Cartagena Protocol on Biosafety to the Convention on Biological Diversity

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity

• The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international treaty governing the movements of living modified organisms (LMOs) resulting from modern biotechnology from one country to another.
• It was adopted on 29 January 2000 as a supplementary agreement to the Convention on Biological Diversity and entered into force on 11 September 2003.
• objectives Protocol states that it aims to “contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements”.
• It seeks to protect biodiversity from the potential risks of living modified organisms (LMOs) resulting from modern biotechnology.

The Protocol covers

• The Protocol covers the “transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health”.It does not cover:
• Products derived from LMOs (e.g. paper from GM trees)
• LMOs, which are pharmaceuticals for humans that are addressed by other relevant international agreements or organizations.

The Biosafety Protocol do

• It assists developing countries in building their capacity for managing modern biotechnology
• It creates an advanced informed agreement (AIA) procedure that requires exporters to seek consent from importing countries before the first shipment of LMOs meant to be introduced into the environment (e.g. seeds for planting, fish for release, and microorganisms for bioremediation)
• It establishes an internet-based “Biosafety Clearing-House” to help countries exchange scientific, technical, environmental and legal information about LMOs.
• 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” LMOs and are “not intended for intentional introduction into the environment”.
• The Protocol includes a clause that makes clear the parties’ intent that the agreement does not alter the rights and obligations of governments under the World Trade Organization (WTO) or other existing international agreements.

The Biosafety Protocol not do

• The Protocol does not address food safety issues. This is addressed by experts in other international fora.
• The Protocol does not require segregation of bulk shipments of commodities that may contain living modified organisms.
• It does not require consumer product labelling.
• It does not subject shipments of bulk commodities to the Protocol’s AIA procedure.

Advanced Informed Agreement (AIA)

• The Protocol’s main mechanism is it’s Advanced Informed Agreement (AIA) requirement.
• It is a procedure that must be followed before the first intentional transboundary movement of an LMO into the environment of the importing country.
• The exporter must provide a notification to the importing country containing detailed information about the LMO, previous risk assessments of the LMO and its regulatory status in the exporting country.
• The importing country must acknowledge receiving the information within 90 days and whether the notifier should proceed under a domestic regulatory system or under the Protocol procedure. In either case, the importing country must decide whether to allow the import, with or without conditions or deny it within 270 days.

Living modified organism (LMO)

• The protocol defines a ‘living modified organism’ as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology, and ‘living organism’ means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids.
• ‘Modern biotechnology’ is defined in the Protocol to mean the application of in vitro nucleic acid techniques, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and are not techniques used in traditional breeding and selection.
• ‘Living modified organism (LMO) Products’ are defined as processed material that is of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology.
• Common LMOs include agricultural crops that have been genetically modified for greater productivity or for resistance to pests or diseases.
• Examples of modified crops include tomatoes, cassava, corn, cotton and soybeans.
• Living modified organism intended for direct use as food or feed, or for processing (LMO-FFP)’ are agricultural commodities from GM crops. Overall the term ‘living modified organisms’ is equivalent to the genetically modified organism – the Protocol did not make any distinction between these terms and did not use the term ‘genetically modified organism.