6722 
Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
amendment, I must ask for a 
clarification of the intent of the sentence 
in question. As I read the relevant 
paragraph, these ‘expression’ 
experiments are understood to be 
appropriately carried out at the Pi + EKl 
level of containment. I am afraid that an 
alternate, presumably unintended, 
reading would be that each IBC is urged 
to set its own standards on these 
experiments. This policy, 1 am sure you 
would agree, would be disastrous." 
On the other hand, three 
commentators wrote in favor. — "I agree 
with your decision to require that 
experiments in which there is a 
deliberate attempt to have expression of 
a eukaryotic gene be reviewed and 
approved by the local IBC prior to their 
being performed." 
In response, I do not judge this 
requirement to be “superfluous." I 
discussed it in my November 30, 1979, 
Decision Document/Environmental 
Impact Assessment under the 
alternative "Treat Experiments Equally 
In Which There Is Or Is Not A 
Deliberate Attempt To Achieve Gene 
Expression." There, I concluded the 
discussion on "this issue by stating, 
“Therefore, experiments in which there 
is a deliberate attempt to achieve gene 
expression continue to merit special 
attention. . . . This will allow the IBC to 
judge whether it wishes to require any 
added restrictions to be placed on the 
experiment, and to remain fully 
informed of its progress.” 
In response to the request that the 
Guidelines “should explicitly state that 
Pi containment is recommended,” I note 
that the Guidelines do explicitly state in 
Section III— O that “. . . experiments 
using E. coli K-12 shall use Pi physical 
containment. . . including those "in 
which there is a deliberate attempt to 
have the E. coli K-12 efficiently express 
any gene coding for a eukaryotic 
protein. It is not NIH’s intention that the 
IBC must require higher containment for 
such experiments. 
One commentator suggested a 
rewording of this sentence as follows — 
"An exception, however, which does 
require prior review and approval by the 
IBC is any experiment in which there is 
a deliberate attempt to have the E. coli 
K-12 efficiently express as a protein 
product the information carried in any 
gene derived either from a eukaryotic 
organism or from any virus or viroid 
which infects a eukaryotic organism.” I 
will have this suggestion published for 
at least 30 days public comment, and 
will ask the RAC to consider it at its 
next (March 1980) meeting before I take 
action on it. 
III-B-2-g. Use of Poorly Mobilizab/e 
Plasmids 
One commentator suggested that 
experiments described in Section III— O 
of the Guidelines which specify that 
"the host shall not contain conjugation- 
proficient plasmids" add an additional 
safety feature by the use of “a poorly 
mobilizable plasmid. By that I mean one 
that is mobilizable at frequencies of 
<10" 5 by a derepressed conjugative 
plasmid." I will have this suggestion 
published for at least 30 days public 
comment and will ask that it be 
considered first by the RAC 
Subcommittee on Host-Plasmid Vector 
Systems, and then by the full RAC at its 
March 1980 meeting, before I take action 
on it. 
!II-B-2-h. Trqnsfer of Clones to Other 
Laboratories 
One correspondent discussed "the 
requirement that clones subject to the 
guidelines can be transferred to other 
laboratories only after the recipient 
submits an approved MUA to the 
supplying laboratory” and questioned 
whether this should apply to clones 
described in Section III— O of the 
Guidelines. 
Detailed instructions on the 
administration of the NIH Guidelines 
are contained in the “Administrative 
Practices Supplement to the NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules" (APS). 
Currently, a Memorandum of 
Understanding and Agreement (MUA) is 
required to be submitted to NIH for each 
NIH-funded recombinant DNA project 
subject to the Guidelines. As described 
in the APS, the MUA must contain a 
statement “agreeing to abide by the 
provisions of the NIH Guidelines and 
the requirements of this Supplement 
concerning shipment and transfer of 
recombinant DNA materials." The 
revised NIH Guidelines, issued today, 
specify that for experiments described 
in Section III-O, "no Memorandum of 
Understanding and Agreement (MUA) 
. . . need be submitted . . NIH will 
soon issue a revised version of the APS 
taking into account the changes in the 
Guidelines promulgated today. At that 
time, requirements concerning shipment 
of clones described under Section III-O 
of the Guidelines will be described. 
lll-B-3. Comments on the Proposed 
Revised Guidelines Other Than Section 
III-O 
Only three comments were received 
dealing with a "major action" 
recommended at the September 6-7, 
1979, RAC meeting, other than the "E. 
coli K-12/Pl Recommendation." These 
three requested that the Proposed 
Supplement (Part VI) on Voluntary 
Compliance not be added to the 
Guidelines. The reason given by one 
commentator was that it may “lead to 
unnecessary and wasteful legislative 
attempts.” The other two commentators, 
on the other hand, specifically called for 
mandatory compliance. 
In my November 30 Decision 
Document, I reviewed the history of this 
proposed supplement in detail including 
endorsement of it by the Federal 
Interagency Committee on Recombinant 
DNA Research and by the RAC. In 
accord with the analysis in that 
document, I accept the recommendation 
of these two committees to add Part VI 
to the Guidelines. 
III-B^t. Comments on the Guidelines 
Other Than Changes Recommended by 
the RAC 
The Decision Document/ 
Environmental Impact Assessment/ 
Proposed Revised Guidelines, as 
published for public comment on 
November 30, were based upon changes 
in the Guidelines recommended by the 
RAC at its September 6-7, 1979, meeting. 
During the comment period, five letters 
were received proposing additional 
changes in the Guidelines totally 
unrelated to the RAC recommendations. 
One commentator requested exemption 
from the Guidelines of “return to host of 
origin” type experiments. One 
commentator requested that the 
Institutional Biosafety Committee 
members not affiliated with the 
institution "shall be appointed by the 
governing body of the community in 
which the institution is situated.” Two 
commentators submitted a proposed 
addition to Appendix B of the 
Guidelines to deal with plant pathogens. 
One commentator requested elimination 
of Prohibition I-D-3, and a revision of 
Sublist A of Appendix A to the 
Guidelines. 
I will have the proposals mentioned 
above under III— B — 4 published for at 
least 30 days public comment, and will 
ask the RAC to consider them at its next 
(March 1980) meeting before I take 
action on them. 
III-C. Decision of the NIH Director on 
Promulgation of Revised Guidelines 
Based on my analysis of the 
comments received during this comment 
period, I am today promulgating revised 
NIH Guidelines for Research Involving 
Recombinant DNA Molecules. They 
differ from the proposed revised 
Guidelines as published in the Federal 
Register on November 30, 1979, by the 
incorporation of the additional changes 
which were recommended by the RAC 
at its December 6-7, 1979, meeting, and 
which were promulgated in the Federal 
Register on January 7, 1980 (45 FR 3552). 
Dated: January 23, 1980. 
Donald S. Fredrickson, 
Director, National Institutes of Health. 
[FR Doc. 80-2821 Filed 1-28-80: 8:45 am) 
BILLING CODE 4110-08-M 
[14] 
