Annex I

(1) Being Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, which was opened for signature on 10 April 1972, and entered into force on 26 March 1975, hereinafter referred to as the Convention,

(2) Reaffirming the purposes laid down in the preamble to the Convention as well as their obligations under the Convention, and desiring to further its objectives,

(3) Emphasizing that [the principles and objectives of] the Geneva Protocol of 1925 and the Convention represent an unequivocal determination for the sake of all humankind to exclude completely the possibility of bacteriological (biological) agents and toxins being used as weapons,

[(4) Mindful of their obligations under the Convention never in any circumstances to develop, produce, stockpile or otherwise acquire or retain 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 or weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict,]

(5) Stressing the importance of the final declarations of successive Review Conferences of the Convention, and emphasizing, in particular, the unanimous reaffirmation that the use by States Parties, in any way and under any circumstances, of microbial or other biological agents or toxins, that is not consistent with prophylactic, protective or other peaceful purposes, is effectively a violation of Article I of the Convention,

(6) Stressing the importance of all the provisions of the Convention, and determined to implement these fully and effectively in order to maintain and enhance regional and international peace and security and promote international development,

(7) Convinced that strengthening and enhancing the preamble and the provisions of the Convention, adopting specific measures to improve its implementation and effectiveness, and encouraging universal adherence to the Convention and this Protocol, will deliver significant benefits in terms of international security and development,

(8) Determined to accomplish the total elimination of all types of weapons of mass destruction,

(9) Determined also to achieve general and complete disarmament under strict and effective international control, which is the ultimate objective of the efforts [of States] in the disarmament process,

[(8+9)[2] Determined to act with a view to achieving effective progress toward general and complete disarmament under strict and effective international control, including the prohibition of all types of weapons of mass destruction,]

(10) Welcoming the entry into force of the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on Their Destruction, signed at Paris on 13 January 1993,

(11) Recognizing the significant advances in the field of biotechnology since the entry into force of the Convention, and the potential implications, both positive and negative, of these advances for the implementation and effectiveness of the Convention,

[(12) Conscious of the apprehension arising from relevant scientific and technological developments as expressed by States Parties at Review Conferences of their use for purposes inconsistent with the objectives and the provisions of the Convention,]

(13) Determined to ensure that all achievements in this field are used exclusively for the benefit of mankind,

[(14) Reaffirming the obligation of each State Party to the Convention under Article III not to transfer to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in Article I of the Convention,]

[(15) Concerned with the increasing gap between the developed and the developing countries in the field of biotechnology, genetic engineering, microbiology and other related areas,]

(16) Desiring to promote international cooperation and exchange of bacteriological (biological) agents and toxins, and equipment, materials and scientific and technological information in the field of biotechnology for purposes not prohibited under the Convention to enhance the economic and technological development of all States Parties,

(17) Emphasizing the increasing importance of the implementation of the provisions of Article X of the Convention and the obligations of each State Party under that Article [as well as under this Protocol], especially in the light of recent scientific and technological developments in the field of biotechnology, bacteriological (biological) agents and toxins for peaceful purposes, which have vastly increased the potential for cooperation between States to help to promote economic and social development, and scientific and technological progress [particularly in developing countries],

[(18) Determined to promote international cooperation on all developments in the field of frontier science and high technology in areas relevant to the Convention, and urging the developed countries possessing advanced biotechnology and knowledge in such fields as medicine, public health and agriculture to adopt positive measures and to continue to promote technology transfer and cooperation on an equal and non-discriminatory basis, in particular with the developing countries, for the benefit of all mankind,]

(19+7) Convinced that the most effective way to promote a world free of biological and toxin weapons is through strengthening the provisions of the Convention by the measures contained in this Protocol, and through promoting universal adherence to the Convention and this Protocol; further convinced that this will [contribute to delivering] [deliver] significant benefits in terms of international security and development,[3]

(20) Determined to strengthen and improve the effective implementation of the Convention,

Have agreed as follows:

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ARTICLE I

[[GENERAL PROVISIONS]

[1. Each State Party to this Protocol reaffirms its obligations under the Biological and Toxin Weapons Convention [and the Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare] and particularly undertakes:

(a) Never to develop, produce, stockpile, or otherwise acquire or retain:

(i) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes;

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

(b) Never to transfer to any recipient whatever, directly or indirectly, and in any way to assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in Article I of the Convention;

(c) bis To reaffirm that under any circumstances the use, development, production and stockpiling of bacteriological (biological) and toxin weapons are effectively prohibited under Article I of the Convention;

(d) To facilitate and have the right to participate in the fullest possible exchange of equipment, materials and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes and not to hamper the economic and technological development of States Parties;

(d) bis Never to use the provisions of the Convention to impose restrictions and/or limitations on transfers for purposes consistent with the objectives and provisions of the Convention of scientific knowledge, technology, equipment and materials;

(d) ter To make specific measures to ensure effective and full implementation

of Article X of the Convention.]

[1 bis This Protocol is aimed at strengthening the effectiveness and improving the implementation of the Convention through measures set out therein which include, inter alia:

(a) Declarations to be submitted and visits to be conducted in accordance with Article III, section D of this Protocol;

(b) Investigations to be conducted in accordance with Article III, section G of this Protocol;

(c) Measures to be taken in accordance with Article VII of this Protocol to enhance compliance and ensure effective and full implementation of Article X of the Convention.]

[2. Each State Party to this Protocol undertakes not to use pests and vectors as a method of warfare or for hostile purposes.]

[3. To promote the goals of the Convention for a world free of biological weapons and to promote these goals through cooperative endeavours, the implementation of this Protocol shall include the requirement for multilaterally negotiated, universal, comprehensive and non-discriminatory sensitive technology transfer agreements.]

4. In implementing this Protocol States Parties shall have the right to protect commercial proprietary information and national security information [in accordance with the provisions of this Protocol]. [This right may not be invoked by a State Party to conceal evasion of its obligations nor to engage in activities prohibited under the Convention.]

5. The measures set out in this Protocol shall be implemented [by the organs of the Organization] in a manner to ensure full protection of commercial proprietary information and national security information. To this end, such measures shall be carried out in the least intrusive manner consistent with the fulfilment of their objectives pursuant to this Protocol.

[6. In carrying out its responsibilities, the Organization shall consider only such sources of information which are objective, unbiased, legal and do not violate the sovereignty of States Parties.][4]

7. To enhance confidence in compliance with the Convention and the Protocol by all States Parties [, through increased transparency of relevant facilities and activities,] information about the implementation of the measures set out in this Protocol shall be provided to States Parties and to the relevant organs of the Organization in the performance of their functions [, in accordance with the provisions of this Protocol].

8. Each State Party to this Protocol shall, in accordance with its constitutional and legal processes, take any measures required to implement its obligations under this Protocol [in a manner that does not contravene its provisions].

[9. All provisions under the Protocol shall apply to States Parties on [a non-discriminatory] an equal basis.]

[10. Without prejudice to their rights and obligations under Article V of the Convention, the States Parties to this Protocol undertake to consult one another and to cooperate in solving any problems which may arise in relation to the object and purpose of the Convention or the full and effective implementation of the measures set out in this Protocol by all States Parties, inter alia, through the procedures for consultation, clarification and cooperation set out in Article III, section E of this Protocol.]

[11. In implementing the provisions of this Protocol, the States Parties and the Director-General shall, when appropriate, take into account existing agreements and competences of other relevant international organizations and agencies as well as the activities of States Parties in order to avoid duplication as well as to ensure an effective and coordinated use of resources for the effective implementation of the measures identified in this Protocol.]][5]

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ARTICLE II

DEFINITIONS[6]

1. Aerobiology means

The study of [or work with] aerosols of materials comprising biological agents and toxins [or simulants] in a facility or open air.

2. Approved equipment means

The devices and instruments necessary for the performance of the visiting or investigation team’s duties as approved by the First and subsequent Conferences of States Parties in accordance with provisions contained in Annex C, section I, paragraphs 34 and 35.

[3. Bacteriological (biological) and toxin weapons[7] mean

A type of weapon, the damaging effects of which are based on the properties of biological agents and toxins, to cause harm to human beings, animals or plants.

The term “Bacteriological (biological) and toxin weapons” together or separately shall be applied to the following:

(1) Materials containing 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;

(2) Weapons, any apparatus, equipment, device or means of delivery designed to use [and loaded with] such agents or toxins, or possessing special design features for the loading and use of such agents or toxins for hostile purposes or in armed conflict. It also applies to a vector (insect, pest or any living organism) intentionally infected with microbial agents for hostile purposes or in armed conflict.]

4. Biocontrol agent[8] means

[A living organism or biologically active substance originated from such organism used for the prevention, elimination or reduction of plant diseases and pests or unwanted plants.]

[5. Biological agents[9] mean

Any organism, either natural or modified, which can cause death, disease and/or incapacitate human beings and animals or which can also cause death, disease or harm to plants.]

[6. Biological defence facility[10] means

Facility which is [directly] involved in a biological defence programme and/or activities.]

[7. Biological defence programme and/or activities (against biological and toxin weapons)[11] [12] means

Programme and/or activities involving research and development, testing and evaluation, production and storage designed to detect and/or 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/or neutralize the impact of biological and toxin weapons on humans, animals or plants.]

8. Diagnostic facility means

Facility which tests only samples for the purpose of diagnosis of subclinical, clinical, or latent infection or intoxination in humans, animals or plants; or for the purpose of analysis of microbial or toxin contamination in food, water, soil and air by means of detection, isolation, and/or identification of microbial or other biological agents or toxins and serology.

9. Facility means

Any [room or suite of rooms, laboratory(ies),] building(s), or parts of building(s), or other structures [either at a fixed location or mobile] which is (are) [designed or] used to conduct activity(ies) [in the field of biology] [related to the Convention]. Such a facility may have an identifiable boundary and/or a single operational control [or may be placed within a final perimeter].

10. Genetic modification means

A process of arranging and manipulating nucleic acids of an organism and microorganisms to produce novel molecules or to add to them new characteristics or to modify the original characteristics.

[11. High biological containment [(BL-3 - WHO and OIE classification)] means

Any room or suite of rooms, laboratory(ies) or other buildings or structures:

(a) Designed [or] [and] used to handle and work with biological agents causing disease and known [or suspected] to meet either:

(i) The classification criteria of Risk Group 3 human pathogens, as determined by each State Party for itself and specified in the 1993 WHO Laboratory Biosafety Manual; or

(ii) The classification criteria of Group 3 animal pathogens, as determined by each State Party for itself and specified in the Amendment to the International Animal Health Code adopted by the International Committee of the OIE during its 66th General Session, 1998; [or] [and]

(b) Having characteristics consistent with the guidelines specified in the 1993 WHO Laboratory Biosafety Manual [for work with infectious agents that present a high risk to laboratory workers but a low risk to the community,] with respect to the maintenance of negative air pressure to the environment, access control and the rendering safe of exhaust air and of contaminated material and waste, including effluents by HEPA filtration, steam sterilization, incineration or other physical or chemical means.]

[11 bis The term “high biological containment [(BL-3 - WHO classification)]” means

Any room or suite of rooms, laboratory(ies) or other buildings or structures which meet(s) the requirements specified in the 1993 WHO Laboratory Biosafety Manual with respect to the maintenance of negative air pressure to the environment, access control and the rendering safe of exhaust air and of contaminated material and waste, including effluents by HEPA filtration, steam sterilization, incineration or other physical or chemical means.]

[12. Hostile purposes[13] mean

[Any purpose, which has no prophylactic, protective or other peaceful intention.]

[12 bis (a) The use of bacteriological (biological) or toxin weapons or the threat of use by a State with a view to inflicting military, economic, or other kind of damage;

[(b) Any other purpose, which has no prophylactic, protective or other peaceful intention.]]]

[13. Maximum biological containment [(BL-4 - WHO and OIE classification)] means

Any room or suite of rooms, laboratory(ies) or other buildings or structures:

(a) Designed [or] [and] used to handle and work with biological agents causing disease and known or suspected to meet either:

(i) The classification criteria of Risk Group 4 human pathogens, as determined by each State Party for itself and specified in the 1993 WHO Laboratory Biosafety Manual; or

(ii) The classification criteria of Group 4 animal pathogens, as determined by each State Party for itself and specified in the Amendment to the International Animal Health Code adopted by the International Committee of the OIE during its 66th General Session, 1998; [or] [and]

(b) Consistent with the guidelines specified for high biological containment (BL‑3 - WHO classification) and the additional requirements specified in the 1993 WHO Laboratory Biosafety Manual for BL-4, [for work with infectious agents that present or are suspected of presenting a high risk to both laboratory workers and to the community,] having the following features and mandatory procedures:

(i) Entry and exit of personnel and supplies is through an airlock or pass-through system. On entering, personnel put on a complete change of clothing; before leaving, they remove and discard this clothing, and shower;

(ii) Negative pressure is maintained in the facility by a mechanical, individual, inwardly directed, HEPA-filtered supply, and an exhaust air system with HEPA filters in the exhaust;

(iii) All fluid effluents from the contained area, including hand washing and shower water, are rendered safe before the final discharge;

(iv) A double-door, pass-through autoclave is available;

(v) An efficient primary containment system is in place. For work with human and zoonotic pathogens, primary containment is provided by use of one or more of the following: (i) Class III biological safety cabinets, or (ii) positive-pressure ventilated suits. In the latter case a special chemical decontamination shower is provided for personnel leaving the suit area.]

[13 bis Maximum biological containment [(BL-4 - WHO classification)] means

Any room or suite of rooms, laboratory(ies) or other buildings or structures with the following features, in addition to the features specified for high biological containment (BL‑3 - WHO classification):

(a) Controlled access. Entry and exit of personnel and supplies must be through an airlock or pass-through system. On entering, personnel must put on a complete change of clothing; before leaving, they should shower before putting on their street clothing;

(b) 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;

(c) Decontamination of effluents. All fluid effluents from the facility, including shower water, must be rendered safe before final discharge;

(d) Sterilization of waste and materials. A double-door, pass-through autoclave must be available;

(e) An efficient primary containment system must be in place. For work with human and zoonotic pathogens, primary containment must be provided by use of one or more of the following: (i) Class III biological safety cabinets, or (ii) positive-pressure ventilated suits. In the latter case a special chemical decontamination shower must be provided for personnel leaving the suit area. For work with animal pathogens, primary containment must be provided by use of Class III biological safety cabinets;

(f) Airlock entry ports for specimens and materials.]

14. Perimeter means

In case of a facility investigation, the boundary around a facility, defined by either geographic coordinates or a description on a map:

(a) Requested perimeter means the perimeter requested by a requesting State Party, in accordance with the provisions contained in Annex C, section III, paragraph 1 (d);

(b) Alternative perimeter means the perimeter as specified by the receiving State Party alternatively to the requested perimeter, in accordance with the provisions contained in Annex C, section III, part C;

(c) Final perimeter means the perimeter that resulted from negotiations between the investigation team and the receiving State Party, in accordance with the provisions contained in Annex C, section III, part C.

15. Plant inoculant means

[Any formulation containing a pure or predetermined mixture of microorganisms which alter the properties of plants or crops.]

[16. Plant pathogen containment means

Any laboratory or other building or structure specifically designed and used to handle and work with plant pathogens and pests that pose a high risk of infection or propagation to the plant population that are of economic importance and endangered thereby and which are being controlled by official regulatory measures. Such a design includes access control through a vestibule bounded by outer and inner doors, hand washing facilities, the ability to apply negative or positive pressure to the environment, the exhaust air sterilized by HEPA filtration, incineration, or other physical or chemical means and the ability to control the internal temperature. Decontamination of all waste is achieved by a suitable chemical or physical process before exhausting into a public or communal system.]

17. Point of entry/point of exit means

A location designated by the State Party pursuant to this Protocol for the in-country arrival of investigation and visiting teams or for their departure after completion of their mission.

18. Primary production containment means

Features in any system of equipment for the production of microbial or other biological agents, or toxins, that are designed to separate the production process from the environment thereby preventing release that could compromise the health of workers or cause other harm to [the product or] the environment. [Sample collection, addition of material and transfers to another system are performed so as to prevent such release. Before discharge, exhaust gases, effluents and wastes from the system should be decontaminated by appropriate physical or chemical means.]

19. Production[14] means

[Mass] Cultivation of replicative biological agents by any means, or the synthesis, biosynthesis, or extraction of non-replicative biological agents including toxins.

[20. Purposes not prohibited by the Convention[15] mean

(a) Purposes, involving the identification, prevention and treatment of diseases caused by biological agents and toxins;

(b) Purposes, linked with protection from biological and toxin weapons;

(c) Other peaceful purposes, including industrial, agricultural, veterinary, research, medical and pharmaceutical purposes.]

[20 bis Any purpose, which has prophylactic, protective or other peaceful intention.]

[21. Research and development (R & D) means

Applied research directed towards innovation or improvement of large scale production of biological products.]

[22. Simulants of biological agents or toxins mean

Chemicals or microorganisms used to mimic one or more properties of biological agents or toxins in experimental studies.]

23. [Site[16] means

The location and integration of one or more biological defence facilities within a geographically and/or physically defined area which may have an identifiable boundary, which can not be smaller than a building.]

24. [The receiving or visited State Party and the host State Party[17]

The receiving or visited State Party means the State Party on whose territory or in any other place under whose jurisdiction or control an investigation or a visit is proposed, taking place or has been completed. In the specific case where an investigation or a visit is proposed, taking place or has been completed on the territory of a State Party/State, but in a place under the jurisdiction or control of another State Party/State, the former State Party/State shall not be the “receiving or visited State Party”, but shall be defined as the “host State Party/State of a visit or an investigation”.][18]

[25. Toxin[19] means

Any compound originated from any organisms including microorganisms, animals or plants, whatever their method of production, whether natural or modified, or which are chemically synthesized, which can cause death, disease or other harms to human beings, animals or plants.]

26. Vaccine means

Any preparation, including live-attenuated, killed or otherwise modified microorganisms or components obtained from organisms, including inactivated toxins and nucleic acids, which, when introduced by any routes into a human being or animal, induces in it a specific immune response for prophylaxis or protection against infectious disease(s) or intoxination and which is safe for human beings and/or animals.

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ARTICLE III

COMPLIANCE MEASURES

A. [LISTS AND CRITERIA (AGENTS AND TOXINS)]

[Each State Party shall declare agents and toxins from the lists set out in Annex A, section I, in accordance with the formats for declarations of facilities, activities and transfers referred to in Annex A, section IV.]

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B. [EQUIPMENT]

[1. Each State Party shall supply information concerning equipment installed at the declared facility from the list contained in Annex A, section II, and also concerning the transfer of such equipment, in accordance with the formats for the declaration of facilities, activities and transfers referred to in Annex A, section IV.

2. The Conference of States Parties shall, taking into account scientific and technical achievements, examine proposals whereby equipment is to be included in or excluded from the list, and shall take a decision thereon.]

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C. [THRESHOLDS][20]

[1. Each State Party can store at facilities participating in a programme for protection against biological weapons established quantities of biological materials containing listed agents (Annex A, section I). Specific values of quantities of biological materials shall be determined in accordance with Annex A, section III. This requirement shall not cover quantities of biological materials that are used at the facilities in question in day-to-day work and for the production of immune and other biological preparations for medical, veterinary and agricultural purposes.

2. Upper and lower threshold quantities of biological materials are established for each listed agent or toxin.[21]

3. The lower threshold is used in the declaration format and corresponds to the maximum quantity of biological material containing an agent or toxin which, if exceeded, is subject to annual declaration in a yes/no format.

4. The upper threshold is used in carrying out on-site measures and corresponds to the minimum quantity of biological material containing an agent or toxin of a specific type which may not be exceeded at the facility.]

[5. Each State Party can receive and store at facilities subject to declaration in accordance with Annex A, section IV, established quantities of listed agents and toxins (Annex A, section I). Specific values of quantities of agents and toxins shall be determined in accordance with Annex A, section III.

6. Total and current threshold quantities are established for each listed agent or toxin.

7. Total threshold corresponds to the total quantity of listed agents or toxins received and/or produced at any facility during the previous year which, if exceeded, is subject to accounting and annual declaration in facility format.

8. The current threshold corresponds to the quantity of a listed agent or toxin of a specific type stored currently at any facility which, if exceeded, is subject to accounting and immediate notification through the Organization.

9. Each State Party shall have an obligation to notify through the Organization as soon as possible any necessary information concerning the exceeding of the current threshold level of listed agents and toxins.

10. Each State Party shall have the right to request, through the Organization, and seek the immediate provision of any necessary information concerning the exceeding of the current threshold level of listed agents and toxins by another State Party.

11. The Organization shall have the right to require of a State Party, on the basis of well-founded concerns on the part of other States Parties, that it should prevent the current threshold level from being exceeded for specific facilities, agents and toxins.

12. The Conference of State Parties shall, taking into account scientific and technical achievements and in accordance with a principle of the effective collective safety, examine proposals whereby total and current threshold levels to the specific listed agent or toxin are to be included, changed or excluded from Annex A, and shall take a decision thereon.][22]

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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 exist or existed on its territory or in any other place under its jurisdiction or control during the period specified.

2. [In cases where these activities take place or facilities exist in places on the territory of a State Party, but which are under the jurisdiction or control of another State which is not a party to the Protocol, this provision shall not apply to that State Party.] In cases where these activities take place or facilities exist in places on the territory of a State Party, but which are under the jurisdiction or control of another State Party, this provision shall only apply to the State Party under whose jurisdiction or control those places are. [That State Party shall inform the State Party on whose territory those places are, of the presence of such facilities or activities and 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.] [The State Party exercising jurisdiction or control over those places on the territory of the aforementioned State Party shall inform this State Party of the presence of such facilities or activities. The State Party on whose territory those places are, shall inform the Organization about the fact of the presence of such facilities or activities in cases where the fact of their presence is known to this State Party.]

3. All declarations submitted in accordance with paragraphs 1 and 2 above shall be submitted to the Organization, in accordance with the appropriate format in the Appendix, not later than 180[23] 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.

[4.[24] The Executive Council may review periodically the declaration formats’ structure and contents to ensure the effective implementation and operation of Article III, section D. Any State Party may propose modifications to the declaration formats which shall be subjected to review by the Executive Council. In reviewing the declaration formats, the Executive Council shall consider, inter alia, scientific and technological developments that may affect their operational structure and contents.]

[5. 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 required to fulfil its obligations under this section, from the other State Party.]

INITIAL DECLARATIONS

[(A) OFFENSIVE BIOLOGICAL AND TOXIN PROGRAMMES AND/OR ACTIVITIES CONDUCTED PRIOR TO ENTRY INTO FORCE OF THE PROTOCOL FOR EACH STATE PARTY

6. Each State Party shall declare, in accordance with paragraphs 1 to 3 above whether at any time since [17 June 1925] [1 January 1946] [26 March 1975] it has

[conducted any offensive biological and toxin programmes and/or activities.]

[developed, produced, stockpiled or otherwise acquired or retained, and whether, during the same period, it has used:

(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.

[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 since ... .]]]

(B) DEFENSIVE BIOLOGICAL AND TOXIN PROGRAMMES AND/OR ACTIVITIES CONDUCTED PRIOR TO ENTRY INTO FORCE OF THE PROTOCOL FOR EACH STATE PARTY

7. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, whether at any time [since [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] [31 December 1991]] [starting five years prior to the first annual declaration for that State Party] [until entry into force for that State Party] it has conducted [research and development] programmes and/or activities as specified in subparagraph (b) below as part of any effort 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:

(a) The general objectives of activities that were part of such programmes and/or activities;

(b) Any research and development [, testing or evaluation, and production] conducted as part of such programmes and/or activities that involved prophylaxis, pathogenicity/virulence, diagnostic techniques, detection, aerobiology, treatment, toxinology, physical protection, decontamination.]

7 bis Each State Party shall declare any information that subsequently comes to its notice that would have been required to have been declared pursuant to paragraphs 6 and 7 above had such information been known one year after this Protocol entered into force for that State Party, not later than 180 days after such information is discovered.]

[(A) OFFENSIVE AND/OR DEFENSIVE BIOLOGICAL AND TOXIN PROGRAMMES AND/OR ACTIVITIES CONDUCTED PRIOR TO ENTRY INTO FORCE OF THE PROTOCOL FOR EACH STATE PARTY

6. Each State Party shall declare, in accordance with paragraphs 1 to 3 above whether at any time since 1 January 1946 until entry into force of the Protocol for that State Party it has conducted any offensive and/or defensive biological and toxin programmes and/or activities. The State Party shall provide a summary of any such programmes and/or activities, indicating work performed concerning:

(a) Research and development, production, testing, weaponization, stockpiling of biological agents, toxins and/or weapons, destruction of such agents, toxins and/or diversion of the activity of facilities to peaceful purposes;

(b) Research and development that involved prophylaxis, pathogenicity/virulence, diagnostic techniques, detection, aerobiology, treatment, toxinology, physical protection, decontamination.

7. Each State Party shall declare any information that subsequently came to its notice that would have been required to have been declared pursuant to paragraph 6 above, had such information been known one year after this Protocol entered into force for that State Party, not later than 180 days after such information is discovered.]

ANNUAL DECLARATIONS

8. Each State Party shall declare, in accordance with paragraphs 1 to 3 above:

[(a) The presence of all / absence of defensive biological and toxin programmes and/or activities involving research and/or development, testing and evaluation, production and storage 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 taking part in such programmes and/or activities [and conducting work on microorganisms or toxins as well as material imitating their properties].]

[(a) Whether at any time during the previous calendar year it has conducted any [research and development] [testing and evaluation, production] activities as part of programmes and/or activities 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, it shall declare:

[(i) All such activities;]

(ii) The general objectives and main elements, and funding arrangements of such [research and development] [testing and evaluation, production] programmes and/or activities;

(iii) In summary form, the research and development [, testing and evaluation] conducted as part of such programmes and/or activities on prophylaxis, pathogenicity/virulence, diagnostic techniques, detection, aerobiology, medical treatment or toxinology, physical protection, decontamination [and production fermentation capacities];]

[(b) One of the following:

(i) All facilities where five or more person years of technical and scientific effort were devoted to the programmes and/or activities specified in subparagraph (a) above; or

(ii) All facilities where five or more such people worked on such programmes and/or activities; or

(iii) All facilities which individually accounted for more than ... per cent of the total funding devoted by the State Party to such programmes and/or activities.

Where less than five facilities have to be declared pursuant to this subparagraph, declare in addition, on the same basis, all facilities where more than [10 per cent of the total scientific and technical [person years] [persons] were] [... per cent of the total funding was] devoted by the State Party to such programmes and/or activities;

(b) bis List and provide general information in accordance with Appendix D on all facilities not declared in accordance with subparagraph (b) above where more than Y but less than ...;]

[(b) Declare facilities which performed research and development on pathogenicity/virulence, aerobiology or toxinology specified in subparagraph (a) above, as follows:

(i) Declare all such facilities at up to five sites where the greatest amount of technical or professional staff effort was devoted to activities referred to in the chapeau of this subparagraph; and

(ii) If there were more than five sites where more than ... person years of technical and scientific staff effort were devoted to activities specified in the chapeau of this subparagraph, declare the facilities at all such sites;]

[(c) List and provide general information in accordance with Appendix D on all facilities [on sites] not declared in accordance with subparagraph (b) above where more than [2] but less than [5] person years of scientific or technical staff effort were devoted to programmes and/or activities referred to in subparagraph (a) above.]]

9. For the purpose of paragraph 8 above, the following definitions apply:[25]

(D) VACCINE PRODUCTION FACILITIES

10. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, each facility which, during the previous calendar year with primary production containment [or high containment] produced with the use of fermenters and/or bioreactors, embryonated eggs or other means, or produced with the use of fermenters and/or bioreactors, embryonated eggs or other means and recovered by concentration or isolation, microorganisms or substances, causing a specific and protective immune response [against listed agents and toxins] as an ingredient of:

(a) Any vaccine for humans [for public use or for armed forces] [that is for the general public or for armed forces], or which was licensed, registered or otherwise approved by a component of the government of the State Party for distribution or sale;

(b) Any vaccine for animals [for public sale] [that is available to the general public, or] which was licensed, registered or otherwise approved by a component of the government of the State Party for distribution or sale.

(E) MAXIMUM BIOLOGICAL CONTAINMENT [(BL-4 - WHO [AND OIE] CLASSIFICATION)] FACILITIES

11. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, all facilities designated as maximum biological containment [(BL-4 - WHO [and OIE] classification)] as defined in paragraph 13/13 bis of Article II.

[(F) HIGH BIOLOGICAL CONTAINMENT [(BL-3 - WHO [AND OIE] CLASSIFICATION)] FACILITIES

12. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, all facilities designated as high biological containment [(BL-3 - WHO [and OIE] classification)] as defined in paragraph 11/11 bis of Article II, [and working with listed agents or toxins,] but excluding purely diagnostic and medical facilities.]

[(G) PLANT PATHOGEN CONTAINMENT

13. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, all facilities designated as plant pathogen containment as defined in paragraph 16 of Article II.]

(H) WORK WITH LISTED AGENTS AND/OR TOXINS

14. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, each facility which, during the previous calendar year, has conducted any [of the following] activities with [pathogenic strains of] agents and/or toxins listed in Annex A [:

[(a) Research and development performed in areas protected by high biological containment (BL-3);]

(b) Production [with the purpose of recovery] of [one or more] [any single] agent[s] and/or toxin[s] listed in Annex A, using:

(i) Any fermenter(s)/bioreactor(s) with a total internal volume of [10] [25] [50] [100] litres or more; or

(ii) Continuous or perfusion fermenters/bioreactors with a flow rate capable of exceeding [2] litres an hour; or

(iii) A chemical reaction vessel or equipment used for recovery with a total internal volume of [10] [50] [100] litres or more; or

(iv) More than [1,000] [2,000] embryonated eggs on an annual basis; or

(v) More than [100] [1,000] [2,500] litres of tissue culture or other medium on an annual basis;

(c) Modification of any nucleic acid sequence of agents, or coding for toxins, listed in Annex A [which would increase pathogenicity/virulence or facilitate the production of toxins or their toxic subunits] [which creates or results in change of antigenicity or immunogenicity, increased antibiotic resistance, stability, or toxic or disease-causing properties, or ease of production];

[(d) Insertion of a nucleic acid sequence coding for any pathogenicity/virulence factor from an agent or toxin listed in Annex A, or for a subunit of such toxin, into any organism, resulting in a genetically modified organism with increased disease-causing or toxic properties [(including facilitating the production of the toxin or its toxic subunit(s))];]

[(d) Insertion of a nucleic acid sequence from an agent or coding for any toxin listed in Annex A or coding for a toxic subunit of such a toxin, into any organism, resulting in a genetically modified organism with imposed disease-causing or toxic properties characteristic of one or more agents and/or toxins listed in Annex A or facilitating the production of any such toxin or its toxic subunit;]

[(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 in/by:

(i) An explosive aerosol test chamber; or

(ii) A dynamic aerosol test chamber; or

(iii) A static aerosol test chamber; or

(iv) Open air; or

(v) Application to the respiratory tract of an animal;]

[(e) Intentional aerosolization of any agent and/or toxin listed in Annex A in:

(i) An explosive aerosol test chamber; or

(ii) Any other aerosol test chamber that has a total internal volume of 5 m³ or more;][26]

[(f) Maintenance of culture collections in maximum or high biological containment [(BL-3 or BL-4 - WHO [and OIE] classification)] installations.]]

[15. A facility shall not be declared under paragraph 14 above if it works with listed agents and/or toxins only for the purpose of [detection, identification or] diagnosis of human, animal or plant disease, or for carrying out medical treatment or prophylactic activities, or for testing for food or water hygiene, or for testing the efficacy of antimicrobial preparations, vaccines, toxoids or immunoglobulin preparations [, pesticide preparations, or for non-clinical studies for the safety of agricultural pesticides].]

[(I) OTHER PRODUCTION FACILITIES

16. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, each facility which, during the previous calendar year, [under high biological containment (BL-3)] [under primary production containment]

(i) Produced; or

(ii) Produced or recovered by concentration or isolation;

any microorganisms [or other substances] for use, directly or after chemical modification, as an active ingredient in:

(i) Any preparation, other than vaccine or food and beverages for humans and animals, for the prevention or treatment of disease in humans and animals; or

(ii) Diagnostic reagents; or

(iii) Biocontrol agents or plant inoculants;

using one of the following:

(a) Any fermenter/bioreactor exceeding [30] [300] litres in volume; or

(b) Any continuous or perfusion fermenter/bioreactor with a flow rate exceeding [2] [50] litres per hour; or

(d) More than 10,000 litres of tissue culture medium annually; or

(e) More than 10,000 litres of growth medium annually.

[17. A facility shall not be declared under paragraph 16 above if such production of microbial or biological agents or toxins was performed exclusively for:

(a) Bioremediation or waste treatment; or

(b) Manufacture for sale or use of soap, cosmetics, detergents, fertilizers, [non-active ingredients of pharmaceuticals,] [pharmaceuticals,] or foods or beverages for humans or animals; or

(d) Teaching the manufacture of the products listed in subparagraph (b) above.]]

[(J) OTHER FACILITIES

18. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, each facility which, during the previous calendar year, 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, animal husbandry or forestry;]

[(c) Conducted genetic modification to enhance pathogenicity, virulence, stability or resistance to antibiotics or 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 (BL-3).]]

[(K) TRANSFERS

19. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, all international transfers during the previous calendar year of agents and/or toxins, equipment [or means of delivery] listed in Annex A.][27]

[(L) DECLARATIONS ON THE IMPLEMENTATION OF ARTICLE X OF THE CONVENTION AND ARTICLE VII OF THE PROTOCOL[28]

20. Each State Party shall declare, in accordance with paragraphs 1 to 3 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.

21. 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]

[(M) NATIONAL LEGISLATION AND REGULATIONS[29]

22. Each State Party [shall at the request of the Organization within [10] days] [may on a voluntary basis] declare, in accordance with paragraphs 1 to 3 above, a list of the number, dates and titles of legislation, regulations [, directives, orders] or other administrative and legal measures that govern, regulate, provide guidance on or otherwise control:

(a) 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 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.

23. 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 D, subsection II, 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 22. 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 fulfil its functions.]

[(N) OUTBREAKS OF DISEASE[30]

24. 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.

25. If all of the required information has been submitted by a State Party to a competent international body, such as the WHO, OIE and FAO, and this international body has supplied the information to the Organization, such provision of information shall satisfy a State Party’s obligation under paragraph 24 of this subsection.]

[(O) CURRENT EXCEEDING OF THRESHOLD

26. Each State Party shall provide to the Organization as soon as possible information, in accordance with Article III, section C, paragraph 5, on the fact of any listed agent or toxin which is currently (or planned to be) stored at any facility subject to declaration, in quantities that exceed the current threshold level, established in Annex A. This information should include specification of facility, agent (toxin), its maximum quantity, general purposes and period(s) of corresponding activity. Any additional information on this occasion to provide necessary transparency with compliance of the provisions of the Protocol should be submitted at the request of the Organization.]

II. FOLLOW-UP AFTER SUBMISSION OF DECLARATIONS

1. The Technical Secretariat shall receive, process, analyse, and store declarations submitted by States Parties in accordance with the provisions of this Protocol.

2. 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 D 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 State(s) Party(ies) concerned that copies of their declarations have been made available to the requesting State Party.

[3. In order to [determine that the declarations submitted by States Parties are complete and accurate] [promote the accurate fulfilment of the declaration obligations under this Protocol], in accordance with the provisions set out in this Protocol, the Technical Secretariat shall:

[(a) Process and analyse the declarations;]

(b) Conduct a limited number per year of [randomly-selected] visits to [declared] [biodefence and BL4 with the principle of proportionality] [BL4] facilities [declared pursuant to Article III, section D, subsection I, parts (C), (D), (E), [(G),] (H) and (I)] [in accordance with the procedures set out in part A below];

[(c) If it, in its analysis pursuant to paragraph 3 (a) above, identifies any ambiguity, uncertainty, anomaly or omission [of a purely technical nature] related solely to the content of the declaration, seek clarification from the State Party concerned, in accordance with the procedures set out in part B below;]

(d) 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, in accordance with the procedures set out in part C below.]

4. A State Party which identifies any ambiguity, uncertainty, anomaly or omission in the declaration of another State Party may seek clarification from the State Party concerned, in accordance with the provisions of section E of this Article, or it may initiate the clarification process set out in part B below.

Visit schedule

5. The total number of all visits conducted pursuant to this Article [shall be approved by the [First] Conference of States Parties and] shall not exceed [30] [75] [140] [...] in each calendar year.

[6. The number of visits pursuant to paragraph 3 (b) shall be at least a half of the total for visits specified in paragraph 5. The number of visits pursuant to paragraph 3 (d) and part C shall be [at least] [not more than] one quarter of the total for visits specified in paragraph 5. [The first visit in any year resulting from the procedure set forth in paragraph 3 (c) or paragraph 4 shall be deducted from the quota allocated for visits pursuant to paragraph 3 (b). Thereafter any visits required under paragraph 3 (c) or paragraph 4 shall be deducted alternately from the quotas allocated to paragraph 3 (d) and part C and paragraph 3 (b).] OR [All visits in any year resulting from the procedures set forth in paragraphs 3 (c), 3 (d) and 4 shall be deducted from the total number allocated in paragraph 5. The resultant number, once all deductions are made, will be the new number of visits pursuant to paragraph 3 (b).]]

[7. The initial Review Conference held pursuant to Article XIII may revise the figures for the categories of visits pursuant to paragraphs 3 and 5 of this subsection, taking into account the resources available and the implementation of this Protocol. Thereafter each Conference of States Parties may revise the figures allocated to each category of visits specified in paragraphs 5 and 6.]

8. The Director-General shall not later than seven days after the first session of the year of the Executive Council notify all States Parties of the schedule for the [voluntary] visits planned for that year.

9. The Director-General shall submit to the Executive Council every three months, or earlier if necessary, a report on the implementation of visits of each type and on outstanding invitations for voluntary assistance and [voluntary clarification visits]. [If it judges it necessary, the Executive Council may decide to adjust the initial allocations, between the types of visits, proposed by the Director-General in accordance with paragraphs 5 and 6.] [The number of [randomly-selected visits] [transparency visits] shall over a five-year period be fixed to ... visits.] [If during the year, the numbers of invitations for voluntary assistance and/or [voluntary clarification visits] exceed the initial provision, the Director-General shall reduce the provision for [randomly-selected visits] [transparency visits] in order to accommodate the extra voluntary assistance and/or [voluntary clarification visits] correspondingly. The Director-General shall notify the Executive Council of all changes to the visits schedule at its next session.]

[(A) [RANDOMLY-SELECTED VISITS] [TRANSPARENCY VISITS]

Purpose

[10. The Technical Secretariat shall conduct, in accordance with this Article, a limited number per year of [randomly-selected visits] [transparency visits] pursuant to this section, which shall be confidence-building in nature, to [declared] [biodefence and BL4] facilities. These visits shall, in cooperation with the State Party to be visited, promote the Protocol’s overall objectives by:

[(a) Increasing confidence in the consistency of declarations with the [activities] [situation at the facility] seen during a visit and encouraging submission of complete declarations;]

(b) Enhancing transparency of [declared] [biodefence and BL4] facilities and activities;

(c) [Promoting accuracy of declarations] [Promoting the accurate fulfilment of the declaration obligations under this Protocol]; and

(d) Helping the Technical Secretariat to acquire and retain a comprehensive and up-to-date understanding of the [different types of] [biodefence and BL4] facilities and activities declared globally.

11. In addition, if so requested by the State Party to be visited in its acknowledgement of receipt of notification of the visit, the visit shall be extended by up to [1] [...] working day[(s)] for the visiting team to provide to the extent possible technical advice or information to the visited State Party and/or to visited facility personnel on any of the subjects listed in paragraphs ... of Article VII or to provide any of the technical assistance and cooperation activities contained in programmes as specified in Article VII, section D, paragraph 19.]

[10. The Technical Secretariat shall conduct, in accordance with this Article, not more than ... [randomly-selected visits] [transparency visits] per year, which shall be confidence-building in nature, to [declared] [biodefence and BL4] facilities. The primary purpose of these visits shall be to confirm, in cooperation with the State Party to be visited, that declarations are accurate and complete in accordance with provisions set out in section D of this Article.

11. These visits shall also serve to enhance transparency of declared facilities and activities, provide, as requested and appropriate, technical advice or information, [or implement technical assistance and cooperation activities or programmes as specified in Article VII, section D, paragraph 19,] and [help] to ensure that the Technical Secretariat acquires and retains a comprehensive and up-to-date understanding of the different types of facilities and activities declared globally.]

Selection of facilities[31]

[12. [During the course of each calendar year,] the Technical Secretariat shall randomly select facilities [specified in paragraph 3 (b) of this subsection for a visit] [from among all [declared] [biodefence and BL4] facilities]. The mechanism of selection shall be approved by the first Conference of States Parties and may be amended by future Conferences of States Parties.

13. In selecting facilities to be visited, the Technical Secretariat shall utilize the approved mechanism of selection on the basis of the following [weighting] factors in order to ensure that:

(a) Such visits shall be spread among the [broadest possible range of] [two types of] facilities subject to the provisions of this section, in terms of their scientific and technical characteristics;

[(b) Such visits shall be selected on the basis of the principle of proportionality;]

(d) No facility shall be subject to more than ... such visits in a five-year period;

(e) No State Party shall receive more than ... such visit per year;

[(f) Such visits are distributed as widely and equitably as possible among States Parties submitting declarations;]

(g) The prediction of when any particular facility will be subjected to such a visit shall be precluded.]

[12.[32] During the course of each calendar year, the Technical Secretariat shall randomly select facilities to be visited from among those specified in paragraph 3 (b). The mechanism of random selection shall be appropriately weighted to ensure that:

(a) Visits are distributed as widely and equitably as possible among States Parties submitting declarations and among a broad range of types of eligible facilities;

(b) All States Parties submitting declarations are visited over time, but no State Party or individual facility receives an unreasonable number of visits taking into account, inter alia, the number of visits it has received in previous years;

13. The mechanism of selection shall be approved by the First Conference of States Parties, and may be adjusted by future Conferences of States Parties in the light of experience with implementation. The mechanism shall be designed to meet the following conditions, which may be revised by a Review Conference held pursuant to Article XIII:

(a) The probability of a State Party receiving a visit shall be proportional to the cube root of the number of declared facilities in that State Party;

(b) The maximum number of visits which a State Party may receive in any year shall be limited to a number proportional to the cube root of the number of declared facilities in that State Party. This maximum number shall be higher than the average number of visits expected in accordance with subparagraph (a), but shall be not more than 6 per cent of the total number of visits pursuant to paragraph 3 (b) carried out in that year;

(c) No State Party with declared facilities shall receive less than 0.5 per cent of the total number of visits pursuant to paragraph 3 (b) carried out in any five year period;

(d) No individual facility shall receive more than three visits pursuant to paragraph 3 (b) in any five year period.

Until the Conference of States Parties approves the mechanism, facilities shall be selected using an interim mechanism designed to meet the above conditions.]

Duration

14. Visits pursuant to this part may last up to two consecutive working days. This time excludes the inspection of approved equipment. The duration of the visit may be extended if the visited State Party and visiting team so agree.

15. If so requested by the State Party to be visited in its acknowledgement of receipt of notification of the visit, the visit shall be extended by up to two days for the visiting team to provide technical advice or information, [or to provide any of the technical assistance and cooperation activities contained in the programmes as specified in Article VII, section D, paragraph 19,] requested by the State Party to be visited. [The resources required for this assistance visit shall be charged against the technical assistance portion of the budget of the Organization.]

Equipment

[16. The visiting team shall bring to the visited facility only items from the list of approved equipment pursuant to paragraph 35 of Annex C, section I. The visiting team shall normally only bring to the visited facility items of equipment meeting the specifications for [instant developing cameras, voice recorders and] personal computers. Instant developing cameras and voice recorders shall only be used for collecting factual information for the visit report. Instant developing cameras shall only be operated by the representatives of the visited State Party. The use and disposition of equipment during the visit shall be at the discretion of the visited State Party. The bringing and use of additional items of approved equipment at the declared facility shall be with the agreement of the visited State Party.

17. If required, the visited State Party shall provide protective equipment meeting the specifications of appropriate items from the list of approved equipment. If agreed by the visited State Party, or if the visited State Party is unable to provide such equipment, the visiting team shall be permitted to use its own protective equipment from the list of approved equipment.]

Administrative arrangements

18. The visited State Party shall provide or arrange for the amenities necessary for the visiting team such as communication means, interpretation services to the extent necessary for the performance of interviewing and other tasks, in-country transportation, working space, lodging, meals and urgent medical care. The visited State Party may, to the extent possible, provide approved equipment as requested by the visiting team. The visited State Party shall be reimbursed by the Organization for any assistance provided pursuant to this paragraph within 30 days after receipt of a detailed and validated claim from the visited State Party.

PRE-VISIT ACTIVITIES

Mandate

19. The Director-General shall issue a standard mandate for the visit. The mandate shall be confined to the purposes set out in paragraphs 10 and 11 of this subsection. The mandate shall contain:

(a) The name of the visited State Party;

(b) The name of the host State Party/State, if applicable;

(d) The declaration submitted by the facility;

(e) The names of the leader and other members of the visiting team;

(f) The approved equipment to be used [agreed to by the visited State Party] during the visit in accordance with paragraphs 16 and 17 above;

[(g) Operational instructions to the visiting team necessary for the visiting team to fulfil its mandate;]

[(h) Specific objective to be achieved by the visiting team.]

20. If the visited State Party has requested in its acknowledgement of receipt of the visit notification, that the visiting team provide technical advice or information, [or to provide any of the technical assistance and cooperation activities contained in the programmes as specified in Article VII, section D, paragraph 19,] such activities shall, as appropriate, be added to the visit mandate to be conducted at the end of the visit activities. The addendum to the visit mandate shall be made available to the State Party to be visited as soon as possible before the commencement of the visit.

21. The mandate for each visit shall be issued by the Director-General to the visiting team leader.

Notification

22. The Director-General shall notify the State Party to be visited and, if applicable, the host State Party 14 days before the arrival of the visiting team at the point of entry, of its intention to conduct a visit to a declared facility; 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 48 hours after receipt of the notification. The notification shall include:

(a) The name of the State Party to be visited;

(b) The name of the host State Party/State, if applicable;

(d) The point of entry where the visiting team will arrive as well as the means of arrival;

(e) The date and estimated time of arrival of the visiting team at the point of entry;

(f) The names of the leader and of the other members of the visiting team;

(g) The visit mandate;

[(h) Additional items of approved equipment the visiting team requests to bring to the visited facility pursuant to paragraph 16 above;]

(i) Information on the existing cooperation and assistance activities or programmes, if any, which the Technical Secretariat considers may be applicable to the facility to be visited and from which the facility could benefit.

23. In its acknowledgement of receipt, the State Party shall provide its response to the request for additional approved equipment and it may also indicate whether it requires technical advice and information [and specify which technical assistance and cooperation activities contained in the programmes as specified in Article VII, section D, paragraph 19, it requests] to be provided by the visiting team, without prejudice to its right to request technical advice and information at any time during the visit which shall be provided after conclusion of the visit. [The State Party to be visited shall acknowledge receipt of the notification within 24 hours after receipt. Within three days of receipt, the State Party, as a rule, shall confirm acceptance of the dates proposed for the visit, but it may, in exceptional circumstances, propose alternative dates occurring within 30 days of receipt of the notification. The Technical Secretariat, as a rule, shall accept such proposed alternative dates, but may, if operational requirements so dictate, propose other dates occurring within 30 days of the issuing of the notification. If a State Party can not accept these dates, its proposed alternative dates shall be the dates for the visit.]

Appointment of visiting team

24. The Director-General shall appoint the members of the visiting team from among only the full-time personnel of the Technical Secretariat designated in accordance with Annex C, section I, paragraphs 1 to 10, taking into account the specific nature of the facility to be visited. The members of the visiting team shall be selected on as wide an equitable geographical basis as possible. The Director-General shall limit the size of the visiting team to the minimum necessary for the proper fulfilment of the mandate. In any event the team shall not exceed four members. No national of the State Party to be visited [, or, if applicable, the host State Party,] shall be a member of the visiting team.

Designation of visited State Party representatives

25. The visited State Party may designate personnel to assist visited facility personnel, prepare for and host the visiting team. The visited State Party shall designate visited facility personnel to accompany the visiting team for the duration of the visit.

ACTIVITIES UPON ARRIVAL OF THE VISITING TEAM

Inspection of approved equipment

26. The State Party to be visited shall have the right to inspect the equipment of the visiting team including the additional equipment the State Party to be visited approved, to ensure that it is properly sealed, appears on the list of approved equipment and conforms to the standards as set out in Annex C, section I, paragraph 35. The visited State Party may exclude items of equipment that do not conform to the provisions set out in Annex C, section I, paragraph 40, as well as paragraphs 16 and 17 above, and may retain them at the point of entry.

CONDUCT OF THE VISIT

27. The visiting team and the visited State Party shall cooperate with each other to fulfil the mandate while protecting the interests of the visited State Party.

28. In this regard the visited State Party shall:

(a) Provide access to the visiting team to the facility to be visited [and sufficient access to fulfil its mandate within the visited facility]. The nature and extent of access inside the facility shall be at the discretion of the visited State Party;

(b) Allow the visiting team to conduct the activities, described in paragraph 34 of this subsection, proposed by the visiting team as necessary to fulfil its mandate;

(d) Have the right to object to questions posed to the facility personnel if those questions are deemed not relevant to the objectives of the visit mandate or compromise commercial proprietary or national security information;

(e) Make every reasonable effort to provide alternative means to allow the visiting team to fulfil its mandate if any of the activities proposed by the visiting team in accordance with paragraph 34 are not possible.

29. The visiting team shall:

(a) Collect only that information necessary to carry out its mandate and treat any information, documents and data obtained during the visit, which contain commercial proprietary or national security information and which are identified as such by the visited State Party, as confidential and handle such information, documents and data in accordance with the confidentiality provisions of this Protocol;

(b) Arrange its activities so as to ensure the timely and effective discharge of its duties in accordance with the visit mandate in the least intrusive manner possible, and every reasonable effort shall be made to avoid inconvenience to the visited State Party and disturbance to the visited facility;

(c) Make every effort to avoid hampering or delaying the operation of the facility. In particular, the visiting team shall not operate any facility equipment;

(d) Strictly observe established safety and working practices at the facility, whether instituted for the protection of personnel, animals, plants, the environment or of the processes performed or their products;

(e) Provide the visited State Party with copies of all the information and data obtained during the course of the visit;

[(f) Have the right to state the relevance of questions asked by the visiting team and objected to by the visited State Party; the team leader may ask the visited State Party to reconsider its objection. The visiting team may note in the final report any refusal to permit interviews or to allow questions to be answered without any justification given for any such refusal by the visited State Party.]

Briefing

30. Upon arrival at the facility to be visited, the visiting team shall be briefed on the facility and the activities carried out there by a facility representative and, at their discretion, the representatives of the visited State Party. The facility representative may be supported by any other facility personnel, as required.

[31. The briefing shall not exceed three hours. It shall include, inter alia:

(a) The scope and a general description of current declared activities of the facility including a description of the main scientific and technical information relating to the declared activity(ies), including written and visual documentation, if available, such as photographs, brochures, drawings, as appropriate;

(b) Short background description of the declared facility covering the date of establishment, current ownership, organizational structure and, wherever possible, general information on the declared facility’s role within the overall structure of company or government agency or entity operating the declared facility; organizational structure of the facility and any previous uses or changes in ownership;

(c) General information on the physical layout [, including laboratories, equipment] and other relevant characteristics of the visited facility, including a map or sketch showing all structures and significant geographic features;

(d) Numbers and types of personnel involved in the declared activity(ies) and whether they are military or civilian [, scientific or administrative];

(e) General information concerning the safety regulations in force, including rules of observation and quarantine [and vaccination policy, and on any other regulatory frameworks which may apply];

(f) Indication of areas the visited State Party considers sensitive;

(g) General information on any relevant changes in activities or equipment at the facility since the submission of the most recent declaration;

(h) Explanation for any levels of containment and the rationale for operating or not operating at such levels; and for work involving listed agents and/or toxins, including main objectives and rationales;

[(i) A description of the technical assistance and cooperation activities requested by the visited State Party pursuant to paragraph 23 above;]

[(j) General information on the method used for any treatment or disposal of waste or effluent from the declared facility;]

[(k) General information on any experimental animal usage related to the declared activities;]

(l) The administrative and logistical arrangements necessary for the visit.]

32. The visited facility shall provide to the visiting team a written summary of the key points of the briefing. It may also provide additional information, such as documentation related to either the briefing or tour, at its discretion. At its discretion, the visited facility may also provide in writing any additional information contained in the briefing. The visiting team may discuss with the visited State Party and the visited facility personnel the content of the briefing and any other information made available by the visited State Party and visited facility personnel.

Tour of the visited facility

33. [To complement the briefing,] the visited State Party [may] [shall] invite the visiting team to tour [all] areas within the declared facility relevant to the visit mandate. [All access during the tour shall be at the discretion of the visited State Party.] [The areas to be visited by the visiting team shall be determined by the visited State Party.] The duration of the tour shall not exceed two hours.

Visit plan

34. After the briefing and tour, the visiting team shall prepare an initial visit plan which shall indicate which of the following activities the visiting team wishes to conduct, in accordance with the provisions of paragraphs 27 to 29:

(a) Review and discuss with facility personnel the declaration and the information contained in the briefing and tour provided by the visited facility;

(b) Discuss, with the consent of the visited State Party, specific factual points, related to the visit mandate, on the [declared] activities of the declared facility as described in the facility declaration, briefing and tour, with facility personnel who are able to address those factual points. The visited State Party may make available national representatives to respond to questions on matters relating to national health and safety legislation and other regulatory matters, or to provide information on such matters. All discussions shall be conducted in the presence of representatives of the visited State Party. The visiting team shall only request information and data that are necessary for the fulfilment of the visit mandate;

[(c) Examine, with the consent of the visited State Party, documentation relevant to the mandate in order to facilitate the visiting team’s understanding of the activities being conducted at the declared facility. The visited State Party shall endeavour to provide such documentation, or to provide alternative means to address the questions of the visiting team if provision of any documentation is denied;]

(d) [Re]visit, pursuant to subparagraph 28 (a), parts of the facility, and observe equipment, relevant to the mandate and the declared activities at the facility;

[(e) The visited State Party [and/or the visited facility] may, at their discretion, offer access to other areas within the declared facility;]

(f) At any time during the visit, the visited State Party may [, at its own initiative or at the suggestion of the visiting team, grant] [offer] the visiting team the opportunity to conduct other on-site activities to assist fulfilment of the visit mandate. It may also offer additional access that the visited State Party believes may help the visiting team to fulfil its mandate. Any such on-site activities or access shall be subject to the provisions of paragraphs 27 to 29.

35. The visit plan and any changes to it shall be subject to agreement by the visited State Party.

36. If any [ambiguities] [technical inaccuracies] or other questions related to the visited State Party’s declarations are identified during the visit, the visited State Party and the facility shall seek to resolve these cooperatively, with the assistance, if necessary, of the visiting team.

Debriefing

37. At the completion of the agreed activities, the visiting team, facility personnel and visited State Party representatives shall meet to discuss the outcome of the visit and, if necessary, to confirm any details of fact for inclusion in the preliminary report which shall be a factual account of the visit. Such a meeting shall not take place if the visited State Party and the visiting team agree that it is not necessary.

POST-VISIT ACTIVITIES

Cooperation and assistance activities

38. If requested in accordance with paragraphs 11 and 15 above, after the conclusion of the other activities related to the visit, the visiting team shall provide the technical advice and information [and any of the cooperation and assistance activities contained in the programmes specified in the addendum to the visit mandate] pursuant to paragraph 20 above or requested during the visit.

Preliminary report

39. Within 24 hours of the completion of the visit, the visiting team shall provide to the representatives of the visited State Party a preliminary report in written form. The preliminary report shall only contain a description of the visit activities and the factual findings of the visiting team. The preliminary report shall be signed by the visiting team leader. In order to indicate that he/she has taken note of the contents of the preliminary report, the representative of the visited State Party shall sign the preliminary report.

40. If, during the visit, the visited State Party has provided to the visiting team any information which the visited State Party has identified as commercial proprietary or national security information not already included in the declaration, the visited State Party may require that any such information shall not be included in the draft or final report.

Departure

41. On completion of the debriefing [and, if applicable, the relevant cooperation and assistance activities], the visiting team shall depart from the territory of the visited State Party as soon as possible.

REPORTS[33]

Draft report

42. Not later than [14] [21] days after the visit, the visiting team shall prepare a draft report which shall include the contents of the preliminary report and an account of the cooperation and assistance activities of the visiting team during the visit. [At the request of the visited State Party, the draft report may contain technical recommendations and possible follow-up cooperation and assistance activities of the Organization or, in the assessment of the visiting team, other international organizations from which the facility could continue to benefit.] [The draft report shall also include a factual account of the degree and nature of access and the cooperation provided by the visited State Party in order to fulfil the visit mandate.] The report may also include comments from both the visited State Party and visiting team on the extent to which the information provided during the visit furthered the purpose of the visit as specified in paragraph 10 of this subsection. The visiting team [may record but shall not] [shall not record or] comment upon any requests for access or information that were made during the visit by the visiting team and which the visited State Party did not accede to.

43. The draft report shall immediately upon completion be submitted to the visited State Party. The visited State Party may make any comments or suggestions on the draft report to ensure factual and technical accuracy and the full protection of commercial proprietary and national security information. The visited State Party may identify any information contained in the report which it considers confidential and to be handled as such. The visited State Party may also identify any information which due to its confidential nature, or because it is in the visited State Party’s view not related to the visit mandate, should not be included in the final report. Any such comments shall be submitted to the visiting team not later than seven days after receipt of the draft report.

44. The visiting team shall consider comments received from the visited State Party. In preparing the final report, the visiting team shall, as a rule, adjust the draft report to reflect those comments, to identify any information requested by the visited State Party to be handled as confidential and to remove any information requested by the visited State Party to be removed. The final report shall, unless previously requested by the visited State Party, include as an annex all the comments made by the visited State Party on the draft report.

Final report

45. The final report shall be the draft report adjusted by the visiting team in accordance with paragraph 44. The visiting team shall submit the final report to the Director-General and the visited State Party not later than seven days after receipt of any comments from the visited State Party. [The Director-General may, with the consent of the visited State Party, provide copies of the final report, on request, to any other State Party.] [The Director-General shall, as a rule, provide copies of the final report, on request, to any other State Party, taking into account the provisions of Article IV, paragraph 4 (d) [, unless otherwise indicated by the visited State Party].]

46. If the Director-General considers it necessary that the visited State Party redresses its declaration by revising or supplementing it or submitting a new declaration, the Director-General shall attach to the final report the details of, and reasons for, the points on which the declaration concerned should be redressed, which shall be submitted to the visited State Party.]

(B) DECLARATION CLARIFICATION PROCEDURES

47. Concerns related to the declaration of a State Party [concerning any facility pursuant to Article III, section D, subsection I, parts (C), (D), (E), [(G),] (H) and (I)] shall [, as a rule,] be sought to be resolved either through the process of consultation, clarification and cooperation as provided for in paragraphs 1 (a) and 3 of section E of this Article, or through the procedures set out in this section. The State Party to which the concern is related may volunteer for the Technical Secretariat to conduct a visit in accordance with the provisions set out in this section to the facility in question with a view to resolving the concern.

Requests for clarification

[48. When a State Party considers that there is an ambiguity, uncertainty, anomaly or omission in the declaration [concerning any declared facility or activity] of another State Party, [or identifies any facility which it believes meets the criteria for declaration as set forth in Article III, section D, and that facility has not been included in the declaration(s) concerned,] it shall either seek clarification from the other State Party (hereinafter referred to as “the requested State Party”) through the process of consultation, clarification and cooperation as provided for in paragraphs 1 (a) and 3 of section E of this Article, or it may submit a request in writing to the Director-General to initiate the clarification procedures set out in this section on its behalf. The request shall include all relevant information on which it is based [including, in the case of the possible omission of a facility from a declaration, the reasons why it is believed that the facility may be required to be declared and a delimitation of the location of the facility].]

[49. When a State Party identifies any facility on the territory or under the jurisdiction or control of another State Party which it believes meets the criteria for declaration as set forth in Article III, section D, and that facility has not been included in the declaration(s) concerned, it shall seek clarification from the other State Party through the process of consultation, clarification and cooperation as provided for in section E of this Article.]

[50. Any State Party which has not fulfilled the obligations required under Article III, section D, subsection III, shall not have the right to seek clarification from another State Party under this section until it has submitted all outstanding declarations.]

51. Any State Party which has not taken any necessary measures it may have been required to take in accordance with a decision of the Executive Council pursuant to paragraphs 102 and 103 of this subsection, shall not have the right to seek clarification from another State Party under this section until any measures required pursuant to paragraphs 102 and 103 of this subsection are implemented.

52. Upon receipt of a request pursuant to paragraph 48 above [, or if as a result of his/her analysis pursuant to paragraph 3 (a) above, the Director-General considers that there is an ambiguity, uncertainty, anomaly or omission [of a purely technical nature] [related solely to the content of the declaration submitted by] [in the declaration concerning any declared facility or activity of] a State Party] [or identifies any facility which he/she believes meets the criteria for declaration as set forth in Article III, section D, and that facility has not been included in the declaration(s) concerned], the Director-General shall submit a written request for clarification to the State Party concerned (hereinafter referred to as “the requested State Party”). The request shall include all relevant information on which it is based [including, in the case of the possible omission of a facility from a declaration, the reasons why it is believed that the facility may be required to be declared and a delimitation of the location of the facility].

Consultations including a consultative meeting

53. The requested State Party shall provide the clarification in writing to the Director-General not later than 20 days after receipt of the request. In cases where a State Party initiated the clarification procedures, such response shall be forwarded to the requesting State Party by the Director-General not later than 24 hours after its receipt by the Director-General.

54. If within 14 days of receipt of the written response either the requesting State Party, for reasons which it shall set out in writing to the Director-General, or the Director-General himself/herself considers that the written response does not resolve the matter, the Director-General shall submit to the requested State Party a written request for a consultative meeting between staff of the Technical Secretariat and representatives of the requested State Party, which may include representatives of the facility concerned, in order to resolve the matter.

55. Upon receipt of such a request, the requested State Party shall make arrangements for the consultative meeting. The consultative meeting shall take place at any location agreed by the Director-General and the requested State Party. Wherever possible, the consultative meeting shall take place in the capital or at any other location on the territory of the requested State Party, beginning not later than 10 days after receipt of the request for such a meeting, and its duration shall not exceed 48 hours.

56. In cases where a State Party initiated the clarification procedures, the Director-General shall inform the requesting State Party of the outcome of the consultative meeting not later than 24 hours after the end of that meeting.

57. Information regarding on-going [or completed] [voluntary] clarification procedures (consultations) conducted pursuant to paragraphs 48 to 58 of this subsection, including requests for such consultations, and information resulting therefrom shall be restricted to the Technical Secretariat, the requested State Party, and, if applicable, the requesting State Party unless further release is expressly authorized by the requested State Party [without prejudice to the right of the requesting State Party to refer the issue to the Executive Council].

58. If a [voluntary clarification visit] is [requested] [offered], the Director-General shall provide the members of the Executive Council with such information on a confidential basis. In the event of a visit [request] [offer], information related to the [request] [offer] and information resulting from the [request or] visit shall be restricted to the members of the Executive Council, the Technical Secretariat, the requested State Party, and, if applicable, the requesting State Party unless further release is expressly authorized by the requested State Party. If an on-site activity occurs pursuant to the section, the final report of the visit shall only be distributed to the members of the Executive Council, the Technical Secretariat, the requested State Party, and, if applicable, the requesting State Party unless further release is expressly authorized by the requested State Party. Information that the requested State Party considers to be commercial proprietary information or national security information shall not be included in the final report.

[VOLUNTARY CLARIFICATION VISIT]

59. The visit shall be conducted in the least intrusive manner and shall [as far as possible] not affect or interrupt [in any way] the activities taking place in the facility. The inviting State Party and the visiting team shall cooperate with each other in the achievement of the objectives of the mandate.

Offering of a voluntary clarification visit

60. The requested State Party may, at its discretion and at any time during the clarification procedures or in cases where the concern has not been resolved through the process of consultation, clarification and cooperation pursuant to paragraphs 48 and 49 above, invite the Technical Secretariat to conduct a [voluntary clarification visit] to the [declared] facility in question which shall be conducted in accordance with the provisions set forth in paragraphs [59 to 101] [...], with a view to resolving satisfactorily and expeditiously any matter which has been raised pursuant to paragraphs 48 and 49 above.

61. The invitation to visit the [declared] facility shall be addressed to the Director-General in writing at any time during the consultations pursuant to paragraphs 53 to 58 above or as soon as possible [, but in no case later than seven days] after the completion of the consultative meeting pursuant to paragraph 55 above. The invitation shall be accompanied by an explanation for the invitation, the purpose of the proposed visit, the specific issue(s) to be clarified, [the location of the [declared] facility to be visited] [the location for the voluntary visit identified by geographic coordinates, and a diagram identifying and describing the specific place(s) and facility(ies) where the visit would occur].

[62. The Director-General shall ensure that the visit [request] [offer] is acceded to, if necessary by making adjustments in the overall programme of visits for that year. If in implementing the provisions of this paragraph, the Director-General encounters resource constraints, he/she shall report to the Executive Council which shall decide on how to proceed.]

[63. The Director-General shall handle the invitation in accordance with the provisions set out in paragraphs 5 to 9 of this subsection. The Director-General and the inviting State Party shall decide by mutual consent on the time of the visit taking into account the overall visit schedule. If consensus cannot be reached on the dates for the visit, every effort shall be made by the Director-General and the State Party to be visited to make the visit possible at the earliest possible opportunity.]

[64. In offering a visit, the inviting State Party shall ensure necessary access to the facility so as to enable the visiting team to fulfil its mandate. The voluntary visit shall be conducted according to the procedures set forth in paragraphs 59 to 101 of this subsection. The inviting State Party may, at its discretion, offer additional access and rights to the visiting team.]

65. The Director-General shall, in consultation with the inviting State Party, finalize any [additional] arrangements for the [voluntary clarification visit]. The requesting State Party shall be informed of the arrangements for the [voluntary clarification visit].

[66. In the event that a request for an investigation is submitted to the Director-General in connection with the same matter as a [voluntary clarification visit] invitation, the Director-General shall continue with the preparations for but not proceed with the voluntary visit, pending an Executive Council determination on the investigation request. If the Executive Council [decides against] [does not approve] the investigation request, then the [voluntary clarification visit] shall proceed.]

[67. If the requesting State Party considers that the consultative meeting has not resolved the matter and that all reasonable steps have been taken to clarify the matter, the Director-General shall submit a report to the Executive Council [for consideration and a decision on further action].

68. The requesting State Party, if applicable, shall submit any such proposal to the Director-General in writing within [7] days after the conclusion of the consultative meeting. Any such proposal shall include an explanation of why the requesting State Party considers that the previously-conducted clarification procedures have not resolved the matter.]

[Executive Council review

[69. If the Director-General has initiated a clarification process pursuant to paragraph 52 and considers that the consultative meeting has not resolved the matter, he/she shall submit a proposal to conduct a clarification visit within seven days after the conclusion of the consultative meeting. Any such proposal shall include an explanation of why the Director-General considers that the previously conducted clarification procedures have not resolved the matter. The Director-General shall then place the proposed visit on the agenda of the next regular Executive Council meeting for review and vote.]

70. The Director-General or the requesting State Party may refer the matter to the Executive Council only if all of the following conditions apply:

(a) If the Director-General or the requesting State Party consider that the consultative meeting has not resolved the matter; and

(b) If the requested State Party has not offered a voluntary clarification visit to resolve the matter.

71. The requesting State Party, if applicable, shall submit any such proposal to the Director-General in writing within seven days after the conclusion of the consultative meeting. Any such proposal shall include an explanation of why the requesting State Party considers that the previously-conducted clarification procedures have not resolved the matter.

72. If all of the conditions set out in paragraph 70 above apply, the Director-General shall request the requested State Party to offer a voluntary clarification visit within a specified time frame. He/she shall also submit a full report on the matter in writing to the Executive Council, including all relevant information pertaining to the implementation of the clarification procedures set out in this section.

73. If the requested State Party declines to offer a clarification visit, the Director-General shall inform the Executive Council which shall consider the matter at its next regular session and may decide, inter alia:

(a) That no further action is justified;

(b) To recommend further consultations with the requested State Party;

(d) To seek the assistance of other relevant international organizations in resolving the matter;

(e) To refer the matter to a special session of the Conference of States Parties;

(f) To request the requested State Party to offer a clarification visit within a specified time frame taking into account the specific circumstances of each case;

(g) By a ... majority of all its members present and voting, to initiate a clarification visit to be conducted according to the procedures set out in this section.

74. If not all of the conditions set out in paragraph 70 above apply, no further action under this section shall be taken, without prejudice to the rights of any State Party to pursue the matter through other relevant provisions of this Article.]

75. During the Executive Council’s consideration of the matter, the requested and, if applicable, the requesting State Party shall have the right to participate in the discussions [but shall not have the right to participate in any decision on further action].

Duration

76. The inviting State Party and the Director-General shall determine the duration of the visit, but in no case shall the duration exceed two days. The “period of visit” means the consecutive period of time from the arrival of the visiting team at the visited facility until the completion of their visit activities provided for in this section.

Equipment

[77. The visiting team shall only bring to the visited facility from the list of approved equipment, instant developing cameras, tape recorders, personal computers and protective equipment. Any other items of approved equipment may only be brought with the prior approval of the visited State Party. Any request for additional items of approved equipment shall be kept to the minimum necessary and shall be included in the notification. The visited State Party shall indicate its response in its acknowledgement of the notification.

78. Instant developing cameras and tape recorders shall only be used for collecting factual information for the visit report. The use of cameras shall be at the discretion of the visited State Party and such cameras shall only be operated by the representatives of the visited State Party. The use of additional items of approved equipment at the declared facility shall be with the agreement of the visited State Party.]

[77. The visiting team shall only bring to the visited facility equipment from the list of approved equipment. The items of approved equipment shall be kept to the minimum necessary and shall be included in the notification.

78. Any approved position-locating equipment shall be used only to confirm the location of the facility. Any approved photographic equipment and audio tape recording equipment shall be used only for collecting factual information for the visit report. The use of any approved photographic equipment shall be at the discretion of the visited State Party and such equipment shall only be operated by the representatives of the visited State Party. The use and disposition of audio tape recording equipment or any additional items from the appropriate approved equipment list at the declared facility shall be with the agreement of the visited State Party.]

Administrative arrangements

79. The visited State Party shall provide or arrange for the amenities necessary for the visiting team such as communication means, interpretation services to the extent necessary for the performance of interviewing and other tasks, in-country transportation, working space, lodging, meals and urgent medical care. The visited State Party may, to the extent possible, provide approved equipment on request to the visiting team. The visited State Party shall be reimbursed by the Organization for any assistance pursuant to this paragraph within 30 days after receipt of a detailed and validated claim from the visited State Party.

PRE-VISIT ACTIVITIES

Mandate

80. The Director-General shall issue a mandate for the visit which shall be limited to the clarification of the specific issue in the declaration of the requested State Party which was the subject of the prior consultations held pursuant to paragraphs 53 to 58 above. The mandate shall be included in the notification of the visit made by the Director-General. The mandate shall be made available to the representative of the State Party to be visited immediately upon the arrival of the visiting team at the point of entry. The mandate shall contain at least the following:

(a) The name of the visited State Party;

(b) The name of the host State Party, if applicable;

(d) The objectives of the visit and the possible means to resolve the issue related to the declaration of the requested State Party which was the subject of the consultative meeting pursuant to paragraphs 53 to 58 above;

(e) The names of the leader and other members of the visiting team;

(f) The list of approved equipment to be used during the visit pursuant to paragraphs 77 and 78 above;

(g) The declaration submitted by the facility.

Notification

81. The Director-General shall notify the State Party to be visited [and, if applicable, the host State Party,] confirming the visit not later than seven days in advance of the planned arrival of the visiting team at the point of entry. The notification shall include, inter alia:

(a) The name of the State Party to be visited;

(b) The name of the host State Party/State, if applicable;

(d) The purpose of the visit and the specific issue(s) to be clarified [as provided by the State Party to be visited in its invitation] [and the steps taken by the Director-General to resolve the matter];

(e) The point of entry;

(f) The means of arrival;

(g) The date and estimated time of arrival of the visiting team at the point of entry;

(h) The names of the leader and of the other members of the visiting team;

(i) The visit mandate.

82. The State Party to be visited shall acknowledge receipt of the notification not later than 48 hours after receipt of such notification. [The State Party shall confirm acceptance of the proposed dates for the visit or propose alternative dates occurring within [7] [...] days of the Director-General’s proposed visit date.] [If the dates suggested by the State Party to be visited cannot be met by the Director-General, the original dates shall be the dates of the visit.]

Appointment of visiting team

83. The Director-General shall appoint members of the visiting team from [among only the full-time personnel of] the Technical Secretariat designated in accordance with Annex C, section I, paragraph ..., taking into account the specific nature of the facility to be visited. Members of the visiting team shall be selected on as wide an equitable geographical basis as possible. The Director-General shall limit the size of the visiting team to the minimum necessary for the proper fulfilment of the mandate. In any event the team shall not exceed four members. No national of the requesting State Party, the visited State Party [or, if applicable, the host State Party] shall be a member of the visiting team.

Designation of visited State Party representatives

84. The State Party to be visited shall designate personnel to assist visited facility personnel prepare for and host the visiting team and to accompany the visiting team for the duration of the visit.

ACTIVITIES UPON ARRIVAL OF THE VISITING TEAM

Inspection of approved equipment

85. The visited State Party shall have the right to inspect the equipment of the visiting team to ensure that it is properly sealed, appears on the list of approved equipment, and conforms to the standards as set out in Annex C, section I, paragraph 40. The visited State Party may exclude equipment that does not conform to the provisions set out in Annex C, section I, paragraph 39, and paragraph 77 above and may retain them at the point of entry.

CONDUCT OF THE VISIT

86. The visiting team and the visited State Party shall cooperate with each other to fulfil the mandate while protecting the interests of the visited State Party.

[87. In this regard, the visited State Party shall:

(a) Provide access to the visiting team to the facility to be visited and sufficient access to fulfil its mandate within the visited facility. The nature and extent of access inside the facility shall be [at the discretion of] [negotiated between the visiting team and] the visited State Party;

(b) Allow the visiting team to conduct the activities, described in paragraph 93 of this subsection, proposed by the visiting team as necessary to fulfil its mandate;

88. The visiting team shall:

(c) Avoid unnecessarily hampering or delaying the operation of the facility. In particular, the visiting team shall not operate any facility equipment;

(d) Strictly observe established safety and working practices at the facility;

[(e) Provide the visited State Party with copies of all the information and data obtained during the course of the visit;]

(f) Have the right to state the relevance of questions asked by the visiting team and objected to by the visited State Party. The team leader may ask the visited State Party to reconsider its objection. The visiting team may note in the final report any refusal to permit interviews or to allow questions to be answered without any justification given for any such refusal by the visited State Party.]

[87. For activities conducted pursuant to paragraphs 92 and 93 below, the rights and obligations of the visiting team and the visited State Party shall be the same as those provided pursuant to the access provisions set forth in paragraphs 30 to 37 of section G of this Article.

88. The sole purpose of such activities shall be to clarify the specific issue related to the requested State Party’s declaration identified in the mandate.]

Briefing

89. Upon arrival at the facility to be visited, the visiting team shall be briefed by the facility representatives and/or the representatives of the visited State Party. The briefing shall include the scope and a general description of activities of the facility relevant to the issue(s) to be clarified as specified in the visit mandate, details of the physical layout and other relevant characteristics of the facility, including a map or sketch showing the relevant 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 or not related to the visit mandate. The briefing shall not exceed three hours.

90. The visited facility shall provide to the visiting team a written summary of the key points of the briefing. At their discretion, the visited facility may also provide in writing any additional information contained in the briefing. The visiting team may discuss with the visited State Party and the visited facility personnel the content of the briefing and any other information made available by the visited State Party and visited facility personnel.

91. The visited State Party may offer or the visiting team may request an orientation tour of areas within the facility relevant to the issue(s) to be clarified as specified in the visit mandate. The visiting team and the visited State Party shall discuss the arrangements for the tour. [All access during the tour shall be at the discretion of the visited State Party.] [The areas to be visited by the visiting team shall be determined by the visited State Party.] The orientation tour shall not exceed two hours.

92. After the briefing and any orientation tour, the visiting team shall, in consultation with the representatives of the visited State Party, prepare an initial visit plan and immediately make it available to the visited State Party. The visit plan shall specify the activities the visiting team proposes to carry out, including the specific areas of the facility to be visited and any proposals for the visiting team to subdivide. The visiting team may propose changes to the visit plan at any time to the visited State Party. Any changes to the visit plan made during the visit and any proposals for the visiting team to subdivide shall be agreed by the visited State Party.

93. One or more of the following activities may be conducted:

(a) Ask questions about the declaration relevant to the facility and on the issue to be clarified;

(b) [With their consent,] interview those individuals responsible, or their representatives, or other knowledgeable personnel in respect of the scientific, technical, medical, accounting or managerial activities upon which the information in the declaration [, relevant to the issue to be clarified,] is or should be based in order to facilitate the clarifying of the issue specified in the mandate. At the discretion of the visited State Party, the visiting team may interview other facility personnel who may be able to assist in clarifying the issue specified in the visit mandate. All interviews shall be conducted in the presence of representatives of the visited State Party, with the purpose of establishing relevant facts. The visiting team shall only request information and data which are necessary for the fulfilment of the visit mandate;

(c) Examine any documentation the visited State Party [may] [shall] provide in order to facilitate the clarifying of the issue specified in the mandate. The visited State Party shall endeavour to provide alternative means to clarify the issue described in the visit mandate if provision of any documentation is denied. [The visited State Party at its discretion may make arrangements to permit the visiting team to examine at the visited facility relevant documentation normally held in other locations];

(d) Visually observe parts of the facility as well as equipment, relevant to the mandate;

[(e) The visited State Party may [, at its own initiative or at the suggestion of the visiting team,] offer the visiting team, at any time during the visit, any other on-site activities which the visited State Party believes may assist the visiting team to fulfil its mandate;]

[(f) Sampling shall not be conducted unless offered by the visited State Party and visited facility personnel and deemed useful by the visiting team. Any mutually agreed sampling and analysis shall be performed by facility personnel in the presence of the visiting team and representatives of the visited State Party. The visiting team shall not seek to remove samples from the facility.]

[94. The visited State Party shall, at the request of the visiting team, make available documentation which in the judgement of the visited State Party and visiting team may help clarify the issue specified in the mandate. The nature and extent of any examination of such documentation shall be agreed between the visited State Party and the visiting team.]

[95. The visit plan shall be implemented after approval by the visited State Party.]

POST-VISIT ACTIVITIES

Debriefing and preliminary findings

96. Upon completion of the visit the visiting team shall meet with representatives of the visited State Party and the visited facility at the visited facility to review the preliminary findings of the visiting team and to clarify any remaining ambiguities. The visiting team shall provide to the visited State Party its preliminary findings in written form, together with a list and copies of documents and other material obtained, that it proposes, subject to the agreement of the visited State Party, to remove from the facility. The document shall not contain any information or data unrelated to the issue to be clarified as stated in the visit mandate. It shall, as a rule, not contain information or data identified as confidential by the visited State Party [and not related to the issue to be clarified as stated in the visit mandate]. The document shall be signed by the visiting team leader. In order to indicate that the visited State Party has reviewed the contents of the document, the visited State Party representative shall countersign it. This meeting shall be completed not later than 24 hours after completion of the visit.

Departure

97. On completion of the visit the visiting team shall depart from the territory of the visited State Party in the minimum time possible.

REPORT

Visit report

98. The visiting team shall prepare and process a draft report. The draft report shall be considered confidential. The draft report shall summarize the general activities undertaken during the visit and the factual findings of the visiting team. It shall only contain facts relevant to the clarification of the issue to be clarified as stated in the visit mandate. The draft report shall be submitted to the visited State Party not later than 14 days after the end of the visit. The visited State Party may submit to the visiting team any written comments on the draft report not later than 21 days after receipt of the draft report. In particular, it may identify any information and data which, in its view, should not be contained in the final version of the report, because it is considered to be not relevant to the issue to be clarified as stated in the visit mandate, or due to its confidential nature.

99. The visiting team shall consider any comments received from the visited State Party and incorporate those comments and, as a rule, remove any information and data as requested pursuant to paragraph 98 before submitting the draft final report to the Director-General and the visited State Party [and, if applicable, the requesting State Party] not later than seven days after receipt of such comments.

100. The visited State Party may submit further comments to the Director-General on the draft final report within 14 days after receipt of the draft final report. The Director-General shall annex any such comments to the draft final report, which together shall become the final report. The Director-General shall provide copies of the final report to the visited State Party and, if applicable, to the requesting State Party.

[101. The Director-General shall submit the final report to the Executive Council for its consideration only when the requesting State Party considers that the matter to be clarified has not been resolved.]

[101. The Director-General shall submit the final report to the Executive Council for its consideration when either:

(a) [The Director-General or, if applicable, the requesting State Party] consider that the matter to be clarified has not been resolved; or

(b) The clarification visit resulted from the provisions set forth in paragraph 73 above.

In all other cases, no further action shall be taken.]

[Executive Council review and decision on any follow-up action]

[102. The Executive Council shall, in accordance with its powers and functions, review the final report of the visiting team and consider and decide on whether [the matter to be clarified has been resolved or not] [there still exists an ambiguity, uncertainty, anomaly or omission in the declaration concerning any declared facility or activity of the visited State Party]. If the Executive Council reaches the conclusion that the matter has not been resolved and, in keeping with its powers and functions, that further action [may be] [is] necessary, it shall take appropriate measures to redress the situation, which may include requiring the visited State Party to take any necessary measures such as revision of, or addition to, the declaration concerned or submission of a new declaration and the time limit of fulfilment.

103. The Director-General shall inform the visited State Party of the outcome of the review of the report and on any decision on any subsequent measures pursuant to paragraph 102 as soon as possible. The visited State Party shall take the necessary measures as required by the Executive Council. If applicable, the Director-General shall also inform the requesting State Party of the outcome of the review of the report and on any decision on any subsequent measures pursuant to paragraph 102.]

[102. The Executive Council shall, in accordance with its powers and functions, review the final report of the visiting team. In keeping with its powers and functions, the Executive Council may, if it considers that further action may be necessary, agree upon appropriate measures to redress the situation, which may include making recommendations to the States Parties involved.

103. The Director-General shall inform the visited State Party of the outcome of the review of the report and on any recommendation on any subsequent measures pursuant to paragraph 102 as soon as possible. If applicable, the Director-General shall also inform the requesting State Party of the outcome of the review of the report and on any subsequent recommendations pursuant to paragraph 102.]

104. Each State Party may, through the Director-General, invite the Technical Secretariat to undertake a visit(s) to a facility(ies) on its territory or in any other place under its jurisdiction or control. In its invitation the State Party shall indicate the purpose(s) of the visit, which shall be to enhance transparency and promote confidence among States Parties, and [specify] one or more of the following:

(a) To obtain relevant technical assistance and information [as specified in Article III, section II, paragraph 11];

(b) To obtain any of the technical assistance and cooperation activities contained in programmes as specified in Article VII, section D, paragraph 19;

(c) To obtain from the Technical Secretariat technical advice or information on the implementation of the [declaration] obligations of this Protocol [with respect to specific facilities] [as specified in Article VII, section D, paragraph 20].

Invitations for visits

105. Each invitation for a voluntary assistance visit shall be addressed to the Director-General and shall be accompanied by an explanation for the invitation and the purpose(s) of the proposed visit. Invitations shall, wherever possible, be submitted by not later than 31 December each year to enable the Director-General to plan a visit programme for the subsequent year. On receipt of an invitation for such a visit, the Director-General shall include the visit in his/her schedule for visits for the following year in accordance with the provisions set out in paragraphs 5 to 9 of this subsection. If the number of invitations exceeds the ceiling prescribed in paragraphs 5 and 6 of this subsection, the Director-General shall report this to the Executive Council, together with recommendations on the priority of each visit in light of the information submitted by the State Party [, and other available relevant information] [for a decision on how to proceed].

[106. The Executive Council shall decide on the programme for the year including, if necessary, how to proceed if the number of invitations exceeds the overall ceiling provided for in this article.]

107. Any subsequent invitations for voluntary assistance visits to be conducted in the same year shall be considered in light of [the existing visit schedule,] [available resources] and the information provided in support of the invitation.

108. The Director-General shall issue a mandate for each visit which shall be written in cooperation with the State Party to be visited.

109. The visited State Party and the visiting team shall cooperate with each other in the achievement of the objectives of the mandate.

110. The detailed arrangements for, and contents of, a voluntary visit, such as size and composition of the visiting team, duration of the visit, and procedures upon arrival of the visiting team at the point of entry, shall be agreed beforehand between the Director-General and the State Party to be visited.

111. The costs of scheduled voluntary assistance visits incurred by the Technical Secretariat shall be borne by the Technical Secretariat. [The costs of voluntary assistance visits additional to those provided for in the initial schedule pursuant to paragraphs 5 and 6 shall be shared by the visited State Party and the Technical Secretariat.]

112. A visit report, prepared jointly by the visiting team in consultation and cooperation with the visited State Party, shall be submitted to the Director-General not later than 14 days after the completion of the visit. The Director-General shall submit the report to the Cooperation Committee for consideration.

III. MEASURES TO ENSURE SUBMISSION OF DECLARATIONS[34]

1. As soon as possible after the deadline for the submission of the initial or annual declarations specified in paragraph 3 of section D, subsection I, of this Article has passed, the Director-General shall issue a written request to States Parties which have not submitted all their declarations, as required in section D, subsection I, of this Article, to submit the required declarations and/or a written explanation of why the submission of the declarations is delayed. Such declarations and/or explanation shall be submitted as soon as possible after receipt of the request.

2. On receipt of such an explanation, the Director-General may offer to provide assistance in the preparation of declarations in accordance with paragraph 104 of Article III, section D, subsection II, and paragraph 20 of Article VII.[35]

3. The Director-General shall provide a report to each regular session of the Conference of the States Parties, to each regular session of the Executive Council, and to any special session, as appropriate, of the Executive Council, on the implementation of the declaration obligations set out in section D, subsection I, of this Article. The Director-General shall include in this report information relating to paragraphs 1 and 2 above.

[4. Notwithstanding the action taken by the Director-General specified in paragraphs 1 to 3 above, if any State Party has not submitted its

[initial or annual declarations by the expiry of a [6] month period following the relevant deadline for submission established under paragraph 3 of section D, subsection I, of this Article,]

[initial declarations by the expiry of a two year period, or its successive annual declarations by the expiry of a [6] month period, following the relevant deadline for submission established under paragraph 3 of section D, subsection I, of this Article,]

[the following provisions shall apply] [the Executive Council shall consider any explanations provided by the State Party and, if not satisfied, may decide whether to apply one or more of the following measures] until the Director-General confirms receipt of the declarations concerned:

[(a) The State Party shall have no vote in the Conference of the States Parties;]

[(b) The State Party shall not be eligible for election as a member of the Executive Council or, if already a member of the Executive Council, shall be suspended from membership;]

(c) The State Party may not invoke the declaration clarification procedure, as provided for in section D, subsection II, of this Article, or a facility investigation;

(d) The State Party may not request from the Technical Secretariat technical assistance under Article VII other than assistance in the preparation of declarations including the establishment and functioning of the National Authority;

(e) The State Party may not have access to the declarations of other States Parties;

(f) The State Party may not invoke those provisions on consultation, clarification and cooperation as provided for in section E of this Article which directly involve the Organization.]

[4. Notwithstanding the action taken by the Director-General specified in paragraphs 1 to 3 above, if any State Party has not submitted its initial or annual declarations by the expiry of a six month period following the relevant deadline for submission established under paragraph 3 of section D, subsection I, of this Article, the Executive Council shall consider any explanations provided by the State Party and, if not satisfied, may decide whether to apply one or more of the following measures until the Director-General confirms receipt of the declarations concerned:

(a) The State Party may not invoke the declaration clarification procedure, as provided for in section D, subsection II, of this Article, or a facility investigation;

(b) The State Party may not request from the Technical Secretariat technical assistance under Article VII other than assistance in the preparation of declarations including the establishment and functioning of the National Authority;

(d) The State Party may not invoke those provisions on consultation, clarification and cooperation as provided for in section E of this Article which directly involve the Organization.

4 bis If by the expiry of a [2] year period following the relevant deadline for submission established under paragraph 3 of section D, subsection I, of this Article, any State Party has not submitted its initial or annual declarations, the following provisions shall apply unless subsequently reviewed by the Conference, until the Director-General confirms receipt of the declarations concerned:

(a) The State Party shall have no vote in the Conference of the States Parties;

(b) The State Party shall not be eligible for election as a member of the Executive Council or, if already a member of the Executive Council, shall be suspended from membership.]

5. The Executive Council shall consider the operation of these provisions. The Executive Council may decide in light of the explanations submitted by the State Party concerned to suspend the operation of any of the measures in paragraph 4 above and specify a prescribed time frame for remedial action. The Executive Council shall keep the matter under review.

[6. The provisions of paragraph 4 above shall not be applied until the beginning of the second year after entry into force of this Protocol. For a State whose instrument of ratification or accession is deposited after the entry into force of this Protocol, the provisions of paragraph 4 above, if applicable, shall not be applied until the beginning of the second year after the Protocol enters into force for it.][36]

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E. CONSULTATION, CLARIFICATION AND COOPERATION

1. States Parties [shall] [may] without prejudice to their rights and obligations under Article V of the Convention, [and without prejudice to their right to request an investigation,] 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 obligations of this Protocol or the Convention. For these purposes, States Parties [shall] [prior to the submission of any request for an investigation, first make every effort to] [may] [without prejudice to their right to request an investigation,] follow, inter alia, one or more of the following procedures:

(a) Seek clarification from another State Party directly, or through the offices of a third State Party, or other appropriate international procedures. In the case of a written request for clarification, the requested State Party shall provide the clarification to the requesting State Party as soon as possible, but in any case not later than [15] [30] days after receipt of the request. The requesting and requested States Parties may, if they agree, keep the Executive 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 [15] [30] 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 Council and/or all other States Parties informed of the request and the basis for the request as well as the response;

(c) If the case is particularly serious, submit a written request for clarification concerning another State Party, together with information upon which the request is made, to the Executive Council which shall forward the request to the requested State Party through the Director-General not later than 24 hours after its receipt. The requested State Party shall provide the response to the Executive Council as soon as possible, but in any case not later than [15] [30] days after receipt of the request. The Executive Council shall take note of the response and forward it to the requesting State Party not later than 24 hours after its receipt. The Executive 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.

2. For the purposes of [considering the matter under paragraph 5 (a) or] obtaining further clarification [under paragraph 3], the Executive Council may call on the Director-General to:

(a) [Consult the Scientific Advisory Board and/or] establish [on the basis of equitable geographical distribution [if possible]] [a group of experts from the list of investigation personnel designated and approved in accordance with the procedures set out in Annex C, section I,] to examine all available information and data relevant to the situation causing concern. The [Scientific Advisory Board] [group of experts] shall submit a factual report to the Executive Council on its findings as soon as possible; and/or

[(b) In the case of a concern involving compliance with the declaration obligations of this Protocol, mandate the Technical Secretariat to carry out a visit for the sole purpose of resolving the concern. The visit shall be conducted according to the procedures for voluntary clarification visits set out in section D, subsection II, paragraphs ... to ... of this Article.]

3. If, following receipt of the clarification obtained pursuant to paragraph 1, the requesting State Party considers that the response does not resolve the concern, and that it needs to seek further clarification, or if it has not received the clarification within the times specified in paragraph 1, or if the requested State Party makes it clear to the requesting State Party, that it will not provide the requested clarification, the requesting State Party may request in writing, providing reasons why the clarification does not resolve the concern:

[(a) The Director-General to request the requested State Party to offer a voluntary clarification visit within a specified time frame; or]

(b) The Executive Council to obtain further clarification from the requested State Party or to obtain from the requested State Party the reasons as to why it has not provided the clarification as required under the provisions of this Article within the times specified in paragraph 1, or why the requested State Party will not provide the requested clarification; and/or

(c) A special session of the Executive Council in which States Parties involved that are not members of the Executive Council shall be entitled to take part. In such a special session the Executive Council shall consider the matter and may recommend to the States Parties involved any measure it deems appropriate to resolve the situation, [including the conduct of a clarification visit pursuant to the procedures set forth in paragraphs 76 to 94 in section D, subsection II of this Article][37] [in accordance with Articles V, IX or XII].

4. If the concern of a State Party about possible non-compliance has not been resolved within 60 days after the submission of the request for clarification to the Executive Council, and if the State Party believes its concern warrants urgent consideration, it may request in writing a special session of the Conference of States Parties in accordance with Article IX, paragraph 12 (c). At such a special session, the Conference shall consider the matter and may recommend any measure it deems appropriate to resolve the situation [in accordance] [consistent] with Article V.

5. The requested State Party may [, at its discretion and] at any time during the consultation, clarification and cooperation process or simultaneously with providing its response in accordance with paragraph 1:

(a) Request the Executive Council to consider the matter on the basis of the information which was made available in the request as well as on information which has been made available by the requested State Party, and, if appropriate, also on the basis of information received from the Technical Secretariat based on the declarations submitted by the States Parties [and any other relevant information which it has acquired in the performance of its functions as [specified in] [mandated in accordance with] Articles VII and IX [and consistent with the provisions of Article I]];

(b) Invite the Director-General to send a visiting team to conduct a [voluntary clarification] visit at the [declared] facility [of which there is a concern that it should have been declared,] in order to resolve the concern. Such a visit shall be conducted in accordance with the procedures for voluntary clarification visits set out in Article III, section D, subsection II, paragraphs ... to ... .

6. If requested by all the States Parties concerned, other States Parties or relevant international organizations may undertake to assist in clarifying or resolving matters related to a concern about non-compliance which has been raised as a matter for consultation, clarification and cooperation.

7. Nothing in the above arrangements shall prejudice States Parties’ rights to arrange by mutual consent for any procedures among themselves.

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[F. [MEASURES TO STRENGTHEN THE IMPLEMENTATION OF ARTICLE III]

[(A) TRANSFERS]

[1. States Parties shall undertake all necessary measures to ensure that obligations under Article III of the Convention are implemented fully and effectively, consistent with the objectives and purposes of the Convention, in particular Article X. These measures shall be implemented in a manner that does not hinder or hamper the peaceful economic or technological development of States Parties. The provisions of Article III of the Convention shall not be used to impose restrictions and/or limitations on transfers for peaceful purposes of biological agents, toxins, scientific knowledge, equipment and materials consistent with the objectives and purposes of the Convention. Transfers to non-States Parties to the Convention shall be prohibited, subject to the exceptions in paragraphs ... below.]

[2. In accordance with Article III of the Convention, no State Party shall authorize transfers to any recipient whatsoever unless that State Party has, where appropriate, assured itself that such transfers will only be for prophylactic, protective or other peaceful purposes.]

[2. In accordance with Article III of the Convention, States Parties shall authorize transfers to any recipient only for prophylactic, protective or other peaceful purposes.]

[2. No State Party shall authorize transfers of items listed below to any recipient whatsoever, unless such transfers are consistent with the guidelines in paragraphs ... below.

Listed items

[(a) Fermenters or bioreactors designed to prevent the release of aerosols with a total internal volume of 100 litres or more;

[(b) Equipment designed for use in aerobiology:

(i) Chambers designed for the dissemination and study of aerosols containing microorganisms or toxins;

(ii) Equipment designed to generate aerosols;

(iii) Analytical equipment designed to determine the size of aerosol particles up to 20 microns in diameter;

[(b) Aerosol chambers designed for the dissemination and study of aerosols containing microorganisms or toxins;

(c) Equipment designed for the use in experimental aerobiology studies to generate aerosol particles up to 20 microns in diameter that contain microorganisms or toxins;

(d) Aerosol analytical equipment designed to determine the size of aerosol particles up to 20 microns in diameter that contain microorganisms or toxins.]]]

3. In pursuance of paragraph 2, recognizing that most of the biological agents, toxins, equipment and technologies may be of a dual-use nature, and with the objective of preventing such items from being utilized for purposes prohibited by the Convention, the guidelines [for authorizing] [regarding] any such transfers shall be as follows:

[(a) Each State Party shall require that any request pursuant to the Convention for authorizing the transfer of a [specific] [listed] item that could be used both for prophylactic, protective and other peaceful purposes, and for purposes prohibited by the Convention, hereafter referred to as a dual-use item, shall be accompanied by information on end-use, quantity or size required, location for proposed use, quantity to be produced at the location, place where intended to be stored, and end-use certificate;]

[(b) Any request for transfer or procurement of equipment envisaged to be declared under CBMs, for use by a State Party in a BL4 facility, including details of its proposed application and the site/facility for intended use, shall be intimated to the Organization;

(c) Any transfer of technology related to means of delivery, aerosol dispersion of toxins and pathogens, stabilization of agents/toxins to environmental stress shall be intimated to the Organization;

(d) Transfer of agents, equipment and material shall not be allowed to non-States Parties [without prior approval of the Organization];]

[(e) Each State Party shall [, for any request made for the authorization of a transfer,] take into account, as appropriate, the stated end-use of the transfer and any supporting information, the nature and implementation in the requesting State Party/State of measures [specified in paragraph 11 of this section] [to comply with the purposes of the Convention], and the extent to which these measures are effective in fulfilling the [obligations of Articles III and IV] [purposes] of the Convention.]

[4. No transfer of microbial or other biological agents or toxins, whatever their origin or method of production, or equipment or material [which is capable of using such agents or toxins] for purposes which would contravene Article I [or III] of the Convention, shall be [allowed to non-States Parties of the Convention [and the Protocol]] [authorized].][38]

[5. In implementation of Article III, each State Party undertakes to refrain from applying restrictions to other States Parties, in contravention of its commitments to Article X of the Convention, which might hamper their access to biological material, equipment and technology.]

[(B) NOTIFICATIONS]

[Notification prior to transfers]

[Notification after transfers]

6. In order to promote transparency and to enhance confidence-building among States Parties, each State Party shall, according to the standardized formats for reporting international transfers contained in Appendix H, notify the Technical Secretariat annually of [aggregated exports [and imports]] [any exports and aggregated imports] of the following equipment [, agents and toxins] which have been completed for prophylactic, protective or other peaceful purposes, during the previous calendar year:

(a) Fermenters or bioreactors designed to prevent the release of aerosols with a total internal volume of 100 litres or more for which the end-use indicated by the State Party requesting the transfer is use in a maximum biological containment laboratory or facility;

(b) Chambers designed for aerosol challenge testing with microorganisms or toxins, and having a capacity of one cubic metre or more.

[7. Following submission of the national reports pursuant to paragraph 6 above, States Parties may, if they deem it appropriate, consult and exchange further information on an ad hoc basis, in order to improve clarity and avoid discrepancies in the data and information reported.]

[8. Information submitted pursuant to paragraph 6 above shall be made available to States Parties on request.]

9. Each State Party shall, in accordance with its national constitutional and/or legislative procedures, review and, if necessary, amend or establish any legislation, regulatory and/or administrative provisions to regulate the transfer of agents, toxins, equipment and technologies relevant to the Convention in accordance with its obligations under the Convention and this Protocol. [National legislation, regulatory and/or administrative provisions shall be reviewed, amended or adopted, as necessary, in accordance with Article VII, subparagraph 6 (c).] [The States Parties undertake to refrain from establishing new discriminatory ad hoc export control regimes and to invalidate the existing ones.]

[10. (a) To ensure compliance with Article III of the Convention, 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, [if that State Party has determined that these will be used] solely for prophylactic, protective or other peaceful purposes.

(b) (i) Each State Party shall report to the Organization on the national laws and regulations it has adopted to implement Article III of the Convention 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 Convention not later than ... days after the entry into force of this Protocol for that State Party and whenever an amendment thereto is made.

[(c) Each State Party, in implementing these measures, shall ensure that they do not impede the peaceful economic and technological development of States.]]

[11. Each State Party shall notify the Technical Secretariat on the national laws, regulations and administrative measures it has adopted to implement Articles III and IV of the Convention not later than 180 days after entry into force of this Protocol for that State Party. Each State Party shall submit to the Technical Secretariat annually any modifications or additions made to such national laws, regulations and administrative measures during the previous calendar year.]

[12. Transfer guidelines

(a) [The provisions of the Protocol shall not be used to impose] [and States Parties shall not maintain among themselves] restrictions and/or limitations on the transfer of scientific knowledge, technology, equipment and materials for purposes not prohibited under the Convention.

(b) In order to promote transparency in the biological trade, the States Parties may agree on arrangements for exchanging the end-user certificate related to biological exports in a manner that will entail no restrictions or impediments on access to biological materials, equipment or technological information by all States Parties. This would replace all existing ad hoc regulations in the biological trade at the time of entry into force of the Protocol for States Parties.

(c) An end-user certificate may be required from the recipients stating, in relation to the transferred biological agents or toxins and equipment (to be identified as relevant by the Ad Hoc Group), the following:

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

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

(iii) Their types and quantities;

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

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

(d) States Parties shall resolve suspicions arising from such transfers through the process of consultation and clarification in accordance with Article V of the Convention.]

[Settlement of disputes arising as a result of denial of transfers

13. If a State Party is denied a transfer or transfers for reasons which it considers are inconsistent with the provisions of the Convention and Article VII of the Protocol, it shall have the right to seek the measures contained in subparagraphs (a) to (k).

(a) A requesting State Party may initiate consultation and clarification procedures in order to establish that the transfer in question is not intended for purposes prohibited under the Convention. A requesting State Party may seek clarifications bilaterally from the requested State Party or it may submit its request in writing to the Director-General to seek clarification on its behalf. In the case of a request for consultations and clarifications through the Director-General, upon receipt of such a request, the Director-General shall submit a written request to the requested State Party.

(b) If a request for consultations and clarifications is made pursuant to subparagraph (a) above, the requested State Party shall provide its reply within 15 days of the date of its receipt of the request. If the requested State Party fails to respond to the request for providing a clarification either directly or through the Director-General, the requesting State Party may proceed to bring the case to the attention of the Executive Council which shall consider ways and means of resolving the situation through the process of consultations and clarifications within 60 days.

(c) In cases where consultations have been initiated but fail to resolve the situation within 60 days after the date of receipt of the request, the requesting State Party may bring the issue to the attention of the Executive Council.

(d) The requesting State Party or the requested State Party may indicate the means of good offices, conciliation or mediation including by the Director-General as procedures deemed appropriate for resolving the situation. These procedures may be undertaken if the requesting and requested States Parties so agree. They may be commenced or terminated at any time.

(e) If good offices, conciliation or mediation fail to resolve the situation within 30 days, the requesting State Party may bring the issue to the attention of the Executive Council.

(f) If neither the consultations, nor good offices, conciliation and mediation resolved the situation, the requesting State Party may opt for a panel for dispute settlement to be established. The Director-General shall, within 10 days from the date of request, establish the panel and appoint the panelists. The Director-General shall consult the requesting and requested States Parties regarding the composition of the panel. The panel shall be composed of three panelists unless the parties to the dispute agree to a panel composed of five panelists.

(g) The panelists shall be duly qualified and competent, composed of well-qualified governmental and/or non-governmental individuals. Panelists shall be selected with a view to ensuring their independence, sufficiently diverse background and experience.

(h) Citizens of States Parties which are parties to the dispute shall not serve on a panel concerned with that dispute, unless the parties to the dispute agree otherwise. To assist in the selection of panelists, the Director-General shall maintain a list of governmental and non-governmental individuals possessing necessary qualifications from which panelists may be drawn as appropriate.

(i) Panelists shall serve in their individual capacities and not as representatives of States Parties, nor as representatives of any organizations. States Parties shall therefore not give them instructions or seek to influence them.

(j) The panel shall make an objective assessment of the matter before it, based on the facts of the case and the applicability of and their conformity with the relevant provisions of the Convention and the Protocol. The panel shall consult, regularly with the States Parties to the dispute and shall provide 60 days to the parties to the dispute to prepare their submissions. The panel proceedings shall be confidential. The panel shall decide on its rulings and recommendations by a majority of the panelists. The panel shall submit its findings in a written report to the Director-General and the Executive Council not later than six months from the date of its establishment. The opinions expressed in the panel report by individual panelists shall be anonymous.

(k) The States Parties to the dispute shall abide by the rulings or recommendations of the panel. In case of failure to abide by the rulings or recommendations of the panel, the situation shall be redressed and compliance ensured in accordance with the provisions of Article V of this Protocol.]]

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G. INVESTIGATIONS

(A) TYPES OF INVESTIGATIONS

1. Each State Party shall have the right to request an investigation which shall be carried out for the sole purpose of determining the facts relating to a specific concern about possible non-compliance with the Convention by any other State Party.

2. Each State Party shall be under the obligation to keep all requests within the scope of the Convention and refrain from unfounded or abusive requests.

3. The requesting State Party shall specify in each request which one of the following types of investigations it is seeking:

(a) Investigations to be conducted in geographic areas where [the release of, or] exposure of humans, animals or plants to microbial or other biological agents and/or toxins has given rise to a concern about possible non-compliance under Article I of the Convention or alleged use of biological weapons, hereinafter referred to as “field investigations”;

(b) Investigations of alleged breaches of obligations under Article I of the Convention, to be conducted inside the perimeter of a particular facility at which there is a substantiated concern that it is involved in activities prohibited by Article I of the Convention, hereinafter referred to as “facility investigations”;

[(c) Investigations where there is a concern that a transfer has taken place in violation of Article III of the Convention.]

(B) OUTBREAKS OF DISEASE

[Exclusion of all outbreaks of disease which are due to natural causes]

4. All outbreaks of disease which are due to natural causes do not pose a compliance concern under the Convention and shall not be a reason for an investigation of a non-compliance concern.

5. Nothing in this Protocol shall prejudice the right of a State Party to investigate, as per its national regulations, outbreaks of disease which occur on its territory or in any place under its jurisdiction or control, or if it so wishes, with the assistance of other State(s) and/or relevant international organizations.

Investigation of a concern that an outbreak of disease is directly related to activities prohibited by the Convention

6. If a State Party has a concern that an outbreak of disease is directly related to activities prohibited by the Convention, it shall have the right to request a field investigation to address the non-compliance concern. In accordance with the requirements of Annex C, section II, paragraphs 1 and 2, such request shall contain detailed evidence, and other information, and analysis substantiating why, in its view, it considers the outbreak of disease not to be naturally occurring and directly related to activities prohibited by the Convention. [Reports coming from the mass media cannot be considered as evidence.] [Information from private persons cannot be the sole evidence on the basis of which the request shall be made.]

7. The Executive Council shall not [consider a request for] [authorize] a field investigation of an outbreak of disease, unless it determines that there is a basis for concern substantiated by detailed evidence, and other information, and analysis that the outbreak(s) of disease, is not naturally occurring and is directly related to activities prohibited by the Convention. The Executive Council, if it deems it appropriate for its [consideration] [authorization] of the above request, shall also request from the most relevant international organization(s) such as, but not limited to, the WHO, OIE, FAO, all available information in its/their possession, that may be relevant to the outbreak. When a State Party requests a field investigation of an outbreak(s) of disease on the territory or in any place under the jurisdiction or control of another State Party, the State Party where the investigation is proposed to occur shall have the right to provide evidence, and other information, and analysis that indicates that the outbreak of disease is naturally occurring or otherwise unrelated to activities prohibited by the Convention. If deemed appropriate by the Executive Council as a matter of procedure under Article IX, paragraph 30, other State(s) Party(ies) may also provide information relevant to whether the outbreak(s) of disease is naturally occurring and/or whether it is related to activities prohibited by the Convention. All of the evidence, and other information, and analysis submitted, shall be taken into account by the Executive Council in its consideration of the investigation request in accordance with the request procedures of paragraphs 13 to 28 of this section of Article III.

[(C) ALLEGED USE OF A BIOLOGICAL WEAPON

8. A State Party has a right to request a field investigation of an alleged use of a biological weapon if it believes that a biological weapon was used against it on the territory under its jurisdiction and control.]

[Unusual outbreaks of disease

9. The diseases which are endemic in the region and present the expected epidemiological features shall not be considered as an unusual outbreak of disease. An outbreak of disease which appears to be unusual, shall be investigated by the affected State Party, as per guidelines set out in Annex C, section V, and concluded as soon as possible.][39]

(D) CONSULTATION, CLARIFICATION AND COOPERATION

10. States Parties [shall] [may], without prejudice to their right to request an investigation, and [first make every effort to] prior to the submission of any request for an investigation [first make full use of and] follow the relevant procedures set out in section E of this Article on consultation, clarification and cooperation in order to clarify and resolve satisfactorily any matter which may cause concern about possible non-compliance with the obligations of the Convention.

(E) INITIATION OF INVESTIGATIONS

11. An investigation may be requested to be conducted on the territory of a State Party, or in any other place under its jurisdiction or control, regardless of the form of ownership of the facility or the area subject to the investigation, in accordance with the provisions of this Protocol. The receiving State Party means the State Party on whose territory or in any other place under whose jurisdiction or control an investigation is proposed, taking place or has been completed. In the specific case where an investigation is proposed, taking place or has been completed on the territory of a State Party/State, but in a place under the jurisdiction or control of another State Party/State, the former State Party/State shall not be the “receiving State Party”, but shall be defined as the “host State Party/State of an investigation”.

12. An investigation may also be requested to be conducted in any place on the territory of a non-State Party which is under its jurisdiction or control, if any State Party has a concern(s) that another State Party, which shall be identified in the request, is the alleged cause of the non-compliance concern. Upon receipt of such a request, the Director-General shall immediately contact the non-State Party concerned to seek:

(a) Its consent to the conduct of the investigation; and, subject to such consent

(b) Its agreement that the provisions of this Protocol governing the conduct of investigations shall apply to the investigation or, alternatively, its agreement to different procedures for the conduct of the investigation which the Director-General is satisfied would enable the facts relating to the specific concern about non-compliance raised in the request to be determined.

The Director-General shall inform the Executive Council and the requesting State Party of the outcome of such consultations as soon as possible.

13. Requests for investigations to be conducted in accordance with this Protocol shall be submitted in writing by the requesting State Party to the Executive Council and at the same time to the Director-General for processing in accordance with procedures as set out in paragraphs 20 to 29 of this section.

[14. If, during the course of a field investigation, the investigation team has acquired information (as a result of the conduct of the activities specified in Annex C, section II, subsection D) indicating that a facility on the territory or in any other place under the jurisdiction or control of a State Party, is directly relevant to the alleged non-compliance concern that has been identified in the field investigation mandate, the investigation team leader shall provide a factual statement of the information and a factual description of how the information was obtained to the receiving State Party. The receiving State Party may within ... comment on the factual statement. The investigation team leader shall then submit the factual statement, description of how the information was obtained and the comments of the receiving State Party to the Executive Council through the Director-General.

15. Upon receipt of the information, the Executive Council shall provide the information to the receiving State Party, the requesting State Party, and, if appropriate, the State Party on whose territory or under whose jurisdiction or control the facility in question is located. Only these States Parties may submit a request for a facility investigation which involves this information. Such request shall be considered in accordance with the provisions contained in paragraphs 10 to 13 and 18 to 21 of this section.

16. The Executive Council’s consideration of the information or any request for a facility investigation received from a State Party which received its information in accordance with paragraph 15 above and any decision made thereon shall be conducted in accordance with the provisions set out in paragraphs 20 to 28 of this section.

17. If the Executive Council decides that a facility investigation must be conducted, the investigation shall be conducted in accordance with the provisions for facility investigations set out