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Federal Register / Vol. 59, No. 127 / Tuesday, July 5, 1994 1 Notices 
Appendix M-VI-J. Data on all 
patients undergoing gene transfershall 
be provided to the RAC v\ithin six 
montlis of the procedure. 
Appendix M-VII. Footnotes of Appendix 
M 
Appendix M-Vil-A. The Food and 
Drug Administration has jurisdiction 
over products intended for use in 
Human gene transfer clinical trials. For 
general information on the Food and 
Drug A dmin istration’s policies and 
regulatory requirements, see the Federal 
Register, Volume 51, pages 23309- 
23313, 1986. 
Appendix M-VII-B. The term 
“patient” and its variants are \ised in 
the text as a shorthand designation for 
"patient-subject.” 
Appendix P, Physical and Biological 
Containment for Recombinant DNA 
Research Involving Plants 
Appendix P specifies physical and 
biological containment conditions and 
practices suitable to the greenhouse 
conduct of experiments involving 
recombinant DNA-containing plants, 
plant-associated microorganisms, and 
small animals. All provisions of the NIH 
Guidelines apply to plant research 
activities with the following 
modifications: 
Appendix P shall supersede 
Appendix G when the research plants 
are of a size, number, or have growth 
requirements that preclude the use of 
containment conditions described in 
Appendix G. 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. 
Plant-associated microorganisms 
include virouls, virusoids, viruses, 
bacteria, fungi, protozoans, certain small 
algae, and microorganisms that have a 
benign or beneficial association with 
plants, such as certain Rhizohium 
species and microorganisms known to 
cause plant diseases. The appendix 
applies to microorganisms which are 
being modified wih the objective of 
fostering an association with plants. 
Plant-associated small animals 
include those arthropods that:<ij Are in 
obligate association with plants, Jii) are 
plant pests, Jiii) are plant pollinators, or 
(iv) transmit plant disease ^ents, 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 Je.g., pathogens or 
symbiontsj are iniduded. 
•The Institutional Biosafety Gommittee 
shall include at least one individual 
with expertise in plant, plant pathogen, 
or plant pest containment principles 
when experiments utilizing Appendix P 
require prior approval by the 
Institutional Biosafety Committee. 
Appendix P-1. General Plant Biosafety 
Le^Is 
Appendix P-I-A. The principal 
purpose of plant containment is to avoid 
the unintentional transmission of a 
recombinant DNA-containing plant 
genome, including nuclear or organelle 
hereditary material or release of 
recombinant DNA-derived organisms 
associated with plants. 
Appendix P-I-B. The containment 
principles are based on the recognition 
that the organisms that are used pose no 
health threat to humans or higher 
animals (unless deliberately modified 
for that purpose), and that the 
containment conditions minimize the 
possibility of an unanticipated 
deleterious effect on organisms and 
ecosystems outside of the experimental 
facility, e.g., 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. 
Appendix P-I-C. Four biosafety 
levels, referred to as Biosafety Level 
(BL) 1— Plants (P), BL2-P, BL3-P, and 
BL4-P, are established in Section II. The 
selection of containment levels required 
for research involving recombinant DNA 
molecules in plants or associated writh 
plants is specified in Section III. These 
biosafety levels are described in 
Appendix P-II. This appendix describes 
greenhouse practices and special 
greenhouse facilities for physical 
containment. 
Appendix P-I-D. BLl-P through 
BL4-P are designed to provide 
differential levels of biosafety for plants 
in the absence or presence of other 
experimental organisms that contain 
recombinant DNA. These biosafety 
levels, in conjxmction with biological 
containment conditions described in 
Appendix P-III, provide flexible 
approaches to ensure the safe conduct of 
research. 
Appendix P-I-E. For experiments in 
which plants are grown at the BLl 
through BL4 laboratory settings, 
contaimhenl practices shall be followed 
as described in Appendix G. These 
containment practices include the use of 
plant tissue culture rooms, growth 
chambers writhin laboratory facilities, or 
experiments performed on open 
benches. Additional biological 
contaiiunent practices should be added 
by the Greenhouse Director or 
Institutional Biosafety Committee as 
necessary (see Appendix P-IIIJ, if 
botanical reproductive structures are 
produced that have the potential of 
being released. 
Appendix P-II. Physical Containment 
Levels 
Appendix P-II-A. Biosafety Level 1 — 
Plants (BLl-P) 
Appendix P-U-A-l. Standard ffractices 
(BLl-P) 
Appendix P-Il-A-l-a. Greenhouse 
Access (BLl-P) 
Appendix P-II-A-l-a-{l). Access to 
the greenhouse shall be limited or 
restricted, at the discretion of the 
Greenhouse Director, when experiments 
are in progress. 
Appendix P-II-A-l-a-{2). Prior to 
entering the greenhouse, personnel shall 
be required to read and follow 
instructions on BLl-P greenhouse 
practices and procedures. All 
procedures .shall be performed in 
accordance with accepted greenhouse 
practices thal are appropriate to the 
experimental organism. 
Appendix P— U-A-l-b. Records (BLl-P) 
Appendix P-II-A-l-b-{l). A record 
shall be kept of experiments currently in 
progress in the greenhouse facility. 
Appendix P-II-A-l-c. Decontamination 
and Inactivation (BLl-P) 
Appendix P-II-A-l-c-(l). 
Experimental organisms shall be 
rendered biologically inactive by 
appropriate methods before disposal 
outside of the greenhouse facility. 
Appendix P-4I-A— 1-d. Control of 
Undesired Species and Motile 
Macroorganisms (BLl— P) 
Appendix P-II-A-l-d-Kl)- A program 
shall be implemented to control 
imdesired 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-II-A-l-d-(2). 
Arthropods and other motile 
macroorganisms shall be housed in 
appropriate cages. If macrooigani sms 
(e.g.. flying arthropods or nematodes) 
are released wi thin the greenhouse, 
precautions shall be taken to minimize 
escape from the greenhouse facility. 
Appendix P-II-A-l-e. Concurrent 
Experiments Conducted in the 
Greenhouse (BLl-P) 
Appendix P-II-A-l-^e-(lJ . 
Experiments involving other organisms 
that require a containment level lower 
than BLl-P may be comlucted in the 
greenhouse concurrently with 
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