Federal Register / Vol. 49, No. 80 / Tuesday, April 24, 1984 / Notices 
17677 
Appendix C-ll-B-4-f. An autoclave for 
decontaminating laboratory wastes is 
available. 
h. The following language would be 
substituted for Appendix C-II-C, P3 
l.evel. 
Appendix C-/I-C. Biosafety l.evel 3 (HU) 
1 16 ). 
Appendix C-/I-C-1. Standard 
Microbiological Practices. 
Appendix G-ll-C-l-a. Work surfaces are 
decontaminated at least once a day and after 
any spill of viable material. 
Appendix C-ll-C-l-b. All contaminated 
liquid or solid wastes are decontaminated 
before disposal. 
Appendix G-H-C-l-c. Mechanical 
pipetting devices are used; mouth pipetting Is 
prohibited. 
Appendix C-ll-C-l-d. Eating, drinking, 
smoking, storing food, and applying 
cosmetics are not permitted in the work area. 
Appendix G-H-C-l- e. Persons wash their 
hands after handling materials involving 
organisms containing recombinant DNA 
molecules, and animals, and when they leave 
the laboratory. 
Appendix G-ll-C-l-f. All procedures are 
performed carefully to minimize the creation 
of aerosols. 
Appendix G-ll-C-l-g. Persons under 18 
years of age shall not enter the laboratory. 
Appendix G-ll-C-l~h. If experiments 
involving other organisms which require 
lower levels of containment are to be 
conducted in the same laboratory 
concurrently with experiments requiring BL3 
level physical containment, they shall be 
conducted in accordance with all BL3 level 
laboratory practices. 
Appendix G-/I-C-2. Special Practices. 
Appendix G-II-C-2-a. Laboratory doors 
are kept closed when experiments are In 
progress. 
Appendix G-H-C-2-b. Contaminated 
materials that are to be decontaminated at a 
site away from the laboratory are placed in a 
durable leakproof container which is closed 
before being removed from the laboratory. 
Appendix G-Il-C-2-c. The laboratory 
director controls access to the laboratory and 
restricts access to persons whose presence is 
required for program or support purposes. 
The director has die final responsibility for 
assessing each circumstance and determining 
who may enter or work in the laboratory. 
Appendix G-H-C-2-d. The laboratory 
director establishes policies and procedures 
whereby only persons who have been 
advised of the potential biohazard, who meet 
any specific entry requirements (e.g., 
immunization), and who comply with all 
entry and exit procedures enter the 
laboratory or animal rooms. 
Appendix G-ll-C-2-e. When organisms 
containing recombinant DNA molecules or 
experimental animals are present in the 
laboratory or containment module, a hazard 
warning sign incorporating the universal 
biohazard symbol, is posted on all laboratory 
and animal room access doors. The hazard 
warning sign identifies the agent, lists the 
name and telephone number of the laboratory 
director other responsible person(s). and 
indicates any special requirements for 
entering the laboratory, such as the need for 
immunizations, respirators, or other personal 
protective measures. 
Appendix C-ll-C-2-f. All activities 
involving organisms containing recombinant 
DNA molecules are conducted in biological 
safety cabinets or other physical containment 
devices within the containment module. No 
work in open vessels is conducted on the 
open bench. 
Appendix C-ll-C-2-g. The work surfaces 
of biological safety cabinets and other 
containment equipment are decontaminated 
when work with organisms containing 
recombinant DNA molecules is finished. 
Plastic-backed paper toweling used on 
nonperforated work surfaces within 
biological safety cabinets facilitates clean-up. 
Appendix G-H-C-2-h. An insect end 
rodent control program is in effect. 
Appendix G-Il-C-2-i. Laboratory clothing 
that protects street clothing (e.g., solid front 
or wrap-around gowns, scrub suits, coveralls) 
is wom in the laboratory. Laboratory clothing 
is not wom outside the laboratory, and it is 
decontaminated before being laundered. 
Appendix G-Il-C-2-j. Special care is taken 
to avoid skin contamination with 
contaminated materials; gloves should be 
wom when handling infected animals and 
when skin contact with infectious materials 
is unavoidable. 
Appendix G-U-C-2-k. Molded surgical 
masks or respirators are wom in rooms 
containing experimental animals. 
Appendix G-/I-C-2-I. Animals and plants 
not related to the work being conducted are 
not permitted in the laboratory. 
Appendix G-ll-C-2-m. Laboratory animals 
held in a BL3 area shall be housed in partial- 
containment caging systems, such as Horsfall 
units (11), open cages placed in ventilated 
enclosures, solid-wall and bottom cages 
placed on holding racks equipped with 
ultraviolet radiation lamps and reflectors. 
Note. — Conventional caging systems may- 
be used, provided that all personnel wear 
appropriate 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 required. 
Appendix G-ll-C-2-n. All wastes from 
laboratories and animal rooms are 
appropriately decontaminated before 
disposal. 
Appendix G-II-C-2-o. Vacuum lines are 
protected with high efficiency particulate air 
(HEPA) filters and liquid disinfectant traps. 
Appendix G-U-C-2-p. Hypodermic needles 
and syringes are 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) are used for the injection or 
aspiration of fluids containing organisms that 
contain recombinant DNA molecules. 
Extreme caution should be used when 
handling needles and syringes to avoid 
autoinoculation and the generation of 
aerosols during use and disposal. Needles 
should not be bent, sheared, replaced in the 
sheath or guard or removed from the syringe 
following use. The needle and syringe should 
be promptly placed in a puncture resistant 
container and decontaminated, preferably by 
autoclaving, before discard or reuse. 
Appendix G -H-C-2-q. Spills and accidents 
which result in overt or potential exposures 
to organisms containing recombinant UNA 
molecules are immediately reported to the 
laboratory director Appropriate medical 
evaluation, surveillance. ar,d treatment are 
provided and written records are maintained 
Appendix G-ll-C-2-r. Baseline serum 
samples for all laboratory and other at-risk 
personnel should be collected and stored. 
Additional serum specimens may be 
collected periodically, depending on the 
agents handled or the function of the 
laboratory. 
Appendix G-H-C-2-s. A biosafety mununl 
is prepared or adopted. Personnel are 
advised of special hazards and are required 
to read instructions on practices and 
procedures and to follow them. 
Appendix C-ll-C-2-t. Alternative 
Selection of Containment Equipment. 
Experimental procedures involving a host- 
vector system that provides a or.e-step higher 
level of biological containment than that 
specified can be conducted in the BL3 
laboratory using containment equipment 
specified for the BL2 level of physical 
containment. Experimental procedures 
involving a host-vector system that provides 
a one-step lower level of biological 
containment than that specified can be 
conducted in the BL3 laboratory using 
containment equipment specified for the BL4 
level of physical containment. Alternative 
combination of containment safeguards are 
shown in Table 1. 
Appendix G-H-C-3. Containment 
Equipment. 
Appendix C-U-C-a. Biological safety 
cabinets (Class 1, 11, or III) (see Appendix G- 
111-12) or other appropriate combinations of 
personal protective or physical containment 
devices (e.g., special protective clothing, 
masks, gloves, respirators, centrifuge safety 
cups, sealed centrifuge rotors, and 
containment caging for animals) are used for 
all activities with organisms containing 
recombinant DNA molecules which pose a 
threat of aerosol exposure. These include; 
manipulation of cultures and of those clinical 
or environmental materials which may be a 
source of aerosols; the aerosol challenge of 
experimental animals; and harvesting of 
tissues or fluids from experimental animals 
and embryonate egga. and necropsy of 
experimental animals. 
Appendix G-H-C-4. Laboratory Facilities 
Appendix G-H-C-4-a. The laboratory Is 
separate from areas which are open to 
unrestricted traffic flow within the building. 
Passage through two sets of doors is the basic 
requirement for entry into the laboratory 
from access corridors or other contiguous 
areas. Physical^separation of the high 
containment laboratory from access corridors 
or other laboratories or activities may also be 
provided by a double-doored clothes change 
room (showers may be included), airlock, or 
other access facility which requires passage 
through two sets of doors before entering the 
laboratory. 
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