Annex I

(1) Being Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, which was opened for signature on 10 April 1972, and entered into force on 26 March 1975, hereinafter referred to as the Convention,

(2) Reaffirming the purposes laid down in the preamble to the Convention as well as their obligations under the Convention, and desiring to further its objectives,

(3) Emphasizing that [the principles and objectives of] the Geneva Protocol of 1925 and the Convention represent an unequivocal determination for the sake of all humankind to exclude completely the possibility of bacteriological (biological) agents and toxins being used as weapons,

[(4) Mindful of their obligations under the Convention never in any circumstances to develop, produce, stockpile or otherwise acquire or retain 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 or weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict,]

(5) Stressing the importance of the final declarations of successive Review Conferences of the Convention, and emphasizing, in particular, the unanimous reaffirmation that the use by States Parties, in any way and under any circumstances, of microbial or other biological agents or toxins, that is not consistent with prophylactic, protective or other peaceful purposes, is effectively a violation of Article I of the Convention,

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

(7) Convinced that strengthening and enhancing the preamble and the provisions of the Convention, adopting specific measures to improve its implementation and effectiveness, and encouraging universal adherence to the Convention and this Protocol, will deliver significant benefits in terms of international security and development,

(8) Determined to accomplish the total elimination of all types of weapons of mass destruction,

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

[(8+9)[2] Determined to act with a view to achieving effective progress toward general and complete disarmament under strict and effective international control, including the prohibition of all types of weapons of mass destruction,]

(10) Welcoming the entry into force of the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on Their Destruction, signed at Paris on 13 January 1993,

(11) Recognizing the significant advances in the field of biotechnology since the entry into force of the Convention, and the potential implications, both positive and negative, of these advances for the implementation and effectiveness of the Convention,

[(12) Conscious of the apprehension arising from relevant scientific and technological developments as expressed by States Parties at Review Conferences of their use for purposes inconsistent with the objectives and the provisions of the Convention,]

(13) Determined to ensure that all achievements in this field are used exclusively for the benefit of mankind,

[(14) Reaffirming the obligation of each State Party to the Convention under Article III not to transfer to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in Article I of the Convention,]

[(15) Concerned with the increasing gap between the developed and the developing countries in the field of biotechnology, genetic engineering, microbiology and other related areas,]

(16) Desiring to promote international cooperation and exchange of bacteriological (biological) agents and toxins, and equipment, materials and scientific and technological information in the field of biotechnology for purposes not prohibited under the Convention to enhance the economic and technological development of all States Parties,

(17) Emphasizing the increasing importance of the implementation of the provisions of Article X of the Convention and the obligations of each State Party under that Article [as well as under this Protocol], especially in the light of recent scientific and technological developments in the field of biotechnology, bacteriological (biological) agents and toxins for peaceful purposes, which have vastly increased the potential for cooperation between States to help to promote economic and social development, and scientific and technological progress [particularly in developing countries],

[(18) Determined to promote international cooperation on all developments in the field of frontier science and high technology in areas relevant to the Convention, and urging the developed countries possessing advanced biotechnology and knowledge in such fields as medicine, public health and agriculture to adopt positive measures and to continue to promote technology transfer and cooperation on an equal and non-discriminatory basis, in particular with the developing countries, for the benefit of all mankind,]

(19+7) Convinced that the most effective way to promote a world free of biological and toxin weapons is through strengthening the provisions of the Convention by the measures contained in this Protocol, and through promoting universal adherence to the Convention and this Protocol; further convinced that this will [contribute to delivering] [deliver] significant benefits in terms of international security and development,[3]

(20) Determined to strengthen and improve the effective implementation of the Convention,

Have agreed as follows:

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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) 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.]

[1 bis This Protocol 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 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. The measures set out in this Protocol shall be implemented [by the organs of the Organization] in a manner to ensure full protection of commercial proprietary information and national security information. To this end, such measures shall be carried out in the least intrusive manner consistent with the fulfilment of their objectives pursuant to this Protocol.

[6. 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.][4]

7. To enhance confidence in compliance with the Convention and the Protocol 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 provided to States Parties and to the relevant organs of the Organization in the performance of their functions [, in accordance with the provisions of this Protocol].

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

[9. All provisions under the Protocol shall apply to States Parties on [a non-discriminatory] an equal basis.]

[10. 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.]

[11. In implementing the provisions of this Protocol, the States Parties and the Director-General shall, when appropriate, 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 Protocol.]][5]

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ARTICLE II

DEFINITIONS[6]

1. Aerobiology means

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

2. 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 C, section I, paragraphs 34 and 35.

[3. 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.]

4. Biocontrol agent[8] 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.]

[5. Biological agents[9] 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.]

[6. Biological defence facility[10] means

Facility which is [directly] involved in a biological defence programme and/or activities.]

[7. Biological defence programme and/or activities (against biological and toxin weapons)[11] [12] means

Programme and/or activities involving research and 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.]

8. 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.

9. Facility means

Any [room or suite of rooms, laboratory(ies),] building(s), or parts of building(s), or other structures [either at a fixed location or mobile] which is (are) [designed or] used to conduct activity(ies) [in the field of biology] [related to the Convention]. Such a facility may have an identifiable boundary and/or a single operational control [or may be placed within a final perimeter].

10. 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.

[11. High biological containment [(BL-3 - WHO and OIE classification)] means

Any room or suite of rooms, laboratory(ies) or other buildings or structures:

(a) Designed [or] [and] 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 [for work with infectious agents that present a high risk to laboratory workers but a low risk to the community,] 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

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. Hostile purposes[13] mean

[Any purpose, which has no prophylactic, protective or other peaceful intention.]

[12 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, or other kind of damage;

[(b) Any other purpose, which has no prophylactic, protective or other peaceful intention.]]]

[13. Maximum biological containment [(BL-4 - WHO and OIE classification)] means

Any room or suite of rooms, laboratory(ies) or other buildings or structures:

(a) Designed [or] [and] 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 classifi