J 24548 Federal Register / Vol. 48, No. 100 / Wednesd ay, June 
,| - ■ - 
DEPARTMENT OF HEALTH AND 
!j HUMAN SERVICES 
; National Institutes of Health 
Recombinant DNA Research; Actions 
i Under Guidelines 
j agency: National Institutes of Health. 
I PUS. HHS. 
| action: Notice of Actions Under Nil I 
| Guidelines for Research Involving 
j Recombinant DftfA Molecules. 
summary: This notice sets forth actions 
taken by the Director, National Institute 
of Allergy and Infectious Diseases 
(NIAID), by authority of the Director, 
Nil I, under the August 1982 NIH 
Guidelines for Research Involving 
Recombinant DNA Moleeuies (47 FR 
38048). 
EFFECTIVE DATE: June 1, 1983. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health, Dethesda, 
Maryland 20205, (301) 4 96-6051. 
supplementary information: Several 
major actions under the NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules are being promulgated 
today. These proposed actions were 
published for aomment in the Federal 
Register of March 4, 1983 (48 FR 9438), 
and reviewed and recommended for 
approval by the Recombinant DNA 
Advisory Committee (RAC) at its 
meeting on April 11, 1983. In accordance 
wth Section IV-C-l-b of the NIH 
Guidelines, these actions have been 
found to comply with the Guidelines and 
to present no significant risk to health or 
the environment. 
Part 1 of this announcement provides 
background information on the actions. 
Part II provides a summary of the 
actions and additional announcements 
of the Director, NIAID. 
Following this announcement, there 
appears in a separate section of the 
Federal Register the revised NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. These 
revised Guidelines differ from the 
previous version of the Guidelines 
promulgated on August 27, 1982 (47 FR 
38048) by incorporating within them 
both the chunges in the Guidelines 
which were recommended at the RAC 
meeting of October 25, 1982, and 
promulgated on January 10, 1903 (48 FR 
1150), and April 15. 1983 (48 FR 10459), 
and the changes in the Guidelines which 
were recommended at the RAC meeting 
of April 11, 1983, and which are 
discussed iri this announcement. 
I. Decisions on Actions Under 
Guidelines 
A. Fide I Testing of Genetically 
Engineered Plants — At hi it ion of 
Appendix L 
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 were 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 lll-B-4-c. 
A new section, II I— B — 4— c, would be 
added as follows: 
III-B-4-c. Approval may be granted by the 
1I3C with notification to ORDA for growing 
plants containing recombinant UNA in the 
field under the following guidelines: 
III— B — 4 — c-1. The plant species is an annual 
cultivated crop of a genus that has no species 
known to be a noxious weed, 
I II— 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 murker traits if 
stable integration into the host DNA is 
known to occur, 
1II-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-pathogenio 
prokaryotes or non-pHthogenic lower 
eukaryotic plants; ( i v ) plant pathogens if 
known sequences causing disease symptoms 
have been deleted; or (v) DNA constructed 
from specific sequences of any of the above 
sources. 
'Ihe 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. 
1, 1983 / Notices 
III— B-4— c — 4. Plants are grown in control 
access fields under specified conditions 
appropriate lor the plant under study in 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 preventing plants containing recombinant 
DNA from becoming established in the 
environment. Review of the IRC should 
include an appraisal by scientists 
knowledgeable in the crop, its production 
practices, and the local geographic 
conditions. 
The proposal was published in the 
March 4, 1983, Federal Register (48 FR 
9430). During the comment period, one 
comment was received which was 
distributed to the RAC. 
The current Guidelines require not 
only IBC approval, but also RAC review 
and NIH approval of "deliberate release 
into Ihe environment of any organism 
containing recombinant DNA.” The 
proposal would have changed this so 
that, provided they met certain criteria, 
growing plants containing recombinant 
DNA in the field could proceed without 
RAC review and NIH approval, with 
only IBC approval and notification to 
ORDA. 
The RAC considered the proposal at 
its April 11, 1983, meeting and discussed 
it extensively. The RAC made several 
modifications in the specific criteria as 
the result of scientific considerations. 
The RAC also modified the procedural 
aspects of the proposal, recommending 
that the paragraphs proposed to be 
added as Section III— B — 4 — c instead be 
incorporated into a new appendix, 
which would require review and 
approval of experiments both by the 
Institutional Biosafety Committee (IBC) 
and also a RAC Plant Working Group. 
The RAC then voted twelve in favor, six 
opposed, and two abstentions, to 
incorporate the proposal as modified 
into the Guidelines. 
An alternative motion to allow such 
experiments to be approved by the local 
IBC only without the necessity for 
review by the RAC Plant Working 
Group failed to pass by a vote of eight in 
favor, eleven opposed, and one 
abstention. 
[129] 
