Federal Register / Vol. 48, No. 227 / Wednesday, November 23, 1983 / Notices 
53057 
The RAC discussed this proposed 
modification at its September 19. 1983, 
meeting. Dr. Tolin noted that, under the 
]une 1, 1983, Federal Register language, 
the Plant Working Group review might 
have to be conducted using the strictest 
definition of the word “disease." This 
may preclude the approval of some 
plasmid and virus-derived nucleic acids 
as vectors, since their replication might 
be construed as a disease process even 
though no symptoms develop in the 
plants. Dr. Tolin stated that it is her 
belief that if all other stipulations of 
Appendix L are satisfied, this minor 
change will result in no greater 
probability of risk of introducing plants 
containing recombinant DNA into the 
environment. 
Dr. Tolin said sequences causing 
disease symptoms might be necessary to 
introduce the recombinant DNA into the 
plant. There are, however, methods for 
removing these sequences before the 
plants are tested in the field. Data 
showing elimination of these sequences 
would be evaluated by the Plant 
Working Group. 
The RAC recommended the proposed 
modification by a vote of 13 in favor, 0 
opposed, and 0 abstentions. 
I accept this modification and 
Appendix L— II— C is modified to reflect 
this change. 
II. Summary of Actions 
A. Inclusion of S. Mu tans in Sublist F of 
Appendix A 
Sublist F of Appendix A is modified to 
read: 
"Sublist F 
“1. Streptococcus sanguis 
“2. Streptococcus pneumoniae 
"3. Streptococcus faecalis 
"4. Streptococcus pyogenes 
"5. Streptococcus mulans" 
D. Modification of Appendix L — Release 
Into the Environment of Certain Plants 
Appendix L-II-C of Appendix L is 
modified to read as follows: 
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 resulting in production of 
disease symptoms 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. If sequences resulting 
in production of disease symptoms are 
retained for purposes of introducing the 
DNA into the plant, greenhouse-grown 
plants must be shown to be free of such 
sequences before such plants, 
derivatives, or seed from them can be 
used in field tests. 
Additional Announcement of the 
Director, NIAID 
In connection with the incorporation 
of Appendix K into the Guidelines on 
June 1, 1983, it was stated in the note in 
48 FR 24551 that Section III-B-5 of the 
Guidelines was to be changed to delete 
reference to 45 FR 24968 and to add 
instead a reference to Appendix K. 
However, due to an error, this change 
was not made when the Guidelines were 
published (48 FR 24559). To correct this 
error, Section III— B— 5 of the Guidelines 
is now modified to read as follows: 
III-B-5. Experiments Involving More Than . 
10 Liters of Culture. The appropriate 
containment will be decided by the !BC. 
Where appropriate. Appendix K. Physical 
Containment for Large-Scale Uses of 
Organisms Containing Recombinant DNA 
Molecules, should be used. 
Dated: November 15, 1983. 
Richard M. Krause, 
Director. National Institute of Allergy and 
Infectious Diseases, National Institutes of 
Health. 
Note. — 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 program 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 organizations, 
both national and international, have elected 
to follow the NIH Guidelines. In lieu of the 
individual program listing, NIH invites 
readers to direct questions to the information 
address above about whether individual 
programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
|FR Doc. 83-31428 Filed 11-22-83: 8:45 *m| 
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