46258 
Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
"Appendix G-II-A-3. Containment 
Equipment. 
"Appendix G-II-A-3-a. Special 
containment equipment is generally not 
required for manipulations of agents 
assigned to Biosafety Level 1. 
"Appendix G-II-A-4. Laboratory 
Facilities. 
"Appendix G-II-A^4-a. The 
laboratory is designed so that it can be 
easily cleaned. 
"Appendix G-II-A-4-b. Bench tops 
are impervious to water and resistant to 
acids, alkalis, organic solvents, and 
moderate heat. 
"Appendix G-II-A-4-c. Laboratory 
furniture is sturdy. Spaces between 
benches, cabinets, and equipment are 
accessible for cleaning. 
“Appendix G-II-A-4— d. Each 
laboratory contains a sink for hand- 
washing. 
"Appendix G-II-A^L-e. If the 
laboratory has windows that open, they 
are fitted with fly screens." 
g. The following language is 
substituted for Appendix G-II-B, P2 
Level: 
"Appendix G-II-B. Biosafety Level 2 
(BL2) [14], 
"Appendix G-II-B-1. Standard 
Microbiological Practices. 
"Appendix G-II-B-l-a. Access to the 
laboratory is limited or restricted by the 
laboratory director when work with 
organisms containing recombinant DNA 
molecules is in progress. 
"Appendix G— II-B-l-b. Work surfaces 
are decontaminated at least once a day 
and after any spill of viable material. 
"Appendix G-II-B-l-c. All 
contaminated liquid or solid wastes are 
decontaminated before disposal. 
"Appendix G-II-B-l-d. Mechanical 
pipetting devices are used; mouth 
pipetting is prohibited. 
"Appendix G-II-B-l-e. Eating, 
drinking, smoking, and applying 
cosmetics are not permitted in the work 
area. Food may be stored in cabinets or 
refrigerators designated and used for 
this purpose only. 
"Appendix G— II— B — 1— f. Persons wash 
their hands after handling materials 
involving organisms containing 
recombinant DNA molecules, and 
animals, and when they leave the 
laboratory. 
"Appendix G— II— B — 1— g. All procedures 
are performed carefully to minimize the 
creation of aerosols. 
"Appendix G— II-B-l-h. Experiments 
of lesser biohazard potential can be 
carried out concurrently in carefully 
demarcated areas of the same 
laboratory. 
"Appendix G-II-B-2. Special 
Practices. 
"Appendix G-II-B-2-a. 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-II-B-2-b. The 
laboratory director limits access to the 
laboratory. The director has the final 
responsibility for assessing each 
circumstance and determining who may 
enter or work in the laboratory. 
"Appendix G-II-B-2-c. The 
laboratory director establishes policies 
and procedures whereby only persons 
who have been advised of the potential 
hazard and meet any specific entry 
requirements (e.g., immunization) enter 
the laboratory or animal rooms. 
"Appendix G-II-B-2-d. When the 
organisms containing recombinant DNA 
molecules in use in the laboratory 
require special provisions for entry (e.g., 
vaccination), a hazard warning sign 
incorporating the universal biohazard 
symbol is posted on the access door to 
the laboratory work area. The hazard 
warning sign identifies the agent, lists 
the name and telephone number of the 
laboratory director or other responsible 
person(s), and indicates the special 
requirement(s) for entering the 
laboratory. 
“Appendix G-II-B-2-e. An insect and 
rodent control program is in effect. 
“Appendix G-II-B-2-f. Laboratory 
coats, gowns, smocks, or uniforms are 
worn while in the laboratory. Before 
leaving the laboratory for nonlaboratory 
areas (e.g., cafeteria, library, 
administrative offices), this protective 
clothing is removed and left in the 
laboratory or covered with a clean coat 
not used in the laboratory. 
“Appendix G-II-B-2-g. Animals not 
involved in the work being performed 
are not permitted in the laboratory. 
"Appendix G-II-B-2-h. Special care is 
taken to avoid skin contamination with 
organisms containing recombinant DNA 
molecules; gloves should be worn when 
handling experimental animals and 
when skin contact with the agent is 
unavoidable. 
"Appendix G-II-B-2-i. All wastes 
from laboratories and animal rooms are 
appropriately decontaminated before 
disposal. 
“Appendix G-II-B-2-j. 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 needle 
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-II-B-2-k. Spills and 
accidents which result in overt 
exposures to organisms containing 
recambinant DNA molecules are 
immediately reported to the laboratory 
director. Medical evaluation, 
surveillance, and treatment are provided 
as appropriate and written records are 
maintained. 
"Appendix G-II-B-2-1. When 
appropriate, considering the agen(s) 
handled, baseline serum samples for 
laboratory and other at-risk personnel 
are collected and stored. Additional 
serum specimens may be collected 
periodically, depending on the agents 
handled or the function of the facility. 
"Appendix G-II-B-2-m. A biosafety 
manual 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 G-II-B-3. Containment 
Equipment. 
“Appendix G-II-B-3-a. Biological 
safety cabinets (Class I or II) (see 
Appendix G-III-12) or other appropriate 
personal protective or physical 
containment devices are used whenever: 
“Appendix G-II-B-3-a-(l}. 
Procedures with a high potential for 
creating aerosols are conducted [15]. 
These may include centrifuging, 
grinding, blending, vigorous skaking or 
mixing, sonic disruption, opening 
containers of materials whose internal 
pressures may be different from ambient 
pressures, inoculating animals 
intranasally, and harvesting infected 
tissues from animals or eggs. 
“Appendix G-II-B-3-a-(2). High 
concentrations or large volumes of 
organisms containing recombinant DNA 
molecules are used. Such materials may 
be centrifuged in the open laboratory if 
sealed heads or centrifuge safety cups 
are used and if they are opened only in 
a biological safety cabinet. 
"Appendix G-II-B-4. Laboratory 
Facilities. 
“Appendix G-II-B-4-a. The 
laboratory is designed so that it can be 
easily cleaned. 
“Appendix G-II-B— 4-b. Bench tops 
are impervious to water and resistant to 
[ 256 ] 
