Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
6719 
III. Analysis of Comments on Decision 
Document /Environmental Impact 
Assessment /Proposed Revised 
Guidelines as Published for Comment in 
the Federal Register on November 30, 
1979 (44 FR 69210) 
I II- A. Discussion at RAC Meeting on 
December 6, 1979 
The Decision Document/ 
Environmental Impact Assessment/ 
Proposed Revised Guidelines as sent to 
the Federal Register to appear on 
November 30, 1979, were simultaneously 
sent to RAC members who received the 
documents on November 29. The 
material was discussed by the RAC at 
its December 6-7, 1979, meeting. At this 
meeting, the RAC Chairman presented 
the document pointing out the changes 
between the "if. coli K-12/P1 
Recommendation” as adopted by the 
RAC on September 6, 1979, and the 
somewhat revised version of this 
recommendation (Section III— O of the 
proposed revised Guidelines) as issued 
by the NIH Director for public comment 
in the Federal Register on November 30, 
1979. She noted that the NIH Director . 
had eliminated the reference to these 
experiments as “exempt from the 
Guidelines" and had added a 
requirement for prior review and 
approval by the IBC for experiments in 
which there is a deliberate attempt to 
have the E. coli K-12 efficiently express 
a gene coding for a eukaryotic protein. 
The Chairman asked for comments from 
the RAC. Except for questions of 
clarification from RAC members, which 
were answered by. NIH staff, there were 
no comments either on these particular 
items or on the recommendations 
generally. NIH staff urged RAC 
members to write individually to the 
NIH Director during the comment period 
giving their views. (Six RAC members 
did write. Four endorsed Section III— O 
of the Guidelines^Two, who had voted 
against the "E. coli K-12/Pl 
Recommendation" at the September 6-7, 
1979, meeting, wrote. One urged the 
“exemption" not be approved. The other 
urged that the final decision not be 
delayed.) 
III-B. Public Comments 
The Decision Document/ 
Environmental Impact Assessment/ 
Proposed Revised Guidelines as they 
appeared in the Federal Register on 
November 30, 1979, were sent out to 
over 2000 people for comment — this 
included the chairmen of all Institutional 
Biosafety Committees registered with 
NIH, all principal investigators doing 
recombinant DNA experiments 
supported by NIH, and all persons who 
had previously requested their inclusion 
on a mailing list to receive information 
concerning the NIH Guidelines. During 
the period up to January 18, 1980, 185 
letters signed by a total of 205 
individuals were received. All of these 
letters: (i) are now available for public 
inspection at ORDA: (ii) can be made 
available (in whole or in part) to any 
requester upon payment of reproduction 
costs; and (iii) will be published (and 
subsequently may be purchased through 
the U.S. Government Printing Office) as 
part of Volume 5 of "Recombinant DNA 
Research," a series constituting a public 
record of activities in regard to the NIH 
Guidelines. 
The Decision Document/ 
Environmental Impact Assessment 
consisted of an analysis of the six 
"major actions" which were 
recommended favorably at the 
September 6-7, 1979, RAC meeting. 
These six "major actions” were: “The E. 
coll K-12/P1 Recommendation”: 
"Proposed Amendment of Sections II— D— 
l-a-(l) and III— A— 1— b— (1 ) of the 
Guidelines”; "Proposed Exemption for 
Pseudomonas Putida and Pseudomonas 
Florescens"; "Cloning in Bacillus 
Subtilis and Streptomyces Coelicolor”; 
"Use of Agrobacterium Tumefaciens as 
a Host-Vector System"; and "Proposed 
Supplement (Part VI) to the Guidelines." 
The bulk of the November 30 Decision 
Document/Environmental Impact 
Assessment consisted of an analysis of 
the "E. coli K-12/P1 Recommendation"; 
it was ponted out thaf'of all the 
recommendations arising from the last 
three meetings of the RAC [this 
recommendation was] the one that has 
generated the greatest number of letters 
and the most discussion at the RAG 
meetings.” The analysis included the 
NIH Director's proposed acceptance of a 
modified version of this 
recommendation to become Section III— 
O of the proposed revised Guidelines. 
In the comment period only three 
letters were received that included 
comments dealing specifically with any 
of the other five "major actions" i.e., all 
other letters made reference to the 
entire proposed revised Guidelines or 
commented specifically upon the “ E . 
coli K-12/P1 Recommendation." The 
remainder of this document is organized 
as follows: III— B— 1. Comments on The 
Entire Proposed Revised Guidelines; III— 
B-2. Comments on the “ E . coli K-12/P1 
Recommendation” or Section III— O of 
the Proposed Revised Guidelines: III— B— 
3. Comments on the Proposed Revised 
Guidelines Other Than Section III— O; 
III— B — 4. Comments on the Guidelines 
Other Than Changes Recommended by 
the RAC: III— C. Decision of the NIH 
Director on Promulgation of Revised 
Guidelines. 
III-B-1. Comments on the Entire 
Proposed Revised Guidelines 
Eighty-three letters signed by a total 
of 100 individuals were received in 
support of the proposed revised 
Guidelines. (Many of these 
commentators also specifically endorsed 
Section III— O of the proposed 
Guidelines.) Comments included the 
following— "I heartily support the 
changes that you propose for the NIH 
Guidelines for Research Involving 
Recombinant DNA Molecules. I am 
especially impressed by the detailed and 
reasoned consideration that the 
Advisory Committee (RAC) and you 
have used to reach these very 
enlightened decisions." — "This letter is 
to indicate my wholehearted support of 
the revisions." — “Although I am highly 
concerned with laboratory safety, I 
believe the revised guidelines are 
certainly reasonable.” — "They are 
reasonable and sensible Guidelines 
which take into account the body of new 
information and research experience 
which has become available since the 
formulation and enactment of the 
original guidelines.” — "The proposed 
new Guidelines are a very sensible step 
forward. By freeing scientists from 
unnecessary red tape, and 
administrative delays in doing 
experiments, they will appreciably 
accelerate the progress of research and 
the realization of its benefits." 
III-B-2. Comments on the "E. coli K-12/ 
Pi Recommendation" or Section lll-O of 
the Proposed Revised Guidelines 
Comments received on the RAC’s "E. 
coli K-12/P1 Recommendation” or the 
NIH Director’s proposed incorporation 
of a modified version of this 
recommendation to become Section III— 
O of the proposed revised Guidelines 
are discussed below. 
III-B-2-a. Endorsement of the “E. coli 
K-12/P1 Recommendation ” or Section 
III-O of the Proposed Revised 
Guidelines 
In addition to the 83 letters mentioned 
above which endorsed the entire 
proposed revised Guidelines, another 86 
letters signed by a total of 89 individuals 
were received endorsing what was 
referred to as either the proposed new 
"Section III-O of the Guidelines,” the 
“E. coli K-12/P1 Recommendation,” or 
the “decision to reclassify recombinant 
DNA experiments performed in E. coli 
K-12 as Pi." Thus, of the 185 letters 
received, 169 supported the proposed 
new Section III-O. 
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