Article 18. Handling, transport, packaging and identification

502. Article 18 addresses the handling, transport, packaging an identification of LMOs. It has two main functions:

503. Article 18 has three elements:

504. The ICCP has set in motion a process for further consideration of Article 18, including meetings of technical experts on this issue. One key issue for further consideration in relation to the implementation of Article 18 is to what extent existing relevant national and/ or international rules might be used and adapted to address more comprehensively the handling, packaging, transport and identification of LMOs, and to what extent new specialized rules for LMOs will need to be developed and applied.

505. Article 18(1) imposes a general obligation on each Party to the Protocol to require safe handling, packaging and transport of LMOs subject to transboundary movement. This obligation extends to all LMOs subject to intentional transboundary movement that are within the scope of the Protocol in accordance with Article 4 – i.e. it includes LMOs in transit, LMOs destined for contained use in the Party of import, and LMO-FFPs. (But not the transboundary movement of LMOs which are pharmaceuticals for humans that are addressed by other international agreements or organizations (Article 5)).

506. This provision is linked to more general obligations upon Parties to the Protocol and to the CBD to regulate, manage and control risks associated with LMOs (Article 8(g) CBD; and Article 16 of the Protocol). A number of countries have in place rules and standards that are relevant to ensuring safe handling, packaging and transport of LMOs.97

507. “Relevant international rules and standards” could be those covering handling, packaging and transport of LMOs and might extend to general international rules and standards governing health, safety and the environment or international trade. At present, specific LMOs may be covered by relevant international rules and standards on the basis of their characteristics rather than because they are LMOs as such. These may include, for example, relevant rules and standards promulgated under the International Plant Protection Convention, by the World Health Organization, or in the UN Recommendations on the Transport of Dangerous Goods. Relevant rules and standards may also be developed in the future by the Parties in accordance with Article 18(3).

Box 33. The United Nations Recommendations on the Transport of Dangerous Goods (the “Orange Book”)

One of the principal collections of relevant international rules and standards in relation to handling, packaging and transport of dangerous goods is the “Orange Book”, formally known as the United Nations Recommendations on the Transport of Dangerous Goods. The Orange Book contains a list of dangerous goods most commonly carried (including some LMOs) and their identification and classification; consignment procedures (labelling, marking and transport documents); standards for packing, test procedures and certification; and standards for multi-modal tank-containers, test procedures and certification.

The Recommendations adopt a system that categorizes goods by the types of risk associated with their transportation. There are nine different classes, including division 6.2 (“Infectious Substances”) and division 9 (“Miscellaneous Dangerous Substances and Articles”).

Infectious substances are defined as substances known or reasonably expected to contain pathogens, which are defined as micro-organisms or recombinant micro-organisms that are known or reasonably expected to cause infectious diseases in humans or animals. “Miscellaneous dangerous substances and articles” cover substances and articles not covered under the other divisions. Genetically modified micro-organisms that are not dangerous for animals or humans, but which could modify animals, plants, microbiological substances and ecosystems in a way that does not occur naturally, are included in this division. It also comprises genetically modified organisms that are known or suspected to be dangerous to the environment, and which shall be carried in accordance with conditions specified by the competent authority of the country of origin.

A review of division 6.2 provisions and Model Regulations on “Infectious Substances” is underway.

The outcome of the meetings of the ICCP has been brought to the attention of the Sub-Committee of Experts on the Transport of Dangerous Goods. Cooperation was established between the Sub-Committee and the ICCP on matters concerning handling, packaging, transport and identification. Amendment of the provisions of the relevant Model Regulations may be possible to accommodate the transport regulatory needs of the Protocol on the basis of proposals from the Protocol process.

Sources: ST/SG/AC.10/11/Rev.3; UNEP/CBD/ICCP/1/6; UNEP/CBD/ICCP/2/12; UNEP/CBD/ICCP/3/7

(a)     Living modified organisms that are intended for direct use as food or feed, or for processing, clearly identifies that they “may contain” living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall take a decision on the detailed requirements for this purpose, including specification of their identity and any unique identification, no later than two years after the date of entry into force of this Protocol;

(b)     Living modified organisms that are destined for contained use clearly identifies them as living modified organisms; and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the living modified organisms are consigned; and

(c)     Living modified organisms that are intended for intentional introduction into the environment of the Party of import and any other living modified organisms within the scope of the Protocol, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter.

508. Article 18(2) requires Parties to take measures to ensure that LMOs subject to intentional transboundary movement are accompanied by documentation identifying the LMOs and providing contact details for individuals and institutions responsible for the movement of the LMOs.

509. The Protocol recognizes the need for the specific identification of shipments of LMOs. The documentation requirements in Article 18(2) are a means of identifying and tracking the transboundary movement of LMOs. They will be a key element in ensuring that Parties of import know when they are receiving a transboundary movement of LMOs, whether for import or in transit. In addition, in the event of accidental releases during transport, documentation can provide information that might assist efforts to reduce risk of damage. All shipments of LMOs within the scope of the Protocol must be accompanied by details of a contact point from which further information about the shipment can be sought.

510. In the initial stages of negotiation of the Protocol, documentation requirements for all LMOs were dealt with as one issue. However, under the agreed text of Article 18(2), the documentation requirements vary according to the nature of the LMO concerned and its intended use in the Party of import. These distinctions were part of the compromise agreed upon by countries in order to bring LMO-FFPs within the scope of the Protocol.

511. Article 18(2) does not specify the language of documentation accompanying LMOs. If Article 18 is to ensure safe movement of LMOs and the provision of information to those handling and importing LMOs, this issue needs to be considered by the Parties.

LMO-FFPs

512. Article 18(2)(a) addresses the documentation requirements for LMO-FFPs. These were an extremely controversial issue in the final stages of the negotiations of the Protocol, and this provision was the final element to be agreed upon before the Protocol was adopted. Some countries in the negotiations were concerned that imposing clear identification requirements for transboundary movements of LMO-FFPs would indirectly impose costly segregation or identity preservation obligations, for example requiring genetically modified and non-genetically modified crops and grains to be segregated at all stages of the production process and during shipment, and measures to be taken to avoid any accidental trace contamination by LMOs of non-modified grain shipments.

Box 34. Unique identification of LMOs

Work is underway to develop an international system of unique identifiers that would apply to each individual genetic modification. The unique identifier system is similar in concept, for example, to the ISBN system for book publishing. The unique identifier would take the form of a code that would then provide a link to a database which would include full information about the specific modification to which the unique identifier referred. Further information on progress on development of a unique identifier system for the Protocol can be found through the Biosafety Clearing-House website. The system for unique identifiers, when it is developed and implemented, will assist the identification and monitoring of LMO-FFPs that have been approved by one or more national authorities, and will also assist the flow of information between Parties and their competent authorities, and with the public.

The OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology has developed and adopted “Guidance for the designation of a unique identifier for transgenic plants”.98 The purpose of this unique identifier is to be used as a “key” to access information in the OECD product database and interoperable systems (for example, the Biosafety Clearing-House) for modern biotechnology products approved for commercial application. The Guidance was adopted at a meeting of the OECD Working Group in January 2002. The agreed alphanumeric code for a unique identifier is composed of three elements using a maximum of nine digits to designate the applicant and the transformation event (rather than other options such as a new variety), and contains a final single digit for verification. The OECD's Business and Industry Advisory Committee (BIAC) played a role in the discussions of the unique identifier through their Expert Group on Biotechnology. According to the guidance, it is the developers of transgenic products who will generate the unique identifier.

The OECD Guidance was presented at ICCP 3, which took note of the adoption of the Guidance and recommended that “OECD product database establish interoperability with the pilot phase of the Biosafety Clearing-House, incorporating the use of the OECD unique identifiers for transgenic plants, as appropriate and as they become available, and to further elaborate on its applicability for the Protocol and to report on this to the first meeting of the [COP/MOP]”.99

513. Article 18(2)(a) avoids this issue, temporarily at least, by providing that transboundary movements of LMO-FFPs must be accompanied by documentation identifying that they “may contain” LMOs. A contact point for further information must also be specified. The documentation must also specify that the LMO-FFPs are not intended for intentional introduction into the environment. More detailed requirements for identification of LMO-FFPs are to be decided by the COP/MOP within two years of the Protocol entering into force. This will include consideration of specification of the identity of LMO-FFPs and a system of unique identification. In practice, because of the potential timing and frequency of meetings of the COP/MOP (see commentary on Article 29), a decision under Article 18(2)(a) will likely need to be taken at the first or second meeting of the COP/MOP after the Protocol enters into force.

LMOs that are destined for contained use

514. Article 18(2)(b) sets out the basic requirements for documentation accompanying LMOs destined for contained use (see commentary on Article 3(b)). This must include:

515. Some countries already address elements of Article 18(2)(b) in their national regulations on contained use of LMOs.100

LMOs destined for intentional introduction into the environment

516. Article 18(2)(c) sets out the detailed information to be provided in documentation accompanying transboundary movements of LMOs intended for intentional introduction into the environment of the Party of import, as well as other LMOs within the scope of the Protocol. This must include:

517. The phrase “any other LMOs within the scope of the Protocol” would appear to exclude LMO-FFPs and LMOs destined for contained use, which are addressed separately in Article 18(2)(a) and (b)). However, it would appear to cover LMOs in transit, which, though excluded from the AIA procedure (Article 6(1)) are within the Protocol's scope. This phrase would also include any LMOs that may in the future be excluded from the scope of application of AIA by the COP/MOP (see commentary on Article7(4)).

The ICCP and Article 18

518. A significant amount of work on the elaboration of Article 18 was initiated by the ICCP for consideration by the COP/MOP. The ICCP mandated two meetings of experts to consider the needs and modalities for developing measures for Parties to meet their future obligations under Article 18(2)(b) and (c). It also mandated an additional meeting of technical experts to consider Article 18(2)(a).

519. Article 18(2)(a) (LMO-FFPs) ICCP 3 considered the report and detailed recommendations of the technical expert group meeting on Article 18(2)(a), but was unable to make further significant progress towards consensus.Recommendation 3/6 of the ICCP101 submitted the report and recommendations of the meeting of technical experts on Article 18(2)(a) to the first meeting of the COP/MOP, and invited Parties and other States to closely consider the issues and facilitate their resolution with a view to ensure the timely implementation of the requirements in the first sentence of Article 18(2)(a).

520. Article 18(2)(b) (LMOs destined for contained use) and Article 18(2)(c) (LMOs destined for intentional introduction into the environment) ICCP recommendation 3/6 sets out the information to be provided to meet the requirements of Article 18(2)(b) and (c). It also urged Parties and governments to take measures to include these information requirements into existing documentation practices accompanying LMOs supplied by the originator of the shipment (e.g. commercial invoices); and encouraged Parties to consider whether the provision of additional information especially the intended use of the LMOs (e.g. commercial or research), would facilitate implementation of Article 18(2)(b) and (c).Model templates for the inclusion of such information were developed by the technical experts meeting. These are annexed to recommendation 3/6 for further consideration by the COP/MOP.

521. Article 18(3) requires the COP/MOP to consider whether it is necessary to develop specific standards for handling, packaging, transport and identification of LMOs. Article 18(3) is not limited to LMOs subject to transboundary movement. The ICCP has initiated preparatory consideration of this issue.

522. As discussed above, there are a number of existing rules and standards that would cover aspects of handling, packaging, transport and identification of LMOs and several international organizations are in the process of developing more relevant rules and standards such as the Codex Alimentarius Commission, the OECD, the Interim Commission on Phytosanitary Measures (under the International Plant Protection Convention) and the United Nations Economic Commission for Europe.

523. It is not clear to what extent existing or draft rules and standards cover all aspects of handling, packaging, transport and identification of LMOs under the Protocol. The Parties will need to examine the existing and draft rules and standards to determine whether they are sufficient for the purposes of the Protocol. If the Parties consider it necessary to develop specific standards for the Protocol, existing and draft rules and standards might provide useful models.


97 See for example, the synthesis prepared by the CBD Secretariat for the first Meeting of Technical Experts on Handling, Transport, Packaging and Identification of living modified organisms, based on information submitted by governments and organizations, in UNEP/CBD/BS/TE-HTPI/1/2, available at http://www.biodiv.org

98 ENV/MONO(2002)7 reproduced in UNEP/CBD/ICCP/3/INF/12.

99 ICCP Recommendation 3/3, paragraph 2, UNEP/CBD/ICCP/3/10, 27 May 2002, Annex.

100 See for example, the synthesis prepared by the CBD Secretariat for the first Meeting of Technical Experts on Handling, Transport, Packaging and Identification of living modified organisms, based on information submitted by governments and organizations, in UNEP/CBD/BS/TE-HTPI/1/2, available at http://www.biodiv.org

101 ICCP Recommendation 3/6, UNEP/CBD/ICCP/3/10.

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