BACKGROUND HISTORY o 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 ..." o Cartagena Bio Safety Protocol (CBSP) negotiated
from 1996-2000; entered into force in Sept. 2003; over 100 Party Members; an international treaty.
----------------------
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 o 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.
KEY ELEMENTS OF THE PROTOCOL . Objective and scope Advance informed agreement o LMO-FFPs o
Risk assessment and management Identification of LMOs (labeling) o Information sharing; Biosafety
Clearing House Capacity building Socio-economic considerations o Liability and redress Compliance
MAIN PILLARS OF THE PROTOCOL AIA PROCEDURE RISK ASSESSMENT RISK MANAGEMENT BIOSAFETY
CLEARING HOUSE SAFE HANDLING, TRANSPORT AND ID
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) o 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
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 o
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
DECISION PROCEDURE o 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 o Importer submits risk assessment o
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 decisionmaking period beyond the 270 days o Importer may review/change its decision in light of new
information Exporter may also request a review
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 o Risk Management • Methods applied to minimize
potential hazards or adverse effects identified by the assessment . Measures to manage and control
risks o Prevent unintentional LMO movement . Ensure that LMOs are observed for an appropriate
period before use
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
CONVENTION ON BIOLOGICAL Diversity 1992 DO CAI 196 Parties Objectives: - Conservation and
sustainable use of biodiversity - Fair and Equitable sharing of benefits arising from the useof genetic
resources
CARTAGENA PROTOCOL ON BIOSAFETY • 2000 • 171 Parties Objective: - Safe use of living modified
organisms (focus on importand export) Highlight: mandatory environmental risk assessments