Article 6. Transit and contained use

247. Article 6 provides for two limited and qualified exceptions from the general scope of applicability of the Protocol provided for in Article 4. These apply to:

248. These LMOs are within the scope of the Protocol. But Article 6 exempts them from the application of the Protocol's provisions on the advance informed agreement procedure (see commentary on Articles 7, 8, 9, 10, and 12). All other provisions of the Protocol remain applicable to such LMOs. Moreover, Article 6 recognizes the right of Parties to regulate the entry of such LMOs into their territory.

249. Article 6(1) identifies the first category of LMOs to be exempt from the application of the AIA procedure. These are LMOs that are “in transit”– i.e. LMOs that are moving or passing through or across the territory of one or more Parties to the Protocol. Thus, the Protocol's specific AIA rules do not apply to LMOs in transit. However, the Protocol does not affect the rights of a State of transit under general international law to regulate activities within its territory. In this regard, a Party (or a non-Party) through whose territory a LMO in transit is passing may regulate the transport and handling of that LMO while it is on its territory – e.g. it may impose handling and other transport safety and health precautions and regulatory measures on transiting LMOs.

250. With regard to transit of LMOs through the territorial sea or exclusive economic zone of a coastal State, Article 2(3) of the Protocol is also relevant. Article 2(3) of the Protocol recognizes the sovereignty of States over their territorial sea, their sovereign rights and jurisdiction over their exclusive economic zones, and the exercise by ships and aircraft of navigational rights and freedoms provided for under international law (see commentary on Article 2(3) and Box 11).

251. In sum, subject to international law, Parties (and non-Parties as well) can require prior notification of transit through their national law. While Article 6(1) exempts LMOs in transit from the AIA procedure, there is nothing in the Protocol which prohibits Parties from imposing such regulatory and safety rules as they deem necessary, including requiring risk assessment, and positive consent by State authorities before transit is permitted. These rights arise under general international law (and the law of the sea) and thus are also available to non-Parties to the Protocol.

252. Any decision made by a Party with respect to the transit of LMOs through its territory should be made available to the Biosafety Clearing-House established under Article 20 of the Protocol.

253. Although the AIA provisions of the Protocol do not apply to LMOs in transit, other provisions of the Protocol remain applicable. In particular it should be noted that Article 18, which provides the rules for handling, transport, packaging and identification of LMOs, applies to LMOs in transit.

254. Finally, if a LMO moves from one Party to another through a transit State, subject to the terms of Article 7 (see below), that LMO may still be subject to the AIA procedure as between the Party of export and the Party of import. Article 6(1) simply provides that the AIA procedure does not apply as between the Party of export and the transit Party.

255. During the negotiation of the Protocol, specific concerns were raised by some countries, particularly small island developing States, regarding transshipment of LMOs. Simply put this is where LMOs are moved from one ship (or mode of transport) to another whilst on the way to their final destination. There was some discussion as to whether this activity should be subject to special notification, consent or documentation requirements. It appears to be addressed now within the general provision in Article 6, i.e. the AIA procedure does not apply, but the right of a Party (or non-Party) through whose territory a LMO is being transshipped may, in accordance with its rights under general international law, regulate the handling of that LMO while it is on its territory.

256. Article 6(2) of the Protocol identifies the elements for a second category of LMOs to be exempted solely from the coverage of the AIA procedure, but not from the other provisions of the Protocol. The conditions to be fulfilled for this exception to apply are:

257. All of these must be present for the exception to be applicable. Thus, if the LMO is not destined for contained use, or if the contained use is not undertaken in accordance with the importing Party's standards relating to such contained use of LMOs, the LMO in question will continue to be subject to the AIA procedure under the Protocol.

258. A number of countries have adopted standards for contained use of LMOs. For example, in the European Union Directive 90/219/EEC (as amended by Directives 94/51/EC, 98/81/EC and Council Decision 2001/204/EC)79 lays down common measures for the contained use of genetically modified micro-organisms (GMMs) with a view to protecting human health and the environment. The Directive requires users of GMMs to carry out an assessment of the contained use as regards the risks to human health and the environment that the contained use may incur, using as a minimum the elements of assessment and the procedure set out in an annex to the Directive. This assessment “shall result in the final classification of the contained uses in four classes applying the procedure set out in Annex III, which will result in the assignment of containment levels”. These four classes refer to activities of no or negligible risk, activities of low risk, activities of moderate risk and activities of high risk. Prior to the contained use of the GMMs the user shall submit a notification, which varies according to the classification of the contained use to the competent authorities, including the information listed in Annexes to the Directive. The competent authorities will in turn “examine the conformity of the notification,…the accuracy of the information,…the correctness of the assessment,…the class of contained uses and, where appropriate, the suitability of the containment and other protective measures, the waste management, and emergency response measures”.

259. Despite Article 6(2), Parties (and non- Parties) still have the right to subject all LMOs to risk assessment and to set standards and regulations for the contained use of LMOs within their territorial jurisdiction. Serious concerns were voiced during the final negotiations regarding the potential implications of the contained use provisions of the Protocol. The AIA procedure in the Protocol is essentially triggered by the exporter (see commentary on Article 7). However, there is no specific obligation in the Protocol on the exporter or the Party of export to ensure that the final use of the LMO in the Party of import conforms to the intended use. Thus if an exporter intends to export a LMO for contained use in the Party of import, it is not required to ensure that the LMO is subsequently used only in containment nor that standards of containment in the Party of import are adequate. In cases where there is a possibility or where it is likely that a LMO initially imported for contained use may subsequently be introduced into the environment, the Party of import may be justified in requiring the application of the AIA procedure prior to the first import.

79 OJ L 117/1, 8 May 1990; OJ L 297/29, 18 November 1994; OJ L 330/13 5 December 1998; OJ L 73/32, 15 March 2001.

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