BWC/AD Hoc Group/43 (Part II)

Annex IV

page 32

Proposals for further consideration by the Friend of the Chairon Measures to Promote Compliance

(as contained in BWC/AD HOC GROUP/FOC/2)

ARTICLE III

D. DECLARATIONS

I. SUBMISSION OF DECLARATIONS

1. Each State Party shall declare to [the Organization], regardless of the form of their ownership or control, all activities and facilities listed below which existed on its territory or in any other place under its jurisdiction or control during the period specified. [In cases where these activities or facilities exist on the territory of the State Party, but are in a place under the jurisdiction or control of another State or State Party, this provision shall not apply to the State Party.] All such declarations shall be submitted to [the Organization], in accordance with the appropriate format in the Appendix, not later than [180] days after this Protocol enters into force for it and, in the case of annual declarations, not later than [30 April] of each successive year thereafter.

2. [A State Party hosting a facility or facilities owned or controlled by another State Party, shall have the right to gain access to information and/or to receive such information from the other State Party.] [A State Party which has jurisdiction or control over a facility located on the territory of another State Party shall provide to that State Party a copy of its declaration in respect of that facility simultaneously with the submission of the declaration to [the Organization].]

3. Upon receipt of a request by a State Party [which has submitted its own declarations], the Director-General 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 Director-General shall simultaneously inform the States Parties concerned that copies of their declarations have been made available to the requesting State Party.]

(It is suggested to move this paragraph to the start of a new second section on “Follow-up after submission of declarations”.)

INITIAL DECLARATIONS

[(A) PAST OFFENSIVE AND/OR DEFENSIVE PROGRAMMES]

[4. Each State Party shall declare, in accordance with paragraph 1 above [according to the format and scope provided for under CBMs (form F) as adopted by the Third Review Conference]:

(The format and scope of the declaration is addressed in the work on the declaration formats in the Appendix.)

[- Past offensive and/or defensive biological research [and] development [testing or production] programmes or their use [at any time since [17 June 1925] [1 January 1946] [26 March 1975]] [unless this information has already been provided under the CBMs].]

[(a) Whether, at any time since ..., it has developed, produced, stockpiled or otherwise acquired or retained, and whether, during the same period, it has used:

(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 [specifically] designed to use such agents or toxins for hostile purposes or in armed conflict;

The declaration shall provide summaries of any research and development activities, of any use, and of any work performed on production, [testing, evaluation,] weaponization, stockpiling or acquisition of microbial or other biological agents or toxins and equipment or means of delivery for hostile purposes or in armed conflict, and on their destruction. [The declaration shall also include a list of all participating facilities and test ranges that have been converted/dismantled or destroyed.]1

(b) Whether, at any time since [17 June 1925] [1 January 1946] [26 March 1975, or, if it acceded to the Convention after 26 March 1975, since the date of entry into force of the Convention for that State Party], it has conducted activities [for the direct purpose of protecting or defending] [to directly protect or directly defend] humans, animals or plants against the use of microbial or other biological agents or toxins for hostile purposes or in armed conflict. If so, the State Party shall declare, in summary form:

(i) The general objectives [and funding arrangements] [of any research and development activities that were part] of such activities;

(ii) Any [research and development activities] [relevant [experimental] [pilot] studies] conducted as part of the programme that involved prophylaxis, pathogenicity and virulence, diagnostic techniques, [detection,] aerobiology, [medical] treatment, toxinology/toxicology [, physical protection, decontamination];

[(iii) The principal objectives of any production or other acquisition activities for equipment or other items as part of the programme for the purpose of protecting or defending humans, animals or plants against the use of microbial or other biological agents or toxins for hostile purposes or in armed conflict.]2]]

[5. Each State Party shall declare any information that subsequently comes to its notice that would have been required to have been declared pursuant to paragraph 4 (a) or (b) above had such information been known [180] days after this Protocol entered into force for that State Party, no later than [90] days after such information is discovered.]

[(B) NATIONAL LEGISLATION AND REGULATIONS3

6. Each State Party [shall] [may on a voluntary basis] declare, in accordance with paragraph 1 above, a list of the number, dates and titles of legislation, regulations [, directives, orders] or other legal measures that govern, regulate, provide guidance on or otherwise control:

[(a) [Use of, activities in and] access to buildings or other structures in which pathogens or toxins are being produced, handled or stored;]

[(b) Access to buildings or other structures or areas in which an outbreak of infectious disease affecting humans, animals or plants is suspected or is known to be occurring.]

The State Party [shall] [may on a voluntary basis] notify changes in such a list within [90] days of their entry into force or of their being promulgated within the State Party.

7. In cases where a State Party has either:

[(a) Been requested to provide a clarification under the provisions of section E of this Article; or]

[(b) Has jurisdiction or control over a facility or area which has been selected, as appropriate, for a [visit] under section F of this Article;]

[the Organization] may request the State Party concerned to provide a copy of a specific document(s), directly related to the issue to be clarified or to the facility to be visited, the title of which was declared under paragraph 6. The State Party [shall] [may] provide such copies within ... days of receiving the request, whenever possible in one of the official languages of the United Nations. [The Organization] shall keep all such requests to the minimum necessary to fulfill its functions.]

ANNUAL DECLARATIONS

[(C) CURRENT DEFENSIVE PROGRAMMES]4

[8. Each State Party shall submit to [the Organization], not later than [180] days after this Protocol enters into force for it and on an annual basis thereafter, not later than [30 April] of each successive year, a declaration, in which it shall declare, in accordance with the format in Appendix ...: declare, in accordance with paragraph 1 above:

(a) The presence of all / absence of [biological] defence programmes [against biological and toxin weapons];

(b) All facilities taking part in [biological] defence programme(s) [against biological and toxin weapons].

9. For the purposes of paragraph 8 above the term “[military] [civilian] [national] [biological] defence programmes [against biological and toxin weapons]” means involving the [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.]

(b) All facilities [which as their main task are] taking part in [biological] defence such programme(s) [against biological and toxin weapons]. [and conducting work on microorganisms or toxins as well as material imitating their properties] [as one of its principle and/or permanent roles in research, development, testing, production and evaluation].

10. [The declarations shall include the following] [The following shall be declared]:

[(a) Activities

(i) The presence [of all] / absence of [military] [civilian] [national] [biological] defence programmes [against biological and toxin weapons];

[(ii) Any additional information related to past offensive and/or defensive activities not provided in the initial declaration.]]

(b) Facilities

(i) [All facilities] [which as their main task are] [taking part in] [military] [civilian] [national] [biological] defence [facilities taking part in] programme(s) [against biological and toxin weapons [as per listed agents or toxins]] [and conducting work on microorganisms or toxins as well as material imitating their properties].

11. For the purpose of paragraph 10 above, the following definitions apply:5

(a) The term “[military] [civilian] [national] [biological] defence programme [against biological and toxin weapons]” means a [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;

(b) The term “biological defence facility” means a 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].

(D) VACCINE PRODUCTION FACILITIES

12. Each State Party shall declare, in accordance with paragraph 1 above, each facility which, during the previous calendar year, produced [with the use of bioreactors and/or fermenters6] [against listed agents and toxins,] [with primary production containment,] [with an aggregate fermenter capacity [of 100 litres or more] [as specified in Annex ...]][against infectious diseases]:

 (a) Vaccines [or toxoids] for humans, that were licensed, registered or otherwise approved by a component of the government of the State Party for distribution, sale or use;

[(b) More than 5,000 dose equivalents of any one type of human vaccine [or toxoid];]

(c) Vaccines [or toxoids] for animals for public sale or use or that were licensed, registered or otherwise approved by a component of the government of the State Party for distribution, sale or use.

[13. For the purposes of paragraph 12 above the following definitions apply:

(a) The term “vaccine” means preparations, including liveattenuated, killed or otherwise modified organisms or their [modified] components, [including toxins or] 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 [and safe for human beings and animals];

(b) The term “toxoid” means a toxin that has been inactivated to [neutralize] [lose] its toxicity, but to retain its antigenicity, that is, its capability to stimulate the production of specific antitoxin antibodies, so as to induce an active immune response in a human or animal;

(c) The term “dose equivalent” means the amount of a single vaccine or toxoid administration regardless of whether multiple administrations are necessary to confer or preserve immunity in the human or animal recipient. When vaccines or toxoids are in an intermediate or bulk state, declaration of the number of doses should be based on the equivalent amount of finished product needed for a single administration for paediatric or adult recipients, whichever is greater, regardless of whether the vaccine or toxoid is intended for paediatric or adult use;

(d) The term “vaccine production” means the process of making vaccine by whatever method including the use of fermentors, bioreactors and embryonated eggs.

Formulating, filling, bottling and packaging of vaccines may be included in the production process, but are not considered as vaccine production when conducted separately without prior processing.7]

(E) [MAXIMUM BIOLOGICAL CONTAINMENT] [/ BIOSAFETY LEVEL 4 (BL4)] [LABORATORIES] [FACILITIES]

[14. Each State Party shall declare, in accordance with paragraph 1 above, all facilities which, during the previous calendar year, were either:

[(a) Designated as [Biosafety Level 4 (BL4 according to WHO Classification) or P4 (according to WHO Classification) or equivalent standards] [maximum biological containment or]] OR [(a) identified as “BL-4”, “BSL-4”, “P-4”, “maximum biological containment”, “class 4”, “containment level 4” or an equivalent by the State Party’s legislation, regulations, guidelines or other standards; or

(b) Which would normally be used to handle biological agents [and/or toxins] causing [human] disease which [are recognized] as requireing maximum biological containment or are known, or [suspected to] or [potentially capable] to meet all the following criteria:

(i) They pose a high risk of aerosol-transmitted laboratory infections of life-threatening human disease;

(ii) They pose a high or unknown risk of spread to the community;

(iii) Effective treatment and prophylactic measures are not usually available in that State Party; or]

[(c) The facility would be used to handle biological agents and/or toxins causing animal disease which meet all the following criteria:

 ... ; or

(d) The facility would be used to handle biological agents and/or toxins causing plant disease which meet all the following criteria:

... .]]

15. For the purpose of paragraph 14 above the following definitions apply:

 [The term “maximum biological containment (BL4 - WHO classification)” means the following:

 [The term maximum biological containment (BL4-WHO classification) means any facility which either:

 (l) Meets the requirements specified in the 1993 WHO Laboratory Biosafety Manual and/or P4 standards or equivalent standards, either national or international.]

 [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.

 7. The work with animal pathogens primary containment [must] [should] be provided by use of Class [I, II or] III biological safety cabinets.]]

[(F) [HIGH BIOLOGICAL CONTAINMENT] [/ BIOSAFETY LEVEL 3 (BL3)] [LABORATORIES] [FACILITIES]

16. Each State Party shall declare, in accordance with paragraph 1 above, each facility which, during the previous calendar year, contained areas protected [by high biological containment] [according to /Biosafety Level 3 (BL3) [as specified in the 1993 WHO Laboratory Biosafety Manual]] [and working with listed agents or toxins] but excluding purely diagnostic [and medical] facilities working purely on the diagnosis of human, animal or plant disease, or carrying out purely medical treatment activities.

17. For the purpose of paragraph 16 above the following definitions apply:

[The term “high biological containment (BL3 - WHO classification)” means the following:

[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.]]

[For the purposes of this Protocol high biological containment (biosafety level 3) shall comprise 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 [double door entry into the room,] access control [and sealable windows;] [ventilation systems that establish a directional airflow from the access space into the laboratory room], 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. [Equipment used inside includes biosafety cabinets and specialized autoclaves.] Such laboratories also apply [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].]

[The term “High biological containment (biosafety level 3)” means [any facility] [room(s)] which [either]:

[(i) Meets the requirements specified in the 1933 WHO Laboratory Biosafety Manual and/or P3 standards or equivalent [international] standards; [and/or]]

[(ii) Is designed and equipped to conduct [work on microbial agents] [research, development, testing, evaluation or production [work] [involving] microbial [or other agents or [toxins]] agents that pose a [high] [moderate] risk [to laboratory workers] [but a low community risk] [to health] and to prevent accidental release of these agents [to the environment] by means of features including negative pressure to the environment [in one or more areas], access control and the rendering safe of exhaust air [from safety cabinets] [biosafety cabinets] [and of contaminated material and waste] [and of effluents] through, as appropriate, high-efficiency particulate air (HEPA) filtration, incineration or other physical or chemical means.]

[(iii) The State Party’s legislation, regulations, guidelines, or other standards identify the facility as “BL-3”, “P-3”, “high containment”, “containment level 3”, or an equivalent.]

[(iv) Any room or enclosure with features consistent with the guidelines specified in the 1993 WHO Laboratory Biosafety Manual for “The Containment laboratory - Biosafety Level 3”; or which the State Party’s legislation, regulations, guidelines or other standards identify as “BL3”, “BSL-3”, “P-3”, “high biological containment”, or an equivalent; or which comprises the safety practices, building designs and structures, and equipment used to handle material known or suspected to contain pathogens causing human or animal disease that does not ordinarily spread from one infected individual to another and for which effective treatment and preventive measures are available, so as to protect laboratory workers or the community against aerosol spread or infection.]]]

[(G) WORK WITH LISTED AGENTS AND/OR TOXINS]

18. Each State Party shall declare, in accordance with paragraph 1 above, each facility which, during the previous calendar year, [had an aggregate fermenter capacity of 100 litres or more and] has conducted any of the following activities with agents and/or toxins listed in Annex A:

[Worked with listed agents and/or toxins;]

OR

[[(a) Research and development, with certain containment characteristics including negative air pressure;]

(b) Production and recovery of one or more agents and/or toxins listed in Annex A:]

[(a+b) bis Multiplication of one or more agents or biosynthesis of one or more toxins listed in Annex A, and/or their recovery:

[using certain containment characteristics including negative air pressure]]

[in (i) Fermenters/bioreactors with a total internal volume exceeding 10 litres; or

[(ii) Chemical reaction vessels with a total internal volume exceeding [10] litres; or]

(iii) More than ... embryonated eggs on an annual basis; or

(iv) More than ... litres of tissue culture or other medium on an annual basis; or

(v) Animals];

[(c) [Production and] recovery of any non-microbial toxin listed in Annex A;]

(d) [Genetic] modification in any one or more of the following ways:

(i) Modification of any agent and/or toxin listed in Annex A, which creates or results in change of antigenicity or immunogenicity, increased antibiotic resistance, stability, or toxic or disease-causing properties;

(ii) Modification of nucleic acid sequences [coding for] [or] [relating to] any toxin in Annex A, including for the subunits of any such toxin, which results in enhanced toxicity, stability or ease of production;

(iii) Transfer of nucleic acid sequences relating to any agent and/or toxin listed in Annex A including for the subunits of any such toxin into any organism, resulting in a genetically modified organism with new disease-causing or toxic properties;

(iv) Transfer of nucleic acid sequences coding for any toxin listed in Annex A, or for the subunits of any such toxin, into an other organism to facilitate the production of the toxin or its toxic subunit(s);

(e) Intentional aerosolization of any agent and/or toxin listed in Annex A or any work with aerosolized agents and/or toxins listed in Annex A;

[(f) Administration of any agent and/or toxin listed in Annex A to animals via the respiratory tract;]

[(g) Maintenance of culture collections registered and designated by the government and provision of professional services on demand.]

[19. A facility should not be declared under paragraph 18 above if it works with listed agents and/or toxins only for the purpose of diagnosis of human, animal or plant disease, or for carrying out medical treatment activities, or for testing for food or water hygiene, or for testing the efficacy of antimicrobial preparations, vaccines, toxoids or immunoglobulin preparations [or for academic research or prophylactic activities].]

20. For the purpose of paragraph 18 above the following definitions apply:

[(a) The term “work with listed [biological] agents and toxins” means [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, treatment methods and maintenance of [registered] culture collections] [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];]

[(b) The term “genetic modification” means [a process of arranging and manipulating nucleic acids of an organism to produce novel molecules or to add to it new characteristics or to modify the original characteristics, [particularly in order to achieve increased pathogenicity, antibiotic resistance, infectivity across species or resistance to vaccines and stability in the environment].]]

[(H) OTHER PRODUCTION FACILITIES]

21. Each State Party shall declare, in accordance with paragraph 1 above, each facility which, during the previous calendar year:

[(a) Produced microorganisms in [areas protected by high biological containment (BL3)] [primary production containment] [closed systems] [or produced medicines, antimicrobials, [pesticides, insecticides,] plant inoculants, [enzymes, fine chemicals,] proteins other than enzymes, peptides or amino acids, nucleic acids or genetic elements or microorganisms for use in biotransformation processes [in areas protected by high biological containment (BL3)]], when:

(i) This involved [possession] [use] of a fermenter/bioreactor exceeding [30] [300] litres in capacity, or smaller fermenters/bioreactors with an aggregate capacity exceeding [100] [300] [1,000] litres, or continuous or perfusion fermenters/bioreactors with a flow rate capable of exceeding [2] [20] litres per hour; or

(ii) This involved production by other methods using more than ... embryonated eggs or ... litres of tissue culture medium or ... litres of other medium annually;]

[(b) Produced plant inoculants and/or biological control agent(s) inside a plant quarantine capability [and worked with agents and/or toxins listed in Annex A].]

[22. A facility should not be declared under paragraph 21 if the [fermenters/bioreactors were] [facility it was] solely [possessed] [used] for bioremediation or waste treatment, or for manufacture for sale or use of soap, cosmetics, detergents, fertilizers, or of foods or beverages for humans or animals [, or of single cell proteins]8.]

[23. For the purpose of paragraph 21 above the following definitions apply:

 (a) The term “fermenter/bioreactor” means any vessel that is designed, intended or used for cultivation of microorganisms or human, animal or plant cells or tissue cultures;

 (b) The term “medicines” means substances for treating or preventing disease, or for diagnosing disease. Medicines do not include vaccines;

 [(c) The term “antimicrobials” means antibiotics, antivirals, and antifungals, whether based on chemicals or microorganisms including phages. Preparations used as growth promoters in animal feedstuffs are thus included;]

 (d) The term “plant inoculant” means [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];

 (e) The term “biocontrol agent” means a living organism or natural active substance originated from such organism used for the prevention, elimination or reduction of diseases, pests or unwanted plants;

 (f) The term “plant quarantine capability” means [the safety practices, building designs and equipment used to prevent the accidental release of [living organisms or natural active substances originated from such organisms] 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 or propagation to the plant population [in the vicinity]. Such a capability includes separate buildings or clearly demarcated parts of a structure with access control, [negative or positive 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, entry doors with vestibule and hand washing facilities];

 [(g) The term “closed system” means a system consisting of containers and equipment for preparation, growth and storage of biological agents and toxins that is designed to physically separate the process from the environment with joints and seals to [minimize] [the risk of] or [prevent] release of viable microorganisms, cells or other active biological material from the system [or to prevent the ingress of 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 or toxins to another system, is performed so as to [minimize] [prevent] release [or to prevent the ingress of contamination]. [This system could be located within a controlled area.]]]

[(I) OTHER FACILITIES

24. Each State Party shall declare, in accordance with paragraph 1 above, each facility which, during the previous calendar year, [did not conduct any activities with agents and/or toxins listed in Annex A but which] [conducted activities with any biological agent and/or toxin and which also]:

 [(a) Possessed aerosol test chambers of [0.1] [10] m3 or above for work with microorganisms or toxins;]

 (b) Possessed equipment with a capacity of ... litres or more for aerosol dissemination in the open air with a particle mass median diameter not exceeding [10] microns excluding those for agricultural, health or environmental use;

 [(c) Conducted [genetic] modification to enhance pathogenicity, virulence, stability or resistance to antibiotics [chemical or physical methods of disinfection, or which altered the host range, the infection route or the ease of identification or diagnosis] [within a high biological containment facility (biosafety level 3) [and had an aggregate production capacity of [100] litres or more on site]].]

[25. For the purposes of paragraph 24 above on other facilities, the following definitions apply:

 (a) The term “genetic modification”: The definition contained in paragraph 20 shall apply;

 (b) The term “high biological containment (biosafety level 3)”: The definition contained in paragraph 17 shall apply.]]

[(J) TRANSFERS

26. Each State Party shall declare, in accordance with paragraph 1 above, all international transfers during the previous calendar year of agents and/or toxins, equipment [or means of delivery] listed in Annex A.]9

[(K) DECLARATIONS ON THE IMPLEMENTATION OF ARTICLE X OF THE CONVENTION10

27. Each State Party shall declare, in accordance with paragraph 1 above, all the measures taken during the previous calendar year individually or together with other States Parties, with [the Organization] and other international organizations in implementing Article X of the Convention and Article VII of the Protocol.

28. 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.]

[NOTIFICATIONS]

[(L) OUTBREAKS OF DISEASE]11

[29. Each State Party shall provide to [the Organization] within ... days information, in accordance with Appendix ..., on outbreaks of disease [relevant to the Convention] [and not endemic in the region] occurring on its territory.

30. If all of the required information has been submitted by a State Party to a competent international body, such as the WHO, and this international body has supplied the information to [the Organization], such provision of information shall satisfy a State Party’s obligation under paragraph 29 of this section.]

(It is suggested to add a new subsection to the section on declarations, which might include the existing proposals for random, clarification and voluntary/request visits, since each of these measures relates directly and exclusively to declarations. Other forms of clarification might best be addressed in the section on consultation, clarification and cooperation. Other forms of voluntary visits might be taken up in the specific contexts to which they apply, e.g. cooperation and assistance under Article VII.)

II. FOLLOW-UP AFTER SUBMISSION OF DECLARATIONS

31. The Technical [Secretariat] [Body] shall receive, process, analyse, distribute and store declarations submitted by States Parties in accordance with the provisions of this Article and Annex B.

(Expanded version of paragraph 41 (a) from Article IX on organization / implementational arrangements.)

[32. In order to ensure that the declarations submitted by States Parties are fully consistent with their obligations set out in this Article, the Technical [Secretariat] [Body] shall:

 [(a) Conduct a limited number per year of random visits to declared facilities, as set out in section A below and in Annex B;]

 [(b) Analyze the declarations and, if it identifies any ambiguity, uncertainty, anomaly or omission, seek clarification from the State Party concerned, as set out in section B below and in Annex B;]

 [(c) Provide technical assistance to States Parties to help them compile individual facility and national declarations including, if requested, by means of visiting a State Party, as set out in section C below and in Annex B.]]

(Drawn from existing language on random, clarification and voluntary visits in the visits section.)

33. Upon receipt of a request by a State Party [which has submitted its own declarations], the Director-General 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 Director-General shall simultaneously inform the States Parties concerned that copies of their declarations have been made available to the requesting State Party.]

(Former paragraph 3 of declarations text.)

[34. If a State Party which has received a copy of a declaration of another State Party identifies in it any ambiguity, uncertainty, anomaly or omission, it may seek clarification directly from the State Party concerned and/or it may submit a written request to the Director-General requesting that the matter be clarified. Upon receipt of such a request, the Director-General shall initiate the clarification process set out in section B below and in Annex B.]

(New language, drawn from working papers on clarification visits submitted by Japan and by the UK and France.)

(It is proposed to merge here the text on visits. The following text is taken directly from the former section on visits. For the sake of clarity, the old paragraph numbers have been retained in round brackets.)

F. [VISITS AND INVESTIGATIONS]12 13 14

[I. [Visits15]

[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]16

[Purpose

35.(2.) [The Organization] shall conduct, in accordance with [this Article and] the detailed provisions contained in the Annex B [on implementation of random visits]17 [...], a limited number per year of random visits [which shall be non-confrontational [and 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.

[36.(3.) In the case of a facility or facilities owned or controlled by in a place under the jurisdiction or control of a State Party but located in another State Party’s territory, the States Parties concerned shall cooperate and make arrangements to allow the visit to be conducted in accordance with the provisions as contained in section ... of this Protocol regarding visits and investigations.]18

[4. 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].]

(Repeated in paragraph 18 ter below.)

Selection of facilities

[37.(5.) There shall be no more than [50] [60] 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] equally among the [5] [6] [regional] groups of States Parties represented in the [Executive] [Consultative] Council. 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] [Body]] 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.]

38.(6.) The Technical [Secretariat] [Body] shall, at random, identify declared facilities for random visits through appropriate mechanisms as specified in the Annex B [on implementation] [...].

Mandate

39.(7.) 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.]

Notification

40.(8.) 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.

Designation of visiting team

41.(9.) 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 Organization]]. 10. The Director-General shall identify members for appointment to the visit team according to the specific nature of the facility and the submitted declaration. Members of the visit team shall be drawn from the permanent staff of the Technical [Secretariat] [Body]. The size of the visit team shall be kept to the minimum necessary for the proper fulfilment of the mandate, and shall not exceed [4] [6] persons. No national [or resident] of the State Party to be visited shall be a member of the visit team.

Duration

42.(11.) 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. This time excludes the time for inspection of approved equipment, the initial briefing and the time to prepare the initial visit plan.

Equipment

43.(12.) The visit team shall only bring approved equipment, according to Annex/Appendix ... B on to the facility unless the visited State Party agrees that other, additional equipment may also be brought.

13. 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.

Activities to be conducted

44.(14.) 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.

45.(15.) The briefing shall not exceed 3 hours and shall include the scope and a general description of activities of 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. It shall include information concerning the safety regulations in force, including rules of observation and quarantine. It may also include an indication of areas the visited State Party considers sensitive.

46.(16.) The briefing shall also include information on any relevant changes in activities or equipment at the facility since the submission of the most recent declaration.

47.(17.) After the briefing the visit team shall prepare an initial visit plan in accordance with Annex B. The visit plan shall be agreed by the facility representatives and the representatives of the visited State Party.

48.(18.) The visit plan shall specify the activities to be carried out by the team, including the specific areas of the facility. The visit plan may be changed during the course of the visit.

49.(19.) Representatives of the visited State Party and of the facility shall accompany the visit team throughout the duration of the visit to the facility. The visited State Party shall cooperate with the visit team in the achievement of the objectives of the mandate.19

50.(20.) The principal on-site measures shall be interviewing, visual observation, identification of key equipment and auditing as appropriate.

51.(21.) The visit team shall have the right to interview any relevant personnel in the presence of the representatives of the visited State Party, with the purpose of establishing relevant facts. These representatives of the visited State Party may include a legal adviser and a senior member of the facility staff. The team shall only request information and data which are necessary for the fulfilment of the visit mandate, focusing on questions related to the obligations of this Protocol.

52.(22.) The visit team shall have the right to observe visually any part of the visited facility relevant to its mandate.

53.(23.) The visit team shall have the right to identify equipment at the visited facility.

54.(24.) The visit team may also note the size and quantity of equipment at the facility, or the absence of any equipment, and compare this with information provided in the facility declarations.

55.(25.) The visit team shall have the right to examine documentation and records they deem relevant to the conduct of their mission.

56.(26.) If any of the principal on-site measures are not possible because of national security, commercial proprietary or health and safety considerations, the visited State Party shall provide other means to demonstrate that the submitted declarations are in compliance with the obligations of this Protocol. These may include, for example, the use of a video camera, photographs or drawings.

57.(27.) The visit team shall have the right to ask questions about [other] parts of the facility and the activities conducted therein where the visit teams considers that [these are] relevant to [improving its understanding of] the facility declaration. 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.

28. 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

[58.(29.) If any ambiguities or other related questions related to the visited State Party's declarations arise are identified during the visit, the visited State Party and the facility should seek to resolve these cooperatively with the assistance, if necessary, of the visit team.]

[59.(30.) 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.]

Access

60.(31.) 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, 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. Article and in Annex B.

61.(32.) The visited State Party shall have the right, in accordance with the obligation to demonstrate compliance and the right, if necessary, to protect sensitive information as set out in Annex B, to take specific measures which may include the following:

(a) Removal of sensitive papers from direct view;

(b) Shrouding of sensitive displays, stores, and equipment;

(c) Shrouding sensitive pieces of equipment, such as computer or electronic systems;

(d) Logging off of computer systems and turning off data indicating devices;

(e) Using random selective access techniques whereby the team is requested to select a given percentage or number of buildings of their choice to investigate; the same principle can apply to the interior and content of sensitive buildings or documents;

(f) In exceptional cases, limiting the number of team members who have access to certain parts of a facility; and limiting the viewing angle; the reasons for such limitations shall be stated;

(g) Limiting the time team members may spend in any area or building, while allowing the team to fulfil its mandate; and limiting the viewing angle; the reasons for such limitations shall be stated;

(h) The visited State Party may at any time during the visit identify products and processes in which it has a proprietary interest in order to help the team respect the visited State Party's right to safeguard proprietary information. It may request that if a specific piece of information is released to the team, it should be accorded the most stringent protection measures by [the Organization].

62.(33.) Sampling shall only be conducted if offered by the facility and deemed useful by the visit team. [Any] such mutually agreed sampling and analysis [shall] may be performed by facility personnel, but in the presence of the visit team.

63.(34.) The visit team shall collect only that information necessary to carry out its mandate.

64.(35.) The visit team shall not divide into more than two subgroups, unless otherwise agreed by the visited State Party.

Report

65.(36.) 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.

[66.(37.) The draft report shall summarize the general activities undertaken during the visit and the factual findings of the visit team.]

[67.(38.) 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.]

68.(39.) 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.]

69.(40.) 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. The Director-General shall circulate the summary to all States Parties.

Outstanding questions regarding the declaration

70.(41.) In cases where declarations remain inaccurate or incomplete, or where ambiguities remain, the Director-General shall inform the [Executive] [Consultative] Council [the politically representative body] which shall consider what, if any, further action is required.]]

[(B) [CLARIFICATION VISITS PROCEDURES]20

(The following attempts to merge the three separate texts in the rolling text: the text from BWC/AD HOC GROUP/41, from the working paper submitted by Japan and from the working paper submitted by the UK and France. The paragraphs have been renumbered, but the former paragraph numbers are shown in round brackets.)

Declared facilities

[44. In cases where [the BTWC Organization] [the Technical [Secretariat] [Body]] [or] [a State Party] [alone or] [through the [BTWC Organization] [Technical [Secretariat] [Body]]] 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 of this Article], the [BTWC Organization] [Technical [Secretariat] [Body]] [may] [shall] [, upon the request of a State Party] [and following appropriate review by the [Executive] [Consultative] [Council]] visit the [declared] facility(ies) in respect of which the ambiguity, uncertainty, anomaly or omission has arisen.]

[45. In cases where the Technical [Secretariat] [Body] 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] [Body] shall upon request of the State Party which originally sought the clarification, and following appropriate review by the [Executive] [Consultative] [Council], visit the facility(ies) concerned.]21

71.(53.) In cases where the Technical [Secretariat] [Body], as a result of its own examination or upon request of any State Party in accordance with paragraph 54 34 above, considers that there is any undeclared facility which might have to be declared, or that there is any ambiguity, uncertainty, anomaly or omission in a declaration submitted by a State Party, it shall enter into consultations with the State Party concerned through ordinary channels of communication to resolve the matter. (part of 79) in the first instance seek clarification from the State Party concerned. It shall do so in writing. The State Party concerned shall respond in writing within 20 days of receipt of such a written communication.

(54.) In cases where a State Party considers that another State Party has not declared a facility which might have to be declared or that any ambiguity, uncertainty, anomaly or omission exists in a declaration submitted by another State Party, it shall have the right to request in writing that the Technical Secretariat enter into consultations with the State Party concerned in accordance with paragraph 53 2. However, the any State Party which has not submitted its initial declaration or has not taken necessary measures in accordance with the decision of the Executive Council pursuant to paragraph 76 … shall not exercise this right until the initial declaration is submitted and/or the necessary measures are taken pursuant to paragraph 76.

(The point covered here is now addressed in the chapeau paragraphs to this entire section.)

72.(55.) If either the State Party requested for consultations pursuant to paragraph 53 71, or the Technical [Secretariat] [Body], considers that the matter cannot be resolved through the ordinary channels of communication, (part of 79) or that the written response does not resolve the matter, consultations shall be held at the offices of the National Authority of the State Party. it may propose the Technical Secretariat to conduct consultations in its capital. The period of these consultations shall not exceed [24] [48] hours after their commencement. If the State Party, facility concerned and Technical [Secretariat] [Body] agree that a meeting is such consultations are not needed, then a visit may proceed.

73.(56.) If the consultations referred to in paragraph 53 71 have been requested by a State Party in accordance with paragraph 54 ... and the matter concerned has been resolved through those consultations, the Director-General shall inform the State Party of the result of consultations.

79. If the Technical Secretariat identifies any anomaly or omission related to a facility declaration it shall in the first instance seek clarification from the State Party concerned. It shall do so in writing. The State Party concerned shall respond in writing within 20 days of receipt of such a written communication. The Technical Secretariat may request a consultation meeting with representatives of the State Party if the written response does not resolve the matter. Such a meeting shall be held at the offices of the National Authority of the State Party. The consultation meeting shall not exceed two working days. If the State Party, facility concerned and Technical Secretariat agree that a meeting is not needed, then a visit may proceed.

Undeclared facilities

74.(81.) In cases where the Technical [Secretariat] [Body], as a result of its own examination or upon request of any State Party in accordance with paragraph 75, If the Technical Secretariat identifies any facility which it believes meets the criteria for declaration as specified in Article III, section D, and that facility has not been declared by a State Party, (part of 79) it shall in the first instance seek clarification from the State Party concerned. It shall do so in writing. The State Party concerned shall respond in writing within 20 days of receipt of such a written communication. may begin the clarification procedures specified in paragraphs 83, 84 and 85 below to resolve the matter.

75.(82.) If a State Party has reason to believe that a facility meets the criteria for declaration as specified in Article III, section D, and that facility has not been declared, it may request in writing that the Technical [Secretariat] [Body] initiate on its behalf the clarification procedures specified in paragraphs 83, 84 and 85 of this section. in accordance with paragraph 74 above. The State Party shall submit all relevant supporting evidence in its request to the Director-General. Such evidence shall include a precise delimitation of the site where activities that should have been declared are believed to be taking place.

83. The Technical Secretariat shall in the first instance seek written clarification from the State Party concerned. If a request for clarification has come from another State Party, the Technical Secretariat shall seek a written explanation from the State Party from which clarification is sought within 48 hours of receipt of the request. The State Party shall provide an explanation in writing within 20 days of receipt of the written request for clarification. The Technical Secretariat may request a consultation meeting with representatives of the State Party if the written response does not resolve the matter. Such a meeting shall be held at the offices of the National Authority of the State Party. The consultation meeting shall not exceed two working days.

76. If either the State Party requested for consultations pursuant to paragraph … or the Technical [Secretariat] [Body] considers that the matter cannot be resolved through the ordinary channels of communication, (part of 79) or that the written response does not resolve the matter, consultations shall be held at the offices of the National Authority of the State Party .it may propose the Technical Secretariat to conduct consultations in its capital. The period of these consultations shall not exceed 48 hours after their commencement.

77.(84.) The State Party, at its discretion, may invite the Technical [Secretariat] [Body] to conduct a visit in accordance with the provisions in Annex B, with a view to resolving the declaration anomaly or omission.

78. If the consultations referred to in paragraph 75 have been requested by a State Party in accordance with paragraph 75 and the matter concerned has been resolved through those consultations, the Director-General shall inform the State Party of the result of consultations.

79.(85.) If the consultation meeting does not resolve the matter, the Technical [Secretariat] [Body] may request that a clarification visit be conducted at the facility in question. Such a visit may only be requested when the Technical [Secretariat] [Body] is satisfied that a visit is justified and that all reasonable steps have been taken to clarify the situation through the processes allowed for under this Article.

80.(86.) If the State Party believes that it has made every reasonable effort to resolve the matter it may refuse the clarification visit requested by the Technical [Secretariat] [Body]. The State Party shall submit a written explanation to the Technical [Secretariat] [Body] within 48 hours of receipt of the notification of intent to conduct a clarification visit. The [Executive] [Consultative] Council shall consider such a refusal as soon as possible and decide on any further action.

Clarification visits: purpose/basic principles

81.(42.) [The Organization] The Technical [Secretariat] [Body] [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 (52.) For the purpose of ensuring accurate declarations by States Parties, the Technical Secretariat shall conduct, in accordance with the provisions in this section, visits to facilities of States Parties (hereinafter referred to as “clarification visits”), [regardless of whether they have been declared or undeclared] 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 (78.) The Technical Secretariat may initiate declaration clarification visit procedures whenever it discovers an anomaly or omission related to a facility declaration, (examples of which may include failure to complete all questions in the declaration format; contradictory statements and data in the declaration format; exclusion of information that ought to have been included in the declaration format; or inclusion of information inconsistent with other data available to the Technical [Secretariat] [Body]) and to promote accuracy and comprehensiveness in future declarations.

[Preparation of implementation plan of clarification visits]

82.(57.) In cases where the matter cannot be resolved within [14] days through the consultations referred to in paragraphs 53 ... which may include the consultations in capital pursuant to paragraph 55 ..., the Technical [Secretariat] [Body] shall prepare a draft implementation plan of clarification visits listing the facilities of States Parties to which the Technical [Secretariat] [Body] considers it necessary to conduct visits in order to ensure accurate declarations. The draft implementation plan shall contain, inter alia, the specific points which should be clarified by each individual visit as well as the results of the preceding consultations related to each planned visit.

83.(58.) In preparing a draft implementation plan of clarification visits, the Technical [Secretariat] [Body] shall pay due regard to the following priorities:

 (a) First priority facilities: any facilities of States Parties not having submitted their initial declarations;

 (b) Second priority facilities: any undeclared facilities of States Parties having submitted their initial declarations;

 (c) Third priority facilities: any declared facilities of States Parties.

84.(59.) A draft implementation plan of clarification visits shall comprise a list of proposed clarification visits to be carried out during the period after a [quarterly] session of the [Executive] [Consultative] Council to which the draft plan is submitted until [14] days before the next [quarterly] session of the [Executive] [Consultative] Council.

Numbers of Visits

85.(60.) In preparing a draft implementation plan of clarification visits, the Technical [Secretariat] [Body] shall ensure that the total number of clarification visits through one fiscal year shall not exceed [20] and that a State Party shall not receive more than two visits through the same fiscal year. However, the limitation of two visits per one State Party per fiscal year shall not apply to the State Party which has not submitted its initial declaration or has not taken necessary measures in accordance with paragraph 76 ....

[47. The [BTWC Organization] [Technical [Secretariat] [Body]] [shall have the right to] [may] carry out [the minimum necessary within] [a maximum of] [...] clarification visits during each two-year period.

48. Within the overall limit specified in paragraph …47, the [BTWC Organization] [Technical [Secretariat] [Body]] 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] [...].

49. The [BTWC Organization] [Technical [Secretariat] [Body]] may carry out no more than [...] clarification visits to any State Party during each two-year period.]

or

[50. The [BTWC Organization] [Technical [Secretariat] [Body]] [shall] [may] carry out clarification visits only when necessary to clarify a specific ambiguity, uncertainty, anomaly or omission from a declaration.]22

[Examination of implementation plan of clarification visits]

86.(61.) A draft implementation plan of clarification visits shall be submitted to a [quarterly] session of the [Executive] [Consultative] Council by the Technical [Secretariat] [Body]. It shall be prepared not later than [14] days in advance of a [quarterly] session of the [Executive] [Consultative] Council.

87.(62.) A prepared draft implementation plan of clarification visits shall be immediately transmitted to the members of the [Executive] [Consultative] Council and a State Party, any facility of which is sought to be visited in the plan. If a visit in the draft plan is related to the request for consultations by a State Party in accordance with paragraph 54 ..., the draft implementation plan shall also be transmitted to that State Party.

88.(63.) During the period after the completion of preparation of a draft implementation plan of clarification visits until its adoption by the [Executive] [Consultative] Council, the Technical [Secretariat] [Body] and the State Party, any facility of which is sought to be visited in the draft implementation plan, may continue their consultations to resolve the matter. The Technical [Secretariat] [Body] shall promptly delete the facility concerned from the draft implementation plan and inform the members of the [Executive] [Consultative] Council and the State Party of this deletion if it considers that the matter has been resolved through those consultations. If a State Party has requested the consultations pursuant to paragraph 54 ..., it shall also be informed of this deletion.

89.(64.) The [Executive] [Consultative] Council shall examine and consider the necessity of the visits to facilities listed in a draft implementation plan of clarification visits. A draft implementation plan shall be adopted during the same [quarterly] session of the [Executive] [Consultative] Council to which it has been submitted unless the [Executive] [Consultative] Council decides against adopting it by [a two-thirds majority] [a majority] of its members.

90.(65.) When the [Executive] [Consultative] Council decides against adopting a draft implementation plan of clarification visits, the Technical [Secretariat] [Body] shall promptly prepare a revised draft implementation plan and submit it to the same [quarterly] session of the [Executive] [Consultative] Council to which the original implementation plan has been submitted. A revised draft implementation plan shall be adopted in accordance with the procedure provided in paragraph 64 ... .

91.(66.) The Director-General shall inform all the States Parties of the implementation plan of clarification visits after its adoption by the [Executive] [Consultative] Council.

Mandate

92.(46.) The Director-General shall [, in consultation with the State Party to be visited,] and [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.]

Notification

93.(51.) The Director-General shall notify the visited State Party of the visit at least [7] [14] days in advance of the planned arrival of the visit team at the point of entry in accordance with the provisions in the Annex. (80).If the consultation meeting does not resolve the matter, the Technical Secretariat may request a clarification visit to the facility concerned. The Technical Secretariat shall notify the State Party in accordance with the provisions of Annex B of this Protocol. The notification shall include the reasons for the need to conduct a visit and the steps taken by the Technical [Secretariat] [Body] to resolve the matter with the State Party concerned and why these have been unable to clarify the situation. The notification shall also include a copy of the clarification visit mandate. (51). [[...] 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 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.]

[Activities involved in clarification visit]

94.(92.) All visits shall be conducted in accordance with the provisions in Annex B.]23]

95.[(43). 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].]

96.(68.) The visit team may interview facility personnel, audit documentation and records, visually observe the visited facility and carry out other activities as agreed between the visit team and the visited State Party. These activities shall be conducted in accordance with the principle of managed access and after consultations with the visited State Party.

97.(69.) Sampling shall not be conducted unless offered by the visited State Party. Even in a case where sampling is offered, analysis of samples shall be performed in the territory of the visited State Party and under the terms agreed by the visited State Party.

98.(70.) The period of visit shall not exceed [48] [72] hours. The “period of visit” means the consecutive period of time from the arrival of the visit team at the visited facility until the completion of their visit activities provided in paragraphs 17 and 18 ... . The period of visit may be extended once within the maximum length of ... days by agreement between the visit team and the representatives of the visited State Party.

99.(71.) The size of the visit team shall be no more than [5] persons. The team shall not be divided into two or more sub-groups unless agreed by the visited State Party.

[Debriefing]

100.(72.) Within [24] hours after completion of the visit, the visit team shall meet with representatives of the visited State Party and the personnel responsible for the visited facility, to review the findings of the visit team and clarify any ambiguities. This meeting shall not exceed 2 hours. After the meeting, the visit team shall provide to the representatives of the visited State Party its preliminary report in written form according to a standardized format. The preliminary report shall only contain the factual findings of the visit team. In order to indicate that he has taken note of the contents of the report, the representative of the visited State Party shall sign the report.

[Final report and its review]

101.(73.) Not later than 10 days after the visit, the visit team shall prepare a draft report on the activities conducted by the visit team and the factual findings of the visit team, and transmit it to the visited State Party. The visited State Party may submit to the Technical [Secretariat] [Body] any written comments on the factual findings not later than 10 days after receipt of the draft report.

102.(74.) The visit team shall submit a draft final report to the Director-General not later than 30 days after the visit. Any written comments, which the visited State Party may make in accordance with paragraph 73 ..., shall be annexed to it.

103.(75.) The Director-General shall prepare a final report and submit it to the earliest [quarterly] session of the [Executive] [Consultative] Council for its consideration. If the Director-General considers it necessary that the visited State Party redresses its declaration by revising or supplementing it or submits a new declaration, the Director-General shall include in its final report the details of, and reasons for, the points on which the declaration concerned should be redressed or a new declaration should be submitted.

104.(87.) Unless otherwise specified, final reports shall not be circulated outside the Technical [Secretariat] [Body]. If the final report of a clarification visit to a declared or undeclared facility does not resolve the issue, or the facts established are of a nature to suggest that obligations undertaken under this Protocol have not been met, the Director-General shall inform the [Executive] [Consultative] Council immediately. The Director-General shall also inform the State Party concerned of his decision to submit the report to the [Executive] [Consultative] Council.

105.(88.) In the case of a clarification visit to an undeclared facility, the final report shall be provided to the [Executive] [Consultative] Council, the requesting State Party and to all States Parties upon request. If the requesting State Party believes that its concerns have not been resolved it may raise the matter at the [Executive] [Consultative] Council.

106.(89.) If the visited State Party believes that its views have not been fairly reflected in the report of either a visit to a declared or undeclared facility, it may submit its comments on the report in writing to the Director-General who shall forward them to the requesting State Party, and to the [Executive] [Consultative] Council.

107.(90.) The [Executive] [Consultative] Council shall consider reports when:

(a) A clarification visit has been conducted at an undeclared facility;

(b) A visited State Party submits comments as specified in paragraph 89 106 of this section, dissenting from the factual findings in the final report of a visit to a declared or undeclared facility;

(c) The Technical [Secretariat] [Body] or a requesting State Party believes that a clarification visit has not resolved the matter; or

(d) The circumstances specified in paragraph 88 105 of this section apply.

108.(91.) In all cases the [Executive] [Consultative] Council shall [decide on any further action as appropriate] 76. The Executive Council shall consider the final report of the Director-General and, [if it deems it appropriate, decide by [a two-thirds majority] [a majority] of its members on necessary measures such as revision of, or addition to, the declaration concerned or submission of a new declaration and the time limit of its fulfilment]. The Director-General shall inform the visited State Party of the decision. If such decision is made on a case where a visit has been conducted based on request by a State Party in accordance with paragraph 54 ..., the Director-General shall also inform that State Party of the decision. The visited State Party shall take the necessary measures in accordance with this decision.

109.(77.) The Director-General shall submit an annual report on the implementation of clarification visits to the [Executive] [Consultative] Council during the last [quarterly] session of the fiscal year.]24

[(C) [VOLUNTARY REQUEST VISITS]

(The following is drawn from paragraphs 93-97 on voluntary visits, in as far as they concern assistance in the compilation of declarations. If this concept is to be pursued, more detailed text may need to be elaborated.)

110.[(93.) Each State Party may [request] [volunteer for] [invite] [the Organisation] to undertake visits to facilities on its territory or in any other place under its jurisdiction or control in order to fulfil one or more of the following objectives:

 [(a) To help compile individual facility and national declarations [and/or to clarify a specific ambiguity that may be contained in it;]]

[(b) To further the cooperation and assistance provisions of this Protocol;]

(It is suggested that this type of visit might be taken up in Article VII; it is not, strictly, a compliance measure.)

[(c) To resolve a specific concern related to declarations, including any ambiguity;]

[(d) To resolve a specific concern, as provided for in paragraph 8 (d) of section E of this Article, on Consultation, Clarification and Cooperation.]

(It is suggested that this type of visit should be taken up in the separate section on consultation, cooperation and clarification, since it would potentially apply to matters other than those limited to declarations, such as a concern of non-compliance with the Convention.)

111.(94.) The Director-General shall [in consultation with the [Executive] [Consultative] Council] decide on the [implementation] [initiation] of [requests for] such visits in accordance with the [procedures set out in Annex B\] [relevant criteria and guidelines approved by the [Executive] [Consultative] Council [Conference of the States Parties]] [taking into account, [inter alia, the resource implications] [the availability of resources within the Technical [Secretariat] [Body] and the nature and purposes of the visit]].

112.(95.) The detailed arrangements for, and contents of, a voluntary visit shall be agreed beforehand between the Director-General and the State Party concerned.

113.(96.) The Director-General shall [, in accordance with Annex B,] issue a [standard] mandate for each visit [which shall be completed in cooperation with the State Party to be visited].

[97. 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].]]

[(D) VOLUNTARY CONFIDENCE-BUILDING VISITS

98. For the purpose of confidence-building, the number, intensity, duration, timing and mode of voluntary visits to particular facilities shall be arranged and agreed between States Parties in accordance with Annex G, section VI.]

(It is suggested that this type of visit might best be taken up in the Article on CBMs as it is not, strictly, a compliance measure.)

[(E) PROCEDURES FOR VISITS

[114.(99.) 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.

115.(100.) 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.]25]

E. CONSULTATION, CLARIFICATION AND COOPERATION26

1. 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 of the Convention, or the implementation of the provisions of this Protocol and to clarify and resolve any matter which may cause concern about possible non-compliance with the [basic] obligations of this Protocol or the Convention. For these purposes, States Parties [may, without prejudice to their [and the Technical [Secretariat’s] [Body’s]] rights and obligations under this Protocol with respect to investigations and visits] [shall [, prior to the submission of any request for an investigation [or visit],] first make every effort to] follow, inter alia, one or more of the following procedures:

 (a) [Seek clarification from another State Party. In the case of] [Submit] a written request for clarification directly to another State Party. T, the requested 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 receipt of the request. The requesting and requested States Parties [may] [shall] keep the [Executive] [Consultative] Council and Director-General informed of the request and the response;

(b) Submit a written request for clarification concerning another State Party, together with information upon which the request is made, to the Director-General. The Director-General shall immediately forward the request to the State Party concerned. The requested State Party shall provide the clarification to the Director-General as soon as possible, but in any case not later than [10 days] after receipt of the request. The Director-General shall immediately forward the clarification to the requesting State Party. [If agreed by both the requesting and requested States Parties] the Director-General shall keep the [Executive] [Consultative] Council [and/or all other States Parties] informed of the request and the basis for the request as well as the response;

(c) Submit a written request for clarification concerning another State Party, together with information upon which the request is made, to the [Executive] [Consultative] Council which shall forward the request to the requested State Party through the Director-General no later than 24 hours after its receipt. The requested State Party shall provide the response to the [Executive] [Consultative] Council as soon as possible, but in any case no later than [96 hours] [10 days] after receipt of the request. The [Executive] [Consultative] Council shall take note of the response and forward it to the requesting State Party no later than 24 hours after its receipt. The [Executive] [Consultative] Council shall inform without delay all other States Parties about any such request for clarification and the basis for this request as well as the response provided by the requested State Party.

Notes

1. It was proposed that this paragraph should be incorporated in the relevant declaration format.

2. It was proposed that this paragraph should be incorporated in the relevant declaration format.

3. Views were expressed that this section should be removed to Annex G on CBMs or be addressed in Article X of the Protocol on national implementation measures.

4. This section was not discussed during the twelfth session of the Ad Hoc Group. It was agreed to discuss it at the thirteenth session.

5. Views were expressed that this and other paragraphs in the section on declarations containing definitions of terms should be discussed in the group of the FOC on Definitions or in joint sessions of the FOCs on Definitions and on Compliance Measures, and that all such definitions should appear solely in a part of the Protocol dedicated to definitions, such as Article II or Annex A, section I.

6. Further consideration needs to be given to excluding facilities solely engaged in formulating, bottling, filling or packaging vaccines.

7. This definition was added at the twelfth session and was not discussed.

8. The term “single cell protein” would need to be defined.

9. 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.

10. Views were expressed that this section should be removed to Article VII. Other delegations considered that this section should remain here for further discussion.

11. Some delegations expressed strong reservations over the inclusion of this section.

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

13. 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.

14. 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.

15. 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.

16. Reordering of this section took place as suggested in BWC/AD HOC GROUP/WP.308.

17. 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.

18. This paragraph reproduces BWC/AD HOC GROUP/WP.303. It was not discussed during the twelfth session of the Ad Hoc Group.

19. Language taken from paragraph 31, page 50, BWC/AD HOC GROUP/41.

20. The proposals contained in paragraphs 52 to 92 of this section were not discussed at the twelfth session of the Ad Hoc Group but were introduced by delegations into the rolling text for discussion at the thirteenth session.

Serious concerns and reservations were expressed on the inclusion of these proposals in the Protocol which would largely change the whole scope and nature of the “visits and investigations” section and would negatively affect the outcome of the discussions on investigations within the compliance measures and the role of the Technical [Secretariat] [Body] in the future [Organization].

Another view was that the establishment of provisions for visits to facilities in order to promote accurate and complete declarations and thus further enhance transparency and confidence is essential for an effective compliance Protocol to the BTWC.

21. 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.

22. It was proposed that this paragraph should replace paragraphs 47 to 49.

23. Paragraphs 78 to 92 reproduce BWC/AD HOC GROUP/WP.311. They were not discussed during the twelfth session of the Ad Hoc Group.

24. Paragraphs 52 to 77 reproduce BWC/AD HOC GROUP/WP.307. They were not discussed during the twelfth session of the Ad Hoc Group.

25. Paragraphs 99 and 100 were carried over from BWC/AD HOC GROUP/41.

26. A view was expressed that this section could be considered for inclusion in section F, subsection III, part C.