STOA Workshop Ethical and Social Challenges of Agricultural Technologies - Issues for Decision-Makers

STOA workshop Ethical and social challenges of agricultural technologies - Issues for decision-makers

Participants’ booklet

EPRS | European Parliamentary Research Service Scientific Foresight Unit (STOA) PE 598.618

STOA workshop

Ethical and social challenges of agricultural technologies Issues for decision-makers

Participants’ Booklet

25 January 2017, 14:30-17:00 Paul-Henri Spaak Building, Room 7C050 European Parliament, Brussels Prepared by Nera Kuljanic and Mihalis Kritikos, Scientific Foresight Unit (STOA)

Available at: www.europarl.europa.eu/stoa/cms/home/workshops/ethical

2 Contents

1. Programme ...... 4

2. Introduction ...... 5

Marijana Petir, MEP, STOA Panel member ...... 8

Julian Kinderlerer, University of Cape Town, South Africa, former President (2010-2016) of

the European Group on Ethics in Science and New Technologies...... 9

Helge Torgersen, Institute of Technology Assessment, Austrian Academy of Sciences ....10

Anne Ingeborg Myhr, GenØk-Centre for Biosafety, Tromsø, Norway ...... 11

Amir Muzur, School of Medicine, University of Rijeka, Croatia...... 12

4. About STOA ...... 13

5. STOA Panel members...... 14

STOA Bureau...... 14

STOA Panel...... 15

6. STOA administration...... 17

3 1. Programme

Chair: Marijana Petir, STOA Panel Moderator: Julian Kinderlerer, University of Cape Town, South Africa, former President (2010-2016) of the European Group on Ethics in Science and New Technologies (EGE)

14.30-14.40 Opening Marijana Petir, MEP, STOA Panel

14.40-15.00 Setting the scene: Innovation and (bio)ethics Julian Kinderlerer

15.00-15.20 Synthetic biology in agriculture and challenges for risk governance Helge Torgersen, Institute of Technology Assessment, Austrian Academy of Sciences

15.20-15.40 Genetic modification in agriculture and challenges for risk governance Anne Ingeborg Myhr, GenØk-Centre for Biosafety, Tromsø, Norway

15.40-16.00 The precautionary principle – between European bioethical tradition and American pragmatism Amir Muzur, School of Medicine, University of Rijeka, Croatia

16.00-16.30 Debate

16.30-16.40 Conclusions Julian Kinderlerer

16.40-16.45 Closing Marijana Petir, MEP, STOA Panel

4 2. Introduction

Agriculture is not only technical, economic or political in nature but also inherently ethical - to feed the world’s population while respecting future generations’ needs and expectations in terms of food security, safety and sustainability. New agricultural technologies, whether they modify the genes of plants or not, can increase yields, improve the way we use natural resources such as land and water, enhance nutritional value of food and help to feed the world in a more sustainable and efficient way.

The need to broaden the scope of authorisation and regulatory frameworks for agricultural biotechnologies so as to take into account the relevant socio-economic and ethical impacts has been a long-standing query of societal actors and of a wide range of stakeholders. The inclusion of socio-economic and ethical considerations in biosafety decision-making is a widely debated issue at international, regional and national levels considering that these could define the way technologies are introduced and disseminated in society. The arguments both in favour and against the inclusion socio-economic considerations in biosafety decision-making are varied. On the one hand, there are those that argue in favour of recognising the relevance of socio-economic considerations in risk assessment and management of genetically modified organisms (GMOs) due to their potential impacts on biological diversity that may in turn jeopardize rural livelihoods, indigenous knowledge and local farming practices. Opinions against the acknowledgment of socio-economic considerations mostly focus on the potential increase of the cost of compliance.

There is a substantial body of literature on anticipated and documented impacts of genetically modified crops beyond the health and environmental dimension. These impacts are referred to as ethical, economic, agronomic, agro-environmental, societal, social, socio-economic etc. At international level, in the context of the Cartagena Protocol on Biosafety1 and the Aarhus Convention2, as well as the level of the European Union (EU), socio-economic aspects of genetically modified organisms are being elaborated to a greater extent. During the sixth meeting of the Conference of the Parties serving as the meeting of the Parties (COP-MOP) to the Cartagena Protocol on Biosafety, the Parties recognised the need for further guidance when choosing to take into account socio-economic considerations3 and made reference to the operational objective 1.7 of the Strategic Plan of the Cartagena Protocol on Biosafety for the period 2011–2020. The objective 1.7 aims: “To, on the basis of research and information exchange, provide relevant guidance on socio-economic considerations that may be taken into account in reaching decisions on the import of living modified organisms.” Finally, in March

1 The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. It was adopted on 29 January 2000 and entered into force on 11 September 2003. 2 The United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters was adopted on 25 June 1998 in the Danish city of Aarhus (Århus) at the Fourth Ministerial Conference as part of the ‘Environment for Europe’ process. It entered into force on 30 October 2001. 3 Decision BS-VI/13 (http://bch.cbd.int/protocol/decisions/?decisionID=13246)

5 2015 a new directive on GMOs was approved (Directive (EU) 2015/4124), allowing a Member State (or region) to adopt measures restricting or prohibiting the cultivation in all or part of its territory of a GMO, or of a group of GMOs defined by crop or trait, based on compelling grounds such as those related to socio-economic impacts, avoidance of GMOs presence in other products, agricultural policy objectives or public policy (article 1.3).

Although the consideration of these aspects is possible according to European legislation and socio-economic aspects can be taken into account, a clear definition of socio-economic aspects is not available, nor is there any guidance on respective criteria for their identification and assessment. The AdHoc Technical Group on Socio-Economic Considerations (AHTEG-Sec) of the Convention of Biological Diversity, recognised that there is no single agreed definition but considered that the scope of the term includes five dimensions: (a) economic; (b) social; (c) ecological; (d) cultural/traditional/religious/ethical; and (e) human-health related5.

As a result, assessing the socio-economic sustainability, societal benefits and ethical acceptability of agricultural biotechnologies in the frame of the established risk assessment procedures have, for a long time, been debated but hardly exert a major role in shaping the respective authorisation procedures. Rapid developments in the field of genetic engineering and synthetic biology trigger the need to re-examine the traditional risk assessment model and employ methodologies that will strengthen the responsiveness and inclusiveness of the current framework. New challenges may come from emergent properties of synthetic biology products and systems and the increased speed of modifications; with gene drive, genetic elements distribute themselves among the population, which means no traditional containment. While socio-economic issues have played a major role in the long standing EU debate on GMOs, there is, however, very little experience in explicitly and systematically assessing their socio-economic impacts.

What to expect from the workshop Against this backdrop, this workshop aims to identify and explore the issues relevant to the topic and provide options for policy development and further research with a particular focus on the socio-economic effects of agricultural technologies, the relevant issues and controversies, on whether and how socio-economic effects can be differentiated, clustered and assessed in the course of the established authorisation framework.

The workshop will provide the space for a debate on this challenging aspect of public policy and will offer the opportunity for an analysis of how feasible or even necessary the inclusion of socio-economic considerations into the current framework may be.

The various methodological options for assessment, the experience with socio-economic evaluations, the role of participatory involvement in the risk governance and the practical steps and indicators that could be introduced in risk assessment and decision making related to

4 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory Text with EEA relevance, OJ L 68, 13.3.2015, p. 1–8 5 AdHoc Technical Expert Group on Socioeconomic considerations. Report of the AdHoc Technical Expert Group on Socioeconomic Considerations. UNEP/CBD/BS/AHTEG-SEC/1/3. 2014. Available online: https://www.cbd.int/doc/meetings/bs/bs-ahteg-sec-01/official/bs-ahteg-sec-01-03-en.pdf

6 synthetic biology and genetic modification in agriculture will be discussed by Helge Torgersen, from the Institute of Technology Assessment, Austrian Academy of Sciences, and Anne Ingeborg Myhr, from the GenØk-Centre for Biosafety, Tromsø, Norway. For example, in Norway, sustainability, benefit to society and ethics are important criteria in GMO assessment prior to cultivation, import and use as food or feed. How has this evolved?

Put simply, if a measure, an action or a policy may harm the public or the environment, and there is no scientific consensus that it is not harmful, then one willing to act must prove the absence of danger. This is known as the precautionary principle and belongs to the domain of risk management. However, there are differences in ways this is defined and applied across the world. Amir Muzur, from the School of Medicine, University of Rijeka, Croatia, will speak about differences between the EU and the US.

How could policy-makers in the EU deal with socio-ethical considerations as well as regulatory challenges raised by scientific uncertainties, speed of technological advances, technological complexities and issues related to public perception? How is this shaping of decision-making in the field of agricultural biotechnologies? The workshop continues STOA’s practice of discussing the socio-ethical dimensions of techno-scientific developments.

7 3. Speakers' Biographies

Marijana Petir, MEP, STOA Panel member

Marijana Petir was born on 4th October 1975 in Kutina, Croatia. She graduated in Biology and Ecology from the University of Zagreb, Faculty of Sciences, and Theology from the University of Zagreb, Faculty of Catholic Theological Studies, where she also obtained a Master's degree in Management of Non Profitable Organizations and Social Advocacy. She was a Member of Croatian Parliament for two mandates (2002-2003; 2007-2011), and at the same time Chairperson of the Croatian Parliament's Deputy Club of the Croatian Peasant Party (Hrvatska seljacka stranka, HSS) and of the Committee for Environmental Protection. She was also Member of the Delegation to the Parliamentary Assembly of the Council of Europe and of the Croatia - EU Joint Parliamentary Committee, while served as an external member of the Croatian Parliament Committee on Human and National Minority Rights as a representative of the Croatian Catholic Bishops Conference. In 2014 Marijana Petir has become Member of the European Parliament (MEP). In the Parliament she is a member of the Committees on Agriculture and Rural Development (AGRI) and Women's Rights and Gender Equality (FEMM) and Delegation to the EU-Former Yugoslav Republic of Macedonia. She is also a substitute in the Committee on the Environment, Public Health and Food Safety (ENVI), Delegation for relations with Israel and Delegation to the Parliamentary Assembly of the Union for the Mediterranean.

8 Julian Kinderlerer, University of Cape Town, South Africa, former President (2010-2016) of the European Group on Ethics in Science and New Technologies

Julian Kinderlerer is the immediate past president of the European Group on Ethics in Science and New Technologies (EGE). The group, which consists of 15 individuals – 5 lawyers, 5 scientists and 5 ‘philosophers/ethicists, advises the President of the European Commission (EC) on ethical issues arising from scientific research or technology at his request, or on its own initiative. Each mandate lasts five years, and the last mandate was completed in February 2016. A new mandate is currently being drafted by the Commission. Julian was one of the rapporteurs for an Opinion on the ethics of modern developments in agriculture, published in 2008. Julian Kinderlerer graduated in chemistry (with first class honours) at the University of Cape Town (UCT) before completing a PhD degree in Cambridge in Biochemistry. He was a lecturer and Senior lecturer in the Department of Molecular Biology and Biotechnology at the University of Sheffield before transferring to the Faculty of Law and becoming Professor of Biotechnology Law. He acted as the specialist adviser to the United Kingdom House of Lords select committee on Agriculture when it reported on the regulation of biotechnology at the end of the last century and during 2000 was seconded to the United Nations Environment Programme (UNEP) as director responsible for assisting developing countries in implementing the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Funds were obtained to assist well over 120 countries in implementing a system of regulation for the possible release of living modified organisms into the environment. Julian has served as Professor of Biotechnology and Society at the Technology University in Delft, the Netherlands, and until his retirement was Professor of Intellectual Property Law at the UCT where he set up a new research unit looking at Intellectual Property Law and policy and its relation to innovation. He remains the emeritus Professor of IP Law at UCT. He has assisted the South African Government in devising a code of practice for nanotechnology research and for synthetic biology. He has also acted as a participant or coordinator of a number of EC funded projects in ethics and law in relation to modern biology or nanotechnology. He has recently chaired a small international group assisting the South African Department of Science and Technology in drafting policy on both a database for recording indigenous knowledge and drafting a bill currently before the South African Parliament recognising indigenous knowledge.

9 Helge Torgersen, Institute of Technology Assessment, Austrian Academy of Sciences

Helge Torgersen studied biology at the University of Salzburg and received his PhD in 1981. In 1990, after having held research and teaching positions in molecular biology at the University of Vienna, he joined the Institute of Technology Assessment (ITA) where he worked on the safety regulation of GMO releases, technology controversies and biotechnology policy. Over two decades, his interests included public attitudes to novel technologies as well as science studies in biotechnology, nanotechnology and other fields of emerging technologies. A special interest was devoted to methods in, opportunities from and problems of participatory technology assessment. Since the mid-nineties, he contributed widely to a considerable number of EU-funded projects on ethical, legal and social aspects of biotechnology including various Eurobarometer surveys. He also coordinated a number of national projects on biotechnology policy and the implications from genomics and synthetic biology. Most recently, he coordinated a work package on policy implications of neuroenhancement within the NERRI (Neuro- Enhancement: Responsible Research and Innovation, an FP7-funded project) consortium, and he is involved in an on-going STOA project on 3D printing in the medical field.

10 Anne Ingeborg Myhr, GenØk-Centre for Biosafety, Tromsø, Norway

Anne Ingeborg Myhr is Director at GenØk – Centre for Biosafety, Norway. She holds a Master’s degree in Biotechnology from the Norwegian University of Science and Technology (NTNU), Trondheim, and a PhD from the Institute of Medical Biology at the University of Tromsø. Her main experience is within risk assessment and risk management of GMOs as well as on ethical, social and legal aspects (ELSA) related to genetic engineering, emerging biotechnologies including synthetic biology and nanobiotechnology. She was a member of the Norwegian Scientific Committee for Food Safety (VKM), The National Committee for Research Ethics in Science and Technology (NENT), The Norwegian Advisory Board on Ethical Aspects of Patenting, The NANOMAT program board in the Research Council of Norway, The Nordic Committee on Bioethics and is at present a member of The Norwegian Technology Board. Internationally she has been involved in various issues related to GMOs, including an EU expert-working group on GMO monitoring, and related to socio-economic issues under the Cartagena Protocol on Biosafety.

11 Amir Muzur, School of Medicine, University of Rijeka, Croatia

Amir Muzur graduated from University of Rijeka – Faculty of Medicine in 1993, earned a Master of Arts degree in medieval studies at Central European University (CEU) in Budapest, Hungary, in 1996, and a PhD degree in cognitive neuroscience at International School for Advanced Studies (ISAS-SISSA) in Trieste, Italy, in 2000. He worked for one year in Laboratory of Neurophysiology at Harvard Medical School Department of Psychiatry (Massachusetts Mental Health Center, Boston, USA). Presently, he is Full Professor (since 2013) and Head of Department of Social Sciences and Medical Humanities (since 2008) at University of Rijeka – Faculty of Medicine, and Vice-Dean for Business Affairs and Quality at University of Rijeka – Faculty of Health Studies. Since 2016, he is Head of the UNESCO Chair for Social Sciences and Medical Humanities at University of Rijeka, and president of the Scientific Board of the Scientific Centre of Excellence for Integrative Bioethics. His major fields of research/teaching interest are history of medicine and bioethics and theoretical neuroscience. He published more than twenty books (local history, history of medicine, popularisation of neuroscience, essays, travelogues, poetry) and about 500 articles, and participated in more than 140 conferences. He won the first prize at the Drago Gervais Literary Contest (1999). While serving as the mayor of Opatija (Croatia), from 2005 until 2009, he was awarded the title Mayor of the Year (Croatian National Television and Croatian Chamber of Economy, 2006), the title Commendatore della Stella della solidarieta' italiana (President of the Republic of Italy, 2008), and the title of the Honorary Consul of the Republic of Poland (2011). Amir Muzur was president of Croatian Bioethics Society (2012-2016), and now is director of the Fritz Jahr Documentary & Research Centre for European Bioethics at University of Rijeka (since 2013), honorary member of Serbian Bioethics Society, vice-president of the Rijeka History Society and Croatian Scientific Society for History of Health Culture. He was the founder and Editor-in-Chief of Jahr – European Journal of Bioethics (2010-2014), and is now member of editorial boards of Holistic Approach to Environment, Global Bioethics, Sučačka revija and Vinodolski zbornik.

12 4. About STOA

The Science and Technology Options Assessment (STOA) Panel forms an integral part of the structure of the European Parliament. Launched in 1987, STOA is tasked with identifying and independently assessing the impact of new and emerging science and technologies. The goal of its work is to assist, with independent information, the Members of the European Parliament (MEPs) in developing options for long-term, strategic policy-making.

The STOA Panel The STOA Panel consists of 25 MEPs nominated from the nine permanent parliamentary committees: AGRI (Agriculture & Rural Development), CULT (Culture & Education), EMPL (Employment & Social Affairs), ENVI (Environment, Public Health & Food Safety), IMCO (Internal Market & Consumer Protection), ITRE (Industry, Research & Energy), JURI (Legal Affairs), LIBE (Civil Liberties, Justice and Home Affairs) and TRAN (Transport & Tourism). Ms Mairéad McGuinness MEP has been the European Parliament Vice-President responsible for STOA in the first half of the 8th legislature. The STOA Chair for the first half of the 8th legislature has been Paul Rübig, with Eva Kaili and Evžen Tošenovský acting as 1st and 2nd Vice-Chairs.

The STOA Approach STOA fulfils its mission primarily by carrying out science-based projects. Whilst undertaking these projects, STOA assesses the widest possible range of options to support evidence-based policy decisions. A typical project investigates the impacts of both existing and emerging technology options and presents these in the form of studies and options briefs. These are publicly available for download via the STOA website: www.europarl.europa.eu/stoa/. Some of STOA's projects explore the long-term impacts of future techno-scientific trends, with the aim to support MEPs in anticipating the consequences of developments in science. Alongside its production of 'hard information', STOA communicates its findings to the European Parliament by organising public events throughout the year. STOA also runs the MEP-Scientist Pairing Scheme aimed at promoting mutual understanding and facilitating the establishment of lasting links between the scientific and policy-making communities.

Focus areas STOA activities and products are varied and are designed to cover as wide a range of scientific and technological topics as possible, such as nano-safety, e-Democracy, bio-engineering, assistive technologies for people with disabilities, waste management, cybersecurity, smart energy grids, responsible research & innovation, sustainable agriculture and health. They are grouped in five broad focus areas: eco-efficient transport and modern energy solutions; sustainable management of natural resources; potential and challenges of the Internet; health and life sciences; science policy, communication and global networking.

13 5. STOA Panel members

STOA Bureau

Mairéad McGUINNESS (EPP, IE) EP Vice-President responsible for STOA

Paul RÜBIG (EPP, AT) Chair of STOA

Committee on Industry, Research and Energy (ITRE)

Eva KAILI (S&D, EL) First Vice-Chair of STOA

Committee on Industry, Research and Energy (ITRE)

Evžen TOŠENOVSKÝ (ECR, CZ) Second Vice-Chair of STOA

Committee on Industry, Research and Energy (ITRE)

14 STOA Panel

Panel Member Committee Panel Member Committee

Jan Philipp LIBE Danuta EMPL ALBRECHT JAZŁOWIECKA (Greens/EFA, DE) (EPP, PL)

Tiziana BEGHIN ITRE Andrew LEWER CULT (EFDD, IT) (ECR, UK)

Renata BRIANO ITRE Bogusław TRAN (S&D, IT) LIBERADZKI (S&D, PL)

Carlos COELHO IMCO Anthea McINTYRE AGRI (PPE, PT) (ECR, UK)

Mady DELVAUX JURI Clare MOODY ITRE (S&D, LU) (S&D, UK)

Vicky FORD IMCO Momchil NEKOV AGRI (ECR, UK) (S&D, BG)

Andrzej GRZYB ENVI Marijana PETIR AGRI (EPP, PL) (EPP, HR)

15 Panel Member Committee Panel Member Committee

Georgi PIRINSKI EMPL Kay SWINBURNE ENVI (S&D, BG) (ECR, UK)

Virginie ROZIERE IMCO Dario ITRE (S&D, FR) TAMBURRANO (EFDD, IT)

Claudia SCHMIDT TRAN Cora VAN ITRE (EPP, AT) NIEUWENHUIZEN (ALDE, NL)

AGRI: Agriculture and Rural Development CULT: Culture and Education EMPL: Employment and Social Affairs ENVI: Environment, Public Health and Food Safety IMCO: Internal Market and Consumer Protection ITRE: Industry, Research and Energy JURI: Legal Affairs LIBE: Civil Liberties, Justice and Home Affairs TRAN: Transport and Tourism

16 6. STOA administration

Directorate-General for Parliamentary Research Services (DG EPRS) European Parliament Rue Wiertz 60 B-1047 Brussels E-mail: [email protected]

Director-General Anthony Teasdale

Director Wolfgang Hiller

Head of Unit - Scientific Foresight Unit (STOA) Theo Karapiperis

Head of Service - STOA Secretariat Zsolt G. Pataki

Head of Service - Scientific Foresight Service Lieve Van Woensel

Administrators Philip Boucher Mihalis Kritikos Nera Kuljanic Christian Kurrer Gianluca Quaglio

Assistants Serge Evrard Rachel Manirambona Marie Massaro Damir Plese

Trainee James Tarlton

This is a publication of the Directorate for Impact Assessment and European Added Value Directorate-General for Parliamentary Research Services, European Parliament

PE 598.618