The definitional problem of GMOs

Responses to the challenges raised by agricultural biotechnology seem to have diverged. In the regulatory arena, the differences in approach are significant. At the heart of the divergence is the fact that the definition of genetically modified organisms (GMOs) is far from clear. The differences are clearly reflected in the

Biotech dispute.

The US and Canada consider ‘Genetic modification’ a broad term, covering a variety of scientific methods designed to improve the productivity and functionality of plants, animals, and micro-organisms. They provide historical and scientific development of traditional techniques of plant breeding and present ‘modern biotechnology’ or ‘recombinant technology’ (rDNA) as simply the latest and most

88 advanced technique in genetic modification of crop plants. In other words, genetic modification is basically an extension of traditional breeding techniques. 9

The US denies any potential hazards arising from GMOs.10 _{The US chose to use}

the expression ‘biotech products’ which refers to ‘plant cultivars that have been developed through recombinant deoxyribonucleic acid (“recombinant DNA) technology.’11 _{The US government use the term ‘genetic modification’ to cover}

both modern (recombinant DNA) techniques and traditional breeding techniques.12

Argentina uses the phrase ‘biotech agriculture products’ to describe ‘genetically modified organisms (GMOs)’ or ‘novel foods’ as they are designated in EU legislation.13

The EU considered that the terms used by the Complainants were misleading since biotechnology covers techniques and practices other than genetic modification, referring to a press release concerning the Food and Agriculture Organization of the United Nations’ (FAO) annual report, ‘The State of Food and Agriculture 2003- 04’,14 _{which pointed out that ‘…biotechnology, one of the tools of the gene}

revolution, is much more than genetically modified organisms (GMOs), [and] sometimes also called transgenic organisms.’ These were at issue in the Biotech case. Consequently, some of the potential benefits described in paragraphs 17-26 of the first written submission of the USA might not derive from GMOs, but other forms of modern biotechnology.

The EU’s legislation relevant to the dispute refers to ‘genetically modified organisms’ (GMOs) as contained in Article 2(2) of EC Directive 2001/18 ‘on the

9 _{First Written Submission of Canada, Biotech, paras. 3-6. Traditional breeding methods include,}

selective breeding, crossbreeding (hybridization) and grafting. See also First Submission of the United States, Biotech, paras. 7-15.

10 _{First Submission of the United States, Biotech, para. 27.}

11 _{First Submission of the United States, Biotech, para 10. The US in their submission used the}

phrase “ modern technology” to refer to “recombinant DNA”

12 _{7 Code of Federal Regulation, Section 340.1, see ‘Statement on Biotechnology Issues’, by James}

H. Maryanski, FDA Biotechnology Coordinator, before the senate Committee on Agriculture, Nutrition and Forestry, 7 October 1999, available at

www.hhs.gov/progorg/asl/testify/t991007a.htm. Accessed 13 April 2010.

13 _{Directive 2001/18/EC and its predecessor Directive 90/220/EEC and Regulation (EC) No. 258/97.}

14 _{‘The Gene Revolution: Great Potential for The Poor, But No Panacea’ FAO Press Release 17}

May 2004, http://www.fao.org/newsroom/en/news/2004/41714/index.html Accessed 13 April 2010.

89 deliberate release into the environment of genetically modified organisms’15 _{( and}

Article 2(2) of its predecessor, EC Directive 90/22016_{), and under Articles 1(2)(a)}

and 1(2)(b) of EC Regulation 258/97, concerning ‘novel foods and novel food ingredients’.17 _{Naturally, ‘genetically modified organisms’ (GMOs) is the EUs term}

of reference in the dispute.18 _{The EU defined GMO as ‘an organism, with the}

exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination.’19 _The

European Communities argues that none of the current biotech gene transfer methods are able to precisely control where a foreign gene will be inserted into the recipient cell's genome, or whether that insertion will be stable, and further describes the screening for the desired traits.20 _{The EU highlights main difference}

between genetic modification and conventional breeding practices as being that the latter does not allow for the crossing of natural species barriers or for the transfer of a single or few genes instead of whole genomes.21 _{Similarly, Norway, a third}

party to the dispute, defined GMOs as one of the results of modern biotechnology, which are created by a particular set of techniques used to genetically modify (or ‘genetically engineer’) organisms.22

The amicus curiae brief submitted by NGOs to the WTO Panel provided that ‘Genetic Modification’, the process through which an organism is modified by the application of recombinant DNA (rDNA) technology, can involve either the transfer of genes from one (or more) species to another or the manipulation of genetic material within species.23 _{The amicus curiae brief submitted by a trans-}

Atlantic group of expert academics defined ‘genetic modification’ or ‘genetic engineering’ as involving the manipulation of an organism’s genetic endowment by introducing or eliminating specific genes through modern molecular biology

15 _{OJ 17.4.2001 L106/1}

16 _{OJ 8.5.1990 L117/15, preamble as amended by Directive 94/15/EC, OJ 22.4.1994 L 103 and}

Directive 97/35/EC, OJ 27. 6.1997 L169.

17 _{OJ 14.2.1997 L043/1.}

18 _{See Chapter 3 sections 2.1-3 for discussion of EU legislation.}

19 _{Article 2(2) of Directive 2001/18/EC See also, First Written Submission by the European}

Communities, Biotech, at para. 17.

20 _{First Written Submission by the European Communities, Biotech, paras. 26-28.}

21_{First Written Submission by the European Communities, Biotech, paras. 19-20.}

22 _{Third Party Submission by Norway, Biotech, May 24, 2004.}

23 _{Amicus curiae Brief submitted by CIEL, FOE-US, Defenders of Wildlife, IATP and OCA-USA.}

European Communities- Measures Affecting the Approval and Marketing of Biotech Products (WT/DS/291, 292 and 293), para. 5.

90 techniques. The production process of genetically modified crops involves transgenesis, or the transfer of genes from one plant, animal, or virus into another organism.24

At the international level, the EU made reference to the Convention on Biological Diversity, which defines the revolutionary technology of ‘biotechnology’ as ‘any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.’25 _The

use of biotechnology in agriculture has produced a growing number of ‘genetically modified organisms’ (GMOs) and products derived from them.26

Article 3(g-i) to the Cartagena Protocol to the Convention on biological diversity refers to GMOs as ‘living modified organisms’.27 _{According to the Protocol, a}

‘living modified organism’ is defined as ‘any living organism that processes a novel combination of genetic material obtained through the use of modern biotechnology.’28 _{In everyday usage, LMOs are usually considered to be the same}

as GMOs, but their definition and interpretation vary widely.

Article 3(h) of the Cartagena protocol on Biosafety defines ‘living organisms’ as ‘any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids.’

Under Article 3(i), "modern biotechnology" means the application of:

a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or b. Fusion of cells beyond the taxonomic family,

24 _{Amicus Curiae Brief, Biotech, WT/DS/291,292, and293 (1 June 2004) authored by CIEL, FOE-}

US, Defenders of wild life, IATP, and OCA-US [hereinafter Group of five NGOs] p. 9.

25 _{The Convention on Biological Diversity, 1760 UNTS 79. 31 ILM (1992) 818; B&B Docs, 390.}

Adopted on June 1992 at Rio de Janero Earth Summit, entered into force 29 December 1993. [hereinafter ‘CBD’]

26 _{The biotechnology industry provides products for human health care, industrial processing,}

environmental bioremediation, and food and agriculture. See section 2.6 below

27 _{Cartagena Protocol on Biosafety to the Convention on Biological Diversity, adopted 29 January}

2000, 1760 UNTS 9[hereinafter Cartagena Protocol’] Article 3(g).

91 that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.29

The Biotech panel in its Reports briefly noted these differences, choosing to use interchangeably the terms ‘biotech products’, ‘GMOs’, ‘GM plants’, ‘GM crops’ or ‘GM products’, ‘without prejudice to the views of the Parties to the dispute’.30

Of these terms, the Panels’ preferred choice throughout the reports is ‘Biotech

products’, as used by the United States to refer to ‘plant cultivars that have been

developed through recombinant deoxyribonucleic acid (“recombinant DNA”) technology.’31 _{It did not use ‘GMOs’ as reference, or as used by the EU. This thesis}

tends to more frequently use the term ‘GMOs’, which is the term used in EU legislation at heart of this dispute.32 _{For the purpose of this thesis, a broad definition}

is used, in which genetically modified organism is an organism that has been modified through the use of modern biotechnology, such as recombinant DNA techniques.

This wide terminology used to describe GMOs only adds to the confusion. The next three sections take a back step in order to explain biotechnology (the science of GMOs). It begins with background information on plant breeding, clarifying what ‘plant biotechnology’ is. It then explains techniques used to genetically modify plants. These sections will place modern biotechnology techniques in their historical and scientific context.