Working Paper by Friend of the Chair on Compliance Measures (WP.214)
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BWC/AD HOC GROUP/WP.214
10 September 1997
Original: ENGLISH
________________________________________________________________________________
Eighth session
Geneva, 15 September - 3 October 1997
Working Paper submitted by the Friend of the Chair
on Compliance Measures
D. DECLARATIONS
1. Each State Party shall declare [, regardless of the form of their ownership or control,] all activities or facilities listed in paragraphs 4 and 5 below which exist on its territory or in any other place under its jurisdiction or control.
2. [Each State Party shall submit [to the Organization] an initial declaration according to the format in Annex ..., not later than [60] days after the Protocol has entered into force for that State Party. This declaration shall include information on past offensive and/or defensive biological research [and] development [testing and production] programmes [at any time since [1 January 1946]] unless this information has already been provided under the CBMs].
3. Thereafter, each State Party shall submit a declaration, according to the format (s) in Annex ..., not later than one year after its previous declaration.
4. The declarations shall cover the following:
(a) activities
(i) [the presence/absence of] [national] [biological] defence programmes [against biological and toxin weapons].
(b) facilities
(i) taking part in [national] [biological] defence programmes [against biological and toxin weapons] [and conducting work on microorganisms or toxins as well as material imitating their properties];
(ii) which produce vaccines [and/or antitoxins] [licensed by the State Party] for the protection of humans [and animals] [and plant inoculants] [against listed agents/toxins] [with a certain production capacity and containment level];
GE.97-64143
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[(iii) which produce plant inoculants and/or biological control agent/s and have a plant quarantine capacity.];
(iv) which have any maximum containment laboratories meeting criteria designated as biosafety level 4 ((BL4) according to WHO classification) or P4 (according to WHO classification) or equivalent standards;
[(v) containing areas protected against [listed agents or toxins] according to biosafety level 3 (BL3) as specified in the 1993 WHO laboratory Biosafety Manual but excluding purely diagnostic [and medical] facilities.];
(vi) which:
[work with listed agents and toxins];
[work with listed agents/toxins and have a microbiological productions capability on site];
[work with listed agents/toxins and possess a microbiological production capability and have certain containment characteristics [including negative air pressure]];
[have an aggregate fermenter capacity of 100 litres or more, and work with or produce listed agents];
[- carry out production of listed agents and toxins;
- carry out aerobiology with [or genetic modification of] listed agents and toxins;
- carry out other research and development involving listed agents or toxins, and which have a microbiological production capability on site of 100 litres or above;
- maintain culture collections of listed agents and provide professional services on demand];
[(vii) [other production facilities] [all microbiological production facilities (including development facilities)] [not [necessarily] working with listed agents] which have [an aggregate] [self-sterilizing] fermenter[s] [production] [with a] capacity [above a specified level] [of 100 litres or more] [and which contain areas protected with: [negative] [differential] pressure, physical separation from public areas, filtration of exhaust air by HEPA filtration, access control, Class III biological safety cabinets and airtight seals, and aggregated self-sterlizing fermenters with operational closed systems [; or which have special technical characteristics, such as physically separated production equipment (bioreactors, fermenters), sealed production equipment, continuous production systems, and access to closed/controlled areas restricted to specific personnel]];
[ that is (are) operated as a closed system which prevents the escape of viable biological agents or toxins];
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[within a facility contained according to guidelines for containment facilities using Risk Group 3 microorganisms (Biosafety Guidelines for Personnel Engaged in the Production of Vaccines and Biological products for Medical Use, World Health Organisation, WHO/CDS/BVI/95.5)];
[which produce by fermentaation (i) medicines and/or (ii) antibiotics or (iii) other microorganisms in closed systems].
(viii) all [facilities] [[excluding those for purely agricultural purposes] [not necessarily working on listed agents] which possess [aerosol test chambers of a certain size for work with microorganisms or toxins] [equipment for aerosol dissemination in the open air] [with a particle mass median diameter not exceeding 10 microns]]
[not working with listed agents which:
- possess aerosol [explosive] test chambers of ... m3 or above, for work with biological agents and toxins;
- conduct genetic modification to enhance pathogenicity and virulence;
[ - conduct genetic modification in BL3 containment or equuivalent standards]].
[ conducting genetic modification not necessarily on listed agents [to enhance pathogenicity and virulence] with BL4 or BL3 containment on site.]
[Transfers
5. Each State Party shall declare annually all transfers of listed agents, toxins, equipment or means of delivery.
6. Each State Party declaring such transfers shall submit information according to the format in Annex ...]
[Appearance of outbreaks of disease or epidemics
7. Each State Party shall declare to an international epidemiological network, in accordance with guidelines to be determined, any relevant information on outbreaks of disease, epidemics (or similar occurrences caused by toxins) that occur on its territory or in areas under its jurisdiction or control, caused by listed agents or toxins for humans, animals or plants.]
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