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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. 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 • Key Terms - Biodiversity Clearing House • The role of Customs and border control in implementing the CBD Protocol

  3. Presentation 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. How International Treaties Work International Public Concern over Issue Scientific Evaluation of Issue International Governments come together to Negotiate Treaty to Address Issue of Concern including Mechanisms to Address Concern International Governments sign on to Treaty to Make it legally binding Governments pass National Laws to give effect to Requirements of Treaty

  6. Why do we Need the Biosafety Protocol • Rapid development and commercialisation of biotechnology and its products, including LMOs • Recognition of potential contribution that biotechnology can make to improving human well-being • Uncertainties regarding potential risks of LMOs on biodiversity and human health • Lack/limited capacities of many countries to make enlightened decisions concerning imports of LMOs

  7. Why do we Need the Biosafety Protocol GM crops are presently the principal category of LMOs on the market In 2004, the value of global transgenic seeds was evaluated at US$ 4.7 billion GM crops can be found in 17 countries

  8. Why do we Need the Biosafety Protocol Between 1996 and 2003, GM crops coverage went from 1,7 million hectares to 67,7 million hectares 99% of this coverage is concentrated in 6 countries: United States of America (66%), Argentina (22%), Canada (6%), Brazil, China and South Africa

  9. Why do we Need the Biosafety Protocol Principal crops: soy, maize, cotton and canola Principal characteristics : tolerance to herbicides (75%) and resistance to pests (17%) 5 major multinationals control the LMO market: Monsanto (91%), Dupont, Syngenta, Bayer and Dow

  10. 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

  11. 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

  12. Biosafety Protocol Benefits of modern biotechnology: “Recognizing that modern biotechnology has great potential for human well-being if developed and used with adequate safety measures for the environment and human health.” Concerns about potential risks: “Aware of the rapid expansion of modern biotechnology and the growing public concern over its potential adverse effects on biological diversity, taking also into account risks to human health.” Limited capacities: “Taking into account the limited capabilities of many countries, particularly developing countries, to cope with the nature and scale of known and potential risks associated with living modified organisms.”

  13. Key Elements of the Biosafety Protocol • Scope • Advance Informed Agreement Procedure • Procedure for living modified organisms intended for direct use as food or feed, or for processing • Risk assessment and management • Handling, Transport, Packaging and Identification • Information-sharing and the Biosafety Clearing-House • Capacity Building • Socio-economic considerations • Liability and redress • Compliance • Public Awareness and Participation

  14. 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

  15. 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)

  16. 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.

  17. 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)

  18. 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.

  19. 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

  20. 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.

  21. 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

  22. 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 import requirements of the Ministry of Agriculture. Customs must receive either a Phyto-santitary certificate or other permit before releasing such consignments

  23. 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

  24. 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

  25. 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

  26. 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  

  27. The Role of Customs Officials Other general responsibilities: • Regular communication with the Competent National Authority (ECU) 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

  28. 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)

  29. 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

  30. Questions

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