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Federal Register / Vnl. 48, No. 10G / Wednesday, June 1, 1983 / Notices 
Appendix L Unloose Into the Envimnnwn ‘ 
of Certain Plants 
Appendix L-1. General Information. 
Appendix L specifies conditions under 
which certuin plants, as specified below, may 
be approved for release into the environment. 
Kxperiments in this category cannot be 
initiated without submission or relevant 
information on the proposed experiment to 
N1H, review by the RAC Plant Working 
Croup, and specific approval by Nil I. Such 
experiments also require the approval of the 
IBC before initiation. Information on specific 
experiments which have been approved will 
be available in ORDA and will be listed in 
Appendix L— III when the Guidelines are 
republished. 
Experiments which do not meet the 
specifications of Appendix L— II fall under 
Section III— A and require RAC review and 
NIH and IBC approval before initiation." 
Appendix HI. Criteria Allowing Review 
hv the RAC Plant Working Croup Without 
the Requirement for Full RAC Review. 
A.pproval may be granted by ORDA in 
consultation with the RAC Plant Working 
Group without the requirement for full RAC 
review (IBC review is also necessary) for 
growing plants containing recombinant DNA 
in the field under the following conditions: 
Appendix L.II— A. The plant species is a 
cultivated crop of a genus that has no species 
known to be a noxious weed. 
Appendix HII-B. The introduced DNA 
consists of well-characterized genes 
containing no sequences harmful to humans, 
animals, or plants. 
Appendix L-II-C. The vector consists of 
DNA (i) from exempt host-vector systems 
(Appendix C); (ii) from plants of the same or 
closely related species; (iii) from 
nonpathogenic prokaryotes or nonpathogenic 
lower eukaryotic plants; (iv) from plant 
pathogens only if sequences causing disease 
have been deleted; or (v) chimeric vectors 
constructed from sequences defined in (i) to 
(iv) above. The DNA may be introduced by 
any suitable method. 
Appendix L — II— D. Plants are grown in 
controlled access fields under specified 
conditions appropriate for the plant under 
study and the geographical location. Such 
conditions should include provisions for 
using good cultural and pest control 
practices, for physical isolation from plants of 
the same species outside of the experimental 
plot in accordance with pollination 
characteristics of the species, and for 
preventing plants containing recombinant 
DNA from becoming established in the 
environment. Review by the IBC should 
include an appraisal by scientists 
knowledgeable of the crop, its production 
practices, and the local geographical 
conditions. Procedures for assessing 
alterations in and the spread of organisms 
containing recombinant DNA must be 
developed. The results of the outlined tests 
must be submitted for review by the IBC. 
Copies must also be submitted to the Plant 
Working Croup of the RAC. 
Appendix Hill. Specific Ao'trova/s. 
Ii. Addition to Appendix D — Unloose of 
Strains of Pseudomonas Syringae and 
Erwinia Herbic.nl 
The following paragraph is added to 
Appendix D: 
Appendix D-X. Permission is granted to 
Drs. Steven I.indow and Nicholas Panopoulos 
of the University of California, Berkeley, to 
release under specified conditions 
Pseudomonas syringae pv. syringae and 
Erwinia herbicola carrying in vitro generated 
deletions of all or part of the genes involved 
in ice nucleation. 
C. Modifications of Physical 
Containment Recommendations for 
Large-Scale Uses of Organisms 
Containing Recombinant DNA 
Molecules 
1. Modification of Section VU-D-ti. 
Section VII-D-6 is modified to read: 
VII-D. A closed system used for the 
propagation and growth of viable organisms 
containing recombinant DNA molecules shall 
beoperated so that the space above the 
culture level will be maintained at a pressure 
as low as possible, consistent with equipment 
design, in order to maintain the integrity of 
containment features. 
2. Modification of Section VII-B-3. 
Section VII-B-3 is modified to read: 
VII-B-3. Sample collection from a closed 
system, the addition of materials to a closed 
system and the transfer of culture fluids from 
one closed system to another shall be done in 
a manner which minimizes the release of 
aerosols or contamination of exposed 
surfaces. 
See D below for incorporation of these 
sections in new Appendix K. 
D. Incorporation Into Guidelines of 
Physical Containment 
Recommendations for Large-Scale Uses 
of Organisms Containing Recombinant 
DNA Molecules 
The Physical Containment 
Recommendations for Large-Scale Uses 
of Organisms Containing Recombinant 
DNA Molecules are incorporated into 
the Guidelines as Appendix K. All 
sections are renumbered. Minor 
editorial changes are introduced through 
the document to reflect the 
modifications introduced into the 
Guidelines since the Recommendations 
were published in April 1980. Revisions 
are introduced to reflect the decisions in 
C above. 
Additional Announcements of the 
Director, NIAID 
A. Modification of Section Ill-C 
An Institutional Biosafety Committee 
(IBC) commented that the text in the 
first paragraph of Section Ill-C does not 
make clear that the IBC must be notified 
simultaneously with initiation of 
experiments covered by this section. 
The RAC, at its April 11, 1983, meeting 
also recommended that the wording of 
this section be clarified. Accordingly, 
the first paragraph of Section Ill-C is 
amended to read as follows: 
Ill-C. Experiments that Require IRC Notice 
Simultaneously with Initiation of 
Experiments. Experiments not included in 
Sections 1 1 1— A, III-B. Ill— D. and subsections of 
these sections are to be considered in Section 
III-C. All such experiments can be carried out 
at Pi containment. For experiments in this 
category, a registration document as 
described in Section III-B must be dated and 
signed by the investigator and filed with the 
local IBC at the time of initiation of the 
experiment: The IBC shall review all such 
proposals, but IBC review prior to initiation 
of the experiment is not required. (The reader 
should refer to the policy statement in the 
first two paragraphs of Section IV-A.) 
B. Modification of Appendix K-A 
A representative of the Public and 
Scientific Affairs Board of the American 
Society for Microbiology commented 
that a mechanism for establishing 
requirements for P4 large-scale 
containment is not specified in the new 
Appendix K. Accordingly, the last 
sentence of Appendix K-A is amended 
to read as follows: 
If necessary, these requirements will be 
established by NIH on an individual basis. 
C. Modifications to Appendix F-IV 
Additional specific approvals for 
experiments involving toxins are added 
to Appendix F-IV. 
OMB's "Mandatory Information 
Requirements for Federal Assistance 
Program Announcements” (45 FR 39592) 
requires a statement concerning the 
official government programs contained 
in the Catalog of Federal Domestic 
Assistance. Normally NIH lists in its 
announcements the number and title of 
affected individual programs for the 
guidance of the public. Because the 
guidance in this notice covers not only 
virtually every NIH program but also 
essentially every federal research 
p r ogram in which DNA recombinant 
molecule techniques could be used, it 
has been determined to be not cost 
effective or in the public interest to 
attempt to list these programs. Such a 
list would likely require several 
additional pages. In addition, NIH could 
not be certain that every federal 
program would be included as many 
federal agencies, as well as private 
r i33] 
