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The Regulatory Challenge of Animal Cloning for Food – The Risks of Risk Regulation in the European Union

Published online by Cambridge University Press:  20 January 2017

Maria Weimer
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Abstract

In this article I describe and analyse the current regulatory developments at EU level concerning the marketing of foods produced from cloned animals. As they are on the verge of commercialisation in countries outside the EU, especially in the United States, foods from cloned animals are likely to reach the European consumers in the foreseeable future. Yet at the moment there is no specific legal framework that regulates such products in the EU. The European institutions have, however, opened up a debate to determine the appropriate European policy approach towards animal cloning. The recent discussion reveals that the variety of potential yet very uncertain risks associated with animal cloning renders the drafting of suitable legislation difficult. At the same time, Europe's regulation of food risks also entails certain regulatory risks of its own (e.g. risks of political, economic, and legal conflicts within the EU as well as with EU's trade partners). By considering the discussion on animal cloning in the broader context of EU's regulation of genetically modified organisms and of nanotechnology, I identify the legal and political problems of current regulatory options. I argue that such problems should be openly addressed in the regulatory discussion; it is possible for them to be minimised if lessons are drawn from previous regulatory experience.

Type
Articles
Information
European Journal of Risk Regulation , Volume 1 , Issue 1 , March 2010 , pp. 31 - 39
Copyright
Copyright © Cambridge University Press 2010

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References

1 Well known precedents are EC – Measures Concerning Meat and Meat Products, Report of the Appellate Body, WTO doc. WT/DS26/AB/R and WT/DS48/AB/R, 16 January 1998; and EC – Measures Affecting the Approval and Marketing of Biotech Products, Report of the Panel, WTO doc. WT/DS291, WT/ DS292, WT/DS293, 29 September 2006.

2 See, however, the Commission announcement in 2009 that it would review all relevant existing legislation within two years to ensure safety of all applications of nanomaterials in products with potential environmental, health, and safety impacts over their life cycle; see European Commission, “Towards a strategic nanotechnology action plan (SNAP) 2010-2015,” Public Consultation available on the Internet at http://ec.europa.eu/research/consultations/snap/consultation_en.htm (last accessed on 8 February 2010); for further comments see Montfort, Jean-Philippe/ Indirli, Giovanni/Carrega, Claire-Marie, “Nanomaterials under REACH: Legal Aspects”, European Journal of Risk Regulation, in this issue.

3 See with regards to food safety the ongoing amendment of Regulation (EC) No 257/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients, OJ 1997 L 43/1; further discussion infra at IV; only in the case of nanomaterials see European Parliament and Council Regulation 1907/2006 of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/ EEC, 93/105/EC and 2000/21/EC; see discussion in Montfort et al, “Nanomaterials,” supra note 2.

4 See in more detail The European Group on Ethics in Science and New Technologies, Ethical aspects of animal cloning for food supply, Opinion No 23 from 16 January 2008, p. 6 (hereinafter EGE opinion).

5 See EGE opinion supra note 4, pp. 12–13.

6 See European Food Safety Authority, “Food Safety, Animal Health and Welfare and Environmental Impact of Animals derived from Cloning by Somatic Cell Nucleus Transfer (SCNT) and their offspring and Products Obtained from those Animals,” Scientific Opinion from 15 July 2008, The EFSA Journal (2008) 767, pp. 1 et sqq., at p. 10 (hereinafter EFSA opinion).

7 See EFSA opinion ibid, at p. 7.

8 See Weise, Elizabeth, “Dolly was World's Hello to Cloning’s Possibilities”, USA Today, 4 July 2006 available on the Internet at http://www.usatoday.com/tech/science/genetics/2006-07-04-dolly-anniversary_x.htm (last accessed on 3 February 2010).

9 USA is the country in which most of the companies aiming to use animal cloning for the food industry have been established. See EGE opinion supra note 4, at p. 19.

10 See US Food and Drug Administration, “Animal Cloning: A Risk Assessment”, opinion from 1 August 2008 available on the Internet at http://www.fda.gov/AnimalVeterinary/SafetyHealth/AnimalCloning/ucm055489.htm (last accessed on 3 February 2010).

11 See Reuters, “No end in site for animal cloning moratorium: USDA”, 7 April 2008, available on the Internet at http://www.reuters.com/article/scienceNews/idUSTON77972120080407 (last accessed on 26 July 2009).

12 See EGE opinion supra note 4, at p. 14.

13 For an indicative timeline for the commercialisation of food from cloned animals see EGE opinion supra note 4, p. 14 with further references.

14 For example, frozen semen from cloned cattle, bulls, and pigs is sold for artificial insemination purposes; for more information see EGE opinion supra note 4, at p. 14.

15 There is, however, EU legislation, which could be applied to regulate certain aspects of animal cloning for food supply. Among the most immediate sources of EU law applicable to animal cloning there are, for example, Directive 98/58/EC on the protection of animals kept for farming purposes; Directives 91/496/EEC and 97/78/EC on veterinary checks on the import of animals and products. For further overview see “Legal aspects of research on and use of farm animal cloning within the EU”, report from the project Cloning in Public available on the Internet at http://209.85.129.132/search?q=cache:i5MCLsX-KDQJ:www.sl.kvl.dk/cloninginpublic/+Legal+aspects+of+research+on+and+use+of+farm+animal+cloning+within+the+EU+%E2%80%93+A+synthesis&cd=2&hl=it&ct=clnk&gl=it&client=firefox-a (last accessed on 27 July 2009).

16 The EGE is an independent advisory body created by the Commission. Its last mandate lasted from 2005 to 2009. Its task was to advise the Commission on ethical questions related to sciences and new technologies, either on request of the Commission or on its own initiative; the President of the Commission appointed the EGE members, who were asked to advise the Commission independently from any other influence; see Commission Decision of 11 May 2005 on the renewal of the mandate of the European Group on Ethics in Science and New Technologies, OJ 2005 L 127/17.

17 Regulation (EC) No 257/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients, OJ 1997 L 43/1.

18 See EFSA opinion supra note 6.

19 See EFSA opinion supra note 6, p. 33.

20 See EFSA opinion supra note 6, p. 2.

21 See EFSA statement, “Further advice on the implications of Animal Cloning (SCNT)”, 23 July 2009, The EFSA Journal (2009) RN 319, p. 1 et sqq.

22 See EGE opinion supra note 4.

23 See Eurobarometer, “European's attitudes towards animal cloning”, available on the Internet at http://ec.europa.eu/public_opinion/flash/fl_238_en.pdf (last accessed on 2 February 2010).

24 See European Parliament resolution on the cloning of animals for food supply, 3 September 2008, available on the Internet at http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P6-TA-2008-0400&language=EN&ring=B6-2008-0373 (last accessed on 2 February 2010).

25 See USDA Foreign Agricultural Service, “EC Orientation Debate on Animal Cloning”, GAIN Report Number E41010, 30 January 2009, available on the Internet at http://www.fas.usda.gov/gainfiles/200902/146327190.pdf (last accessed on 2 February 2010).

26 See ibid.

27 See supra note 3.

28 Commission Proposal for a Regulation of the European Parliament and of the Council on novel foods, COM (2007) 872 final, available on the Internet at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2007:0872:FIN:EN:PDF (last accessed on 3 February 2010).

29 Note that another purpose of this amendment is to include foods produced using nanotechnology into the scope of the Novel Foods Regulation, see Commission Proposal, supra note 28, point 6) of the preamble.

30 Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, OJ 2002 L 31/1.

31 See Commission proposal, supra note 28, p. 16.

32 See Commission proposal, supra note 28, p. 16.

33 See European Parliament legislative resolution of 25 March 2009 on the proposal for a regulation of the European Parliament and of the Council on novel foods, available on the Internet at http://www.europarl.europa.eu/oeil/file.jsp?id=5583302 (last accessed on 3 February 2010).

34 See Council of the European Union, “Council agrees on new rules for novel foods”, Press Release, 22 June 2009 11218/1/09 REV 1 (Presse 188).

35 Cite Pollack, Mark A. and Shaffer, Gregory C., When Cooperation Fails – The International Law and Politics of Genetically Modified Foods (Oxford: Oxford University Press 2009), pp. 68 et sqq CrossRefGoogle Scholar.

36 See Alemanno, Alberto, “How to Get Out of the Transatlantic Regulatory Deadlock over GMOs? Time for Regulatory Cooperation”, in Swinnen, J. and Vogel, D. (eds) Cooperating in Managing Biosafety and Biodiversity: California, The United States and the European Union (Cheltenham: Edward Elgar 2010 forthcoming), available on the Internet at SSRN: http://ssrn.com/abstract=1419928 (last accessed on 4 February 2010).

37 See Case C-376/98, Germany v Parliament and Council; see also Slater, Donald, “The scope of EC harmonizing powers revisited?”, 4 German Law Journal (2003) No. 2, pp. 137 et sqq.

38 OJ 1998 L 221/23.

39 Article 4 of the Directive and its Annex point 20 state that breeding procedures that cause or are likely to cause suffering or injury to any of the animals concerned must not be practiced.

40 Under the new provisions of the Lisbon Treaty, the Court of Justice and the General Court, see Article 251 et sqq. of the TFEU.

41 See, for example, Case C-301/06 Ireland v European Parliament, Council, Judgment of 10 February 2009, OJ 2009 C 82/03.

42 See, as the latest confirmation of the so-called Plaumann-Formula of ‘direct and individual concern’, Case C-50/00 Union de Pequenos Agricultores (2002) ECR I-6677.

43 If the EU authorities issued a decision directly addressed to a producer or importer of foods from cloned animals (for example under a prior-authorisation scheme), or which was of direct and individual concern to them, the admissibility of an annulment procedure under Article 263 IV TFEU, following the lines of long standing case law on Article 230 IV EC-Treaty, should not be problematic.

44 See recital (2) of the preamble of Regulation (EC) No. 258/97.

45 See Weimer, Maria, “Applying Precaution in Community Authorisation of Genetically Modified Organisms – Challenges and Suggestions for Reform”, European Law Journal forthcoming; also as Recon Online Working Paper 2009/14 available on the Internet at http://www.reconproject.eu/projectweb/portalproject/AbstractRECONwp0914.html (last accessed on 3 February 2010); Majone, Giandomenico, “Foundations of Risk Regulation: Science, Decision-Making, Policy Learning and Institutional Reform”, European Journal of Risk Regulation, in this issue.

46 Lee, Maria, EU Regulation of GMOs (Edward Elgar 2008); Shaffer and Pollack, When Cooperation Fails, supra note 35.

47 Namely between 1998 and 2004, see Shaffer and Pollack ibid, at p. 68.

48 On previous WTO case law and the meaning of precaution under WTO law see Flett, James, “If in Doubt, leave it out? EU Precaution in WTO Regulatory Space”, European Journal of Risk Regulation, in this issue.

49 Problems of a factual kind can be expected concerning the feasibility of labeling and traceability of food products from cloned animals, which would be a prerequisite for the functioning of the prior-authorisation system. This problem would be particularly acute for foods from clone progeny, which don't seem to show any nutritional difference to conventional food products.