29804 
Federal Register / Vol. 52, No. 154 / Tuesday. August 11. 1987 / Notices 
The plants covered in Appendix P 
include but are not limited to mosses, 
liverworts, macroscopic algae, and 
vascular plants including terrestrial 
crops, forest, and ornamental species." 
74. “Plant-associated microorganisms 
include viroids. virusoids. viruses, 
bacteria, fungi, protozoans, and certain 
small algae. They include 
microorganisms that have a benign or 
beneficial association with plants, such 
as certain Rhizobium species, as well as 
micro-organisms known to cause plant 
diseases. The NIH Guidelines also apply 
to microorganims which are being 
modified with the ohjective of fostering 
an association with plants." 
75. "Plant-associated small animals 
include those insects that: (1) Have an 
abligate association with plants. (Z) are 
plant pests. (3) are plant pollinators, or 
(4) transmit plant disease agents, as well 
as other small animals, such as 
nematodes, for which tests of biological 
properties necessitate the use of plants. 
Microorganisms associated with such 
small animals as. for example, 
pathogens or symbionts are also 
included. 
78. “The Institutional Biosafety 
Committee shall include at least one 
scientist with expertise in plant, plant 
pathogen, or plant pest containment 
principles when experiments utilizing 
Appendix P require IBC prior approval." 
77. "Appendix P-I. General Plant 
Biosafety Levels . " 
78. "the principal purpose of plant 
containment is to avoid unintentional 
transmission of a recombinant DNA- 
containing plant genome, including 
nuclear or organelle hereditary material, 
or release of recombinant DNA-denved 
organisms associated with plants." 
79. "The containment principles are 
based on the recognition that the 
organisms to which they apply pose no 
health threat to humans or higher 
animals (unless deliberately modified to 
do so), and that the containment 
minimizes the possibility of an 
unanticipated deleterious effect on 
organisms and ecosystems outside of 
the experimental facility. Examples of 
deleterious effects to be minimized are 
the inadvertent spread of a serious 
pathogen from a greenhouse to a local 
agricultural crop or the unintentional 
introduction and establishment of an 
organism in a new ecosystem." 
80. "Four biosafety levels, referred to 
as BLl-P. BL2-P. BL3-P. and BL4-P are 
established in Section U of the NIH 
Guidelines. The selection of 
containment levels required for research 
involving recombinant DNA molecules 
in or associated with plants Is specified 
in Section III of the NIH Guidelines. The 
biosafety levels are described in 
Appendix P-U. The descriptions include: 
(1) Greenhouse practices, and (2) special 
greenhouse facilities for physical 
containment." 
81. "The biosafety levels are designed 
to provide differential levels of biosafety 
for plants in the absence or presence of 
other expenmental organisms that 
contain recombinant DNA. These 
biosafety levels, in conjunction with 
biological containment described in 
Appendix P-LU. provide flexible 
approaches to assure research is 
conducted safely.” 
82. "In experiments in which plants 
are grown within BL1-BL4 laboratory 
facilities, including plant tissue culture 
rooms, growth chambers within 
laboratory facilities, or on open 
benches, containment practices 
described for Biosafety Levels 1-4 in 
Appendix G in these NIH Guidelines 
shall be followed. Additional practices 
should be added by the principal 
investigator or IBC as needed from the 
descriptions in Appendix P-IU if 
botanical reproductive structures are 
produced and have the potential of 
being released." 
83. "Appendix P-D. Physical 
Containment Levels." 
84. "Appendix P-D- A. BLl-P 
(Biosafety Level 1 — plants)." 
85. "Appendix P-II-A-1. Standard 
Practices — BLl-P." 
86. "Access to the greenhouse is 
limited or restricted at the discretion of 
the principal investigator when 
experiments are in progress." 
87. "Personnel are required to read 
instructions on BI.l-P greenhouse 
practices and procedures and to follow 
them." 
88. "All procedures are performed in 
accordance with practices appropriate 
to the experimental organism. A 
greenhouse practices manual is 
prepared to describe these practices. It 
should advise personnel of potential 
consequences if practices are not 
followed and outline contingency plans 
in the event containment loss results in 
release of organisms with recognized 
potential for serious detrimental 
impact." 
89. "A log is kept of expenmental 
plant, microorganisms, or small animals 
that are brought in or removed from the 
greenhouse facility." 
90. "Experimental organisms are 
rendered biologically inactive by 
appropriate methods before disposal 
outside of the greenhouse facility." 
91a. "A program is utilized to control 
undesired species, such as weed, rodent, 
or insect pests and pathogens, by 
methods appropriate to the organisms 
and in accordance with applicable state 
and federal laws." 
91b. "Insects and other motile 
macroorganisms are housed in 
appropriate cages. If macroorganisms, 
such as flying insects or nematodes, are 
released within the greenhouse, 
precautions are taken to minimize 
escape beyond the facility." 
91c. "A sign incorporating the 
universal biohazard symbol and the 
name of the recombinant DNA-niodified 
organism(s) is posted on greenhouse 
access doors." 
91d. "Experiments involving other 
organisms which require a containment 
level lower than BLl-P may be 
conducted in the same greenhouse 
concurrently with those requiring the 
BLl-P level provided all work is 
conducted in accordance with BLl-P 
greenhouse practices." 
92. "Appendix P-II-A-2. Facilities — 
BLl-P." 
93a. "The term greenhouse' refers to a 
permanent structure with walls, roof, 
and floor designed and utilized 
principally for growing plants in a 
controlled and protected environment. 
Walls and roof are usually constructed 
of transparent or translucent material to 
allow passage of sunlight for plant 
growth. The term greenhouse facility' 
includes the actual greenhouse rooms or 
compartments for growing plants plus 
all immediately contiguous hallways 
and headhouse areas, and i6 considered 
pari of the confinement area." 
93b. 'The floor may be of gravel or 
other porous material but. at a minimum, 
impervious (e g., concrete) walkways 
are recommended." 
93c. "Windows and other openings in 
the walls and roof of the greenhouse 
compartments may be open for 
ventilation as needed for proper 
operation and reouire no special barrier 
to contain or exclude pollen, 
microorganisms, or small flying animals 
(e g., insects, birds). Screens to exclude 
the latter are, however, utilized in most 
standard greenhouses and are 
recommended." 
94. "Appendix P-II-B, BL2-P 
(Biosafety Level 2 — plants)." 
95. "Appendix P-IJ-B-1. Standard 
Practices — BL2-P." 
96. "Access to the greenhouse is 
limited or restricted at the discretion of 
the principal investigator to individuals 
directly involved in the experiments 
when they are in progress." 
97. "Personnel are required to read 
instructions on BL2-P greenhouse 
practices and procedures and to follow 
them." 
98. "All procedures are performed in 
accordance with accepted greenhouse 
practices appropriate to the 
experimental organisms. A greenhouse 
Recombinant DNA Research, Volume 13 
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