Memorandum 35
Submission from the British Embassy, Beijing,
China
1. The state implements classified management
of the pathogenic microorganisms on the basis of Regulations
on Biosafety Management in Pathogenic Microorganism Laboratories.
The pathogenic microorganisms are divided into four categories
according to their infectivity and their damage to individuals
or groups after infection.
— The first category includes microorganisms
that can cause very serious disease to humans or animals as well
as to those that haven't been found in China or have been declared
extinct.
— The second category includes the
microorganisms that can cause serious disease to humans or animals
and which spread comparatively easily from human to human, animal
to human, and animal to animal.
— The third category includes the microorganisms
that can cause disease to humans or animals but in general won't
result in serious damage to humans, animals or the environment,
have limited risk of spreading, will not cause serious disease
after laboratory infection and can be controlled through effective
treatments and precautions.
— The fourth category includes the
microorganisms that can't in general cause disease to humans or
animals.
2. The current List of Human Infectious
Pathogenic Microorganisms issued by Ministry of Health in
2006 includes three types of category tables. Table 1 lists 160
viruses followed by a Prion appendix. Table 2 lists 155 bacteria,
actinomycete chlamydiae, mycoplasmas, rickettsiae and spirochetes.
Table 3 is a category list of 59 eumycetes.
All pathogenic microorganisms are classified
according to the level of harm they can do, their transportation
needs and storage requirements. The biosafety laboratory levels
required by different experiments are also stipulated. Comparatively
detailed notes and instructions are attached to each table.
3. The state implements graded management
of pathogenic microorganism laboratories. Measures on the Administration
of the Examination and Approval of Human Infectious Highly Pathogenic
Microorganism Laboratories and Biosafety of such Laboratory's
Activities (No 50 Order issued by Ministry of Health) applies
to the examination and approval of highly pathogenic microorganism
experiments related to human health as well as highly or suspected
highly pathogenic microorganism experiments for G3 and G4 biosafety
laboratories. The Measures stipulate that G3 and G4 biosafety
laboratories engaging in highly pathogenic microorganism experiments
should obtain a Qualification Certificate of Highly Pathogenic
Microorganism Laboratories issued by Ministry of Health. If
engaging in certain highly or suspected highly pathogenic microorganism
experiments, the laboratories should obtain approval from health
administrative departments at above provincial level.
4. The laboratory and its parent organization
should strengthen biosafety protection and the management of laboratory
activities according to relevant provisions of Regulations
on Biosafety Management in Pathogenic Microorganism Laboratories,
such as to formulate scientific and strict managerial system,
to regularly inspect the implementation of relevant biosafety
regulations, and to regularly examine, maintain and upgrade laboratory
facilities, equipment and materials etc. to ensure they measure
up to the national standard. The health administrative departments
at all levels should supervise and inspect the highly pathogenic
microorganism laboratories and such laboratory activities based
on Regulations on Biosafety Management in Pathogenic Microorganism
Laboratories.
5. The laboratory or its parent organization
should regularly provide training for the staff each year based
on Regulations on Biosafety Management in Pathogenic Microorganism
Laboratories and conduct examinations to ensure staff have
mastered laboratory technical specifications, operating rules,
biosafety protection knowledge and practical operating skills.
Qualified staff passing the examination are permitted to work
in the laboratory.
6. The Regulations on Transportation
of Human Infectious Highly Pathogenic Bacterium (Virus) or Its
Specimen (No 45 Order issued by Ministry of Health) has taken
effect since 1 February 2006. The Rules on Managing the Storage
of Human Infectious Pathogenic Bacterium (Virus) is in the
process of formulation.
7. Corresponding protective measures should
be taken for suspected highly pathogenic microorganisms according
to its biosafety category.
8. The laboratory staff (including students
conducting research work) engaging in experiments related to highly
pathogenic microorganisms should pass an examination and gain
approval from the laboratory principal, who is the first person
responsible for laboratory biosafety and should supervise the
safety of laboratory staff (including students conducting research
work) engaging in experiments related to highly pathogenic microorganisms.
The university should provide training for the
students on biosafety education and relevant knowledge about pathogenic
microorganism laboratories.
1
January 2008
| 
