Federal Register / Vol. 59, No. 127 / Tuesday. July 5, 1994 / Notices 
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prepared or adopted. This manual shall: 
(i) Advise personnel of the potential 
consequences if such practices are not 
followed, and (ii) outline contingency 
plans to be implemented in the event of 
the unintentional release of organisms. 
Appendix P-Il-B-2. Facilities (BL2-P) 
Appendix P-lI-B-2-a. Definitions (BL2- 
P) 
Appendix P-II-B-2-a-(l). The term 
‘greenhouse’ refers to a structure with 
walls, a roof, and a floor designed and 
used principally for growing plants in a 
controlled and protected environment. 
The walls and roof are usually 
constructed of transparent or 
translucent material to allow passage of 
sunlight for plant growth. 
Appendix P-lI-^2-a-(2). The term 
'greenhouse facility’ includes the actual 
greenhouse rooms or compartments for 
growing plants, including all 
immediately contiguous hallways and 
head-house areas and is considered part 
of the confinement area. 
Appendix P-II-B-2-b. Greenhouse 
Design (BL2-P) 
Appendix P-II-B-2-b-(l). A 
greenhouse floor composed of an 
impervious material. Concrete is 
recommended, but gravel or other 
porous material under benches is 
acceptable unless propagules of 
experimental organisms are readily 
disseminated through soil. Soil beds are 
acceptable unless propagules of 
experimental organisms are readily 
disseminated through soil. 
Appendix P-lI-B-2-b-(2). Windows 
and other openings in the walls and roof 
of the greenhouse facility may be open 
for ventilation as needed for proper 
operation and do not require any special 
barrier to exclude pollen or 
microorganisms; however, screens are 
required to exclude small flying animals 
(e.g., arthropods and birds). 
Appendix P-II-B-2-c. Autoclaves (BL2- 
P) 
Appendix P-II-B-2-c-(l). An autoclave 
shall be available for the treatment of 
contaminated greenhouse materials. 
Appendix P-lI-B-2-d. Supply and 
Exhaust Air Ventilation Systems (BL2- 
P) 
Appendix P-lI-B-2-d-(l). If intake fans 
are used, measures shall be taken to 
minimize the ingress of arthropods. 
Louvers or fans shall be constructed 
such that they can only be opened when 
the fan is in operation. 
Appendix P-lI-B-2-e Other (BL2-P) 
Appendix P-II-B-2-e-(l). BL2-P 
greenhouse containment requirements 
may be satisfied by using a growth 
chamber or growth room within a 
building provided that the external 
physical structure limits access and 
escape of microorganisms and 
macroorganisms in a manner that 
satisfies the intent of the foregoing 
clauses. 
« 
Appendix P-II-C. Biosafety Level 3 — 
Plants (BL3-P) 
Appendix P-II-C-1. Standard Practices 
(BL3-P) 
Appendix P-II-C-l-a. Greenhouse 
Access (BL3-P) 
AppendixP-II-C-l-a-(l). Authorized 
entry into the greenhouse shall be 
restricted to individuals who are 
required for program or support 
purposes. The Greenhouse Director 
shall be responsible for assessing each 
circumstance and determining those 
individuals who are authorized to enter 
the greenhouse facility. 
Appendix P-Il-C-l-a-(2). Prior to 
entering the greenhouse, personnel shall 
be required to read and follow 
instructions on BL3-P practices and 
procedures. All procedures shall be 
conducted in accordance with accepted 
greenhouse practices that are 
appropriate to the experimental 
organisms. 
Appendix P-II-C-l-b. Records (BL3-P) 
Appendix P-ll-C-l-b-(l). A record 
shall be kept of experimental plants, 
microorganisms, or small animals that 
are brought into or removed from the 
greenhouse facility. 
Appendix P-Il-C-l-b-(2). A record 
shall be kept of experiments currently in 
progress in the greenhouse facility. 
Appendix P-II-C-l-b-(3). 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, 
Mar>'land 20892, (301) 496-9838. 
Documentation of any such accident 
shall be prepared and maintained. 
Appendix P-Il-C-l-c. Decontamination 
and Inactivation (BL3-P) 
Appendix P-II-C-l-c-(l). All 
experimental materials shall be 
sterilized in an autoclave or rendered 
biologically inactive by appropriate 
methods before disposal, except those 
that are to remain in a viable or intact 
state for experimental purposes: 
including water that comes in contact 
with experimental microorganisms or 
with material exposed to such 
microorganisms, and contaminated 
equipment and supplies. 
Appendix P-II-C-l-d. Control of 
Undesired Species and Motile 
Macroorganisms (BL3-P) 
Appendix P-II-C-l-d-(l). A program 
shall be implemented to control 
undesired species (e.g., weed, rodent, or 
arthropod pests and pathogens) by 
methods appropriate to the organisms 
and in accordance with applicable state 
and Federal laws. 
Appendix P-Il-C-l-d-(2). Arthropods 
and other motile macroorganisms 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-Il-C-l-e. Concurrent 
Experiments Conducted in the 
Greenhouse (BL3-P) 
Appendix P-II-C-1 -e-(l). Experiments 
involving organisms that require a 
containment level lower than BL3-P 
may be conducted in the greenhouse 
concurrently with experiments that 
require BL3-P containment provided 
that all work is conducted in accordance 
with BL3-P greenhouse practices. 
Appendix P-II-C-l-f. Signs (BL3-P) 
Appendix P-Il-C-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-Il-C-l-f-(2). If organisms 
are used that have a recognized 
potential for causing serious detrimental 
impacts on managed or natural 
ecosystems, their presence should be 
indicated on a sign posted on the 
greenhouse access doors. 
Appendix P-II-C-l-f-(3). If there is a 
risk to human health, a sign shall be 
posted incorporating the universal 
biosafety symbol. 
Appendix P-lI-C-l-g. Transfer of 
Materials (BL3-P) 
Appendix P-ll-C-l-g-(l). 
Experimental materials that are brought 
into or removed from the greenhouse 
facility in a viable or intact state shall 
be transferred to a non-breakable sealed 
secondary container. At the time of 
transfer, if the same plant species, host, 
or vector are present within the effective 
dissemination distance of propagujes of 
the experimental organism, the surface 
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Recombinant DNA Research, Volume 19 
