Federtil Kegistef f 
“Appendix K-I— Selection of Physical 
Containment Levels 
“The selection of the physical 
containment level required for 
recombinant DNA research or . 
production involving more than, 10. liters 
of culture is based on the containment 
guidelines established in part III of the 
Guidelines. For purposes of large-scale 
research or production four physical 
containment levels are established. 
These are referred to as GILSP, BLl-LS, 
BL2-LS, and BL3-LS. The GILSP (Good 
Industrial Large-Scale Practice) level of 
physical containment is recommended 
for large-scale research or production 
involving viable, nbn-pathogenic, and 
non-toxigenic recombinant strains 
derived from host organisms that have 
an extended history of safe industrial 
use. Likewise, the GILSP level of 
physical containment is recommended 
for organisms such as those included in 
appendix C that have built-in 
environmental limitations that permit . 
optimum growth in the industrial setting 
but limited survival without adverse 
consequences in the environment For 
those organisms that do not qualify for 
GILSP, the BLl-LS (Biosafety Level 1 — 
Large-Scale) level of physical 
containment is recommended for large- 
scale research or production of viable 
organisms containing recombinant DNA 
molecules that require BLl containment 
at the laboratory scale. The BL2-iS 
(Biosafety bevel .2 — Large Scale) level of 
physical containment is required for 
Jl:*B5, No. '178," f • Thursday,' 'September i , 1990 '/ Nbtifcfes ^ J37l^7 
large-scale research dr production of 
viable organisms containing ^ 
recombinant DNA molecules that 
require BL2 containment at the 
laboratory scale. The BL3-LS (Biosafety 
Level 3— -Large Scale) level of physical 
coittainihent is required for large-scale 
research or production of Viable 
organisms containing recombinant DNA 
molecules that require BL3 containment 
at the laboratory scale. No provisions 
are made for large-scale research or 
production of viable organisms 
containing recombinant DNA molecules 
that require BL4 containment at the 
laboratory scale. If necessary, these 
requirements will be established by NIH* 
on an individual basis. 
“Appendix K-II — GILSP Level. 
"Appendix K-JI-A. Cultures of viable 
organisms containing recombinant DNA 
molecules shall be handled in facilities 
intended to safeguard health during 
work with microorganisms that do not 
require containment. Processes and 
equipment should be designed and 
constructed to assure the integrity of the 
production organism and resulting 
product. 
"Appendix K-II-B. Addition of 
materials 4o a system, sample collection, 
transfer of culture fluids within/between 
systems, and processing of culture fluids 
shall be conducted in a manner that 
maintains employee exposure to viable 
organisms containing recombinant DNA 
molecules at a level that does not 
adversely.affect the health and safety of 
employees.' 
"Appendix K-II-C. 'Wt'xWen 
instructions and training of personnel 
shall be provided to assure that cultures 
of viable organisms containing 
recombinant DNA molecules are 
handled prudently and, that the 
workplace is kept clean and orderly. 
"Appendix K-II-D. In the'interest of 
good personal hygiene, facilities (e.g., 
handwashing sink, shower, changing 
room) and protective clothing (e.g.. 
uniforms, laboratory coats) shall be 
provided that are appropriate for the 
risk of exposure to viable organisms 
containing recombinant DNA molecules. 
In addition, eating, drinking, smoking, 
applying cosmetics and mouth pipetting 
shall be prohibited in the work area. 
"Appendix K-II-E. The facility’s 
emergency response plan shall include 
provisions for handhng spills. 
"Appendix K-II-F. Discharges 
containing viable recombinant 
organisms shall be handled in 
accordance with applicable 
environmental regulations. 
"Appendix K-II-G. Institutional codes 
of practice shall be formulated and 
implemented to assure adequate control 
of health and safety matters,” 
(Remainder of appendix K remains 
unchanged with the exception of the 
following: renumber appendix K-U to 
appendix K-III; renumberappendix K-III to 
appendix K-IV; renumber appendix K-IV to , 
appendix K-V] 
BUXINQ CODE 4140r04-M 
[330] 
Recombinant DNA Research, Volume 14 
