REGULATIONS OF THE PEOPLE’S REPUBLIC OF CHINA ON EXPORT CONTROL OF DUAL-USE BIOLOGICAL AGENTS AND RELATED EQUIPMENT AND TECHNOLOGIES
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The State Council Decree of the State Council of the People’s Republic of China No.365 Regulations of the People’s Republic of China on Export Control of Dual-Use Biological Agents and Related Equipment and Technologies Premier of the State Council, Zhu Rongji October 14, 2002 Regulations of the People’s Republic of China on Export Control of Dual-Use Biological Agents and Related Equipment and Technologies Article 1 These Regulations are formulated for the purposes of strengthening export control of dual-use biological agents and related equipment Article 2 The export of dual-use biological agents and related equipment and technologies referred to in these Regulations means the export Article 3 The export of dual-use biological agents and related equipment and technologies shall be in accordance with relevant laws, administrative Article 4 The State shall exercise strict control on the export of dual-use biological agents and related equipment and technologies so as to Article 5 The State shall practice a licensing system for the export of dual-use biological agents and related equipment and technologies in Article 6 Exporters of dual-use biological agents and related equipment and technologies shall register themselves with the competent department Article 7 The receiving party of dual-use biological agents and related equipment and technologies shall guarantee: (1) Not to use the imported dual-use biological agents and related equipment and technologies for the purpose of biological weapons; (2) Not to use dual-use biological agents and related equipment and technologies supplied by China for the purposes other than the declared (3) Not to transfer dual-use biological agents and related equipment and technologies to any third party other than the declared end-user Article 8 Anyone who intends to export dual-use biological agents and related equipment and technologies listed in the Control List shall apply (1) Identifications of the applicant’s legal representative, chief manager(s) and the person(s) handling the deal; (2) Duplicates of the contract or agreement, or other certification documents; (3) Technical specifications of the dual-use biological agents and related equipment and technologies; (4) Certificate of end-user and end-use; (5) Documents of guarantee as defined in Article 7 of these Regulations; and (6) Other documents as may be required by the competent foreign economic and trade department of the State Council. Article 9 An applicant shall truthfully fill in the export application form. Export application forms shall be uniformly produced by the competent foreign economic and trade department of the State Council. Article 10 The competent foreign economic and trade department of the State Council shall, from the date of receiving the export application The competent foreign economic and trade department of the State Council shall, within 15 working days, make a decision of approval Article 11 Where the export of dual-use biological agents and related equipment and technologies entails significant impact on the State security Where the export of dual-use biological agents and related equipment and technologies is submitted to the State Council for approval, Article 12 Where an application for the export of dual-use biological agents and related equipment and technologies is examined and approved, Article 13 An export license holder who intends to change the dual-use biological agents and related equipment and technologies originally applied Article 14 While exporting dual-use biological agents and related equipment and technologies, the exporter shall present the export license to Article 15 Where the receiving party contravenes the guarantees made according to the provisions of Article 7 of these Regulations, or there Article 16 Where any unit or individual knows or should know that the dual-use biological agents and related equipment and technologies to be Article 17 Upon approval by the State Council, the competent foreign economic and trade department of the State Council may, jointly with relevant Article 18 Those who export dual-use biological agents and related equipment and technologies without being licensed or export dual-use biological Article 19 Those who forge, alter, buy or sell the license for the export of dual-use biological agents and related equipment and technologies Article 20 Where a license for the export of dual-use biological agents and related equipment and technologies is obtained by fraud or other Article 21 Where, in violation of the provisions of Article 6 of these Regulations, the export of dual-use biological agents and related equipment Article 22 Where the State functionaries in charge of control on the export of dual-use biological agents and related equipment and technologies Article 23 In light of actual situations, the competent foreign economic and trade department of the State Council may, jointly with relevant Article 24 In the case of the re-export of dual-use biological agents and related equipment and technologies after import, these Regulations Article 25 These Regulations shall be effective as of December 1, 2002. 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 (3) The pathogens controlled in the List include any isolated living creature of a pathogen agent, and any kind of biological materials (4) Toxins controlled in the List do not include immunotoxins, and human medical products approved by the competent department of the (5) Genetic elements controlled in the List include chromosomes, genomes, plasmids, transposons, and vectors whether genetically modified (6) Related technologies controlled in the List include technical data and technical assistance and so on, except knowledge in the public (7) Once the dual-use biological equipment controlled in the List is approved to export, the export of basic technologies related to the 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, (2) “Pathogen” means the natural or genetically modified pathogenic microorganism which can cause death, disease or other harms to human (3) “Toxin” means the biological active material, originated from any microorganism, animal or plant, whatever their method of production, (4) “Vaccine” means the medicinal product that has entered into clinical trial, production or marketing as approved by the competent department (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 (7) “Biosafety Level 4 (BL4)” means the containment level and biosafety treatment capabilities that can meet the criteria of BL4 containment (8) “Basic scientific research” means experimental or theoretical work undertaken principally to acquire new knowledge of the fundamental (9) “Knowledge in the public domain” means technology that has been made available without restrictions upon its further dissemination (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 onsite installation), maintenance (checking), repair, overhaul, etc. Part I 1. Human or Zoonotic Pathogens (1) Bacteria (a) Clostridium perfringens; (b) Clostridium tetani; (c) Enterohaemorrhagic Escherichia coli, serotype O157 and other verotoxin producing serotypes; (d) Legionella pneumophila; (e) Yersinia pseudotuberculosis. (2) Viruses (a) Kyasanur Forest virus; (b) Louping ill virus; (c) Murray Valley encephalitis virus; (d) Omsk haemorrhagic fever virus; (e) Oropouche virus; (f) Powassan virus; (g) Rocio virus; (h) St Louis encephalitis virus. 2. Plant Pathogens (1) Bacteria (a) Xanthomonas campestris pv. oryzae; (b) Xylella fastidiosa. (2) Viruses Banana bunchy top virus (3) Fungi (a) Deuterophoma tracheiphila (syn. Phoma tracheiphila); (b) Monilia rorei (syn. Moniliophthora rorei). 3. 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 I of the (2) Genetically-modified organisms that contain nucleic acid sequences associated with the pathogenicity of any of the microorganisms 4. Dual-Use Biological Equipment (1) Equipment for the micro-encapsulation of live microorganisms and toxins in the range of 1-10 micron particle size, specifically: (a) interfacial polycondensors; (b) phase separators. (2) Fermenters of less than 100 litres capacity with special emphasis on aggregate orders or designs for use in combined systems. (3) Conventional or turbulent air-flow clean-air rooms and self-contained fan-HEPA filter units that may be used for BL3 or BL4 containment 5. Related Technology The technology for development or production of biological agents or dual-use biological equipment in Part I of the List. Part II 1. Human or Zoonotic Pathogens (1) Bacteria (a) Bacillus anthracis; (b) Brucella abortus; (c) Brucella melitensis; (d) Brucella suis; (e) Chlamydia psittaci; (f) Clostridium botulinum; (g) Francisella tularensis; (h) Burkholderia mallei (Pseudomonas mallei); (i) Burkholderia pseudomallei (Pseudomonas pseudomallei); (j) Salmonella typhi; (k) Shigella dysenteriae; (l) Vibrio cholerae; (m) Yersinia pestis. (2) Viruses (a) Chikungunya virus; (b) Congo-Crimean haemorrhagic fever virus; (c) Dengue fever virus; (d) Eastern equine encephalitis virus; (e) Ebola virus; (f) Hantaan virus; (g) Junin virus; (h) Lassa fever virus; (i) Lymphocytic choriomeningitis virus; (j) Machupo virus; (k) Marburg virus; (l) Monkey poxvirus; (m) Rift Valley fever virus; (n) Tick-borne encephalitis virus (Russian Spring-Summer encephalitis virus); (o) Variola virus; (p) Venezuelan equine encephalitis virus; (q) Western equine encephalitis virus; (r) White pox; (s) Yellow fever virus; (t) Japanese encephalitis virus. (3) Rickettsiae (a) Coxiella burnetii; (b) Bartonella quintana (Rochalimea quintana, Rickettsia quintana); (c) Rickettsia prowazeki; (d) Rickettsia rickettsii. 2. Toxins as Follows and Subunits (1) Botulinum toxins (2) Clostridium perfringens toxins (3) Conotoxin (4) Shiga toxin (5) Staphylococcus aureus toxins (6) Tetrodotoxin (7) Verotoxin (8) Microcystin (syn. Cyanginosin) (9) Aflatoxins (10) Abrin (11) Cholera toxin (12) Diacetoxyscirpenol toxin (13) T-2 toxin (14) HT-2 toxin (15) Modeccin toxin (16) Volkensin toxin (17) Viscum Album Lectin 1 (syn. Viscumin) 3. Animal Pathogens (1) Bacteria Mycoplasma mycoides (2) Viruses (a) African swine fever virus; (b) Avian influenza virus; (c) Bluetongue virus; (d) Foot and mouth disease virus; (e) Goat poxvirus; (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 poxvirus; (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 (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 (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 (2) Fermenters Fermenters capable of cultivation of pathogenic microor-ganisms, viruses or for toxin production, without the propagation of aerosols, (3) Centrifugal Separators (including decanters) Centrifugal separators capable of continuous separation of pathogenic microorganisms, without the propagation of aerosols, and having (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 (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 (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 (7) Aerosol Inhalation Chambers Chambers designed for aerosol challenge testing with pathogenic microorganisms, viruses or toxins and having a capacity of 1 cubic 7. Related Technology The technology for development or production of biological agents or dual-use biological equipment in Part II of the List. |
The State Council
2002-10-14