Federal Register / Vol. 48, No. 44 / Friday, March 4, 1983 / Notices 
9441 
automatically operated valves shall be 
located at each major work area and 
near each primary exit. 
Appendix K-D-13-f. A shower facility 
shall be provided. This facility shall be 
located in close proximity to the 
controlled area. 
Appendix K-D-13-g. The controlled 
area shall be designed to preclude 
release of culture fluids outside the 
controlled area in the event of an 
accidental spill or release from the 
closed systems or other primary 
containment equipment. 
Appendix K-D-13-h. 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 
areas 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 discharge 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-D-14. The following 
personnel and operational practices 
shall be required: 
Appendix K-D-14-a. Personnel entry 
into the controlled area shall be through 
the entry area specified in Appendix K- 
D-13-a. 
Appendix K-D-14-b. 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-D-14-c. 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-D-14-d. Persons under 18 
years of age shall not be permitted to 
enter the controlled area. 
Appendix K-D-14— e. 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 docontamination 
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-D-14-f. The controlled 
area shall be kept neat and clean. 
Appendix K-D-14-g. Eating, drinking, 
smoking, and storage of food are 
prohibited in the controlled area. 
Appendix K-D-14-h. Animals and 
plants shall be excluded from the 
controlled area. 
Appendix K-D-14-i. An effective 
insect and rodent control program shall 
be maintained. 
Appendix K-D-14-j. 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-D-14-k. Persons shall 
wash their hands when leaving the 
controlled area. 
Appendix K-D-14-1. Persons working 
in the controlled area shall be trained in 
emergency procedures. 
Appendix K-D-14-m. 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-D-14-n. The controlled 
area shall be decontaminated in 
accordance with established procedures 
following spills or other accidental 
release of viable organisms containing 
recombinant DNA molecules. 
V. Proposed Field Testing of Genetically 
Engineered Plants 
Cetus Madison Corporation requests 
permission to field test genetically 
engineered plants. The proposal is 
divided into there separate requests: 
A. Field test in Wisconsin very small 
plots (less than 0.5 acre per experiment) 
of wheat, cotton, soybean, corn, 
tobacco, tomato and potato plants 
growm from seeds containing 
recombinant DNA. There will be 
"extremely close nonitoring" as defined 
by the submitter. 
B. Field test in several southern U.S. 
states very small plots (less than 0.5 
acre per experiment) of cotton, rice and 
tomato plants grown from seeds 
containing recombinant DNA. There will 
be “very close monitoring" as defined 
by the submitter. 
C. If the above experiments succeed, 
aproximately fifty field plots or less than 
5 acres such would be tested in many 
U.S. locations. There will be “close 
monitoring" as defined by the submitter. 
VI. Request to Release Strains of 
Pseudomonas Syringae and Erwinia 
Herbicola 
Drs. Nickolas Panopoulos and Steven 
Lindown of the University of California, 
Berkeley, request permission to 
construct and release Pseudonomas 
syringae pv. syringae and Erwinia 
herbicola carrying in vitro generated 
deletions of all or part of the genes 
involved in ice nucleation for purposes 
of biological control of frost damage in 
plants. 
VII. Proposed Amendment of Section 
III— A— 2 and Addition of a New Section 
III-B-4-c 
The RAC Working Group on Revision 
of the Guidelines, at its January 21, 1983, 
meeting, recommended that guidelines 
for field experimentation involving 
plants modified by recombinant DNA 
techniques be developed for 
consideration at the April 11, 1983, RAC 
meeting. The following changes in the 
Guidelines have been proposed. 
Section III— A— 2 would be modified to 
read as follows: 
III— A— 2. Deliberate release into the 
environment of any organism containing 
recombinant DNA except certain plants as 
described in Section III-B-4-c. 
A new Section, III-B-4-c, would be 
added as follows: 
III-B-4-c. Approval may be granted by the 
[BC with notification to ORDA for growing 
plants containing recombinant DNA in the 
field under the following guidelines: 
III-B-4-c-l. The plant specleB is an annual 
cultivated crop of a genus that has no species 
known to be a noxious weed, 
III-B-4-C-2. The Introduced DNA consists 
of well characterized genes containing no 
sequences harmful to humans, animals, or 
plants. Antibiotic resistance genes may be 
introduced as selectable marker traits if 
stable integration into the host DNA known 
to occur, 
Ill-B-4— c-3. The vector consists of DNA 
from (i) exempt host-vector systems 
(Appendix C), (ii) plants of the same or 
closely related species; (iii) non-pathogenic 
prokaryotes or non-pathogenic lower 
eukaryotic plants; (iv) plant pathogens if 
known sequences causing disease symptoms 
have been deleted; or (v) DNA constructed 
from specific sequences of any of the above 
sources. 
The DNA may be introduced by any 
suitable method but if co-infection or co- 
cultivation is utilized absence of the assisting 
organism must be demonstrated. 
Ill— B — 4 — c — 4. Plants are grown in control 
access fields under specified conditions 
appropriate for the plant under study in the 
geographical location. Such conditions should 
include provisions for using good cultural and 
pest control practices, for physical isolation 
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