Federal Register / Vol. 47, No. 77 / Wednesday. April 21. 1982 / Notices 
17173 
considered the issues, taking into careful 
account the many letters received. 
The First of the motions passed by the 
RAC discussed above in Part Il-A of 
this announcement was to recommend 
acceptance of the "Gottesman" proposal 
for revision of the Guidelines as it had 
appeared in the December 7, 1981, 
Fe^ral Register with the addition of the 
phrase "biologically active” before the 
word “polynucleotide" in the last 
sentence of Section I-B of the 
Guidelines, and with the stipulation that 
a working group be appointed to review 
and attempt to further simplify the 
Guidelines, to report to the RAC at a 
future meeting. 
I accept the RAC recommendation of 
the "Gottesman" proposal for revision of 
the Guidelines with the addition of the 
phrase "biologically active." This is 
discussed fur^er in Part IV of this 
announcement 
The stipulation "that a working group 
be appointed to review and attempt to 
simplify further the guidelines, and to 
report to the RAC at a future meeting" 
has been accepted. Members of a new 
Working Croup on Revision of the 
Guidelines have been appointed by the 
RAC Chairman, a First meeting is 
scheduled in April 1982. and it is hoped 
that the Working Croup will have 
proposed revisions ready to present at 
the next RAC meeting on June 28, 1982. 
A second motion passed by the RAC 
discussed above in Part Il-A of this 
announcement was to “speciFically call 
to the Director's attention that the action 
taken on the December 7, 1981, proposal 
results from analysis and consideration 
of the report entitled ‘Evaluation of the 
Risks Associated With Recombinant 
DNA Research' prepared by the 
Working Croup on Revision of the 
Guidelines.” During the discussion prior 
to the adoption of this motion, there 
were suggestions that the entire report 
"Evaluation of the Risks Associated 
With Recombinant DNA Research” be 
published as an integral part of the 
Decision Document accompanying the 
Guideline revision, i.e.. be published in 
this announcement. 
I do note that the RAC action, 
recommending adoption of the 
December 7, 1981. proposal was based 
on analysis and consideration of the 
report entitled “Evaluation of the Risks 
Associated With Recombinant DNA 
Research.” I commend this report and 
urge interested readers to consult it. I 
have reproduced in Part I of this 
announcement the headings of the 
Report. I do not feel, however, that it is 
necessary to reproduce the entire report 
here. It can be found on pages 5938.‘>- 
59394 of the Federal Register of 
December 4. 1981. 
During RAC discussion of another 
motion, which was not approved, as 
discussed above in Part II-A of this 
announcement. Dr. Ahmed said he 
hoped that in the Director's preamble to 
the new Guidelines (i.e.. in this 
announcement) it would be stated that 
neither RAC nor the NIH deals with 
mechanical aspects of industrial scale- 
up activities. 
In response to this, it might be helpful 
to review the history and the current 
status of the relationship of the NIH 
Guidelines to industrial scale-up. The 
Guidelines are mandatory for 
institutions which receive Federal funds 
for recombinant DNA research. They 
are not mandatory for institutions which 
receive no Federal funds for 
recombinant DNA research other than in 
those States and localities which have 
local ordinances requiring all to follow 
the NIH Guidelines. The Guidelines 
promulgated today stipulate, in Section 
III-B-5. that experiments involving more 
than 10 liters of culture require prior 
approval by the IBC (but not NIH). They 
refer to the "Physical Containment 
Recommendations for Large-Scale Uses 
of Organisms Containing recombinant 
DNA Molecules" which NIH issued in 
the Federal Register on April 11, 1980 (45 
FR 24968) and which deFine the 
containment levels Pl-LS. P2-LS. and 
P3-LS. Previous versions of the 
Guidelines, in effect earlier, involved 
prior RAC review and NIH approval of 
recombinant DNA experiments over 10 
liters in volume. Industry voluntarily 
submitted requests to go over 10 liters in 
volume, which were reviewed at RAC 
meetings In September 1979. December 
1979. March 1980. June 1980. September 
1980. January 1981, and April 1981. 
Through the September 1980 meeting the 
information submitted included details 
of the “applicant's laboratory practices, 
containment equipment and facilities 
At the request of the RAC. and as 
accepted by NIH In November 1980 (45 
FR 77378), this was changed to no longer 
require such physical containment 
details. 
During RAC discussion of another 
motion, which was not approved, as 
discussed in Part II-A of this 
announcement Dr. Nightingale 
suggested that the Director’s preamble 
to the revised Guidelines (i.e., this 
announcement) might state that the 
"Guidelines are based on the best 
available information, and it is hoped 
they will be applied nationally." 1 
heartily endorse this sentiment and 
hope that any State or local government 
contemplating enactment of legislation 
governing recombinant DNA activities, 
will First study the documentation of the 
huge effort the RAC and NIH have put 
into establishing and modifying the NIH 
Guidelines, and will defer to the NIH 
Guidelines unless it clearly establishes 
by credible scientiFic evidence that 
unique risk in fact exists in their 
particular jurisdiction. 
III. Analysis of Correspondence 
Received 
As noted above. 86 letters were 
received commenting on the proposed 
revisions of the Guidelines between 
November 1981 and February 5, 1982. 
These 86 letters were provided to the 
RAC and considered at their meeting on 
February 8-9. 1982. Nine additional 
letters were received between February 
8. 1982. and March 31, 1982. This Part 
(111) of this announcement contains an 
analysis of the 95 letters received. 
Copies of all letters received are 
available for inspection at the Office of 
recombinant DNA Activities, Building 
31. Room 4A52, NIH, Bethesda. 
Maryland 20205. It is expected that they 
will be published in a Volume 7 of 
"Recombinant DNA Research.” a series 
constituting a public record of 
documents related to the NIH 
Guidelines for Research Involving 
recombinant DNA Molecules. 
Letters in Favor of Removing All 
Guidelines 
One commentator wrote: 
i conclude that Drs. Adelberg and Zinder 
has the correct position: There is no scicntiFic 
iustiFication for maintaining any Guidelines 
in force. 
Two other commentators also wrote 
in support of abolishing the Guidelines. 
Tiiis represents one end of the spectrum 
of views in regard to the Guidelines. The 
Adelberg-Zinder recommendation was 
reproduced in Annex C of the December 
4. 1981. Federal Register (46 FR 59394). 
As noted in the minutes of the 
September 10-11. 1981. RAC meeting 
(Annex D of the December 4. 1981. 
Federal Register (46 FR 59398)): 
Dr. Zinder requested that a motion be 
introduced in support of the Adelberg-Zinder 
proposal to eliminate the Guidelines and the 
RAC. No motion was introduced. 
I share the view of the RAC that the 
proposal does not merit support, at this 
time. 
Support for the September 1981 RAC 
Proposal 
As discussed above, the September 
1981 RAC proposal (published for 
comment in the Federal Register on 
December 4. 1981) would have retained 
the Guidelines and the RAC. but would 
have changed the Guidelines from 
mandatory to voluntary, would have 
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