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Federal Register / Vol. 48, No. 106 / Wednesday, ]une 1. 1983 / Notices 
Appendix K-IV-M-8. The controlled 
area shall have a ventilation system that 
is capable of controlling air movement. 
The movement of air shall be from areas 
of lower contamination potential to 
ureas of higher contamination potential. 
If the ventilation system provides 
positive pressure supply air. the system 
shall operate in a manner that prevents 
the reversal of the direction of air 
movement or shall be equipped with an 
alarm that would be actuated in the 
event that reversal in the direction of air 
movement were to occur. The exhaust 
air from the controlled area shall not be 
recirculated to other areas of the 
facility. The exhaust air from the 
controlled area may be discharged to 
the outdoors without filtration or other 
means for effectively reducing an 
accidental aerosol burden provided that 
it can be dispersed clear of occupied 
buildings and air intakes. 
Appendix K-IV-N. The following 
personnel and operational practices 
shall be required. 
Appendix K-IV-N-1. Personnel entry 
into the controlled area shall be through 
the entry area specified in Appendix K- 
D-13-a. 
Appendix K-IV-N-2. Persons entering 
the controlled area shall exchange or 
cover their personal clothing with work 
garments such as jumpsuits, laboratory 
coats, pants and shirts, head cover, and 
shoes or shoe covers. On exit from the 
controlled area the work clothing may 
be stored in a locker separate from that 
used for personal clothing or discarded 
for laundering. Clothing shall be 
decontaminated before laundering. 
Appendix K-IV-N-3. Entry into the 
controlled area during periods when 
work is in progress shall be restricted to 
those persons required to meet program 
or support needs. Prior to entry all 
persons shall be informed of the 
operating practices, emergency 
procedures, and the nature of the work 
conducted. 
Appendix K-IV-N— 4. Persons under 18 
years of age shall not be permitted to 
enter the controlled area. 
Appendix K-IV-N-5. The universal 
biohazard sign shall be posted on entry 
doors to the controlled area and all 
internal doors when any work involving 
the organism is in progress. This 
includes periods when decontamination 
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 door 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-1 1. 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 NTH, 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— II fall 
under Section III— A and require RAC 
review and NIH and IBC approval 
before initiation. 
Appendix L— II. 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 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 L-II-B. The introduced 
DNA consists of woll-chaructcrized 
genes containing no sequences harmful 
to humans, animals, or plants. 
Appendix I.-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-Il-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 IBC. Copies must also be 
submitted to the Plant Working Group of 
the RAC. 
Appendix L-III. Specific Approvals. 
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 
Drogram listing, NIH invites readers to 
direct questions to the information 
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