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Article 1. The present Regulation has been enacted for the purpose of strengthening the control of dual-purpose biological products and affiliated equipments and technologies and safeguarding the security of the state as well as the social public good. Article 2. The term "export of dual-purpose biological products and affiliated equipments and technologies" mentioned in the present Regulation refers to the trade-based export of the dual-purpose biological products and affiliated equipments and technologies mentioned in the List of Dual-purpose Biological Products and Affiliated Equipments and Technologies Subject to Export Control (hereafter "List of Export Control") and the technological transfer conducted by means of foreign intercourse, exchange, donation, exhibition, aid, services and other means. Article 3. The provisions of relevant laws, administrative regulations and the present Regulation shall be observed in the export of dual-purpose biological products and affiliated equipments and technologies, and neither the security of the state nor the social public good may be impaired. Article 4. The state imposes rigid control over the export of dual-purpose biological products and affiliated equipments and technologies so as to prevent the dual-purpose biological products and affiliated equipments and technologies mentioned in the List of Export Control from being used for biological weapon purposes. Article 5. The state practices a license system with regard to the export of dual-purpose biological products and affiliated equipments and technologies mentioned in the List of Export Control. No entity or individual may, without permission, export any of the dual-purpose biological products and affiliated equipments and technologies mentioned in the List of Export Control. Article 6. Any business operator that is engaged in the export of dual-purpose biological products and affiliated equipments and technologies shall be subject to registration at the department in charge of foreign trade and economic cooperation under the State Council (hereafter "foreign trade department under the State Council"). No entity or individual may, without being registered, run the export of dual-purpose biological products and affiliated equipments and technologies. The specific measures for registration shall be formulated by the foreign trade department under the State Council. Article 7. The acceptor of any of the exported dual-purpose biological products and affiliated equipments and technologies shall guarantee that: (1) the imported dual-purpose biological products and affiliated equipments and technologies will not be used for the purpose of biological weapons; (2) it will not, without obtaining the permission of the Chinese government, use any of the dual-purpose biological products and affiliated equipments and technologies supplied by China for any purpose other than declared ultimate purposes; (3) it will not, without the permission of the Chinese government, transfer any of the dual-purpose biological products and affiliated equipments and technologies supplied by China to any third party except the declared ultimate end users. Article 8. To export any of the dual-purpose biological products and affiliated equipments and technologies mentioned in the List of Export Control, one shall file an application to the foreign trade department under the State Council, fill in an Application Form for Exporting Dual-purpose Biological Products and Affiliated Equipments and Technologies (hereafter "Application Form for Export"), and submit the following documents: (1) Certificates of the identity of the legal representative, major management personnel and dealers of the applicant; (2) Copies of the contracts and agreements or other attestation documents; (3) Technical specifications about the dual-purpose biological products and affiliated equipments and technologies; (4) Certifications of end users and ultimate purposes of use; (5) Documents of guarantee provided in Article 7 of the present Regulation; (6) Other documents required by the foreign trade department under the State Council. Article 9. All applicants shall fill in the Application Form for Export true to the fact. The Application Forms for Export shall be subject to the uniform printing of the foreign trade department under the State Council. Article 10. The foreign trade department under the State Council shall, as of the day when it receives the Application Form for Export and the documents mentioned in Article 8 of the present Regulation, examine the said documents by itself or in collaboration with other relevant departments. The foreign trade department under the State Council shall decide within 15 workdays whether to approve or not to approve the application for exporting any of the dual-purpose biological products and affiliated equipments and technologies mentioned in Part I of the List of Export Control. Article 11. The export of any of the dual-purpose biological products and affiliated equipments and technologies that will impose significant impact upon the security of the state or social public good shall be submitted by the foreign trade department under the State Council jointly with the relevant departments concerned to the State Council for approval. Where the export of any of the dual-purpose biological products and affiliated equipments and technologies has been approved by the State Council, it shall not be subject to the limitation of time limit provided in Article 10 of the present Regulation. Article 12. Where an application for the export of any of the dual-purpose biological products and affiliated equipments and technologies has been approved upon examination, the foreign trade department under State Council shall issue a certificate of approval to the applicant for the export of the dual-purpose biological products and affiliated equipments and technologies (hereafter "export approval certificate") and inform the customs offices in written form. Article 13. In case the holder of the export approval certificate changes the export of any of the dual-purpose biological products and affiliated equipments and technologies that it had applied for, it shall return the original export approval certificate and apply anew for export approval by observing the relevant provisions of the present Regulation. Article 14. When exporting dual-purpose biological products and affiliated equipments and technologies, the exporting entity or individual shall show its export approval certificate to the customs office, go through the customs procedures according to the provisions of the Customs Law and accept the supervision of the customs office. Article 15. In case the recipient violates any of its guarantees made according to Article 7 of the present Regulation or the risk of diffusing any of the dual-purpose biological products and affiliated equipments and technologies mentioned in the List of Export Control that may be used for biological weapons occurs, the foreign trade department under the State Council shall suspend or cancel the export approval certificates it has issued and inform the customs in written form. Article 16. In case any entity or individual knows or should have known that any of the exported dual-purpose biological products and affiliated equipments and technologies will be used directly by the recipient for the purpose of biological weapons, it shall not be exported no matter the dual-purpose biological product or affiliated equipment or technology has been included in the List of Export Control. Article 17. Upon the approval of the State Council, the foreign trade department under the State Council may, in collaboration with the relevant departments, provisionally decide whether any dual-purpose biological product or affiliated equipment or technology that is not included in the List of Export Control shall be subject to control according to the present Regulation. Article 18. Any one who, without approval, unlawfully exports any of the dual-purpose biological products or affiliated equipments or technologies or unlawfully exports any of the dual-purpose biological products or affiliated equipments or technologies beyond the permitted scope shall be subject to criminal liabilities according to the provisions of the Criminal Law concerning the crimes of smuggling, illegal business operations, divulging state secrets or other crimes. If the circumstance is not serious enough for criminal punishment, the offender shall, according to the specific situation, be punished according to the relevant provisions of the Customs Law or be given a warning by the foreign trade department under the State Council with its illegal gains be confiscated and be fined not less than 50,000 yuan but not more than 250,000 yuan. The foreign trade department under the State Council may suspend or even cancel the foreign trade permit thereof. Article 19. Any one who forges or alters or trades approval certificates of dual-purpose biological products and affiliated equipments and technologies shall be subject to criminal liabilities according to the provisions of the Criminal Law concerning the crime of illegal business operations or the crime of forging, altering and trading the official documents of state organs, certificate and seals. If the circumstance is not serious enough for criminal punishment, the offender shall be punished according to the relevant provisions of the Customs Law, and the foreign trade department under the State Council may cancel the foreign trade permit thereof. Article 20. In case any one obtains its approval certificate for exporting dual-purpose biological products and affiliated equipments and technologies by unlawful means, the export approval certificates thereof shall be taken over by the foreign department under the State Council, and the illegal gains thereof shall be confiscated with the offender being fined not less than 20,000 yuan but not more than 100,000 yuan, and the foreign trade permit thereof may be suspended or even canceled. Article 21. In case any one violates Article 6 of the present Regulation by unlawfully exporting any of the dual-purpose biological products or affiliated equipments or technologies without being registered, the illegal activities thereof shall be clamped down by the foreign trade department under the State Council and the offender shall be punished by the relevant departments in charge according to the provisions of relevant laws and administrative regulations. Article 22. Any functionary of the state organ that effects control over the export of dual-purpose biological products and affiliated equipments and technologies abuses his power or neglects his duties and functions or exerts or accepts any property of other people by taking advantage of his position shall be subject to criminal liabilities according to the provisions of the Criminal Law concerning the crimes of abusing power, neglecting one's duties and functions, taking bribes or other crimes. If the circumstance is not serious enough for criminal punishment, the offender shall be given an administrative punishment. Article 23. The foreign trade department under the State Council may, in collaboration with the relevant departments, make readjustments to the List of Export Control on the basis of the practical situations and execute them after obtaining approval from the State Council. Article 24. The provisions of the present Regulation shall be applicable to the export of dual-purpose biological products and affiliated equipments and technologies mentioned in the List of Export Control after they are imported. Article 25. The present Regulation shall take effect as of December 1, 2002. Attachment: Dual-Use Biological Agents And Related Equipment And Technologies Export Control List ATTACHMENT: DUAL-USE BIOLOGICAL AGENTS AND RELATED EQUIPMENT AND TECHNOLOGIES EXPORT CONTROL LIST I. Introduction (1) The list is divided into 2 parts. (2) Items included in the list are mainly based on their dual-use biological characteristics, especially risk of non-peaceful application. They may and may not be found in our territory. They may also have been eliminated. (3) Pathogens included in the list include bacteria, viruses, all kinds of live cultures, and a variety of biological materials containing pathogens (such as cell, tissue, serum, infected animals, etc) or non-biological materials, whether they are natural pathogens or genetically modified, except in the form of vaccine. (4) Toxins included in the list do not include immunization with toxins and drug products approved by the relevant state authorities. (5) Genetic materials included in the list include chromosomes, genomes, plasmids, transposons, vectors (whether or not they are genetically modified). (6) Related technologies included in the list include technical data, technical and other forms of assistance but do not include knowledge in the public domain, basic scientific research (whether or not they are on the list), and common knowledge necessary for the patent application. Technical data can be design, planning, diagrams, models, formulas, tables, engineering designs and specifications, manuals and instructions in the form of written or recorded on other media/devices (disk, tape, read-only memory). Technical assistance can be instruction, skills, training, working knowledge, consulting services and technical data transfer. (7) Once item included in the list is approved for export, relevant installation, operation, maintenance and other basic technologies of the approved item will also be authorized for export to the same end-user. II. Definition £¨1£© "Biological dual-use" includes health care, prevention and protection for peace, and development and production of biological weapons for non-peace. Pathogens, toxins, genetic materials with such characteristics are known as "biological agents". Devices with such features are known as "biological dual-use equipment". £¨2£© "Pathogen" refers to those that can compromise, or cause people, animals or plants death, whether they are natural or genetically modified pathogenic microorganisms. £¨3£© "Toxins" refer to microorganisms, animals or plants that can compromise, or cause people, animals or plants death, regardless of the manner in which natural or modified bioactive substances are formed. £¨4£© "Vaccine" refer to biological agents that can stimulate human/animal to have protective immune response to prevent diseases caused by microorganism, and approved by the relevant state departments for clinical trails, production and sale. £¨5£© "Skills" refer to required expertise in development, production or use of the product. (6) "Bio-safety level three (BL3) " refers to biological/medical microbiology laboratories that employ HEPA filters (HEPA),maintain negative pressure in the external environment, the implementation of access control personnel and goods, waste gas waste disposal, have microbiological procedures, personal protection, etc., that meet World Health Organization "Laboratory Biosafety Manual" (second edition, 1993, Geneva) laboratory biosafety standards prescribed three closed and biosafety level processing capabilities. (7) "Bio-safety level four (BL4) " refers to biological/medical microbiology laboratories that employ HEPA filters (HEPA),maintain negative pressure in the external environment, the implementation of access control personnel and goods, waste gas waste disposal, have microbiological procedures, personal protection, etc., that meet World Health Organization "Laboratory Biosafety Manual" (second edition, 1993, Geneva) laboratory biosafety standards prescribed three closed and biosafety level processing capabilities. Based on the fundermentals of BL3, more air system and the separator system of channels are added, dedicated air control systems, and level three biological safety cabinets and positives overalls are used. (8) "Basic scientific research" refers to experimental/theoretical work for acquiring new knowledge about basic phenomena/observable facts, without any specific practical goal. £¨9£©"Knowledge in the public domain" refers to technology without any dissemination restrictions (including technology with copyright restrictions in the public domain) £¨10£© "Development" refers to the various stages of pre-production-related activities, such as: 1. Design 2. Design research 3. Design & analysis 4. Design concept 5. prototype assembly 6. small batch processes 7. Design data 8. Processing or design data into a product 9. Structural design 10. Overall design and planning (11) "Production" refers to all activities of the production process, such as: 1.Infrastructure 2. Production 3. Manufacturing 4. Integration 5. Assembly (installation) 6. Check 7. Inspection 8. Quality assurance (12) "Use" refers to operation, installation (including on-site installation), maintenance (checking), repair, overhaul and other activities. Section I I. Man And Zoonosis Pathogens (A) Bacteria 1. Clostridium perfringens 2. Clostridium tetani 3. Enterohaemorrhagic Escherichia coli, serotype 0157 and other verotoxin producing serotypes 4. Legionella pneumophila 5. Yersinia pseudotuberculosis (B) Virus 1. Kyasanur Forest virus 2. Louping ill virus 3. Murray Valley encephalitis virus 4. Omsk haemorrhagic fever virus 5. Oropouche virus 6. Powassan virus 7. Rocio virus 8. St Louis encephalitis virus II. Plant Pathogens (A) Bacteria 1. Xanthomonas campestris pv. oryzae 2. Xylella fastidiosa (B) Banana bunchy top virus (C) Fungi 1. Deuterophoma tracheiphila (syn. Phoma tracheiphila) 2. Monilia rorei(syn. Moniliophthora rorei) III. Genetic Material And Genetically Modified Organisms (A) Genetic materials containing microorganisms pathogenicity-related nucleic acid sequence in the 1st portion of the list (B) Genetically modified materials containing microorganisms pathogenicity-related nucleic acid sequence in the 1st portion of the list IV. Biological Dual-use Equipment (1) device for creating particle diameter of 1-10 microns live microorganisms and toxin microcapsules, in particular: a. Interface type polycondensors; b. Phase separator. (2) fermenter below 100L specifically designed for joint system or polymers requirements (3) Bio-safety level three or four conventional or turbulent enclosed clean room facilities with HEPA filters with fan (HEPA) unit V. Related technology for the development, production techniques listed in the first part of the list of biological agents or biological dual-use equipment Section II I. Man And Zoonosis Pathogens (A) Bacteria 1. Bacillus anthracis 2. Brucella abortus 3. Brucella melitensis 4. Brucella suis 5. Chlamydia psittaci 6. Clostridium botulinum 7. Francisella tularensis 8. Burkholderia mallei (Pseudomonas mallei) 9. Burkholderia pseudomallei (Pseudomonas pseudomallei) 10. Salmonella typhi 11. Shigella dysenteriae 12. Vibrio cholerae 13. Yersinia pestis (B) Virus 1. Chikungunya virus 2. Congo-Crimean haemorrhagic fever virus 3. Dengue fever virus 4. Eastern equine encephalitis virus 5. Ebola virus 6. Hantaan virus 7. Junin virus 8. Lassa fever virus 9. Lymphocytic choriomeningitis virus 10. Machupo virus 11. Marburg virus 12. Monkey pox virus 13. Rift Valley fever virus 14. Tick-borne encephalitis virus £¨Russian Spring-Summer encephalitis virus£© 15. Variola virus 16. Venezuelan equine encephalitis virus 17. Western equine encephalitis virus 18. White pox 19. Yellow fever virus 20. Japanese encephalitis virus (C) Rickettsia 1. Coxiella burnetii 2. Bartonella quintana (Rochalimea quintana, Rickettsia quintana) 3. Rickettsia prowazeki 4. Rickettsia rickettsii II. Toxin & Subunits (A) Botulinum toxins (B) Clostridium perfringens toxins (C) Conotoxin (D) Shiga toxin (E) Staphylococcus aureus toxins (F) Tetrodotoxin (G) Verotoxin (H) Microcystin (syn. Cyanginosin ) (I) Aflatoxins (J) Abrin (K) Cholera toxin (L) Diacetoxyscirpenol toxin (M) T-2 toxin (N) HT-2 toxin (O) Modeccin toxin (P) Volkensin toxin (Q) Viscum Album Lectin 1 (syn. Viscumin) III. Animal Pathogens (A) Mycoplasma Mycoides (B) Virus 1. African swine fever virus 2. 1 Avian influenza virus 3. Bluetongue virus 4. Foot and mouth disease virus 5. Goat pox virus 6. Herpes virus (Aujeszky's disease) 7. Hog cholera virus (syn. swine fever virus) 8. Lyssa virus 9. Newcastle disease virus 10. Peste des petits ruminants virus 11. Porcine enterovirus type 9 (syn. swine vesicular disease virus) 12. Rinderpest virus 13. Sheep pox virus 14. Teschen disease virus 15. Vesicular stomatitis virus IV. Plant Pathogens (A) Virus 1. Xanthomonas albilineans 2. Xanthomonas campestris pv.citri (B) Fungi 1. Colletotrichum coffeanum var. Virulans(Colletotrichum kahawae) 2. Cochliobolus miyabeanus (Helminthosporium oryzae) 3. Microcyclus ulei(syn. Dothidella ulei) 4. Puccinia graminis(syn. Puccinia graminis f.sp.tritici) 5. Puccinia striiformis(syn. Puccinia glumarum) 6. Pyricularia grisea/Pyricularia oryzae V. Genetic Material & Genetically Modified Organisms (A) Genetic materials containing microorganisms pathogenicity-related nucleic acid sequence in the 2nd portion of the list (B) Genetic materials containing toxins in the 2nd portion of the list (C) Genetically modified materials containing microorganisms pathogenicity-related nucleic acid sequence in the 2nd portion of the list (D) Genetically modified materials containing toxins in the 2nd portion of the list VI. Biological Dual-use Equipment (A) Bio-safety level three or four conventional or turbulent enclosed clean room facilities with HEPA filters with fan (HEPA) unit (B) Fermenter without the propagation of aerosols, pathogenic microorganisms can be cultured or toxin production, and volume greater than 20 liters fermentor. Fermenters include bioreactors, chemostats and continuous-flow systems (C) Centrifugal separator (including decanter) Continuous separation of pathogenic microorganisms without propagation of aerosols, having all of the following characteristics: 1. the steam zone has one or more sealed airtight connection; 2. the flow rate of greater than 100 liters per hour; 3. polished stainless steel or titanium; 4. confined conditions may be steam-sterilized. (D) Closure filtration equipment It can be used for continuous separation of pathogenic microorganisms, toxins and cell culture filter apparatus of the closure, and having all of the following characteristics: 1. is equal to or greater than 5m; 2. may be disinfected. (E) Freeze-drying equipment with 24 hours Iceborne greater than 10 kg, less than 1000 kg, and steam sterilization (F) Sealed protective equipment 1. Rely on external air supply and operational use of the body or half suits, or hoods under positive pressure. (Note: The self-contained breathing apparatus protective clothing does not control) 2. Level three biological safety cabinet, or a similar operating standards isolation devices (such as isolators, oven, anaerobic chambers, glove boxes, or laminar flow hood). (G) Inhalation aerosol container Aerosol infection boxes for pathogenic microorganisms, toxins aerosol challenge test, and a capacity equal to or greater than 1 cubic meter. |
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