DECREE NO. 5,705, OF February 16, 2006.

Promulgates the Cartagena Protocol on Biosafety of the Convention on Biological Diversity.

THE PRESIDENT OF THE REPUBLIC, in the use of the assignment that gives him the art. 84, inciso IV, of the Constitution, and

Considering that the National Congress has approved, by the Legislative Decree No. 908 of November 21, 2003, the text of the Cartagena Protocol on Biosafeing of the Convention on Biological Diversity, concluded in Montreal on January 29, 2000;

Considering that the Brazilian Government deposited the instrument of accession with the UN General Secretariat in 24 of November 2003;

Whereas the Protocol entered into international force in September 11, 2003, and entered into force for Brazil on February 22, 2004;

DECRETA:

Art. 1º The Protocol of Cartagena on Biosafetion of the Convention on Biological Diversity, celebrated in Montreal on January 29, 2000, aped by copy to the present Decree, will be executed and fulfilled as entirely as it contains.

Art. 2º Are subject to the approval of the National Congress any acts that may result in revision of the said Protocol or that carries charges or commitments engraved to the national heritage, pursuant to art. 49, inciso I, of the Constitution.

Art. 3º This Decree goes into effect on the date of its publication.

Brasilia, February 16, 2006; 185º of Independence and 118º of the Republic.

LUIZ INÁCIO LULA DA SILVA

Celso Luiz Nunes Amorim

CARTAGENA PROTOCOL ON BIOSAFEING

OF THE CONVENTION ON BIOLOGICAL DIVERSITY

The Parties to the present Protocol,

Being Parties to the Convention on Biological Diversity, henceforth referred to as "the Convention",

Recording Article 19, paragraphs 3º and 4º, and Articles 8º g) and 17 of the Convention,

Recalling also Decision II/5 of the Conference of the Parties to the Convention, of November 17, 1995, on the development of a Protocol on biosafety, specifically focused on the cross-border movement of any modified living organism resulting from modern biotechnology that could have adverse effects on conservation and sustainable use of the biological diversity, which establishes in particular, appropriate procedures for prior informed agreement,

Restating the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development,

Ciente that modern biotechnology develops rapidly and the growing concern of society over their potential adverse effects on biological diversity, taking also into consideration the risks to human health,

Recognizing that modern biotechnology offers considerable potential for human well-being if it is developed and used with appropriate security measures for the environment and human health,

Recognizing also the crucial importance they have for humanity the centers of origin and the centers of genetic diversity,

Taking into consideration the limited means of many countries, especially developing countries, to cope with the nature and dimension of the known and potential risks associated with the modified living organisms,

Recognizing that the trade and environment agreements should support each other with views to achieving the sustainable development,

stressing that this Protocol will not be interpreted in the sense that it modifies the rights and obligations of a Party in relation to any other international agreements in force,

On the understanding that the text above does not aim to subordinate the present Protocol to other international agreements,

Wake up the following:

Article 1º

Objective

From agreement with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the aim of this Protocol is to contribute to ensuring an adequate level of protection in the field of transfer, from the handling and safe use of modified living organisms resulting from modern biotechnology that can have adverse effects on conservation and sustainable use of biological diversity, taking into account risks to human health, and focusing on specifically the cross-border movements.

Article 2º

General provisions

1. Each Party shall take the necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol.

2. The Parties shall ensure that the development, manipulation, transport, use, transfer and release of all modified living organisms are carried out in a way to avoid or reduce risks to biological diversity, taking also into consideration the risks to human health.

3. Nothing in this Protocol will affect in any way the sovereignty of states over their territorial sea established in accordance with international law, neither the sovereign rights and nor the jurisdiction that states have in their exclusive economic zones and its continental platforms by virtue of international law, nor the exercise by ships and aircraft of all States of the rights and freedoms of navigation conferred by international law and reflected in the international instruments relevant.

4. Nothing in this Protocol shall be interpreted in such a way as to restrict the right of a Party to adopt measures that are more stringent for the conservation and sustainable use of biological diversity that those provided for in this Protocol, provided that such measures shall be compatible with the objective and the provisions of this Protocol and are in accordance with the obligations of that Party under international law.

5. The Parties are encouraged to take into consideration, as the case may be, the expertise, available tools and work carried out in the relevant international forums in the area of risks to human health.

Article 3º

Use of the Terms

For the purposes of this Protocol:

a) by "Conference of the Parties" is understood to be the Conference of the Parties to the Convention;

b) by "use in contention" if it understands any operation, carried out within a location, installation, or other physical structure that involves manipulation of living organisms modified that are controlled by specific measures that effectively limit your contact with the external environment and its impact on the same;

c) by "export" if it understands the intentional cross-border movement of a Party to another Party;

d) by "exporter" if it understands any physical or legal person, subject to the jurisdiction of the exporting Party, that arrange for the export of the modified living organism;

e) by "import" if understands the intentional cross-border movement for a Part of another Party;

f) by "importer" if it understands any physical or legal person, subject to the jurisdiction of the importing Party, that arrange for the import of the modified living organism;

g) by' modified living organism ' if it understands any living organism that has a combination of unheard genetic material obtained through the use of biotechnology modern;

h) by "living organism" if it understands any biological entity capable of transfer or replicate genetic material, inclusive of sterile organisms, viruses and viroids;

i) by "modern biotechnology" if it is understood:

a. the application of in vitro techniques, of nucleic acid inclusive deoxyribonucleic acid (DNA) recombinant and direct injection of nucleic acids into cells or organelles, or

b. the fusion of cells from organisms that do not belong to the same taxonomic family, which overcome the natural barriers of the physiology of reproduction or recombination and which are not techniques used in traditional reproduction and selection;

j) by "regional economic integration organization" if it understands a constituted organization by sovereign states of a particular region, to which its Member States have transferred competence in relation to matters governed by this Protocol and which has been duly authorized, in accordance with their internal procedures, to be signed, ratify, accept, approve the same or as it accede;

k) by " movement cross-border " if it understands the movement of a modified living organism from one Party to another Party, with the exception that for the purposes of Articles 17 and 24, the cross-border movement also includes the movement between Parties and non-Parties.

Article 4º

Scope

The present Protocol will apply to the cross-border movement, transit, manipulation and use of all modified living organisms that may have effects warns in the conservation and sustainable use of biological diversity, taking also into account the risks to human health.

Article 5º

Fármacos

Notwithstanding the provisions of Article 4º and without prejudice to the right of any Party to submit all living organisms modified to a risk assessment before making the decision on its importation, the present Protocol shall not apply to the movement cross-border of modified living organisms that are fasts for human beings that are contemplated by other organizations or other relevant international agreements.

Article 6º

Transit and Use in Contention

1. Notwithstanding the provisions of Article 4º and without prejudice to any right of a transit Party to regulate the transport of modified living organisms on its territory and to make available to the Mechanism of Information Intermediation on Biosafecertainty, any decision of that Party, subject to Article 2º, paragraph 3º, on transit in its territory of a specific modified living organism, the provisions of this Protocol with respect to the procedure of prior agreement informed will not apply to the modified living organisms in transit.

2. No Notwithstanding the provisions of Article 4º and without prejudice to any right of a Party to submit all living organisms modified to a risk assessment before making a decision on their importation and to establish standards for their use in containment within its jurisdiction, the provisions of this Protocol with respect to the procedure of prior informed agreement shall not apply to the cross-border movement of modified living organisms intended for the use in realized restraint of agreement with the norms of the importing Party.

Article 7º

Application of the Prior Informed Arrangement Procedure

1. Subject to the provisions of Articles 5º and 6º, the procedure of prior informed agreement of Articles 8º to 10 and 12 shall apply to the first intentional cross-border movement of modified living organisms intended for the deliberate introduction in the environment of the importing Party.

2. The "deliberate introduction into the environment" referred to in paragraph 1º above, does not refer to the modified living organisms intended for their direct use as human or animal food or to the beneficiation.

3. Article 11 will apply before the first cross-border movement of modified living organisms intended for direct use as human or animal food or to the beneficiation.

4. The procedure for prior informed agreement shall not apply to the intentional cross-border movement of modified living organisms included in a decision adopted by the Conference of the Parties acting on the quality of meeting of the Parties of the present Protocol, in which it is stated not to be likely to have adverse effects on the conservation and sustainable use of biological diversity, taking into consideration the risks to human health.

Article 8º

Notification

1. The exporting Party shall notify, or require the exporter to ensure the written notification, to the competent national authority of the importing Party prior to the intentional cross-border movement of a modified living organism contemplated in the Article 7º, paragraph 1º. The notification shall contain, at a minimum, the information specified in Annex I.

2. The exporting Party shall ensure that there is a legal determination as to the accuracy of the information provided by the exporter.

Article 9º

Indictment of the Notification Receipt

1. The importing Party shall accuse the receipt of the notification, in writing, to the notifier within ninety days from the date of receipt.

2. Constant in the indictment:

a) the date of receipt of the notification;

b) if the notification contains, prima facie, the information referred to by Article 8º;

c) whether to proceed in accordance with the internal legal planning of the importing Party or in accordance with the procedures specified in Article 10.

3. The internal legal order referred to in paragraph 2º c) above shall be compatible with this Protocol.

4. The lack of prosecution by the importing Party of the receipt of a notification will not imply its consent to an intentional cross-border movement.

Article 10

Procedure for Taking Decisions

1. The decisions taken by the importing Party shall be in accordance with Article 15.

2. The importing Party shall inform, within the time limit set by Article 9º, the notifier, in writing, if the intentional cross-border movement may proceed:

a) solely after the importing Party has given its consent in writing; or

b) transcurrents at least ninety days without there being received a written consent.

3. Within two hundred and seventy days from the date of receipt of the notification, the importing Party shall communicate, in writing, to the notifier and to the Mechanism of Information Intermediation on Biosafety the decision referred to in paragraph 2º to) above:

a) to approve the import, with or without conditions, including as the decision will be applied to later imports of the same modified living organism;

b) of prohibit the importation;

c) of requesting additional relevant information of agreement with its internal legal planning or Annex I; when calculating the time frame for the answer will not be taken into account the number of days the importing Party has waited for the additional relevant information; or

d) from informing the notifier that the period specified in this paragraph is extended by a period of time determined.

4. Except in the case where the consent is unconditional, a decision under paragraph 3º above shall specify the reasons on which it is founded.

5. The absence of the communication by the importing Party of its decision within two hundred and seventy days from the date of receipt of the notification will not imply its consent to an intentional cross-border movement.

6. The absence of scientific certainty due to the insufficiency of the relevant information and scientific knowledge on the size of the potential adverse effects of a modified living organism on conservation and sustainable use of diversity biological in the importing Party, taking also into account the risks to human health, will not prevent this Party in order to avoid or minimise these potential adverse effects, to make a decision, as the case may be, on the import of the living organism modified in question as it is stated in paragraph 3º above.

7. The Conference of the Parties acting on the quality of meeting of the Parties will decide, at their first meeting, the appropriate procedures and mechanisms to facilitate the decision making by the importing Parties.

Article 11

Procedure for the Modified Living Organisms Intended for Direct Use as Human or Animal Feed or the Beneficiation

1. A Party that has made a definite decision regarding internal use, including its placing on the market, of a modified living organism that may be the object of a cross-border movement for direct use as human or animal food or to the benefit, it informs you to the Parties, within fifteen days after making such a decision, by means of the Mechanism of Information Intermediation on Biosafees. This information will contain, at a minimum, the data specified in Annex II. The Party shall provide a copy of the written information to the focal point of each Party that informs the Secretariat beforehand that it does not have access to the Information Intermediation Mechanism on Biosafetiation. Such a provision shall not apply to decisions on field trials.

2. The Party making a decision in the context of paragraph 1º above, shall ensure that there is a legal determination as to the accuracy of the information provided by the applicant.

3. Any Party will be able to request additional information from the authority identified in paragraph b) of Annex II.

4. A Party may make a decision on the import of modified living organisms intended for direct use as human or animal food or to the beneficiation, under its internal legal planning that is compatible with the purpose of the present Protocol.

5. Each Party shall make available to the Exemplary Biosafeed Information Intermediation Mechanism of all laws, regulations and national guidelines that apply to the importation of modified living organisms intended for direct use as human or animal food or to the benefit, if available.

6. A developing country or a Party with a transitional economy may, in the absence of an internal legal planning referred to in paragraph 4º above, and in the exercise of its internal jurisdiction declare by means of the Intermediation Mechanism of Biosafeed Information that its decision before the first importation of a modified living organism intended for direct use as human or animal food or to the beneficiation, upon which information was propelled in the framework of the paragraph 1º above, will be taken in accordance with the following:

a) a risk assessment carried out in accordance with Annex III; and

b) a decision made within a time limit predictable from no more than two hundred and seventy days.

7. The absence of communication by a Party of its decision in accordance with paragraph 6º above, will not imply its consent or its refusal to the importation of a modified living organism intended for direct use as human or animal food or to the benefit, save if otherwise specified by the Party.

8. The absence of scientific certainty due to the insufficiency of the relevant information and scientific knowledge on the size of the potential adverse effects of a modified living organism on conservation and sustainable use of diversity biological in the importing Party, taking also into account the risks to human health, will not prevent this Party in order to avoid or minimise these potential adverse effects, to make a decision, as the case may be, on the import of the living organism modified intended for the direct use as human or animal food or the beneficiation.

9. A Party will be able to manifest its need for financial and technical assistance and capacity development with respect to the modified living organisms intended for direct use as human or animal food or to the beneficiation. The Parties will cooperate to meet these requirements in accordance with Articles 22 and 28.

Article 12

Revision of Decisions

1. An importing Party may, at any time, in the light of new scientific information on the potential adverse effects on conservation and sustainable use of biological diversity, taking into account risks to human health, review and modify a decision regarding intentional cross-border movement. In such a case, the Party shall, within thirty days, inform all notifiers who had previously notified movements of the modified living organism referred to in that decision, as well as the Information Intermediation Mechanism on Biosafeed, and will specify the reasons for your decision.

2. An exporting Party or a notifier may ask the importing Party to review a decision made by virtue of Article 10 with respect to that Party or exporter, when the exporting Party or the notifier considers that:

a) has occurred a change in the circumstances that could influence the outcome of the risk assessment on which the decision has grounded; or

b) has become available information additional scientific or relevant techniques.

3. The importing Party shall respond in writing to such solicitation within a period of ninety days and shall specify the reasons for its decision.

4. The importing Party may, at its sole discretion, request a risk assessment for subsequent imports.

Article 13

Simplified procedure

1. An importing Party may specify in advance to the Biosafety-free Information Intermediation Mechanism, provided that appropriate measures are implemented to ensure the safe intentional cross-border movement of living organisms modified in accordance with the objective of this Protocol:

a) the cases in which the intentional cross-border movement to that Party may be carried out at the same time as the movement is notified to the importing Party; and

b) the imports of living organisms modified to that Party that are exempted from the procedure of informed prior agreement.

The notifications in the scope of sub-paragraph a) above, you will be able to apply to subsequent movements similar to the same Part.

2. The information relating to a intentional cross-border movement that will be provided in the notifications referred to in paragraph 1º to) above, will be the information specified in Annex I.

Article 14

Agreements and Bilateral, Regional and Multilateral Adjustments

1. The Parties will be able to conclude bilateral, regional and multilateral agreements and adjustments on intentional cross-border movements of modified living organisms, compatible with the objective of this Protocol and provided that such agreements and adjustments do not result in a level of protection lower than that propelled by the Protocol.

2. As Parties will inform each other, by means of the Biosafeed Information Intermediation Mechanism, about any bilateral, regional and multilateral agreements and adjustments that they have completed before or after the date of entry into force of the this Protocol.

3. The provisions of this Protocol shall not affect the intentional cross-border movements carried out in accordance with those agreements and adjustments between the Parties to those agreements or adjustments.

4. Every Party will be able to determine that its internal standards will apply to certain specific imports intended for it and will notify the Information Intermediation Mechanism on Biosafeque of its decision.

Article 15

Risk Assessment

1. The risk assessments carried out in accordance with this Protocol will be conducted in a scientifically sound manner in accordance with Annex III and taking into account the recognized risk assessment techniques. These risk assessments will be based, at the very least, on information provided in accordance with Article 8º and other scientific evidence in order to identify and evaluate the possible adverse effects of the living organisms modified on conservation and in the sustainable use of biological diversity, taking also into account the risks to human health.

2. The importing Party shall ensure that the risk assessments for the decision-making of Article 10 are carried out. The importing Party will be able to request the exporter to conduct the risk assessment.

3. The cost of the risk assessment will be arched by the notifier if the importing Party thus requires it.

Article 16

Manejo de Risks

1. The Parties, taking into account Article 8º (g) of the Convention, shall establish and maintain appropriate mechanisms, measures and strategies for regulating, manning and controlling the risks identified in the risk assessment provisions of this Protocol associated with the use, manipulation, and cross-border movement of modified living organisms.

2. Measures will be imposed based on risk assessment as it is necessary to avoid the adverse effects of the modified living organism on conservation and use sustainable biological diversity, taking also into account the risks to human health, in the territory of the importing Party.

3. Each Party will take appropriate measures to prevent the unintended cross-border movements of modified living organisms, including measures such as the requirement that a risk assessment be conducted before the first release of a modified living organism.

4. Without prejudice to paragraph 2º above, each Party shall ensure that every modified living organism, whether imported or locally developed, is subjected to an appropriate observation period that corresponds to its life cycle or time of generation before you give your intended use.

5. The Parties shall cooperate with views to:

a) to identify the modified living organisms or specific traits of modified living organisms that may have adverse effects on conservation and the sustainable use of biological diversity, taking also into account the risks to human health; and

b) take appropriate measures regarding the treatment of these modified living organisms or traits specific.

Article 17

Non-Intentional Transboundary Movements and Emergency Measures

1. Each Party will take appropriate measures to notify affected or potentially affected states, the Biosafety-related Information Intermediation Mechanism and, as the case may be, the relevant international organizations, when it has knowledge of an occurrence within its jurisdiction that has resulted in the release that leads, or may lead, to a non-intentional cross-border movement of a modified living organism that is likely to have adverse effects significant in the conservation and sustainable use of biological diversity, while also taking into account the risks to human health in these states. Notification will be provided as soon as Part is aware of this situation.

2. Each Party shall communicate, at the latest on the date of entry into force of this Protocol to it, to the Mechanism of Information Intermediation on Biosafees relevant details about its point of contact for the purposes of receiving the notifications in the context of this Article.

3. Every notification issued in accordance with paragraph 1º above, should include:

a) the relevant available information about the estimated quantities and characteristics and / or relevant traits of the modified living organism;

b) the information about the estimated circumstances and date of the release, as well as on the use of the modified living organism in the source Party;

c) all available information on the possible adverse effects on conservation and sustainable use of the biological diversity, taking also into account the risks to human health, as well as the available information on possible risk-manhandling measures;

d) any other relevant information; and

and) a point of contact for greater information.

4. In order to minimise any adverse effect on the conservation and sustainable use of biological diversity, also taking into account the risks to human health, each Party in whose jurisdiction has occurred the release of the modified living organism referred to by paragraph 1º above shall immediately consult with affected or potentially affected States to enable them to determine appropriate interventions and to initiate the necessary actions, including emergency measures.

Article 18

Handling, Transport, Packaging and Identification

1. In order to prevent the adverse effects on conservation and sustainable use of biological diversity, taking also into account the risks to human health, each Party will take the necessary measures to require all living organisms to be modified objects of an intentional cross-border movement within the framework of this Protocol are manipulated, packaged and transported under security conditions, taking into consideration the relevant international rules and norms.

2. Each Party shall take measures to require that the documentation that it accompany:

a) modified living organisms intended for uses of human or animal food or the benefit clearly identify that these "may contain" modified living organisms and that are not intended for intentional introduction into the environment, as well as a point of contact for greater information. The Conference of the Parties acting on the quality of meeting of the Parties to this Protocol will take a decision on the detailed requirements for that purpose, inclusive of specification on their identity and any unique identifier, in the most not later than two years after the entry into force of this Protocol;

b) the bodies modified living intended for the use in containment clearly identifies them as modified living organisms; and specify all requirements for the safe handling, storage, transport and use of these organisms, as well as the point of contact for greater information, including the name and address of the individual and the institution to which the modified living organisms are consigned; and

c) the modified living organisms that are intended for the intentional introduction into the environment of the importing Party and any other living organisms modified within the framework of the Protocol, clearly identify them as modified living organisms; specify their identity and their traits and / or relevant characteristics, all requirements for the safe handling, storage, transport and use; and indicate the point of contact for greater information and, as the case may be, the name and address of the importer and exporter; and that it contains a statement that the movement is in compliance with the requirements of this Protocol applicable to the exporter.

3. The Conference of the Parties acting on the quality of meeting of the Parties to this Protocol will consider the need to draw up standards for the practices of identification, manipulation, packaging and transportation, and the modalities of such elaboration, in consultation with other relevant international bodies.

Article 19

Competent National Authorities and National Focal Points

1. Each Party shall designate a national focal point which shall carry out, on its behalf, the connection with the Secretariat. Each Party shall also designate one or more competent national authorities who shall be those responsible for carrying out the administrative functions required by this Protocol and who shall be authorized to act on their behalf in relation to those duties. A Party may designate a single entity to fill the functions of both focal point and competent national authority.

2. Each Party shall notify the Secretariat at the latest on the date of entry into force of this Protocol for that Party, the names and addresses of its focal point and your competent authority or national authorities (is). If a Party designates more than one competent national authority, it shall communicate to the Secretariat, together with its notification, relevant information about the respective responsibilities of those authorities. As the case may be, such information shall specify, at a minimum, which competent authority is responsible for which type of modified living organism. Each Party shall immediately notify the Secretariat of any change in the designation of its focal point or in the name and address or the responsibilities of its competent authority or national authorities (is).

3. The Secretariat shall immediately inform the Parties of the notifications it receives by virtue of paragraph 2º above, and will also make such information available through the Biosafets Information Intermediation Mechanism.

Article 20

Information Interchange and the Information Intermediation Mechanism on Biosafety

1. An Information Intermediation Mechanism on Biosafeed falls through this established as part of the mechanism of facilitation referred to in Article 18, paragraph 3º, of the Convention, in order to:

a) facilitate the exchange of scientific, technical, environmental, and legal information on living organisms modified and experiences with the same; and

b) assist the Parties to implement the Protocol, taking into consideration the special needs of the developing countries, in particular those of minor relative economic development and the small island developing States among them, and the countries with economies in transition as well as countries that are centres of origin and centers of genetic diversity.

2. The Information Intermediation Mechanism on Biosafees will serve as a means of making information available for the purposes of paragraph 1º above. It will facilitate access to the information provided by the Parties of interest for the implementation of the Protocol. It will also facilitate access, when possible, to other international mechanisms for exchange of information on biosafete.

3. Without prejudice to the protection of confidential information, each Party shall provide the Mechanism of Information Intermediation on Biosafeed any information it should provide to the Mechanism of Information Intermediation on Biosafees in the scope of this Protocol, and also:

a) all laws, regulations and guidelines existing national for the implementation of the Protocol, as well as the information required by the Parties for the informed prior arrangement procedure;

b) all bilateral, regional and multilateral accords and adjustments;

c) the summaries of their risk assessments or environmental assessments of modified living organisms that have been carried out as part of their regulation and carried out in accordance with Article 15, inclusive, where appropriate, relevant information on products of them derived, namely, beneficiary materials that have as their origin a modified living organism, containing new detectable combinations of replicable genetic material obtained through the use of modern biotechnology;

d) your definitive decisions on the import or release of modified living organisms; and

e) the reports by it submitted in accordance with Article 33, inclusive of those on implementation of the informed prior arrangement procedure.

4. The modalities of the operation of the Biosafeed Information Intermediation Mechanism, inclusive of reports on its activities will be considered and decided by the Conference of the Parties acting on the quality of meeting of the Parties of the present Protocol in your first session, and will be the object of later exams.

Article 21

Confidential information

1. The importing Party shall allow the notifier to identify information submitted by virtue of the procedures set out in this Protocol or required by the importing Party as part of the prior informed agreement procedure established in the Protocol to be considered as confidential information. In such cases, when so requested, justifications will be presented.

2. The importing Party shall consult with the notifier if it decides that the information identified by the notifier as being confidential does not merit such processing and will inform the notifier of its decision before releasing the information, explaining, when requested, their reasons, and providing an opportunity to conduct inquiries and an internal review of the decision before releasing the information.

3. Each Party shall protect confidential information received in the framework of this Protocol, including any confidential information received in the context of the prior informed agreement procedure set out in the Protocol. Each Party shall ensure that it has procedures to protect such information and will protect the confidentiality of such information in no less favourable manner than its handling of confidential information relating to its living organisms modified domestically produced.

4. The importing Party will not use this information for commercial purposes, save with the written consent of the notifier.

5. If a notifier withdraws or has withdrawn the notification, the importing Party shall respect the confidentiality of commercial and industrial information, including research and development information, as well as information on which the Party and the notifier are not in agreement about their confidentiality.

6. Without prejudice to the provisions of paragraph 5º above, the following information will not be considered confidential:

a) the name and address of the notifier;

b) a general description of the organism or modified living organisms;

c) a summary of the risk assessment on the effects on conservation and sustainable use of biological diversity, also taking into account the risks to human health; e

d) the methods and response plans in case of emergency.

.Article 22

Capacity Development

1. The Parties shall cooperate in the development and / or strengthening of human resources and institutional capacities in biosafety, including biotechnology as it is necessary for biosafety, for the purposes of the implementation effective of this Protocol, in the Parties developing countries, in particular in those of minor relative economic development and in small island developing States among them, and in the Parties with economies in transition, including by means of existing global, regional, sub-regional and national institutions and organizations and, as the case may be, facilitating private sector participation.

2. For the purposes of the implementation of paragraph 1º above, in relation to the cooperation for the development of capacities in biosafety, will be taken fully into consideration of the needs of the developing Parties, in particular in those of minor relative economic development and in small island developing States among them, of financial resources and access to technology and know-how, and of their transfer, in accordance with the relevant provisions of the Convention. The cooperation in capacity development will include, taking into account the different situations, capabilities and needs of each Party, scientific and technical training in the proper and safe manhandling of biotechnology, and in the use of risk assessments and risk-to-biosafecial manhandling, and the strengthening of institutional and technological capabilities in biosafeness. The needs of the Parties with economies in transition will also be taken fully into account for this capacity development in biosafeties.

Article 23

Conscientization and Public Participation

1. The Parties:

a) will promote and facilitate awareness, education and participation public regarding the transfer, manipulation and safe use of the living organisms modified in relation to the conservation and sustainable use of biological diversity, taking also into account the risks to human health. In doing so, the Parties shall cooperate, as the case may be, with other States and international bodies;

b) will seek to ensure that public awareness and education include access to information on the modified living organisms identified according to the this Protocol that may be imported.

2. In accordance with their respective laws and regulations, the Parties shall consult the public during the decision-making process on the modified living organisms and shall make public the results of those decisions, while respecting confidential information in accordance with the provisions of the Article 21.

3. Each Party will ensure that its audience knows the means of having access to the Information Intermediation Mechanism on Biosafees.

Article 24

Non-Parties

1. The cross-border movements of living organisms modified between Parties and non-Parties shall be compatible with the purpose of this Protocol. The Parties will be able to conclude bilateral, regional, and multilateral agreements and adjustments with non-Parties on such cross-border movements.

2. Parties shall encourage the non-Parties to accede to this Protocol and to contribute appropriate information to the Information Intermediation Mechanism on Biosafety on the modified living organisms released or introduced in areas under their internal jurisdiction, or carried out of them.

Article 25

Cross-border Movements Illicit

1. Each Party shall adopt appropriate internal measures with the aim of preventing and, as the case may be, penalizing the cross-border movements of modified living organisms carried out in contravention of the internal measures governing the implementation of the this Protocol. These moves will be considered illicit cross-border movements.

2. In the case of an illicit cross-border movement, the affected Party may request the Party of origin to give an end, with burden, to the modified living organism in question by means of repatriation or destruction, as the case may be.

3. Each Party shall make available to the Mechanism of Information Intermediation on Biosafees the information on cases of illicit cross-border movements concerning him.

Article 26

Socio-Economic Considerations

1. The Parties, when making a decision on import within the framework of this Protocol or of their internal measures implementing the Protocol, will be able to take into account, in a manner compatible with their international obligations, socio-economic considerations advinds of the impact of living organisms modified on conservation and the sustainable use of biological diversity, especially in what tange the value that biological diversity has for indigenous and local communities.

2. Parties are encouraged to cooperate in the exchange of information and research on the impacts socio-economic of modified living organisms, especially in indigenous and local communities.

Article 27

Responsibility and Compensation

The Conference of the Parties acting on the quality of meeting of the Parties to this Protocol will adopt, at their first meeting, a process in relation to the appropriate elaboration of international standards and procedures in the field of liability and compensation for damages that result from the cross-border movements of modified living organisms, analyzing and taking into due consideration the ongoing processes in the international law on such matters and will seek to complete that process within four years.

Article 28

Financial Mechanism and Financial Resources

1. When considering the financial resources for the implementation of this Protocol, the Parties shall take into account the provisions of Article 20 of the Convention.

2. The financial mechanism set out in Article 21 of the Convention will be, by means of the institutional structure charged with its operation, the financial mechanism for this Protocol.

3. With respect to the development of capacities referred to in Article 22 of this Protocol, the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol, by providing guidance on the financial mechanism referred to in the paragraph 2º above for consideration by the Conference of the Parties, will take into account the need for financial resources by the developing Parties, in particular those of minor relative development and the small island States in development between them.

4. In the context of paragraph 1º above, the Parties shall also take into account the needs of the developing Parties, in particular those of minor relative development and small island developing States among them, and of the Parties with savings in transition, in their efforts to determine and satisfy their capacity development needs for the purposes of the implementation of this Protocol.

5. The guidance for the financial mechanism of the Convention in the relevant decisions of the Conference of the Parties, including those agreed upon before the adoption of this Protocol, shall apply mutatis mutandis to the provisions of this Article.

6. Developed country Parties will also be able to provide financial and technological resources from which the developing Parties and Parties with economies in transition will be able to have the implementation of the provisions of the present Protocol by means of bilateral, regional and multilateral channels.

Article 29

Conference of the Parties Acting in the Meeting Quality of the Present Protocol

1. The Conference of the Parties shall act on the quality of meeting of the Parties to this Protocol

2. Parties to the Convention that are not Parties to this Protocol will be able to participate as an observer during the deliberations of any meeting of the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol. When the Conference of the Parties act on the quality of meeting of the Parties to this Protocol, decisions under this Protocol shall be taken only by those that are Parties to the Protocol.

3. When the Conference of the Parties act on the quality of meeting of the Parties to this Protocol, any member of the Conference of Parties ' table representing a Party to the Convention but which at that time is not a Party to this Protocol shall be replaced by a member to be elected by and between the Parties to this Protocol.

4. The Conference of the Parties acting on the quality of meeting of the Parties to this Protocol shall regularly examine the implementation of this Protocol and shall take, in accordance with its mandate, the decisions necessary to promote its effective implementation. The Conference of the Parties shall carry out the duties to it designated by this Protocol and will:

a) make recommendations on the subjects necessary for the implementation of this Protocol;

b) establish the subsidiary organs that deem themselves necessary for the implementation of the present Protocol;

c) seek and use, as the case may be, the services, cooperation and information provided by the relevant international organizations and intergovernmental and non-government;

d) establish the form and intervals for transmission of information to be submitted in accordance with Article 33 of this Protocol and to consider such information, as well as reports submitted by any subsidiary body;

and) consider and adopt, as necessary, amendments to this Protocol and its Annexes, as well as other additional Annexes to this Protocol, which are thought to be necessary for their implementation; and

f) carry out other functions that may be necessary for the implementation of this Protocol.

5. The rules of procedure of the Conference of the Parties and the financial rules of the Convention shall apply mutatis mutandis within the framework of this Protocol, unless otherwise decided by consensus by the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol.

6. The first meeting of the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol shall be convened by the Secretariat together with the first session of the Conference of the Parties scheduled to be held after the entry into force of this Protocol. Subsequent ordinary meetings of the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol shall be held together with the ordinary sessions of the Conference of the Parties, unless otherwise decided by the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol.

7. Extraordinary meetings of the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol shall be held when they are deemed necessary by the Conference of the Parties acting on the quality of meeting of the Parties of the this Protocol, or when they are requested in writing by any Party, provided that, within six months of the communication of the solicitation to the Parties by the Secretariat, it is supported by at least one third of the Parties.

8. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as those States that are members or observers of those organizations that are not Parties to the Convention, may be represented as observers at the meetings of the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol. Every organ or agency, whether national or international, governmental or non-governmental, with competence in the matters covered by this Protocol and who has informed the Secretariat of its interest in making itself represented at a meeting of the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol as an observer, may be admitted, unless at least one third of the Parties present oppose. Unless otherwise disposed of in this Article, the admission and participation of observers shall be subject to the rules of procedure referred to in paragraph 5º above.

Article 30

Organs Subsidiaries

1. Any subsidiary body established by the Convention or in its scope, may by decision of the Conference of the Parties acting on the quality of meeting of the Parties to this Protocol, provide services to the Protocol, and in this case, the meeting of the Parties will specify the functions to be performed by that organ.

2. The Parties of the Convention that are not Parties to this Protocol will be able to participate as observers in the debates of meetings of any of these subsidiary bodies. When a subsidiary body of the Convention shall act as a subsidiary organ of this Protocol, decisions under the Protocol shall be taken by the Parties to the Protocol only.

3. Where a subsidiary organ of the Convention shall perform its duties in respect of matters concerning this Protocol, the members of the table of that subsidiary body representing Parties to the Convention but that at that time, are not Parties of the Protocol, shall be replaced by members elected by and between the Parties to the Protocol.

Article 31

Secretariat

1. The Secretariat established by Article 24 of the Convention shall act as the Secretariat of this Protocol.

2. Article 24, paragraph 1º, of the Convention on the functions of the Secretariat shall, mutatis mutandis, apply to the present Protocol.

3. In so far as it is possible to differentiate them, the costs of the services of the Secretariat for this Protocol shall be arched by the Parties of this. The Conference of the Parties acting on the quality of meeting of the Parties to this Protocol shall decide, in their first meeting, the budgetary provisions necessary for that purpose.

Article 32

Relation to the Convention

Unless otherwise disposed of in this Protocol, the provisions of the Convention relating to its Protocols shall apply to this Protocol.

Article 33

Monitoring and Informes

Each Party shall monitor the implementation of its obligations under this Protocol, and shall inform the Conference of the Parties acting on the quality of meeting of the Parties of this Protocol, at intervals to be decided by this, on the measures taken to implement the Protocol.

Article 34

Fullsupply

The Conference of the Parties acting on the quality of meeting of the Parties to this Protocol will consider and approve, at their first meeting, cooperation procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and to deal with cases of non-compliance. These procedures and mechanisms will include provisions to provide advice or assistance, as the case may be. These will be distinct and will not undermine the procedures and mechanisms set forth by Article 27 of the Convention on the solution of controversies.

Article 35

Evaluation and Revision

The Conference of the Parties acting on the quality of meeting of the Parties to this Protocol shall be held, five years after the entry into force of this Protocol and at least every five subsequent years, an assessment of the effectiveness of the Protocol, including an evaluation of its procedures and Attachments.

Article 36

Signature

This Protocol will be open for signature by States and regional economic integration organizations in the United Nations Office in Nairobi from 15 a to May 26, 2000, and at the United Nations Seat in New York from June 5, 2000 to 4, June 2001.

Article 37

Input in Vigor

1. This Protocol shall enter into force on the ninth day after the date of deposit of the Fifteenth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations that are Parties to the Convention.

2. This Protocol shall enter into force for a State or a regional economic integration organization that ratifies, accede to or approves this Protocol or accede to it after its entry into force in accordance with paragraph 1º above, in the nineteenth day after the date on which that State or regional economic integration organization shall deposit its instrument of ratification, acceptance, approval or accession, or on the date on which the Convention enters into force for that State or organization regional of economic integration, whatever it is after.

3. For the purposes of paragraphs 1º and 2º above, any instrument deposited by a regional economic integration organization shall not be considered additional to those deposited by Member States of that organization.

Article 38

Reserves

No reservation can be made to this Protocol.

Article 39

Denpronunciation

1. After two years of the entry into force of this Protocol to a Party, that Party may at any time be able to report it by means of written notification to the Depositary.

2. Such denunciation takes effect one year after the date of its receipt by the Depositary, or at a later date if so it is stipulated in the notification of denunciation.

Article 40

Authentic Texts

The original of this Protocol, whose texts in Arabic, Chinese, English, French, Russian and Spanish are equally authentic, shall be deposited with the Secretary-General of the United Nations.

IN WITNESS TO WHICH the undersigned, duly authorized for that purpose, have signed this Protocol.

FEITO in Montreal in this twentieth ninth day of january of the year two thousand.

Annex I

Information required in the Notifications according to Articles 8º, 10, and 13

a) Name, address, and contact details of the exporter.

b) Name, address, and contact details of the importer.

c) Name and identity of the modified living organism, as well as of the national classification, if any, of the level of biosafed of the modified living organism in the exporting State.

d) Date or predicted dates of the cross-border movement, if known.

e) Situation taxonomic, vulgar name, collection point or acquisition point and characteristics of the recipient organism or the biosafemal-related parental organisms.

f) Centres of origin and centres of genetic diversity, if known from the receptor body and / or parental organisms and a description of habitats where organisms may persist or proliferate.

g) Taxonomic status, vulgar name, point of collection or acquisition and characteristics of the body or donor organisms related to biosafete.

h) Description of the nucleic acid or the introduced modification, of the technique used and the resulting characteristics of the modified living organism.

i) predicted use of the modified living organism or products from it derived, namely, materials that are benefited from have as their origin a modified living organism, containing new detectable combinations of replicable genetic material obtained by the use of modern biotechnology.

j) Quantity or volume of the modified living organism to be transferred.

k) An earlier and existing report of the risk assessment according to Annex III.

l) Methods suggested for the handling, storage, transportation and safe use, inclusive packaging, labelling, documentation and procedures of elimination and of emergency, when appropriate.

m) Legal condition of the modified living organism in the Exporting State (for example, if it is prohibited in the exporting State or if it is subject to other restrictions or if it has been approved for general release) and, should the modified living organism have been prohibited in the exporting State, the reasons thereof prohibition.

n) The result and the purpose of any notification of the exporter to other states in relation to the modified living organism to be transferred.

o) A statement that the data included in the information mentioned above is correct.

Annex II

Information required on modified living organisms intended for direct use as human or animal food or processing in accordance with Article 11

a) The name and contact details of the applicant of a decision for national use.

b) The name and contact details of the authority responsible for the decision.

c) The name and identity of the modified living organism.

d) Description of the genetic modification, the technique used and the resulting characteristics of the living organism modified.

e) Any unique identification of the modified living organism.

f) Taxonomic status, vulgar name, point of collection or acquisition and characteristics of the receptor body or parental organisms related to biosafeme.

g) Centres of origin and centres of genetic diversity, if known from the recipient organism and / or the parental organisms and a description of habitats where organisms can persist or proliferate.

h) Taxonomic status, vulgar name, point of collection or acquisition and characteristics of the organism or organisms donors related to biosafete.

i) approved Uses of the living organism modified.

j) A risk assessment report in accordance with Annex III.

l) Methods suggested for handling, storage, transportation, and use insurance, inclusive packaging, labeling, documentation and disposal and emergency procedures, when appropriate.

Annex III

Evaluation of risk

Objective

1. The objective of the risk assessment, within the framework of this Protocol, is to identify and evaluate the potential adverse effects of the modified living organisms on the conservation and sustainable use of biological diversity in the probable medium receptor, leading also in account of the risks to human health.

Use of risk assessment

2. The risk assessment is, among others, used by the competent authorities to make informed decisions about the modified living organisms.

General principles

3. The risk assessment should be carried out in a transparent and scientifically sound manner and could take into account the specialized advising of relevant international organizations and guidelines by them.

4. The lack of scientific knowledge or scientific consensus will not necessarily be interpreted as indicative of a particular level of risk, an absence of risk, or an acceptable risk.

5. The risks associated with modified living organisms or the products of them derived, namely, benefited materials that have as their origin a modified living organism, containing new detectable combinations of replicable genetic material obtained by means of the use of modern biotechnology, should be considered in the context of the risks presented by the unmodified receptors or parental organisms in the likely half-receptor.

6. The risk assessment should be carried out on a case-by-case. The required information may vary in nature and level of case-to-case detail, depending on the modified living organism in question, its intended use and the likely half-receiver.

Methodology

7. The risk assessment process could, on the one hand, give rise to the need for greater information on specific aspects, which can be identified and requested during the evaluation process, while on the other hand, information on other aspects may not be relevant in certain cases.

8. In order to achieve its goal, the risk assessment comprises, as the case may be, the following steps:

a) an identification of any genotypic or phenotypic trait novel associated with the modified living organism that may have adverse effects on diversity biological in the likely half-receptor, taking also into account the risks to human health;

b) an assessment of the probability of these adverse effects if they come to fruition, taking into account the level and type of exposure of the likely medium receptor to the living organism modified;

c) an evaluation of the consequences should these fact-adverse effects occur;

d) an estimate of the overall risk presented by the living organism modified based on the assessment of the probability of the identified adverse effects occurring and of their consequences;

and) a recommendation as to whether the risks are acceptable or maneuverable or not, including, when necessary, the identification of strategies to handle these risks; and

f) when there is uncertainty regarding the level of risk, such uncertainty may be treated by asking for greater information about specific troubling aspects or by the implementation of appropriate risk manhandling strategies and / or monitoring of the modified living organism in the receiving medium.

Aspects to consider

9. Depending on the case, the risk assessment takes into consideration the relevant scientific and technical details about the characteristics of the following elements:

a) receptor body and parental organisms. The biological characteristics of the recipient organism or parental organisms, including information on the taxonomic situation, vulgar name, origin, centres of origin and centres of genetic diversity, if known, and a description of where the organisms may persist or proliferate;

b) organism or donor organisms. Taxonomic situation, vulgar name, source and the relevant biological characteristics of donor organisms;

c) vector. Characteristics of the vector, including, if any, its source or origin and area of distribution of its hosts;

d) insertion or inserts and / or modification characteristics. The genetic characteristics of the inserted nucleic acid and the function that specifies, and / or the characteristics of the introduced modification;

e) modified living organism. Identity of the modified living organism, and the differences between the biological characteristics of the modified living organism and those of the receiving organism or the parental organisms;

f) detection and identification of the modified living organism. Suggested methods for the detection and identification and their specificity, sensitivity and reliability;

g) information about the predicted use. The information on the predicted use of the modified living organism, inclusive of new or modified uses compared to the receiving organism or parental organisms; and

h) half-receiver. Information on location, geographical, climatic and ecological characteristics, including relevant information on the biological diversity and source centers of the likely half-receptor.