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Biosafety Protocol Final Draft of Biosafety Protocol Approved at Montreal Meeting On Biological Diversity Convention, Released Jan. 29, 2000 (Final Text)

Article 1 - Objective

Article 2 - General Provisions

Article 3 - Use of Terms

Article 4 - Scope

Article 5 - Pharmaceuticals

Article 6 - Transit And Contained Use

Article 7 - Application Of The Advance Informed Agreement Procedure

Article 8 - Notification

Article 9 - Acknowledgement Of Receipt Of Notification

Article 10 - Decision Procedure

Article 11 - Procedure for Living Modified Organisms Intended for Direct use as Food or Feed, or for Processing

Article 12 - Review Of Decisions

Article 13 - Simplified Procedure

Article 14 - Bilateral, Regional and Multilateral Agreements and Arrangements

Article 15 - Risk Assessment

Article 16 - Risk Management

Article 17 - Unintentional Transboundary Movements And Emergency Measures

Article 18 - Handling, Transport, Packaging And Identification

Article 19 - Competent National Authorities And National Focal Points

Article 20 - Information-Sharing and the Biosafety Clearing-House

Article 21 - Confidential Information

Article 22 - Capacity-Building

Article 23 - Public Awareness And Participation

Article 24 - Non-Parties

Article 25 - Illegal Transboundary Movements

Article 26 - Socio-Economic Considerations

Article 27 - Liability And Redress

Article 28 - Financial Mechanism and Resources

Article 29 - Conference of the Parties Serving as the Meeting of the Parties

Article 30 - Subsidiary Bodies

Article 31 - Secretariat

Article 32 - Relationship With The Convention

Article 33 - Monitoring And Reporting

Article 34 - Compliance

Article 35 - Assessment And Review

Article 36 - Signature

Article 37 - Entry Into Force

Article 38 - Reservations

Article 39 - Withdrawal

Article 40 - Authentic Texts

Annex I - Information Required In Notifications Under Articles 8, 10 And 13

Annex Ii - Risk Assessment Under Article 15

Objective

Use of risk assessment

Methodology

Points to consider

Annex III - Information Required For Living Modified Organisms Intended For Direct Use As Food Or Feed, Or For Processing Under Article 11

Metadata

SiSU Metadata, document information

Manifest

SiSU Manifest, alternative outputs etc.

Biosafety Protocol Final Draft of Biosafety Protocol Approved at Montreal Meeting On Biological Diversity Convention, Released Jan. 29, 2000 (Final Text)

copy @ Lex Mercatoria

Biosafety Protocol Final Draft of Biosafety Protocol Approved at Montreal Meeting On Biological Diversity Convention, Released Jan. 29, 2000 (Final Text)

Article 10 - Decision Procedure

1. Decisions taken by the Party of import shall be in accordance with Article 15.

2. The Party of import shall, within the period of time referred to in Article 9, inform the notifier, in writing, whether the intentional transboundary movement may proceed:

(a) Only after the Party of import has given its written consent; or

(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 Annexes I and II; 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 the period specified in this paragraph is extended by a defined period of time.

4. 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.

5. 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.

6. Lack of scientific certainty due to insufficient relevant scientific information and acknowledge 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.

7. 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.


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