Cartagena Protocol on Biosaefty

7/30/2019 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

Documents

Cartagena Protocol on Biosaefty