ARTICLE III

COMPLIANCE MEASURES
(continued)

F. [MEASURES TO STRENGTHEN THE IMPLEMENTATION OF ARTICLE III]

[1. States Parties [, in order to ensure compliance with Article III of the Convention,] shall only transfer [among themselves] dual-use microbial and other biological agents, toxins and equipment for purposes not prohibited by the Convention, in accordance with the following guidelines.]

OR

[1. To further ensure that transfers of items specified in this paragraph are consistent with Article III of the Convention, no State Party shall authorize transfers to any recipient whatsoever unless that State Party has, where appropriate, assured itself that such items will only be used for prophylactic, protective or other peaceful purposes:

(a) Fermenters or bioreactors designed to prevent the release of aerosols with a total internal volume of 100 litres or more;

(b) Aerosol chambers designed for use for the dissemination of aerosols of microorganisms or toxins;

(c) Equipment designed for use in experimental aerobiology studies to generate aerosols of microorganisms or toxins;

(d) Aerosol analytical equipment designed to determine the size of aerosol particles up to 20 microns in diameter that contain microorganisms or toxins.]

[2. In pursuance of paragraph 1, and recognizing that most of the agents, toxins, equipment and technologies are of a dual-use nature and with the objective of preventing dual-use items from being utilized for purposes prohibited by the Convention, the guidelines shall be as follows:

(a) Any request made by a State Party for the procurement of a specific agent/toxin reagent shall be accompanied by information on purpose, quantity required, site or facility for proposed use, quantity to be produced at the site or facility, place where intended to be stored and end-use certificate;³⁶

(b) Any request for transfer or procurement of equipment envisaged to be declared under CBMs, for use by a State Party in a BL4 facility, including details of its proposed application and the site/facility for intended use, shall be intimated to the Organization;

(c) Any transfer of technology related to means of delivery, aerosol dispersion of toxins and pathogens, stabilization of agents/toxins to environmental stress shall be intimated to the Organization;

(d) Transfer of agents, equipment and material shall not be allowed to non-States Parties without prior approval of the Organization.]

[3. In fulfilment of the obligation in paragraph 1 above each State Party shall take into account as appropriate the stated end-use of the transfer and any supporting information; the nature and implementation in the State Party requesting the transfer of the measures specified in paragraph 10 of this section; and the extent to which these measures are effective in fulfilling the obligations of Articles III and IV of the Convention.]

[4. No transfer of microbial or other biological agents or toxins, whatever their origin or method of production, or equipment or material which is capable of using such agents or toxins for purposes which would contravene Article I of the Convention, shall be allowed to non-States Parties of the Convention and the Protocol.]³⁷

[5. In order to promote transparency and to enhance confidence-building among States Parties, each State Party shall, according to the standardized formats for reporting international transfers contained in Appendix G, notify the Technical Secretariat annually of any imports or exports of the following equipment which have been completed for prophylactic, protective or other peaceful purposes, during the previous calendar year:

(a) Fermenters or bioreactors with a total internal volume of 100 litres or more for which the end-use indicated by the State Party requesting the transfer is use in a maximum biological containment laboratory or facility;

(b) Chambers designed for aerosol challenge testing with microorganisms or toxins, and having a capacity of one cubic metre or more.]

[6. Following submission of the national reports pursuant to paragraph 5 above, States Parties may, if they deem it appropriate, consult and exchange among themselves further information on an ad hoc basis, in order to improve clarity and avoid discrepancies in the data and information reported.]

[7. Information submitted pursuant to paragraph 5 above shall be made available to States Parties on request.]

[8. Each State Party shall in terms of, and in accordance with, its national constitutional and/or legislative requirements, establish the legislation, regulatory and/or administrative provisions for controls to regulate the transfer of agents, toxins, equipment and technologies relevant to the Convention in accordance with its obligations under the Convention.]

[9.

(a) To ensure compliance with Article III of the Convention, each State Party shall only authorize transfers to any recipient whatsoever, of microbial or other biological agents, or toxins whatever their origin or method of production, or equipment which is capable of using such agents or toxins, [if that State Party has determined that these will be used] solely for prophylactic, protective or other peaceful purposes.

(b)

(i) Each State Party shall report to the Organization on the national laws and regulations it has adopted to implement Article III of the Convention not later than ... days after the entry into force of this Protocol for that State Party and whenever an amendment thereto is made.

(ii) Each State Party shall report to the Organization on its administrative and other national measures to implement Article III of the Convention not later than ... days after the entry into force of this Protocol for that State Party and whenever an amendment thereto is made.

[(c) Each State Party, in implementing these measures, shall ensure that they do not impede the peaceful economic and technological development of States.]]

[10. Each State Party shall notify the Technical Secretariat on the national laws, regulations and administrative measures it has adopted to implement Articles III and IV of the Convention not later than 180 days after entry into force of this Protocol for that State Party. Each State Party shall submit to the Technical Secretariat annually any modifications or additions made to such national laws, regulations and administrative measures during the previous calendar year.]

[11. Transfer guidelines

(a) [The provisions of the Protocol shall not be used to impose] [and States Parties shall not maintain among themselves] restrictions and/or limitations on the transfer of scientific knowledge, technology, equipment and materials for purposes not prohibited under the Convention.

(b) In order to promote transparency in the biological trade, the States Parties may agree on arrangements for exchanging the end-user certificate related to biological exports in a manner that will entail no restrictions or impediments on access to biological materials, equipment or technological information by all States Parties. This would replace all existing ad hoc regulations in the biological trade at the time of entry into force of the Protocol for States Parties.

(c) An end-user certificate may be required from the recipients stating, in relation to the transferred biological agents or toxins and equipment (to be identified as relevant by the Ad Hoc Group), the following:

(i) That they will only be used for purposes not prohibited under this Convention for the States not party to the Convention;

(ii) That they will not be retransferred without receiving the authorization from the supplier(s);

(iii) Their types and quantities;

(iv) Their end-use(s); and

(v) The name and address(es) of the end-user(s).

(d) States Parties shall resolve suspicions arising from such transfers through the process of consultation and clarification in accordance with Article V of the Convention.]

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