Presentation on theme: "Risk Assessment and Risk Management of Living Modified Organisms under the Cartagena Protocol on Biosafety Ryan Hill and Cyrie Sendashonga Secretariat."— Presentation transcript:
1 Risk Assessment and Risk Management of Living Modified Organisms under the Cartagena Protocol on BiosafetyRyan Hill and Cyrie SendashongaSecretariat of theConvention on Biological Diversity
2 OutlineIntroduction to the Protocol, including current status and key provisionsRisk assessment – provisions and relevant decisions of the COP/MOPRisk management – provisions and relevant decisions of the COP/MOPFuture work
3 What is the Biosafety Protocol? A Protocol to the Convention on Biological DiversityThe 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 arisingMandate for a Protocol came from Article 19.3 of the Convention, and from Chapter 16 of Agenda 21- Rio Earth Summit chapter 16 of agenda 21 called for “Environmentally sound management of biotechnology”
4 Defining LMOArticle 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.”- Term LMO is used in the Protocol and is defined specifically; for general purposes it is interchangable with GMO- The focus on transboundary movements means that the Protocol is essentially concerned with potential effects on biodiversity associated with trade in GMOs
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 StatusNegotiated from mid-90s; adopted in January 2000; entered into force September 2003Currently 124 PartiesFirst Meeting of Parties (MOP-1) was held Feb 2004; adopted a medium-term programme of work ( )MOP-2 was held May-June 2005MOP-3 scheduled for March 2006
8 Key ProvisionsDecision-making procedures for import of LMOs (Advance Informed Agreement; LMOs-FFP)Risk assessment and risk managementInformation-sharing and the Biosafety Clearing-HouseHandling, Transport, Packaging, IdentificationCapacity-BuildingComplianceLiability and redressPublic Awareness and ParticipationSocio-economic considerations
9 Decision-Making Procedures 1. Advance Informed Agreement ProcedureApplies to first transboundary movement of LMOs for release into the environment (e.g., crops for planting)Exporter notifies importer in advanceImporter takes decision in accordance with risk assessment, and may take into account socio-economic considerationsImporter 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 ProcessingDomestic regulatory framework appliesMost regulatory frameworks require risk assessment3. 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 UseRequirements for Exporter or Party of ExportRequirements for Party of ImportDomestic use within country A, not subject to transboundary movementNo exporter or importerCountry 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 processingPost domestic decision on BCH (11.1)Documentation (18.2a)Optional import decision (11.4 / 11.6) [default is to allow import]
12 Scenarios for Transboundary Movements of LMOs Origin, Destination, Intended UseRequirements for Exporter or Party of ExportRequirements for Party of ImportCountry A to B for contained useAIA 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 frameworkCountry A to B in transit onlyAIA not relevant (6.2)May be requirements set by transit country (6.2)Documentation depends on use at final destinationProduct derived from LMO shipped from country A to BProtocol 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 basisScientifically sound and transparent, taking into account recognized risk assessment techniquesLack of scientific knowledge or consensus does not indicate particular level of risk, absence of risk, or acceptable riskComparative 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 effectsConsequences if those effects occurRisk = fcn (likelihood, consequences), for each risk pathway or mechanismAre risks manageable and how?Management strategies and monitoring
15 Risk Management (Article 16) Parties are required tomanage and control risks identified in risk assessments carried out under the Protocoltake measures to prevent unintentional transboundary movementsensure LMOs undergo appropriate periods of observation prior to usecooperate 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 managementRequested the Executive Secretary to convene regional workshops on capacity-building and exchange of experiencesEstablished an Ad Hoc Technical Expert Group on risk assessment, which will meet in November 2005 and make recommendations to MOP-3
17 Risk Assessment AHTEGTerms of Reference:Consider the nature and scope of existing approaches and guidance materials for risk assessmentEvaluate the above, and identify gapsIdentify areas where limitations in capacity are of critical importance
18 MOP-3MOP-3 will consider risk assessment and risk management in more detail based on:the report of the AHTEGthe review of guidance materials, and submissions received for MOP-2information on experiences and progress in implementing Articles 15 and 16 submitted in interim national reports
19 Capacity-BuildingProtocol calls for cooperation in the development and/or strengthening of human resources and institutional capacities in biosafetyMOP-1 adopted an action plan for building capacity, and a coordination mechanism for implementation of the action planThe most pressing capacity needs in general include:Capacity to use and provide all required information to the Biosafety Clearing-HouseCapacity to make informed decisions based on risk assessment and other factors
20 The Importance of Collaboration A wide-range of expertise is needed to contribute to operationalizing the provisions of the Protocol that have a scientific underpinningMany international agreements have overlapping areas of competenceParties to the Protocol have an obligation to implement Articles 15 and 16; consistency with IPPC standards (e.g., ISPM-11) is importantCBD and IPPC secretariats have a joint work planBiosafety Protocol expertise was involved in the revision of ISPM-11MOP-2 specifically requested the Executive Secretary to reinforce cooperation with IPPC, Codex and OIEThere 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 appropriateOffer 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)