Cyrie Sendashonga

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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

• Background
• Key elements of the Protocol
• 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 80s.
• 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)
Sustainable use

• Objectives of the CBD
• 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

Fair and equitable sharing of benefits
Conservation of biodiversity
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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
• CBDs 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/stake
  holders 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_at_cbd.int
• Tel. [phone]
• Web www.cbd.int