At the international level, the Cartagena Protocol for Biosafety (Bail et al., 2002, hereafter referred to as the Protocol) came into force on September 11, 2003, 90 days after the fiftieth instrument of ratification had been deposited by signatory countries to the Convention on Biological Diversity (CBD). The Protocol is the most important single international treaty, and will play a dominant role in shaping the future of transgenic technology in the world. It is the first legally binding international regulatory framework for the transboundary movement of living modified organisms (LMOs). The need to have an international regulatory framework for GM organisms was discussed by countries during the drafting of the CBD, which was adopted at the 1992 Earth Summit in Rio de Janeiro. At that time, the first GM crops were coming to the market in the USA, and their use would increase exponentially during the following years. In the final document, the CBD did not specifically address biosafety, but Article 19 called for the signatories to consider the ‘need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the areas of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity’.The international community will need time to gain experience as to how the various instruments and mechanisms of the Protocol can operate effectively to ensure the safe transfer of LMOs from country to country, taking into account biodiversity considerations. In carefully worded language, the Protocol obviates antagonism with national regulatory frameworks, by explicitly giving precedence to national standards regarding the safety assessment of LMOs, and in this sense does not lay any claims to standard setting. Parties are sovereign under the Protocol to have their own national standards. What the Protocol brings forth is a set of ideals or socio-ethical endpoints that parties should consider in deciding about LMOs and their applications, particularly concerning a precautionary approach, sustainable development and the conservation of biological diversity.
One of the Protocol's goals is to serve as a minimal baseline regulatory framework for countries that do not yet have domestic frameworks. The Protocol distinguishes three types of LMO applications: for food, feed or processing (LMO-FFP); for either contained use or for intentional introduction into the environment. For LMO-FFP and contained use with LMOs (Article 18), parties are obliged, under the Protocol, to inform the other parties of their decision regarding transboundary movement, but domestic standards and regulations prevail for the approval process. On the other hand, LMOs intended for introduction into the environment, for example, as seeds, are subject to the advance informed agreement (AIA) procedure of the Protocol, applicable to the first transboundary movement. As such, the Protocol is both product and process based. According to the AIA, the party of export must notify the competent authority of the country of import, prior to the first transboundary movement of the LMO. The exporter is required to supply the party of import with all necessary information regarding the LMO, including a risk-assessment report and the regulatory status of the particular organism in the exporting country. Within 270 days after the receipt of notification, the party of import communicates, in writing, to the exporter and to the Biosafety Clearing House (BCH) on the decision it has taken. The AIA procedure is meant to prevent an uncontrolled dissemination of LMOs, for example, in developing countries that do not yet have the appropriate biosafety framework for regulating these products.
An ambiguous case for the regulation of LMO-FFPs would be the import of grains as food by farmers in developing countries that do not have domestic regulatory frameworks, particularly when the grains could also be used as seed material. The solution put forth in the Montreal negotiations of the Cartagena Protocol was to make reference to the precautionary approach and to require precise wording ‘not intended to be used in the environment’ on the accompanying documentation (Article 18.2a). If a domestic framework does not exist, developing countries or countries with economies in transition can indicate that the final decision will be taken according to a risk assessment undertaken in accordance with the provisions of the Protocol and within a predictable time frame.
There is also an information-sharing aspect included in the AIA procedure, since the party of import is required to communicate with other parties through the BCH. In addition, the party of import may also request the opinions of independent biosafety experts or seek out further sources of information. The BCH is, therefore, the main information-sharing mechanism of the Protocol and is meant to assist parties in its implementation. It is an Internet-based platform for the exchange of scientific, technical, environmental and legal information about LMOs at national, regional and international levels. Information available in the BCH includes contact information for national competent authorities, rosters of biosafety experts, and risk-assessment reports, as well as national decisions regarding the import of LMOs (www.biodiv.org).
The Cartagena Protocol is a de facto trade agreement, since its scope includes export and import activities. The Protocol could be positive for trade: trade rules would be clearer with AIA; trade could be fairer; scientific risk assessment would be used systematically for decision making and a basic, operative regulatory framework for LMOs would be available for countries without domestic regulations. Seed companies would benefit from a system with mutual acceptance of safety evaluations and science-based risk assessments (de Greef, 2000). The Protocol is a decentralised approach that recognises national standards and allows them to be more restrictive. At the same time, and as the Preamble states, the Protocol is not subordinate to other international agreements and its implementation should work in accordance with them.
One of the Protocol's goals is to serve as a minimal baseline regulatory framework for countries that do not yet have domestic frameworks. The Protocol distinguishes three types of LMO applications: for food, feed or processing (LMO-FFP); for either contained use or for intentional introduction into the environment. For LMO-FFP and contained use with LMOs (Article 18), parties are obliged, under the Protocol, to inform the other parties of their decision regarding transboundary movement, but domestic standards and regulations prevail for the approval process. On the other hand, LMOs intended for introduction into the environment, for example, as seeds, are subject to the advance informed agreement (AIA) procedure of the Protocol, applicable to the first transboundary movement. As such, the Protocol is both product and process based. According to the AIA, the party of export must notify the competent authority of the country of import, prior to the first transboundary movement of the LMO. The exporter is required to supply the party of import with all necessary information regarding the LMO, including a risk-assessment report and the regulatory status of the particular organism in the exporting country. Within 270 days after the receipt of notification, the party of import communicates, in writing, to the exporter and to the Biosafety Clearing House (BCH) on the decision it has taken. The AIA procedure is meant to prevent an uncontrolled dissemination of LMOs, for example, in developing countries that do not yet have the appropriate biosafety framework for regulating these products.
An ambiguous case for the regulation of LMO-FFPs would be the import of grains as food by farmers in developing countries that do not have domestic regulatory frameworks, particularly when the grains could also be used as seed material. The solution put forth in the Montreal negotiations of the Cartagena Protocol was to make reference to the precautionary approach and to require precise wording ‘not intended to be used in the environment’ on the accompanying documentation (Article 18.2a). If a domestic framework does not exist, developing countries or countries with economies in transition can indicate that the final decision will be taken according to a risk assessment undertaken in accordance with the provisions of the Protocol and within a predictable time frame.
There is also an information-sharing aspect included in the AIA procedure, since the party of import is required to communicate with other parties through the BCH. In addition, the party of import may also request the opinions of independent biosafety experts or seek out further sources of information. The BCH is, therefore, the main information-sharing mechanism of the Protocol and is meant to assist parties in its implementation. It is an Internet-based platform for the exchange of scientific, technical, environmental and legal information about LMOs at national, regional and international levels. Information available in the BCH includes contact information for national competent authorities, rosters of biosafety experts, and risk-assessment reports, as well as national decisions regarding the import of LMOs (www.biodiv.org).
The Cartagena Protocol is a de facto trade agreement, since its scope includes export and import activities. The Protocol could be positive for trade: trade rules would be clearer with AIA; trade could be fairer; scientific risk assessment would be used systematically for decision making and a basic, operative regulatory framework for LMOs would be available for countries without domestic regulations. Seed companies would benefit from a system with mutual acceptance of safety evaluations and science-based risk assessments (de Greef, 2000). The Protocol is a decentralised approach that recognises national standards and allows them to be more restrictive. At the same time, and as the Preamble states, the Protocol is not subordinate to other international agreements and its implementation should work in accordance with them.
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