Rolling text (AHG 8th session)

The Rolling Text for Article III is provided below (this is from the 8th Session of the Ad Hoc Group). The page numbers given are those which appear in the original text. The detailed footnotes are provided at the end of the main text.

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Annex I
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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 the Annex 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.]

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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 days after the end of the previous calendar year on the activities of that year.]

4. [The initial and annual declarations required under this Article shall be made available by [the BTWC Organization] on request to all States Parties.]

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) [taking part in] [military] [civilian] [national] [biological] defence [facilities taking part in] programme(s) [against biological and toxin weapons]¹¹ [and conducting work on microorganisms or toxins as well as material imitating their properties];

(ii) which produce vaccines¹² [and/or antitoxins] [licensed by the State Party] for the protection of humans [and animals] [against listed agents or toxins] [with a production capacity as specified in Annex ...] [with primary production containment];

[(iii) which produce plant inoculants and/or biological control agent(s)¹³ 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;

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[(v) containing areas protected according to biosafety level 3¹⁴ (BL3) [as specified in the 1993 WHO laboratory Biosafety Manual] [and working with listed agents or toxins] but excluding purely diagnostic [and medical] facilities;]

(vi) which

[work with listed agents or toxins]¹⁵ [with the exclusion of facilities involved only in diagnostic and/or medical treatment activities];

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 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]];

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[- maintaining culture collections [registered and designated by the government] and provide professional services on demand];

[- genetic modification¹⁶] [applying genetic modification 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];

[- aerobiology];

[- any of the above activities and with areas protected according to biosafety level 3 (BL3)];

[(vii) other microbiological production facilities [including development facilities¹⁷] not working with listed agents which have an aggregate fermenter production capacity of [100] [1000] litres or more

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[with primary production containment;] ^{18 19}

[- which produce by fermentation (i) medicines and/or (ii) antibiotics or (iii) other microorganisms in closed systems²⁰].]

[(viii) not working with listed agents or toxins which

- possess [aerosol [explosive] test chambers of ... m3 or above for work with microorganisms or toxins] [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]²¹;

[- conduct genetic modification¹⁶ [to enhance pathogenicity and virulence²² [or resistance to environmental factors/antibiotics]] [with BL3 containment or equivalent standard] [and have an aggregate production capacity of 100 litres or more].]]]

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[Transfers

6. Each State Party shall declare annually all 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 ... .]²³

[Appearance of outbreaks of disease or epidemics

8. [Each State Party shall declare to an international epidemiological network,] 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 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 Convention

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 COOPERATION²⁴

[1. Each State Party shall have the right to submit [to the BTWC Organization] a request for clarification of any ambiguity, uncertainty, anomaly, omission or any other issue [relating to the declaration obligations of any State Party under this Protocol].

[2. [Each State Party] [and/or] [the BTWC Organization] shall have the right to seek [directly or through [the BTWC Organization]] clarification from any State Party of any ambiguity, uncertainty, anomaly or omission relating to the declaration obligations of any State Party under this Protocol, through consultations with the State Party concerned.]

[3. Each State Party shall also have the right to request visits in accordance with ... .]

4. [Without prejudice to the right of a State Party to request an investigation] [the BTWC Organization] and the requested State Party [may, as appropriate, make efforts] [shall] [as a rule] [make every effort] to resolve the ambiguity, uncertainty, anomaly, contradiction in, or omission from, the State Party's declarations through consultations and/or correspondence, as provided for in section ... of this Protocol.]

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F. [VISITS AND INVESTIGATIONS] ^{25 26 27}

[I. [Visits ²⁸]

(A) [Random Visits]

1. [The BTWC Organization] shall conduct, in accordance with the detailed provisions contained in the Annex on Implementation, a limited number per year of Random Visits [which shall be non-confrontational [and confidence-building] in nature] to declared facilities [which shall be designed [, inter alia,] to confirm, in cooperation with the Visited State Party] that declarations are consistent with the obligations under this Protocol.

2. The [Technical] Secretariat shall, at random, identify declared facilities for Random Visits through appropriate mechanisms as specified in the Annex on Implementation.²⁹

3. There shall be no more than [...] Random Visits per year, and they shall be distributed [fairly] among the regional groups [and proportional to the number of the declared facilities of each State Party].

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4. In the case of Random Visits, [the Director-General] shall issue a standard mandate for the visit, which shall confirm that declarations are consistent with the obligations under this Protocol. [The mandate shall also encourage cooperation with the Visited State Party and shall require that the visit take place in the least confrontational manner possible.]

5. [...] hours before the arrival of the Visit Team, [the Director-General] shall notify the representative of the Visited State Party and, at the same time, shall make available to the Visited State Party the mandate for the visit.

[(B) [Ambiguity-Related Visits]

6. [The BTWC Organization] may also conduct, in accordance with the provisions of this article and the detailed provisions contained in the Annex on Implementation, Ambiguity-Related Visits to declared facilities to resolve ambiguities in declarations.

7. In cases where the [Technical] Secretariat has identified ambiguities in the declarations of facilities, and has not been able to resolve these ambiguities [through the process of consultation provided for in Section E], the [Technical] Secretariat may, in accordance with the detailed provisions contained in the Annex on Implementation, identify those facilities for Ambiguity-Related Visits.

8. In the case of Ambiguity-Related Visits, [the Director-General] shall, in consultation with the Visited State Party, issue a mandate for the visit which shall be limited to resolving the identified ambiguities. [The mandate shall also encourage cooperation with the Visited State Party and shall require that the visit takes place in the least confrontational manner possible.]]

9. [...] hours before the arrival of the Visit Team, [the Director-General] shall notify the representative of the Visited State Party and, at the same time, shall make available to the Visited State Party the mandate for the visit.]

[(C) [Clarification Visits]

10. [The BTWC Organization] may also conduct, in accordance with the provisions of this Article and the detailed provisions contained in the Annex D, 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.

11. Should [the BTWC Organization] and the requested State Party be unable to resolve the ambiguity, uncertainty, anomaly or omission satisfactorily [through the process of consultation and clarification initiated by [a State Party][and/or][the BTWC Organization] under Section E],

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[the BTWC Organization] [shall have the right to] [may, upon the request of the State Party] visit the declared facility or facilities in respect of which the ambiguity, uncertainty, anomaly or omission has arisen.

[12. [The BTWC Organization] may also visit other relevant sites [specified in the visit plan and with the] [by] agreement [with] [of] the requested State Party.]

[13. 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].]

14. [The BTWC Organization] shall carry out a maximum of [...] visits under this Section [Article] during each two year period.

15. Within the overall limit specified in paragraph 14, [the BTWC Organization] shall carry out a maximum of [...] visits under this Section [Article] during each two year period, to States Parties within each of the five regional groups of countries - Africa, Asia, Eastern Europe, Latin America and the Caribbean, and the Western European and other States.

16. [The BTWC Organization] shall carry out no more than [...] visits under this Section [Article] to each State Party during each two-year period.

17. A State Party may offer visits in addition to those stipulated above in order to clarify any situation. [The Director-General] shall decide on the implementation of such visits, taking into account the resource implications.

18. The Director-General] shall, in consultation with the Visited State Party, issue a mandate for the visit which shall be limited to resolving the identified ambiguities, uncertainties anomalies, contradictions or omissions. [The mandate shall also encourage cooperation with the Visited State Party and shall require that the visit takes place in the least confrontational manner possible.]

19. [21] days before the arrival of the Visit Team, [the Director-General] shall notify the representative of the Visited State Party and, at the same time, shall make available to the Visited State Party the mandate for the visit.]

(D) [Request Visits]

[20. 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

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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 before hand between the [BTWC Organization] and the State Party concerned.]

[(E) [Voluntary Visits]

[21. 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

22. [The Director-General] shall designate the Visit Team, limiting its number to the minimum necessary to carry out the visit, and, in any case, no more than [4] [6] from [the BTWC Organization]. Approved equipment shall be brought on to the facility only 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. The Visit Team, the facility representatives and the representatives of the Visited State Party shall then prepare the Visit Plan.

[24. 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.]

25. Representatives of the Visited State Party and of the facility shall accompany the Visit Team throughout the duration of the visit to the facility.

26. 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.

27. [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 D, 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.

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28. The focus of a Clarification Visit shall be the declared facilities and activities, especially those aspects connected with the ambiguity, uncertainty, anomaly, contradiction in, or omission from, the declaration. The visiting team shall have the right to ask questions about other parts of the facility and its activities where these are relevant to improving its understanding of the facility declaration and the specific issues under clarification. The visiting team shall also have the right to request access to other parts of the facility. Access shall be by agreement of the facility.

29. The principal on-site measures shall be interviewing, identification of key equipment, auditing and visual observation as appropriate. Sampling shall only be conducted if offered by the facility and deemed useful by the visiting side. Any mutually agreed sampling and analysis shall be performed by facility personnel, but in the presence of the visiting team.

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

[31. During the conduct of the visits, 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, bio-safety standards, and good laboratory or manufacturing practices.]

32. The duration of the visit shall be no more than [...] days unless extended by agreement of the Visit Team and the Visited State Party.

33. At the end of the visit, the Visit Team shall prepare its report.

34. The report shall summarize the general activities undertaken during the visit and the factual findings of the Visit Team. The report shall be considered confidential.

[35. The report may make recommendations if requested and in cooperation with the facility representatives, in such areas as the fulfilment of declaration obligations, bio-safety standards, and good laboratory or manufacturing practices.]

36. The 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 any findings relevant to the issue(s) raised under the clarification and consultation procedures, to all States Parties.

37. 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:

(i) 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;³⁰

(ii) 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 BL-4 facility, including details of its proposed application and the site/facility for intended use, shall be intimated to [the BTWC Organization];

(iii) 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];

(iv) 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.

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(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 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.]³¹

[(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

(i) 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.

(ii) 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.

(iii) 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:

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(a) That they will only be used for purposes not prohibited under this Convention for the States not party to the Convention;

(b) That they will not be retransferred without receiving the authorization from the supplier(s);

(d) Their end-use(s); and

(e) The name and address(es) of the end-user(s).

(iv) 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. INVESTIGATIONS³²

(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].]

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(B) INITIATION

3. Each State Party³³ [to the Protocol]³⁴ 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

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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 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.]

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.]

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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]].]

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.]³⁶

[ [(i) [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;]]

(ii) 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

(a) 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;

(b) weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict;

(iii) 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 co-ordinates, specified to the nearest second, if possible;

(iv) The approximate period during which the non-compliant activity or event is alleged to have taken place;

[(v) 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;]

[(vi) Information to demonstrate that the non-compliance concern is not a natural outbreak of disease.]

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The following other types of information could also be important:

(vii) 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;

(viii) If not, any information to suggest that the facility concerned should have been declared under the Protocol;

(ix) Details of the ownership and/or operation of the facility concerned;

(x) 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.³⁷]³⁸

[ [(i) Name of the State Party in whose territory or under whose jurisdiction or control the alleged [event] [use] has taken place;]

(ii) [Approximate] date [and] time [and duration] of the alleged [event] [use];

(iii) 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];

(iv) [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];

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[(v) The victims (human, 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;]

(vi) Information [to the extent possible] on:

(a) The [use] [release] of microbial or other biological agent(s) or toxin(s) for other than peaceful purposes;

(b) The use of weapons, equipment or means of delivery;

[(vii) 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];]

[(viii) Information to demonstrate that the non-compliance concern is not a natural outbreak of disease;]

[(ix) Information from and/or the outcome for results of [any] prior consultations / clarifications relevant to the request.]

The following other types of information could also be important:

(x) Reports of any internal investigation including results of any laboratory investigations;

[(xi) The victims (human, 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;]

(xii) [Any] affidavits of eye witness accounts, photographs, samples or other physical evidence;

(xiii) Data on natural disease profiles and occurrences in the area affected, as well as demographic data;

(xiv) A description of the control measures and their result in the affected area, if available;

(xv) Other corroborative information;

[(xvi) Requests for specific assistance, if applicable.]]

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(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.]]

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.]³⁹

[(F) PRE-INVESTIGATION [PROCEDURES] [ACTIVITIES] ^{40 41}

Designation of the [site] [facility] under investigation

23. The [facility or] [site] designated for investigation by the requesting State Party shall be designated as precisely as possible by providing a site diagram related to a reference point, with

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geographic coordinates specified to the nearest second if possible. [Whenever feasible] the requesting State Party shall also submit a map specifying the site under investigation, which shall also include the [site's] [requested] perimeter [clearly delineated].

[24. The [requested] perimeter [of the [facility or] site] under investigation shall:

(a) [where possible] run at least [10] metres outside any buildings or other structures;

(b) not cut through existing security enclosures; and

(c) [where possible] run at least [10] metres outside any existing security enclosures that the requesting State Party wishes to include within the [requested] perimeter [of the [facility or] site] under investigation.]

[25. If the [requested] perimeter does not conform with the specifications of paragraph 24, it shall be re-drawn by the investigation team in consultation with the State Party to be investigated to ensure that it conforms with that provision. [If the perimeter is not agreed to by the State Party to be investigated ...]]

[Designation of the area under investigation

26. The area designated for the [field] investigation [of the alleged use of biological weapons] by the requesting State Party shall be designated as precisely as possible by providing the geographic co-ordinates, specified to the nearest second if possible, within which the affected area falls. [Whenever feasible] the requesting State Party shall also submit a map specifying the area under investigation as well as the geographic characteristics of the area.]

Issue of investigation mandate

[27. Investigations should have a clear and specific mandate [which should be strictly observed by the investigation team].]

28. 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.

29. 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.

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[Appointment] [Assignment] of investigation team⁴²

[30. [The Director-General shall prepare a list of qualified experts whose particular fields of expertise could be ... . This list shall be communicated in writing to each State Party not later than ... after the entry into force of the Protocol.] The [Director-General] shall determine the size of the investigation team and select its members [on as wide a geographical basis [as possible]] taking into account the circumstances of the particular request. The size of the investigation team shall be kept to a minimum necessary for the proper fulfilment of the mandate. No national [or resident] of the requesting State Party or the State Party to be investigated shall be a member of the investigation team.]

[31. The investigators and investigator assistants shall be designated as set out in Annex D. Members of the investigation team shall be selected in accordance with the procedures set out in Annex D. The privileges and immunities of the investigators and investigator assistants shall be as set out in Annex D.]

[Observer

32. The requesting State Party may, subject to the agreement of the State Party to be investigated, send a representative who may be a national either of the requesting State Party or of a third State Party, to observe the conduct of the facility or [field] investigation [of the alleged use of biological weapons].

[33. The State Party to be investigated shall notify its acceptance or non-acceptance of the proposed observer to ... .]

[34. [In case of acceptance,] the State Party to be investigated shall grant access to the observer in accordance with Annex D.] [The observer shall have access to the investigation site as granted by the State Party to be investigated.]

[35. The State Party to be investigated shall, as a rule, accept the proposed observer, but if the State Party to be investigated exercises a refusal, that fact shall be recorded in the final report.]]

Notification

[36. The [Director-General] shall, not less than [12] [36] [48] hours before the planned arrival of the investigation team at the point of entry, inform the [politically representative body of States Parties] [Executive Council] about the location of the requested facility as specified in paragraphs

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23 and 24. At the same time, he shall also transmit the request to the State Party to be investigated, including the [precise] location of the [facility] [site].]

[37. The [Director-General] shall immediately acknowledge receipt to the requesting State Party of its request for a [field] investigation [of the alleged use of biological weapons] and inform [the Executive Council and] all States Parties.]

[38. If applicable, [the Director-General] shall, not later than [12] [36] [48] hours prior to the arrival of the [field] investigation [of the alleged use of biological weapons] team at the point of entry, notify the State Party on whose territory the investigation has been requested. [The Director-General] shall also notify other States Parties if access to their territories might be required during the investigation.]

39. The State Party to be investigated shall acknowledge receipt of the notification of an investigation not later than [one] [two] [hour[s]] [days] after receipt of such a notification.

Time-frame for an investigation

40. The [Director-General] shall dispatch an investigation team as soon as possible after an investigation request has been received [and approved in accordance with agreed procedures]. The investigation team shall arrive at the point of entry specified in the request in the minimum time possible consistent with agreed procedures for the notification and review of requests.

41. The period of the investigation shall not exceed [84] hours, unless extended by agreement with the State Party to be investigated. [The period of investigation means the period from ... until ... .]

[42. The estimated period of duration of a [field] investigation [of the alleged use of biological weapons] shall be indicated in the investigation mandate [and finalised after the pre-investigation briefing and shall not exceed that time unless extended by agreement of the State Party to be investigated] [shall not exceed ... days unless an extension is authorized by [the Executive Council]].] [The period of investigation means the period from ... until ... .]

Monitoring of site

[43. Not later than [12] hours after [the arrival of the investigation team at the point of entry] [its notification], the State Party to be investigated shall begin collecting factual information of all vehicular exit activity from all exit points for all land, air and water vehicles of the investigated site's perimeter. This obligation may be met by collecting factual information in the form of traffic logs, photographs or video recordings.]

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[44. Upon the investigation team's arrival at the site under investigation, it shall have the right to begin implementing exit monitoring procedures in order to secure the site such procedures shall include: the identification of vehicular exits, the making of traffic logs, the taking of photographs, and the making of video recordings of exits and exit traffic by the investigation team. The investigation team has the right to go, under escort, to any other part [of] [within] [along] the perimeter to check that there is no other exit activity.]

[45. All activities for securing the site and exit monitoring shall take place within a band around the outside of the perimeter, where possible not exceeding [50] metres in width, measured outward.]

[46. The investigation team has the right to inspect on a managed access basis vehicular traffic exiting the site. The State Party to be investigated shall make every reasonable effort to demonstrate to the investigation team that any vehicle, subject to inspection, to which the investigation team is not granted full access, is not being used for purposes related to the possible non-compliance concerns raised in the investigation request.]

47. The application of the above procedures may continue for the duration of the investigation, but shall not unreasonably hamper or delay the normal operation of the site.

Pre-investigation briefing

[48. The State Party to be investigated shall provide a pre-inspection briefing to the investigation team prior to granting it access, which shall not normally exceed [three] hours. [This shall include information concerning safety regulations in force in the facility, including rules of observation and quarantine, a medical examination of the members of the investigation team and documentary evidence that they have been vaccinated.] The briefing should wherever possible include a windshield tour of the site. It shall include the scope and a general description of activities at the facility, details of the physical layout and other relevant characteristics of the site (including a map or sketch showing all structures and significant geographic features) [, and details of the availability of facility personnel and records]. It may also include an indication of areas the State Party to be investigated considers sensitive or not related to the purpose of the investigation.]

[49. In the case of [field] investigations [of the alleged use of biological weapons], the investigation team shall have the right to be briefed by representatives of the State Party to be investigated upon arrival and at any time during the investigation according to the guidelines as set out in Annex D.]

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Investigation plan

[50. After the pre-inspection briefing the investigation team shall prepare an initial plan which specifies the activities to be carried out by the team, including the specific areas of the site, [documentation and personnel] to which access is desired, and whether the team intends to divide into sub-groups. The investigation team [may] [shall] not divide into [more than [two]] sub-groups [, in addition to members of the investigation team responsible for perimeter activities] unless otherwise agreed by the State Party to be investigated. This plan shall be made available to the State Party to be investigated [prior to the commencement of the investigation].]]

[51. Before the commencement of a [field] investigation [of the alleged use of biological weapons], the investigation team shall prepare an initial investigation plan to serve inter alia as a basis for logistical and safety arrangements. The investigation plan [shall] [may] be updated as need arises.]

[Situation report

52. The [field] investigation [of the alleged use of biological weapons] team shall, not later than 24 hours after its arrival on the territory of the State Party to be investigated, send a situation report to [the Director-General]. It shall send further investigation progress reports as necessary.]

(G) [ACCESS AND MEASURES TO GUARD AGAINST ABUSE DURING THE] [CONDUCT OF INVESTIGATIONS]

[53. The investigated State Party shall provide access [to the investigation team] [within the time frame specified in paragraph 41] [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 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.]

54. 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 fulfill its mandate.

55. [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].]

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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.

[56. 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 53].]]⁴³

[57. 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;

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(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.]⁴⁴

58. 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.

59. 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].

60. 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.

61. 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 ... .

62. 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].

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[63. 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) POST-INVESTIGATION [PROCEDURES] [ACTIVITIES]

[Preliminary findings and evaluation] [Initial report]

64. Upon completion of the investigation, the investigation team shall meet with the investigated State Party to review the team's preliminary findings and to clarify any remaining ambiguities. The team shall provide to the investigated State Party its preliminary findings in written form [having taken into account the provisions of the Confidentiality Annex], together with a list of any samples and copies of written information and data gathered and other material [intended] [proposed] to be taken off site. This document shall be signed by the team leader. In order to indicate that the investigated State Party has [taken notice of] [reviewed] the contents of the initial findings, the representative of the investigated State Party shall countersign the document. This meeting and these procedures shall be completed not later than [24] hours after completion of the investigation.

65. In accordance with [the applicable principles of managed access and] the detailed provisions set out above and in Annex ..., [and without prejudice to the obligation of the investigated State Party to allow the investigation team to fulfill its mandate] the investigated State Party may [place restrictions] [request that restrictions be placed] on [or deny altogether] the removal of specific samples, documents or other materials, if [it deems this] necessary to protect commercial proprietary or national security information. The investigated State Party may also draw to the attention of the investigation team any information in the initial findings which, in its view, is unrelated to the investigation mandate [and should therefore be deleted]. [In these cases the investigated State Party may request that the information be considered confidential or deleted.] [In such cases the investigated State Party shall have the right to ensure that such information is deleted.] [The investigated State Party shall have the right to request the removal from the initial [factual] [findings] [report] of any information unrelated to the investigation mandate.]

Departure

66. The investigation team shall depart from the territory of the investigated State Party [at the point of entry] in the minimum time possible, following completion of the [investigation and the [meeting] [review] described in paragraphs 64 and 65 above] [post-investigation [procedures] [activities]].

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[Interim field investigation report

67. An interim [field] investigation [of the alleged use of biological weapons] report [containing details as set out in Annex D,] shall be made available to the investigated State Party not later than [30] days after completion of the investigation. The investigated State Party shall have the right to comment on the contents of the report.]

[Laboratory reports

68. Laboratory investigations and identification of agents shall be reported by means of the following types of reports :

(a) Initial laboratory report. An initial laboratory report shall be made available to the leader of the investigation team, by the laboratory as soon as possible after receipt of the sample(s) and shall indicate initial findings and an estimate of the duration of further work.

(b) Intermediate laboratory report. The laboratory shall make an interim laboratory report to the leader of the investigation team if its has not finalised its work after 30 days since the initial report. It shall report progress in work and a final estimate of further work.

(c) Final laboratory report. The laboratory shall make a final report of its findings to the leader of the investigation team as soon as it has finalised its work, but not later than 6 months after receipt of the sample(s).]

Final Report

69. The report shall [describe] [summarise in a general way] the activities conducted by the investigation team and its factual findings [, particularly with regard to the concerns regarding possible non-compliance with Article I of the BTWC,] and shall be limited to information directly related to these [non-compliance concerns] [findings]. It shall also include an account by the team of the degree and nature of access and cooperation granted to the team and the extent to which this enabled it to fulfil the inspection mandate.

70. A draft final facility investigation report shall be made available to the investigated State Party not later than [20] days after completion of the investigation. The investigated State Party shall have the right to identify any information and data not related to the non-compliance concern which in its view, due to its confidential nature, should not be contained in the final version of the report to be circulated to States Parties. [The investigation team shall consider these observations and, using its own discretion, wherever possible adopt them.]

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71. [The field investigation shall be considered completed upon receipt of the final laboratory reports from all the laboratories that were tasked, as applicable, but not later than 6 months after the end of the on-site investigation.] A draft final field investigation report shall [then] be made available to the investigated State Party not later than [20] days after completion of the investigation. The investigated State Party shall have the right to identify any information and data not related to the non-compliance concern which in its view, due to its confidential nature, should not be contained in the final version of the report to be circulated to States Parties. [The investigation team shall consider these observations and, using its own discretion, wherever possible adopt them,] before submitting the final report to the Director-General.

[72. The final investigation report shall [immediately] be made available to the investigated State Party, but not later than ... . There shall be attached to it any written comments that the investigated State Party may at once make concerning the findings contained in it. The final report, together with the attached comments by the investigated State Party, shall be transmitted to [the Technical Body] no later than [...] days after the completion of the investigation.]

Further clarification

73. [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.]

[Adoption of a decision on the basis] [Consideration] of the findings of the investigation

[74. [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.]

[75. [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;

(b) Whether the request had been in accordance with the provisions of this Protocol;

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76. With respect to any concerns raised under 75 (c), one or more of the following factors could be taken into account, where relevant:

(i) 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);

(ii) Whether any of the information submitted as part of the investigation request was shown to be false;

(iii) Information from and/or outcome or results of [any] prior consultations/clarifications relevant to the request;

(iv) 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);

(v) 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.

77. 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].

[78. 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 75, it shall take the appropriate measures to redress the situation and to ensure compliance, including specific recommendations to the Conference of States Parties.]

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Footnotes

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 micro-organisms 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 "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.

13. 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 [[A material of biological origin or] An [micro-]organism used for the prevention, elimination or reduction of the disease, pest [or] which may have negative impact on a plant or crop.]

14. 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.]]

15. 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] [any manipulation or production of listed agents and toxins involving the application of techniques used in genetic modification, whatever the outcome].]

16. The term "Genetic modification" is defined in this specific context as follows: [Genetic modification involves a process of arranging and manipulating nucleic acids of an organism to give it a capability to produce novel molecules or to add to it new characteristics, [excluding classical genetic techniques, natural processes and applications involving somatic hybridoma cells] [any manipulation of listed agents and toxins involving the application of techniques used in genetic modification, whatever the outcome].

It may include alterations in the genetic material of organisms in performing new functions like: enhancement or reduction in pathogenicity and/or virulence; resistance to biotic and abiotic stress; change in antigenicity; enhancement of stability in environment and ease in cultivation.]

Genetic modification requires further discussion. [It may be necessary to:

- restrict genetic modification to enhancement of pathogenicity, virulence, or resistance to environmental factors/antibiotics;

- focus on genetic elements containing nucleic acid sequences coding for the determinants of pathogenicity of listed microorganisms;

- focus on genetic elements containing nucleic acid sequences coding for listed toxins.]

17. The term "development facility" is defined in this specific context as follows: (A definition of this term has yet to be discussed.)

18. The term "Primary production containment" is defined in this specific context as follows: [Primary containment in production comprises the safety practices and equipment design features used in production activities involving microbial or other biological agents or toxins where there is a need to prevent incidental release into the environment. [Microorganisms, [viruses] and eukaryotic cells are handled in a [closed] system which physically separates the process from the environment (closed system) with seals so as to prevent release of organisms from the system, exhaust gases from the system treated so as to prevent release [and effluent treated before final discharge,] [from the system].] Sample collection, addition of material to the system and transfer of viable organisms to another closed system, performed so as to prevent release. This system could be located within a controlled area.]

[Primary production containment comprises the safety practices and equipment design features used in production activities involving microbial or other biological agents or toxins where is a need to prevent incidental release into the environment. Microorganisms and eukaryotic cells are handled in a closed system.]

19. This term has been referred to the Group of the Friend of the Chair on Definitions for further discussion.

20. The term "Closed System" is defined in this specific context as follows: [A system, which physically separates the process from the environment with seals so as to prevent release of organisms from the system, exhaust gases from the system are treated so as to prevent release and effluent is treated before final discharge. Sample collection, addition of material to the system and transfer of viable organisms to another system, is performed so as to prevent release. This system could be located within a controlled area.

A closed system may also contain closed vessels used for the preparation, growth and storage of bacteriological (biological) agents and toxins.]

21. This term has been recognized to need further clarification during forthcoming sessions.

22. This term has been referred to the Group of the Friend of the Chair on Definitions for further discussion.

23. The format developed by the FOC 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.

24. This section requires further consideration.

25. The need for general provisions on visits and investigations will be considered in the light of the forthcoming discussions.

26. 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.

27. 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.

28. 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.

29. Procedures for selecting Random Visits need further consideration.

30. 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.

31. Further consideration should be given to possible humanitarian implications of such a prohibition.

32. 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)".

33. 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".

34. The term "Protocol" is used without prejudice to a decision on the form of the legally binding instrument.

35. 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.

36. Subparagraphs (i) to (x) of this paragraph have been reproduced in Annex D.

37. 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.

38. Subparagraphs (i) to (xvi) of this paragraph have been reproduced in Annex D.

39. Further detailed consideration of this concept and these alternative options is required.

40. This section addresses investigations of facilities and of any other alleged breach of obligations under the provisions of the Convention. Further consideration needs to be given to the procedures for other types of investigation.

41. Further consideration has to be given to whether all or parts of this section should be moved to the Annex.

42. Delegations raised a number of issues under this sub-heading which require further consideration.

43. Paragraphs 53 to 56 and paragraph 57 were regarded by some delegations as alternatives.

44. Paragraphs 53 to 56 and paragraph 57 were regarded by some delegations as alternatives.

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