The Cartagena Protocol on Biosafety is an international agreement that establishes rules for international trade in living modified organisms (LMOs) to ensure the safe handling, transport, and use of LMOs. It allows countries to decide whether to accept imports of LMOs and establishes procedures for obtaining prior informed consent. Key aspects include an advance informed agreement procedure for imports, requiring risk assessments and managing risks of LMOs, accounting for socioeconomic impacts, and promoting public awareness and participation in decision making. The protocol also addresses illegal trade, information sharing, capacity building, and establishing a biosafety clearinghouse.

1. CARTAGENA PROTOCOL ON BIOSAFETY
PRESENTED BY
VARUN H R
19TUST4040
3RD SEM BIOTECHNOLOGY
J B CAMPUS
GUIDED BY
Dr. ANUPAMA S K
DEPARTMENT OF MICROBIOLOGY AND
BIOTECHNOLOGY
J B CAMPUS

2. INTRODUCTION
• “The Cartagena Protocol on Biosafety to the Convention on Biological
Diversity” (CBD) is an international treaty governing the movements
of ‘living modified organisms’ (LMOs) resulting from modern
biotechnology from one country to another.
• The protocol has been developed in response to advancements in the
area of modern biotechnology and associated concerns that LMOs
resulting from modern biotechnology may have negative effects on
‘biodiversity and human health’.
• It is an attempt to produce ‘globally harmonized regime’ for biosafety
to ensure the safe use of modern biotechnology.

3. • “The convention on biological diversity” was finalized in ‘Nairobi’ in
may 1992.
• Opened for signature at the “United Nations Conference on
Environment and Development” (UNCED) in ‘Rio de janerio’ on 5 June
1992.
• It entered into force on ‘29 December 1993’.
• Today, the convention is the main international instrument for
addressing ‘biodiversity issues’.
• It provides a “comprehensive and holistic” approach to the
‘conservation of biological diversity’.

4. • Biosafety is one of the issues addressed by the convention. This
concept refers to the need to protect ‘human health and
environment’ from the possible adverse effects of the products of
modern biotechnology.
• At the same time, modern biotechnology is recognized as having a
great potential for the promotion of human well-being, particularly in
meeting critical needs for food, agriculture and healthcare.
• The convention clearly recognizes these twin aspects of modern
biotechnology
a. It provides for the access to and safe transfer of technologies.
b. Seek to ensure the development of appropriate procedures to
enhance the safety of biotechnology.

5. • At its second meeting, held in November 1995, the conference of
parties to the convention established an open-ended Ad Hoc working
group on biosafety to develop a draft protocol on Biosafety, focusing
specially on the ‘transboundary movement’ of “Living Modified
Organism” (LMO).
• After several years of negotiations, the protocol, known as The
“Cartagena Protocol on Biosafety to the Convention on Biological
Diversity”, was finalized and adopted in ‘Montreal’ on ‘29 January
2000’ at an extraordinary meeting of the conference of parties.

6. • The conclusion of the Biosafety Protocol has been hailed as a
significant step forward in that it provides an ‘international regulatory
framework’ to reconcile the respective needs of ‘trade and
environment protection’ with respect to a rapidly growing industry,
the biotechnology industry.
• The protocol thus creates an enabling environment for the
environmentally sound application of biotechnology, making it
possible to derive ‘maximum benefit’ from the potential that
biotechnology has to offer, while ‘minimizing the possible risks’ to the
environment and to human health.

7. OBJECTIVE
• In accordance with the ‘Precautionary approach’ contained in
‘principle 15’ of the “Rio Declaration on Environment and
Development”, the objective of this protocol is “to contribute to
ensuring an adequate level of protection in the field of the safe
transfer, handling and use of LMO resulting from modern
biotechnology that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to
human health, and specifically focusing on transboundary
movements”.

8. GENERAL PROVISIONS
• Each party shall take necessary and appropriate legal, administrative and
other measures to implement its obligations under this protocol.
• The parties shall ensure that the development, handling, transport, use,
transfer and release of any LMO are undertaken in a manner that prevents
or reduces the risks to biological diversity, taking also into account risks to
human health.
• Nothing in this protocol shall affect in any way the ‘sovereignty’ of states
over their territorial sea established in accordance with international law,
and the ‘sovereign rights’ and the ‘jurisdiction’ which states have in their
‘economic zones’ and their ‘continental shelves’ in accordance with
international law, and the exercise by ships and aircraft of all states of
‘navigational rights and freedoms’ as provided for in international law and
as reflected in relevant international instruments.

9. • Nothing in this protocol as restricting the right of a party to take
action that is more protective of the ‘conservation and sustainable
use of biological diversity’ than that called for in this protocol,
provided that such action is consistent with the objective and the
provisions of this protocol and is in accordance with that party’s other
‘obligations’ under international law.
• The parties are encouraged to take into account, as appropriate,
available expertise, instruments and work undertaken in international
forums with competence in the area of risks to human health.

10. USE OF TERMS
For the purposes of this protocol:
• “conference of parties”- conference of parties to the convention.
• “contained use”- any operation involving LMO, controlled by specific
measures.
• “Export and Import” – any transboundary movement from one party
to another.
• “exporter”- any legal or natural person, who arranges for LMO to be
exported.
• “importer”- who arranges for LMO to be imported.
• “living modified organism”- any living organism that possess a novel
combination of genetic material obtained through the use of modern
biotechnology.

11. • “living organism”- any biological entity capable of transferring or
replicating genetic material.
• “modern biotechnology” means the application of:
a. Invitro nucleic acid techniques, including recombinant DNA and
direct injection of nucleic acid into cells/organelles or
b. Fusion of cells beyond the taxonomic family, that overcome natural
physiological reproductive or recombination barriers and that are
not techniques used in traditional breeding and selection.

12. • “regional economic integration organization”- an organization
constituted by ‘sovereign states’ of a given region, to which its
member states have transferred competence in respect of matters
governed by this protocol.
• “transboundary movement”- movement of LMOs from one party to
another party.

13. SCOPE
“This protocol shall apply to the transboundary movement, transit,
handling and use of all LMO that may have adverse effects on the
conservation and sustainable use of biological diversity, taking also into
account risks to human health”.

14. PHARMACEUTICALS
This protocol shall not apply to the transboundary movement of
LMOs which are ‘pharmaceuticals’ for humans that are addressed by
other relevant international agreements or organizations.

15. LIVING MODIFIED ORGANISMS(LMO)
• LMO means any “living organism that possesses a novel combination of
genetic material obtained through the use of modern biotechnology”.
• This means that only living organisms that contain ‘novel combinations of
genetic material’, and which have been produced using techniques of
modern biotechnology are defined as LMOs.
• Many countries use the term ‘LMO’ and ‘GMO’ interchangeably, and
consider that the term refers to same thing.
• The products of LMO which are ‘not living’ are excluded from the definition
of LMO, which are therefore not covered by scope of the protocol.
Example; oil produced from genetically modified (GM) canola or meat from
GM animals.

16. ADVANCE INFORMED AGREEMENT (AIA)
PROCEDURE
• Protocol has a special focus on ‘transboundary movements’.
• The procedure by which transboundary movements of LMOs are
regulated is known as “Advance Informed Agreement” (AIA)
procedure.
Steps involved are –
1. The party of export notifies or requires its exporters to notify the
party of import if there is an ‘intention’ to export a LMO.
2. Notification is then acknowledged by the party of import.

17. 3. The party of import may take a decision on the notification
according to its ‘domestic regulatory framework’.
4. The decision by the party of import is based on ‘risk assessment and
precaution’, and the party of import may take into account ‘socio-
economic considerations’ when making its decision.
5. A party is obliged to consult its ‘public’ in the decision-making
process, and must make the results of such decisions available to
public.
6. A party may make the following decisions; unconditional approval,
approval with conditions, prohibition of the import, request for
additional relevant information, or extension of the time period for
making a decision.

18. 7. The party of import is required to acknowledge receipt of the
notification within ‘90 days’ and has a total of 270 days from the time it
receives the notification to communicate its decision on transboundary
movement.

19. PROCEDURE FOR LMO - FFPS
• LMOs intended for direct use as food or feed, or for processing (LMO-
FFPS) are excluded from the AIA procedure.
• These LMOs makeup the bulk of traded GMOs, but they are not
subject to the AIA procedure.
• These LMOs include, GM foods, GM animal feed and GM microbes
used in industrial production.
• For this category, an alternative system, based on information sharing
via the “Biosafety Clearing House” (BCH) (a website database
administered by the CBD secretariat in Montreal) applies.

20. • When party makes a ‘final domestic decision’ on LMOs intended for
the ‘direct use as food or feed, or for processing’, that may be subject
to transboundary movement, minimal information must be posted on
BCH within ‘15 days’. This is the basically the extent of the ‘obligation
of the potential exporting party’.
• A party may take a decision on the import of the LMO-FFPs under its
‘domestic regulatory framework’ which must be consistent with the
‘objective of the protocol’.
• This explicitly preserves the right of parties to regulate LMO-FFPs in
much the same way as other LMOs, according to an AIA-like
procedure at national level.

21. How? To regulate LMO-FFPs, if at all, in the protocol was the subject of
much debate.
• It was argued by the majority of developing countries that the
intended use of LMO, even though for food, animal feed, or for
processing would not ensure that the LMO did not end up being,
example, planted or released into the environment, which might
entail ‘risks to environment and biological diversity’.
• Hence developing countries had wanted LMO-FFPs to be subject to
the same AIA procedure as other kinds of LMOs.
• This was resisted by the ‘Miami’ group in particular, and the resulting
procedure for LMO-FFPs, while preserving the rights of parties to
regulate LMO-FFPs according to their domestic regulatory framework,
is a compromise.

22. • Parties which are developing countries or which are economics in
transition may, if they do not have a domestic regulatory framework,
declare that their decision prior to the first import of LMO-FFPs will
be taken according to a risk assessment in accordance with the risk
assessment annex of the protocol, and that the decision will be made
within a predictable timeframe, which will not exceed 270 days.
• Again, this allows for an AIA like notification and decision-making
procedure for countries without domestic regulatory framework.

23. • The ‘multilateral nature’ of the notification procedure for LMO-FFPs is
vastly different from the bilateral nature of the AIA procedure for
other LMOs.
• The burden is placed on potential importing parties to constantly
monitor the BCH for any notifications for domestic approvals in
producer parties.
• Potential importing parties may have to initiate procedures for risk
assessment and decision making without knowing whether a given
LMO will ever be exported, or whether it will be exported to them.
• The burden of regulation of LMO-FFPs has thus been shifted from
exporting parties onto other parties, and from international to
domestic regulatory procedures.

24. RISK ASSESSMENT
• Risk assessments undertaken pursuant to this protocol shall be
carried out in a ‘scientifically sound manner’, such risk assessments
shall be based, at a minimum on information provided in accordance
with ‘article8’ and other available scientific evidence in order to
‘identify and evaluate’ the possible adverse effects of LMOs on
“conservation and sustainable use of biological diversity, taking also
into account risks to human health”.
• The party of import shall ensure that risk assessments are carried out
for decisions taken under ‘article 10’. It may require the exporter to
carry out the risk assessment.
• The cost of risk assessment shall be borne by the ‘notifier’ if the party
of import so requires.

25. RISK MANAGEMENT
• Measures based on risk assessment shall be imposed to the extent
necessary to ‘prevent adverse effects’ of LMOs on the conservation
and sustainable use of biological diversity, taking also into account
risks to human health, within the territory of the party of import.
• Each party shall take appropriate measures to prevent ‘unintentional
transboundary movements’ of living organisms, including such
measures as requiring a risk assessment to be carried out prior to the
first release of a LMO.

26. • Each party shall endeavor to ensure that any LMO, whether imported
or locally developed, has undergone an appropriate period of
observation that is commensurate with its “life-cycle or generation
time” before it is put to its intended use.

27. SOCIO-ECONOMIC CONSIDERATIONS
• Parties are entitled to take into account “socio-economic
considerations” arising from the impact of LMOs on biological
diversity when taking decisions on imports of all LMOs, as well as in
decision making at the national level.
• In particular, the value of biological diversity to ‘indigenous and local
communities’ is highlighted, and parties are encouraged to cooperate
on ‘research and information’ exchange on any socio-economic
impacts, especially on indigenous and local communities.

28. PUBLIC AWARENESS, EDUCATION AND
PARTICIPATION
• Public consultation in decision making is ‘mandatory’ under the
protocol, in accordance with ‘national laws and regulations’.
• The results of such decisions must also be made available to public,
parties are also under an obligation to ‘promote and facilitate public
awareness’, ‘education and participation’ on the impact of LMO
activities on biological diversity and human health, and to endeavor
to ensure that public awareness and education include access to
information on imported LMOs.

29. ILLEGAL TRANSBOUNDARY MOVEMENT OF
GMOs
• Parties must adopt appropriate measures to ‘prevent and penalize
import and export of any LMOs that are in contravention of domestic
measures’ implementing the protocol, which are illegal
transboundary movements.
• In such cases, the affected party may request the party of origin to
either ‘repatriate or destroy’ the LMO in question at its own expense.
• Parties must make a ‘available information’ about cases of illegal
transboundary movements pertaining to it, to the BCH.

30. HANDLING, TRANSPORT, PACKAGING AND
IDENTIFICATION OF TRANSBOUNDARY SHIPMENTS
“Parties are to take necessary measures to require that all LMOs that
are subject to transboundary movement within the scope of the
protocol are handled, packaged and transported under conditions of
safety, taking into consideration relevant international rules and
standards”.

31. INFORMATION SHARING AND BIOSAFETY
CLEARING HOUSE
• The protocol establishes a Biosafety Clearing House (BCH) to function
as a mechanism for the procedure that applies for LMO-FFPs and as a
means through which information relevant to the implementation of
the protocol is made available by the parties.
• It also serves to facilitate the exchange of scientific, technical,
environmental and legal information and experience with LMOs and
to assist parties to implement the protocol.
• Parties must make available to the BCH any information required to
be made available to the BCH under the protocol.

32. CAPACITY-BUILDING
• The parties shall cooperate in the development or strengthening of
human resources and institutional capacities in biosafety, including
biotechnology to the extent that it is required for biosafety.
• Cooperation in capacity building in biosafety shall subject to different
situation, capabilities and requirements of each party, include
scientific and technical training in the proper and safe management of
biotechnology and in the use of risk assessment and risk management
for biosafety and the enhancement of technological and institutional
capacities in biosafety.
• The needs of parties with economics in transition shall also be taken
fully into account for such capacity-building in biosafety.

33. LIABILITY AND REDRESS
The conference of the parties serving as the meeting of the parties to
this protocol shall, at its first meeting, adopt a process with respect to
the appropriate elaboration of international rules and procedures in
the field of liability and redress of damage resulting from
transboundary movements of LMOs, analyzing and taking due account
of the ongoing processes in international law on these matters, and
shall endeavor to complete this process within four years.

34. SECRETARIAT
• The secretariat established by “article 24 of the convention” shall
serve as the secretariat to this protocol.
• To the extent that they are distinct, the costs of the secretariat
services for this protocol shall be met by the parties hereto.
• The conference of parties serving as the meeting of the parties to this
protocol shall, at its first meeting decide on the ‘necessary budgetary
arrangements’ to this end.

35. MONITORING AND REPORTING
Each party shall monitor the ‘implementation of its obligations’ under
this protocol, and shall, at intervals to be determined by the
‘conference of the parties’ serving as the meeting of the parties to this
protocol, report to the conference of the parties serving as the meeting
of the parties to this protocol on measures that it has taken to
implement the protocol.

36. COMPLIANCE
The conference of the parties serving as the meeting of the parties to
this protocol shall -
• Consider and approve ‘cooperative procedures and institutional
mechanisms’ to promote compliance with the provisions of this
protocol and to address cases on non-compliance.
• These procedures and mechanisms shall include provisions to offer
‘advice or assistance’, where appropriate.
• They shall be separate from and without prejudice to the dispute
settlement procedures and mechanisms established by ‘Article27’ of
the convention.

37. ASSESSMENT AND REVIEW
The conference of the parties serving as the meeting of the parties to
this protocol shall undertake –
• “Five years after the entry into force of this protocol and at least
every five years thereafter, an evaluation of the effectiveness of the
protocol, including an assessment of its procedures and annexes”.

38. SIGNATURE
This protocol shall be open for signature at the “United Nations
Office” at ‘Nairobi’ by “states and regional economic integration
organizations” from 15 to 26 may 2000, and at ‘United Nations
Headquarters’ in New York from 5 June 2000 to 4 June 2001.

39. WITHDRAWAL
• At any time after ‘2 years’ from the date on which this protocol has
entered into force for a party, that party may withdrawal from the
protocol by giving ‘written notification’ to the ‘Depositary’.
• Any such withdrawal shall take place upon ‘expiry’ of one year after
the date of its receipt by the depositary, or on such later date as may
be specified in the ‘notification of the withdrawal’.

40. NATIONAL IMPLEMENTATION OF THE
PROTOCOL
• The protocol sets ‘minimum standards’ for the regulation of LMOs-
parties may take action that is ‘more protective’ of the conservation
and sustainable use of biological diversity than that called for in the
protocol. However, the action must be consistent with “objectives
and provision of the protocol” and be in ‘accordance with the parties
other obligations under international law’.
• Parties are also under an obligation to take the necessary and
appropriate legal, administrative and other measures to implement
their obligations under the protocol. This means that national
measures such as a “national biosafety law” should be put in place to
implement protocol obligations.

41. CONCLUSIONS
• The protocol contains many important principles, which are now
established in ‘international law’. However, it is a negotiated text with
deficiencies for biosafety.
• While strengthening the protocol and rectifying its deficiencies should
be long-term goal, it is critical that ‘national governments and
developing countries’ in particular, formulate “domestic biosafety
laws” that improve on the ‘scope and standards’ set by the protocol,
and which also comprehensively regulate the domestic development
and use of GMOs.
• As an international law that is binding on countries that are party to
it, the protocol presents “obligations on and opportunities for
sovereign countries”.

42. • As a negotiated text, many flexibilities for ‘interpretation and
implementation’ are available for countries to utilize, putting real
biosafety at the ‘heart of national regulation’.
• In conclusion, the protocol is just the start of the long and difficult
road to effective “international regulation of genetic engineering”.
• Much more needs to be done and countries must act to ensure that
‘real biosafety becomes a reality’.

43. REFERENCES
• “Cartagena protocol on biosafety to the convention on Biological
Diversity”, text and Annexes, Montreal 2000, secretariat of the
convention on Biological diversity. ISBN: 92-807-1924-6.
• Cartagena protocol on biosafety: an overview, phase 2 capacity
building project on biosafety, ministry of environment, forest and
climate change, government of India , 2015.
• Lim li lin, Cartagena protocol on biosafety, third world network.
• Cartagena protocol on biosafety: A guide, phase 2 capacity building
project on biosafety, ministry of environment, forest and climate
change, government of India , 2017.

44. THANK YOU