- The Cartagena Protocol on Biosafety functions as an extension to the Convention on Biological Diversity (CBD).
- Biosafety, in this context, pertains to the imperative need to shield human health and the environment from potential risks associated with modern biotechnology products.
- The Convention explicitly recognizes two aspects of modern biotechnology: the acquisition and transfer of technology and the implementation of appropriate procedures to enhance the safety of biotechnological technology.
- The Protocol establishes specific procedures to govern the import and export of Living Modified Organisms (LMOs) between countries.
- It mandates Parties to ensure the safe handling, packaging, and transportation of LMOs during cross-border movements.
- Accompanying documentation for shipments must unambiguously identify the LMOs, outline any requirements for their safe handling, storage, transport, and use, and provide contact information for additional inquiries.
- Two distinct sets of procedures are delineated by the Protocol: one for LMOs intended for direct introduction into the environment, known as the Advance Informed Agreement (AIA) procedure, and another for LMOs intended for direct use as food or feed, or for processing (LMOs-FFP).
BACKGROUND
- The Cartagena Protocol on Biosafety, also known as the Biosafety Protocol, was conceived after a CBD Open-ended Ad Hoc Working Group on Biosafety convened six times between July 1996 and February 1999.
- The decision to adopt the protocol was made in January 2000 during an extraordinary meeting of the Conference of the Parties, specifically convened for this purpose.
- The Working Group submitted a draft of the Protocol for review during the extraordinary meeting, which was dedicated to adopting a biosafety protocol for the CBD.
- After a few delays, the Cartagena Protocol was ultimately accepted on January 29, 2000.
- The Biosafety Protocol addresses the potential hazards to biological diversity posed by living modified organisms facilitated by contemporary biotechnology.
LIVING MODIFIED ORGANISMS
- As per the Cartagena Protocol on Biosafety, a “living modified organism” (LMO) refers to any living entity characterized by a distinct combination of genetic material resulting from the application of contemporary biotechnology.
The Protocol provides specific definitions:
- “Living organism” encompasses any biological entity capable of transferring or replicating genetic material, inclusive of sterile organisms, viruses, and viroids.
- “Modern biotechnology” is defined as the utilization of in vitro nucleic acid techniques or the fusion of cells from different taxonomic families, bypassing natural physiological or recombination barriers. These methods are not employed in conventional breeding and selection.
- “Living modified organism (LMO) Products” are materials subjected to contemporary biotechnology, exhibiting observable unique genetic material combinations. An example includes processed items like flour derived from genetically modified (GM) maize.
- Agricultural products originating from GM crops fall under the category of “living modified organisms intended for direct use as food or feed, or for processing (LMO-FFP).”
- It’s noteworthy that, within the Protocol, the terms “living modified organism” and “genetically modified organism” are used interchangeably. The Protocol does not make a distinction between these terms nor does it employ the term “genetically modified organism” specifically.
Cartagena Protocol – Objectives:
The primary objectives of the Cartagena Protocol on Biosafety are:
- Ensuring Safe Transfer, Handling, and Use: The protocol aims to establish an adequate level of protection in the field of the safe transfer, handling, and use of “living modified organisms resulting from modern biotechnology” to prevent negative effects on conservation.
- Consideration of Risks to Human Health: The protocol emphasizes the sustainable use of biological diversity, taking into account potential risks to human health.
- This aligns with Principle 15 of the Rio Declaration on Environment and Development.
PARTIES AND NON PARTIES:
- The governing body of the Cartagena Protocol is the Conference of the Parties to the Convention, which also serves as the Protocol’s Conference of the Parties (COP-MOP).
- Only Parties to the Protocol have the authority to make decisions under it.
- Parties to the Convention, not Parties to the Protocol, may participate as observers in COP-MOP sessions.
- The Protocol outlines obligations concerning transboundary movements of Living Modified Organisms (LMOs) between Parties and non-Parties, emphasizing consistency with the Protocol’s goals.
SCOPE:
The Cartagena Protocol covers all LMOs that may have adverse impacts on the preservation and sustainable use of biological diversity, posing risks to human health.
Key areas under its purview include:
- LMOs deliberately added to the environment (e.g., trees, seeds, or fish).
- Genetically modified (GM) agricultural products (e.g., grain and corn used for animal feed, food, or processing).
- Exclusions: Human drugs covered by other international agreements, LMO-derived goods like cooking oil from GM corn.
Provisions for AIA Procedure:
- The protocol establishes an Advance Informed Agreement (AIA) mechanism.
- AIA includes notification from the exporter, acknowledgment of the importer’s receipt, decision-making process, and review of decisions.
- Governments must be provided with sufficient information before accepting LMO imports, ensuring informed decision-making.
LMOs-FFP Procedure:
- Parties approving and placing LMOs on the market follow the LMOs-FFP procedure.
- Decisions and relevant information, including risk assessment reports, must be made publicly available through the Biosafety Clearing-House (BCH).
CARTAGENA PROTOCAL AND INDIA:
- India is a signatory to the Cartagena Protocol since its ratification in 2003.
- The Ministry of Environment, Forest and Climate Change (MOEF&CC) in India serves as the nodal agency (Competent National Authority-CNA) for implementing the Protocol.
- India has pioneered the creation of a biosafety regulatory framework since the 1980s, ensuring a science-based approach.
- Indian legislation uses phrases like “genetically engineered organism” or “genetically modified organism” interchangeably with LMOs.
- Guidelines for risk management and risk evaluation of GMOs are available in India.
FAQs about BIOSAFETY and the Cartagena Protocol:
1. What is Biosafety in the context of the Cartagena Protocol on Biosafety?
A: Biosafety, as addressed in the Cartagena Protocol, refers to the essential measures taken to protect human health and the environment from potential risks associated with modern biotechnology products.
2. How does the Convention on Biological Diversity (CBD) relate to Biosafety and the Cartagena Protocol?
A: The Cartagena Protocol on Biosafety serves as an extension to the Convention on Biological Diversity (CBD), addressing specific concerns related to the safe transfer, handling, and use of living modified organisms (LMOs) resulting from modern biotechnology.
3. What are the main objectives of the Cartagena Protocol on Biosafety?
A: The primary objectives include ensuring a safe transfer, handling, and use of LMOs to prevent negative effects on conservation and considering risks to human health, aligning with Principle 15 of the Rio Declaration on Environment and Development.
4. Who governs the Cartagena Protocol, and what is the role of Parties and Non-parties?
A: The governing body is the Conference of the Parties to the Convention, which also serves as the Protocol’s Conference of the Parties (COP-MOP). Only Parties to the Protocol have decision-making authority, while Parties to the Convention can participate as observers in COP-MOP sessions.
5. What falls under the scope of the Cartagena Protocol?
A: The Protocol covers all LMOs that may adversely impact the preservation and sustainable use of biological diversity, posing risks to human health. This includes LMOs deliberately added to the environment and genetically modified agricultural products, with some exclusions like human drugs covered by other international agreements.
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