Nineteenth Session Index

PROCEDURAL REPORT OF THE AD HOC GROUP OF THE

STATES PARTIES TO THE CONVENTION ON THE PROHIBITION

OF THE DEVELOPMENT, PRODUCTION AND STOCKPILING OF

BACTERIOLOGICAL (BIOLOGICAL) AND TOXIN WEAPONS

AND ON THEIR DESTRUCTION

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

Proposals for further consideration by the Friend of the Chair on Investigations

ARTICLE III

D. DECLARATIONS

I. SUBMISSION OF DECLARATIONS

1. Each State Party shall declare to the Organization, regardless of the form of their ownership or control, all activities and facilities listed below which exist or existed on its territory or in any other place under its jurisdiction or control during the period specified.

3. All declarations submitted in accordance with paragraph 1 above shall be submitted to the Organization, in accordance with the appropriate format in the Appendix, not later than 180 days after this Protocol enters into force for it and, in the case of annual declarations, not later than 30 April of each successive year thereafter.

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

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

INITIAL DECLARATIONS

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

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

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

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

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

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

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

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

7. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, whether at any time [since [1 January 1946] [26 March 1975, or, if it acceded to the Convention after 26 March 1975, since the date of entry into force of the Convention for that State Party] [31 December 1991]] [starting five years prior to the first annual declaration for that State Party] [until entry into force for that State Party] it has conducted the programmes and/or activities as specified in subparagraph (b) below as part of any effort to [directly] protect or [directly] defend humans, animals or plants against the use of microbial or other biological agents or toxins for hostile purposes or in armed conflict. [If so, the State Party shall declare, in summary form:

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

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

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

ANNUAL DECLARATIONS

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

[(a) The presence of all / absence of defensive biological and toxin programmes and/or activities involving research and/or development, testing and evaluation, production and storage designed to detect and assess the impact of any use of microbial or other biological agents or toxins for hostile purposes or in armed conflict, and/or to prevent, reduce and neutralize the impact of biological and toxin weapons on humans, animals or plants;

(b) All facilities taking part in such programmes and/or activities [and conducting work on microorganisms or toxins as well as material imitating their properties].]

[(a) Whether at any time during the previous calendar year it has conducted any [research and development] [testing and evaluation, production] activities as part of programmes and/or activities to [directly] protect or [directly] defend humans, animals, or plants against the use of microbial or other biological agents or toxins for hostile purposes or in armed conflict. [If so, it shall declare:

[(i) All such activities;]

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

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

[(b) One of the following:

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

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

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

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

(b) bis List and provide general information in accordance with Appendix D on all facilities not declared in accordance with subparagraph (b) above where more than ¼ but less than ...;]

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

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

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

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

[(a) Whether at any time during the previous calendar year it has conducted any research and/or development, testing and/or evaluation or production as part of a programme(s) and/or activities specifically designed to detect or protect humans, animals or plants against the use of microbial or other biological agents or toxins for hostile purposes or in armed conflict or to assess the impact of the use of such agents;

(b) All facilities taking part in such programme(s) and/or activities and conducting:

(i) Research and development;

(ii) Testing and/or evaluation;

(iii) Production;

in one or more of the following fields:

(i) Prophylaxis and treatment of humans, animals and plants;

(ii) Aerobiology;

(iii) Detection;

(iv) Decontamination;

(v) Pathogenicity and virulence;

(vi) Toxinology.]

10. For the purpose of paragraph 9 above, the following definitions apply:¹⁵

(D) VACCINE PRODUCTION FACILITIES

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

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

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

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

12. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, all facilities designated as maximum biological containment [BL-4 - WHO and OIE classification] as defined in paragraph 12/12 bis of Article II.

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

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

[(G) PLANT PATHOGEN CONTAINMENT

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

(H) WORK WITH LISTED AGENTS AND/OR TOXINS

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

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

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

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

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

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

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

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

[(c) Insertion of a nucleic acid sequence into an agent listed in Annex A;]

[(c) Insertion of any nucleic acid sequence, which would increase pathogenicity/virulence or facilitate the production of toxins or their toxic subunits, into an agent listed in Annex A;]

[OR]

[(c) Modification of nucleic acid sequences relating to any agent and/or toxin listed in Annex A, which creates or results in change of antigenicity or immunogenicity, increased antibiotic resistance, stability, or toxic or disease-causing properties, or ease of production;]

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

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

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

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

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

(i) A static aerosol test chamber; or

(ii) An explosive aerosol test chamber; or

(iii) A dynamic aerosol test chamber that has a total internal volume of 5 m3 or more.]¹⁶

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

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

[(I) OTHER PRODUCTION FACILITIES

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

(i) Produced; or

(ii) Produced or recovered by concentration or isolation;

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

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

(ii) Diagnostic reagents; or

(iii) Biocontrol agents or plant inoculants;

using one of the following:

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

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

(c) More than 15,000 embryonated eggs annually; or

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

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

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

(a) Bioremediation or waste treatment; or

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

(c) Research and development of the products listed in subparagraph (b) above; or

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

[(J) OTHER FACILITIES

19. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, each facility which, during the previous calendar year, conducted activities with any biological agent and/or toxin and which also:

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

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

[(c) Conducted genetic modification to enhance pathogenicity, virulence, stability or resistance to antibiotics or chemical or physical methods of disinfection, or which altered the host range, the infection route or the ease of identification or diagnosis, within a high biological containment facility (BL-3).]]

[(K) TRANSFERS

20. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, all international transfers during the previous calendar year of agents and/or toxins, equipment [or means of delivery] listed in Annex A.]¹⁷

[(L) DECLARATIONS ON THE IMPLEMENTATION OF ARTICLE X OF THE CONVENTION AND ARTICLE VII OF THE PROTOCOL¹⁸

21. Each State Party shall declare, in accordance with paragraphs 1 to 3 above, all the measures taken during the previous calendar year individually or together with other States Parties, with the Organization and other international organizations in implementing Article X of the Convention and Article VII of the Protocol.

22. Each State Party shall [have the right to] declare any restrictions, in non-compliance with the obligations under Article X, on the transfer of biological materials, equipment and technology for peaceful purposes.]

[NOTIFICATIONS]

[(M) NATIONAL LEGISLATION AND REGULATIONS¹⁹

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

(a) Access to buildings or other structures in which pathogens or toxins are being produced, handled or stored;

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

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

24. In cases where a State Party has either:

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

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

the Organization may request the State Party concerned to provide a copy of a specific document(s), directly related to the issue to be clarified or to the facility to be visited, the title of which was declared under paragraph 23. The State Party [shall] [may] provide such copies within ... days of receiving the request, whenever possible in one of the official languages of the United Nations. The Organization shall keep all such requests to the minimum necessary to fulfil its functions.].

[(N) OUTBREAKS OF DISEASE²⁰

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

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

[(O) CURRENT EXCEEDING OF THRESHOLD

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

II. FOLLOW-UP AFTER SUBMISSION OF DECLARATIONS

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

2. Upon receipt of a request by a State Party which has submitted its own declarations, the Director-General shall make available to that State Party in accordance with the provisions on confidentiality contained in Article IV and Annex E of this Protocol copies of the initial and/or annual declarations of other States Parties, as specified in the request. The Director-General shall simultaneously inform the State(s) Party(ies) concerned that copies of their declarations have been made available to the requesting State Party.

3. 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 visits to [declared] [biodefence and BL4 with the principle of proportionality] facilities in accordance with the procedures set out in part A below;]

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

(d) Provide technical assistance to States Parties to help them compile individual facility and national declarations including, if requested, by means of visiting a State Party, in accordance with the procedures set out in part C below.

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

Visit schedule

5. The total number of all visits conducted pursuant to this Article shall not exceed [75] [140] in each calendar year.

5 bis The number of visits pursuant to paragraph 3 (b) shall be at least a half of the total for visits specified in paragraph 5. The number of visits pursuant to paragraph 3 (d) and section C shall be at least one quarter of the total for visits specified in paragraph 5. The first visit in any year resulting from the procedure set forth in paragraph 3 (c) or paragraph 4 shall be deducted from the quota allocated for visits pursuant to paragraph 3 (b). Thereafter any visits required under paragraph 3 (c) or paragraph 4 shall be deducted alternately from the quotas allocated to paragraph 3 (d) and section C and paragraph 3 (b).

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

Annual programme

6 bis 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 for voluntary assistance visits and, where known, clarification visits volunteered, not later than 1 December 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 include the visit in his/her schedule for visits for the following year.

7. The Director-General shall submit the schedule containing the details for the voluntary assistance visits and voluntary clarification visits already known to the Executive Council at its first session of each year. If the number of invitations exceeds the ceiling prescribed above, the Director-General shall report this fact to the Executive Council at its first session of each year. If during the year, the numbers of invitations for voluntary assistance visits exceed the initial provision pursuant to paragraph 5, the Director-General shall report this fact to the Executive Council. The Director-General shall also include recommendations on the priority of each visit in light of the information submitted by the State Party and available resources.

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

9. The Director-General shall not later than seven days after the first session of the Executive Council notify all States Parties of the schedule for the voluntary assistance visits and any outstanding visits pursuant to paragraph 3 (c) and paragraph 4

Review of annual programme

10. The Director-General shall submit to the Executive Council every three months, or earlier if necessary, a report on the implementation of visits of each type and on outstanding invitations for voluntary assistance and voluntary clarification visits. If it judges it necessary, the Executive Council may decide to adjust the initial allocations, between the types of visits, specified in paragraph 5. The Director-General shall notify the Executive Council of any changes to the visit schedule at its next session.

10 bis If the procedure in paragraph 5 bis above results in the number of visits of any type falling below the minimum allocation for that visit type, the Executive Council shall decide on any deductions or re-allocations and make any re-adjustments as necessary.

[(A) VISITS

Purpose²¹

13. The Technical Secretariat shall conduct, in accordance with the provisions of paragraphs 5, 7 and 10 of this subsection, visits pursuant to paragraph 3 (b) of this subsection, which shall be confidence-building in nature. These visits shall, through cooperation with the visited State Party, promote the overall objectives of the Protocol by:

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

(b) Checking the consistency of declarations submitted by States Parties;

(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.]

14. 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 working days for the visiting team to provide to the extent possible technical advice or information to the visited State Party and/or to visited facility personnel on any of the subjects listed in paragraphs ... of Article VII or to provide any of the technical assistance and cooperation activities contained in programmes as specified in Article VII, section D, paragraph 19. The resources required for this assistance visit shall be charged against the technical assistance portion of the budget of the Organization.

Selection of facilities²²

15. During the course of each calendar year, the Technical Secretariat shall randomly select facilities specified in paragraph 3 (b) of this subsection for a visit. The mechanism of selection shall ensure that:

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

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

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

(c) No facility shall be subject to more than two such visits in a five year period;

(d) No State Party shall receive more than two such visits per year;

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

The mechanism of selection may be changed at any time by the Conference of States Parties in light of experience gained from the operation of this provision.

Duration

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

17. If so requested by the State Party to be visited in its acknowledgement of receipt of notification of the visit, the visit shall be extended by up to two days pursuant to paragraph 14 of this section.

Equipment

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

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

Administrative arrangements

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

PRE-VISIT ACTIVITIES

Mandate

21. The Director-General shall issue a standard mandate for the visit. The mandate shall be confined to the purposes set out in paragraph 13 of this section. The mandate shall contain:

(a) The name of the visited State Party;

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

(c) The name and location of the facility to be visited;

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

(e) The approved equipment proposed to be brought to the facility in accordance with paragraph 18 above; and any additional equipment approved by the visited State Party pursuant to paragraph 18;

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

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

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

Notification

24. The Director-General shall notify the visited State Party and, if applicable, the host State Party two weeks before the arrival of the visiting team at the point of entry, of its intention to conduct a visit to a declared facility; and at the same time, shall make available to the State Party to be visited the mandate for the visit. The visited State Party shall acknowledge receipt of the notification within 24 hours after receipt of the notification. The notification shall include:

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

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

(c) The name and location of the facility to be visited;

(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 approved equipment the visiting team requests to bring to the visited facility pursuant to paragraph 18 above;

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

25. In its acknowledgement of receipt, the State Party shall provide its response to the request for additional approved equipment. The visited State Party may also indicate whether it requires technical advice and information and specify which technical assistance and cooperation activities contained in the programmes as specified in Article VII, section D, paragraph 19, it requests to be provided by the visiting team, without prejudice to its right to request technical advice and information at any time during the visit which shall be provided to the extent possible after conclusion 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 D, section I, paragraphs 1 to 10, taking into account the specific nature of the facility to be visited. The members of the visiting team shall be selected on as wide an equitable geographical basis as possible. The Director-General shall limit the size of the visiting team to the minimum necessary for the proper fulfilment of the mandate. In any event the team shall not exceed four members. No national of the visited State Party or, if applicable, the host State Party, shall be a member of the visiting team.

Designation of visited State Party representatives

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

ACTIVITIES UPON ARRIVAL OF THE VISITING TEAM

Inspection of approved equipment

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 the additional equipment the visited State Party approved, to ensure that it is properly sealed, appears on the list of approved equipment and conforms to the standards as set out in Annex D, section I, paragraph 35. The visited State Party may exclude items of equipment that do not conform to the provisions set out in Annex D, section I, paragraph 40, as well as paragraph 18 above, and may retain them at the point of entry for the duration of the visit.

CONDUCT OF THE VISIT

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

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 35 below 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, described in paragraph 36 of this section, proposed by the visiting team as relevant to fulfil its mandate;

(c) Have the right to take measures to protect national security and commercial proprietary information;

(d) Wherever possible, endeavour to provide the information necessary to enable the visiting team to fulfil the general purpose of the visit in accordance with paragraph 13.

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 to the visited State Party and disturbance to the visited facility;

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

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

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

]

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:²³

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

(b) Short background description of the declared facility covering the date of establishment, current ownership, organizational structure and, wherever possible, general information on the declared facility's role within the overall structure of the company or government agency or entity operating the declared facility; organizational structure of the 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 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) A description of the technical assistance and cooperation activities requested by the visited State Party pursuant to paragraph 25 above;

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

(j) General information on any experimental animal usage related to the declared activities;

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

Tour of the visited facility

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 activities

36. After the briefing and the tour the visiting team may conduct one or more of the following activities:

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

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

(c) Examine, with the consent of the visited State Party, documentation relevant to the mandate for the sole purpose of facilitating the visiting team's understanding of the activities being conducted at the declared facility;

(d) Revisit parts of the facility, and observe equipment, relevant to the declared activities at the facility;

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

(f) The visited State Party may allow the visiting team, at any time during the visit, any other on-site activities which the visited State Party believes may assist the visiting team to fulfil its mandate.

36 bis The visiting team shall present its proposals for activities in writing to the visited State Party.

37. If the visiting team notes any technical inconsistencies during the discussions and activities referred to in paragraph 36 above it may inform the visited State Party. Such inconsistencies shall not be included in the final visit report.

Debriefing

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

POST-VISIT ACTIVITIES

Cooperation and assistance activities

39. If requested in accordance with paragraph 14, after the conclusion of the other activities related to the visit, the visiting team shall provide the technical advice and information and any of the cooperation and assistance activities contained in the programmes specified in the addendum to the visit mandate pursuant to paragraph 22 above or requested during the visit.

Preliminary report

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

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

Departure

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

REPORTS

Draft report

43. 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 the cooperation and assistance activities of the visiting team during the visit. At the request of the visited State Party, the draft report may identify technical recommendations and possible follow-up cooperation and assistance activities of the Organization. The report may also include comments from both the visited State Party and visiting team on the extent to which the information provided during the visit furthered the purpose of the visit as specified in paragraph 13 of this subsection.

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

45. The visiting team shall consider comments received from the visited State Party. In preparing the final report, the visiting team shall, as a rule, adjust the draft report to reflect those comments. If the visited State Party identifies any information as confidential, the visiting team shall remove such information from the report. 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.

Final report

46. The final report shall be the draft report adjusted by the visiting team in accordance with paragraph 45. The visiting team shall submit the final report to the Director-General and the visited State Party not later than seven days after receipt of any comments from the visited State Party. The Director-General [may] [shall] remove all information identified as confidential as provided for in paragraph 45. [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, taking into account the provisions of Article IV, paragraph 5 (d).] OR [The Director-General may, with the consent of the State Party, provide copies of the final report, on request, to any other State Party.]

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

(B) DECLARATION CLARIFICATION PROCEDURES

48. Concerns related to the declaration of a State Party shall be resolved either through the process of consultation, clarification and cooperation as provided for in paragraphs 1 (a) and 3 of section E of this Article, or through the procedures set out in this section. The State Party to which the concern is related may volunteer for the Technical Secretariat to conduct a visit in accordance with the provisions set out in this section to the facility in question with a view to resolving the concern.

Requests for clarification

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

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

51. Any State Party which has not taken any necessary measures it may have been required to take in accordance with a decision of the Executive Council pursuant to part III of this section shall not have the right to seek clarification from another State Party under this section until any measures required pursuant to paragraphs 100 and 101 of this subsection are implemented.

52. Upon receipt of a request pursuant to paragraph 49 above, or if as a result of his/her analysis pursuant to paragraph 3 (a) above, the Director-General considers that there is an ambiguity, uncertainty, anomaly or omission of a purely technical nature related solely to the content of the declaration submitted by a State Party [or identifies any facility which he/she believes meets the criteria for declaration as set forth in Article III, section D, and that facility has not been included in the declaration(s) concerned], the Director-General shall submit a written request for clarification to the State Party concerned (hereinafter referred to as the requested State Party). The request shall include all relevant information on which it is based [including, in the case of the possible omission of a facility from a declaration, the reasons why it is believed that the facility may be required to be declared and a delimitation of the location of the facility].

[53. 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 III, section D, and that facility has not been included in the State Party's declaration, the State Party from whom the clarification is sought, may at its discretion decide to respond using either the procedures set forth in section E of this Article paragraphs 1 and 3, or the those set forth below in paragraphs 54 to 74.]²⁴

Consultations including a consultative meeting

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

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

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

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

58. Information regarding on-going or completed clarification procedures (consultations) conducted pursuant to paragraphs 49 to 57 of this subsection, including requests for such consultations, and information resulting therefrom shall be restricted to the Technical Secretariat, the requested State Party, and, if applicable, the requesting State Party unless further release is expressly authorized by the requested State Party without prejudice to the right of the requesting State Party to refer the issue to the Executive Council.

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

VOLUNTARY CLARIFICATION VISIT

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

Offering of a voluntary clarification visit

61. The requested State Party may, at its discretion and at any time during the clarification procedures or in cases where the concern has not been resolved through the process of consultation, clarification and cooperation pursuant to paragraphs 49, 54, 55 and 56, invite the Technical Secretariat to conduct a [voluntary clarification visit] to the facility in question which shall be conducted in accordance with the provisions set forth in paragraphs [79 to 98], with a view to resolving satisfactorily and expeditiously any matter which has been raised pursuant to paragraphs 49 and 50 above.

62. The invitation to visit the facility shall be addressed to the Director-General in writing at any time during the consultations pursuant to paragraphs 49 to 56 above or as soon as possible, but in no case later than seven days after the completion of the consultative meeting pursuant to paragraph 55 above. The invitation shall be accompanied by an explanation for the invitation, the purpose of the proposed visit, the specific issue(s) to be clarified, the location of the facility to be visited and a diagram identifying and describing the specific place(s) and facility where the visit would occur.

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

64. The Director-General shall handle the invitation in accordance with the provisions set out in paragraphs 5 to 10 of this subsection. The Director-General and the inviting State Party shall decide by mutual consent on the time of the visit taking into account the overall visit schedule. If consensus cannot be reached on the dates for the visit, every effort shall be made by the Director-General and the State Party to be visited to make the visit possible at the earliest possible opportunity.

65. If offering a visit, the inviting State Party shall ensure necessary access to the facility so as to enable the visiting team to fulfil its mandate. The voluntary visit shall be conducted according to the procedures set forth in paragraphs 79 to 108 of this subsection. The inviting State Party may, at its discretion, offer additional access and rights to the visiting team.

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

CONSULTATIVE MEETING FOLLOW-UP

67. If the requesting State Party considers that the consultative meeting has not resolved the matter, the Director-General shall submit a report to the Executive Council.

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

[69. If the condition set out in paragraph 67 applies, the Director-General shall request the requested State Party to offer a voluntary clarification visit within a specified time frame. He/she shall also submit a full report on the matter in writing to the Executive Council, including all relevant information pertaining to the implementation of the clarification procedures set out in this section.

Executive Council review

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

(a) That no further action is justified;

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

(c) To request further information from the requested and/or requesting State(s) Party(ies);

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

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

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

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

(h) 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.

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

Duration

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

Equipment

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

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

Administrative arrangements

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

PRE-VISIT ACTIVITIES

Mandate

79. The Director-General shall issue a mandate for the visit which shall be limited to the clarification of the specific issue in the declaration of the requested State Party which was the subject of the prior consultations held pursuant to paragraphs 49, 54, 55 and 56 of this section. The mandate shall be included in the notification of the visit made by the Director-General. The mandate shall be made available to the representative of the State Party to be visited immediately upon the arrival of the visiting team at the point of entry. The mandate shall contain at least the following:

(a) The name of the visited State Party;

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

(c) The name and location of the facility to be visited specified as precisely as possible;

(d) The objectives of the visit and the possible means to resolve the issue related to the declaration of the requested State Party which was the subject of the consultative meeting pursuant to paragraphs 55 to 56 above;

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

(f) The list of approved equipment to be used during the visit pursuant to paragraphs 76 and 77 above;

(g) The declaration submitted by the facility.

Notification

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

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

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

(c) The name and location of the facility to be visited;

(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.

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

Appointment of visiting team

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

Designation of visited State Party representatives

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

ACTIVITIES UPON ARRIVAL OF THE VISITING TEAM

Inspection of approved equipment

84. 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 D, section I, paragraph 40. The visited State Party may exclude equipment that does not conform to the provisions set out in Annex D, section I, paragraph 39, and paragraph 91 above and may retain them at the point of entry for the duration of the visit.

CONDUCT OF THE VISIT

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

86. In this regard, the visited State Party shall:

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

(b) Allow the visiting team to conduct the activities, described in paragraph 92 of this subsection, proposed by the visiting team as necessary to fulfil its mandate;

(c) Have the right to take measures to protect national security and commercial proprietary information;

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

(e) Make every reasonable effort to provide alternative means to allow the visiting team to fulfil its mandate if any of the activities proposed by the visiting team in accordance with paragraphs 91 and 92 are not possible.

87. The visiting team shall:

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

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

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

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

(e) Provide the visited State Party with copies of all the 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 without any justification given for any such refusal by the visited State Party.

Briefing

88. 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.

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

90. The visited State Party may offer or the visiting team may request an orientation tour of areas within the facility relevant to the issue(s) to be clarified as specified in the visit mandate. The visiting team and the visited State Party shall discuss the arrangements for the tour. 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

91. 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.

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

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

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

(c) Visually observe parts of the facility as well as equipment, relevant to the mandate.

92 bis The visited State Party may at the suggestion of the visiting team offer the visiting team, at any time during the visit, any other on-site activities which the visited State Party believes may assist the visiting team to fulfil its mandate.

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

POST-VISIT ACTIVITIES

Debriefing and preliminary findings

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

Departure

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

REPORT

Visit report

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

96. The visiting team shall consider any comments received from the visited State Party and incorporate those comments and, as a rule, remove any information and data as requested pursuant to paragraph 95 before submitting the draft final report to the Director-General and the visited State Party [and, if applicable, the requesting State Party] not later than seven days after receipt of such comments.

97. 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.

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

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

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

(b) The clarification visit resulted from the provisions set forth in paragraph 87 above.

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

Executive Council review and decision on any follow-up action

100. 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 and the time limit of fulfilment.

101. The Director-General shall inform the visited State Party of the outcome of the review of the report and on any decision on any subsequent measures pursuant to paragraph 100 as soon as possible. The visited State Party shall take the necessary measures as required by the Executive Council. If applicable, the Director-General shall also inform the requesting State Party of the outcome of the review of the report and on any decision on any subsequent measures pursuant to paragraph 100.

102. 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 one or more of the following:

(a) To obtain relevant technical assistance and information;

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

(c) To obtain from the Technical Secretariat technical advice or information on the implementation of the declaration obligations of this Protocol with respect to specific facilities.

Invitations for visits

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

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

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

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

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

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

III. MEASURES TO ENSURE SUBMISSION OF DECLARATIONS

1. As soon as possible after the deadline for the submission of the initial or annual declarations specified in paragraph 3 of section D, subsection I, of this Article has passed, the Director-General shall issue a written request to States Parties which have not submitted all their declarations, as required in section D, subsection I, of this Article, to submit the required declarations and/or a written explanation of why the submission of the declarations is delayed. Such declarations and/or 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 paragraphs 108 of Article III, section D, subsection II, and paragraph 18 of Article VII.

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

4. Notwithstanding the action taken by the Director-General specified in paragraphs 1 to 3 above, if any State Party has not submitted its initial 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 paragraph 3 of section D, subsection I, of this Article, the State Party may 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 section D, subsection II, of this Article, or a facility investigation;

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

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

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 time frame 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 12 month period, following the relevant deadline for submission established under paragraph 3 of section D, subsection I, of this Article, the following provisions shall apply 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 of States Parties 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 or review of the operation of these measures, but may not vote on the issue.