The Cartagena Protocol on Biosafety to the Convention on Biological Diversity

1. The Cartagena Protocol on Biosafety to the Convention on Biological Diversity Cyrie Sendashonga Currently: Regional Coordinator, CIFOR, Regional Office for Central Africa, Yaounde, Cameroon Formerly: Senior Programme Officer, Head of Biosafety Unit Secretariat of the Convention on Biological Diversity

2. Programme • Background • Key elements of the Protocol • Conclusions

3. 1. Background • The Protocol is an international legally binding treaty which sets procedures and mechanisms to be applied in the transboundary movements of Living Modified Organisms (LMOs)- living organisms that possesses a novel combination of genetic material obtained through the use of modern biotechnology (genetic modification). • The Protocol does not apply to other products of biotechnogy.

4. Objective of the Protocol (Article 1) • «  Contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements. » • The Protocol is not a moratorium on modern biotechnology.

5. Origin of the Protocol • Broad recognition of the need to protect human health and the environment from possible adverse effects of the products of modern biotechnology began to emerge as advances in molecular biology and genetic engineering were breaking new frontiers in the 80’s. • UNCED (World Summit, Rio, June 1992): Agenda 21, Chapter 16 : recognition of the need for need for sound environmental management of biotechnology • Principle 15 of the Rio Declaration on Environment and Development: the precautionary approach “…where there is a threat… lack of full scientific certainty should not be used as a reason for postponing measures to avoid or minimize such a threat.”

6. Origin of the Protocol (continued) Sustainable use Objectives of the CBD: Article 8(g) of the CBD: “Each Contracting Party shall, as far as possible and as appropriate: (g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health” Fair and equitable sharing of benefits Conservation of biodiversity

7. Origin of the Protocol (continued) Article 19.3 of the CBD: “The Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity. ”

8. 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

9. Why do we need a 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

10. Excerpts from Preamble: • 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.”

11. Excerpts from Preamble: • Trade and environment imperatives: “Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development.” • Importance of avoiding “contamination”: “Recognizing also the crucial importance to humankind of centres of origin and centres of genetic diversity”.

12. Facts on LMOs • 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 • In 2004, GM crops could be found in 17 countries

13. Facts on LMOs (continued) • 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 • 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

14. Definitions/Use of terms (Article 3) • Living modified organism (LMO): any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology • Living organism: any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids • Modern biotechnology: application of in vitro nucleic acid techniques (e.g. recDNA and direct injection of nucleic acid into cells or organelles),or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection

15. Potential benefits of biotechnology • Proponents of genetic engineering claim that it holds great promises and remarkable advances in medicine (e.g.: new medical treatments, vaccines, etc), industrial products, improved fibres and fuels, increases in food security, decreased pressure on land use, sustainable yield increase in marginal lands or inhospitable environments, reduced use of water and agrochemicals in agriculture.

16. 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.)

17. 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 2. Key Elements of the Protocol

18. 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.

19. 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).

20. 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

21. 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)

22. 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

23. 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

24. Procedurefor 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.

25. 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

26. 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

27. 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

28. 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 Characteristics of the BCH (continued)

29. 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

30. 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.

31. 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

32. 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

33. 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

34. 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)

35. 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.

36. 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

37. 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

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