Proposal for a Council Decision on the signature, on behalf of the European Community, of the Cartagena Protocol on Biosafety
COMMISSION OF THE EUROPEAN COMMUNITIES Brussels, 30. 3. 2000 COM(2000) 182 final 2000/0072 (ACC) Proposal for a COUNCIL DECISION on the signature, on behalf of the European Community, of the Cartagena Protocol on Biosafety (presented by the Commission) EXPLANATORY MEMORANDUM On 19 October 19951 the Council authorised the Commission to participate, on behalf of the Community, in the negotiations on a Protocol on Biosafety under the Convention on Biological Diversity. The Community reached in these negotiations all its main objectives as set out in its negotiation directives, in particular the Council Conclusions of 13 December 19992. Promoting measures at international level to deal with regional or worldwide environmental problems is one of the objectives of the Community’s policy on the environment, in accordance with Article 174 of the Treaty, which includes the conservation and sustainable use of biological diversity. The main focus of the Cartagena Protocol on Biosafety is the intentional transboundary movements of living modified organisms and it affects therefore international trade. The Decision to sign should therefore be based on article 133 and 174(4), in conjunction with the first sentence of the first subparagraph of art. 300 (2). By decision 93/626/EEC3, the Community concluded the Convention on Biological Diversity under the auspices of the United Nations Environment Programme. Pursuant to Article 19 (3) of the Convention, the second Conference of the Parties to the Convention established in 19954 a negotiation process to consider the need for and modalities of a protocol on biosafety. The Cartagena Protocol on Biosafety provides a framework, based on the precautionary principle, for 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 taking also into account risks to human health and specifically of biological diversity, focussing on transboundary movements. The Cartagena Protocol on Biosafety was adopted by consensus in Montreal on 29 January 2000 during the Extraordinary Conference of the Parties to the Convention on Biological Diversity. The Protocol will be open for signature in Nairobi during the fifth meeting of the Conference of the Parties to the Convention in Nairobi from 15 to 26 May 2000, and at the UN Headquarters in New York from 5 June 2000 to 4 June 2001. The Commission considers that by signing the Cartagena Protocol on Biosafety in Nairobi in May, the European Community would give an important political signal to all parties that signature and ratification of the Protocol should be an absolute priority. Community competence is preponderant. Linked with the principle of unity in the international representation of the Community this militates in favour of simultaneous signature and eventual deposit of the respective instruments of ratification or approval by the Community and its Member States. In any case, Member States should not sign the Protocol, 1 Council Document 10887/95 ENV 265. 2 Council Document 13799/99 ENV 428. 3 OJ L 309, 13. 12. 1993, p. 1-20. 4 Consideration of the need for and modalities of a protocol for the safe transfer, handling and use of living modified organisms, Decision II/5 of the second Conference of the Parties to the Convention on Biological Diversity. 2 nor eventually deposit their instruments of ratification or approval before the Community does. The Commission therefore requests the Council to authorise the President to designate the persons empowered to sign the Cartagena Protocol on Biosafety on behalf of the Community and to confer on them the necessary powers. Considering the above, the Community intends to sign the Cartagena Protocol on Biosafety at the fifth meeting of the Conference of the Parties to the Convention on Biological Diversity in Nairobi in May 2000. 3 2000/0072 (ACC) Proposal for a COUNCIL DECISION on the signature, on behalf of the European Community, of the Cartagena Protocol on Biosafety THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular articles 133 and 174 (4), in conjunction with the first sentence of the first subparagraph of art. 300 (2) thereof, Having regard to the proposal from the Commission5, Whereas: (1) (2) (3) (4) (5) (6) promoting measures at to deal with regional or worldwide level environmental problems is one of the objectives of the Community’s policy on the environment, in accordance with Article 174 of the Treaty, which includes the conservation and sustainable use of biological diversity; international by decision 93/626/EEC6, the Community concluded the Convention on Biological Diversity under the auspices of the United Nations Environment Programme; the Commission, which was authorised in 19957 to negotiate on behalf of the Community, and the Member States, participated in the negotiations for a Protocol on Biosafety as stipulated in Article 19 (3) of the Convention on Biological Diversity; the Cartagena Protocol on Biosafety was adopted in Montreal on 29 January 2000; the Protocol provides a framework, based on the precautionary principle, for 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 focussing on transboundary movements; the Protocol, pursuant to Article 36 thereof, shall be open for signature by States and regional economic integration organisations at the 5th Conference of the Parties to the Convention on Biological Diversity in Nairobi from 15 to 26 May 2000, and at United Nations Headquarters in New York from 5 June 2000 to 4 June 2001; 5 OJ C , , p. 6 OJ L 309, 13. 12. 1993, p. 1-20. 7 Council Document 10887/95 ENV 265. 4 (7) (8) preponderant Community competence linked with the principle of unity in the international representation of the Community militate in favour of simultaneous signature and eventual deposit of the respective instruments of ratification or approval by the Community and its Member States, and prevent Member States to sign the instruments of ratification or approval before the Protocol or eventually deposit Community does; it is therefore convenient that the Cartagena Protocol on Biosafety be signed on behalf of the Community during the 5th Conference of the Parties to the Convention on Biological Diversity, subject to subsequent conclusion; HAS DECIDED AS FOLLOWS: Sole Article is hereby authorised to designate the person or persons The President of the Council empowered to sign, on behalf of the Community, subject to subsequent conclusion, the Cartagena Protocol on Biosafety, and to confer upon them the powers necessary for that purpose. Done at, For the Council The President 5 CARTAGENA PROTOCOL ON BIOSAFETY to the convention on biological diversity The Parties to this Protocol, Being Parties to the Convention on Biological Diversity, hereinafter referred to as "the Convention", Recalling Article 19, paragraphs 3 and 4, and Articles 8 (g) and 17 of the Convention, Recalling also decision II/5 of 17 November 1995 of the Conference of the Parties to the Convention to develop a Protocol on biosafety, specifically focusing on transboundary movement of any living modified organism resulting from modern biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity, setting out for consideration, in particular, appropriate procedures for advance informed agreement, Reaffirming the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, 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, Recognizing that modern biotechnology has great potential developed and used with adequate safety measures for the environment and human health, for human well-being if Recognizing also the crucial importance to humankind of centres of origin and centres of genetic diversity, 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, Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development, Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements, Understanding that the above recital is not intended to subordinate this Protocol to other international agreements, Have agreed as follows: 1. ARTICLE 1 OBJECTIVE ANNEX In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to 6 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. 2. ARTICLE 2 GENERAL PROVISIONS 1. 2. 3. 4. 5. Each Party shall take necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol. The Parties shall ensure that the development, handling, transport, use, transfer and release of any living modified organisms are undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account risks to human health. Nothing in this Protocol shall affect in any way the sovereignty of States over their territorial sea established in accordance with international law, and the sovereign rights and the jurisdiction which States have in their exclusive economic zones and their continental shelves in accordance with international law, and the exercise by ships and aircraft of all States of navigational rights and freedoms as provided for in international law and as reflected in relevant international instruments. Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for in this Protocol, provided that such action is consistent with the objective and the provisions of this Protocol and is in accordance with that Party's other obligations under international law. The Parties are encouraged to take into account, as appropriate, available instruments and work undertaken in international forums with expertise, competence in the area of risks to human health. 3. ARTICLE 3 USE OF TERMS For the purposes of this Protocol: (a) (b) "Conference of the Parties" means the Conference of the Parties to the Convention; "Contained use" means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment; 7 (c) (d) (e) (f) (g) "Export" means intentional transboundary movement from one Party to another Party; "Exporter" means any legal or natural person, under the jurisdiction of the Party of export, who arranges for a living modified organism to be exported; "Import" means intentional transboundary movement another Party; into one Party from "Importer" means any legal or natural person, under the jurisdiction of the Party of import, who arranges for a living modified organism to be imported; "Living modified organism" means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology; (h) "Living organism" means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids; (i) "Modern biotechnology" means the application of: a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or b. Fusion of cells beyond the taxonomic family, that overcome natural physiological recombination barriers and that are not techniques used in traditional breeding and selection. reproductive or (j) (k) economic integration organization" means "Regional an organization constituted by sovereign States of a given region, to which its member States have transferred competence in respect of matters governed by this Protocol and which has been duly authorized, in accordance with its internal procedures, to sign, ratify, accept, approve or accede to it; "Transboundary movement" means the movement of a living modified organism from one Party to another Party, save that for the purposes of Articles 17 and 24 transboundary movement extends to movement between Parties and non-Parties. 4. ARTICLE 4 SCOPE 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. 8 5. ARTICLE 5 PHARMACEUTICALS Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to the making of decisions on import, this Protocol shall 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. 6. ARTICLE 6 TRANSIT AND CONTAINED USE 1. 2. Notwithstanding Article 4 and without prejudice to any right of a Party of to regulate the transport of living modified organisms through its transit territory and make available to the Biosafety Clearing-House, any decision of that Party, subject to Article 2, paragraph 3, regarding the transit through its territory of a specific living modified organism, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to living modified organisms in transit. Notwithstanding Article 4 and without prejudice to any right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for contained use within its jurisdiction, the provisions of this Protocol with respect to the advance informed agreement procedure shall not apply to the transboundary movement of living modified organisms destined for contained use undertaken in accordance with the standards of the Party of import. 7. ARTICLE 7 APPLICATION OF PROCEDURE THE ADVANCE INFORMED AGREEMENT 1. 2. 3. 4. Subject to Articles 5 and 6, the advance informed agreement procedure in Articles 8 to 10 and 12 shall apply prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import. "Intentional introduction into the environment" in paragraph 1 above, does not refer to living modified organisms intended for direct use as food or feed, or for processing. Article 11 shall apply prior to the first transboundary movement of living modified organisms intended for direct use as food or feed, or for processing. The advance informed agreement procedure shall not apply to the intentional transboundary movement of living modified organisms identified in a decision of the Conference of the Parties serving as the meeting of the Parties to this Protocol as being not likely to have adverse effects on the conservation and 9 sustainable use of biological diversity, taking also into account risks to human health. 8. ARTICLE 8 NOTIFICATION 1. 2. The Party of export shall notify, or require the exporter to ensure notification to, in writing, the competent national authority of the Party of import prior to the intentional transboundary movement of a living modified organism that falls within the scope of Article 7, paragraph 1. The notification shall contain, at a minimum, the information specified in Annex I. The Party of export shall ensure that there is a legal requirement for the accuracy of information provided by the exporter. 9. ARTICLE 9 ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION 1. The Party of import shall acknowledge receipt of the notification, in writing, to the notifier within ninety days of its receipt. 2. The acknowledgement shall state: (a) The date of receipt of the notification; (b) Whether the notification, prima facie, contains the information referred to in Article 8; (c) Whether to proceed according to the domestic regulatory framework of the Party of import or according to the procedure specified in Article 10. 3. 4. The domestic regulatory framework referred to in paragraph 2 (c) above, shall be consistent with this Protocol. A failure by the Party of import to acknowledge receipt of a notification shall not imply its consent to an intentional transboundary movement. 10. ARTICLE 10 DECISION PROCEDURE 1. 2. Decisions taken by the Party of import shall be in accordance with Article 15. The Party of import shall, within the period of time referred to in Article 9, inform the notifier, transboundary movement may proceed: in writing, whether the intentional (a) Only after the Party of import has given its written consent; or 10 (b) After no less than ninety days without a subsequent written consent. 3. Within two hundred and seventy days of the date of receipt of notification, the Party of import shall communicate, in writing, to the notifier and to the Biosafety Clearing-House the decision referred to in paragraph 2 (a) above: (a) Approving the import, with or without conditions, including how the decision will apply to subsequent imports of the same living modified organism; (b) Prohibiting the import; (c) Requesting additional relevant information in accordance with its domestic regulatory framework or Annex I; in calculating the time within which the Party of import is to respond, the number of days it has to wait for additional relevant information shall not be taken into account; or (d) Informing the notifier that extended by a defined period of time. the period specified in this paragraph is Except in a case in which consent is unconditional, a decision under paragraph 3 above, shall set out the reasons on which it is based. A failure by the Party of import to communicate its decision within two hundred and seventy days of the date of receipt of the notification shall not imply its consent to an intentional transboundary movement. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects. The Conference of the Parties serving as the meeting of the Parties shall, at its first meeting, decide upon appropriate procedures and mechanisms to facilitate decision-making by Parties of import. 4. 5. 6. 7. 11. ARTICLE 11 PROCEDURE FOR LIVING MODIFED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING 1. A Party that makes a final decision regarding domestic use, including placing on the market, of a living modified organism that may be subject to transboundary movement for direct use as food or feed, or for processing shall, within fifteen days of making that decision, inform the Parties through the Biosafety Clearing-House. This information shall contain, at a minimum, the information specified in Annex II. The Party shall provide a copy of the information, in writing, to the national focal point of each Party that informs 11 in advance that the Secretariat it does not have access to the Biosafety Clearing-House. This provision shall not apply to decisions regarding field trials. The Party making a decision under paragraph 1 above, shall ensure that there is a legal requirement for the accuracy of information provided by the applicant. Any Party may request additional information from the authority identified in paragraph (b) of Annex II. A Party may take a decision on the import of living modified organisms intended for direct use as food or feed, or for processing, under its domestic regulatory framework that is consistent with the objective of this Protocol. Each Party shall make available to the Biosafety Clearing-House copies of any national laws, regulations and guidelines applicable to the import of living modified organisms intended for direct use as food or feed, or for processing, if available. A developing country Party or a Party with an economy in transition may, in the absence of the domestic regulatory framework referred to in paragraph 4 above, and in exercise of its domestic jurisdiction, declare through the Biosafety Clearing-House that its decision prior to the first import of a living modified organism intended for direct use as food or feed, or for processing, on which information has been provided under paragraph 1 above, will be taken according to the following: (a) A risk assessment undertaken in accordance with Article 15; and (b) A decision made within a predictable timeframe, not exceeding two hundred and seventy days. Failure by a Party to communicate its decision according to paragraph 6 above, shall not imply its consent or refusal to the import of a living modified organism intended for direct use as food or feed, or for processing, unless otherwise specified by the Party. Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of that living modified organism intended for direct use as food or feed, or for processing, in order to avoid or minimize such potential adverse effects. A Party may indicate its needs for financial and technical assistance and capacity-building with respect to living modified organisms intended for direct use as food or feed, or for processing. Parties shall cooperate to meet these needs in accordance with Articles 22 and 28. 2. 3. 4. 5. 6. 7. 8. 9. 12 12. ARTICLE 12 REVIEW OF DECISIONS 1. 2. 3. 4. A Party of import may, at any time, in light of new scientific information on potential adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health, review and change a decision regarding an intentional transboundary movement. In such case, the Party shall, within thirty days, inform any notifier that has previously notified movements of the living modified organism referred to in such decision, as well as the Biosafety Clearing-House, and shall set out the reasons for its decision. A Party of export or a notifier may request the Party of import to review a decision it has made in respect of it under Article 10 where the Party of export or the notifier considers that: (a) A change in circumstances has occurred that may influence the outcome of the risk assessment upon which the decision was based; or (b) Additional relevant scientific or technical information has become available. The Party of import shall respond to such a request within ninety days and set out the reasons for its decision. The Party of import may, at subsequent imports. its discretion, require a risk assessment for 13. ARTICLE 13 SIMPLIFIED PROCEDURE 1. A Party of import may, provided that adequate measures are applied to ensure the safe intentional transboundary movement of living modified organisms in accordance with the objective of this Protocol, specify in advance to the Biosafety Clearing-House: (a) Cases in which intentional transboundary movement to it may take place at the same time as the movement is notified to the Party of import; and (b) Imports of living modified organisms to it to be exempted from the advance informed agreement procedure. Notifications under subparagraph (a) above, may apply to subsequent similar movements to the same Party. 2. The information relating to an intentional transboundary movement that is to be provided in the notifications referred to in paragraph 1 (a) above shall be the information specified in Annex I. 13 14. ARTICLE 14 BILATERAL, REGIONAL AND MULTILATERAL AGREEMENTS AND ARRANGEMENTS 1. 2. 3. 4. regarding intentional Parties may enter into bilateral, regional and multilateral agreements and arrangements living modified organisms, consistent with the objective of this Protocol and provided in a lower level of that such agreements and arrangements do not result protection than that provided for by the Protocol. transboundary movements of The Parties shall inform each other, through the Biosafety Clearing-House, of any such bilateral, regional and multilateral agreements and arrangements that they have entered into before or after the date of entry into force of this Protocol. transboundary The provisions of this Protocol shall not affect movements that take place pursuant to such agreements and arrangements as between the parties to those agreements or arrangements. intentional Any Party may determine that its domestic regulations shall apply with respect to specific imports to it and shall notify the Biosafety Clearing-House of its decision. 15. ARTICLE 15 RISK ASSESSMENT 1. 2. 3. Risk assessments undertaken pursuant to this Protocol shall be carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques. Such risk assessments shall be based, at a minimum, on information provided in accordance with Article 8 and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health. The Party of import shall ensure that risk assessments are carried out for decisions taken under Article 10. It may require the exporter to carry out the risk assessment. The cost of risk assessment shall be borne by the notifier if the Party of import so requires. 16. ARTICLE 16 RISK MANAGEMENT 1. The Parties shall, taking into account Article 8 (g) of the Convention, establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment provisions of this 14 Protocol associated with the use, handling and transboundary movement of living modified organisms. 2. Measures based on risk assessment shall be imposed to the extent necessary to prevent adverse effects of the living modified organism on the conservation and sustainable use of biological diversity, taking also into account risks to human health, within the territory of the Party of import. 3. take appropriate measures to prevent unintentional Each Party shall transboundary movements of including such measures as requiring risk assessments to be carried out prior to the first release of a living modified organism. living modified organisms, 4. Without prejudice to paragraph 2 above, each Party shall endeavour to ensure that any living modified organism, whether imported or locally developed, has undergone an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use. 5. Parties shall cooperate with a view to: (a) Identifying living modified organisms or specific traits of 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; and (b) Taking appropriate measures regarding the treatment of such living modified organisms or specific traits. 17. ARTICLE 17 UNINTENTIONAL TRANSBOUNDARY MOVEMENTS AND EMERGENCY MEASURES 1. 2. Each Party shall take appropriate measures to notify affected or potentially affected States, the Biosafety Clearing-House and, where appropriate, relevant international organizations, when it knows of an occurrence under its jurisdiction resulting in a release that leads, or may lead, to an unintentional transboundary movement of a living modified organism that is likely to have significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health in such States. The notification shall be provided as soon as the Party knows of the above situation. Each Party shall, no later than the date of entry into force of this Protocol for it, make available to the Biosafety Clearing-House the relevant details setting out its point of contact for the purposes of receiving notifications under this Article. 3. Any notification arising from paragraph l above, should include: (a) Available relevant information on the estimated quantities and relevant characteristics and/or traits of the living modified organism; 15 (b) Information on the circumstances and estimated date of the release, and on the use of the living modified organism in the originating Party; (c) Any available information about the possible adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, as well as available information about possible risk management measures; (d) Any other relevant information; and (e) A point of contact for further information. 4. In order to minimize any significant adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party, under whose jurisdiction the release of the living modified organism referred to in paragraph l above, occurs, shall immediately consult the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures. 18. ARTICLE 18 HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION 1. In order to avoid adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, each Party shall take necessary measures to require that living modified organisms that are subject transboundary movement within the scope of this Protocol are handled, packaged and transported under conditions of safety, taking into consideration relevant international rules and standards. to intentional 2. Each Party shall take measures to require that documentation accompanying: (a) (b) Living modified organisms that are intended for direct use as food or feed, or for processing, clearly identifies that they "may contain" living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall take a decision on the detailed requirements for this purpose, identity and any unique identification, no later than two years after the date of entry into force of this Protocol; including specification of their Living modified organisms that are destined for contained use clearly identifies them as living modified organisms; and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the living modified organisms are consigned; and (c) Living modified organisms that are intended for intentional introduction into the environment of the Party of import and any other living modified 16 organisms within the scope of the Protocol, clearly identifies them as traits living modified organisms; specifies the identity and relevant and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that is in conformity with the the movement requirements of this Protocol applicable to the exporter. 3. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall consider the need for and modalities of developing standards with regard to identification, handling, packaging and transport practices, in consultation with other relevant international bodies. 19. ARTICLE 19 COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL POINTS 1. 2. Each Party shall designate one national focal point to be responsible on its behalf for liaison with the Secretariat. Each Party shall also designate one or more competent national authorities, which shall be responsible for performing the administrative functions required by this Protocol and which shall be authorized to act on its behalf with respect to those functions. A Party may designate a single entity to fulfill the functions of both focal point and competent national authority. Each Party shall, no later than the date of entry into force of this Protocol for it, notify the Secretariat of the names and addresses of its focal point and its competent national authority or authorities. Where a Party designates more than one competent national authority, it shall convey to the Secretariat, with its notification thereof, relevant information on the respective responsibilities of those authorities. Where applicable, such information shall, at a minimum, specify which competent authority is responsible for which type of living modified organism. Each Party shall forthwith notify the Secretariat of any changes in the designation of its national focal point or in the name and address or responsibilities of its competent national authority or authorities. 3. The Secretariat shall forthwith inform the Parties of the notifications it receives under paragraph 2 above, and shall also make such information available through the Biosafety Clearing-House. 20. ARTICLE 20 INFORMATION SHARING AND THE BIOSAFETY CLEARING-HOUSE 1. A Biosafety Clearing-House is hereby established as part of the clearing-house mechanism under Article 18, paragraph 3, of the Convention, in order to: (a) Facilitate the exchange of scientific, technical, environmental and legal information on, and experience with, living modified organisms; and 17 (b) Assist Parties to implement the Protocol, taking into account the special needs of developing country Parties, in particular the least developed and small island developing States among them, and countries with economies in transition as well as countries that are centres of origin and centres of genetic diversity. 2. The Biosafety Clearing-House shall serve as a means through which information is made available for the purposes of paragraph 1 above. It shall provide access to information made available by the Parties relevant to the implementation of the Protocol. It shall also provide access, where possible, to other international biosafety information exchange mechanisms. 3. Without prejudice to the protection of confidential information, each Party shall make available to the Biosafety Clearing-House any information required to be made available to the Biosafety Clearing-House under this Protocol, and: (a) Any existing laws, regulations and guidelines for implementation of the Protocol, as well as information required by the Parties for the advance informed agreement procedure; (b) Any bilateral, regional and multilateral agreements and arrangements; (c) Summaries of its risk assessments or environmental reviews of living modified organisms generated by its regulatory process, and carried out in accordance with Article 15, including, where appropriate, relevant information regarding products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology; (d) Its final decisions regarding the importation or release of living modified organisms; and (e) Reports submitted by it pursuant to Article 33, including those on implementation of the advance informed agreement procedure. 4. The modalities of the operation of the Biosafety Clearing-House, including reports on its activities, shall be considered and decided upon by the Conference of the Parties serving as the meeting of the Parties to this Protocol at its first meeting, and kept under review thereafter. 21. ARTICLE 21 CONFIDENTIAL INFORMATION 1. 2. The Party of import shall permit the notifier to identify information submitted under the procedures of this Protocol or required by the Party of import as part of the advance informed agreement procedure of the Protocol that is to be treated as confidential. Justification shall be given in such cases upon request. The Party of import shall consult the notifier if it decides that information identified by the notifier as confidential does not qualify for such treatment and 18 shall, prior to any disclosure, inform the notifier of its decision, providing reasons on request, as well as an opportunity for consultation and for an internal review of the decision prior to disclosure. Each Party shall protect confidential information received under this Protocol, including any confidential information received in the context of the advance informed agreement procedure of the Protocol. Each Party shall ensure that it has procedures to protect such information and shall protect the confidentiality of such information in a manner no less favourable than its treatment of confidential information in connection with domestically produced living modified organisms. The Party of import shall not use such information for a commercial purpose, except with the written consent of the notifier. If a notifier withdraws or has withdrawn a notification, the Party of import the confidentiality of commercial and industrial information, shall respect including research and development information as well as information on which the Party and the notifier disagree as to its confidentiality. 3. 4. 5. 6. Without prejudice to paragraph 5 above, the following information shall not be considered confidential: (a) The name and address of the notifier; (b) A general description of the living modified organism or organisms; (c) A summary of the risk assessment of the effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health; and (d) Any methods and plans for emergency response. 22. ARTICLE 22 CAPACITY-BUILDING 1. 2. The Parties shall cooperate in the development and/or strengthening of human resources and institutional capacities in biosafety, including biotechnology to the extent that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in developing country Parties, in particular the least developed and small island developing States among them, and in Parties with economies in transition, including through existing global, regional, subregional and national institutions and organizations and, as appropriate, through facilitating private sector involvement. the purposes of implementing paragraph 1 above, For in relation to cooperation, the needs of developing country Parties, in particular the least developed and small island developing States among them, for financial technology and know-how in resources and access to and transfer of accordance with the relevant provisions of the Convention, shall be taken fully into account for capacity-building in biosafety. Cooperation in capacity- 19 building shall, subject to the different situation, capabilities and requirements of each Party, include scientific and technical training in the proper and safe management of biotechnology, and in the use of risk assessment and risk management technological and institutional capacities in biosafety. The needs of Parties with economies in transition shall also be taken fully into account for such capacity-building in biosafety. for biosafety, and the enhancement of 23. ARTICLE 23 PUBLIC AWARENESS AND PARTICIPATION 1. The Parties shall: (a) Promote and facilitate public awareness, education and participation living modified concerning the safe transfer, handling and use of organisms in relation to the conservation and sustainable use of biological diversity, taking also into account risks to human health. In doing so, the Parties shall cooperate, as appropriate, with other States and international bodies; (b) Endeavour to ensure that public awareness and education encompass access to information on living modified organisms identified in accordance with this Protocol that may be imported. 2 3. The Parties shall, in accordance with their respective laws and regulations, consult the public in the decision-making process regarding living modified organisms and shall make the results of such decisions available to the public, while respecting confidential information in accordance with Article 21. Each Party shall endeavour to inform its public about the means of public access to the Biosafety Clearing-House. 24. ARTICLE 24 NON-PARTIES 1. 2. Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol. The Parties may enter into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding such transboundary movements. The Parties shall encourage non-Parties to adhere to this Protocol and to contribute appropriate information to the Biosafety Clearing-House on living modified organisms released in, or moved into or out of, areas within their national jurisdictions. 20 25. ARTICLE 25 ILLEGAL TRANSBOUNDARY MOVEMENTS 1. 2. 3. Each Party shall adopt appropriate domestic measures aimed at preventing and, living modified if appropriate, penalizing transboundary movements of organisms carried out in contravention of its domestic measures to implement this Protocol. Such movements shall be deemed illegal transboundary movements. In the case of an illegal transboundary movement, the affected Party may request the Party of origin to dispose, at its own expense, of the living modified organism in question by repatriation or destruction, as appropriate. Each Party shall make available to the Biosafety Clearing-House information concerning cases of illegal transboundary movements pertaining to it. 26. ARTICLE 26 SOCIO-ECONOMIC CONSIDERATIONS 1. 2. The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities. The Parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of living modified organisms, especially on indigenous and local communities. 27. ARTICLE 27 LIABILITY AND REDRESS The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, adopt a process with respect to the appropriate elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms, analysing and taking due account of the ongoing processes in international law on these matters, and shall endeavour to complete this process within four years. 28. ARTICLE 28 FINANCIAL MECHANISM AND RESOURCES 1. In considering financial resources for the implementation of this Protocol, the Parties shall take into account the provisions of Article 20 of the Convention. 21 2. 3. 4. 5. 6. The financial mechanism established in Article 21 of the Convention shall, through the institutional structure entrusted with its operation, be the financial mechanism for this Protocol. Regarding the capacity-building referred to in Article 22 of this Protocol, the Conference of the Parties serving as the meeting of the Parties to this Protocol, in providing guidance with respect to the financial mechanism referred to in paragraph 2 above, for consideration by the Conference of the Parties, shall the need for financial resources by developing country take into account Parties, in particular the least developed and the small island developing States among them. In the context of paragraph 1 above, the Parties shall also take into account the needs of the developing country Parties, in particular the least developed and island developing States among them, and of the Parties with the small their economies in transition, capacity-building requirements for the purposes of the implementation of this Protocol. in their efforts to identify and implement The guidance to the financial mechanism of the Convention in relevant decisions of the Conference of the Parties, including those agreed before the adoption of this Protocol, shall apply, mutatis mutandis, to the provisions of this Article. The developed country Parties may also provide, and the developing country Parties and the Parties with economies in transition avail themselves of, financial and technological resources for the implementation of the provisions of this Protocol through bilateral, regional and multilateral channels. 29. ARTICLE 29 CONFERENCE OF THE PARTIES SERVING AS THE MEETING OF THE PARTIES TO THIS PROTOCOL 1. 2. The Conference of the Parties shall serve as the meeting of the Parties to this Protocol. Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, decisions under this Protocol shall be taken only by those that are Parties to it. 3. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, any member of the bureau of the Conference of the Parties representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from among the Parties to this Protocol. 4. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall keep under regular review the implementation of this Protocol and shall make, within its mandate, the decisions necessary to promote its 22 effective implementation. It shall perform the functions assigned to it by this Protocol and shall: (a) Make recommendations on any matters necessary for the implementation of this Protocol; (b) (c) Establish such subsidiary bodies as are deemed necessary for implementation of this Protocol; the Seek and utilize, where appropriate, the services and cooperation of, and information provided by, competent international organizations and intergovernmental and non-governmental bodies; (d) Establish the form and the intervals for transmitting the information to be submitted in accordance with Article 33 of this Protocol and consider such information as well as reports submitted by any subsidiary body; (e) Consider and adopt, as required, amendments to this Protocol and its annexes, as well as any additional annexes to this Protocol, that are deemed necessary for the implementation of this Protocol; and (f) Exercise such other functions as may be required for the implementation of this Protocol. The rules of procedure of the Conference of the Parties and financial rules of the Convention shall be applied, mutatis mutandis, under this Protocol, except as may be otherwise decided by consensus by the Conference of the Parties serving as the meeting of the Parties to this Protocol. The first meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be convened by the Secretariat in conjunction with the first meeting of the Conference of the Parties that is scheduled after the date of the entry into force of this Protocol. Subsequent ordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held in conjunction with ordinary meetings of the Conference of the Parties, unless otherwise decided by the Conference of the Parties serving as the meeting of the Parties to this Protocol. Extraordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held at such other times as may be deemed necessary by the Conference of the Parties serving as the meeting of the Parties to this Protocol, or at the written request of any Party, provided that, within six months of the request being communicated to the Parties by the Secretariat, it is supported by at least one third of the Parties. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any State member thereof or observers thereto not party to the Convention, may be represented as observers at meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol. Any body or agency, whether national or international, governmental or non- governmental, that is qualified in matters covered by this Protocol and that has informed the Secretariat of its wish to be represented at a meeting of the Conference of the Parties serving as a meeting of the Parties to this Protocol as 23 5. 6. 7. 8. an observer, may be so admitted, unless at least one third of the Parties present the admission and object. Except as otherwise provided in this Article, participation of observers shall be subject to the rules of procedure, as referred to in paragraph 5 above. 30. ARTICLE 30 SUBSIDIARY BODIES 1. 2. Any subsidiary body established by or under the Convention may, upon a decision by the Conference of the Parties serving as the meeting of the Parties to this Protocol, serve the Protocol, in which case the meeting of the Parties shall specify which functions that body shall exercise. Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of any such subsidiary bodies. When a subsidiary body of the Convention serves as a subsidiary body to this Protocol, decisions under the Protocol shall be taken only by the Parties to the Protocol. 3. When a subsidiary body of the Convention exercises its functions with regard to matters concerning this Protocol, any member of the bureau of that subsidiary body representing a Party to the Convention but, at that time, not a Party to the Protocol, shall be substituted by a member to be elected by and from among the Parties to the Protocol. 31. ARTICLE 31 SECRETARIAT 1. 2. 3. The Secretariat established by Article 24 of the Convention shall serve as the secretariat to this Protocol. Article 24, paragraph 1, of the Convention on the functions of the Secretariat shall apply, mutatis mutandis, to this Protocol. To the extent that they are distinct, the costs of the secretariat services for this Protocol shall be met by the Parties hereto. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, decide on the necessary budgetary arrangements to this end. 32. ARTICLE 32 RELATIONSHIP WITH THE CONVENTION Except as otherwise provided in this Protocol, the provisions of the Convention relating to its protocols shall apply to this Protocol. 24 33. ARTICLE 33 MONITORING AND REPORTING Each Party shall monitor the implementation of its obligations under this Protocol, and shall, at intervals to be determined by the Conference of the Parties serving as the meeting of the Parties to this Protocol, report to the Conference of the Parties serving as the meeting of the Parties to this Protocol on measures that it has taken to implement the Protocol. 34. ARTICLE 34 COMPLIANCE The Conference of the Parties serving as the meeting of the Parties to this Protocol its first meeting, consider and approve cooperative procedures and shall, at institutional mechanisms to promote compliance with the provisions of this Protocol and to address cases of non-compliance. These procedures and mechanisms shall include provisions to offer advice or assistance, where appropriate. They shall be separate from, and without prejudice to, the dispute settlement procedures and mechanisms established by Article 27 of the Convention. 35. ARTICLE 35 ASSESSMENT AND REVIEW The Conference of the Parties serving as the meeting of the Parties to this Protocol shall undertake, five years after the entry into force of this Protocol and at least every five years thereafter, an evaluation of the effectiveness of the Protocol, including an assessment of its procedures and annexes. 36. ARTICLE 36 SIGNATURE This Protocol shall be open for signature at the United Nations Office at Nairobi by States and regional economic integration organizations from 15 to 26 May 2000, and at United Nations Headquarters in New York from 5 June 2000 to 4 June 2001. 37. ARTICLE 37 ENTRY INTO FORCE 1. 2. This Protocol shall enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations that are Parties to the Convention. This Protocol shall enter into force for a State or regional economic integration organization that ratifies, accepts or approves this Protocol or accedes thereto 25 after its entry into force pursuant to paragraph 1 above, on the ninetieth day after the date on which that State or regional economic integration organization deposits its instrument of ratification, acceptance, approval or accession, or on the date on which the Convention enters into force for that State or regional economic integration organization, whichever shall be the later. 3. For the purposes of paragraphs 1 and 2 above, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization 38. ARTICLE 38 RESERVATIONS No reservations may be made to this Protocol. 39. ARTICLE 39 WITHDRAWAL 1. 2. At any time after two years from the date on which this Protocol has entered into force for a Party, that Party may withdraw from the Protocol by giving written notification to the Depositary. Any such withdrawal shall take place upon expiry of one year after the date of its receipt by the Depositary, or on such later date as may be specified in the notification of the withdrawal. 40. ARTICLE 40 AUTHENTIC TEXTS The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary- General of the United Nations. IN WITNESS WHEREOF the undersigned, being duly authorized to that effect, have signed this Protocol. DONE at Montreal on this twenty-ninth day of January, two thousand. 26 Annex I INFORMATION REQUIRED IN NOTIFICATIONS UNDER ARTICLES 8, 10 AND 13 Name, address and contact details of the exporter. Name, address and contact details of the importer. Name and identity of the living modified organism, as well as the domestic classification, if any, of the biosafety level of the living modified organism in the State of export. Intended date or dates of the transboundary movement, if known. Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety. Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate. Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety. Description of the nucleic acid or the modification introduced, the technique used, and the resulting characteristics of the living modified organism. Intended use of the living modified organism or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology. Quantity or volume of the living modified organism to be transferred. A previous and existing risk assessment report consistent with Annex III. Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate. (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) (l) (m) Regulatory status of the living modified organism within the State of export (for example, whether it is prohibited in the State of export, whether there are other restrictions, or whether it has been approved for general release) and, if the living modified organism is banned in the State of export, the reason or reasons for the ban. (n) Result and purpose of any notification by the exporter to other States regarding the living modified organism to be transferred. (o) A declaration that the above-mentioned information is factually correct. 27 Annex II INFORMATION REQUIRED CONCERNING LIVING MODIFIED ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING UNDER ARTICLE 11 (a) (b) (c) (d) (e) (f) (g) (h) (i) (j) (k) The name and contact details of the applicant for a decision for domestic use. The name and contact details of the authority responsible for the decision. Name and identity of the living modified organism. Description of characteristics of the living modified organism. the gene modification, the technique used, and the resulting Any unique identification of the living modified organism. Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety. Centres of origin and centres of genetic diversity, if known, of the recipient organism and /or the parental organisms and a description of the habitats where the organisms may persist or proliferate. Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety. Approved uses of the living modified organism. A risk assessment report consistent with Annex III. including Suggested methods for the safe handling, storage, transport and use, packaging, labelling, documentation, disposal and contingency procedures, where appropriate. 28 Annex III RISK ASSESSMENT UNDER ARTICLE 15 Objective 1. The objective of risk assessment, under this Protocol, is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health. Use of risk assessment 2. Risk assessment decisions regarding living modified organisms. is, inter alia, used by competent authorities to make informed General principles 3. 4. 5. 6. Risk assessment should be carried out in a scientifically sound and transparent manner, and can take into account expert advice of, and guidelines developed by, relevant international organizations. Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk. Risks associated with living modified organisms or products thereof, namely, processed materials that are of living modified organism origin, containing detectable novel combinations of replicable genetic material obtained through the use of modern biotechnology, should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment. Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment. Methodology 7. The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances. 8. To fulfil its objective, risk assessment entails, as appropriate, the following steps: (a) An identification of any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health; 29 (b) An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the living modified organism; (c) An evaluation of the consequences should these adverse effects be realized; (d) An estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized; (e) A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks; and (f) Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment. Points to consider 9. Depending on the case, risk assessment takes into account the relevant technical and scientific details regarding the characteristics of the following subjects: (a) Recipient organism or parental organisms. The biological characteristics of the recipient organism or parental organisms, including information on taxonomic status, common name, origin, centres of origin and centres of genetic diversity, if known, and a description of the habitat where the organisms may persist or proliferate; (b) Donor organism or organisms. Taxonomic status and common name, source, and the relevant biological characteristics of the donor organisms; (c) Vector. Characteristics of the vector, including its identity, if any, and its source or origin, and its host range; (d) (e) Insert or inserts and/or characteristics of modification. Genetic characteristics of the inserted nucleic acid and the function it specifies, and/or characteristics of the modification introduced; Living modified organism. Identity of the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the recipient organism or parental organisms; (f) Detection and identification of the living modified organism. Suggested detection and identification methods and their specificity, sensitivity and reliability; (g) Information relating to the intended use. Information relating to the intended use of the living modified organism, including new or changed use compared to the recipient organism or parental organisms; and 30 (h) Receiving environment. Information on the location, geographical, climatic information on biological and ecological characteristics, diversity and centres of origin of the likely potential receiving environment. including relevant 31