Biosafety Protocol Final Draft of Biosafety Protocol Approved at Montreal Meeting On Biological Diversity Convention,
The Parties to this Protocol, Being Parties
to the Convention on Biological Diversity, hereinafter referred to as "the
Convention",
Recalling Article 19, paragraphs 3 and 4, and
Articles 8(g) and 17 of the Convention,
Recalling also decision II/5 of 17 November
1995 of the Conference of the Parties to the Convention to develop a Protocol
on biosafety, specifically
focusing on transboundary movement of any
living modified organism
resulting from modern biotechnology that may
have adverse effect on the conservation and sustainable use of biological
diversity, setting out for consideration, in particular, appropriate procedures
for advance informed agreement, Reaffirming the precautionary approach
contained in Principle 15 of the Rio Declaration on Environment and
Development,
Aware of the rapid expansion of modern
biotechnology and the growing public concern over its potential adverse effects
on biological diversity, taking also into account risks to human health,
Recognizing that modern biotechnology has
great potential 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,
Recognizing that trade environment agreements
should be mutually supportive with a view to achieving sustainable development,
Emphasizing that this Protocol shall not be
interpreted as implying a change in the rights and obligations of a Party under
any existing international agreements,
Understanding that the above recital is not
intended to subordinate this Protocol to other international agreements,
Have agreed as follows:
OBJECTIVE
In accordance with the precautionary approach
contained in Principle 15 of the Rio Declaration on Environment and
Development, the objective of this Protocol 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 effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health, and specifically
focusing on transboundary movements.
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.
3. Nothing in this Protocol shall affect in
any way the sovereignty of States over their territorial sea established in
accordance with international law, and the sovereign rights and the
jurisdiction which States have in their exclusive economic zones and their
contentional 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 fora with competence in the area of risks to human health.
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 to 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 deoxyribonucleic acid (DNA) and
direct injection of nucleic acid into cells or organelles, or
(ii) Fusion of cells beyond the
taxonomic family 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 duly authorized, 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 Article 17 and 24 transboundary movement
extends to movement between Parties and non-Parties.
SCOPE
The Protocol shall apply to the transboundary
movement, transit, handling and use of all living modified organisms that may
have adverse effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health.
PHARMACEUTICALS
Notwithstanding Article 4 and without
prejudice to any right of a Party to subject all living modified organisms to
risk assessment prior to the making of decisions on import, this Protocol shall
not apply to the transboundary movement of living modified organisms which are
pharmaceuticals for humans that are addressed by other relevant international
agreements or organisations.
TRANSIT AND CONTAINED USE
1. Notwithstanding Article 4 and without
prejudice to any right of a Party of transit to regulate the transport of
living modified organisms through its territory and make available to the
Biosafety ClearingHouse, any decision of that Party, subject to Article 2,
paragraph 3 of this Protocol, regarding the transit through its territory of a
specific living modified organism, the provisions of this Protocol with respect
to the advance informed agreement procedure shall not apply to living modified
organisms in transit.
2. Notwithstanding Article 4 and without
prejudice to any right of a Party to subject all living modified organisms to
risk assessment prior to decisions on import and to set standards for contained
use within its jurisdiction, the provisions of this Protocol with respect to
the advance informed agreement procedure shall not apply to the transboundary
movement of living modified organisms destined for contained use undertaken in
accordance with the standards of the Party of import.
APPLICATION OF THE ADVANCE INFORMED AGREEMENT
PROCEDURE
1. Subject to Articles 5 and 6, the advance
informed agreement procedure in Articles 8-10 and 12 shall apply prior to the
first intentional transboundary movement of living modified organisms for
intentional introduction into the environment of the Party of import.
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. Article 11 shall apply prior to the first
transboundary movement of living modified organisms intended for direct use as
food or feed, or for processing.
4. The advance informed agreement procedure
shall not apply to the intentional transboundary movement of living modified
organisms identified in a decision of the Conference of the Parties serving as
the meeting of the Parties to this Protocol as being not likely to have adverse
effects on the conservation and sustainable use of biological diversity, taking
also into account risks to human health.
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 the Article 7, 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 legal requirement for the accuracy of information provided by the
exporter.
ACKNOWLEDGEMENT OF RECEIPT OF NOTIFICATION
1. The Party of import shall acknowledge
receipt of the notification, in writing, to the notifier within ninety days of
its receipt.
2. The acknowledgement shall state:
(a) The date of receipt of the
notification;
(b) Whether the notification, prima
facie, contains the information referred to in Article 8;
(c) Whether to proceed according to the
domestic regulatory framework of the Party of import or according to the
procedure specified in Article 10.
3. 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.
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.
PROCEDURE FOR LIVING MODIFIED ORGANISMS
INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING
1. A Party that makes a final decision
regarding domestic use, including placing on the market, of a living modified
organism that may be subject to transboundary movement for direct use as food
or feed, or for processing shall, within fifteen days of making that decision,
inform the Parties through the Biosafety Clearing-House. This information shall
contain, at a minimum, the information specified in Annex III. The Party shall
provide a written copy of the information to the national focal point of each
Party that informs the Secretariat in advance that it does not have access to
the Biosafety Clearing-House. This provision shall not apply to decisions
regarding field trials.
2. The Party making a decision under
paragraph 1 above shall ensure that there is a legal requirement for the
accuracy of information provided by the applicant.
3. Any Party may request additional
information from the authority identified in paragraph (b) of Annex III.
4. A Party may take a decision on the import
of living modified organisms intended for direct use as food or feed, or for
processing, under its domestic regulatory framework that is consistent with the
objective of this Protocol.
5. Each Party shall make available to the
Biosafety Clearing-House copies of any national laws, regulations and
guidelines applicable to the import of living modified organisms intended for
direct use as food or feed, or for processing, if available.
6. A developing country Party of a Party with
an economy in transition may, in the absence of the domestic regulatory
framework referred to in paragraph 4 above, and in exercise of its domestic
jurisdiction, declare through the Biosafety Clearing-House that its decision
prior to the first import of a living modified organism intended for direct use
as food or feed, or for processing, on which information has been provided
under paragraph 1 above, will be taken according to the following:
(a) A risk assessment undertaken in accordance
with Annex II; and
(b) A decision made within a predictable
timeframe, not exceeding two hundred and seventy days.
7. Failure by a Party to communicate its
decision according to paragraph 6 above, shall not imply its consent or refusal
to the import of a living modified organism intended for direct use as food or
feed, or for processing, unless otherwise specified by the Party.
8. Lack of scientific certainty due to
insufficient relevant scientific information and knowledge regarding the extent
of the potential adverse effects of a living modified organism on the
conservation and sustainable use of biological diversity in the Party of
import, taking also into account risks to human health, shall not prevent that
Party from taking a decision, as appropriate, with regard to the import of that
living modified organism intended for direct use as food or feed, or for
processing in order to avoid or minimize such potential adverse effects.
9. A Party may indicate its needs for
financial and technical assistance and capacity-building with respect to living
modified organisms for direct use as food or feed, or for processing. Parties
shall cooperate to meet these needs in accordance with Article 22 and 28.
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 biological diversity, taking also into
account the risks to human health, review and change a decision regarding an
intentional transboundary movement. In such case, the Party shall, within
thirty days, inform any notifier that has previously notified movements of the
living modified organisms referred to in such decision, as well as the Biosafety
Clearing-House, and shall set out 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 10 where the Party of export or the notifier considers that:
(a) A change in circumstances has
occurred that may influence the outcome of the risk assessment upon which the
decision was based; or
(b) Additional relevant scientific or
technical information has become available.
3. The Party of import shall respond to
such a request in writing within ninety days and set out the reasons for its
decision.
4. The Party of import may, at its
discretion, require a risk assessment for subsequent imports.
SIMPLIFIED PROCEDURE
1. A Party of import may, provide that
adequate measures are applied to ensure the safe intentional transboundary
movement of living modified organisms in accordance with the objective of this
Protocol, specify in advance to the Biosafety Clearing-House:
(a) Cases in which intentional
transboundary movement to it may take place at the same time as the movement is
notified to the Party of import: such notifications may apply to subsequent
similar movements to the same Party; and
(b) Imports of living modified organisms
to it to be exempted from the advance informed agreement procedure.
2. The information relating to an intentional
transboundary movement that is to be provided in the notifications referred to
in paragraph 1(a) above shall be in the information specified in Annex I.
BILATERAL, REGIONAL AND MULTILATERAL
AGREEMENTS AND ARRANGEMENTS
1. Parties may enter into bilateral, regional
and multilateral agreements and arrangements regarding intentional
transboundary movements of living modified organisms, consistent with the
objective of this Protocol and provided that such agreements and arrangements
do not 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
affect 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.
RISK ASSESSMENT
1. Risk assessments undertaken pursuant to
this Protocol shall be carried out 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 in accordance with Article 8 and other available scientific evidence
in order to identify and evaluate the possible adverse effects of living
modified organisms on the conservation and sustainable use of biological
diversity, taking also into account risks to human health.
2. The Party of import shall ensure that risk
assessments are carried out for decisions taken under Article 10. It may
require the exporter to carry out the risk assessments.
3. The cost of risk assessment shall be borne
by the notifier if the Party of import so requires.
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 risk 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 be carried out prior
to the first release of a living organism.
4. Without prejudice to paragraph 2 above,
each Party shall endeavour to ensure that any living modified organism, whether
imported or locally developed, has undergone an appropriate period of
observation that is commensurate with its life-cycle or generation time before
it is put to its intended use.
5. Parties shall cooperate with a view to:
(a) Identifying living modified
organisms or specific traits of living modified organisms that may have adverse
effects on the conservation and sustainable use of biological diversity, taking
also into account risks to human health; and
(b) Taking appropriate measures
regarding the treatment of such living modified organisms or specific traits.
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 it knows of
an occurrence under its jurisdiction resulting in a release that leads or may
lead to an unintentional transboundary movements of a living modified organism
that is likely to have significant adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to
human health in such States. The notification shall be provided as soon as the
Party knows of the above situation.
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 setting out its 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 organism;
(b) Information on the circumstances and
estimated date of the release, and on the use of the living modified organism
in the originating Party;
(c) Any available information about the
possible adverse effects on the conversation and sustainable use of biological
diversity, taking also into account risks to human health, as well as available
information about possible risk management measures;
(d) Any other relevant information; and
(e) A point of contact for further
information.
4. In order to minimize any significant
adverse effect on conservation and sustainable use of biological diversity,
taking also into account risks to human health, each Party, under whose
jurisdiction the release of the living modified organism referred to in
paragraph 1 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.
HANDLING, TRANSPORT, PACKAGING AND
IDENTIFICATION
1. In order to avoid adverse effects on the
conservation and sustainable use of biological diversity, taking also into
account risks to human health, each Party shall take necessary measures to
require that living modified organisms that are subject to intentional
transboundary movement within the scope of the Protocol are handled, packaged
and transported under conditions of safety, taking into consideration relevant
intentional rules and standards.
2. Each Party shall take measures to require
that at a minimum documentation
accompanying;
(a) Living modified organism that are
intended for direct use as food or feed, or for processing, clearly identifies
them as "may contain" living modified organisms and as not intended
for intentional introduction into the environment, as well as a contact point
for further information. The Conference of the Parties serving as the meeting
of the Parties to this Protocol shall take a decision on the detailed
requirements for this purpose, including specification of their identity and
any unique identification, no later than two years after the entry into force
of this Protocol.
(b) Living modified organisms that are
destined for contained use clearly identifies them as living modified
organisms; and specifies any requirements for the safe handling, storage,
transport and use, the contact point for further information, including the
name and address of the individual and institution to whom the living modified
organisms are consigned; and
(c) Living modified organisms that are
intended for intentional introduction into the environment of the Party of
import and any other living modified organisms within the scope of the
Protocol, clearly identifies them as living modified organisms; specifies the identity
and relevant traits and/or characteristics, any requirements for the safe
handling, storage, transport and use, the contact point for further information
and, as appropriate, the name and address of the importer and exporter; and
contains a declaration that the movement is in conformity with the requirements
of this Protocol applicable to the exporter.
3. The Conference of the Parties serving as
the meeting of the Parties to this Protocol shall consider the need for and
modalities of developing standards with regard to identification, handling,
packaging and transport practices, in consultation with other relevant
international bodies.
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 designate one or more competent national authorities,
which shall be responsible for performing the administrative functions required
by this Protocol and which shall be authorized to act on its behalf with
respect to those functions. A Party may designate a single entity to fulfill
the functions of both focal point and competent national authority.
2. Each Party shall, no later than the date
of entry into force of this Protocol for it, notify the Secretariat of the
names and addresses of its focal point and its competent national authority or
authorities. Where a Party designates more than one competent national
authority, it shall convey to the Secretariat, with its notification thereof,
relevant information on the respective responsibilities of those authorities.
Where applicable, such information shall, at a minimum, specify which competent
authority is responsible for which type of living modified organism. Each Party
shall forthwith notify the Secretariat of any changes in the designation of its
national focal point or in the name and address or responsibilities of its
competent national authority or authorities.
3. The Secretariat shall forthwith inform the
Parties of the notifications it receives under paragraph 2 above, and shall
also make such information available through the Biosafety Clearing-House.
INFORMATION-SHARING AND THE BIOSAFETY
CLEARING-HOUSE
1, A Biosafety Clearing-House is hereby
established as part of the clearing-house mechanism under Article 18, paragraph
3, of the Convention, in order to:
(a) Facilitate the exchange of
scientific, technical, environmental and legal information on, and experience
with, living modified organisms; and
(b) Assist Parties to implement the
Protocol, taking into account the special needs of developing country Parties,
in particular the least developed and small island developing States among
them, and countries with economies in transition as well as countries that are
centres or origin and centres of genetic diversity.
2. The Biosafety Clearing-House shall serve
as a means through which information is made available for the purposes of
paragraph 1 above. It shall also provide access to information made available
by the Parties relevant to the implementation of the Protocol. It shall also
provide access, where possible, to other international biosafety information
exchange mechanisms.
3. Without prejudice to the protection of
confidential information, each Party shall make available to the Biosafety
Clearing-House any information required to be made available to the Biosafety
Clearing-House under this Protocol, and:
(a) Any existing laws, regulations and
guidelines for implementation of the Protocol, as well as information required
by the Parties for the advance informed agreement procedure;
(b) Any bilateral, regional and
multilateral agreements and arrangements;
(c) Summaries of its risk assessments or
environmental reviews of living modified organisms generated by its regulatory
process, and carried out in accordance with Article 15, including, where
appropriate, relevant information regarding products thereof, namely, processed
materials that are of living modified organism origin, containing detectable
novel combinations of replicable genetic material obtained through the use of
modern biotechnology;
(d) Its final decisions regarding the
importation or release of living modified organisms; and
(e) Reports submitted by it pursuant to
Article 33, including those on implementation of the advance informed agreement
procedure.
4. The modalities of the operation of the
Biosafety Clearing-House, including reports on its activities, shall be
considered and decided upon by the Conference of the Parties serving as the
meeting of the Parties at its first
meeting, and kept under review thereafter.
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 Party of import as part of the advance informed
agreement procedure of the Protocol that is to be treated as confidential.
Justification shall be given in such cases upon request.
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 as
well as an opportunity for consultation and for an internal review of the
decision prior to disclosure.
3. Each Party shall protect confidential
information received under this Protocol, including any confidential
information received in the context of the advance informed agreement procedure
of the Protocol. Each Party shall ensure that it has procedures to protect such
information and shall protect the confidentiality of such information in a manner
no less favourable than its treatment of confidential information in connection
with domestically produced living modified organisms.
4. The Party of import shall not use such
information 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
commercial and industrial information, including research and development
information as well as 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 living
modified organism or organisms;
(c) A summary of the risk assessment of
the effects on the conservation and sustainable use of biological diversity,
taking also into account risks to human health; and
(d) Any methods and plans for emergency
response.
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 Convention, shall be
taken fully into account for capacity-building in biosafety. Cooperation in
capacity-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.
PUBLIC AWARENESS AND PARTICIPATION
1. The Parties shall:
(a) Promote and facilitate public
awareness, education and participating concerning the safe transfer, handling
and use of living modified organisms in relation to the conservation and
sustainable use of biological diversity, taking also into account risks to
human health. In doing so, the Parties shall cooperate, as appropriate, with
other States and international bodies;
(b) Endeavour to ensure that public
awareness and education encompass access to information on living modified
organisms identified in accordance with this Protocol that may be imported.
2. The Parties shall, in accordance with
their respective laws and regulations, consult the public in the
decision-making process regarding living modified organisms and shall make the
results of such decisions available to the public, while respecting
confidential information in accordance with Article 21.
3. Each Party shall endeavour to inform its
public about the means of public access to the Biosafety Clearing-House.
NON-PARTIES
1. Transboundary movements of living modified
organisms between Parties and non-Parties shall be consistent with the
objective of this Protocol. The Parties may enter into bilateral, regional and
multilateral agreements and arrangements with non-Parties regarding such
transboundary movements.
2. The Parties shall encourage non-Parties to
adhere to this Protocol and to contribute appropriate information to the
Biosafety Clearing-House on living modified organisms released in, or moved
into or out of, areas within their national jurisdictions.
ILLEGAL TRANSBOUNDARY MOVEMENTS
1. Each Party shall adopt appropriate
domestic measures aimed at preventing and, if appropriate, penalizing
transboundary movements of living modified organisms carried out in
contravention of its domestic measures to implement this Protocol. Such movements
shall be deemed illegal transboundary movements.
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 living 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.
SOCIO-ECONOMIC CONSIDERATIONS
1. The Parties, in reaching a decision on
import under this Protocol or under its domestic measures implementing the
Protocol, may take into account, consistent with their international
obligations, socio-economic considerations arising from the impact of living
modified organisms on the conservation and sustainable use of biological
diversity, especially with regard to the value of biological diversity to
indigenous and local communities.
2. The Parties are encouraged to cooperate on
research and information exchange on any socio-economic impacts of living
modified organisms, especially on indigenous and local communities.
LIABILITY AND REDRESS
The Conference of the Parties serving as the
meeting of the Parties to this Protocol shall, at its first meeting, adopt a
process with respect to the appropriate elaboration of international rules and
procedures in the field of liability and redress for damage resulting from
transboundary movements of living modified organisms, analysing and taking due
account of the ongoing processes in international law on these matters, and
shall endeavour to complete this process within four years.
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 22 of this Protocol, the Conference of the Parties serving as the
meeting of the Parties to this Protocol, in providing guidance with respect to
the financial mechanism referred to in paragraph 2 above, for consideration by
the Conference of the Parties, shall take into account the need for financial
resources by developing country Parties, in particular the least developed and
the small island developing 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 developing
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 the
implementation of the provisions of this Protocol through multilateral,
bilateral and regional channels.
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
Conference of the Parties representing a Party to the Convention but, at that
time, not a Party to this Protocol, shall be substituted by a member to be
elected by and from among the Parties to this Protocol.
4. The Conference of the Parties serving as
the meeting of the Parties to this Protocol shall keep under regular review the
implementation of this Protocol and shall make, within its mandate, the
decisions necessary to promote its effective implementation. It shall perform
the functions assigned to it by this Protocol and shall:
(a) Make recommendations on any matters
necessary for the implementation of this Protocol;
(b) 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 transmitting the information to be submitted in accordance with Article 33
of this Protocol and consider such information as well as reports submitted by
any subsidiary body;
(e) Consider and adopt, as required,
amendments to this Protocol and its annexes, as well as any additional annexes
to this Protocol, that are deemed necessary for the implementation of this
Protocol; and
(f) Exercise such other functions as may
be required for the implementation of this Protocol.
5. The rules of procedure of the Conference
of the Parties and financial rules of the Convention shall be applied, mutatis
mutadis, 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
Parties serving as the meeting of the Parties to this Protocol shall be
convened by the Secretariat in conjunction with the first meeting of the
Conference of the Parties that is scheduled after the date of the entry into
force of this Protocol. Subsequent ordinary meetings of the Conference of the
Parties serving as the meeting of the Parties to this Protocol shall be held in
conjunction with ordinary meetings of the Conference of the Parties, unless
otherwise decided by the Conference of the Parties serving as the meeting of
the Parties to this Protocol.
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 the Parties to this Protocol. Any body or agency, whether
national or international, governmental or non-governmental, that is qualified
in matters covered by this Protocol and that has informed the Secretariat of
its wish to be represented at a meeting of the Convention of the Parties serving
as a 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.
SUBSIDIARY BODIES
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 taken only by the Parties to the Protocol.
3. When a subsidiary body of the Convention
exercises its functions with regard to matters concerning this Protocol, any
member of the bureau of that subsidiary body representing a Party to the
Convention but, at that time, not a Party to the Protocol, shall be substituted
by a member to be elected by and from among the Parties to the Protocol.
SECRETARIAT
1. The Secretariat establish by Article 24 of
the Conveniton 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.
RELATIONSHIP WITH THE CONVENTION
Except as otherwise provided in this
Protocol, the provisions of the Convention relating to its Protocols shall
apply to this Protocol.
MONITORING AND REPORTING
Each Party shall monitor the implementation
of its obligations under this Protocol, and shall, at intervals to be
determined by the Conference of the Parties serving as the meeting of the
Parties to this Protocol, report to the Conference of the Parties serving as
the meeting of the Parties to this Protocol on measures that it has taken to
implement the Protocol.
COMPLIANCE
The Conference of the Parties serving as the
meeting 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, where appropriate. They shall be separate from, and
without prejudice to, the dispute settlement procedures and mechanisms
established by Article 27 of the Convention.
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.
SIGNATURE
This Protocol shall be open for signature at
Nairobi by States and regional economic integration organizations from 15 to 26
May 2000, and at United Nations Headquarters in New York from 5 June 2000 to 4
June 2001.
ENTRY INTO FORCE
1. This Protocol shall enter into force on
the ninetieth day after the date of deposit of the fiftieth instrument of
ratification, acceptance, approval or accession by States or regional economic
integration organizations that are Parties to the Convention.
2. This Protocol shall enter into force 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
Protocol enters into force for that State or regional economic integration
organization, whichever shall be the later.
3. For the purposes of paragraphs 1 and 2
above, any instrument deposited by a regional economic integration organization
shall not be counted as additional to those deposited by member States of such
organization.
RESERVATIONS
No reservations may be made to this Protocol.
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 Depository.
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.
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.
INFORMATION
REQUIRED IN NOTIFICATIONS UNDER ARTICLES 8, 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 living modified
organism, as well as the domestic classification, if any, of the biosafety
level of the living modified organism in the State of export.
(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 centers 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) Descripton 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, namely, processed materials that are of living
modified organism origin, containing detectable novel combinations of
replicable genetic material obtained through the use of modern biotechnology.
(j) Quantity or volume of the living modified
organism to be transferred.
(k) A previous and existing risk assessment
report consistent with Annex II.
(i) 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
organism within the State of export (for example, whether it is prohibited in
the State of export, whether there are other restrictions, or whether it has
been approved for general release) and, if the living modified organism is
banned in the State of export, the reason or reasons for the ban.
(n) Result and purpose of any notification by
the exporter to other States regarding the living modified organism to be
transferred.
(o) A declaration that the above-mentioned
information is factually correct.
RISK ASSESSMENT UNDER ARTICLE 15
Objective
1. The objective of risk assessment, under
this Protocol, is to identify and evaluate the potential adverse effects of
living modified organisms on the conservation and sustainable use of biological
diversity in the likely potential receiving environment, taking also into
account risks to human health.
Use of risk assessment 2. Risk assessment 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
orgamisms or products thereof, namely, processed materials that are of living
modified organism origin, containing detectable novel combinations of
replicable genetic material obtained through the use of modern biotechnology,
should be considered in the context of the risks posed by the non-modified
recipients or parental organisms in the likely potential receiving environment.
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 assessment process, while on
the other hand information on other subjects may not be relevant in some
instances.
8. To fulfil its objective, risk assessment
entails, as appropriate, the following steps:
(a) An identification of any novel
genotypic and phenotypic characteristics associated with the living modified
organism that may have adverse effects on biological diversity in the likely
potential receiving environment, taking also into account risks to human
health;
(b) An evaluation of the likelihood of
these adverse effects being realized, taking into account the level and kind of
exposure of the likely potential receiving environment to the living modified
organism;
(c) An evaluation of the consequences
should these adverse effects be realized;
(d) An estimation of the overall risk
posed by the living modified organism based on the evaluation of the likelihood
and consequences of the identified adverse effects being realized;
(e) A recommendation as to whether or
not the risks are acceptable or manageable, including, where necessary,
identification of strategies to manage these risks; and
(f) Where there is uncertainty regarding
the level of risk, it may be addressed by requesting further information on the
specific issues of concern or by implementing appropriate risk management
strategies and/or monitoring the living modified organism in the receiving
environment.
Points to
consider
9.
Depending on the case, risk assessment takes into account the relevant
technical and scientific details regarding the characteristics of the following
subjects:
(a) Recipient organism or parental
organisms. The biological characteristics of the recipient organism or parental
organisms, including information on taxonomic status, common name, origin,
centres of origin and centres of genetic diversity, if known, and a description
of the habitat where the organisms may persist or proliferate;
(b) Donor organism or organisms.
Taxonomic status and common name, source, and the relevant biological
characteristics of the donor organism;
(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. Identify
of the living modified organism, and the differences between the biological
characteristics of the living modified organism and those of the recipient
organism or parental organisms;
(f) Detection and identification of the
living modified organism. Suggested detection and identification methods and
their specificity, sensitivity and reliability;
(g) Information relating to the intended
use. Information relating to the intended use of the living modified organism,
including new or changed use compared to the recipient organism or parental
organisms; and
(h) Receiving environment. Information
on the location, geographical, climatic and ecological characteristics,
including relevant information on biological diversity and centres of origin of
the likely potential receiving environment.
Annex
III
INFORMATION REQUIRED FOR LIVING MODIFIED
ORGANISMS INTENDED FOR DIRECT USE AS FOOD OR FEED, OR FOR PROCESSING UNDER
ARTICLE 11
(a) The name and contact details of the
applicant for a decision for domestic use
(b) The name and contact details of the
authority responsible for the decision.
(c) Name and identify of the living modified
organism.
(d) Description of the gene modification, the
technique used, and the resulting
characteristics of the living modified organism.
(e) Any unique identification of the living
modified organism.
(f) Taxonomic status, common name, point of
collection or acquisition, and characteristics of recipient organism or
parental organisms related to biosafety.
(g) 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.
(h) Taxonomic status, common name, point of
collection or acquisition, and characteristics of the donor organism or
organisms related to biosafety.
(i) Approved uses of the living modified
organism.
(j) A risk assessment report consistent with
Annex II of this Protocol. (k) Suggested methods for safe handling, storage,
transport and use,
including packaging, labelling, documentation, disposal and contingency procedures, where appropriate. <<...>>
Gruss, Jürg Schrank Interpharma