12 potential risks of modern biotechnology very new

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Potential risks of modern biotechnology Very new field: little is known about the interaction of LMOs with various ecosystems, potential adverse effects on biological diversity and human health Areas of concern: changes in biological characteristics of the target species (e.g: increased virulence, weediness, competitiveness with other species, toxicity, allergenicity, gene flow/transfer to wild relatives, stability of the transgene, etc.) 13
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Key Elements of the Protocol 1. Scope 2. Advance Informed Agreement Procedure 3. Procedure for living modified organisms intended for direct use as food or feed, or for processing 4. Risk assessment and management 5. Handling, Transport, Packaging and Identification 6. Information-sharing and the Biosafety Clearing-House 7. Capacity Building 8. Socio-economic considerations 9. Liability and redress 10. Compliance 11. Public Awareness and Participation 14
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Scope of the Protocol The protocol applies to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health (Article 4). Exclusion: The protocol does not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans that are addressed by other relevant international agreements or organisations (Article 5). 15
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The AIA procedure (Articles 7, 8, 9, 10 & 12) The advance informed agreement procedure (AIA) applies to the first intentional transboundary movement of LMOs for intentional introduction into the environment Exemptions: LMOs intended for direct use as food or feed, or for processing are subject to a simplified procedure (Article 11) The AIA procedure does not apply to LMOs in transit or destined for contained use (Article 6) The AIA procedure does not apply to LMOs identified in a decision of the Conference of the Parties, as being not likely to have adverse effects on the conservation and sustainable use of biodiversity (Article 7.4) 16
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The AIA procedure (continued) Steps: Notification from the exporter to the competent national authority of the Party of import prior to the transboundary movement of the LMO Acknowledgement of receipt of notification within 90 days of its receipt The Party of import shall ensure that risk assessments are carried out A decision is taken by the Party of import within 270 days of the date of receipt of the notification 17
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The AIA procedure (continued) Results of the AIA procedure: Approving the import, with or without conditions Prohibiting the import Requesting additional relevant information Extension of the 270 day period by a defined period of time Review and change of decisions – at any time 18
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Procedure for living modified organisms intended for direct use as food or feed or for processing (Article 11) Revolves around a multilateral exchange of information regarding such LMOs between potential Parties of export and potential Parties of import Any Party that makes a final decision regarding domestic use, including placing on the market, of a n LMO that may be subject to
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