3552 
Federal Register / Vol. 45, No. 12 / Thursday, January 17, 1980 / Notices 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
National Institutes of Health 
Recombinant DNA Research; Actions 
Under Guidelines 
AGENCY: National Institutes of Health, 
PHS, HEW. 
ACTION: Notice of actions under NTH 
Guidelines for Research Involving 
Recombinant DNA Molecules. 
summary: This notice sets forth actions 
taken by the Director, NIH, under the 
1978 NIH Guidelines for Research 
Involving Recombinant DNA Molecules 
(43 FR 60108). 
EFFECTIVE DATE: January 17, 1980. 
FOR FURTHER INFORMATION CONTACT: 
Additional information can be obtained 
from Dr. William J. Gotland, Office of 
Recombinant DNA Activities (ORDA), 
National Institutes of Health, Bethesda, 
Maryland 20205. (301) 496-6051. 
SUPPLEMENTARY INFORMATION: I am 
promulgating today several major 
actions under the NIH Guidelines for 
Research Involving Recombinant DNA 
Molecules. These Guidelines (43 FR 
60108) include procedures for changing 
the Guidelines. As detailed in Section 
IV-E-l-b-(l) of the Guidelines, this 
involves: (1) publication of the proposed 
changes in the Federal Register for 
public comment, at least 30 days prior to 
a meeting of the NIH Recombinant DNA 
Advisory Committee (RAC); (2) 
consideration of the proposed changes 
by the RAC; and (3) publication in the 
Federal Register of the final decision by 
the Director, NIH/ 
In accordance with these procedures, 
proposed changes in the Guidelines 
appeared in the Federal Register on 
January 15, 1979 (44 FR 3226), were 
considered by the RAC at its February 
16-17, 1979, meeting, and were 
promulgated by the NIH Director in the 
Federal Register on April 11, 1979 (44 FR 
21730). 
Proposed changes in the Guidelines 
appeared in the Federal Register on 
April 13, 1979 (44 FR 22314), were 
considered by the RAC at its May 21-23 
1979, meeting, and were promulgated by 
the NIH Director in the Federal Register 
on July 20, 1979 (44 FR 42914). 
Proposed changes in the Guidelines 
appeared in the Federal Register on July 
31, 1979 (44 FR 45088), and were 
considered by the RAC at its September 
6-7, 1979, meeting. Rather than 
promulgating the recommended changes, 
the Director, NIH, instead issued them 
for 30 days of additional public 
comment in the Federal Register on 
November 30, 1979 (44 FR 69210). Final 
action on these proposed changes has 
not yet been taken. 
Proposed changed in the Guidelines 
appeared in the Federal Register on 
November 1, 1979, (44 FR 63074) and 
were considered by the RAC at its 
December 6-7, 1979, meeting. This notice 
discusses the four “major actions” that 
were recommended favorably at the 
December 6-;7, 1979, RAC meeting. Part I 
of this announcement provides 
background information on the actions; 
and Part II provides a summary of the 
major actions promulgated today. In 
accordance with Section IV-E-l-b of 
the NIH Guidelines, I find that these 
actions comply with the Guidelines and 
present no significant risk to health or 
the environment. 
I. Decision on Actions Under Guidelines 
I-A. Amendment of Sections III-B-2, 
III-C-5, and 1I1-C-6 of the Guidelines 
A proposal appeared in the Federal 
Register on November T, 1979, to amend 
Sections III-B-2, III-C-5, and III-C-6 to 
change the words “. . . may be inserted 
into a lambdoid phage vector or into a 
vector from a certified EK2 host-vector 
system and propagated . . .” to “. . . 
may be inserted into a vector and 
propagated. . . ." 
No comments were received during 
the 30-day comment period. 
At the December 6-7, 1979, RAC 
meeting support was voiced for these 
changes dealing with "return to host of 
origin” experiments. It was stated that 
the changes would give scientists more 
flexibility in designing experiments 
without significantly affecting safety in 
any way. A motion to accept these 
changes passed by a vote of 15 in favor 
and none opposed, with 3 abstentions. 
I accept this recommendation. 
I-B. Transfer of Cloned Segments of 
Anabaena Into Klebsiella 
A request from Dr. Robert Haselkorn 
of the University of Chicago to transfer 
cloned segments of DNA from the 
cyanobacterium Anabaena into 
Klebsiella was discussed at the 
September 6-7, 1979, RAC meeting, 
when the proposal was not accepted 
pending further information from Dr. 
Haselkorn. 
Notice was placed in the Federal 
Register on November 1, 1979, that the 
RAC would be considering this again at 
its December 6-7, 1979, meeting. 
No comments were received during 
the 30-day comment period. 
Copies of a November 16, 1979, letter 
from Dr. Haselkorn in response to the 
questions raised at the September'6-7, 
1979, RAC meeting were mailed to the 
RAC members prior to their December 
6-7, 1979, meeting. 
At the December 6-7, 1979, RAC 
meeting it was pointed out that Dr. 
Haselkom's November 16 letter clarifies 
that he is using an Anabaena cylindrica 
strain that does not produce a toxin. It 
was stated that the experiment is 
scientifically important and seems safe. 
The use of conjugative plasmids has a 
precedent in the previous approval by 
the RAC of the use of the Ti plasmid of 
Agrobacterium tumefaciens in certain 
experiments. A motion to approve the 
requested experiments to be performed 
at P2 physical containment passed by a 
vote of 12 in favor, none opposed, with 4 
abstentions. 
I accept this recommendation. 
I-C. Request for Exception to 
Prohibition to Clone Foot-and-Mouth 
Disease Virus in E. coli K-12 
Notice was placed in the Federal 
Register on November 1, 1979, that the 
RAC would be considering at its 
December 6-7, 1979, meeting a requested 
exception to a prohibition in order to 
clone foot-and-mouth disease virus 
(FMDV) in E. coli K-12. 
No comments were received during 
the 30-day comment period. 
FMDV is classified as a Class 5 agent 
in the Center for Disease Control’s 
"Classification of Etiologic Agents on 
the Basis of Hazard” (4th edition, July 
1974). The NIH guidelines prohibit, in 
Section I-D-l, "Formation of 
recombinant DNAs derived from the 
pathogenic organisms classified [1] as 
Class 3, 4, or 5 [2] or from cells known 
[2AJ to be infected with such agents, 
regardless of the host-vector system 
used.” However, “experiments in these 
categories may be excepted [4] from the 
prohibitions (and will at that time be 
assigned appropriate levels of physical 
and biological containment) provided 
that these experiments are expressly 
approved by the Director, NIH, with 
advice of the Recombinant DNA 
Advisory Committee after appropriate 
notice and opportunity for public 
comment." 
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