Management of Bio-safety and Bio-security is based on the “Regulations Governing Management of Infectious Biological Materials” and related rules. 

Bio-laboratories are classified into four bio-safety levels, i.e.. level 1 (BSL1) to level 4 (BSL4) according to their operational practices, barriers, and safety equipment and facilities.  Currently, there’re only BSL1 and BSL2 laboratories in the NTHU campus.

The pathogens are classified into four risk groups, risk group 1 (RG1) to risk group 4 (RG4) according to the hazardous level of their pathogenicity.  Researchers and students are allowed to use RG1 and RG2 pathogens in the NTHU campus, but not other higher levels of pathogens.

Vaccine strains and Lentiviral vector that pass related tests and are identified as lentivirus shall be managed and treated as RG2 pathogens.

A list of RG1 to RG4 pathogens and biotoxins are provided in the Appendixes 1-5 of the ‘Operation Directions Governing Management of Infectious Biological Materials, Ministry of Health and Welfare’ document.

Researchers in biological laboratories can keep, use, or dispose RG2 pathogens or biotoxins only after submitting proposals and receiving permission from the NTHU bio-safety committee.

To import or export infectious biological materials, bio-researchers have to submit application forms and relevant documents to the central competent authority to request for permission. In the cases of RG2 pathogens or biotoxins, a documentation of consent by the bio-safety committee or biosafety personnel of the laboratory shall be enclosed along with the application.

To transport infectious biological materials, one shall follow the triple packaging rules set forth by the central competent authority, and use appropriate vehicles in compliance with the rules and regulations set forth by the central transportation and communications authority.

Safety practices:

1. Personnels in bio-laboratories should attend at least 8 hours of basic education and training courses on bio-safety and bio-security in the first year, as well as refresher bio-security education and training course (4 h) every year in the following years before graduation.
2. All laboratories should develop or adopt a bio-safety operations manual that describes hazardous chemicals to be used in the laboratory.  In the manual, it should be described procedures how to minimize or eliminate exposures to these hazardous chemicals.
3. Access to any bio-laboratory should be regulated. No access is allowed without permission.
4. Safety equipments including BSCs, enclosed containers, and other engineering controls should be designed in such a way to avoid or minimize exposures to hazardous biological materials. A BSC is the major device, and should be used to provide containment of infectious droplets or aerosols generated in many microbiological procedures.
5. A supervisor of a bio-laboratory should adopt improved engineering and work practice controls to reduce the risk of  injuries by sharp needles and others.
6. One should de-contaminate the surface of a work place/table after any spilling or splash of any potentially infectious material as well as at the end of a day using appropriate disinfectants.
7. One should wear gloves are worn to protect hands from exposure to hazardous materials when working in a bio-laboratory. A risk assessment should be performed to identify the appropriate glove for a particular experiment. Alternatives to latex gloves should be available. Replace a new pair of gloves when the ones in hands are contaminated, or damaged.
8. All personnel in bio-laboratories should  obey the regulations and rules set by the CDC.