Biosafety and Biosecurity in the Context of the Cartagena Protocol on Biosafety. David Duthie, UNEP-DGEF, Geneva, Switzerland

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1 Biosafety and Biosecurity in the Context of the Cartagena Protocol on Biosafety David Duthie, UNEP-DGEF, Geneva, Switzerland

2 The Protocol originated from Article 19(3) of the Convention on Biological Diversity, that entered in force in 1992, which states that: 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.

3 Objective of the Biosafety Protocol In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration, to contribute to ensuring 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 biological diversity, taking into account risks to human health

4 Scope of the Biosafety Protocol Applies to: - Transboundary movement (main focus) - Transit - Handling and -Use - of all LMOs that may have adverse effects on the conservation and sustainable use of biodiversity, taking into account risks to human health

5 Scope (II) Applies to three categories of LMOs: LMOs for intentional introduction into the environnment (e.g. seeds) LMOs intended for direct use as food or feed or for processing (e.g. agricultural commodities) LMOs for contained use (e.g. scientific experiment)

6 Article 3: Use of terms (I) "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;

7 Article 3: Use of terms (II) (i) "Modern biotechnology" means the application of: a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or b. Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;

8 (Ab)use of terms (III) The word biosafety is mentioned in the text of the Protocol mostly to refer to the Biosafety Clearing House (BCH), and in general reference to capacity building, but nowhere is it defined explicitly; Biosafety Protocol often translates in French/Spanish, on the internet, as Protocole sur la biosécurité/seguridad although not in the original text, where it is explicitly: protocol sur la prévention des risques biotechnologiques and protocolo sobre seguridad de la biotecnología ; In Arabic, Russian and Chinese?

9 AIA Procedures Advanced Informed Agreement (AIA) Procedure Applies to the first intentional transboundary movement of LMOs for intentional introduction into the environment of the Party of import Party of Export: provides Notification and Dossier Party of Import: Acknowledgement RA/RM Other Considerations Decision-making notify via BCH Monitoring

10 Procedure for Import of Food, Feed or Food Processing (FFP) The procedure for import of LMOs intended for direct use as food or feed, or for processing (FFP) is (slightly) simpler: Parties may take a decision on the import of the LMO-FFP under domestic regulatory framework (but still including RA/RM), consistent with objective of the Protocol; or If no domestic regulatory framework, then declare, through the BCH,that a decision on import will be taken (i) in accordance with risk assessment under Annex III of the Protocol; and (ii) within a predictable timeframe not exceeding 270 days.

11 Additional Considerations: Preamble: Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development - i.e. decisions may be based on the precautionary approach when there is a lack of scientific certainty due to insufficient relevant scientific information and knowledge; Article 26: a decision may take into account socioeconomic considerations arising from the impact of LMOs on the conservation and sustainable use of biological diversity.

12 Capacity building The CBD Secretariat, the GEF and its implementing agencies, including UNEP, are collaborating in the implementation of two categories of biosafety capacity building projects: 1. The UNEP/GEF project on the development of national biosafety frameworks, including national BCHs - with more than 120 participating countries; plus 2. Projects to support the implementation of biosafety frameworks at the national or regional level in 30+ countries.

13 The 5 NBF Components 1. Biosafety Policy 2. Regulatory regime 3. System to handle requests (administrative, risk assessment & management, decision making, national BCH, etc.) 4. Follow up activities (enforcement, monitoring for environmental effects, etc.) 5. Public Awareness and Participation

14 Capacity building related activities 123 NBF projects completed 110 active BCH projects 12 NBF Implementation projects completed; another 11 underway and 30+ starting

15 Contact

16 Further Information Briefing from Mr Ahmed Djoghlaf, Executive Secretary of the CBD on the outcome of the CBD CoP 9, held in Bonn, Germany in May 2008 and prospects for the forthcoming CBD CoP10, to be held in Nagoya, Japan in 2010 International Environment House, Chatelaine, Geneva Monday September 8th morning Contact: Fatma Gordon (fatma.gordon@unep.ch)