Rolling Text (9th Session) : Appendices

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Rolling Text (9th Session) : Appendices

The Appendices to the Rolling Text are provided below. This material is from the 9th Session of the Ad Hoc Group of States Parties to the Convention.

Please note: the page numbers given are those which appear in the original text, these appear at the top of the page. The detailed footnotes are provided at the end of the main text.

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BWC/AD HOC GROUP/39
Annex 1
page 231

APPENDICES

BWC/AD HOC GROUP/39
Annex 1
page 232

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/39
Annex 1
page 233

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 microorganisms or toxins, as well as materials imitating their properties].]

BWC/AD HOC GROUP/39
Annex 1
page 234

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.

(a) Total number of personnel __________________

(b) Division of personnel:

Military __________________

Civilian __________________

Scientists __________________

Engineers __________________

BWC/AD HOC GROUP/39
Annex 1
page 235

Technicians __________________

Administrative and support staff __________________

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

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

(f) 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?

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

Research ________________________

Development ________________________

Test and evaluation ________________________

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

(i) Provide a list of publicly available 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 microorganisms¹³⁴ and/or toxins studied, as well as outdoor studies of biological aerosols [any work with biological aerosols, including open air test ranges, aerosolization activities, work with test chambers].]

BWC/AD HOC GROUP/39
Annex 1
page 236

[6. The initial and subsequent annual declarations¹³⁵of facilities participating in the biological weapon protection programme and carrying out work on any microorganisms 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 BL4 level of biosafety.

- The presence of types of key equipment.]

BWC/AD HOC GROUP/39
Annex 1
page 237

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/39
Annex 1
page 238

[APPENDIX D

INFORMATION TO BE PROVIDED IN DECLARATIONS OF OTHER FACILITIES¹³⁶

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.

BWC/AD HOC GROUP/39
Annex 1
page 239

[[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 listed agents or toxins:

(a) Name of facility.

(b) Location (address and geographical location).

[For facilities with BL4 protected areas (Biosafety Level 4 (BL4) according to WHO Classification) or P4 (according to WHO Classification) or equivalent standard:

1. Name of facility.

2. Location (address and geographical location).

3. Ownership (government department or company).

4. Area of laboratories with Biosafety Level 4 (BL4), in square metres.

5. Indicate listed agents and toxins on which work is carried out.

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

6. Indicate the main areas of activity in the facility (development of preventive agents and methods, observation, identification; genetic manipulation; aerobiology; toxinology; disinfection and other activities related to the purposes of the Convention).]

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

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

BWC/AD HOC GROUP/39
Annex 1
page 240

[For facilities (except for diagnostic facilities) at which work is carried out on listed agents or toxins:

- Name of facility.

- Location (address and geographical location).

- Ownership (government department or company).

- Indicate the listed agents and toxins on which work is being carried out.

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

- Indicate all equipment present according to the following list:

... .]

[For facilities with equipment for production in the open air of aerosols with particle size not greater than 10 micrometres of any microorganisms or toxins, as well as materials that imitate their properties:

1. Name of facility.

2. Location (address and geographical location).

3. Ownership (government department or company).

4. List the microorganisms or toxins, as well as materials that imitate their properties, on which work is being carried out.

5. Indicate the main areas of activity of the facility (development of means and methods of prophylaxis, detection and isolation; genetic manipulation; aerobiology; toxinology; disinfection and other activities related to the purposes of the Convention).]]

BWC/AD HOC GROUP/39
Annex 1
page 241

PART A¹³⁷

Information is required for [facility activities] [the following functions/activities at the site] not involving commercial proprietary or national security information:

[(a) The triggered function/activity, that is the function/activity at the site which has been triggered for declaration.

[(b) Specified linked functions/activities at the site (see question 12).]

[(c) Other activities at the site. A general description only is required (see question 21).]]

Complete separate declaration formats for each triggered function/activity.138

GENERAL INFORMATION ABOUT THE TRIGGERED FUNCTION/ACTIVITY

1. Precise location including postal address and/or street address.

2. Scale map of the locality, showing the declared facility.

3. Owner(s). Specify if wholly or partly owned by government or a defence organization.

4. Operator(s). Specify if government departments/organizations/agencies, or companies.

5. List sources of funding for the triggered function/activity that are government departments/organizations/agencies, other than to support the part/full time education of personnel.

6. Staff resources. Estimate the total number of personnel (staff and contractors) man years involved in work on the declared function/activity, combining the following categories of personnel:

- Those who work full time on the declared function/activity;

- Those who work part time on the declared function/activity; and

- Those who divide their time between the declared and other functions/activities.

BWC/AD HOC GROUP/39
Annex 1
page 242

(a) Number of scientific/technical/medical/veterinary personnel (as a single total).

Specify which range applies: [1-10 / 10s / 100s / 1000s].

(b) Number of military personnel.

Specify which range applies: [0 / 1-10 / 10s / 100s / 1000s].

[(c) Number of reservist military personnel.

Specify which range applies: [0 / 1-10 / 10s / 100s / 1000s].]

[7. Is the triggered function/activity supported by an animal holding unit or a waste treatment/disposal plant at a location other than that indicated above?

Yes / No

If yes, specify, and provide the location and address for each such unit or plant.]

8. General description of type of work. For example, specify if: military (oriented) research and development, testing or evaluation/other military/commercial research and development/commercial production/university/other educational/other non-profit.

SCIENTIFIC AND TECHNICAL INFORMATION

[Information for the triggered function/activity

Fields of activity]

9. Trigger: Specify which trigger applies.¹³⁹

10. Is this triggered function/activity involved in work in any of the following subject areas? Such work may be, inter alia, research, development, testing, evaluation or production. Purely diagnostic work, for example in a medical, veterinary or food hygiene context, need not be declared. Work performed purely in order to set up standard operating procedures for equipment at the facility need not be declared.

(a) Vaccines¹⁴⁰ Yes / No

(b) Other prophylaxis or therapy techniques for humans or animals Yes / No

BWC/AD HOC GROUP/39
Annex 1
page 243

(d) Pathogenicity, virulence, infectivity or stability in the environment Yes / No

of microbial or other biological agents or toxins, or resistance

to antimicrobial agents

(e) Toxicity Yes / No

(f) Studies involving genetic modification Yes / No

(g) Aerobiology¹⁴¹Yes / No

(h) Detection, identification or diagnostic techniques Yes / No

(i) Physical protection techniques Yes / No

(j) Decontamination/disinfection techniques Yes / No

(k) Insect/pest control techniques for use in agriculture/horticulture Yes / No

(l) Production¹⁴²using fermenters Yes / No

(m) Production¹⁴³ of microbial or other biological agents or toxins Yes / No

other than in fermenters

11. If the triggered function/activity includes work with biological agents or toxins on the list at Annex, specify the agents worked with by annotating the corresponding entry in the list [as 'T'].

[Information for any specified linked functions/activities¹⁴⁴

12. Does the triggered function/activity have any links involving the cooperative handling of microbial or other biological agents or toxins, with the following areas at this site:

(a) Laboratories Yes / No

(b) Animal houses Yes / No

(d) Waste treatment areas Yes / No

[If yes, indicate whether such linked areas:

[- Work in any additional subject areas on the list at question 10. If so, indicate which areas by annotating the corresponding entry in the list as 'A'.]

BWC/AD HOC GROUP/39
Annex 1
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[- Handle any additional biological agents or toxins in the list at Annex. If so, indicate which agents or toxins by annotating the corresponding entry in the list at Annex as 'A'.]]]

[Information for all the above declared functions/activities]

13. If vaccines are produced, list them.¹⁴⁵

Containment areas

14. (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 ¹⁴⁶

[If Yes, specify the floor area of the working areas (for example, excluding shower areas) 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 of the working areas (for example, excluding shower areas) in ranges [up to 30 sq.m. / 31-100 sq.m. / over 100 sq.m.].]

(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.].]

BWC/AD HOC GROUP/39
Annex 1
page 245

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 size 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. etc.

Scale of production

15. If the answer to questions 10 (l) or (m) was "Yes", provide the following information:

- 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/proteins other than enzymes/other (specify).

- If more than one product applies, indicate which type constitutes the major activity.

- State, if any items were produced for general sale or use, either directly or after further processing, formulation or packaging.

Information on aggregate capacity of fermenters has been provided above under "Equipment". Provide the following additional information:

16. Scale of use of tissue culture media used in the previous year.

Specifiy which range applies: [up to a 1000 litres / 1000s of litres / 10,000s of litres].

17. Scale of use of inoculated eggs for growth of microorganisms used in the previous year.

Specifiy which range applies: [up to a 1000 eggs / 1000s of eggs / 10,000s of eggs].

BWC/AD HOC GROUP/39
Annex 1
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18. Chemical reactors above 100 litres in capacity.

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

[Vaccination requirements

19. 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). [List any vaccines that apply.]]

[International collaboration/cooperation

20. List any projects/activities funded or supported in any way by [international organizations] [by other states and/or intergovernmental or non-governmental organizations¹⁴⁷].]

[ADDITIONAL INFORMATION FOR SITES COMPRISING FUNCTIONS/ACTIVITIES OTHER THAN THOSE DECLARED ABOVE

21. If the site comprises functions/activities other than those declared above, provide a general description of the type of work at the site as a whole. For example, specify if: military (oriented) research and development, testing or evaluation/other military/commercial research and development/commercial production/university/other educational/other non-profit.]

BWC/AD HOC GROUP/39
Annex 1
page 247

PART B

Information is required for [facility activities] [the following functions/activities at the site] which are projects supporting [facilities] [which as their main task are] [taking part in] [military] [civilian] [national] [biological] defence [facilities taking part in] programme(s) [against biological and toxin weapons [as per listed agents and toxins]] [and conducting work on microorganisms or toxins as well as material imitating their properties] [not involving commercial proprietary or national security information]:

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.]

Notes

134. Including viruses and prions.

135. 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".

136. This work was presented by the Friend of the Chair on 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 Friend of the Chair, 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 Friend of the Chair 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, multidisciplinary facilities.

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 and 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.

137. A view was expressed that if the Protocol includes one or more combination triggers, some of the questions in part A may be redundant and some may have to be reformulated.

138. A view was expressed that separate declaration formats should be completed for each 'element' in any combination trigger used in the Protocol.

139. A view was expressed that this question should be stated early in the declaration format.

140. To be defined.

141. To be defined.

142. A view was expressed that production would have to be defined as above a specified threshold, in order to rule out normal laboratory scale of work.

143. A view was expressed that production would have to be defined as above a specified threshold, in order to rule out normal laboratory scale of work.

144. A view was expressed that information under this item could be submitted on a voluntary basis.

145. A view was expressed that this question was not needed here as it should be the subject of dedicated declaration formats where it would be the trigger question.

146. A view was expressed that this question was not needed here as it should be the subject of dedicated declaration formats where it would be the trigger question.

147. A view was expressed that information under this item could be submitted on a voluntary basis.

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