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SWATI BANSAL
• 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).

• Ent ers into force 90 days after 50th ratification.

• COP serving asthe Meeting of the Parties (COP/MOP) will be

the sovereign body when in force.
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.
• 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
1993 • CBDentered into force on Dec.29,1993.

• EXCOP1-Decisions on the continuation of the first

1999 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.
2000 • Fifth meeting of the CoP- Work plan of the Intergovernmental
Committee for the Cartagena Protocol (ICCP1) on Biosafety.

2001 • ICCP2,Nairobi,Kenya

2002 • ICCP3, The Hague,Netherlands

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

2003 Netherlands
To contribute in 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.
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.
For intentional
introduction
For direct use as
• e.g. Seeds, live fish FFP( food, feed
or for
processing) For contained
use
• e.g. Agril.
Commodities • e.g. bacteria for
laboratory
purposes, scientific
experiments.
 Advance Informed Agreement Procedure
Risk Assessment and Management
Handling, transport, identification
Information sharing and the Bio-safety Clearing House
Capacity Building
Economic considerations
Liability and redress compliance
Public awareness and participation
• Applies prior to the first international trans
boundary movement of a LMO for intentional
introduction into the environment.

• Consists of the following majorsteps:

– Notification
– Risk assessment
– Decision making

• Some exceptions: pharmaceuticals, LMOs

in transit, LMOs for contained use,LMO-
FFPs.
• Annex III specifies risk assessment principles
and scientific methodology.
• Sciencebasedcase-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 acceptablerisk.
• Requires Parties to take measures to ensure
safe handling, transport, and packaging.
• Includes identification / documentation.
• Requiers the Parties to consider theneed for
standards for HTPI practices, in
consultation with other international
bodies.
• The Protocol establishes a Biosafety Clearing-House to:
– Facilitate exchange of information including laws,scientific
data, risk assessments, decisions, etc.
– Assist Parties to implement theProtocol.
• Under the ICCP, a pilot phase of the BCHhas
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 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.
• Article 22 mandates Parties to cooperate in capacity-
building 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.

• Other agencies and institutions are heavily involved in

capacity-building activities (e.g. UNEP/GEF project on NBFs)
• Revisiting the context for biosafety regulation of GEcrops to ensure
that both the risk assessment and any non-safetyconsiderations.

• Rationalizing environmental risk assessment information and data

requirements to focus exclusively on issues that are relevant to
assessing plausible adverse environmental impacts of GEcrops.

• Incorporating the assessment of environmental benefits of GEcrops

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.
• Management pest 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
• Government rules for GMOs.
• Recombinant DNA guidelines, 1990
• Guidelines for Research in Transgenic Plants,1998
• Seed Policy, 2002
• Prevention of Food AdulterationAct.
• 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.
• 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.