The Cartagena Protocol on Biosafety to the Convention

on Biological Diversity
 Intorduction

1. Background
2. Key elements of the Protocol
3. Conclusions
 Chronology of the Events on the Global Environment and Development
Leading to the Convention on Biological Diversity and the Cartagena Protocol
on Biosafety

 1962 Rachel Carson’s SILENT SPRING

 1972 UN Conference on the Human Environment organized in Stockholm,

Sweden (The Stockholm Conference)

 1981 IUCN began drafting the “ Convention on Biological Diversity”

 1987 UN World Commission on Environment and Development

(The concept of Sustainable Development initiated)

 December 1989 UN General Assembly (UNGA) called for a meeting of all

the nations on earth to deal with the problems and resolutions on matters
related to the environment and development (“ An Earth Summit” )
 May 22, 1992 UN Convention on Biological Biodiversity (CBD) adopted

 June 13, 1992 UN Conference on Environment and Development

(UNCED) (The Earth Summit/The Rio Summit) organized in Rio de
Janeiro, Brazil (Signing of the CBD)

 January 29, 2000 the Cartagena Protocol on Biosafety adopted in

Montreal, Canada
Origin of the protocol

 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
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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 Bio- Safety Protocol

 The Protocol is 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.
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 20124, the value of global transgenic seeds was evaluated
at US$ 5.7 billion
 In 20124, GM crops could be found in 26 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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 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 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.
Definitions

 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
General principles

 necessary and appropriate legal, administrative and other

measures
 Freedom of Navigation and sovereignty
 Minimum Protection.
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
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 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
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 Continues

 The Protocol distinguishes LMOs in three categories:

 LMOs for voluntary introduction into the environment –
such as seeds for planting, live fish for release, micro-
organisms for bioremediation;
 LMOs destined for contained use, being defined in Article
3(b) of the Protocol to include activities in which LMOs are
controlled by specific measures that effectively limit their
contact with, and their impact on, the external environment;
 LMOs intended for direct use as food or feed, or for
processing
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
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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Procedure
 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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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
 Required Information detailed in Annex 11

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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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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:

 Facilitatethe 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)

 Partiescooperate in the development

and/or strengthening of human resources
and institutional capacities
 Cornerstone for the implementation of the
Protocol

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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
 Liability Protocol concluded in 2010

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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

 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.
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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Liability Protocol Salient
features
 Art. 1 Objective: “ …to contribute to the conservation and
sustainable use of biological diversity…by providing
international rules and procedures in the field of liability and
redress relating to living modified organisms” ”
 Core obligation: Art. 5 and Art.12 (1) first half: obligation to
establish domestic legal system to address biodiversity damage
by requiring the operators to take response measures.”
 Far-reaching “ response measures” (Art.2 (2)(d))."
 Controversial “ financial security” (Art.10) and civil liability
(Art.12 (2)) provisions.
Liability Protocol 2010

 Scope
 This Supplementary Protocol applies to
damage resulting from living modified
organisms which find their origin in a
transboundary movement.
 Supplementary Protocol also applies to
damage resulting from unintentional
transboundary movements as well as damage
resulting from illegal transboundary
movements as referred to in Article 25 of the
Protocol.
Liability Protocol 2010

 A causal link shall be established between the damage and

the living modified organism in question in accordance with
domestic law
 Response measures consists of notification and evaluation
 Response measures shall be implemented in accordance
with domestic law.
Liability Protocol 2010

 “ Protocol defines the damage in its degree (significance) and its quality
(measurability or observability)."
 (2) Use of scientifically-established baselines recommended. "
 (3) Factors to determine “ significance” include: long-term change; beyond
natural recovery; reduction in providing goods and services; and effects on
human health."
 BUT no specifics as to:"
 (1) What constitutes biological diversity (beyond definition in
 CBD);"
 (2) What constitutes effects on conservation and sustainable use of
biodiversity;“
 Parties may use criteria set out in their domestic law to address damage
 Liability Protocol

 The operator’s primary liability (or consequent obligation after

causing damage) is to take response measures, rather than to
pay monetary compensation. (Art.5 (1), Art. 12 (1))"
 The operator’s liability is incurred in relation to the
administrative organ of the government, rather than in relation
to the victim of damage. (Art. 5 (2) (4) and (5)) "
 The operator’s liability will be pursued in most cases within the
administrative apparatus, rather than in the courts, and most
likely by applying administrative laws and procedures, rather
than civil or tort law. But see Art. 5 (7).
 Liability Protocol

 Exceptions
 Act of God or force majeure; and Act of war or civil unrest.
 Limitation of time and Finance
 This Supplementary Protocol shall not affect the rights and
obligations of States under the rules of general international
law with respect to the responsibility of States for
internationally wrongful acts.
 Parties to develop rules on Liability
Liability Protocol 2010

 “ Liability occlusion” : Problems facing civil liability

regimes"
 Academia: Brunnée (2004) questioning the “ sensibility” of
negotiating civil liability treaties."
 Most recent civil liability treaties not attracted support in the
form of ratifications."
 ILC’s work wandering over the concept of “ liability” "
 Rio Principle 13 (1992) enthusiasm faded?"
Cartagena Protocol on Biosafety Negotiating Groups:

 European Union (EU)

 Central and Eastern European Group (CEE)

 Miami Group (Argentina, Australia, Canada, Chile, United States, Uruguay)

 Like-minded Group (most developing countries)

 Compromise Group (Japan, Mexico, Norway, Republic of Korea and

Switzerland, later New Zealand and Singapore joined)

Law suits

 Canadian Percy Schmeiser got sued by Monsanto

after his fields became contaminated by their patented
GMOs in 1996. Monsanto wanted the profits from his
entire crop, a technology charge, plus a million dollars
in court costs. After years of court battles, the Supreme
Court of Canada dismissed Monsanto's financial
claims in 2004, but ruled the patented GM crops are
the company's property. This ruling opened the door
for massive class action lawsuits currently underway
Law Suits

 In EC Measures Concerning Meat and Meat Products

(Hormones) (Beef Hormones)
 WTO determined that an EC ban on the import of US beef
treated with artificial growth hormones could not be
justified by application of the precautionary principle. The
particular risk in question could not be established with
sufficient specificity as it was not clearly scientifically
proven: there was not a “rational relationship between the
trade measure and the risk assessment.”
 Law Suits

 Europe invoked the precautionary principle as a justification for its decision

to regulate genetically modified organisms (GMOs) in food, even in the
admitted absence of scientific evidence that GMOs are harmful to human
health or the environment. The United States argued that the EU’s actions
were not scientifically based as required under the WTO rules. The United
States said the EU’s position was protectionist and ran counter to all
existing scientific evidence. (WTO)
 The EU, in turn, argued that it had a right to set its own environmental and
public health standards and noted that the treaty establishing the
Community states that environmental policy should be ‘‘based on the
precautionary principle.’’ The controversy led among other things to the
European Commission issuing a communication setting forth the proper use
of the precautionary principle in the Community.
 Websites

 http://bch.cbd.int/protocol/cpb_faq.shtml#faq2

 Seeds Of Death Documentary

Thank you