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Federal Register / Vol. 47, No. 77 / Wednesday, April 21, 1982 / Notices 
After a brief recess. Dr. Mason moved 
to reconsider the action in order to 
provide the Director with a clear 
indication of RAC intent. He felt the 
previous vote revolved about procedural 
issues rather than intent. By a vote of 
ten in favor, four opposed, and three 
abstentions, the motion to reconsider 
was adopted. 
Ms. King then moved that “the RAC 
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 
Group on Revision of the Guidelines. 
The vote on the December 7, 1981, 
proposal implements the Working Group 
report." 
By a vote of nineteen in favor, none 
opposed, and one abstention, the RAC 
adopted Ms. King’s motion as a 
substitute for the previous motion. Mr. 
Thornton then rules that unless there 
were objection (which there was not), 
the substitute motion is adopted by 
unanimuous consent as the 
recommendation of the RAC. 
Following an overnight recess, Mr. 
Thornton called the committee to order 
to consider language developed by Dr. 
McGarrity and Mr. Mitchell regarding 
local and state legislation. Mr. Mitchell 
moved acceptance of the following 
language; 
Whereas RAC has voted to recommend 
significant reductions in mandatory 
guidelines regarding recombinant DNA 
activity, and 
Whereas RAC in establishing said reduced 
guidelines did so based upon collective 
credible scientific knowledge and experience, 
and 
Whereas RAC believes it to be in the best 
interest of recombinant DNA activity to have 
a central arena for the dissemination of 
information and continuous review, and 
Whereas RAC believes the existence of 
uniform guidelines thereby establishes 
certainty and clarity in the scientific 
community, and 
Whereas RAC believes it would be 
detrimental to the advancement of 
recombinant DNA activity to have 
fragmentation of guidelines across the 
country. 
'Therefore, be it resolved that RAC strongly 
recommends that local and state 
governments defer to the NIH Guidelines if 
enacting legislation governing recombinant 
DNA activity, unless it clearly establishes by 
credible scientific evidence that unique risk 
in fact exists in their particular jurisdiction. 
Dr. McGarrity seconded the motion. 
He said the RAC action taken yesterday 
on the December 7, 1981, proposal would 
significantly relax the Guidelines. When 
considered in the content of possible 
additional local legislation, 
Mitchell’s statement expressed RAC's 
judgement that the NIH Guidelines are 
the best possible approach at this time. 
It would be counterproductive for RAC 
to strip away bureaucracy and 
paperwork at the national level, only to 
have more bureaucracy and paperwork 
added at the state and local level. 
Dr. Miller of the FDA strongly 
endorsed the sense of the motion. He 
said, almost without exception, the 
mosaic of local regulations has been 
more draconian and much less 
enlightened that the NIH Guidelines, 
and slower to evolve, 
Dr. Martin suggested that the phrase 
“best interests of the public" be 
substituted for the phrase “best interest 
of recombinant DNA activity." Mr. 
Mitchell agreed. 
Dr. Nightingale requested a 
clarification of the word “activity" in the 
motion. Mr. Mitchell replied that 
"activity" is an all inclusive term meant 
to cover research, development, 
production, etc. 
Drs. Ahmed and Goldstein supported 
the sentiment expressed by the motion. 
However, Dr. Goldstein said he would 
vote against the language as he felt local 
communities would regard it as 
arrogant. Mr. Mitchell said he had 
chosen the verb "defer” to avoid the 
appearance of arrogance. The language 
urges that any actions be based on 
scientific grounds, and places the 
burden of proof upon advocates of local 
action. Dr. Friedman agreed. 
Dr. Ahmed asked whether addition of 
the phrase “in as much as possible" 
would soften the language of the 
sentences: 
* * * therefore, be it resolved that RAC 
strongly recommends that local and State 
governments defer to the NIH Guide 
lines * * * 
Mr. Thornton thought the verb “defer" 
alone was actually softer. 
Dr. Mason said he could envisage 
situations in which local action might be 
necessary because of irresponsible 
action by a local academic or industrial 
group. He hoped RAC did not intend to 
say that local action should not be taken 
in such cases. Dr. Goldstein stated that 
communities realize that while 
universities are under sanctions, 
industry is not. Dr. Berns said that Mr. 
Mitchell’s language specifies that when 
local entities legislate, they should defer 
to the NIH Guidelines in the scientific 
component of the legislation. 
Dr. Mason said that many aspects of 
industrial scale-up are not covered by 
the Guidelines, yet the proposed 
language implies the existence of such 
guidance. He questioned whether RAC 
might amend the language to remove 
such implications. Dr. McGarrity 
suggested the phrase “DNA activity” be 
modified to “DNA research activity.” 
Dr. Ahmed said he supported the 
resolution but would prefer that a 
statement, delineating the scope of RAC 
activities, be appended to the language. 
If the committee could not formulate 
such a statement today, he hoped the 
Director’s preamble to the acceptance of 
the December 7, 1981, proposal would 
state that neither RAC nor the NIH 
deals with mechanical aspects of 
industrial scale-up activities. 
Dr. Pinon requested that the word 
“credible” be deleted from the phrase 
"credible scientific evidence"; he 
thought the term redundant. Dr. Saginor, 
however, disagreed as he felt 
“scientific" and “credible" are not 
synonymous to the public. 
Dr. Gottesman saw the proposed 
language as intending to say to local 
legislators “we are listening to your 
concerns, we believe we are responding 
to them, and we hope you will continue 
to have faith in RAC.” She warned, 
however, that the language might lead 
legislators who had not previously 
thought of legislation to consider it. Dr. 
Nightingale concurred. She thought 
acceptance of Mr. Mitchell’s statement 
might be counterproductive. Instead she 
suggested that the Director’s preamble 
to the revised Guidelines might state 
that these Guidelines are based on the 
best available information and, it is 
hoped they will be applied nationallyT 
She preferred this procedure to a motion 
indicating RAC’s concern over possible 
local legislation. Dr. Holmes agreed, 
expressing concern that the motion 
appeard arrogant and would be counter- 
productive. Dr. Berns called for the 
question. 
By a vote of sixteen in favor, none 
opposed, and no abstentions, the RAC 
voted to stop debate and to vote on the 
motion proposed by Mr. Mitchell, as 
amended. By a vote of six in favor, nine 
opposed, and one abstention, the motion 
offered by Mr. Mitchell was defeated. 
Il-B. Response of the Acting Director, 
NIAID, to the RAC Recommendations 
As the deciding Federal official, 
having been delegated responsibility for 
actions relative to the NIH Guidelines, I 
note the following: 
I was present throughout the entire 
February 8-9, 1982, RAC meeting (as 1 
have been present throughout all but the 
first of the twenty-three meetings of the 
RAC.) I attest to the accuracy of the 
draft minutes appearing above in Part 
II-A of this announcement. I commend 
the diligence with which the RAC 
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