Zakon o ratifikaciji Kartagenskega protokola o biološki varnosti h Konvenciji o biološki raznovrstnosti (MKPBV) - UL 89/2002
Na podlagi druge alinee prvega
odstavka 107. člena in prvega odstavka 91. člena Ustave Republike
Slovenije izdajam
U K A
Z
O RAZGLASITVI ZAKONA O
RATIFIKACIJI KARTAGENSKEGA PROTOKOLA O BIOLOŠKI VARNOSTI H
KONVENCIJI O BIOLOŠKI RAZNOVRSTNOSTI (MKPBV)
Razglašam Zakon o ratifikaciji
Kartagenskega protokola o biološki varnosti h Konvenciji o biološki
raznovrstnosti (MKPBV), ki ga je sprejel Državni zbor Republike
Slovenije na seji 27. septembra 2002.
Št. 001-22-115/02
Ljubljana, 7. oktobra
2002
Predsednik
Republike Slovenije
Milan Kučan l. r.
Z A K O
N
O RATIFIKACIJI KARTAGENSKEGA
PROTOKOLA O BIOLOŠKI VARNOSTI H KONVENCIJI O BIOLOŠKI
RAZNOVRSTNOSTI (MKPBV)
1.
člen
Ratificira se Kartagenski
protokol o biološki varnosti h Konvenciji o biološki
raznovrstnosti, sestavljen v Montrealu 29. januarja
2000.
2.
člen
Protokol se v izvirniku v
angleškem jeziku in prevodu v slovenskem jeziku glasi:
CARTAGENA
PROTOCOL ON BIOSAFETY
TO THE CONVENTION ON BIOLOGICAL
DIVERSITY
The Parties to this
Protocol,
- Being Parties to the Convention on Biological
Diversity, hereinafter referred to as the Convention,
- Recalling Article 19, paragraphs 3 and
4, and Articles 8 (g) and 17 of the Convention,
- Recalling also decision II/5 of
17 November 1995 of the Conference of the Parties to the Convention
to develop a Protocol on biosafety, specifically focusing on
transboundary movement of any living modified organism resulting
from modern biotechnology that may have adverse effect on the
conservation and sustainable use of biological diversity, setting
out for consideration, in particular, appropriate procedures for
advance informed agreement,
- Reaffirming the precautionary
approach contained in Principle 15 of the Rio Declaration on
Environment and Development,
- Aware of the rapid expansion of
modern biotechnology and the growing public concern over its
potential adverse effects on biological diversity, taking also into
account risks to human health,
- Recognizing that modern
biotechnology has great potential 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 and
environment agreements should be mutually supportive with a view to
achieving sustainable development,
- Emphasizing that this Protocol
shall not be interpreted as implying a change in the rights and
obligations of a Party under any existing international
agreements,
- Understanding that the above
recital is not intended to subordinate this Protocol to other
international agreements,
- Have agreed as
follows:
Article
1
OBJECTIVE
In accordance with the
precautionary approach contained in Principle 15 of the Rio
Declaration on Environment and Development, the objective of this
Protocol is to 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.
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.
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 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 that Partys
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:
a. In vitro nucleic acid
techniques, including recombinant deoxyribonucleic acid (DNA) and
direct injection of nucleic acid into cells or organelles, or
b. Fusion of cells beyond the taxonomic
family,
that overcome natural
physiological 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 Articles 17 and 24
transboundary movement extends to movement between Parties and
non-Parties.
Article
4
SCOPE
This Protocol shall apply to the
transboundary movement, transit, handling and use of all living
modified organisms that may have adverse effects on the
conservation and sustainable use of biological diversity, taking
also into account risks to human health.
Article
5
PHARMACEUTICALS
Notwithstanding Article 4 and
without prejudice to any right of a Party to subject all living
modified organisms to risk assessment prior to the making of
decisions on import, this Protocol shall not apply to the
transboundary movement of living modified organisms which are
pharmaceuticals for humans that are addressed by other relevant
international agreements or organisations.
Article
6
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 Clearing-House, any decision of
that Party, subject to Article 2, paragraph 3, regarding the
transit through its territory of a specific living modified
organism, the provisions of this Protocol with respect to the
advance informed agreement procedure shall not apply to living
modified organisms in transit.
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.
Article
7
APPLICATION OF THE ADVANCE INFORMED
AGREEMENT PROCEDURE
1. Subject to Articles 5 and 6,
the advance informed agreement procedure in Articles 8 to 10 and 12
shall apply prior to the first intentional transboundary movement
of living modified organisms for intentional introduction into the
environment of the Party of import.
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.
Article
8
NOTIFICATION
1. The Party of export shall
notify, or require the exporter to ensure notification to, in
writing, the competent national authority of the Party of import
prior to the intentional transboundary movement of a living
modified organism that falls within the scope of Article 7,
paragraph 1. The notification shall contain, at a minimum, the
information specified in Annex I.
2. The Party of export shall ensure that
there is a legal requirement for the accuracy of information
provided by the exporter.
Article
9
ACKNOWLEDGEMENT OF RECEIPT OF
NOTIFICATION
1. The Party of import shall
acknowledge receipt of the notification, in writing, to the
notifier within ninety days of its receipt.
2. The acknowledgement shall
state:
(a) The date of receipt of the
notification;
(b) Whether the notification, prima
facie, contains the information referred to in Article 8;
(c) Whether to proceed according to the
domestic regulatory framework of the Party of import or according
to the procedure specified in Article 10.
3. 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
10
DECISION PROCEDURE
1. Decisions taken by the Party
of import shall be in accordance with Article 15.
2. The Party of import shall, within the
period of time referred to in Article 9, inform the notifier, in
writing, whether the intentional transboundary movement may
proceed:
(a) Only after the Party of
import has given its written consent; or
(b) After no less than ninety days
without a subsequent written consent.
3. Within two hundred and
seventy days of the date of receipt of notification, the Party of
import shall communicate, in writing, to the notifier and to the
Biosafety Clearing-House the decision referred to in paragraph 2
(a) above:
(a) Approving the import, with
or without conditions, including how the decision will apply to
subsequent imports of the same living modified organism;
(b) Prohibiting the import;
(c) Requesting additional relevant
information in accordance with its domestic regulatory framework or
Annex I; in calculating the time within which the Party of import
is to respond, the number of days it has to wait for additional
relevant information shall not be taken into account; or
(d) Informing the notifier that 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 knowledge
regarding the extent of the potential adverse effects of a living
modified organism on the conservation and sustainable use of
biological diversity in the Party of import, taking also into
account risks to human health, shall not prevent that Party from
taking a decision, as appropriate, with regard to the import of the
living modified organism in question as referred to in paragraph 3
above, in order to avoid or minimize such potential adverse
effects.
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.
Article
11
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 II. The
Party shall provide a copy of the information, in writing, 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
II.
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 or a Party
with an economy in transition may, in the absence of the domestic
regulatory framework referred to in paragraph 4 above, and in
exercise of its domestic jurisdiction, declare through the
Biosafety Clearing-House that its decision prior to the first
import of a living modified organism intended for direct use as
food or feed, or for processing, on which information has been
provided under paragraph 1 above, will be taken according to the
following:
(a) A risk assessment undertaken
in accordance with Annex III; 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 intended for direct use as
food or feed, or for processing. Parties shall cooperate to meet
these needs in accordance with Articles 22 and 28.
Article
12
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 organism 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 in writing to such a request 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.
Article
13
SIMPLIFIED PROCEDURE
1. A Party of import may,
provided that adequate measures are applied to ensure the safe
intentional transboundary movement of living modified organisms in
accordance with the objective of this Protocol, specify in advance
to the Biosafety Clearing-House:
(a) Cases in which intentional
transboundary movement to it may take place at the same time as the
movement is notified to the Party of import; and
(b) Imports of living modified organisms
to it to be exempted from the advance informed agreement
procedure.
Notifications under subparagraph
(a) above, may apply to subsequent similar movements to the same
Party.
2. The information relating to an
intentional transboundary movement that is to be provided in the
notifications referred to in paragraph 1 (a) above, shall be the
information specified in Annex I.
Article
14
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 the date of 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.
Article
15
RISK ASSESSMENT
1. Risk assessments undertaken
pursuant to this Protocol shall be carried out in a scientifically
sound manner, in accordance with Annex III and taking into account
recognized risk assessment techniques. Such risk assessments shall
be based, at a minimum, on information provided in accordance with
Article 8 and other available scientific evidence in order to
identify and evaluate the possible adverse effects of living
modified organisms on the conservation and sustainable use of
biological diversity, taking also into account risks to human
health.
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
assessment.
3. The cost of risk assessment shall be
borne by the notifier if the Party of import so
requires.
Article
16
RISK MANAGEMENT
1. The Parties shall, taking
into account Article 8 (g) of the Convention, establish and
maintain appropriate mechanisms, measures and strategies to
regulate, manage and control risks identified in the risk
assessment provisions of this 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 a risk
assessment to be carried out prior to the first release of a living
modified 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.
Article
17
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 movement of a
living modified organism that is likely to have significant adverse
effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health in such
States. The notification shall be provided as soon as the Party
knows of the above situation.
2. Each Party shall, no later than the
date of entry into force of this Protocol for it, make available to
the Biosafety Clearing-House the relevant details setting out its
point of contact for the purposes of receiving notifications under
this Article.
3. Any notification arising from
paragraph 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 conservation and sustainable use of
biological diversity, taking also into account risks to human
health, as well as available information about possible risk
management measures;
(d) Any other relevant information;
and
(e) A point of contact for further
information.
4. In order to minimize any
significant adverse effects on the conservation and sustainable use
of biological diversity, taking also into account risks to human
health, each Party, under whose jurisdiction the release of the
living modified organism referred to in paragraph 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.
Article
18
HANDLING, TRANSPORT, PACKAGING AND
IDENTIFICATION
1. In order to avoid adverse
effects on the conservation and sustainable use of biological
diversity, taking also into account risks to human health, each
Party shall take necessary measures to require that living modified
organisms that are subject to intentional transboundary movement
within the scope of this Protocol are handled, packaged and
transported under conditions of safety, taking into consideration
relevant international rules and standards.
2. Each Party shall take measures to
require that documentation accompanying:
(a) Living modified organisms
that are intended for direct use as food or feed, or for
processing, clearly identifies that they may contain living
modified organisms and are not intended for intentional
introduction into the environment, as well as a contact point for
further information. The Conference of the Parties serving as the
meeting of the Parties to this Protocol shall take a decision on
the detailed requirements for this purpose, including specification
of their identity and any unique identification, no later than two
years after the date of 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.
Article
19
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 fulfil 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.
Article
20
INFORMATION SHARING AND THE BIOSAFETY
CLEARING-HOUSE
1. A Biosafety Clearing-House is
hereby established as part of the clearing-house mechanism under
Article 18, paragraph 3, of the Convention, in order to:
(a) Facilitate the exchange of
scientific, technical, environmental and legal information on, and
experience with, living modified organisms; and
(b) Assist Parties to implement the
Protocol, taking into account the special needs of developing
country Parties, in particular the least developed and small island
developing States among them, and countries with economies in
transition as well as countries that are centres of origin and
centres of genetic diversity.
2. The Biosafety Clearing-House
shall serve as a means through which information is made available
for the purposes of paragraph 1 above. It shall provide access to
information made available by the Parties relevant to the
implementation of the Protocol. It shall also provide access, where
possible, to other international biosafety information exchange
mechanisms.
3. Without prejudice to the protection of
confidential information, each Party shall make available to the
Biosafety Clearing-House any information required to be made
available to the Biosafety Clearing-House under this Protocol,
and:
(a) Any existing laws,
regulations and guidelines for implementation of the Protocol, as
well as information required by the Parties for the advance
informed agreement procedure;
(b) Any bilateral, regional and
multilateral agreements and arrangements;
(c) Summaries of its risk assessments or
environmental reviews of living modified organisms generated by its
regulatory process, and carried out in accordance with Article 15,
including, where appropriate, relevant information regarding
products thereof, namely, processed materials that are of living
modified organism origin, containing detectable novel combinations
of replicable genetic material obtained through the use of modern
biotechnology;
(d) Its final decisions regarding the
importation or release of living modified organisms; and
(e) Reports submitted by it pursuant to
Article 33, including those on implementation of the advance
informed agreement procedure.
4. The modalities of the
operation of the Biosafety Clearing-House, including reports on its
activities, shall be considered and decided upon by the Conference
of the Parties serving as the meeting of the Parties to this
Protocol at its first meeting, and kept under review
thereafter.
Article
21
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.
Article
22
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.
Article
23
PUBLIC AWARENESS AND
PARTICIPATION
1. The Parties shall:
(a) Promote and facilitate
public awareness, education and participation 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.
Article
24
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.
Article
25
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.
Article
26
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.
Article
27
LIABILITY AND REDRESS
The Conference of the Parties
serving as the meeting of the Parties to this Protocol shall, at
its first meeting, adopt a process with respect to the appropriate
elaboration of international rules and procedures in the field of
liability and redress for damage resulting from transboundary
movements of living modified organisms, analysing and taking due
account of the ongoing processes in international law on these
matters, and shall endeavour to complete this process within four
years.
Article
28
FINANCIAL MECHANISM AND
RESOURCES
1. In considering financial
resources for the implementation of this Protocol, the Parties
shall take into account the provisions of Article 20 of the
Convention.
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 bilateral, regional and multilateral
channels.
Article
29
CONFERENCE OF THE PARTIES SERVING AS THE
MEETING OF THE PARTIES TO THIS PROTOCOL
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, 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 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 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
Conference 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.
Article
30
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 to
this Protocol, 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.
Article
31
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
32
RELATIONSHIP WITH THE
CONVENTION
Except as otherwise provided in
this Protocol, the provisions of the Convention relating to its
protocols shall apply to this Protocol.
Article
33
MONITORING AND
REPORTING
Each Party shall monitor the
implementation of its obligations under this Protocol, and shall,
at intervals to be determined by the Conference of the Parties
serving as the meeting of the Parties to this Protocol, report to
the Conference of the Parties serving as the meeting of the Parties
to this Protocol on measures that it has taken to implement the
Protocol.
Article
34
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.
Article
35
ASSESSMENT AND REVIEW
The Conference of the Parties
serving as the meeting of the Parties to this Protocol shall
undertake, five years after the entry into force of this Protocol
and at least every five years thereafter, an evaluation of the
effectiveness of the Protocol, including an assessment of its
procedures and annexes.
Article
36
SIGNATURE
This Protocol shall be open for
signature at the United Nations Office at Nairobi by States and
regional economic integration organizations from 15 to 26 May 2000,
and at United Nations Headquarters in New York from 5 June 2000 to
4 June 2001.
Article
37
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
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 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.
Article
38
RESERVATIONS
No reservations may be made to
this Protocol.
Article
39
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
40
AUTHENTIC TEXTS
The original of this Protocol,
of which the Arabic, Chinese, English, French, Russian and Spanish
texts are equally authentic, shall be deposited with the
Secretary-General of the United Nations.
IN WITNESS WHEREOF the
undersigned, being duly authorized to that effect, have signed this
Protocol.
DONE at Montreal on this twenty-ninth day
of January, two thousand.
Annex
I
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 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, 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 III.
(l) Suggested methods for the 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.
Annex
II
INFORMATION REQUIRED CONCERNING 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 identity 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 III.
(k) Suggested methods for the safe
handling, storage, transport and use, including packaging,
labelling, documentation, disposal and contingency procedures,
where appropriate.
Annex
III
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 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
organisms or products thereof, namely, processed materials that are
of living modified organism origin, containing detectable novel
combinations of replicable genetic material obtained through the
use of modern biotechnology, should be considered in the context of
the risks posed by the non-modified recipients or parental
organisms in the likely potential receiving environment.
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 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; 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.
KARTAGENSKI PROTOKOL
O BIOLOŠKI VARNOSTI
H KONVENCIJI O BIOLOŠKI
RAZNOVRSTNOSTI
Pogodbenice tega protokola,
ki
- so pogodbenice Konvencije o
biološki raznovrstnosti, v nadaljevanju konvencija,
- se sklicujejo na tretji in četrti
odstavek 19. člena, točko g 8. člena in 17. člen konvencije,
- se sklicujejo tudi na sklep II/5
konference pogodbenic konvencije z dne 17. novembra 1995, da se
pripravi protokol o biološki varnosti, ki bo osredotočen predvsem
na čezmejno gibanje živih spremenjenih organizmov, ki so nastali s
sodobno biotehnologijo in bi lahko škodljivo vplivali na ohranjanje
in trajnostno uporabo biološke raznovrstnosti, in bodo dale v
premislek zlasti ustrezne postopke za soglasje po vnaprejšnjem
obveščanju,
- ponovno potrjujejo previdnostni
pristop iz 15. načela Deklaracije o okolju in razvoju iz Ria,
- se zavedajo hitre širitve sodobne
biotehnologije in vedno večje zaskrbljenosti javnosti zaradi možnih
škodljivih vplivov na biološko raznovrstnost ob upoštevanju tveganj
za zdravje ljudi,
- priznavajo, da sodobna
biotehnologija daje velike možnosti za blaginjo človeka, če se
razvija in uporablja ob ustreznih varnostnih ukrepih za okolje in
zdravje ljudi,
- priznavajo tudi, da so središča
izvora in središča genske raznovrstnosti bistvenega pomembna za
človeštvo,
- upoštevajo omejene zmožnosti
mnogih držav, zlasti držav v razvoju, da se uspešno spopadejo z
naravo in obsegom znanih in možnih tveganj, povezanih z živimi
spremenjenimi organizmi,
- priznavajo, da bi se morali
sporazumi o trgovini in okolju medsebojno dopolnjevati, da se
zagotavlja trajnostni razvoj,
- poudarjajo, da se ta protokol ne sme
razlagati tako, kot da predvideva spremembe pravic in obveznosti
pogodbenice po katerem koli veljavnem mednarodnem sporazumu,
- razumejo, da namen zgornje
navedbe ni podrediti ta protokol drugim mednarodnim sporazumom,
- so se sporazumele o:
1.
člen
CILJ
Skladno s previdnostnim
pristopom iz 15. načela Deklaracije o okolju in razvoju iz Ria je
cilj tega protokola prispevati k zagotavljanju primerne ravni
varstva pri varnem prenosu in uporabi živih spremenjenih
organizmov, ki so nastali s sodobno biotehnologijo in bi lahko
škodljivo vplivali na ohranjanje in trajnostno uporabo biološke
raznovrstnosti, ter pri ravnanju s takimi organizmi, pri čemer je
treba upoštevati tudi tveganje za zdravje ljudi in se še zlasti
osredotočiti na čezmejno gibanje.
2.
člen
SPLOŠNE DOLOČBE
1. Vsaka pogodbenica sprejme
potrebne in ustrezne zakonske, upravne in druge ukrepe za izvajanje
obveznosti po tem protokolu.
2. Pogodbenice zagotovijo, da se kakršni
koli živi spremenjeni organizmi razvijajo, prevažajo, uporabljajo
in sproščajo ter da se z njimi ravna tako, da se preprečuje ali
zmanjšuje tveganje za biološko raznovrstnost, pri čemer je treba
upoštevati tudi tveganje za zdravje ljudi.
3. Nič v tem protokolu na noben način ne
vpliva na suverenost držav nad njihovim teritorialnim morjem,
določenem po mednarodnem pravu, niti na suverene pravice in
pristojnosti, ki jih imajo države v svojih izključnih ekonomskih
conah in svojih epikontinentalnih pasovih skladno z mednarodnim
pravom, ter na uveljavljanje plovnih pravic in svoboščin ladij in
zrakoplovov vseh držav, kot je predvideno v mednarodnem pravu in se
kaže v ustreznih mednarodnih instrumentih.
4. Nič v tem protokolu se ne razlaga kot
omejevanje pravice pogodbenice, da sprejme strožje ukrepe za
zaščito ohranjanja in trajnostne uporabe biološke raznovrstnosti,
kot so ukrepi, ki jih zahteva ta protokol, če so ti skladni s
ciljem in določbami tega protokola ter z drugimi obveznostmi
pogodbenice po mednarodnem pravu.
5. Pogodbenice naj po potrebi upoštevajo
razpoložljivo strokovno znanje, instrumente in delo mednarodnih
forumov, pristojnih za tveganje za zdravje ljudi.
3.
člen
UPORABLJENI IZRAZI
V tem protokolu:
(a) Konferenca pogodbenic pomeni
Konferenco pogodbenic konvencije;
(b) uporaba v zaprtih sistemih pomeni
kakršno koli delo v objektu, napravi ali drugi zgradbi z živimi
spremenjenimi organizmi, nadzorovanimi s posebnimi ukrepi, ki
učinkovito omejujejo njihov stik z zunanjim okoljem in njihov vpliv
nanj;
(c) izvoz pomeni namerno čezmejno gibanje
iz ene pogodbenice v drugo;
(d) izvoznik pomeni katero koli pravno
ali fizično osebo, ki je v pristojnosti pogodbenice izvoznice in
ureja izvoz živih spremenjenih organizmov;
(e) uvoz pomeni namerno čezmejno gibanje
v pogodbenico iz druge pogodbenice;
(f) uvoznik pomeni katero koli pravno ali
fizično osebo, ki je v pristojnosti pogodbenice uvoznice in ureja
uvoz živih spremenjenih organizmov;
(g) živ spremenjen organizem pomeni
kateri koli živ organizem z novo kombinacijo genskega materiala, ki
je nastala z uporabo sodobne biotehnologije;
(h) živ organizem pomeni kakršno koli
biološko enoto, sposobno prenosa ali podvajanja genskega materiala,
vključno s sterilnimi organizmi, virusi in viroidi;
(i) sodobna biotehnologija pomeni
uporabo:
a. tehnik in vitro nukleinske
kisline, vključno z rekombinantnodeoksiribonukleinsko kislino (DNK)
in neposrednim injiciranjem nukleinske kisline v celice ali
organele, ali
b. fuzije celic nad sistematsko enoto
družine,
ki presegajo naravne fiziološke
reprodukcijske ali rekombinacijske ovire in niso tehnike,
uporabljane pri tradicionalnem gojenju in izboru;
(j) regionalna organizacija za
gospodarsko povezovanje pomeni organizacijo, ki jo ustanovijo
suverene države neke regije in na katero so države članice prenesle
pristojnosti glede zadev, ki jih ureja ta protokol, ter je bila v
skladu s svojimi notranjimi postopki pravilno pooblaščena za
podpis, ratifikacijo, sprejetje, odobritev ali pristop k temu
protokolu;
(k) čezmejno gibanje pomeni gibanje živih
spremenjenih organizmov iz ene pogodbenice v drugo, za namene 17.
in 24. člena pa čezmejno gibanje pomeni tudi gibanje med
pogodbenicami in nepogodbenicami;
4.
člen
PODROČJE
Ta protokol se uporablja za
čezmejno gibanje, tranzit in uporabo živih spremenjenih organizmov,
ki lahko škodljivo vplivajo na ohranjanje in trajnostno uporabo
biološke raznovrstnosti, ter za ravnanje z njimi, pri čemer je
treba upoštevati tveganje za zdravje ljudi.
5.
člen
FARMACEVTSKI IZDELKI
Ne glede na 4. člen in brez
vpliva na kakršno koli pravico pogodbenice, da za vsak živ
spremenjen organizem oceni tveganje, preden se odloči o uvozu, se
ta protokol ne uporablja za čezmejno gibanje živih spremenjenih
organizmov, ki so farmacevtski izdelki za ljudi in jih obravnavajo
drugi ustrezni mednarodni sporazumi ali organizacije.
6.
člen
TRANZIT IN UPORABA V ZAPRTIH
SISTEMIH
1. Ne glede na 4. člen in brez
vpliva na pravico pogodbenice tranzita, da uredi prevoz živih
spremenjenih organizmov čez svoje ozemlje in da omogoči Uradu za
izmenjavo informacij o biološki varnosti vpogled v svojo odločitev
o tranzitu določenih živih spremenjenih organizmov čez njeno
ozemlje, pri čemer pa mora upoštevati tretji odstavek 2. člena, se
določbe tega protokola glede postopka soglasja po vnaprejšnjem
obveščanju ne uporabljajo za žive spremenjene organizme v
tranzitu.
2. Ne glede na 4. člen in brez vpliva na
kakršno koli pravico pogodbenice, da za vsak živ spremenjen
organizem izvede oceno tveganja, preden se odloči o uvozu, in da
določi standarde za uporabo v zaprtih sistemih, ki so v njeni
pristojnosti, se določbe tega protokola glede postopka soglasja po
vnaprejšnjem obveščanju ne uporabljajo za čezmejno gibanje živih
spremenjenih organizmov, namenjenih za uporabo v zaprtih sistemih,
ki je skladna s standardi pogodbenice uvoznice.
7.
člen
UPORABA POSTOPKA SOGLASJA PO VNAPREJŠNJEM
OBVEŠČANJU
1. Ob upoštevanju 5. in 6. člena
se postopek soglasja po vnaprejšnjem obveščanju iz 8., 9., 10. in
12. člena uporablja pred prvim namernim čezmejnim gibanjem živih
spremenjenih organizmov za nameren vnos teh organizmov v okolje
pogodbenice uvoznice.
2. Nameren vnos v okolje iz prvega
odstavka se ne nanaša na žive spremenjene organizme, ki so
namenjeni za neposredno uporabo kot hrana ali krma ali pa za
predelavo.
3. Enajsti člen se uporablja pred prvim
čezmejnim gibanjem živih spremenjenih organizmov, ki so namenjeni
za neposredno uporabo kot hrana ali krma ali pa za predelavo.
4. Postopek soglasja po vnaprejšnjem
obveščanju se ne uporablja za namerno čezmejno gibanje živih
spremenjenih organizmov, ki so po sklepu Konference pogodbenic kot
zasedanje pogodbenic tega protokola določeni kot organizmi, za
katere ni verjetno, da škodljivo vplivajo na ohranjanje in
trajnostno uporabo biološke raznovrstnosti, pri čemer je treba
upoštevati tudi tveganje za zdravje ljudi.
8.
člen
OBVESTILO
1. Pred namernim čezmejnim
gibanjem živih spremenjenih organizmov v skladu s prvim odstavkom a
7. člena pogodbenica izvoznica pisno obvesti pristojni državni
organ pogodbenice uvoznice ali zahteva od izvoznika, da zagotovi
pisno obvestilo temu organu. Obvestilo vsebuje vsaj informacije,
navedene v prilogi I.
2. Pogodbenica izvoznica zagotovi, da je
zahteva za točnost podatkov, ki jih navede izvoznik, pravno
predpisana.
9.
člen
POTRDITEV PREJEMA
OBVESTILA
1. Pogodbenica uvoznica
obvestitelju pisno potrdi prejem obvestila v devetdesetih dneh od
njegovega prejema.
2. V potrdilu se navede:
(a) datum prejema obvestila;
(b) ali prvotno obvestilo vsebuje
podatke, navedene v 8. členu;
(c) ali nadaljevati skladno z
notranjepravno ureditvijo pogodbenice uvoznice ali skladno s
postopkom, določenim v 10. členu.
3. Notranjepravna ureditev iz
točke c drugega odstavka mora biti skladna s tem protokolom.
4. Če pogodbenica uvoznica ne potrdi
prejema obvestila, to ne pomeni, da soglaša z namernim čezmejnim
gibanjem.
10.
člen
POSTOPEK ODLOČANJA
1. Odločitve pogodbenice
uvoznice morajo biti skladne s 15. členom.
2. Pogodbenica uvoznica v času, navedenem
v 9. členu, pisno obvesti obvestitelja, ali se namerno čezmejno
gibanje lahko nadaljuje:
(a) šele po tem, ko je
pogodbenica uvoznica izdala pisno soglasje, ali
(b) pa po preteku najmanj devetdeset dni
brez naknadnega pisnega soglasja.
3. Pogodbenica uvoznica v dvesto
sedemdesetih dneh od prejema obvestila pisno sporoči obvestitelju
in Uradu za izmenjavo informacij o biološki varnosti svojo
odločitev iz točke a drugega odstavka, s katero:
(a) odobri uvoz s pogoji ali
brez njih, vključno s tem, kako se bo odločitev uporabljala pri
kasnejšem uvozu istega živega spremenjenega organizma;
(b) prepove uvoz;
(c) zaprosi za ustrezne dodatne
informacije skladno s svojo notranjepravno ureditvijo ali prilogo
I; pri izračunavanju časa, v katerem mora pogodbenica uvoznica
odgovoriti, se ne upoštevajo dnevi, ko pogodbenica čaka na ustrezne
dodatne informacije, ali
(d) obvesti obvestitelja, da se obdobje,
navedeno v tem odstavku, podaljša za določen čas.
4. V odločitvi iz tretjega
odstavka se navedejo razlogi za takšno odločitev, razen če je
soglasje brezpogojno.
5. Če pogodbenica uvoznica v dvesto
sedemdesetih dneh po prejemu obvestila ne sporoči svoje odločitve,
to ne pomeni, da soglaša z namernim čezmejnim gibanjem.
6. Pomanjkanje znanstvene zanesljivosti
zaradi pomanjkljivih znanstvenih informacij in pomanjkljivega
znanja o obsegu možnih škodljivih vplivov živega spremenjenega
organizma na ohranjanje in trajnostno uporabo biološke
raznovrstnosti v pogodbenici uvoznici, pri čemer je treba
upoštevati tudi tveganje za zdravje ljudi, ne preprečuje tej
pogodbenici, da se ustrezno odloči o uvozu tega živega
spremenjenega organizma, kot je navedeno v tretjem odstavku, da se
izogne takim škodljivim vplivom ali jih čim bolj zmanjša.
7. Konferenca pogodbenic kot zasedanje
pogodbenic na svojem prvem zasedanju odloči o ustreznih postopkih
in mehanizmih za pomoč pogodbenicam uvoznicam pri
odločanju.
11.
člen
POSTOPEK ZA ŽIVE SPREMENJENE ORGANIZME,
NAMENJENE ZA NEPOSREDNO UPORABO KOT HRANA ALI KRMA ALI PA ZA
PREDELAVO
1. Pogodbenica, ki se dokončno
odloči o domači uporabi, vključno z dajanjem v promet, živih
spremenjenih organizmov, ki so lahko predmet čezmejnega gibanja in
se neposredno uporabijo kot hrana ali krma ali pa za predelavo, v
petnajstih dneh od te odločitve obvesti pogodbenice prek Urada za
izmenjavo informacij o biološki varnosti. Obvestilo vsebuje vsaj
informacije, navedene v prilogi II. Pogodbenica pošlje kopijo
obvestila v pisni obliki osebi za stike vsake pogodbenice, ki je
sekretariat vnaprej obvestila, da nima dostopa do Urada za
izmenjavo informacij o biološki varnosti. Ta določba se ne
uporablja za odločitve o poljskih poskusih.
2. Pogodbenica, ki se odloči skladno s
prvim odstavkom, zagotovi, da je zahteva za točnost podatkov, ki
jih navede prosilec, pravno predpisana.
3. Vsaka pogodbenica lahko od organa,
opredeljenega v odstavku b priloge II, zahteva dodatne
informacije.
4. Pogodbenica se lahko odloči o uvozu
živih spremenjenih organizmov, ki so namenjeni za neposredno
uporabo kot hrana ali krma ali pa za predelavo, skladno s svojo
notranjepravno ureditvijo, ki se ujema s ciljem tega protokola.
5. Vsaka pogodbenica da Uradu za
izmenjavo informacij o biološki varnosti na voljo kopije svojih
zakonov, predpisov in smernic, ki se uporabljajo za uvoz živih
spremenjenih organizmov, namenjenih za neposredno uporabo kot hrana
ali krma ali pa za predelavo, če obstajajo.
6. Če pogodbenica, ki je država v razvoju
ali katere gospodarstvo je v prehodu, nima notranjepravne ureditve
iz četrtega odstavka in izvaja svoje pristojnosti, lahko prek Urada
za izmenjavo informacij o biološki varnosti razglasi, da bo svojo
odločitev pred prvim uvozom živega spremenjenega organizma, ki je
namenjen za neposredno uporabo kot hrana ali krma ali pa za
predelavo in o katerem so bile zagotovljene informacije skladno s
prvim odstavkom, sprejela glede na:
(a) oceno tveganja, opravljeno
skladno s prilogo III, in
(b) odločitev, sprejeto v predvidljivem
časovnem obdobju, ki ne presega dvesto sedemdeset dni.
7. Če pogodbenica ne sporoči
svoje odločitve po šestem odstavku, to ne pomeni, da soglaša z
uvozom živega spremenjenega organizma, ki je namenjen za neposredno
uporabo kot hrana ali krma ali pa za predelavo, ali da uvoz takega
organizma zavrača, razen če pogodbenica odloči drugače.
8. Pomanjkanje znanstvene zanesljivosti
zaradi pomanjkljivih znanstvenih informacij in pomanjkljivega
znanja o obsegu možnih škodljivih vplivov živega spremenjenega
organizma na ohranjanje in trajnostno uporabo biološke
raznovrstnosti v pogodbenici uvoznici, pri čemer je treba
upoštevati tudi tveganje za zdravje ljudi, ji ne preprečuje, da se
ustrezno odloči o uvozu tega živega spremenjenega organizma, ki je
namenjen za neposredno uporabo kot hrana ali krma ali pa za
predelavo, da se izogne takim škodljivim vplivom ali jih čim bolj
zmanjša.
9. Pogodbenica lahko izrazi svoje potrebe
po denarni ali strokovni pomoči ter institucionalni in kadrovski
krepitvi v zvezi z živimi spremenjenimi organizmi, ki so namenjeni
za neposredno uporabo kot hrana ali krma ali pa za predelavo.
Pogodbenice sodelujejo, da zadovoljijo potrebe skladno z 22. in 28.
členom.
12.
člen
PREGLED ODLOČITEV
1. Pogodbenica uvoznica lahko
glede na nova znanstvena spoznanja o možnih škodljivih vplivih na
ohranjanje in trajnostno uporabo biološke raznovrstnosti, pri čemer
je treba upoštevati tudi tveganje za zdravje ljudi, kadar koli
pregleda in spremeni svojo odločitev o namernem čezmejnem gibanju.
V takem primeru pogodbenica o tem v tridesetih dneh obvesti vse
obvestitelje, ki so predhodno prijavili gibanje živega
spremenjenega organizma, o taki odločitvi in tudi Urad za izmenjavo
informacij o biološki varnosti ter navede razloge za svojo
odločitev.
2. Pogodbenica izvoznica ali obvestitelj
lahko zaprosi pogodbenico uvoznico, da pregleda svojo odločitev,
sprejeto skladno z 10. členom, če pogodbenica izvoznica ali
obvestitelj meni:
(a) da so se okoliščine tako
spremenile, da to lahko vpliva na izid ocene tveganja, na kateri je
temeljila odločitev, ali
(b) da so na voljo dodatne ustrezne
znanstvene in strokovne informacije.
3. Pogodbenica uvoznica v
devetdesetih dneh pisno odgovori na tako prošnjo in navede razloge
za svojo odločitev.
4. Pogodbenica uvoznica lahko po lastni
presoji zaprosi za oceno tveganja za nadaljnji uvoz.
13.
člen
POENOSTAVLJENI
POSTOPEK
1. Če se izvajajo primerni
ukrepi za zagotavljanje varnega namernega čezmejnega gibanja živih
spremenjenih organizmov skladno s ciljem tega protokola, lahko
pogodbenica Uradu za izmenjavo informacij o biološki varnosti
vnaprej navede:
(a) v katerih primerih se lahko
namerno čezmejno gibanje izvede v to državo uvoznico hkrati, ko je
o tem obveščena, in
(b) vsakokratni uvoz živih spremenjenih
organizmov v to državo uvoznico, ki ga je treba izvzeti iz postopka
soglasja po vnaprejšnjem obveščanju.
Obvestila iz pododstavka a se
lahko uporabljajo za nadaljnja podobna gibanja v isto
pogodbenico.
2. Informacije, ki se nanašajo
na namerno čezmejno gibanje in jih je treba navesti v obvestilih,
navedenih v točki a prvega odstavka, so informacije, določene v
prilogi I.
14.
člen
DVOSTRANSKI, REGIONALNI IN VEČSTRANSKI
SPORAZUMI, DOGOVORI
1. Pogodbenice lahko sklenejo
dvostranske, regionalne in večstranske sporazume ter dogovore o
namernem čezmejnem gibanju živih spremenjenih organizmov, ki so
skladni s ciljem tega protokola, če taki sporazumi in dogovori ne
znižajo ravni varstva, ki ga zagotavlja ta protokol.
2. Pogodbenice prek Urada za izmenjavo
informacij o biološki varnosti druga drugo obvestijo o vsakem takem
dvostranskem, regionalnem in večstranskem sporazumu ter dogovoru,
ki so ga sklenile pred uveljavitvijo tega protokola ali po
njej.
3. Določbe tega protokola ne vplivajo na
namerno čezmejno gibanje, ki se izvede na podlagi takih sporazumov,
dogovorov med pogodbenicami teh sporazumov ali dogovorov.
4. Vsaka pogodbenica lahko določi, da za
posamezen uvoz veljajo njeni predpisi, in o svoji odločitvi obvesti
Urad za izmenjavo informacij o biološki varnosti.
15.
člen
OCENA TVEGANJA
1. Ocena tveganja se na podlagi
tega protokola izvede na znanstveno dobro premišljen način skladno
s prilogo III in ob upoštevanju priznanih postopkov ocene tveganja.
Taka ocena temelji vsaj na informacijah, pridobljenih skladno z 8.
členom, in drugih razpoložljivih znanstvenih dokazih, zato da se
določijo in ovrednotijo možni škodljivi vplivi živih spremenjenih
organizmov na ohranjanje in trajnostno uporabo biološke
raznovrstnosti, pri čemer je treba upoštevati tudi tveganje za
zdravje ljudi.
2. Pogodbenica uvoznica zagotovi, da se
za vsako odločitev, sprejeto skladno z 8. členom, izvede ocena
tveganja. Od izvoznika lahko zahteva, da izvede oceno tveganja.
3. Stroške izvedbe ocene tveganja krije
obvestitelj, če tako zahteva pogodbenica uvoznica.
16.
člen
OBVLADOVANJE TVEGANJA
1. Pogodbenice ob upoštevanju
točke g 8. člena konvencije uvedejo in vzdržujejo primerne
mehanizme, ukrepe in strategije za uravnavanje, obvladovanje in
nadzor nad tveganjem, določene v določbah o oceni tveganja iz tega
protokola, povezane z uporabo in čezmejnim gibanjem živih
spremenjenih organizmov in ravnanjem z njimi.
2. Ukrepi, ki temeljijo na oceni
tveganja, se uvedejo v obsegu, ki je potreben za preprečevanje
škodljivih vplivov živih spremenjenih organizmov na ohranjanje in
trajnostno uporabo biološke raznovrstnosti, pri čemer je treba
upoštevati tudi tveganje za zdravje ljudi na ozemlju pogodbenice
uvoznice.
3. Vsaka pogodbenica sprejme ustrezne
ukrepe za preprečevanje nenamernega čezmejnega gibanja živih
spremenjenih organizmov, vključno s takimi ukrepi, kot je zahteva,
da se pred prvo sprostitvijo živega spremenjenega organizma izvede
ocena tveganja.
4. Brez vpliva na drugi odstavek si vsaka
pogodbenica prizadeva zagotoviti, da se vsak živ spremenjen
organizem, uvožen ali razvit doma, opazuje, preden se uporabi za
svoj namen, in sicer v obdobju, ki je sorazmerno z njegovim
življenjskim ciklusom ali generacijsko dobo.
5. Pogodbenice sodelujejo z
namenom:
(a) da določijo žive spremenjene
organizme ali posebne gensko pogojene lastnosti živih spremenjenih
organizmov, ki bi lahko škodljivo vplivali na ohranjanje in
trajnostno uporabo biološke raznovrstnosti, pri čemer je treba
upoštevati tudi tveganje za zdravje ljudi, in
(b) da sprejmejo primerne ukrepe glede
obravnavanja takih živih spremenjenih organizmov ali posebnih
gensko pogojenih lastnosti.
17.
člen
NENAMERNO ČEZMEJNO GIBANJE IN IZREDNI
UKREPI
1. Vsaka pogodbenica sprejme
ustrezne ukrepe za obveščanje držav, ki so ali bi lahko bile
prizadete, Urada za izmenjavo informacij o biološki varnosti, in če
je primerno, ustreznih mednarodnih organizacij, kadar ve za
dogodek, ki je v njeni pristojnosti in katerega posledica je bila
sprostitev, ki vodi ali bi lahko vodila k nenamernemu čezmejnemu
gibanju živih spremenjenih organizmov, za katere je verjetno, da
bodo občutno škodljivo vplivali na ohranjanje in trajnostno uporabo
biološke raznovrstnosti, pri čemer je treba upoštevati tudi
tveganje za zdravje ljudi v teh državah. Pogodbenice pošljejo
obvestilo takoj, ko izvejo za tak dogodek.
2. Vsaka pogodbenica najkasneje na dan,
ko zanjo začne veljati protokol, Uradu za izmenjavo informacij o
biološki varnosti omogoči dostop do ustreznih podatkov o osebi za
stike za sprejemanje obvestil iz tega člena.
3. Vsako obvestilo iz prvega odstavka
mora vsebovati:
(a) ustrezne razpoložljive
informacije o ocenjeni količini in ustreznih značilnostih in/ali
gensko pogojenih lastnostih živih spremenjenih organizmov;
(b) informacije o okoliščinah in
predvidenem datumu sprostitve živih spremenjenih organizmov ter o
uporabi teh organizmov v pogodbenici izvora;
(c) vse razpoložljive informacije o
možnih škodljivih vplivih na ohranjanje in trajnostno uporabo
biološke raznovrstnosti, pri čemer je treba upoštevati tudi
tveganje za zdravje ljudi, ter razpoložljive informacije o možnih
ukrepih obvladovanja tveganja;
(d) druge ustrezne informacije in
(e) naslov osebe za stike za nadaljnje
informacije.
4. Vsaka pogodbenica, v
pristojnosti katere je prišlo do sprostitve živih spremenjenih
organizmov in je omenjena v prvem odstavku, se takoj posvetuje z
državami, ki so ali bi lahko bile prizadete, da jim omogoči, da se
ustrezno odzovejo in začnejo izvajati potrebne ukrepe, vključno z
izrednimi ukrepi, da na najmanjšo možno raven zmanjšajo vse občutno
škodljive vplive na ohranjanje in trajnostno uporabo biološke
raznovrstnosti, pri čemer je treba upoštevati tudi tveganje za
zdravje ljudi.
18.
člen
PREVOZ, PAKIRANJE IN OZNAČEVANJE ŽIVIH
SPREMENJENIH ORGANIZMOV TER RAVNANJE Z NJIMI
1. Vsaka pogodbenica sprejme
potrebne ukrepe, s katerimi zahteva, da se živi spremenjeni
organizmi, ki so predmet namernega čezmejnega gibanja po tem
protokolu, pakirajo in prevažajo ter da se z njimi ravna skladno s
pogoji, ki zagotavljajo varnost, ob upoštevanju ustreznih
mednarodnih pravil in standardov, da bi se izognili škodljivim
vplivom na ohranjanje in trajnostno uporabo biološke
raznovrstnosti, pri čemer je treba upoštevati tudi tveganje za
zdravje ljudi.
2. Vsaka pogodbenica sprejme potrebne
ukrepe, s katerimi zahteva, da spremljajoči dokumenti jasno
opredeljujejo:
(a) da živi spremenjeni
organizmi, ki so namenjeni za neposredno uporabo kot hrana, krma
ali pa za predelavo, lahko vsebujejo žive spremenjene organizme in
niso namenjeni namernemu vnosu v okolje, pa tudi naslov osebe za
stike za nadaljnje informacije. Konferenca pogodbenic kot zasedanje
pogodbenic tega protokola se odloči o podrobnih zahtevah za ta
namen, vključno z natančno določitvijo njihove istovetnosti in
oznake, najkasneje dve leti po uveljavitvi tega protokola;
(b) žive spremenjene organizme, ki so
namenjeni za uporabo v zaprtih sistemih, kot žive spremenjene
organizme in določajo zahteve za varno ravnanje z njimi in njihovo
varno shranjevanje, prevažanje in uporabo ter naslov osebe za stike
za nadaljnje informacije in ime in naslov posameznika in ustanove,
katerima so bili organizmi izročeni, in
(c) žive spremenjene organizme, ki so
namenjeni namernemu vnosu v okolje pogodbenice uvoznice, in druge
žive spremenjene organizme po tem protokolu kot žive spremenjene
organizme; določajo istovetnost in ustrezne lastnosti in/ali
značilnosti, zahteve za varno ravnanje z njimi in njihovo varno
shranjevanje, prevažanje in uporabo, naslov osebe za stike za
nadaljnje informacije, in če je potrebno, ime in naslov uvoznika in
izvoznika; vsebujejo tudi izjavo, da je gibanje skladno z zahtevami
tega protokola, ki veljajo za izvoznika.
3. Konferenca pogodbenic kot
zasedanje pogodbenic tega protokola prouči potrebnost ter pogoje in
načine priprave standardov glede na postopke označevanja,
pakiranja, prevoza in ravnanja, o čemer se posvetuje z drugimi
ustreznimi mednarodnimi organi.
19.
člen
PRISTOJNI DRŽAVNI ORGANI IN OSEBE ZA
STIKE V DRŽAVI
1. Vsaka pogodbenica imenuje eno
osebo za stike, ki je v njenem imenu odgovorna za stike s
sekretariatom. Vsaka pogodbenica imenuje tudi enega ali več
pristojnih državnih organov, odgovornih za izvajanje upravnih
nalog, ki jih zahteva ta protokol, in pooblaščenih, da v zvezi s
temi nalogami delujejo v imenu pogodbenice. Pogodbenica lahko
imenuje organ, ki deluje hkrati kot točka za stike in pristojni
državni organ.
2. Vsaka pogodbenica najkasneje na dan,
ko zanjo začne veljati ta protokol, sekretariat obvesti o imenih in
naslovih svojih oseb za stike in pristojnega državnega organa ali
organov. Če pogodbenica imenuje več kot en pristojen državni organ,
v obvestilu o tem sporoči sekretariatu ustrezne informacije o
odgovornostih posameznega organa. Če je to primerno, je v takih
informacijah navedeno vsaj to, kateri pristojni organ je odgovoren
za posamezno vrsto živih spremenjenih organizmov. Vsaka pogodbenica
nemudoma obvesti sekretariat o spremembah pri imenovanju svojih
oseb za stike ali o spremembah imen in naslovov ali odgovornosti
njenega pristojnega državnega organa ali organov.
3. Sekretariat nemudoma obvesti
pogodbenice o obvestilih, ki jih je prejel skladno z drugim
odstavkom, in prek Urada za izmenjavo informacij o biološki
varnosti omogoči dostopnost do teh informacij.
20. člen
IZMENJAVA INFORMACIJ IN URAD ZA IZMENJAVO
INFORMACIJ O BIOLOŠKI VARNOSTI
1. Ustanovi se Urad za izmenjavo
informacij o biološki varnosti kot del mehanizma za izmenjavo
informacij iz tretjega odstavka 18. člena konvencije:
(a) da olajša izmenjavo
znanstvenih, strokovnih, okoljskih in pravnih informacij o živih
spremenjenih organizmih ter o izkušnjah z njimi;
(b) da pomaga pogodbenicam pri izvajanju
protokola ob upoštevanju posebnih potreb pogodbenic držav v
razvoju, zlasti najmanj razvitih držav in majhnih otoških držav v
razvoju, ter držav, katerih gospodarstvo je v prehodu ali so
središča izvora in genske raznovrstnosti.
2. Urad za izmenjavo informacij
o biološki varnosti je organ, prek katerega je za namene prvega
odstavka omogočen dostop do informacij. Urad omogoči dostop do
informacij, ki so jih pogodbenice dale na razpolago in so pomembne
za izvajanje tega protokola. Če je mogoče, olajša tudi dostop do
drugih mednarodnih mehanizmov za izmenjavo informacij o biološki
varnosti.
3. Brez vpliva na varovanje zaupnih
informacij vsaka pogodbenica Uradu za izmenjavo informacij o
biološki varnosti omogoči dostop do vsake informacije, ki mora biti
skladno s tem protokolom dostopna uradu in do:
(a) vseh veljavnih zakonov,
predpisov in smernic za izvajanje protokola ter informacij, ki jih
pogodbenice zahtevajo za postopke soglasja po vnaprejšnjem
obveščanju;
(b) vseh dvostranskih, regionalnih ter
večstranskih sporazumov in dogovorov;
(c) povzetkov izdelanih ocen tveganja ali
okoljskih pregledov živih spremenjenih organizmov na podlagi pravne
ureditve, ki so bil izvedeni skladno s 15. členom, če je primerno,
pa tudi z ustreznimi informacijami, ki se nanašajo na izdelke iz
teh organizmov (predelan material, ki izvira iz živih spremenjenih
organizmov), ki vsebujejo zaznavne nove kombinacije genskega
materiala, ki se lahko podvaja in je bil pridobljen z uporabo
sodobne biotehnologije;
(d) svojih končnih odločitev v zvezi z
uvažanjem ali sproščanjem živih spremenjenih organizmov in
(e) poročil, ki jih predloži skladno s
33. členom skupaj s tistimi o izvajanju postopka soglasja po
vnaprejšnjem obveščanju.
4. Pogoje in način delovanja
Urada za izmenjavo informacij o biološki varnosti skupaj s poročili
o njegovih dejavnostih prouči in o njih odloči Konferenca
pogodbenic kot zasedanje pogodbenic tega protokola na svojem prvem
zasedanju ter jih nato redno pregleduje.
21. člen
ZAUPNE INFORMACIJE
1. Pogodbenica uvoznica dovoli
obvestitelju določiti, katere informacije, ki so bile predložene
skladno s postopki tega protokola ali jih je pogodbenica uvoznica
zahtevala kot del postopka soglasja po vnaprejšnjem obveščanju iz
tega protokola, se obravnavajo kot z zaupne. V takih primerih
obvestitelj na zahtevo utemelji svojo odločitev.
2. Pogodbenica uvoznica se posvetuje z
obvestiteljem, če odloči, da informacije, ki jih je obvestitelj
določil za zaupne, ne izpolnjujejo pogojev za tako obravnavo in
pred razkritjem takih informacij obvesti obvestitelja o svoji
odločitvi; na zahtevo navede razloge ter pred razkritjem informacij
omogoči posvetovanje in notranje preverjanje odločitve.
3. Vsaka pogodbenica varuje zaupne
informacije, ki jih prejme po tem protokolu, skupaj s katero koli
zaupno informacijo, ki jo prejme v zvezi s postopkom soglasja po
vnaprejšnjem obveščanju iz tega protokola. Vsaka pogodbenica
zagotovi postopke za varovanje takih informacij in varuje zaupnost
takih informacij na način, ki ni nič manj ugoden kot način
obravnavanja zaupnih informacij v zvezi z živimi spremenjenimi
organizmi, proizvedenimi v tej pogodbenici.
4. Pogodbenica uvoznica ne uporabi takih
informacij v tržne namene, razen s pisnim soglasjem
obvestitelja.
5. Če obvestitelj umakne ali je že
umaknil obvestilo, pogodbenica uvoznica spoštuje zaupnost tržnih in
industrijskih informacij skupaj z informacijami o raziskavah in
razvoju ter informacijami, o katerih zaupnosti se pogodbenica in
obvestitelj ne strinjata.
6. Ne glede na peti odstavek se ne
štejejo kot zaupni:
(a) ime in naslov
obvestitelja;
(b) splošen opis živega spremenjenega
organizma ali organizmov;
(c) povzetek izdelane ocene tveganja na
ohranjanje in trajnostno uporabo biološke raznovrstnosti, pri čemer
je treba upoštevati tveganje za zdravje ljudi;
(d) postopke in načrte ukrepov ob
nevarnosti.
22.
člen
INSTITUCIONALNA IN KADROVSKA
KREPITEV
1. Pogodbenice sodelujejo pri
razvoju in/ali krepitvi institucij in kadrov na področju biološke
varnosti, vključujoč biotehnologijo do mere, ki je potrebna za
biološko varnost zaradi učinkovitega izvajanja tega protokola v
pogodbenicah državah v razvoju, zlasti v najmanj razvitih in
majhnih otoških državah v razvoju ter državah, katerih gospodarstvo
je v prehodu, tudi prek obstoječih globalnih, regionalnih,
subregionalnih in nacionalnih institucij in organizacij, in če je
primerno, s spodbujanjem vključevanja zasebnega sektorja.
2. Za izvajanje prvega odstavka se za
krepitev kadrov in institucij na področju biološke varnosti pri
sodelovanju v celoti upoštevajo potrebe pogodbenic držav v razvoju,
zlasti najmanj razvitih in majhnih otoških držav v razvoju, po
finančnih virih in dostopu do tehnologije in strokovnega znanja in
po njunem prenosu skladno z ustreznimi določbami konvencije.
Sodelovanje pri kadrovski in institucionalni krepitvi glede na
različne razmere zmogljivosti in zahteve vsake pogodbenice
vključuje znanstveno in tehnično usposabljanje o pravilnem in
varnem obvladovanju biotehnologije in o uporabi ocenjevanja in
obvladovanja tveganja za zagotavljanje biološke varnosti ter
povečevanje tehnoloških in institucionalnih zmogljivosti na
področju biološke varnosti. Pri taki kadrovski in institucionalni
krepitvi se v celoti upoštevajo tudi potrebe pogodbenic z
gospodarstvom v prehodu.
23.
člen
OZAVEŠČANJE IN SODELOVANJE
JAVNOSTI
1. Pogodbenice:
(a) spodbujajo in pomagajo pri
ozaveščanju, izobraževanju in sodelovanju javnosti v zvezi z
varnostjo pri prenosu in uporabi živih spremenjenih organizmov ter
ravnanju z njimi, ki se nanaša na ohranjanje in trajnostno uporabo
biološke raznovrstnosti, pri čemer je treba upoštevati tudi
tveganje za zdravje ljudi. Pri tem pogodbenice sodelujejo, če je
potrebno, z drugimi državami in mednarodnimi organi;
(b) si prizadevajo zagotoviti, da
ozaveščanje in izobraževanje javnosti vključujeta dostop do
informacij o živih spremenjenih organizmih, za katere se v skladu s
tem protokolom določi, da se lahko uvozijo.
2. Pogodbenice se pri odločanju o živih spremenjenih organizmih
skladno s svojimi ustreznimi zakoni in predpisi posvetujejo z
javnostjo in zagotovijo, da so izidi takih odločitev dostopni
javnosti ob spoštovanju tajnosti informacij v skladu z 21.
členom.
3. Vsaka pogodbenica si prizadeva
obveščati javnost o načinih dostopa do informacij Urada za
izmenjavo informacij o biološki varnosti.
24.
člen
NEPOGODBENICE
1. Čezmejno gibanje živih
spremenjenih organizmov med pogodbenicami in nepogodbenicami mora
biti skladno s ciljem tega protokola. Pogodbenice lahko z
nepogodbenicami sklenejo dvostranske, regionalne in večstranske
sporazume ter dogovore o takih čezmejnih gibanjih.
2. Pogodbenice spodbujajo nepogodbenice,
da upoštevajo ta protokol in Uradu za izmenjavo informacij o
biološki varnosti pošljejo ustrezne informacije o živih
spremenjenih organizmih, ki so bili sproščeni na območjih v njeni
pristojnosti, so prešli na taka območja ali z njih
odšli.
25.
člen
NEZAKONITO ČEZMEJNO
GIBANJE
1. Vsaka pogodbenica sprejme
ustrezne ukrepe, namenjene preprečevanju, in če je primerno,
kaznovanju čezmejnega gibanja živih spremenjenih organizmov, ki je
v nasprotju z njenimi ukrepi za izvajanje tega protokola. Takšno
čezmejno gibanje se šteje za nezakonito.
2. Pri nezakonitem čezmejnem gibanju
živih spremenjenih organizmov lahko prizadeta pogodbenica zahteva
od pogodbenice izvora, da na lastne stroške odstrani take organizme
z vrnitvijo ali uničenjem, kot je primerno.
3. Vsaka pogodbenica da Uradu za
izmenjavo informacij o biološki varnosti na razpolago informacije o
primerih nezakonitega čezmejnega gibanja, ki se nanašajo
nanjo.
26.
člen
SOCIALNO-EKONOMSKI
VIDIKI
1. Pri odločanju o uvozu po tem
protokolu ali skladno s svojimi ukrepi za izvajanje protokola lahko
pogodbenice skladno s svojimi mednarodnimi obveznostmi upoštevajo
socialno-ekonomske vidike vpliva živih spremenjenih organizmov na
ohranjanje in trajnostno uporabo biološke raznovrstnosti, zlasti v
zvezi z vrednostjo biološke raznovrstnosti za domorodne in lokalne
skupnosti.
2. Pogodbenice naj sodelujejo pri
raziskavah in izmenjavi informacij o kakršnih koli
socialno-ekonomskih vplivih živih spremenjenih organizmov, zlasti
na domorodne in lokalne skupnosti.
27.
člen
ODGOVORNOST IN
NADOMESTILA
Konferenca pogodbenic kot
zasedanje pogodbenic tega protokola na svojem prvem zasedanju
sprejme postopek za ustrezno pripravo mednarodnih pravil in
postopkov na področju odgovornosti in nadomestila za škodo, ki je
nastala zaradi čezmejnega gibanja živih spremenjenih organizmov,
pri čemer analizira in v zadostni meri upošteva vse postopke v
mednarodnem pravu o teh zadevah in si jih prizadeva končati v
štirih letih.
28.
člen
FINANČNI MEHANIZEM IN
VIRI
1. Pri obravnavanju finančnih
virov za izvajanje tega protokola pogodbenice upoštevajo določbe
20. člena konvencije.
2. Finančni mehanizem, vzpostavljen v 21.
členu konvencije s pomočjo institucionalne strukture, ki ji je bilo
zaupano njegovo delovanje, postane finančni mehanizem za ta
protokol.
3. V zvezi s kadrovsko in institucionalno
krepitvijo iz 22. člena Konferenca pogodbenic kot zasedanje
pogodbenic tega protokola pri zagotavljanju smernic glede
finančnega mehanizma iz drugega odstavka za obravnavo na Konferenci
pogodbenic upošteva potrebo pogodbenic držav v razvoju, zlasti
najmanj razvitih in majhnih otoških držav, po finančnih
sredstvih.
4. V smislu prvega odstavka pogodbenice
upoštevajo tudi potrebe držav pogodbenic v razvoju, zlasti najmanj
razvitih držav in majhnih otoških držav ter pogodbenic, katerih
gospodarstvo je v prehodu, pri njihovem prizadevanju opredeliti in
zadovoljiti svoje potrebe, povezane s kadrovsko in institucionalno
krepitvijo za izvajanje tega protokola.
5. Navodila za finančni mehanizem
konvencije v ustreznih sklepih Konference pogodbenic, tudi tistih,
sprejetih pred sprejetjem tega protokola, se smiselno uporabljajo
za določbe tega člena.
6. Razvite države pogodbenice lahko
zagotovijo finančna in tehnološka sredstva za izvajanje določb tega
protokola; pogodbenice države v razvoju in pogodbenice, katerih
gospodarstvo je v prehodu, lahko taka sredstva uporabijo po
dvostranskih, regionalnih in večstranskih poteh.
29.
člen
KONFERENCA POGODBENIC, NAMENJENA
ZASEDANJU POGODBENIC TEGA PROTOKOLA
1. Konferenca pogodbenic je
namenjena zasedanju pogodbenic tega protokola.
2. Pogodbenice konvencije, ki niso
pogodbenice tega protokola, lahko sodelujejo kot opazovalke na
katerem koli zasedanju Konference pogodbenic kot zasedanju
pogodbenic tega protokola. Če je Konferenca pogodbenic namenjena
zasedanju pogodbenic tega protokola, sklepe na podlagi tega
protokola sprejmejo le tiste države, ki so njegove pogodbenice.
3. Če je Konferenca pogodbenic namenjena
zasedanju pogodbenic tega protokola, se vsak član urada Konference
pogodbenic, ki predstavlja pogodbenico konvencije, ki pa takrat ni
pogodbenica protokola, zamenja s članom, ki ga pogodbenice tega
protokola izvolijo med svojimi člani.
4. Konferenca pogodbenic kot zasedanje
pogodbenic tega protokola redno preverja izvajanje tega protokola
in v okviru svoje pristojnosti sprejme sklepe, potrebne za
spodbujanje učinkovitega izvajanja. Opravlja naloge, ki ji jih
določa ta protokol, in:
(a) izdaja priporočila, potrebna
za izvajanje tega protokola;
(b) ustanovi take pomožne organe, ki so
potrebni za izvajanje tega protokola;
(c) išče, in če je potrebno, izkoristi
storitve in sodelovanje pristojnih mednarodnih, medvladnih in
nevladnih organizacij ter uporabi njihove informacije;
(d) določi obliko in časovni razmik
pošiljanja informacij, ki jih je treba poslati skladno s 33. členom
protokola, in prouči take informacije ter poročila, ki jih pošlje
kateri koli pomožni organ;
(e) obravnava, in če je potrebno,
sprejema spremembe tega protokola in njegovih prilog ter vseh
dodatnih prilog k protokolu, ki so potrebne za izvajanje tega
protokola, in
(f) opravlja druge naloge, ki so potrebne
za izvajanje tega protokola.
5. Poslovnik Konference
pogodbenic in finančni pravilnik konvencije se smiselno uporabljata
skladno s tem protokolom, razen če Konferenca pogodbenic kot
zasedanje pogodbenic tega protokola soglasno odloči drugače.
6. Prvo zasedanje Konference pogodbenic
kot zasedanje pogodbenic tega protokola skliče sekretariat skupaj s
prvim zasedanjem Konference pogodbenic, ki je načrtovano po dnevu
uveljavitve tega protokola. Naslednja redna zasedanja Konference
pogodbenic kot zasedanje pogodbenic tega protokola potekajo skupaj
z rednimi zasedanji Konference pogodbenic, razen če Konferenca
pogodbenic kot zasedanje pogodbenic tega protokola odloči
drugače.
7. Izredna zasedanja Konference
pogodbenic kot zasedanje pogodbenic tega protokola potekajo, kadar
Konferenca pogodbenic kot zasedanje pogodbenic tega protokola meni,
da je to potrebno, ali na pisno zahtevo katere koli pogodbenice, če
to zahtevo v šestih mesecih od dneva, ko Sekretariat pogodbenice
obvesti o taki zahtevi, podpre vsaj ena tretjina pogodbenic.
8. Združeni narodi, njihove posebne
agencije in Mednarodna agencija za atomsko energijo ter katera koli
njihova država članica ali opazovalka, ki ni pogodbenica
konvencije, so lahko opazovalci na zasedanjih Konference pogodbenic
kot zasedanje pogodbenic tega protokola. Agencija ali organ,
državen ali mednaroden, vladen ali nevladen, je lahko opazovalec na
zasedanju Konference pogodbenic kot zasedanje pogodbenic tega
protokola, če ima izkušnje na področju, ki ga pokriva ta protokol,
in če je o tej želji obvestil sekretariat, razen če temu nasprotuje
najmanj ena tretjina navzočih pogodbenic. Če v tem členu ni drugače
določeno, za sprejem in sodelovanje opazovalcev velja poslovnik,
kot je navedeno v petem odstavku.
30.
člen
POMOŽNI ORGANI
1. Pomožni organ, ustanovljen s
konvencijo ali v njenem okviru, lahko na podlagi sklepa Konference
pogodbenic kot zasedanje pogodbenic tega protokola pomaga pri
izvajanju protokola, pri čemer se na zasedanju pogodbenic določi,
katere naloge bo opravljal.
2. Pogodbenice konvencije, ki niso
pogodbenice protokola, lahko na zasedanju pomožnih organov
sodelujejo kot opazovalke. Če pomožni organ konvencije pomaga pri
izvajanju tega protokola, sklepe protokola sprejmejo le pogodbenice
protokola.
3. Če pomožen organ konvencije pomaga pri
izvajanju tega protokola, se vsak član urada tega pomožnega organa,
ki zastopa pogodbenico konvencije, ki takrat ni pogodbenica
protokola, zamenja s članom, ki ga pogodbenice tega protokola
izvolijo med svojimi člani.
31. člen
SEKRETARIAT
1. Sekretariat, ustanovljen po
24. členu konvencije, je tudi sekretariat tega protokola.
2. Prvi odstavek 24. člena konvencije o
nalogah sekretariata se uporablja smiselno za ta protokol.
3. Stroške, ki se dajo določiti kot
stroški storitev sekretariata za ta protokol, krijejo njegove
pogodbenice. Konferenca pogodbenic kot zasedanje pogodbenic tega
protokola na svojem prvem zasedanju odloči o ureditvi proračuna,
potrebni za ta namen.
32.
člen
POVEZAVA S KONVENCIJO
Če v protokolu ni drugače
predvideno, določbe konvencije, ki se nanašajo na njene protokole,
veljajo za ta protokol.
33.
člen
SPREMLJANJE, NADZIRANJE TER
POROČANJE
Vsaka pogodbenica spremlja in
nadzira izpolnjevanje svojih obveznosti iz tega protokola in v
časovnih razmikih, ki jih določi Konferenca pogodbenic kot
zasedanje pogodbenic tega protokola, poroča Konferenci pogodbenic
kot zasedanje pogodbenic tega protokola o ukrepih, ki jih je
sprejela za izvajanje tega protokola.
34.
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SKLADNOST
Konferenca pogodbenic kot
zasedanje pogodbenic tega protokola na svojem prvem zasedanju
obravnava in sprejme postopke sodelovanja in institucionalne
mehanizme za spodbujanje skladnosti z določbami tega protokola in
reševanje primerov neskladnosti. Ti postopki in mehanizmi
vključujejo določbe o svetovanju in pomoči, če je to primerno, in
so ločeni od postopkov in mehanizmov za reševanje sporov, določenih
s 27. členom konvencije, ter ne vplivajo nanje.
35.
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OCENA IN PREGLED
Konferenca pogodbenic kot
zasedanje pogodbenic tega protokola pet let po uveljavitvi tega
protokola in vsaj vsakih pet let po tem oceni učinkovitost
protokola, vključno z njegovimi postopki in prilogami.
36.
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PODPIS
Države in regionalne
organizacije za gospodarsko povezovanje lahko podpišejo ta protokol
od 15. do 26. maja 2000 v Uradu Združenih narodov v Nairobiju in od
5. junija 2000 do 4. junija 2001 na sedežu Združenih narodov v New
Yorku.
37.
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UVELJAVITEV
1. Ta protokol začne veljati
devetdeseti dan po dnevu deponiranja petdesete listine o
ratifikaciji, sprejetju, odobritvi ali pristopu države ali
regionalne organizacije za gospodarsko povezovanje, ki je
pogodbenica konvencije.
2. Ta protokol začne veljati za državo
ali regionalno organizacijo za gospodarsko povezovanje, ki
ratificira, sprejme, odobri protokol ali pristopi k njemu, po
uveljavitvi na podlagi prvega odstavka devetdeseti dan po dnevu, ko
ta država ali regionalna organizacija za gospodarsko povezovanje
deponira svojo listino o ratifikaciji, sprejetju, odobritvi ali
pristopu, ali na dan uveljavitve konvencije za to državo ali
regionalno organizacijo za gospodarsko povezovanje, kar je
kasneje.
3. Za namene prvega in drugega odstavka
se nobena listina, ki jo deponira regionalna organizacija za
gospodarsko povezovanje, ne šteje kot dodatna k tistim, ki jih
deponirajo države članice take organizacije.
38.
člen
PRIDRŽKI
Pridržki k temu protokolu niso
mogoči.
39.
člen
ODSTOP
1. Kadarkoli dve leti po dnevu,
ko za pogodbenico začne veljati ta protokol, lahko pogodbenica
odstopi od protokola, tako da o tem pisno obvesti depozitarja.
2. Vsak tak odstop začne veljati eno leto
po tem, ko je depozitar prejel obvestilo o tem, ali kasneje, in
sicer na dan, ki se lahko določi v obvestilu o odpovedi.
40.
člen
VERODOSTOJNOST
BESEDIL
Izvirnik tega Protokola,
katerega besedila v angleškem, arabskem, francoskem, kitajskem,
ruskem in španskem jeziku so enako verodostojna, se deponira pri
generalnem sekretarju Združenih narodov.
DA BI TO POTRDILI, so spodaj
podpisani, ki so bili za to pravilno pooblaščeni, podpisali ta
protokol.
SESTAVLJENO v Montrealu devetindvajsetega
januarja leta dva tisoč.
Priloga I
INFORMACIJE, KI MORAJO BITI V
OBVESTILIH IZ 8., 10. in 13. ČLENA
(a) ime, naslov izvoznika in
drugi podatki o njem, potrebni za navezavo stikov,
(b) ime, naslov uvoznika in drugi podatki
o njem, potrebni za navezavo stikov,
(c) ime in identiteta živega
spremenjenega organizma ter razvrstitev, če obstaja, ravni biološke
varnosti tega organizma v državi izvoznici,
(d) načrtovani datum ali datumi
čezmejnega gibanja, če so znani,
(e) sistematska uvrstitev in domače ime
prejemnega ali starševskih organizmov, kraj, kjer so bili nabrani
ali pridobljeni, in njihove značilnosti, povezane z biološko
varnostjo,
(f) središča izvora in središča genske
raznovrstnosti, če so znana, prejemnega organizma in/ali
starševskih organizmov in opis habitatov, v katerih bi organizmi
lahko obstali ali se razmnoževali,
(g) sistematska uvrstitev in domače ime
organizma ali organizmov dajalcev, kraj, kjer so bili nabrani ali
pridobljeni, in njihove značilnosti, povezane z biološko
varnostjo,
(h) opis nukleinske kisline ali vnesene
spremembe, uporabljene tehnike in tako nastale značilnosti živega
spremenjenega organizma,
(i) namen uporabe živega spremenjenega
organizma ali izdelkov iz njega (predelani material, ki izvira iz
živih spremenjenih organizmov), ki vsebujejo zaznavne nove
kombinacije genskega materiala, ki se lahko podvaja in je bil
pridobljen z uporabo sodobne biotehnologije,
(j) število ali količina živih
spremenjenih organizmov, ki bodo preneseni,
(k) prejšnje in zadnje poročilo o
izdelani oceni tveganja, skladno s prilogo III,
(l) predlagane metode za varno
shranjevanje, prevoz in uporabo živih spremenjenih organizmov ter
ravnanje z njimi skupaj s pakiranjem, označevanjem,
dokumentiranjem, odstranjevanjem in postopki za ravnanje v posebnih
razmerah, če je to primerno,
(m) s predpisi urejen status živega
spremenjenega organizma v državi izvoznici (na primer ali je v
državi izvoznici prepovedan, ali zanj veljajo druge omejitve, ali
je bilo njegovo sproščanje odobreno) in če je v državi izvoznici ta
organizem prepovedan, razlog ali razloge za prepoved,
(n) izid in namen obvestil izvoznika
drugim državam o živem spremenjenem organizmu, ki bo prenesen,
(o) izjava, da so zgoraj navedene
informacije točne.
Priloga
II
INFORMACIJE O ŽIVIH SPREMENJENIH
ORGANIZMIH, NAMENJENIH ZA NEPOSREDNO UPORABO KOT HRANA ALI KRMA ALI
PA ZA PREDELAVO, KI SO POTREBNE SKLADNO Z 11.
ČLENOM
(a) ime in drugi podatki,
potrebni za navezavo stikov, o prosilcu za odločitev o domači
uporabi,
(b) ime in drugi podatki, potrebni za
navezavo stikov, o organu, pristojnem za odločitev,
(c) ime in identiteta živega
spremenjenega organizma,
(d) opis genske spremembe, uporabljene
tehnike in tako nastalih značilnosti živega spremenjenega
organizma,
(e) identifikacijska oznaka živega
spremenjenega organizma,
(f) sistematska uvrstitev in domače ime
prejemnega ali starševskih organizmov, kraj, kjer so bili nabrani
ali pridobljeni, in njihove značilnosti, povezane z biološko
varnostjo,
(g) središča izvora in središča genske
raznovrstnosti, če so znana, prejemnega organizma in/ali
starševskih organizmov in opis habitatov, v katerih bi organizmi
lahko obstali ali se razmnoževali,
(h) sistematska uvrstitev in domače ime
organizma ali organizmov dajalcev, kraj, kjer so bili nabrani ali
pridobljeni, in njihove značilnosti, povezane z biološko
varnostjo,
(i) odobreni načini uporabe živih
spremenjenih organizmov,
(j) poročilo o izdelani oceni tveganja,
skladno s prilogo III,
(k) predlagane metode za varno
shranjevanje, prevoz in uporabo živih spremenjenih organizmov ter
ravnanje z njimi skupaj s pakiranjem, označevanjem,
dokumentiranjem, odstranjevanjem in postopki za ravnanje v posebnih
razmerah, če je to primerno.
Priloga
III
OCENA TVEGANJA
Cilj
1. Po tem protokolu je cilj izdelave
ocene tveganja na podlagi analize opredeliti in ovrednotiti možne
škodljive vplive živih spremenjenih organizmov na ohranjanje in
trajnostno uporabo biološke raznovrstnosti v okolju, ki bo verjetno
prejelo te organizme, pri čemer je treba upoštevati tveganje za
zdravje ljudi.
Uporaba ocene tveganja
2. Oceno tveganja med drugim uporabljajo
pristojni organi za odločanje o živih spremenjenih organizmih na
podlagi prejetih informacij.
Splošna načela
3. Ocena tveganja mora biti izdelana na
znanstveno dobro premišljen in pregleden način, pri čemer se lahko
upoštevajo strokovni nasveti ustreznih mednarodnih organizacij in
smernice, ki so jih te organizacije pripravile.
4. Pomanjkanje znanstvenih dognanj ali
nesoglasje znanstvenikov ne kaže nujno določene ravni tveganja,
odsotnosti tveganja ali sprejemljivega tveganja.
5. Tveganja, povezana z živimi
spremenjenimi organizmi ali izdelki iz njih (predelani material, ki
izvira iz živih spremenjenih organizmov), ki vsebujejo zaznavne
nove kombinacije genskega materiala, ki se lahko podvaja in je bil
pridobljen z uporabo sodobne biotehnologije, je treba obravnavati z
vidika tveganj, ki jih predstavljajo nespremenjeni prejemni ali
starševski organizmi v okolju, ki bo verjetno prejelo spremenjene
organizme.
6. Ocena tveganja se izdela za vsak
primer posebej. Potrebne informacije se lahko od primera do primera
razlikujejo v naravi in podrobnostih, odvisno od posameznega živega
spremenjenega organizma, namena njegove uporabe in okolja, ki bo
verjetno prejelo tak organizem.
Metodologija
7. Na eni strani postopek izdelave ocene
tveganja lahko vzbudi potrebo po nadaljnjih informacijah o posebnih
temah, lahko pa se izkaže, da v nekaterih primerih informacije o
drugih temah niso pomembne.
8. Da bi izdelava ocene tveganja
izpolnila svoje cilje, po potrebi vključuje te stopnje:
(a) določitev kakršnih koli
novih genotipskih in fenotipskih značilnosti, povezanih z živim
spremenjenim organizmom, ki bi lahko škodljivo vplivale na biološko
raznovrstnost v okolju, ki bo verjetno prejelo take organizme, pri
čemer je treba upoštevati tudi tveganje za zdravje ljudi;
(b) ovrednotenje verjetnosti nastanka
takih škodljivih vplivov ob upoštevanju ravni in vrste
izpostavljenosti okolja, ki bo verjetno prejelo živ spremenjen
organizem, temu organizmu;
(c) ovrednotenje posledic, če taki
škodljivi vplivi res nastanejo;
(d) ovrednotenje celotnega tveganja, ki
ga predstavlja živ spremenjen organizem, temelječe na presoji
tveganja in posledic nastanka opredeljenih škodljivih vplivov;
(e) priporočilo o tem, ali so tveganja
sprejemljiva ali obvladljiva, skupaj z opredelitvijo strategij za
obvladovanje teh tveganj, kadar je to potrebno;
(f) če ni mogoče zanesljivo določiti
ravni tveganja, se lahko zahtevajo dodatne informacije o posebnih
vprašanjih v zvezi z zadevo ali pa se izvedejo ustrezne strategije
obvladovanja tveganja in/ali se spremlja in nadzoruje živ
spremenjen organizem v prejemnem okolju.
Dejstva, ki jih je treba
upoštevati
9. Pri oceni tveganja se, odvisno od
primera, upoštevajo ustrezni tehnični in znanstveni podatki o
značilnostih teh dejavnikov:
(a) prejemni ali starševski
organizmi. Biološke značilnosti prejemnega ali starševskih
organizmov skupaj z informacijami o sistematski uvrstitvi, domačem
imenu, izvoru, središčih izvora in središčih genske raznovrstnosti,
če so ta znana, in opisom habitata, v katerem bi organizmi lahko
obstali ali se razmnoževali;
(b) organizem ali organizmi dajalci.
Sistematska uvrstitev in domače ime, vir in ustrezne biološke
značilnosti organizmov dajalcev;
(c) vektor. Značilnosti vektorja z
njegovo identiteto vred, če je znana, njegovim virom ali izvorom in
spektrom gostiteljev;
(d) vnesen material in/ali značilnosti
spremembe. Genske značilnosti vnesene nukleinske kisline in
funkcija, ki jo določa, in/ali značilnosti vnesene spremembe;
(e) živ spremenjen organizem. Identiteta
živega spremenjenega organizma in razlike med biološkimi
značilnostmi živega spremenjenega organizma in značilnostmi
prejemnega ali starševskih organizmov;
(f) odkrivanje in prepoznavanje živega
spremenjenega organizma. Predlagane metode za odkrivanje in
prepoznavanje ter njihova posebnost, občutljivost in
zanesljivost;
(g) informacije v zvezi z namenom
uporabe. Informacije v zvezi z namenom uporabe živega spremenjenega
organizma skupaj z novo ali spremenjeno uporabo v primerjavi s
prejemnim ali starševskimi organizmi;
(h) prejemno okolje. Informacije o
lokacijskih, geografskih, podnebnih in ekoloških značilnostih
skupaj z ustreznimi informacijami o biološki raznovrstnosti in
središčih izvora okolja, ki bo verjetno prejelo spremenjeni
organizem.
3.
člen
Za izvajanje protokola skrbi
Ministrstvo za okolje in prostor.
4.
člen
Ta zakon začne veljati naslednji
dan po objavi v Uradnem listu Republike Slovenije Mednarodne
pogodbe.
Št. 802-06/02-9/1
Ljubljana, dne 27. septembra
2002
Predsednik
Državnega zbora
Republike Slovenije
Borut Pahor l. r.
Avtor: ZŽI