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The Cartagena Protocol on Biosafety Fact sheet released by the Office of the Spokesman U.S. Department of State Washington, DC, February 16, 2000

The Biosafety Protocol was adopted by more than 130 countries on January 29, 2000, in Montreal, Canada. It is called the Cartagena Protocol on Biosafety to honor Colombia, which hosted the extraordinary Conference of the Parties in Cartagena last year. Upon entry into force, this first Protocol to the Convention on Biological Diversity will provide a framework for addressing environmental impacts of bio-engineered products (referred to as living modified organisms or "LMOs") that cross international borders. The Biosafety Protocol will help protect the environment without unnecessarily disrupting world food trade.

What it Does

• The Protocol establishes an Internet-based "Biosafety Clearing-House" to help countries exchange scientific, technical, environmental and legal information about living modified organisms.

• It creates an advance informed agreement (AIA) procedure that in effect requires exporters to seek consent from importers before the first shipment of living modified organisms (LMOs) meant to be introduced into the environment (such as seeds for planting, fish for release, and microorganisms for bioremediation).

• It requires bulk shipments of LMO commodities, such as corn or soybeans that are intended to be used as food, feed or for processing, to be accompanied by documentation stating that such shipments "may contain" living modified organisms and are "not intended for intentional introduction into the environment."

• The Protocol establishes a process for considering more precise identification of LMO commodities in international trade.

• The Protocol includes a "savings clause" that makes clear the Parties' intent that the agreement does not alter the rights and obligations of governments under the WTO or other existing international agreements.

• It assists developing countries in building their capacity for managing modern biotechnology.

What It Does Not Do

• The Protocol does not address food safety issues. Food safety is addressed by experts in other international fora.

• It does not require segregation of bulk shipments of commodities that may contain living modified organisms (LMOs).

• It does not change rights and obligations under the WTO or other international agreements in any way.

• It does not subject shipments of bulk commodities to the Protocol's AIA procedure, which would have significantly disrupted trade in bulk commodities and would have jeopardized food access, without commensurate benefit to the environment.

• It does not require detailed identification requirements for bulk commodity shipments (any such requirements will be subject to a further negotiation to be concluded no later than two years after the Protocol enters into force).

• The Protocol does not require consumer product labeling. The mandate of the Protocol was to address potential risks to biodiversity that may be presented by living modified organisms. Issues related to consumer preference were not part of this negotiation. The Protocol's requirement for documentation identifying bulk commodity shipments as "may contain LMOs", and as "not intended for direct introduction into the environment" will be accomplished through shipping documentation.

The Protocol will enter into force on the ninetieth day after it is ratified by the fiftieth Party to the Convention on Biological Diversity (CBD). Although the United States is not a Party to the CBD and therefore can not become a Party to the Biosafety Protocol, the U.S. participated in the negotiations as a member of the Miami Group, a coalition of leading agricultural exporters that also included Argentina, Australia, Canada, Chile and Uruguay. The other negotiation groups included the European Union, the Eastern and Central European countries, the Like-Minded Group of developing countries, and the Compromise Group (Japan, Korea, Mexico, New Zealand, Norway, Singapore and Switzerland).

The Protocol provides countries the opportunity to obtain information before new biotech organisms are imported. It acknowledges each country's right to regulate bio-engineered organisms, subject to existing international obligations. It also creates a framework to help improve the capacity of developing countries to protect biodiversity.

Key Provisions of the Biosafety Protocol

a. Advance Informed Agreement (AIA) Procedure

• The Protocol's AIA procedure, in effect, requires an exporter to seek consent from an importing country prior to the first shipment of a living modified organism (LMO) intended for intentional introduction into the environment (e.g., seeds for planting, fish for release and microorganisms for bioremediation).

• The procedure does not apply to LMO commodities that are intended for food, feed, or processing (e.g., corn, soy or cotton), to LMOs in transit, or to LMOs destined for contained use (e.g., vials for scientific research). LMO commodities and LMOs destined for contained use are addressed under documentation.

• Importers are to make decisions on the import of LMOs intended for introduction into the environment based on a scientific risk assessment and within 270 days of notification of an intent to export.

b. Commodity Requirements/Biosafety Clearinghouse

• The agreement requires governments to provide the Biosafety Clearing-House with information concerning any final decisions on the domestic use of an LMO commodity within 15 days of making a decision.

c. Documentation

• The agreement sets forth different shipping documentation requirements for different types of LMOs, which will be effective after the Protocol comes into force. Documentation accompanying shipments of:
  • LMOs intended for intentional introduction into the environment (e.g., seeds for planting) must identify the shipment as containing LMOs along with the identity and relevant traits of the LMO;

  • LMO commodities must indicate that the shipment "may contain" LMOs, that the shipment is not intended for intentional introduction into the environment, and specify a contact point for further information. The Protocol provides for a decision by the Parties to further elaborate detailed requirements for this purpose, including specification of the identity and any unique identification of the LMOs, no later than two years after the entry into force of the Protocol; and

  • LMOs destined for contained use (e.g., for scientific or commercial research) must identify the shipment as containing LMOs.

d. Savings Clause

• Countries participating in the negotiation had no intention of using the Protocol to alter their existing international rights and obligations. Therefore the Protocol includes a savings clause which states: "this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreement."

e. Precaution

• The Protocol includes language that states: "Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account the risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the LMO in question ... in order to avoid or minimize such potential adverse effects."

• The language acknowledges the role that precaution may serve during decision making. However, the language does not replace science-based decision-making, nor does it authorize decisions contrary to a country's WTO obligations.

f. Trade With Non-Parties

• The Protocol states that the "transboundary movement of [LMOs] between Parties and non-Parties shall be consistent with the objective of this Protocol."

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