Federal Register / Vol. 51, No. 158 / Friday, August 15, 1980 / Notices 
29423 
DEPARTMENT OF HEALTH AND 
HUMAN SERVICES 
National Institutes of Health 
Recombinant DNA Research; 
Proposed Actions Under Guidelines 
agency: National Institutes of Health, 
PHS, DHHS. 
action: Notice of Proposed Actions 
under NIH Guidelines for Research 
Involving Recombinant DNA Molecules. 
summary: This notice sets forth 
proposed actions to be taken under the 
National Institutes of Health (NIH) 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
Interested parties are invited to submit 
comments concerning these proposals. 
These proposals will be considered by 
the Recombinant DNA Advisory 
Committee (RAC) at its meeting on 
September 29, 1980. After consideration 
of these proposals and comments by the 
RAC, the Director of the National 
Institutes of Health will issue decisions 
on these proposals in accord with the 
Guidelines. 
date: Comments received by September 
19, 1986, will be reproduced and 
distributed to the RAC for consideration 
at its September 29, 1986 meeting. 
address: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombinant 
DNA Activities, Building 31, Room 3B10, 
National Institutes of Health, Bethesda, 
Maryland 20892. All comments received 
in timely response to this notice will be 
considered and will be available for 
public inspection in the above office on 
weekdays between the hours of 8:30 
a.m. and 5:00 p.m. 
FOR FURTHER INFORMATION CONTACT: 
Background documentation and 
additional information can be obtained 
from the Office of Recombinant DNA 
Activities, National Institutes of Health, 
Bethesda, Maryland 20892, (301) 496- 
6051. 
SUPPLEMENTARY INFORMATION: The 
Federal Register of June 25, 1986 (51 FR 
23210), contained notice of the 
September 29, 1980, meeting of the RAC 
and one proposed modification of the 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules. In 
addition, the following additional 
proposed modifications of the NIH 
Guidelines will be considered. 
I. Proposed Amendment of Section III- 
A— 2 
Dr. Susan Gottesman, National 
Cancer Institute, Bethesda, Maryland, 
has proposed the following changes in 
the NIH Guidelines. 
Section III— A— 2 would be amended to 
read as follows (words in italics 
represent changed wording): 
“III— A— 2. Deliberate release into the 
environment of any organism containing 
recombinant DNA, except: 
“a. Certain plants as described in 
Appendix L 
"b. Deletion derivatives not otherwise 
covered by these Guidelines. 
“c. Organisms covered in exemption 
II1-D-2 . " 
Dr. Gottesman offers the following 
rationale for this proposal: 
The NIH Guidelines for Recombinant DNA 
Research were orginally designed to 
safeguard the environment from "new*' 
organisms, created by recombinant DNA 
research, which might cause disease or 
otherwise disrupt the ecology. Recombinant 
DNA as a technique was specifically cited 
because of its immense potential for creating 
a variety of “new" and therefore untested 
organisms. The original Guidelines wisely 
assumed we knew little about the potential 
properties of such organisms and therefore 
limited their use to the laboratory. As the 
Guidelines evolved, an important task was 
the exemption from review of certain classes 
of experiments which, while involving the use 
of recombinant DNA techniques, did not in 
fact create new and untested organisms. Thus 
rearrangements within a plasmid or viral 
genome were exempted (Guidelines, section 
Ul-D-2), and even those within a single 
prokaryotic host, including its resident 
plasmids or viruses, were considered to be 
likely to occur at some frequency in nature 
and therefore not to require special review 
(Guidelines, section III-D-3). A similar 
principle has recently been proposed by the 
Biotechnology Science Coordinating 
Committee, in defining "new” organisms, for 
the purpose of regulatory oversight as those 
resulting from combinations between 
different genera. 1 Deletions and 
* Coordinated Framework for Regulation of 
Biotechnology: Announcement of Policy and Notice 
for Public Comment Federal Reglater, June 26, 1986, 
p. 23302-23303. 
rearrangements of single DNA sources, in 
particular, occur In nature. If similar 
rearrangements or deletions are created by 
recombinant DNA techniques, it seems 
reasonable to treat such molecules as we 
would treat those which are isolated as a 
result of classical genetic manipulations. 
Therefore, I propose that organisms in which 
the only use of recombinant DNA has been to 
remove or rearrange genetic information 
within a genome should not be subject to 
special scrutiny. Such experiments are 
already exempt from NIH Guidelines 
requirements for laboratory experimentation. 
This proposal would extend that exemption 
to experiments Involving release of such 
organisms Into the environment. 
II. Proposal To Add Badllus Sphaericus 
To Appendix C-V 
Dr. William F. Burke, Jr., of Arizona 
State University, Tempe, Arizona, has 
requested that Bacillus sphaericus be 
added to the list of Gram positive 
bacteria in Appendix C-V. 
Dr. Burke has supplied information 
supporting this request to the Office of 
Recombinant DNA Activities. 
Dated: August 12, 1986. 
Bernard Talbot, 
Acting Director, National Institute of Allergy 
and Infectious Diseases. 
OMB's "Mandatory Information 
Requirements for Federal Assistance Program 
Announcementa” (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 program listing. NIH Invites 
readers to direct questions to the information 
address above about whether individual 
Programs listed in the Catalog of Federal 
Domestic Assistance are affected. 
(FR Doc. 88-18481 Filed 8-14-86: 6:45 am) 
BILL! NO COO£ 4140-01-M 
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