The Biosafety Protocol-An Overview

• 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.