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Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
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 
agents handled or the function of the 
facility. 
Appendix Q-lI-D-l-e-(4). A 
permanent record book indicating the 
dale and lime of each entry and exit 
shall' be signed by all personnel. 
Appendix Q-U-D-l-f. Transfer of 
Materials (BL4-N) 
Appendix Q-II-D-l-f-{l). No 
materials, except for biological materials 
that are to remain in a viable or intact 
state, shall be removed from the 
maximum containment laboratory 
unlesslhey have been atitoclaved 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-II-I>-l-f-(2). Biological 
materials removed from the animal 
maximum containment laboratory in a 
viable or intact .state shall be transferred 
to a non-breakable sealed primary 
container and then enclosed in a non- 
breakable sealed secondary container 
that shall be removed from the animal 
facility through a disinfectant dunk 
tank, fumigation chamber, or an airlock 
designed for this purpose. Advance 
approval for transfer of material shall be 
obtained from the Animal Facility 
Director. Such packages containing 
viable agents can only be opened in 
another BL4-N animal facility if the 
agent is btiologically inactivated or 
incapable of reproduction. Special 
.safety testing, decontamination 
procedures, and Institutional Bio.safety 
Committee approval shall be required to 
transfer agents or tissue/organ 
specimens from a BL4-N animal facility 
to one with a lower containment 
classification. 
Appendix Q-II-D-l-f-(3). 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. After securing the outer doors, 
personnel within the animal facility 
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 animal facility. 
Appendix Q-II-D-l-g. Other (BL4-N) 
Appendix Q-lI-D-l-g-(l). All 
genetically engineered neonates shall be 
permanently marked within 72 hours 
after birth, if their size permits. If their 
size does not permit marking, their 
containers should be marked. In 
addition, transgenic animals should 
contain distinct and biochemically 
assayable DNA sequences that allow 
identification of transgenic animals 
from among non-transgenic animals. 
Appendix Q-II-E>-l-g-{2). Eating, 
drinking, .smoking, and applying 
cosmetics shall not be permitted in the 
work area. 
Appendix Q-II-D-l-g-(3). Individuals 
who handle materials and animals 
containing recombinant DNA molecules 
.shall be required to wash their hands 
before exiting the containment area. 
Appendix Q-II-D-l-g-(4). Experiments 
involving other organisms that require 
containment levels lower than BL4-N 
may be conducted in the same area 
concurrently with experiments 
requiring BL4-N containment provided 
that they are conducted in accordance 
with BL4-N practices. 
Appendix Q-II-D-l-g-(.')). Animal 
holding areas shall be cleaned at least 
once a day and decontaminated 
immediately following any spill of 
viable materials. 
Appendix Q-II-D-l-g-(6). All 
procedures shall be performed carefully 
to minimize the creation of aerosols. 
Appendix Q-II-D-l-g-(7). A double 
barrier shall be provided to separate 
male and female animal.s. Animal 
isolation barriers shall be sturdy and 
accessible for cleaning. Reproductive 
incapacitation may be used. 
Appendix Q-II-D-l-g-(8). The 
containment area shall be in accordance 
with state and Federal laws and animal 
care requirements. 
Appendix Q-Il-D-l-g-(9). The life 
support system for the ventilated suit or 
head hood is equipped with alarms and 
emergency back-up air tanks. The 
exhaust air from the suit area shall be 
filtered by two sets of high efficiency 
particulate air/HEPA filters installed in 
series or incinerated. A duplicate 
filtration unit, exhaust fan, and an 
automatically starting emergency power 
source shall be provided. The air 
pressure within the suit .shall be greater 
than that of any adjacent area. 
Emergency lighting and communication 
systems shall be provided. A double- 
door autoclave shall be provided for 
decontamination of waste materials to 
he removed from the .suit area. 
Appendix Q-II-D-l-g-(lO). 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. Extreme caution shall be used 
when handling needles and syringes to 
avoid autoinoculation and the 
generation of aerosols during use and 
disposal. Following use, needles shall 
not be bent, sheared, replaced in the 
needle sheath or guard, or removed from 
the syringe. The needles and syringes 
shall be promptly placed in a puncture- 
resistant container and decontaminated, 
preferably by autoclaving, before 
di.scard or reuse. 
Appendix Q-ITD-l-g-(ll). An 
essential adjunct to the reporting- 
surveillance system is the availability of 
a facility for quarantine, isolation, and 
medical care of personnel with potential 
or known laboratory-associated 
illnesses. 
Appendix Q-II-D-l-g-(12). A biosah;!;, 
manual shall be prepared or adopted. 
Personnel shall be advised of special 
hazards and required to read and follow 
instructions on practices and 
procedures. 
Appendix Q-II-D-l-g-(13). Vacuum 
lines shall be protected with high 
efficiency particulate air/HEPA filters 
and liquid disinfectant traps. 
Appendix Q-lI-D-2. Animal Facilitic's 
(BL4-N) 
Appendix Q-II-D-2-a. Animals shall 
be contained wdthin an enclosed 
structure (animal room or equivalent) to 
minimize the possibility of theft or 
unintentional release and avoid 
arthropod access. 
Appendix Q-II-D-2-b. The interior 
walls, floors, and ceilings shall be 
impervious to water and resistant to 
acids, alkalis, organic solvents, and 
moderate heat, to facilitate cleaning. 
Penetrations in these structures and 
surfaces (e.g., plumbing and utilities) 
shall be sealed. 
Appendix Q-Il-D— 2-c. Windows in the 
animal facility shall be clo.sed, sealed, 
and breakage resistant (e.g., double-pane 
tempered glass or equivalent). 
Appendix Q-II-D-2-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 should 
be positioned to allow removal of 
mnt(;rial from the containment area. 
Recombinant DNA Research, Volume 19 
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