The Biological and Toxin Weapons Convention (BTWC) Database
Rolling Text (9th Session) : Articles I - II
Articles I and II of the Rolling Text are provided below. This material is from the 9th Session of the Ad Hoc Group of States Parties to the Convention.
Please note: the page numbers given are those which appear in the original text, these appear at the top of the page. The detailed footnotes are provided at the end of the main text.
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BWC/AD HOC GROUP/39
Annex 1
page 15
ARTICLE I
GENERAL PROVISIONS
BWC/AD HOC GROUP/39
Annex 1
page 16
ARTICLE II
[DEFINITIONS2
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.]3
[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.]4
BWC/AD HOC GROUP/39
Annex 1
page 17
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.]
BWC/AD HOC GROUP/39
Annex 1
page 18
6. [Purely] Diagnostic facility
Facility which tests [only] samples for the purpose of diagnosis of human, animal and plant disease5 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.]
BWC/AD HOC GROUP/39
Annex 1
page 19
[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.]6
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.
BWC/AD HOC GROUP/39
Annex 1
page 20
[14. Purposes not prohibited by the Convention
[Industrial, agricultural and medical research] Treatment, prophylactic, protective or other peaceful purposes.]7
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.]8
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.]
BWC/AD HOC GROUP/39
Annex 1
page 21
[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.
BWC/AD HOC GROUP/39
Annex 1
page 22
- 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/anatoxin9
[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.]]
Notes
2. 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.
3. 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.
4. Ibid.
5. "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.
6. See footnote 3.
7. See footnote 3.
8. See footnote 3.
9. This has not been discussed and needs further consideration.
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