538 
Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 / Notices 
Appendix P-II-D-l-b. Records (BL4-P) 
Appendix P-II-E>-l-b-(l). A record 
shall be kept of all experimental 
materials brought into or removed from 
the greenhouse. 
Appendix P-II-I>-l-b-{2). A record 
shall be kept of experiments currently in 
progress in the greenhouse facility. 
Appendix P-II-D-l-b-{3). A record 
shall be kept of all personnel entering 
and exiting the greenhouse facility, 
including the date and time of each 
entry. 
Appendix P-II-D-l-b-(4). The 
Principal Investigator shall report any 
greenhouse accident involving the 
inadvertent release or spill of 
microorganisms to the Biological Safety 
Officer. Greenhouse Director, 
Institutional Biosafety Committee, NIH/ 
ORDA, and other appropriate 
authorities immediately (if applicable). 
Reports to the NIH/ORDA shall be sent 
to the Office of Recombinant DNA 
Activities, National Institutes of Health, 
Building 31, Room 4B11, Bethesda, 
Maryland 20892, (301) 496-9838. 
Documentation of any such accident 
shall be prepared and maintained. 
Appendix P-Il-D-l-c. Decontamination 
and Inactivation (BL4-P) 
Appendix P-II-D-l-c-(l). All 
materials, except for those that are to 
remain in a viable or intact state for 
experimental purposes, shall be 
autoclaved prior to removal from the 
maximum containment greenhouse. 
Equipment or material that could be 
damaged by high temperatures or steam 
shall be decontaminated by alternative 
methods (e.g., gas or vapor sterilization) 
in an airlock or chamber designed for 
this purpose. 
Appendix P-II-D-l-c-(2). Water that 
comes in contact with experimental 
microorganisms or wth material 
exposed to such microorganisms (e.g., 
run-off from watering plants) shall be 
collected and decontaminated before 
disposal. 
Appendix P-II-D-l-c-(3). Standard 
microbiological procedures shall be 
followed for decontamination of 
equipment and materials. Spray or 
liquid waste or rinse water from 
containers used to apply the , 
experimental microorganisms shall be 
decontaminated before disposal. 
Appendix P-II-D-l-d. Control of 
Undesired Species and Motile 
Macroorganisms (BL4-P) 
Appeiidix P-II-D-l-d-(l). A 
chemical control program shall be 
implemented to eliminate undesired 
pests and pathogens in accordance with 
applicable state and Federal laws. 
Appendix P-II-D-l-d-(2). 
Arthropods and other motile 
macroorganisms used in conjunction 
with experiments requiring BL4-P level 
physical contaiiunent shall be housed in 
appropriate cages. When appropriate to 
the organism, experiments shall be 
conducted within cages designed to 
, contain the motile organisms. 
Appendix P-II-D-l-e. Concurrent 
Experiments Conducted in the 
Greenhouse (BL4— P) 
Appendix P-II-D-l-e-(l). 
Experiments involving organisms that 
require a containment level lower than 
BL4-P may be conducted in the 
greenhouse concurrently with 
experiments that require BL4-P 
containment provided that all work is 
conducted in accordance with BL4-P 
greenhouse practices. When the 
experimental microorganisms in use 
require a containment level lower than 
BL4-P, greenhouse practices reflect the 
level of containment required by the 
highest containment level 
microorganisms being tested. 
Appendix P-II-D-l-f. Signs (BL4-P) 
Appendix P-II-D-l-f-(l). A sign 
shall be posted indicating that a 
restricted experiment is In progress. The 
sign shall indicate the following: (i) The 
name of the responsible individual, (ii) 
the plants in use, and (iii) any special 
requirements for using the area. 
Appendix P-II-D-l-f-(2). If 
organisms are used that have ^ 
recognized potential for causing serious 
detrimental impacts on managed or 
natural ecosystems, their presence shall 
be indicated by a sign posted on the 
greenhouse access doors. 
Appendix P-II-D-l-f-(3). If there is a 
risk to human health, a sign shall be 
posted incorporating the universal 
biosafety symbol. 
Appendix P-II-D-l-g. Transfer of 
Materials (BL4-P) 
Appendix P-II-D-l-g-(l). 
Experimental materials that are brought 
into or removed from the greenhouse in 
a viable or intact state shall be 
transferred to a non- breakable, sealed, 
primary container then enclosed in a 
non-breakable, sealed secondary 
container. These containers shall be 
removed from the greenhouse facility 
through a chemical disinfectant, 
fumigation chamber, or an airlock 
designed for this purpose. 
Appendix P-li-I>-g-(2). Supplies and 
materials shall be brought into the 
greenhouse facility through a double- 
door autoclave, fumigation chamber, or 
airlock that is appropriately 
decontaminated between each use. After 
securing the outer doors, personnel 
within the greenhouse facility shall 
retrieve the materials by opening the 
interior door of the autoclave, 
fumigation chamber, or airlock. These 
doors shall be secured after the 
materials are brought into the 
greenhouse facility. 
Appendix P-II-D-l-h. Greenhouse 
Practices Manual (BL4— P) 
Appendix P-II-D-l-h-{l). A 
greenhouse practices manual shall be 
prepared or adopted. This manual shall 
include^ontingency plans to be 
implemented in the event of the 
unintentional release of experimental 
organisms. 
Appendix P-II-D— 1-i. Protective 
Clothing (BL4-P) 
Appendix P-II-D-l-i-(l). Street 
clothing shall be removed in the outer 
clothing change room. Complete 
laboratory clothing (may be disposable) 
including undergarments, pants, and 
shirts, jump suits, shoes, and hats shall 
be provided and worn by all persoimel 
entering the greenhouse facility. 
Appendix P-II-D— l-i-(2). Personnel 
shall remove laboratory clothing when 
exiting the greenhouse facility and 
before entering the shower area. This 
clothing shall be stored in a locker or 
hamper in the inner change room. 
Appendix P-Il-D-l-i-{3). All 
laboratory clothing shall be autoclaved 
before laundering. 
Appendix P-II-D-2. Facilities (BL4-P) 
Appendix P-II-D-2— a. Greenhouse 
Design (BL4-P) 
Appendix P-II-D-2-a-(l). The 
maximum containment greenhouse 
facility shall consist of a separate 
building or a clearly demarcated and 
isolated area within a building. The 
need to maintain negative pressure 
should be considered when constructing 
or renovating the greenhouse facifity. 
Appendix P-II-D-2-a-(2). Outer and 
inner change rooms, separated by a 
shower, shall be provided for personnel 
entering and exiting the greenhouse 
facility. 
Appendix P-II-D— 2— a— (3). Windows 
shall be closed and sealed. All glazing 
shall be resistant to breakage (e.g., 
double-pane tempered glass or 
equivalent). 
Appendix P-II-D-2-a-(4). Access 
doors to the greenhouse shall be self- 
closing and locking. 
Appendix P-II-D-2-a-(5). The 
greenhouse facility shall be surrounded 
by a security fence or protected by 
equivalent security measures. 
Appendix P-II-D— 2— a— (6). The walls, 
floors, and ceilings of the greenhouse 
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