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Federal Register / Vol. 50. No. 219 / Wednesday. November 13. 1985 / Notices 
National Institutes of Health 
Recombinant DNA Research; Action 
Under Guidelines 
aqency: National Institutes of Health 
(NIH). PHS. DHHS. 
action: Notice of action under NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
Summary; This notice sets forth an 
action taken by the Director, NIH. under 
tho November 1984 NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules (49 FR 46280). 
EFFECTIVE date: November 13. 1985. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland, Office of 
Recombinant DNA Activities. National 
Institutes of Health. Bethbsda. Maryland 
20892 (301) 496-6051. 
SUPPLEMENTARY INFORMATION; Today 
an action is being promulgated under 
the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
In accordance with Section IV-C-l-b of 
the NIH Guidelines, this action has been 
found to comply with the NIH 
Guidelines and to present no significant 
risk to health or the environment. 
I. Approval to Field-Test Disease 
Resistant Tobacco Plants 
In a submission dated May 5. 1983, Dr. 
Winston Brill of Cetus Madison 
Corporation ((JMC) requested approval 
under Appendix L of the NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules to field test plants 
grown from seeds containing 
recombinant DNA. CMC and its 
successor, Agracetus, do not receive any 
support for recombinant DNA research 
from the NIH and, therefore, are not 
required to comply with the NIH 
Guidelines. All submissions bv CMC 
were made voluntarily under Part VI of 
the NIH Guidelines. A review by the 
Plant Working Group of the NIH 
Recombinant DNA Advisory’ Committee 
(RAC) concluded that the submission 
did not meet the criteria required for 
approval under Appendix L of the NIH 
Guidelines and would, therefore, require 
review not only by the RAC Plant 
Working Group but also by the full RAC. 
On July 1. 1983, CMC submitted a 
revised proposal to Geld test plants 
grown from seeds containing 
recombinant DNA. After review by the 
Plant Working Group, additional 
information was requested. 
On August 19. 1983, CMC submitted a 
revised proposal to Geld test plants 
engineered by recombinant DNA 
techniques, The proposal was reviewed 
by the RAC Plant Working Group on 
September 7. 1983, and by the full RAC 
on Septebmerl9, 1983. At its September 
19. 1983 meeting, the RAC passed a 
motion by a vote of 12 in favor and 1 
opposed. The motion stated that while 
the proposal was acceptable in 
principle, it required further 
amplification and clarification before 
approval. 
On October 21. 1983, Dr. Brill provided 
further data on the field design and the 
types of observations to be made and 
also limited the request to tobacco 
plants. 
On December 21. 1983, the RAC Plant 
Working Group unanimously 
recommended approval of the request as 
described in the submissions from CMC 
of August 19, 1983. and October 21. 1983. 
On January 24. 1984, the U.S. 
Department of Agriculture (USDA) 
Recombinant DNA Committee 
unanimously concurred with the 
recommendation of the NIH RAC Plant 
Working Group. 
The proposal was reviewed by the 
RAC at its June 1. 1934, meeting. The 
RAC with no negative votes 
recommended approval of the proposal. 
On August 30. 1984, NIH was 
informed that the business of CMC had 
been transferred to a partnership having 
the name “Agracetus." 
On'September 14, 1983, a lawsuit was 
filed (Foundation on EconomicTrends, 
et al. v. Margaret Heckler et ah, Civil 
Action #83-2714 in the United States 
District Court forthe District of 
Columbia). On May 18, 1984, Judge John 
Sirica issued a preliminary injunction in 
this case. The injunction was partly 
affirmed and partly vacated by the 
Appeals Court in a decision of February 
27, 1985. Although the preliminary 
injunction specifically does not apply to 
proposals voluntarily submitted to the 
NIH (as is the case with the Agracetus 
proposal), 1 requested that an 
Environmental Assessment be prepared 
prior to my approval of this proposal. I 
signed an Environmental assessment 
and Finding of Nonsignificant Impact on 
August 14, 1985. 
Both the material submitted by 
Agracetus and the Environmental 
Assessment contain material identified 
by Agracetus as proprietary information. 
1 accept the recommendation of the 
RAC and the USDA Recombinant DNA 
Committee: and Appendix Duf the NIH 
Guidelines Is amended to reflect this 
decision. 
II. Summary of Action 
The following new section is added to 
Appendix D of the NIH Guidelines: 
Appendix D-XI. Agracetus ofMiddelton. 
Wisconsin, mrfy field test under specified 
conditions disease resistant tobacco plants 
prepared by recombinant DNA techniques. 
Dated: September 25. 1985. 
lames B. Wyngaarden, M.D., 
Director. National Institutes of Health. 
|FR Doc. 85-28910 Filed 11-12-85: 8:45 am) 
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