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 ;
(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.
