34526 
Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 199_4 / Notices 
Involving viable organisms containing 
recombinant DNA molecules. 
Appendix K-V— L. The universal 
biosafety sign shall be posted on each 
closed system and primary containment 
equipment when used to contain viable 
organisms containing recombinant DNA 
molecules. 
Appendix K-V-M. Emergency plans 
required by Sections rV-B-2-b-(6) and 
IV-B-3-c-^3) shall include methods 
and procedures for handling large losses 
of culture on an emergency basis. 
Appendix K-V-N. Closed systems 
and other primary containment 
equipment used in handling cultures of 
viable organisms containing 
recombinant DNA molecules shall be 
located within a controlled area which 
meets the following requirements; 
Appendix K-V-N-1. The controlled 
area shall have a separate entry area. 
The entry area shall be a double-doored 
space sudi as an air lock, antm-oom, or 
change room that separates the 
conti^led area &om the balance of the 
facility. 
Appendix K-V-N-2. The surfaces of 
walls, ceilings, and floors in the 
controlled area shall be such as to 
permit ready cleaning and 
decontamination. 
Appendix K-V-N-3. Penetrations 
into the controlled area shall be sealed 
to permit liquid or vapor phase space 
decontamination. 
Appendix K-V-N— 4. All utilities and 
service or process piping and wiring 
entering the controlled area shall be 
protected against contamination. 
Appendix K-V-N-5. Hand washing 
facilities equipped with foot, elbow, or 
automatically operated valves shall be 
located at each major work area and 
near each primary exit. 
Appendix K-V-N-6. A shower 
facility shall be provided. This facility 
shall be located in dose proximity to 
the controlled area. 
Appendix K-V-N-7. The controlled 
area shall be designed to preclude 
release of culture fluids outside the 
controlled area in the event of an 
accidental spill or release from the 
closed systems or other primary 
containment equipment 
Appendix K-V-N-6. The controlled 
area ^all have a ventilation system that 
is capable of controlling air movement. 
The movemenUof air shall be from areas 
of lower contamination potential to 
areas of higher contamination 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 air 
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 high effidency 
p»articulate air/HEPA filtered, subjected 
to thermal oxidation, or othmwise 
treated to prevent the release of viable 
organisms. 
Appendix K-V-O. The following 
perstmnel and operational practices 
shall be required: 
Appendix K-V-O-1. Persoimel entry 
into the controlled area shall be throu^ 
the entry area specified in Appendix K- 
V-N-1. 
Appendix K-V-O-2. Persons entering 
the controlled area .shall exchange or 
cover their personal clothing with work 
garments such as jump suits, laboratory 
coats, pants and shirts, head cover, and 
shoes or shoe covma. On exit from the 
controlled area the>vork clothing may 
be stored in a locker separate from that 
used for piersonal dothing or discarded 
for laundering. Clothing shall be 
decontaminated before laundering. 
Appendix K-V-O-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 needs. Prior to entry, all 
persons shall be informed of the 
operating practices, emergency 
procedures, and the nature of the work 
conducted. 
Appendix K-V-O-4. Persons under 18 
years of age shall not be permitted to 
enter the controlled area. 
Appendix K-V-O-5. The universal 
biosafety sign shall be posted on entry 
doors to the controlled area and all 
internal doors when any work involving 
the organism is in progress. This 
includes 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 persoimel 
authorized to enter the controlled area. 
Appendix K-V-O-6. The controlled 
area shall be kept neat and clean. 
Appendix K-V-O-7. Eating, drinking, 
smoking, and storage of food are 
prohibited in the controlled area. 
Appendix K-V-O-8. Animals and 
plants shall be excluded from the 
controlled area. 
Appendix K-V-O-9. An effective 
insect and rodent control program shall 
be maintained. 
Appendix K-V-O-10. Access doors to 
the controlled area shall be kept closed, 
except as necessary for access, while 
work is in progress. Serve doors leading 
directly outdoors shall be sealed and 
locked while work is in progress. 
Apptendix K-V-0-11. Persons shall 
wash their hands when exiting the 
controlled area^ 
Appendix K-V-O-1 2. Persons working 
in the controlled area shall be trained in 
emergency procedures. 
Appendix K-V-O-13. Equipment and 
materials required for the management 
of accidents involving viable organisms 
containing recombinant DNA molecules 
shall be available in the controlled area. 
Appendix K-V-O-14. The controlled 
area shall be decontaminated in 
accordance with established procedures 
following spills or othm- accidental 
release of viable organisms containing 
recombinant DNA molecules. 
Appendix K — ^Table 1. Comparison of Good Large Scale Practice (GLSP) and Biosafety Level (BL) — Large Scale (LS) 
Practice (see Appendix K-VI-A) 
Criterion (See Appendix K-Vl-B] 
GLSP 
BL1-LS 
BL2-LS 
BLIM.S 
1. Formulate and implement ir^titutiortat codes of practice for safe- 
K-H-A 
G-l 
G-l 
G-l 
ty of personnel and adequate controt of hygiene and safety 
measures. 
2. Provide adequate written ir>struct>ons and training of persorwel 
K-ll-B 
G-tm 
G-lUt 
G-lSl 
to keep work place dean and tidy and to keep exposure to bio- 
logical, chemical or physical agents at a level that does not ad- 
versely affect health arid safety of employees. 
3. Provide changing and hand washing fadlities as v«tt as protec- 
K-lt-C 
G-li-A-T-h 
G-ll-B-2-f 
G-n-C-2-l 
th/e clothing, appropriate to the risk, to be worn during work. 
4. ProWbit eating, drinkmg, snwking, nxKJth pipetting, and applying 
K-M-C 
G-fl-A-t-d 
C 
cosmetics In the work place. 
G-rtl-A-1-e 
G-«-B-1-e 
G-ff-C->-d 
5, Intemai acddent reporimg 
K-H-G 
K-W-A 
Ik-(v-a 
Ik-iv-a 
Recombinant DNA Research, Volume 19 
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