The Cartagena Protocol on Biosafety to the

Convention on Biological Diversity

Cyrie Sendashonga
Currently: Regional Coordinator, CIFOR, Regional Office for
Central Africa, Yaounde, Cameroon

Formerly: Senior Programme Officer, Head of Biosafety Unit

Secretariat of the Convention on Biological Diversity

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 Programme
1. Background
2. Key elements of the Protocol
3. Conclusions

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 1. Background
• The Protocol is an international legally binding treaty
which sets procedures and mechanisms to be applied in the
transboundary movements of Living Modified Organisms
(LMOs)- living organisms that possesses a novel
combination of genetic material obtained through the use
of modern biotechnology (genetic modification).
• The Protocol does not apply to other products of
biotechnogy.

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 Objective of the Protocol (Article 1)
• «  Contribute to ensuring an adequate level of protection in
the field of the safe transfer, handling and use of living
modified organisms 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. »
• The Protocol is not a moratorium on modern
biotechnology.

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 Origin of the Protocol
• Broad recognition of the need to protect human health and the
environment from possible adverse effects of the products of modern
biotechnology began to emerge as advances in molecular biology and
genetic engineering were breaking new frontiers in the 80’s.
• UNCED (World Summit, Rio, June 1992): Agenda 21, Chapter 16 :
recognition of the need for need for sound environmental management
of biotechnology
• Principle 15 of the Rio Declaration on Environment and Development:
the precautionary approach “…where there is a threat… lack of full
scientific certainty should not be used as a reason for postponing
measures to avoid or minimize such a threat.”

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 Origin of the Protocol (continued)
Objectives of the CBD:
Sustainable use
Conservation of Fair and equitable
biodiversity sharing of benefits

Article 8(g) of the CBD: “Each Contracting Party shall, as far as possible and as
appropriate: (g) Establish or maintain means to regulate, manage or control the
risks associated with the use and release of living modified organisms resulting
from biotechnology which are likely to have adverse environmental impacts that
could affect the conservation and sustainable use of biological diversity, taking
also into account the risks to human health”

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 Origin of the Protocol (continued)
Article 19.3 of the CBD:
“The Parties shall consider the need for and modalities of a
protocol setting out appropriate procedures, including, in
particular, advance informed agreement, in the field of the
safe transfer, handling and use of any living modified
organism resulting from biotechnology that may have
adverse effect on the conservation and sustainable use of
biological diversity. ”

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 Facts and Figures
• Protocol adopted on 29 January 2000 in Montreal at
an extraordinary meeting of the Conference of the
Parties to the Convention on Biological Diversity.
• 143 ratifications/accessions ( as of 03 October 2007,
of which 40 African countries)
• 17 countries have signed but not yet ratified.

Entered into force on 11 September 2003

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 Why do we need a Protocol?
• Rapid development and commercialisation of
biotechnology and its products, including LMOs
• Recognition of potential contribution that biotechnology
can make to improving human well-being
• Uncertainties regarding potential risks of LMOs on
biodiversity and human health
• Lack/limited capacities of many countries to make
enlightened decisions concerning imports of LMOs

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 Excerpts from Preamble:
• Benefits of modern biotechnology:
“Recognizing that modern biotechnology has great potential for
human well-being if developed and used with adequate safety
measures for the environment and human health.”
• Concerns about potential risks:
“Aware of the rapid expansion of modern biotechnology and the
growing public concern over its potential adverse effects on
biological diversity, taking also into account risks to human health.”
• Limited capacities:
“Taking into account the limited capabilities of many countries,
particularly developing countries, to cope with the nature and scale of
known and potential risks associated with living modified
organisms.”

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 Excerpts from Preamble:
• Trade and environment imperatives:
“Recognizing that trade and environment agreements should be
mutually supportive with a view to achieving sustainable
development.”
• Importance of avoiding “contamination”:
“Recognizing also the crucial importance to humankind of centres of
origin and centres of genetic diversity”.

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 Facts on LMOs

• GM crops are presently the principal category of LMOs on

the market
• In 2004, the value of global transgenic seeds was evaluated
at US$ 4.7 billion
• In 2004, GM crops could be found in 17 countries

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 Facts on LMOs (continued)
• Between 1996 and 2003, GM crops coverage went from
1,7 million hectares to 67,7 million hectares
• 99% of this coverage is concentrated in 6 countries: United
States of America (66%), Argentina (22%), Canada (6%),
Brazil, China and South Africa
• Principal crops: soy, maize, cotton and canola
• Principal characteristics : tolerance to herbicides (75%)
and resistance to pests (17%)
• 5 major multinationals control the LMO market: Monsanto
(91%), Dupont, Syngenta, Bayer and Dow

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 Definitions/Use of terms (Article 3)
• Living modified organism (LMO): any living organism that possesses a novel
combination of genetic material obtained through the use of modern
biotechnology
• Living organism: any biological entity capable of transferring or replicating
genetic material, including sterile organisms, viruses and viroids
• Modern biotechnology: application of in vitro nucleic acid techniques (e.g.
recDNA and direct injection of nucleic acid into cells or organelles),or fusion
of cells beyond the taxonomic family, that overcome natural physiological
reproductive or recombinant barriers and that are not techniques used in
traditional breeding and selection

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 Potential benefits of biotechnology
• Proponents of genetic engineering claim that it holds great
promises and remarkable advances in medicine (e.g.: new
medical treatments, vaccines, etc), industrial products,
improved fibres and fuels, increases in food security,
decreased pressure on land use, sustainable yield increase
in marginal lands or inhospitable environments, reduced
use of water and agrochemicals in agriculture.

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 Potential risks of modern biotechnology

• very new field: little is known about the interaction of LMOs with
various ecosystems, potential adverse effects on biological diversity
and human health
• Areas of concern: changes in biological characteristics of the target
species (e.g: increased virulence, weediness, competitiveness with
other species, toxicity, allergenicity, gene flow/transfer to wild
relatives, stability of the transgene, etc.)

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 2. Key Elements of the Protocol
• Scope
• Advance Informed
Agreement Procedure
• Procedure for living
modified organisms intended
for direct use as food or feed,
or for processing
• Risk assessment and
management
• Handling, Transport,
Packaging and Identification
• Information-sharing and the
Biosafety Clearing-House
• Capacity Building
• Socio-economic
considerations
• Liability and redress
• Compliance
• Public Awareness and
Participation
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 Scope of the Protocol (Article 4)
• The Protocol applies to the transboundary movement,
transit, handling and use of all living modified organisms
that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into
account risks to human health.

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 Scope of the Protocol (continued)

• Exclusion: The Protocol does not apply to the

transboundary movement of living modified
organisms which are pharmaceuticals for humans
that are addressed by other relevant international
agreements or organisations (Article 5).

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 The AIA procedure (Articles 7, 8, 9, 10 & 12)

• The advance informed agreement procedure (AIA) applies

to the first intentional transboundary movement of LMOs
for intentional introduction into the environment

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 The AIA procedure (continued)
Exemptions:
• LMOs intended for direct use as food or feed, or for
processing are subject to a simplified procedure
(Article 11)
• The AIA procedure does not apply to LMOs in transit
or destined for contained use (Article 6)
• The AIA procedure does not apply to LMOs identified
in a decision of the Conference of the Parties, as being
not likely to have adverse effects on the conservation
and sustainable use of biodiversity (Article 7.4)

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 The AIA procedure (continued)
Steps:
• Notification from the exporter to the competent national
authority of the Party of import prior to the transboundary
movement of the LMO
• Acknowledgement of receipt of notification within 90 days
of its receipt
• The Party of import shall ensure that risk assessments are
carried out
• A decision is taken by the Party of import within 270 days
of the date of receipt of the notification

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 The AIA procedure (continued)
Results of the AIA procedure:
• Approving the import, with or without conditions
• Prohibiting the import
• Requesting additional relevant information
• Extension of the 270 day period by a defined period of
time
• Review and change of decisions – at any time

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Procedure for living modified organisms intended for direct use as
food or feed or for processing (Article 11)

• Revolves around a multilateral exchange of information regarding

such LMOs between potential Parties of export and potential Parties of
import
• Any Party that makes a final decision regarding domestic use,
including placing on the market, of a n LMO that may be subject to
transboundary movement shall, within 15 days of making that
decision, inform the Parties through the Biosafety Clearing-house
(BCH);
• In return, each Party shall make available to the BCH copies of any
national laws, regulations and guidelines applicable to the import of
such LMOs on their national territory.

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Risk Assessment and Risk Management (Articles 15 & 16)
• Annex III specifies the scope of risk assessment
• Scientific sound manner; transparency; case by case
• Absence/Lack or insufficiency of scientific knowledge or
scientific consensus does not indicate an absence of risk or
an acceptable risk
• Each Party shall establish and maintain appropriate
mechanisms, measures and strategies to regulate, manage
and control risks and to prevent unintentional
transboundary movements of LMOs

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 Handling, Transport, Packaging and Identification
(Article 18)
• Each Party takes necessary measures to require that LMOs ar handled,
packaged and transported under conditions of safety
• The Protocol sets minimal measures concerning documentation
accompanying LMOs that are subject to transboundary movements:
LMOs-FFP, LMOs for contained use, LMOs for intentional
introduction in the environment.

N.B. Not to confuse identification/documentation of LMOs under the

Protocol with “labelling” in everyday use

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Information Sharing and the Biosafety Clearing-House
(Article 20)
• A clearing-house (BCH) is established to:
– Facilitate the exchange of scientific, technical,
environmental and legal information and experience
with LMOs
– Assist Parties to implement the Protocol
• http://bch.cbd.int

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 Characteristics of the BCH (continued)
• Open to all governments
• Was developed as a distributed network composed of a Central
Portal maintained by the Secretariat and national nodes or data
bases that are inter-operable with the Central Portal
• Information is controlled and managed by the supplier
• Management Centre
• BCH National Focal Points
• Designed for use via the Internet but non-internet options are
available upon request

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 Capacity Building (Article 22)

• Parties cooperate in the development and/or

strengthening of human resources and institutional
capacities
• Cornerstone for the implementation of the
Protocol

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 Capacity Building (continued)
• An Action Plan adopted by governments at the first
meeting of the Parties (February 2004); updated at the
third meeting of the Parties (March 2006)
• A Roster of Experts in biosafety has been established to
help developing country Parties with the implementation
of the Protocol, especially concerning risk assessment and
risk management of LMOs in order to make informed
decisions regarding imports of LMOs.

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 Socio-Economic Considerations (Article 26)
• In reaching a decision on import, Parties may take into
account socio-economic considerations arising from the
impact of LMOs on the conservation and sustainable use
of biological diversity, especially with regard to the value
of biological diversity to indigenous and local
communities
• However, this must be consistent with other international
obligations

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 Liability and Redress (Article 27)
• The Protocol provides for a process to elaborate
appropriate international rules and procedures regarding
liability and redress for damage resulting from
transboundary movements of LMOs
• The first meeting of the Parties has set this process in
motion by establishing an Open-ended Working Group of
Legal and Technical experts to develop options for a
liability and redress regime under the Protocol
• Negotiations expected to be completed in 2007

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 Compliance (Article 34)
• Cooperative procedures and institutional mechanisms to
promote compliance and to address cases of non-
compliance have been approved at the first meeting of the
Parties
• Among them, a compliance committee composed of 15
experts has been set up

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Public awareness and participation (Article 23)
Parties are encouraged to:
• Promote and facilitate public awareness, education and
participation concerning the safe transfer and use of LMOs
• Endeavour to ensure public access to information on
LMOs that may be imported
• Consult the public in the decision-making process
regarding LMOs and make the results of such decisions
available to the public
• Inform the public about the means of public access to the
Biosafety Clearing-House (BCH)

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 GMOs in Forestry
GM Trees: CBD COP Decision VIII/19

• Uncertainties related to potential environmental and socio-economic impacts of GM

trees on global forest biological diversity as well as on livelihoods of indigenous/local
communities
• COP recommends Parties to take a precautionary approach when addressing the issue of
GM trees
• CBD’s SBSTTA to assess the potential environmental, cultural and socio-economic
impacts of GM trees on the conservation and sustainable use of forest biological
diversity and report to COP9
• Parties, governments, relevant organizations/stakeholders invited to submit views and
information to the Secretariat for inclusion in the assessment.

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 3. Conclusions
• The Protocol is a recognition in international law that LMOs
may have adverse effects on biodiversity and human health and
that a harmonized international framework regulating
transboundary movements of LMOs is indispensable
• The Protocol endorses and operationalizes the precautionary
approach
• The concept of the advance informed agreement in decision-
making regarding import of LMOS is the backbone of the
Protocol for LMOs intended for introduction into the
environment
• Capacity building/strengthening is paramount in this regard

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 3. Conclusions (continued)
• The exchange of information between all relevant stakeholders via
the BCH is indispensable for the functioning of the Protocol
• The Protocol recognizes the right of States to take more protective
measures for biodiversity than what the Protocol requires as long as
they are consistent with the objective and provisions of the Protocol
• It is important that Parties clearly understand their rights and
obligations under the Protocol, including the obligation to promote
and facilitate public awareness, education and public participation
in decision-making regarding LMOs

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 Information

• Secretariat of the CBD, Montreal

• E-mail: secretariat@cbd.int
• Tel.: (1 514) 288-2220
• Web: www.cbd.int

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