ANNEX D INVESTIGATIONS
I. GENERAL
PROVISIONS
II. FIELD
INVESTIGATIONS
III. FACILITY
INVESTIGATIONS
ANNEX E CONFIDENTIALITY PROVISIONS
I. GENERAL
PRINCIPLES FOR THE HANDLING OF
CONFIDENTIAL INFORMATION
II. CONDITIONS
OF STAFF EMPLOYMENT RELATING TO
THE PROTECTION OF CONFIDENTIAL
INFORMATION
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General Provisions
ARTICLE I
[[GENERAL
PROVISIONS]
[1. Each
State Party to this Protocol reaffirms its obligations under the Biological and
Toxin Weapons Convention [and the Protocol for the Prohibition of the Use in
War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods
of Warfare] and particularly undertakes:
(a) Never to develop, produce, stockpile, or
otherwise acquire or retain;
(i) Microbial or other biological agents,
or toxins whatever their origin or method of production, of types and in
quantities that have no justification for prophylactic, protective or other
peaceful purposes;
(ii) Weapons,
equipment or means of delivery designed to use such agents or toxins for
hostile purposes or in armed conflict;
(b) Never to
transfer to any recipient whatever, directly or indirectly, and in any way to
assist, encourage, or induce any State, group of States or international
organizations to manufacture or otherwise acquire any of the agents, toxins,
weapons, equipment or means of delivery specified in Article I of the
Convention;
(c) To exclude
completely the possibility of the use of bacteriological (biological) agents
and toxins as weapons;
(c) bis To reaffirm that under any circumstances the
use, development, production and stockpiling of bacteriological (biological)
and toxin weapons are effectively prohibited under Article I of the Convention;
(d) To
facilitate and have the right to participate in the fullest possible exchange
of equipment, materials and scientific and technological information for the
use of bacteriological (biological) agents and toxins for peaceful purposes and
not to hamper the economic and technological development of States Parties;
(d) bis Never to use the provisions of the Convention
to impose restrictions and/or limitations on transfers for purposes consistent
with the objectives and provisions of the Convention of scientific knowledge,
technology, equipment and materials;
(d) ter To make specific measures to ensure
effective and full implementation
of
Article X of the Convention.]
OR
[1 bis This Protocol [,being
supplementary to the Convention,] is aimed at strengthening the
effectiveness and improving the implementation of the Convention through
measures set out therein which include, inter
alia:
(a) Declarations to be submitted and visits
to be conducted in accordance with Article III, section D of this Protocol;
(b) Investigations to be conducted in
accordance with Article III, section G of this Protocol;
(c) Measures to be taken in accordance with
Article VII of this Protocol to enhance compliance and ensure effective and
full implementation of Article X of the Convention.]
[2. Each
State Party to this Protocol undertakes not to use pests and vectors as a
method of warfare or for hostile purposes.]
[3. To
promote the goals of the Convention for a world free of biological weapons and
to promote these goals through cooperative endeavours, the implementation of
this Protocol shall include the requirement for multilaterally negotiated,
universal, comprehensive and non-discriminatory sensitive technology transfer
agreements.]
[4. In
implementing this Protocol, each State Party shall have the right to protect
commercial and proprietary information and national security information.]
[3 bis The measures set out in
this Protocol shall be implemented in a manner to ensure full protection of
commercial proprietary information and national security information. To this end, they shall be carried out in
the least intrusive manner consistent with the fulfilment of their objectives
pursuant to this Protocol. States
Parties shall have the right to protect commercial proprietary information and
national security information in accordance with the provisions of this
Protocol. This right may not be invoked
by a State Party to conceal evasion of its obligations not to engage in
activities prohibited under the Convention.]
[4+3 bis States Parties shall have the right to
protect commercial proprietary information and national security information in
accordance with the provisions of this Protocol. This right may not be invoked by a State Party to conceal evasion
of its obligations nor to engage in activities prohibited under the
Convention.]
[5. In
carrying out its responsibilities, the Organization shall consider only such
sources of information which are objective, unbiased, legal and do not violate
the sovereignty of States Parties.]
[6. Without
prejudice to the provisions on confidentiality, the relevant organs of the
Organization shall be entitled to information available with the Secretariat if
it is considered that
such information is necessary for the performance of functions entrusted to
those organs.]
[2 bis To enhance confidence in
the continued compliance with the Convention by all States Parties, through
increased transparency of relevant facilities and activities, information about
the implementation of the measures set out in this Protocol shall be routinely
provided to States Parties and to the relevant organs of the Organization in
accordance with the provisions of this Protocol.]
[6+2 bis To enhance confidence in the continued
compliance with the Convention by all States Parties, through increased
transparency of relevant facilities and activities, information about the
implementation of the measures set out in this Protocol shall be routinely provided,
in accordance with the provisions of this Protocol:
(a) To
States Parties;
(b) To
the relevant organs of the Organization if it is considered that such
information is necessary for the performance of functions entrusted to those
organs.]
[7. In
assuming the responsibilities and obligations under the Protocol, States
Parties shall not enact national legislation the provisions of which are
incompatible with the provisions of the Protocol.]
[4 bis Each State Party to this
Protocol shall, in accordance with its constitutional and legal processes,
adopt the necessary measures to implement its obligations under this Protocol.]
[7+4 bis Each State Party to this Protocol shall, in
accordance with its constitutional and legal processes:
(a) Ensure
that this Protocol and its national legislation are compatible with each other;
(b) Adopt
the necessary measures to implement its obligations under this Protocol.]
[8. All
provisions under the Protocol shall apply to States Parties on [a
non-discriminatory] an equal basis.]
[5 bis 9. Without prejudice to their rights and
obligations under Article V of the Convention, the States Parties to this
Protocol undertake to consult one another and to cooperate in solving any
problems which may arise in relation to the object and purpose of the
Convention or the full and effective implementation of the measures set out in
this Protocol by all States Parties, inter
alia through the procedures for consultation, clarification and cooperation
set out in Article III, section E of this Protocol.]
[6 bis 10.
This Protocol, being [supplementary] [and] [additional] to the Convention,
shall not be interpreted as in any way modifying or amending the Convention, or
limiting or detracting from the rights and obligations assumed by any State
under the Convention.]]
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Definitions of Terms and Objective Criteria
ARTICLE II
[DEFINITIONS
[CATEGORY I:
FOR THE PURPOSES OF THIS PROTOCOL:]
[1. Bacteriological
(biological) and toxin weapons
mean
A type of
weapon, the damaging effects of which are based on the properties of biological
agents and toxins, to cause harm to human beings, animals or plants.
The term
“Bacteriological (biological) and toxin weapons” together or separately shall
be applied to the following:
(1) Materials containing biological agents
or toxins whatever their origin or method of production, of types and in
quantities that have no justification for prophylactic, protective or other
peaceful purposes;
[(2) Weapons, any apparatus, equipment, device
or means of delivery designed to use and loaded with such agents or toxins, or
possessing special design features for the loading and use of such agents or
toxins for hostile purposes or in armed conflict. It also applies to a vector (insect, pest or any living organism)
intentionally infected with microbial agents for hostile purposes or in armed
conflict.]]
[2. Biological
agents mean
Any
organism, either natural or modified, which can cause death, disease and/or
incapacitate human beings and animals or which can also cause death, disease or
harm to plants.
For the
purpose of implementing this Protocol, a list of biological agents [relevant
to declarations] is contained in Annex A.]
[3. Toxin means
Any
compound originated from [any organisms including]
microorganisms, animals or plants, whatever their method of production, whether
natural or modified, [or which are chemically synthesized,] which
can cause death, disease or other harms to human beings, animals or plants.
For the
purpose of implementing this Protocol, a list of toxins [relevant to
declarations] is contained in Annex A.]
[4. Hostile
purposes mean
[Any
purpose, which has no prophylactic, protective or other peaceful intention.]
[4 bis (a) The
use of bacteriological (biological) or toxin weapons or the threat of use [by
a State] with a view to inflicting military, economic, [moral] or other
kind of damage;
[(b) Any
other purpose, which has no prophylactic, protective or other peaceful
intention.]]]
[5. Purposes
not prohibited by the Convention mean
(a) Purposes, involving the identification, prevention and treatment of
diseases caused by biological agents and toxins;
(b) Purposes, linked with protection from
biological and toxin weapons;
(c) Other peaceful purposes, including
industrial, agricultural, veterinary, research, medical and pharmaceutical
purposes.]
[5 bis Any purpose, which has
prophylactic, protective or other peaceful intention.]
6. Facility
means
Any [room(s),]
laboratory(ies), buildings, or parts of buildings, or other structures [either
at a fixed location or mobile] which [can be or] is (are) [to
be] used to conduct activity(ies) [in the field of biotechnology
biology] [related to
the Convention]. Such a facility
may have an identifiable boundary and/or a single operational control.
7. [Site
means
The
location and integration of one or more facilities within a geographically
and/or physically defined area which may have an identifiable boundary, which
can not be smaller than a building.]
[8. The
receiving or visited State Party and the host State Party
The
receiving or visited State Party means the State Party on whose territory or in
any other place under whose jurisdiction or control an investigation or a visit
is proposed, taking place or has been completed. In the specific case where an
investigation or a visit is proposed, taking place or has been completed on the
territory of a State Party/State, but in a place under the jurisdiction or control
of another State Party/State, the former State Party/State shall not be the
“receiving or visited State Party”, but shall be defined as the “host State
Party/State of a visit or an investigation”.]
[CATEGORY II: DEFINITIONS FOR THE PURPOSES OF ARTICLE III,
SECTION D ON DECLARATIONS AND DECLARATION FORMATS:]
[9. Biological defence programme and/or
activities (against biological and toxin weapons)
means
[Programme and/or activities designed to detect and/or assess the impact
of any use of microbial or other biological agents or toxins for hostile
purposes or in armed conflict, and/or to prevent, reduce and/or neutralize the
impact of biological and toxin weapons on humans, animals or plants.]
[9 bis Programme in legal
conformance with the national legislation or activities designed to detect,
assess, prevent, reduce or neutralize the impact of biological or toxin weapons
on humans, animals or plants.]
[9 ter bis Programme
and/or activities [involving research and/or development, testing and evaluation,
production and storage] designed to detect and/or assess the impact of any use
of microbial or other biological agents or toxins for hostile purposes or in
armed conflict, and/or to prevent, reduce and/or neutralize the impact of
biological and toxin weapons on humans, animals or plants.]
[10. Biological defence facility
means
Facility
which works in a biological defence programme and/or activities (against
biological and toxin weapons).]
[11. High
biological containment [(BL-3 - WHO and OIE classification)] means
Any room or
suite of rooms, laboratory(ies) or other buildings or structures with the
following features:
(a) Designed or used to handle and work with
biological agents causing disease and known or suspected to meet either:
(i) The classification criteria of Risk
Group 3 human pathogens, as determined by each State Party for itself and
specified in the 1993 WHO Laboratory Biosafety Manual; or
(ii) The classification criteria of Group 3
animal pathogens, as determined by each State Party for itself and specified in
the Amendment to the International Animal Health Code adopted by the
International Committee of the OIE during its 66th General Session, 1998; [or]
[and]
(b) Having characteristics consistent with
the guidelines specified in the 1993 WHO Laboratory Biosafety Manual with
respect to the maintenance of negative air pressure to the environment, access
control and the rendering safe of exhaust air and of contaminated material and
waste, including effluents by HEPA filtration, steam sterilization,
incineration or other physical or chemical means.]
[11 bis The term “high
biological containment [(BL-3 - WHO classification)]” means
(b) Any
room or suite of rooms, laboratory(ies) or other buildings or structures which
meet(s) the requirements specified in the 1993 WHO Laboratory Biosafety Manual
with respect to the maintenance of negative air pressure to the environment,
access control and the rendering safe of exhaust air and of contaminated
material and waste, including effluents by HEPA filtration, steam
sterilization, incineration or other physical or chemical means.]
[12. Maximum
biological containment [(BL-4 - WHO and OIE classification)] means
Any room or
suite of rooms, laboratory(ies) or other buildings or structures with the following
features:
(a) Designed or used to handle and work with
biological agents causing disease and known or suspected to meet either:
(i) The classification criteria of Risk
Group 4 human pathogens, as determined by each State Party for itself and specified
in the 1993 WHO Laboratory Biosafety Manual; or
(ii) The classification criteria of Group 4
animal pathogens, as determined by each State Party for itself and specified in
the Amendment to the International Animal Health Code adopted by the International
Committee of the OIE during its 66th General Session, 1998; [or] [and]
(b) Consistent with the guidelines specified
for high biological containment
(BL-3 - WHO
classification) and the additional requirements specified in the 1993 WHO
Laboratory Biosafety Manual for BL-4, as follows:
(i) An airlock system for a
complete change of clothing and a shower on exit;
(ii) A pass-through
autoclave system;
(iii) For work with human or
zoonotic pathogens, a Class III biological safety cabinet and/or self-contained
positive-pressure ventilated suits and a special chemical decontamination
shower for leaving the containment area;
(iv) Collection and
decontamination of hand washing and shower water;
(v) HEPA filtration of
incoming air;
(vi) For work with animal
pathogens Class I, II or III biological safety cabinets.]
[12 bis Maximum biological
containment [(BL-4 - WHO classification)] means
(b) Any
room or suite of rooms, laboratory(ies) or other buildings or structures with
the following features, in addition to the features specified for high
biological containment (BL-3 - WHO classification):
(a) (i) Controlled access. Entry and exit of personnel and supplies
must be through an airlock or pass-through system. On entering, personnel must put on a complete change of clothing;
before leaving, they should shower before putting on their street clothing;
(b) (ii) Controlled air system. Negative pressure must be maintained in the
facility by a mechanical, individual, inwardly directed, HEPA-filtered supply,
and an exhaust air system with HEPA filters in the exhaust and, where
necessary, in the intake;
(c) (iii) Decontamination of effluents. All fluid effluents from the facility,
including shower water, must be rendered safe before final discharge;
(d) (iv) Sterilization of waste and
materials. A double-door, pass-through
autoclave must be available;
(e) (v) An efficient primary containment system
must be in place. For work with human
pathogens or zoonoses, primary containment must be provided by use of, one or
more of the following: (i) Class III
biological safety cabinets, or (ii) positive-pressure ventilated
suits. In the latter case a special
chemical decontamination shower must be provided for personnel leaving the suit
area. For work with animal pathogens, primary containment must be provided by
use of Class III biological safety cabinets;
(f) (vi) Airlock entry ports for specimens and
materials.]
[13. Plant pathogen containment means
Any
laboratory or other building or structure specifically designed and used to
handle and work with plant pathogens and pests that are of economic importance
to a specific area endangered thereby, and not yet present there, or present
but not widely distributed and which are also being controlled by official regulatory
measures. Such a design includes access
control through a vestibule bounded by outer and inner doors, hand washing
facilities, the ability to apply negative or positive pressure to the
environment, the exhaust air sterilized by HEPA filtration, incineration, or
other physical or chemical means and the ability to control the internal
temperature. Decontamination of all
waste is achieved by a suitable chemical or physical process before exhausting
into a public or communal system.]
14. Diagnostic
facility means
Facility
which tests only samples for the purpose of diagnosis of subclinical, clinical,
or latent infection or intoxination in humans, animals or plants; or for the
purpose of analysis of microbial or toxin contamination in food, water, soil
and air by means of detection, isolation, and/or identification of microbial or
other biological agents or toxins and serology.
15. Genetic
modification means
A process
of arranging and manipulating nucleic acids of an organism and microorganisms
to produce novel molecules or to add to them new characteristics or to modify
the original characteristics.
16. Primary production
containment means
[Features
in any system of equipment for the production of microbial or other biological
agents, or toxins, that are designed to separate the production process from
the environment thereby preventing
release that could compromise the health of workers or cause other harm to the
product or the environment. Sample
collection, addition of material, transfers to another system, and final
discharge of exhaust gases, effluents and wastes, are performed so as to
prevent such release.] [Before
discharge, exhaust gases, effluents and wastes from the system should be
decontaminated by appropriate physical or chemical means.]
17. Vaccine
means
Preparations,
including live‑attenuated, killed or otherwise modified microorganisms or
components obtained from organisms, including inactivated toxins and nucleic
acids, which, when introduced by any routes into a human being or animal,
induces in it a specific immune response for prophylaxis or protection against
infectious disease(s) or intoxination [and generally efficient and safe for
human beings and/or animals].
18. Production
means
Cultivation
of replicative biological agents by any means, or synthesis, or biosynthesis,
or extraction of non-replicative biological agents including toxins.
19. Aerobiology
means
The study
of or work with aerosols of materials comprising biological agents and toxins
or simulants in a facility or open air.
[20. Simulants
of biological agents and toxins mean
Substances
of biological, chemical or other origin which, due to their characteristics are
used for research on the properties of biological agents or toxins.]
21. Plant
inoculant means
[Any formulation containing a pure or
predetermined mixture of microorganisms which alter the properties of plants or
crops.]
22. Biocontrol agent
means
[A living organism or biologically
active substance originated from such organism used for the prevention,
elimination or reduction of plant diseases and pests or unwanted plants.]
[CATEGORY III]
The following definitions of terms relating to
other specific measures can be moved to the appropriate sections of the
Protocol after discussion.
23. Approved
equipment means
The devices
and instruments necessary for the performance of the visiting or investigation
team’s duties as approved by the First and subsequent Conferences of States
Parties in accordance with provisions contained in Annex D, section I,
paragraphs 34 and 35.
24. Perimeter
means
In case of
facility investigation, the boundary around facility[(ies)], defined by
either geographic coordinates or a description on a map:
(a) Requested perimeter means the
perimeter requested by a requesting State Party, in accordance with the
provisions contained in Annex D, section III, paragraph 1 (d);
(b) Alternative perimeter means the
perimeter as specified by the receiving State Party alternatively to the
requested perimeter, in accordance with the provisions contained in Annex D,
section III, part C;
(c) Final perimeter means the
perimeter that resulted from negotiations between the investigation team and
the receiving State Party, in accordance with the provisions contained in Annex
D, section III, part C.
25. Point
of entry/point of exit means
A location
designated by the State Party pursuant to this Protocol for the in-country
arrival of investigation and visiting teams or for their departure after
completion of their mission.
[26. Threshold quantity for listed biological
agent or toxin means
A minimum
quantity of listed biological agent or toxin handled and stored at a specified
type of facility on the territory of a State Party that needs to be notified
and justified to the Organization by the State Party concerned. The justification of such quantity means
incorporating all necessary data to explain that amount of materials containing
biological agent or toxin is required for protective or other peaceful
purposes.
For the
purpose of implementing this Protocol threshold quantities of listed biological
agents and toxins for specific types of facilities and different State Parties
to the Protocol are contained in Annex A.]]
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Measures to Promote Compliance
ARTICLE
III, SECTION D, SUBSECTION I
INITIAL DECLARATIONS
(A) OFFENSIVE BIOLOGICAL AND TOXIN PROGRAMMES
AND/OR ACTIVITIES CONDUCTED PRIOR TO ENTRY INTO FORCE OF THE PROTOCOL FOR EACH
STATE PARTY
5. Each
State Party shall declare, in accordance with paragraphs 1 to 3 above whether
at any time since [17 June 1925] [1 January 1946] [26 March 1975]
until entry into force of the Protocol
for that State Party, it has
[conducted any offensive biological
and toxin programmes and/or activities.]
OR
[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 State Party shall provide summaries of any a summary of any such programme(s) and/or
activities, indicating work performed concerning research and development activities,
of any use, and of any work performed on production, [testing,
and evaluation,]
weaponization, and/or
stockpiling or acquisition of microbial or other biological
agents, or toxins and/or weapons. 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 ... .]]] The
State Party shall also provide a summary of activities performed to destroy
such agents, toxins and/or weapons and/or to divert them to peaceful purposes.
When any such programme(s) and/or activities took place after 26 March
1975, or where the products of such programme(s) and/or activities were not
destroyed or diverted to peaceful purposes by 26 December 1975, the State Party
shall additionally declare the information required in the appropriate format
in the Appendix.
(B) DEFENSIVE BIOLOGICAL AND TOXIN PROGRAMMES
AND/OR ACTIVITIES CONDUCTED PRIOR TO ENTRY INTO FORCE OF THE PROTOCOL FOR EACH
STATE PARTY
6. Each
State Party shall declare, in accordance with paragraphs 1 to 3 above, whether
at any time [since [1 January 1946] [26 March 1975, or,
if it acceded to the Convention after 26 March 1975, since the date of
entry into force of the Convention for that State Party] [the date 30 years prior to entry into
force of the Protocol] [31 December 1991]] [starting five years
prior to the first annual declaration for that State Party] [until entry
into force of the Protocol for that
State Party] it has conducted [research and development]
programmes and/or activities as specified in subparagraph (b) below as part of
any effort to [directly] protect or [directly]
defend humans, animals or plants against the use of microbial or other
biological agents or toxins for hostile purposes or in armed conflict. [If so, the State Party shall provide a summary of 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.]
The State Party shall additionally declare information on such
programmes and/or activities performed during the period from [31 December
1991] [the date ten years prior to entry into force of the Protocol] until
entry into force of the Protocol for that State Party, as required in the
appropriate format in the Appendix.
7. Each
State Party shall declare any information that subsequently comes to its notice
that would have been required to have been declared pursuant to paragraphs 5
and 6 above had such information been known one year after this Protocol
entered into force for that State Party, not later than 180 days after such
information is discovered.
(H) WORK
WITH LISTED AGENTS AND/OR TOXINS
14. Each
State Party shall declare, in accordance with paragraphs 1 to 3 above, each
facility which, during the previous calendar year, has conducted any [of the
following] activities with [pathogenic strains of] agents and/or toxins listed
in Annex A [:
[(a) Research and development performed in
areas protected by high biological containment (BL-3);]
(b) Production [with the purpose of
recovery] of [one or more] [any single] agent[s] and/or toxin[s] listed in
Annex A, using:
(i) Any fermenter(s)/bioreactor(s) with a
total internal volume of [10] [25] [50] [100] litres or more; or
(ii) Continuous or perfusion
fermenters/bioreactors with a flow rate capable of exceeding [2] litres an
hour; or
(iii) A chemical reaction vessel or equipment
used for recovery with a total internal volume of [10] [50] [100] litres
or more; or
(iv) More than [1,000] [2,000] embryonated
eggs on an annual basis; or
(v) More than [100] [1,000] [2,500] litres
of tissue culture or other medium on an annual basis;
(c) Modification of any nucleic acid
sequence of agents, or coding for toxins, listed in Annex A [which would
increase pathogenicity/virulence or facilitate the production of toxins or
their toxic subunits] [which creates or results in change of antigenicity or
immunogenicity, increased antibiotic resistance, stability, or toxic or
disease-causing properties, or ease of production];
[(d) Insertion of a nucleic acid sequence
coding for any pathogenicity/virulence factor from an agent or toxin listed in
Annex A, or for a subunit of such toxin, into any organism, resulting in a
genetically modified organism with increased disease-causing or toxic
properties [(including facilitating the production of the toxin or its toxic
subunit(s))];]
OR
[(d) Insertion of a nucleic acid sequence from
an agent or coding for any toxin listed in Annex A or coding for a toxic
subunit of such a toxin, into any organism, resulting in a genetically modified
organism with imposed disease-causing or toxic properties characteristic of one
or more agents and/or toxins listed in Annex A or facilitating the production
of any such toxin or its toxic subunit;]
[(e) Intentional aerosolization of any agent
and/or toxin listed in Annex A or any work with aerosolized agents and/or
toxins listed in Annex A in/by
(i) An explosive aerosol test chamber; or
(ii) A dynamic aerosol test chamber; or
(iii) A static aerosol test chamber; or
(iv) Open air; or
(v) Application to the respiratory tract of
an animal;]
OR
[(e) Intentional
aerosolization of any agent and/or toxin listed in Annex A in:
(i) An
explosive aerosol test chamber; or
(ii) Any other aerosol test chamber that has
a total internal volume of 5 m3 or more;]
[(f) Maintenance of culture collections in
maximum or high biological containment [(BL-3 or BL-4 - WHO [and OIE]
classification)] installations.]]
[15. A
facility shall not be declared under paragraph 14 above if it works with listed
agents and/or toxins only for the purpose of [detection, identification or]
diagnosis of human, animal or plant disease, or for carrying out medical
treatment or prophylactic activities, or for testing for food or water hygiene,
or for testing the efficacy of antimicrobial preparations, vaccines, toxoids or
immunoglobulin preparations [, pesticide preparations, or for non-clinical
studies for the safety of agricultural pesticides].]
II. FOLLOW-UP AFTER SUBMISSION OF DECLARATIONS
1. The
Technical Secretariat shall receive, process, analyse, and store declarations
submitted by States Parties in accordance with the provisions of this Protocol.
2. Upon
receipt of a request by a State Party which has submitted its own declarations,
the Director-General shall make available to that State Party in accordance
with the provisions on confidentiality contained in Article IV and Annex E of
this Protocol copies of the initial and/or annual declarations of other States
Parties, as specified in the request.
The Director-General shall simultaneously inform the State(s) Party(ies)
concerned that copies of their declarations have been made available to the
requesting State Party.
[3. In
order to [determine that the declarations submitted by States Parties are
complete and accurate] [promote the accurate fulfilment of the declaration
obligations under this Protocol], in accordance with the provisions set out in
this Protocol increase confidence in
the consistency of declarations submitted by States Parties and to encourage
submission of comprehensive declarations, the Technical Secretariat shall:
[(a) Process
and analyse the declarations;]
(b) Conduct a limited number per year of [randomly-selected]
visits to [declared] [biodefence and BL4 with the principle of
proportionality] [BL4] facilities [declared pursuant to Article III,
section D, subsection I, parts [(C),
(D), (E), [(G),] (H) and (I)] [in accordance with the procedures set out
in part A below];
[(c) If
it, in its analysis pursuant to paragraph 3 (a) above, identifies any
ambiguity, uncertainty, anomaly or omission [of a purely technical
nature] related solely to the content of the declaration, seek
clarification from the State Party concerned, in accordance with the procedures
set out in part B below;]
(d) Provide technical assistance to States
Parties to help them compile individual facility and national declarations
including, if requested, by means of visiting a State Party, in accordance with
the procedures set out in part C below.]
4. A
State Party which identifies any ambiguity, uncertainty, anomaly or omission in
the declaration of another State Party may seek clarification from the State
Party concerned, in accordance with the provisions of section E of this Article,
or it may initiate the clarification process set out in part B below.
Visit schedule
5. The
total number of all visits conducted pursuant to this Article [shall be
approved by the [First] Conference of States Parties and] shall not exceed
[30] [75] [140] [...] in each calendar year. The Third Conference of
States Parties shall review the total numbers of visits in light of experience
gained in the operation of this section.
[6. The
number of visits pursuant to paragraph 3 (b) shall be at least a half of the
total for visits specified in paragraph 5.
The number of visits pursuant to paragraph 3 (d) and
part C shall be [at least] [not more than] one quarter of the total for
visits specified in paragraph 5. [The
first visit in any year resulting from the procedure set forth in paragraph 3
(c) or paragraph 4 shall be deducted from the quota allocated for visits
pursuant to paragraph 3 (b). Thereafter
any visits required under paragraph 3 (c) or paragraph 4 shall be deducted
alternately from the quotas allocated to paragraph 3 (d) and part C and
paragraph 3 (b).] OR [All visits in any year resulting from the
procedures set forth in paragraphs 3 (c), 3 (d) and 4 shall be deducted
from the total number allocated in paragraph 5. The resultant number, once all deductions are made, will be the
new number of visits pursuant to paragraph 3 (b).]]
6. The quota for individual
types of visits shall be as follows:
(a) The
quota for visits pursuant to paragraph 3 (b) shall be half of the total for
visits specified in paragraph 5;
(b) The
quota for visits pursuant to paragraph 3 (d) and part C shall be one quarter of
the total for visits specified in paragraph 5;
(c) Subject
to the provisions in paragraph 5 above and subparagraph (d) below, the total
number of visits conducted each year for each category of visits referred to in
subparagraphs (a) and (b) above may exceed the quota allocated for the
respective category of visit if the Executive Council deems it
appropriate. In deciding on any
reallocation, the Executive Council shall take into account the budget for
visits and the objectives set forth in paragraph 3;
(d) The
first visit in any year resulting from the procedures set forth in paragraphs 3
(c) or 4 shall be deducted from the total number of visits conducted pursuant
to paragraph 3 (b). Thereafter any
visits required under paragraph 3 (c) or 4 shall be deducted alternately from
the quotas allocated to visits conducted pursuant to paragraph 3 (d) and part
C, and visits conducted pursuant to paragraph 3 (b).
[7. The
initial Review Conference held pursuant to Article XIII may revise the figures
for the categories of visits pursuant to paragraphs 3 and 5 of this subsection,
taking into account the resources available and the implementation of this Protocol. Thereafter each Conference of States Parties
may revise the figures allocated to each category of visits specified in
paragraphs 5 and 6.]
8. The
Director-General shall not later than seven days after the first session of the
year of the Executive Council notify all States Parties of the schedule for the
[voluntary] visits planned for that year.
9. The
Director-General shall submit to the Executive Council every three months, or
earlier if necessary, a report on the implementation of visits of each type and
on outstanding invitations for voluntary assistance and [voluntary
clarification visits]. [If it judges it
necessary, the Executive Council may decide to adjust the initial allocations,
between the types of visits, proposed by the Director-General in accordance
with paragraphs 5 and 6.] [The number
of [randomly-selected visits] [transparency visits] shall over a five-year
period be fixed to ... visits.] [If
during the year, the numbers of invitations for voluntary assistance and/or
[voluntary clarification visits] exceed the initial provision, the
Director-General shall reduce the provision for [randomly-selected visits]
[transparency visits] in order to accommodate the extra voluntary assistance
and/or [voluntary clarification visits] correspondingly. The Director-General shall notify the
Executive Council of all changes to the visits schedule at its next session.]
Annual programme
7. 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 bis 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 quota pursuant to paragraph 6, 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.
8 bis 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 paragraphs 3 (c) and 4.
Review of annual programme
9. The Director-General
shall submit to the Executive Council every three months, or earlier if
necessary, a report on the implementation of visits of each type and on
outstanding invitations for voluntary assistance and voluntary clarification
visits. If it judges it necessary, the
Executive Council may decide to adjust the initial allocations, between the types
of visits, specified in paragraph 6.
The Director-General shall notify the Executive Council of any changes
to the visit schedule at its next session.
9 bis If the procedure in paragraph 6 (d) 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 reallocations and make
any readjustments as necessary.
[(A) [RANDOMLY-SELECTED
VISITS] [TRANSPARENCY VISITS]
Purpose
[10. The
Technical Secretariat shall conduct, in accordance with this Article, a
limited number per year of [randomly-selected visits] [transparency visits]
pursuant to paragraph 3 (b) of
this subsection, which shall be
confidence-building in nature, to [declared] [biodefence and BL4] facilities. These visits shall, in through cooperation with the visited State Party to be visited,
promote the Protocol’s overall objectives of the Protocol by:
(a) Increasing
confidence in the consistency of declarations submitted by States Parties and
encouraging submission of comprehensive declarations; and also by
(ab) Enhancing
transparency of [declared] [biodefence and BL4] facilities and activities;
(b) [Promoting accuracy of declarations]
[Promoting the accurate fulfilment of the declaration obligations under this
Protocol]; and
(c) Helping
the Technical Secretariat, subject to
the provisions of this section, to acquire and retain a comprehensive and
up-to-date understanding of the [different types of] [biodefence and BL4]
facilities and activities declared globally.
11. In
addition, if so requested by the visited
State Party to be visited in its acknowledgement of receipt of
notification of the visit, the visit shall be extended by up to [1] [...]
two working day[(s)].
The purpose of any requested extension shall be 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.
OR
[10. The
Technical Secretariat shall conduct, in accordance with this Article, not more
than ... [randomly-selected visits] [transparency visits] per year,
which shall be confidence-building in nature, to [declared] [biodefence and
BL4] facilities. The primary purpose of
these visits shall be to confirm, in cooperation with the State Party to be
visited, that declarations are accurate and complete in accordance with
provisions set out in section D of this Article.
11. These
visits shall also serve to enhance transparency of declared facilities and
activities, provide, as requested and appropriate, technical advice or
information, [or implement technical assistance and cooperation activities or
programmes as specified in Article VII, section D, paragraph 19,] and [help] to
ensure that the Technical Secretariat acquires and retains a comprehensive and
up-to-date understanding of the different types of facilities and activities
declared globally.]
Selection of facilities
[12. [During
the course of each calendar year,] the Technical Secretariat shall randomly
select facilities [specified in paragraph 3 (b) of this subsection for a visit]
[from among all [declared] [biodefence and BL4] facilities]. The mechanism of selection shall be approved
by the first Conference of States Parties and may be amended by future
Conferences of States Parties.
13. In
selecting facilities to be visited, the Technical Secretariat shall utilize the
approved mechanism of selection on the basis of the following [weighting]
factors in order to ensure that:
(a) Such visits shall be spread among the
[broadest possible range of] [two types of] facilities subject to the
provisions of this section, in terms of their scientific and technical
characteristics;
[(b) Such visits shall be selected on the basis
of the principle of proportionality;]
(c) No State Party shall receive more than
... such visits in a five-year period;
(d) No facility shall be subject to more
than ... such visits in a five-year period;
(e) No State Party shall receive more than
... such visit per year;
[(f) Such visits are distributed as widely and
equitably as possible among States Parties submitting declarations;]
(g) The prediction of when any particular
facility will be subjected to such a visit shall be precluded.]
OR
[12. During the course of each calendar
year, the Technical Secretariat shall randomly select facilities to be visited
from among those specified in paragraph 3 (b).
The mechanism of random selection shall be appropriately weighted
to ensure that:
(a) Visits are distributed as widely and
equitably as possible among States Parties submitting declarations and among a
broad range of types of eligible facilities;
(b) All States Parties submitting
declarations are visited over time, but no State Party or individual facility
receives an unreasonable number of visits taking into account, inter alia, the number of visits it
has received in previous years;
(c) Prediction of when any particular
facility will or will not be subject to a visit is precluded.
13. The
mechanism method of selection, and in particular the provisions of
subparagraph (a) below, shall be approved reviewed, and revised if necessary, by the First Third Conference of States Parties, and
may be adjusted by future Conferences of States Parties in the light of
experience with implementation. The mechanism
method of selection shall be
designed to meet the following conditions, which may be revised by a Review
Conference held pursuant to Article XIII:
(a) The probability of a State Party receiving
a visit shall be proportional to the cube root of the number of declared
facilities in that State Party;
(b) The maximum number of visits which a
State Party may receive in any year shall be limited to a number proportional
to the cube root of the number of declared facilities in that State Party. This maximum number shall be higher than the
average number of visits expected in accordance with subparagraph (a), but
shall be not more than 6 per cent of the total number of visits pursuant to
paragraph 3 (b) carried out in that year;
(c) No State Party with declared facilities
shall receive less than 0.5 per cent of the total number of visits pursuant to
paragraph 3 (b) carried out in any five year period;
(d) No individual facility shall receive more
than three visits pursuant to paragraph 3 (b) in any five year period.
Until the Conference of States
Parties approves the mechanism, facilities shall be selected using an interim
mechanism designed to meet the above conditions.]
Duration
14. Visits pursuant to this part may last up
to two consecutive working days. This
time excludes the inspection of approved equipment. The duration of the visit may be extended if the visited State
Party and visiting team so agree.
15. If
so requested by the State Party to be visited in its acknowledgement of receipt
of notification of the visit, the visit shall be extended by up to [1] [3]
two days for the visiting team to
provide technical advice or information, [or to provide any of the
technical assistance and cooperation activities contained in the programmes as
specified in Article VII, section D, paragraph 19,] requested by
the State Party to be visited. [The
resources required for this assistance visit shall be charged against the
technical assistance portion of the budget of the Organization.]
Equipment
[16. The
visiting team shall only bring to the visited facility only items from the list of approved
equipment. The visiting team shall normally only bring to the visited
facility items of equipment meeting the specifications for, [instant
developing cameras, tape voice
recorders,] and personal
computers and protective equipment.
Any other items of approved equipment may only be brought with the
prior approval of the visited State Party.
Any request for additional items of approved equipment shall be kept to
the minimum necessary and shall be included in the notification. The visited State Party shall indicate its
response in its acknowledgement of the notification.
17. [Instant developing cameras and tape
voice recorders shall only be used
for collecting factual information for the visit report. Instant
developing cameras shall only be operated by the representatives of the visited
State Party. The use and disposition of cameras such equipment during the visit 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 bringing
and use of additional items of approved equipment at the declared facility
shall be with the agreement of the visited State Party.]
OR
[16. The
visiting team shall bring to the visited facility only items from the
appropriate list of approved equipment.
The use and disposition of equipment during the visit shall be at the
discretion of the visited State Party.
17. If
required, the visited State Party shall provide protective equipment meeting
the specifications of appropriate
items from the appropriate list of approved equipment. If agreed by the visited State Party, or if
the visited State Party is unable to provide such equipment, the visiting team
shall be permitted to use its own protective equipment from the appropriate
list of approved equipment.]
Administrative arrangements
18. The visited State Party shall provide or
arrange for the amenities necessary for the visiting team such as communication
means, interpretation services to the extent necessary for the performance of
interviewing and other tasks, in-country transportation, working space,
lodging, meals and urgent medical care.
The visited State Party may, to the extent possible, provide approved
equipment as requested by the visiting team.
The visited State Party shall be reimbursed by the Organization for any
assistance provided pursuant to this paragraph within 30 days after receipt of
a detailed and validated claim from the visited State Party.
PRE-VISIT ACTIVITIES
Mandate
19. The Director-General shall issue a
standard mandate for the visit. The
mandate shall be confined to the purposes set out in paragraphs 10 and 11 of
this subsection. The mandate shall
contain:
(a) The name of the visited State Party;
(b) The name of the host State Party/State,
if applicable;
(c) The name and location of the facility to
be visited;
(d) The declaration submitted by the facility;
(e) The names of the leader and other
members of the visiting team;
(f) The approved equipment to be used [agreed
to by the visited State Party] during the visit in accordance with
paragraphs 16 and 17 above;
[(g) Operational
instructions to the visiting team necessary for the visiting team to fulfil its
mandate;]
[(h) Specific objective to be achieved by the
visiting team.]
20. If
the visited State Party has requested in its acknowledgement of receipt of the
visit notification, that the visiting team provide technical advice or
information, [or to provide any of the technical assistance and
cooperation activities contained in the programmes as specified in Article VII,
section D, paragraph 19,] such activities shall, as
appropriate, be added to the visit mandate to be conducted at the end of the
visit activities. The addendum to the
visit mandate shall be made available to the State Party to be visited as soon
as possible before the commencement of the visit.
21. The
mandate for each visit shall be issued by the Director-General to the visiting
team leader.
Notification
22. The Director-General shall notify the
State Party to be visited [and, if applicable, the host State Party]
[2] [7] [30] 14 working days
before the arrival of the visiting team at the point of entry, of its intention
to conduct a visit to a declared facility; and at the same time, shall make
available to the State Party to be visited the mandate for the visit. The State Party to be visited shall
acknowledge receipt of the notification within [12 hours] [24 hours]
[two days] after receipt of the notification. The notification shall include:
(a) The name of the State Party to be
visited;
(b) The name of the host State Party/State,
if applicable;
(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) The visit mandate;
[(h) Additional
approved equipment the visiting team requests to bring to the visited facility
pursuant to paragraph 16 above;]
(i) Information on the existing cooperation
and assistance activities or programmes, if any, which the Technical
Secretariat considers may be applicable to the facility to be visited and from
which the facility could benefit.
23. In
its acknowledgement of receipt, the State Party shall provide its response to
the request for additional approved equipment and it may also indicate whether
it requires technical advice and information [and specify which
technical assistance and cooperation activities contained in the programmes as
specified in Article VII, section D, paragraph 19, it requests] to
be provided by the visiting team, without prejudice to its right to
request technical advice and information at any time during the visit which
shall be provided after conclusion of the visit.
[23 bis The State Party to be visited shall
acknowledge receipt of the notification within 24 hours after
receipt. Within three days of receipt,
the State Party, as a rule, shall confirm acceptance of the dates proposed for
the visit, but it may, in exceptional circumstances, propose alternative dates
occurring within 30 days of receipt of the notification. The Technical Secretariat, as a rule, shall
accept such proposed alternative dates, but may, if operational requirements so
dictate, propose other dates occurring within 30 days of the issuing of the
notification. If a State Party can not
accept these dates, its proposed alternative dates shall be the dates for the
visit.]
Appointment of visiting team
24. The Director-General shall appoint the
members of the visiting team from among only the full-time personnel of the
Technical Secretariat designated in accordance with Annex D, section I,
paragraphs 1 to 10, taking into account the specific nature of the facility to
be visited. The members of the visiting
team shall be selected on as wide an equitable geographical basis as
possible. The Director-General shall
limit the size of the visiting team to the minimum necessary for the proper
fulfilment of the mandate. In any event
the team shall not exceed four members.
No national of the State Party to be visited [, or, if
applicable, the host State Party,] shall be a member of the visiting
team.
Designation of visited State Party
representatives
25. The
visited State Party may designate personnel to assist visited facility
personnel, prepare for and host the visiting team. The visited State Party shall designate visited facility
personnel to accompany the visiting team for the duration of the visit.
ACTIVITIES UPON ARRIVAL OF THE
VISITING TEAM
Inspection of approved equipment
26. The
State Party to be visited shall have the right to inspect the equipment of the
visiting team including the additional equipment the State Party to be visited
approved, to ensure that it is properly sealed, appears on the list of approved
equipment and conforms to the standards as set out in Annex D, section I,
paragraph 35. The visited State Party
may exclude items of equipment that do not conform to the provisions set out in
Annex D, section I, paragraph 40, as well as paragraphs 16 and 17
above, and may retain them at the point of entry.
CONDUCT OF THE VISIT
27. The visiting team and the visited State
Party shall cooperate with each other to fulfil the mandate while protecting
the interests of the visited State Party.
28. In this regard the
visited State Party shall:
(a) Provide access to the visiting team to
the facility to be visited [and sufficient access to fulfil its mandate
within the visited facility]. The
nature and extent of access inside the facility shall be at the discretion of
the visited State Party;
(b) Allow the visiting team to conduct the
activities, described in paragraph 35 of this subsection, proposed by the
visiting team as necessary to fulfil its mandate;
(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 34
and 35 are not possible.
29. The
visiting team shall:
(a) Collect only that information necessary
to carry out its mandate and treat any information, documents and data obtained
during the visit, which contain commercial proprietary or national security
information and which are identified as such by the visited State Party, as
confidential and handle such information, documents and data in accordance with
the confidentiality provisions of this Protocol;
(b) Arrange its activities so as to ensure
the timely and effective discharge of its duties in accordance with the visit
mandate in the least intrusive manner possible, and every reasonable effort
shall be made to avoid inconvenience to the visited State Party and disturbance
to the visited facility;
(c) Make every effort to avoid hampering or
delaying the operation of the facility.
In particular, the visiting team shall not operate any facility
equipment;
(d) Strictly observe established safety and
working practices at the facility, whether instituted for the protection of
personnel, animals, plants, the environment or of the processes performed or
their products;
(e) Provide the visited State Party with
copies of all the information and data obtained during the course of the visit;
[(f) Have the right to state the relevance of
questions asked by the visiting team and objected to by the visited State
Party; the team leader may ask the visited State Party to reconsider its
objection. The visiting team may note
in the final report any refusal to permit interviews or to allow questions to
be answered without any justification given for any such refusal by the visited
State Party.]
Briefing
30. Upon
arrival at the facility to be visited, the visiting team shall be briefed on
the facility and the activities carried out there by a facility representative
and, at their discretion, the representatives of the visited State Party. The facility representative may be supported
by any other facility personnel, as required.
[31. The
briefing shall not exceed three hours.
It shall include, inter alia:
(a) The scope and a general description of
current declared activities of the facility including a description of the main
scientific and technical information relating to the declared activity(ies),
including written and visual documentation, if available, such as photographs,
brochures, drawings, as appropriate;
(b) Short background description of the
declared facility covering the date of establishment, current ownership,
organizational structure and, wherever possible, general information on the
declared facility’s role within the overall structure of company or government
agency or entity operating the declared facility; organizational structure of
the facility and any previous uses or changes in ownership;
(c) General information on the physical
layout [, including laboratories, equipment] and other
relevant characteristics of the visited facility, including a map or sketch
showing all structures and significant geographic features;
(d) Numbers and types of personnel involved
in the declared activity(ies) and whether they are military or civilian
[, scientific or administrative];
(e) General information concerning the
safety regulations in force, including rules of observation and quarantine [and
vaccination policy, and on any other regulatory frameworks which may apply];
(f) Indication of areas the visited State
Party considers sensitive;
(g) General information on any relevant
changes in activities or equipment at the facility since the submission of the
most recent declaration;
(h) Explanation for any levels of
containment and the rationale for operating or not operating at such levels;
and for work involving listed agents and/or toxins, including main objectives
and rationales;
[(i) A
description of the technical assistance and cooperation activities requested by
the visited State Party pursuant to paragraph 23 above;]
[(j) General
information on the method used for any treatment or disposal of waste or
effluent from the declared facility;]
[(k) General information on any experimental
animal usage related to the declared activities;]
(l) The administrative and logistical
arrangements necessary for the visit.]
32. The
visited facility shall provide to the visiting team a written summary of the
key points of the briefing. It may also
provide additional information, such as documentation related to either the
briefing or tour, at its discretion. At
its discretion, the visited facility may also provide in writing any additional
information contained in the briefing.
The visiting team may discuss with the visited State Party and the
visited facility personnel the content of the briefing and any other
information made available by the visited State Party and visited facility
personnel.
Tour of the visited facility
33. [To complement the briefing,]
the visited State Party [may] [shall] invite the visiting team to
tour [all] areas within the declared facility relevant to the visit
mandate. [All access during the
tour shall be at the discretion of the visited State Party.] [The areas to be visited by the visiting
team shall be determined by the visited State Party.] The duration of the tour shall not exceed
two hours.
[Visit plan]
[34. After
the briefing and tour, the visiting team shall prepare an initial visit
plan. The visit plan shall specify the
activities the visiting team proposes to carry out, including the specific
areas of the facility to be visited and any proposals for the visiting team to
subdivide. The visit plan, any changes to it during the course of the visit and
any proposals for the visiting team to subdivide, need to be agreed by the
visited State Party.]
35. [After
the briefing and the tour,] the visiting team may propose to conduct one
or more of the following activities in
accordance with the provisions of paragraphs 27 to 29:
(a) Review and discuss with facility
personnel the declaration and the information contained in the briefing and tour provided by the visited
facility;
(b) Discuss, with the consent of the visited
State Party, [specific factual points, related to the visit mandate, on
the activities of the declared facility as described in the facility
declaration, briefing and tour, with facility personnel who are able to address
those factual points] [with facility personnel in a position to do so, any
specific factual points upon which the information in the declaration is based,
with the purpose of establishing relevant facts]. The visited State Party may make available national
representatives to respond to questions on matters relating to national health
and safety legislation and other regulatory matters, or to provide information
on such matters. All discussions shall
be conducted in the presence of representatives of the visited State
Party. The visiting team shall only
request information and data which that
are necessary for the fulfilment of the visit mandate;
[(c) Examine
Review, with the consent of the
visited State Party, documentation relevant to the mandate in order to
facilitate further the visiting
team’s understanding of the declared
activities as presented in the facility
briefing, tour and declaration being conducted at the declared facility. The visited State Party, if it agrees to such a review, shall endeavour to provide such
documentation, or to provide alternative means to address the any questions raised by of the visiting team pursuant to this paragraph if provision of any documentation is
denied;]
(d) [Re]visit, and revisit if necessary to ensure fulfilment of the mandate pursuant
to subparagraph 28 (a), parts of the facility, and observe equipment, relevant
to the mandate and the mentioned in
the briefing and where declared activities are conducted at the facility;
[(e) The visited State Party [and/or the
visited facility] may, at their discretion, offer access to other areas within
the declared facility;]
[(f) At any time during the visit, the
visited State Party may [, at its own initiative or at the
suggestion of the visiting team, grant
offer] [suggest to] the visiting team, at any time during the visit,
the opportunity to conduct any
other on-site activities. It may also offer additional rights of
access that which the visited State Party believes may help assist the visiting team to fulfil
its mandate. Any such on-site activities or levels of access shall be subject to the
provisions of paragraphs 27 to 29 above.]
OR
[(f) The visited State Party may extend
additional cooperation to the visiting team, at any time during the visit, if
it believes it helpful in fulfilling the mandate.]
[36. Once
agreed by the visited State Party, the visit plan shall be implemented.]
37. If
any [ambiguities] [technical inaccuracies] or other questions related to
the visited State Party’s declarations and briefing are identified during the visit, the visited State
Party and the facility shall seek to resolve these cooperatively, with the
assistance, if necessary, of the visiting team.
Debriefing
38. At
the completion of the visit agreed
activities, the visiting team, facility personnel and visited State Party
representatives shall meet to discuss the outcome of the visit and, if
necessary, to confirm any details of fact for inclusion in the preliminary
report which shall be a factual account of the visit. Such a meeting shall not take place if the visited State Party and
the visiting team agree that it is not necessary.
POST-VISIT ACTIVITIES
Cooperation and assistance activities
39. If requested in accordance with
paragraphs 11 and 15 above, after the conclusion of the other activities
related to the visit, the visiting team shall provide the technical advice and
information [and any of the cooperation and assistance activities
contained in the programmes specified in the addendum to the visit mandate]
pursuant to paragraph 20 above or requested during the visit.
Preliminary report
40. Within 24 hours of the completion of the
visit, the visiting team shall provide to the representatives of the visited
State Party a preliminary report in written form. The preliminary report shall only contain a description of the
visit activities and the factual findings of the visiting team. The preliminary report shall be signed by
the visiting team leader. In order to
indicate that he/she has taken note of the contents of the preliminary report,
the representative of the visited State Party shall sign the preliminary report.
41. If,
during the visit, the visited State Party has provided to the visiting team any
information which the visited State Party has identified as commercial
proprietary or national security information not already included in the
declaration, the visited State Party may require that any such information
shall not be included in the draft or final report.
Departure
42. On completion of the debriefing [and,
if applicable, the relevant cooperation and assistance activities], the
visiting team shall depart from the territory of the visited State Party as
soon as possible.
REPORTS
Draft report
43. Not later than [14] [21]
days after the visit, the visiting team shall prepare a draft report which
shall include the contents of the preliminary report and an account of the
cooperation and assistance activities of the visiting team during the
visit. [At the request of the
visited State Party, the draft report may contain identify technical recommendations and possible follow-up
cooperation and assistance activities of the Organization or, in the
assessment of the visiting team, other international organizations from which
the facility could continue to benefit.] [The draft report shall also include an account of the degree and
nature of access and the cooperation provided by the visited State Party in
order to fulfil the visit mandate.]
The report may also include
comments from both the visited State Party and visiting team on the extent to
which the information provided during the visit furthered the purpose of the
visit as specified in paragraph 10 of this subsection.
44. The
draft report shall immediately upon completion be submitted to the visited
State Party. The visited State Party
may make any comments or suggestions on the draft report to ensure factual and
technical accuracy and the full protection of commercial proprietary and
national security information. The
visited State Party may identify any information contained in the report which
that 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 view of
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, to identify any
information requested by the visited State Party to be handled as
confidential, the visiting team shall
and to remove any such
information requested by the visited State Party to be removed from the report. The final report shall, unless previously
requested by the visited State Party, include as an annex all the comments
made by the visited State Party on the draft report, 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, with the
consent of the visited State Party, provide copies of the final report, on
request, to any other State Party.] [The
Director-General shall, as a rule, provide copies of the final report, on
request, to any other State Party, taking into account the provisions of
Article IV, paragraph 4 (d) [, unless otherwise indicated by the
visited State Party].]
47. If
the Director-General considers it necessary that the visited State Party redresses
revise its declaration by
revising or supplementing it or submitting a new declaration, the
Director-General shall inform the State
Party separately in writing of the 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.]
Proposals for further consideration by the
Friend of the Chair
on
Investigations
G. INVESTIGATIONS
(A) TYPES
OF INVESTIGATIONS
1. Each
State Party shall have the right to request an investigation which shall be
carried out for the sole purpose of determining the facts relating to a
specific concern about possible non-compliance with the Convention by any other
State Party.
2. Each
State Party shall be under the obligation to keep all requests within the scope
of the Convention and refrain from unfounded or abusive requests.
3. The
requesting State Party shall specify in each request which one of the following
types of investigations it is seeking:
(a) Investigations to be conducted in
geographic areas where the release of, or exposure of humans, animals or plants
to microbial or other biological agents and/or toxins has given rise to a
concern about possible non-compliance under Article I of the Convention or use
of biological weapons, hereinafter referred to as “field investigations”;
(b) Investigations of alleged breaches of
obligations under Article I of the Convention, to be conducted inside the perimeter
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
[Exclusion of all] outbreaks of
disease which are due to natural causes
4. All
outbreaks of disease which are due to natural causes do not pose a compliance
concern under the Convention and shall not be a reason for an investigation of
a non-compliance concern.
5. Nothing
in this Protocol shall prejudice the right of a State Party to investigate, as
per its national regulations, outbreaks of disease which occur on its territory
or in any place under its jurisdiction or control, or if it so wishes, with the
assistance of other State(s) and/or relevant international organizations.
Investigation of disease outbreaks
relating to a specific concern about possible non-compliance with 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
D, section II, paragraphs 1 and 2, such request shall contain detailed
evidence, and other information, and analysis substantiating why, in its view,
it considers the outbreak of disease not to be naturally occurring and directly
related to activities prohibited by the Convention. Information coming from the mass media or from private persons
can not be considered as evidence on the basis of which the request shall be
made. Relevant information from private
persons who have direct knowledge of the alleged event(s) or of the results
and/or details of any prior national or international investigation of the
event(s) can be considered as evidence.
7. The
Executive Council shall not [consider a request for] [authorize] a field
investigation of an outbreak of disease, unless it determines that there is a
basis for concern substantiated by detailed evidence, and other information,
and analysis that the outbreak(s) of disease, is not naturally occurring and is
directly related to activities prohibited by the Convention. The Executive Council, if it deems it
appropriate for its [consideration] [authorization] of the above request, shall
also request from the most relevant international organization(s) such as, but
not limited to, the WHO, OIE, FAO, all available information in its/their
possession, that may be relevant to the outbreak. When a State Party requests a field investigation of an
outbreak(s) of disease on the territory or in any place under the jurisdiction
or control of another State Party, the State Party where the investigation is
proposed to occur shall have the right to provide evidence, and other
information, and analysis that indicates that the outbreak of disease is
naturally occurring or otherwise unrelated to activities prohibited by the
Convention. If deemed appropriate by the Executive Council as a matter of
procedure under Article IX, paragraph 30, other State(s) Party(ies) may also
provide information relevant to whether the outbreak(s) of disease is naturally
occurring and/or whether it is related to activities prohibited by the
Convention. All of the evidence, and
other information, and analysis submitted, shall be taken into account by the
Executive Council in its consideration of the investigation request in
accordance with the request procedures of paragraphs 13 to 27 of this section.
[Unusual outbreaks of disease
8. The
diseases which are endemic in the region and present the expected
epidemiological features shall not be considered as an unusual outbreak of
disease. An outbreak of disease which
appears to be unusual, shall be investigated by the affected State Party, as
per guidelines set out in Annex D, section V, and concluded as soon as
possible.]
[(C) ALLEGED
USE OF A BIOLOGICAL WEAPON]
9. A
State Party has a right to request a field investigation of an alleged use of a
biological weapon if it believes that a biological weapon was used against it
on the territory under its jurisdiction and control.
(D) CONSULTATION,
CLARIFICATION AND COOPERATION
10. States Parties [shall] [may], without
prejudice to their right to request an investigation, and prior to the
submission of any request for an investigation make use of and follow the
relevant procedures set out in section E of this Article on consultation,
clarification and cooperation in order to clarify and resolve satisfactorily
any matter which may cause concern about possible non-compliance with the
obligations of the Convention.
(E) INITIATION OF
INVESTIGATIONS
11. An investigation may be requested to be
conducted on the territory of a State Party, or in any other place under its
jurisdiction or control, regardless of the form of ownership of the facility or
the area subject to the investigation, in accordance with the provisions of
this Protocol.
12. An
investigation may also be requested to be conducted in any place on the territory
of a non-State Party which is under its jurisdiction or control, if any State
Party has a concern(s) that another State Party, which shall be identified in
the request, is the alleged cause of the non-compliance concern. Upon receipt of such a request, the
Director-General shall immediately contact the non-State Party concerned to
seek:
(a) Its consent to the conduct of the
investigation; and, subject to such consent
(b) Its agreement that the provisions of
this Protocol governing the conduct of investigations shall apply to the
investigation or, alternatively, its agreement to different procedures for the
conduct of the investigation which the Director-General is satisfied would
enable the facts relating to the specific concern about non-compliance raised
in the request to be determined.
The Director-General shall inform
the Executive Council and the requesting State Party of the outcome of such
consultations as soon as possible.
13. Requests
for investigations to be conducted in accordance with this Protocol shall be
submitted in writing by the requesting State Party to the Executive Council and
at the same time to the Director-General for processing in accordance with
procedures as set out in paragraphs 19 to 27 of this section.
14. If,
during the course of a field investigation, the investigation team has acquired
information (as a result of the conduct of the activities specified in Annex D,
section II, subsection D) indicating
that a facility on the territory or in any other place under the jurisdiction
or control of a State Party, is directly relevant to the alleged non-compliance
concern that has been identified in the field investigation mandate, the
investigation team leader shall provide a factual statement of the information
and a factual description of how the information was obtained, to the receiving
State Party. The receiving State Party
may within 24 hours comment on the factual statement. The investigation team leader shall then submit the factual statement, description
of how the information was obtained and the comments of the receiving State
Party to the Executive Council through the Director-General.
15. Upon
receipt of the information, the Executive Council shall provide the information
to the receiving State Party, the requesting State Party, and, if appropriate,
the State Party on whose territory or under whose jurisdiction or control the
facility in question is located. Only
these States Parties may submit a request for a facility investigation which
involves this information. Such request
shall be considered in accordance with the provisions contained in paragraphs
10 to 13 and 18 to 20 of this section.
16. The
Executive Council’s consideration of the information or any request for a
facility investigation received from a State Party which received its
information in accordance with paragraph 15 above and any decision made
there-on shall be conducted in accordance with the provisions set out in
paragraphs 19 to 27 of this section.
17. If
the Executive Council decides that a facility investigation must be conducted,
the investigation shall be conducted in accordance with the provisions for
facility investigations set out in this section, and Annex D, sections I and
III. The reports of the field and
facility investigations shall be considered independently or simultaneously as
determined by the Executive Council depending on the specific circumstances
involved.
(F) INFORMATION TO BE SUBMITTED WITH A
REQUEST FOR AN INVESTIGATION TO ADDRESS A CONCERN OF NON-COMPLIANCE WITH THE
CONVENTION
18. A
State Party requesting an investigation shall provide supporting evidence and
other information required in accordance with the provisions set out in Annex
D. All such evidence and other
information shall be as precise as possible.
(G) FOLLOW-UP AFTER SUBMISSION OF AN
INVESTIGATION REQUEST AND EXECUTIVE COUNCIL DECISION-MAKING
19. The
Director-General, after receiving an investigation request, shall acknowledge
receipt of it to the requesting State Party within two hours and shall provide
a copy of the investigation request to the State Party sought to be
investigated within six hours.
20. The
Director-General shall ascertain within six hours after receipt of the
investigation request whether the investigation request meets the requirements
set out in paragraph 1 of section II of Annex D, for field investigations, and
paragraph 1 of section III of Annex D, for facility investigations. If the Director-General is satisfied that
the investigation request meets these requirements, he/she shall so inform the
Executive Council immediately, and the State Party sought to be investigated
and, if applicable, the potential host State Party/State, within six
hours. If the Director-General
determines that the investigation request does not meet these requirements, the
Director-General shall so inform the Executive Council and the requesting State
Party, and shall inform the requesting State Party of the reasons for this
determination. The requesting State
Party may submit a revised request, which shall be submitted and processed in
the same way as an original request.
21. When
the investigation request fulfils the requirements, the Director-General may
begin with appropriate preparations for the investigation.
22. The
Director-General, may upon receipt of an investigation request referring to an
investigation area under the jurisdiction or control of a State Party, propose
to the requesting State Party to immediately seek clarification from the State
Party sought to be investigated in order to clarify and resolve the concern
raised in the request. A State Party
which receives a request for clarification pursuant to this paragraph shall
provide the requesting State Party and the Director-General with explanations
and with other relevant information as soon as possible but no later than 24
hours after receipt of the request for clarification without prejudice to its
rights to provide additional relevant information during the entire process of
the consideration of the investigation request by the Executive Council. Unless the requesting State Party considers
the concern raised in the investigation request to be resolved and withdraws
the request, the Executive Council shall take a decision on the request in
accordance with paragraph 24.
23. The
Executive Council shall begin its consideration of an investigation request
immediately after it is informed by the Director-General, in accordance with
paragraph 20, that the request meets the requirements and shall come to a
conclusion on the request not later than 36 hours after it is so informed. Upon the conclusion of the Executive
Council’s consideration of an investigation request, the Director-General shall
provide a copy of the request and the decision to all States Parties within 24
hours.
24. The
investigation shall proceed [in the case of a request for a facility
investigation] [if formally approved by at least a [two-thirds]
[three-quarters] majority [present and voting] of the Executive Council]
[unless the Executive Council decides by a three-quarters majority of [all] its
members [present and voting] against carrying out the investigation] [and, in
the case of a request for a field investigation, if formally approved by a
simple majority of the Executive Council members present and voting].
25. The
State Party sought to be investigated shall have the right to inform the
Executive Council about the nature of the facility or area indicated in the
investigation request, and provide information to indicate why, in its view,
this facility is unrelated to the Convention.
It may also state, if it believes it necessary to do so, why in its view
the investigation request is unfounded or abusive. [It may also inform the Executive Council that access to such
facility or area is prohibited for reasons of national security unrelated to
the Convention.]
26. In
its examination of the investigation request, the Executive Council shall
consider all the evidence and other information as well as analysis provided by
the requesting State Party and the State Party sought to be investigated, as
well as [any] [the] information resulting from [any] [the] prior consultation
or clarification process and may also take into account other relevant
information available to it. In doing
so, the Executive Council may also decide, without prejudice to the time-line
set out in paragraph 23, to seek more information from the requesting State
Party, the State Party sought to be investigated and from other relevant
international organizations. If such
information cannot be provided by other relevant international organizations
within the time-line set out in paragraph 23, the Director-General shall inform
the Executive Council as appropriate. In the case of the Executive Council not
approving the request for investigation, it may recommend other actions to
resolve the matter such as bilateral or multilateral consultations to resolve
the issue.
27. The
requesting State Party as well as the State Party sought to be investigated,
and, if applicable, in the case of a request for a field investigation, the
State Party identified in the request as the alleged cause of the
non-compliance concern, may participate in the Executive Council’s
consideration of an investigation request, but shall not have the right to vote
on the request, whether or not such States Parties are members of the Executive
Council.
28. The
investigation mandate shall be made available to the receiving State Party
immediately after the mandate is issued to the investigation team by the
Director-General which shall be no later than 12 hours before the team’s
arrival at the point of entry.
(H) ACCESS AND MEASURES TO GUARD AGAINST
ABUSE DURING THE CONDUCT OF INVESTIGATIONS
General principles
29. The
receiving State Party shall provide access to the investigation team within the
areas specified in paragraphs 38 and 41 and at the same time have the right to
take such measures it deems necessary in accordance with the provisions of this
section to protect its national security interests and/or to protect confidential
information and data (including commercial proprietary information) during an
investigation within the relevant time frames specified in Annex D in
accordance with the following:
(a) All such access shall be for the sole
purpose of establishing facts relevant to the investigation mandate;
(b) The receiving State Party shall have the
right to inform the investigation team about the areas, facilities or buildings
which it considers sensitive and/or not related to the Convention;
(c) The nature and extent of access to a
particular facility, place(s) or information within the areas specified in
paragraphs 38 and 41 below, as set out in the mandate, shall be negotiated
between the investigation team and the receiving State Party;
(d) The investigation team and the receiving
State Party shall also negotiate the activities to be performed during the
investigation; all activities shall be performed in accordance with the
relevant provisions for these activities contained in Annex D, sections II and
III;
(e) The receiving State Party shall have the
right to make the final decision on the [nature and extent of such] [regarding
any] access, taking into account its rights and obligations under this
Protocol;
(f) In meeting the requirements to provide
access, the receiving State Party shall be under the obligation to provide the
greatest degree of access possible, taking into account any constitutional
obligations it may have with regard to proprietary rights or searches and
seizures;
(g) The receiving State Party shall make
every reasonable effort to demonstrate its compliance with the Convention and,
to this end, to enable the investigation team to fulfil its mandate.
30. The
receiving State Party shall have the right to take measures, as it deems
necessary to protect national security and/or to protect confidential
information and data (including commercial proprietary information) in
accordance with the provisions of this section and taking into account its
obligations under this Protocol. Such
measures may include but shall not be limited to the following:
(a) Removal
of sensitive papers from office spaces and direct view;
(b) Shrouding of sensitive displays, stores,
and equipment;
(c) Shrouding sensitive pieces of equipment,
such as computer or electronic systems;
(d) Logging off of computer systems and
turning off data indicating devices;
(e) Using random selective access techniques
whereby the team is requested to select a given percentage or number of
buildings of their choice to investigate; the same principle can apply to the
interior and content of sensitive buildings or documents;
(f) Limiting the number of team members who
have access to certain buildings, structures or places within the area
specified in paragraphs 38 and 44;
(g) Limiting the viewing angle;
(h) Limiting the time investigation team
members may spend in any area or building;
(i) At any time during the investigation,
notifying the investigation team of the products and processes which involve
national security and/or the protection of confidential information and data
(including commercial proprietary information) and its rights to safeguard
it. It may request that if a specific
piece of information is released to the team, it should be accorded the most
stringent protection measures in conformity with the confidentiality
provisions.
31. The
receiving State Party may, in accordance with paragraph 29 and 30 above deny
access to particularly sensitive buildings, structures or parts thereof not
related to the investigation mandate, taking into account its obligations under
this section.
32. If
the receiving State Party provides less than full access to places, activities
or information, it shall make every reasonable and feasible effort to provide
alternative means to demonstrate compliance and to clarify the possible
non-compliance concern that generated the investigation. The nature and extent of access, including
any alternative means to demonstrate compliance, provided by the receiving State
Party, and the extent to which this enabled the investigation team to fulfil
its mandate, shall be recorded factually in the investigation report.
33. These
provisions may not be invoked by the receiving State Party to conceal any
evasion of its obligations not to engage in activities prohibited under the
Convention.
34. In
carrying out the investigation in accordance with the investigation mandate,
the investigation team shall use only those methods necessary to provide
sufficient relevant facts to clarify the concern about possible non-compliance
with the provisions of the Convention, and shall refrain from activities not
relevant thereto. It shall request,
collect and/or document only such facts as are related to the investigation
mandate, but shall neither seek nor document information which is clearly not
related thereto, unless the receiving State Party expressly requests it to do
so. Any material collected and
subsequently found not to be relevant shall not be retained.
35. The
investigation team shall conduct the investigation in the least intrusive
manner possible consistent with the effective and timely implementation of its
mandate. As a rule, it shall begin with
the procedures it deems least intrusive and proceed to more intrusive procedures
only as required to fulfil its mandate.
36. The
investigation team shall take into consideration suggested modifications of the
investigation plan and proposals which may be made by the receiving State
Party, at any stage of the investigation, including the pre-investigation
briefing, to ensure, inter alia, that
sensitive equipment, information or places are protected. The investigation plan shall be handled in
accordance with section II, paragraph 17, and section III, paragraph 30, of
Annex D.
37. If
the investigation team considers it necessary in order to fulfil its mandate,
the investigation team shall have the right to request clarification in
connection with ambiguities that may arise during an investigation. Such requests shall be made promptly to or
through the representative of the receiving State Party. The representative shall make every
reasonable effort to provide the investigation team with such clarification as
may be necessary to remove the ambiguity.
Field investigations
38. The
receiving State Party shall provide access into the investigation area within
[48] hours after arrival at the point of entry in order to conduct
activities pursuant to this Article and sections I and II of Annex D for
the duration of the investigation as specified in Annex D, section II, paragraph 10.
39. The
receiving State Party shall provide access in accordance with paragraph 29 of
this section within the investigation area for the sole purpose of enabling the
investigation team to conduct specific on-site activities identified in, and in
accordance with, Annex D, section II, paragraphs 21 to 50. The extent and nature of access within the
investigation area shall be negotiated between the investigation team and the
receiving State Party in accordance with paragraphs 29 to 37 of this section. Such negotiated access in accordance with
paragraphs 29 to 37 of this section, shall allow access to all humans,
animals and/or plants that may have been affected by microbial or other
biological agents or toxins directly related to the non-compliance concern
being investigated.
40. The
access provided for in these paragraphs shall not interfere or impede with any
national measures taken to deal with the outbreak of disease.
Facility investigations
41. The
receiving State Party shall provide access within the requested and, if
different, final perimeter not later than 108 hours after arrival at the point
of entry pursuant to Annex D, section III, paragraph 5 for the conduct of
activities pursuant to this Article and sections I and III of Annex D for the
duration of the investigation as specified in Annex D, section III, paragraph
8.
(I) FINAL
REPORT
42. The
preparation and handling of the final report shall be conducted in accordance
with Annex D.
(J) REVIEW
AND CONSIDERATION OF THE FINAL REPORT
43. The
Executive Council shall, in accordance with its powers and functions as
determined in Article IX, section C, review and consider the final report of
the investigation team as soon as it is presented, and address [and decide on]
any concern as to whether:
(a) Any non-compliance has occurred;
(b) The request had been in accordance with
the provisions of this Protocol;
(c) The right to request an investigation
has been abused.
44. With
respect to any concerns raised under paragraph 43 (c), one or more of the
following factors could be taken into account, where relevant:
(a) Information relating to the investigated
site available prior to the investigation request (the authenticity and
reliability of any information would need to be carefully assessed);
(b) Whether any of the information submitted
as part of the investigation request was shown to be false;
(c) Information from and/or outcome or
results of prior consultations/ clarifications relevant to the request, if
applicable;
(d) Whether any investigation(s) (including
any instituted under Article VI of the Convention) had previously been
requested by the same State Party vis-à-vis
the same investigated site, and if so, their number, frequency and outcome
(including any follow-up action).
45. If
the Executive Council reaches the conclusion, in keeping with its powers and
functions, that there has been abuse, it shall consider and decide on, inter alia, whether:
(a) The requesting State Party shall bear
some or all of the financial implications of the investigation, including those
which have been borne by the receiving State Party;
(b) To suspend the right of the requesting
State Party to request an investigation for a period of time, as determined by
the Executive Council;
(c) To suspend the right of the requesting
State Party to serve on the Executive Council for a period of time.
46. If
the Executive Council reaches the conclusion, in keeping with its powers and
functions, that further action may be necessary with regard to paragraph 43, it
shall take the appropriate measures to redress the situation and to ensure
compliance, including, if appropriate, specific recommendations to the
Conference which shall consider the recommendations in accordance with Article
IX and take the appropriate measures in accordance with Article V.
47. If
the Executive Council reaches the conclusion, in keeping with its powers and
functions, that further action may be necessary with regard to paragraph 43
(a), it shall distribute the investigation report to all States Parties before
the next session of the Conference.
48. The
receiving State Party, the requesting State Party and any other State Party
that has been identified in an investigation request as the alleged cause of
the non-compliance concern, shall have the right to participate in the review
process in the Executive Council but shall have no vote.
49. The
Executive Council shall inform the States Parties and the next session of the
Conference of States Parties of the outcome of the process.
Back to Contents
Proposals for further consideration by the
Friend of the Chair
on
Confidentiality Issues
ARTICLE IV
CONFIDENTIALITY
PROVISIONS
3. The
Director-General shall have the primary responsibility for ensuring the
protection of all confidential information which comes into possession of the
Technical Secretariat. Based on
guidelines provided for within this Protocol, the Director-General shall
establish and maintain a stringent [policy] [system] [regime]
[provisions] procedures
governing the handling of confidential information by the Technical Secretariat
(hereinafter referred to as “the Confidentiality [Policy] [System] [Regime]
[Provisions]”)
which shall include measures to protect confidential information obtained in
the course or as a result of on-site activities as well as the necessary
procedures to be followed in case of breaches or alleged breaches of
confidentiality to ensure effective protection against unauthorized
disclosure. This regime These procedures shall be approved and
periodically reviewed by the Conference of the States Parties.
5. The
relevant organs and subsidiary organs of the Organization shall be entitled to
receive from the Technical Secretariat information and data necessary for the
performance of the functions entrusted to them by the provisions of this
Protocol. The provision of any
confidential information and data shall be strictly limited to the minimum
necessary for the performance of these functions and shall be in conformity
with the procedures of the Confidentiality Regime established pursuant to paragraph 3.
Back to Contents
Proposals for further consideration by the
Friend of the Chair
on
Measures Related to Article X
ARTICLE
VII
SCIENTIFIC
AND TECHNOLOGICAL EXCHANGE FOR PEACEFUL
PURPOSES
AND TECHNICAL COOPERATION
(A) GENERAL
PROVISIONS
1. Each
State Party undertakes to implement specific measures, including those set out
in this Article, designed to enhance compliance and ensure effective and full
implementation of Article X of the Convention among the States Parties to the
Protocol. The implementation of such
measures shall be aimed at:
(a) Promoting scientific and technological
exchanges and fostering international cooperation, as appropriate, on a
multilateral, regional or bilateral basis, directly or through the
Organization, in the field of peaceful bacteriological (biological) and toxin
activities;
(b) Facilitating free trade and the fullest
possible exchange in biological agents, toxins, equipment and materials for
peaceful purposes in order to enhance the economic and technological
development of States Parties and ensuring the right of States Parties to
participate in such exchanges to the fullest extent possible;
(c) Avoiding hampering the economic and
technological development of States Parties [or] [imposing and maintaining]
[through] any restrictions incompatible with the obligations undertaken under
the Convention and/or limitations on the transfer for purposes consistent with
the objectives and the provisions of the Convention of scientific knowledge,
technology, equipment and materials.
2. The
Organization shall provide a forum for consultation and creation of
opportunities for cooperation on matters related to the promotion of scientific
and technological exchange in the field of peaceful bacteriological
(biological) and toxin activities and review of the implementation of Article X
assistance
provisions of the Convention among the States Parties to the Protocol. The Organization shall also develop a
framework for activities aimed at promoting scientific and technological
cooperation and exchange and providing technical assistance, including protocol
implementation assistance, upon request, to States Parties, in particular to
developing countries which are States Parties.
Such a framework may include activities conducted in collaboration with
relevant international organizations and agencies.
(B) MEASURES
TO PROMOTE SCIENTIFIC AND TECHNOLOGICAL EXCHANGES
3. Each State Party undertakes to
facilitate, and have the right to participate in, the fullest possible exchange
of equipment, materials and scientific and technological information for the
use of bacteriological (biological) agents and toxins for peaceful purposes
and, in its implementation of these measures, to ensure that any transfers or
exchanges of materials, equipment, technology, and any information pursuant to
this Article shall take place in compliance with the provisions of Articles III
and X of the Convention.
4. Each
State Party shall promote and support, in furtherance of any current endeavours
relevant to and in accordance with the Convention, [where appropriate,]
individually, jointly, through arrangements, with relevant international
organizations and agencies, including, but not limited to, the FAO, ICGEB, IVI,
OIE, OPCW, UNEP, UNIDO, WHO and the Secretariat of the CBD, or the
institutional mechanisms provided for under section D of this Article:
(a) The publication, exchange and
dissemination of information, including through workshops, training programmes
and conferences, on current and recent developments, as well as on research and
development on the peaceful uses of microorganisms and toxins, biosafety,
[biodefence,] biotechnology, good laboratory practice and current good
manufacturing practice, and diagnosis, surveillance, detection, treatment and
prevention of diseases caused by biological agents or toxins, in particular
infectious diseases;
(b) The work of existing laboratories on the
prevention, surveillance, detection and diagnosis of diseases caused by
biological agents or toxins, in particular infectious diseases, to improve the
capabilities of such laboratories and their effectiveness, through, inter alia, the provision of
training and technical advice, equipment and reagents;
(c) The improvement and development of States Parties’ capabilities, [, including, where necessary the establishment and operation
of new [laboratories] [capabilities] upon the specific request of the State
Party concerned,] in the surveillance, prevention, detection, diagnosis
and treatment of diseases caused by biological agents or toxins, in particular
infectious diseases, as an integral part of a global effort to improve the
monitoring of emerging and re-emerging diseases in humans, animals and plants;
(d) The improvement and development of research capabilities in relevant fields of
biosciences and biotechnology for peaceful purposes, through collaborative
research programmes and projects, [, including,
where necessary the establishment and operation of new research [institutes]
[capabilities] upon the specific request of the State Party concerned,]
in particular in the use of microorganisms and toxins for medical,
agricultural, veterinary and industrial purposes;
(e) The establishment, operation and
updating of biological data bases including those maintained by the Technical
Secretariat on information relevant to the purposes of the Convention as well
as accessibility to such data bases;
(f) The monitoring, diagnosis, detection,
prevention and control of outbreaks of diseases, and international cooperation
on the research, development and production of vaccines;
(g) Transfer among States Parties of
technology for the peaceful uses of genetic engineering, the prevention,
diagnosis and treatment of diseases caused by biological agents or toxins, in
particular infectious diseases, and for other relevant fields of biosciences
and biotechnology for peaceful purposes;
(h) Participation [on [a [fair and
equitable] [non-discriminatory] basis] [and as wide a geographic basis as
possible]] at the bilateral, regional or multilateral levels in the application
of biotechnology and scientific research and development, for the prevention,
surveillance, detection, diagnosis and treatment of diseases caused by
biological agents or toxins, in particular infectious diseases;
(i) The establishment and conduct of
training programmes on the diagnosis, surveillance, detection, prevention and
treatment of diseases caused by biological agents or toxins, in particular
infectious diseases;
[(j) The establishment of a framework of cooperative
activities aimed at improving and strengthening the States Parties’
capabilities in the field of biodefence, including through the fullest possible
exchange of instruments, equipment and technologies, training of personnel as
well as collaborative research and development projects amongst States
Parties;]
[(k) Any
other specific measure(s) recommended approved by the Conference of States Parties on the further
strengthening of the implementation of Article X of the Convention and this
Article in accordance with paragraph ... of Article IX.]
(C) MEASURES TO AVOID HAMPERING THE ECONOMIC
AND TECHNOLOGICAL DEVELOPMENT OF STATES PARTIES
5. Nothing
in this Protocol shall prejudice the rights of States Parties to, individually
or collectively, conduct research with, develop, produce, acquire, retain,
transfer and use biological agents and toxins for peaceful purposes.
6. Each
State Party shall:
[(a) [In fulfilment of its obligations under
Article X,] Not establish or maintain, either individually or collectively,
[regimes which conflict with Article X of the Convention] [restrictions,
including those in any international agreements, or] any discriminatory measure
[, incompatible with the obligations undertaken under the Convention,]
which would restrict or impede [trade and the development and promotion of
scientific and technological knowledge] [the fullest possible exchange of
equipment, materials and scientific and technological information] for the use
of bacteriological (biological) agents and toxins for peaceful
purposes, [in particular] [including] in the fields of biological
research, [including] microbiology, biotechnology, genetic engineering, and
their industrial, agricultural, medical, pharmaceutical applications, and other
related areas for peaceful purposes;
[(b) Not use any other international agreement
or arrangement for pursuing an objective inconsistent with the Convention, nor
use the Convention or this Protocol as grounds for applying any measures other
than those provided or permitted under the Convention or this Protocol;]
(c) Undertake to review [periodically], and
amend [or adopt] as necessary, national regulations governing international
exchanges and transfers of bacteriological (biological) agents and toxins, and
equipment, materials and scientific and technological information for the use
of such agents and toxins in order to ensure their consistency with the
objectives and relevant provisions of the Convention and this Protocol [,
within ... days of the entry into force of this Protocol for it]. [The first review shall be completed not
later than 180 days after the entry into force of this Protocol.] The Director-General shall collate on an annual
basis a report containing information on the implementation of this subparagraph. [The Conference of States Parties shall
consider the report of the Director-General and may make recommendations to
States Parties.] [Those recommendations
may include measures to be taken by States Parties participating in any other
international agreement or arrangement in order to ensure their consistency
with the objectives and provisions of the Convention and this Article.]]
[7. A
State Party which considers its peaceful economic and technological development
has been hampered by restrictions or measures imposed or maintained by another
State Party or States Parties, incompatible with the provisions of Article X of
the Convention and this Article and generally applicable principles of
international law, shall have the right, in accordance with Article V, to seek
measures to redress such a situation and ensure compliance with the provisions
of Article X of the Convention and this Article.]
(D) INSTITUTIONAL MECHANISMS FOR
INTERNATIONAL COOPERATION AND PROTOCOL IMPLEMENTATION ASSISTANCE
The Cooperation Committee
8. The
Cooperation Committee (hereinafter referred to as “the Committee”), established
by the Conference of States Parties in accordance with Article IX,
paragraph ..., shall be a forum for consultation aimed at promoting the
effective and full implementation among the States Parties to the Protocol of
the provisions of Article X of the Convention and this Article. To this end, the Committee shall consult on,
[monitor] and review activities fostering international cooperation and
assistance and the fullest possible [transfer and] exchange of
equipment, materials and scientific and technological information for the use
of bacteriological (biological) agents and toxins for peaceful purposes. [The Committee shall also contribute
to efforts by the Organization to develop a framework for activities aimed at
promoting scientific and technological exchanges for peaceful purposes and
technological cooperation for peaceful purposes.]
9. The
Committee shall review the implementation of measures, pursuant to section B of
this Article, to promote scientific and technological exchanges and make
recommendations thereon to the Conference of States Parties.
10. The
Committee shall review and make recommendations to the Executive Council on:
(a) Cooperative relationships of the
Organization with other international organizations and agencies, pursuant to
section F of this Article;
(b) The programmes and activities of the
Technical Secretariat, pursuant to paragraphs 18 to 21 of this section;
(c) The use of [a] [the]
voluntary fund [and/or] contributions in activities relevant to
this Article, as well as the operation of the regular budget where it relates
to activities of the Organization in the implementation of this Article.
The Executive Council may, as
appropriate, take action on any recommendations by the Committee pursuant to
this paragraph.
11. The
Committee shall prepare an annual report on its activities, containing the
results of its review of measures agreed upon or taken by the relevant organs
of the Organization and its recommendations pursuant to paragraphs 8 to 10
above. The report shall be forwarded to
the Executive Council for consideration, at its next regular session, for any
additional recommendations or comments it may wish to annex to the report. The report of the Committee, with any
recommendations, comments or decisions annexed by the Executive Council, shall
then be submitted to the Conference of States Parties.
[12. The
Committee shall submit a report to the Review Conference of States Parties to
the Protocol on its work, including any summation of any recommendations it has
made to the Executive Council and the Conference of States Parties, containing
its proposals and recommendations on the further strengthening of the implementation
of Article X of the Convention and this Article.]
13. The
Committee shall receive and consider the annual declarations submitted by the
States Parties in accordance with section H of this Article and Appendix F.
14. [The
members of the Committee shall be elected for a term of two years, on the basis
of an equitable geographical distribution, in accordance with Article IX,
paragraph ... of this Protocol.]
[The Committee shall be a pluridisciplinary body open to the
participation of all States Parties and shall comprise government
representatives competent in the relevant fields of expertise.] The Committee may establish working groups
on an ad hoc basis.
15. The
Committee shall elaborate its rules of procedure and submit them to the
Conference of States Parties for approval.
16. The
Committee shall meet at least twice a year, once immediately prior to the
Conference of States Parties.
Additional meetings may be convened in accordance with the rules of
procedure referred to in paragraph 15 above.
17. The
chairmanship of the Committee shall rotate annually between each regional
group, as defined in Article IX, paragraph ..., represented in the
Committee. [Decisions]
[Recommendations] shall be agreed [by consensus] [in the same manner as decisions
by the Conference of States Parties in accordance with Article IX, paragraph
...].
OR
[The
chairmanship of the Committee shall rotate annually between each regional
group, as defined in Article IX, paragraph ..., represented in the
Committee. Decisions on specific
recommendations for inclusion in the report of the Committee to the Executive
Council and the Conference of States Parties shall be agreed by consensus. Decisions on specific recommendations to the
Executive Council, pursuant to paragraph 10 shall be agreed by consensus.]
Role of the Technical Secretariat
18. The
Director-General, assisted by the Technical Secretariat, shall promote and
facilitate scientific and technical cooperation and exchange among States
Parties and shall develop a framework of programmes and activities to implement
the decisions of the relevant organs of the Organization, as specified in
paragraph ... of Article IX. The
Technical Secretariat shall, in accordance with paragraphs ..., where
appropriate:
[(a) Promote and finance the establishment of
vaccine production facilities, particularly in developing countries [which are
States Parties];]
[(a) bis
Provide advice and identify possible sources of financial and technical
assistance for the establishment and operation of collaborative vaccine
research and development programmes, and on the requirements for vaccine
production facilities meeting current Good Manufacturing Practice standards;]
[(a) ter
Promote collaborative vaccine research and development programmes, which
would examine the requirements for vaccine production facilities meeting
current Good Manufacturing Practice standards, including through the
identification of sources of financial and technical assistance;]
(b) Establish and maintain a network to
facilitate contact and communications, using the available electronic systems
between States Parties, other relevant international
organizations and the Technical
Secretariat, for the purposes of enabling and promoting scientific cooperation
and exchange among States Parties;
(c) Convene regional or international
seminars with a view to optimizing cooperation on the peaceful uses of
bacteriological (biological) agents and toxins;
(d) Develop a framework, including through
either [a] [the] voluntary fund [and/or] voluntary
contributions, for States Parties to support an international system for the
global monitoring of emerging diseases in humans, animals and plants, and to
support other specific programmes to improve the effectiveness of national and
international efforts on the diagnosis, prevention and treatment of diseases
caused by biological agents and toxins, in particular infectious diseases;
(e) Advise and assist States Parties to
promote the objective of, employment of personnel on a wide and equitable
geographical basis, on the design and conduct of training programmes to help
develop and enhance the expertise and skills necessary for their nationals to
serve on the staff of the Technical Secretariat;
(f) Conduct internship programmes for appropriately
qualified personnel, on the basis of equitable geographical distribution, to
optimize cooperation on the peaceful uses of bacteriological (biological)
agents and toxins and technical cooperation amongst the States Parties;
(g) Promote the exchange, dissemination and
the publication of information on research centres, current research and
training programmes and conferences on the diagnosis, treatment and prevention
of diseases caused by biological agents and toxins, in particular infectious diseases;
(h) Provide
information on the availability of and accessibility to publications and other
publicly available forms of information containing the results of recent and
current research programmes on the uses of bacteriological (biological) agents and
toxins for industrial, pharmaceutical, medical and agricultural purposes [as
well as developments in biodefence activities];
(i) Promote cooperation [Implement
programmes amongst] [Inform] States Parties and provide information, upon request, on equipment and technology
exchanges relevant to the peaceful uses of bacteriological (biological) agents
and toxins [including] [for] the diagnosis,
treatment and prevention of diseases caused by biological agents and toxins, in particular infectious diseases;
(j) Implement at the request of States
Parties, programmes of support and assistance for upgrading laboratories
nominated for designation and certification pursuant to paragraph 25 of Annex D, section I, part B;
(k) Implement programmes of support and assistance
for designation and certification of laboratories pursuant to paragraph 25 of
Annex D, section I, part B.
Cooperation and assistance in the
context of visits
19. If
specifically requested by a State Party in the context of visits pursuant to Article
III, section D, subsection II, paragraphs 11 and 105 (a) and (b), and of
paragraph 2 of this Article, the visiting team shall provide information and
advice on, and implement, where appropriate, any cooperation and assistance
activities contained in programme(s) of the Organization in, inter alia:
(a) Biosafety, including environmental
protection and occupational health issues;
(b) The principles of Good Laboratory
Practice and current Good Manufacturing Practices;
[(c) [The identification of agents,]
diagnostics and the [development of innovative vaccines] [availability of
existing vaccines and the possible timetable for the introduction of new
vaccines];]
[(c) bis
Diagnostic techniques for infectious diseases and the availability of
vaccines;]
(d) The principles and requirements of
national and international regulatory mechanisms governing the production,
validation, marketing and sale of biological products for prophylactic,
diagnosis and treatment of diseases caused by biological agents or toxins, in
particular infectious diseases, and
pharmaceutical products and vaccines;
(e) Training requirements for facility and
national regulatory personnel, and sources of such training;
(f) The evaluation of the methodology
underpinning the State Party’s or facility’s declaration process and the
formulation of suggestions, if necessary, for methodological improvements to
future declarations;
(g) The provision of information, guidance
or the identification of any specific training opportunities for facility
personnel on efficient biosafety, occupational health and safety practices and
environmental protection relevant to the facility. This may include facilitating contact with relevant international
bodies;
(h) The provision of information on
publications and other publicly available forms of information containing
current research programmes in the biosciences and biotechnology, conferences,
research centres, information databases and other scientific and technological
developments and activities about which the visiting team are cognizant of
relevance to the Convention and facility;
(i) The provision of information and
guidance as well as the identification of any specific training opportunities
for facility personnel to facilitate the development, evaluation or licensing
of products;
(j) The identification of national,
regional and international sources of information for more detailed follow-up
enquiries and specialized assistance on these topics.
Protocol implementation assistance
20. Upon
a specific request by a State Party, the Technical Secretariat shall provide
advice and assistance either by itself or in cooperation with other States
Parties on:
(a) The establishment and functioning of
[national authorities];
(b) The preparation of declarations required
under Article III of this Protocol;
(c) The drawing up of internal legislation
necessary under the provisions of this Protocol;
(d) The content and conduct of training
courses and seminars for [National Authority] and declared facility personnel
on the compilation of declarations and the planning and hosting of visits.
21. All
requests for assistance by States Parties shall be submitted to the
Director-General and shall include detailed information and reasons for the
assistance sought. Where requests for
assistance exceed the available resources of the Technical Secretariat, the
Director-General shall
take into the account one or more of the following factors:
(a) The effective implementation of this
Protocol;
(b) The relative capacities and needs of
individual States Parties, particularly of developing countries being States
Parties;
(c) The specific details of each request;
(d) Whether the State Party seeking
assistance has benefitted from technical and assistance programmes established
by the Technical Secretariat within the last two years, and, if so, the
financial extent of them;
(e) The extent to which the assistance
requested would improve the operation and utility of existing national,
regional and international efforts in the area of the assistance sought.
(E) [REVIEW OF] [CONSIDERATION OF
CONCERNS RELATED TO] THE IMPLEMENTATION OF ARTICLE X OF THE CONVENTION
AND THIS ARTICLE
22. The
Executive Council shall, in accordance with paragraph ... of Article IX of the
Protocol, consider concerns raised by a State Party on the
implementation [by another State Party] of Article X of the Convention
and this Article.
23. The
State Party which raises concerns related to the implementation of Article X of
the Convention and this Article shall provide the Executive Council with
supporting evidence and other information substantiating its concerns. Any other State Party may provide relevant
information to support or clarify the concern.
[24. The
Executive Council may make recommendations to the States Parties concerned on
ways in which they may wish to [resolve] [redress] [address] the
situation. [The Executive Council may
also bring the issue to the attention of the Conference of States Parties [for
further action] [for further necessary action under Article V of this
Protocol].]]
[24 bis The Executive Council
may make recommendations that would apply collectively to all States Parties
concerned on matters of a general nature related to the ways in which they may
wish to [resolve] [address] [redress] the situation. The Executive Council may also bring the issue to the attention
of the Conference of States Parties.]
[24 ter The Executive Council
shall bring the issue to the attention of the Conference of States
Parties. The Conference of States
Parties may make recommendations to the States Parties concerned on ways in
which they may wish to resolve the situation.]
[24 quater The Executive
Council may make recommendations to the States Parties concerned on ways in
which they may wish to resolve the situation.
Should it consider that it would be of general applicability and/or of
interest to all States Parties, the Executive Council may decide to bring the
matter to the attention of the Conference of States Parties.]
(F) COOPERATIVE RELATIONSHIPS WITH OTHER
INTERNATIONAL ORGANIZATIONS AND AMONG STATES PARTIES
25. The
Organization may, where appropriate, conclude agreements and arrangements
pursuant to paragraphs 22 (j), 32 (l) and 36 (f) of Article IX with
relevant international organizations and agencies, including, but not limited
to, the FAO, ICGEB, IVI, OIE, OPCW, UNEP, UNIDO, WHO and the Secretariat of the
CBD, as envisaged in paragraph 6 of Article IX, to enhance compliance and
ensure effective and full implementation of Article X of the Convention and
this Article in order to, inter alia:
(a) Derive the greatest possible synergy in,
and benefits from:
(i) The collection and dissemination of
information on the peaceful uses of biological agents and toxins [including
developments in biodefence activities];
(ii) Sharing information on environmental
release of genetically modified organisms;
(iii) Current Good Manufacturing Practices
(GMP), Good Laboratory Practice (GLP), biological containment and other
biosafety regulations and practices;
(iv) Facilitation of access to databases
containing information on the peaceful uses of bacteriological (biological)
agents and toxins, biosafety, and results of scientific research in the life
sciences in areas of particular relevance to the Convention;
(v) The collection and dissemination of
information on the diagnosis, surveillance, detection, treatment and prevention
of diseases caused by biological agents or toxins, in particular infectious
diseases;
(vi) Regulations governing the handling,
transportation, use and release of bacteriological (biological) agents and
toxins;
(b) Coordinate its activities with those of
international organizations and agencies on the peaceful uses of
bacteriological (biological) agents and toxins, and on the diagnosis,
detection, treatment and prevention of diseases caused by biological agents or
toxins, in particular infectious diseases, and raise awareness of and
facilitate access to those activities by States Parties to the Protocol;
(c) Promote the establishment of and support [establish] a framework for
multilateral cooperation among the States Parties, including exchange of
information among scientists and technologists, with the aim of, inter alia:
(i) Utilizing the scientific and
technological capabilities, experience and know-how of States Parties;
(ii) [Facilitating harmonization] [Improving
knowledge] of relevant existing national regulatory and administrative
procedures [and facilitating any
steps being taken to promote harmonization of such procedures];
(iii) Assisting developing countries which are
States Parties to strengthen their scientific and technological capabilities in
the peaceful uses of [biosciences,] genetic engineering and
biotechnology;
(d) Facilitate the provision of information
and advice about relevant existing regulatory procedures on the peaceful uses
of bacteriological (biological) agents and toxins.
[26. The
Conference of States Parties may consider and decide on possible ad hoc
collaborative arrangements between the Organization and relevant
non-governmental organizations only for the specific purposes set out in
paragraph 25 above. Such consideration
shall be preceded by detailed examination by the Executive Council, assisted, where
necessary, by the Technical Secretariat, of the terms and conditions of the
proposed arrangements, taking into account the qualification, competence,
impartiality and sources of financing of the non-governmental organization(s)
in question.]
27. The
Technical Secretariat shall maintain a record of cooperative activities with
other relevant international organizations and agencies, pursuant to paragraph
25, and shall make such a record available to States Parties on request, as
well as to the Cooperation Committee.
28. The
Technical Secretariat, including upon request by the Executive Council, after
consultation with relevant international organizations and agencies with which
the Organization has cooperative relationships, pursuant to paragraph 25, may
make recommendations, as appropriate, to the Cooperation Committee, the
Executive Council or the Conference of States Parties for further practical
steps with a view to the effective implementation of the cooperative
relationships envisaged in this section.
[29. The
Organization shall contain a department devoted to the implementation of
[Article X of the Convention] [and] [this Article].]
[(G) SAFEGUARDS
[30. The
obligations set out in this Article are subject to, and limited by, the right
of each
State Party to protect commercial
proprietary information and national security.
[Such obligations are also subject to the availability of national
resources.]]
[31. In
implementing the provisions of this Article, the States Parties and the
Director-General shall take into account existing agreements and competences of
other relevant international organizations and agencies as well as the
activities of States Parties in order to avoid duplication as well as to ensure
an effective and coordinated use of resources for the effective implementation
of the measures identified in this Article.]]
(H) DECLARATIONS
32. Each State Party shall submit a
declaration annually to the Director-General, in accordance with the format set
out in Appendix F, with a general description of measures taken, individually
or together with other States and international organizations and agencies, in
order to implement the provisions of Article X of the Convention and this
Article. At the recommendation of the
Cooperation Committee, the Director-General shall consider these declarations
with the aim of suggesting specific practical steps for the enhanced
effectiveness and improved implementation of Article X of the Convention and
this Article. The Cooperation Committee
shall receive and consider these declarations and any other suggestions,
including those from the Director-General, in the preparation of its annual
report to the Conference of States Parties, as specified under paragraph 11 of
this Article.
[33. 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.]
Back to Contents
Proposals for further consideration by the
Chairman
on
Organization/Implementational Arrangements
ARTICLE
IX
THE
ORGANIZATION
(E) PRIVILEGES
AND IMMUNITIES
...
51. The
Organization shall not be held liable for any breach of confidentiality
committed by members of the Technical Secretariat unless otherwise decided in
accordance with the provisions of this Protocol. The Conference shall take the decision on the waiver of immunity
of the Organization. Waiver of immunity
from jurisdiction in respect of civil or administrative proceedings shall not
be held to imply waiver of immunity in respect of the execution of the
judgement, for which a separate waiver shall be necessary. The Conference, taking into account the
recommendations of the Executive Council, shall take its decisions on the
waiver of immunity of the Organization from both jurisdiction and execution of
judgement by unanimous consent of States Parties present and voting. Waiver shall always be express. The amount of any financial liability of the
Organization in any particular case shall not exceed 5 per cent of the annual
budget of the Organization in the financial year when the Organization is held
liable for breach of confidentiality, and the aggregate amount of financial
liability of the Organization in any financial year shall not exceed 10 per
cent of the annual budget of the Organization for that year. The provisions of
this paragraph shall be implemented from the time set forth in paragraph ¼, unless otherwise decided by
unanimous consent of States Parties present and voting by the Conference taking
place at that time.
...
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Proposals for further consideration by the
Friend of the Chair
on
Definitions of Terms and Objective Criteria
ANNEX
A. DECLARATIONS
I. LISTS AND CRITERIA (AGENTS AND TOXINS)
1. The
list of agents and toxins following below is for use with specific measures in
accordance with Article III, [section D, subsection I, paragraphs
...] [and section F].
[2. The
following criteria in subparagraph (a) were used for developing the list of
agents and toxins, and [the Executive Council] shall [be used] consider,
[inter alia,] these
criteria as well as the additional factors in subparagraphs (b) and (c) shall be used in reviewing any proposed
modifications to the list:
(a) The potential of individual agents and
toxins for use as weapons:
- Agents or toxins known to have been
developed, produced or used as weapons;
- Agents or toxins which have severe
public health and/or socio-economic effects;
- High morbidity, incapacity and/or
mortality rates;
- Low infective/toxic dose;
- High level of transmissibility and/or
contagiousness;
- Low effective or cost-effective
prophylaxis, protection or treatment available;
- Ease of production and/or
dissemination;
- Stability in the environment;
- 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 technical research
and development.]
[2 bis In reviewing the list of
agents and toxins the Executive Council shall consider, inter alia, the following:
(a) The potential of individual agents and
toxins for use as weapons, based on the following criteria which were used in
developing the list of agents and toxins:
- Agents or toxins known
to have been developed, produced or used as weapons;
- Agents or toxins which
have severe public health and/or socio-economic effects;
- High morbidity, incapacity and/or
mortality rates;
- Low infective/toxic dose;
- High level of transmissibility and/or
contagiousness;
- Low effective or
cost-effective prophylaxis, protection or treatment available;
- Ease of production and/or
dissemination;
- Stability in the environment;
- 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 technical research
and development.]
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[(s) III and] XIV.
4. The
list is not exhaustive, it does not exclude the relevance for the Protocol of
unlisted microbial or other biological agents or toxins which potentially can
be used as weapons or vectors.
5. Pathogens
causing zoonotic diseases appearing in one section of the list shall also apply
to the other sections.
AGREED PATHOGENS
A. HUMAN AND ZOONOTIC PATHOGENS
Viruses
1. Crimean-Congo haemorrhagic fever virus
2. Eastern equine encephalitis virus
3. Ebola virus
4. Sin Nombre virus
5. Junin virus
6. Lassa fever virus
7. Machupo virus
8. Marburg virus
9. Rift Valley fever virus
10. Tick-borne encephalitis virus
11. Variola major virus (Smallpox virus)
12. Venezuelan equine encephalitis virus
13. Western equine encephalitis virus
14. Yellow fever virus
15. Monkeypox virus
Bacteria
1. Bacillus anthracis
3. Brucella melitensis
5. Burkholderia mallei
6. Burkholderia pseudomallei
7. Francisella tularensis
8. Yersinia pestis
9. Coxiella burnetii
10. Rickettsia prowazekii
11. Rickettsia rickettsii
B. ANIMAL
PATHOGENS
Bovine
pathogens
3. Rinderpest virus
Swine
pathogens
7. African swine fever virus
Avian pathogens
10. Newcastle
disease virus
C. PLANT
PATHOGENS
Cereal
pathogens
1. Tilletia indica
Sugar cane
pathogens
3. Xanthomonas albilineans
Cash crop
pathogens
4. Colletotrichum coffeanum var. virulans
5. Erwinia amylovora
6. Ralstonia solanacearum
Forest
pathogens
9. Dothistroma pini (Scirrhia pini)
D. TOXINS
Bacteriotoxins
1. Botulinum toxins
2. Clostridium perfringens toxins
3. Staphylococcal enterotoxins
4. Shigatoxins
Phycotoxins
1. Anatoxins
2. Ciguatoxins
3. Saxitoxins
Mycotoxins
1. Trichothecene toxins
Phytotoxins
1. Abrins
2. Ricins
Zootoxins
1. Bungarotoxins
PATHOGENS TO BE AGREED
A. HUMAN AND ZOONOTIC PATHOGENS
Bacteria
2. [Brucella abortus]
4. [Brucella suis]
[Protozoa
1. Naegleria fowleri
2. Naegleria australiensis]
B. ANIMAL
PATHOGENS
Bovine
pathogens
1. [Contagious bovine
(pleuropneumonia)/Mycoplasma mycoides var. mycoides]
2. [Foot and mouth disease virus]
4. [Vesicular stomatitis virus]
Ovine
pathogens
