Article 3. Use of terms

For the purposes of this Protocol:

187. The inclusion of an article defining certain terms used in the text of an international instrument is a legal technique often used in multilateral environmental agreements. This is intended to achieve a high degree of clarity and accuracy in describing the meaning attached to the term defined. It also facilitates the drafting of the subsequent articles, which then may use the term without any further explanation – as the term may only be understood as defined. Legal definitions are specific to a particular legal text, and only meant to facilitate its drafting. Thus they may depart from scientific or technical definitions, and often do so.

188. Many words and phrases used in the Protocol are, of course, not specifically defined in Article 3. Under Article 31 of the Vienna Convention on the Law of Treaties, the terms used in a treaty, in the absence of special meaning of the term expressed in the treaty by the parties, are to be “interpreted in good faith in accordance with the ordinary meaning to be given to the terms of the treaty in their context and in the light of its object and purpose”.

189. As described in the Introduction, the Protocol was adopted under the auspices of the 1992 CBD. Article 29 of the Protocol stipulates that the Conference of the Parties to the CBD shall serve as the “meeting of the Parties to this Protocol”.

190. Contained use is addressed in Article 6(2) of the Protocol, which excludes from the advance informed agreement procedure the transboundary movement of LMOs destined for contained use, provided that the contained use is undertaken in accordance with the standards for contained use that have been set– for example, in domestic legislation – by the Party of import. Documentation requirements for LMOs destined for contained use are addressed in Article 18(2)(b).

191. The emphasis in the definition is on characteristics which effectively limit both contact with the external environment, and (as a result) the impact thereon, as is normally the case in a laboratory.

192. However, what constitutes an appropriate barrier was the subject of much debate during the negotiations, in particular whether physical barriers were required or whether chemical or biological barriers would be sufficient. The essence, however, of such barriers is that they should effectively limit the contact, and the impact, of the LMOs intended for contained use on the external environment. In this respect, the definition provides some flexibility for national legislation for purposes of Article 6, but it does not provide clear guidance in order to harmonize the use of this term in national legislation. Several examples of national legislation on contained use adopted to date require chemical or biological barriers, where used, to be used in combination with physical barriers (see Box 13 below).

Box 13. Examples of definition of “contained use” in national legislation

Philippines Administrative Order No. 8 of 3 April 2002 on Rules and Regulations for the Importation and Release into the Environment of Plants and Plant Products derived from the Use of Modern Biotechnology

Contained Use means the use of a regulated article for research and development inside a physical containment facility intended to limit its contact with, and to provide for a high level of safety for, the general population and the environment which has been inspected and approved by NCBP (the National Committee on Biosafety of the Philippines).

Norway's Gene Technology Act No. 38 of 2 April 1993

The term contained use means any operation in which genetically modified organisms are produced, grown, stored destroyed or used in some other way in a closed system which physical barriers are employed, either alone or together with chemical and/or biological barriers, to limit contact between the organism on the one hand and humans and the environment on the other.

Swiss Ordinance on the Contained Use of Organisms (Containment Ordinance 814.912) of 25 August 1999

Contained use shall mean any containment measure using physical barriers or a combination of physical and chemical or biological barriers to limit or prevent contact between organisms and people or the environment.

193. The cluster of definitions on import, export, importer and exporter is at the core of many Protocol provisions. Only intentional, i.e. deliberate, transboundary movements constitute export or import, and exclusively those respectively from and to Parties. Unintentional, or accidental, transboundary movements are dealt with in Article 17.

194. It is important to note that both export and import are defined as “transboundary movement”, with the result that the use of the term “transboundary movement” in the Protocol may mean either export or import. The definition of exporter and importer refers to persons carrying out these activities under the jurisdiction of a Party.

195. A “natural” person is an individual; a “legal” person is a company or any other institution which, according to the national legislation under which it is constituted, has a separate legal personality.

196. The definition of LMO is central to defining the scope of the Protocol itself. During the negotiations a special working group was established to consider technical definitions and the annexes to the Protocol.

197. The definitions in Article 3(g) and (h) are closely intertwined, and their elements are considered together below. The term “genetic material” is considered first, as this is an important concept in the subsequent consideration of the terms “living organism” and “modified organism”.

Genetic material

198. Genetic material is not defined in the Protocol. The CBD, however, provides a definition in Article 2, which reads: “Genetic material' means any material of plant, animal, microbial or other origin containing functional units of heredity.” In biological and genetic terms, functional units of heredity are made up of nucleic acids containing genetic information: the functioning of the unit as a whole is affected by any change that occurs within the unit – for example, a change modifying the unit by altering, inserting or deleting one or more nucleotides within the unit. A further description of genetic material, and of chromosomes, genes and nucleic acids which comprise such material, is provided in Box 14.

199. The definition provided in the CBD therefore covers nucleic acids of plant, animal, microbial or other origin, that contain genetic information; but, in addition, also covers any material of plant, animal, microbial or other origin – such as whole organisms or parts of organisms – which contains nucleic acids that contain genetic information. This reflects the CBD's concern to address access to genetic resources and benefit sharing (Article 1 and Article 15, CBD).

200. The context in which the term “genetic material” is used in Articles 3(h), 20(3)(c), Annex I(i) and Annex III(5) of the Protocol suggests that the term is being used specifically to refer to nucleic acids that contain genetic information. Article 3(h) refers to a “biological entity capable of … replicating genetic material”. In biology and genetics, replication is a term that is applied specifically to the process of making copies of nucleic acids – therefore “replicating genetic material” would only be possible if the material being replicated were a nucleic acid. Similarly, Article 20(3)(c), Annex I(i) and Annex III(5), refer to “replicable genetic material”– again, in biological and genetic terms, the only material that is replicable is nucleic acid.

201. The term “genetic material” is therefore used in the Protocol in a manner that is consistent with the definition provided in Article 2 of the CBD, but refers specifically to nucleic acids containing genetic information. Based on this, it is suggested that the term “genetic material” in the Protocol can be understood to refer to nucleic acids that contain functional units of heredity.

Box 14. Genetic material: chromosomes, genes and nucleic acids

Genetic material in organisms is mostly contained in structures called chromosomes. Within each chromosome, genetic material is divided into genes, including various control elements and other elements of currently unknown function. Genes represent functional units of heritable genetic information present within an organism or a cell.

The genetic information of each gene is coded in a nucleic acid molecule: for all organisms (other than some viruses and viroids) this nucleic acid molecule is DNA – for some viruses and viroids the genetic information is stored on molecules of the nucleic acid, RNA. These nucleic acid molecules contain and transmit genetic information. The collective term “genome” is applied to all the nucleic acid molecules carrying heritable genetic information that are present within an organism or a cell. This may include sequences of “junk” or “nonsense” DNA, which on the basis of current knowledge and understanding of genetics, is not believed to have any functions.

The nucleic acid molecules are made up of sequences of nucleotides. The overall sequence of nucleotides in chromosomes – comprising genes including control elements, and other nucleotide sequences – can affect gene activity and expression; changes to this overall nucleotide sequence can therefore result in changes to gene activity and expression. It is also important to note that chromosomes incorporate a variety of proteins and other biological molecules which provide important structural components and control mechanisms that participate in the regulation of gene activity.

For all organisms (except for bacteria, blue-green algae, viruses and viroids) the chromosomes are contained in a cellular structure called the cell nucleus, which also contains various proteins and other biological molecules. While the chromosomes contain most of the genetic material of such organisms, some further genetic material is contained in other organelles (such as chloroplasts and mitochondria) and in the cytoplasm (including plasmids and other discrete genetic elements, termed episomes, that are not part of the chromosomes in the nucleus).

For bacteria or blue-green algae, the chromosomes are found free in the cytoplasm, and are of a much less complicated structure – and usually are a single circular structure formed of either single or double-stranded DNA. In viruses, the chromosome is either single or double-stranded DNA or RNA, which may be packaged in an envelope of proteins and other molecules.

Cellular structures and controls of all organisms and their genetic material, including bacteria and blue-green algae, are complex, and there remains a long way to go in understanding the way in which genes are controlled and expressed. This is one of the reasons for invoking the precautionary provisions in relation to LMOs covered by the Protocol.

Living organism

202. Aliving organism is defined in Article 3(h) as a biological entity that can replicate and/or transfer genetic material.

203. Replication is the process whereby exact copies of nucleic acids – the molecules which contain genetic information – are produced.

204. The phrase “or transfer genetic material” was included in Article 3(h) to ensure that entities such as viruses and viroids, which by themselves cannot actively replicate genetic material, are nonetheless covered by the definition of living organism in the Protocol. Viruses are non-cellular micro-organisms which consist of protein and of nucleic acid (DNA or RNA) containing genetic material, which are incapable of self-replication, and which can insert their genetic material into other (animal, plant or microbial) cells where it is then replicated by the machinery of those cells.68 Viroids are plant pathogenic infectious agents comprising small, naked RNA molecules (i.e. not encased in protein) that contain approximately 240–380 monomer units in a closed circle.69 Viroids, like viruses, use the cells of host organisms to replicate their genetic material. Viruses and viroids are both explicitly mentioned in Article 3(h), reflecting the intention of the negotiators that they be included.

205. Sterile organisms are also explicitly mentioned. Although such organisms cannot reproduce themselves through the processes of sexual reproduction, they can replicate their genetic material, and may be able to reproduce themselves through non-sexual or vegetative processes. A sterile plant growing in the field is most certainly alive, and many plants used in agriculture – such as potatoes and bananas – are often not grown from seed, but are propagated by vegetative means.

Naked DNA and plasmids

206. There was consensus not to include plasmids70 and naked DNA71 as such within the definition of living organism in Article 3(h).

207. However, where a novel combination of genetic material is introduced into a recipient living organism through the use of naked DNA or plasmids as part of a technique of modern biotechnology, the resultant organism will qualify as an LMO as defined in Article 3(h). The same goes for a living organism in which a plasmid created by modern biotechnology and which contains a novel combination of genetic material is present, even where the plasmid is not integrated into the chromosomes of that organism.

Living modified organism

208. The term “living modified organism” is defined in the Protocol to include only those living organisms that:

Novel combination of genetic material

209. A novel combination may be regarded as a combination that was not previously known to exist at the time it was first produced. Based on the Protocol's usage of the term “genetic material” (see paragraphs 198–201), it is suggested that the Protocol's references to “novel combination of genetic material” can be understood to refer to a novel combination of nucleic acid containing functional units of heredity.

210. It is important to note that the novel combination relates solely to a combination of genetic material; it does not depend on any other changes that may or may not occur to material in a LMO, other than its genetic material. Even if a novel combination of genetic material did not result in an observable change in, for example, the phenotype or appearance and behaviour of an organism, the combination would still be novel.

211. The novelty of a combination could arise through the presence of a novel form of a functional unit of heredity – resulting from a change that modifies the unit by altering, inserting or deleting one or more nucleotides within the unit, so that the overall sequence of nucleotides is changed within the unit – or as a novel arrangement of functional units of heredity. Such novel arrangements arise, for example, from introduction of genetic material from different species into a recipient organism. Novel arrangements could also arise from rearrangement of genetic material of the same species.

212. A novel combination could arise from a change to even just a single nucleotide in a nucleotide sequence, as well as from larger changes, such as the introduction of genes hundreds or thousands of nucleotides in length.

Obtained through the use of modern biotechnology

213. The novel combination of genetic material must be “obtained through the use of modern biotechnology”, the term “modern biotechnology” being defined by the Protocol (see article 3(i)).

214. This fundamental criterion for definition of LMO applies irrespective of whether the resulting genotype or phenotype could have arisen naturally or not. The question as to whether the genotype or phenotype of an organism could also have occurred naturally has no bearing on whether an altered organism is a LMO under the Protocol or not. Whether an organism is, or is not, a modified organism under the Protocol, is only dependent on the use of specific techniques defined by the Protocol as techniques of modern biotechnology (see Article 3(i)), to create a novel combination of genetic material. Furthermore, any organism into which such a novel combination of genetic material that has been obtained through the use of modern biotechnology, is subsequently transferred, even if that transfer is achieved through traditional breeding and selection techniques, will also be a LMO under the terms of the Protocol.

Box 15. Comparison of the term LMO in the CBD and in Article 3 of the Protocol

The term “LMO resulting from biotechnology” is used in Article 8(g) and 19(2) of the CBD. The term had been interpreted as covering all organisms resulting from biotechnology that are alive. During the CBD negotiations there had been seen to be two distinct categories of LMOs: the first being those modified using traditional techniques; and the second being “genetically modified” organisms, a sub-set produced using modern biotechnology, particularly recombinant techniques.72

In the negotiations on the CBD, there was a great deal of discussion as to whether to refer to “LMOs resulting from biotechnology” or to “genetically modified organisms”. The former term is much wider in that it does not require the insertion of genetic material. Because some of the concerns directed towards GMOs – such as the risk of invasiveness, the spread of introduced traits, selection for resistant organisms from bio-pesticides, and displacement of traditional methods of agriculture and traditional crops – might be, under some circumstances, equally applicable to traditionally developed or bred organisms, it was decided to use the wider term.73

However, in CBD COP decision II/5 which provided the terms of reference for the negotiation of the Protocol and, therefore in the Protocol itself, the definition has been narrowed by the reference to modern biotechnology, the term being defined in the Protocol in such a way as to exclude LMOs produced using traditional breeding methods.

In many countries, the terms “genetically modified organism”, “genetically engineered organism”, and “transgenic organism”, are widely used, including in domestic legislation, to describe LMOs covered by the Protocol.

215. The Protocol defines modern biotechnology as both the application of in vitro nucleic acid techniques, and fusion of cells beyond the taxonomic family. This includes, but is not limited to, in vitro nucleic acid techniques applied to insertion of genetic material, deletion of such material or the alteration of genetic material (see Box 16). The techniques applied must also overcome natural physiological reproductive or recombination barriers.

Box 16. Description of gene constructs used in in vitro nucleic acid techniques

Once a gene has been isolated from a donor organism, it is modified in the laboratory so that it can be inserted effectively into the intended recipient organism. The modifications include making a large number of copies of the gene to be introduced, and possibly introducing changes to the sequence of nucleotides in the isolated gene in specific ways to enhance the expression of the gene once it is introduced into the intended recipient organism.

Following this, the gene to be introduced is built into a “gene construct”. The gene construct includes a “promoter sequence” which is necessary to ensure that the gene is expressed correctly in the recipient organism. Different promoter sequences control gene expression in different ways – some allow continuous expression of the gene, while others switch expression of the gene on or off at different stages of the life-cycle of the organisms, or control the particular tissues or organs in which the gene will be expressed. “Termination” and “signalling” sequences are also incorporated into the gene construct. The termination sequence acts as a signal that flags where the end of the introduced gene is located: like the promoter sequence, the termination sequence is also important in ensuring that the introduced gene is expressed correctly. The signalling sequence provides information about the processing of the product produced from the gene construct.

A “marker gene” is often incorporated into the gene construct – this helps to make it easier to identify which individuals of a recipient organism have been modified by the introduction of the gene construct. Commonly used markers genes are those for antibiotic resistance: following introduction of the gene construct, individuals of the recipient organism are grown in the presence of antibiotics, and under these conditions, only those individuals that have been modified by the gene construct will show antibiotic resistance and therefore will be able to grow. Marker genes may be removed from the LMOs formed by this process at a later stage. Because of concerns over possible spread of antibiotic resistance traits, the use of antibiotic resistance marker genes is being phased out.

Finally, a vector may be incorporated into the gene construct. The purpose of the vector is to assist transfer the gene construct into the recipient organism. An example of a gene construct including a bacterial DNA vector (Agrobacterium plasmid), is shown below.

The following diagram gives an example of a very simple gene construct:

(Note: Gene constructs currently used may include multiple elements – for example, several promoter sequences and desired genes)

The gene construct is built from genetic material isolated from several different organisms, for example, a promoter from the Cauliflower Mosaic Virus, a bacterial DNA vector (Agrobacterium plasmid), one or more genes that may have been modified artificially in the laboratory, termination and signalling sequences, and a selectable marker gene, for example for resistance to the antibiotic kanamycin.

216. In vitro nucleic acid techniques, or cell fusion, are techniques which allow very large evolutionary barriers to be crossed, and for genes to be moved between organisms which have not been known to have genetic contact. 74 It is now possible directly to insert genetic material using laboratory techniques. A gene or genes may be copied from any (donor) organism, modified so as to look like a gene from an organism similar to the recipient organism, and inserted into the recipient. Even without crossing evolutionary barriers, these techniques allow for rearrangements of genetic material into combinations that would not occur through recombination events during normal cell and organism reproduction.

217. New techniques of modifying the genetic information within organisms are being discovered all the time. The negotiators of the Protocol recognized that it was necessary to provide a definition of “modern biotechnology” that would cover new techniques not yet envisaged at the time that the Protocol was adopted, but which may emerge in the future. Any definition, therefore, needed to be drafted so as not to exclude new technological processes not yet identified but which may give rise to novel combinations of genetic material through the use of modern biotechnology.

218. The negotiators agreed that it would not be possible to cover future developments by including detailed lists of existing techniques in the Protocol. Indeed, such lists would tend to have the effect of excluding future techniques. The definition in Article 3(i) seeks to reflect the need to cover future techniques, by using the wording “in vitro nucleic acid techniques”, giving two existing examples of such techniques, and leaving open whether new techniques will be regarded as “in vitro nucleic acid techniques” or not; and by referring to fusion of cells.

Box 17. Cell fusion

Cell fusion involves cells from two different organisms that are fused resulting in an organism containing the genetic information from both parental cells. Recombination between the two sets of genetic material becomes possible before the fused cell once again splits into two cells each containing a part of the genetic information from the fused cell. This produces hybrid cells in which a variety of things may occur, including recombination and segregation, or a chromosome doubling to allow segregation in subsequent cell divisions. Cell fusion can be applied to bacterial, fungal, plant or animal cells, using a variety of techniques to promote fusion.

219. The insertion of specific foreign DNA into a bacterial, fungal, plant or animal cell –which is one of the techniques included covered by the term “in vitro nucleic acid techniques”– is discussed in Section III of the Introduction and described in Box 18 below.

Box 18. Stages in making a new LMO using insertion of recombinant DNA

There are usually at least four stages in making a new LMO using insertion of DNA, which is currently the most commonly applied in vitro nucleic acid technique. It should be noted that other techniques of modern biotechnology, some of which also involve application of in vitro nucleic acid techniques, and others which involve cell fusion, may also be applied to produce LMOs.

Stage 1

An organism (the “donor”) with a desired characteristic (trait) is found, and a gene (or more than one) is identified that confers that trait. The characteristic may be found in micro-organisms, plants or animals. An example might be tolerance of a particular herbicide or a particular pesticidal property. These genes are abstracted from the “donor organism”.

Stage 2

Copies of the gene are made, possibly changing the sequence to take into account the preferential codon usage found in the intended recipient organism.75 Other genes including control elements that may be needed for the system to work may be added to form a package, termed a “gene construct”: the new genes including their control units may be derived from different organisms.

Stage 3

The ‘gene construct’ is usually inserted into some form of transfer system that is used to introduce the modification into the recipient organism.

There are a number of methods used to insert the genetic material, depending on the recipient. In bacteria and fungi changes are easily accomplished. The single-cell organisms are transformed76– genes are usually inserted into a plasmid that is then inserted into the cell, effecting the desired change in phenotype. This results in a change to the characteristics of the single-cell organism which is heritable and also separable from the main genetic information.

The most common method for modifying animals is micro-injection. This involves the injection of the foreign DNA into a fertilized egg, which is then inserted into a mother (in the case of mammals) and allowed to develop to term. The DNA may be incorporated into a chromosome or exist as an autonomous DNA fragment which may be replicated and passed on to offspring which may express the inserted characteristics. The first animal modified in this way was made in the early 1980s and the technique has been applied to many animals, including cattle, pigs, sheep, fish and insects.

Another method for modifying animals uses retroviruses – a widespread group of viruses – as vectors for transferring information into animal cells. Retroviruses contain information which causes part or all of their sequence to be inserted into the genome of the animal they infect; it is possible to remove genes that make these viruses virulent and introduce genes that are likely to provide the desired characteristics. Retroviruses have been isolated from a wide variety of vertebrates, including mammals, birds and reptiles and similar organisms have been found in insects. They are ribonucleic acid (RNA) molecules that are copied to form a complementary DNA molecule that is then transported to the cell nucleus and one or more copies inserted into the recipient's DNA. This integrative step is apparently an essential step in virus replication and appears to occur at random sites in the recipient DNA.

For plants two principal methods are currently used to introduce new genetic material into the cells. The first, often called biolistics is a non-biological method of insertion. It involves the direct insertion of the nucleic acid package using a ballistic method. Very small metal particles (usually gold) are coated with the nucleic acid and fired at a high velocity into plant cells. For reasons not fully understood, some of the DNA enters a tiny proportion of the cells and is incorporated into the genome. A whole plant can be regenerated from a single cell, hence some selection system is used where one of the inserted genes codes for tolerance to a particular chemical or stress. If the cells that have been subjected to the bombardment are separated and grown under these conditions, only those that have not been badly harmed and which contain the package are able to grow. Traditional methods may then be used to select from those cells (or plants) that have successfully been modified those that might be commercially (or scientifically) useful.

The second method is microbiological. It uses a bacterium, Agrobacterium tumifaciens, that infects plants by inserting a small plasmid (or circular piece of DNA) into the plant. The genes that this plasmid contains then become incorporated into the genome of the plant. Scientists have adapted the system that this bacterium has evolved, to provide a tool to insert novel genetic material, modified by in vitro nucleic acid techniques, into plants. The cells are separated, and as for biolistics, selection of those that have been successfully modified and have the right agronomic characteristics follows. There are many plants that are susceptible to infection by Agrobacterium.

Stage 4

A selection marker is often introduced into the modified organisms. Whatever technique is used to modify the organism, the number of cells that have been effectively modified may be very small. A technique which detects un-transformed cells is essential. Transformed cells may also have been irreparably harmed by the process, and even if they contain the desired characteristics, may now not be viable or have unwanted characteristics, so further selection is essential.

In the case of plants, the cells are treated and cultured under appropriate conditions (including chemical treatments) so that they grow into a complete plant. These modified plants and their offspring may be grown for several generations to ensure that they are stable and maintain the inserted characteristics over a period of time. During this stage many individual modified organisms may be excluded from further use as they display unwanted characteristics or the change introduced is not as effective as desired. Changes that work in the laboratory may also not be effective when tested in the field.

220. The definition of modern biotechnology is qualified by the requirement that the techniques applied should be techniques that overcome natural physiological reproductive or recombination barriers. Descriptions of these various barriers are provided in Box 19 below.

Box 19. Description of natural physiological reproductive and recombination barriers

A natural physiological barrier is one where the physiology of the individuals concerned would normally prevent exchange of genetic material – an example is where physiological conditions would prevent fertilization of a female gamete by a male gamete, even though those gametes could come into contact with each other through the reproductive process; another example is where fertilization occurs, but physiological factors prevent the full development of an embryo into a viable individual.

A natural reproductive barrier is one where various mechanisms, which could include, but are not limited to, physiological mechanisms, prevent exchange of genetic material. Natural reproductive barriers also include geographical separation, separation in time of the reproductive periods of individuals, or separation in the ecology of the individuals concerned.

A natural recombination barrier is one beyond which recombination would not be possible under normal conditions for an organism's genetic system. Recombination under natural conditions is associated with the ordered pairing of gene sequences, such that like genes pair with each other along the arms of chromosomes, and segments of gene sequences may be exchanged between the chromosome pair. This exchange process is called recombination. Since genes for various traits can exist in various forms (termed “alleles”), the exchange of genes during recombination results in new combinations of alleles of the genes on each chromosome.

221. The definition of modern biotechnology is also qualified by the requirement that the techniques are not techniques used in traditional breeding and selection. Traditional breeding methods are based on selecting and using those individuals – within a species, or amongst closely related species – which exhibit desired traits, as breeding stock for new varieties. Traditional breeding methods include methods that involve use of inter-specific hybrids, which may form under natural conditions. They also include methods which can be used to assist exchange of genetic material between species that would not normally come into contact and which are not normally sexually compatible. Other traditional techniques used for breeding and selection include the use of vegetative (non-sexual) reproduction through a variety of mechanisms, including the use of tissue culture.

222. The initial and most important technique used was the selection of those organisms displaying desired characteristics, their multiplication and subsequent use. A simple example would be the retention of the best produce obtained in a season for use as seed for a following season rather than its consumption. “Best”, however, will have depended upon where the product was grown. The “best” seed selected by a grower in one climatic region may not be the best for use elsewhere. Techniques that subject the organism to “stress” allow for selection of those individuals most adapted to the harsh conditions that stress implies. These stresses could include cold, heat, disease, insect depredation, competition with weeds, drought or excess water, too much or too little sunlight.

223. Cross-breeding techniques are important in assuring that a variety of desired characteristics may be incorporated into an organism used in agriculture. These techniques include crossing and subsequent backcrossing to achieve the desired set of characteristics and various forms of aided pollination or insemination. Modern breeding techniques inlude embryo rescue and haploid techniques.

224. Methods to assist exchange of genetic material between species mostly are applied with plants, especially in taxonomic groups within which interspecific hybridization occurs naturally. In some cases, mutagenic agents, such as certain chemicals or ionizing radiation, have been used to cause mutations in an organism's genetic material, following which selection and further breeding are undertaken to select those changes that are both non-lethal and which appear to provide a desired improvement in the behaviour of the organism.

225. Thus, there are now many techniques available to the plant breeder by which to seek to introduce and select for desired improvements to particular organisms. With care, it is possible to make crosses, and achieve hybrids between organisms which are less closely related, and which would not interbreed under natural conditions, by techniques which are accepted as part of traditional breeding.

226. It should be noted that selection techniques are used, following use of in vitro nucleic acid techniques, or of cell fusion techniques, to select those individuals that exhibit desired traits; and that these individuals are used for further reproduction using a variety of techniques, which may include techniques of traditional breeding. The criterion that determines whether an organism is a LMO under the terms of the Protocol is the application of an in vitro nucleic acid technique, or a cell fusion technique beyond the taxonomic family, to obtain an organism that contains a novel combination of genetic material. Any organism into which such a novel combination of genetic material is subsequently transferred, even if that transfer is achieved through traditional breeding and selection techniques, will also be a LMO under the terms of the Protocol.

227. This definition reproduces the definition of this term in Article 2 of the CBD. The European Union is so far the only “regional economic integration organization” to satisfy the definition. The transfer of competence is particularly relevant, in the context of this Protocol, to the right to vote, as described in Article 31(2) of the CBD, applicable to Protocols concluded thereunder.

228. The purpose of this definition is to indicate that, generally, the term transboundary movement in the Protocol is restricted to movements of LMOs between Parties to the Protocol – except for the purposes of two specific articles. Article 17 addresses unintentional transboundary movements of LMOs, and Article 24 addresses transboundary movements of LMOs involving non-Parties. In these Articles, transboundary movement does not have, and logically cannot have, the meaning provided in the definition in Article 3(k).

68 Dictionary of Microbiology and Molecular Biology (Second Edition) (1987, Reprinted 1989) A. Wiley Interscience Publications, Editors Diana Sainsbury and Paul Singleton, pp. 945–946.

69 Dictionary of Microbiology and Molecular Biology (Second Edition) (1987, Reprinted 1989) A. Wiley Interscience Publications, Editors Diana Sainsbury and Paul Singleton.

70 Plasmids are linear or circular molecules of DNA which can replicate autonomously and which may encode products and/or functions that modify the phenotype of the host cell. They do not form part of the chromosome of an organism, but incorporate functional units that are heritable (Dictionary of Microbiology and Molecular Biology (Second Edition) (1987, Reprinted 1989) A. Wiley Interscience Publications, Editors Diana Sainsbury and Paul Singleton, pp. 682-683). Plasmids may either be maintained by incorporation within appropriate vector organisms, such as bacteria, or they may be kept as isolated DNA in which case they are not incorporated into any organism.

71 ‘Naked DNA’ is DNA that is not attached to or in close association with other biological molecules.

72 Glowka et al, p.45.

73 Glowka et al, p.45.

74 Sidney Brenner (1978), from Wright, S. in Molecular Politics – Developing American and British Regulatory Policy for Genetic Engineering 1972–1982 (University of Chicago Press, 1994), p. 76.

75 The genetic code has many redundancies; it uses a three letter code constructed from the four units that make up the polymeric nucleic acid, hence there are 64 possible combinations. Approximately twenty of these combinations are actually needed, hence there may be many different combinations coding for the same ‘amino-acid’ that will be incorporated into a protein. It was found that different organisms use different sets of these codons preferentially.

76 Transformation is a process whereby DNA is taken up by a cell or organisms from outside and is incorporated into the genetic material of the organism.

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