Federal Register / Vol. 48. No. 74 / Friday, April 15. 1983 / Notices 
16459 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; Action 
Under Guidelines 
agency: National Institutes of Health. 
PHS. DHHS. 
actions Notice of action under NIH 
guidelines for research involving 
recombinant DNA molecules. 
summary: This notice sets forth an 
action taken by the Director, NIA1D, 
under the August 1982 NIH Guidelines 
for Research Involving Recombinant 
DNA Molecules (47 FR 38048). 
EFFECTIVE DATE: April 15. 1983. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gartland, Jr., Office 
of Recombinant DNA Activities, 
National Institutes of Health, Bethesda, 
Maryland 20205; (301) 496-6051. 
SUPPLEMENTARY INFORMATION: Today a 
major action Is being promulgated under 
the NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
The proposed action wa published for 
comment in the Federal Register of 
September 22, 1982,- and reviewed and 
recommended for approval by the 
Recombinant DNA Advisory Committee 
(RAC) at its meeting on October 25, 
1982. Final action on the proposal was 
deferred pending a review by the USDA 
Recombinant DNA Committee (48 FR 
1156). In accordance with section IV-G- 
lb of the NIH Guidelines, this action has 
been found to comply with the 
Guidelines and to present no significant 
risk to health or the environment 
I. Approval to Field-Test Transformed 
Tomato and Tobacco Plants 
In a letter dated June 9, 1982, Dr. John 
Sanford of Cornell University requested 
permission to field-test tomato and 
tobacco plants tranformed with 
bacterial (E. coli K-12) and yeast DNA 
using pollen as a vector. Plants would 
then be screened in the field to detect 
transformation events. Dr. Sanford 
argued that Pi Containment is 
impractical when the screening of 
thousands of whole seedlings become 
necessary. 
The proposal was summarized in the 
September 22, 1982. Federal Register (47 
FR 41925). During the comment period, 
no comments were received. 
The RAC reviewed the request at its 
meeting on October 25. 1982. Although 
the RAC recommended approval of this 
proposal by a vote of ten in favor, one 
opposed, and three abstentions, final 
action on the recommendation was 
deferred pending a review of the 
proposal by the USDA Recombinant 
DNA Committee (48 FR 1156). 
The USDA Recombinant DNA 
Committee met on February 23, 1983, 
and discussed the proposal. The USDA 
Committee unanimously approved the 
proposal and could foresee no potential 
hazard to humans or the environment as 
a result of having these experiments 
tested in the fields of the New York 
State Agricultural Experiment Station at 
Geneva, New York. The Committee said 
that it recognizes the need to field test 
plants, produced by whatever method, 
in order to assess the value of the 
putative "engineered plant" 
I accept the recommendations of the 
RAC and the USDA Recombinant DNA 
Committee, and Appendix D of the 
Guidelines is amended to reflect this 
decision. 
II. Summary of Action 
The following new section is added to 
Appendix D of the Guidelines: 
“Appendix D-IX. Permission Is granted to 
Dr. John Sanford of Cornell University to Held 
test tomato and tobacco plants transformed 
with bacterial (£ coli K-12) and yeast DNA 
using pollen as s vector." 
Note. — 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 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 whether individual programs 
listed in the Catalog of Federal Domestic 
Assistance are affected.' 
Dated: April 4. 1983. 
Richard M. Krause, 
Director. National Institute of Allergy and 
Infectious Disease. National Institutes of 
Health. 
(FX Doc. SJ-ooao FlUd 4-U-tt Ml »| 
BrtJJNO COOC 4140-01-M 
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