AD HOC GROUP OF THE STATES PARTIES

AD HOC GROUP OF THE STATES PARTIES

TO THE CONVENTION ON THE PROHIBITION

OF THE DEVELOPMENT, PRODUCTION AND BWC/AD HOC GROUP/52 (Part I)

STOCKPILING OF BACTERIOLOGICAL 11 August 2000

(BIOLOGICAL) AND TOXIN WEAPONS

AND ON THEIR DESTRUCTION Original: ENGLISH

Twentieth session

Geneva, 10 July - 4 August 2000

PROCEDURAL REPORT OF THE AD HOC GROUP OF THE

STATES PARTIES TO THE CONVENTION ON THE PROHIBITION

OF THE DEVELOPMENT, PRODUCTION AND STOCKPILING OF

BACTERIOLOGICAL (BIOLOGICAL) AND TOXIN WEAPONS

AND ON THEIR DESTRUCTION

PART I

1. The Ad Hoc Group of States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction held its twentieth session at the Palais des Nations, Geneva from 10 July to 4 August 2000, in accordance with the decision taken at its seventeenth session. The Group held 31 meetings during that period under the chairmanship of Ambassador Tibor Tóth of Hungary. Ambassador Leslie Luck of Australia and Ambassador Juan Enrique Vega Patri of Chile served as Vice-Chairmen of the Group. Ms. Silvana F. da Silva, Senior Political Affairs Officer, and Mr. Vladimir Bogomolov, Political Affairs Officer, both of the Department for Disarmament Affairs, served, respectively, as Secretary and Deputy-Secretary of the Group.

2. At the twentieth session, the following States Parties to the Convention participated in the work of the Ad Hoc Group:

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran (Islamic Republic of), Ireland, Italy, Japan, Libyan Arab Jamahiriya, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Kingdom of Great Britain and Northern Ireland, and United States of America. The following signatory State to the Convention also participated in the work of the Group: Morocco.

3. At the 1st meeting, the Ad Hoc Group decided to continue its consideration of Agenda Item 9 entitled "Strengthening of the Convention in accordance with the mandate as it is contained in the Final Report of the Special Conference of the States Parties of the Biological Weapons Convention" (BWC/SPCONF/1, September 1994).

4. At the twentieth session, the Chairman of the Ad Hoc Group was assisted by Friends of the Chair in his consultations and negotiations on particular issues, as follows:

Preamble

- Mr. Malik Azhar Ellahi (Pakistan)

General Provisions

- Ambassador Hubert de La Fortelle (France)

Definitions of Terms and Objective Criteria

- Dr. Ali A. Mohammadi (Islamic Republic of Iran)

Measures to Promote Compliance

- Ambassador Ian Soutar (United Kingdom of Great Britain

and Northern Ireland)

Investigations

- Mr. Peter Goosen (South Africa)

Confidentiality Issues

- Ambassador Dr. Günther Seibert (Germany)

Legal Issues

- Ambassador Leslie Luck (Australia)

National Implementation and Assistance

- Mr. Ajit Kumar (India)

Measures Related to Article X

- Mr. Antonio de Aguiar Patriota (Brazil)

Declaration Formats

- Dr. Anthony Phillips (United Kingdom of Great Britain and Northern Ireland)

Seat of the Organization

- Ambassador Seiichiro Noboru (Japan)

5. Out of the 40 meetings available to the Ad Hoc Group in accordance with the programme of work, 3 1/6 meetings were devoted to plenary meetings.

6. In accordance with the programme of work, the Group devoted 1 1/2 meetings to “Preamble”; 1/2 of a meeting to “General Provisions”; 5 1/2 meetings to “Definitions of Terms and Objective Criteria”; 4 2/3 meetings to “Measures to Promote Compliance”; 4 2/3 meetings to “Investigations”; 2/3 of a meeting to “Confidentiality Issues”; 2/3 of a meeting to “Legal Issues”; 1/2 of a meeting to “National Implementation and Assistance”; 5 meetings to “Measures Related to Article X”; 4 meetings to “Declaration Formats”; and 1/6 of a meeting to “Seat of the Organization”. The Friends of the Chair were assisted by Mr. Vladimir Bogomolov, and by Ms. Iris Hunger and Mr. Jeremy Littlewood, Professional Assistants.

7. The results of the discussions are attached to this report (Annex I). In addition to the statement of the Chairman that the positions of delegations are not prejudiced by this paper, individual brackets have been introduced to cover specific preliminary concerns of delegations and it is recognized that further and detailed consideration of all elements will be required at future sessions.

8. Proposals for future consideration from the Chairman and Friends of the Chair on the respective parts of the Rolling Text regarding the work undertaken in the respective areas are attached to this report (Annex V) without prejudice to the positions of delegations. It was reaffirmed that the Rolling Text is the only basis for negotiations in the Ad Hoc Group.

9. Throughout the four weeks of the twentieth session, the Chairman conducted a series of bilateral consultations with representatives of States Parties participating in the work of the Ad Hoc Group. The consultations focussed on issues in the Rolling Text on which there were strong conceptual differences in views. The consultations were aimed at a conceptual exploration of possible future solutions in the following areas: Investigations; Compliance Measures and Objective Criteria; Transfers; Cooperation; Legal Issues and Issues related to the Organization. The Chairman reported verbally to the Ad Hoc Group on a weekly basis on his bilateral consultations. At the end of the session the Chairman provided an overall oral summary regarding those consultations.

10. In addition to the documents presented at its previous sessions, the Ad Hoc Group had before it 12 working papers. These are listed in Annex IV.

11. Further to its recommendations at the seventeenth session on the programme of work for 2000, the Ad Hoc Group decided to hold its twenty-first session in the period of 20 November to 8 December 2000.

12. The Ad Hoc Group considered and adopted the Indicative Programme of Work for the twenty-first session to be held from

20 November to 8 December 2000 (Annex III).

ARTICLE XV DURATION AND WITHDRAWAL

ARTICLE XVI STATUS OF THE ANNEXES AND APPENDICES

ARTICLE XVII SIGNATURE

ARTICLE XVIII RATIFICATION

ARTICLE XIX ACCESSION

ARTICLE XX ENTRY INTO FORCE

ARTICLE XXI RESERVATIONS

ARTICLE XXII DEPOSITARY/IES

ARTICLE XXIII AUTHENTIC TEXTS

ANNEXES

A. DECLARATIONS

I. LISTS AND CRITERIA (AGENTS AND TOXINS)

II. LIST OF EQUIPMENT

III. [THRESHOLDS]

IV. PROGRAMMES AND FACILITIES

V. DECLARATION FORMATS

B. [VISITS]

C. [MEASURES TO STRENGTHEN THE

IMPLEMENTATION OF ARTICLE III]

D. INVESTIGATIONS

I. GENERAL PROVISIONS

II. FIELD INVESTIGATIONS

III. FACILITY INVESTIGATIONS

[IV. [INVESTIGATIONS WHERE THERE IS A CONCERN

THAT A TRANSFER HAS TAKEN PLACE IN

VIOLATION OF ARTICLE III OF THE CONVENTION]]

[V. INVESTIGATIONS OF NATURAL AND UNUSUAL

OUTBREAKS OF DISEASE]

E. CONFIDENTIALITY PROVISIONS

I. GENERAL PRINCIPLES FOR THE HANDLING

OF CONFIDENTIAL INFORMATION

PREAMBLE ¹

The States Parties to this Protocol,

(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) Determined to implement all the provisions of the Convention in a comprehensive and balanced manner,

(7) Reaffirming that the full and effective implementation of the Convention is essential for maintaining and enhancing regional and international peace and security and [stressing its benefits for] promoting international development,]

[(6+7) Determined to implement all the provisions of the Convention in a comprehensive and balanced manner in order to maintain and enhance regional and international peace and security and promote international development,]

(8) 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,

[(9) Determined to achieve effective progress toward the prohibition and [complete] [to accomplish the total] elimination of all types of weapons of mass destruction,

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

[(9+10) 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,]

(11) 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,

(12) 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,

[(13) 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,]

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

[(15) 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,]

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

(17) 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,

(18) 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],

[(19) 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,]

(20+8) 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,²

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

Have agreed as follows:

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.]

[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, each State Party shall have the right to protect commercial and proprietary information and national security information.]

[5. 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.]³

[6. Without prejudice to the provisions on confidentiality, the relevant organs of the Organization shall be entitled to information available with the Secretariat if it is considered that such information is necessary for the performance of functions entrusted to those organs.]⁴

[7. In assuming the responsibilities and obligations under the Protocol, States Parties shall not enact national legislation the provisions of which are incompatible with the provisions of the Protocol.]

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

[1 bis This Protocol [,being supplementary to the Convention,] 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.]⁵

[2 bis To enhance confidence in the continued compliance with the Convention 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 routinely provided to States Parties and to the relevant organs of the Organization in accordance with the provisions of this Protocol.]

[3 bis The measures set out in this Protocol shall be implemented in a manner to ensure full protection of commercial proprietary information and national security information. To this end, they shall be carried out in the least intrusive manner consistent with the fulfilment of their objectives pursuant to 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 not to engage in activities prohibited under the Convention.]

[4 bis Each State Party to this Protocol shall, in accordance with its constitutional and legal processes, adopt the necessary measures to implement its obligations under this Protocol.]

[5 bis 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.]

[6 bis This Protocol, being supplementary to the Convention, shall not be interpreted as in any way modifying or amending the Convention, or limiting or detracting from the rights and obligations assumed by any State under the Convention.]]

ARTICLE II

[DEFINITIONS⁶

[CATEGORY I: FOR THE PURPOSES OF THIS PROTOCOL:]⁷

[1. Bacteriological (biological) and toxin weapons⁸ 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.]]

[2. Biological agents 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.

For the purpose of implementing this Protocol, a list of biological agents [relevant to declarations] is contained in Annex A.]

[3. Toxin 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.

For the purpose of implementing this Protocol, a list of toxins [relevant to declarations] is contained in Annex A.]

[4. Hostile purposes mean

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

[4 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, [moral] or other kind of damage;

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

[5. Purposes not prohibited by the Convention 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.]

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

6. Facility⁹ means

Any [room(s),] laboratory(ies), buildings, or parts of buildings, or other structures [either at a fixed location or mobile] which [can be or] is (are) [to be] used to conduct activity(ies) [in the field of biotechnology] [related to the Convention]. Such a facility may have an identifiable boundary and/or a single operational control.

7. [Site means

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

[8. The receiving or visited State Party and the host State Party

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”.]¹⁰

[CATEGORY II: DEFINITIONS FOR THE PURPOSES OF ARTICLE III, SECTION D ON DECLARATIONS AND DECLARATION FORMATS:]

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

Programme and/or activities 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.]

[9 bis Programme in legal conformance with the national legislation or activities designed to detect, assess, prevent, reduce or neutralize the impact of biological or toxin weapons on humans, animals or plants.]

[9 ter Programme and/or activities [involving research and/or 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.]

[10. Biological defence facility¹² means

Facility which works in a biological defence programme and/or activities (against biological and toxin weapons).]

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

Any room or suite of rooms, laboratory(ies) or other buildings or structures with the following features:

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

Any room or suite of rooms, laboratory(ies) or other buildings or structures with the following features:

(a) Designed or 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, as follows:

(i) An airlock system for a complete change of clothing and a shower on exit;

(ii) A pass-through autoclave system;

(iii) For work with human or zoonotic pathogens, a Class III biological safety cabinet and/or self-contained positive-pressure ventilated suits and a special chemical decontamination shower for leaving the containment area;

(iv) Collection and decontamination of hand washing and shower water;

(v) HEPA filtration of incoming air;

(vi) For work with animal pathogens Class I, II or III biological safety cabinets.]

[12 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 pathogens or zoonoses, 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.]

[13. 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 are of economic importance to a specific area endangered thereby, and not yet present there, or present but not widely distributed and which are also 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.]

14. Diagnostic facility¹³ 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.

15. Genetic modification¹⁴ 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.

16. Primary production containment¹⁵ 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, transfers to another system, and final discharge of exhaust gases, effluents and wastes, 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.]

17. Vaccine means

Preparations, 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 generally efficient and safe for human beings and/or animals].

18. Production¹⁶ means

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

19. Aerobiology means

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

[20. Simulants of biological agents and toxins mean

Substances of biological, chemical or other origin which, due to their characteristics are used for research on the properties of biological agents or toxins.]

21. Plant inoculant means

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

22. Biocontrol agent¹⁷ 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.]

[CATEGORY III]¹⁸

The following definitions of terms relating to other specific measures can be moved to the appropriate sections of the Protocol after discussion.

23. 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 D, section I, paragraphs 34 and 35.

24. Perimeter means

In case of facility investigation, the boundary around facility[(ies)], 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 D, 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 D, 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 D, section III, part C.

25. 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.

[26.¹⁹ Threshold quantity for listed biological agent or toxin means

A minimum quantity of listed biological agent or toxin handled and stored at a specified type of facility on the territory of a State Party that needs to be notified and justified to the Organization by the State Party concerned. The justification of such quantity means incorporating all necessary data to explain that amount of materials containing biological agent or toxin is required for protective or other peaceful purposes.

For the purpose of implementing this Protocol threshold quantities of listed biological agents and toxins for specific types of facilities and different State Parties to the Protocol are contained in Annex A.]]

ARTICLE III

COMPLIANCE MEASURES

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

[1. 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 V.

2. The Conference of States Parties shall, taking into account scientific and technical achievements and in accordance with the criteria contained in Annex A, section I, examine proposals whereby microbiological or other biological agents and toxins are to be included in or excluded from the lists, and shall take a decision thereon.]

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 V.

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.]

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 V, 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

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 180²³ 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. 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

5. 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

6. 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. 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 5 and 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 ¼ 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:²⁴

(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 12/12 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 13 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;]²⁵

[(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.]²⁶

[(L) DECLARATIONS ON THE IMPLEMENTATION OF ARTICLE X OF THE CONVENTION AND ARTICLE VII OF THE PROTOCOL²⁷

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 REGULATIONS²⁸

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 DISEASE²⁹

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 E of this Protocol copies of the initial and/or annual declarations of other States Parties, as specified in the request. The Director-General shall simultaneously inform the 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) Enhancing transparency of [declared] [biodefence and BL4] facilities and activities;

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

(c) 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 facilities³⁰

[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.]

[12.³¹ 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 [1] [3] 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 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.

17. [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.]

[16. The visiting team shall bring to the visited facility only items from the appropriate list of approved equipment. The use and disposition of equipment during the visit shall be at the discretion of the visited State Party.

17. If required, the visited State Party shall provide protective equipment meeting the specifications of items from the appropriate 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 appropriate 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] [2] [7] [30] working 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 [12 hours] [24 hours] [two days] 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 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 D, 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 D, section I, paragraph 35. The visited State Party may exclude items of equipment that do not conform to the provisions set out in Annex D, 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 35 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 paragraphs 34 and 35 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. 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 visit plan, any changes to it during the course of the visit and any proposals for the visiting team to subdivide, need to be agreed by the visited State Party.]

35. [After the briefing and the tour,] the visiting team may propose to conduct one or more of the following activities:

(a) Review and discuss with facility personnel the declaration and the information contained in the briefing 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 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] [with facility personnel in a position to do so, any specific factual points upon which the information in the declaration is based, with the purpose of establishing relevant facts]. 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 which 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) The visited State Party may [, at its own initiative or at the suggestion of the visiting team, offer] [suggest to] 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) The visited State Party may extend additional cooperation to the visiting team, at any time during the visit, if it believes it helpful in fulfilling the mandate.]

[36. Once agreed by the visited State Party, the visit plan shall be implemented.]

37. 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

38. 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

39. 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

40. 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.

41. 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

42. 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.

REPORTS³²

Draft report

43. 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 an account of the degree and nature of access and the cooperation provided by the visited State Party in order to fulfil the visit mandate.]

44. 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.

45. 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

46. The final report shall be the draft report adjusted by the visiting team in accordance with paragraph 45. 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].]

47. 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

48. 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

[49. 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].]

[50. 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.]

[51. 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.]

52. 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 103 and 104 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 103 and 104 of this subsection are implemented.

53. Upon receipt of a request pursuant to paragraph 49 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

54. 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.

55. 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.

56. 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.

57. 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.

58. Information regarding on-going [or completed] [voluntary] clarification procedures (consultations) conducted pursuant to paragraphs 49 to 59 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].

59. 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]

60. 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

61. 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 49 and 50 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 [60 to 102] [...], with a view to resolving satisfactorily and expeditiously any matter which has been raised pursuant to paragraphs 49 and 50 above.

62. 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 54 to 59 above or as soon as possible [, but in no case later than seven days] after the completion of the consultative meeting pursuant to paragraph 56 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].

[63. 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.]

[64. 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.]

[65. 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 60 to 102 of this subsection. The inviting State Party may, at its discretion, offer additional access and rights to the visiting team.]

66. 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].

[67. 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.]

[68. 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].

69. 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

[70. If the Director-General has initiated a clarification process pursuant to paragraph 53 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.]

71. 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.

72. 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.

73. If all of the conditions set out in paragraph 71 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.

74. 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.

75. If not all of the conditions set out in paragraph 71 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.]

76. 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

77. 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

[78. 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.

79. 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.]

[78. 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.

79. 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

80. 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

81. 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 54 to 59 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 54 to 59 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 78 and 79 above;

(g) The declaration submitted by the facility.

Notification

82. 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.

83. 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

84. 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 D, 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

85. 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.

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