The Biosafety Protocol-An Overview

Representatives from 170 countries are currently negotiating international provisions governing the shipment and use of products from biotechnology. These provisions, officially known as the "Biosafety Protocol," are intended to provide uniform international requirements for ensuring the safe transport and use of these products. The Protocol could offer a framework to guide countries that currently lack national regulatory systems for products of biotechnology.

If the Protocol is not carefully crafted, however, it could seriously impede international trade, product development, technology transfer, and scientific research. Potential benefits could also be significantly offset by huge costs, uncertainty, and delays. Protocol development is proceeding rapidly; negotiations will be completed in February 1999.

Background:
The Biosafety Protocol (BSP) is an outgrowth of the Convention on Biological Diversity (CBD), a multilateral treaty for protecting biodiversity. The CBD's sound and commendable goals are to: Conserve biodiversity and provide for its sustainable use, and promote the fair and equitable sharing of benefits derived from the genetic resources inherent in biodiversity.

A Biosafety Working Group (BSWG) was established under the CBD to draft a Protocol dealing with the " transfer, handling and use of 'living modified organisms' (LMOs) derived from biotechnology that may have an adverse effect on the conservation and sustainable use of biodiversity." The BSWG is negotiating aspects of the BSP, including Protocol scope, advanced informed agreements for shipments of LMOs, risk assessment parameters, liability, labeling, confidentiality, status of non-Parties to the treaty, and the relationship of the BSP to other international agreements. The CBD website (www.biodiv.org) contains detailed information on the CBD and BSP.

Protocol Scope:
The BSWG is currently considering which materials, genetic modification techniques and activities the BSP will cover. Many Parties favor expanding the scope beyond organisms that may have an adverse effect on biodiversity to include most, and perhaps all, LMOs. Others want to expand the scope even further to include products derived from or produced by LMOs. If this approach is accepted, the BSP would cover bulk commodity grains, raw and processed foods and food ingredients, animal feed, and pharmaceuticals. Covered products of biotechnology will likely include most genetically modified organisms, including modified cells and seeds, and may also include: products derived from or produced by genetically modified organisms/cells/seeds or vectors and plasmids used to create genetically modified organisms/cells/seeds. There are many methods for "altering the genetic material in a way that does not occur naturally," some of which have been used for decades. The methods of genetic modification covered by the BSP, which are still under debate, will include recombinant DNA techniques and direct injection of nucleic acids into cells and may also include cell fusion and other genetic modification techniques. Therefore, LMOs genetically modified using any of these techniques and products derived from those LMOs may be captured.

Activities covered by the BSP will include transboundary movement and deliberate releases, and may also include handling, transfer and use of genetically modified organisms, including contained uses.

Key Requirement:
According to current language in the negotiating text, shipments of products captured by the provisions would require an explicit advanced informed agreement (AIA) between the exporting and importing country before the product can be shipped. The exporter would provide a written notification of shipment, accompanied by an extensive risk assessment, to the importer. The time frame for accepting or rejecting the shipment is unclear, but could be as long as 6 months or even undefined.

Potential Impacts:
If concepts and language currently supported by some delegates are adopted, the BSP could:

• Impose severe trade barriers on biotechnology products such as bulk grain commodities, processed foods, medical diagnostics and pharmaceuticals.
• Increase shipping costs, delays and uncertainties which will be reflected in the costs of goods.
• Disrupt international research collaborations.
• Inhibit the transfer of technologies to developing countries.
• Stifle scientific research within developing countries.
• Impose burdensome provisions, with perhaps no regard to actual risk, on countries with little capacity or few resources to implement them.
• Conflict with provisions of certain other international trade agreements.
• Desired Outcomes
• Biodiversity is a global resource of tremendous value to all of humankind. The CBD provides an important opportunity for nations to work together on an issue vitally important to us and future generations. To that end, we support a BSP that furthers the goals of the CBD: The conservation and sustainable use of biodiversity and equitable sharing of the benefits of biotechnology. To contribute to these goals, the BSP must:
• Be based on sound scientific principles.
• Take into account the actual environmental risks and the benefits of biotechnology, especially its role in facilitating biodiversity conservation.
• Focus on the transboundary movement of LMOs that may threaten biodiversity.
• Not unnecessarily restrict the transboundary movement of LMOs that pose no threat to biodiversity, thus increasing costs and delays without compensatory increases in environmental protection.
• Be consistent with existing international obligations to protect the environment.
• Encourage technology transfer and information sharing so all countries can benefit from advances in medical, agricultural and environmental biotechnology, while, at the same time, allowing for the protection of confidential information and intellectual property.
• Not divert resources from the protection of biodiversity to the development and administration of a regulatory system requiring case-by-case review of low-risk products.
• Be flexible so that any country can respond rapidly and appropriately to favorable developments in the new and evolving field of biotechnology.

THE PROPOSED BIOSAFETY PROTOCOL: KEY ISSUES
The Parties to the Convention on Biological Diversity intended for the Biosafety Protocol to govern the transboundary movement of Living Modified Organisms (LMOs) that may have an adverse effect on the conservation and sustainable use of biological diversity. Jakarta Decision II/5, which established the negotiating parameters, provides that the Protocol:

• Not exceed the scope of the Convention;
• Not override or duplicate any other international legal instrument;
• Not unduly hinder access to and transfer of technology, and
• Be efficient, effective and minimize unnecessary negative impacts on biotechnology research and development.
• To serve the goals of the Convention and meet the conditions specified by Decision II/5, the Protocol must provide for the conservation and sustainable use of biological diversity, while at the same time allowing for the development and use of valuable new products. It must also be consistent with other international agreements and not cause unwarranted disruptions in the transboundary movement and trade of essential materials.

To meet these objectives we recommend that the Biosafety Protocol be built on the following key positions:

The scope of the Protocol must govern only those LMOs and intended uses that may have a significant adverse effect on biodiversity. Extending the scope of the Protocol cover LMOs and intended uses that, based on scientific principles, will not have significant adverse effects on biodiversity would impede access to agricultural, medical and other beneficial products without a compensatory increase in biodiversity protection. LMOs and intended uses that realistically will not have adverse effects on biodiversity should not be included in the scope of the Protocol. This will allow resources to be focused more effectively. Appropriate exclusions include, at a minimum, LMOs that have been reviewed and accepted for commercial or research use by the importing country; LMOs destined for contained use or transport; commodities approved for commercialization, and pharmaceuticals.

The Advanced Informed Agreement (AIA) procedures should be applied only to those LMOs and intended uses that may realistically have a significant adverse effect on biodiversity. A "Notice of First Shipment" should be the primary mechanism to inform countries of the proposed shipment of an LMO. An AIA provision that requires written notification and consent for all LMOs will be extremely costly, demanding and burdensome for governments to administer, especially as the number of shipments covered by the Protocol increases. Moreover, if an intricate, lengthy and repetitive AIA process is applied to all LMOs, access to food, fiber and health care products will be impeded as will the development of new products.

The Protocol must be consistent with international trade rules. If the scope of the Protocol is unnecessarily broad and the AIA procedure is excessively burdensome, the Protocol could have serious negative impacts on the trade. As such, the Protocol's scope and AIA provisions must be limited to those LMOs and intended uses that may realistically have a significant adverse effect on biodiversity. The decision to approve or deny shipment of an LMO covered by the Protocol must be based on sound science regarding real or reasonably anticipated effects on biodiversity. Speculative, non-significant adverse effects on biodiversity must not be used to reject products. Discrimination of products based on their production techniques must also be avoided.

The Protocol must provide for the protection of confidential business information and other intellectual property. The Protocol must contain clear and appropriate procedures for designating and protecting confidential information and intellectual property shared in conjunction with the notification provisions of the Protocol. Procedures for resolving disputes over confidentiality claims regarding protected and privileged information must also be defined in the Protocol. In the absence of protection afforded by such procedures, companies and institutions will be reluctant to engage in commercial trade, international product development or exchange of research materials involving LMOs covered by the Protocol.

The Protocol should not create an international system of liability. Existing national and regional legal systems should be relied upon to determine what triggers legal liability for harm to biodiversity, the nature and extent of harm that can be compensated, and the procedural system to obtain relief from liable parties.

For more information, consult the Convention on Biological Diversity website.