WORLD TRADE
ORGANIZATIONWT/CTE/W/124
9 August 1999
(99-3378)
Committee on Trade and Environment Original:  English
CONVENTION ON BIOLOGICAL DIVERSITY (CBD)
DRAFT PROTOCOL ON BIOSAFETY
Full Text of the Protocol
This document contains the full text of the Draft Protocol on Biosafety that is being
negotiated under the Convention on Biological Diversity  (CBD).  It has been obtained from the Draft
Report of the Extraordinary Meeting of the Conference of Parties for the Adoption of the Protocol on
Biosafety to the Convention on Biological  Diversity (UNEP/CBD /ExCOP/1/L.2/Rev.1).1
                                                     
1 Please be advised that the pagination of the attached Draft Protocol on Biosafety has been changed,
and does not correspond to that of document UNEP/CBD/ExCOP/1/L.2/Rev.1.WT/CTE/W/124
Page 2
ANNEX V
Draft Protocol On Biosafety2
Contents
Page
Article
Preamble ....................................................................................................................... ...........5
1. Objective...................................................................................................................4
2. General pr ovisions ....................................................................................................4
3. Use of terms ..............................................................................................................5
4. Scope........................................................................................................................ .6
5. Application of the advance in formed agreemen t procedure .....................................6
6. Notificat ion ...............................................................................................................7
7. Acknowledgement of rece ipt of noti fication ............................................................7
8. Decision procedure ...................................................................................................7
9. Review of decisions..................................................................................................810. Simplified procedure.................................................................................................9
11. Multilateral, bilateral and regiona l agreements and arrangements ...........................9
12. Risk asse ssment ........................................................................................................9
13. Risk management....................................................................................................10
14. Unintentional transboundary move ments and emergency measures ......................10
15. Handling, transport, pack aging and iden tification..................................................11
16. Competent national authorities and national fo cal poin ts.......................................12
17. Information sharing and the Biosafety Clearing-House .........................................12
18. Confidential informa tion.........................................................................................13
19. Capacity- building....................................................................................................14
                                                     
2 Text of the draft protocol as contained in Appendix I to the report of the sixth meeting of the
Open-Ended Ad Hoc Working Group on Biosafety (UNEP/CBD/ExCOP/1/2).WT/CTE/W/124
Page 3
20. Public awareness a nd particip ation.........................................................................14
21. Non-Parties .............................................................................................................15
22. Non-discrimination .................................................................................................15
23. Illegal transbounda ry movements...........................................................................15
24. Socio-economic c onsiderations ..............................................................................15
25. Liability a nd redress................................................................................................16
26. Financial mechanis m and resources........................................................................16
27. Conference of the Parties serving as the meeting
of the Pa rties ...........................................................................................................16
28. Subsidiary bodies and mechanisms ........................................................................18
29. Secretariat ...............................................................................................................18
30. Relationship with the Convention...........................................................................1831. Relationship with other in ternational ag reements...................................................18
32. Monitoring a nd reporting........................................................................................19
33. Compliance .............................................................................................................19
34. Assessment and review...........................................................................................19
35. Signature .................................................................................................................1936. Entry into  force .......................................................................................................19
37. Reservations............................................................................................................20
38. Withdrawal .............................................................................................................20
39. Authentic texts ........................................................................................................20
Annexes
I. Information required  in notifications...................................................................................21
II. Risk a ssessment ............................................................................................................. ......22WT/CTE/W/124
Page 4
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 bi otechnology 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 ha s great potential for human well-being if
developed and used with adequate safety measures for the environment and human health,
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,
Have agreed as follows:
Article 1
OBJECTIVE
In accordance with the precautionary approach contained in Principle l5 of the Rio
Declaration on Environment and Development, the objective of this Protocol is to 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 effect on theconservation and sustainable use of biological diversity, taking also into account risks to human
health, and specifically focusing on transboundary movements.
Article 2
GENERAL PROVISIONS
1. Each Party shall take necessary and appropriate legal, administrative and other measures to
implement its obligations under this Protocol.
2. 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.WT/CTE/W/124
Page 5
3. Nothing in this Protocol shall affect in any wa y 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.
4. 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 its other obligations under international law.
5. The Parties are encouraged to take into account, as appropriate, available expertise,
instruments and work undertaken in international forums with competence in the area of risks to
human health.
Article 3
USE OF TERMS
For the purposes of this Protocol:
(a) "Conference of the Parties" means the Conference of the Parties to the Convention.
(b) "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.
(c) "Export" means intentional transboundary movement from one Party to another Party.
(d) "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.
(e) "Import" means intentional transboundary movement into one Party from another
Party.
(f) "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.
(g) "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:
(i) In vitro nucleic acid techniques, including recombinant DNA and direct
injection of nucleic acid into cells or organelles,
(ii) Fusion of cells beyond the taxonomic family,WT/CTE/W/124
Page 6
that overcome natural physiological reproductive or recombination barriers and that
are not techniques used in traditional breeding and selection.
(j) "Regional economic integration organization" means 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 dulyauthorized, in accordance with its internal procedures, to sign, ratify, accept, approve
or accede to it.
(k) "Transboundary movement" means the movement of a living modified organism from
one Party to another Party, save that for the purposes of Articles 11, 14 and 21
transboundary movement extends to movement between Parties and non-Parties.
Article 4
SCOPE
1. This Protocol shall, subject to paragraph 2 below, apply to the transboundary movement,
handling and use of living modified organisms that may have an adverse effect on the conservation
and sustainable use of biological diversity, taking also into account risks to human health.
2. Without prejudice to the right of the Parties to subject all living modified organisms to risk
assessment prior to the making of decisions on import, this Protocol shall not apply to:
(a) Transboundary movements of living modified organisms that are not likely to have
adverse effects on the conservation and sustainable use of biological diversity, taking
also into account risks to human health, as may be specified in an annex to the
Protocol;
(b) Transit of living modified organisms, except as regards Articles 2, 14 and 15, and
intentional transboundary movements of living modified organisms destined for
contained use, except as regards Articles 2, 14, 15 and 17, paragraphs 1, 2, 3(a) and
3(b);
(c) transboundary movements of living modified organisms that are pharmaceuticals for
humans.
Article 5
APPLICATION OF THE ADVANCE INFORMED AGREEMENT PROCEDURE
1. Subject to Article 4, paragraph 2, the advance informed agreement procedure in Articles 6, 7,
8 and 9 shall apply prior to the first intentional transboundary movements of living modified
organisms for intentional introduction into the environment of the Party of import.
2. "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.
3. The Parties may, under their respective domestic laws, require procedures consistent with
advance informed agreement for living modified orga nisms other than those specified in paragraph 1
above.WT/CTE/W/124
Page 7
4. Subject to paragraph 3 above, the advance informed agreement procedure shall not apply to
the intentional transboundary movements 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 sustainable use of biological diversity, taking also into
account risks to human health.
Article 6
NOTIFICATION
1. The Party of export shall notify, or require the exporter to ensure notification in writing to, 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 5, paragraph 1.  The notification
shall contain, at a minimum, the information specified in Annex I.
2. The Party of export shall ensure that there is a legal requirement for the accuracy of
information provided by the exporter.
Article 7
ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION
1. The Party of import shall acknowledge receipt of the notification, in writing, to the notifier
within 90 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 6;
(c) whether to proceed according to the domestic regulatory framework of the Party of
import or according to the procedure specified in Article 8.
3. The domestic regulatory framework referred to in paragraph 2(c) above, shall be consistent
with this Protocol.
4. A failure by the Party of import to acknowledge receipt of a notification shall not imply its
consent to an intentional transboundary movement.
Article 8
DECISION PROCEDURE
1. Decisions taken by the Party of import shall be in accordance with Article 12.
2. The Party of import shall, within the period of  time referred to in Article 7, inform the
notifier, in writing, whether the intentional transboundary movement may proceed:
(a) After no less than ninety days without a subsequent written consent;
(b) only after the Party of import has given its written consent.WT/CTE/W/124
Page 8
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(b) 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 legal
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;
(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 for the decision.
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. Parties concerned shall cooperate with a view to identifying, as soon as possible, the extent to
which in relation to the procedures, and the cases in which, an intentional transboundary movement
may not proceed between them without explicit consent.
7. Lack of full scientific certainty or scientific consensus regarding the potential adverse effects
of a living modified organism shall not prevent the Party of import from prohibiting the import of the
living modified organism in question as referred to in paragraph 3(b) above.
8. 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.
Article 9
REVIEW OF DECISIONS
1. 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 biol ogical diversity, taking also into account the
risks to human health, review and change its decisions regarding intentional transboundary
movements.  In such case, the Party shall, within thirty days, inform any notifier that has previously
notified movements, as well as the Biosafety Clearing-House, and shall give details of the reasons for
its decision.
2. 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 8 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;WT/CTE/W/124
Page 9
(b) additional relevant scientific or technical information has become available.
3. Parties of import shall respond to such requests in writing within ninety days and provide
details on the basis of their decision.
4. The Party of import may, at its discretion, require a risk assessment for subsequent imports of
a living modified organism.
Article 10
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 objectives
of this Protocol, specify in advance to the Biosafety Clearing-House:
(a) Cases for which intentional transboundary movement can take place at the same time
as the movement is notified to the Party of import:  such notifications may apply tosubsequent similar movements to the same Party;
(b) living modified organisms to be exempt ed from the advance informed agreement
procedure.
2. The information relating to an intentional tran sboundary movement that is to be provided in
the notifications referred to in paragraph 1(a) above shall be the information specified in Annex I.
Article 11
MULTILATERAL, BILATERAL AND REGIONAL AGREEMENTS AND ARRANGEMENTS
1. Parties may enter into multilateral, bilateral and regional agreements and arrangements with
Parties or non-Parties regarding intentional transboundary movements of living modified organisms,
consistent with the objectives of this Protocol and provided that such agreements and arrangements donot result in a lower level of protection than that provided for by the Protocol.
2. 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 entry into force of this Protocol.
3. The provisions of this Protocol shall not af fect intentional transboundary movements that take
place pursuant to such agreements and arrangements as between the parties to those agreements or
arrangements.
4. 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.
Article 12
RISK ASSESSMENT
1. Risk assessments conducted pursuant to this Protocol shall be undertaken in a scientifically
sound manner in accordance with Annex II and taking into account recognized risk assessment
techniques.  Such risk assessments shall be based at a minimum on information provided inWT/CTE/W/124
Page 10
accordance with Article 6 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.
2. The Party of import shall ensure that risk assessments are carried out for decisions taken
under Article 8.  It may require the exporter to carry out the risk assessments.
3. Financial responsibility for conducting risk assessments shall rest with the notifier.
Article 13
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 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. Each Party shall take appropriate measures to prevent unintentional transboundary
movements of living modified organisms, including such measures as requiring risk assessments to becarried out prior to the first release of a living modified organism.
4. Without prejudice to paragraph 2 above, each Party, in order to ensure genomic and trait
stability in the environment, shall endeavour to en sure that any living modified organism, whether
imported or locally developed, undergoes a period of observation commensurate with its life-cycle or
generation time as the case may be 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;
(b) taking appropriate measures regarding the treatment of such living modified
organisms or specific traits.
Article 14
UNINTENTIONAL TRANSBOUNDARY MOVEMENTS
AND EMERGENCY MEASURES
1. Each Party shall take appropriate measures to notify affected or potentially affected States,
the Biosafety Clearing-House and, where appropriate, relevant international organizations, when itknows of an occurrence under its jurisdiction resulting in a release that leads or may lead to an
unintentional transboundary movement of living modified organisms 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 Parties
know of the above situation.WT/CTE/W/124
Page 11
2. Each Party shall, no later than the date of entry into force of the Protocol for it, make
available to the Biosafety Clearing-House the relevant details of the point of contact for the purposes
of receiving notifications under this Article.
3. Any notification arising from paragraph 1 above should include:
(a) Available relevant information on the estimated quantities and relevant characteristics
and/or traits of the living modified organisms;
(b) a point of contact for further information;
(c) information on the circumstances and estimated date of the release, and on the use of
the living modified organism in the originating Party;
(d) 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;
(e) any other relevant information.
4. Each Party, under whose jurisdiction the release of the living modified organism referred to in
paragraph I 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, in order to minimize any significant ad verse effects on the conservation and sustainable use
of biological diversity, taking also into account risks to human health.
Article 15
HANDLING, TRANSPORT, PACKAGING AND IDENTIFICATION
1. The Parties shall take measures to require that living modified organisms that are subject to
intentional transboundary movement within the scope of the Protocol:
(a) Are handled, packaged and transported under conditions of safety, taking into
consideration relevant international rules and standards, in order to avoid adverse
effects on the conservation and sustainable use of biodiversity, taking also into
account risks to human health;
(b) are clearly identified, including in accompanying documentation specifying:
(i) the presence, identity and relevant characteristics and/or traits;
(ii) any requirements for safe handling, storage, transport and use;
(iii) the contact point for further information and, as appropriate, the name and
address of the importer and exporter;
(iv) a declaration that the movement is in conformity with the requirements of this
Protocol, except that the Party of import may indicate that, in relation to
imports, these requirements will not apply.
2. 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,WT/CTE/W/124
Page 12
packaging and transport practices, taking into cons ideration the results of consultations with other
international bodies.
Article 16
COMPETENT NATIONAL AUTHORITIES AND NATIONAL FOCAL POINTS
1. Each Party shall designate one national focal point to be responsible on its behalf for liaison
with the Secretariat.  Each Party shall also de signate 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 fulfil the functions of both focal point and competent national authority.
2. Each Party shall, no later than the date of entr y 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 m odified 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.
Article 17
INFORMATION-SHARING AND THE BIOSAFETY CLEARING-HOUSE
1. A Biosafety Clearing-House is hereby establis hed as part of the clearing-house mechanism
under Article 18, paragraph 3, of the Convention, in order to:
(a) Facilitate the exchange of scientific, t echnical, environmental and legal information
on, and experience with, living modified organisms;
(b) assist Parties to implement the Protocol, taking into account the special needs of
developing countries, in particular the least-developed countries and small island
developing States among them, and countries with economies in transition as well as
countries that are centres of origin.
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 info rmation required to be made available to the
Biosafety Clearing-House under this Protocol, and:
(a) National laws, regulations and guidelines for implementation of the Protocol, as well
as information required by the Parties for the advance informed agreementprocedures;WT/CTE/W/124
Page 13
(b) any multilateral, bilateral and regional 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 12, including, where appropriate, relevant information regarding products
thereof, i.e., 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;
(e) reports submitted by it pursuant to Article 32, including those on implementation of
the advance informed agreement procedures.
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 themeeting of the Parties at its first meeting, and kept under review thereafter.
Article 18
CONFIDENTIAL INFORMATION
1. The Party of import shall permit the notifier to identify information submitted under the
procedures of this Protocol or required by the importing Party as part of the advance informedagreement process of the Protocol that is to be treated as confidential.  Justification shall be given in
such cases upon request.
2. 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 shall, prior to any disclosure, inform
the notifier of its decision providing reasons on request and an opportunity for consultation and for aninternal review of the decision prior to disclosure.
3. Each Party shall, in accordance with its nationa l legislation, protect confidential information
received under the Protocol, including any confidenti al information received in the context of the
advance informed agreement process of the Protocol.  Each Party shall ensure that it has procedures to
protect such information and shall protect the conf identiality of such information in a manner no less
favourable than its treatment of confidential in formation in connection with domestically produced
living modified organisms.
4. The Party of import shall not use such informa tion for a commercial purpose, except with the
written consent of the notifier.
5. If a notifier withdraws or has withdrawn a notification, the Party of import shall respect the
confidentiality of all information identified as confidential, including information on which the Party
and the notifier disagree as to its confidentiality.
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 livi ng modified organism or organisms;WT/CTE/W/124
Page 14
(c) a summary of the risk assessment of the effects on the conservation and sustainable
use of biological diversity, taking also into account human health;
(d) any methods and plans for emergency response.
Article 19
CAPACITY-BUILDING
1. 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.
2. For the purposes of implementing paragraph 1 above, in relation to cooperation, the needs of
developing country Parties, in particular the least developed and small island developing States
among them, for financial resources and access to and transfer of technology and know-how in
accordance with the relevant provisions of the C onvention, shall be taken fully into account for
capacity-building in biosafety.  Cooperation in cap acity-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
for biosafety, and the enhancement of 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.
Article 20
PUBLIC AWARENESS AND PARTICIPATION
1. The Parties shall:
(a) Promote and facilitate public awareness, education and participation concerning
safety in the transfer, handling and use of living modified organisms in relation to theconservation 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. The Parties shall, in accordance with their respective laws, 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 18.
3. Each Party shall endeavour to inform its public about the means of public access to the
Biosafety Clearing-House.WT/CTE/W/124
Page 15
Article 21
NON-PARTIES
1. Transboundary movements of living modified organisms between Parties and non-Parties
shall be consistent with the objective and principles of this Protocol.  The Parties are encouraged to
conduct such transboundary movements in accordance with multilateral, bilateral and regionalagreements and arrangements with non-Parties under Article 11.
2. The Parties shall encourage non-Parties to adhere to this Protocol and to contribute
appropriate information to the Biosafety Clearing-H ouse on living modified organisms released in, or
moved into or out of, their territory.
Article 22
NON-DISCRIMINATION
1. The Parties shall ensure that measures taken to implement this Protocol, including risk
assessment, do not discriminate unjustifiably between or among imported and domestically produced
living modified organisms.
2. The Parties shall also ensure that measures taken to implement this Protocol do not create
unnecessary obstacles to international trade.
Article 23
ILLEGAL TRANSBOUNDARY MOVEMENTS
1. Each Party shall adopt appropriate domestic measures aimed at preventing and penalizing
transboundary movements of living modified organisms carried out in contravention of the relevant
provisions of this Protocol.  Such transboundary movements shall be deemed illegal.
2. 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 liv ing modified organism in question by repatriation or
destruction, as appropriate.
3. Each Party shall make available to the Biosafety Clearing-House information concerning
cases of illegal transboundary movements pertaining to it.
Article 24
SOCIO-ECONOMIC CONSIDERATIONS
1. The Parties, in reaching a decision on import, may take into account, consistent with their
international obligations, socioeconomic 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.
2. The Parties are encouraged to cooperate on research and information exchange on any
socioeconomic impacts of living modified organisms, especially on indigenous and localcommunities.WT/CTE/W/124
Page 16
Article 25
LIABILITY AND REDRESS
The Conference of the Parties serving as the meeting of the Parties 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 modifiedorganisms, analysing and taking due account of an y ongoing processes in international law on these
matters, and shall endeavour to complete this process within four years.
Article 26
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.
2. 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.
3. Regarding the capacity-building referred to in Article 19 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 take into account the need for financial resources by developing country Parties, inparticular, the least developed and the small island States among them.
4. 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 the small island States among them,
and of the Parties with economies in transition, in their efforts to identify and implement their
capacity-building requirements for the purposes of the implementation of this Protocol.
5. 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.
6. 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 theimplementation of the provisions of this Protocol through multilateral, bilateral and regional channels.
Article 27
CONFERENCE OF THE PARTIES SERVING AS THE MEETING
OF THE PARTIES
1. The Conference of the Parties shall serve as the meeting of the Parties to this Protocol.
2. 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, atWT/CTE/W/124
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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 Pr otocol and shall make, within its mandate, the
decisions necessary to promote its effective implementation.  It shall perform the functions assignedto it by this Protocol and shall:
(a) Make recommendations on any matters necessary for the implementation of this
Protocol;
(b) establish such subsidiary bodies as are deemed necessary for the implementation of
this Protocol;
(c) 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 tr ansmitting the information to be submitted in
accordance with Article 32 of this Protocol and, as well, 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;
(f) exercise such other functions as may be required for the implementation of this
Protocol.
5. 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.
6. The first meeting of the Conference of the Partie s 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.  Subsequentordinary 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.
7. 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.
8. 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 theParties to this Protocol.  Any body or agency, whet her 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 aWT/CTE/W/124
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meeting of the Parties to this Protocol as an observer, may be so admitted, unless at least one third of
the Parties present object.  Except as otherwise provided in this Article, the admission and
participation of observers shall be subject to the rules of procedure, as referred to in paragraph 5
above.
Article 28
SUBSIDIARY BODIES AND MECHANISMS
1. 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, serve the Protocol, in which case the
meeting of the Parties shall specify which functions that body shall exercise.
2. 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 takenonly 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.
Article 29
SECRETARIAT
1. The Secretariat established by Article 24 of the Convention shall serve as the secretariat to
this Protocol.
2. Article 24, paragraph 1, of the Convention on the functions of the Secretariat shall apply,
mutatis mutandis , to this Protocol.
3. 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.
Article 30
RELATIONSHIP WITH THE CONVENTION
Except as otherwise provided in this Protocol, th e provisions of the Convention relating to its
protocols shall apply to this Protocol.
Article 31
RELATIONSHIP WITH OTHER INTERNATIONAL AGREEMENTS
The provisions of this Protocol shall not affect the rights and obligations of any Party to the
Protocol deriving from any existing international ag reement to which it is also a Party, except where
the exercise of those rights and obligations would cause serious damage or threat to biological
diversity.WT/CTE/W/124
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Article 32
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 Pa rties serving as the meeting of the Parties to this
Protocol on measures that it has taken to implement the Protocol.
Article 33
COMPLIANCE
The Conference of the Parties serving as the mee ting of the Parties to this Protocol shall, at
its first meeting, consider and approve cooperative procedures and 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, whereappropriate.  They shall be separate from, and wi thout prejudice to, the dispute settlement procedures
and mechanisms established by Article 27 of the Convention.
Article 34
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.
Article 35
SIGNATURE
This Protocol shall be open for signature by States and regional economic integration
organizations at United Nations Headquarters in New York from 24 May 1999 to 23 May 2000.
Article 36
ENTRY INTO FORCE
1. This Protocol shall enter into force on the ninetieth day after the date of the deposit of the
fiftieth 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 regional economic integration organization
that ratifies, accepts or approves this Protocol or accedes thereto 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 integrationorganization, whichever shall be the later.WT/CTE/W/124
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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.
Article 37
RESERVATIONS
No reservations may be made to this Protocol.
Article 38
WITHDRAWAL
1. 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.
2. 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.
Article 39
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.WT/CTE/W/124
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Annex I
INFORMATION REQUIRED IN NOTIFICATIONS
(a) Name, address and contact details of the exporter.
(b) Name, address and contact details of the importer.
(c) Name, identity and domestic classification, if any, of the biosafety level in the State of export
of the living modified organism.
(d) Intended date or dates of the transboundary movement, if known.
(e) Taxonomic status, common name, point of collection or acquisition, and characteristics of
recipient organism or parental organisms related to biosafety.
(f) 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.
(g) Taxonomic status, common name, point of collection or acquisition, and characteristics of the
donor organism or organisms related to biosafety.
(h) Description of the nucleic acid or the modification introduced, the technique used, and the
resulting characteristics of the living modified organism.
(i) Intended use of the living modified organism or products thereof, i.e., processed materials that
are of living modified organism origin, c ontaining detectable novel combinations of
replicable genetic material obtained through the use of modern biotechnology.
(j) Quantity or volume of the living modified organism to be transferred
(k) A previous and existing risk assessment report consistent with Annex II.
(l) Suggested methods for safe handling, storage, transport and use, including packaging,
labelling, documentation, disposal and contingency procedures, where appropriate.
(m) Regulatory status of the living modified orga nism 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 Governments regarding the
living modified organism to be transferred.
(o) A declaration that the above-mentioned information is factually correct.WT/CTE/W/124
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Annex II
RISK ASSESSMENT
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 environm ent, taking also into account the risk to human
health.
Use of risk assessment
2. Risk assessment is, inter alia , used by competent authorities to make informed decisions
regarding living modified organisms.
General principles
3. 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.
4. 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.
5. Risks associated with living modified organism s or products thereof, i.e., 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 recipi ents or parental organisms in the likely potential
receiving environment.
6. 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 assessmentprocess, 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 the
risk to human health;
(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;WT/CTE/W/124
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(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;
(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.  Taxonom ic status and common name, source, andthe
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) 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;
(e) 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;
(h) Receiving environment.  Information on the location, geographical, climatic and
ecological characteristics, including relevant information on biodiversity and centres
of origin of the likely potential receiving environment.
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