Monitoring and reporting under the
Protocol (Article 33): format and timing for reporting
The Conference of the Parties serving as the meeting of the
Parties to the Cartagena Protocol on Biosafety
1. Takes note of the note of the Executive Secretary on
monitoring and reporting (UNEP/CBD/BS/COP-MOP/1/10);
2. Recognizes the need for clear and simple reporting
requirements that:
(a) Consider technical, technological and financial capacity
limitations in developing countries, 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;
(b) Avoid duplication of other requirements pursuant to the
Convention on Biological Diversity;
(c) Support statistical analysis and compilation;
(d) Encourage Parties to provide detailed information at
national as well as at regional levels, where such information can
be useful to other Parties;
3. Requests Parties to make use of the reporting format
as annexed to this decision;
4. Recommends that Parties prepare their reports
through a consultative process involving all relevant stakeholders,
as appropriate;
5. Requests Parties to submit their reports:
(i) On a general frequency of every four years, but in the
initial four-year period to submit an interim report two years
after the entry into force of the Protocol;
(ii) Twelve months prior to the meeting of the Conference of the
Parties serving as the meeting of the Parties to the Protocol that
will consider the report;
(iii) In an official language of the United Nations;
(iv) In both hard copy and electronic format;
6. Decides that the intervals and formats of the
reports should be kept under review, building on the experience of
Parties in preparing their reports.
(i)
Annex
DRAFT FORMAT FOR THE INTERIM
NATIONAL REPORT ON IMPLEMENTATION OF THE CARTAGENA PROTOCOL ON
BIOSAFETY
GUIDELINES FOR USE OF THE
REPORTING FORMAT
The following format for preparation of the 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.
Parties are requested to submit an interim national report on
implementation of the Cartagena Protocol on Biosafety in this
format to the Executive Secretary no later than 11 September 2005.
The reporting format is intended to be specific to the interim
national report only. It is expected that the format for the first
national report will be slightly more detailed, to allow for
reporting on decisions that will have been taken by the Conference
of the Parties serving as the meeting of the Parties to the
Protocol. Similarly, for 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 Parties,
while eliciting the important information regarding implementation
of the provisions of the Protocol. Many questions require only a
tick in one or more boxes. 13/ Other questions seek a qualitative
description of experiences and progress,
includingobstacles and impediments to the
implementation of particular provisions. 24/ 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 answers 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 relevant 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 393 St. Jacques Street West, suite 300 Montreal, Quebec H2Y 1N9 Canada Fax: (+1 514) 288 6588 e-mail: [email protected] |
Origin of report
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Party | |
Contact officer for report |
Name and title of contact officer: | |
Mailing address: | |
Telephone: | |
Fax: | |
E-mail: | |
Submission |
Signature of officer responsible for submitting report: | |
Date of submission: | |
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 its 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 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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Information required to be provided to the Biosafety
Clearing-House:
(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))
(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);
(c) Bilateral, multilateral and regional agreements and
arrangements (Articles 14.2, 20.3(b), and 24.1);
(d) Contact 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));
(e) In cases of multiple competent national authorities,
responsibilities for each (Articles 19.2 and 19.3);
(f) Reports submitted by the Parties on the operation of the
Protocol (Article 20.3(e));
(g) Occurrence of unintentional transboundary movements that are
likely to have significant adverse effects on biological diversity
(Article 17.1);
(h) Illegal transboundary movements of LMOs (Article 25.3);
(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 20.3(d));
(j) Information on the application of domestic regulations to
specific imports of LMOs (Article 14.4);
(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);
(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
Article20.3(d))
(m) Declarations regarding the framework to be used for LMOs
intended for direct use as food or feed, or for processing (Article
11.6)
(n) Review and change of decisions regarding intentional
transboundary movements of LMOs (Article 12.1);
(o) LMOs granted exemption status by each Party (Article
13.1)
(p) 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); and
(q) Summaries of risk assessments or environmental reviews of
LMOs generated by regulatory processes and relevant information
regarding products thereof (Article 20.3(c)).
Article 2 - General provisions
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1. 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) | |
b) some measures introduced (please give details below) | |
c) no measures yet taken | |
2. 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 regarding provision of information to the
Biosafety Clearing-House.
| |
1. Is there a legal requirement for the accuracy of information
provided by exporters 5/ under
the jurisdiction of your country? (Article 8.2) |
a) yes | |
b) no | |
c) not applicable - not a Party of export | |
2. 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) | |
b) no | |
c) not applicable - not a Party of export | |
3. Did your country take decisions regarding import under
domestic regulatory frameworks as allowed by Article 9.2(c). |
a) yes | |
b) no | |
c) not applicable - no decisions taken during the reporting
period | |
4. 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: |
| |
5. 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.
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1. 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 | |
b) no | |
c) not applicable (please give details below) | |
2. 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) | |
b) no | |
c) not relevant | |
3. Did your country take decisions regarding import under
domestic regulatory frameworks as allowed by Article 11.4? |
a) yes | |
b) no | |
c) not applicable - no decisions taken during the reporting
period | |
4. 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: |
| |
5. 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.
1. If your country has used the simplified procedure during the
reporting period, 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 Clearing-House.
1. If your country has entered into bilateral, regional or
multilateral agreements or arrangements, 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
| |
1. 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 | |
b) no (please clarify below) | |
c) not a Party of import | |
2. If yes, did you require the exporter to carry out the risk
assessment? |
a) yes - in all cases | |
b) yes - in some cases (please specify the number and give
further details below) | |
c) no | |
d) not a Party of import | |
3. 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 | |
b) yes - in some cases (please specify the number and give
further details below) | |
c) no | |
4. 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 | |
b) no | |
5. Has your country adopted appropriate measures to prevent
unintentional transboundary movements of living modified organisms?
(Article 16.3) |
a) yes | |
b) no | |
6. 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 | |
b) yes - in some cases (please give further details below) | |
c) no (please give further details below) | |
d) not applicable (please give further details below) | |
| |
7. Has your country cooperated with others for the purposes
specified in Article 16.5? |
a) yes (please give further details below) | |
b) no (please give further details below) | |
8. 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: |
| |
Article 17 - Unintentional transboundary movements
and emergency measures
See question 1 regarding provision of information to the
Biosafety Clearing-House.
| |
1. 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 | |
b) partially (please clarify below) | |
c) no (please clarify below) | |
2. 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: |
| |
Article 18 - Handling, transport, packaging and
identification
| |
1. 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) | |
b) no | |
c) not applicable (please clarify below) | |
2. 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 | |
b) no | |
3. 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 | |
b) no | |
4. 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 | |
b) no | |
5. 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 18, including any
obstacles or impediments encountered: |
| |
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.
1. 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
| |
1. 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 | |
b) no | |
2. 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 | |
If yes, please give number of cases | |
b) no | |
c) not applicable - not a Party of import | |
3. If you answered yes to the previous question, please provide
information on your experience including description of any
impediments or difficulties encountered: |
| |
4. 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
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1. 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) | |
b) no | |
b) not applicable - not a developed country Party | |
2. If yes, how has such cooperation taken place: |
| |
3. 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) | |
b) yes - capacity-building needs partially met (please give
details below) | |
c) no - capacity-building needs remain unmet (please give
details below) | |
b) no - we have no unmet capacity-building needs in this
area | |
e) not applicable - not a developing country Party or a Party
with an economy in transition | |
4. 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) | |
b) yes - capacity-building needs partially met (please give
details below) | |
c) no - capacity-building needs remain unmet (please give
details below) | |
b) no - we have no unmet capacity-building needs in this
area | |
e) not applicable - not a developing country Party or a Party
with an economy in transition | |
| |
5. 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) | |
b) yes - capacity-building needs partially met (please give
details below) | |
c) no - capacity-building needs remain unmet (please give
details below) | |
b) no - we have no unmet capacity-building needs in this
area | |
e) not applicable - not a developing country Party or a Party
with an economy in transition | |
6. 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
participation
| |
1. 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 | |
b) yes - limited extent | |
c) no | |
2. If yes, do you cooperate with other States and international
bodies? |
a) yes - significant extent | |
b) yes - limited extent | |
c) no | |
3. 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 | |
b) yes - limited extent | |
c) no | |
4. 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 | |
b) yes - limited extent | |
c) no | |
5. Has your country informed its public about the means of
public access to the Biosafety Clearing-House? (Article 23.3) |
a) yes - fully | |
b) yes - limited extent | |
c) no | |
6. 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 1regarding provision of
information to the Biosafety
Clearing-House.
1. 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.
| |
1. 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 | |
b) no | |
2. 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: |
| |
Article 26 - Socio-economic
considerations
| |
1. 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 | |
b) yes - limited extent | |
c) no | |
d) not a Party of import | |
2. 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 | |
3. 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
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1. 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 financial resources from other Parties or
financial institutions | |
c) both | |
d) neither | |
2. 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
1. 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:
Notes:
3/ 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.
4/ Please
feel free to append to the report further information on any of the
questions.
5/ The use
of terms in the questions follows the meanings accorded to them
under Article 3 of the Protocol
