Federal Register / Vol. 51. No. 88 / Wednesday, May 7, 1986 / Notices 
16905 
Croup without the requirement for full 
RAC review (1BC review is also 
necessary) for growing plants containing 
recombinant DNA in the field under the 
following conditions: 
Appendix L-D-A. The plant species is 
a cultivated crop of a genus that has no 
■pedes known to be a noxious weed. 
Appendix L-Il-B. The introduced 
DNA consists of well-characterized 
genes containing no sequences harmful 
to humans, animals, or plants. 
Appendix L-D-C The vector consists 
of DNA (i) From exempt host-vector 
•ystems (Appendix C): (ii) from plants of 
the same or closely related species; (iii) 
from nonpathogenic prokaryotes or 
nonpathoger.ic lower eukaryotic plants: 
(iv) from plant pathogens only if 
sequences resulting in production of 
disease symptoms have been daleted: 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 arc 
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. 
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 
further 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 ’j}'".. Copies must also be 
submitted to the Plant Working Croup of 
the RAC. 
Appendix L-lll — Specific Approvals 
As of publication of the revised 
Guidelines, no specific proposals have 
been approved. An updated list may be 
obtained from the Office of 
Recombinant DNA Activities, National 
Institutes of Health. Building 31. Room 
3B10. Bethesda. Maryland 20G92. 
lOMB's "Mandatory Information 
Requirements for Federal Assistance Program 
Announcements" (45 FR 39592) requires a 
statement concerning the official government 
pregrams contained in the Catalog of Federal 
Domestic Assistance. Normally NIK 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 NIK 
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. NIK 
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 N'lH 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 Fednrcl 
Domestic Assistance are affteted.) 
Dated: April 18. 1986. 
Tuo.r.as E. Malone, 
Acting Director. National Institutes of Health. 
(FR Doc. 86-10120 Filed 5-8-36: 8:45 am] 
eiUJSO CODE 4U0-01-M 
Recombinant DNA Research, Volume 1 1 
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