Federal Register / VoL 56, No. 138 / Thursday. July 16. 199i / Notices 
"S3181 
or otherwise treated to prevent the 
release of viable organisms. 
Appendix K-V-N, The following 
personnel and operational practices 
shall be required: 
Appendix K-V-N-L Personnel entry 
into the controlled area shall be through 
the entry area specified in Appendix K- 
V-M-1. 
Appendix K-V-N-2. Persons entering 
the controlled area shall exchange or . 
cover their personal clothing with work 
garments such as jumpsuits, lalwratory 
coats, pants and shirts, head cover, «tiH . 
shoes or shoe covers. On exit torn Ae - 
controlled area the work clothing' may 
be stored in a locker separate from that 
used for personal clothi^ or discarded 
for laundering, aothing shall be 
decontaminated before laundering. 
Appendix K-V-N-3, Entry into the 
controlled area during periods when 
work is in progress shall be restricted to 
those persons required to meet program 
or support need& Prior to entry all 
persons shall bb informed of the 
operating practices, emergency 
procedures and the natiure of the work 
conducted. 
Appendix K-V-N-4. Persons under 18 
years of age shall not be permitted to 
enter the controlled area. 
Appendix K-V-N-S. The universal 
biohazard sign shall be posted on entry 
doors to die controlled area and all 
internal doors %dien My work involving 
the otgai^m Is In progress. This 
indudes periods when decontamination 
.procedures are in progress. The sign 
posted on the entry doors to the 
controlled area shall include a statement 
of agents in use and personnel 
authorized to enter the controlled area. 
Appendix K-V-^i-8. The controlled 
area shall be kept neat and dean. 
Appendix K-V-J^-7. Eating, drinking, 
smoking, and stcxage of food are 
prohibited in the controlled area. 
Appendix K-V-N-8. Animals and 
plants shall be exduded from the 
controlled area. 
Appendix K-V-N-9. An effective insect 
and rodent control program shall be 
maintained. 
Appendix K-V-n.iq. Access doors to ' 
the controlled area shall be kept dosed, 
except as necessa^ fpj. access, while 
work is in progress. Serve doors leading 
directly outdoors shall b® sealed and 
locked while work is in progress. 
y^pendix K-V-N-11. Persons shall 
wash their hands when leaving the • ' 
controlled area. . • - 
Appendix K-V-^-12. Persons wqrkihg ' 
in the control!^ area shall be trainedib 
emergency procedures.' ■ ; rivt- ? 
Appenchx K-V^N-IS. Equipment and r 
materials required for the management 
of acddents involving viable organisms 
containing recombinant DMA molecules 
shall be available in the controlled area. 
Appendix K-V^-14. -The controlled 
area shall be decontaminated in 
accordance %vith established procedures 
following spills or other acddental 
release of viable organisms containing 
recombinant DNA molecules. 
■ li' 
Appendix K.— Comparison of GLSP and BL-LS Practjces t1] 
Criterion [2] 
GLSP 
' BL1-LS 
B12-LS 
rij 
ir-M-R 
rs_M^ 1 
K-lt-C 
rs_ii_R_ej 
ir_K_r. 
G-n-e-1-d. 
fl I* ^ 1 11 
ir-run 
tr-iiL-a 
G-n-8-2-kand 
GU-8-2-L 
un 
NR 
60 
fjQ 
tr.jii-R 
•rjv-a 
NR 
•rjii_r 
K-fV-8 
ir-iLj: 
ir_iiur; 
lfJV_R 
Minimize 
Minimize Errgirteer 
Prevent Engirreer 
- Procedure K-W- 
K-4U-a 
K-fV-C 
F. . 
' , *■ 
NR 
Minimize K-lll-E ' 
Prevent K-IV-0 
NR 
K-ni-P 
NR 
NR 
NR ■ - 
■WQ 
NR 
NR ■ 
NR 
icjv-r; 
NR ' 
NR 
K-fV-H 
wn 
NR 
NR - 
NR 
K-n/^i 
xji-r; 
x-Jit-r; 
ir-iv-K 
#aR 
a_a_Fui_e 
MR • 
NR 
NR 
1. Formulats and imptemerit Insttbjiional codes of pnfcSce for safety, of person* 
■ nel and adequate control of hygiene and safety measures. - 
• G-1 ■ 
2. Provide adequate written Instnictions and talning of pefsorineS to Iceep 
woriqslace de^ and tidy arid to keep axposure to biological, chemical or 
physical agents at a level that does not adversely affect health and safety of 
employees.' ' - • ^ • 
G-tlfl 
a. Provide changing and handwashing CacSties as well as protective clothing. 
- appropriate to the risk, to be worn during work. 
4. Prohibit eating, drinking, smoking, mouth pipetting, and applying cosmetics in 
the workplace. 
5. Interrial accident reporting i::: : ! L. 
6 . Medical surveillance ^ ; 
7. Viabie organii^ should be handled In a system that physically separates the 
process from the eirtemal environment (dosed syst^ or other primary 
'tentairiment). ■•• • •.■. . . 
8 . Culture fluids not removed from a system until organisms Inactivated 
6 . Iroctivatlon of waste solutions artd materuJs with respect to their biohazard 
potontiaL ■ ' * , " ' 
10. Control of aetosob by engineering oir prooedural dontrola to prevent or 
. - criinimize letease of organisms dtdng satiipllng from a system, addition of 
-■,fnaterisls to a,aystem. transfer of cuKvatad celts, and removal of material, 
product^ vrid affkionts bom a aystom. ■.--■'y'." ' 
11. - Treatment of exhatdt gasses from a dosed system to minimize oir prevent 
.releese of viable organisma. - * . 7 ; '.'.•i i- ' 
^2. Oosed aystsm that has contained viable oqjanisms not to be op«r^ 4 intil 
• ^ at erifaed by a validated procedure. 7 ' . , - 
- ia Oosed system to be maintained at as a low pressure as possible to nuJntain 
V'totegrity by coritawnent (eaturds. ' ^ » 
14. Rotating seals and other penetrations into dosed system ciesigned to 
prevent or minimize leakage. . . . . 
15. Oosed aysl^ ahaH tocoqporate moohorirvg or aenshvg devices to monitor the 
totegrity'ql containment. '. ’ , • . . v . . ' .' 
16. Valldatod Integrity testing of closed coritaitvTv^ system 
t7. Oosed system to be permanently identified for record keepmg purposes. 
; 16. Universal biohazard dgn to be potted on each dosed system 
; ,19. Emergency plw required lor hsndiirvg large losses of cuftt.Tes_____ 
; 2a Access to the workplaoe. ■ 
21 Requirements for controlled access area .1. 
If- I.-. , . - .. 1 - 
G-ll-C-2-4. 
G-ll-C-l-c. 
G-ll-C-l-d. 
G-ll-C-2-q and 
G-«-C-2-r. 
Da 
K-V-A 
K-V-B. 
K-V- 8 . 
Prevent Engineer 
K-V-C. 
Prevent K-V-O. 
K-V-E. 
K-V-F. 
Preverrl K-V-G. 
K-V-H. • 
K-V-l. 
K-V-J. 
K-V-K. - 
K-V-E - ' ' 
K-V-M. 
K-V-UIN. 
. ...“NR.-^Otrepdred. 
[ 874 ] 
Recombinant DNA Research, Volume 14 
