Federal Register / Vol. 5^^ No. 127 / Tuesday, fuly 5, 1994 7 Notices 
34545 
agents handled -or the hmction of the 
facility. 
Appendix Q-II-D-l-e-(4j. A 
permanent record boohlndicating the 
date and time of each entry and exit 
shall he signed by all personnel. 
Appendix Q-H-D-l-f. Transfer of 
Materials (BL4— Nj 
Appendix Q-II-I>-l-f-{l). No 
materials, except Tor biological materials 
that are to remain in a viable or intact 
state, shah 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-n-D-l-T-{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, ^raigation chamber, or an airlock 
designed for this purpose. Advance 
approval for traarferof 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 biologically inactivated or 
incapable of TeproducSon. Special 
safety testing. decontamination 
procedures, and 'Institutional Biosafety 
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-ll—D-l-f-{3). Supplies 
ccnd 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. Aker socuring the outer doors, 
personnel within the animal facility 
retrieve the materials by opening the 
interior doors of the autoclave, 
fumigation chamber, ox airlock. These 
doors shall be secured after materials 
are brought into the ainiinal facility. 
Appendix Q-H-D-l-g Other (DL4-NJ 
Appendix All 
genetically ongineered neonates shall be 
permanenUy marked within 72 hours 
after birth, if their size permits. If tljoir 
size does not ^>ermit marking, their 
containers should be marked. In 
addition, tranagerxic animals sliould 
contain distinct and biodiemically 
assayable DNA sequences that allow 
identification of transgenic animals 
from among non-transgenic animals. 
Appendix Q-ll-D-l-g-l2j. Eating, 
drinking, smoking, and applying 
cosmetics shall not be permitted in the 
work area. 
Appendi x Q-H-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-Il-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 
corrtainment provided that they are 
conducted in accordance "with fiL4— N 
practices. 
Appendix Q-T1-T>-1^-{51. Animal 
holding areas shall be cleaned at least 
once a day and decontaminated 
immediately following any spill of 
vi^le -materials. 
Appendix-Q-II-D-l-g— (6). All 
procedures shall be performed carefully 
to minimizethe creation of aerosols. 
Appendix Q-lI-I)-l-g-{73. A double 
barrier shall be provided to separate 
male and female animals. Animal 
isolation barriers shall be sturdy and 
accessible for cleaning. Reproductive 
irucapacitalion may be used. 
Appendix Q-U^D-l-g-(8). The 
containment area shall be in acoordanoe 
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 duplicale 
nitration uzrit, exhaust fan, and an 
automatically 'Starting emergency power 
sounce shall be provided. The air 
pressure within the suit shall be greater 
than that ol any adjacent area. 
Emergency lighting and communication 
systems shall be provided. A double- 
door autodlave ^all he provided for 
decontamination of -waste materials to 
be -removed from the suit area. 
Appendix Q-II-E>-l-g-(10). Needles 
and syringes siiall be used only for 
parenteral injection «nd aspiration of 
fluids from laboratory animals and 
diaphragm bottles. Only needle-locking 
syringes or disposable syringe-needle 
units (i.e.. needle is iotegral to tlic 
syringej shall be used for the injection 
or aspiration of fluids containing 
organisjiis that contain recombinant 
DNA. Extreme caution shall he 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 autodlaving, before 
discard -or -reuse. 
Appendix Q-Il-D-l-g-fll). An 
essential adjunct to the reporting- 
surveillanoe 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-C-l-g-^1 2). A 
biosafety 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-II-D-i2. Animal Facilities 
(BL4-N) 
Appendix Q-B—D-2-a. Animals shall 
be corrtained within an enclosed 
structure (animal room or equivalent) to 
minimize the possibility of theft or 
unintentional release and avoid 
arthropod access. 
Appendix Q-II-O-2-b. The interior 
v\'alls, floors, and ceilings shall be 
impervious to water and resistant to 
acids, alkalis, organic solvents, and 
moderate heat,4o facilitate cleaning. 
PenetTcrtions in these structures and 
surfaces i(e;g., plumbing and utilities) 
shall be sealed. 
Appendix Q-H-4T-2-C. Windows in 
the animal facifity «hall be closed, 
sealed, and breakage -resistant (e.g., 
double-pane tempered glass or 
equivalent). 
Appendix Q-lI-D-2-d. An autoclave, 
mrinerator, or other effective means to 
dacontammate animals and wastes shall 
be available, preferably within the 
containment area. W feasible, a double- 
door autociaveis preferred and should 
be positioned to allow removal of 
material from the containment area. 
Appendix Q-U-D-2— e. A(x»ss doors 
to the containment area shall he self- 
closing. 
Appendix Q-4I-I>42-if. All perimeter 
joints and openings shall he sealed to 
form an arthropod^roof structure. 
Appendix TheBL4-N 
laboratory provides a double barrier to 
prevent the release of recombinant DNA 
containing microorgamsms into the 
environment. Design of the animal 
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Recombinant DNA Research, Volume 19 
