Biosafety Guidelines For Research On Genetically Modified ...

APPENDIX 9: REQUIREMENTS FOR GENETIC MODIFICATION BIOSAFETY LEVEL
4 (GM-BSL4)
GM-BSL 3 and 4 facilities must be approved by the relevant regulatory agency before
commencement of work. The requirements for Biosafety Level 4 in the Laboratory
Biosafety Manual (3 rd Ed, WHO) and the OSH Guidelines for Laboratories and
Production Facilities in the Biomedical Sciences Industry shall apply for GM-BSL4.
Essentially, work in laboratories at GM-BSL4 level shall conform with the procedures set
out for GM-BSL3 laboratories, with the following additional requirements:
Laboratory Procedures
1. All street clothing, including underwear, shall be removed and retained in the
outer clothing change room. Complete laboratory clothing, including shoes, shall
be provided by the organisation and shall be used by all personnel entering the
facility. When leaving the facility, personnel shall remove their laboratory clothing
and store or discard it in the inner change room before showering.
2. Personnel entering or leaving the laboratory shall indicate, either manually or
electronically, the time of each exit and entry.
3. There should always be at least two workers present (or, if only one, a second
person located at an observation window or in telecommunication or video
surveillance) to assist in case of an emergency.
4. The autoclave and fumigation chamber shall be decontaminated after each
exposure to the laboratory environment.
5. A primary container holding viable or intact biological material shall be opened
only in a flexible film isolator or a maximum containment laboratory. Containers
may be opened in other laboratories only if the biological material has been
rendered non-infectious or non-toxic, and the space in the primary and
secondary containers has been decontaminated.
Laboratory Construction
6. A telephone or other means of outside communication shall be provided inside
the laboratory unit.
7. Walls, floors and ceilings of the facility shall be constructed in such a manner as
to form a sealed internal shell which facilitates easy fumigation. The internal
surfaces of the shell shall be resistant to liquids and chemicals used in the facility
and shall facilitate easy cleaning and decontamination. All apertures in the
structures and surfaces shall be sealed to prevent vermin or insects from
entering the area. Any windows shall be resistant to breakage.
8. A pass-through dunk tank, fumigation chamber or equivalent decontamination
equipment shall be provided, so that materials and equipment that cannot be
decontaminated in the autoclave can be rendered safe for removal from the
facility.
9. A shatter-resistant observation window, or suitable alternative monitoring
facilities, shall be installed so that laboratory occupants can be observed from
outside the laboratory.
Appendix - Page 19