1. Cartagena Protocol on Biosafety Jebunnesa Chowdhury

2. Biosafety Due to growing concerns arising from GMOS throughout the word the UNIDO/ WHO/FAO/UNEP has built up an Informal Working Group on Biosafety. In 1991, this group prepared the ‘ Voluntary Code of Conduct For The Release of Organisms Into The Environment’. Biotechnology is safe when practice properly.The main areas for safety aspects in biotechnology are as below: i.Pathogenicity of living organisms and viruses to infects humans, animals and plants to cause disease. ii.Toxicity of allergy associated with microbial production. iii.Increasing number of antibiotic resistant pathogenic microorganisms. iv.Problem associated with the disposal of spent microbial biomasss and purification of effluent from biotechnological processes. v.Safety aspects associated with contamination, infection or mutation of process strains. vi.Safety aspects associated with the industrial use of microorganisms.

3. Convention On Biological Diversity  On December 29, 1993 173 nations signed The International Convention on Biological Diversity. It recognizes the sovereign rights of nations over their genetic resources and also for determine access to them based on prior informed consent and linking to transfer of relevant technologies and sharing of benefits.  The CBD has recognized two outstanding issues that needed resolution as follows: 1.The mechanism for implementing farmers right 2. The status of ex situ germplasm collections that were not acquired according to provisions of CBD.

4. Cartagena Protocol on Biosafety More than 130 countries adopted the Biosafety Protocol on January 29, 2000, in Montreal, Canada. It is called the Cartagena Protocol on Biosafety to honor Colombia, which hosted the extraordinary Conference of the Parties to the Convention on Biological Diversity (CBD) in Cartagena in 1999. The protocol was developed over a period of about 5 years.

5. 5 Facts and Figures Protocol adopted on 29 January 2000 in Montreal at an extraordinary meeting of the Conference of the Parties to the Convention on Biological Diversity. 143 ratifications/accessions ( as of 03 October 2007, of which 40 African countries) 17 countries have signed but not yet ratified. Entered into force on 11 September 2003

6. Cartagena Protocol on Biosafety Objectives: The objective of this first Protocol to the CBD is to contribute to the safe transfer, handling and use of living modified organisms (LMOs) -- such as genetically engineered- plants, animals, and microbes -- that cross international borders. The Biosafety Protocol is also intended to avoid adverse effects on the conservation and sustainable use of biodiversity without unnecessarily disrupting world food trade. The Protocol provides countries the opportunity to obtain information before new biotech organisms are imported. It acknowledges each country's right to regulate bio-engineered organisms, subject to existing international obligations. It also creates a framework to help improve the capacity of developing countries to protect biodiversity.

7. What It Does: The Protocol establishes an Internet-based "Biosafety Clearing- House" (BCH) to help countries exchange scientific, technical, environmental, and legal information about living modified organisms (LMOs).  It creates an advance informed agreement (AIA) procedure that in effect requires exporters to seek consent from an importing country before the first shipment of an LMO meant to be introduced into the environment (such as seeds for planting, fish for release, or microorganisms for bioremediation). It requires shipments of LMO commodities, such as maize or soybeans that are intended for direct use as food, feed, or for processing, to be accompanied by documentation stating that such shipments "may contain" living modified organisms and are "not intended for intentional introduction into the environment." The Protocol establishes a process for considering more detailed identification and documentation of LMO commodities in international trade.

8.  It also sets out information to be included on documentation accompanying LMOs destined for contained use, including any handling requirements and contact points for further information and for the consignee.  The Protocol includes a "savings clause," which states that the agreement shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreement, including, for example, WTO agreements.  The Protocol calls on Parties to cooperate with developing countries in building their capacity for managing modern biotechnology.

9. What It Does Not Do  The Protocol does not address food safety issues. Experts in other international fora, such as Codex Alimentarius, address food safety.  It does not pertain to non-living products derived from genetically engineered plants or animals, such as milled maize or other processed food products.  It does not require segregation of commodities that may contain living modified organisms.  It does not subject commodities to the Protocol's AIA procedure, which would significantly disrupt trade and jeopardize food access, without commensurate benefit to the environment. The Protocol does not require consumer product labeling. The mandate of the Protocol is to address risks to biodiversity that may be presented by living modified organisms. Issues related to consumer preference were not part of the negotiation.

10. There are several elements in the Protocol. I’ve listed some of the main elements here – I won’t talk about all of them, but I will touch on the first few……

11. 11 2. Key Elements of the 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

12. 12 Scope of the Protocol (Article 4) 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.

13. 13 Scope of the Protocol (continued) 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).

14. 14 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.

15. 15 The AIA procedure (continued) 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. 16 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 will be taken by the Party of import within 270 days of the date of receipt of the notification

17. 17 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. 18 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 transboundary movement shall, within 15 days of making that decision, inform the Parties through the Biosafety Clearing-house (BCH); In return, each Party shall make available to the BCH copies of any national laws, regulations and guidelines applicable to the import of such LMOs on their national territory.

19. 19 Risk Assessment and Risk Management (Articles 15 & 16) Annex III specifies the scope of risk assessment Scientific sound manner; transparency; case by case Absence/Lack or insufficiency of scientific knowledge or scientific consensus does not indicate an absence of risk or an acceptable risk Each Party shall establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks and to prevent unintentional transboundary movements of LMOs

20. 20 Handling, Transport, Packaging and Identification (Article 18) Each Party takes necessary measures to require that LMOs ar handled, packaged and transported under conditions of safety The Protocol sets minimal measures concerning documentation accompanying LMOs that are subject to transboundary movements: LMOs-FFP, LMOs for contained use, LMOs for intentional introduction in the environment. N.B. Not to confuse identification/documentation of LMOs under the Protocol with “labelling” in everyday use

21. 21 Information Sharing and the Biosafety Clearing-House (Article 20) A clearing-house (BCH) is established to: –Facilitate the exchange of scientific, technical, environmental and legal information and experience with LMOs –Assist Parties to implement the Protocol http://bch.cbd.int

22. 22 Characteristics of the BCH (continued) Open to all governments Was developed as a distributed network composed of a Central Portal maintained by the Secretariat and national nodes or data bases that are inter-operable with the Central Portal Information is controlled and managed by the supplier Management Centre BCH National Focal Points Designed for use via the Internet but non-internet options are available upon request

23. 23 Capacity Building (Article 22) Parties cooperate in the development and/or strengthening of human resources and institutional capacities Cornerstone for the implementation of the Protocol

24. 24 Capacity Building (continued) An Action Plan adopted by governments at the first meeting of the Parties (February 2004); updated at the third meeting of the Parties (March 2006) A Roster of Experts in biosafety has been established to help developing country Parties with the implementation of the Protocol, especially concerning risk assessment and risk management of LMOs in order to make informed decisions regarding imports of LMOs.

25. 25 Socio-Economic Considerations (Article 26) In reaching a decision on import, Parties may take into account socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities However, this must be consistent with other international obligations

26. 26 Liability and Redress (Article 27) The Protocol provides for a process to elaborate appropriate international rules and procedures regarding liability and redress for damage resulting from transboundary movements of LMOs The first meeting of the Parties has set this process in motion by establishing an Open-ended Working Group of Legal and Technical experts to develop options for a liability and redress regime under the Protocol Negotiations expected to be completed in 2007

27. 27 Compliance (Article 34) Cooperative procedures and institutional mechanisms to promote compliance and to address cases of non- compliance have been approved at the first meeting of the Parties Among them, a compliance committee composed of 15 experts has been set up

28. 28 Public awareness and participation (Article 23) Parties are encouraged to: Promote and facilitate public awareness, education and participation concerning the safe transfer and use of LMOs Endeavour to ensure public access to information on LMOs that may be imported Consult the public in the decision-making process regarding LMOs and make the results of such decisions available to the public Inform the public about the means of public access to the Biosafety Clearing-House (BCH)

29. 29 GMOs in Forestry GM Trees: CBD COP Decision VIII/19 Uncertainties related to potential environmental and socio- economic impacts of GM trees on global forest biological diversity as well as on livelihoods of indigenous/local communities COP recommends Parties to take a precautionary approach when addressing the issue of GM trees CBD’s SBSTTA to assess the potential environmental, cultural and socio-economic impacts of GM trees on the conservation and sustainable use of forest biological diversity and report to COP9 Parties, governments, relevant organizations/stakeholders invited to submit views and information to the Secretariat for inclusion in the assessment.

30. 30 3. Conclusions The Protocol is a recognition in international law that LMOs may have adverse effects on biodiversity and human health and that a harmonized international framework regulating transboundary movements of LMOs is indispensable The Protocol endorses and operationalizes the precautionary approach The concept of the advance informed agreement in decision-making regarding import of LMOS is the backbone of the Protocol for LMOs intended for introduction into the environment Capacity building/strengthening is paramount in this regard

31. 31 3. Conclusions (continued) The exchange of information between all relevant stakeholders via the BCH is indispensable for the functioning of the Protocol The Protocol recognizes the right of States to take more protective measures for biodiversity than what the Protocol requires as long as they are consistent with the objective and provisions of the Protocol It is important that Parties clearly understand their rights and obligations under the Protocol, including the obligation to promote and facilitate public awareness, education and public participation in decision-making regarding LMOs

32. 32 Information Secretariat of the CBD, Montreal E-mail: secretariat@cbd.intsecretariat@cbd.int Tel.: (1 514) 288-2220 Web: www.cbd.intwww.cbd.int