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CRISPR-Cas9 and Food in the European Union: An Organic Solution to an Undetectable Problem for Food Business Operators

Published online by Cambridge University Press:  03 December 2021

Shane Michael Hughes Open the ORCID record for Shane Michael Hughes [Opens in a new window]
Shane Michael Hughes*
Affiliation:
University of Groningen, Groningen, The Netherlands Email: [email protected]
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Abstract

Various methods of genetic modification have been applied to plant breeding as an integral part of agriculture. This article examines a method of targeted mutagenesis – CRISPR-Cas9 – and its dysregulation in the European Union (EU). It provides clarity for food business operators relating to the traceability and labelling of food products induced using this biotechnology. In addition, it outlines policy recommendations to improve the regulation of such food products in the EU.

Keywords

CRISPR-Cas9food lawGMOmutagenesisorganic
Type
Articles
Information
European Journal of Risk Regulation , Volume 13 , Issue 2 , June 2022 , pp. 254 - 269
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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References

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14 Case C-528/16, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, supra, note 9, para 47.

15 B Voigt and A Münichsdorfer, “Regulation of Genome Editing in Plant Biotechnology: European Union” in H-G Dederer and D Hamburger (eds), Regulation of Genome Editing in Plant Biotechnology (New York, Springer International Publishing 2019) p 183 <http://link.springer.com/10.1007/978-3-030-17119-3_5> (last accessed 1 December 2020).

16 General Food Law, Arts 18(3) and (4).

17 JRC116289, supra, note 6, p 15.

18 Purnhagen and Wesseler, supra, note 12, p 9; Voigt and Münichsdorfer, supra, note 15, p 137.

19 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control [2008] OJ 2 250/1.

20 Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 [2007] OJ 2 189/1 (Organic Regulation).

21 Organic Regulation, Arts 3 and 4.

22 Organic Regulation, Arts 5–7.

23 Purnhagen and Wesseler, supra, note 12, p 9.

24 In the EU, the controversy regarding the AstraZeneca vaccine rollout is the most recent manifestation of a company suffering severe reputational damage as a result of contractual discrepancies. The domino effect of a party in a supply chain reneging on their contractual obligations can be detrimental to multiple actors; “Martin Welcomes EU Decision to Withdraw Article 16 in Row over AstraZeneca Vaccine in Northern Ireland” (Irish Independent) <https://www.independent.ie/irish-news/martin-welcomes-eu-decision-to-withdraw-article-16-in-row-over-astrazeneca-vaccine-in-northern-ireland-40030300.html> (last accessed 14 February 2021); “Prospects for Game-Changing AstraZeneca Vaccine Become Increasingly Clouded” (Irish Times) <https://www.irishtimes.com/business/health-pharma/prospects-for-game-changing-astrazeneca-vaccine-become-increasingly-clouded-1.4470349> (last accessed 14 February 2021).

25 Reg 889/2008, Art 66(1).

26 A list of control bodies has been collated by the Directorate General of the European Commission for Agriculture and Rural Development: <https://ec.europa.eu/agriculture/ofis_public/actor_cbeu/ctrl.cfm?targetUrl=home> (last accessed 10 December 2020).

27 General Food Law, Arts 18(2) and (3); Organic Regulation, Art 29(2).

28 Reg 889/2008, Art 66(2).

29 Reg 889/2008, Art 63(2)(a).

30 Reg 889/2008, Art 63(1).

31 Reg 889/2008, Art 81.

32 Reg 889/2008, Art 63(3)(a)(b)(c)(f).

33 Reg 889/2008, Art 63(1)(a)(b)(c).

34 Reg 889/2008, Art 63(1)(b).

35 Reg 889/2008, Art 63(2)(c).

36 Reg 889/2008, Art 26(5)(a)(b)(c).

37 Reg 889/2008, Arts 26(5)(d) and (2).

38 Reg 889/2008, Art 26(3).

39 Reg 889/2008, Arts 30 and 34.

40 Reg 889/2008, Art 31(1).

41 Reg 889/2008, Art 31(1)(a).

42 Reg 889/2008, Art 31(1)(b)(c)(d).

43 Reg 889/2008, Art 31(1).

44 Reg 889/2008, Art 34.

45 Reg 889/2008, Art 34.

46 Reg 889/2008, Art 31(2)(a)(b)(c).

47 Reg 889/2008, Art 83.

48 Reg 889/2008, Art 83.

49 Reg 889/2008, Art 84(a).

50 Reg 889/2008, Art 84(b)(i).

51 Reg 889/2008, Art 84(b)(ii).

52 Reg 889/2008, Art 85.

53 Reg 889/2008, Arts 70–89.

54 Reg 889/2008, Art 70(1)(b).

55 Reg 889/2008, Art 70(1)(c).

56 Reg 889/2008, Art 80.

57 Reg 889/2008, Art 80.

58 Reg 889/2008, Art 86(a)(b).

59 Reg 889/2008, Art 82(1).

60 Reg 889/2008, Art 82(1).

61 Reg 889/2008, Arts 82(2) and 83.

62 Organic Regulation, Art 27(5)(a).

63 Organic Regulation, Art 27(5)(b)(i)(ii)(iii).

64 Organic Regulation, Art 27(6)(a).

65 Organic Regulation, Art 32(1)(a)(b).

66 Organic Regulation, Art 32(1)(c); Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries [2008] OJ 2 334, Art 6.

67 Organic Regulation, Art 32(2).

68 Organic Regulation, Art 32(2).

69 Organic Regulation, Art 33(1)(a)(b).

70 Organic Regulation, Arts 33(2) and (3).

71 Reg 1235/2008, Art 7.

72 Reg 1235/2008, Art 10.

73 Organic Regulation, Art 33(1)(c).

74 Organic Regulation, Arts 33(2) and (3); Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods (GL 32 – 1999, Rev. 1 – 2001) <http://www.fao.org/docs/eims/upload/230124/cxg_032e.pdf> (last accessed 18 October 2020); Organic Regulation, Art 33(3).

75 Organic Regulation, Art 33(2).

76 Organic Regulation, Art 33(1)(d).

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78 ibid, p 30.

79 Organic Regulation, Art 27(5)(e).

80 Regulation (EC) No 889/2008, Art. 92(a)(1); Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries [2008] OJ 2 334, Art 15.

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83 European Court of Auditors, supra, note 77, p 37.

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85 New GM methods are constantly trialled in the EU. See further: European Medicines Agency “Genome Editing EU-IN Horizon Scanning Report.Pdf” p 4 <https://www.ema.europa.eu/en/documents/report/genome-editing-eu-horizon-scanning-report_en.pdf> (last accessed 6 September 2021).

86 Consolidated version of the Treaty on the Functioning of the European Union [2012] OJ 1 326/47, Art 290.

87 Regulation (EC) 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [2003] OJ 2 268/24, Art 4(4).

88 General Food Law, Arts 18(3) and (4).

89 E Waltz, “With a Free Pass, CRISPR-Edited Plants Reach Market in Record Time” (2018) 36 Nature Biotechnology 6 <http://www.nature.com/articles/nbt0118-6b> (last accessed 17 December 2020).

90 E Castellari et al, “Food Processor and Retailer Non-GMO Standards in the US and EU and the Driving Role of Regulations” (2018) 78 Food Policy 26, p 35 <https://linkinghub.elsevier.com/retrieve/pii/S0306919218301088> (last accessed 29 November 2020).

91 Organic Regulation, Art 23(3).

92 Organic Regulation, Arts 23(1), (6), 23(4) and 25(1).

93 Reg 889/2008, Art 26(4)(c).

94 Organic Regulation, Art 23(4).

95 Organic Regulation, Art 23(3).

96 Organic Regulation, Recitals 9 and 10, Arts 9 (1), 25(3) and 69.

97 Organic Regulation, Recital 10; Deliberate Release Directive, Arts 21(1) and (3); Reg 1829/2003, Recital 29, Arts 12(1) and 24.

98 R Ferreira, F David and J Nielsen, “Advancing Biotechnology with CRISPR/Cas9: Recent Applications and Patent Landscape” (2018) 45 Journal of Industrial Microbiology & Biotechnology 467, p 475 <https://academic.oup.com/jimb/article/45/7/467-480/5996688> (last accessed 25 February 2021).

99 A Churi and S Taylor, “Continuing CRISPR Patent Disputes May Be Usurped by Its Potential Role in Fighting Global Pandemics” (2020) 39 Biotechnology Law Report 184, p 188 <https://www.liebertpub.com/doi/10.1089/blr.2020.29180.ac> (last accessed 25 February 2021).

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101 General Food Law, Art 17(1); Reg 1830/2003, Art 3(3).

102 Deliberate Release Directive, Art 33; Reg 1829/2003, Arts 45(1) and (2); Reg 1830/2003, Arts 11(1) and (2).

103 General Food Law, Arts 17 and 19.

104 Reg 889/2008, Art 91(1).

105 Reg 889/2008, Art 91(2).

106 JRC116289, supra, note 6, p 9.

107 Organic Regulation, Recital 10, Art 9(1).

108 Organic Regulation, Art 9(2).

109 Organic Regulation, Art 9(2).

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111 ibid.

112 Waltz, supra, note 91.

113 Organic Regulation, Art 2(a).

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116 “BSE Crisis in 1990s Caused Havoc in Industry” (Irish Independent) <https://www.independent.ie/business/farming/bse-crisis-in-1990s-caused-havoc-in-industry-31296502.html> (last accessed 22 April 2021).

117 “Horsemeat Scandal: The Essential Guide” (The Guardian, 15 February 2013) <http://www.theguardian.com/uk/2013/feb/15/horsemeat-scandal-the-essential-guide> (last accessed 22 April 2021).

118 S Charlebois et al, “Comparison of Global Food Traceability Regulations and Requirements: Global Food Traceability Regulations…” (2014) 13 Comprehensive Reviews in Food Science and Food Safety 1104, p 1111 <http://doi.wiley.com/10.1111/1541-4337.12101> (last accessed 16 February 2021).

119 Reuters Staff, “Bayer, BASF to Pursue Plant Gene Editing Elsewhere after EU Ruling” (Reuters, 27 July 2018) <https://www.reuters.com/article/us-eu-court-gmo-companies-idUSKBN1KH1NF> (last accessed 7 April 2021); PAC Hundleby and WA Harwood, “Impacts of the EU GMO Regulatory Framework for Plant Genome Editing” (2019) 8 Food and Energy Security e00161, p 3 <https://onlinelibrary.wiley.com/doi/abs/10.1002/fes3.161> (last accessed 20 July 2020).

120 Organic Regulation, Art 23(3).

121 JE Hobbs, WA Kerr and PWB Phillips, “Identity Preservation and International Trade: Signaling Quality across National Boundaries” (2001) 49 Canadian Journal of Agricultural Economics/Revue canadienne d’agroeconomie 567, p 576 <http://doi.wiley.com/10.1111/j.1744-7976.2001.tb00327.x> (last accessed 15 February 2021).

122 Reg 889/2008, Art 66(1).

123 General Food Law, Arts 18(2) and (3).

124 E Nuijten, M Messmer and EL van Bueren, “Concepts and Strategies of Organic Plant Breeding in Light of Novel Breeding Techniques” (2016) 9 Sustainability 18, p 4 <http://www.mdpi.com/2071-1050/9/1/18> (last accessed 23 July 2020).

125 T Ruttink et al, “Knowledge-Technology-Based Discovery of Unauthorized Genetically Modified Organisms” (2010) 396 Analytical and Bioanalytical Chemistry 1951, p 1956 <http://link.springer.com/10.1007/s00216-009-3218-6> (last accessed 17 December 2020); N Kalaitzandonakes, R Maltsbarger and J Barnes, “Global Identity Preservation Costs in Agricultural Supply Chains” (2001) 49 Canadian Journal of Agricultural Economics/Revue canadienne d’agroeconomie 605, p 607 <http://doi.wiley.com/10.1111/j.1744-7976.2001.tb00330.x> (last accessed 11 November 2020); Varacca and Soregaroli, supra, note 112, p 40; J Bovay and JM Alston, “GMO Food Labels in the United States: Economic Implications of the New Law” (2018) 78 Food Policy 14, pp 14, 23 <https://linkinghub.elsevier.com/retrieve/pii/S0306919218301295> (last accessed 25 February 2021).

126 TR Abbott et al, “Development of CRISPR as a Prophylactic Strategy to Combat Novel Coronavirus and Influenza” (Bioengineering 2020) preprint <http://biorxiv.org/lookup/doi/10.1101/2020.03.13.991307> (last accessed 23 April 2021); “How MRNA Technology Could Upend the Drug Industry” (Time) <https://time.com/5927342/mrna-covid-vaccine/> (last accessed 23 April 2021).

127 Hobbs et al, supra, note 123, p 575.

128 “Big Pharma Lobby’s Self-Serving Claims Block Global Access to Vaccines” (Corporate Europe Observatory) <https://corporateeurope.org/en/2021/04/big-pharma-lobbys-self-serving-claims-block-global-access-vaccines> (last accessed 23 April 2021); “Could Waiving Covid-19 Vaccine Patents Save the World?” (France 24, 16 April 2021) <https://www.france24.com/en/europe/20210416-could-waived-covid-19-patents-save-the-world> (last accessed 23 April 2021).