February 2000

U.S. Department of Agriculture Foreign Agricultural Service Fact Sheet International Protocol on Biosafety: What It Means for Agriculture

The Biosafety Protocol to the United Nations Convention on Biological Diversity will provide a regulatory framework for international trade in bio-engineered products referred to as living modified organisms (LMOs). The Protocol is an environmental agreement aimed at protecting bio-diversity. It was adopted by more than 130 countries on January 29, 2000, in Montreal, Canada, but must be ratified by 50 countries before it can go into effect. This process could take 2-3 years.

The Protocol preserves countries' rights under other international agreements, including the World Trade Organization (WTO). It requires that regulatory decisions under the Protocol be based on risk assessments and sound science. Countries will not be able to use unfounded concerns about biotechnology as disguised trade barriers. Consistent with the Sanitary and Phytosanitary Agreement under the WTO, the Protocol reiterates that lack of scientific certainty does not prevent a country from taking an appropriate decision on granting entry to a product in order to avoid or minimize potential adverse effects. The Protocol does not undermine an exporting country's right to challenge, under the WTO, an unwarranted decision of an importing country not to accept a bio-engineered product.

It establishes a biosafety clearinghouse to help countries exchange scientific, technical, environmental and legal information about living modified organisms produced through the use of biotechnology. The agreement requires governments to provide the clearinghouse with information on final decisions on the domestic use of an LMO commodity within 15 days of making that decision. The clearinghouse should provide needed transparency on where products have been approved and on countries' regulatory requirements.

What the Protocol Means for Agriculture

Because the Protocol is designed primarily to protect the environment from the potential effects of introducing a living modified organism, the most immediate impact on agricultural trade will be for seeds exported for planting.

Bio-engineered seeds for planting will be part of an Advance Informed Agreement procedure. This means that before a biotech seed can be shipped for the first time, the importing country must decide whether to approve it. If the seeds are approved for import, they will need documentation specifying their identity and traits. This formalizes the steps that seed and biotech companies currently go through in countries where they want to sell seed.

To a large extent, the Protocol will not alter the status quo for bulk commodities containing a biotech component. These commodities will not have to be segregated. Countries may, as many currently do, require the approval of new biotech crop varieties under their national laws and regulations. The Protocol, however, does not mandate or that countries to take such action nor does it mandate any transaction-by-transaction notice and consent procedure for commodities.

After the Protocol enters into force, documentation for shipments of bulk commodities will have to state that the shipment "may contain" living modified organisms and that the contents of the shipment are not intended for planting. In addition, the Protocol establishes a 2-year process under which further documentation requirements will be considered.

The scope of the Protocol does not cover food safety. Processed food products are not covered by the Protocol.

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