33175 
Federal Register / VoL 56, No. 138 / Thursday, July 18. 1991 / Notices 
Appendix K-U-B. Written instructions and 
training of personnel shall be provided to 
assure that cultures of viable organisms 
containing recombinant DNA molecules are 
bandied prudently and that the workplace is 
kept clean and orderly. 
Appendix K-tl-C. 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 ere 
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-H-D. Cultures of viable- 
organisms containing recombinant DN.A 
molecules shall be handled in facilities 
intended to-safeguard health during work 
%vith microorganisms that do not require 
containment. 
Appendix K-H-E. Discharges containing 
viable recombinant organisms shall be 
handled in accordance with applicable 
goverruncntal environmental regulations. 
Appendix K-n-F. Addition of materials to 
a system, sample collection, transfer of 
culture Quids within/between systems, and 
processing of culture fluids shall be 
conducted in a m ann er (hat maintains 
employee e.xposure to viable organisms 
containing recombinant DNA molecules at a 
level that does not adversely affect the health 
and safety of employees. 
Appendix Kr-lI-G. The facility's emergency 
response plan shall include provisions for 
handling spills. 
Appeiidix K-HI-A. Spills and accidents 
which result in overt exposures to organisms 
contanung recombinant DNA molecules are 
immediately reported to the laboratory • 
director. Medici evaluatioti. suix'eillance. 
and treatment are provided as appropriate 
and written records are maintained. 
Appendix K-IV-M-8. The controlled area 
shall have a ventilation system that is 
capable of controlling air movement The 
■ movement of air shall be from areas of lower 
contamination potential to areas of higher 
contaminatian potentiaL If the ventilation 
system provides positive pressure supply air. 
the system shall operate in a manner that 
prevents the reversal of the direction of air 
movement or shall be equipped with an alarm 
that would be actuated in the event that 
reversal in the direction of «ir movement 
were to occur. The exhaust air from the 
controlled area shall not be recirculated to 
other areas of the facility. The exhaust air 
from the controlled area may not be 
discharged to the outdoors without being 
HEPA tiered, subjected to thermal 
oxidation, or otherwise treated to prevent the 
release of viable organisms. 
(Remainder of appmidix K remains 
unchanged with the exception of the 
following; renumber so that appendix K-U-A 
becomes K-BI-B; K-II-B become K-QI-C: K- 
II-C becomes K-III-D: K-B-D becomes K-III- 
E; K-II-E becomes K-Ht-F; K-IW becomes 
K-III-G; renumber appendix K-III to 
appendix K-TV; renumber appendix K-IV to 
appendix K-V.J 
AppEttotx K. — Comparison of GLSP and BL-LS Practices * 
Criterion* 
GLSP 
BLi-CS 
BL2-I.S 
BL3-LS 
1 FormulatB and 'knpleinent institutional codes of practice (or safety at 
personnel.and. adequate oootroi o( hygiene and safety measures. .. 
2. Provide adequste uiritten instnictions and ttamir«g of personnel to keep 
workplace dean and tidy and to ke^ exposure to biotogicsl, criemicel or 
priysical agents at a level trial does not adversely affect rieaitri and safety of 
employees. 
3. Provide crianging and riandwasrieng facilities as weC as protective doming, 
appropriate to trie risk, to be worn dutmg work. 
4. Proriitxt eatmg, drinking, smoking, moutri pipetting, end apptyinq cosmetics in 
the workplace. 
K n 
G-1 
ir-n-R 
G-11 ? 1 
ir-ii-r 
G-11-B-2-f 
G-U-C-2-c. 
G— G— IJ— 
G-«-S-1-d. G-n- 
G-K-C-1-c. G-ff- 
irjtjh 
K-nt-A 
G-«-6-2-*and 
C-1-d. 
G-ti-O-2-q and 
MP 
NR ’ 
G-U-B-2-1- 
do 
G-«-C-2-r. 
Da 
7. Viable organisms should be riarxlled in s s^-stem that priys<ca'>ly separates 
the process from the external environment (dosed system or other primary 
containment. 
UQ 
K--1U-R 
K-IV-A 
K-V-A. 
NC . . 
K-llI-C 
K-IV-8 
K-V-3. 
9. Inactivatioo of waste sotuierts a."td materials with respect to their biohazard 
potential. 
10. Control cf aerosols by engir.ee.'ir.g or proceC-jral controls to prevent or 
rrJnimize release of orgar^sms during sa.mpiirvg from a system, addition of 
matcriats to a system, trsnster of cuffivated cels, and removal of material, 
products, and efflue-tls (rotr. a systeru. 
It. Treatment of exhax.'sl gasses from a dosed system to rri'jrjzo cr prevent 
release of viable organis.'ns. 
12. Closed system Siat has cerCained vtabie organisms not to be opened unUt 
sterilized by a validated procedure. - 
13. Closed system to be maintaflied at as a tow pressure as posdbie to maintain 
integrity of containment features. 
t-t. Rotating seals and other penetrations into dosed system deigned to 
prevent or minimize leakage. 
15. Closed system shall incorporate monitoring or sensing devices to monSor the 
integrity of conlainmenL 
K-UUC 
K-IV-B 
K-V-B. 
Mitun-rze 
Procedure K-d- 
F. 
MR 
Minimize E=-. 5 .,-,eef 
K-’ti-O. 
Mjvmize K-li‘-£ _ 
r»event Enginee: 
K-IV<. 
Prevent K-iV-0 
Prevent £nc>-ee< 
K-V-C. 
Prevent K-V-C. 
NQ 
K-((!-F 
K-IV-E. 
K-V-E. 
MP 
WK . . 
NR. 
KvV-F. 
fJR 
MR ■ 
Preverit K-IV-F 
Prevent K-V-G 
MR 
IsJP 
K-IV-C . 
K-V-H. 
NP 
MR. 
K-IV-« 
K-V-l. 
1 7. Closed system to bo pormanenUy identified for record keeping purposes 
NR 
K-IV-t 
K-V-J. 
MP 
NR 
K-IV^ .. .. 
K-V-K 
K-IV-K. 
K-V-C 
■9(1 to the worktv'^rv. 
MP * 
G-lt-B-1-a 
K-V-M. 
P«qfiiremefrts for controlled 
^fQ 
NR. 
NR 
K-V-MiN. 
r^R c not required. 
Appendix K. Footnotes. 
1 . This table is derived from the te.xt in 
' Appendices G and K and it not to be used in 
lieu of Appendices C and K. 
2. The criteria in this grid address only the 
b ological hazard associated with organisms 
containing recombinant DNA. Other hazards 
accompanying the large scale cultivation of 
such organisms (e.g., toxic properties of 
products: physical, mechanical and chemical 
aspects of downstream processing) ere not 
addressed and must be considered 
separately, albeit in conjunction with Ibis 
grid. 
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Recombinant DNA Research, Volume 14 
