Article 4. Scope
This Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
229. Article 4 specifies the activities and organisms to which the Protocol applies: i.e. in what circumstances must a Party apply the provisions of the Protocol.
230. Articles 4, 5, and 6 of the Protocol are closely linked to each other.
Article 4 states the general rule as to the Protocol's areas of applicability;
Article 5 exempts, under certain conditions, the transboundary movement of one specific class of LMOs – i.e. LMOs “which are pharmaceuticals for humans”– from the applicability of the Protocol; and
Article 6 provides a more limited exception– it exempts LMOs “in transit” and LMOs “destined for contained use” from the application of the advance informed agreement (AIA) procedure laid down in Articles 7 to 10 and 12 of the Protocol.
231. Some of the terms used in Article 4 are specifically defined in Article 3 – so the applicability of the Protocol to specific organisms and activities also depends upon these definitions– in particular the definitions of “LMO” (including the terms “living organism” and “modern biotechnology”) and “transboundary movement”.
232. The scope of the Protocol was the subject of intense negotiations among States as early as the 1995 negotiations at CBD COP2 on the mandate to negotiate a Protocol. It was a major issue in the meetings of the BSWG and in the two sessions of ExCOP. Generally speaking, developing countries pushed for the application of the Protocol to all LMOs. Developed countries in general pushed for a more limited scope to the Protocol. Among the major issues in dispute here was the applicability of the Protocol to LMOs that are pharmaceuticals, and to the transit and contained use of LMOs. The structure and content of Articles 4, 5, and 6 of the Protocol reflects the compromises finally agreed upon during the resumed session of the ExCOP in Montreal, Canada, in January 2000.
233. The concept of scope in Article 4 has two elements:
(1) the activities to which it is applicable; and
(2) the subject matter to which it is applicable, i.e. to which organisms it applies.
234. The Protocol is made applicable to the following activities:
transboundary movement– this term is defined in Article 3(k) as follows. “the movement of a LMO from one Party to another Party, save that for the purposes of Articles 17 and 24 transboundary movement extends to movement between Parties and non-Parties”. This appears to exclude from the scope of the Protocol any movement of a LMO from the territory of one Party into an area beyond national jurisdiction, e.g. the high seas. The Protocol addresses both intentional and unintentional transboundary movement of LMOs although, as will be seen, most of its operative provisions are concerned with intentional transboundary movements. Unintentional transboundary movements are specifically addressed in Article 17.
transit– the Protocol does not contain a definition of “transit”. However, the ordinary meaning of “transit” within the context of the Protocol and in the light of the Protocol's objective and purpose is the passage of a LMO across or through the territory of one or more States.77
handling and use– the Protocol also does not contain any definition of the terms “handling” or “use”. The ordinary meaning of “handling” would appear to refer to the manual or mechanical process or method by which LMOs are moved, carried, transported, delivered, or worked with. The term “use” is also not defined, although Article 3(b) provides a definition of “contained use”. Seen in its ordinary meaning and within the context of the definition of “contained use” in the Protocol and in the light of the Protocol's objective and purpose, the term “use” would appear to refer to any operation involving LMOs.
235. As to subject matter, the Protocol applies to “all living modified organisms”. The term “living modified organism” is expressly defined in the Protocol as containing three essential elements (see commentary on Article 3(g)–(i)):
(1) it must be a “living organism”;
(2) it must possess a “novel combination of genetic material”; and
(3) such genetic material must have been “obtained through the use of modern biotechnology”.
236. For the implications on the scope of the Protocol of the phrase “that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health”, see commentary on Article 1.
77 The terms used in a treaty, in the absence of a 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”. Article 31(1) in relation to Article 31(4), 1969 Vienna Convention on the Law of Treaties. For similar definitions or expressions of “transit” in other treaties, see e.g. Article 124(1)(c) of the 1982 UN Convention on the Law of the Sea, defining “traffic in transit”; and Article 2(12) of the 1989 Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal, defining “State of transit”.
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