Regulations on Export Control of Dual-Use Biological Agents and Related Equipment and Technologies

    Updated : 2015-09-11

3. Animal Pathogens

(1)Bacteria

Mycoplasma mycoides

(2)Viruses

(a) African swine fever virus;

(b) Avian influenza virus ; (This includes only those Avian influenza viruses of high pathogenicity Type A viruses with an IVPI (intravenous pathogenicity index) in 6-week-old chickens of greater than 1.2 or type A viruses H5 or H7 subtype for which nucleotide sequencing has demonstrated multiple basic amino acids at the cleavage site of haemagglutinin.)

(c) Bluetongue virus;

(d) Foot and mouth disease virus;

(e) Goat pox virus;

(f) Herpes virus (Aujeszky's disease);

(g) Hog cholera virus (syn. swine fever virus);

(h) Lyssa virus;

(i) Newcastle disease virus;

(j) Peste des petits ruminants virus;

(k) Porcine enterovirus type 9 (syn. swine vesicular disease virus);

(l) Rinderpest virus;

(m) Sheep pox virus;

(n) Teschen disease virus;

(o) Vesicular stomatitis virus.

4. Plant Pathogens

(1)Bacteria

(a) Xanthomonas albilineans;

(b) Xanthomonas campestris pv.citri.

(2)Fungi

(a) Colletotrichum coffeanum var. Virulans (Colletotrichum kahawae);

(b) Cochliobolus miyabeanus (Helminthosporium oryzae);

(c) Microcyclus ulei (syn. Dothidella ulei);

(d) Puccinia graminis (syn. Puccinia graminis f.sp.tritici);

(e) Puccinia striiformis (syn. Puccinia glumarum);

(f) Pyricularia grisea/Pyricularia oryzae.

5. Genetic Elements and Genetically-modified Organisms

(1)Genetic elements that contain nucleic acid sequences associated with the pathogenicity of any of the microorganisms in Part II of the List.

(2)Genetic elements that contain nucleic acid sequences coding for any of the toxins in Part II of the List, or for their sub-units.

(3)Genetically-modified organisms that contain nucleic acid sequences associated with the pathogenicity of any of the microorganisms in Part II of the List.

(4)Genetically-modified organisms that contain nucleic acid sequences coding for any of the toxins in the list or for their sub-units.

6. Dual-Use Biological Equipment

(1)Complete containment facilities at BL3 or BL4 containment level

Complete containment facilities that meet the criteria for BL3 or BL4 containment as specified in the WHO Laboratory Biosafety Manual (2nd edition, Geneva, 1993) should be subject to export control.

(2)Fermenters

Fermenters capable of cultivation of pathogenic microorganisms, viruses or for toxin production, without the propagation of aerosols, having a capacity of 20 litres or greater. Fermenters include bioreactors, chemostats and continuous-flow systems.

(3)Centrifugal Separators (including decanters)

Centrifugal separators capable of continuous separation of pathogenic microorganisms, without the propagation of aerosols, and having all the following characteristics:

(a) one or more sealing joints within the steam containment area;

(b) a flow rate greater than 100 litres per hour;

(c) components of polished stainless steel or titanium;

(d) capable of in-situ steam sterilisation in a closed state.

(4)Cross (tangential) Flow Filtration Equipment

Cross (tangential) flow filtration equipment capable of continuous separation of pathogenic microorganisms, viruses, toxins and cell cultures, having all the following characteristics:

(a) equal to or greater than 5 square metres;

(b) capable of in-situ sterilization.

(5)Freeze-drying Equipment

Steam sterilisable freeze-drying equipment with a condenser capacity of 10 kgs of ice or greater in 24 hours less than 1,000 kgs of ice in 24 hours.

(6)Protective and Containment Equipment

(a) Protective full or half suits or hoods dependent upon a tethered external air supply and operating under positive pressure;

Note: This does not control suits designed to be worn with self-contained breathing apparatus.

(b) Class 3 biological safety cabinets or isolators with similar performance standards (e.g. flexible isolators, dry boxes, anaerobic chambers, glove boxes, or laminar flow hoods (closed with vertical flow)).

(7)Aerosol Inhalation Chambers

Chambers designed for aerosol challenge testing with pathogenic microorganisms, viruses or toxins and having a capacity of 1 cubic metre or greater.

7. Related Technology

The technology for development or production of biological agents or dual-use biological equipment in Part II of the List.

The English translation is for reference only and if there is any discrepancy, the Chinese version shall prevail.