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APPENDICES¹¹⁵

BWC/AD HOC GROUP/38
Annex I
page 230

APPENDIX A

[INFORMATION TO BE PROVIDED IN DECLARATIONS OF [BIOLOGICAL] DEFENCE PROGRAMMES [AGAINST BIOLOGICAL WEAPONS]

1. State the objectives and funding of the programme and summarize the principal research, development, testing, production and evaluation [give a general description of the objectives and main elements of] activities conducted in the programme. Areas to be addressed shall include: prophylaxis, studies on pathogenicity and virulence, diagnostic techniques, aerobiology, detection, treatment, toxinology, physical protection, decontamination and other related research.

2. State:

- The total funding for the programme and its sources [(military, government, private)];

[- The total number of staff employed, including those contracted for less than six months;

- Details in the following categories:

      - Military: scientists, technicians, engineers, medical, weapons experts, support and administrative;

      - Civilian: scientists, technicians, engineers, medical, support and administrative;

- The discipline of the scientific and engineering staff;

- All [listed] agents they keep and work with;

- Production of and stockpiling of [listed] agents in the programme including amounts of each [listed] agent;

- All [listed] agents on which genetic modification is being done.]

3. Are aspects of this programme conducted under contract with industry, academic institutions, or in other nondefence facilities?

      Yes / No

BWC/AD HOC GROUP/38
Annex I
page 231

4. If yes, what proportion of the total funds for the programme is expended in these contracted or other facilities?

5. Summarize the objectives and research areas of the programme performed by contractors and in other facilities with the funds identified under paragraph 4.

6. Provide a diagram of the organizational structure of the programme and the reporting relationships (include individual facilities participating in the programme).

7. Provide a declaration in accordance with Annex B for each facility [both governmental and nongovernmental, which has a substantial proportion of its resources devoted to the national biological defence research and development programme, within the territory of the reporting State, or under its jurisdiction or control anywhere] [which participates in the biological weapon protection programme and carrying out work on any micro-organisms or toxins, as well as materials imitating their properties].]

BWC/AD HOC GROUP/38
Annex I
page 232

APPENDIX B

INFORMATION TO BE PROVIDED IN DECLARATIONS OF FACILITIES TAKING PART IN [BIOLOGICAL] DEFENCE PROGRAMMES [AGAINST BIOLOGICAL WEAPONS]

    [In shared facilities, provide the following information for the biological defence research and development portion only.

1. What is the name of the facility?

2. Where is it located (include both address and geographical location)?

3. [Number of rooms and] floor area of laboratory areas by containment level:

BL2 _______________ (m2) [ _____ rooms]

BL3 _______________ (m2) [ _____ rooms]

BL4 _______________ (m2) [ _____ rooms]

or highest level of containment

if none of the above __________ (m2) [ _____ rooms]

Total laboratory floor area ______ (m2)

[Aggregate fermenter capacity on site _______________ ]

[4. The organizational structure of each facility.

(i) Total number of personnel __________________

(ii) Division of personnel:

Military __________________

Civilian __________________

BWC/AD HOC GROUP/38
Annex I
page 233

(iii) Division of personnel by category:

Scientists __________________

Engineers __________________

Technicians __________________

Administrative and support staff __________________

(iv) List the scientific disciplines represented in the scientific/engineering staff.

(v) Are contractor staff working in the facility? If so, provide an approximate number.

(vi) What is (are) the source(s) of funding for the work conducted in the facility, including indication if activity is wholly or partly financed by the Ministry of Defence?

(vii) What are the funding levels for the following programme areas?

Research ________________________

Development ________________________

Test and evaluation ________________________

(viii) Briefly describe the publication policy of the facility.

(ix) Provide a list of publiclyavailable papers and reports resulting from the work during the previous 12 months. (To include authors, titles and full references.)]

5. Briefly describe the [biological defence work] [the work carried out at the facility as part of the [biological] defence programme [against biological weapons]] including type(s) of microorganisms¹¹⁶ and/or toxins studied, as well as outdoor studies of biological aerosols [any work with biological aerosols, including open-air test ranges, aerosolisation activities, work with test chambers].

BWC/AD HOC GROUP/38
Annex I
page 234

[The initial and subsequent annual declarations¹¹⁷ of facilities participating in the biological weapon protection programme and carrying out work on any micro-organisms or toxins, as well as materials imitating their properties should include the following information:

- Name.

- Location.

- Ownership (government department or company).

- List of biological agents and toxins on which work is being carried out.

- Main areas of activity (development of preventive agents and methods, observation, identification; genetic manipulation; aerobiology; toxinology; disinfection and other activities related to the purposes of the Convention.

- The existence of premises with a BL-4 level of biosafety.

- The presence of types of key equipment.]

BWC/AD HOC GROUP/38
Annex I
page 235

APPENDIX C

INFORMATION TO BE PROVIDED IN DECLARATIONS OF PAST BIOLOGICAL AND TOXIN OFFENSIVE AND/OR DEFENSIVE RESEARCH AND DEVELOPMENT PROGRAMMES

1. Date of entry into force of the Convention for the State Party.

2. Past offensive biological research and development programmes

-  Yes / No

-  Period(s) of activities.

-  Summary of the research and development activities indicating whether work was performed concerning production, test and evaluation, weaponization, stockpiling of biological agents, the destruction programme of such agents and weapons, and other related research.

3. Past defensive biological research and development programmes

-  Yes / No

-  Period(s) of activities.

-  Summary of the research and development activities indicating whether or not work was conducted in the following areas: prophylaxis, studies on pathogenicity and virulence, diagnostic techniques, aerobiology, detection, treatment, toxinology, physical protection, decontamination, and other related research, with location if possible.

BWC/AD HOC GROUP/38
Annex I
page 236

APPENDIX D

[INFORMATION TO BE PROVIDED IN DECLARATIONS OF OTHER FACILITIES

1. General Information

- Name of facility.

- Location (postal address).

- Sources of funding (military, government, private).

- A general description of the objectives and main elements of activities such as work in studies of pathogenicity and virulence, diagnostic techniques, aerobiology, detection, treatment, toxinology, physical protection, decontamination. Other related activities including whether the facility was ever involved in a past or present BW programme, details of any open source publications on the work of the facility.

2. Activities, including

- Work with listed agents.

- Production, stockpiling of and work with listed pathogens or toxins.

- Work on genetic material [derived from listed pathogens].

3. Equipment

- Indicate whether any of the pieces of listed equipment are present on site [and quantity of each].

4. Quantitative data (using, as appropriate, laboratory records)

- Number of rooms, laboratories at BL3/BL4 or equivalent, or highest level of containment.

- Aggregate fermenter capacity on site (the facility to declare which of various ranges is most accurate).

- Total number of staff employed, including those contracted for more than six months.

BWC/AD HOC GROUP/38
Annex I
page 237

- Numbers of staff working in the following categories: civilian, military, scientific, technician/engineers, support and administrative staff, contractor staff.

5. Cooperative activity

- Information on any cooperative activities in which the facility is involved e.g. between it and other international organizations.

[For vaccine production facilities:

- List of vaccines produced including average quantities produced the previous year.]

[For facilities producing vaccines and/or anatoxins to protect humans and animals against biological agents and toxins included in the list:

- Name.

- Location.

- Types of vaccines being produced.]

[For facilities with BL4 protected areas:

- List all the agents contained in the area, and production, stockpiling of, work with and genetic modification of agents contained in the area.]

[For facilities that work with listed organisms and have a production capability on-site and other production facilities not necessarily working with listed agents:

- List of products including average quantities produced the previous year.]

[For facilities (except for diagnostic facilities) at which work is carried out on biological agents and toxins included in the list:

- Name.

- Location.

- Ownership (government department or company).

BWC/AD HOC GROUP/38
Annex I
page 238

- List of agents and toxins on which work is being carried out.

- Main areas of activity (development of preventive agents and methods, observation, identification, genetic manipulation, aerobiology, toxinology).

- Disinfection and other activities related to the purposes of the Convention.

- The existence of premises with a BL4 level of biosafety.

- The presence of types of key equipment.]]

BWC/AD HOC GROUP/38
Annex I
page 239

[APPENDIX E

INFORMATION TO BE PROVIDED IN DECLARATIONS OF FACILITIES¹¹⁸

Declarations should be annual, and due [...]. The initial declaration for each facility should cover the previous period of [...] years. Subsequent annual declarations may indicate only changes in the information declared.

For the purpose of declaration, the facility is considered to be the functional unit in which the functions triggered for declaration are integrated with other scientific and technical functions essential to the day to day running and the aims and objectives of the unit.

BWC/AD HOC GROUP/38
Annex I
page 240

For facilities where stand alone triggers apply, complete Part A. In Part A, complete the section on General Information, and when more than one trigger applies return separate copies of the Fields of Activity questions 10-12 for each trigger.

Certain combination triggers specify two or more functions in a facility that do not have direct scientific or technical links. When such triggers apply answer the questions in Part B.

For [facilities] [taking part in] [military] [civilian] [national] [biological] defence [facilities taking part in] programme(s) [against biological and toxin weapons], answer the additional questions in Part C.

BWC/AD HOC GROUP/38
Annex I
page 241

PART A

GENERAL INFORMATION

1. Name and postal address.

2. Location (longitude, latitude).

3. Scale map of the locality, showing the facility.

4. Owner(s). Specify if Government departments / organizations / agencies, or companies. Indicate any that have defence responsibilities.

5. Operator(s). Specify if Government departments / organizations / agencies, or companies.

6. List sources of funding that are Government departments / organizations / agencies, other than to support the part/full time education of personnel.

7. Staff resources. Numbers of scientific/technical/ medical/veterinary staff and contractors in specified ranges [.../.../...].

Numbers of military staff in specified ranges [0/.../.../...].

8. Are there other essential scientific and technical functions integrated with the triggered function(s) but at a different location? An example may be an animal holding unit.

Yes / No

If Yes, specify: type of function, location and address for each.

9. General description of type of work. For example, specify if: military (oriented) R & D, testing or evaluation / other military / commercial R & D / commercial production / university / other educational / other non-profit.

BWC/AD HOC GROUP/38
Annex I
page 242

SCIENTIFIC AND TECHNICAL DETAIL

INFORMATION FOR THE FUNCTIONS OF THE FACILITY THAT ARE DECLARED

Fields of activity

If more than one function at the facility is triggered for declaration, return separate answers to questions 10 and 11 for each function

10. Trigger: Specify which trigger applies.

11. Is this triggered function associated with work in any of the following areas? Areas may include work that is inter alia research, development, testing, evaluation or production, other than purely diagnostic work for example in a medical, veterinary or food hygiene context.

(Answer Yes or No for each)

- Vaccines

- Other prophylaxis or therapy techniques for humans or animals

- Plant inoculants

- Pathogenicity, virulence, infectivity or stability in the environment of microbial or other biological agents or toxins, or resistance to antimicrobial agents

- Toxicity

- Studies involving genetic modification

- Aerobiology

- Detection, identification or diagnostic techniques

- Physical protection techniques

- Decontamination/disinfection techniques

- Insect/pest control techniques for use in agriculture/horticulture

- Production using fermenters

- Production of microbial or other biological agents or toxins other than in fermenters

12. If the declaration was triggered because of work with biological agents or toxins on the list at Annex, specify the agents worked with.

BWC/AD HOC GROUP/38
Annex I
page 243

INFORMATION FOR THE FACILITY AS A WHOLE

13. Does the facility as a whole perform any of the above studies other than those already specified in the answers to questions 10-12 above as associated with a trigger function?

Yes / No

If Yes, specify.

14. If vaccines are produced, list them.

15. Does the facility carry out production of microbial or other biological agents or toxins, other than as vaccines?

Yes / No

If Yes, specify the type(s) of product: antibiotic / pesticide / insecticide / plant inoculant / human or animal foodstuff / human or animal food additive / enzyme or enzyme source / fine chemical or fine chemical source / other (specify).

16. Containment areas.

(a) Does the facility have rooms/other enclosures with a maximum level of biological containment for human or animal pathogens, BL4 as specified in the 1993 WHO Laboratory Biosafety Manual) or equivalent?

Yes / No

If Yes, specify the floor area in ranges [up to 30 sq.m. / 31-100 sq.m. / over 100 sq.m.].

(b) Does the facility have rooms/other enclosures with a high level of biological containment for human or animal pathogens, BL3 (as specified in the 1993 WHO Laboratory Biosafety Manual) or equivalent?

Yes / No

If Yes, specify the floor area in ranges [up to 30 sq.m. / 31-100 sq.m. / over 100 sq.m.].

BWC/AD HOC GROUP/38
Annex I
page 244

(c) Does the facility have rooms/other enclosures with a high level of biological containment/quarantine for plants or plant pathogens?

Yes / No

If Yes, specify the floor area in ranges [up to 30 sq.m. / 31-100 sq.m. / over 100 sq.m.].

Equipment

OPTION A

Indicate any of the specified types of equipment that are present in the facility, regardless of whether or not the equipment is operational. For each item, indicate Yes or No, or indicate the range that applies, as appropriate.

OPTION B

Facility equipment information should be provided according to the trigger(s) that applies:

When the trigger ... applies, answer equipment questions .......... only

When the trigger ... applies, answer equipment questions .......... only

When the trigger ... applies, answer equipment questions .......... only etc.

Other indicators of scale of activity

17. Scale of use of tissue culture media.

State volume of tissue culture media used in ranges [0/.../.../...].

18. Scale of use of inoculated eggs for growth of microorganisms.

State number of eggs used in ranges [0/.../.../...].

19. Chemical reactors above 100 litres in capacity.

State aggregate reactor capacities, in ranges [101-1000 litres / over 1000 litres].

BWC/AD HOC GROUP/38
Annex I
page 245

[Vaccination requirements

20. Are there any areas which can only be entered by personnel who have been vaccinated?

Yes / No

If yes, are these areas in laboratories / production areas / downstream processing areas / other (specify).]

[International collaboration / co-operation

21. List any projects / activities funded or supported in any way by international organizations.]

BWC/AD HOC GROUP/38
Annex I
page 246

PART B¹¹⁹

Certain combination triggers specify two or more functions in a facility that do not have direct scientific or technical links. If such a trigger applies, answer the following questions:

GENERAL INFORMATION

Questions 1-3 in Part A are appropriate.

Questions 4-9 in Part A should be answered but in this case in respect of the functional areas at the facility that correspond to the trigger.

SCIENTIFIC AND TECHNICAL DETAIL

   When a facility is declared under a combination trigger, separate answers to questions 10 to 12 should be returned for each of the functional areas in the facility that correspond to the trigger:

10-12. As in Part A.

Questions 13-14 in Part A are not appropriate.

Questions 15-21 in Part A should be answered but in this case in respect of the functional areas at the facility that correspond to the trigger.

BWC/AD HOC GROUP/38
Annex I
page 247

PART C

ADDITIONAL INFORMATION FOR [FACILITIES] [TAKING PART IN] [MILITARY] [CIVILIAN] [NATIONAL] [BIOLOGICAL] DEFENCE [FACILITIES TAKING PART IN] PROGRAMME(S) [AGAINST BIOLOGICAL AND TOXIN WEAPONS]

1. State the aims and objectives of the [military] [civilian] [national] [biological] defence programme(s) [against biological and toxin weapons] work at the facility.

2. What are the funding levels for the [military] [civilian] [national] [biological] defence programme(s) [against biological and toxin weapons] work at the facility. If (parts of the) programme has shared objectives, for example shared with chemical defence, indicate approximate proportion of the funding that is shared.

3. What is the publication policy for the [military] [civilian] [national] [biological] defence programme(s) [against biological and toxin weapons] work at the facility?

4. Briefly describe the [military] [civilian] [national] [biological] defence programme(s) [against biological and toxin weapons] work at the facility.

5. Indicate on the list of biological agents and toxins at Annex, any agents or toxins worked on at the facility.

6. Does the facility include laboratory activities involved in routine medical / veterinary / phytopathology diagnosis? Yes / No

7. List of published papers, in scientific/ technical/medical/veterinary journals or in conference proceedings.]

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Footnotes

115. The draft text in Appendices A - D reproduces without change, the draft text in Appendices A - D of BWC/AD HOC GROUP/35. At this stage, no proposals for changes to the text were proposed. Initial discussions on Declaration Formats made clear that further consideration of the issues involved was necessary. Following these initial discussions, the Friend of the Chair tabled BWC/AD HOC GROUP/WP.185 to offer a basis for this further work.
116. Including viruses and prions.
117. The initial declarations should comply with the agreed format for declarations. Subsequent declarations should contain only necessary refinements of the initial information or an indication that there are "no declarable changes".
118. This work was presented by the Friend of the Chair for Compliance Measures as an interim step in the design of future declaration formats, in particular addressing whether formats need to differ according to the type of declaration trigger. In the view of the FOC, it may be useful for the present to consider two broad categories of trigger, referred to in earlier work of the Group as stand-alone triggers and combination triggers, because there may be different practical considerations in ensuring that these two categories of trigger achieve an appropriate focus in a facility declaration. This dichotomy is suggested by the FOC as a temporary expedient to aid the work of the Group, with the ultimate objective of declaration format(s) based on a simple, uniform relationship between the trigger and the focus of information required.
    Notwithstanding present uncertainties about the definition of the term 'facility' in the context of specific measures, many delegations felt that the declaration of a facility should reflect scientific and technical functions rather than geographic relationships. In the light of this, some felt that formats may have to treat certain combination triggers differently from stand alone triggers in order to avoid confusion about what information should be required for very large, multi-disciplinary facilities. To stimulate further consideration of this, the following suggests different approaches for these two trigger categories. It is clear that, until triggers are decided on by the Ad Hoc Group, and while such a range of options of stand alone and combination triggers exist, a simple and unequivocal declaration format cannot be attempted.
    Many delegations also felt that more information should be provided in declarations of biodefence facilities than in declarations of other facilities. There was a view that declaration formats for such 'other' facilities should be tailored to reflect the particular trigger especially in respect of equipment declared. To assist further consideration, the following draft formats contain options for equipment questions which the Ad Hoc Group could choose between in deciding on the final format.
    It was suggested that any information required on the existence and content of national regulations/guidelines relating to health & safety, including for work involving genetic modification, or relating to good laboratory practice or good manufacturing practice, should be provided as a national declaration by the State Party rather than in the declaration return for a declared facility.
    Declared information will be passed to all States Parties to the Protocol. Accordingly, the design of the declaration formats is intended to avoid reference to confidential proprietary information or national security information. [However, procedures need to be developed for handling and protecting such information should the need arise.]
    A list of equipment is being developed by the Friend of the Chair on Definitions of terms and objective criteria in the context of declaration formats.
119. To save paper in the work of the Group, this text of this draft is not provided in full, but differences from the format for single triggers are indicated.