ANNEX G
I. SURVEILLANCE OF PUBLICATIONS
1. Collection and survey of relevant information on publicly available printed matter and the media with special attention to activities directly related to the BTWC and its Protocol.
2. Collection
2.1 States Parties and international organizations (WHO, FAO, OIE, ...) are requested to provide relevant information.
2.2 The Organization is to collect relevant information from publicly available sources (paragraph 4).
3. Survey
3.1 Management, categorization and synthesis.
3.2 To be carried out by personnel with specific expertise, relying on information technology.
3.3 Survey will have to be focused (paragraph 5).
4. Sources of information
4.1 Scientific publications.
4.2 Scientific journals.
4.3 Specific statistical data.
4.4 Relevant press databases.
4.5 Scientific databases.
4.6 Records and reports of scientific meetings and congresses.
4.7 Information on vaccine-programmes, other programmes and research concerning pathogenic organisms and toxins directed under high-containment conditions.
4.8 Information on new market products related to rapid identification of toxins and microbial pathogens including WHO risk groups III and IV.
5. Information to be collected and surveyed
5.1 Key identifiers (triggers) should be used.
5.1.1 Same triggers as for declarations (compliance measures).
5.1.2 Possibility of combining triggers.
5.1.3 Other possible triggers (source of information linked to triggers).
6. Activities to be covered
6.1 Unclassification of basic research and applied research in biosciences; biological research publication policy; scientific publications (1991 CBM "C" approach).
6.2 All compliance relevant activities (as defined by triggers).
7. Modalities
7.1 States Parties and international organizations are requested to provide information on an annual basis.
7.2 The Organization is to collect and survey information continuously.
7.3 Information is to be provided:
7.3.1 In one of the United Nations official languages.
7.3.2 With a short resume of publications.
7.3.3 Preferably in computerized format (floppy disk).
7.4 Information collected can be accessed by States Parties.
II. SURVEILLANCE OF LEGISLATION
1. Collection and survey of information with regard to legislation that is directly related to the BTWC and its Protocol. (Existence or absence of legislation may not be an indication of compliance or non-compliance).
2. Collection
2.1 States Parties are requested to provide relevant information.
2.2 The Organization is to collect, as appropriate, relevant information.
3. Survey
3.1 Management, categorization and synthesis.
3.2 To be carried out by personnel with specific expertise, relying on information technology.
3.3 Survey will have to be focused.
4. Sources of information
4.1 Legislation directly related to the BTWC and its Protocol.
4.1.1 Enabling legislation with regard to the BTWC and its Protocol.
4.2 Regulations related to activities / facilities / programmes / agents covered by the BTWC and its Protocol.
4.3 Other measures related to activities / facilities / programmes / agents covered by the BTWC and its Protocol.
4.4 Legislative, regulatory and relevant statistical databases.
5. Information to be collected and surveyed
5.1 Besides legislation directly related to BTWC and Protocol (enabling legislation) key identifiers (triggers) should be used.
5.1.1 Same triggers as for declarations (compliance measures).
5.1.2 Possibility of combining triggers.
5.1.3 Other possible triggers.
6. Activities to be covered
6.1 Development, production, stockpiling, acquisition, or retention of microbial or other biological agents, or toxins, weapons, equipment and means of delivery specified in Article I; export of microorganisms and toxins; imports of microorganisms and toxins (1991 CBM "E" approach).
6.2 All activities covered by BTWC and Protocol and activities related to triggers.
7. Modalities
7.1 States Parties are requested to provide baseline information.
7.2 States Parties are requested to provide information on an annual basis about changes.
7.3 The Organization is to collect and survey information continuously.
7.4 Information to be provided.
7.4.1 Copies of legislation in original languages if possible with unofficial translation in one of United Nations official languages.
7.4.2 A short resume in one of the United Nations official languages.
7.4.3 Preferably in computerized format (floppy disk).
7.5 Information can be used to provide, as appropriate, "model" legislation.
7.6 Information can be accessed by States Parties.
III. DATA ON TRANSFERS AND TRANSFER REQUESTS AND ON PRODUCTION
As this measure is under consideration as a mandatory one in the compliance measures Friend of the Chair discussions, it should be further studied in the light of the outcome of those discussions.
1. Collection and survey of national export and import data (e.g. government and industrial production statistics, culture collection records and other relevant information going beyond declaration requirements and to be provided voluntarily by States Parties).
2. Collection
2.1 States Parties are requested to provide relevant information.
2.2 The Organization is to collect relevant information from publicly available sources.
2.3 Confidentiality concerns need to be considered.
3. Survey
3.1 Management, categorization and synthesis.
3.2 To be carried out by personnel with specific expertise, relying on information technology.
3.3 Survey will have to be focused.
4. Sources of information
4.1 Trade publications.
4.2 Specific statistical data.
4.3 Regulations and other measures (including control).
5. Information to be collected and surveyed
5.1 Key identifiers (triggers) should be used.
5.1.1 Same triggers as for transfer and production declarations.
5.1.2 Other possible triggers (e.g. for data collection under paragraph 2.2).
5.2 Information on
5.2.1 Suppliers and recipients.
5.2.2 Agents.
5.2.3 Equipment.
6. Modalities
6.1 States Parties are requested to provide information on an annual basis (collection of national data might require national regulation).
6.2 The Organization is to collect and survey information continuously.
6.3 Information is to be provided
6.3.1 In one of the United Nations official languages.
6.3.2 In accordance with agreed format.
6.3.3 Preferably in computerized format (floppy disk).
IV. MULTILATERAL INFORMATION SHARING
1. Sharing of information including electronic networking on issues relating to materials and activities of potential relevance to and in harmony with the BTWC and the legally binding measure.
2. Sharing of information
2.1 Between States Parties (with the assistance of the Organization).
2.2 Between the Organization and international organizations.
2.3 The Organization is to collect information from non-governmental organizations and programmes/initiatives.
3. Areas which could be covered
3.1 Confidence building measures reports (as agreed in 1991).
3.1.1 Exchange of data on research centres and laboratories.
3.1.2 Exchange of information on national biological defence research and development programmes.
3.1.3 Exchange of information on outbreaks of infectious diseases and similar occurrences caused by toxins.
3.1.4 Encouragement of publication of results and promotion of use of knowledge.
3.1.5 Active promotion of contacts.
3.1.6 Declaration of legislation, regulations and other measures.
3.1.7 Declaration of past activities in offensive and/or defensive biological research and development programmes.
3.1.8 Declaration of vaccine production facilities.
3.2 Consultation in completing CBM requirements and reporting obligations.
3.3 Surveillance of disease outbreaks and unusual disease outbreak reports.
3.3.1 Surveillance of human disease outbreak and unusual disease outbreak reports.
3.3.1.1 WHO Weekly Epidemiological Record (on World Wide Web), containing information on disease events obtained through the implementation of the International Health Regulations, from the WHO communicable disease and antimicrobial resistance monitoring systems, and from country experiences in disease surveillance and control.
3.3.1.2 WHO EMC's (Division of Emerging and other Communicable Diseases Surveillance and Control) electronic distribution system providing regular updates on epidemics of international importance, communicable disease and global surveillance (on World Wide Web).
3.3.2 Surveillance of animal disease outbreak reports.
3.3.2.1 OIE Disease Information, a weekly collection of reports of animal diseases for urgent dispatch (on World Wide Web).
3.3.2.2 OIE Bulletin, a monthly publication which describes the course of the most contagious animal diseases.
3.3.2.3 OIE World Animal Health, an annual review of world wide status regarding OIE List A and B diseases.
3.3.2.4 FAO/OIE/WHO Animal Health Yearbook containing the data received in the joint FAO/OIE/WHO questionnaires. 3
.3.2.5 OIE HandiSTATUS, an electronic information programme containing data related to OIE and FAO/OIE/WHO questionnaires.
3.3.3 Surveillance of plant disease outbreak reports.
3.3.3.1 Joint FAO/OIE/WHO questionnaire sent out by FAO.
3.4 Information on pharmaceutical and vaccine production, good manufacturing practices, biosafety capabilities and procedures.
3.4.1 ICGEB net. Information, clearing house mechanism on biotechnology, genetic engineering and biosafety.
3.4.2 BINAS (Biosafety Information Network Advisory System developed in conjunction with UNIDO and ICGEB).
3.5 Information concerning research and exchange programmes covering areas related to the BTWC and the Protocol.
3.6 Information related to obligations under the BTWC, e.g. information that may be related to the production, development, stockpiling or means of delivery of pathogens and toxins for hostile purposes.
4. Possible forms of information sharing
4.1 Between States Parties (Organization as "hub") and between States Parties and international organizations (WHO, FAO, OIE, ICGEB, UNIDO, etc).
4.1.1 Creation of a computer network to integrate through INTERNET connectivity databases covered in paragraph 3. (via secure World Wide Web page access).
4.1.2 INTERNET connectivity and video conferencing connectivity/network to support information sharing (vaccines, GMP, biosafety, etc.).
4.1.3 "Virtual" attendance at scientific conferences. Consultation and training in relevant areas.
4.2 Between the Organization and non-governmental organizations and programmes/initiatives.
4.2.1 INTERNET connectivity with PROMED, NEED, OUTBREAK, MEDSCAPE, on relevant disease outbreaks.
4.2.2 INTERNET connectivity with national and international databases of relevance for the BTWC and the Protocol (CDC Reports, MEDLINE, GENEBANK, etc.).
4.3 Possible contribution from international organizations (WHO, etc.).
4.3.1 Communication of information technically validated by staff in the field as part of a global alert system both on general and protected basis.
4.3.2 Provision of technical expertise through WHO's network of Collaborating Centres for the investigation of disease outbreaks and the confirmation of diagnosis.
4.3.3 Liaison with health authorities in developing countries through WHO staff and Collaborating Centres.
4.3.4 Liaison with military communicable disease surveillance and laboratory facilities.
4.3.5 Provision of information on national vaccination practices and coverage.
4.3.6 Guidelines on containment of specific pathogens in public health and laboratory settings.
4.3.7 Providing a focal point for global data and information exchange.
4.3.8 Revision of the International Health Regulations to provide a common policy for strengthening surveillance and reporting.
V. EXCHANGE VISITS (INTERNATIONAL ARRANGEMENTS AND OFF-SITE VISITS)
1. Visits of experts arranged for scientific purposes by a State Party to comparable facilities (for off-site visits: to facilities of potential relevance for the BTWC and the Protocol) of another State Party.
2. Visits
2.1 Visits would be under bilateral and/or multilateral agreement.
2.2 On a voluntary and/or reciprocal basis.
2.3 Visits should be in harmony with the provisions of the BTWC and the Protocol.
3. Experts will have expertise in areas relevant for the BTWC and the Protocol (illustrative list)
3.1 Administrators with expertise in science administration and related matters
3.2 Agriculture
3.3 Bacteriology
3.4 Biochemistry
3.5 Biological defence experts
3.6 Biosafety
3.7 Biotechnology
3.8 Engineers of fermentation technology, equipment, buildings, etc.
3.9 Entomology
3.10 Epidemiology
3.11 Immunology
3.12 Medicine
3.13 Pharmaceutical sciences (antibiotics and other ethiotropic drugs)
3.14 Quality control experts
3.15 Toxicology
3.16 Veterinary science
3.17 Virology
4. Scope
4.1 Bilateral/multilateral exchanges (for international arrangements: long-term scientific exchanges) made in selected programme areas where common interest exists between countries.
4.2 Bilateral/multilateral exchanges (for international arrangements: long-term scientific exchanges) covering all areas directly related to the BTWC and the Protocol.
4.3 Bilateral/multilateral long-term scientific exchanges covering all areas of potential relevance for the BTWC and the Protocol (not restricted to declared facilities).
5. Modalities
5.1 Could be negotiated through bilateral and/or multilateral agreements.
5.2 For the selection and/or appointment of experts, help may be sought from specialized United Nations agencies (WHO, FAO, OIE, UNDP, etc.) and international organizations (ICGEB).
5.3 Arranged with mutual agreement on the
5.3.1 Areas of interest.
5.3.2 Selection of personnel.
5.3.3 Length of the scientific exchange.
5.3.4 Costs.
VI. CONFIDENCE-BUILDING VISITS
1. A coordinated set of visits with voluntary participation to promote confidence between States Parties, as well as in the future Organization.
2. Advantages of confidence-building visits
2.1 Regular contact could help developing confidence among States Parties to the BTWC.
2.2 Such visits might help States Parties to demonstrate transparency in matters related to the BTWC.
2.3 Confidence-building visits could be means of establishing open communication channels between similar institutions in different countries and could contribute to create the climate for the interchange of information and technology. As such, these visits could also be a further step towards the implementation of Article X of the Convention.
2.4 The contacts established between international experts could assist with the interchange of information and establish networks of expertise which will be beneficial to all States Parties participating.
2.5 Confidence-building visits would not be intrusive.
3. Visits
3.1 Visits could be coordinated through bilateral and/or multilateral arrangements.
3.2 Participation in the visits should be voluntary.
4. Participation
4.1 The persons participating in the visits (confidence-building visiting teams) could be nominated from the States Parties who are participating in the confidence-building measures.
4.2 States Parties participating in the confidence-building visits could annually update their list of experts who are available for participation in confidence- building visiting teams.
4.3 Experts would need to be available for periods of no longer than two to three weeks per year.
5. Potential Scope
5.1 Each participating State Party could on a voluntary basis make available a list of facilities which the confidence-building visiting team could visit, including
5.1.1 Facilities which are to be declared in terms of other measures developed to strengthen the BTWC.
5.1.2 Facilities not to be declared (commercial, teaching and research facilities).
5.2 Each participating State Party could on a voluntary basis include additional facilities in the list of facilities which the confidence-building visiting teams could visit.
5.3 Visit at each facility might include
5.3.1 Review of declared, planned and other activities.
5.3.2 Visual overview of current activities.
5.3.3 Discussion of any anomalies.
5.3.4 Discussion of latest trends in safety, containment, quality control, etc., as relevant.
5.3.5 Scientific exchanges.
6. Potential Modalities
The potential modalities could be arranged on a bilateral and/or multilateral basis. Such modalities could include
6.1 Measures to protect commercial and other information.
6.2 Frequency and duration of visits.
6.3 Adequate notification of visits.
6.4 As appropriate, cooperation with the future Organization.
6.5 The funding of visits and the arrangements thereof.
[71(A) PURPOSE
1. The Technical Secretariat of the Organization shall coordinate a system of voluntary confidence-building visits between States Parties with the aim to promote confidence between States Parties.
2. Confidence-building visits shall be arranged through bilateral agreements between States Parties or between States Parties and the Organization.
3. A State Party may initiate a confidence-building visit to obtain assistance from the Technical Secretariat in specific areas related to the Convention. These areas may include, inter alia, fulfilment of declaration obligations, biosafety standards and good laboratory or manufacturing practices.
4. Participation by States Parties in confidence-building visits shall be voluntary.
(B) INITIATION
5. The Technical Secretariat may request a State Party to conduct a confidence-building visit at a facility on the territory or under the jurisdiction of the State Party.
6. Any State Party may invite the Technical Secretariat and/or other States Parties to conduct a confidence-building visit at a facility on its territory or under its jurisdiction.
7. The Technical Secretariat or another requesting State Party shall arrange the details of the visit with the visiting State(s) Party(ies) before dispatching the visiting team.
8. The Technical Secretariat shall notify all other States Parties of the visit.
9. The duration of each confidence-building visit shall be subject to agreement between participating States Parties and/or the Technical Secretariat.
10. There shall be not more than [2] confidence-building visits per annum per participating State Party.
11. Each participating State Party shall, on a voluntary basis, make available to the Technical Secretariat a list of facilities which may be subjected to confidence-building visits. These facilities shall include:
(a) Facilities which are to be declared in terms of Article III of this Protocol;
(b) Facilities which are not to be declared in terms of Article III, including commercial, teaching and research facilities.
12. Each participating State Party may on a voluntary basis include additional facilities in its list of facilities which may be subjected to confidence-building visits.
(C) PRE-VISIT ACTIVITIES
Visit mandate
13. The Director-General shall issue a visit mandate for the visit. The visit mandate shall be compiled with the cooperation of the visited State(s) Party(ies).
14. The leader of the visiting team will make available the mandate to the visited State Party upon arrival at the point of entry.
Appointment of the visiting team
15. States Parties participating in confidence-building visit system may nominate experts who could be available for participation in non-permanent confidence-building visiting teams. States Parties may annually update their list of experts.
16. The Director-General shall determine the size of a confidence-building visiting team visiting a participating State Party taking into account the circumstances of the particular visit. The size of the visiting team shall be kept to a minimum necessary for the proper fulfilment of its mandate. No national of the State Party subject to a confidence-building visit shall be a member of the visiting team.
17. Nominated experts from participating States Parties shall not be utilized for longer than three weeks per annum.
18. The costs for a confidence-building visit shall be borne by all parties involved in such visit.
Briefing
19. Upon arrival at the facility to be visited and before the commencement of the visit, the visiting team shall be briefed by a facility representative on the facility and the activities carried out there.
20. When the visit takes place on request of the visited State Party, the visiting team shall also be briefed by a representative of the visited State Party on the details of the request and the support required.
21. After the briefings the visiting team and representatives of the visited State Party and facility shall prepare a visit plan.
Conduct of visits
22. Representatives of the visited State Party and of the facility shall accompany the visiting team throughout the duration of the visit to the facility.
23. The visit shall be carried out according to the visit plan and in the least intrusive manner possible. The visited State Party shall cooperate with the visiting team in the achievement of the objectives of the mandate.
24. The visiting team shall collect only that information necessary to carry out its mandate.
25. The duration of the visit shall be not more than ... days unless extended by agreement of the visiting team and the visited State Party.
26. Visits may include, inter alia, the following activities in accordance with the agreed visit mandate:
(a) Review of declared, planned and other activities;
(b) Visual overview of current activities;
(c) Discussion of any anomalies;
(d) Discussion of latest trends in safety, containment, quality control, etc. as relevant;
(e) Scientific exchanges;
(f) Any support activities as required by the visited State Party.
Managed access
27. All the rules concerning managed access described in this Protocol shall apply to confidence-building visits.
Reporting
28. A joint report by both participating States Parties and/or the Technical Secretariat shall be submitted to the Director-General and shall be made available to all States Parties.
29. The report shall summarize the general activities undertaken during the visit and the factual findings of the visiting team.
30. The report may make recommendations as appropriate and in cooperation with the facility representatives, in such areas as the fulfilment of declaration obligations, biosafety standards, and good laboratory or manufacturing practices.]