Cartagena Protocol on Biosafety to the Convention on Biological Diversity.pptx

Cartagena protocol slides

1. Cartagena Protocol on Biosafety to the Convention on Biological Diversity 1

2. Protocol A Protocol is a binding international instrument, separate from, but related to, another treaty A protocol must be individually negotiated, signed and eventually ratified. It is only binding on States that become Parties to it. It has its own Parties, and creates separate rights and obligations for them, as any other treaty. 2

3. The Convention on Biological Diversity (CBD) History CBD was adopted in May 1992 in Nairobi It was opened for signature in Rio de Janeiro on 5 June 1992 at the UN Conference on Environment and Development. It entered into force on 29 December 1992, and as of 2016 has 196 Parties Objectives the conservation of biological diversity, the sustainable use of its components the fair and equitable sharing of benefits arising out of the utilization of genetic resources. 3

4. The Convention on Biological Diversity (CBD) In 1995 the Conference of the Parties (COP) agreed to consider the need to develop appropriate procedures to address the safe transfer handling and use of any LMOs resulting from biotechnology a protocol on biosafety specifically focusing on transboundary movement 4

5. Biosafety & Bioregulation Shorthand for the regulatory systems designed to ensure that applications of biotechnology are safe for Human health Agriculture & Environment seek to ensure the safe transfer, handling, use & disposal of LMOs. 5

6. Cartagena Protocol on Biosafety - HISTORY The protocol is named after the city Cartagena in Colombia which hosted the COP’s first meeting on biosafety in 1999 The protocol was finally adopted by COP in Montreal on the 29 th Jan, 2000 Officially approved & opened for signature in Nairobi, Kenya in May 2000 by COP - 135 countries were present Inter-governmental committee for the Cartagena protocol (ICCP) was formed in Montreal (2000) to make recommendations on implementation - 142 countries have signed 6

7. Cartagena Protocol on Biosafety - OBJECTIVE To contribute to ensuring an adequate level of protection in the field of the safe transfer, handling & 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, specially focusing on transboundary movements (Article 1) 7

8. Content Article 1 Objective Article 2 General Provisions Article 3 Use of Terms Article 4 Scope Article 5 Pharmaceuticals Article 6 Transit and Contained Use Article 7 Application of the Advance Informed Agreement Procedure Article 8 Notification Article 9 Acknowledgement of Receipt of Notification Article 10 Decision Procedure Article 11 Procedure for Living Modified Organisms Intended for Direct Use as Food or Feed, Or For Processing Article 12 Review of Decisions Article 13 Simplified Procedure Article 14 Bilateral, Regional and Multilateral Agreements and Arrangements Article 15 Risk Assessment Article 16 Risk Management Article 17 Unintentional Transboundary Movements and Emergency Measures Article 18 Handling, Transport, Packaging and Identification Article 19 Competent National Authorities and National Focal Points Article 20 Information Sharing and the Biosafety Clearing-House Article 21 Confidential Information Article 22 Capacity-Building Article 23 Public Awareness and Participation Article 24 Non-Parties Article 25 Illegal Transboundary Movements Article 26 Socio-Economic Considerations Article 27 Liability and Redress Article 28 Financial Mechanism and Resources Article 29 Conference of the Parties Serving as the Meeting of the Parties to this Protocol Article 30 Subsidiary Bodies Article 31 Secretariat Article 32 Relationship With the Convention Article 33 Monitoring and Reporting Article 34 Compliance Article 35 Assessment and Review Article 36 Signature Article 37 Entry Into Force Article 38 Reservations Article 39 Withdrawal Article 40 Authentic Texts Annex I Information required in notifications under articles 8, 10 and 13 Annex II Information required concerning living modified organisms intended for direct use as food or feed, or for processing under article 11 Annex III Risk Assessment

9. Cartagena Protocol on Biosafety - SCOPE Article 4 states ‘This protocol shall apply 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 5 effectively exempts pharmaceuticals for humans from the protocol. Article 6 makes clear that its advance informed agreement (AIA) procedure does not apply to LMOs in transit or to the movement of LMOs intended for contained use. 9

10. Cartagena Protocol International biosafety protocol - goal is to protect biodiversity while regulating trade of GMO’s. Accepts “precautionary principle” Can reject GM products if there is a lack of scientific certainty about the risks Provides aid to developing countries to develop GM regulatory frameworks 10

11. Key elements of the international biosafety protocol It offers a number of tools for promoting Biosafety Advanced Informed Agreement Procedure (AIA) Biosafety Clearing House (BCH) Risk assessment and risk management framework (RA&RM) Capacity building Public awareness 11

12. I. Advanced Informed Agreement Procedure (AIA) Establishes an advanced informed agreement (AIA) procedure for first time shipments of LMOs, including seeds LMOs not intended for release into the environment excluded from AIA provisions LMOs intended for direct use as food, feed & processing LMOs in transit LMOs destined for contained use LMOs identified by the meeting of parties as being not likely to have adverse impacts. 12

13. Advanced Informed Agreement Procedure Party of export/exporter notifies party of import of it’s intention to ship LMOs. It must provide a detailed, written description of the organism The party of import is to acknowledge receipt of this information within 90 days and explicitly authorize the shipment within 270 days or state it’s reasons for rejecting the LMO or request additional relevant information in accordance with it’s domestic regulatory framework Absence of response within 270 days is not to be interpreted as implying consent 13

14. II. Biosafety Clearing House Article 20 of the biosafety protocol established a biosafety clearing –house (BCH) as part of the clearing-house mechanism under Article 18 in order to: Facilitate the exchange of scientific, technical, environmental & legal information and experience with on LMO Assist parties to implement the protocol, taking into account the special needs of developing country parties, and countries with economies in transition, countries that are centre of origin and centers of genetic diversity. 14

15. II. Biosafety Clearing House To give notice of domestic authorizations of LMOs & to make available copies of national laws and regulations concerning these LMOs. Information that should be made available to the BCH Any existing laws, regulations and guidelines for implementation of the protocol Information required by the parties for the AIA procedure Any bilateral, regional and multilateral agreements and arrangements Summaries of it’s risk assessments or environmental reviews of LMOs generated by it’s regulatory process Relevant information regarding products thereof It’s final decisions regarding the importation or release of LMO. 15

16. II. Biosafety Clearing House The pilot phase of the biosafety clearing-house website has been created to assist governments to fulfill their information- sharing obligations under the Cartagena Protocol on Biosafety. The BCH provides access to information relevant to the Biosafety Protocol. Users can search the BCH databases for information in the Following categories: National contacts Laws and regulations Decision information Capacity building Roster of experts 16

17. III. Risk Assessment & Risk Management The objective of risk assessment is to identify and evaluate the potential adverse effects of LMOs on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health Requires governments to establish and maintain mechanisms, measures and strategies for regulating , managing and controlling risks identified in the risk assessment procedures of LMOs in the use, handling and transboundary movement To take into account socio-economic considerations such as the value of biological diversity to it’s indigenous and local communities in reaching a decision on import of GMOs. RM Means of managing the risk to reduce the probability of occurrence or to reduce the magnitude of the consequence - Manage the risks throughout the stages 17

18. III. Risk Assessment To be undertaken in a scientific manner based on recognized risk assessment techniques. Involve multidisciplinary efforts among physical scientists, toxicologists, biologists In cases where the relevant scientific understanding is incomplete, a country may decide to use the precautionary principle and refuse to permit imports. 18

19. Standard for acceptable Risk Substantial Equivalence- “as safe as” products produced by alternative means. Not substitute for a safety assessment but part of a safety assessment process. Precautionary Principle/ Approach- “where there are threats of serious or irreversible damage, lack of full scientific certainty Shall not be used as a reason for postponing cost-effective measures to prevent environment degradation” 19

20. IV. Capacity Building Development and/or strengthening of human resources and institutional capacities in for Biosafety, including biotechnology to the extent that it is required for biosafety, for of the purpose of the effective implementation of this protocol. Promote international cooperation to help developing countries build the needed human resources and institutional capacities Encourages governments to assist with scientific and technical training In the proper & safe management of biotechnology In the use of risk assessment (RA) Risk management for Biosafety (RM) The enhancement of technological institutional capacities in Biosafety. 20

21. V. Public Awareness and Participation Promote and facilitate public awareness Concerning the safe transfer, handling and use of LMOs Consult the public in the decision-making process regarding LMOs Public access to the Biosafety Clearing- House Illegal shipments and accidental releases of LMOs 21

22. T he Nagoya – Kuala Lumpur Supplementary Protocol The Nagoya – Kuala Lumpur Supplementary Protocol is an international agreement that supplements the Cartagena Protocol on Biosafety. It focuses on liability and redress for damage resulting from transboundary movements of living modified organisms (LMOs). 22

23. Purpose and objectives of the Protocol 23 Promote Environmental Protection The Protocol aims to enhance environmental protection by ensuring that those responsible for the introduction of LMOs bear the cost of any damage that may occur. Foster Legal Certainty It seeks to provide legal certainty and clarity regarding the process for seeking redress in the event of damage caused by LMOs. Facilitate Access to Justice By establishing clear liability rules, the Protocol facilitates access to justice for affected parties in transboundary LMO cases.

24. Key provisions and scope of the Protocol Scope The Protocol covers damage resulting from transboundary movements of LMOs under the Cartagena Protocol's advanced informed agreement (AIA) procedure. Provisions It lays down specific rules and procedures for addressing, documenting, and providing redress for damage caused by LMOs.

25. Liability and redress mechanisms for damage resulting from transboundary movements of LMOs Liability Determination The Protocol establishes clear guidelines for determining liability in cases of damage caused by transboundary movements of LMOs. Redress Procedures It outlines the procedures for seeking redress, including the submission of claims and the process for assessment and compensation. Compensation Mechanisms It defines the mechanisms for ensuring fair and adequate compensation to parties affected by LMO-related damage.

26. Implementation and compliance with the Protocol 1 National Legislation Countries are required to incorporate the Protocol's provisions into their national legal frameworks. 2 Capacity Building Efforts are made to enhance the capacity of countries to effectively implement the liability and redress mechanisms. 3 Monitoring and Reporting The Protocol includes provisions for monitoring and reporting of incidents and the effectiveness of the liability and redress systems.

27. Benefits and potential challenges of the Protocol Environmental Protection The Protocol offers enhanced protection to the environment by ensuring that the impact of LMOs is properly addressed and compensated. Complex Implementation Implementing the liability and redress mechanisms across different legal systems and jurisdictions poses significant challenges. International Cooperation The Protocol requires close international cooperation to effectively address transboundary LMO damage and ensure fair compensation.

28. Other International Instruments Relevant to the Protocol UNIDO voluntary code of conduct for the release of organisms into the environment (1992) UNEP international Technical Guidelines for safety in Biotechnology (1995) IPPC international plant protection convention (1997) Codex Alimentarius Commission 28