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Cartagena Protocol on Biosafety

Implementation of the Documentation Requirements of Paragraphs 2(b) and 2(c) of the Cartagena Protocol.

Note: This document was prepared by the Global Industry Coalition (GIC) with the active participation of ISF members and the Secretariat.

Each company is solely responsible for it being compliant with the requirements.

Guidance Language

On 11 September 2003, the Cartagena Protocol on Biosafety (the “Protocol”) entered into force - the first legally binding international agreement governing the movement of living modified organisms (LMOs) across national borders. Following entry into force, those countries that ratified the Protocol became Parties to the Protocol and are required to comply with and implement all of its provisions. In addition, Article 24 of the Protocol states that transboundary movements of LMOs between Parties and non-Parties shall be consistent with the objectives of the Protocol. As such, entities in countries that have not ratified the Protocol but that export LMOs to Parties are encouraged to comply with the Protocol’s provisions implemented in the importing country. Thus, entry into force ultimately impacts both Party and non-Party countries that export LMOs to countries that are Parties to the Protocol that have national implementing legislation1.

Although the Protocol officially entered into force in September 2003, a decision on the documentation requirements for Article 18.2(b) and (c) indicating specific implementation and compliance requirements was not finalized. Therefore, at the time of entry into force of the Protocol, the users and developers of biotechnology suggested guidelines that were based on the recommendations made at the third meeting of the Intergovernmental Committee for the Cartagena Protocol2 for entities shipping LMOs (including research material) from or to Parties in order to meet the requirements outlined in the Protocol. These documentation recommendations were discussed again at the Conference of the Parties serving as the first meeting of the Parties to the Protocol, and the Global Industry Coalition revised its guidelines to reflect the Parties’ decision at this meeting regarding the documentation requirements for Article 18.2(b) and (c)3. These guidelines are as follows:

1. Determine whether there is necessary clearance for the shipment of the LMO.

• With respect to LMO seeds, if the LMO is for cultivation (deliberate release into the environment) either as a commercial product or as research and development material, an Advanced Informed Agreement (AIA) prior to the first shipment may be required. The technology developer will typically perform this procedure and the importing country should post its decisions on the Biosafety Clearing House (BCH). Since the BCH is still under development, complete information may not be available on the website4. To date, countries that have completed risk assessments and approved local production of an LMO consider that approval equivalent to an AIA, but may or may not have posted this decision on the BCH. In the absence of information about a particular LMO on the BCH, licensees of a commercial or research and development transgenic plant trait may need to clarify with the technology provider and/or importing authority that a risk assessment and clearance to ship to a country has been previously approved. In the future, this clearance and risk assessment information should be available on the Biosafety Clearing-House.
• For contained use under Article 18.2(b)5, an AIA is not required by the Protocol, but existing national regulations may require an approval or permit number for shipping or experimental use.

2. Ensure the appropriate information is included on the shipping documentation specific to a shipment of LMOs for contained use or for intentional introduction into the environment.

In order to meet the documentation requirements of the Protocol, users and developers of biotechnology suggest that the private sector include the following information on existing shipping documentation for shipments of LMOs for contained use (Article 18.2(b)) and LMOs for intentional release into the environment (Article 18.2(c)):

• LMOs destined for contained use (Article 18.2(b)):
  In order to meet the documentation requirements of Article 18.2(b) of the Protocol, the private sector suggests that the following information be included on existing shipping documentation (such as pro forma invoices);
  • (i) The following statement outlining the shipment contents:
    “This shipment contains living modified organisms for contained use” (may specify common and scientific name of the organism here, such as “Bacillus subtilis containing the a-amylase gene from B. stearothermophilus”);
  • (ii) The name and address of the exporter, importer or consignee, as appropriate, including contact details necessary to reach them as fast as possible in case of emergency; and
  • (iii) A brief description of any requirements for the safe handling, storage, transport and use of the LMO. Note that safe handling requirements may be covered under other international agreements (such as the International Plant Protection Convention or the UN Model Regulations on the Transport of Dangerous Goods) and are not specific to the LMO status of the shipment. In the event that there is no requirement, indicate that there is no specific requirement.
• b. LMOs for intentional introduction into the environment (Article 18.2(c)):
  In order to meet the documentation requirements of Article 18.2(c) of the Protocol, the private sector suggests that the following information be included on existing shipping documentation (such as commercial invoices):
• (i) The following statement outlining the shipment contents:
  “This shipment contains living modified organisms”;
• (ii) A brief description of the LMO, including category, common and scientific name, relevant traits and/or characteristics, and a reference to a system of unique identification, where available;
• (iii) A brief description of any requirements for the safe handling, storage, transport and use of the LMO as provided under applicable existing international requirements (such as the requirements under the OECD Seed Schemes) under domestic regulatory frameworks, under the advanced informed agreement procedure, or under any agreement by the importer and exporter. In the event that there is no requirement, indicate that there is no specific requirement;
• (iv) The name and address of the exporter and importer, including contact details necessary to reach them as fast as possible in case of emergency (designate which is to be used as the contact point for further information); and
• (v) The following declaration:
  “The exporter declares that the transboundary movement of this LMO is in conformity with the requirements of the Cartagena Protocol on Biosafety applicable to the exporter.” Examples are provided in Annexes I and II that demonstrate how the language required by Paragraphs 2(b) and 2(c) of Article 18 can be included on existing documentation in a clear and transparent manner. Note that the language suggested here is in addition to existing national regulations or requirements and the language may already be a part of existing shipping documentation.

Experience to Date

In preparation for the Workshop on capacity-building and exchange of experiences as related to the implementation of paragraph 2 of Article 18 of the Biosafety Protocol that was held in November 2004, the Global Industry Coalition surveyed its members to determine their experiences with shipments under Article 18.2(b) and (c).

With respect to Article 18.2(b), the informal survey showed that such shipments comprise the entire range of organisms and microorganisms, including viruses, bacteria, fungi, parasites, insects and plants. The majority of shipments are for research and development purposes, mainly for the testing and treatment of disease. In any event, shipments of products under Article 18.2(b) classified as dangerous goods are already regulated appropriately by the UN Model Regulations on the Transport of Dangerous Goods, even in the absence of any Protocol-specific documentation requirements.

The majority of shipments that fall under Article 18.2(c) are for commercial purposes, crop or seed production. In these cases, the LMO has completed approval in the importing country for commercial use. A smaller number are for research and development purposes, and are planted to assess the suitability of the crop variety for local use or to develop data in order to complete regulatory requirements for commercialization. Requirements for safe handling for the LMO research material are typically specified in national regulations. The survey showed that the guidance language provided by the Global Industry Coalition and based on the decision by the Parties was working satisfactorily in identifying shipments of LMOs under Article 18.2(b) and (c), in conjunction with other country-specific information. In order for such shipments to continue to move across boundaries in a practical and problem-free manner, it is suggested that countries continue to recognize this simple, step-wise process for Article 18 documentation requirements added to existing shipping documentation.

The Global Industry Coalition (GIC) represents over 2,200 firms from more than 130 countries worldwide. Its membership includes companies from a variety of industrial sectors including plant and animal agriculture, food production, human and animal health care, and the environment.

1. Many countries, whether Parties or non-Parties, have existing national regulatory requirements for shipping LMOs with which exporters must currently comply.
2. See UNEP/CBD/ICCP/3/10.
3. See UNEP/CBD/BS/COP-MOP/1/15.
4. Note that there have been no AIA decisions posted on the BCH to date.
5. Article 3 of the Protocol defines “contained use” as meaning “any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment.”