Federal Register / Vol. 52, No. 154 / Tuesday, August 11, 1987 / Notices 
29807 
145. "Street clothing is removed in the 
outer clothing change room and kept 
there. Complete laboratory clothing 
(may be disposable) including 
undergarments, pants, and shirts or 
jumpsuits, shoes, and hats is provided 
and worn by all personnel entering the 
facility. When leaving the laboratory 
and before proceeding into the shower 
area, personnel remove their laboratory 
clothing and store it in a locker or 
hamper in the inner change room. All 
laboratory clothing must be autoclaved 
before laundering." 
146. "Greenhouse accidents involving 
inadvertent release or spills of 
microorganisms are reported 
immediately to the laboratory director 
and other authorities as appropriate. 
Written records of such accidents are 
prepared and maintained." 
147. "Insects or other microorganisms 
used in conjunction with experiments 
requiring BL4-P level physical 
containment shall be housed in 
appropriate cages. W'hen appropriate to 
the organism, experiments are 
conducted within cages designed to 
contain the motile organism." 
148. “A chemical control program is 
implemented to eliminate undesired 
pests and pathogens in accordance with 
state and federal laws." 
149. "Experimental microorganisms 
assigned to a containment level lower 
than BL4-P may be tested in a BL4-P 
greenhouse concurrently with 
microorganisms assigned to BL4-P 
provided that the tests are conducted in 
accordance with BL4-P greenhouse 
practices. When the experimental 
microorganisms in use require a 
containment level lower than BL4-P, 
greenhouse practices will reflect the 
level of containment required by the 
highest containment level 
microorganisms being tested." 
150. "Appendix P-U-D-2. Facilities — 
BL4-P." 
151. “The maximum containment 
greenhouse facility consists of either a 
separate building or a clearly 
demarcated and isolated zone within a 
building. The need to maintain negative 
pressure should be considered when 
constructing or renovating the facility. 
Access doors to the greenhouse are self- 
closing and lockable. Outer and inner 
change rooms separated by a shower 
are provided for personnel entering and 
leaving the facility. A double-doored 
autoclave, fumigation chamber, or 
ventilated airlock is provided for 
passage of those materials, supplies, or 
equipment which are not brought into 
the facility through the change room." 
152. "The greenhouse facility is 
surrounded by a security fence or is 
protected by an equivalent means of 
security." 
1.53. "Walls, floor, and ceiling of the 
greenhouse are constructed to form a 
sealed internal shell which facilitates 
fumigation and is animal and insect 
proof. These internal surfaces are 
resistant to penetration and degradation 
by liquids and chemicals, thus 
facilitating cleaning and 
decontamination of the area. All 
penetrations (plumbing, utilities) in 
these structure and surfaces are sealed. 
Sewer vents and other ventilation lines 
contain HEPA filters. HEPA filter must 
be certified annually." 
154. "It is recommended that bench 
tops and other work surfaces have 
seamless surfaces impervious to water 
and resistant to acids, alkalis, organic 
solvents, and moderate heat." 
155. "A double-doored autoclave is 
provided for decontaminating materials 
passing out of the facility. The autoclave 
door which opens to the area external to 
the facility is sealed to the outer wall 
and automatically controlled so that the 
outside door can only be opened after 
the autoclave "sterilization” cycle has 
been completed." 
156. "A pass-through dunk tank 
fumigation chamber, or an equivalent 
decontamination method is provided so 
that materials and equipment that 
cannot be decontaminated in the 
autoclave can be safely removed from 
the facility." 
157. "Liquid effluents from sinks, 
floors, and autoclave chambers are 
decontaminated by heat or chemical 
treatment before being released from the 
maximum containment facility'. Liquid 
wastes from shower rooms and toilets 
may be decontaminated with chemical 
disinfectants or by heat in the liquid 
waste decontamination system. The 
procedure used for autoclaving or 
chemically decontaminating liquid 
wastes is evaluated by appropriate 
standard procedures for autoclaved 
wastes. The procedure is evaluated 
mechanically and biologically by using a 
recording thermometer and an indicator 
microorganism with a defined heat 
susceptibility pattern. If liquid wastes 
are decontaminated wiih chemical 
disinfectants, the chemical used is of 
demonstrated efficacy against the target 
or indicator microorganisms." 
158. “If there is a central vacuum 
system, it does not serve areas outside 
the facility. In-line HEPA filters are 
placed as near as practicable to each 
use point or vacuum service cock. Other 
liquid and gas services to the facility are 
protected by devices that prevent 
backflow. HEPA filters must be certified 
annually." 
159. Windows are closed and sealed. 
All glazing is resistant to breakage (e.g., 
double pane tempered glass or 
equivalent)." 
160. “An individual supply and 
exhaust air ventilation system is 
provided. The system maintains 
pressure differentials and directional 
airflow as required to assure flows 
inward from areas outside of the 
greenhouse. Differential pressure 
transducers are used to sense pressure 
levels. If a system malfunctions, the 
transducers sound an alarm. A backup 
source of electricity is provided to run 
the air handling equipment if the main 
power source should fail. The supply 
and exhaust airflow is interlocked to 
assure inward (or zero) airflow at all 
times. The integrity of the greenhouse 
must have an air leak rate (decay rate) 
not to exceed 7% per minute (logarithm 
of pressure against time) over a 20- 
minute period at 2' of water gauge 
pressure. Nominally, this is 0.05' of 
water gauge pressure loss in 1 minute at 
2' water gauge pressure." 
161. “The exhaust air from the facility 
i6 filtered through HEPA filters and 
discharged to the outside so that it is 
dispersed away from occupied buildings 
and air intakes. The filter chambers are 
designed to allow in situ 
decontamination before filters are 
removed and to facilitate certification 
testing after they are replaced. HEPA 
filters are provided to treat air supplied 
to the facility. HEPA filters must be 
certified annually.” 
162. "Appendix P— III. Biological 
Containment Practices. " 
163. "An appropriate selection of the 
following biological containment 
practices can be used to meet the 
containment requirements for a given 
organism. The present list is not 
exhaustive and there may be other ways 
of preventing effective dissemination, by 
which is meant dissemination leading to 
the establishment in the environment of 
the organism or its genetic material with 
deleterious consequences to managed or 
natural ecosystems." 
164. "Appendix P-III-A, Plants. 
Effective dissemination of plants by 
pollen or seed can be prevented by one 
or more of the following:” 
165. "Covering reproductive structures 
to prevent pollen dissemination at 
flowering and seed dissemination at 
maturity." 
166. Removing reproductive 
structures, employing male sterile 
strains or terminating the experiment 
and harvesting the plant material pnor 
to the reproductive stage." 
167. "Ensuring that the experimental 
plants flower at a time of year when no 
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Recombinant DNA Research, Volume 13 
