STOA workshopEthical and socialchallenges of agriculturaltechnologies - Issues fordecision-makersParticipants’ booklet

EPRS | European Parliamentary Research Service

Scientific Foresight Unit (STOA)

PE 598.618

STOA workshop

Ethical and social challengesof agricultural technologies

Issues for decision-makers

Participants’ Booklet

25 January 2017, 14:30-17:00Paul-Henri Spaak Building, Room 7C050

European Parliament, Brussels

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Prepared by Nera Kuljanic and Mihalis Kritikos, Scientific Foresight Unit (STOA)

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

© European Union, 2017© Cover image: Sergey Nivens / Fotolia

PE 598.618

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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

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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 OpeningMarijana Petir, MEP, STOA Panel

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

15.00-15.20 Synthetic biology in agriculture and challenges for risk governanceHelge Torgersen, Institute of Technology Assessment, Austrian Academy ofSciences

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

15.40-16.00 The precautionary principle – between European bioethical tradition andAmerican pragmatismAmir Muzur, School of Medicine, University of Rijeka, Croatia

16.00-16.30 Debate

16.30-16.40 ConclusionsJulian Kinderlerer

16.40-16.45 ClosingMarijana Petir, MEP, STOA Panel

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2. Introduction

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

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

There is a substantial body of literature on anticipated and documented impacts of geneticallymodified crops beyond the health and environmental dimension. These impacts are referred toas ethical, economic, agronomic, agro-environmental, societal, social, socio-economic etc. Atinternational level, in the context of the Cartagena Protocol on Biosafety1 and the AarhusConvention2, as well as the level of the European Union (EU), socio-economic aspects ofgenetically modified organisms are being elaborated to a greater extent. During the sixthmeeting of the Conference of the Parties serving as the meeting of the Parties (COP-MOP) to theCartagena Protocol on Biosafety, the Parties recognised the need for further guidance whenchoosing to take into account socio-economic considerations3 and made reference to theoperational objective 1.7 of the Strategic Plan of the Cartagena Protocol on Biosafety for theperiod 2011–2020. The objective 1.7 aims: “To, on the basis of research and informationexchange, provide relevant guidance on socio-economic considerations that may be taken intoaccount 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 whichaims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modernbiotechnology 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, PublicParticipation in Decision-Making and Access to Justice in Environmental Matters was adopted on 25 June 1998 in theDanish 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)

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

Although the consideration of these aspects is possible according to European legislation andsocio-economic aspects can be taken into account, a clear definition of socio-economic aspectsis not available, nor is there any guidance on respective criteria for their identification andassessment. The AdHoc Technical Group on Socio-Economic Considerations (AHTEG-Sec) ofthe Convention of Biological Diversity, recognised that there is no single agreed definition butconsidered 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 ethicalacceptability of agricultural biotechnologies in the frame of the established risk assessmentprocedures have, for a long time, been debated but hardly exert a major role in shaping therespective authorisation procedures. Rapid developments in the field of genetic engineeringand synthetic biology trigger the need to re-examine the traditional risk assessment model andemploy methodologies that will strengthen the responsiveness and inclusiveness of the currentframework. New challenges may come from emergent properties of synthetic biology productsand systems and the increased speed of modifications; with gene drive, genetic elementsdistribute themselves among the population, which means no traditional containment. Whilesocio-economic issues have played a major role in the long standing EU debate on GMOs, thereis, however, very little experience in explicitly and systematically assessing their socio-economicimpacts.

What to expect from the workshopAgainst this backdrop, this workshop aims to identify and explore the issues relevant to thetopic and provide options for policy development and further research with a particular focuson 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 thecourse of the established authorisation framework.

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

The various methodological options for assessment, the experience with socio-economicevaluations, the role of participatory involvement in the risk governance and the practical stepsand 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 Directive2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of geneticallymodified organisms (GMOs) in their territory Text with EEA relevance, OJ L 68, 13.3.2015, p. 1–85 AdHoc Technical Expert Group on Socioeconomic considerations. Report of the AdHoc Technical Expert Group onSocioeconomic 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

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synthetic biology and genetic modification in agriculture will be discussed by Helge Torgersen,from the Institute of Technology Assessment, Austrian Academy of Sciences, and AnneIngeborg Myhr, from the GenØk-Centre for Biosafety, Tromsø, Norway. For example, inNorway, sustainability, benefit to society and ethics are important criteria in GMO assessmentprior 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, andthere is no scientific consensus that it is not harmful, then one willing to act must prove theabsence of danger. This is known as the precautionary principle and belongs to the domain ofrisk management. However, there are differences in ways this is defined and applied across theworld. Amir Muzur, from the School of Medicine, University of Rijeka, Croatia, will speak aboutdifferences between the EU and the US.

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

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3. Speakers' Biographies

Marijana Petir, MEP, STOA Panel member

Marijana Petir was born on 4th October 1975 in Kutina, Croatia. She graduated in Biology andEcology from the University of Zagreb, Faculty of Sciences, and Theology from the Universityof Zagreb, Faculty of Catholic Theological Studies, where she also obtained a Master's degree inManagement of Non Profitable Organizations and Social Advocacy.

She was a Member of Croatian Parliament for two mandates (2002-2003; 2007-2011), and at thesame 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 wasalso Member of the Delegation to the Parliamentary Assembly of the Council of Europe and ofthe Croatia - EU Joint Parliamentary Committee, while served as an external member of theCroatian Parliament Committee on Human and National Minority Rights as a representative ofthe Croatian Catholic Bishops Conference.

In 2014 Marijana Petir has become Member of the European Parliament (MEP). In theParliament 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 YugoslavRepublic of Macedonia. She is also a substitute in the Committee on the Environment, PublicHealth and Food Safety (ENVI), Delegation for relations with Israel and Delegation to theParliamentary Assembly of the Union for the Mediterranean.

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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 theEuropean 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 Presidentof the European Commission (EC) on ethical issues arising fromscientific research or technology at his request, or on its owninitiative. Each mandate lasts five years, and the last mandatewas completed in February 2016. A new mandate is currentlybeing drafted by the Commission. Julian was one of therapporteurs for an Opinion on the ethics of moderndevelopments in agriculture, published in 2008.

Julian Kinderlerer graduated in chemistry (with first classhonours) at the University of Cape Town (UCT) beforecompleting a PhD degree in Cambridge in Biochemistry. He wasa lecturer and Senior lecturer in the Department of Molecular Biology and Biotechnology at theUniversity of Sheffield before transferring to the Faculty of Law and becoming Professor ofBiotechnology Law. He acted as the specialist adviser to the United Kingdom House of Lordsselect committee on Agriculture when it reported on the regulation of biotechnology at the endof the last century and during 2000 was seconded to the United Nations EnvironmentProgramme (UNEP) as director responsible for assisting developing countries in implementingthe Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Funds wereobtained to assist well over 120 countries in implementing a system of regulation for the possiblerelease of living modified organisms into the environment.

Julian has served as Professor of Biotechnology and Society at the Technology University inDelft, the Netherlands, and until his retirement was Professor of Intellectual Property Law atthe UCT where he set up a new research unit looking at Intellectual Property Law and policyand its relation to innovation. He remains the emeritus Professor of IP Law at UCT. He hasassisted the South African Government in devising a code of practice for nanotechnologyresearch and for synthetic biology. He has also acted as a participant or coordinator of a numberof EC funded projects in ethics and law in relation to modern biology or nanotechnology. Hehas recently chaired a small international group assisting the South African Department ofScience and Technology in drafting policy on both a database for recording indigenousknowledge and drafting a bill currently before the South African Parliament recognisingindigenous knowledge.

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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. In1990, after having held research and teaching positions in molecular biology at the Universityof Vienna, he joined the Institute of Technology Assessment (ITA) where he worked on thesafety regulation of GMO releases, technology controversies and biotechnology policy. Overtwo decades, his interests included public attitudes to novel technologies as well as sciencestudies in biotechnology, nanotechnology and other fields of emerging technologies. A specialinterest was devoted to methods in, opportunities from and problems of participatorytechnology assessment. Since the mid-nineties, he contributed widely to a considerable numberof EU-funded projects on ethical, legal and social aspects of biotechnology including variousEurobarometer surveys. He also coordinated a number of national projects on biotechnologypolicy and the implications from genomics and synthetic biology. Most recently, he coordinateda work package on policy implications of neuroenhancement within the NERRI (Neuro-Enhancement: Responsible Research and Innovation, an FP7-funded project) consortium, andhe is involved in an on-going STOA project on 3D printing in the medical field.

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

Anne Ingeborg Myhr is Director at GenØk – Centre for Biosafety, Norway. She holds a Master’sdegree 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. Hermain 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 biotechnologiesincluding synthetic biology and nanobiotechnology. She was a member of the NorwegianScientific Committee for Food Safety (VKM), The National Committee for Research Ethics inScience and Technology (NENT), The Norwegian Advisory Board on Ethical Aspects ofPatenting, The NANOMAT program board in the Research Council of Norway, The NordicCommittee 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 EUexpert-working group on GMO monitoring, and related to socio-economic issues under theCartagena Protocol on Biosafety.

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

Amir Muzur graduated from University of Rijeka – Faculty of Medicine in 1993, earned aMaster 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 forAdvanced Studies (ISAS-SISSA) in Trieste, Italy, in 2000. He worked for one year in Laboratoryof Neurophysiology at Harvard Medical School Department of Psychiatry (MassachusettsMental Health Center, Boston, USA). Presently, he is Full Professor (since 2013) and Head ofDepartment 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 andMedical Humanities at University of Rijeka, and president of the Scientific Board of the ScientificCentre of Excellence for Integrative Bioethics. His major fields of research/teaching interest arehistory of medicine and bioethics and theoretical neuroscience.

He published more than twenty books (local history, history of medicine, popularisation ofneuroscience, essays, travelogues, poetry) and about 500 articles, and participated in more than140 conferences. He won the first prize at the Drago Gervais Literary Contest (1999). Whileserving as the mayor of Opatija (Croatia), from 2005 until 2009, he was awarded the title Mayorof the Year (Croatian National Television and Croatian Chamber of Economy, 2006), the titleCommendatore 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 theFritz Jahr Documentary & Research Centre for European Bioethics at University of Rijeka (since2013), honorary member of Serbian Bioethics Society, vice-president of the Rijeka HistorySociety and Croatian Scientific Society for History of Health Culture. He was the founder andEditor-in-Chief of Jahr – European Journal of Bioethics (2010-2014), and is now member ofeditorial boards of Holistic Approach to Environment, Global Bioethics, Sučačka revija andVinodolski zbornik.

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4. About STOA

The Science and Technology Options Assessment (STOA) Panel forms an integral part of thestructure of the European Parliament. Launched in 1987, STOA is tasked with identifying andindependently 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 EuropeanParliament (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 parliamentarycommittees: 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 (LegalAffairs), LIBE (Civil Liberties, Justice and Home Affairs) and TRAN (Transport & Tourism).

Ms Mairéad McGuinness MEP has been the European Parliament Vice-President responsible forSTOA in the first half of the 8th legislature. The STOA Chair for the first half of the 8th legislaturehas 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 undertakingthese projects, STOA assesses the widest possible range of options to support evidence-basedpolicy decisions. A typical project investigates the impacts of both existing and emergingtechnology options and presents these in the form of studies and options briefs. These arepublicly available for download via the STOA website: www.europarl.europa.eu/stoa/. Someof STOA's projects explore the long-term impacts of future techno-scientific trends, with the aimto support MEPs in anticipating the consequences of developments in science. Alongside itsproduction of 'hard information', STOA communicates its findings to the European Parliamentby organising public events throughout the year. STOA also runs the MEP-Scientist PairingScheme aimed at promoting mutual understanding and facilitating the establishment of lastinglinks 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 scientificand technological topics as possible, such as nano-safety, e-Democracy, bio-engineering,assistive technologies for people with disabilities, waste management, cybersecurity, smartenergy 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; healthand life sciences; science policy, communication and global networking.

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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)

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STOA Panel

Panel Member Committee Panel Member Committee

Jan PhilippALBRECHT(Greens/EFA, DE)

LIBE DanutaJAZŁOWIECKA(EPP, PL)

EMPL

Tiziana BEGHIN(EFDD, IT)

ITRE Andrew LEWER(ECR, UK)

CULT

Renata BRIANO(S&D, IT)

ITRE BogusławLIBERADZKI(S&D, PL)

TRAN

Carlos COELHO(PPE, PT)

IMCO Anthea McINTYRE(ECR, UK)

AGRI

Mady DELVAUX(S&D, LU)

JURI Clare MOODY(S&D, UK)

ITRE

Vicky FORD(ECR, UK)

IMCO Momchil NEKOV(S&D, BG)

AGRI

Andrzej GRZYB(EPP, PL)

ENVI Marijana PETIR(EPP, HR)

AGRI

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Panel Member Committee Panel Member Committee

Georgi PIRINSKI(S&D, BG)

EMPL Kay SWINBURNE(ECR, UK)

ENVI

Virginie ROZIERE(S&D, FR)

IMCO DarioTAMBURRANO(EFDD, IT)

ITRE

Claudia SCHMIDT(EPP, AT)

TRAN Cora VANNIEUWENHUIZEN(ALDE, NL)

ITRE

AGRI: Agriculture and Rural DevelopmentCULT: Culture and EducationEMPL: Employment and Social AffairsENVI: Environment, Public Health and Food SafetyIMCO: Internal Market and Consumer ProtectionITRE: Industry, Research and EnergyJURI: Legal AffairsLIBE: Civil Liberties, Justice and Home AffairsTRAN: Transport and Tourism

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6. STOA administration

Directorate-General for Parliamentary Research Services (DG EPRS)European ParliamentRue Wiertz 60B-1047 BrusselsE-mail: stoa@europarl.europa.eu

Director-GeneralAnthony Teasdale

DirectorWolfgang Hiller

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

Head of Service - STOA SecretariatZsolt G. Pataki

Head of Service - Scientific Foresight ServiceLieve Van Woensel

AdministratorsPhilip BoucherMihalis KritikosNera KuljanicChristian KurrerGianluca Quaglio

AssistantsSerge EvrardRachel ManirambonaMarie MassaroDamir Plese

TraineeJames Tarlton

PE 598.618

This is a publication of theDirectorate for Impact Assessment and European Added ValueDirectorate-General for Parliamentary Research Services, European Parliament