Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-12-02T19:29:27.148Z Has data issue: false hasContentIssue false

Gene Editing for the EU Agrifood: Risks and Promises in Science Regulation

Published online by Cambridge University Press:  22 October 2019

Luca LEONE*
Affiliation:
Faculty of Business and Law, Università Cattolica del Sacro Cuore, Piacenza, Italy; email: [email protected]

Abstract

In today’s innovation-driven agrifood domain, the perspective of using so-called New Breeding Techniques (NBTs) on both non-human animals and plants calls into question the regulatory approach (process/product-based) to be used, while asking for a critical reflection on the potential impact of products on the industrial sector and citizens. A possible reconfiguration of European (EU) discipline will have to grapple with not only agrifood market’s interests and needs, but mostly and primarily with the growing quest for public and participatory discussion on the current dominant vision on life sciences. Only through restoring visibility to the intertwining of knowledge production will it be possible to obtain EU governance of gene editing that is more authoritatively reliable from a scientific stance, as well as more transparently discussed and democratically shared at legal and policy level.

Type
Articles
Copyright
© Cambridge University Press 2019

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 European Commission, New Perspectives on the Knowledge-based Bio-economy (Conference Report 2005)Google Scholar.

2 OECD (Organisation for Economic Co-operation and Development), The Bioeconomy to 2030: Designing a Policy Agenda (Paris, OECD 2005)Google Scholar.

3 Such as organics, agroecology and regenerative agriculture. See Leone, L, Organic Regulation – A Legal and Policy Journey between Europe and the United States (Libellula, Tricase 2019)Google Scholar.

4 EGE (European Group on Ethics in Science and New Technologies to the European Commission), Ethics of Modern Developments in Agricultural Technologies (Luxembourg, Office for Official Publications of the European Communities 2009)Google Scholar.

5 SAM (Scientific Advice Mechanism), New Techniques in Agricultural Biotechnology, High Level Group of Scientific Advisors Explanatory (Luxembourg, Publications Office of the European Union 2017)Google Scholar.

6 National Academies of Sciences, Engineering and Medicine, Human Genome Editing (Washington, DC, National Academies Press 2017)Google Scholar; Chu, VTet al, “Increasing the Efficiency of Homology-directed Repair for CRISPR-Cas9-Induced Precise Gene Editing in Mammalian Cells” (2015) 33 Nature Biotechnology 543CrossRefGoogle ScholarPubMed.

7 Zhang, Yet al, “Applications and Potential of Genome Editing in Crop Improvement” (2018) 19 Genome Biology 210, <doi.org/10.1186/s13059-018-1586-y> accessed 19 September 2019.CrossRefGoogle ScholarPubMed

8 Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [2001] OJ L 106/1, Art 2(2).

9 ibid. The techniques are those listed in Annex IA, Part 1; additionally, techniques listed in Annex IA, Part 2 are deemed not to give rise to GMOs.

10 It stands for “site-Directed Nuclease-3”.

11 EFSA (European Food Safety Authority), “Scientific Opinion Addressing the Safety Assessment of Plants Developed Using Zinc Finger Nucleases 3 and Other Site-Directed Nucleases with Similar Function” (2012) 10 EFSA J 2943 <doi.org/10.2903/j.efsa.2012.2943> accessed 19 September 2019.CrossRef+accessed+19+September+2019.>Google Scholar

12 Schiemann, J and Hartung, F, “EU Perspectives on New Plant-Breeding Techniques” in Eaglesham, A and Hardy, RWF (eds), DNA-Editing Approaches: Methods, Applications and Policy for Agriculture (NABC Report 26, 2014) pp 201210Google Scholar. Summarising the discussions carried out at the institutional level on the legal status of the NBTs, the authors conclude, “There is general agreement amongst experts to define a GMO on the presence of foreign recombinant DNA. When an organism does not contain recombinant DNA, it should not be risk assessed and regulated as a GMO” (p 207).

13 Shukla-Jones, Aet al, Gene Editing in An International Context: Scientific, Economic and Social Issues across Sectors (Paris, OECD Publishing 2018)Google Scholar.

14 Jasanoff, S, The Ethics of Invention. Technology and the Human Future (New York, WW Norton & Co 2016)Google Scholar.

15 Gaskell, Get al, “Public Views on Gene Editing and Its Uses” (2017) 35(11) Nature Biotechnology 1021CrossRefGoogle ScholarPubMed.

16 Dürnberger, Cet al (eds), Genome Editing in Agriculture: Between Precaution and Responsibility (Baden-Baden, Nomos Verlagsgesellschaft 2019)CrossRefGoogle Scholar.

17 Federal Ethics Committee on Non-Human Biotechnology ECNH, New Plant Breeding Techniques – Ethical Considerations (Berne, Ariane Willemsen, ECNH Secretariat 2016)Google Scholar.

18 Jasanoff, S, Designs on Nature: Science and Democracy in Europe and the United States (Princeton, Princeton University Press 2005)CrossRefGoogle Scholar.

19 Millstone, Eet al, “Regulating Genetic Engineering: the Limits and Politics of Knowledge” (2015) Issues in Science and Technology 23 at p 24Google Scholar.

20 Zetterberg, C and Bjornberg, KE, “Time for a New EU Regulatory Framework for GM Crops?” (2017) 30(3) J Agric Environ Ethics 325 <doi.org/10.1007/s10806-017-9664-9> accessed 19 September 2019.CrossRefGoogle Scholar

21 Biddle, JB, “Genetically Engineered Crops and Responsible Innovation” (2017) 4(1) Journal of Responsible Innovation 24 <doi.org/10.1080/23299460.2017.1287522> accessed 19 September 2019.CrossRefGoogle Scholar

22 Case C-528/16, Confédération paysanne, Réseau Semences Paysannes, Les Amis de la Terre Frane, Collectif Vigilance OGM et pesticides 16, Vigilance OG2M, CSFV49, OGM dangers, Vigilance OGM 33, Fédération Nature et Progrès t. Premier ministre, Ministre de l’Agriculture, Agroalimentaire et de la Forêt, ECLI:EU:C:2018:583.

23 Garden, H and Winickoff, D, Gene Editing for Advanced Therapies: Governance, Policy and Society (Paris, OECD Publishing 2018)Google Scholar.

24 The Center for Food Integrity, Gene Editing Engage in Conversation (2018) <geneediting.foodintegrity.org/wp-content/uploads/sites/2/2018/11/CFI_GeneEditingCommunicationResource_2018.pdf> accessed 19 September 2019.

25 CRISPR/Cas9 stands for “Clustered Regularly Interspaced Short Palindromic Repeats” associated to a Cas9 protein.

26 TALEN stands for “Transcription Activator-Like Effector Nucleases”.

27 ZNF stands for “Zinc-Finger Nucleases”.

28 Zhang et al, supra, note 7.

29 Khandagale, K and Nadaf, A, “Genome Editing for Targeted Improvement of Plants” (2016) 10(6) Plant Biotechnology Reports 327 <http://doi.org/10.1007/s11816-016-0417-4> accessed 19 September 2019.CrossRefGoogle Scholar

30 Tan, Wet al, “Gene Targeting, Genome Editing: From Dolly to Editors” (2016) 25 Transgenic Res 273CrossRefGoogle ScholarPubMed; Laible, Get al, “Improving Livestock for Agriculture – Technological Progress from Random Transgenesis to Precision Genome Editing Heralds a New Era” (2015) 10 Biotechnol J 109CrossRefGoogle ScholarPubMed; Bruce, Aet al, “Novel GM Animal Technologies and their Governance” (2013) 22 Transgenic Res 681.CrossRefGoogle ScholarPubMed

31 Zhou, Jet al, “Gene Targeting by the TAL Effector PthXo2 Reveals Cryptic Resistance Gene for Bacterial Blight of Rice” (2015) 82(4) The Plant Journal 632CrossRefGoogle ScholarPubMed.

32 Haun, Wet al, “Improved Soybean Oil Quality by Targeted Mutagenesis of the Fatty Acid Desaturase 2 Gene Family” (2014) 12(7) Plant Biotechnology Journal 934CrossRefGoogle ScholarPubMed.

33 For insightful reflections on this matter, see Weimer, M and de Ruijter, A (eds), Regulating Risks in the European Union: The Co-production of Expert and Executive Power (Oxford, Hart Publishing 2017)Google Scholar; see also the EJRR’s Inaugural Issue: The Past, Present And Future of Risk Regulation (2017) <www.cambridge.org/core/journals/european-journal-of-risk-regulation> accessed 19 September 2019.

34 Kosicki, Met al, “Repair of Double-strand Breaks Induced by CRISPR–Cas9 Leads to Large Deletions and Complex Rearrangements” (2018) 36 Nature Biotechnology 765CrossRefGoogle ScholarPubMed; Shin, HYet al, “CRISPR/Cas9 Targeting Events Cause Complex Deletions and Insertions at 17 Sites in the Mouse Genome” (2017) 8 Nature Communications 15464CrossRefGoogle ScholarPubMed.

35 Lusser, Met al, New Plant Breeding Techniques: State-of-the-art and Prospects for Commercial Development (Luxembourg, Publications Office of the European Union 2011)Google Scholar.

36 Coles, Det al, “Ethical Issues and Potential Stakeholder Priorities Associated with the Application of Genomic Technologies Applied to Animal Production Systems” (2015) 28 J Agric Environ Ethics 231CrossRefGoogle Scholar.

37 Bruce, A, “Genome Edited Animals: Learning from GM Crops?” (2017) 26(3) Transgenic Res 385CrossRefGoogle ScholarPubMed.

38 Zimny, Tet al, “Certain New Plant Breeding Techniques and Their Marketability in the Context of EU GMO Legislation – Recent Developments” (2019) 25(51) New Biotechnology 49CrossRefGoogle Scholar.

39 Eriksson, D, “The Evolving EU Regulatory Framework for Precision Breeding” (2019) 132 Theoretical and Applied Genetics 569CrossRefGoogle ScholarPubMed.

40 Weimer, M, Risk Regulation in the Internal Market. Lessons from Agricultural Biotechnology (Oxford, Oxford University Press 2019)CrossRefGoogle Scholar.

41 “From a first review of the situation, it would appear that the application of current Community regulations in the various fields (pharmaceuticals, veterinary medicines, chemical substances, food additives, bioprotein feedstuffs) will meet current regulatory needs, provided that there is close cooperation between the competent authorities in the Member States and the Commission” (Commission of the European Communities, Biotechnology in the Community [Communication from the Commission to the Council], COM(83) 672 final/2, Brussels, 1983, at 11).

42 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [2003] OJ L 268.

43 Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients [1997] OJ L 043, Art 3(4). This Regulation has been replaced by Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 [2015] OJ L 327/1.

44 See Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms [1990] OJ L 117; Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms [1990] OJ L 117; Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) [1990] OJ L 374. A fourth directive on the matter was enacted in 1994 (Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road [1994] OJ L 319).

45 Tallacchini, M, “To Bind or Not Bind? European Ethics as Soft Law” in Hilgartner, Set al (eds), Science and Democracy: Making Knowledge and Making Power in the Biosciences and Beyond (Florence, KY, Taylor and Francis 2015) p 156Google Scholar.

46 Siune, Ket al, Challenging Futures of Science in Society. Emerging Trends and Cutting-Edge Issue (Luxembourg, European Commission 2009) at p 32Google Scholar.

47 Wynne, Bet al, Taking European Knowledge Society Seriously (Luxembourg, Office for Official Publications of the European Communities 2007) at p 52Google Scholar.

48 Commission, Research, Science and Society (cited in Wynne et al, supra, note 47, at p 48).

49 Tallacchini, M, “Governing by Values, EU Ethics: Soft Tool, Hard Effects” (2009) 47(3) Minerva 281CrossRefGoogle Scholar.

50 EASAC (European Academies Science Advisory Council), “New Breeding Techniques” (Statement, 2015), <easac.eu/fileadmin/PDF_s/reports_statements/Easac_14_NBT.pdf> accessed 19 September 2019.

51 EASAC confirmed this position in its Report “Genome Editing: Scientific Opportunities, Public Interests and Policy Options in the EU” (EASAC Policy Report 31, 2017) <www.easac.eu/fileadmin/PDF_s/reports_statements/Genome_Editing/EASAC_Report_31_on_Genome_Editing.pdf> accessed 19 September 2019.

52 For an overview of the different positions and opinions, see European Parliament, New plant-breeding techniques Applicability of GM Rules (May 2016) <www.europarl.europa.eu/RegData/etudes/BRIE/2016/582018/EPRS_BRI(2016)582018_EN.pdf> accessed 19 September 2019; T Sprink et al, “Regulatory Hurdles for Genome Editing: Process- vs. Product-based Approaches in Different Regulatory Contexts” (2016) 35 Plant Cell Rep 1493.

53 See supra, note 23.

54 Art 3(1) provides as follows: “This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex IB”. Annex IB provides as follows: “Techniques referred to in Article 3. Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are: (1) mutagenesis (2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods”.

55 On the ambiguous character of this question from a legal viewpoint, see Albujar, GF and van der Meulen, B, “The EU’s GMO Concept: Analysis of the GMO Definition in EU Law in the Light of New Breeding Techniques (NBTs)” (2018) 1 EFFL 14Google Scholar.

56 Case C-528/16, supra, note 22, at para 30.

57 ibid, at para 28.

58 ibid, at para 29.

59 ibid, at para 54.

60 Somsen, H, “Scientists Edit Genes, Courts Edit Directives. Is the Court of Justice Fighting Uncertain Scientific Risk with Certain Constitutional Risk?” (2018) 9(4) EJRR 701Google Scholar.

61 Directive 2015/412/EC as regards the possibility for the Member States to restrict or prohibit the cultivation ofngenetically modified organisms (GMOs) in their territory, OJ [2015] L 68/1.

62 On the role played by the so-called “opt-out” clause, see Geelhoed, M, “Divided in Diversity: Reforming The EU’s GMO Regime” (2016) 18 Cambridge Yearbook of European Legal Studies 20CrossRefGoogle Scholar.

63 E Rehbinder, “European Court of Justice Ruling on Genome Editing” (IUCN, 2018) <www.iucn.org/news/world-commission-environmental-law/201808/european-court-justice-ruling-genome-editing> accessed 19 September 2019.

64 See “Expert Reaction to Court of Justice of the European Union Ruling that GMO Rules Should Cover Plant Genome Editing Techniques” (Science Media Centre, 2018) <www.sciencemediacentre.org/expert-reaction-to-court-of-justice-of-the-european-union-ruling-that-gmo-rules-should-cover-plant-genome-editing-techniques/> accessed 19 September 2019.

65 “The decision is not only an obstacle to faster successes in modern agriculture in the breeding of more robust crops with higher yields; it also impairs the production of biopharmaceuticals and bio-based chemicals. The Court takes the wrong standpoint on how to regulate genome editing methods, since researchers obtain with Crispr/CAS the same results as with conventional breeding methods – but much faster” <www.vci.de/vci-online/presse/pressemitteilungen/backward-minded-and-hostile-to-progress-vci-on-ecj-judgment-on-genome-editing.jsp> accessed 19 September 2019.

66 “We regret that implementation of this ruling could cause European life science innovation effectively to come to a halt. If fast mitigation is not done, the ruling will cause a halt to EU sustainability and competitiveness ambitions by hindering the delivery of innovative bio-based products to the market, sustainable innovative food-solutions and certain healthcare solutions to patients” <www.europabio.org/sites/default/files/EuropaBio_statement_CourtRuling_final_forWEB.pdf> accessed 19 September 2019.

67 Bioökonomierat, “Genome editing: Europe Needs New Genetic Engineering Legislation” (2018) BÖRMEMO 07 <biooekonomierat.de/fileadmin/Publikationen/berichte/BOER-Memo_Genome-Editing_ENG.pdf> accessed 19 September 2019.

68 “These new ‘GMO 2.’” genetic engineering techniques must be fully tested before they are let out in the countryside and into our food. We welcome this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically-modified products onto our fields and plates” <foeeurope.org/eu-top-court-confirms-safety-checks-needed-new-gmo-250718> accessed 19 September 2019.

69 Gelinsky, E and Hilbeck, A, “European Court of Justice Ruling Regarding New Genetic Engineering Methods Scientifically Justified: A Commentary on the Biased Reporting about the Recent Ruling” (2018) 30(1) Environ Sci Eur 52CrossRefGoogle ScholarPubMed.

70 “Open Letter to Member States on the EU Court Ruling on Mutagenesis” (2019) <cefs.org/wp-content/uploads/2019/04/Letter-to-Member-States-at-Scopaffs-April-2019.pdf> accessed 19 September 2019.

71 ENGL (European Network of GMO Laboratories), “Detection of Food and Feed Plant Products Obtained by New Mutagenesis Techniques” (JRC116289, 2019).

72 SAM (Scientific Advice Mechanism), “statement by the Group of Chief Scientific Advisors A Scientific Perspective on the Regulatory Status of Products Derived from Gene Editing and the Implications for the GMO Directive” (2018) <ec.europa.eu/info/sites/info/files/2018_11_gcsa_statement_gene_editing_1.pdf> accessed 19 September 2019.

73 Ozolina, Ket al, Global Governance of Science (Brussels, European Commission, 2009)Google Scholar.

74 Siune et al, supra, note 46, at p 51.

75 EFSA, “Guidance on the Environmental Risk Assessment of Genetically Modified Plants” (2010) 8 EFSA J 1879, <www.efsa.europa.eu/en/efsajournal/pub/1879> accessed 19 September 2019.

76 EFSA, “Scientific Opinion on Guidance for Risk Assessment of Food and Feed from Genetically Modified Plants” (2011) 9 EFSA J 2150 <efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2011.2150> accessed 19 September 2019.

77 SZ Agapito-Tenfen et al, “Revisiting Risk Governance of GM Plants: The Need to Consider New and Emerging Gene-Editing Techniques” (2018) 21 Front Plant Sci <doi.org/10.3389/fpls.2018.01874> accessed 19 September 2019.

79 EFSA, “Guidance to Develop Specific Protection Goals Options for Environmental Risk Assessment at EFSA, in Relation to Biodiversity and Ecosystem Services” (2016) 14 EFSA J 4499 <efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2016.4499> accessed 19 September 2019.

80 See supra, note 78.

81 Stirling, A, “Precaution in the Governance of Technology” in Brownsword, Ret al (eds), The Oxford Handbook of Law, Regulation and Technology (Oxford, Oxford University Press, 2017) p 645Google Scholar.

82 As well as decreased discretionary funding, perverse incentives and reduced quality of peer review. See, on this matter, Edwards, MA and Roy, S, “Academic Research in the 21st Century: Maintaining Scientific Integrity in a Climate of Perverse Incentives and Hypercompetition” (2017) 34(1) Environmental Engineering Science 51CrossRefGoogle Scholar.

83 <www.efsa.europa.eu/en/topics/topic/open-efsa> accessed 19 September 2019.

86 EFSA, Guidance on Communication of Uncertainty in Scientific Assessments (2018) <efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5520> accessed 19 September 2019.

86 EFSA, Guidance on Communication of Uncertainty in Scientific Assessments (2018) <efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5520> accessed 19 September 2019.

87 Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC, OJ L 231/1.

88 See, for instance, the European Consumer Organisation’s (BEUC) clarifications/changes to strengthen the proposal: “It must better ensure that public health prevails over commercial considerations when examining industry confidentiality requests. No important piece of safety-related information should be hidden away from the public. It must allow independent scientists to quote or re-use the data disclosed by EFSA without having to ask for industry’s permission. It must foresee meaningful sanctions for industry applicants failing to notify EFSA of studies commissioned to support a regulatory dossier. If pre-submission meetings between EFSA staff and industry applicants are introduced, the proposal must guarantee that they are held in full transparency and that they do not lead to any shift in the allocation of EFSA internal resources, at the expense of other activities of public interest” (BEUC, Closing the Trust Gap between Consumers and the EU Food Regulatory System (2018) at 1 <www.beuc.eu/publications/beuc-x-2018-059_beuc_position_paper_general_food_law_revision.pdf> accessed 19 September 2019).

90 A Liberatore and S Funtowicz, “‘Democratising’ Expertise, ‘Expertising’ Democracy: What Does This Mean, and Why Bother?” (2003) 30(3) Science and Public Policy 146.

91 European Commission, “Future of Europe: President Juncker Creates Task Force on ‘Doing Less More Efficiently’” (Press Release, Brussels 2017)Google Scholar.

92 Leone, L and Tallacchini, M, “Nudging Citizens’ Knowledge in Knowledge-based EU: The Case of Breast Cancer Screening Programmes and Participatory Rights in Choice Architectures” in Straßheim, H and Beck, S, Handbook of Behavioural Change and Public Policy (Edward Elgar 2019) pp 148162CrossRefGoogle Scholar.

93 Ehnert, T and Vos, E, “Innovating Regulatory Approaches to New Technologies in Food: The EU Approach to Bio and Nanofoods” in Leonini, Fet al, Innovating Food, Innovating the Law. An Interdisciplinary Approach to the Challenges in the Agro-food Sector (Tricase, Libellula 2014) p 175Google Scholar.

94 Jasanoff, S, “Technologies of Humility: Citizen Participation in Governing Science” (2003) 41 Minerva 223CrossRefGoogle Scholar.

95 S Schubert, “Regulating Biotechnology in the Age of Digitalization: The Open Access Paradigm” in Dürnberger et al, supra, note 16.

96 E Gambini, “The Seeds of Dispute. The Doctrine of Patent Exhaustion in the Bowman Case” in Leonini et al, supra, note 93, p 345.

97 Cappè, Set al, “Editorial: The Future of Data in EFSA” (2019) 17(1) EFSA Journal e17011CrossRefGoogle Scholar; Alemanno, A, “Big Data for Good: Unlocking Privately-Held Data to the Benefit of the Many” (2018) 9(2) EJRR 183Google Scholar; Leone, L, “Towards New ‘Digital Insights’”. The Value of Open Data for Food Information in Europe” (2017) 2 Rivista di diritto alimentare 4Google Scholar.

98 Case T-329/17, Heidi Hautala and Others v European Food Safety Authority, ECLI:EU:T:2019:142.

99 National Academies of Sciences, Engineering, and Medicine, On Human Gene Editing: International Summit Statement (2015) at Section 5.

100 Jasanoff, S and Hurlbut, JB, “A Global Observatory for Gene Editing” (2018) 555 Nature 435.CrossRefGoogle ScholarPubMed

101 Burall, S, “Rethink Public Engagement for Gene Editing” (2018) 555 Nature 438CrossRefGoogle ScholarPubMed.

102 Sarewitz, D, “CRISPR: Science Can’t Solve It” (2015) 522 Nature 413CrossRefGoogle Scholar.

103 Benessia, Aet al, The Rightful Place of Science: Science on the Verge (Tempe 2016)Google Scholar.

104 Hartley, Set al, “Essential Features of Responsible Governance of Agricultural Biotechnology” (2016) 14(5) PLoS Biol e1002453 <doi.org/10.1371/journal.pbio.1002453>.CrossRefGoogle ScholarPubMed

105 Nuffield Council on Bioethics, Genome Editing: An Ethical Review (London, Nuffield Council on Bioethics 2016)Google Scholar.

106 European Commission, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. The Future of Food and Farming, COM(2017) 713 final, Brussels, 2017.

107 Bertolaso, M and Sterpetti, F (eds), Will Science Remain Human? A Critical Reflection on Automated Science (Cham, Springer forthcoming)Google Scholar.