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: