More than 130 countries adopted the Biosafety
Protocol 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 to the Convention on Biological Diversity (CBD) in
Cartagena in 1999. The objective of this first Protocol to the CBD is to
contribute to the safe transfer, handling and use of living modified organisms (LMOs)
-- such as genetically engineered plants, animals, and microbes -- that cross
international borders. The Biosafety Protocol is also intended to avoid adverse
effects on the conservation and sustainable use of biodiversity without
unnecessarily disrupting world food trade.
The Protocol will enter into force on September 11, 2003. Although the United
States is not a Party to the CBD and therefore cannot become a Party to the
Biosafety Protocol, the U.S. participated in the negotiation of the text and the
subsequent preparations for entry into force under the Intergovernmental
Committee on the Cartagena Protocol. We will participate as an observer at the
first Meeting of the Parties (MOP1), scheduled for February 2004 in Kuala
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.
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 (LMOs).
- It creates an advance informed agreement (AIA) procedure that in effect
requires exporters to seek consent from an importing country before the
first shipment of an LMO meant to be introduced into the environment (such
as seeds for planting, fish for release, or microorganisms for
- It requires shipments of LMO commodities, such as maize or soybeans that
are intended for direct use 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 detailed identification and
documentation of LMO commodities in international trade.
- It also sets out information to be included on documentation accompanying
LMOs destined for contained use, including any handling requirements and
contact points for further information and for the consignee.
- The Protocol includes a "savings clause," which states that the
agreement shall not be interpreted as implying a change in the rights and
obligations of a Party under any existing international agreement,
including, for example, WTO agreements.
- The Protocol calls on Parties to cooperate with developing countries in
building their capacity for managing modern biotechnology.
What It Does Not Do
- The Protocol does not address food safety issues. Experts in other
international fora, such as Codex Alimentarius, address food safety. It does
not pertain to non-living products derived from genetically engineered
plants or animals, such as milled maize or other processed food products.
- It does not require segregation of commodities that may contain living
- It does not subject commodities to the Protocol's AIA procedure, which
would significantly disrupt trade and jeopardize food access, without
commensurate benefit to the environment.
- The Protocol does not require consumer product labeling. The mandate of
the Protocol is to address risks to biodiversity that may be presented by
living modified organisms. Issues related to consumer preference were not
part of the negotiation. The Protocol's requirement for documentation
identifying commodity shipments as "may contain living modified
organisms" and "not intended for direct introduction into the
environment" can be accomplished through shipping documentation.
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 introduction into the environment
(e.g., seeds for planting, fish for release, and microorganisms for
- The AIA procedure does not apply to LMO commodities that are intended for
food, feed, or processing (e.g., maize, soy or cottonseed), to LMOs in
transit, or to LMOs destined for contained use (e.g., organisms intended
only for scientific research within a laboratory).
- 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 Clearing-House
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.
- The agreement sets forth different shipping documentation requirements for
different types of LMOs. These requirements will be in effect after the
Protocol comes into force.
- Documentation accompanying shipments of LMOs intended for introduction
into the environment (e.g., seeds for planting) must identify the
shipment as containing LMOs along with the identity and relevant traits
and/or characteristics of the LMO, any requirements for safe handling,
storage, transport and use, the contact point for further information, a
declaration that the movement is in conformity with the Protocol and, as
appropriate, the name and address of the importer and exporter.
- Documentation accompanying shipments of LMO commodities intended for
direct use as food or feed, or for processing, 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 on the need for detailed requirements for this purpose,
including specification of the identity and any unique identification of
the LMOs, no later than 2 years after the entry into force of the
- Documentation accompanying LMOs destined for contained use (e.g., for
scientific or commercial research within contained facilities) must
identify the shipment as containing LMOs and must specify any
requirements for safe handling, storage, transport and use, the contact
point for further information, including the name and address of the
individual and institution to whom the LMOs are consigned.
d. Existing Rights and Obligations Unaffected
As evidenced by both the substantive content of the Protocol and its
preambular "savings clause," Parties must implement rights and
obligations under the Protocol consistent with their existing international
rights and obligations, including with respect to non-Parties to the Protocol.
- Precaution is reflected in the Protocol’s preamble, objective (with a
reference to Principle 15 of the Rio Declaration on Environment and
Development), and provisions on an importing Party’s decision-making
process regarding the import of an LMO:
"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
risks to human health, shall not prevent that Party from taking a decision,
as appropriate, with regard to the import of that living modified organism
in order to avoid or minimize such potential adverse effects."
- Both the substantive content of the Protocol's precaution provisions and
the preambular "savings clause" make clear that a Party's use of
precaution in decision-making must be consistent with the Party's trade and
other international obligations.
f. Trade With Non-Parties
The Protocol states that the "transboundary movement of living modified
organisms between Parties and non-Parties shall be consistent with the objective
of this Protocol." Therefore, although the Protocol only requires trade
between Parties and non-Parties in LMOs to be consistent with the
"objective" of the Protocol, we anticipate that, as a practical
matter, firms in non-Party countries wishing to export to Parties will need to
abide by domestic regulations put in place in the importing Parties for
compliance with the Protocol.
This information was downloaded from the
Department of State Web site.