Introduction
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.
Definition of LMO
A living modified organism
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.
Timeline
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.
2002 2003
Cartagea protocol came into force on Sept. 11,03.The Hague, The Netherlands
S ome exceptions: pharmaceuticals, LMOs in transit, LMOs for contained use, LMO-FFPs.
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.
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.
Opportunities
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.
Provides a level of public confidence that products placed on the market have been assessed as safe.
India ratified the protocol on 23 January 2003 and it came into force in September 2003.
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.
Compositional analysis Allergenicity studies Toxicological studies Presence of Bt protein in cotton seed oil Feeding studies on cows, buffaloes, poultry and fish.
RISK ASSESSMENT
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