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 [phone]
• The CBD Website www.biodiv.org
• The BCH Website bch.biodiv.org