Generation Challenge Program Workshop Plant Genetic Diversity and Molecular Marker Assisted Breeding

1
Generation Challenge Program WorkshopPlant
Genetic Diversity and Molecular Marker Assisted
Breeding

• The Cartagena Protocol on
• Biosafety

2
Cartagena Protocol on Biosafety

• What is it?
• What does it mean for you?

3
The background

• In order to be in a position to take full
  advantage of new biotechnologies, countries must
  have the necessary infrastructure, financial
  support and expertise.
• Particularly in the case of genetically modified
  organisms, countries will also need to put the
  necessary regulatory framework in place to
  minimise the risks.
• A significant number developing countries lack
  these prerequisites and will need assistance in
  strengthening their overall capabilities in
  biotechnology research and development and at the
  regulatory level in order to meet the potentials
  and challenges of the many new technologies.

4
What is the Cartagena Protocol?

• A binding international agreement
• Linked to the international Convention on
  Biodiversity
• Entered into force in 2003
• Covers the safe transfer, handling and use of
  LMOs (GMOs)
• Specific focus on trans-boundary movement

5
The Precautionary Principle

• Uncertainty regarding serious potential harm to
  the environment or human health is not a valid
  reason for refraining from preventative measures
• Lack of scientific knowledge should not
  necessarily be interpreted as indicating a
  particular level of risk, an absence of risk, or
  an acceptable risk
• The Protocol aims to entrench the precautionary
  principle in participating countries to
  facilitate decision making

6
Living Modified Organism

• Means any living organism that possesses a novel
  combination of genetic material obtained through
  the use of modern biotechnology
• Living organism means any biological entity
  capable of transferring or replicating genetic
  material, including sterile organisms, viruses
  and viroids
• Modern biotechnology includes
• In vitro nucleic acid techniques
• Fusion of cells beyond the taxonomic family

7
Advance Informed Agreement

• LMOs subject to the protocol
• All LMOs which may have adverse effects on the
  conservation and use of biological diversity
• LMOs subject to AIA
• LMOs intended for intentional introduction into
  the environment
• LMOs excluded from AIA
• LMOs in transit
• LMOs for food or feed, or for processing
• LMOs identified as not likely to have adverse
  impacts
• LMOs excluded from provisions on transboundary
  movements
• LMOs that are human pharmaceuticals

8
Import of LMOs

• Party of import must decide whether to approve
  the import based on
• Risk assessment
• Socio-economic considerations (optional may be
  included in so far as they impact on biological
  diversity)
• Precautionary approach

9
Import for food, feed and processing

• Handled under domestic regulatory processes
• If no domestic regulatory framework exists, then
  decision should be made based on a risk
  assessment

10
Transit and contained use

• Up to individual countries to decide on specific
  requirements for transit
• For contained use, normally the submission of a
  notification and a risk assessment is sufficient

11
Risk assessment

• Identification of hazards
• Likelihood of hazards being realised
• Consequences if hazards are realised
• Likelihood x Consequences Overall risk

12
Risk management and decision making

• Generally separated from the risk assessment
  processs
• Decide if risks are acceptable and identify
  strategies to manage risk.
• Other issues taken into account in making
  decisions
• Eg socio-economic considerations
• Impact on trade, IP issues etc

13
Transport and identification

• All LMOs subject to transboundary movement must
  be identified as such
• Products for food, feed or processing should be
  identified if they may contain LMOs

14
Biosafety Clearing House

• Established centrally to
• Facilitate exchange of information on LMOs
• Assist countries to implement the Protocol
• Countries should make all relevant information
  available to the BCH

15
Capacity building

• The Protocol specifies support for developing
  countries in development/strengthening of
• Human resources and institutional capacities
• Biosafety and biotechnology to the extent it is
  required for biosafety

16
UNEP-GEF project on the development of biosafety
frameworks

• Designed to help countries comply with the
  Protocol
• Provides support for capacity building to develop
  and implement in-country regulatory processes to
  handle LMOs

17
What will it mean for you?

• If you want to work with any LMOs in the lab or
  field you will have to make sure you comply with
  the requirements
• You might get involved in the development of
  regulations in your own countries
• You now have some experience in molecular marker
  techniques that can be used to test for the
  presence of LMOs this is one requirement for
  implementation of the Protocol