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.]

[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.

- 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.

- 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).]]

PART A¹³²

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.¹³³

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.

(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.¹³⁴

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) Vaccines¹³⁵ Yes / No

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

(c) Plant inoculants Yes / No

(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) Aerobiology¹³⁶ Yes / 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) Production¹³⁷ using fermenters Yes / No

(m) Production¹³⁸ 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/activities¹³⁹

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

(c) Production areas 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'.]

[- 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.¹⁴⁰

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 ¹⁴¹

[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.].]

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.

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].

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 organizations¹⁴²].]

[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.]

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.]

APPENDIX E

[LIST OF APPROVED INVESTIGATION/VISIT EQUIPMENT

 

	Description	Notes
	SAMPLING AND IDENTIFICATION EQUIPMENT143
1	Sample tubes and microbiological transport media
2	Containers for samples
3	Preserving media (i.e. formalin, alcohol, silica gel)
4	Forceps (various sizes)
5	Post mortem instruments: Scissors, scalpels, bone forceps	Other post mortem instruments to be added.
6	Syringes and needles for blood samples
7	Thermometers and probes
8	Incinerator and disinfectant tanks/sprays
9	Biohazard bench, glove box
10	Gas burners and gas
11	Microscopes, stains and slides
12	Culture media: Diploid cell culture media	Other types of culture media may be added.
13	Autoclave/pressure cooker
14	Incubator and anaerobic equipment
15	Freezer: -70°C best/dry ice
16	Refrigerator
17	Portable PH metre/millivolt metre with ion-specific electrodes
18	Glucose analyser
19	Dissolve oxygen metre
20	Pruning shears
21	Spades and plastic bags for ground samples
22	Soil augers
23	Water sampling equipment including filter disks
24	Portable water pump
25	Liquid nitrogen in cylinders
26	Seals (fibre optic and packages)
27	Seals (frangible, fractural, adhesive)
28	Vacuum sealing equipment
29	Plastic bags for vacuum packing of samples
30	Tags/tie on/markers (permanent)
31	Centrifuge
32	Portable spectroscopic analyser
33	Portable flow cytometers
34	Thermal cyclers
35	Pipettes
36	Freeze drying equipment (lyophilizers)
37	Water baths
38	Hand held test kits
39	Diagnostic kits: ELISA based detection systems	Other types of diagnostic kits to be added.
40	Sampling equipment for: Air samples Surface samples Fluid samples other than water	Pieces of equipment to be identified in detail.
41	Mobile blood gas analyser
42	Blood cell counters - Coulter counters
	PROTECTIVE EQUIPMENT
1	Protective clothing
2	Boots (disposable)
3	Protective gloves with liners
4	Protective masks (military type)
5	Spare canisters (military)
6	Spare canisters (industrial)
7	Surgical gloves
8	Safety goggles
9	Leather work gloves
10	Industrial safety helmet
11	Hearing protection
12	Cotton coveralls
13	Disposable coveralls
14	UV protective glasses
15	Water bottle
16	Flashlight explosion proof
17	First aid kits (personal)
18	Self-contained breathing apparatus (SCBA)
19	Respirator (industrial)
20	Equipment bags
21	Mask fit test kit
22	Cooling vest
23	Cold weather gear
24	Safety lantern
25	Safety shoes
26	Flammability/explosive/air quality/monitor
27	Mosquito nets
28	Insect repellent
29	Water filter kit
	MEDICAL EQUIPMENT
1	General first aid kit containing necessary antibiotics, vaccines and other medicine
2	Patient monitoring equipment - EKG, pulse oximeter
3	General medical examination equipment such as sphygmomanometer, ophthalmoscope/otoscope, patella hammer	Other pieces of equipment to be added.
	ADMINISTRATIVE EQUIPMENT
1	Portable photo-copying machine
2	Portable document scanner
3	Portable document shredder
4	Waterproof pens
5	Tape measure (3 m, 30 m, 100 m)
6	Callipers and steel ruler
7	Maps	Geographic maps necessary for a specific field investigation procured for that investigation.
8	Graph paper, pencils and labels
9	Calculator
10	Computer (notebook) with printer/plotter and modem
11	Satellite link telephones
12	Portable fax machines
13	Exterior extension cords
14	Secure voice telephone
15	Short-range radios
16	Electric plug-socket adaptors
17	Portable over-head projector
18	Image transmission equipment	This aspect needs further discussion.
	OTHER TECHNICAL EQUIPMENT
1	Maintenance tool kit
2	Equipment transport containers
3	Global positioning system (GPS)
4	Weighing equipment
5	Polaroid-type camera with flash, zoom, macro lens systems and films
6	35 mm camera with flash, zoom, macro lens systems and films
7	Digital video camera - portable video player with tapes
8	Audio (tape) recorder with tapes
9	Binoculars
10	Data scope
11	Night-vision scope
12	Magnifying glass
13	Rechargeable batteries (Ni-Cd) and battery chargers
14	Shoulder bag
15	Tool belt
16	Compass
17	Thermochromic tape packages
18	Electrical power generators
19	Barometer, anemometer, hygrometer with recording attachments	For use in establishing background conditions which might influence survival of microorganisms.
20	Wet bulb globe thermometer
21	[Chemical agent monitor]
	NON-DESTRUCTIVE EVALUATION EQUIPMENT
1	Portable X-ray equipment
2	Ultrasonic pulse echo

]

Notes

^129. Including viruses and prions.

¹³⁰. 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".

¹³¹. 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.

¹³². 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.

¹³³. A view was expressed that separate declaration formats should be completed for each  'element' in any combination trigger used in the Protocol.

¹³⁴. A view was expressed that this question should be stated early in the declaration format.

¹³⁵. To be defined.

¹³⁶. To be defined.

¹³⁷. 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.

¹³⁸. 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.

¹³⁹. A view was expressed that information under this item could be submitted on a voluntary basis.

¹⁴⁰. 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.

¹⁴¹. 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.

¹⁴². A view was expressed that information under this item could be submitted on a voluntary basis.

¹⁴³. The list of sampling equipment will depend on whether analyses will be done on-site or off-site.

 Other Ad Hoc Group Documents

File updated 24 May 1999.