Annex

Dual-Use Biological Agents and Related Equipment and Technologies Export Control List

1. Introduction

(1) This List comprises two parts.

(2) Items controlled in the List are included mainly according to their dual-use specialty in biological area, especially their risk grade for non-peaceful purpose. Thus, biological agents, found or never found, or eradiated in China are all listed in the List.

(3) The pathogens controlled in the List include any isolated living creature of a pathogen agent, and any kind of biological materials (e.g. cell, tissue, serum and animal), or non-biological materials contaminated with these pathogens. Whatever these pathogens are, natural or genetically modified, is under export control, except those in the form of a vaccine.

(4) Toxins controlled in the List do not include immunotoxins, and human medical products approved by the competent department of the State.

(5) Genetic elements controlled in the List include chromosomes, genomes, plasmids, transposons, and vectors whether genetically-modified or unmodified.

(6) Related technologies controlled in the List include technical data and technical assistance and so on, except knowledge in the public domain, or basic scientific research whether controlled in the List, or knowledge required for general patent. The forms of technical data include blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions written or recorded on other media or devices such as disks, tapes, read-only memories. The forms of technical assistance include offering instruction, skills, training, working knowledge, consulting services, as well as transfer of technical data.

(7) Once the dual-use biological equipment controlled in the List is approved to export, the export of basic technologies related to the equipment, such as installation, operation, maintenance, repair or overhaul to the same end-user is also authorized.

2. Definitions

For the purposes of this List, the following definitions apply:

(1) "Biological dual-use specialty" means the character of being used either for peaceful purposes, such as medicine, prevention, protection, or for non-peaceful purposes, such as development and production of biological weapons. The pathogens, toxins and genetic elements with such character are called dual-use biological agents; and the equipment with such character is called dual-use biological equipment.

(2) "Pathogen" means the natural or genetically-modified pathogenic microorganism which can cause death, disease or other harms to human beings, animals or plants.

(3) "Toxin" means the biological active material, originated from any microorganism, animal or plant, whatever their method of production, whether natural or modified, which can cause death, disease or other harms to human beings, animals, and plants.

(4) "Vaccine" means the medicinal product that has entered into clinical trial, production or marketing as approved by the competent department of the State, which is intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or which it is administered.

(5) "Technology" means specific information necessary for the development, production or use of a product.

(6) "Biosafety Level 3 (BL3)" means the containment level and biosafety treatment capabilities that can meet the criteria of BL3 containment as specified in the WHO Laboratory Biosafety Manual (2nd edition, Geneva, 1993) with respect to biological medicine and microbiology facilities in 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, microorganism operating regulation and personnel precaution.

(7) "Biosafety Level 4 (BL4)" means the containment level and biosafety treatment capabilities that can meet the criteria of BL4 containment as specified in the WHO Laboratory Biosafety Manual(2nd edition, Geneva, 1993) with respect to biological medicine and microbiology facilities in 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, microorganism operating regulation, personnel precaution and so on. The feature is that, on the basis of BL3, the airlock or pass-through autoclave system, biosafety cabinet class III or positive-pressure ventilated suits and a special controlled air system are used to reach a higher biosafety containment and capacity than BL3.

(8) "Basic scientific research" means experimental or theoretical work undertaken principally to acquire new knowledge of the fundamental principles of phenomena or observable facts, not primarily directed towards a specific practical aim or objective.

(9) "Knowledge in the public domain" means technology that has been made available without restrictions upon its further dissemination (copyright restrictions do not remove technology from being in the public domain).

(10) "Development" is related to all stages before production, such as:

(a) design;

(b) design research;

(c) design analysis;

(d) design concepts;

(e) assembly of prototypes;

(f) pilot production schemes;

(g) design data;

(h) process or transforming design data into a product;

(i) configuration design;

(j) integration design and layouts.

(11) "Production" means all production phases, such as:

(a) construction;

(b) production engineering;

(c) manufacture;

(d) integration;

(e) assembly (mounting);

(f) inspection;

(g) testing;

(h) quality assurance.

(12) "Use" means operation, installation (including on-site installation), maintenance (checking), repair, overhaul, etc.