RISK IN INNOVATION Balancing Benefits and Hazards

Workshop

PARTICIPANTS BOOKLET

30 January 2013

Science and Technology

Options Assessment

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TITLE OF THE WORKSHOP Risk in Innovation: Balancing Benefits and Hazards TIME AND PLACE

January 30, 2013, 14.30-16.30, Room: ASP5G-3

ADMINISTRATOR RESPONSIBLE

Gianluca Quaglio (with the collaboration of Antoine Haarscher)

Science and Technology Options Assessment

Directorate G: Impact Assessment and European Added Value

DG Internal Policies, European Parliament

Rue Wiertz 60 - RMD 00J014, B-1047 Brussels

E-mail: gianluca.quaglio@ep.europa.eu

DISCLAIMER

This is a discussion document for a meeting, and not an official STOA publication. The opinions expressed in this document are the sole responsibility of the authors and do not necessarily represent the official position of the European Parliament.

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CONTENTS

1. PROGRAMME.......................................................................................4

2. PRESENTATION OF THE SPEAKERS..............................................5

3. SLIDES OF THE PRESENTATIONS

A. Risk, Hazard and Innovation...............................................10

B. Case Study 1...........................................................................16

C. Case Study 2............................................................................34

4. STOA ADMINISTRATION................................................................49

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1. PROGRAMME

14.00-14.30 Registration 14.30-14.40 Welcome and Opening Remarks

Chair: Paul RUBIG, MEP and STOA Vice-Chairman

14.40-14.55 Risk, hazard and innovation

Wolfgang DEKANT, University of Würzburg

14.55-15.10 Case study 1: Endocrine disruption - what's it all about?

Richard SHARPE, University of Edinburgh

15.10-15.25 Case study 2: Nanotechnologies - Innovation and risks in the food sector

Milena RIEDE, Dialog Basis

15.25-16.00 Panel debate: addressing risks in society and policy-making

Takis DASKALEROS, DG Health and Consumers, EC Ivana FEGERT, European Centre for Ecotoxicology and Toxicology of Chemicals Bjorn HANSEN, DG Environment, EC Thomas HARTUNG, Johns Hopkins University

16.00-16.20 Questions & Answers 16.20-16.30 Closing remarks

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2. PRESENTATION OF THE SPEAKERS

Wolfgang DEKANT

Prof. Dekant has a track record of research on the biotransformation of xenobiotics

and studies related to interactions of biologically reactive intermediates with cellular

macromolecules and function. Part of this is based on the application of in vitro

models to study mechanisms of toxicity. His laboratory is funded by the European

Union, the Deutsche Forschungsgemeinschaft, the Bundesministerium für

Forschung und Technologie, the Umweltbundesamt, the US Environment Protection

Agency (EPA), the US Health Effects Institute (HEI), industry and a number of

foundations. Prof. Dekant was a member of the Scientific Committee on Toxicity,

Ecology and the Environment (CSTEE) of the European Union. Presently he is

member of the Scientific Committee on Health and Environmental Risks (SCHER)

and of the Food Additives Panel of the European Food Safety Authority (EFSA). He

also is Editor of Toxicology Letters, associate editor of Toxicology and Applied

Pharmacology and is member of the editorial board of Chemical Research in

Toxicology, Toxicological Sciences, and Xenobiotica.

Richard SHARPE

Richard Sharpe heads a research programme on developmental disorders of male

reproductive health in the University Centre for Reproductive Health in Edinburgh.

His expertise and research interests cover sexual differentiation, development and

puberty (and disorders thereof), foetal programming, endocrinology, the effects of

lifestyle (smoking, obesity, diet, use of personal care products) and environmental

chemical exposures on reproductive development and function. He is also interested

in diet, obesity, inflammation and aging and how these intersect with reproductive

health. He Co-chairs the Society for Endocrinology Special Interest Group on

„Endocrine disruptors‟. He has published more than 300 papers and has served on

numerous advisory bodies in Europe and USA.

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Milena RIEDE

Prof. Dr. Milena Riede studied social science and economics and teaches at Catholic

University of Applied Sciences in Berlin in the field of Theory and Methods of Social

Work, Participation and Community Organizing. Her doctor thesis in economics

was on “Determinants of successful stakeholder dialogues”. Besides theoretical

expertise on dialogues she has more than 15 years of practical experience in the field

of participatory processes and dialogues at local, regional, national and EU-level on

various issues such as nanotechnology, climate change, brain science and energy. Ms

Riede works for the team of Antje Grobe and DIALOG BASIS for more than 8 years

and has been involved in expert delphi surveys and various stakeholder dialogues

on nanotechnologies on behalf of industry and governmental bodies.

Takis DASKALEROS

Takis Daskaleros was trained as a medical microbiologist, molecular biologist, and

toxicologist. He is at the European Commission since 1996, where he has worked in

the area of research, consumer safety, and risk assessment. He is now Head of Sector

for Health and Environment Risk in the Unit in charge of Risk Assessment at the

Health and Consumer Protection Directorate General. The unit ensures the technical

support and co-ordination for three Scientific Committees in charge of health,

environmental, consumer and new or emerging risks in non-food areas and is

responsible for policy coordination in the areas of Electromagnetic Fields and

Nanotechnology.

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Ivana FEGERT

Dr. Ivana Fegert is the head of Regulatory Toxicology for Crop Science at BASF. She

heads a team of toxicologists who are responsible for providing advice on all aspects

of toxicological assessment and reviewing, interpreting and summarising

toxicological data associated with regulatory dossiers for pesticides and biocides.

The group is also dealing with classification and labelling. She is a pharmacist and

holds a PhD in Food Chemistry and Environmental Toxicology from the University

of Kaiserslautern. Prior to joining BASF she worked at the German Cancer Research

Centre (Heidelberg) as well as a post-doc at MIT (USA) and ETH (Switzerland).

Bjorn HANSEN

Bjorn Hansen obtained his Masters degree from the State University of New York at

Stony Brook, New York, U.S.A. in 1985 and his Ph.D. in 1988 from the Technical

University in Eindhoven, the Netherlands. After a “habilitation post” at the Geog

August University in Göttingen, Germany, he joined the European Commission

Joint Research Centre in Ispra, Italy, in 1991 and has been work area co-ordinator for

the team working on existing substances (Reg. 793/93) in the European Chemicals

Bureau from 1993 to June, 2003. In June, 2003 he joined the Chemicals, Biocides and

Nanomaterials Unit of DG Environment in Brussels, which he now heads. From 2007

to 2008 he was seconded as Director of Operations to the European Chemicals

Agency.

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Thomas HARTUNG

Thomas Hartung, MD PhD, is Professor of Toxicology (Chair for Evidence-based

Toxicology), Pharmacology, Molecular Microbiology and Immunology at Johns

Hopkins Bloomberg School of Public Health, Baltimore, and University of Konstanz,

Germany. He also is Director of their Centers for Alternatives to Animal Testing

(CAAT). CAAT hosts the secretariat of the Evidence-based Toxicology Collaboration

and the industry refinement working group. He heads the Human Toxome project

funded as an NIH Transformative Research Grant. He is the former Head of the

European Center for the Validation of Alternative Methods (ECVAM), Ispra, Italy.

He has authored more than 370 scientific publications.

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3. SLIDES OF THE PRESENTATIONS

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A. RISK, HAZARD AND INNOVATION (W. DEKANT)

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12

13

14

15

16

B. CASE STUDY 1 (R. SHARPE)

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18

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23

24

25

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27

28

29

30

31

32

33

34

C. CASE STUDY 2 (M. RIEDE)

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36

37

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43

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46

47

48

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4. STOA ADMINISTRATION1

European Parliament

STOA Secretariat

Directorate G: Impact Assessment and European Added Value

Directorate-General for Internal Policies of the Union

European Parliament

Rue Wiertz 60

B-1047 Brussels

Tel. +32 2 284 4545

Fax +32 2 284 4984

E-mail: stoa@europarl.europa.eu

Director-General:

Riccardo Ribera d'Alcalà

Director:

Anthony Teasdale

Head of Unit:

Theo Karapiperis

Administrators:

Peter Ide-Kostic

Lieve Van Woensel

Gianluca Quaglio (Seconded National Expert)

Assistants:

Serge Evrard

Karin Hoitsch

Damir Plese

Marie-Claire Uwizera

Anne Villers

Trainees:

Antoine Haarscher

Johanna van Vrede

Nadja Zivenko

www.europarl.europa.eu/stoa

1 STOA Administration at the moment of the publication of this report