34544 
Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
specific entry requirements (e.g., 
vaccination) piay enter the laboratory or 
animal room. 
Appendix Q-II-I>-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 C^II-D-l-a-(8). Animal 
room doors, gates, and other closures 
shall be kept closed when experiments 
are in progress. 
Appendix Q-II-D-l-b. 
Decontamination and Inactivation (BL4- 
N) 
Appendix Q-II-D-l-b-(l). All 
contaminated liquid or solid wastes 
shall be decontaminated before 
disposal. 
Appendix Q-II-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. 
Appendix Q-Il-D-l-b-{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 airlo^ or chamber 
designed for this purpose. 
Appendix Q-II-D-l-b-(5). When 
ventilated suits are required, the animal 
personnel shower entrance/e^t 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 
though an airlock fitted with airtight 
doors. 
. Appendix Q-II-D-l-b-(6). Needles 
and syringes shall be promptly placed 
in a pimcture-resistant container and 
decontaminated, preferably by 
autoclaving, before discard or reuse. 
Appendix Q-Il-I>-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-II-I>-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 in^vidual, and (iv) any 
special requirements for entering the 
laboratory. 
Appendix Q-II-D-l-d. Protective 
Clothing (BL4-N) 
Appendix Q-II-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 
the outer clothing change room. 
Complete laboratory clothing (may be 
disposable),'including undergarments, 
pants, ^irts, jump suits, and shoes shall 
be provided for all personnel entering 
the animal 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 time 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 exposmes that 
are a resiilt 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, Maryland 20892, (301) 
496-9838. Medical evaluation, 
surveillance, and treatment shall be 
provided as appropriate and written 
records maintained. If necessary, the 
area shall be appropriately 
decontaminated. 
Appendix Q-Il-D-l-e-(3). When 
appropriate and giving consideration to 
the agents handled, baseline serum 
samples shall be collected and stored for 
animal care and other at-risk personnel. 
Additional serum specimens may be 
collected periodically depending on the 
Recombinant DNA Research, Volume 19 
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