(Promulgated by Decree No. 365 of the State Council of the
People's Republic of China on October 14, 2002, and effective as of December 1,
2002)
Article 1 These Regulations are formulated for the
purposes of strengthening export control of dual-use biological agents and
related equipment and technologies, and safeguarding the State security and
social and public interests.
Article 2 The export of dual-use biological agents and
related equipment and technologies referred to in these Regulations means the
export for trade of dual-use biological agents and related equipment and
technologies listed in the "Dual-Use Biological Agents and Related Equipment and
Technologies Export Control List" (hereinafter referred to as the Control List)
attached to these Regulations, and the exchange with, interchange with, gift to,
exhibition in, assistance to, provision of service for as such and other forms
of technological transfer thereof to foreign countries and regions.
Article 3 The export of dual-use biological agents and
related equipment and technologies shall be in accordance with relevant laws,
administrative regulations of the State and these Regulations, and shall not
imperil the State security and social and public interests.
Article 4 The State shall exercise strict control on the
export of dual-use biological agents and related equipment and technologies so
as to prevent dual-use biological agents and related equipment and technologies
from being used for the purpose of biological weapons.
Article 5 The State shall practice a licensing system for
the export of dual-use biological agents and related equipment and technologies
in the Control List. Without being licensed, no unit or individual shall export
such dual-use biological agents and related equipment and technologies.
Article 6 Exporters of dual-use biological agents and
related equipment and technologies shall register themselves with the competent
department in charge of foreign economic relations and trade of the State
Council (hereinafter referred to as the competent foreign economic and trade
department of the State Council). Without such registration, no unit or
individual shall export dual-use biological agents and related equipment and
technologies. The specific measures for such registration shall be formulated by
the competent foreign economic and trade department of the State Council.
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 end-use
without the consent of the Chinese Government; and
(3) not to transfer dual-use biological agents and related equipment and
technologies to any third party other than the declared end-user without the
consent of the Chinese Government.
Article 8 Anyone who intends to export dual-use biological
agents and related equipment and technologies listed in the Control List shall
apply to the competent foreign economic and trade department of the State
Council, fill in the export application form for dual-use biological agents and
related equipment and technologies (hereinafter referred to as the export
application form), and submit the following documents:
(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) certificates 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 form and the documents set forth in Article 8 of these Regulations,
examine the application, or examine the application jointly with other relevant
departments.
The competent foreign economic and trade department of the State Council
shall, within 15 working days, make a decision of approval or denial of the
application for the export of dual-use biological agents and related equipment
and technologies listed in Part I of the Control List; the competent foreign
economic and trade department of the State Council shall, within 45 working
days, make a decision of approval or denial of the application for the export of
dual-use biological agents and related equipment and technologies listed in Part
II of the Control List.
Article 11 Where the export of dual-use biological agents
and related equipment and technologies entails significant impact on the State
security and social and public interests, the competent foreign economic and
trade department of the State Council shall, jointly with relevant departments,
submit the case to the State Council for approval.
Where the export of dual-use biological agents and related equipment and
technologies is submitted to the State Council for approval, the timing
restrictions set forth in Article 10 of these Regulations shall not be applied.
Article 12 Where an application for the export of dual-use
biological agents and related equipment and technologies is examined and
approved, the competent foreign economic and trade department of the State
Council shall issue a licence for the export of dual-use biological agents and
related equipment and technologies (hereinafter referred to as an export
licence), and notify the Customs in writing.
Article 13 An export licence holder who intends to change
the dual-use biological agents and related equipment and technologies originally
applied for export shall return the original export licence and file a new
application to obtain an export licence according to relevant provisions of
these Regulations.
Article 14 While exporting dual-use biological agents and
related equipment and technologies, the exporter shall present the export
licence to the Customs, complete the customs procedures and accept supervision
and control of the Customs in accordance with the provisions of the Customs Law.
Article 15 Where the receiving party contravenes the
guarantees made according to the provisions of Article 7 of these Regulations,
or there is a risk of proliferation of dual-use biological agents and related
equipment and technologies listed in the Control List that can be used for the
purpose of biological weapons, the competent foreign economic and trade
department of the State Council shall suspend or revoke the export licence
granted and notify the Customs in writing.
Article 16 Where any unit or individual knows or should
know that the dual-use biological agents and related equipment and technologies
to be exported will be used by the receiving party directly for the purpose of
biological weapons, it shall not export such dual-use biological agents and
related equipment and technologies, whether included in the Control List or not.
Article 17 Upon approval by the State Council, the
competent foreign economic and trade department of the State Council may,
jointly with relevant departments of the State Council, temporarily decide to
exercise export control on specific dual-use biological agents and related
equipment and technologies other than those listed in the Control List in
accordance with the provisions of these Regulations.
Article 18 Those who export dual-use biological agents and
related equipment and technologies without being licensed or export dual-use
biological agents and related equipment and technologies beyond the scope of the
export licence without authorization, shall be investigated for criminal
liability in accordance with the provisions of the criminal law on the crime of
smuggling, the crime of illegal business operations, the crime of divulging
State secrets or other crimes; if such acts are not serious enough for criminal
punishment, by distinguishing different circumstances, they shall be punished in
accordance with relevant provisions of the Customs Law, or be given a warning,
confiscated of their illegal income, and fined not less than 50,000 yuan but not
more than 250,000 yuan by the competent foreign economic and trade department of
the State Council; the competent foreign economic and trade department of the
State Council may concurrently suspend or even revoke the licensing for their
foreign trade operations.
Article 19 Those who forge, alter, buy or sell the licence
for the export of dual-use biological agents and related equipment and
technologies shall be investigated for criminal liability in accordance with the
provisions of the criminal law on the crime of illegal business operations or
the crime of forging, altering, buying or selling official documents,
certificates or seals of a State organ; if such acts are not serious enough for
criminal punishment, they shall be punished in accordance with relevant
provisions of the Customs Law, and the competent foreign economic and trade
department of the State Council may concurrently revoke the licensing for their
foreign trade operations.
Article 20 Where a licence for the export of dual-use
biological agents and related equipment and technologies is obtained by fraud or
other illegal means, the competent foreign economic and trade department of the
State Council shall revoke such an export licence, confiscate the illegal
income, impose a fine of not less than 20,000 yuan but not more than 100,000
yuan, and suspend or even revoke the licensing for their foreign trade
operations.
Article 21 Where, in violation of the provisions of
Article 6 of these Regulations, the export of dual-use biological agents and
related equipment and technologies is operated without registration, the
competent foreign economic and trade department of the State Council shall ban
such illegal activities according to law, and relevant competent departments of
the State shall impose punishment thereon in accordance with relevant laws and
administrative regulations.
Article 22 Where the State functionaries in charge of
control on the export of dual-use biological agents and related equipment and
technologies abuse their powers, neglect their duties or extort or accept money
or properties from others by taking advantage of their positions, they shall be
investigated for criminal liability in accordance with the provisions of the
criminal law on the crime of abuse of power, the crime of neglect of duties, the
crime of accepting bribes and other crimes; if such acts are not serious enough
for criminal punishment, they shall be given administrative sanctions according
to law.
Article 23 In light of actual situations, the competent
foreign economic and trade department of the State Council may, jointly with
relevant departments, amend the Control List and submit it to the State Council
for approval before implementation.
Article 24 In the case of the re-export of dual-use
biological agents and related equipment and technologies after import, these
Regulations shall apply.
Article 25 These Regulations shall be effective as of
December 1, 2002.
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.
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
List.
(2)Genetically-modified organisms that contain nucleic
acid sequences associated with the pathogenicity of any of the microorganisms in
Part I of the List.
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
facilities.
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 pox virus;
(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 ; (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.
