Risk Assessment and Risk Management of Living Modified Organisms under the Cartagena Protocol on Biosafety - PowerPoint PPT Presentation

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Risk Assessment and Risk Management of Living Modified Organisms under the Cartagena Protocol on Biosafety

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Title: Risk Assessment and Risk Management of Living Modified Organisms under the Cartagena Protocol on Biosafety


1
Risk Assessment and Risk Management of Living
Modified Organisms under the Cartagena Protocol
on Biosafety
  • Ryan Hill and Cyrie Sendashonga
  • Secretariat of the
  • Convention on Biological Diversity

2
Outline
  • Introduction to the Protocol, including current
    status and key provisions
  • Risk assessment provisions and relevant
    decisions of the COP/MOP
  • Risk management provisions and relevant
    decisions of the COP/MOP
  • Future work

3
What is the Biosafety Protocol?
  • A Protocol to the Convention on Biological
    Diversity
  • The CBD was one of three conventions agreed by
    governments at the 1992 Rio Earth Summit, and has
    three objectives conservation of biodiversity,
    sustainable use of its components, fair and
    equitable sharing of the benefits arising
  • Mandate for a Protocol came from Article 19.3 of
    the Convention, and from Chapter 16 of Agenda 21

4
Defining LMO
  • Article 3
  • Living modified organism means any living
    organism that possesses a novel combination of
    genetic material obtained through the use of
    modern biotechnology.
  • Terms living organism and modern
    biotechnology are also defined.

5
Objective of the Protocol
  • In accordance with the precautionary approach
    contained in Principle 15 of the Rio Declaration,
    to contribute to ensuring an adequate level of
    protection in the field of the safe transfer,
    handling and use of LMOs resulting from modern
    biotechnology that may have adverse effects on
    the conservation and sustainable use of
    biodiversity, taking also into account risks to
    human health, and specifically focusing on
    transboundary movements.

6
Scope of the Protocol
  • Article 4
  • This Protocol shall apply to the transboundary
    movement, transit, handling and use of all LMOs
    that may have adverse effects on the conservation
    and sustainable use of biological diversity,
    taking also into account risks to human health.

7
Current Status
  • Negotiated from mid-90s adopted in January
    2000 entered into force September 2003
  • Currently 124 Parties
  • First Meeting of Parties (MOP-1) was held Feb
    2004 adopted a medium-term programme of work
    (2005-2008)
  • MOP-2 was held May-June 2005
  • MOP-3 scheduled for March 2006

8
Key Provisions
  • Decision-making procedures for import of LMOs
    (Advance Informed Agreement LMOs-FFP)
  • Risk assessment and risk management
  • Information-sharing and the Biosafety
    Clearing-House
  • Handling, Transport, Packaging, Identification
  • Capacity-Building
  • Compliance
  • Liability and redress
  • Public Awareness and Participation
  • Socio-economic considerations

9
Decision-Making Procedures
  • 1. Advance Informed Agreement Procedure
  • Applies to first transboundary movement of LMOs
    for release into the environment (e.g., crops for
    planting)
  • Exporter notifies importer in advance
  • Importer takes decision in accordance with risk
    assessment, and may take into account
    socio-economic considerations
  • Importer can require exporter to conduct and/or
    pay for the assessment

10
Decision-Making Procedures
  • 2. LMOs for Direct Use as Food or Feed, or for
    Processing
  • Domestic regulatory framework applies
  • Most regulatory frameworks require risk
    assessment
  • 3. LMOs in transit or for contained use are not
    subject to the AIA procedure
  • Note The decision-making procedures will be
    reviewed at MOP-4, in accordance with the
    medium-term programme of work and Articles 29.4
    and 35 concerning review of implementation of the
    Protocol.

11
Scenarios for Transboundary Movements of LMOs
Origin, Destination, Intended Use Requirements for Exporter or Party of Export Requirements for Party of Import
Domestic use within country A, not subject to transboundary movement No exporter or importer Country A responsible for preventing unintentional TB movements (16.3), and for taking measures in the event of an unintentional TB movement (17) No exporter or importer Country A responsible for preventing unintentional TB movements (16.3), and for taking measures in the event of an unintentional TB movement (17)
Country A to B for intentional introduction -AIA procedure notification (8), possibly conduct and/or pay for risk assessment (15.2, 15.3) -Documentation (18.2c) AIA procedure acknowledgment (9), decision (10) based on risk assessment (15) Risk management (16.1, 16.2) Information to BCH (20.3)
Country A to B for direct use as food or feed, or for processing Post domestic decision on BCH (11.1) Documentation (18.2a) Optional import decision (11.4 / 11.6) default is to allow import Information to BCH (20.3)
12
Scenarios for Transboundary Movements of LMOs
Origin, Destination, Intended Use Requirements for Exporter or Party of Export Requirements for Party of Import
Country A to B for contained use AIA not relevant (6.1) May be requirements set by importing country (6.1) Documentation (18.2b) -Information to BCH (20.3) if decisions taken under domestic framework
Country A to B in transit only AIA not relevant (6.2) May be requirements set by transit country (6.2) Documentation depends on use at final destination -Information to BCH (20.3) if decisions taken under domestic framework
Product derived from LMO shipped from country A to B Protocol does not apply if the product that is subject to TB movement does not meet the definition of LMO Protocol does not apply if the product that is subject to TB movement does not meet the definition of LMO
13
Risk Assessment(Article 15 and Annex III)
  • To be carried out on a case-by-case basis
  • Scientifically sound and transparent, taking into
    account recognized risk assessment techniques
  • Lack of scientific knowledge or consensus does
    not indicate particular level of risk, absence of
    risk, or acceptable risk
  • Comparative risk assessment (i.e., consider risks
    in the context of risks posed by non-modified
    recipients or parental organisms)
  • General methodology and points to consider
    described in Annex III (follows the conventional
    paradigm)

14
Risk Assessment Methodology(Annex III, Paragraph
8)
  • Hazard identification what could go wrong?
  • Likelihood of adverse effects
  • Consequences if those effects occur
  • Risk fcn (likelihood, consequences), for each
    risk pathway or mechanism
  • Are risks manageable and how?
  • Management strategies and monitoring

15
Risk Management(Article 16)
  • Parties are required to
  • manage and control risks identified in risk
    assessments carried out under the Protocol
  • take measures to prevent unintentional
    transboundary movements
  • ensure LMOs undergo appropriate periods of
    observation prior to use
  • cooperate regarding identification of LMOs and
    their traits, and associated management of LMOs
  • Links between risk assessment and management
    are made in Article 16 and Annex III

16
MOP Decisions
  • MOP-2 (decision BS-II/9)
  • considered a review of existing guidance
    materials on risk assessment and risk management
  • Requested the Executive Secretary to convene
    regional workshops on capacity-building and
    exchange of experiences
  • Established an Ad Hoc Technical Expert Group on
    risk assessment, which will meet in November 2005
    and make recommendations to MOP-3

17
Risk Assessment AHTEG
  • Terms of Reference
  • Consider the nature and scope of existing
    approaches and guidance materials for risk
    assessment
  • Evaluate the above, and identify gaps
  • Identify areas where limitations in capacity are
    of critical importance

18
MOP-3
  • MOP-3 will consider risk assessment and risk
    management in more detail based on
  • the report of the AHTEG
  • the review of guidance materials, and
    submissions received for MOP-2
  • information on experiences and progress in
    implementing Articles 15 and 16 submitted in
    interim national reports

19
Capacity-Building
  • Protocol calls for cooperation in the development
    and/or strengthening of human resources and
    institutional capacities in biosafety
  • MOP-1 adopted an action plan for building
    capacity, and a coordination mechanism for
    implementation of the action plan
  • The most pressing capacity needs in general
    include
  • Capacity to use and provide all required
    information to the Biosafety Clearing-House
  • Capacity to make informed decisions based on risk
    assessment and other factors

20
The Importance of Collaboration
  1. A wide-range of expertise is needed to contribute
    to operationalizing the provisions of the
    Protocol that have a scientific underpinning
  2. Many international agreements have overlapping
    areas of competence
  3. Parties to the Protocol have an obligation to
    implement Articles 15 and 16 consistency with
    IPPC standards (e.g., ISPM-11) is important
  4. CBD and IPPC secretariats have a joint work plan
  5. Biosafety Protocol expertise was involved in the
    revision of ISPM-11
  6. MOP-2 specifically requested the Executive
    Secretary to reinforce cooperation with IPPC,
    Codex and OIE
  7. There is need for collaboration at national level
    among agencies that take the lead in various fora
    (as noted, for example, by ICPM-7)

21
Participation in Protocol-related Processes
  • Participate at MOPs as government delegates, or
    as representatives of organizations (observers
    are welcome)
  • Organize side-events at MOPs (governments,
    organizations, and institutions)
  • Submit views (as governments or organizations)
    when appropriate
  • Offer expertise to existing capacity-building
    projects (see databases on the BCH)
  • Offer expertise directly to Parties if requested
    (funding available if on the biosafety roster of
    experts)

22
Further Information
  • The CBD Secretariat (Biosafety Programme)Montreal
    , Canada
  • Email secretariat_at_biodiv.orgTel 1 514
    288-3330Fax 1 514 288-6588
  • The CBD Website www.biodiv.org
  • The BCH Website bch.biodiv.org
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