EXECUTIVE SUMMARY

In May of 1992, the Conference for the Adoption of the Agreed Text of the Convention on Biological Diversity (CBD) agreed to three resolutions. Resolution 2 invited the United Nations Environmental Programme (UNEP) to "identify processes and activities which have or are likely to have an adverse impact on biological diversity...." in general (2.a.ii.). In particular it invited UNEP to consider article 19.3 of the CBD (Handling of Biotechnology and the Distribution of its Benefits), which states:

"The Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of 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 introduction to the present analysis and critique provides a brief history of the negotiation of the CBD, especially article 19.3, UNEP Expert Panel IV and a statement of this paper's purpose. The first substantive section concerns the relationship of the CBD to bio-safety: the relevance of its provisions, its scientifically based context and the political will to develop a bio-safety protocol. The next section explains the US rejection of the Expert Panel report as a background document for the Conference of the Parties (COP) to the Convention. The third section--the core of this study--is a review of the minority position of the Report of Expert Panel IV, which opposed development of a bio-safety protocol to the CBD This section follows the order of issues presented in the Report. The last section sums up the reasons for developing and implementing a bio-safety protocol.

The four main substantive sections may be outlined as follows.

The relationship of the CBD to bio-safety

• Article 19.3 is one of only five articles that mandate specific work to the COP. That the COP at its first meeting in 1994 made consideration of article 19.3 the main subject of its Medium-Term Programme of Work indicates that political interest has not diminished since the CBD was negotiated. The rapid development of biotechnological methods and products, as well as releases of genetically modified organisms worldwide, since the negotiation of the Convention, makes consideration of bio-safety regulation urgent.
• The CBD reiterates the "precautionary principle" (Principle 15) of the non-binding Rio Declaration done at UNCED in 1992, and the Expert Panel IV report explains that the principle is justified by the studied consideration of environmental damage wrought by the misapplication of new technologies in the past.
• A bio-safety protocol is clearly within the scope of the CBD. A number of its provisions are clearly relevant, including those on identification of processes and activities likely to have an adverse impact on the environment (article 7.c); regulation, management and control of living modified organisms (8.g); environmental impact assessments (14.1); and exchange of information (17.1; 18.3; 19.4).
• Article 19.3 stipulates that the Parties should consider advance informed agreement on the transfer, handling and use of living modified organisms (LMOs) resulting from biotechnology. Advance informed agreement is an indispensable element of any effective international regulation, including a future bio-safety protocol.
• Among international agreements, the context of the CBD is best suited to development of bio- safety regulation. It is the only binding international convention on conservation and development that is based firmly on the science of ecology. Many agreements that overlap the purview of the CBD are not legally binding, while those that are have a too restricted a scope to deal with the various products of biotechnology. The CBD is also designed to be a framework for integrating and setting standards for national and regional regulation.

US objection to the Expert Panel IV Report

• The US objected to the presentation of Report of Expert Panel IV ostensibly because it was not "consensus document," like others discussed at meetings of the Intergovernmental Committee of the CBD, and to which the Parties agreed.
• Official US rationales notwithstanding, commercial motivation for such an objection is evident. The main political force behind President Bush's refusal to sign the CBD at UNCED was the biotechnology industry, which was worried about the status of intellectual property rights and the regulation of biotechnology under the CBD.
• Complaints from biotechnology industry leaders that current promotion of a bio-safety protocol is unscientific are groundless and ironic. The scientific case for the need for a bio- safety protocol (outlined below) is strong--and based in the current knowledge of ecological complexity.

Review of Expert Panel IV minority position

The scientific case for a bio-safety protocol

• Blanket assurances are not scientifically sound. They cannot account for the range of possible genetically engineered trait-organism combinations, the expression of the same transgene or transgenes (genes from dissimilar organisms or artificially constructed genes added to other organisms by techniques of molecular biology) in different circumstances and in different ecosystems, or the ability of genetically modified organisms (GMOs) to "invade" and disrupt ecosystems, including agricultural ecosystems.
• Substitution of GMOs in human and nonhuman ecosystems may threaten biological diversity and ecosystem health. "Centers of diversity" of crop plants (mainly in the South) are at particular risk of "genetic erosion." Genetically engineered hybrids may require environmentally damaging chemical pesticides and fertilizers, as well as excessive amounts of water. Genetically engineered microorganisms can have a deleterious effects on soil organisms and nutrients.
• The release of GMOs into the environment poses unique toxic risks. Release of GMOs contain viral genes into the environment runs the risk of creating new viral pathogens. Production and consumption of transgenic plants that express bio-pesticides both pose risks to human health and could speed the selection of resistant pests. Chemicals produced using recombinant-DNA (rDNA) and other molecular biological techniques may also threaten human health.

Points of implementation

• Adaptability/modalities. A bio-safety protocol should be flexible and should not be based on sweeping generalities about the effects of biotechnological products on the environment. Nevertheless, a comprehensive protocol needs to cover:

  § all living modified organisms produced by nontraditional breeding techniques (e.g. rDNA), including GMOs;

  § contained use and release of GMOs;

  § development of national implementation and capacity building; advance informed agreement;

  § competent national authorities;

  § environmental impact assessment;

  § socio-economic impact assessment;

  § standards for case-by-case and step-by-step risk assessment and management--guided by the precautionary principle;

  § determination of liability and redress;

  § provision of information to the public through the Convention's clearing-house mechanism;

  § a trade ban with non-Parties.

  
  
• Public perception. Calls for regulation of the biotechnology industry have not increased public concerns. The public is already concerned about the risks of biotechnology, based on previous experience and knowledge of the damage done to health and the environment by other new technologies. Furthermore, the motivation of sound industry-public relations should not be to sell the technology to the public first and then assess the possible dangers. As a first step toward honestly informing the public, Parties should consider the question of proper labelling of LMOs produced by biotechnology. Development of scientifically sound standards of assessing and managing risks will not only allow biotechnology to be transferred and applied properly, but will also facilitate the international transfer of the standards themselves.
• Overlap/duplication. No existing international agreement covers all the potential risks that the various LMOs resulting from biotechnology pose. A bio-safety protocol would be legally binding and set minimum--but high--international standards for transfer, handling and use of LMOs.
• Codes of conduct/"soft law." Codes of conduct and voluntary guidelines do not alert governments sufficiently to the importance of complying with their stipulations. Furthermore, parties in developing countries have complained that they do not receive proper information about the use of potentially hazardous substances through voluntary codes. Developing countries also often do not have the capacity to regulate substances and therefore want manufacturers to take responsibility in the form of a mandatory agreement.
• Administrative costs of separate treatment. A bio-safety protocol would be administered under the auspices of the COP, not by a separate governing body. While the Party importing an LMO should be responsible for advance informed agreement, the CBD clearing-house mechanism (article 18.3) could provide for transfer of the relevant information. Article 6 of the Convention calls upon Parties to integrate the conservation of biological diversity--bio-safety by implication--into all sectoral and cross- sectoral plans and programs, thereby only enhancing efficiency.
• Implementing Agenda 21. Chapters 14 and 16 of Agenda 21 (also done at UNCED) are particularly important to development of a bio-safety protocol. Chapter 14, on sustainable agriculture and rural development, refers to the environmental and socio-economic vulnerability that comes with reliance on technological inputs and specialized production. Chapter 16 encourages the development of internationally agreed principles for the environmentally sound management of biotechnology, including measures that enhance safety and develop international mechanisms for cooperation. A bio-safety protocol would be a concrete step toward these goals.
• Quantifying risks. The long-term, cumulative risks of releasing large numbers of GMOs are still not well understood. However, what is known confidently about ecosystems and the effect of natural or genetically engineered species on them is enough to recommend that biotechnology be managed with extraordinary caution. Criteria for assessing risk must be developed as part of a bio-safety protocol. Scientific experts have provided tables of combinations of significant types of methods, organism attributes and environments that future meetings on a bio-safety protocol may wish to consider in their discussion of indicators and measures of risk. Lists of attributes are not enough for meaningful risk assessment. Regulators cannot rely on containment as the sole means of risk management, when GMOs are produced commercially for global distribution.
• Products to be covered by a protocol. Given the evidence above, a bio-safety protocol's provisions and stipulations should extend only to those "alien species" arising from modern biotechnological techniques, which are not based on natural mechanisms, such as fertilization and propagation.

The need for a protocol

Legally and politically, a protocol is needed to:

• provide a legally binding framework of high minimum standards for national regulation and regional agreements;
• integrate and make efficient the numerous existing multilateral instruments which affect the regulation of biotechnology products;
• expedite the development and implementation of national bio-safety regulations;
• facilitate the diffusion of techniques beneficial to biological diversity and essential to the progress of human health and medicine, as well as sustainable agriculture (Chapters 14 and 16, Agenda 21);
• apply the precautionary principle to international regulation of the release of LMOs produced by biotechnology, which will help prevent damage to biological diversity (Principle 15 of the Rio Declaration).

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