Working Paper by the Friend of the Chair on Definitions : Definitions (WP.228)
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AD HOC GROUP OF THE STATES PARTIES
TO THE CONVENTION ON THE PROHIBITION
OF THE DEVELOPMENT, PRODUCTION AND
STOCKPILING OF BACTERIOLOGICAL
(BIOLOGICAL) AND TOXIN WEAPONS AND
ON THEIR DESTRUCTION
BWC/AD HOC GROUP/WP.228
24 September 1997
Original: ENGLISH
________________________________________________________________________________
Eighth session
Geneva, 15 September - 3 October 1997
Working paper submitted by the Friend of the Chair
on Definitions
ARTICLE II
[DEFINITIONS1
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.]2
GE.97-64374
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[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 disease and incapacitate] human beings, animals or plants.]3
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
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 specialised 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.]]
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6. Diagnostic Facility
[Any] [A] facility which tests [only] samples for the purpose of diagnosis of human, animal and plant diseases [by means of detection, isolation and 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 involves a process of arranging and manipulating nucleic acids of an organism to give it a capability to produce novel molecules or to add to it new characteristics, [excluding classical genetic techniques, natural processes and applications involving somatic hybridoma cells].4
[8.bis In the context of declaration triggers, genetic modification of listed agents and toxins means any manipulation of listed agents and toxins involving the application of techniques used in genetic modification, whatever the outcome.]
[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.]5
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
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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 containment in production comprises the safety practices and equipment design features used in production activities involving microbial or other biological agents or toxins where there is a need to prevent incidental release into the environment. [Microorganisms, [viruses] and eukaryotic cells are handled in a [closed] system which physically separates the process from the environment (closed system) with seals so as to prevent release of organisms from the system, exhaust gases from the system treated so as to prevent release [and effluent treated before final discharge,] [as discharged from the system].] Sample collection, addition of material to the system and transfer of viable organisms to another closed system, performed so as to prevent release. This system could be located within a controlled area.]
[11.bis Primary Production Containment
Primary production containment comprises the safety practices and equipment design features used in production activities involving microbial or other biological agents or toxins where is a need to prevent incidental release into the environment. Microorganisms and eukaryotic cells are handled in a closed system.]
12. Production capability
Expertise and capability to produce microbial or other biological agents or toxins, whatever their origin or method of production.
[13.
Purposes not prohibited by the Convention
[Industrial, agricultural and medical research] Treatment, prophylactic, protective or other peaceful purposes.]6
14. 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.
[15. Toxins
Toxic by-products of microorganisms, natural poisons of animal or plant origin, whatever their method of production,
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designed to [destroy] [cause disease and incapacitate] human beings, animals or plants.]7
16. Vaccine
Preparations, including live-attenuated, 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.
17. 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].]
[17. bis In the context of declaration triggers, genetic modification of 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.]
[18. 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.]
[19. Biocontrol agent
[A material of biological origin or]An [micro-]organism used for the prevention, elimination or reduction of the disease, pest or which may have negative impact on a plant or crop.]
[20 . 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
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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.]
[21. Closed System
A system, which physically separates the process from the environment with seals so as to prevent release of organisms from the system, exhaust gases from the system are treated so as to prevent release and effluent is treated before final discharge. Sample collection, addition of material to the system and transfer of viable organisms to another system, is performed so as to prevent release. This system could be located within a controlled area.
A closed system may also contain closed vessels used for the preparation, growth and storage of bacteriological (biological) agents and toxins.]
_________
1 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.
2 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.
3 Ibid.
4 It may include alterations in the genetic material of organisms in performing new functions like enhancement or reduction in pathogenicity and/or virulence; resistance to biotic and abiotic stress; and change in antigenicity.
5 See footnote 3.
6 See footnote 3.
7 See footnote 3.
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