The development of institutional and legal frameworks for managing certain aspects of GMOs and biosafety at the national, regional and international levels is a critical part of the overall process of addressing biosafety concerns. For purposes of this already lengthy paper, however, a detailed accounting of the provisions of the relevant instruments would not be a useful addition. The following is a very brief summary of the relevant international instruments and institutions, followed by some critical questions that must be addressed both nationally and internationally, if the international framework is to be successfully implemented.
Readers who are interested in more detail concerning the international instruments relating to biosafety are encouraged to obtain copies of the newly published Explanatory Guide to the Cartagena Protocol, (F. Burhenne-Guilmin and R. Mackenzie, editors) IUCN Environmental Policy and Law Paper No. 46 (2003).
Although many international agreements and institutional mandates are very relevant to the topic of biosafety, the Cartagena Protocol on Biosafety, a protocol under the Convention on Biological Diversity, is pre-eminent, both because it addresses several key GMO issues specifically, and because it is the product of the most comprehensive global debate so far relating to GMO concerns. For this reason this section will begin with an examination of the Cartagena Protocol, before turning to a brief summary of other important international forums and instruments that are relevant to the GMO issue.57
1. The Cartagena Protocol on Biosafety 2000
From the date of adoption of the Convention on Biological Diversity (CBD) in 1992, the apparent need for a protocol on biosafety was recognised internationally. This is reflected in the fact that Article 19(3) of the CBD specifically mandated the Parties to consider the need for a Protocol on biosafety. After eight more years of negotiations, that protocol was adopted in January 2000.
The Protocol focuses only on specific elements of the GMO issue, namely, all critical aspects of the transboundary movement, transit, handling and use of Living Modified Organisms (LMOs)58 that may have an adverse effect on the conservation and sustainable use of biological diversity, taking also into account the risks to human health. Other key issues remain open, including liability for GMO-engendered damage or injury to people, animals, and ecosystems.
Although not a primary topic of discussion, one of the Protocol’s most important provisions is found in indirect references in Articles 9, 14, and 26, which note that the Parties should each have a “domestic [biosafety] regulatory framework” to serve as a basis for the national implementation of the Protocol. It is clear from the text of the Protocol that this framework, which must be “consistent with the Protocol”59 will encompass more than the implementation of the Protocol – that it will embody and implement the broader national policy and practice regarding GMOs and biosafety within national jurisdiction.
Within its mandate, the Protocol generally requires its Parties to regulate all introductions of LMOs, subject to a limited number of exceptions. LMOs that are “pharmaceuticals for humans” are excluded from the Protocol’s scope, to the extent that they are addressed by other international organisations or agreements. Other more specific exclusions apply as well, including most notably “LMOs intended for direct use as food or feed, or for processing,” which are excluded from certain aspects of the AIA mechanism, discussed below. And other LMOs may be excluded from the scope in future, if agreed by the Meeting of the Parties to the Protocol (MOP), if they are “unlikely to have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health.”
The Protocol’s centrepiece is the establishment of an Advance Informed Agreement procedure (AIA), for the transboundary movement of GMOs intended for introduction into the environment. This requires the exporter to notify the Party of import of its intention and also to provide information (detailed in the Protocol) permitting the Party of import to accept or refuse the import, or impose certain conditions to it, based on a risk assessment. Connected to the AIA, the Protocol creates a Biosafety Clearing House (BCH), which is designed to address capacity problems of developing countries, as well as to serve as a registry for critical information. The BCH has a specific role in the implementation of the Protocol in addition to one of facilitating the exchange of information on GMOs. It also contains provisions on capacity-building, financial resources and provides for institutional arrangements within the framework of the CBD.
As noted above, the Protocol is one of the most significant advances in the promotion of Precaution, incorporating the “precautionary principle” into operative provisions of the Protocol. In addition, it provides relatively lenient, but firmly required provisions for labelling LMOs in transit. These provisions may be adjusted, given that detailed requirements on documentation will be revisited by the MOP within two years after the Protocol enters into force.
2. Other Relevant Instruments and Institutions
The Cartagena Protocol on Biosafety represents the first attempt to regulate LMOs internationally. Beyond it, however, a limited number of standard-setting, binding and nonbinding instruments have been adopted or are being developed, that address a broader range of biosafety issues:
UNIDO Voluntary Code of Conduct for the Release of Organisms into the Environment 1992. The Code establishes general principles in respect of the introduction of organisms into the environment and in that regard encourages the establishment of regulatory regimes at national level.
UNEP Technical Guidelines on Safety in Biotechnology – adopted pursuant to the Global Consultation of Government-Designated Experts in 1995. The Guidelines refer to the evaluation of biosafety, risk management, information exchange, research and monitoring The motivating factor behind the preparation of the Guidelines, was that they should be used on an interim basis pending the adoption of the Protocol.
Codex Alimentarius —a non-binding code adopted under the auspices of FAO/WHO, the Codex relates primarily to food issues and has adopted Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods. These Guidelines particularly note that GMO foods cannot generally be given this label, and also established a Committee on General Principles, now preparing Working Principles for Risk Analysis.
The Commission which oversees the development of the Codex has established a task force on foods derived from biotechnology, which is expected to complete its work in around 2004. Other Committees of the Codex Commission are currently examining a number of key labelling issues, including
Proposed Draft Guidelines for the Labelling of Foods Obtained Through Certain Techniques of Genetic Modification/Genetic Engineering,
a Proposed Revised Code of Ethics for International Trade in Food and the Proposed Draft Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant DNA Plants, and
a Proposed Code of Practice on Good Animal Feeding.
Food Labelling, recommendations on this subject for foods obtained from biotechnology.
The International Plant Protection Convention (IPPC) 60 is primarily a “trade” convention, focused, like the Cartagena Protocol, on the ways in which countries can reasonably control plants and pests that might enter their territory. It is presently developing (among its body of international standards for phytosanitary measures) a standard to address the plant-pest risk of products of modern biotechnology.61
Within the framework of the UN/ECE Convention on Access to Information, Public Participation in Decision-Making an Access to Justice in Environmental Matters, which entered into force on 30 October 2001, discussions are taking place on how to address GMOs.
As the financial mechanism of the Convention on Biological Diversity 1992, the Global Environment Facility is also called upon under the Biosafety Protocol to serve as its financial mechanism. At its meeting in November 2000, it adopted the “Initial Strategy for Assisting Countries to Prepare for the Entry into Force of the Cartagena Protocol on Biosafety”, the main objectives of which are: to assist countries in the establishment of national biosafety frameworks; to promote information sharing and collaboration (in particular at the regional and sub-regional level); and, to promote collaboration with other organisations to assist in capacity building for the Protocol. It is envisioned that these objectives should be achieved through:
assisting in biosafety capacity building at the domestic level;
applying the guidelines established by the Intergovernmental Commission on the Cartagena Protocol (ICCP – the interim body addressing the Biosafety Protocol, which will now be subsumed into the bi-annual Meetings of the Parties (MOPs) to the Protocol);
applyingapplying biosafety procedures with a view to enhancing environmental management;
applyingharmonising or co-ordinating regional and sub-regional regulations;
applying involving all stakeholders in the adoption of national regulations;
applying assessing technological capacity in relation to national regulations; and
applyinginvolving the public in an informed and transparent debate on biosafety matters.
A GEF/UNEP project for the 'Development of National Biosafety Frameworks' is now being implemented in co-ordination with IUCN-ELC to assist GEF eligible countries that have signed the Cartagena Protocol on Biosafety to prepare national biosafety frameworks and promote regional and sub-regional co-operation.
57The Protocol received its 50th ratification on 13 June 2003. It will enter into force on 11 September 2003. Its first Meeting of the Parties will be held in February 2004 in Kuala Lumpur, immediately after CBD-COP-7.
58The Protocol speaks of LMOs instead of GMOs, presumably to ensure that the terminology was not burdened by current imprecise uses of the latter term in public and government circles. It defines LMO to mean “any living organism that possesses a novel combination of genetic material, obtained through the use of modern biotechnology”. For these purposes, a “living organism” is “any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids;” and “modern technology” includes in-vitro nucleic acid techniques (recombinant DNA and direct injection) and “fusion of cells beyond the taxonomic family. “ (Article 3(g), (h), and (i).)
59Cartagena Protocol, Art. 9.3.
60Adopted in 1951, revised in 1997.
61See discussion of the issues of standard “risk analysis” above.
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