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ANNEXES

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A. DECLARATIONS

[I. DEFINITIONS⁸⁹

The definitions of the following terms were discussed by or proposed to the Ad Hoc Group and may need further consideration in the context of specific measures. The appearance of any term on this list is without prejudice to whether that term has either an acceptable definition content or is acceptable for inclusion in any final legally binding instrument.

[1. Bacteriological (biological) and toxin weapons

A type of weapon specifically designed [to cause disease, death or any harm to] [for mass destruction] of human beings, animals or plants, the effects of which are based on the properties of biological agents and toxins.

The term "Bacteriological (biological) and toxin weapons" shall be applied to the following:

- Biological agents and toxins (except when they are designed for purposes not prohibited by the Convention, provided that the types of agents and toxins and their quantities are appropriate for those purposes);

- Weapons, equipment or means of delivery designed for the use of biological agents or toxins for hostile purposes or in armed conflict.]⁹⁰

[2. Biological agents (microbiological and other biological agents, bacteriological (biological) means, bacteriological (biological) agents) [organisms]

Microorganisms, their genetically modified forms and other biological agents [designed] to [destroy] [cause death, disease and incapacitate] human beings, animals or plants.]⁹¹

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3. Biological defence facility

Facility which works in [one or more of the following areas of] [a biological defence programme] [/defence programme against biological and toxin weapons] [as one of its principal and/or permanent roles in research, development, testing, production and evaluation].

4. [Military] [civilian] [biological defence programme] [/Defence programme against biological and toxin weapons]

[Research, development, production, testing and evaluation] programme designed to detect and assess the impact of any use of microbial or other biological agents or toxins for hostile purposes or in armed conflict, and[/or] to prevent, reduce and neutralize the impact of biological and toxin weapons on humans, animals or plants.

5. Biosafety Level 3 [High containment]

Biosafety Level 3 comprises the [safety practices] [as specified in the 1993 WHO Laboratory Biosafety Manual], [and the] building designs and [structure], equipment used in research, development, testing or diagnostic work in laboratory activities involving [pathogens that pose a high risk of infection] [microbial or other biological agents, or toxins that pose a high risk [to health] [of causing infectious disease or a similar occurrence in the case of toxins (intoxination)] [of infection] [or intoxination] [or intoxication]].

[Biosafety Level 3 characteristics include buildings with negative pressure to the environment and access control and the exhaust air from safety cabinets that pass through high-efficiency particulate air (HEPA) filters. Other characteristics could also include buildings sealable for decontamination, with a ventilation system that establishes a directional airflow from the access space into the laboratory room, double door entry into the room, sealable windows [and effluent] disinfected. Equipment used inside include biosafety cabinets and specialized autoclaves. [The two person rule whereby no individual ever works alone in the laboratory applicable, biohazard warning signs displayed when work is in progress and, where applicable, protective laboratory clothing, worn inside.]]

[High containment comprises the [safety practices], building designs and [structure] and equipment used in laboratories, conducting research, development, testing or diagnostic work involving [pathogens that pose a high risk of infection] [microbial or other biological agents, or toxins that pose a high risk [to health] [of causing infectious disease or a similar occurrence in the case of toxins (intoxination)] [of infection] [or intoxination] [or intoxication]], to prevent accidental release of these agents to the environment. Such laboratories are fitted with negative pressure to the environment, have access control and the exhaust air [and effluents] are sterilized and rendered safe through one or more processes of high-efficiency particulate air (HEPA) filtration, incineration or other physical or chemical means.]

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6. [Purely] Diagnostic facility

Facility which tests [only] samples for the purpose of diagnosis of human, animal and plant disease⁹² [or facilities dealing with food and water hygiene] [contamination] [by means of detection, isolation and/or identification of microbial or other biological agents or toxins].

7. Facility

A combination of physical structures, equipment, workforce and principal associated support infrastructure [having an identifiable boundary and a single administration] whether under construction, operational or non-operational [for [the] [either] [research,] development, production, testing, processing, stockpiling, otherwise acquiring or retaining microbial or other biological agents or toxins].

8. Genetic modifications

[Genetic modification is a process of arranging and manipulating nucleic acids of an organism to produce novel molecules or to add to it new characteristics. For the purpose of declaration requirements for this Protocol, genetic modification is arranging and manipulating nucleic acids of microorganisms to achieve increased pathogenicity, antibiotic resistance, infectivity across species or resistance to vaccines and stability in the environment.]

[For the purpose of Declarations, "genetic modification" means any alteration of genetic material in a microorganism by means of artificial (that is non-natural) recombination, unless:

- The recipient or parental microorganism is unlikely to cause disease to humans, animals or plants; and

- The nature of the vector and the insert is such that they do not endow the genetically modified microorganism with a phenotype likely to cause disease to humans, animals or plants, or likely to cause adverse effects in the environment; and

- The genetically modified microorganism is unlikely to cause disease to humans, animals or plants and is unlikely to cause adverse effects in the environment.]

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[9. Hostile purposes

The use of bacteriological (biological) or toxin weapons or biological agents by a State (States) to [destroy] [cause death, disease and incapacitate] human beings, animals or plants in a State (States) which is (are) not engaged in a military conflict with the former State (States) with a view to inflicting military, economic or moral damage.]⁹³

10. Military medical programme

Medical programme to monitor, maintain and/or restore the physical, mental and social health, including detection, diagnosis, prophylaxis and treatment of infectious diseases and intoxications [that occur naturally] of serving and/or retired military personnel and their dependents, as well as civilians other than in the context of defence against the use of microbial or other biological agents or toxins for hostile purposes or in armed conflict.

11. [Primary production containment]

[Primary production containment comprises the equipment and design features used in production activities involving viable microorganisms and cells where there is a need to prevent incidental release into the environment which could compromise health of workers or contaminate the environment. [Microorganisms and eukaryotic cells are handled in one or more of: a closed system, biological safety cabinets or with personal protection equipment.]]

[12. Closed system

A system consisting of containers and equipment for preparation, growth and storage of bacteriological agents and toxins that is designed to physically separate the process from the environment with joints and seals to [minimize] [prevent] release of viable microorganisms, cells or other active biological material from the system [or to prevent the ingress of unwanted contamination]. Exhaust gases [and effluents] from the system are rendered safe before [final discharge]. Sample collection, addition of material to the system and transfer of viable organisms to another system, is performed so as to [minimize] [prevent] release [or to prevent the ingress of unwanted contamination]. [This system could be located within a controlled area.]]

13. Production capability

Expertise and capability to produce microbial or other biological agents or toxins, whatever their origin or method of production.

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[14. Purposes not prohibited by the Convention

[Industrial, agricultural and medical research] Treatment, prophylactic, protective or other peaceful purposes.]⁹⁴

15. Site

A geographically defined location or area having an identifiable boundary that contains [or has contained (in a time frame to be specified)] one or more facilities.

[16. Toxins

Toxic by-products of microorganisms, natural poisons of animal or plant origin, whatever their method of production, designed to [destroy] [cause death, disease and incapacitate] human beings, animals or plants.]⁹⁵

17. Vaccine

Preparations, including liveattenuated, killed or otherwise modified organisms or their components, and nucleic acids, which when introduced by any of multiple routes into a human being or animal induces in it an active immune response for prophylactic or protective use.

18. Work with [listed] biological agents and toxins

[Any manipulations with [listed] biological agents and toxins that cover for instance research, development, production and diagnosis using [listed] biological agents and toxins including the study of properties of biological agents and toxins, detection and identification methods, genetic modification, aerobiology, prophylaxis and treatment methods [maintenance of culture collections] [registered culture collection].]

[18 bis In the context of declaration triggers, work with listed agents and toxins means any manipulation or production of listed agents and toxins involving the application of techniques used in genetic modification, whatever the outcome.]

[19. Plant inoculant

A formulation containing pure or predetermined mixture of microorganisms, such as living bacteria, fungi or virus particles for the treatment of seeds, seedlings, other plant propagation material, or plants for the purpose of enhancing the growth capabilities, or disease, or frost resistance or otherwise altering the properties of the eventual plants or crop.]

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[20. Biocontrol agent

An [micro] organism used for the prevention, elimination or reduction of the disease, pest [or] unwanted plants.]

[21. Plant quarantine capability

Plant quarantine capability comprises [the safety practices], building designs and equipment used to prevent the accidental release of agents into the environment, when working with phytosanitary activities, in plant inoculant and biocontrol agent production facilities involving plant pathogens and pests that pose a high risk of infection to the plant population in the vicinity. Such a capability includes separate buildings or clearly demarcated parts of a structure with access control, negative pressure to the environment, the exhaust air sterilized by (HEPA) filtration, incineration, or other physical or chemical means. Decontamination of all waste is achieved by a suitable chemical or physical process before exhausting into a public or communal system, [double entry doors with vestibule] and [hand washing facilities].]

22. [Maximum containment laboratory] [BL4 - WHO Classification]

[A maximum containment laboratory for handling microorganisms has the following features in addition to those of a high containment laboratory:

- Entry and exit of personnel and supplies must be through an airlock or pass-through system. On entering, personnel should put on a complete change of clothing; before leaving, they should shower before putting on their street clothing.

- Negative pressure must be maintained in the laboratory by a mechanical, individual, inwardly directed, HEPA-filtered supply, and an exhaust air system with HEPA filters in the exhaust and, where necessary, in the intake.

- All fluid effluents from the laboratory, including shower water, must be rendered safe before final discharge.

- A double-door, pass-through autoclave must be available for sterilization of waste and materials.

- For work with human pathogens or zoonoses, an efficient primary containment system must be in place, consisting of one or more of the following: (a) Class III biological safety cabinets; (b) positive pressure ventilated suits. In the latter case a special chemical decontamination shower must be provided for personnel leaving the suit area.

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- For work with animal pathogens, primary containment must be provided by use of Class I, II or III biological safety cabinets.]

[BL4 - WHO-Classification. The features of a containment laboratory - Biosafety Level 3 apply to a maximum containment laboratory - Biosafety Level 4 with the addition of the following: 1. Controlled access. Entry and exit of personnel and supplies must be through an airlock or pass-through system. On entering, personnel should put on a complete change of clothing; before leaving, they should shower before putting on their street clothing. 2. Controlled air system. Negative pressure must be maintained in the facility by a mechanical, individual, inwardly directed, HEPA-filtered supply, and an exhaust air system with HEPA filters in the exhaust and, where necessary, in the intake. 3. Decontamination of effluents. All fluid effluents from the facility, including shower water, must be rendered safe before final discharge. 4. Sterilization of waste and materials. A double-door, pass-through autoclave must be available. 5. Primary containment. An efficient primary containment system must be in place, consisting of one or more of the following: (a) Class III biological safety cabinets, (b) positive-pressure ventilated suits. In the latter case a special chemical decontamination shower must be provided for personnel leaving the suit area. 6. Airlock entry ports for specimens and materials.]

23. [Aerobiology

The study of aerosols comprising particles of biological origin.]

24. [Toxoid/anatoxin⁹⁶

[For the purpose of Declarations, "toxoid/anatoxin" means a toxin that has been inactivated so as to destroy its toxic property but to retain its antigenicity, i.e. its capability of stimulating the production of antitoxin antibodies and thus producing an active immunity.]]

[25. Antitoxin/therapeutic serum

Immunizing product formed of serum taken from an animal or human which has developed antibodies to a disease and used to protect and treat a patient from that disease. Any other products produced by cellular culture directed to accomplish the same objective, or directed to diminish a toxic effect are also included under this definition.] [Human or animal blood serum which contains antibodies to a microorganism or toxin and is used to protect or treat humans and animals from the disease caused by this microorganism or toxin.]]

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II. LISTS AND CRITERIA (AGENTS AND TOXINS)⁹⁷

[A.] Human Pathogens

The following list of human pathogens and toxins was discussed by the Group and recognized to be relevant for developing a list or lists of bacteriological (biological) agents and toxins for specific measures [in particular for initiating or triggering declarations] to strengthen the Convention:

[I. Natural organisms]

Viruses

1. Crimean-Congo haemorrhagic fever virus
2. Eastern equine encephalitis virus
3. Ebola virus
4. Hanta viruses⁹⁸
5. Junin virus
6. Lassa fever virus
7. Machupo virus
8. Marburg virus
9. Rift Valley fever virus
10. [Tick-borne encephalitis virus]⁹⁹

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11. Variola virus (Smallpox virus)
12. Venezuelan equine encephalitis virus
13. Western equine encephalitis virus
14. Yellow fever virus

Bacteria

1. Bacillus anthracis
2. Brucella spp.¹⁰⁰
3. Burkholderia (Pseudomonas) mallei
4. Burkholderia (Pseudomonas) pseudomallei
5. [Chlamydia psittaci]
6. Francisella tularensis (tularemia)¹⁰¹
7. Yersinia pestis

Rickettsiae

1. Coxiella burnetti
2. Rickettsia prowazekii
3. Rickettsia rickettsii

Fungi

1. Histoplasma capsulatum (incl. var. duboisii)

[II. Molecular agents]

Toxins

1. Abrin (A. precatorius)
2. Botulinum toxins (Clostridium botulinum)
3. Clostridium perfringens (tox)
4. Corynebacterium diphteriae (tox)
5. Cyanginosins (Microcystins) (Microcystis aeruginosa)
6. [Enterotoxins] [Enterotoxin B] (Staphylococcus aureus)
7. Ricin (Ricinus communis)
8. Saxitoxin (Ganyaulax catanella)
9. Shigatoxin (Shigella dysenteriae)

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10. Tetanus toxin (Clostridium tetani)
11. Tetrodotoxin (Spheroides rufripes)
12. Trichothecene mycotoxins [T2]
13. Verrucologen (Myrothecium verrucaria)
14. Aflatoxins

[III. Other agents]

[Prions]

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Criteria for human pathogens and toxins

The following criteria were discussed by the Group and may be used in combination for selection of human pathogens and toxins to be included in a list of bacteriological (biological) agents and toxins:

1. [Vectors or]¹⁰² Agents known to have been developed, produced, stockpiled or used as weapons;

2. Low infection dose or high toxicity;

3. [Short incubation and] High level of morbidity;

4. High level of contagiousness in population;

5. Infection or intoxication [by variety of route, especially] by respiratory route;

6. High level of incapacity or mortality;

7. No effective prophylaxis (i.e. immune sera, vaccines, antibiotics) and/or therapy commonly available and widely in use;

8. Stability in the environment;

9. Difficulty of detection or identification [at the early stage];

10. Ease of production [and transportation].

Definition of some terms:

Morbidity: Ratio of [sick] [new cases of disease] to [healthy persons] [total population];

Contagiousness: Capability to be [communicable] [transmissible specially through contact];

Incapacity: Lack of physical or intellectual power;

Mortality: Ratio of dead to [sick persons] [total population].

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[B.] Animal Pathogens¹⁰³

The following list of animal pathogens was discussed by the Group for further consideration with a view to developing a future list or lists of bacteriological (biological) agents and toxins, where relevant, for specific measures designed to strengthen the Convention:

[I. Natural organisms]

1. African swine fever virus
2. Avian influenza virus (Fowl plague virus)
3. [Bluetongue virus]
4. [Camel pox virus]
5. [Classic swine fever virus (Hog cholera virus)]
6. [Contagious bovine (pleuropneumonia)/Mycoplasma mycoides var. mycoides]
7. [Contagious caprine (pleuropneumonia)/Mycoplasma mycoides var. capri]
8. Foot and mouth virus
9. [Herpes B virus (monkey)]
10. [Newcastle disease virus]
11. [Peste des petits ruminants virus]
12. [Porcine enterovirus type 9]
13. [Rabies virus]
14. Rinderpest virus (Cattle plague virus)
15. [Sheep pox virus]
16. [Teschen disease virus]
17. [Vesicular stomatitis virus]
18. [African horse sickness virus]
19. [Swine vesicular disease virus]
20. [Lumpy Skin disease virus]

[II. Molecular agents]

[III. Other agents]

[Prions]

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[Animal Pathogens

1.          Viruses

	Disease	Family	Genus	Type species
1	African swine fever		African swine fever-like viruses	African swine fever virus
2	Highly pathogenic avian influenza (fowl plague)	Orthomyxoviridae	Influenzavirus A, B	Influenzavirus A (subtype H)
3	Bluetongue	Reoviridae	Orbivirus	Bluetongue virus Type 1-24
4	Camel pox	Poxviridae	Orthopoxvirus	CP virus
5	Classic swine fever	Flaviviridae	Pestivirus	Hog cholera Virus
6	Foot-and-mouth	Picornaviridae	Aphtovirus	F&MD virus A,C,O,Asia1, SAT1,SAT2, SAT3
7	Herpes B virus (monkey)	Herpesviridae	Simplexvirus	Herpesvirus B
8	Newcastle disease	Paramyxoviridae	Rubulavirus	NCD virus
9	Peste des petits ruminants	Paramyxoviridae	Morbillivirus	PPR virus
10	Porcine enterovirus type 9	Picornaviridae	Enterovirus	Porcine enterovirus type 9
11	Rabies	Rhabdoviridae	Lyssavirus	Rabies virus
12	Rinderpest	Paramyxoviridae	Morbillivirus	RP virus
13	Sheep pox	Poxviridae	Capripox	Sheep pox virus
14	Teschen disease	Picornaviridae	Enterovirus	Porcine enterovirus type 1
15	Vesicular stomatitis	Rhabdoviridae	Vesiculovirus	Vesicular stomatitis indiana virus
16	Swine vesicular disease	Picornaviridae	Enterovirus	SVD virus
17	African horse sickness	Reoviridae	Orbivirus	AH 1-9

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2.      Mycoplasmas

	Disease	Species	Subspecies	Type strain
1	Contagious bovine pleuropneumonia (CBPP)	Mycoplasma mycoides	mycoides	SC (small colonies)
2	Contagious caprine pleuropneumonia (CCPP)			F38

Notes:

Viruses

No. 1: African swine fever viruses were formerly Iridoviruses, but they have lately been classified into a genus of their own called "Swine fever-like viruses" not belonging to any family of viruses.

No. 16: The Enterovirus causing Swine vesicular disease is similar to human Coxsackie virus B5.

Mycoplasmas

No. 2: The Mycoplasma causing (CCPP) was previously classified as Mycoplasma mycoides subspecies capri, but it was found that the disease is caused by a strain called F38 which is not yet fully classified.]

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Criteria for animal pathogens

The following criteria were discussed by the Group and may be used in combination for selection of animal pathogens to be included in a list of bacteriological (biological) agents and toxins:

1. [Vectors or]¹⁰⁴ Agents known to have been developed, produced or used as weapons;

2. Agents which have severe socio-economic and/or significant adverse human health impacts to be evaluated against a combination of the following criteria:

(a) High morbidity and/or mortality rates;

(b) Short incubation period and/or difficult to diagnose/identify at an early stage;

(c) High transmissibility and/or contagiousness;

(d) Lack of availability of cost effective protection/treatment;

(e) Low infective/toxic dose;

(f) Stability in the environment;

(g) Ease of production.

Definition of selected terms:

Morbidity:	Ratio of sick to healthy animals;
Mortality:	Ratio of dead to sick animals;
Contagiousness:	Capability to be communicable from a sick to healthy animal;
Stability in the environment:	Ability of the agent to retain its properties and resist temperature, humidity and insolation;
Infective dose:	The smallest quantity of the agent which infects animals.

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[C.] Plant Pathogens

The following list of plant pathogens was discussed by the Group for further consideration with a view to developing a future list or lists of bacteriological (biological) agents and toxins, where relevant, for specific measures designed to strengthen the Convention:

[I. Natural organisms]

1. [Citrus greening disease bacteria]
2. Colletotrichum coffeanum var. virulans
3. [Chochliobolus miyabeanus]
4. Dothistroma pini (Scirrhia pini)
5. Erwinia amylovora
6. Erwinia carotovora
7. [Phytophthora infestans]
8. Pseudomonas solanacearum¹⁰⁵
9. [Puccinia graminis]
10. Puccinia striiformiis (Puccinia glumarum)
11. Pyricularia oryzae
12. [Sugar cane Fiji disease virus]
13. [Tilletia indica]
14. Ustilago maydis
15. Xanthomonas albilineans
16. Xanthomonas campestris pv citri
17. Xanthomonas campestris pv oryzae
18. [Sclerotinia sclerotiorum]
19. [Peronospora hyoscyami de Bary f.sp. tabacina (Adam) skalicky]
20. [Claviceps purpurea]

[II. Molecular agents]

[III. Other agents]

[Thrips palmi Karny

Frankliniella occidentalis]¹⁰⁶

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[Definition of selected terms

Natural organisms: Bacteria, viruses, funguses, rickettsiae, chlamydias, mycoplasmas, protozoa, insects and any other living organisms which, owing to their characteristics and in accordance with the selection criteria, could be used as biological weapons.

New organisms resulting from genetic manipulation: Organisms whose genetic material has been altered using genetic manipulation techniques. The following must be included:

(a) Genetically modified organisms containing nucleic acid sequences associated with the pathogenicity derived from listed agents;

(b) Genetically modified organisms containing nucleic acid sequences coding for any of the listed molecular agents;

(c) Genetically modified organisms containing nucleic acid sequences associated with the pathogenicity of agents classified in risk groups 3 and 4 (in accordance with the criteria set out in the 1993 WHO Laboratory Biosafety Handbook), which are not necessarily listed;

(d) Genetically modified organisms which, owing to their new characteristics, would fall in risk groups 3 and 4 (in accordance with the criteria set out in the 1993 WHO Laboratory Biosafety Handbook).

Molecular agents: Toxins, bioregulators or chemical substances of biological origin.

Other agents: Prions (at the stage of research, development and production, excluding diagnostic activities) and any other new agent not included in the previous groups.]

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Criteria for plant pathogens

The following criteria were discussed by the Group and may be used in combination for selection of plant pathogens to be included in a list of bacteriological (biological) agents and toxins:

1. [Pests or]¹⁰⁷ Agents known to have been developed, produced or used as weapons;

2. Agents which have severe socio-economic and/or significant adverse human health impacts, due to their effect on staple crops¹⁰⁸, to be evaluated against a combination of the following criteria:

(a) Ease of dissemination (wind, insects, water, etc.);

(b) Short incubation period and/or difficult to diagnose/identify at an early stage;

(c) Ease of production;

(d) Stability in the environment;

(e) Lack of availability of cost-effective protection/treatment;

(f) Low infective dose;

(g) High infectivity;

(h) Short life cycle.

Definition of selected terms:

Infective dose: The smallest quantity of the agent which infects plants;

Stability in the environment: Ability of the agent to retain its properties and resist temperature, humidity and insolation;

Infectivity: Ratio of infected plants to the total number of plants exposed.

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III. LIST OF EQUIPMENT¹⁰⁹

The following list of equipment was discussed by the Group in the context of a declaration format for a declared facility [working with listed agents and toxins].

[- Aerosol chambers [with a working volume exceeding [... m3]] [(dynamic, static and explosive)] [designed and/or] used for test or study of microorganisms or toxins.

Type	Yes / No	[Volume]	Lab.Containment110	Application111
[dynamic	...	...	...	...
static	...	...	...	...
explosive]	...	...	...	...

Total

- Aerosol dissemination equipment [for use in aerosol chambers] [with the ability of generating [[90 % of particles] [monodisperse particles] of size [1-10 micrometres]] [of particles mass median diameter not exceeding 10 micrometres].]

	Yes / No	Indoor or outdoor use	Application
Powder aerosol capacity ... gram/minute	...	...	...
Liquid aerosol capacity ... ml/minute	...	...	...
[Aerosol [particle] [sample] analysing equipment]	...	...	... ]

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[- [Aggregate] fermenters/bioreactors.

Total volume range	Yes / No	Lab. Containment	Process Containment112
[5-99 litres]	...	...	...
100-999 litres	...	...	...
1000-9999 litres	...	...	...
10000 litres or more	...	...	...

[- Equipment for batch fermentation with a volume of over 300 litres.

Yes / No                             ...

- Equipment for continuous or perfusion fermentation with a volume of over 50 litres.

Yes / No                             ... ]

- High speed self-sterilizable centrifugal separators or decanters for continuous or semi-
continuous operation.

Capacity range	Yes / No	Lab. Containment	Process Containment
5-99 litres/hour	...	...	...
100 litres/hour or more	...	...	...

[- Plate press filter separators with a capacity of over ... litres per hour.

Yes / No ...

- Rotor continuous flow centrifuges with a capacity of over 100 litres per hour.

Yes / No ... ]

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	Yes / No	Lab. Containment	Process Containment
Cross-flow or tangential filtration equipment; capacity of filter area greater than [5] [square metres] [diameter of pore size less than 5 microns].	...	...	...
Freeze-drying equipment; with a condenser capacity more than 5 kg of ice in 24 hours.	...	...	...
Cell disruption equipment [capable of continuous operation without the release of aerosols] with a flow rate greater than 10 litres per hour.	...	...	...
Spray drying equipment.	...	...	...
Drum drying equipment.	...	...	... ]

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Yes / No

Lab. Containment

[- Biological safety cabinets class III.

...

...

- Class II cabinets being used at BL4.

...

...

- Class I cabinets that are marketed as convertible into Class III cabinets.

...

...

- Flexible isolators with air-handling characteristics equivalent to Class III cabinets.

...

...

- Microencapsulation equipment.

...

... ]

[- Automatic DNA sequencing equipment.

...

...

- Automatic DNA synthesizer.

...

... ]

[- Protein sequencing equipment

...

... - Protein synthesizer ... ... ]

[- Milling equipment having a capacity of milling grain size less than [10] microns and a production capacity of over ... kg per hour.

                                     Yes / No                    ... ]

	Yes / No	[Total working area (m2)] [Area ranges]
[- Rooms/other enclosures providing quarantine utilized for plant growth.	...	...

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	Yes / No	[Total working area (m2)] [Area ranges]
- Plant inoculation chambers providing quarantine.	...	...
	Yes / No	[Total working area (m2)] [Area ranges]
- Insect rearing chambers providing quarantine.	...	... ]

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IV. [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)¹¹³ of an agent with the highest virulence (cells or plaque forming units)¹¹⁴;

- Characteristic "b" - genuinely achievable concentration of the agent in biological material (cells/ml or plaque forming units/ml)¹¹⁵;

- Characteristic "d" - maximum quantity of biological material containing this agent, which can be held at the facility at one time (kg)¹¹⁶.

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).

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Table

Value of effective doses of biological agents

Biological agent	Experimental animal	Method of infection	Effective dose
1	2	3	4
Crimean-Congo haemorrhagic fever virus	white mice	intracerebrum	0,1 PFU117
Chikungunya virus	white mice	intracerebrum	0,5 PFU
Eastern encephalitis virus	white mice	intracerebrum	0,1 PFU
Ebola virus	white mice guinea pigs	intracerebrum intraperitoneum	0,3 PFU 0,1 PFU
Hanta virus	rats	aerogenic	0,5 PFU
Japanese encephalitis virus	white mice	intracerebrum	0,01 PFU
Junin virus	guinea pigs	intraperitoneum	0,02-150 PFU
Lassa fever virus	guinea pigs	hypodermic	0,3 PFU
Machupo virus	guinea pigs	hypodermic	2 PFU
Marburg virus	guinea pigs	intraperitoneum	0,1 PFU
Rift Valley virus	white mice white mice white mice	intracerebrum intraperitoneum aerogenic	0,03 PFU 3 PFU 0,2-0,3 PFU
Tick-borne encephalitis virus (Russian spring-summer encephalitis virus)	white mice white mice	intracerebrum intraperitoneum	0,01 PFU 0,1 PFU

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Table cont'd

Variola virus (Smallpox virus)	rabbits	aerogenic	15 PFU
Venezuelan encephalitis virus	white mice guinea pigs	hypodermic intraperitoneum	0,3 PFU 3 PFU
Western encephalitis virus	white mice white mice	intracerebrum intraperitoneum	0,03 PFU 1 PFU
Yellow fever virus	M. mulatta	aerogenic	0,5 PFU
Kyasanur Forest fever virus
Bacillus anthracis	white mice guinea pigs	hypodermic hypodermic	10 cells 30 cells
Brucella spp.	white mice	hypodermic	5 ... 20 cells
Chlamydia psittaci	chicken embryo		1000 cells
Clostridium botulinum
Francisella tularensis	white mice	hypodermic	1..10 cells
Pseudomonas mallei	golden hamsters	hypodermic	10..100
Pseudomonas pseudomallei	white mice golden hamsters guinea pigs	hypodermic hypodermic hypodermic	10 cells 10 cells 10 cells
Yersinia pestis	rats white mice	hypodermic hypodermic	5 cells 15 cells
Coxiella burnetii
Rickettsia prowazekii
Rickettsia rickettsii

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[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.)]¹¹⁸

[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);

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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.]

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V. PROGRAMMES AND FACILITIES

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VI. DECLARATION FORMATS

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B. [[RANDOM] [AND CLARIFICATION] VISITS]¹¹⁹

[(A) RANDOM SELECTION OF FACILITIES

1. The facilities which shall be subject to a Random Visit shall be selected by the [Technical] Secretariat through appropriate mechanisms.

(...)

(B) PRE-VISIT PROCEDURES

2. The Director-General shall identify members for appointment to the Visit Team according to the specific nature of the facility and the submitted declaration. Members of the Visit Team shall be drawn from the permanent staff of the [Technical] Secretariat. The size of the Visit Team shall be kept to the minimum necessary for the proper fulfilment of the mandate, and shall not exceed [4] [6] persons. No national [or resident] of the requesting State Party or the State Party to be visited shall be a member of the Visit Team.

3. The notification of the Random Visit by the Director-General shall include, inter alia:

(a) The name of the State Party or Host State Party on whose territory the visit will take place;

(b) The name and location of the facilities to be visited;

(c) The point of entry where the Visit Team will arrive as well as the means of arrival;

(d) The date and estimated time of arrival of the Visit Team at the point of entry;

(e) The names of the leader and of the other members of the Visit Team;

(f) The visit mandate.

4. The mandate for a Random Visit shall be of a standard nature and contain at least:

(a) Name of the State Party or Host State Party on whose territory the Random Visit will take place;

(b) The name and location of the facilities to be visited;

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(c) The names of the leader and of the other members of the Visit Team;

(d) Point of entry to be used by the Visit Team;

(e) The purpose in general of Random Visits;

(f) The activities that triggered the facility declarations.

5. The duration of a Random Visit [the visit] shall not exceed [48] hours, unless extended by agreement of the Visit Team and the Visited [State Party] [facility]. This time excludes the activities upon arrival of the Visit Team, contained in paragraphs 6, 7 and 8.

(C) ACTIVITIES UPON ARRIVAL OF THE VISIT TEAM

Inspection of approved equipment

6. The visited State Party shall have the right to inspect the equipment of the Visit Team, to ensure that it is properly sealed, appears on the approved list of equipment and conforms to the standards as set out in Appendix ... . The visited State Party may exclude equipment that has not been approved in accordance with ... .

Briefing

7. Upon arrival at the facility to be visited, and before the commencement of the visit, the Visit Team shall be briefed by the facility representatives and the representatives of the visited State Party. The briefing shall not exceed 3 hours and shall include the scope and a general description of activities of the facility, details of the physical layout and other relevant characteristics of the site, including a map or sketch showing all structures and significant geographic features. It shall include information concerning the safety regulations in force, including rules of observation and quarantine. It may also include an indication of areas the visited State Party considers sensitive.

8. The briefing shall also include information on any relevant changes in activities or equipment at the facility since the submission of the most recent declaration.

Visit plan

9. After the briefing the Visit Team, the facility representatives and the representatives of the visited State Party and representatives of the visited facility shall prepare a Visit Plan which specifies the activities to be carried out by the team, including the specific areas of the facility, documentation and personnel to which access is desired, and whether the team intends to divide into subgroups. The Visit Team shall not divide into more than two subgroups, unless otherwise agreed by the visited State Party.

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Time frames for activities

10. Activities upon arrival of the Visit Team, including inspection of equipment, briefing and preparation of the Visit Plan, shall not exceed [4] hours.

(D) CONDUCT OF VISIT

11. The representatives of the visited State Party and of the facility shall accompany the Visit Team throughout the duration of the visit to a facility.

12. The visit shall be carried out according to the Visit Plan and in the least intrusive manner possible. The visited State Party shall cooperate with the Visit Team in the achievement of the objectives of the mandate.

13. The Visit Team shall collect only that information necessary to carry out its mandate.

14. The Visit Team may conduct any of the following activities:

Interviewing

15. The Visit Team shall have the right to interview any relevant personnel in the presence of the representatives of the visited State Party, with the purpose of establishing relevant facts. These representatives of the visited State Party may include a legal adviser and a senior member of the facility staff. The team shall only request information and data which are necessary for the fulfilment of the visit mandate, focusing on questions related to the obligations of this Protocol.

16. Interviews shall be conducted in such a way as to avoid unduly hindering the work of the facility.

Visual observation

17. The Visit Team shall have the right to observe visually any part of the visited facility relevant to its mandate.

18. If direct visual observation is not possible because of national security, commercial proprietary or health and safety considerations, the visited State Party shall provide other means to demonstrate that the submitted declarations are in compliance with the obligations of this Protocol. These may include, for example, the use of a video camera, photographs or drawings.

Identification of key equipment

19. The Visit Team shall have the right to identify equipment at the visited facility.

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20. The Visit Team may also note the size and quantity of equipment at the facility, or the absence of any equipment, and compare this with information provided in the facility declarations.

Auditing

21. The Visit Team shall have the right to examine documentation and records they deem relevant to the conduct of their mission.

22. The visited State Party shall have the right, in accordance with managed access procedures, to protect documentation and records which it considers confidential for reasons of national security or commercial sensitivity.

23. The Visit Team and the Organization shall treat as confidential all documents and print-outs or records and any other information obtained as a result of access to documentation and records, and shall handle them accordingly.

24. Auditing shall be conducted in such a way as to minimize disruption to the normal work of the facility.

Sampling and identification

25. Sampling shall only be conducted if offered by the visited facility, and if deemed useful by the Visit Team. [Any] mutually agreed sampling and analysis [shall] may be performed by facility personnel, but in the presence of the Visit Team.

(E) MANAGED ACCESS

26. The visited State Party shall have the right, in accordance with the obligation to demonstrate compliance and the right, if necessary, to protect sensitive information as set out in ..., to take specific measures which may include but are not limited to the following:

(a) Removal of sensitive papers from direct view;

(b) Shrouding of sensitive displays, stores, and equipment;

(c) Shrouding sensitive pieces of equipment, such as computer or electronic systems;

(d) Logging off of computer systems and turning off data indicating devices;

(e) Using random selective access techniques whereby the team is requested to select a given percentage or number of buildings of their choice to investigate; the same principle can apply to the interior and content of sensitive buildings or documents;

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(f) In exceptional cases, limiting the number of team members who have access to certain parts of a facility; and limiting the viewing angle; the reasons for such limitations shall be stated;

(g) Limiting the time team members may spend in any area or building, while allowing the team to fulfil its mandate; and limiting the viewing angle; the reasons for such limitations shall be stated;

(h) The visited State Party may at any time during the visit identify products and processes in which it has a proprietary interest in order to help the team respect the visited State Party's right to safeguard proprietary information. It may request that if a specific piece of information is released to the team, it should be accorded the most stringent protection measures by the Organization.

(F) POST VISIT [ACTIVITIES] [PROCEDURES]

Draft report

27. At the end of the visit, the Visit Team shall prepare its draft report. The draft report shall be considered confidential.

28. The draft report shall summarize the general activities undertaken during the visit and the factual findings of the Visit Team. It shall also include an account by the Visit Team of the degree and nature of access and cooperation granted to the Visit Team and the extent to which this enabled it to fulfil its mandate.

29. The draft report shall immediately be submitted to the visited State Party. The visited State Party may draw to the attention of the Visit Team any information in the preliminary report which, in its view, is unrelated to the visit mandate or to its obligations concerning declarations. In these cases the visited State Party may request that the information be considered confidential or be deleted, and/or may make written comments which shall be [annexed to] [included, as appropriate, in] the report.

30. The visited State Party may provide any other comments to the draft report. Those comments will then become part of the final report as an addendum.

Departure

31. On completion of the review of the draft report the Visit Team shall depart from the territory of the visited State Party in the minimum time possible.

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Final report

32. The Visit Team shall then submit a final report, which is confidential, to the Director-General. The final report should include a summary, stating the general activities undertaken by the Visit Team and its factual findings related to the declaration obligations of the Protocol. It shall also include an account by the Visit Team of the degree and nature of access and cooperation granted to the Visit Team and the extent to which this enabled it to fulfil its mandate. The Director-General shall circulate the summary to all States Parties.]

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C. [MEASURES TO STRENGTHEN THE IMPLEMENTATION
OF ARTICLE III]

Notes

89. Delegations expressed different views about the appropriate location of any agreed definition. One view was that any agreed definitions should compose an Article of the final document. Another view was that any agreed definitions should be contained in an appropriate Annex.

90. A view was expressed that any proposal to define Article I terms would have the effect of amending the Convention outside the legal provisions of Article XI, contrary to the mandate of the Group. Another view was expressed that defining those terms is indispensable for the purposes of a verification mechanism and will not have the effect of amending the Convention.

91. Ibid.

92. "Disease is commonly considered to be a departure from the normal physiological state of a living organism sufficient to produce overt signs. The initial cause of the diseased state may lie within the individual organism itself. It may result from a course of medical treatment. Finally, the disease may be caused by some agent external to the organism. This may be an inert but toxic agent, or the external agent may be itself a living organism of multiplying within the host." Extracted from Encyclopedia Britannica, 1992.

93. See footnote 3.

94. See footnote 3.

95. See footnote 3.

96. This has not been discussed and needs further consideration.

97. The view was expressed that although the Lists and Criteria section has been the subject of technical discussions during earlier sessions of the Ad Hoc Group as a Friend of the Chair paper, only a preliminary review has been completed with respect to its incorporation into the rolling text. Some individual brackets and footnotes have been introduced at this time to address initial concerns of some delegations. In light of the complexity and importance of the issues involved, this view recognized that further and detailed consideration of this section will be required at future Ad Hoc Group sessions.

Another view was expressed according to which the Ad Hoc Group had had sufficient discussion of the issue relating to the incorporation of the Lists and Criteria section. At the same time in order to reach final agreement on the Lists and Criteria their further discussion would be required at future sessions of the Ad Hoc Group.

A view was expressed that the lists of agents and toxins should be subject to amendment in accordance with the procedure set out in paragraphs 4 and 5 of Article XIV of the Protocol.

The view was expressed that further consideration needs to be given to microorganisms carrying nucleic acid sequences coding for pathogenic properties of listed agents and toxins.

Another view was expressed that further consideration also needs to be given to nucleic acid sequences coding for toxins.

98. A view was expressed that some species of item 4 are of relevance to the BWC and need further consideration.

99. A view was expressed that some species of item 10 are of relevance to the BWC and need further consideration.

100. A view was expressed that some species of item 2 are of relevance to the BWC and need further consideration.

101. A view was expressed that some species of item 6 are of relevance to the BWC and need further consideration.

102. The view was expressed that if vectors were to be considered further on they should be included in the appropriate list.

103. Detailed scientific information is listed in a table attached immediately after this section.

104. The view was expressed that if vectors were to be considered further on they should be included in the appropriate list.

105. The taxonomy of No. 8 Pseudomonas solanacearum is complicated and still changing. The current name for potato brown rot pathogen is Ralstonia solanacearum (that is Pseudomonas solanacearum biovar 2 race 3), but pathogens causing brown rots and bacterial wilts in other crops may have different names.

106. It was suggested that since these items are not agents or toxins they should be discussed in an appropriate section.

107. The view was expressed that if pests were to be considered further on they should be included in the appropriate list.

108. Staple crops: a description/definition will need to be developed for the purposes of the BTWC drawing from usage in relevant international bodies, e.g. FAO, WTO.

109. A list of equipment may also have utility in the context of specific on-site activities during investigations; and in the context of declarations of, and [any] guidelines on [all] transfers of dual-use items.

Some other equipment was also proposed by some delegations, which needs to be discussed by the Group.

110. Used under [BL3] [high containment] or [BL4] [maximum containment] or equivalent containment.

111. Application means work with microorganisms or toxins; or work with the biologically active material or other applications.

112. OECD Category 2 or 3 or equivalent.

113. ED is an effective dose of a biological agent (LD₅₀, ID₅₀) determined through experiments on model animals with the use of certain means of infection under normal conditions.

114. Specific value of the parameter is to be agreed upon in advance.

115. Ibid.

116. Ibid.

117. PFU - plaque forming unit.

118. The toxins have been selected among those reflected in the list of pathogens and serve only as examples.

119. The inclusion of this paper is without prejudice to a final decision on whether provisions for other visits and procedures will form part of the future Protocol.

Updated 12 November 1998.