The relationship of the CBD to bio-safety
The particulars of the CBD
As mentioned above, article 19.3 of the CBD calls upon the COP to consider the need for and modalities of a protocol to Convention on bio-safety. Article 19 is one of only five articles of the CBD that call upon the COP to take specific actions. Thus the negotiating Parties clearly deemed it a matter of priority, ranking with liability and redress (article 14.2), the establishment of an information clearing-house (article 18.3), and financial arrangements (articles 20 and 21). This is not to suggest that there was unanimity in the negotiation of article 19. Commercial opposition to a protocol in the United States and other industrialized countries was a divisive factor. Nonetheless, as with all the provisions of the CBD concerning biotechnology and genetic resources, most Parties--especially developing countries--deemed international regulation of the products of biotechnology to be an urgent priority. Developing countries were, and continue to be, concerned that not only will they not be compensated for the extraction and use of their genetic resources, but that some of the resulting products exported to their countries may be harmful to the human and non-human environment. The rapid development of genetic engineering in the decade preceding UNCED and the existing inadequate--if not obsolete--conventions and non-binding agreements were the main motivations for incorporating the provisions on biotechnology in the CBD. The UNEP Expert Panel IV Report reflects these concerns. Importantly, the Panel noted that the preamble of the CBD reiterates the "precautionary principle" (Principle 15) of the non-binding Rio Declaration, done at UNCED: "Noting also that where there is a threat of significant reduction or loss of biological diversity, lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat." As the Panel explained in its Report:
"It is well known that new technologies often have not been safely applied until the environmental damage has occurred. The sins of the past and increased environmental awareness has lead to a general acceptance of the precautionary approach referred to in Principle 15 of the Rio Declaration. Many countries--but mostly developed countries--have applied the precautionary approach in the field of biotechnology by adopting safety regulations to avoid harmful effects on the environment and on human health."This is to say that the precautionary principle is based on studied consideration of the potential long-term effects of new technologies and is not a dogmatic reaction against science and technology, as some contend.
Panel's consideration of CBD articles
The Panel astutely noted that the following articles are pertinent to the implementation of article 19.3:
7.c--identification of processes and activities that are likely to have significant adverse impact on the environment;
8.g--regulation, management and control of risks associated with the release of "living modified organisms";
8.h--control or eradication of alien speciesthat threaten ecosystems;
14.1--environmental impact assessment of, exchange of information about and notification of imminent danger from projects and activities likely to have "significant adverse impact" on biodiversity;
17.1--exchange of information on conservation and sustainable use of biodiversity, taking into account the "special needs of developing countries";
18.3--establishment of a clearing-house mechanism for scientificand technical cooperation (done at first meeting of COP);
19.4--provision of available information on each Party's use and safety regulations concerning living modified organisms produced by biotechnology, as well as any information on potential adverse impacts of such organisms.
We agree that the articles above must be taken into consideration in
progressing toward negotation of a bio-safety protocol.
Other related articles of the CBD
Article 2 (Definitions) describes "biotechnology" as "any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for a specific use." Although article 2 does not provide a definition for the term "living modified organism" (LMO), the Panel construed it to mean genetically modified organisms (GMOs) whose genetic material does not occur naturally by mating or natural recombination. GMO is a term of different scope than LMO, both in that GMOs might include dead organisms that still have a potential adverse impact on the environment, and in that LMOs might include organisms produced by traditional ("natural") breeding techniques. Early drafts of article 19.3 referred to GMOs, instead of LMOs. The United States introduced "LMO" into the negotiations as a compromise term, despite the strong initial opposition of many countries, because it could not agree to the use of the term "GMO." Future meetings on article 19.3 may need to reopen the debate in the face of new scientific evidence, in order to ensure that the definition is in keeping with the terms of the CBD.
Articles 8.g and 8.h are important in this regard, since they apply to "living modified organisms" and "alien species" respectively, of which the latter term is not defined. "Alien species" may not apply just to threatening non-indigenous species, but may include a variety of potentially harmful products of biotechnology.
Article 14.2--another article mandated to the COP--calls for the examination of liability and redress, including restoration and compensation, for damage to biodiversity. However, the Panel decided that consideration of this article would preempt the work of the COP, because its scope is greater than that of 19.3. Nonetheless, any future protocol on bio-safety must at least refer to article 14.2, if it does not elaborate on the nature of liability and redress. Future meetings to implement article 19.3 may also wish to consider a specific régime for liability and redress, to be incorporated in the protocol.
Articles 20 and 21 on financing the CBD should also be borne in mind, since once implemented, they will provide for the special needs and situations of developing countries, especially the environmentally vulnerable, and will guide priorities for funding.
Finally, the role of the Subsidiary Body on Scientific, Technical, Technological Advice, established by article 25 of the CBD, should also be carefully considered and perhaps integrated into a possible protocol.
"Advance informed agreement" (AIA), as phrased in article 19.3, will be an indispensable element of any effective protocol on bio-safety. Article 19.3 does not define AIA, but the majority of the members of the Panel agreed that it "should be substantially identical to" the "prior informed consent" clauses of the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal, the London Guidelines for the Exchange of Information on Chemicals in International Trade (UNEP) and the FAO International Code of Conduct on the Distribution and Use of Pesticides (voluntary). In this regard article 19.4 is pertinent, since it states that each Party shall provide "any available information on the potential adverse impact of specific organisms concerned to the Contracting Party into which those organisms are to be introduced"--regardless of whether or how article 19.3 is implemented. The crucial term "potential adverse impact" needs to be refined; its definition could range from any adverse effects that might occur to effects known to occur under specific conditions. Moreover, by use of the term "available," article 19.4 does not oblige Parties to create comprehensive and useful information on specific organisms. The development of elements of a future protocol will almost certainly have to take into account standards and time-frames for reporting and communication.
The work of the COP
Biotechnological methods and applications have expanded rapidly in the years since UNCED. Hundreds of genetically engineered organisms have been released into the environment since the middle of the 1980s. Thousands of field tests have been conducted in the throughout the world. Consequently, the first meeting of the COP, in late 1994, recognized that consideration of bio-safety is more urgent than ever. That the main body of the COP Medium-Term Programme of Work (MTPW; UNEP/CBD/COP/1/L.11) is almost entirely concerned with the implementation of article 19.3 is ample evidence that the concerns of the majority of the Parties have not diminished since the formulation of the Convention. (The three-year work plan constitutes the annex to the MTPW.)
The MTPW calls for the establishment of two further expert panels, which are to meet in 1995. The first of these, which met in May at Cairo, considered "existing knowledge and experience on risk assessment and management," as well as existing national guidelines or legislation. It prepared a report for the second meeting: UNEP/CBD/Biosafety Panel/5/L.1. The report from Cairo contains a narrow and problematic definition of LMOs: "all organisms produced through the use of recombinant DNA technology" (except in the case of prokaryotes and yeast), while asserting that "recombinant DNA techniques were an extension of conventional genetic procedures ..." (op. cit.: ¶¶ 23 & 31). It also does not refer by name to a bio-safety protocol to the CBD, but rather to an "international framework" (passim).
The second meeting is to be held in July 1995 to consider, inter alia, "advance informed agreement" on the "safe transfer, handling and use of living modified organisms." The present paper was prepared for this meeting. Both expert panels should convene, according to the MTPW, "with a view to presenting a report for the consideration of the second meeting of the Conference of the Parties."
It is in the context of biodiversity conservation and sustainable use of biological resources that contemporary bio-safety concerns were formulated. Therefore, a comprehensive bio-safety instrument must take into account the factors woven into the fabric of the CBD. The CBD is the global instrument best suited both for developing general regulations for biotechnology and for encouraging the development of adequate, scientifically informed national regulations. The CBD does not necessarily preempt the work of other international or national processes; rather it exists at least to supplement, strengthen and inform them.
The careful legal and political consideration of bio-safety will have to take into account the broader context of the CBD and a comparison of it to other national, regional or global instruments, institutions and processes. The CBD is not only the sole international agreement, legally binding or not, with a scope broad enough to include all living organisms resulting from biotechnology, but it is also the only binding international convention on conservation and development that is based firmly on the science of ecology--an understanding of the complex interactions among genes, species and ecosystems. As demonstrated below, LMOs fall entirely within the purview of the CBD unlike many other products of biological resources.
Although the scope of a number of global and regional agreements overlap to one extent or another that of article 19.3, most of them have no legal force, unlike the CBD. In part these agreements include voluntary codes of conduct, to which governments and some industry groups subscribe, such as the FAO-UNEP-UNIDO-WHO code on the release of organisms into the environment, the Codex Alimentarius (FAO-WHO) on food standards and the FAO code on pesticides, mentioned above. In part they consist of recommendations of diverse scope and complexity, issued by Council of Europe, the Organization of Economic Cooperation and Development (OECD) and various United Nations bodies. The two major contenders with the CBD for regulating biotechnology are the legally binding International Plant Protection Convention and the International Office of Epizootics. Not only is the former restricted to the regulation of the transfer and release into the environment of plants and plant products, but the "phytosanitary certificates" that it issues do not give comprehensive ecological information about the plants, something that the authors deem an essential element of advance informed agreement. The latter is concerned only with human health and sanitary requirements in the international transfer of animals, including microorganisms. It does not house the expertise to conduct overall environmental impact assessments of the introduction and release of animals, not does it mandate the development of national infrastructures, two shortcomings when compared to the provisions of the CBD.
The CBD is, as originally intended, a framework for integrating and setting standards for national and regional regulation and agreement.
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