29812 
Federal Register / VoL 52. No. 154 / Tuesday. August 11. 19e7 / Notices 
work area. The hazard warning sign 
shall identify the agent, animal species, 
list the name and telephone number of 
the director, or other responsible 
person(s) and indicate the special 
requirement(s) for entering the 
laboratory." 
298. "Appendix Q-II-C-2-k. 
Personnel shall enter and leave the 
facility only through the clothing change 
and shower rooms. Street clothing shall 
be removed in the outer clothing change 
room and kept there. Complete 
laboratory clothing, including 
undergarments, pants, and shirts or 
jumpsuits, and shoes shall be provided 
and used by all personnel entering the 
facility. When leaving the BL4-N zone 
and before proceeding into the shower 
area, personnel shall remove their 
laboratory clothing in the inner change 
room and with appropriate discard for 
sterilization. Personnel shall shower 
each time they leave the facility. 
Personnel shall use the airlocks to enter 
or leave the laboratory only in an 
emergency." 
299. "Appendix Q-Il-D-2-l. When 
personnel ventilated suits are required, 
the animal personnel shower entrance/ 
exit zone will be equipped with a 
chemical disinfectant shower to 
decontaminate the surface of the suit 
before the worker leaves the area. A 
neutralization or water dilution device 
will be integral with the chemical 
desinfectant discharge piping before it 
enters the heat sterilization system. 
Entry to this area is through an airlock 
Pitted with airtight doors." 
300. "Appendix Q-ll-D-2-m. The 
ventilated head hood or a one piece 
positive pressure suit that is ventilated 
by a life-support system shall be worn 
by all personnel entering the rooms 
containing experimental animals when 
appropriate." 
301. "Appendix Q-lI-C-2-n The life 
support system for the ventilated suit or 
head hood will be equipped with alarms 
and emergency back-up breathing air 
tanks The exhaust air from the suit area 
is filtered by two sets of HEPA filters 
installed in series or incinerated A 
duplicate filtration unit, exhaust fan. 
and an automatically starting emergency 
power source are provided. The air 
pressure within the suit area is to be 
greater than that of any adjacent area 
Emergency lighting and communication 
systems are provided. A double-doored 
autoclave is provided for 
decontaminating waste materials to be 
removed from the suit area." 
302. "Appendix Q-II-D-2-o. 
Hypodermic needles and syringes shall 
be used only for parenteral injection and 
aspiration of fluids from laboratory 
animals and diaphragm bottles. Only 
needle-locking syringes or disposable 
syringe-needle units (i.e.. needle is 
integral to the syringe) shall be used for 
the injection or aspiration of fluids 
containing organisms that contain 
recombinant DNA molecules. Extreme 
caution shall be used when handling 
needles and syringes to avoid 
autoinoculation and the generation of 
aerosols during use and disposal. 
Needles shall not be bent, sheared, 
replaced in the needle sheath or guard 
or removed from the syringe following 
use. The needles and syringe shall be 
promptly placed in a puncture-resistant 
container and decontaminated, 
preferably by autoclaving, before 
discard or reuse." 
303. "Appendix Q-II-D-2-p. A system 
shall be set up for reporting laboratory 
accidents and exposures which result in 
overt exposures to organisms containing 
recombinant DNA molecules, employee 
absenteeism and for the medical 
surveillance of potential laboratory- 
associated illnesses. Written records are 
prepared and maintained. An essential 
adjunct to such a reporting-surveillance 
system is the availability of a facility for 
quarantine, isolation, and medical care 
of personnel with potential or known 
laboratory-associated illnesses " 
304. "Appendix Q-Il-D-2-q. When 
appropriate with 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 agents handled or the function of 
the facility." 
305. "Appendix Q-tl-D-2-r A 
biosafety manual shall he prepared or 
adopted Personnel shall be advised of 
special hazards and shall he required to 
read instructions on practices and 
procedures and to follow them." 
300. "Appendix Q-U-D-2-s Biological 
materials to be removed from the animal 
maximum containment laboratory in a 
viable or intact state shall he 
transferred to a nonbreakable. scaled 
primary container and then enclosed in 
a nonbreakable. sealed secondary- 
container which shall be removed from 
the facility through a disinfectant dunk 
tank, fumigation chamber, or an airlock 
designed for this purpose. Advance 
approval for transfer of material must be 
obtained from the director. Such 
packages containing viable agents enn 
only be opened in another BL4-N' facility 
unless the agent is biologically- 
inactivated or is nonreproductive. 
Special safety testing, decontamination 
procedures, and IBC approval are 
required to move agents or tissue/orgun 
specimens from e BL4-N facility to one 
with a low er containment 
classification." 
307. "Appendix Q-U-D-2-t. Animal 
room doors and gates shall be kept 
closed when experiments are in 
progress." 
308 "Appendix Q-Il-D-2-u. Molded 
surgical masks or respirators shall be 
worn in rooms containing experimental 
animals." 
309. "Appendix Q-ll-D-2-v. Vacuum 
lines shall be protected with high 
efficiency particulate air (HEPA) filters 
and liquid disinfectant traps." 
310. "Appendix Q-II-D-2-w. A log 
book signed by all personnel shall 
indicate the dale and time of each entry 
and exit." 
311. “Appendix Q-lI-D-2-x. Supplies 
and materials needed in the facility 
shall be brought in by wav of the 
double-doored autoclave, fumigation 
chamber, or airlock which is 
appropriately decontaminated between* 
each use. After securing the outer doors, 
personnel within the facility shall 
retrieve the materials by opening the 
interior doors of the autoclave, 
fumigation chamber, or airlock. These 
doors shall be secured after materials 
are brought into the facility." 
312. "Appendix Q-Il-D-3. Special 
Animal Facilities — BLJ-.V" 
313. "Appendix Q-lI-D-3-a. All 
animals shall be contained within an 
enclosed structure (animal room or 
equivalent) to minimize the possibility 
of theft or unintentional release and 
avoid access of nonexperimental 
arthropods." 
314 "Appendix Q-H-C-3-b. Tne 
interior surfaces of walls, floors, and 
ceilings shall be impervious to water 
and resistant to acids, alkalis, organic 
solvents, and moderate heat so that they 
can be easily cleaned. Penetrations in 
these surfaces shall be sealed to 
facilitate decontaminating the area." 
315. "Appendix Q-II-D-3-c. Windows 
in the laboratory sh.il! be closed, sealed, 
and breakage resistant." 
316. "Appendix Q-II-D-3-d. 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 
positioned to allow- removal of material 
from, the containment zone." 
317. "Appendix Q-II-D-3-e. Liquid 
effluent from containment equipment, 
sinks, biological safety cabinets, animal 
rooms, primary barriers, floor drains, 
and sterilizers is decontaminated by 
heat treatment before being released 
into sanitary system(s). Liquid wastes 
from, shower rooms arid toilets may be 
decontaminated with chemical 
Recombinant DNA Research, Volume 13 
[33] 
