BS-III/14

Third meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (BS COP MOP 3)

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

Origin of report

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:
Time period covered by this report:

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):

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
(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) 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));
(e) In cases of multiple competent national authorities, responsibilities for each (Art icles 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);
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
(h) Ille gal 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 2 0.3(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 Article 20.3(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);
(n) LMOs granted e xemption status by each Party (Article 13.1)
(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);
(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)).

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)
b) some measures introduced (please give details below)
c) no measures yet taken
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:

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
b) no
6. Were you a Party of export during this reporting period?
a) yes
b) no
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
b) not yet, but under development
c) no
d) not applicable - not a Part y of export
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)
b) not yet, but under development
c) no
d) not applicable - not a Party of export
9. 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
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:

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:

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
b) not yet, but under development
c) no
d) not applicable (pl ease give details below)
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)
b) no
c) not relevant
14. 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
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:

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:

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
b) no
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:

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
b) no
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:

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
b) no (please clarify below)
c) not a Party of import / no decisions taken under Article 10
22. If yes to question 21 , 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 / no decisions taken under Article 10
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
b) yes - in some cases (please specify the number and give further details below)
c) no
d) not a Party of import / no decisions taken under Article 10
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
b) not yet, but under development or partially established (please give further details below)
c) no
25. Has your country adopted appropriate measures to prevent unintentional transboundary movements of living modified organisms? (Article 16.3)
a) yes - fully adopted
b) not yet, but under development or partially adopted (please give further details below)
c) no
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
b) yes - in some cases (please give further details below)
c) no (please give further details b elow)
d) not applicable (please give further details below)
27. 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)
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:

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
b) yes - partially consulted, or consultations were delayed (please clarify below)
c) no - did not consult immediately (please clarify below)
d) not applicable (no such occurrences)
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:

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)
b) not yet, but under development
c) no
d) not applicable (please clarify below)
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
b) not yet, but under development
c) no
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
b) not yet, but under development
c) no
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
b) not yet, but under development
c) no
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:

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:

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
b) not yet, but under development
c) no
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
If yes, please give number of cases
b) no
c) not applicable - not a Party of import / no such requests received
39. If you answered yes to the previous question, please provide information on your experience including description of any impediments or difficulties encountered:

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:

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)
b) no
b) not applicable - not a developed country Party
42. If yes to question 41 , how has such cooperation taken place:

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)
b) no
b) not applicable - not a developing country Party
44. If yes to question 43 , how has such cooperation taken place:

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)
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
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)
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-bui lding needs in this area
e) not applicable - not a developing country Party or a Party with an economy in transition
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)
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
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:

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
b) yes - limited extent
c) no
50. If yes, do you cooperate with other States and international bodies?
a) yes - significant extent
b) yes - limited extent
c) no
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
b) yes - limited extent
c) no
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
b) yes - limited extent
c) no
53. 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
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:

Article 24 - Non-Parties

See question 1 regarding provision of information to the Biosafety Clearing-House .

55. Have there been any transboundary movements of living modified organisms between your country and a non-Party during the reporting period?
a) yes
b) no
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:

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
b) no
58. Have there been any illegal transboundary movements of living modified organisms into your country during the reporting period?
a) yes
b) no
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:

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
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.