Federal Register / Vol. 59, No. 127 / Tuesday. July 5. 1994 / Notices 
34491 
Appendix Q-II-D-l-a-{2). The 
containment area shall be locked. 
Appendix Q-II-D-l-a-(3). The 
containment area shall be patrolled or 
monitored at frequent inter\’als. 
Appendix Q-Il-D-l-a-{4). The 
containment building shall be 
controlled and have a locking access. 
Appendix ^Il-D-l-a-(5). The 
Animal Facility Director shall establish 
policies and procedures whereby only 
persons who have been advised of the 
potential hazard and who meet any 
specific entry requirements (e.g., 
vaccination) may enter the laboratory or 
animal room. 
Appendix Q-II-D-l-a-(6). 
Individuals shall enter and exit the 
animal facility only through the clothing 
change and shower rooms. 
Appendix Q-II-D-l-a-{7). Personnel 
shall use the airlocks to enter or exit the 
laboratory only in an emergency. 
Appendix Q-Il-D-l-a-(8). Animal 
room doors, gates, and other closures 
shall be kept closed when experiments 
are in progress. 
Appendix Q-lI-D-l-b. 
Decontamination and Inactivation (BL4- 
N) 
Appendix Q-Il-D-l-h-{l). All 
contaminated liquid or solid wastes 
shall be decontaminated before 
disposal. 
Appendix Q-ll-D-l-b-(2). The work 
surfaces and containment equipment 
shall be decontaminated when work 
with organisms containing recombinant 
DNA molecules is finished. Where 
feasible, plastic-backed paper toweling 
shall be used on nonporous work 
surfaces to facilitate clean-up. 
Appendix Q-II-D-l-b-(3). All wastes 
from animal rooms and laboratories 
shall be appropriately decontaminated 
before disposal in an approved manner. 
Appenoix Q--Il-D-l-o-(4). No 
materials, except for biological materials 
that are to remain in a viable or intact 
state, shall be removed from the 
maximum containment laboratory 
unless they have been autoclaved or 
decontaminated. 
Equipment or material that might be 
damaged by high temperatures or steam 
shall be decontaminated by gaseous or 
vapor methods in an airlock or chamber 
designed for this purpose. 
Appendix Q-lI-D-l-b-(5) When 
ventilated suits are required, the animal 
personnel shower entrance/exit area 
shall be equipped with a chemical 
disinfer tant shower to decontaminate 
the surface of the suit before exiting the 
area A neutralization or water dilution 
device shall be integral with the 
chemical disinfectant discharge piping 
before entering the heat sterilization 
system. Entry to this area shall be 
through an airlock fitted with airtight 
doors. 
Appendix Q-II-D-l-b-{6). Needles and 
syringes shall be promptly placed in a 
puncture-resistant container and 
decontaminated, preferably by 
autoclaving, before discard or reuse. 
Appendix Q-II-D-l-b-(7). Supplies 
and materials needed in the animal 
facility shall be brought in by way of the 
double-door autoclave, fumigation 
chamber, or airlock that shall be 
appropriately decontaminated between 
each use. 
Appendix Q-II-D-l-b-(8). An 
autoclave, incinerator, or other effective 
means to decontaminate animals and 
wastes shall be available, preferably 
within the containment area. If feasible, 
a double-door autoclave is preferred and 
should be positioned to allow removal 
of material from the containment area. 
Appendix Q-II-D-l-b-(9). Liquid 
effluent from containment equipment, 
sinks, biological safety cabinets, animal 
rooms, primary barriers, floor drains, 
and sterilizers shall be decontaminated 
by heat treatment before being released 
into the sanitary system. Liquid wastes 
from shower rooms and toilets shall be 
decontaminated with chemical 
disinfectants or heat by methods 
demonstrated to be effective. The 
procedure used for heat 
decontamination of liquid wastes shall 
be monitored with a recording 
thermometer. The effectiveness of the 
heat decontamination process system 
shall be revalidated every 30 days with 
an indicator organism. Liquid wastes 
from the shower shall be chemically 
decontaminated using an Environmental 
Protection Agency-approved germicide. 
The efficacy of the chemical treatment 
process shall be validated with an 
indicator organism. Chemical 
disinfectants shall be neutralized or 
diluted before release into general 
effluent waste systems. 
Appendix Q-Il-D-l-c. Signs (BL4-N) 
Appendix Q-II-D-l-c-(l). When the 
animal research requires special 
provisions for entry (e.g., vaccination), a 
warning sign incorporating the 
universal biosafety symbol shall be 
posted on all access doors to the animal 
work area. The sign shall indicate: (i) 
The agent, (ii) the animal species, (iii) 
the name and telephone number of the 
Animal Facility Director, or other 
responsible individual, and (iv) any 
special requirements for entering the 
laboratory. 
Appendix Q ll-D-l-d Protective 
Clothing (BL4-N) 
Appendix Q-Il-D-l-d-(l). Individuals 
shall enter and exit the animal facility 
only through the clothing change and 
shower rooms. Street clothing shall be 
removed and kept in (he outer clothing 
change room. Complete laboratory 
clothing (may be disposable), including 
undergarments, pants, shirts, jump 
suits, and shoes shall be provided for all 
personnel entering the anjmal facility. 
When exiting the BL4-N area and before 
proceeding into the shower area, 
personnel shall remove their laboratory 
clothing in the inner change room. All 
laboratory clothing shall be autoclaved 
before laundering. Personnel shall 
shower each lime they exit the animal 
facility. 
Appendix Q-II-D-l-d-(2). A ventilated 
head-hood or a one-piece positive 
pressure suit, which is ventilated by a 
life-support system, shall be worn by all 
personnel entering rooms that contain 
experimental animals when appropriate. 
When ventilated suits are required, the 
animal personnel shower entrance/exit 
area shall be equipped with a chemical 
disinfectant shower to decontaminate 
the surface of the suit before exiting the 
area. A neutralization or water dilution 
device shall be integral with the 
chemical disinfectant discharge piping 
before entering the heat sterilization 
system. Entry to this area shall be 
through an airlock fitted with airtight 
doors. 
Appendix Q-II-D-l-d-(3). Appropriate 
respiratory protection shall be worn in 
rooms containing experimental animals. 
Appendix Q-II-D-l-e. Records (BL4-N) 
Appendix Q-II-D-l-e-(l). Documents 
regarding experimental animal use and 
disposal shall be maintained in a 
permanent record book. 
Appendix Q-II-D-l-e-(2). A system 
shall be established for: (i) Reporting 
laboratory accidents and exposures that 
are a result of overt exposures to 
organisms containing recombinant 
DNA, (ii) employee absenteeism, and 
(iii) medical surveillance of potential 
laboratory-associated illnesses. 
Permanent records shall be prepared 
and maintained. Any incident involving 
spills and accidents that results in 
environmental release or exposures of 
animals or laboratory workers to 
organisms containing recombinant DNA 
molecules shall be reported 
immediately to the Biological Safety 
Officer. Animal Facility Director, 
Institutional Biosafety Committee, NIH/ 
ORDA, and other appropriate 
authorities (if applicable). Reports to the 
NIH/ORDA shall be sent to the Office of 
Recombinant DNA Activities, National 
Institutes of Health. Building 31, Room 
4B11, Bethesda, Maiydand 20892, (301) 
496-9838. Medical evaluation, 
surveillance, and treatment shall be 
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Recombinant DNA Research, Volume 19 
