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Cartagena Protocol on Biosafety

Submitted by: Komal preet Kaur Shivin Shakaya Sorabh Kumar

Adopted on 29 January 2000. 103 signatures, 45 countries and a regional economic integration organization have deposited their instruments of ratification or accession (10 in Africa Botswana, Cameroon, Djibouti, Kenya, Lesotho, Liberia, Mali, Mauritius, Mozambique, Tunisia, Uganda). Enters into force 90 days after 50th ratification. C OP serving as the Meeting of the Parties (COP/MOP) will be the sovereign body when in force. I n the interim, the Intergovernmental Committee for the Cartagena Protocol (ICCP) has been preparing for the first MOP.

Understanding Biosafety
The concept of biosafety encompasses a range of measures, policies and procedures for minimizing potential risks that biotechnology may pose to the environment and human health. Establishing credible and effective safeguards for GMOs is critical for maximizing the benefits of biotechnology while minimizing its risks.

Scope of the Cartagena Protocol

The Cartagena Protocol on Biosafety is an international treaty that seeks to protect biological diversity from the risks posed by living modified organisms (LMOs), also often referred to as genetically modified organisms (GMOs), which are a product of modern biotechnology. The Protocol is a supplementary agreement to the Convention on Biological Diversity

Objective of the protocol

To contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of LMOs resulting from modern biotechnology, that may have adverse effects on the conservation and sustainable use of biodiversity, taking also into account risks to human health, and specifically focusing on trans boundary movements.

Definition of LMO
A living modified organism

(LMO) is any living organism

that possesses a novel combination of genetic

material obtained through

the use of modern biotechnology. Also

frequently known as
genetically modified organism.

Categories of LMOs
For intentional introduction
e.g. Seeds, live fish

For direct use as For contained FFP ( food, feed use. or for e.g. bacteria for processing) laboratory
e.g. Agril. Commodities purposes, scientific experiments.

1993 1999 2000 2001
CBD entered into force on Dec.29, 1993. EXCOP1- Decisions on the continuation of the first extraordinary meeting of the Conference of the Parties to the Convention on Biological Diversity, adoption of the Cartagena Protocol and interim arrangements. The Cartagena Protocol on Biosafety is opened for signature. Fifth meeting of the CoP- Work plan of the Intergovernmental Committee for the Cartagena Protocol (ICCP 1) on Biosafety.

ICCP 2,Nairobi, Kenya

2002 2003

ICCP3, The Hague, Netherlands

Cartagea protocol came into force on Sept. 11,03.The Hague, The Netherlands

Key elements of protocol

Advance Informed Agreement Procedure Risk assessment and management Handling, Transport, Packaging, Identification Information-sharing and the Biosafety ClearingHouse C apacity Building Socio-economic considerations Liability and redress Compliance Public Awareness and Participation

Advance Informed Agreement Procedure

Applies prior to the first international trans boundary movement of a LMO for intentional introduction into the environment. C onsists of the following major steps:
Notification Risk assessment Decision making

S ome exceptions: pharmaceuticals, LMOs in transit, LMOs for contained use, LMO-FFPs.

LMOs Intended for Direct Use as Food or Feed, or for Processing

Parties are obliged to provide to the BCH information on any decisions regarding domestic use of LMO-FFPs. Parties may take decisions on LMO-FFPs under their domestic regulatory framework that is consistent with the objectives of the Protocol. In the absence of a domestic regulatory framework, developing country Parties and Parties with economies in transition may declare through the BCH their intent to take decisions on LMO-FFPs imports based on risk assessment in accordance with Annex III within 270 days or less.

Risk Assessment / Risk Management

Annex III specifies risk assessment principles and scientific methodology. Science-based, case-by-case assessment, transparent process. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk or an acceptable risk.

Handling, Transport, Packaging and Identification

Requires Parties to take measures to ensure safe handling, transport, and packaging. Includes identification / documentation. Requires the Parties to consider the need for standards for HTPI practices, in consultation with other international bodies.

Information Sharing
The Protocol establishes a Biosafety Clearing-House to:
Facilitate exchange of information including laws, scientific data, risk assessments, decisions, etc. Assist Parties to implement the Protocol.

U nder the ICCP, a pilot phase of the BCH has been developed and is operational. Trans-boundary movement of living modified organisms by establishing procedures for the export and import of these organisms and maintaining an information exchange mechanism.

Trans boundary Movement of LMOs-FFP

Trans boundary movements of LMOs-FFP are subject to the following two-step procedure:
Step 1: Informing the Biosafety Clearing-House about the final decision on domestic use. Step 2: Decision making by a potential importing Party. A Party may take a decision on the import of an LMO-FFP under its domestic regulatory framework.

Procedures for trans boundary movements of living modified organisms (LMOs) under the Cartagena Protocol on Biosafety

Article 22 mandates Parties to cooperate in capacitybuilding relevant to the Protocol, including development and strengthening of human resources and institutional capacities in:
Biotechnology, to the extent that it is required for safety. For effective implementation of the Protocol.

Capacity building

O ther agencies and institutions are heavily involved in capacity-building activities (e.g. UNEP/GEF project on NBFs)
The most pressing capacity needs in general include:
Capacity to use and provide all required information to the BCH. Capacity to make informed decisions based on risk assessment and other factors.

Revisiting the context for biosafety regulation of GE crops to ensure that both the risk assessment and any non-safety considerations. Rationalizing environmental risk assessment information and data requirements to focus exclusively on issues that are relevant to assessing plausible adverse environmental impacts of GE crops. Incorporating the assessment of environmental benefits of GE crops in agricultural ecosystems. Improving biosafety capacity building and short-term technical training to pursue sustained commitments to operationalise, monitor, and improve the regulatory systems that are put into place.

Indian Status
Only one crop approved. 14 crops under various stages of contained field trials. Include brinjal, cotton, cabbage, groundnut, pigeon pea, mustard, potato, sorghum, tomato, tobacco, rice, okra and cauliflower. Traits include insect resistance, herbicide tolerance, virus resistance, nutritional enhancement, salt tolerance, fungal resistance.

Need for Biosafety regulations

To regulate production and release of GMOs in any country with a biotechnology programme. Ensures safe access to new products and technologies developed in the country or elsewhere.

Provides a level of public confidence that products placed on the market have been assessed as safe.

Regulatory framework in India

Government rules for GMOs. Recombinant DNA guidelines, 1990 Guidelines for Research in Transgenic Plants, 1998 Seed Policy, 2002 Prevention of Food Adulteration Act. The Food Safety and Standards Bill, 2005 Plant Quarantine Order, 2003. Task force on Application of Agricultural Biotechnology. Draft National Environment Policy, 2004. Draft National Biotechnology Strategy, 2005.

India ratified the protocol on 23 January 2003 and it came into force in September 2003.

Cartagena Protocol: Status of compliance in India rd

Major elements that merit attention include AIA procedure, simplified system for agricultural commodities, risk assessments, risk management and emergency procedures, export documentation, biosafety clearing house, capacity building, public awareness and participation and issue of non parties.
Competent authority and contact points notified. Rules in place but harmonization required with the procedures for trans boundary movements.

DBT guidelines for research in plants but environmental risk assessment procedures to be streamlined including the baseline information.
Detailed guidelines required for handling, transport, packaging and identification. Information sharing needs to be strengthened.

Methods and mechanisms for detecting unintentional or illegal movements.

Mechanisms for determining value addition to specific socio economic groups . National consultation on l&R regime.

Case study on Bt cotton

Bt cotton was for the first time introduced in India in 2002. In 2002, three varieties of Bt cotton hybrids promoted by Mahyco-Monsanto (Mech 12 Bt, Mech 162 Bt, Mech 184 Bt) were approved for commercialization in 6 states of India Biosafety assessment Studies on environmental safety pollen escape/out crossing aggressiveness and weediness effect of bt on non target organisms presence of bt protein in soilstudies

effect of bt protein on soil micro flora studies


Compositional analysis Allergenicity studies Toxicological studies Presence of Bt protein in cotton seed oil Feeding studies on cows, buffaloes, poultry and fish.

MANAGEMENTPEST POPULATION EXPOSED TO Bt CROPS CONTINUOUSLY FOR SEVERAL YEARS MAY DEVELOP RESISTANCE TO THE Bt TOXINS THROUGH NATURAL SELECTION MUTATION, AND SELECTION : To prevent resistance build up it is recommended to plant sufficient non Bt cotton (20%) to serve as a refuge for Bt susceptibility in seeds The refuge strategy is designed to ensure that Bt susceptible insects will be available to mate with Bt resistant insects, should they arise. Available genetic data indicates that susceptibility is dominant over resistance. Therefore, the offspring of these matings would most likely be Bt susceptible, thus mitigating the spread of resistance in the populations