NOTICES 
60111 
II-B-3-a-(10). Persons under 16 
years of age shall not enter the labora- 
tory. 
II-B-3-a-< 1 1 ). The universal bioha- 
zard sign shall be posted on the con- 
trolled access area door and on all lab- 
oratory doors when experiments re- 
quiring P3-level containment are in 
progress. Freezers and refrigerators or 
other units used to store organisms 
containing recombinant DNA mole- 
cules shall also be posted with the uni- 
versal biohazard sign. 
Il-B-3-a-<12). An Insect and rodent 
control program shall be instituted. 
II-B-3-a-<13). Laboratory clothing 
that protects street clothing (e.g., 
long-sleeve solid-front or wrap-around 
gowns, no-button or slipover Jackets) 
shall be worn in the laboratory. Front- 
button laboratory coats are unsuit- 
able. Laboratory clothing shall not be 
worn outside the laboratory and shall 
be decontaminated before it is sent to 
the laundry. 
II-B-3-a-(14). Raincoats, overcoats, 
topcoats, coats, hats. caps, and such 
street outer-wear shall not be kept In 
the laboratory. 
II-B-3-a-(15). Gloves shall be worn 
when handling materials requiring P3 
containment. They shall be removed 
aseptically Immediately after the han- 
dling procedure and decontaminated. 
II-B-3-a-(16). Animals and plants 
not related to the experiment shall 
not be permitted in the laboratory. 
II-B-3-a-(17). Vacuum outlets shall 
be protected by filter and liquid disin- 
fectant traps. 
II-B-3-a-(18). Use of hypodermic 
needle and syringe shall be avoided 
when alternative methods are availa- 
ble. 
II-B-3-a-( 19). The laboratory shall 
be kept neat and clean. 
II-B-3-a-<20). If experiments involv- 
ing other organisms which require 
lower levels of containment are to be 
conducted In the same laboratory con- 
currently with experiments requiring 
P3-level physical containment, they 
shall be conducted in accordance with 
all P3-level laboratory practices. 
II-B-3-b. Containment Equipment 
II-B-3-b-<l). Biological safety cabi- 
nets [201 shall be used for all equip- 
ment and manipulations that produce 
aerosols — e.g., pipetting. dilutions, 
transfer operations, plating, flaming, 
grinding, blending, drying, sonicating, 
shaking, centrifuging— where these 
procedures invoive organisms contain- 
ing recombinant DNA molecules, 
except where equipment design pro- 
vides for containment of the potential 
aerosol. 
II-B-3-b-<2). Laboratory animals 
held In a P3 area shall be housed in 
partial-containment caging systems, 
such as Horsfall units [19 A], open 
cages placed in ventilated enclosures, 
solid-wall and -bottom cages covered 
by filter bonnets, or solid-wall and - 
bottom cages placed on holding racks 
equipped with ultraviolt radiation 
lamps and reflectors. (Note: Conven- 
tional caging systems may be used, 
provided that all personnel wear ap- 
propriate personal protective devices. 
These shall include, at a minimum, 
wrap-around gowns, head covers, 
gloves, shoe covers, and respirators. 
All personnel shall shower on exit 
from areas where these devices are re- 
quired.) 
II-B-3-b-(3). Alternative Selection oj 
Containment Equipment Experimen- 
tal procedures involving a host-vector 
system that provides a one-step higher 
level of biological containment than 
that specified In Part III can be con- 
ducted in the P3 laboratory using con- 
tainment equipment specified for the 
P2 level of physical containment. Ex- 
perimental procedures involving a 
host-vector system that provides a 
one-step lower level of biological con- 
tainment than that specified in Part 
III can be conducted in the P3 labora- 
tory using containment equipment 
specified for the P4 level of physical 
containment. Alternative combina- 
tions of containment safeguards are 
shown in Table I. 
Tablx I .— Combinations a/ Containment Safeguards 
Classification of experiment Alternate combinations of physical and biological containment 
according to Ouldellnes 
Physical Containment 
Physical 
containment 
Biological* 
containment 
Laboratory 
design specified 
tor. 
Laboratory 
practices 
specified for 
Containment 
equipment 
specified for. 
Biological 
containment 
PI 
HV3 
P3 
P3 
P3 
HV3 
P3 
HV3 
P3 
P3 
P4 
HV2 
P3 
HV2 
P3 
P3 
P3 
HV2 
P3 
HV2 
P3 
P3 
P2 
HV3 
PJ 
HV2 
P3 
P3 
PH 
HVl 
P3 
HVl 
P3 
P3 
P3 
HVl 
P3 
HV1 
P3 
PI 
P2 
HV2 
•See section II-D for description of biological containment. 
II-B-3-c. Special Laboratory Design. 
II-B-3-c-(l). The laboratory shall be 
separated by a controlled access area 
from areas that are open to unrestrict- 
ed traffic flow. A controlled access 
area is an anteroom, a change room, 
an air lock or any other double-door 
arrangement that separates the labo- 
ratory from areas open to unrestricted 
traffic flow. 
II-B-3-c-<2). The surfaces of walls, 
floors, and ceilings shall be readily 
cleanable. Penetrations through these 
surfaces shall be sealed or capable of 
being sealed to facilitate space decon- 
tamination. 
II-B-3-c-<3). A foot-, elbow-, or auto- 
matically-operated handwashing facili- 
ty shall be provided near each primary 
laboratory exit area. 
II-B-3-c-<4). Windows in the labora- 
tory shall be sealed. 
II-B-3-c-(5). An autoclave for steril- 
ization of wastes and contaminated 
materials shall be available in the 
same building (and preferably within 
the controlled laboratory area) in 
which organisms containing recombin- 
ant DNA molecules are used. 
II-B-3-c-<6). The laboratory shall 
have a ventilation system that is capa- 
ble of controlling air movement. The 
movement of air shall be from areas of 
lower contamination potential to areas 
of higher contamination potential (i.e. 
from the controlled access area to the 
laboratory area). If the ventilation 
system provides positive pressure 
supply air, the system shall operate in 
a manner that prevents the reversal of 
the direction of air movement or shall 
be equipped with an alarm that would 
be actuated in the event that reversal 
in the direction of air movement were 
to occur. The exhause air from the 
laboratory area shall not be recirculat- 
ed to other areas of the building 
unless the exhaust air is filtered by 
HEPA filters or equivalent. The ex- 
haust air from the laboratory area can 
be discharged to the outdoors without 
filtration or other means for effective- 
ly reducing an accidental aerosol 
burden provided that it can be dis- 
persed clear of occupied buildings and 
air intakes. 
II-B-3-c-(7). The treated exhaust-air 
from Class I and Class II biological 
safety cabinets [20] may be discharged 
either to the laboratory or to the out- 
doors. The treated exhaust-air from a 
class III cabinet shall be discharged di- 
rectly to the outdoors. If the treated 
exhaust-air from these cabinets is to 
be discharged to the outdoors through 
a building exhaust air system, it shall 
be connected to this system so as to 
avoid any interference with the air 
FEDERAL REGISTER, VOL 43, NO. 247— FRIOAY, DECEMBER 22, 1978 
[ 33 ] 
