BWC/AD HOC GROUP/CRP.8

3 April 2001

PROTOCOL TO THE CONVENTION ON THE PROHIBITION OF THE DEVELOPMENT, PRODUCTION AND STOCKPILING OF BACTERIOLOGICAL (Biological) AND TOXIN WEAPONS AND ON THEIR DESTRUCTION

Contents

PREAMBLE

ARTICLE 1 GENERAL PROVISIONS

ARTICLE 2 DEFINITIONS

ARTICLE 3 LISTS AND CRITERIA, EQUIPMENT AND THRESHOLDS

ARTICLE 4 DECLARATIONS

ARTICLE 5 MEASURES TO ENSURE THE SUBMISSION OF DECLARATIONS

ARTICLE 6 FOLLOW-UP AFTER SUBMISSION OF DECLARATIONS

ARTICLE 7 MEASURES TO STRENGTHEN THE IMPLEMENTATION OF ARTICLE III OF THE CONVENTION

ARTICLE 8 CONSULTATION, CLARIFICATION AND COOPERATION

ARTICLE 9 INVESTIGATIONS

ARTICLE 10 ADDITIONAL PROVISIONS ON DECLARATIONS, VISITS AND INVESTIGATIONS

ARTICLE 11 CONFIDENTIALITY PROVISIONS

ARTICLE 12 MEASURES TO REDRESS A SITUATION AND TO ENSURE COMPLIANCE

ARTICLE 13 ASSISTANCE AND PROTECTION AGAINST BACTERIOLOGICAL (BIOLOGICAL) AND TOXIN WEAPONS

ARTICLE 14 SCIENTIFIC AND TECHNOLOGICAL EXCHANGE FOR PEACEFUL PURPOSES AND TECHNICAL CO-OPERATION

ARTICLE 15 CONFIDENCE-BUILDING MEASURES

ARTICLE 16 THE ORGANISATION

ARTICLE 17 NATIONAL IMPLEMENTATION MEASURES

ARTICLE 18 RELATIONSHIP OF THE PROTOCOL TO THE CONVENTION

ARTICLE 19 SETTLEMENT OF DISPUTES

ARTICLE 20 REVIEW OF THE PROTOCOL

ARTICLE 21 AMENDMENTS

ARTICLE 22 DURATION AND WITHDRAWAL

ARTICLE 23 STATUS OF THE ANNEXES AND APPENDICES

ARTICLE 24 SIGNATURE

ARTICLE 25 RATIFICATION

ARTICLE 26 ACCESSION

ARTICLE 27 ENTRY INTO FORCE

ARTICLE 28 RESERVATIONS

ARTICLE 29 DEPOSITARY

ARTICLE 30 AUTHENTIC TEXTS

ANNEXES

ANNEX ON LISTS (ANNEX A)

ANNEX ON INVESTIGATIONS (ANNEX B)

ANNEX ON CONFIDENTIALITY PROVISIONS (ANNEX C)

APPENDICES

APPENDIX A DECLARATIONS OF OFFENSIVE AND/OR DEFENSIVE BIOLOGICAL AND TOXIN PROGRAMMES AND/OR ACTIVITIES CONDUCTED PRIOR TO ENTRY INTO

FORCE OF THE CONVENTION/PROTOCOL FOR EACH STATE PARTY

APPENDIX B DECLARATION OF CURRENT NATIONAL BIOLOGICAL DEFENCE PROGRAMMES AND/OR ACTIVITIES

APPENDIX C DECLARATION FORMAT FOR FACILITIES DECLARED IN ACCORDANCE WITH ARTICLE 4 (6)

APPENDIX D DECLARATION FORMAT FOR FACILITIES DECLARED IN ACCORDANCE WITH ARTICLE 4 (8) TO (14)

APPENDIX E LISTING OF FACILITIES IN ACCORDANCE WITH ARTICLE 4 (7)

APPENDIX F LISTING OF FACILITIES IN ACCORDANCE WITH ARTICLE 4 (15)

APPENDIX G FACILITIES EXISTING ON THE TERRITORY OF A STATE PARTY BUT FALLING UNDER THE JURISDICTION OR CONTROL OF ANOTHER STATE PARTY/STATE

APPENDIX H INFORMATION TO BE PROVIDED IN THE DECLARATIONS REQUIRED UNDER ARTICLE 14 (33)

APPENDIX I FORMAT FOR REPORTING INTERNATIONAL TRANSFERS OF EQUIPMENT

PREAMBLE

The States Parties to this Protocol,

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,

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,

Emphasising that the principles and objectives of, and obligations assumed under, the Geneva Protocol of 1925 and the Convention represent an unequivocal determination for the sake of all humankind to exclude completely the possibility of microbial and other biological agents, and toxins being used as weapons,

Stressing the importance of the Final Declarations of the successive Review Conferences of the Convention, and emphasising 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,

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

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,

Determined to accomplish the total elimination of all weapons of mass destruction,

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

Welcoming the entry into force on 27 April 1997 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,

Recognising 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,

Determined to ensure that all achievements in this field are used exclusively for the benefit of humankind,

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 organisation to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in Article I of the Convention,

Desiring to promote international co-operation and exchange of microbial and other 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 to the Protocol,

Emphasising 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, microbial and other biological agents and toxins for peaceful purposes which have vastly increased the potential for co-operation between States to help to promote economic and social development, and scientific and technological progress,

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 significant benefits in terms of international security and development,

Determined to strengthen and improve the effective implementation of the Convention,

Have agreed as follows:

ARTICLE 1

GENERAL PROVISIONS

1. The purpose of this Protocol shall be to strengthen the effectiveness, and to improve the implementation, of the Convention through the measures set out herein. Each State Party to this Protocol, reaffirming its obligations under the Convention, undertakes to fulfil the provisions contained herein.

2. In implementing this Protocol States Parties shall have the right to protect commercial proprietary information and national security information in accordance with the provisions of this Protocol. This right may not be invoked by a State Party to conceal evasion of its obligations or to engage in activities prohibited under the Convention.

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

4. To enhance confidence in compliance with the Convention and the Protocol by all States Parties, information about the implementation of the measures set out in this Protocol shall be provided to States Parties and to the relevant organs and subsidiary organs of the Organisation in the performance of their functions, in accordance with the provisions of this Protocol.

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

6. In implementing the provisions of this Protocol, the States Parties and the Director-General shall, when appropriate, take into account existing agreements and competencies of other relevant international organisations and agencies as well as the activities of States Parties in order to avoid duplication and to ensure an effective and co-ordinated use of resources.

7. The definitions of terms and objective criteria, which are an integral part of this Protocol, shall be used solely for the application of the specific measures set out in this Protocol.

ARTICLE 2

DEFINITIONS

1. Aerobiology means

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

2. Approved equipment means

The devices and instruments necessary for the performance of the duties of a visiting or an investigation team as approved by the First and subsequent Conferences of States Parties in accordance with provisions contained in Annex B (34) and (35).

3. Bacteriological (biological) and toxin weapons means

(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.

4. Biocontrol agent means

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

5. Biological materials means

Liquid, dry or paste-like products containing any of the agents or toxins listed in Annex A, which are intended for the assessment of the means and methods of defence against bacteriological (biological) and toxin weapons, excluding culture collections of microbial organisms, at facilities declared in accordance with Article 4 (6).

6. Conference means

The Conference of States Parties established in accordance with Article 16.

7. Director-General means

The Director-General of the Technical Secretariat, appointed in accordance with Article 16.

8. Facility means

(a) For the purposes of declarations in accordance with Article 4, and follow-up after submission of declarations in accordance with Article 6:

Any room or suite of rooms, laboratory(ies), building(s), structure(s) or parts of a building(s) or other structures which is or are used to conduct activity(ies) as specified in Article 4. Such a facility may have an identifiable boundary and/or a single operational control;

(b) For the purposes of facility investigations in accordance with Article 9:

The buildings, parts of buildings or other structures within the final perimeter.

9. Genetic modification means

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

10. High biological containment means

Any room or suite of rooms, laboratory(ies), building, structure or parts of a building or other structure:

(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 World Health Organisation 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 Organisation Internationale des Epizootics during its 66th General Session, 1998; or

(b) Having characteristics consistent with the guidelines specified in the 1993 World Health Organisation Laboratory Biosafety Manual for BL-3 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 sterilisation, incineration or other physical or chemical means.

11. Maximum biological containment means

Any room or suite of rooms, laboratory(ies), building, structure or parts of a building or other structure:

(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 World Health Organisation 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 Organisation Internationale des Epizootics during its 66th General Session, 1998; or

(b) Having characteristics consistent with the guidelines specified for high biological containment and the additional requirements specified in the 1993 World Health Organisation Laboratory Biosafety Manual for BL-4, having the following features:

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

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

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

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

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

12. National biological defence programme(s) and/or activities against bacteriological (biological) and toxin weapons means

Any programmes and/or activities, carried out and/or directed or funded by, or on behalf of, a State Party, specifically designed to protect or defend humans, animals or plants, against the use of microbial or other biological agents or toxins for hostile purposes or in armed conflict, or to detect or assess the impact of such use.

13. Organisation means

The Organisation for the Prohibition of Bacteriological (Biological) and Toxin Weapons established in accordance with Article 16.

14. Perimeter means

In case of a facility investigation, the boundary around a facility defined by either geographic co-ordinates 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 B (126);

(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 B (138) and (139);

(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 B (140) to (144).

15. Plant inoculant means

Any formulation containing a pure or predetermined mixture of micro-organisms that alter the properties of plants or crops.

16. Plant pathogen containment means

Any room or suite of rooms, laboratory(ies), building, structure or parts of a building or other structure specifically designed and used to handle and work with plant pathogens and pests that pose a high risk of infection or propagation to a plant population that is of economic importance and endangered thereby, and which are also 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, exhaust air sterilised by HEPA filtration, incineration, or other physical or chemical means. Decontamination of all waste is achieved by a suitable chemical or physical process before exhausting into a public or communal system.

17. Point of entry/point of exit means

A location designated by the State Party in accordance with this Protocol for the in-country arrival of an investigation or visiting team or for its departure after completion of its mission.

18. Primary production containment means

Features in any system of equipment for the production of microbial or other biological agents or toxins, that are designed to separate the production process from the environment thereby preventing release that could compromise the health of workers or cause harm to the product or the environment.

19. Production, for the purposes of declarations, means

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

20. Purposes not prohibited by the Convention means

Prophylactic, protective or other peaceful purposes in accordance with Article I of the Convention.

18. Receiving State Party, visited State Party, the host State Party, and the host State not Party to this Protocol mean

(a) The receiving State Party is the State Party on whose territory or in any other place under whose jurisdiction or control an investigation is proposed, is taking place or has been completed.

(b) The visited State Party is the State Party on whose territory or in any other place under whose jurisdiction or control a visit is proposed, is taking place or has been completed.

(c) The host State Party is the State Party on whose territory lies the facility or area in a place under the jurisdiction or control of another State Party or State not party to this Protocol.

(d) The host State is the State not party to this Protocol, on whose territory lies the facility or area in a place under the jurisdiction or control of a State Party or another State not party to this Protocol.

In the specific case where an investigation or a visit is proposed, is taking place or has been completed on the territory of a host State Party or host State not party to this Protocol, but in a place under the jurisdiction or control of another State Party, the latter State Party shall be the receiving or visited State Party.

22. Simulants of biological agents and toxins mean

Chemicals or micro-organisms used to mimic one or more properties of microbial or other biological agents or toxins in experimental studies.

23. Site means

The location and the integration of one or more facilities to be declared in accordance with Article 4 (6) (c) within a geographically and/or physically defined area which may have an identifiable boundary and which cannot be smaller than a building.

24. Vaccine means

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

ARTICLE 3

LISTS AND CRITERIA, EQUIPMENT AND THRESHOLDS

A. LIST OF AGENTS AND TOXINS

1. The list of agents and toxins in Annex A is for use in conjunction with Article 2 (5), Article 4 (9) and (11), Article 6 (33) (g), Annex B (161) and Appendices A to D.

2. The list is not exhaustive. It does not exclude the relevance for the Protocol either of unlisted microbial or of other biological agents or toxins, which potentially can be used as weapons or as vectors used deliberately to spread disease.

Review and modification of the list

3. Any State Party may propose modifications to the list. The Executive Council shall review such proposed modifications to the list of agents and toxins. Any changes to the list shall be made in accordance with Article 21 (4) and (5).

4. In reviewing and/or modifying the list of agents and toxins, the Executive Council shall consider, inter alia, the following:

(a) The criteria which were taken into account for development of the list of agents and toxins:

(i) Agents or toxins known to have been developed, produced or used as weapons;

(ii) Agents or toxins which have severe public health and/or socio-economic effects;

(iii) High morbidity, incapacity and/or mortality rates;

(iv) Low infective/toxic dose;

(v) High level of transmissibility and/or contagiousness;

(vi) Low effective or low cost-effective prophylaxis, protection or treatment available;

(vii) Ease of production and/or dissemination;

(viii) Stability in the environment;

(ix) Short incubation period and/or difficult to diagnose/identify at an early stage.

(b) Scientific and technological developments that may affect the potential of individual agents or toxins for use as weapons;

(c) Effects of potential inclusion or exclusion of an agent or toxin in the list on scientific and technological research and development.

B. LIST OF EQUIPMENT

5. Each State Party shall supply all the information required concerning equipment specified in Annex A which is present at or used in a facility declared in accordance with Article 4 (6), (8) to (14) and Appendices C and D.

6. The list of equipment specified in Annex A may also be used in accordance with Annex B (159) and (160).

7. Review of, and amendment to, the list shall be conducted in accordance with Article 21 (4) and (5).

C. annual and Current transparency threshold levels

8. In order to enhance transparency, each State Party shall provide in the annual declaration on facilities declared in accordance with Article 4 (6) quantitative data on annual and current transparency threshold levels relating to the presence and quantity of biological materials as defined in Article 2 (5).

9. The dry material equivalents of biological materials shall be calculated either as the actual amounts of dry, purified agent or toxin in such materials, or as follows:

(a) For bacterial or fungal agents listed in Annex A, the dry material equivalent in grams may be regarded as equivalent to the volume of culture produced, in litres, before any concentration of agent;

(b) For other agents listed in Annex A, the dry material equivalent in milligrams may be regarded as equivalent to the volume of culture produced, in litres, before any concentration of agent.

Annual transparency thresholds

10. The annual transparency thresholds for a facility represent the aggregate quantities of all biological materials present at such a facility during the previous calendar year, to be declared in the facility declaration in accordance with Appendix C. They shall be expressed in terms of dry material equivalents, in ranges as specified in paragraph 11.

11. Ranges in accordance with paragraph 10:

(a) Biological materials as an aggregate for agents listed in Annex A, in six ranges: up to 10 grams, 10-50 grams, 50-100 grams, 100-250 grams; 250-500 grams, 500-1000 grams;

(b) Biological materials as an aggregate for toxins listed in Annex A, in three ranges: up to 10 grams, 10-25 grams, 25-100 grams.

12. The modalities for declaring the annual transparency threshold levels shall be as follows:

(a) A nil declaration shall be provided if no biological materials were present at the facility during the previous calendar year;

(b) The first annual declaration for a facility shall specify the ranges within which fall the respective aggregate quantities of biological materials present at that facility during the previous calendar year, and shall contain information concerning the work which required the presence of such quantities at the facility;

(c) If in any calendar year, none of the annual transparency thresholds declared exceeded those declared for the preceding calendar year, additional information concerning the work which required the presence of such quantities of biological materials at the facility shall not be required in the annual declaration;

(d) If in any calendar year, any of the annual transparency thresholds declared exceeded the relevant threshold declared for the preceding calendar year, the annual declaration shall also contain information concerning the work which required the presence of such a quantity(ies) of biological materials at the facility.

(e) If, in any calendar year, the respective aggregate quantities of biological materials present at the facility exceeded any of the highest ranges identified in paragraph 11, this fact shall be recorded in the annual declaration together with information concerning the work which required the presence of such a quantity of biological materials at the facility.

Current transparency thresholds

13. The current transparency thresholds for a facility represent the highest aggregate quantities of biological materials present at the facility at any particular time in the calendar year, to be declared in the facility declaration in accordance with Appendix C. They shall be expressed in terms of dry material equivalents, in ranges as specified in paragraph 14.

14. Ranges in accordance with paragraph 13 shall be as follows:

(a) Biological materials as an aggregate for agents listed in Annex A, in four ranges: up to 10 grams, 10-25 grams, 25-50 grams, 50-100 grams;

(b) Biological materials as an aggregate for toxins listed in Annex A, in two ranges: up to 5 grams, 5-10 grams.

15. The modalities for declaring the current transparency threshold levels shall be as follows:

(a) A nil declaration shall be provided if no biological materials were present at the facility at any time during the previous calendar year;

(b) The first annual declaration for a facility shall specify the ranges within which fall the respective highest quantities of biological materials present at the facility at any time during the previous calendar year, and shall contain information concerning the work which required the presence of such quantities at the facility;

(c) If at any time during the calendar year the highest aggregate quantity of all biological materials did not exceed the current transparency threshold level, additional information concerning the work which requires the presence of such a quantity of biological materials shall not be required in the annual declaration;

(d) If at any time during the calendar year the highest aggregate quantity of all biological materials exceeded the current transparency threshold level declared in any of the ranges, additional information concerning the work which requires the presence of such a quantity of aggregate biological materials shall be provided in the annual declaration;

(e) If at any time during the calendar year, the highest aggregate quantity of all biological materials exceeded by more than one range the current transparency threshold level declared in any of the ranges, the Director-General shall be notified of such an increase within five days. Such a notification shall contain both the new range and information concerning the work that required the presence of such a quantity of biological materials. The new current transparency threshold level, as well as the information concerning the work which required the presence of such a quantity of biological materials, shall be subsequently declared in the annual declaration.

16. The annual and current transparency threshold levels shall:

(a) Be fully consistent with Article I of the Convention. The types and quantities of biological materials present at such facilities shall be in conformity with the provisions of Article I of the Convention;

(b) Not be considered a prohibitive measure;

(d) Provide additional information, which may be used in the course of on-site activities, but not limit, in any way, their scope and procedures, including the right of an investigation team to seek and receive clarification and/or justifications for the presence of biological materials at a facility.

ARTICLE 4

DECLARATIONS

A. SUBMISSION OF DECLARATIONS

1. Each State Party shall declare to the Organisation, 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, except cases as provided for in Article 10, during the period specified.

2. Each State Party shall complete in full in accordance with the appropriate format in the Appendices, and submit to the Organisation all declarations to be submitted in accordance with paragraph 1, not later than 180 days after this Protocol enters into force for the State Party and, in addition, in the case of annual declarations, not later than 30 April of each successive year thereafter.

B. INITIAL DECLARATIONS

Offensive biological and toxin programmes and/or activities conducted prior to entry into force of the Protocol for each State Party

3. Each State Party shall declare, in accordance with paragraphs 1 and 2, whether at any time in the period between 1 January 1946 and entry into force of the Convention for that State Party, it has developed, produced, stockpiled or otherwise acquired or retained, and whether, during the same period, it has used:

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

In its declaration each State Party shall provide a narrative statement summarising offensive biological and toxin programmes and/or activities for the period between 1 January 1946 and entry into force of the Convention for that State Party as well as the other information specified in Appendix A. Each State Party shall also provide information as specified in Appendix A on facilities which produced microbial or other biological agents or toxins which were weaponised or stockpiled, and on any use of such weapons in the period 10 years prior to entry into force of the Convention for that State Party.

4. Each State Party shall declare any information that subsequently comes to its notice that would have been required to have been declared in accordance with paragraph 3 had such information been known when the Protocol entered into force for that State Party, not later than 180 days after such information is discovered.

National biological defence programme(s) and/or activities against bacteriological (biological) and toxin weapons conducted prior to entry into force of the Protocol for each State Party

5. Each State Party shall declare, in accordance with paragraphs 1 and 2, whether at any time 10 years before entry into force of the Protocol for it, it has conducted national biological defence programme(s) and/or activities.

C. ANNUAL DECLARATIONS

National biological defence programme(s) and/or activities against bacteriological (biological) and toxin weapons conducted during the previous year

6. Each State Party shall declare, in accordance with paragraphs 1 and 2, whether at any time in the previous calendar year it has conducted national biological defence programme(s) and/or activities. If so, it shall declare:

(a) A summary of the general objectives and main elements of any such programme(s) and/or activities;

(b) A summary of the research and development conducted as part of such programme(s) and/or activities on prophylaxis, pathogenicity, virulence, diagnostic techniques, detection, aerobiology, medical treatment, toxinology, physical protection and decontamination, and aerobiological testing and evaluation;

(i) All facilities conducting research and development on pathogenicity, virulence, aerobiology or toxinology at any site at which 15 or more technical and scientific person years of effort or 15 or more technical and scientific personnel were engaged on such research and development as part of the national biological defence programme(s) and/or activities;

(ii) If fewer than 10 facilities are declared in accordance with subparagraph (c) (i), a State Party shall declare the largest facilities, measured in terms of whichever criterion (technical and scientific person years of effort, number of technical and scientific personnel employed or level of financial resources expended) it selects, representing 80 per cent of the national biological defence programme(s) and/or activities devoted to research and development on pathogenicity, virulence, aerobiology or toxinology.

7. If no facilities are declared in accordance with paragraph 6 (c) each State Party shall, in accordance with paragraphs 1 and 2, list and provide general information on all of its facilities, at which more than two technical and scientific person years of effort, or two technical and scientific personnel were employed, conducting research and development involving experimental work in the areas identified in paragraph 6 (b) as part of the national biological biodefence programme(s) and/or activities. Where a State Party has three or more facilities subject to listing in accordance with this paragraph, it shall declare the largest facility measured in terms of which ever criterion (technical and scientific person years of effort, number of technical and scientific personnel employed or level of financial resources expended) it selects, and list the remainder. Listed facilities shall not be subject to randomly-selected transparency visits in accordance with Article 6 (3) (b).

Maximum biological containment

8. Each State Party shall declare, in accordance with paragraphs 1 and 2, each facility which, during the previous calendar year, was designated as a maximum biological containment facility as defined in Article 2 (11).

High biological containment

9. Each State Party shall declare, in accordance with paragraphs 1 and 2, each facility which, during the previous calendar year, was designated as a high biological containment facility as defined in Article 2 (10), where the floor area of the working area, excluding changing and shower areas, under a continuous system of high biological containment exceeds 100 m²and any of the following activities was conducted:

(a) Production of vaccines as specified in paragraph 12;

(b) Production as specified in parahgraphs 13 to 15;

(c) Insertion of any nucleic acid sequence(s) into, or other intentional modification of the nucleic acid of, an agent listed in Annex A or an organism producing a toxin listed in Annex A, for the purpose of creating a novel or genetically modified agent, organism or toxin; or to enhance the production of a toxin or its toxic sub-units as specified in paragraph 11 (b);

(d) Insertion of a nucleic acid sequence from any agent, or coding for any toxin listed in Annex A, or coding for a toxic sub-unit of such a toxin, into an organism for the purpose of creating a novel or genetically modified organism with increased disease causing or toxic properties characteristic of one or more agents or toxins listed in Annex A, or to enhance the production of any such toxin or its toxic sub-units specified in paragraph 11 (c).

Plant pathogen containment

10. Each State Party shall declare, in accordance with paragraphs 1 and 2, each facility which, during the previous calendar year, was designated as a plant pathogen containment facility as defined in Article 2 (16) where the floor area of the working area, excluding changing and shower areas, under a continuous system of plant pathogen containment exceeds 100 m².

Work with listed agents and/or toxins

11. Each State Party shall declare, in accordance with paragraphs 1 and 2, each facility which, during the previous calendar year, conducted any of the following activities with agents and/or toxins listed in Annex A:

(a) Production and recovery of one or more agent(s) and/or toxin(s) listed in Annex A, using:

(i) Any fermenter/bioreactor with a total internal volume of 50 litres or more; or

(ii) Any continuous or perfusion fermenter/bioreactor with a flow rate capable of exceeding two litres an hour; or

(iii) Any chemical reaction vessel or equipment used for recovery with a total internal volume of 50 litres or more; or

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

(v) More than 1,000 litres of tissue culture or other growth media on an annual basis;

(b) Insertion of any nucleic acid sequence(s) into, or other intentional modification of the nucleic acid of, an agent listed in Annex A or an organism producing a toxin listed in Annex A, for the purpose of creating a novel or genetically modified agent, organism or toxin; or to enhance the production of a toxin or its toxic sub-units ;

(c) Insertion of a nucleic acid sequence from any agent, or coding for any toxin listed in Annex A, or coding for a toxic sub-unit of such toxin, into an organism for the purpose of creating a novel or genetically modified organism with increased disease causing or toxic properties characteristic of one or more agents or toxin listed in Annex A, or to enhance the production of any such toxin or its toxic sub-units;

(d) Intentional aerosolisation of any agent and/or toxin listed in Annex A in or by:

(i) An explosive aerosol test chamber; or

(ii) Any other aerosol text chamber that has a total internal volume exceeding 5 m³; or

(iii) Open air, other than for the purposes of routine vaccination or routine agricultural application of biocontrol agents or plant inoculants; or

(iv) Application of aerosolised particles to the respiratory tract of a significant number of animals per year, where the significant number is greater than 100 of any single species of rodent, or greater than five of any other mammalian species including non-human primates.

Production facilities

12. Each State Party shall declare, in accordance with paragraphs 1 and 2, each facility which, during the previous calendar year, with primary production containment or high biological containment produced with the use of fermenters and/or bioreactors, embryonated eggs or other means, with or without recovery by concentration or isolation, micro-organisms or substances causing a specific and protective immune response as an ingredient of:

(a) Any vaccine for humans 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 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.

13. Each State Party shall declare, in accordance with paragraphs 1 and 2, each facility which, during the previous calendar year, produced and recovered any micro-organism (other than for food or beverages for humans or as a waste or by-product) or microbially produced diagnostic reagent for public sale, using one of the following:

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

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

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

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

14. Each State Party shall declare, in accordance with paragraphs 1 and 2, each facility which, during the previous calendar year, produced and recovered any biocontrol agent (as defined in Article 2 (4)) or any plant inoculant (as defined in Article 2 (15)) using one of the following:

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

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

(d) More than 10,000 litres of other growth media annually.

15. Each State Party shall, in accordance with paragraphs 1 and 2, list and provide general information on all of its facilities unless otherwise declared under this Article which, during the previous calendar year, produced for public sale microbially produced substances (other than for food or beverages for humans, or as a waste or by-product), whether or not chemically modified, using one of the following:

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

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

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

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

The first Review Conference shall decide whether such facilities should become subject to randomly-selected transparency visits, taking into account the experience gained from the implementation of randomly-selected transparency visits, and fulfilment of the objectives of the Protocol.

ARTICLE 5

MEASURES TO ENSURE SUBMISSION OF DECLARATIONS

1. As soon as possible after the deadline for the submission of the initial or annual declarations specified in Article 4 (2) has passed, the Director-General shall issue a written request to States Parties which have not submitted all their declarations, as required by Article 4, to submit the required declarations and/or a written explanation of why the submission of the declarations is delayed. Such declarations and/or written explanation shall be submitted as soon as possible after receipt of the request.

2. On receipt of such an explanation, the Director-General may offer assistance in the preparation of declarations in accordance with Article 6 (49) (c), and Article 14 (24) (b).

3. The Director-General shall provide a report to each regular session of the Conference of the States Parties, to each regular session of the Executive Council, and to any special session, as appropriate, of the Executive Council, on the implementation of the declaration obligations set out in Article 4. The Director-General shall include in this report information relating to paragraphs 1 and 2 of this Article.

4. Notwithstanding the action taken by the Director-General specified in paragraphs 1 to 3, if any State Party has not submitted its initial declarations by the expiry of a one year period, or its annual declarations by the expiry of a six month period, following the relevant deadline for submission established under Article 4 (2), the State Party shall not have access to the declarations of other States Parties. The Executive Council shall consider any explanations provided by the State Party and, if not satisfied, may decide whether to apply one or more of the following measures until the Director-General confirms receipt of the declarations concerned:

(a) The State Party may not invoke the declaration clarification procedure, as provided for in Article 6, section D, or a facility investigation as provided for in Article 9;

(b) The State Party may not request from the Technical Secretariat technical assistance under Article 14 other than assistance in the preparation of declarations including the establishment and functioning of the National Authority in accordance with Article 14 (24);

(c) The State Party may not invoke those provisions on consultation, clarification and co-operation, as provided for in Article 8, which directly involve the Organisation.

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

6. The State Party concerned may participate in any Executive Council consideration or review of the operation of these measures, but may not vote on the issue.

7. If a State Party has not submitted its initial declarations by the expiry of a two year period, or its annual declarations by the expiry of a twelve-month period, following the relevant deadline for submission established under Article 4 (2), the following provisions shall apply until the Director-General confirms receipt of the declarations concerned:

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

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

8. The Conference of States Parties shall consider the operation of these provisions. The Conference may decide in light of the explanations submitted by the State Party concerned to suspend the operation of any of the measures in paragraph 7 and specify a prescribed time frame for remedial action.

9. The State Party concerned may participate in any Conference of States Parties consideration of the operation of these measures, but may not vote on the issue.

ARTICLE 6

FOLLOW-UP AFTER SUBMISSION OF DECLARATIONS

A. THE ROLE OF THE TECHNICAL SECRETARIAT

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

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 11 and Annex C, 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. The Technical Secretariat shall, in order to promote the fulfilment of the declaration obligations under this Protocol:

(a) Process and make a technical analysis of the declarations;

(b) Conduct a limited number per year of randomly-selected transparency visits to facilities declared in accordance with Article 4 (6) and (8) to (14);

(c) If, in its analysis in accordance with paragraph 3 (a), it identifies any ambiguity, uncertainty, anomaly or omission related solely to the content of the declaration, seek clarification from the State Party concerned, in accordance with the procedures set out in paragraphs 55 to 106;

(d) Provide technical assistance to States Parties and help them compile individual facility and national declarations in accordance with Article 14 (24) (b) including, if requested, by a voluntary assistance visit, in accordance with the procedures set out in paragraphs 49 to 54.

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 Article 8, or it may initiate the clarification process set out in paragraphs 55 to 106.

Allocation of types of visits

5. The total number of all visits conducted in accordance with this Article shall not exceed 120 in each calendar year. The Director-General may, in light of the declarations submitted and requests for visits in accordance with this Article, conduct less than the total number of visits specified in this paragraph. The criteria for the allocation of visits for each category of visits shall be:

(a) The number of randomly-selected transparency visits allocated annually shall not exceed 75 per cent, but shall not be lower than 50 per cent of the maximum number of visits that may be allocated in each calendar year as specified above;

(b) The number of voluntary assistance visits allocated annually shall not exceed 25 per cent but shall not be lower than 5 per cent of the maximum number of visits that may be allocated in each calendar year as specified above, provided there are sufficient request received by the Director-General;

(c) Any visits required in accordance with paragraphs 3 (c) and 4 (herein after referred to as voluntary clarification visits) shall be allocated whilst ensuring that the minimum numbers of visits specified in subparagraphs (a) and (b) are conducted. Such allocation shall be determined as follows:

(i) The first visit in any year shall be deducted from the total number of randomly-selected transparency visits;

(ii) Any subsequent voluntary clarification visit required shall be deducted alternately from the quotas allocated to voluntary assistance visits and randomly-selected transparency visits.

Selection of facilities for randomly-selected transparency visits

6. During each calendar year, the Technical Secretariat shall randomly select, subject to the provisions in paragraph 5, facilities specified in paragraph 3 (b) for randomly-selected transparency visits. The mechanism of selection shall determine the probability of a State Party receiving a visit. Taking into account the principle of proportionality, this mechanism shall ensure that:

(a) Such visits shall be spread among a representative range of facilities subject to the provisions of this Article in terms of their scientific and technical characteristics;

(b) The prediction of when any particular facility will be subjected to such a visit shall, except as required by paragraph 7, be precluded.

Limitations on randomly-selected transparency visits and voluntary clarification visits

7. Taking into account the provisions of paragraphs 5 and 6, the allocation of randomly-selected transparency visits and voluntary clarification visits shall ensure that:

(a) No State Party shall receive more than seven randomly-selected visits in any calendar year;

(b) Each State Party which declares facilities shall receive at least two randomly- selected visit in any five-year period;

(d) The probability of a State Party receiving a visit shall be proportional to the number of declared facilities in that State Party taking into account the provisions of subparagraphs (a) to (c).

8. No State Party shall receive in any five-year period more than five voluntary clarification visits, unless additional visits are offered by that State Party.

Review

9. The first Review Conference and subsequent Review Conferences held in accordance with Article 20 may revise the total number of visits and their allocation between the categories of visits specified in paragraph 5, taking into account, inter alia, the numbers of States Parties, the numbers and types of declared facilities and their distribution, the resources available, the experience of implementation of this Article and fulfilment of the objectives of the Protocol.

Annual programme

10. At the end of each year, the Director-General shall prepare a visit schedule for the following year. States Parties shall, wherever possible, submit invitations or requests for voluntary assistance visits and, where known, voluntary clarification visits, not later than 1 October each year to enable the Director-General to prepare the visit schedule for the subsequent year. On receipt of an invitation for such a visit, the Director-General shall, subject to the provisions of paragraph 8, include the visit in the schedule for visits for the following year.

11. The Director-General shall submit to the Executive Council for its consideration, at its final regular session of each year, the visit schedule, including the details for the voluntary assistance visits and voluntary clarification visits already requested for the following year.

12. The Director-General shall not later than seven days after the final session of each year of the Executive Council notify the States Parties concerned of the schedule for the voluntary assistance visits and any outstanding voluntary clarification visits already known.

13. If, at any time during the year, the number of invitations for visits exceeds the number available for such visits in terms of the application of the provisions of paragraph 5, the Director-General shall report this fact to the Executive Council. The Director-General shall include in the report recommendations on how to resolve the matter. The Executive Council shall decide on how to proceed.

Review of annual programme

14. 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 allocations between the types of visits specified in paragraph 5. The Director-General shall notify the Executive Council of any changes to the visit schedule at its next session.

B. RANDOMLY-SELECTED TRANSPARENCY VISITS

Purpose

15. The Technical Secretariat shall conduct randomly-selected transparency visits, which shall be confidence building in nature. These visits shall, through co-operation with the visited State Party, promote the overall objectives of the Protocol by:

(a) Increasing confidence in the consistency of declarations with the activities of the facility and encouraging submission of complete and consistent declarations;

(b) Enhancing transparency of facilities subject to the provisions of this section;

(c) Helping the Technical Secretariat, subject to the provisions of this section, to acquire and retain a comprehensive and up-to-date understanding of the facilities and activities declared globally.

16. In addition, if so requested by the visited State Party, the visiting team shall 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 Article 14 (21) or provide any of the technical assistance and co-operation activities contained in programmes as specified in Article 14 (23).

Duration

17. Randomly-selected transparency visits may last up to two consecutive days and shall begin with the presentation of the briefing upon arrival at the declared facility and end after the end of the de-briefing in accordance with paragraph 39. 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.

18. In addition, if so requested by the visited State Party in its acknowledgement of receipt of notification of the visit, the visit shall be extended by up to two days, commencing upon completion of the debriefing specified in paragraph 39, for the visiting team to provide assistance in accordance with paragraph 16.

Equipment

19. The visiting team shall bring to the visited facility only items from the list of approved equipment in accordance with Annex B (34) and (35). The visiting team shall normally only bring to the visited facility items of equipment meeting the specifications for instant developing cameras, voice recorders, protective equipment and personal computers. Instant developing cameras and voice recorders shall be used only for collecting factual information for the visit report. Instant developing cameras shall be operated only by the representatives of the visited State Party. The use and disposition of such equipment during the visit shall be at the discretion of the visited State Party. The bringing and use of additional items of approved equipment at the declared facility shall be with the agreement of the visited State Party.

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

Administrative arrangements

21. 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 conduct of discussions and other tasks, in-country transportation, working space, lodging, meals and urgent medical care. The visited State Party may, to the extent possible, provide equipment on the list of approved equipment as requested by the visiting team. The visited State Party shall be reimbursed by the Organisation for any assistance provided in accordance with this paragraph within 30 days after receipt of a detailed and validated claim from the visited State Party.

Notification

22. The Director-General shall notify the visited State Party and, if applicable, the host State Party or State 14 days before the arrival of the visiting team at the point of entry, of its intention to conduct a visit to a declared facility; and, at the same time, shall make available to the visited State Party the mandate for the visit issued in accordance with paragraph 24. The notification shall include:

(a) The name of the visited State Party;

(b) The name of the host State Party or 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) Additional items of equipment on the list of approved equipment the visiting team requests to bring to the visited facility in accordance with paragraph 19;

(h) Information on the existing co-operation 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. The visited State Party shall acknowledge receipt of the notification within 48 hours after its receipt. In its acknowledgement of receipt, the State Party shall provide its response to the request for additional items of equipment from the list of approved equipment. The visited State Party may also indicate whether it requires technical advice and information. It shall specify which technical assistance and co-operation activities contained in the programmes specified in Article 14 (23), it requests to be provided by the visiting team. This shall be without prejudice to its right at any time during the visit to request technical advice and information. Any technical advice and information shall be provided to the extent possible after conclusion of the visit.

Mandate

24. For each visit the Director-General shall issue a standard mandate to the visiting team leader. The mandate shall be confined to the purposes set out in paragraph 15. The mandate shall contain:

(a) The name of the visited State Party;

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

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

(e) The declaration submitted by the facility;

(f) A list of the approved equipment proposed to be brought to the facility in accordance with paragraph 19;

(g) Operational instructions to the visiting team necessary for the visiting team to fulfil its mandate.

25. 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 as specified in Article 14 (21), or that it provide any of the technical assistance and co-operation activities contained in the programmes as specified in Article 14 (23), such activities shall, as appropriate, be added to the visit mandate as an addendum and conducted at the end of the visit activities. The addendum to the visit mandate shall also include any additional equipment approved by the visited State Party in accordance with paragraphs 19, 22 (g) and 24 (f). The addendum to the visit mandate shall be made available to the visited State Party as soon as possible before the commencement of the visit.

Appointment of visiting team

26. 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 B (1) to (9), 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.

Designation of visited State Party representatives

27. The visited State Party may designate personnel to assist visited facility personnel to 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.

Inspection of approved equipment

28. Equipment shall be sealed by the Technical Secretariat to indicate that the items of equipment are properly authenticated as items of approved equipment. The visited State Party shall have the right to inspect the equipment of the visiting team, including any additional equipment which the visited State Party has 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 B (34). The visited State Party may exclude items of equipment that do not conform to the provisions as set out in Annex B (39), as well as paragraph 19, and may retain them at the point of entry for the duration of the visit.

Rights and obligations

29. The visiting team and the visited State Party shall co-operate with each other to fulfil the mandate while protecting the interests of the visited State Party.

30. In this regard the visited State Party shall:

(a) Provide access to the visiting team within the facility to be visited subject to paragraphs 32 to 37, sufficient to fulfil its mandate. The nature and extent of all access inside the facility, and to the information it contains, shall be at the discretion of the visited State Party;

(b) Allow the visiting team to conduct the activities, in accordance with paragraph 36, proposed by the visiting team as relevant to fulfil its mandate;

(d) Make every reasonable effort to provide alternative means to allow the visiting team to fulfil its mandate if any of the activities proposed by the visiting team in accordance with paragraph 36 is not agreed to.

31. 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 make every reasonable effort to avoid inconvenience and disturbance to the visited State Party and 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 or 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;

Briefing

32. 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.

33. 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, organisational structure and, wherever possible, general information on the role of the declared facility within the overall structure of the company, government agency or entity operating the declared facility;

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

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

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

(i) General information on any experimental animal usage at the declared facility;

(j) A description of any technical assistance and co-operation activities requested by the visited State Party in accordance with paragraph 23;

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

34. The visited facility shall provide to the visiting team a written summary of the key points of the briefing. It may at its discretion also provide additional information, such as documentation related to either the briefing or tour. At its discretion, the visited facility may also provide in writing any additional information relating to 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

35. To complement the briefing, the visited State Party shall invite the visiting team to tour areas within the declared facility relevant to the visit mandate. The scope and nature of the tour shall be at the discretion of the visited State Party. The duration of the tour shall not exceed two hours.

Visit plan

36. After the briefing and the tour the visiting team shall prepare an initial visit plan indicating, in accordance with the provisions of paragraphs 29 to 31, whether it wishes to:

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

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

(c) Review, with the consent of the visited State Party, documentation relevant to the mandate in order to facilitate further the understanding of the visiting team of the declared activities as presented in the facility briefing, tour and declaration. The visited State Party, if it agrees to such a review, shall endeavour to provide such documentation, or to provide alternative means to address any questions raised by the visiting team in accordance with this paragraph;

(d) Visit, and revisit if necessary, to ensure fulfilment of the mandate, parts of the facility involved in the declared activities as presented in the facility briefing, tour or declaration;

(e) At any time during the visit, the visited State Party may, at its own initiative or at the suggestion of the visiting team, grant the visiting team the opportunity to conduct other on-site activities to assist in the fulfilment of the visit mandate. It may also offer additional access that the visited State Party believes may help assist the visiting team to fulfil its mandate. Any such on-site activities or access shall be subject to the provisions of paragraphs 29 to 31.

37. Any changes to the visit plan during the visit shall be subject to the consent of the visited State Party.

38. If the visiting team notes any technical inconsistencies during the discussions and activities referred to in paragraph 36 it shall discuss these with the visited State Party.

Debriefing

39. After completion of the visit 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.

Co-operation and assistance activities

40. If requested in accordance with paragraph 23, 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 co-operation and assistance activities contained in the programmes specified in the addendum to the visit mandate in accordance with paragraph 25 or requested during the visit.

Preliminary report

41. Within 24 hours of the completion of the visit or debriefing, the visiting team shall provide to the representatives of the visited State Party a preliminary report in written form. The preliminary report shall be a factual account of the visit. The visiting team leader shall sign the preliminary report. 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 countersign the preliminary report.

42. 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, such information shall not be included in the draft or final report.

Departure

43. On completion of the preliminary report and, if applicable, the relevant co-operation and assistance activities, the visiting team shall depart from the territory of the visited State Party as soon as possible.

Draft report

44. Not later than 14 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 any co-operation and assistance activities provided by the visiting team during the visit. The visiting team shall not comment upon any requests for access or information that were made during the visit by the visiting team and which the visited State Party did not accede to. The draft report may identify technical recommendations and possible follow-up co-operation and assistance activities of the Organisation. The draft report shall include a factual statement of the visit activities conducted. The draft report may also include an account from both the visited State Party and visiting team on the extent to which the information and access provided during the visit furthered the purpose of the visit as specified in paragraph 15.

45. 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 any commercial proprietary and national security information. The visited State Party may also identify any information which, due to its confidential nature, or because in the view of the visited State Party is not related to the visit mandate, should not as a rule be included in the final report. Confidential information shall be included in an annex to the visit report . This annex shall not be made available to other States Parties. Any comments by the visited State Party shall be submitted to the visiting team not later than seven days after receipt of the draft report.

Final report

46. 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. The final report shall include as an annex all the comments made by the visited State Party on the draft report, unless otherwise requested by the visited State Party.

47. The final report shall be the draft report adjusted by the visiting team in accordance with paragraph 46. 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 shall, as a rule, provide copies of the final report, on request to any State Party, unless otherwise indicated by the visited State Party.

48. If the Director-General, in the light of the information contained in the final report, considers it necessary for the visited State Party to submit a new declaration for the facility concerned, the Director-General may make a request to that effect to the visited State Party. The Director-General shall provide the visited State Party with the explanation for such a request.

C. VOLUNTARY ASSISTANCE VISITS

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

(a) To obtain relevant technical assistance and information;

(b) To obtain any of the technical assistance and co-operation activities contained in programmes as specified in Article 14 (21);

(c) To obtain from the Technical Secretariat technical advice or information on the implementation of the obligations of this Protocol as specified in Article 14 (24).

Invitations for visits

50. Each invitation for a voluntary assistance visit shall be addressed in writing to the Director-General and shall be accompanied by an explanation for the invitation and the purpose(s) of the proposed visit. The Director-General shall handle the invitations in accordance with the provisions set out in paragraphs 5 and 10 to 14.

51. The Director-General shall issue a mandate for each visit, which shall be written in co-operation with the visited State Party.

52. The visited State Party and the visiting team shall co-operate with each other in the achievement of the objectives of the mandate.

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

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

D. DECLARATION CLARIFICATION PROCEDURES

55. Concerns related to the declaration of any facility of a State Party in accordance with Article 4 (6) to (14) shall be resolved either through the process of consultation, clarification and co-operation as provided for in Article 8, or through the procedures set out in this section. In the case of a clarification request relating to a facility which is believed to meet the criteria for declaration as set forth in Article 4 (6) to (14), and which has not been included in the declaration of the State Party, the State Party from whom the clarification is sought (hereinafter referred to as the requested State Party), shall at its discretion decide to respond using either the procedures set forth in Article 8, or those set forth in paragraphs 56 to 106. The requested State Party shall notify the Director-General of its choice.

56. Information regarding declaration clarification procedures conducted in accordance with 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 distribution is expressly authorised either in accordance with paragraphs 74 and 77 or by the requested State Party without prejudice to the right of the requesting State Party to refer the issue to the Executive Council.

Requests for clarification

57. When a State Party considers that there is an ambiguity, uncertainty, anomaly or omission in the annual declaration concerning any facility of another State Party in accordance with Article 4 (6) to (14), it shall either seek clarification from the other State Party through the process of consultation, clarification and co-operation as provided for in Article 8, 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. In the case of a possible omission from the declaration of a State Party of a facility which meets the criteria for declaration as set forth in Article 4, the request shall also include a precise delimitation of the location of the facility.

58. Upon receipt of a request in accordance with paragraph 57, the Director-General shall submit a written request for clarification to the State Party concerned. The request shall include all the information supplied by the requesting State Party.

59. 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 shall not have the right to seek clarification from another State Party under this section until any measures required in accordance with paragraph 104 are implemented.

60. If as a result of his/her analysis in accordance with paragraph 3 (a), 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 a State Party, he/she shall submit a written request for clarification to the State Party concerned. The request shall include all relevant information on which it is based.

61. If as a result of his/her analysis in accordance with paragraph 3 (a), the Director-General identifies any facility which he/she believes meets the criteria for declaration as set forth in Article 4 (6) to (14), and which has not been declared in the declaration of a State Party he/she may request the State Party to submit a declaration for the facility concerned. The request shall include all relevant information on which it is based and shall also include a precise delimitation of the location of the facility.

Consultations including a consultative meeting

62. The requested State Party shall provide the clarification in writing to the Director-General not later than 30 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.

63. 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, in cases where he/she requested clarification 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.

64. 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.

65. 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.

Initiation of a voluntary clarification visit

66. The requested State Party may, at its discretion and at any time during the clarification procedure, or in cases where the matter has not been resolved through the processes specified in paragraphs 62 to 65, invite the Director-General to conduct a voluntary clarification visit to the facility in question with a view to resolving satisfactorily and expeditiously any matter which has been raised in accordance with paragraphs 55, 57, 60 or 61.

67. Any such 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 visited State Party and the visiting team shall co-operate with each other in the achievement of the objectives of the mandate.

68. The invitation to visit the facility shall be addressed to the Director-General in writing at any time during the consultations in accordance with paragraphs 62 to 65 or as soon as possible thereafter, but in no case later than 14 days after the completion of the consultative meeting in accordance with paragraph 63. The invitation shall be accompanied by an explanation for the invitation, the purpose of the proposed visit, the specific matter to be clarified, and the precise delimitation of the location of the facility where the visit would occur.

69. The Director-General shall handle the invitation in accordance with the provisions set out in paragraphs 5, 8 and 10 to 14 and shall ensure that the visit request is acceded to in accordance with the procedures set out in paragraphs 10 to 14. 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.

70. The Director-General and the visited 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 visited State Party to make the visit possible at the earliest possible opportunity.

71. If offering a visit, the 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 78 to 103. The State Party may, at its discretion, offer additional access and rights to the visiting team.

72. 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 does not approve the investigation request, then the voluntary clarification visit shall proceed.

Post-consultative meeting procedures

73. The requesting State Party may inform the Director-General if it believes that the consultative meeting in accordance with paragraph 63 has not resolved the matter. It shall inform him/her in writing within seven days after the conclusion of the consultative meeting. Any such notification shall include an explanation of why the requesting State Party considers that the previously conducted clarification procedures have not resolved the matter.

74. After receipt of a notification in accordance with paragraph 73, or in cases where the Director-General himself/herself requested clarification and considers that the previously conducted clarification procedures did not resolve the concern, he/she may suggest to the requested State Party that it might offer a voluntary clarification visit. If in accordance with such a suggestion a visit is not offered within 21 days, the Director-General shall submit the information provided by the requesting State Party in accordance with paragraph 57 to the Executive Council together with all relevant information pertaining to the implementation of the clarification procedures set out in this section.

75. In the light of the information submitted by the Director-General in accordance with paragraph 74, the Executive Council 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 information from other relevant international organisations in resolving the matter;

(e) By a decision to be taken in accordance with Article 16 (19), to initiate a clarification visit to be conducted according to the procedures set out in paragraphs 78 to 103;

(f) Determine whether the declaration clarification process initiated by a State Party has been abused, and if so, whether the requesting State Party should be held to account for such abuse. If so determined, the Executive Council shall decide on appropriate measures.

76. During consideration of the matter by the Executive Council, the requested and, if applicable, the requesting State Party, whether or not they are members of the Executive Council, shall have the right to participate in the discussions and in any decision on further action.

77. If a visit is required in accordance with paragraph 75 (e), the Director-General shall provide the members of the Executive Council with information on a confidential basis. In the event of a visit, information related to it 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 distribution is expressly authorised by the requested State Party. If a visit occurs, 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 distribution is expressly authorised 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.

Duration

78. The visited 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 paragraphs 91 to 98.

Equipment

79. The visiting team shall bring to the visited facility only items from the list of approved equipment in accordance with Annex B (34) and (35). The visiting team shall normally bring to the visited facility only items of equipment meeting the specifications for, instant developing cameras, voice recorders, protective equipment and personal computers. Instant developing cameras and voice recorders shall be used only for collecting factual information for the visit report. Only representatives of the visited State Party shall operate instant developing cameras. The use and disposition of such equipment during the visit shall be at the discretion of the visited State Party. The bringing and use of additional items of approved equipment at the declared facility shall be with the agreement of the visited State Party.

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

Administrative arrangements

81. 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 equipment on the list of approved equipment on request to the visiting team. The visited State Party shall be reimbursed by the Organisation for any assistance in accordance with this paragraph within 30 days after receipt of a detailed and validated claim from the visited State Party.

Notification

82. The Director-General shall notify the visited State Party and, if applicable the host State Party or State, 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 visited State Party;

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

(d) The purpose of the visit and the specific issue(s) to be clarified;

(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;

(j) Additional equipment on the list of approved equipment, the visiting team requests to bring to the visited facility in accordance with paragraph 79.

Mandate

83. The Director-General shall issue a mandate for the visit, which shall be limited to the clarification of the specific matter which was the subject of the prior consultations held in accordance with paragraphs 55, 57, 60 or 61. 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 visited State Party 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 or State, if applicable;

(d) The objectives of the visit and the possible means to resolve the specific matter which was the subject of any prior consultations held in accordance with paragraphs 55, 57, 60 or 61;

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

(f) The list of approved equipment proposed to be brought to the facility in accordance with paragraph 79;

(g) The declaration submitted by the facility, if appropriate.

84. The visited State Party shall acknowledge receipt of the notification not later than 48 hours after receipt of such notification. In its acknowledgement of receipt, the State Party shall provide its response to the request for additional equipment from the list of approved equipment. The State Party shall confirm acceptance of the proposed dates for the visit or propose alternative dates occurring within seven days of the visit date proposed by the Director-General. If the dates suggested by the visited State Party cannot be met by the Director-General, every effort shall be made by the Director-General and the visited State Party to make the visit possible at the earliest possible opportunity.

Appointment of visiting team

85. 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 B (1) to (9), 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

86. The visited State Party 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.

Inspection of approved equipment

87. The visited State Party shall have the right to inspect the equipment of the visiting team to ensure that it is properly sealed, appears on the list of approved equipment, and conforms to the standards as set out in Annex B (34). The visited State Party may exclude items of equipment that do not conform to the provisions as set out in Annex B (39) and may retain them at the point of entry for the duration of the visit.

Rights and obligations

88. The visiting team and the visited State Party shall co-operate with each other to fulfil the mandate while protecting the interests of the visited State Party.

89. 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 negotiated between the visiting team and the visited State Party;

(b) Allow the visiting team to conduct the activities, described in paragraph 93 to 97, 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 it deems that those questions are 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 93 to 97 are not possible.

90. The visiting team shall:

(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 make every reasonable effort to avoid inconvenience to the visited State Party and disturbance to the visited facility;

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

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

(e) Provide the visited State Party with copies of all the documented and electronic 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 along with the justification given for any such refusal by the visited State Party.

Briefing

91. Upon arrival at the facility to be visited, the visiting team shall be briefed by the facility representatives and/or the representatives of the visited State Party. The briefing shall include the scope and a general description of activities of the facility relevant to the issue(s) to be clarified as specified in the visit mandate, details of the physical layout and other relevant characteristics of the facility, including a map or sketch showing the relevant structures and significant geographic features. It shall include information concerning the safety regulations in force, including rules of observation and quarantine. It may also include an indication of areas the visited State Party considers sensitive or not related to the visit mandate. The briefing shall not exceed three hours.

92. The visited facility shall provide to the visiting team a written summary of the key points of the briefing. At their discretion, the visited facility may also provide in writing any additional information related to 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.

Orientation tour

93. The visited State Party may offer, or the visiting team may request, an orientation tour of areas within the facility relevant to the matter to be clarified as specified in the visit mandate. The visiting team and the visited State Party shall discuss the arrangements for the tour. The scope and nature of the tour shall be at the discretion of the visited State Party. The orientation tour shall not exceed two hours.

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

Visit activities

95. The visiting team may conduct one or more of the following activities:

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

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

96. The visited State Party shall, at the request of the visiting team, make available documentation, which, in the judgement of the visited State Party and visiting team, may help clarify the matter in the mandate. The nature and extent of examination of such documentation shall be agreed between the visited State Party and the visiting team.

97. At any time during the visit, the visited State Party may, at its own initiative or at the suggestion of the visiting team, grant the visiting team the opportunity to conduct other on-site activities. It may also offer additional access that the visited State Party believes may help assist the visiting team to fulfil its mandate. Any on-site activities shall be subject to the provisions of paragraphs 88 to 90.

Debriefing and preliminary findings

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

Departure

99. On completion of the debriefing the visiting team shall depart from the territory of the visited State Party as soon as possible.

Reports

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

101. The visiting team shall consider any comments received from the visited State Party and incorporate those comments and, as a rule, remove any information and data as requested in accordance with paragraph 100 before submitting the draft final report to the Director-General and the visited State Party not later than seven days after receipt of such comments.

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

103. The Director-General shall submit the final report to the Executive Council for its consideration only when:

(a) The requesting State Party considers that the matter to be clarified has not been resolved; and/or

(b) The clarification visit resulted from the provisions set forth in paragraph 75 (e).

Executive Council review and decision on any follow-up action

104. In accordance with paragraph 103, the Executive Council shall, in accordance with its powers and functions, review the final report of the visiting team and consider and decide on whether the matter to be clarified has been resolved. If the Executive Council reaches the conclusion that the matter has not been resolved and, in keeping with its powers and functions, that further action may be necessary, it shall take appropriate measures to redress the situation, which may include requiring the visited State Party to take any necessary measures such as revision of, or addition to, the declaration concerned or submission of a new declaration within a specified time limit.

105. During consideration of the matter by the Executive Council, the visited, and if applicable, the requesting State Party, whether or not they are members of the Executive Council, shall have the right to participate in this discussion and in any decision on further action.

106. The Director-General shall inform the visited State Party of the outcome of the review of the report and on any decision on any subsequent measures in accordance with paragraph 104 as soon as possible. The visited State Party shall take the necessary measures as required by the Executive Council. If applicable, the Director-General shall also notify the requesting State Party of the outcome of the review of the report and on any decision on any subsequent measures in accordance with paragraph 104.

ARTICLE 7

MEASURES TO STRENGTHEN THE IMPLEMENTATION OF

ARTICLE III OF THE CONVENTION

A. IMPLEMENTING LEGISLATION

1. Each State Party shall, in accordance with its constitutional or legislative procedures, review and, if necessary, amend or establish any legislation, regulatory or administrative provisions to regulate the transfer of agents, toxins, equipment and technologies relevant to Article III of the Convention in accordance with its obligations under this section. States Parties may request appropriate assistance from the Technical Secretariat or other States Parties on the establishment of administrative authorities or the fulfilment of requirements under this Article, or advice on the implementation of any legislation, regulatory or administrative provisions enacted under this Article.

2. Each State Party shall report to the Technical Secretariat not later than 180 days after entry into force of this Protocol for that State Party any legislative, regulatory or administrative provisions or other measures it has adopted to implement its obligations under Article III of the Convention, and whenever amendments thereto are made.

B. TRANSFER GUIDELINES

3. States Parties shall undertake all measures they deem necessary to ensure that obligations under Article III of the Convention are implemented fully and effectively. Such measures shall be implemented in a manner designed to avoid hampering the economic or technological development of States Parties or international co-operation in the field of peaceful bacteriological (biological) and toxin activities.

4. In order to strengthen the implementation of Article III of the Convention, each State Party shall take measures, as it deems appropriate, to ensure that transfers to any recipient whatsoever of items that could be used both for prophylactic, protective or other peaceful purposes and for purposes not permitted by the Convention (hereinafter referred to as dual-use items) will be used only for prophylactic, protective or other peaceful purposes. These measures may include, inter alia:

(a) Requiring that any request be accompanied by information on end-use, quantity or size required, location for proposed use, quantity of material to be produced at the location, place where intended to be stored, name and address(es) of the end-user(s) and end-use certificate;

(b) Requiring a written undertaking that the item will not be re-transferred to any destination not under the jurisdiction or control of the original receiving State without the prior express written permission of the supplier or supplying State Party;

(c) Requiring submission from the requesting State of information on its national laws and regulations adopted to prevent transfer of items in contravention of the Convention;

(d) Ensuring that authorisation of transfer requests take into account, as appropriate, the nature and implementation in the requesting State Party or State of measures specified in paragraph 1 to comply with the purposes of the Convention, and the extent to which these measures are effective in fulfilling the purpose of the Convention.

5. When implementing paragraph 4, each State Party shall take measures as it deems appropriate in order to ensure that transfers of dual-use items, including the items specified below, to any recipient whatsoever will be made only for prophylactic, protective or other peaceful purposes:

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

(b) Aerosol chambers designed for the dissemination and study of aerosols containing micro-organisms or toxins;

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

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

6. States Parties shall consider the status of implementation of the Convention and this Protocol in a potential recipient when considering a request for a transfer.

C. NOTIFICATIONS

7. In order to promote transparency and to enhance confidence-building among States Parties, each State Party shall, according to the standardised format for reporting international transfers contained in Appendix I, notify the Director-General annually by 30 April of aggregate data on exports or authorisations of exports of the following equipment which have been completed for prophylactic, protective or other peaceful purposes, during the previous calendar year:

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

(b) Chambers having a capacity of one cubic metre or more for which the end-use indicated by the State Party requesting the transfer is aerosol challenge testing with micro-organisms or toxins;

(c) Equipment for which the end-use indicated by the State Party requesting the transfer is use in experimental aerobiology studies to generate aerosol particles up to 20 microns in diameter that contain micro-organisms or toxins;

(d) Aerosol analytical equipment for which the end-use indicated by the State Party requesting the transfer is to determine the size of aerosol particles up to 20 microns in diameter that contain micro-organisms or toxins.

8. Upon receipt of a request by a State Party, which has submitted its declarations in accordance with Article 4 and its national report in accordance with paragraph 7, the Director-General shall make available to that State Party, in accordance with the provisions on confidentiality contained in Article 11 and Annex C, copies of the national reports of other States Parties specified in the request. The Director-General shall simultaneously inform the States Parties concerned that copies of their national reports have been made available to the requesting State Party.

9. States Parties may, if they deem it appropriate, consult and exchange further information among themselves on an ad hoc basis, in order to improve clarity and avoid discrepancies in the data and information reported.

D. CONSULTATIONS

10. States Parties may consult among themselves on the implementation of the provisions of this Article. States Parties may, as they deem it appropriate, inform other States Parties of the outcome of their national authorising procedures and any background relating to the approval of a requested transfer.

11. States Parties may, after the national authorisation procedures of the exporting State Party have been completed, and when they mutually deem it appropriate, consult directly amongst themselves with a view to specifying the context of a request for a transfer in light of the national authorising procedures of the transferring State Party, the guidelines in paragraphs 3 to 6 and the end-user. These consultations may be extended, on an agreed basis, to any State Party involved in a requested transfer.

12. In the case where there is a concern that an authorised transfer could be in violation of Article III of the Convention, a State Party shall have the right, if it deems appropriate, to consult directly with the transferring State Party to discuss the application of the guidelines with respect to the particular transfer, in accordance with paragraphs 3 to 6. These consultations may be extended, on an agreed basis, to any State Party involved in the transfer.

13. In the course of any consultations in accordance with paragraphs 10 to 12, the State Parties involved in those consultations may exchange any additional supporting information that may help clarify national authorising decisions made in accordance with the guidelines in paragraphs 3 to 6, or for approving the transfer including, inter alia, information:

(a) On past and current activities of the end-user;

(b) To be requested from any intermediate State or entity involved in the process of transferring;

(d) From the transferring State Party on what further assurances could be provided by any entity or State Party involved in the process of transferring, including the end-user;

(e) Which might assist the effective operation of the national authorisation procedures of the transferring State Party;

(f) On the status of implementation of the Convention and this Protocol in a potential recipient.

14. On the initiative of the States Parties involved in any consultations, a meeting may be convened to improve the mutual understanding of the possible modalities of the transfer, or to discuss the consistency of the transfer with the national regulations of the transferring State Party.

15. The States Parties involved in any consultations may, if they all agree, keep the Executive Council and Director-General informed of their consultations.

16. Unless otherwise agreed by all the States Parties involved in any consultations, the nature and content of such consultations shall be kept confidential.

17. The States Parties involved in any consultations shall take account of their outcome and may take appropriate measures including, inter alia, the re-examination of their laws and procedures regarding transfer approvals.

E. REVIEW

18. The first Conference of States Parties held after the first Review Conference of States Parties to this Protocol shall review the operation of the provisions of this Article. It shall consider whether the introduction of restrictions or prohibitions on the transfer of items specified in paragraph 5 to States not party to this Protocol or the Convention would further universal adherence to this Protocol.

19. Subsequent Review Conferences shall keep under review the implementation of the provisions of this Article and their relationship to the operation of other Articles of this Protocol and to the Convention, and in particular whether the provisions of this Article have been implemented with a view to strengthening the implementation of Article III of the Convention and in a manner designed to avoid hampering the economic or technological development of States Parties to the Convention and the Protocol or international co-operation in the field of peaceful bacteriological (biological) activities.

ARTICLE 8

CONSULTATION, CLARIFICATION AND CO-OPERATION

1. States Parties should, without prejudice to their rights and obligations under Article V of the Convention, and without prejudice to their right to request an investigation, consult and co-operate, directly among themselves or through the Organisation or other appropriate international procedures, including within the framework of the United Nations and in accordance with its Charter, on any matter which may be raised relating to the object and purpose of the Convention, or the implementation of the provisions of this Protocol, and clarify and resolve any matter which may cause concern about possible non-compliance with the obligations of this Protocol or the Convention. For these purposes, States Parties may follow, inter alia, one or more of the following procedures:

(a) Seek clarification from another State Party directly, or through the offices of a third State Party, or through other appropriate international procedures. In the case of a written request for clarification, the requested State Party shall provide the clarification to the requesting State Party as soon as possible, but in any case not later than 20 days after receipt of the request. The requesting and requested States Parties may, if they agree, keep the Executive Council and Director-General informed of the request and the response;

(b) Submit a written request for clarification concerning another State Party, together with information upon which the request is made, to the Director-General. The Director-General shall immediately forward the request to the State Party concerned. The requested State Party shall provide the clarification to the Director-General as soon as possible, but in any case not later than 20 days after receipt of the request. The Director-General shall immediately forward the clarification to the requesting State Party. If agreed by both the requesting and requested States Parties, the Director-General shall keep the Executive Council and/or all other States Parties informed of the request and the basis for the request as well as the response;

(c) If the case is particularly serious, submit a written request for clarification concerning another State Party, together with information upon which the request is made, to the Executive Council, which shall forward the request to the requested State Party through the Director-General not later than 24 hours after its receipt. The requested State Party shall provide the response to the Executive Council as soon as possible, but in any case not later than 20 days after receipt of the request. The Executive Council shall take note of the response and forward it to the requesting State Party not later than 24 hours after its receipt. The Executive Council shall inform without delay all other States Parties about any such request for clarification and the basis for this request as well as the response provided by the requested State Party.

2. For the purposes of obtaining further clarification the Executive Council may call on the Director-General to consult the Scientific Advisory Board established in accordance with Article 16 (22) (g), or to establish a group of experts from the list of personnel designated and approved in accordance with the procedures set out in Annex B (10) to (12) and 15. The Scientific Advisory Board or the group of experts shall examine all available information and data relevant to the situation causing concern. The Scientific Advisory Board or the group of experts shall submit a factual report to the Executive Council on its findings as soon as possible.

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

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

(b) A special session of the Executive Council be held in which any of the States Parties involved that is not a member of the Executive Council shall be entitled to take part. In such a special session the Executive Council shall consider the matter and may recommend to the States Parties involved any measure it deems appropriate to resolve the situation.

4. If the concern of a State Party about possible non-compliance has not been resolved within 60 days after the submission of the request for clarification to the Executive Council, and if the State Party believes its concern warrants urgent consideration, it may request in writing a special session of the Conference of States Parties in accordance with Article 16 (12) (c). At such a special session, the Conference shall consider the matter and may recommend any measure it deems appropriate to resolve the situation in accordance with Article 12.

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

(a) Request the Executive Council to consider the matter on the basis of the information which was made available in the request as well as on information which has been made available by the requested State Party, and, if appropriate, also on the basis of information received from the Technical Secretariat based on the declarations submitted by the State Party and any other relevant information which it has acquired in the performance of its functions as specified in Articles 14 and 16.

(b) In the case of a concern about compliance with the declaration obligations of this Protocol, request the Director-General to mandate the Technical Secretariat to conduct a visit for the sole purpose of resolving the concern. The visit shall be conducted according to the procedures for voluntary clarification visits set out in Article 6 (78) to (103).

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

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

ARTICLE 9

INVESTIGATIONS

A. TYPES OF INVESTIGATIONS

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

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

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

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

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

B. OUTBREAKS OF DISEASE

Outbreaks of disease, which are due to natural causes

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

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

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

6. If a State Party has a concern that an outbreak of disease is directly related to activities prohibited by the Convention, it shall have the right to request a field investigation to address the non-compliance concern. In accordance with the requirements of Annex B (62), such a request shall contain detailed evidence, and other information, and analysis substantiating why, in its view, it considers the outbreak of disease not to be naturally occurring and directly related to activities prohibited by the Convention. Reports coming exclusively from the mass media cannot be considered as evidence.

7. The Executive Council shall not consider and authorise, in accordance with paragraph 23 (c) and (d), a request for a field investigation of an outbreak of disease, unless it determines that there is a basis for concern substantiated by detailed evidence, other information, and analysis that the outbreak(s) of disease is not naturally occurring and is directly related to activities prohibited by the Convention. The Executive Council, if it deems it appropriate for its decision on the above request, shall also request from the most relevant international organisation(s) such as, but not limited to, the World Health Organisation, the Organisation Internationale des Epizootics and the Food and Agricultural Organisation, all available information in its/their possession that may be relevant to the outbreak.

8. When a State Party requests a field investigation of an outbreak(s) of disease on the territory or in any place under the jurisdiction or control of another State Party, the State Party where the investigation is proposed to occur shall have the right to provide evidence, and other information, and analysis that indicates that the outbreak of disease is naturally occurring or otherwise unrelated to activities prohibited by the Convention. If deemed appropriate by the Executive Council as a matter of procedure under Article 16 (30), other State(s) Party(ies) may also provide information relevant to whether the outbreak(s) of disease is naturally occurring and/or whether it is related to activities prohibited by the Convention. All of the evidence, and other information, and analysis submitted, shall be taken into account by the Executive Council in its consideration of the investigation request in accordance with the request procedures of paragraphs 12 to 26.

Alleged use of bacteriological (biological) and/or toxin weapons

9. A State Party has a right in accordance with paragraph 1 to request a field investigation of an alleged use of a bacteriological (biological) and/or toxin weapons if it believes that such weapons were used.

C. CONSULTATION, CLARIFICATION AND CO-OPERATION

10. Without prejudice to the right of any State Party to request an investigation, States Parties should, whenever possible, first make every effort to clarify and resolve, through exchange of information and consultations among themselves in accordance with the provisions set out in Article 8, any matter which may cause doubt about compliance with the Convention.

D. INITIATION OF INVESTIGATIONS

11. An investigation may be requested to be conducted on the territory of a State Party, or in any other place under its jurisdiction or control, regardless of the form of ownership of the facility or the area subject to the investigation, in accordance with the provisions of this Protocol.

12. An investigation may also be requested to be conducted in any place on the territory of a non-State Party or under the jurisdiction or control of that non-St