AD HOC GROUP OF THE STATES PARTIES

TO THE CONVENTION ON THE PROHIBITION

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

STOCKPILING OF BACTERIOLOGICAL                  16 August 2000

(BIOLOGICAL) AND TOXIN WEAPONS

AND ON THEIR DESTRUCTION                         Original:  ENGLISH

 

 

Twentieth session

Geneva, 10 July - 4 August 2000

 

 

        PROCEDURAL REPORT OF THE AD HOC GROUP OF THE

     STATES PARTIES TO THE CONVENTION ON THE PROHIBITION

      OF THE DEVELOPMENT, PRODUCTION AND STOCKPILING OF

       BACTERIOLOGICAL (BIOLOGICAL) AND TOXIN WEAPONS

                  AND ON THEIR DESTRUCTION

 

 

                           PART II

 

 

                           ANNEX V

 

 

                PROPOSALS FOR FURTHER CONSIDERATION BY THE CHAIRMAN

                                                 AND FRIENDS OF THE CHAIR

 

 

 


Contents

ARTICLE I          [[GENERAL PROVISIONS]]

 

ARTICLE II         [DEFINITIONS]

 

ARTICLE III        COMPLIANCE MEASURES

D.    DECLARATIONS

G.    INVESTIGATIONS

 

ARTICLE IV        CONFIDENTIALITY PROVISIONS

 

ARTICLE VII        SCIENTIFIC AND TECHNOLOGICAL EXCHANGE FOR

PEACEFUL PURPOSES AND TECHNICAL COOPERATION

 

ARTICLE IX        THE ORGANIZATION

 

ANNEX A           DECLARATIONS

I.     LISTS AND CRITERIA (AGENTS AND TOXINS)

II.    LIST OF EQUIPMENT

 


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



 

 

                         Proposals for further consideration by the Friend of the Chair

                                                         on 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.][1]

 

[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.][2]

 

[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.][3]

 

[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.][4]]


Back to Contents



                         Proposals for further consideration by the Friend of the Chair

                                     on Definitions of Terms and Objective Criteria

 

 

                                                                 ARTICLE  II

 

                                                              [DEFINITIONS[5]

 

[CATEGORY I:  FOR THE PURPOSES OF THIS PROTOCOL:][6]

 

[1.        Bacteriological (biological) and toxin weapons[7] 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[8] 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”.][9]

 

[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)[10] 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[11] 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[12] 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