Cartagena Protocol on Biosaefty
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Transcript of Cartagena Protocol on Biosaefty
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Submitted by:
Komal preet Kaur
Shivin Shakaya
Sorabh Kumar
Cartagena Protocol on
Biosafety
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Introduction
Adopted on 29 January 2000.
103 signatures, 45 countries and a regional economic integrationorganization have deposited their instruments of ratification oraccession (10 in Africa Botswana, Cameroon, Djibouti, Kenya,
Lesotho, Liberia, Mali, Mauritius, Mozambique, Tunisia, Uganda).
Enters into force 90 days after 50th ratification.
COP serving as the Meeting of the Parties (COP/MOP) will be the
sovereign body when in force.
In the interim, the Intergovernmental Committee for the CartagenaProtocol (ICCP) has been preparing for the first MOP.
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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.
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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 asgenetically modified organisms (GMOs), which are
a product of modern biotechnology.
The Protocol is a supplementary agreement to theConvention on Biological Diversity
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Objective of the protocol
To contribute to ensuring an
adequate level of protection in the
field of the safe transfer, handlingand use of LMOs resulting from
modern biotechnology, that mayhave adverse effects on theconservation and sustainable use
of biodiversity, taking also into
account risks to human health, andspecifically focusing on trans
boundary movements.
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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.
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Categories of LMOsFor intentionalintroduction
e.g. Seeds, live fish
For direct use asFFP ( food, feedor forprocessing)
e.g. Agril.Commodities
For containeduse.
e.g. bacteria forlaboratorypurposes, scientificexperiments.
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TimelineCBD entered into force on Dec.29, 1993.
1993EXCOP1- Decisions on the continuation of the first extraordinary
meeting of the Conference of the Parties to the Convention onBiological Diversity, adoption of the Cartagena Protocolandinterim arrangements.
1999
The Cartagena Protocol on Biosafety is opened for signature.
Fifth meeting of the CoP- Work plan of the IntergovernmentalCommittee for the Cartagena Protocol (ICCP 1) on Biosafety.2000
ICCP 2,Nairobi, Kenya2001
ICCP3, The Hague, Netherlands2002Cartagea protocol came into force on Sept. 11,03.The Hague, The
Netherlands2003
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Key elements of protocol
Advance InformedAgreement Procedure
Risk assessment and
management Handling, Transport,
Packaging,Identification
Information-sharing andthe Biosafety Clearing-House
Capacity Building
Socio-economicconsiderations
Liability and redress Compliance
Public Awareness andParticipation
f
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Advance Informed Agreement
Procedure
Applies prior to the first international transboundary movement of a LMO for intentionalintroduction into the environment.
Consists of the following major steps: Notification
Risk assessment
Decision making
Some exceptions: pharmaceuticals, LMOs intransit, LMOs for contained use, LMO-FFPs.
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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 theobjectives 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 takedecisions on LMO-FFPs imports based on risk assessment inaccordance with Annex III within 270 days or less.
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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.
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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.
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Information Sharing
The Protocol establishes a Biosafety Clearing-House to:
Facilitate exchange of information including laws, scientificdata, risk assessments, decisions, etc.
Assist Parties to implement the Protocol.
Under the ICCP, a pilot phase of the BCH has beendeveloped and is operational.
Trans-boundary movement of living modifiedorganisms by establishing procedures for theexport and import of these organisms andmaintaining an information exchange mechanism.
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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 thefinal 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-FFPunder its domestic regulatory framework.
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Procedures for trans boundary movements of
living modified organisms (LMOs)
under the Cartagena Protocol on Biosafety
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Capacity building Article 22 mandates Parties to cooperate in capacity-
building relevant to the Protocol, including developmentand strengthening of human resources and institutionalcapacities in: Biotechnology, to the extent that it is required for safety.
For effective implementation of the Protocol.
Other agencies and institutions are heavily involved incapacity-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.
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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 technicaltraining to pursue sustained commitments to operationalise,
monitor, and improve the regulatory systems that are put into
place.
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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, nutritionalenhancement, salt tolerance, fungalresistance.
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Need for Biosafety regulations
To regulate production and release of GMOs inany country with a biotechnology programme.
Ensures safe access to new products and
technologies developed in the country orelsewhere.
Provides a level of public confidence thatproducts placed on the market have beenassessed as safe.
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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.
C P l
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Cartagena Protocol:
Status of compliance in India India ratified the protocol on 23rd January 2003 and it came
into force in September 2003.
Major elements that merit attention include AIA procedure,simplified system for agricultural commodities, riskassessments, risk management and emergency procedures,
export documentation, biosafety clearing house, capacitybuilding, public awareness and participation and issue ofnon parties.
Competent authority and contact points notified.
Rules in place but harmonization required with theprocedures for trans boundary movements.
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DBT guidelines for research in plants but environmental riskassessment procedures to be streamlined including the baseline
information.
Detailed guidelines required for handling, transport, packaging andidentification.
Information sharing needs to be strengthened.
Methods and mechanisms for detecting unintentional or illegalmovements.
Mechanisms for determining value addition to specific socioeconomic groups .
National consultation on l&R regime.
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Case study on Bt cotton
Bt cotton was for the first time introduced in India in 2002. In 2002, three varieties
ofBt 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
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STUDIES ON FOOD SAFETY
Compositional analysis
Allergenicity studies Toxicological studies
Presence of Bt protein in cotton seed oil
Feeding studies on cows, buffaloes, poultryand fish.
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RISK ASSESSMENT
MANAGEMENTPEST POPULATION EXPOSED TO Bt CROPSCONTINUOUSLY FOR SEVERAL YEARS MAY DEVELOP RESISTANCE TO THEBt TOXINS THROUGH NATURAL SELECTION MUTATION, AND SELECTION :
To prevent resistance build up it is recommended to plant sufficient nonBt cotton (20%) to serve as a refuge for Bt susceptibility in seeds
The refuge strategy is designed to ensure that Bt susceptible insects willbe available to mate with Bt resistant insects, should they arise.
Available genetic data indicates that susceptibility is dominant overresistance.
Therefore, the offspring of these matings would most likely be Bt
susceptible, thus mitigating the spread of resistance in the populations