III. Key Elements of the Biosafety Protocol

The stated objective of the Protocol is to “contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account human health.” See Article 1. The Protocol applies to the “transboundary movement, transit, handling and use of all LMOs that may have an adverse effect on biodiversity, taking also into account human health” except for LMOs that are pharmaceuticals for humans. See Articles 4, 5. In practice, the Protocol is likely to focus almost exclusively on transboundary movements even though the stated scope is broader. The foregoing objective and scope are based on definitions that ensure that the Protocol addresses only living organisms (not non-viable “products thereof”) and only those living organisms that have been modified through modern biotechnology, as opposed to traditional breeding methods. See Article 3.

B. Application of the AIA Procedure

The primary mechanism of the Protocol is its Advanced Informed Agreement (“AIA”) procedure. This mechanism requires entities that desire to export LMOs for deliberate release in the environment of another country to get that country’s informed written consent prior to shipment. The mechanism only applies, however, to the first movement of an LMO for intentional introduction into the environment of the party of import. Thus, the importation of LMOs destined for contained use or merely in transit through a country are not subject to the AIA requirement. See Article 6. LMOs also may be exempted from the AIA requirement through explicit action by countries of import or through bilateral or multilateral agreements or by agreement among all of the Parties to the Protocol. See Articles 13, 14, and 7(4).

C. Procedure for Commodities

The AIA procedure explicitly states that LMOs destined for direct use as food, feed or for processing (e.g., commodity grains), are not considered as an intentional introduction into the environment. Therefore such LMOs (known as “LMO-FFPs”) are not subject to the AIA. They are, however, subject to a different procedure. See Article 7(2)-(3). Under this special procedure, a country that approves an LMO that may be subject to transboundary movement as an LMO-FFP, must inform the Biosafety Clearing House (“BCH” - a database run by the Protocol Secretariat) within 30 days of the final decision. Countries also must supply to the BCH summary risk assessment information, etc. Other countries may then take decisions, based on the information in the BCH, on whether to approve that LMO-FFP for future import. Countries can make such decisions under their domestic regulations or in accordance with Protocol procedures. They then may inform the BCH of their decisions, thus allowing or prohibiting shipments of LMO-FFPs to enter their counties. See Article 11. The idea behind the LMO-FFP mechanism is to permit early warning of LMOs entering the commodity stream and to permit countries to take decisions based on that early warning instead of requiring shipment-by-shipment approvals. Whether and how the system functions as envisaged is yet to be seen. It is important to note, for example, that the failure of a country to respond to the posting of information on the BCH or to take a decision shall not be considered consent for importation. See Article 11(7).

D. Identification of LMOs

The Protocol also sets forth specific identification and other requirements for the shipment of LMOs subject to the Protocol. It should be noted, in this regard, that while transit and contained use shipments are excluded from the AIA requirements, they are subject to the identification requirements as follows:

For LMOs imported for the first international introduction into the environment, accompanying documentation must:

1. clearly indicate they are LMOs;
2. Specify the identify and relevant traits and characteristics;
3. Specify any requirements for safe handling, storage, etc.; and
4. Include contact information and a declaration of conformity with Protocol requirements.

For LMOs destined for contained use, accompanying documentation must:

5. Clearly indicate they are LMOs;
6. Specify any requirements for safe handling, storage, etc.; and
7. Include contact information and name/address of consignee.

For LMOs that are imported for direct use as food, feed or for processing, accompanying documentation must:

8. Clearly identify that the shipment “may contain” LMOs and are not intended for introduction into the environment; and
9. A contact point for further information.  

• Introduction
• Process for Implementation of the Biosafety Protocol

Related topics:

• GM Crops and the Environment

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