2nd semester ppt

1. CARTAGENA PROTOCOL ON
BIO SAFETY
NISHANT KUMAR
M.Sc. (BIOTECHNOLOGY)
DEPARTMENT OF BIOTECHNOLOGY (CAMPUS) CCS
UNIVERSITY

2. BACKGROUND HISTORY
 Protocol to the Convention on Biological Diversity
(CBD)
 CBD opened for signature in 1992 and entered into
force on 29 Dec 1993
 As far as possible and as appropriate, establish or
maintain means to regulate, manage or control the risks of
biotechnology”
 Shall consider the need for a protocol setting out
appropriate procedures in the field of the safe transfer,
handling and use of any living modified organism resulting
from biotechnology …”
 Cartagena Bio Safety Protocol (CBSP) negotiated
from 1996-2000; entered into force in Sept. 2003;
over 100 Party Members; an international treaty.

3. .
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BIO SAFETY AND THE CARTAGENA
PROTOCOL: OBJECTIVE & SCOPE
 Biosafety: The need to protect human health and environment
from the possible adverse effects of the products of modern
biotechnology.
 Protocol Objective: Adequate protection in the safe transfer,
handling and use of living modified organisms (LMOs) resulting
from modern biotechnology that may have adverse effects on the
environment & human health
 Scope: Transboundary movement, transit, handling and use of
LMOs that can affect sustainable use of biological diversity.
Phramceuticalsa are excluded.
 Adopts a Precautionary approach.

4. .
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KEY ELEMENTS OF THE PROTOCOL
 Objective and scope
 Advance informed agreement
 LMO-FFPs
 Risk assessment and management
 Identification of LMOs (labeling)
 Information sharing; Biosafety Clearing House
 Capacity building
 Socio-economic considerations
 Liability and redress
 Compliance

5. MAIN PILLARS OF THE PROTOCOL
SAFE HANDLING, TRANSPORT AND ID
RISK MANAGEMENT
RISK ASSESSMENT
BIOSAFETY CLEARING HOUSE
AIA PROCEDURE

6. ADVANCED INFORMED AGREEMENT
 Differentiated procedures for LMOs for intentional
introduction into the environment and LMOs for direct
use as food, feed or for processing (LMO-FFPs)
 AIA=Prior Informed Consent (PIC)
 For first movement of LMOs for intentional introduction into
environment
 Exporter must provide detailed information in advance of first
shipment
 Importer may then authorize/refuse shipment, depending on RA
 AIA Procedure :
 Notification
 Acknowledgement by importer (90 days)
 Decision procedure and review of decisions

7. ADVANCED INFORMED AGREEMENT
 Notification
 Party of export must notify Party of import prior to 1st international
transboundary movement of an LMO for introduction into the
environment of the Party of import
 Exporter must provide, as a minimum, information in Annex 1
 Each Party of export must legally require its exporters to ensure
that information in the notification is accurate
 Acknowledgement
 Party of import must acknowledge receipt within 90 days & state
1. whether the notification contains the minimum information
required (in Article 8) and
2. whether the importation should proceed according to national
law or to the decision procedure in Article 10

8. DECISION PROCEDURE
 Importer asks exporter to do a risk assessment
 The onus is on the Party of export to establish the harmless nature
of the LMO in question
 Importer submits risk assessment
 Importer communicates decision to exporter in 270 days
 To exporter :
i) approval with or without conditions
ii) prohibition/refusal
iii) request for additional information or
iv) extension of decision-making period beyond the 270 days
 Importer may review/change its decision in light of new
information
 Exporter may also request a review

9. RISK ASSESSMENT & RISK MANAGEMENT
 Risk Assessment
 Identification of potential environmental adverse effects or hazards,
and determining, when a hazard is identified, the probability of it
occurring
 In accordance with principles, methodologies & details in Annex III
 Identify/evaluate potential adverse effects—scientifically, case by case
 Minimum information, Annex 1: Ensured by importer, cost by exporter
 Lack of knowledge, not lack of risk
 Risk Management
 Methods applied to minimize potential hazards or adverse effects
identified by the assessment
 Measures to manage and control risks
 Prevent unintentional LMO movement
 Ensure that LMOs are observed for an appropriate period before use

10. HANDLING, TRANSPORT, PACKAGING &
IDENTIFICATION
 Shipments of different categories of LMOs will be
accompanied by documentation with varying details:
 LMO-FFPs: will identify them as ‘may contain’ LMOs, not
intended for introduction into the environment and contact
details of consignee (details to be defined by COP-MOP)
 Contained use: clearly identifies them as LMOs, specifies
conditions for safe handling, storage/use and contact details of
consignee
 For introduction into environment: clearly identifies them as
LMOs, specifies the identity and relevant traits and/or
characteristics, along with any requirements for their safe
handling, storage, transport and use, contact information and
declaration that the movement conforms to the requirements of
the Protocol

11. CONVENTION ON
BIOLOGICAL
•
•
•
Diversity
1992
196Parties
Objectives:
 Conservation and sustainable use
of biodiversity
 Fair and Equitable sharing of
benefits arising from the useof
genetic resources

12. CARTAGENA PROTOCOL ON BIOSAFETY
•
•
•
2000
171Parties
Objective:
 Safeuse of living modified
organisms (focus on importand
export)
• Highlight: mandatory
environmental riskassessments

13. THANK YOU