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Understanding Biosafety

Understanding Biosafety. The concept of biosafety encompasses a range of measures, policies and procedures for minimizing potential risks that biotechnology may pose to the environment and human health.

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Understanding Biosafety

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  1. Understanding Biosafety The concept of biosafety encompasses a range of measures, policies and procedures for minimizing potential risks that biotechnology may pose to the environment and human health. Establishing credible and effective safeguards for GMOs is critical for maximizing the benefits of biotechnology while minimizing its risks.

  2. Unit Objectives • Explain the scope and intention of the Cartagena Protocol • Distinguish between the categories of Living Modified Organisms ( LMOs) • Discuss the trans-boundary Movements of LMOs • Illustrate the Advance informed agreement (AIA) procedure • Refer to the Biodiversity Clearing House • Determine the role of Customs and border control in implementing the CBD Protocol

  3. Unit Outline • Introduction • Scope and Intention of Cartagena Protocol • Categories of LMOs • Transboundary Movement of LMOs • Advance Informed Agreement ( AIA) • Role of Customs & Border Control • Conclusion

  4. Scope of the Cartagena Protocol The Cartagena Protocol on Biosafety is an international treaty that seeks to protect biological diversity from the risks posed by living modified organisms (LMOs), also often referred to as genetically modified organisms (GMOs), which are a product of modern biotechnology. The Protocol is a supplementary agreement to the Convention on Biological Diversity.

  5. Purpose of the Biosafety Protocol Contribute to ensuring the safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on the conservation & sustainable use of biological diversity, taking also into account risks to human health • * In accordance with the precautionary approach • * Focuses specifically on trans-boundary movements

  6. Status of Protocol On 29 January 2000, the Conference of the Parties to the Convention on Biological Diversity adopted a supplementary agreement to the Convention known as the Cartagena Protocol on Biosafety. The Protocol entered into force on 11 September 2003, ninety days after the deposit of the fiftieth instrument of ratification. Currently 163 parties to the Protocol

  7. Status of Ratification in the Caribbean Parties to the Protocol from the region: Antigua and Barbuda, Bahamas, Barbados, Belize, Cuba, Dominica, Dominican Republic, Grenada, Guyana, Haiti, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago

  8. Definition of LMO A living modified organism (LMO) is any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. Also frequently referred to as genetically modified organisms (GMOs)

  9. Categories of LMOs LMOs for intentional introduction into the environment (e.g. seeds, live fish) LMOs intended for direct use as food or feed, or for processing (e.g. agricultural commodities – corn, canola, cotton) LMOs for contained use (e.g. bacteria for laboratory scientific experiment)

  10. Categories of LMOs • These different categories of LMOs under the Protocol have different requirements for their handling, transport, packaging and identification. • Article 18 of the Protocol (& related COP-MOP decisions) set out those requirements.

  11. Transboundary Movement Procedures The Biosafety Protocol regulates the trans-boundary movement of living modified organisms by establishing procedures for the export and import of these organisms and maintaining an information exchange mechanism known as the Biosafety Clearing-House.

  12. Transboundary Movement of LMOs Transboundary movements of LMOs intended for intentional introduction into the environment of the Party of import are subject to the advance informed agreement (AIA) procedure, which applies before the first intentional trans-boundary movement of the LMO in question. Step 1 – Notification by Exporter Step 2 – Acknowledgement of receipt of notification by Importer Step 3 – Decision Making

  13. Transboundary Movement of LMOs-FFP Transboundary movements of LMOs-FFP are subject to the following two-step procedure: Step 1: Informing the Biosafety Clearing-House about the final decision on domestic use. Step 2: Decision making by a potential importing Party. A Party may take a decision on the import of an LMO-FFP under its domestic regulatory framework.

  14. Precautionary Approach The Protocol reflects a fundamental concept known as the Precautionary Approach which means that a government may decide not to permit a particular GMO to be imported across its borders. This is the case even if there is insufficient scientific evidence about the GMO’s potential adverse effects. Concerns could include the risk that imports of genetically engineered foods may replace traditional crops, undermine local cultures and traditions or reduce the value of biodiversity to indigenous communities.

  15. Objective: Safe transfer, handling and use of LMOs • Rules & procedures • Decision making Handling, transport, packaging, identification: - Documentation for shipments - Standards • Risk Assessment • Risk Management - Information sharing - Awareness & participation Precautionary Approach CompetentNationalAuthorities+ Advisors Society(public + privateentities) Customs+ CompetentNationalAuthorities

  16. National / Regional Measures The Ministry of Agriculture would be the government agencies mainly concerned with the importation of animals, plants and the products derived there from. Some Caribbean States have not yet enacted legislation specifically to deal with imports or exports of LMOs /GMOs however they fall under the general requirements of the Ministry of Agriculture. Customs must receive either a Phyto-santitary certificate or other permit before releasing such consignments

  17. Case StudyBiosafety Issues for Belize Read the document provided and discuss in small groups with the aim of identifying some of the challenges to be overcome in the absence of specific legislation to deal with the import of LMOs /GMOs in some member states of CARICOM/ CARIFORUM

  18. The Role of Customs Officials In implementing the Biosafety Protocol customs officials are required to: • Ensure LMO imports have prior approval (decisions) • Ensure LMO shipments are accompanied with proper documentation • Verify that contents of shipments match accompanying documentation • Detect illegal LMO imports • Take appropriate measures

  19. The Role of Customs Officials These information requirements can be provided in different types of documentation such as: • A commercial invoice; • A document required or utilized by existing documentation systems; or • Other documentation as required by domestic regulatory/administrative frameworks

  20. The Role of Customs Officials When a shipment of LMOs arrives at a port of entry, the role of customs is to: 1. Verify if shipment has proper import approvals & if there are any conditions on its import • This information can be obtained from Competent National Authority & BCH 2. Verify that documentation is complete 3. Ensure that contents of shipment correspond to information in accompanying documentation • Follow national procedures on sampling & detection

  21. The Role of Customs Officials When a shipment of LMOs arrives at a port of entry, the role of customs is to (cont.): 4 a. Admit shipment to country if import of LMO has been approved & documentation is complete OR 4 b. Follow domestic rules and procedures for refusing import if import of LMO has not been approved and/or documentation is incomplete  

  22. The Role of Customs Officials Other general responsibilities: • Regular communication with the Competent National Authority regarding LMOs arriving at the ports of entry • Forwarding LMO import documents to relevant national authorities • Detecting and alerting relevant authorities about possible illegal imports and unintentional trans-boundary movements of LMOs

  23. Summary • Cartagena Protocol on Biosafety recognizes the potential of biotechnology if developed and used with adequate safety measures • Protocol is intended to ensure safety of LMOs, not to prohibit their trade • Customs officials have a central role to play in implementation of the Protocol • Domesticregulations are key • It is important to obtain relevant information and keep abreast with new developments (see information sources below)

  24. Contacts for Further Information Secretariat of the Convention on Biological Diversity 413 Saint-Jacques Street, suite 800 Montreal, Quebec Canada H2Y 1N9 Tel.: +1 (514) 288-2220 Fax: +1 (514) 288-6588 E-mail: secretariat@cbd.int Protocol website: www.cbd.int/biosafety Biosafety Clearing-House: bch.cbd.int CNAs: bch.cbd.int/contacts/authorities.shtml NFPs: bch.cbd.int/contacts/focalpoints.shtml

  25. Unit Conclusion • Clarify any questions • Review Unit Objectives • Link to next Unit on Montreal Protocol

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