The Biological and Toxin Weapons Convention (BTWC) Database
Rolling Text (9th Session) : Article III
Article III of the Rolling Text is 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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ARTICLE III
COMPLIANCE MEASURES
A. [LISTS AND CRITERIA (AGENTS AND TOXINS)]
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B. [EQUIPMENT]
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C. [THRESHOLDS]10
1. [Each State Party can store at facilities, for the purposes of developing and testing means of protection against biological weapons, established threshold quantities of biological materials containing listed agents. Specific values of threshold quantities shall be determined in accordance with Annex A, section IV. These thresholds do not cover quantities that are used in day to day work and for the production of immune biological, medical and other preparations.]
2. [Thresholds are meant to limit the scope of Article I of the Biological Weapons Convention and as such are of no value for this Protocol.]
[1. Role of threshold quantities
The determination of threshold quantities of listed microorganisms and toxins is viewed as a useful tool in verification of compliance with the BWC. The use of threshold quantities is not aimed at limiting the sphere of application of Article I of the BWC, since it is not prohibitive in nature.
2. Types of threshold quantities and their use
Two levels of threshold quantities are established for each individual strain (type) of listed microorganism or toxin at the monitored facility lower and upper.
The lower threshold corresponds to the maximum quantity of a pathogenic microorganism or toxin of an individual strain (type) which need not be indicated in the annual declarations of activities at a facility monitored under the Convention at which the biological agent in question is produced and/or stored. The maximum current quantity of the listed microorganism or toxin in excess of the threshold level is subject to mandatory reporting in the annual declaration.
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The upper threshold corresponds to the minimum quantity of a pathogenic microorganism or toxin of an individual strain (type) for which prior written authorization is required for production or handling. The authorization places temporal and quantitative limits on the production and use of the biological agent, and also lays down required methods of analysis of the quantity of biological agent and verification of safety conditions.
Any decision to issue a written authorization for the stockpiling of a listed type (strain) of a microorganism or toxin in quantities in excess of the threshold level is taken by the Organization in response to a written request from the monitored facility indicating the intended purpose (which must not run counter to the aims of the Convention), and on the basis of a preliminary analysis of the safety conditions at the facility making the request. In the analysis account must be taken of the real likelihood of a violation of the Convention, as well as of accidents, with due regard for all the risks and concern on the part of other States Parties as to the activities conducted at the facility.
3. Technical basis for determining threshold quantities
The quantity of listed microorganisms and toxins is evaluated from the total quantity of infective (incapacitating) doses (ID 50) which produce a reaction in 50 per cent of cases for the most sensitive test subjects and the most common method of infection available at the facility. The lower threshold level for the type of listed microorganism or toxin is to be taken as the quantity corresponding to the value 1 x 1013 ID 50. The upper threshold level for the type of listed microorganism or toxin is to be taken as the quantity corresponding to the value 2 x 1014 ID 50.]
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D. DECLARATIONS
1. [Each State Party shall declare, regardless of the form of their ownership or control, all activities or facilities listed below which exist on its territory or in any other place under its jurisdiction or control.]
2. [Each State Party shall submit [to the BTWC Organization] an initial declaration according to the format in Annex ..., not later than [60] [90] 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 or production] programmes [at any time since [17 June 1925] [1 January 1946] [26 March 1975]] [unless this information has already been provided under the CBMs].]]
3. [Thereafter, each State Party shall submit an annual declaration, according to the format[s] in Annex ..., not later than [90] [120] days after the end of the previous calendar year on the activities of that year.]
4. [Upon receipt of a request by a State Party which has submitted its own declarations, [the BTWC Organization] shall make available to that State Party [in accordance with the provisions on confidentiality contained in Article IV and Annex E of this Protocol] copies of the initial and/or annual declarations of other States Parties, as specified in the request. [[The BTWC Organization] shall inform the States Parties concerned that copies of their declarations have been made available to the requesting State Party.]]
5. [The declarations shall include the following] [The following shall be declared]:
[(a) Activities
(i) The presence/absence of [military] [civilian] [national] [biological] defence programmes [against biological and toxin weapons]11;
[(ii) Any additional information related to past offensive and/or defensive activities not provided in the initial declaration.]]
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[(b) Facilities
(i) [Which as their main task are] [taking part in] [military] [civilian] [national] [biological] defence [facilities12 taking part in] programme(s) [against biological and toxin weapons [as per listed agents or toxins]]11 [and conducting work on microorganisms or toxins as well as material imitating their properties];
(ii) Which produce vaccines13 [and/or toxoids/anatoxins]14 [licensed by the State Party] for the protection of humans [against listed agents or toxins] [with a production capacity as specified in Annex ...] [with primary production containment]15;
(iii) Which produce vaccines13 [and/or toxoids/anatoxins]14 [licensed by the State Party] for the protection of animals [against listed agents or toxins] [with a production capacity as specified in Annex ...] [with primary production containment]15;
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[(iv) Which produce plant inoculants and/or biological control agent(s)16 and have a plant quarantine capability17 [with primary production containment]15;]
(v) 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]18 [maximum containment]19;
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[(vi) Containing areas protected [by high containment]20 [according to Biosafety Level 3 (BL3) [as specified in the 1993 WHO Laboratory Biosafety Manual]]21 [and working with listed agents or toxins] but excluding purely diagnostic [and medical] facilities;]
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(vii) Which
[work with listed agents or toxins22 with the exclusion of facilities involved only in diagnostic and/or medical treatment activities;]
or
[have an aggregate fermenter capacity of 100 litres or more and work with22 or produce listed agents;]
or
[conduct any of the following activities with any of the agents or toxins listed in Annex A excluding those involved only in diagnostic and/or medical treatment activities:
[- research and development, including on detection or identification methods [and with an aggregate production capacity on site of 100 litres or more] [and with [high containment]20 [certain containment characteristics including negative air pressure]];]
[- production of such agents or toxins [and/or of vaccines against them] [with an aggregate production capacity on site of 100 litres or more] [and with [certain containment characteristics including negative air pressure] [primary production containment]15];]
[- maintain culture collections [registered and designated by the government] and provide professional services on demand;]
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[- apply genetic modification23 techniques] [[to enhance pathogenicity, virulence or resistance to environmental factors/antibiotics] [focussing on genetic elements containing nucleic acid sequences coding for the determinants of pathogenicity of listed microorganisms or toxins for introduction into agents not listed in Annex A]];
[- aerobiology]24;]
[(viii) Other microbiological production facilities [including development facilities]25 not working with listed agents which have an aggregate fermenter production capacity of [100] [1000] litres or more
[with primary production containment;]15
[- which produce by fermentation (i) medicines and/or (ii) antibiotics or (iii) other microorganisms in closed systems26].]
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[(ix) Not working with listed agents or toxins which
[- possess aerosol [explosive] test chambers of ... m3 or above for work with microorganisms or toxins;]
[- possess equipment for aerosol dissemination in the open air with a particle mass median diameter not exceeding [10] microns [excluding those for purely routine agricultural [, health or environmental] use]27;]
[- conduct research and development with microorganisms containing nucleic acid sequences coding for determinants of pathogenicity or toxicity of listed agents or toxins;]
[- conduct genetic modification23 [to enhance pathogenicity and virulence28 [or resistance to environmental factors/antibiotics]] [with BL3 containment or equivalent standard]21 [with high containment]20 [and have an aggregate production capacity of 100 litres or more].]]]
[Transfers
6. Each State Party shall declare annually all international transfers of listed agents or toxins, equipment [or means of delivery].
7. Each State Party declaring such transfers shall submit information according to the format in Annex ... .]29
[Appearance of outbreaks of disease or epidemics30
8. Each State Party shall declare as quickly as possible in accordance with guidelines set out in Annex ..., 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
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control, caused by listed agents or toxins for humans, animals or plants [or which have clinical and epidemiological effects similar to diseases or syndromes caused by listed agents or toxins but are undiagnosed].]
[Declarations on the implementation of Article X of the Convention31
9. Each State Party shall declare annually the measures taken individually or together with other States and international organizations in implementing Article X of the Convention.
10. Each State Party shall [have the right to] declare any restrictions, in non-compliance with the obligations under Article X, on the transfer of biological materials, equipment and technology for peaceful purposes.
11. Each State Party shall submit a declaration on the implementation of Article X of the Convention according to the format in Annex ... .]
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E. CONSULTATION, CLARIFICATION AND COOPERATION32
[1. Each State Party shall also have the right to request visits in accordance with ... .]
[[2. States Parties shall, without prejudice to their rights and obligations under Article V of the Convention, consult and cooperate, directly among themselves, or through [the Organization] or other appropriate international procedures, including within the framework of the United Nations and in accordance with its Charter, on any matter which may be raised relating to the object and purpose, or the implementation of the provisions of this Protocol [and/or the Convention].]
3. [Without prejudice to the right of any State Party to request an investigation,] States Parties [should] [shall] [, whenever possible,] [, as a rule,] first make every effort to clarify and resolve, among themselves or with or through [the Organization], any matter which may cause concern about possible non-compliance with the obligations of this Protocol or the Convention, or which gives rise to concerns about [a related matter which may be considered ambiguous] [the implementation of the provisions of this Protocol].
4. A State Party that receives a request pursuant to paragraph 3 directly from another State Party shall provide the clarification to the requesting State Party as soon as possible, but in any case not later than [10 days] after the request. The requesting and requested States Parties may keep the [[Executive] [Consultative] Council] [politically representative body] and Director-General informed of the request and the response. In the case where a matter was referred to [the Organization], the requesting and requested States Parties shall keep the [[Executive] [Consultative] Council] [politically representative body] and Director-General informed of the request and the response.
[5. Nothing in this Protocol shall affect the right of any two or more States Parties to arrange by mutual consent for investigations, visits or any other procedures among themselves to clarify and resolve any matter which may cause concern about possible non-compliance with the obligations of this Protocol or the Convention or gives rise to a concern about [a related matter which may be considered ambiguous] [the implementation of the provisions of this Protocol]. [Such arrangements shall not affect the rights and obligations of any State Party under other provisions of this Protocol.]]
[6. Any State Party shall have the right to request the [Director-General] [the Organization] to [assist in seeking] [seek] clarification from any State Party of any [ambiguity, uncertainty, anomaly or omission] [technical matter] relating to its declaration obligations under this Protocol [, or on any other related matter which may be considered ambiguous].]
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[7. The [Technical] Secretariat [shall] [may] [have the right to seek clarification from] [consult with] any State Party of [matters of a purely technical nature] [any [ambiguity, uncertainty, anomaly or omission] [technical matter]] relating to its declaration obligations under this Protocol [, or on any other related matter which may be considered ambiguous].]33
8. A State Party shall have the right to request in writing [the [Executive] [Consultative] Council] to obtain clarification from another State Party on any situation which may be considered ambiguous or which gives rise to a concern about its possible non-compliance with the obligations of the Convention [or Protocol]. [The requesting State Party shall provide [the [Executive] [Consultative] Council] with information upon which its request is made.] In such cases, the following shall apply:
(a) The [[Executive] [Consultative] Council] [Organization] shall forward the request for clarification to the requested State Party through the Director-General no later than 24 hours after its receipt;
(b) The requested State Party shall provide the clarification [to the [Executive] [Consultative] Council] [through the Organization] as soon as possible, but in any case no later than [[48] [96] hours] [10 days] after receipt of the request;
(c) [The [Executive] [Consultative] Council] shall take note of the clarification and forward it to the requesting State Party no later than 24 hours after its receipt;
(d) If the requesting State Party deems the clarification to be inadequate, it shall have the right to request [the [Executive] [Consultative] Council] to obtain further clarification from the requested State Party, providing reasons that the clarification is deemed to be inadequate. The requested State Party may offer a possible [voluntary] visit by [the Organization] [to the site as a means of resolving the concern]. [The requesting State Party may request [the Organization] to conduct a visit to the site as a means of resolving the concern [, with the explicit consent of the requested State Party].]
9. [The [Executive] [Consultative] Council] shall inform without delay all other States Parties about any request for clarification and the basis for this request pursuant to paragraph 8 as well as any response provided by the requested State Party.
10. For the purposes of obtaining further clarification requested under paragraph 8 (d), [the [Executive] [Consultative] Council] may call on the Director-General to [consult the Scientific Advisory Board and] establish [on the basis of equitable geographical distribution [if possible]] a group of experts from the [Technical] Secretariat [, or if appropriate staff are not available in the [Technical] Secretariat, from the list of [ad hoc] [part time] experts nominated for designation by States Parties in accordance with procedures as set out in Annex ... and
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approved in advance34], to examine all available information and data relevant to the situation causing concern. The group of experts shall submit a factual report to [the [Executive] [Consultative] Council] on its findings.
11. If [the requesting] [a] State Party considers the clarification obtained pursuant to paragraphs [5, 6 [, 7] or 8] to be unsatisfactory [, without prejudice to its right to request an investigation], it shall have the right to request in writing a special [session] [meeting] of [the [Executive] [Consultative] Council] in which States Parties involved that are not members of [the [Executive] [Consultative] Council] shall be entitled to take part. In such a special [session] [meeting], [the [Executive] [Consultative] Council] shall consider the matter and may recommend [to all States Parties involved] any measure it deems appropriate to resolve the situation [in accordance with Articles ...].
12. If the doubt or concern of a State Party about possible non-compliance has not been resolved within [21] [60] days after the submission of the request for clarification to [the [Executive] [Consultative] Council], or it believes its doubts warrant urgent consideration, notwithstanding its right to request an investigation, it may request a special session of the Conference of States Parties in accordance with Article IX, paragraph 13 (c). At such a special session, the Conference shall consider the matter and may recommend any measure it deems appropriate to resolve the situation.
[13. A State Party shall also have the right to request [the [Executive] [Consultative] Council] to examine any situation which may have been considered ambiguous, or has given rise to a concern about its possible non-compliance with either this Protocol or the Convention. [The [Executive] [Consultative] Council] shall consider the request and provide assistance as appropriate.]]
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F. [VISITS AND INVESTIGATIONS]35 36 37
[I. [Visits38]
[1. In accordance with [this Article and] the detailed provisions in Annex ..., [the BTWC Organization] [shall] [may] carry out the following kinds of visits:
(a) [Random Visits];
(b) [Clarification Visits];
(c) [Request Visits];
(d) [Voluntary Visits].]
[(A) [Random Visits]
2. [The BTWC Organization] shall conduct, in accordance with [this Article and] the detailed provisions contained in the Annex [on Implementation of Random Visits]39 [...], a limited number per year of Random Visits [which shall be non-confrontational [and
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confidence-building] in nature] to declared facilities. These visits shall be [designed to confirm] [limited to confirming], in cooperation with the State Party to be visited that declarations are consistent with the obligations under this Protocol.
[3. The visits shall be conducted in the least intrusive manner [and shall not affect or interrupt [in any way] the activities taking place in the facility].]
[4. There shall be no more than [50] Random Visits per calendar year [with the following groups of countries receiving no more than [10] Random Visits each: [Africa, Asia, Eastern Europe, Latin America and the Caribbean, and the Western European and other States] [...]]. [Such visits shall be distributed [fairly] among the [5] [...] [regional] groups of countries - [and proportional to the number of the declared facilities of each State Party].] No State Party shall receive more than [10] Random Visits in each five year period. The [Organization] [[Technical] Secretariat] shall ensure that, over a five year period, Random Visits shall be divided between each category of declarable facilities in approximate proportion to the total number of declared facilities in each category.]
5. The [Technical] Secretariat shall, at random, identify declared facilities for Random Visits through appropriate mechanisms as specified in the Annex [on Implementation] [...].
6. The Director-General shall, in accordance with [Annex B], issue a standard mandate for the visit. [The mandate shall be confined to confirming that declarations are consistent with the obligations under this Protocol.]
7. The Director-General shall notify the State Party to be visited [[...] hours] before the arrival of the Visit Team, in accordance with [Annex B], and, at the same time, shall make available to the State Party to be visited the mandate for the visit. The State Party to be visited shall acknowledge receipt of the notification within [...] hours.]
[(B) [Clarification Visits]
8. [The BTWC Organization] [may] [shall] also conduct, [with the consent of the State Party to be visited and] in accordance with the provisions of this Article and the detailed provisions contained in [Annex B], Clarification Visits in order to resolve any ambiguity, uncertainty, anomaly or omission in the declarations of a State Party and to promote accuracy and comprehensiveness in future declarations.
[9. The visits shall be conducted in the least intrusive manner [and shall not affect or interrupt [in any way] the activities taking place in the facility].]
[10. In cases where [the BTWC Organization] [the [Technical] Secretariat] [or] [a State Party] [alone or] [through the [BTWC Organization] [[Technical] Secretariat]] has been unable to resolve any such ambiguity, uncertainty, anomaly or omission [through the process of consultation, clarification and cooperation provided for in [paragraphs 6 or 7 of] section E
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of this Article], [the BTWC Organization] [the [Technical] Secretariat] [may] [shall] [, upon the request of a State Party] [and following appropriate review by the Executive Council] visit the [declared] facility(ies) in respect of which the ambiguity, uncertainty, anomaly or omission has arisen.]
[11. In cases where the [Technical] Secretariat or a State Party has been unable to resolve any such ambiguity, uncertainty, anomaly or omission [through the process of consultation, clarification and cooperation provided for in [paragraphs 6 and 7 of] Section E of this Article] in respect of a facility or facilities which have not been declared, the [Technical] Secretariat shall upon request of the State Party which originally sought the clarification, and following appropriate review by the Executive Council, visit the facility(ies) concerned.]40
12. The Director-General shall [, in consultation with the State Party to be visited,] [in accordance with [Annex B] [...]] [issue] [prepare] a mandate which shall be limited to confirming that declarations are consistent with the obligations under this Protocol and resolving the identified ambiguity, uncertainty, anomaly or omission. [The mandate shall also encourage cooperation with the State Party to be visited.]
[13. [The BTWC Organization] [The [Technical] Secretariat] [shall have the right to] [may] carry out [the minimum necessary within] [a maximum of] [...] Clarification Visits during each two-year period.
14. Within the overall limit specified in paragraph 13, [the BTWC Organization] [the [Technical] Secretariat] may carry out a maximum of [...] Clarification Visits during each two year period, to States Parties within each of the [5] [...] regional groups of countries - [Africa, Asia, Eastern Europe, Latin America and the Caribbean, and the Western European and other States] [...].
15. [The BTWC Organization] [The [Technical] Secretariat] may carry out no more than [...] Clarification Visits to any State Party during each two-year period.]
or
[16. [The BTWC Organization] [The [Technical] Secretariat] [shall] [may] carry out Clarification Visits only when necessary to clarify a specific ambiguity, uncertainty, anomaly or omission from a declaration.]41
17. [[...] hours] [[21] days] before the arrival of the Visit Team, in accordance with [Annex B], the Director-General shall notify the representatives of the State Party to be visited, and, at the same time, shall make available to the State Party to be
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visited the mandate for the visit. The State Party to be visited shall acknowledge receipt of the notification within [...] hours. The Director-General shall also notify all other States Parties of the intention to conduct a Clarification Visit.]
(42C) [Request Visits]
[18. Each State Party shall have the right to request [the BTWC Organization] to undertake up to [...] visits per year in order, inter alia, to help compile individual facility and national declarations as well as to further the cooperation and assistance provisions of this Protocol. [The Director-General shall decide on the implementation of such visits taking into account the resource implications.] Such visits shall be subject to the same procedures, where relevant, as other visits. The detailed arrangements to, and contents of, a Request Visit, shall be agreed beforehand between the [BTWC Organization] and the State Party concerned.]
[(D) [Voluntary Visits]
[19. For the purpose of clarifying the ambiguities, the number, intensity, duration, timing and mode of visits to a particular facility shall be arranged and agreed between the State Party and [the BTWC Organization].]]
[Procedures for visits
20. The Director-General shall, in accordance with Annex B, designate the Visit Team, limiting its number of inspectors to the minimum necessary to carry out the visit, and, in any case, no more than [4] [6] [from [the BTWC Organization]].
21. For [Random] Visits, the Visit Team shall only bring approved equipment, according to Annex/Appendix ... on to the facility. [Approved equipment shall be brought on to the facility only with the agreement of the Visited State Party.]
22. Equipment, additional to the approved equipment according to Annex/Appendix ..., shall only be brought on to the facility with the agreement of the Visited State Party.
23. 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 on the facility and the activities carried out there, according to Annex B.
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24. After the briefing the Visit Team, the facility representatives and the representatives of the Visited State Party shall prepare an initial Visit Plan in accordance with Annex B.
[25. The Visit Plan may identify, as appropriate and at the request of the facility representative, areas in which the Visit Team may, provide technical assistance. These areas may include, inter alia, fulfilment of declaration obligations, biosafety standards, and good laboratory or manufacturing practices.]
26. Representatives of the Visited State Party and of the facility shall accompany the Visit Team throughout the duration of the visit to the facility.
27. 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.
28. The Visit Team shall be granted access subject to the need to protect sensitive information. [Access by the Visit Team shall be negotiated and agreed upon by the Visit Team and the Visited State Party.] The Visited State Party [shall have the right to negotiate the access requested by the Visit Team] [may apply managed access techniques, as illustrated, inter alia, in Annex B, where necessary] to protect sensitive information. The rights and obligations of the Visit Team and of the Visited State Party shall be as contained in this Protocol and the Annexes.
29. The principal on-site measures shall be interviewing, visual observation, identification of key equipment and auditing as appropriate.
30. Sampling shall only be conducted if offered by the facility and 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.
31. The Visit Team shall have the right to ask questions about [other] parts of the facility and [its] the activities conducted therein where [these are] relevant to [improving its understanding of] the facility declaration [and] or the specific issues of interest under clarification. The Visit Team shall also have the right to request access to other parts of the facility. Access shall be by agreement of the facility.
32. The Visit Team shall collect only that information necessary to carry out its mandate.
[33. During the conduct of the visit, as appropriate and at the request of the facility representatives, the Visit Team may give technical assistance in such areas as the fulfilment of declaration obligations, biosafety standards, and good laboratory or manufacturing practices.]
34. The duration of the visit shall be no more than [2] days unless extended by agreement between [of] the Visit Team and the visited facility.
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35. At the end of the visit, the Visit Team shall prepare its draft report in accordance with Annex B. The draft report shall be considered confidential.
[36. The draft report shall summarize the general activities undertaken during the visit and the factual findings of the Visit Team.]
[37. The [draft] report may make recommendations if requested and in cooperation with the facility representatives, in such areas as the fulfilment of declaration obligations, biosafety standards, and good laboratory or manufacturing practices.]
38. The draft report shall immediately be submitted to the Visited State Party. The Visited State Party may make written comments which shall be [annexed to] [included, as appropriate, in] the report. [The report shall then be submitted to the Director-General, who shall circulate it, including findings relevant to the issue(s) raised under the clarification and consultation procedures, to all States Parties.]
39. In the case, that during a visit ambiguities or any other related questions are identified in the declarations, the aim shall be that these should be solved by the visited facility and the Visited State Party with adequate assistance, if necessary, by the Visit Team.
or
40. If any ambiguities or other related questions to the Visited State Party's declarations arise during the visit, the Visited State Party and the facility should seek to resolve these cooperatively with the assistance of the Visit Team.
41. The Visit Team shall then submit the 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 or to the issue(s) raised under the clarification and consultation procedures. [The Director-General] shall circulate the summary to all States Parties.
42. In cases where declarations remain inaccurate or incomplete, or where ambiguities remain, the Director-General shall inform [the Executive Council] [the politically representative body] which shall consider what, if any, further action is required.]]
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II. [MEASURES TO STRENGTHEN THE IMPLEMENTATION OF ARTICLE III]
[1. States Parties, in order to ensure compliance with Article III of the BTWC, shall only transfer dual-use microbial and other biological agents, toxins and equipment for purposes not prohibited by the Convention, in accordance with the following guidelines.
2. In pursuance of paragraph 1, and recognizing that most of the agents, toxins, equipment and technologies are of a dual-use nature and with the objective of preventing dual-use items from being utilized for purposes prohibited by BTWC, the guidelines shall be as follows:
(a) Any request made by a State Party for the procurement of a specific agent/toxin reagent shall be accompanied by information on purpose, quantity required, site or facility for proposed use, quantity to be produced at the site or facility, place where intended to be stored and end-use certificate;43
(b) Any request for transfer or procurement of equipment envisaged to be declared under CBMs, for use by a State participating in the compliance regime in a BL4 facility, including details of its proposed application and the site/facility for intended use, shall be intimated to [the BTWC Organization];
(c) Any transfer of technology related to delivery systems, aerosol dispersion of toxins and pathogens, stabilization of agents/toxins to environmental stress shall be intimated to [the BTWC Organization];
(d) Transfer of agents, equipment and material shall not be allowed to non-States Parties of the compliance regime under the Convention without prior approval of [the BTWC Organization].]
[3. (a) To ensure compliance with Article III of the BTWC, [no] [each] State Party shall [only] authorize transfers to any recipient whatsoever, of microbial or other biological agents, or toxins whatever their origin or method of production, or equipment which [is capable of using such agents or toxins for hostile purposes] [can be used in contravention of Article I of the Convention], [unless that State Party has] [if it is] determined that these will be used solely for prophylactic, protective or other peaceful purposes.
(b) (i) Each State Party shall report to [the Organization] on the national laws and regulations it has adopted to implement Article III of the BTWC
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not later than [...] days after the entry into force of this Protocol for that State Party and whenever an amendment thereto is made.
(ii) Each State Party shall report to [the Organization] on its administrative and other national measures to implement Article III of the BTWC not later than [...] days after the entry into force of this Protocol for that State Party and whenever an amendment thereto is made.
[(iii) Such reports shall contain detailed information. If available, the information contained in these reports may be subject to examination during a visit under the Article I investigation procedures of this Protocol.]
[(c) No transfer of microbial or other biological agents or toxins, whatever their origin or method of production, or equipment which is capable of using such agents or toxins for [hostile purposes] [for purposes which would contravene Article I of the Convention], shall be allowed to non-States Parties of the Convention and the Protocol.]44
[(d) Each State Party, in implementing these measures, shall ensure that they do not impede the peaceful economic and technological development of States.]]
[4. [Proposed] Transfer guidelines
(a) The provisions of the Convention shall not be used to impose restrictions and/or limitations on the transfer of scientific knowledge, technology, equipment and materials for purposes not prohibited under the Convention.
(b) In order to promote transparency in the biological trade, the States Parties may agree on arrangements for exchanging the end-user certificate related to biological exports in a manner that will entail no restrictions or impediments on access to biological materials, equipment or technological information by all States Parties. This would replace all existing ad hoc regulations in the biological trade at the time of entry into force of the Protocol for States Parties.
(c) An end-user certificate may be required from the recipients stating, in relation to the transferred biological agents or toxins and equipment (to be identified as relevant by the Ad Hoc Group), the following:
(i) That they will only be used for purposes not prohibited under this Convention for the States not party to the Convention;
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(ii) That they will not be retransferred without receiving the authorization from the supplier(s);
(iii) Their types and quantities;
(iv) Their end-use(s); and
(v) The name and address(es) of the end-user(s).
(d) States Parties shall resolve suspicions arising from such transfers through the process of consultation and clarification in accordance with Article V of the Convention.]
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III. INVESTIGATIONS45
(A) TYPES OF INVESTIGATION
1. Investigations to address a non-compliance concern may be of two types:
[(1) Field investigations where there is an event(s) of release of, or exposure of humans, animals or plants to microbial or other biological agents and toxins [that cause a concern about non-compliance with Article I of the BTWC by any other State Party]. These investigations would take place in affected geographic areas.]
[(1) Investigation of the alleged use of biological weapons.]
[(2) Facility investigations where there is concern that a particular facility(ies) is involved in activities prohibited by Article I of the BTWC and will be conducted inside the perimeter of the facility.]
[(2) Investigation of any other alleged breach of obligations under the provisions of the Convention.]
A State Party requesting an investigation to address a non-compliance concern [may] [shall] specify which type of investigation it was seeking.
[(3) Investigations where there is a concern that a transfer has taken place in violation of Article III of the Convention.]
[2. [All] [natural] [outbreaks of] disease [which are demonstrated to be natural] [and accidents] are of no concern under the [Convention] [Protocol] [as set out in Annex ...].]46
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(B) INITIATION
3. Each State Party47 [to the Protocol]48 shall have the right to request an investigation (as defined in paragraph 1 above) into a specific concern about non-compliance with [Article I [and Article III]] of the BTWC by any other State Party [to the Protocol].
4. A State Party may request a [field investigation] [investigation of alleged use of biological weapons] (as defined in paragraph 1 above) about a situation [either] on its own territory [, or on the territory of another State Party,] [or of a non-State Party].
5. Investigations may be conducted on the territory of any State Party or in any other place under the jurisdiction or control of the State Party regardless of the form of ownership of the facility or the geographic area subject to the investigation.
6. Each State Party shall be under the obligation to keep all requests within the scope of the Convention and refrain from unfounded requests.
7. The investigations shall be carried out for the sole purpose of determining the facts relating to the possible non-compliance.
8. Requests for investigations [under this Protocol] [may] [shall] be submitted to [the BTWC Organization] [the politically representative body of the States Parties] [the United Nations Security Council, in accordance with Article VI of the Biological Weapons Convention] [and agreed procedures established under the Protocol].
[9. In the case of a non-compliance concern involving a State which is a party to the BTWC but not to the Protocol, [the BTWC Organization and/or] [States Parties], where appropriate, shall use the relevant provisions of the Convention to seek to resolve the concern. In cases where an investigation has been initiated, the provisions and rights with regard to access and conduct of investigations foreseen under the Protocol may be applied to such investigations as [agreed and] appropriate.]
[10. In the case of a State Party requesting a [field] investigation [of the alleged use of biological weapons] on the territory of a non-State Party to the Convention, [another State Party shall be named as the alleged perpetrator]. [Consultations would need to be undertaken with the non-State Party with a view to securing] [[Subject to its agreement] the non-State Party shall be requested to provide] access to the relevant area(s) of concern on its territory. The provisions and rights with regard to access and conduct of investigations foreseen for
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States Parties under the Protocol may be applied to investigations on the territory of a non-State Party as [agreed and] appropriate.]
[11. In cases of investigations of non-compliance concern involving a State not party to the BTWC or in territory not controlled by a State Party, the BTWC Organization should closely cooperate with the Secretary-General of the United Nations. If so requested, the BTWC Organization should put its resources at the disposal of the Secretary-General of the United Nations.]
12. Other States Parties may undertake to assist, to the extent they may be capable and/or are requested, in clarifying or resolving matters related to a concern about non-compliance.
[13. Other States Parties may undertake to assist in clarifying or resolving matters related to a concern about non-compliance. The [BTWC Organization] may also request that States Parties provide such assistance on a voluntary basis.]
(C) CONSULTATION, CLARIFICATION, AND COOPERATION49
14. States Parties [shall] [may] make [full] use [where possible and as appropriate] of opportunities for bilateral and multilateral clarification and consultation [through the Organization] [in accordance with Article V of the BTWC] [and established procedures under the Protocol] to resolve any concern about non-compliance with the Convention [[prior to] [or] [in parallel to] a request].
[15. [International organizations such as WHO, FAO and IOE] [and an international epidemiological network] may play a role in such consultation and clarification procedures.]
(D) INFORMATION TO BE SUBMITTED WITH A REQUEST FOR AN INVESTIGATION TO ADDRESS A CONCERN OF NON-COMPLIANCE
WITH THE CONVENTION
[16. A State Party requesting an investigation shall provide [, to the extent possible,] [all] relevant [available] information indicating a non-compliance concern including [location, how the concern arose, the type of non-compliant activity, the specific event or activities which gave rise to the concern, the date and place of any such event or activities]. All information shall be as precise as possible.]
17. The requesting State Party shall provide relevant information about the source, [confirming [proving] [and demonstrating] its [reliability] [and impartiality,] [its non-discriminatory nature] [that it is well-founded] [and open to multilateral scrutiny]].
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18. Requests for [facility investigations] [investigations of any other alleged breach of obligations under the provisions of the Convention as indicated in section B] shall at least include [the following information:] [the information specified in Annex D.]50
[ [(a) [Name of the State Party in whose territory or under whose jurisdiction or control the non-compliant activity has allegedly taken place;] [The State Party to be investigated;]]
(b) Information [, to the extent possible,] on the [research,] development, production, stockpiling, acquisition or retention [indicating specifically] [which prohibited activity took place] [the specific event, or series of events, which gave rise to a non-compliance concern] of
(i) Microbial or other biological agents or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes;
(ii) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict;
(c) The location [and area] of any alleged non-compliant activity. This shall include as much detail as possible including a description, the location, boundaries and geographic coordinates, specified to the nearest second, if possible;
(d) The approximate period during which the non-compliant activity or event is alleged to have taken place;
[(e) Information from and/or the outcome or results of [any] prior consultations/clarifications [or prior field investigation] [or prior investigation of the alleged use of biological weapons] relevant to the request;]
[(f) Information to demonstrate that the non-compliance concern is not a natural outbreak of disease.]
The following other types of information could also be important:
(g) Whether any facility concerned has been declared under the Protocol; and any information included in or absent from the declaration return relevant to the allegations;
(h) If not, any information to suggest that the facility concerned should have been declared under the Protocol;
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(i) Details of the ownership and/or operation of the facility concerned;
(j) Any additional relevant information, e.g. on extent and nature of the alleged non-compliant activity.]
19. Requests for [field investigations] [investigations into alleged use of biological weapons] shall at least include [enough of the following [precise] information to support a prima facie case of a non-compliance concern] [to the extent possible] [the following [precise] information:] [the [precise] information specified in Annex D.]5152
[ [(a) Name of the State Party in whose territory or under whose jurisdiction or control the alleged [event] [use] has taken place;]
(b) [Approximate] date [and] time [and duration] of the alleged [event] [use];
(c) The location, geographic coordinates and the characteristics of the area(s) involved [, whether the area is on the territory of the requesting State Party, and if not, the name of the State who controls that territory as well as whether that State is a State Party to the Protocol and/or the Convention];
(d) [Aided by epidemiological data,] a description of the circumstances under which the [event] [use] took place, a description of the [event] [use] itself as well as an indication of whether it was a single [event] [use] or a series of [events] [uses]. An indication of the suspected cause and/or perpetrator of the [event] [use];
[(e) The victims (humans, animals or plants), the effects on them and the number affected. Symptoms and signs of the disease [or similar occurrence caused by toxins] [or other physical evidence] [, the treatment and the results of the treatment of the victims] shall be described;]
(f) Information [to the extent possible] on:
(i) The [use] [release] of microbial or other biological agent(s) or toxin(s) for other than peaceful purposes;
(ii) The use of weapons, equipment or means of delivery;
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[(g) Any epidemiological data substantiating an allegation why the event shall not be considered to be a natural outbreak of disease [including data on natural disease profiles and occurrences in the area affected, as well as demographic data];]
[(h) Information to demonstrate that the non-compliance concern is not a natural outbreak of disease;]
[(i) Information from and/or the outcome or results of [any] prior consultations/clarifications relevant to the request.]
The following other types of information could also be important:
(j) Reports of any internal investigation including results of any laboratory investigations;
[(k) The victims (humans, animals or plants), the effects on them and the number affected. Symptoms and signs of the disease [or similar occurrence caused by toxins] [or other physical evidence] [, the treatment and the results of the treatment of the victims] shall be described;]
(l) [Any] affidavits of eye witness accounts, photographs, samples or other physical evidence;
(m) Data on natural disease profiles and occurrences in the area affected, as well as demographic data;
(n) A description of the control measures and their result in the affected area, if available;
(o) Other corroborative information;
[(p) Requests for specific assistance, if applicable.]]
(E) SCREENING (TO GUARD AGAINST ABUSIVE REQUESTS)
20. [Requests for an investigation [into a non-compliance concern] [may] [shall] be submitted to [the United Nations Security Council] for decision on whether to initiate an investigation and on the need to conduct an inspection.] [Requests for an investigation into a non-compliance concern [may] [shall] be submitted to the [politically representative body of States Parties] [the Director-General]. Providing the request satisfied agreed requirements, the investigation would proceed [if formally approved by [at least a two-thirds majority] [a three-quarters majority] [present and voting] of this representative body] [unless this body decides by a three-quarters majority of all its members against carrying out the investigation.]]
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21. [The consideration of investigation requests [may] [shall] be assisted by [technical advice from [an appropriate body of experts] [a scientific support centre]] [consultation with experts of States Parties to the Protocol] [and by advice from relevant international organizations including WHO [and OPCW] where appropriate]. [In this regard, an international epidemiological network could assist in distinguishing natural outbreaks of disease from unusual or artificial phenomena potentially related to a violation [or attempted violation] of the 1972 Convention.]
[22. In considering whether an investigation request should proceed, the politically representative body of the States Parties and/or its technical advisers may also consider whether to request more information; whether to implement bi- or multilateral consultations to resolve the issue; whether to reject the request pending further information or, whether to request the WHO/FAO/IOE to conduct an investigation of an unusual outbreak of disease. The decision to proceed with any of these activities may be determined, in part, by the information submitted with the investigation request.]53
[(F) ISSUE OF INVESTIGATION MANDATE
[23. Investigations should have a clear and specific mandate [which should be strictly observed by the investigation team].]
24. The Director-General shall [issue] an investigation mandate for the conduct of the investigation. The investigation mandate shall be the investigation request put into operational terms, and shall conform with the investigation request.
25. The investigation mandate shall be made available to the State Party to be investigated by the investigation team, upon the latter's arrival at the point of entry.
(G) [ACCESS AND MEASURES TO GUARD AGAINST ABUSE DURING THE] [CONDUCT OF INVESTIGATIONS]
26. The investigation shall be conducted in accordance with the provisions of this Protocol and the Annex.
[27. The investigated State Party shall provide access [to the investigation team] [within the time frame specified in paragraph ... of Annex D] [within the [approved] investigation area for the sole purpose of collecting facts relevant to the mandate and] [in accordance with] [to which it is entitled under] [the Protocol and its Annexes].
[The investigated State Party shall be under the obligation to allow the greatest degree of access to facilities or areas to be investigated for the sole purpose of establishing facts relevant
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to the concern regarding possible non-compliance [taking into account] [without prejudice to] its constitutional obligations with regard to proprietary rights or searches and seizures.]
28. The investigated State Party shall make every reasonable effort to demonstrate its compliance with [the Convention] [and this Protocol] and to this end to enable the investigation team to fulfil its mandate.
29. [The extent and nature of access to a particular place or places within the [approved] investigation area shall be negotiated between the investigation team and the investigated State Party [on a managed access basis].]
The investigated State Party shall have the right [under managed access] to take such measures [as are] [it deems] necessary to protect sensitive national security or commercial proprietary information not related to activities prohibited by the Convention [, or to comply with its constitutional obligations with regard to proprietary rights or searches and seizures].
This may include restricting access to any particularly sensitive [facility], area or information [unrelated to the prohibitions of the BTWC] [not related to activities prohibited by the Convention] [unrelated to the contents of the request].
[The extent and nature of access to a particular place or places will in such cases be negotiated between the investigation team and the investigated State Party [on a managed access basis] [, so as to enable the investigation team to fulfil its mandate].]
An illustrative list of specific measures which an investigated State Party might, if necessary, take to this end is set out in Annex D.
If the investigated State Party provides less than full access to places, activities, or information, it shall [as a rule] make all reasonable [and feasible] efforts to provide [reliable] alternative means to demonstrate compliance.
[30. The investigated State Party shall have the right to restrict [or deny] access to any particularly sensitive [facility], area or information not related to activities prohibited by the Convention.]
[The investigated State Party shall have the right to make the final decision regarding any access of the investigation team, taking into account its obligations under this Protocol and the provisions on managed access [without prejudice to the provisions in paragraph 27].]]54
or
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[31. Pursuant to a request for an investigation of a facility or location, and in accordance with the procedures provided for in Annex D, the investigated State Party shall have:
(a) The right and the obligation to make every reasonable effort to demonstrate its compliance with [the Convention] [and this Protocol] and, to this end, to enable the investigation team to fulfil its mandate;
(b) The obligation to provide access within the [requested site] [[facility or] [site] designated for investigation] for the sole purpose of establishing facts relevant to the concern regarding possible non-compliance [[taking into account] [without prejudice to] constitutional obligations it may have with regard to proprietary rights or searches and seizures]; and
(c) The right to take measures to protect sensitive installations, and to prevent disclosure of confidential information and data, not related to activities prohibited by the Convention.]55
[5632. Pursuant to a request for an investigation of a facility or location, and in accordance with the procedures provided for in Annex D, the investigated State Party shall have:
(a) The right and obligation to make every reasonable effort to demonstrate its compliance with the Convention and, to this end, to enable the investigation team to fulfil its mandate;
(b) The obligation to provide access within the requested site designated for investigation for the sole purpose of establishing facts relevant to the concern regarding possible non-compliance; and
(c) The right to take measures to protect sensitive installations, and to prevent disclosure of confidential information and data, not related to the Convention.
33. The investigated State Party shall provide access to the investigation team within the requested site within ... hours of receiving the notification of the intent to conduct an investigation. The extent and nature of access to a particular place or places within the requested site shall be negotiated between the investigation team and investigated State Party.
34. Upon request of the investigation team, the investigated State Party may provide aerial access to the investigation site.
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35. In meeting the requirement to provide access as specified in paragraph 58, the investigated State Party shall be under the obligation to allow the greatest degree of access taking into account any constitutional obligations it may have with regard to proprietary rights or searches and seizures. The investigated State Party has the right under managed access to take such measures as are necessary to protect national security or commercial proprietary information. The provisions of this paragraph may not be invoked by the investigated State Party to conceal evasion of its obligations not to engage in activities prohibited by the Convention.
36. If the investigated State Party provides less than full access to places, activities or information, it shall be under the obligation to make every reasonable effort to provide alternative means to clarify the possible non-compliance concern that generated the investigation.
37. In carrying out the investigation in accordance with the investigation mandate, the investigation team shall use only those methods necessary to provide sufficient relevant facts to clarify the concern about possible non-compliance with the provisions of the Convention, and shall refrain from activities not relevant thereto. It shall collect and document such facts as are related to the possible non-compliance with the Convention by the investigated State Party, but shall neither seek nor document information which is clearly not related thereto, unless the investigated State Party expressly requests it to do so. Any material collected and subsequently found not to be relevant shall not be retained.
38. The investigation team shall be guided by the principle of conducting the investigation in the least intrusive manner possible, consistent with the effective and timely accomplishment of its mission. Wherever possible, it shall begin with the least intrusive procedures it deems acceptable and proceed to more intrusive procedures only as it deems necessary.
39. The investigation team shall take into consideration suggested modifications of the investigation plan and proposals which may be made by the investigated State Party, at whatever stage of the investigation including the pre-investigation briefing, to ensure that sensitive equipment, information or areas, not related to biological or toxin weapons, are protected.
40. The investigation team and the investigated State Party shall negotiate: the extent of access to any particular place or places within the requested site as provided in paragraph 41; the particular investigation activities, including sampling, to be conducted by the investigation team; the performance of particular activities by the investigated State Party; and the provision of particular information by the investigated State Party.
41. In conformity with the relevant provisions of Annex E of this Protocol, the investigated State Party shall have the right to take measures to protect sensitive installations and prevent disclosure of confidential information and data not related to biological and toxin weapons. Such measures may include, inter alia:
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(a) Removal of sensitive papers from office spaces;
(b) Shrouding of sensitive displays, stores, and equipment;
(c) Shrouding of sensitive pieces of equipment, such as computer or electronic systems;
(d) Logging off of computer systems and turning off of data indication devices;
(e) Using random selective access techniques whereby the investigators are requested to select a given percentage or number of buildings of their choice to inspect; the same principle can apply to the interior and content of sensitive buildings;
(f) In exceptional cases, giving only individual investigators access to certain parts of the investigation site.
42. The investigated State Party shall make every reasonable effort to demonstrate to the investigation team that any object, building, structure, container or vehicle to which the investigation team has not had full access, or which has been protected in accordance with paragraph 41, is not used for purposes related to the possible non-compliance concerns raised in the investigation request.
43. This may be accomplished by means of, inter alia, the partial removal of a shroud or environmental protection cover, at the discretion of the investigated State Party, by means of a visual observation of the interior of an enclosed space from its entrance, or by other methods.]
44. The investigation team shall conduct its investigation in the least intrusive manner possible consistent with its effective and timely implementation of its mandate, and shall collect only relevant information necessary to clarify the specific non-compliance concern.
45. In cases of [field] investigations [of the alleged use of biological or toxin weapons], [the investigated State Party shall provide access to] the investigation team [[shall] [may] with the consent of the receiving State Party, have access] to all such areas that might have been affected, including hospitals, refugee camps and other places, as it considers necessary for the effective conduct of its investigation without interfering with national measures to contain [and remedy the consequences of the alleged use of biological or toxin weapons] [the outbreak] [or the possible outbreak].
46. The investigation team shall have the right to request clarifications in connection with ambiguities that may arise during an investigation. Such requests shall be made promptly to or through the representative of the investigated State Party. The representative shall make every reasonable effort to provide the investigation team with such clarification as may be necessary to remove the ambiguity.
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47. The investigation team may [request to] conduct any or [all] [a combination] of the following on-site activities: interviewing, visual observation, [identification of key equipment,] [auditing,] [medical examination] [and sampling and identification]. These specific on-site activities shall be implemented in accordance with the provisions set out above in this section as well as in Annex ...
48. During [field] investigations [of the alleged use of biological weapons] the investigation team may [request to] conduct any or [all] [combination] of the following activities: interviewing, visual observation, [auditing,] [medical/disease-related examination,] [sampling and identification and collection of background information and data].
[49. These provisions may not be invoked by any investigated State Party to conceal any evasion of its obligations not to engage in activities prohibited under the Convention.]
(H) FINAL REPORT
50. The preparation and handling of the final report shall be conducted in accordance with Annex D, paragraphs ... .
(I) FURTHER CLARIFICATION
51. [The BTWC Organization] [The Technical Body] [may] [shall] undertake consultations with the investigated State Party to allow for further clarification including on matters raised by the investigated State Party, if there are remaining uncertainties identified by the investigation team [, or in case the cooperation offered by the investigated State Party is not considered to meet required standards]. [If the uncertainties cannot be removed or if the established facts are of a nature to imply non-compliance with obligations under the Convention, the Technical Body shall convene the Consultative Council to examine the final report.]
(J) [ADOPTION OF A DECISION ON THE BASIS] [CONSIDERATION]
OF THE FINDINGS OF THE INVESTIGATION
[52. [The Executive Council] [The politically representative body of States Parties] shall consider whether there has been any non-compliant activity and take a decision on any response or further action.]
[53. [The Executive Council] [The politically representative body] shall, in accordance with its powers and functions, review the final report of the investigation team as soon as it is presented, and [address] [decide on] any concern as to]:
(a) Whether any non-compliance has occurred;
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(b) Whether the request had been in accordance with the provisions of this Protocol;
(c) Whether the right to request an investigation has been abused.]
54. With respect to any concerns raised under 53 (c), one or more of the following factors could be taken into account, where relevant:
(a) Information relating to the investigated site available prior to the investigation request (the authenticity and reliability of any information would need to be carefully assessed);
(b) Whether any of the information submitted as part of the investigation request was shown to be false;
(c) Information from and/or outcome or results of [any] prior consultations/clarifications relevant to the request;
(d) Whether any investigation(s) (including any instituted under Article VI of the Convention) had previously been requested by the same State Party vis-à-vis the same investigated site, and if so, their number, frequency and outcome (including any follow-up action);
(e) Whether the same requesting State Party had launched any prior requests for investigation which had been deemed by [the Executive Council] [the politically representative body] to be frivolous, abusive or beyond the scope of the Convention.
55. In the case of abuse, [the Executive Council] [the politically representative body] shall examine whether the requesting State Party should bear any of the financial implications of the investigation. [The Executive Council] [The politically representative body of the] States Parties [United Nations Security Council] [may] [shall] consider appropriate actions, including [possible] sanctions, in accordance with applicable international law, [by the BTWC Organization] if they decide that a request has been frivolous, abusive or beyond the scope of the [Protocol] [Convention].
[56. The investigated State Party and the requesting State Party shall have the right to participate in the review process but shall have no vote. If [the Executive Council] [the politically representative body] reaches the conclusion, in keeping with its powers and functions, that further action may be necessary with regard to paragraph 53, it shall take the appropriate measures to redress the situation and to ensure compliance, including specific recommendations to the Conference of States Parties.]
Notes
10. Views were expressed that the application of threshold limits to the possession of biological agents and toxins is not a useful means to strengthen the Convention and could undermine the provisions of Article I; this would clearly be outside the mandate of the Group. Peaceful quantities of an agent cannot be defined independently of the particular circumstances of the use, which means that fixed thresholds cannot be used. There would be a risk of a threshold for work for defence purposes being used to conceal offensive activities. The application of threshold limits could provide inaccurate impressions of the scale of activities at a facility because the self-replicating nature of microorganisms means that an agent amount at or below a threshold could be exceeded within a matter of hours. Finally, even small quantities of biological agents and toxins could, depending upon their intended purpose, violate the object and purpose of the Convention.
Another view was that the establishment of threshold quantities of biological agents and toxins is essential for an effective verification regime under the BTWC. Such threshold limits do not contradict in any way the mandate of the Group, since the mandate specifies that the Group shall, inter alia, consider "definitions of terms and objective criteria, such as lists of bacteriological (biological) agents and toxins, their threshold quantities ...". This approach does not affect the scope of Article I of the Convention.
11. The term "[Military] [civilian] [national] [biological] defence programme [against biological and toxin weapons]" is defined in this specific context as follows: [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.
12. The term "Biological defence facility" is defined in this specific context as follows: 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].
13. The term "Vaccine" is defined in this specific context as follows: 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.
14. The term "Toxoid/anatoxin" is defined in this specific context as follows: [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.]
15. The term "Primary production containment" is defined in this specific context as follows: [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.]]
16. The terms "Plant inoculant" and "Biocontrol agent" are defined in this specific context as follows: [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.] and [An [micro] organism used for the prevention, elimination or reduction of the disease, pest [or] unwanted plants.]
17. The term "Plant quarantine capability" is defined in this specific context as follows: [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].]
18. The term "Biosafety Level 4" is defined in the WHO Biosafety Manual as follows: [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.]
19. The term "Maximum containment" is defined in this specific context as follows: [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.
- For work with animal pathogens, primary containment must be provided by use of Class I, II or III biological safety cabinets.]
20. The term "High containment" is defined in this specific context as follows: [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.]
21. The term "Biosafety Level 3" is defined in this specific context as follows: 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.]]
22. The term "Work with [listed] biological agents and toxins" is defined in this specific context as follows: [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].]
[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.]
23. The term "Genetic modification" is defined in this specific context as follows: [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.]
24. The term "Aerobiology" is defined in this specific context as follows: [The study of aerosols comprising particles of biological origin.]
25. The term "Development facility" is defined in this specific context as follows: (A definition of this term has yet to be discussed.)
26. The term "Closed system" is defined in this specific context as follows: [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.]]
27. This term has been recognized to need further clarification during forthcoming sessions.
28. This term has been referred to the Group of the Friend of the Chair on Definitions for further discussion.
29. The format developed by the Friend of the Chair on CBMs for Data on Transfers and Transfer Requests may need to be appropriately modified to take into account the provisions of guidelines for strengthening implementation of Article III that may be provided for in the Protocol. Further consideration of the need for such guidelines is required.
30. Views were expressed that this paragraph should be removed to some other appropriate place in this Protocol, e.g. Article VII or the CBM section. Other delegations considered that this paragraph should remain here for further discussion.
31. Views were expressed that this section should be removed to Article VII. Other delegations considered that this section should remain here for further discussion.
32. A view was expressed that this section E could be considered for inclusion in section F, subsection III on Investigations, part C.
33. A view was expressed that issues dealt with in this paragraph should be dealt with in Article IX relating to Organization issues, in the section on the functions of the [Technical] Secretariat [Technical Body].
34. A view was expressed that this approval should be given by an appropriate body, e.g. the Executive Council.
35. The need for general provisions on visits and investigations will be considered in the light of the forthcoming discussions.
36. The inclusion of this section is without prejudice to a final decision on whether provisions for other visits and procedures will form part of the future Protocol.
37. Some delegations expressed the view that it would not be expedient to include Non-Challenge Visits as a compliance measure in a future Protocol to the BTWC. These delegations noted that the declared goals of Non-Challenge Visits could be achieved through other measures. According to this view the efficiency of such visits would be low. Non-Challenge Visits would require additional national structures to provide organizational support to such visits which would lead to a further increase in costs related to the functioning of the BTWC control mechanism for the States Parties. Moreover, Non-Challenge Visits would increase the risk of revealing confidential scientific, technological and commercial information and would unduly hinder the industrial enterprises' activities.
38. Some delegations expressed the view that, to be effective, a future Protocol should include provisions which would allow the possibility of visits to facilities to review the observance of declaration obligations under the Protocol in circumstances other than to investigate a non-compliance concern. These delegations believe that procedures envisaged for Random Visits, Ambiguity-Related Visits, Declaration Clarification and Consultation Procedures (including Request Visits) described in Article III and the visits described in Article VII 20 (d) of document BWC/AD HOC GROUP/36 are all valid concepts which should be further developed and which could form components of an integrated system of Visits. These same delegations expressed the view that further work focusing on their similarities and differences is required.
39. Proposed treaty language on the detailed provisions for the implementation of Random Visits was tabled in BWC/AD HOC GROUP/WP.244 and has been inserted in Annex B. This paper was not discussed at the ninth Ad Hoc Group session.
40. This paragraph requires further discussion, including on its placement. A view was expressed that it would be better placed in Article III, Section F, Subsection III on Investigations.
41. It was proposed that this paragraph should replace paragraphs 13 to 15.
42. Paragraphs 18 to 42 were not discussed during the ninth session of the Ad Hoc Group in January 1998. Paragraphs 18 and 19 reproduce paragraphs 20 and 21 of the same section of BWC/AD HOC GROUP/38. Paragraphs 20 to 42 replace paragraphs 15 to 36 of BWC/AD HOC GROUP/WP.243.
43. The format on Transfers developed by the Friend of the Chair on CBMs on "Data on Transfers and Transfer Requests and on Production" in pages 43-44 of BWC/AD HOC GROUP/32 would need to be modified in this context. Paragraph 2 above may be considered for Annex.
44. Further consideration should be given to possible humanitarian implications of such a prohibition.
45. There is no agreement on terminology of investigations. One possible term is "Investigation to Address a Non-Compliance Concern". Another possible term is "Challenge Inspection (under Article VI)".
46. Specific language on this issue for inclusion in the Annex will be formulated drawing on, without prejudice to other possible proposals, BWC/AD HOC GROUP/WP.262, submitted by the Group of NAM and other countries (attached), which was not addressed at the ninth Ad Hoc Group session.
47. Further consideration is required in each case of whether specific references to "a State Party" mean "a State Party to the Protocol" or "a State Party to the Convention".
48. The term "Protocol" is used without prejudice to a decision on the form of the legally binding instrument.
49. The inclusion of this section is without prejudice to any final decision on whether such procedures shall be mandatory and/or whether they shall take place prior to the initiation of an investigation.
50. Subparagraphs (a) to (j) of this paragraph have been reproduced in Annex D.
51. A view was expressed that information supporting a request will be lacking many precise details regarding the essential elements described above. This should not be allowed to prevent an allegation receiving serious consideration. It may be that one single item of evidence will be sufficient to be decisive. The burden of proof must not be placed unreasonably on to the complainant State. Further consideration needs to be given to whether or how these requirements might be modified in respect of a request for an investigation on the territory of another State Party or a non-State Party.
52. Subparagraphs (a) to (p) of this paragraph have been reproduced in Annex D.
53. Further detailed consideration of this concept and these alternative options is required.
54. Paragraphs 27 to 30 and paragraph 31 were regarded by some delegations as alternatives.
55. Paragraphs 27 to 30 and paragraph 31 were regarded by some delegations as alternatives.
56. Paragraphs 32-43 were not discussed during the ninth session of the Ad Hoc Group in January 1998. They reproduce BWC/AD HOC GROUP/WP.247.