lisboa – IPL, Portugal

3 – Centro de Investigação e Estudos em Saúde Pública, Escola Nacional de Saúde Pública, ENSP, Universidade Nova de Lisboa

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
Phil Bentley, Toxicodynamix International LLC, Hendersonville, NC, USA
Susanne Glowienke, Novartis Institutes for Biomedical Research, Preclinical Safety, Basel, Switzerland
Ester Lovsin Barle, Novartis Pharma AG, BC & HSE, 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
1American Chemistry Council
2USEPA National Center for Computational Toxicology
3Procter & Gamble
4Ted Simon LLC

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
Dr Nathalie Belot, XCellR8 Ltd
Bushra Sim, 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