Federal Register / Vol. 49, No. 227 / Friday, November 23, 1984 / Notices 
46291 
procedures are in progress. The sign 
posted on the entry doors to the 
controlled area shall include a statement 
of agents in use and personnel 
authorized to enter the controlled area. 
Appendix K-IV-N-6. The controlled 
area shall be kept neat and clean. 
Appendix K-IV-N-7. Eating, drinking, 
smoking, and storage of food are 
prohibited in the controlled area. 
Appendix K-IV-N-8. Animals and 
plants shall be excluded from the 
controlled area. 
Appendix K-IV-N-9. An effective 
insect and rodent control program shall 
be maintained. 
Appendix K-IV-N-10. Access doors 
to the controlled area shall be kept 
closed, except as necessary for access, 
while work is in progress. Serve doors 
leading directly outdoors shall be sealed 
and locked while work is in progress. 
Appendix K-IV-N-11. Persons shall 
wash their hands when leaving the 
controlled area. 
Appendix K-IV-N-12. Persons 
working in the controlled area shall be 
trained in emergency procedures. 
Appendix K-IV-N-13. Equipment and 
materials required for the management 
of accidents involving viable organisms 
containing recombinant DNA molecules 
shall be available in the controlled area. 
Appendix K-IV-N-14. The controlled 
area shall be decontaminated in 
accordance with established procedures 
following spills or other accidental 
release of viable organisms containing 
recombinant DNA molecules. 
Appendix L— Release Into the 
Environment of Certain Plants 
Appendix L-l. General Information. 
Appendix L specifies conditions under 
which certain plants as specified below, 
may be approved for release into the 
environment. Experiments in this 
category cannot be initiated without 
submission of relevant information on 
the proposed experiment to NIH, review 
by the RAC Plant Working Group, and 
specific approval by NIH. 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-Il fall 
under Section III— A and require RAC 
review and NIH and IBC approval 
before initiation. 
Appendix L-Il. Criteria Allowing 
Review by the RAC Plant Working 
Group Without the Requirement for Full 
RAC Review. Approval may be granted 
by ORDA in consultation with the 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-1I-A. The plant species is 
a cultivated crop of a genus that has no 
species known to be a noxious weed. 
Appendix L-II-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 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 introduciang 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 6tudy 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 IBC. Copies must also be 
submitted to the Plant Working Group 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 20205. 
Dated: November 15, 19fl4. 
OMB’8 "Mandatory Information 
Requirements for Federal Assistance 
Program Announcements" (45 FR 39592) 
requires a statement concerning the 
official government programs contained 
in th e 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. 84-30668 Filed 11-21-84; 8:45 em| 
BILLING COO€ 4140-01-44 
James B. YVyngaarden, M.D., 
Director, National Institutes of Health. 
[ 288 ] 
