Proposals for further consideration by the Friend of the Chair on Investigations

APPENDIX C

FACILITIES

Guidelines⁵⁰ for completing the declaration format

1. The facility declaration format requires information on facilities meeting the criteria set out in one or more of the declaration triggers of the Protocol. Such facilities are referred to throughout the format as the “declared facility”. The (appropriate)⁵¹ format is to be utilized by declared facilities to report activities captured by declaration triggers.

2. The design of the format takes account of the differing sizes, complexities and scope of facilities satisfying the requirements of one or more of the Protocol declaration triggers. It is recognized that in some cases the rooms etc. that satisfy the requirements of the trigger - and that therefore are to be the declared facility - may involve only part of a building. Indeed, the facility declarable under the Protocol may be at a location with a large number of other facilities engaging in activities that are not declarable.

3. The facility declaration format is designed to cover this range of possibilities. The facility to be declared is the combination of room(s), etc.⁵² which carried out activities during the reporting calendar year that satisfied the requirements of a specific declaration trigger. Where that exact same combination of rooms etc. also satisfies a different trigger, such a combination shall be declared as the same facility (i.e. as a single facility). When the combination of rooms etc. that satisfies a different trigger is not identical, it shall be treated as a separate declarable facility.⁵³

4. When scientific/technical activities which may require declaration under a particular trigger are conducted in different parts of a location, for example in different buildings and/or departments at a university campus or at a commercial installation operated by a single company, and they share one or more rooms etc. they shall be considered as a single facility for the purpose of determining whether a declaration should be made. Scientific/technical activities at the same location that meet the criteria of one or more declaration triggers but do not share one or more rooms etc. shall be considered as separate facilities for the purpose of declaration.

5. Each declared facility shall answer the questions in sections A and B and, according to the trigger[s] involved, the following questions in section C:

Text under Option One, Option Two and Option Three in BWC/AD HOC GROUP/51 (Part I) remains unchanged.

Option Four

When a declared facility has engaged in activities meeting the criteria for more than one of the declaration requirements set out in Article III, section D, subsection I, it shall answer the questions in section B and C for each of the declaration requirements.

Common text

SECTION (A) GENERAL INFORMATION

...

[16.⁵⁴ Fields of activity at the declared facility

Did the work include research and development, testing and evaluation, or [production] [manufacturing] Indicate by ticking the appropriate box whether in any work was carried out in of the following areas. (tick all that apply)? Work performed only in order to establish and carry out routine procedures or to maintain safety at the declared facility shall not be reported.

n.a. = not applicable

* Toxinology is the study of toxins. ]

...

[26.⁵⁵ If the facility conducted work with agents and/or toxins listed in Annex A, whether or not it satisfied the declaration trigger for work with listed agents and/or toxins, provide the following information:

OR

[26. If the facility conducted work with agents and/or toxins listed in Annex A, whether or not it satisfied the declaration trigger for work with listed agents and/or toxins, provide the following information:

(a) List the agents worked with:

...........................................................................................................................................................................

...........................................................................................................................................................................

 

(b) Estimate the quantity of human, animal or plant pathogen agents produced, as a single total for all agents, in ranges of litres of culture or of working suspensions of agents:

up to x

x to y

above y

 

(c) Estimate the quantity of toxins produced, as a single total, in ranges of dry weight or wet packed weight, in grams:

 

up to x

x to y

above y

 

OR

[26.⁵⁶ Indicate if declared activities at the declared facility utilized toxins or [pathogenic strains of] agents listed below: ]

...

YES / NO

...

YES / NO]

26 bis Indicate whether any agents and/or toxins listed in Annex A were transferred outside the declared facility for any of the following purposes:

To perform further studies in research and development, testing or evaluation?						YES / NO
For larger scale production?						YES / NO
For downstream processing?						YES / NO
For animal studies?						YES / NO
For aerobiology studies?						YES / NO

...

30. Were declared activities at Was the declared facility supported at the same location or elsewhere by:

A fixed outdoor site or fixed grid that is designed, intended and used for outdoor studies of biological aerosols?	YES / NO
An experimental facility for animals, or an animal holding facility?	YES / NO
A waste decontamination facility?	YES / NO
A facility for larger scale production, or for downstream processing?	YES / NO

[31. Were any agents and/or toxins listed in Annex A transferred between the declared facility and any other areas at the same location or at a different location (indicate which)?

Same location				YES / NO
Different location				YES / NO

If yes, were any of these other areas at the same location:

Laboratories			YES / NO
Animal houses			YES / NO
Production areas			YES / NO
Areas involved in downstream processing, formulation or packaging			YES / NO
Waste treatment areas			YES / NO
Areas involved in field testing or evaluation			YES / NO ]

...

35. Vaccine production

If the declared facility satisfied the requirements of the declaration trigger for vaccine production, provide the following information for any vaccine ingredients and/or vaccines produced:

Provide the following information for the production of microorganisms or substances causing a [specific] [protective] immune response as an ingredient of a vaccine at the facility declared in accordance with paragraph 10 of Article III, section D, subsection I:

] OR

[(a)

(b) Estimate the total quantity of ingredients produced, as a single total number of dose equivalents of the corresponding vaccines, in ranges:

[ up to 25,000

25,000 to 1,000,000

above 1,000,000 ]]

(a) List the vaccine ingredients produced:

Ingredient	Intended for (tick which applies)		Disease against which the vaccine is directed	Production objectives*
	Human vaccine	Animal vaccine

* Production objectives: A - Public sale or use; B - Defence ministry/department/agency; C - Both

(b) Estimate the total quantity of vaccine ingredients produced (tick the appropriate box):

Intended for	Highest level of containment used in any production		Quantity of vaccine ingredients produced (Litres of culture or of bulk working suspension)
	BL3	BL4	up to 1,000	1,000 to 10,000	above 10,000
Human vaccine
Animal vaccine

(c) List the vaccines produced:

* Production objectives: A - Public sale or use; B - Defence ministry/department/agency; C - Both

(d) Estimate the total quantity of vaccine produced (tick the appropriate box):

Intended for use with	Highest level of containment used in any production		Aggregate number of doses* produced
	BL3	BL4	up to 100,000	100,000 to 5,000,000	above 5,000,000
Humans
Animal 1 ...
Animal 2 ...
...

* State the number of doses produced as an aggregate value for all vaccines intended for use with humans or for each type of animal, as appropriate, in terms of the estimated dose for adults even if a vaccine is intended for use with children or immature animals. ]

OR

Vaccine	Registration/ licence number	Number of doses* produced
		up to 1,000,000	1,000,000 to 5,000,000	above 5,000,000

* State the number of doses produced in terms of the estimated dose for adults even if a vaccine is intended for use with children or immature animals. ]

36. Maximum biological containment (BL-4 - ...)

If the declared facility satisfied the requirements of the declaration trigger for maximum biological containment (BL-4 ...), provide the following information:

(a) Estimate the total floor area of the BL4 containment area, by indicating which range applies:

up to 40 sq.m

41 to 100 sq.m.

100 to 500 sq.m.

. over 500 sq.m.

[(b) Indicate the number of units: . . . ]

[(c) Indicate whether the contained area includes any unit(s) are for the management and/or treatment of patients:

YES / NO]

[(d) Indicate whether work in these laboratories was carried out on:

Human pathogens					YES / NO
[Zoonotic pathogens					YES / NO
Other] animal pathogens					YES / NO
Toxins					YES / NO
Plant pathogens					YES / NO]

[(e) Method/system of decontamination of the biocontainment area(s) (check all that apply):

 

Formaldehyde/paraformaldehyde				YES / NO]
Ultraviolet light				YES / NO
Steam				YES / NO
Chlorine/perchlorate				YES / NO
Hydrogen peroxide				YES / NO
Washdown				YES / NO
Other, specify:				]

(f) Indicate all biological agents on which genetic modification was conducted to enhance pathogenicity, virulence, stability or resistance to antibiotics or chemical or physical methods of disinfection, or which altered the host range, the infection route or the ease of identification or diagnosis, within a high biological containment facility (BL3):

...........................................................................................................................................................................

38. Work with listed agents and/or toxins

Did the declared facility satisfy the requirements of the declaration trigger for work with listed agents and or toxins?

YES / NO

If yes, indicate which activities it has conducted:

(a) Production [with the purpose of recovery] of [one or more] [any single] agent[s] and/or toxin[s] listed in Annex A, using:

(i) Any fermenter(s)/bioreactor(s) with a total internal volume of [10] [25] [50] [100] litres or more

YES / NO

(ii) Continuous or perfusion fermenters/bioreactors with a flow rate capable of exceeding [2] litres an hour

YES / NO

(iii) A chemical reaction vessel or equipment used for recovery with a total internal volume of [10] [50] [100] litres or more

YES / NO

(iv) More than [1,000] [2,000] embryonated eggs on an annual basis

YES / NO

(v) More than 1,000 litres of tissue culture or other medium on an annual basis

YES / NO

(b) Intentional aerosolization of any agent and/or toxin listed in Annex A in:

(i) A static aerosol test chamber

YES / NO

(ii) An explosive aerosol test chamber

YES / NO

(iii) A dynamic aerosol test chamber that has a total volume exceeding 5 m3

YES / NO

[If yes, provide the following information:

]

OR

[

* With reference to question 16.

* With reference to question 16. ]

[(c) Did the facility conduct insertion of any nucleic acid sequence coding for any pathogenicity/virulence factor or for any toxin or subunit of any toxin, into an agent listed in Annex A?

YES / NO

If yes, name the agent(s) and the toxin(s) and give a short description of the purpose:

...........................................................................................................................................................................

...........................................................................................................................................................................

(d) Did the facility conduct insertion of any nucleic acid sequence coding for any pathogenicity/virulence factor from an agent or toxin listed in Annex A, or for a subunit of such toxin into any microorganism, resulting in a genetically modified organism with disease-causing or toxic properties?

YES / NO

If yes, name both organisms or toxins and give a short description of the purpose:

...........................................................................................................................................................................

...........................................................................................................................................................................

(e) Did the facility conduct intentional aerosolization of any agent and/or toxin listed in Annex A or any work with aerosolized agents and/or toxins listed in Annex A?

YES / NO

If yes, name the agent(s) or toxin(s) and give a short description of the purpose:

...........................................................................................................................................................................

...........................................................................................................................................................................

(f) Did the facility conduct the administration of any agent and/or toxin listed in Annex A to animals via the respiratory tract?

YES / NO

If yes, name the agent(s) or toxin(s) and give a short description of the purpose:

...........................................................................................................................................................................

...........................................................................................................................................................................

]

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