ANNEX A

DECLARATIONS

I. LISTS AND CRITERIA (AGENTS AND TOXINS)⁵⁶

1. The list of agents and toxins following below is for use with [specific measures in particular] [Article III,] [Article III, section D, subsection I, paragraphs ...] [and section F].

[2. The following criteria were used for developing the list of agents and toxins, [and] when considering the matters whether an agent or toxin should be included in the list they should be taken into account:

- Agents or toxins known to have been developed, produced or used as weapons;
- Agents or toxins which have severe public health and/or socio-economic effects;
- High morbidity, incapacity and/or mortality rates;
- Low infective/toxic dose;
- High level of transmissibility and/or contagiousness;
- Low effective or cost-effective prophylaxis, protection or treatment available;
- Ease of production and/or dissemination;
- Stability in the environment;
- Short incubation period and/or difficult to diagnose/identify at an early stage.]

[2 bis The following criteria [in subparagraph (a) and the additional factors in subparagraphs (b) and (c)] were considered in developing the list of agents and toxins and shall be considered, inter alia, in reviewing any proposed modifications to the list:

(a) The potential of individual agents and toxins for use as weapons;

[For example, whether they are known to have been developed, produced, stockpiled or used as weapons; would have severe adverse socio-economic and/or public health effects; are difficult to diagnose and identify; have short incubation and high morbidity, incapacity and/or mortality rates; have a lack or limited availability of effective and economical prophylaxis and/or treatment; have a low infective or toxic dose; are easily produced and/or disseminated; are stable in the environment; and/or are highly contagious or easily transmissible.]

[In reviewing the list of agents and toxins the Executive Council shall consider, inter alia, the above-mentioned criteria as well as the following factors:]

(b) Scientific and technological developments that may affect the potential of individual agents or toxins for use as weapons;

(c) Effects of potential inclusion or exclusion of an agent or toxin in the list on scientific and technical research and development.]⁵⁷

[REVISION OF THE LIST]

3. Any State Party may propose modifications to the list. The Executive Council shall review such proposed modifications to the list of agents and toxins. Any changes to the list shall be made in accordance with Article[(s) III and] XIV.⁵⁸

4. The list is not exhaustive, it does not exclude the relevance for the Protocol of unlisted microbial or other biological agents or toxins which potentially can be used as weapons [or vectors] [such as pests, arthropods and helminths].

[5. In accordance with Article XI, this list shall not be interpreted as in any way modifying or amending the Convention.]

[6. The microorganisms enumerated in the lists of human, animal and plant pathogens do not include live-attenuated strains which have been registered as such in official culture collections or are internationally recognized as such.]

7. Pathogens causing zoonotic diseases appearing in one section of the list shall also apply to the other sections.

A. HUMAN AND ZOONOTIC PATHOGENS

Viruses

1. Crimean-Congo haemorrhagic fever virus
2. Eastern equine encephalitis virus
3. Ebola virus
4. Sin Nombre virus
5. Junin virus
6. Lassa fever virus
7. Machupo virus
8. Marburg virus
9. Rift Valley fever virus
10. Tick-borne encephalitis virus
11. Variola major virus (Smallpox virus)
12. Venezuelan equine encephalitis virus
13. Western equine encephalitis virus
14. Yellow fever virus
15. Monkeypox virus

Bacteria

1. Bacillus anthracis
2. [Brucella abortus]
3. Brucella melitensis
4. [Brucella suis]
5. Burkholderia mallei
6. Burkholderia pseudomallei
7. Francisella tularensis
8. Yersinia pestis
9. Coxiella burnetii
10. Rickettsia prowazekii
11. Rickettsia rickettsii

[Protozoa

1. Naegleria fowleri
2. Naegleria australiensis]

B. ANIMAL PATHOGENS

Bovine pathogens

1. [Contagious bovine (pleuropneumonia)/Mycoplasma mycoides var. mycoides]
2. [Foot and mouth disease virus]⁵⁹
3. Rinderpest virus
4. [Vesicular stomatitis virus]

Ovine pathogens

5. [Peste des petits ruminants virus]
6. [Blue tongue virus]

Swine pathogens

7. African swine fever virus
8. [Classic swine fever virus (Hog cholera virus)]
9. [Teschen disease virus (Porcine enterovirus type 1)]

Avian pathogens

10. [Avian influenza virus (Fowl plague virus)]
11. [Newcastle disease virus]

Equine pathogens

12. [African horse sickness virus]

C. PLANT PATHOGENS

Cereal pathogens

1. [Puccinia graminis]
2. Tilletia indica
3. [Claviceps purpurea]

Sugar cane pathogens

4. [Sugar cane Fiji disease virus]
5. Xanthomonas albilineans

Cash crop pathogens

6. Colletotrichum coffeanum var. virulans
7. [Erwinia amylovora]
8. [Ralstonia solanacearum]
9. [Xanthomonas campestris pv citri]
10. [Sclerotinia sclerotiorum]
11. [Peronospora hyoscyami de Bary f.sp. tabacina (Adam) skalicky]

Forest pathogens

12. [Dothistroma pini (Scirrhia pini)]

[Thrips palmi Karny Frankliniella occidentalis]⁶⁰

D. TOXINS

Bacteriotoxins

1. Botulinum toxins
2. Clostridium perfringens toxins
3. Staphylococcal enterotoxins
4. Shigatoxins

Phycotoxins

1. Anatoxins
2. Ciguatoxins
3. Saxitoxins

Mycotoxins

1. Trichothecene toxins

Phytotoxins

1. Abrins
2. Ricins

Zootoxins

1. Bungarotoxins

 

II. LIST OF EQUIPMENT⁶¹

The following list of equipment shall be a component of the reporting format for facilities declared pursuant to Article III, section D [and as an illustrative list of equipment in the context of a facility investigation]. [It may also be used as provided for in Annex D, section III, paragraph 38.]

[1. Dynamic, static and explosive aerosol chambers designed or used for the dissemination of aerosols of microorganisms [or toxins of particles mass median diameter not exceeding 10 micrometres].

(a) Total chamber working volume range which applies to equipment present:

up to 0.2 m3				Yes / No
0.2 - 1.9 m3				Yes / No
2 - 4.9 m3				Yes / No
5 - 10 m3				Yes / No
over 10 m3				Yes / No

(b) Have any been operated at any time during the year

under high biological containment				under maximum biological containment
Yes / No				Yes / No

]

[1 bis Aerosol chambers designed or used for the dissemination of aerosols of microorganisms or toxins [and simulants].

(a) Are dynamic aerosol chambers present:

Yes / No

If Yes, complete the following:

(i) Specify volume(s) of chamber(s) present:

less than 0.2 m3				Yes / No
0.2 - 5 m3				Yes / No
5 - 30 m3				Yes / No
over 30 m3				Yes / No

(ii) Were any of the aerosol chambers used at any time during the previous calendar year:

under high biological containment				under maximum biological containment
Yes / No				Yes / No

(b) Are static aerosol chambers present:

Yes / No

If Yes, complete the following:

(i) Specify volume(s) of chamber(s) present:

up to 0.2 m3				Yes / No
0.2 - 1.9 m3				Yes / No
2 - 4.9 m3				Yes / No
5 - 10 m3				Yes / No
over 10 m3				Yes / No

(ii) Were any of the aerosol chambers used at any time during the previous calendar year:

under high biological containment				under maximum biological containment
Yes / No				Yes / No

(c) Are explosive aerosol chambers present:

Yes / No

If Yes, complete the following:

(i) Specify volume(s) of chamber(s) present:

less than 0.2 m3				Yes / No
0.2 - 5 m3				Yes / No
5 - 30 m3				Yes / No
[30 - 100 m3				Yes / No
over 100 m3				Yes / No]

(ii) Were any of the aerosol chambers used at any time during the previous calendar year:

under high biological containment				under maximum biological containment
Yes / No				Yes / No

]

[1 ter Aerosol chambers (either static, dynamic, or explosive)

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

If present or utilized, respond to the following questions:

(a) Indicate the type(s) of activities conducted by or in these aerosol systems or chambers.

___ Static tests (Study of aerosol properties)
___ Dynamic tests (Study using aerosol flows)
___ Explosive tests (Explosive/shock wave dissemination of aerosols)
___ Other (specify) ..............................................................................

(b) What is the volume of the largest chamber used?

Static

___ Equal to or less than 10 cubic metres
___ More than 10 cubic metres
___ Not applicable, no static chambers used

Explosive

___ Equal to or less than 10 cubic metres
___ More than 10 cubic metres
___ Not applicable, no explosive chambers used

Dynamic

___ Equal to or less than 10 cubic metres
___ More than 10 cubic metres
___ Not applicable, no dynamic chambers used

]

2. Equipment designed or used to generate aerosols of microorganisms or toxins [and simulants].

(a) Form of source material used to generate aerosol(s) (check all that apply):

___ liquid
___ solid
___ not applicable

(b) Mass median diameter of aerosol particles generated (check all that apply):

___ less than 10 microns
___ 10 - 20 microns
___ over 20 microns

(c) For which purpose was the equipment used:

Aerosol chambers				Yes / No
Open-air release				Yes / No
With experimental animals				Yes / No
Not applicable				Yes / No

3. Aerosol analytical equipment to determine the size of particles up to 20 micrometers in diameter.

[4. Aggregate fermenters/bioreactors capacity.

(a) Volume range.

Specify which range applies:

up to 100 litres				Yes / No
101-1,000 litres				Yes / No
1,001-10,000 litres				Yes / No
10,001-100,000 litres				Yes / No
over 100,000 litres				Yes / No

(b) Specify the volume of the largest fermenter/bioreactor.]

5. Fermenters/bioreactors for batch operation with a volume over [300] litres.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

primary production containment				under high biological containment				under maximum biological containment
Yes / No				Yes / No				Yes / No

[5 bis Indicate the presence, utilization, and containment usage of the following equipment at the declared facility (check where applicable):

(a) Fermenter(s) with total/internal volume exceeding [50] litres:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

(b) Bioreactor(s) with total/internal volume exceeding [50] litres:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

(c) Chemical reactors:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

6. Equipment for continuous or perfusion growth of microorganisms with a volume over ... litres.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

primary production containment				under high biological containment				under maximum biological containment
Yes / No				Yes / No				Yes / No

7. Self-sterilizable centrifuges for continuous or semi-continuous operation with a throughput capacity of over 100 litres per hour.

(a) Present: Yes / No

(b) Have any been operated at any time during the previous calendar year

primary production containment				under high biological containment				under maximum biological containment
Yes / No				Yes / No				Yes / No

[7 bis Continuous centrifuge(s) that are self-sterilizable, with throughput capacity greater than 100 litres per hour:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

8. Cross-flow or tangential filtration equipment with a filter area of over 2.5 m².

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

primary production containment				under high biological containment				under maximum biological containment
Yes / No				Yes / No				Yes / No

[8 bis Cross-flow filtration equipment with filter area of over 5 square metres:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

[8 ter Tangential filtration equipment with filter area of over 5 square metres:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

9. Freeze-drying equipment with a condenser capacity of over 5 kg of ice in 24 hours.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

primary production containment				under high biological containment				under maximum biological containment
Yes / No				Yes / No				Yes / No

(c) With steam sterilization: Yes / No

[9 bis Freeze dryer(s) with condenser capacity of over 5 kg of ice in 24 hours:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

10. Cell disruption equipment capable of continuous operation without the release of aerosols with a flow rate greater than 10 litres per hour.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

[primary production containment]				under high biological containment				under maximum biological containment
Yes / No				Yes / No				Yes / No

11. Spray drying equipment.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

[primary production containment]				under high biological containment				under maximum biological containment
Yes / No				Yes / No				Yes / No

[11 bis Spray dryer(s):

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

[12. Drum drying equipment.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

]

[12 bis Drum dryer(s):

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

13. Biological safety cabinets Class III or Class I with accessories for conversion to Class III.

Present: Yes / No

14. Flexible film isolators or other cabinets with air handling characteristics equivalent to Class III and anaerobic boxes.

Present: Yes / No

[15. Biological safety cabinets Class II.

Present: Yes / No ]

16. Equipment for microencapsulation of microorganisms or toxins.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

[16 bis Microencapsulation equipment:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

[17. Automatic DNA sequencing equipment.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

]

[18. Automatic DNA synthesizer.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

]

[19. Automatic peptide sequencing equipment.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

]

[20. Automatic peptide synthesizer.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

]

21. Milling equipment having a capacity of milling grain with mass median diameter less than 10 micrometres.

(a) Present: Yes / No

(b) Has any been operated at any time during the previous calendar year

[21 bis Milling equipment with grain size capacity of less than 10 micrometres:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

22. Plant inoculation cabinets/chambers providing quarantine.

Total cabinet/chamber working volume range which applies to equipment present:

23. Cabinets/chambers designed or used for rearing insects.

(a) Total cabinet/chamber working volume range which applies to equipment present:

up to 3 m3				Yes / No
over 3 m3				Yes / No

(b) Have any been operated at any time during the previous calendar year under quarantine

Yes / No

[24. Indicate the presence, utilization, and containment usage of the following equipment at the declared facility (check where applicable):

(a) Incubator(s):

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

(b) Autoclave(s):

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

(c) Self-contained breathing apparatus for other than fire-fighting purposes:

___ Present
___ Utilized
___ Used in high biological containment or higher
___ Not present

]

III. [THRESHOLDS]

[Specific threshold quantities of biological materials stored at facilities for the purposes of developing and testing means of protection against BW shall be established on the basis of the following characteristics:

- Characteristic "a" - effective dose (ED₅₀)⁶² of an agent with the highest virulence (cells or plaque forming units)⁶³;

- Characteristic "b" - genuinely achievable concentration of the agent in biological material (cells/ml or plaque forming units/ml)⁶⁴;

- Characteristic "d" - maximum quantity of biological material containing this agent, which can be held at the facility at one time (kg)⁶⁵ .

Based on these values the ED₅₀ quantity of this agent ("K" value) which can be held at the facility at one time shall be calculated as follows:

K = d x 1000 x b/a

The quantity of another biological material containing another agent, or the same one with a different virulence or concentration, that can be held at the facility at one time shall be determined by way of inserting the actual concentration and ED50 of the agent (ED50 values are given in table) into the following formula:

M = K x ED₅₀/C x 1000, where

M is the quantity of biological material containing the agent of a given virulence and concentration which can be held at the facility at one time (kg);

C is the concentration of the agent in biological material (cells/ml or plaque forming units/ml).

Value of effective doses of biological agents

]

[For toxins, three general categories could be considered based on their LD₅₀. Accordingly for the specific measure of declaration, the following thresholds could be envisaged for each category of the toxins:

Group 1: Toxins with LD₅₀ of less than 1 microgram/kg, such as:

- Botulinum toxin;
- Neurotoxin (Shigella toxin);
- Tetanus toxin (Clostridium tetani).

Declarations are required for more than 5 milligram of these toxins.

Group 2: Toxins with LD₅₀ of between 1 and 5 microgram/kg, such as:

- Abrin (A. precatorius);
- Enterotoxin (Staphylococcus aureus);
- Ricin (Ricinus communis);
- Saxitoxin (Ganyaulax catanella).

Declarations are required for more than 100 milligram of these toxins.

Group 3: Toxins with LD₅₀ of between 5 and 15 microgram/kg, such as:

- Tetrodotoxin (Spheroides rufripes);
- Trichothecene mycotoxin.

Declarations are required for more than 500 milligram of these toxins.

(The level of toxicity and/or LD₅₀ is based on the experiment on the animals.)]⁶⁷

[Threshold quantities of toxin containing materials stored at facilities for the purposes of developing and testing means of protection against BW shall be determined on the basis of the following characteristics:

a - Effective dose (ED₅₀) of the toxin reduced to 100 kg mass (micrograms);

b - Threshold quantity of effective doses of the toxin stored at the facility;

c - Toxin concentration in biological material (microgram/ml);

m - Threshold quantity of toxin containing material (kg).

With these characteristics in mind, the quantity of a toxin containing material that can be stored at a facility at one time shall be calculated as follows:

m = b x a/c x 1000.

Values of "a" and "b" parameters shall be agreed upon in advance.

Example:

The ED₅₀ value of botulinum toxin has been agreed upon at the level of 100 micrograms.

The agreed threshold quantity of effective doses of toxins authorized for storage at a facility at one time shall be 300 ED50.

Actual toxin concentration in the material shall be 10 microgram/ml.

Inserting the appropriate values into the formula we arrive at:

m = 300 x 100/10 x 1000 = 3 kg.]

IV. PROGRAMMES AND FACILITIES

V. DECLARATION FORMATS

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