Monitoring and reporting
The Conference of the Parties serving as the meeting of the Parties to
the Cartagena Protocol on Biosafety,
Recalling its decision BS-I/9, on monitoring and reporting under
the Protocol,
Recalling also paragraph 6 (a) of the annex to its decision BS-I/12,
on the medium‑term programme of work, providing for it to consider
at its fourth meeting the first regular national reports by Parties on
the implementation of the Protocol,
Taking note of the interim national reports submitted by Parties,
and welcoming the analysis thereof prepared by the Secretariat (UNEP/CBD/BS/COP-MOP/3/12),
Emphasizing the importance of fulfilling monitoring and reporting
obligations under Article 33 of the Protocol, particularly with regard to
its interconnection with capacity-building, promoting compliance, and assessment
and review,
Recognizing the need for capacity‑building to enable developing
country Parties, in particular the least developed and small island developing
States among them, as well as Parties with economies in transition, to
fulfil their national reporting obligations under the Protocol,
1. Adopts the national reporting format annexed
to the present decision ;
2. Reminds each Party to fulfil its monitoring and reporting obligations
and to ensure that its national reports provide information that adequately
respond to the questionnaire in the reporting format and invites eligible
Parties that may face difficulties in the preparation of their national reports
to make these difficulties known to the Secretariat and to seek assistance
from any available opportunities such as the roster of experts;
3. Requests Parties to submit their first regular national report,
covering the period between entry into force of the Protocol for each Party
and the reporting date, 12 months prior to its fourth meeting, to allow consideration
of the reports at that meeting;
4. Reminds Parties that not submitting a national report within the
deadline does not absolve them from fulfilling their obligation for that reporting
period;
5. Invites developed country Parties, other Governments as well as
relevant organizations to provide financial and technical support for capacity-building
to enable developing country Parties, in particular the least developed and
small island developing States among them, as well as Parties with economies
in transition to meet their reporting obligations under the Protocol;
6. Invites the Global Environment Facility to make available financial
resources to facilitate the consultative information-gathering process leading
to the preparation of national reports for those developing country Parties,
in particular the least developed and small island developing States among
them, and Parties with economies in transition, which lack sufficient capacity
in this regard;
7. Requests the Executive Secretary to prepare, in time for the fourth
meeting of the Conference of the Parties serving as the meeting of the Parties
to the Protocol, an analysis based on the information contained in national
reports received.
Annex
FORMAT FOR THE FIRST REGULAR NATIONAL REPORT ON THE IMPLEMENTATION OF THE
CARTAGENA PROTOCOL ON BIOSAFETY
GUIDELINES FOR USE OF THE REPORTING FORMAT
The following format for preparation of the first regular national report
on implementation of the Cartagena Protocol on Biosafety called for under Article
33 of the Protocol is a series of questions based on those elements of the
Protocol that establish obligations for Contracting Parties. Responses to these
questions will help Parties to review the extent to which they are successfully
implementing the provisions of the Protocol and will assist the Conference
of the Parties serving as the meeting of the Parties to the Protocol to assess
the overall status of implementation of the Convention.
The deadline for submission of the first regular national report is no less
than 12 months prior to the fourth meeting of Conference of the Parties serving
as the meeting of the Parties to the Protocol. It is intended to cover activities
undertaken between entry into force of the Protocol for the reporting Party
and the date of reporting.
F or subsequent national reports, the format is expected to evolve, as questions
that are no longer relevant after the first national report may be deleted,
questions that are relevant to ongoing progress in implementation will be retained,
and additional questions will be formulated pursuant to future decisions of
the Conference of the Parties serving as the meeting of the Parties to the
Protocol.
The wording of questions follows the wording of the relevant articles of
the Protocol as closely as possible. The use of terms in the questions follows
the meanings accorded to them under Article 3 of the Protocol .
The format tries to minimize the reporting burden on Pa rties, while eliciting
the important information regarding implementation of the provisions of the
Protocol. Many questions require only a tick in one or more boxes. 1 /
Other questions seek a qualitative description of experiences and progress,
including obstacles and impediments to the implementation of particular provisions. 2 / Although
there is no set limit on length of text, in order to assist with the review
and synthesis of the information in the reports, respondents are asked to ensure
that answe rs are as relevant and as succinct as possible.
The information provided by Parties will not be used to rank performance
or to otherwise compare implementation between individual Parties.
The Executive Secretary welcomes any comments on the adequacy of the questions,
and difficulties in completing the questions, and any further recommendations
on how these reporting guidelines could be improved. Space is provided for
such comments at the end of the report .
It is recommended that Parties involve all relev ant stakeholders in the
preparation of the report, in order to ensure a participatory and transparent
approach to its development and the accuracy of the information requested.
A box is provided in which to identify those groups who have been involved.
Parties are requested to submit an original signed copy by post and an electronic
copy on diskette or by electronic mail. An electronic version of this document
will be sent to all national focal points and this will also be available from
the Convention's website at: http://www.biodiv.org
Completed reports and any comments should be sent to:
The Executive Secretary
Secretariat of the Convention on Biological Diversity
World Trade Centre
413 St. Jacques Street West, suite 800
Montreal , Quebec
H2Y 1N9 Canada
Fax: (+1 514) 288 6588
e-mail: secretariat@biodiv.org
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Party: |
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Contact officer for report |
Name and title of contact officer:
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Mailing address:
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Telephone: |
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Fax: |
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E-mail: |
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Submission |
Signature of officer responsible for submitting
report: |
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Date of submission: |
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Time period covered by
this report: |
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Please provide summary information on the process by which this report has
been prepared, including information on the types of stakeholders who have
been actively involved in i ts preparation and on material which was used as
a basis for the report:
Obligations for provision of information to the Biosafety
Clearing-House
1. Several articles
of the Protocol require that information be provided to the Biosafety
Clearing-House (see the list below). For your Government, if there
are cases where relevant information exists but has not been provided
to the Biosafety Clearing-House (BCH), describe any obstacles or
impediments encountered regarding provision of that information (note:
To answer this question, please check the BCH to determine the current
status of your country's
information submissions relative to the list of required information
below. If you do not have access to the BCH, contact the Secretariat
for a summary): |
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| 2. Please provide an overview
of inform ation that is required to be provided to the Biosafety Clearing-House: |
Type of information |
Information exists and is
being provided to the Biosafety Clearing-House |
Information exists but is
not yet provided to the Biosafety Clearing-House |
Information does not exist
/not applicable
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(a) Existing national legislation,
regulations and guidelines for implementing the Protocol, as well as
information required by Parties for the advance informed agreement procedure
(Article 20.3(a) ) |
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(b) National laws, regulations
and guidelines applicable to the import of LMOs intended for direct use
as food or feed, or for processing (Article 11.5); |
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(c) Bilateral, multilateral
and regional agreements and arrangements (Articles 14.2, 20.3(b), and
24.1); |
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(d) Con tact details for competent
national authorities (Articles 19.2 and 19.3), national focal points
(Articles 19.1 and 19.3), and emergency contacts (Article 17.2 and 17.3(e)); |
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(e) In cases of multiple competent
national authorities, responsibilities for each (Art icles 19.2 and 19.3); |
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(f) Reports submitted by the
Parties on the operation of the Protocol (Article 20.3(e)); |
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(g) Occurrence of unintentional
transboundary movements that are likely to have significant adverse effects
on biological diversity (Article 17.1); |
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Type of information
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Information exists and is
being provided to the Biosafety Clearing-House |
Information exists but is
not yet provided to the Biosafety Clearing-House |
Information does not exist
/not applicable
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(h) Ille gal transboundary
movements of LMOs (Article 25.3); |
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(i) Final decisions regarding
the importation or release of LMOs (i.e. approval or prohibition, any
conditions, requests for further information, extensions granted, reasons
for decision) (Articles 10.3 and 2 0.3(d)); |
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(j) Information on the application
of domestic regulations to specific imports of LMOs (Article 14.4); |
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(k) Final decisions regarding
the domestic use of LMOs that may be subject to transboundary movement
for direct use as food or feed, or for processing ( Article 11.1); |
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(l) Final decisions regarding
the import of LMOs intended for direct use as food or feed, or for processing
that are taken under domestic regulatory frameworks (Article 11.4) or
in accordance with annex III (Article 11.6) (requirement of Article 20.3(d)) |
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(m) Declarations regarding
the framework to be used for LMOs intended for direct use as food or
feed, or for processing (Article 11.6) |
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(n) Review and change of decisions
regarding intentional transboundary movements of LMOs (Article 12.1); |
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(n) LMOs granted e xemption
status by each Party (Article 13.1) |
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(o) Cases where intentional
transboundary movement may take place at the same time as the movement
is notified to the Party of import (Article 13.1); |
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(p) Summaries of risk assessments
or environmental reviews of LMO s generated by regulatory processes and
relevant information regarding products thereof (Article 20.3(c)). |
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Article 2 - General provisions
3. Has your country introduced
the necessary legal, administrative and other measures for implementation
of the Protocol? (Article 2.1) |
a) full domestic regulatory framework in place (please give details
below)
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b) some measures introduced (please give details below)
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c) no measures yet taken
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4. Please provide further details
about your response to the above question, as well as description of
your country's experiences
and progress in implementing Article 2, including any obstacles or
impediments encountered: |
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Articles 7 to 10 and 12: The advance informed agreement procedure
See question 1 r egarding provision of information to the Biosafety Clearing-House.
5. Were you a Party of import
during this reporting period? |
a) yes
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b) no
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6. Were you a Party of export
during this reporting period? |
a) yes
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b) no
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7. Is there a legal requirement
for the accuracy of information provided by exporters 3 /
under the jurisdiction of your country? ( Article 8.2) |
a) yes
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b) not yet, but under development
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c) no
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d) not applicable - not a Part y of
export
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8. If you were a Party of export
during this reporting period, did you request any Party of import to
review a decision it had made under Article 10 on the grounds specified
in Article 12.2? |
a) yes (please give details below)
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b) not yet, but under development
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c) no
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d) not applicable - not a Party of
export
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9. Did your country take decisions
regarding import under domestic regulatory frameworks as allowed by Article
9.2(c). |
a) yes
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b) no
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c) not applicable - no decisions taken
during the reporting period
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10. If your country has been
a Party of export of LMOs intended for release into the environment during
the reporting period, please describe your experiences and progress in
implementing Articles 7 to 10 and 12, including any obstacles or impediments
encountered: |
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11. If your country has taken
decisions on import of LMOs intended for release into the environment
during the reporting period, please describe your experiences and progress
in implementing Articles 7 to 10 and 12, including any obstacles or impediments
encountered: |
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Article 11 - Procedure for living modified organisms
intended for direct use as food or feed, or for processing
See question 1 regarding provision of information to the Biosafety Clearing-House.
12. Is there a legal requirement
for the accuracy of information provided by the applicant with respect
to the domestic use of a living modified organism that may be subject
to transboundary movement for direct use as food or feed, or for processing?
(Article 11.2) |
a) yes
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b) not yet, but under development
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c) no
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d) not applicable (pl ease give details below)
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13. Has your country indicated
its needs for financial and technical assistance and capacity‑building
in respect of living modified organisms intended for direct use as food
or feed, or for processing? (Article 11.9) |
a) yes (please give details below)
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b) no
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c) not relevant
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14. Did your country take decisions
regarding import under domestic regulatory frameworks as allowed by Article
11.4? |
a) yes
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b) no
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c) not applicable - no decisions taken
during the reporting period
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15. If your country has been
a Party of export of LMOs intended for direct use for food or feed, or
for processing, during the reporting period, please describe your experiences
and progress in implementing Article 11, including any obstacles or impediments
encountered: |
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16. If your country has been
a Party of import of LMOs intended for direct use for food or feed, or
for processing, during the reporting period, please describe your experiences
and progress in implementing Article 11, including any obstacles or impediments
encountered: |
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Article 13 - Simplified procedure
See question 1 regarding provision of information to the Biosafety Clearing-House.
17. Have you applied the simplified
procedure during the reporting period? |
a) yes
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b) no
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18. If your country has used
the simplified procedure during the reporting period, or if you have
been unable to do so for some reason, please describe your experiences
in implementing Article 13, including any obstacles or impediments encountered: |
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Article 14 - Bilateral, regional and multilateral agreements and
arrangements
See question 1 regarding provision of information to the Biosafety Clear
ing-House.
19. Has your country entered
into any bilateral, regional or multilateral agreements or arrangements? |
a) yes
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b) no
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20. If your country has entered
into bilateral, regional or multilateral agreements or arrangements,
or if you have been unable to do so for some reason, describe your experiences
in implementing Article 14 during the reporting period, including any
obstacles or impediments encountered: |
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Articles 15 and 16 - Risk assessment and risk management
21.
If you were a Party of import during this reporting period, were risk
assessments carried out for all decisions taken under Article 10? (Article
15.2) |
a) yes
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b) no (please clarify below)
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c) not a Party of import / no decisions taken under Article 10
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22. If yes to question 21 ,
did you require the exporter to carry out the risk assessment? |
a) yes - in all cases
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b) yes - in some cases (please specify
the number and give further details below)
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c) no
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d) not a Party of import / no decisions taken under Article 10
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23. If you took a decision under
Article 10 during the reporting period, did you require the notifier
to bear the cost of the risk assessment? (Article 15.3) |
a) yes - in all cases
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b) yes - in some cases (please specify
the number and give further details below)
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c) no
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d) not a Party of import / no decisions taken under Article 10
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24. Has your country established
and maintained appropriate mechanisms, measures and strategies to regulate,
manage and control risks identified in the risk assessment provisions
of the Protocol? (Article 16.1) |
a) yes - fully established
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b) not yet, but under development or partially established (please
give further details below)
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c) no
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25. Has your country adopted
appropriate measures to prevent unintentional transboundary movements
of living modified organisms? (Article 16.3) |
a) yes - fully adopted
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b) not yet, but under development or partially adopted (please give
further details below)
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c) no
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26. Does your country endeavour
to ensure that any living modified organism, whether imported or locally
developed, undergoes an appropriate period of observation commensurate
with its life-cycle or generation time before it is put to its intended
use? (Article 16.4) |
a) yes - in all cases
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b) yes - in some cases (please give
further details below)
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c) no (please give further details b elow)
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d) not applicable (please give further details below)
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27. Has your country cooperated
with others for the purposes specified in Article 16.5? |
a) yes (please give further details below)
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b) no (please give further details below)
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28. Please provide further details
about your responses to the above questions, as well as description of
your country's experiences
and progress in implementing Articles 15 and 16, including any obstacles
or impediments encountered: |
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Article 17 - Unintentional tr ansboundary movements and emergency
measures
See question 1 regarding provision of information to the Biosafety Clearing-House.
29. During the reporting period,
if there were any occurrences under your jurisdiction that led, or could
have led, to an unintentional transboundary movement of a living modified
organism that had, or could have had, significant adverse effects on
the conservation and sustainable use of biological diversity, taking
also into account risks to human health in such States, did you immediately
consult the affected or potentially affected States for the purposes
specified in Article 17.4? |
a) yes - all relevant States immediately
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b) yes - partially consulted, or consultations
were delayed (please clarify below)
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c) no - did not consult immediately
(please clarify below)
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d) not applicable (no such occurrences)
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30. Please provide further details
about your response to the above question, as well as description of
your country's experiences
in implementing Article 17, including any obstacles or impediments
encountered: |
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Article 18 - Handling, transport, packaging and identification
31. Has your country taken measures
to require that living modified organisms that are subject to transboundary
movement within the scope of the Protocol are handled, packaged and transported
under conditions of safety, taking into account relevant international
rules and standards? (Article 18.1) |
a) yes (please give details below)
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b) not yet, but under development
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c) no
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d) not applicable (please clarify below)
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32. Has your country taken measures
to require that documentation accompanying living modified organisms
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 information? (Article 18.2(a)) |
a) yes
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b) not yet, but under development
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c) no
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33. Has your country taken measures
to require that documentation accompanying 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? (Article 18.2(b)) |
a) yes
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b) not yet, but under development
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c) no
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34. Has your country adopted
measures to require that documentation accompanying 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? (Article 18.2(c)) |
a) yes
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b) not yet, but under development
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c) no
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35. Please provide further details
about your responses to the above questions, as well as a description
of your country's experiences
and progress in implementing Article 18, including any obstacles
or impediments encountered: |
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Article 19 - Competent national authorities and national focal
points
See question 1 regarding provision of information to the Biosafety Clearing-House.
Article 20 - Information-sharing and the Biosafety
Clearing-House
See question 1 regarding provision of information to the Biosafety Clearing-House.
36. In addition to the response to question
1 , please describe any further details regarding your country's
experiences and progress in implementing Article 20, including any obstacles
or impediments encountered: |
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Article 21 - Confidential information
37. Does your country have procedures
to protect confidential information received under the Protocol and that
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? (Article 21.3) |
a) yes
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b) not yet, but under development
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c) no
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38. If you were a Party of import
during this reporting period, did you permit any notifier to identify
information submitted under the procedures of the Protocol or required
by the Party of import as part of the advance informed agreement procedure
that was to be treated as confidential? (Article 21.1) |
a) yes
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If yes, please give number of cases
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b) no
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c) not applicable - not a Party of
import / no such requests received
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39. If you answered yes to the
previous question, please provide information on your experience including
description of any impediments or difficulties encountered: |
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40. If you were a Party of export
during this reporting period, please describe any impediments or difficulties
encountered by you, or by exporters under your jurisdiction if information
is available, in the implementation of the requirements of Article 21: |
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Article 22 - Capacity-building
41.
If a developed country Party, during this reporting period has your
country cooperated in the development and/or strengthening of human
resources and institutional capacities in biosafety for the purposes
of the effective implementation of the Protocol in developing country
Parties, in particular the least developed and small island developing
States among them, and in Parties with economies in transition? |
a) yes (please give details below)
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b) no
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b) not applicable - not a developed
country Party
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42. If yes to question 41 ,
how has such cooperation taken place: |
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43.
If a developing country Party, or Party with an economy in transition,
during this reporting period has your country contributed to the development
and/or strengthening of human resources and institutional capacities
in biosafety for the purposes of the effective implementation of the
Protocol in another developing country Party or Party with an economy
in transition? |
a) yes (please give details below)
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b) no
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b) not applicable - not a developing
country Party
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44. If yes to question 43 ,
how has such cooperation taken place: |
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45. If a developing country
Party or a Party with an economy in transition, have you benefited from
cooperation for technical and scientific training in the proper and safe
management of biotechnology to the extent that it is required for biosafety? |
a) yes - capacity-building needs fully
met (please give details below)
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b) yes - capacity-building needs
partially met (please give details below)
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c) no - capacity-building needs remain
unmet (please give details below)
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b) no - we have no unmet capacity-building
needs in this area
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e) not applicable - not a developing
country Party or a Party with an economy in transition
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46. If a developing country
Party or a Party with an economy in transition, have you benefited from
cooperation for technical and scientific training in the use of risk
assessment and risk management for biosafety? |
a) yes - capacity-building needs fully
met (please give details below)
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b) yes - capacity-building needs partially
met (please give details below)
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c) no - capacity-building needs remain
unmet (please give details below)
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b) no - we have no unmet capacity-bui
lding needs in this area
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e) not applicable - not a developing
country Party or a Party with an economy in transition
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47. If a developing country
Party or a Party with an economy in transition, have you benefited from
cooperation for technical and scientific training for enhancement of
technological and institutional capacities in biosafety? |
a) yes - capacity-building needs fully
met (please give details below)
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b) yes - capacity-building needs partially
met (please give details below)
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c) no - capacity -building needs remain
unmet (please give details below)
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b) no - we have no unmet capacity-building
needs in this area
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e) not applicable - not a developing
country Party or a Party with an economy in transition
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48. Please provide further details
about your responses to the above questions, as well as description of
your country's experiences
and progress in implementing Article 22, including any obstacles
or impediments encountered: |
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Article 23 - Public awareness and parti cipation
49. Does your country 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? (Article 23.1(a)) |
a) yes - significant extent
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b) yes - limited extent
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c) no
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50. If yes, do you cooperate
with other States and international bodies? |
a) yes - significant extent
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b) yes - limited extent
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c) no
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51. Does your country endeavour
to ensure that public awareness and education encompass access to information
on living modified organisms identified in accordance with the Protocol
that may be imported? (Article 23.1(b)) |
a) yes - fully |
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b) yes - limited extent |
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c) no |
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52. Does your country, in accordance
with its respective laws and regulations, consult the public in the decision-making
process regarding living modified organisms and make the results of such
decisions available to the public? (Article 23.2) |
a) yes - fully
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b) yes - limited extent
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c) no
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53. Has your country informed
its public about the means of public access to the Biosafety Clearing-House?
(Article 23.3) |
a) yes - fully
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b) yes - limited extent
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c) no
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54. Please provide further details
about your responses to the above questions, as well as description of
your country's experiences
and progress in implementing Article 23, including any obstacles
or impediments encountered: |
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Article 24 - Non-Parties
See question 1 regarding provision of information to the Biosafety Clearing-House
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55. Have there been any transboundary
movements of living modified organisms between your country and a non-Party
during the reporting period? |
a) yes
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b) no
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56. If there have been transboundary
movements of living modified organisms between your country and a non-Party,
please provide information on your experience, including description
of any impediments or difficulties encountered: |
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Article 25 - Illegal transboundary movements
See question 1 regarding provision of information to the Biosafety Clearing-House.
57. Has your country adopted
appropriate domestic measures to prevent and penalize, as appropriate,
transboundary movements of living modified organisms carried out in contravention
of its domestic measures? (Article 25.1) |
a) yes
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b) no
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58. Have there been any illegal
transboundary movements of living modified organisms into your country
during the reporting period? |
a) yes
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b) no
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59. Please provide further details
about your response to the above question, as well as description of
your country's experiences
in implementing Article 25, including any obstacles or impediments
encountered: |
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Article 26 - Socio-economic considerations
60. If during this reporting
period your country has taken a decision on import, did it take into
account 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? (Article 26.1) |
a) yes - significant extent
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b) yes - limited extent
|
|
c) no
|
|
d) not a Party of import
|
|
61. Has your country cooperated
with other Parties on research and information exchange on any socio-economic
impacts of living modified organisms, especially on indigenous and local
communities? ( Article 26.2) |
a) yes - significant extent
|
|
b) yes - limited extent
|
|
c) no
|
|
62. Please provide further details
about your responses to the above questions, as well as description of
your country's experiences
and progress in implementing Article 26, including any obstacles
or impediments encountered: |
|
Article 28 - Financial mechanism and resources
63. Please indicate if, during
the reporting period, your Government made financial resources available
to other Parties or received financial resources from other Parties or
financial institutions, for the purposes of implementation of the Protocol. |
a) yes - made financial resources
available to other Parties
|
|
b) yes - received finan cial resources
from other Parties or financial institutions
|
|
c) both
|
|
d) neither
|
|
64. Please provide further details
about your response to the above question, as well as description of
your country's experiences,
including any obstacles or impediments encountered: |
|
Other information
65. Please use this box to provide any other
information related to articles of the Protocol, questions in the reporting
format, or other issues related to national implementation of the Protocol: |
|
Comments on reporting
format
The wording of these questions is based on the Articles of the Protocol.
Please provide information on any difficulties that you have encountered in
interpreting the wording of these questions:
1 / If you feel that, in order to properly
reflect the circumstances, it is necessary to tick more than one box, please
do so. In this case, you are encouraged to provide further information in the
text answers that follow to enable any analysis of results to appropriately
reflect the spirit of your answers.
2 / Please feel free to append to the
report further information on any of the questions.
3 / The use of terms in the questions
follows the meanings accorded to them under Article 3 of the Protocol.
