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 o
