U.S. DEPARTMENT OF STATE
Office of the Spokesman
February 16, 2000
FACT SHEET:
THE CARTAGENA PROTOCOL ON BIOSAFETY
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 bioengineered 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
Clearinghouse 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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