Creating a global biosafety regime

International Journal of Biotechnology

Volumn 2, Issue 1-3, 2000, Pages 205-230

  Gupta, Aarti ^a  

^a HARVARD UNIVERSITY   (United States)

Author keywords

Biosafety; Cartagena Protocol; Convention on Biological Diversity; genetically modified organisms (GMOs); governance; informed consent; precautionary principle; sound science

Indexed keywords

ACCIDENT PREVENTION; AGRICULTURE; PUBLIC POLICY; REGULATORY COMPLIANCE;

BIOLOGICAL DIVERSITY; BIOSAFETY; GENETICALLY MODIFIED ORGANISMS; PRECAUTIONARY PRINCIPLE; SOUND SCIENCE;

BIOTECHNOLOGY;

EID: 0033719281     PISSN: 09636048     EISSN: 17415020     Source Type: Journal    
DOI: 10.1504/ijbt.2000.000126     Document Type: Article

References (46)

1. Krimksy, S. and Plough, A. (1988) ‘The release of genetically engineered organisms into the environment. The case of ice-minus in environmental hazards’ Communicating Risks as a Social Process, Dover, MA: Auburn House Publishing Company.
2. Frewer, L.L., Howard, C. and Shepard, R. (1997) ‘Public concerns in the United Kingdom about general and specific applications of genetic engineering: risk, benefit and ethics’, Science, Technology and Human Values, Vol. 22, No. 1, pp.98–124.
3. Gottweis, H, (1998) Governing Molecules. The Discursive Politics of Genetic Engineering in Europe and the US. Cambridge: The MIT Press.
4. Krimsky, S. (1982) Genetic Alchemy. The Social History of the Recombinant DNA Controversy. Cambridge: MIT Press. Deatherage, S. (1987) ‘Scientific uncertainty in regulating deliberate release of genetically engineered organisms: substantive judicial review and institutional alternatives’, Harvard Environmental Law Review, Vol. 11, No. 203; Harlow, R. (1986) ‘The EPA and biotechnology regulation. Coping with scientific uncertainty’, The Yale Law Journal, Vol. 95, No. 506. Tooze, J. (1981) ‘International and European regulation of recombinant DNA research’, The University of Toledo Law Review, Vol. 12, No. 4, pp.869–890.
5. While all claims about risks posed by GMOs remain contested, a variety of ecological and human health risks have been posited in the literature. In the category of ecological risks are included concerns about the transfer of novel genetic material from genetically modified crops to wild relatives, especially in centers of genetic diversity. For genetic modifications intended to bestow herbicide or pesticide resistance, concerns relate to potential build-up of weed or pest resistance, with fear of the development of what have been termed ‘superbugs’ or ‘superweeds’. Concerns pertaining to human health include potential allergenicity and toxicity to humans of novel genetic material in GMOs or processed products deriving from them.
6. Rissler, J. and Mellon, M. (1993) Perils Among The Promise. Ecological Risks of Transgenic Crops In A Global Market Place Cambridge: Union of Concerned Scientists.
7. Nottingham, S. (1998) Eat Your Genes. How Genetically Modified Food Is Entering Our Diet London, Zed Books.
8. Wright, S. (1994) Molecular Politics. Developing American And British Regulatory Policy For Genetic Engineering, 1972–1982. Chicago: University of Chicago Press.
9. James, C. (1998) Global Review Of Commercialized Transgenic Crops: 1998. ISAAA Briefs. No. 8. Ithaca: ISAAA.
10. Rajan, M.G. (1997) Global Environmental Politics. India And The North-South Politics Of Global Environmental Issues, Delhi, Calcutta, Chennai, Oxford University Press, p. 220.
11. Basal Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal [henceforth Basal Convention]. Available at http://www.unep.org
12. Wright [8], Rajan [10], Confidential Interviews 1998–2000. With Aken, Jan van (Greenpeace), Alwi, Des (Indonesia), Anderson, Bill (Ag-West Biotech Inc. Canada), Babu, Dr. G. V. Sarat (India), Bail, Christoph (European Commission), Bättig, Benno (Switzerland), Brown, Linda (UK). Bruno, Dr. Marilyn (USA) Bulbul, Sen (India), Celeste, Laurel (USA), De Paiva, Dr. Genaro (Brazil), Egziabher, Tewolde Berhan Gebre (Ethiopia), Enright, Dr. Cathleen (USA), Flamm, Dr. Eric (USA), Gandhi, Dr. M (India), Ghosh, Dr. P. K (India), Giddings, Dr. L. Val (Biotechnology Industry Organization), Gunatillake, Prof. Nimal (Sri Lanka), Harness, Robert (Monsanto), Husby, Jan (Norway), Ikefuchi, Masakazu (Japan), Jackson, Alex (US Grains Council), Jafri, Syed Afsar Hussan (Research Foundation for Science, Technology and Ecology, India), Jorgensen, Matthias (European Community), Juma, Calestous (CBD Secretariat), Kameke, Conrad von (Monsanto), Kochenderfer, Karil (Grocery Manufactures of America, USA), Koester, Veit (Chairman of the Ad Hoc Working Group on Biosafety and Denmark), Larson, Jorge (Mexico), Leskien, Dan (Friends of the Earth), Lewanika, Dr. Mwannanyanda Mbikusita (Zambia), Lewis, Dr. Glennis M (Canada), Ling, Chee Yoke (Third World Network, Malaysia), McLeod, Mary (USA), Nagulendran, K (Malaysia), Nevill, John (Seychelles), Nijar, Gurdial Singh (Third World Network), Safrin, Sabrina (USA), Schechtman, Dr. Michael (USA), Schipulle, Dr. Hans-Peter (Germany), Schneider, Manfred (Austria), Shark, David (USA), Stabinsky, Dr. Doreen (Council for Responsible Genetics, USA), Tapper, Dr. Richard (WWF), Tuminaro, John (USA), Vaish, Avani (GEF), Von Schomberg, Rene (European Commission), Watson, Dr. John (Australia).
13. COP-CBD [Conference of the Parties to the Convention on Biological Diversity] (1995) Report of the Open-ended Ad Hoc Group of Experts on Biosafety UNEP/CBD/COP/2/7 of 3 August.
14. Council Directive of 23 April 1990 on the contained use of genetically modified microorganisms (90/219/EEC); Council Directive of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (90/220/EEC), Official Journal of the European Communities, No L 117/1–27.
15. Ironically, when negotiation of a protocol was later launched, the term ‘living modified organism’ had to defined such that it included only genetically modified organisms, to avoid the vast spectrum of living entities modified through traditional breeding from falling under the biosafety protocol, an outcome desired by no group of countries, including the US. BSWG (1999). Note by the Co-Chairs of Contact Group I (the scientific and technical group): Programme of work. UNEP/CBD/BSWG/6/Inf. 8.
16. Declaration of Malaysia. Nairobi Final Act to Sign the Convention on Biological Diversity. Text on file with author.
17. Convention on Biological Diversity. Done Rio de Janeiro, 5 June 1992, in force 29 December 1993. Text available in 31, International Legal Materials (1992) 818.
18. For discussions of a biosafety protocol under the CBD in the interim period between finalization of the Convention and launching of the protocol negotiations in 1996, see, for example, COP-CBD 1995 [13].
19. Clearly, there are divergent perspectives on biosafety within each regional group. A discussion of how group positions are shaped by social, economic, political and cultural interactions at the national-level and within regions is beyond the scope of this paper. For national regulation of biotechnology in OECD countries, see [3,8]. For perspectives on the relevance of biotechnology for developing countries, see Shiva, V. (2000) Stolen Harvest: the Hijacking of the Global Food Supply, Cambridge: South End Press; and Persley, G.J. and Lantin, M.M (Eds.) (1999) Agricultural Biotechnology and the Poor: Proceedings of an International Conference, Washington, D.C.: Consultative Group on International Agricultural Research.
20. In 1998, 27.8 million hectares were planted with genetically modified crops worldwide. Of this area, the US contributed 74%, Argentina 15%, Canada 10% and Australia 1%. Mexico, Spain, France, China and South Africa constituted the remaining, each with less than 1%. The main crops grown in 1998 were soybean (consisting of 52% of the global area), corn (constituting 30%), as well as cotton, canola, and potato. The main genetic modifications were for herbicide tolerance (71% of all genetic modification) and insect resistance (21%). The growth in area devoted to genetically modified crops from 1997 to 1998 (from 11 to 27.8 million hectares) was concentrated in industrialized countries. Global sales from transgenics were estimated at $75 million in 1995, $235 million in 1996, $670 million in 1997, and from $1.2 -$1.5 billion in 1998. All data from James [9].
21. Global Industry Coalition (GIC). (1999) Basic Requirements for a Successful Biosafety Protocol. The GIC consists of ‘over 2200 firms from more than 130 countries worldwide…from a variety of industrial sectors, including plant and animal agriculture, food production, human and animal health care, and the environment’. Text on file with author.
22. Ravetz, J. and Brown, J. (1989) ‘Biotechnology. Anticipatory risk management’ in Brown, J. (Ed.) Environmental Threats. Perception, analysis and Management, London: Belhaven Press.
23. Third World Network. (1999) Products-Thereof Are Legally Within The Scope Of The Protocol. Text on file with author.
24. Japanese delegation. (1999) Position Of The Japanese Government Toward A Protocol On Biosafety. Text on file with author.
25. Grocery Manufacturers of America. (1999). Commonly-Asked Questions And Answers About The Inclusion Of ‘Products Thereof’ In The Biosafety Protocol As It Relates To Food, Beverages And Consumer Products. Text on file with author.
26. Rhone-Poulenc R. (1999) Statement on Biosafety Protocol. Text on file with author.
27. Jasanoff, S. (1998) ‘Harmonization—the politics of reasoning together’ in Bal, R. and Halfman, W. (Eds.) The Politics Of Chemical Risk. Dordrecht: Kluwer Academic Publishers, pp.173–194 at p.174.
28. BSWG (1999) Protocol on Biosafety: draft text submitted by the Chair of the Working Group. UNEP/CBD/BSWG/6/L.2/Rev.2. Issued for the Sixth meeting of the Open-Ended Ad Hoc Working Group on Biosafety, Cartagena, Colombia,, 14–19 February.
29. Global Industry Coalition. (1999) Impact Analysis: An Application Of AIA To Agricultural Commodities Text on file with author.
30. Informal group on commodities. (1999) Commodities Non-Paper Cartagena. Text on file with author.
31. Green Group Coalition. (1999). What is Left In? Text on file with author.
32. Australian delegation (1998). Statement by Australia, Open-Ended Ad Hoc Working Group on Biosafety. 5th Meeting. Montreal. 17–28 August, Text on file with author.
33. BSWG [Open-ended Ad Hoc Working Group on Biosafety] (1998) Revised consolidated text of the draft articles. Note by the Secretariat. UNEP/CBD/BSWG/5/Inf.1 of 23 February.
34. For a history of the precautionary principle, see Gullett, W. (1997) ‘Environmental protection and the ‘precautionary principle’: a response to scientific uncertainty in environmental management’, in Environmental And Planning Law Journal, pp.52–69.
35. For a detailed discussion of the SPS Agreement, see Wirth, D.A. (1994) ‘The role of science in the Uruguay round and NAFTA trade disciplines’, in Cornell International Law Journal, Vol. 27, No. 3. pp.817–859.
36. Asfaw, Z. and. Egziabher, T.B.G (1997) ‘Possible adverse socio-economic impacts of genetically modified organisms’, in Mulongay, K.J. (Ed.) Transboundary Movement Of Living Modified Organisms Resulting From Modern Biotechnology: Issues And Opportunities For Policy-Makers, Geneva. International Academy of the Environment. See also [13, p.11]. For a study of how scientific assessments are very differently received in distinct socioeconomic contexts, see Biermann, F. (1999) ‘Big science, small impacts -in the South? The influence of international environmental information institutions on policy-making in India’. ENRP Discussion Paper. Cambridge: Harvard University. Available at http://environment.harvard.edu/gea
37. Meyer, H. (1998) Precise Precaution versus sloppy science - a case study Working Group on Biodiversity. Forum Environment and Development, Germany. Text on file with author.
38. E. C. Measures Concerning Meat and Meat Products (Hormones), report of the Appellate Body AB 1997–94, WT/DS 26 ABIR, 16 January 1998, Available at http://www.wto/org.dispute/dispute/htm
39. For a recent clarification of how the European Commission views the precautionary principle and its implementation, see Communication from the Commission on the Precautionary Principle. Brussels, 2.2.2000, COM (2000)1, final. Text on file with author
40. Worldwide Fund for Nature (1999). Socioeconomic Considerations: Recommendations from WWF and Council for Responsible Genetics/Washington Biotechnology Action Council (1999). Case Study on Evaluation of Socio-Economic Factors. Texts on file with author.
41. Farley, M. ‘Deal struck to regulate genetically modified foods’ Los Angeles Times, 30 January 2000.
42. Cartagena Protocol on Biosafety. Final draft text submitted by the legal drafting group. UNEP/CBD/ExCOP/1/L.5. 28 January 2000. See also Gupta, A. ‘Governing Trade in Genetically Modified Organisms: the Cartagena Protocol on Biosafety’ in Environment, Vol. 42, Number 4, May 2000.
43. Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade UNEP/CHEMICALS/98/17, March 1999.
44. For a detailed discussion of the contrast between the rhetoric of sound science and the criteria for scientific input that has aided protocol negotiations to date, see Gupta. (1999) ‘Framing ‘biosafety’ in an international context’, ENRP Discussion Paper, Cambridge: Harvard University. Available at http://environment.harvard.edu/gea
45. See, for example, Biermann, F. (2000) Multilateral Environmental Agreements and International Trade Law: Options for Reform. Unpublished manuscript, Potsdam Institute for Climate Impact Research, Potsdam, Germany. Biermann suggests that particular MEAs could be endorsed by a meeting of the Ministerial Conference of the WTO as the accepted international standard in their regulatory domain. While this may be possible for some MEAs, the political feasibility of a WTO endorsement of the Cartagena Protocol as the international standard for LMO regulation remains unlikely, given the long-drawn out fight to make sure that the protocol does not trump the WTO. Furthermore, while any such endorsement could have different ramifications, one such ramification might be to shift the battle over differential interpretations of the protocol’s provisions to the WTO and by extension to its dispute settlement mechanism. The repurcussions of this for the cause of biosafety and for the relationship between MEAs and the trade regime remain unclear and merit further analysis.
46. On the contentious issue of substantial equivalence, see the debate sparked in Nature by E. Millstone, E. Brunner and S. Mayer, ‘Beyond ‘Substantial Equivalence’ ‘ Nature, Vol. 401, 7 October 1999, pp. 524.