Federal Register / Vol. 47, No. 77 / Wednesday, April 21, 1982 / Notices 
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language by adding the phrase 
"biologically active" before the word 
"polynucleotide" in the last sentence. 
Dr. Nightingale, who had proposed the 
motion being considered, and Dr. 
Feroroff, the seconder of the motion, 
accepted the amendment. 
Dr. Saginor then proposed an 
amendment which would explicitly state 
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. Dr. Nightingale, 
noting this intent was part of her 
original motion, accepted the 
amendment, as did Dr. Fedoroff. 
Mr. Thornton called the question on 
Dr. Nightingale's motion as modified by 
amendments. By a vote of seventeen in 
favor, three opposed, and no abstentions 
the RAC recommended adoption of the 
December 7, 1981. proposal with 
amendments. Mr. Thornton said a 
working group to refine the proposal 
would be designated at a later date, in 
accordance with the motion. 
Dr. McCarrity asked the committee to 
state for the record that RAC sees no 
need for additional state and local 
ordinances governing recombinant DNA 
activities. Dr. Liberman, the biological 
safety officer at MIT, advised against 
adoption of E)r. McCarrity’s statement 
as he viewed it as counter-productive. 
Based on his experience as a member of 
the Boston Biohazards Committee he 
sees growing community interest in 
overseeing non-recombinant biohazards 
as recombinant systems as being 
handled. 
Dr. Ahmed said he thought adoption 
of Dr. McCarrity's statement would be 
viewed as arrogance on the part of the 
RAC saying "our views are gospel, and 
don't second guess us." 
Mr. Mitchell said that he is in 
sympathy with the motion since he is 
concerned about fragmentation at the 
State and local level. However, knowing 
the independence of legislative bodies, it 
might not be well taken. He suggested 
that if the statement were rewo^ed it 
might be more successful. Dr. McCarrity 
agreed and withdrew the proposal in 
order that revised text could be 
prepared for consideration later in the 
meeting. 
Dr. Mason spoke against Dr. 
McCarrity's proposal, as it runs counter 
to usual regulatory practice, in which 
Slates and localities may regulate as 
long as their requirements are at least as 
stringent as Federal requirements. He 
added that RAC's recommendation 
would not be binding. 
Dr. Holmes made a motion that there 
be added to the Guidelines a statement 
to the effect that 
It is not clear that the biohazards 
associated with recombinant DNA are unique 
or different from biohazards associated with 
other work with pathogenic organisms: 
therefore. RAC encourages local Institutional 
Biosafety Committees to establish procedures 
for review of experiments not involving 
recombinant DNA. which nonetheless, 
involve biohazards such as those addressed 
in Section ID of the Guidelines. 
Dr. Fedoroff seconded the motion. Dr. 
Landy suggested that a different 
statement be substituted for Dr. Holmes' 
proposed language to the effect that: 
The Recombinant DNA Advisory 
Committee wants to point out the absence of 
demonstrated risk or danger posed by 
recombinant DNA research The continuance 
of the Guidelines for recombinant DNA 
research is made with full appreciation of the 
fact that other areas of research in which 
some risk has been demonstrated are without 
analogous guidelines. 
Dr. Landy said such a statement 
would make clear to the public that 
RAC's recommendation to maintain 
guidelines is not based on demonstrated 
risk, but on potential risk. 
Dr. Ahmed asked whether NIH has 
the authority to expand the purview of 
the IBC's as in Dr. Holmes' statement. 
Dr Talbot replied that such a statement 
could be sent to the IBCs as a 
recommendation. 
Dr. Goldstein said that he thought Dr. 
Landy’s proposal could "stir up a 
hornet's nest," regenerating the situation 
of previous years with recombinant 
DNA. Ms. King said she could not 
support Dr. Landy's proposal as she 
questioned the phrase "absence of 
demonstrated risk." Dr. Bems moved to 
table Dr. Holme's proposal. By a vote of 
seventeen in favor, three opposed, and 
no abstentions, the proposal was tabled. 
Dr. Levine called the committee's 
attention to the report of the Working 
Group on Revision of the Guidelines 
entitled "Evaluation of the Risks 
Associated with Recombinant DNA 
Research" and particularly Part IV-A of 
the report, "Summary Analysis of Risks" 
(46 FR 59390). He said the conclusion is 
that most potential recombinant DNA 
risks envisaged in 1975 are now 
considered nonexistent. Ms. Kir\g said 
RAC should emphasize that available 
data cited in that report support and 
justify RACs recommendation of the 
December 7, 1981, proposal. She 
suggested the RAC might formally 
reaffirm the "Summary Analysis of 
Risks." Dr. Martin suggested this text 
might be used as a preamble to the 
introduction of the new Guidelines by 
the NIH Director. Dr. Holmes moved 
that the Director is requested to 
consider the "Summary Analysis of 
Risks" (48 FR 59390) as he determines a 
preamble to the revised Guidelines. Dr. 
Nightingale seconded the motion. She 
emphasized that her earlier motion for 
adoption of the December 7, 1981, 
proposal was based on the document 
"Evaluation of the Risks Associated 
with Recombinant DNA." She expected 
this document would be published as an 
integral part of the decision document. 
Dr. Mason hoped the document would 
note the different options considered by 
the RAC. 
Ms. King suggested Dr. Holmes' 
motion be amended to call the attention 
of the NIH Director not just the 
"Summary Analysis of Risks" (46 FR 
59390) but also the motion which 
originally established the Working 
Croup on Revision of the Guidelines, the 
Working Group's agenda, and its 
complete report. 
Dr. Talbot asked if the motion might 
not be withdrawn, with the assurance 
that NIH would bring all of these items 
to the Director's attention without the 
necessity of a motion. Ms. King said she 
would prefer a specific motion since the 
Working Croup report had not been 
formally endorsed by the RAC at the 
September 1981 meeting and since the 
RAC action today accepting the 
December 7, 1981. proposal is based on 
that report. Dr. Holmes reworded his 
motion to request the summary 
information discussed be included in the 
Director's preamble. Dr. Nightingale, 
who had seconded Dr. Holmes' earlier 
motion, also agreed. 
Dr. Wright said that if there were to 
be a general statement on risks, then it 
should be made clear which industrial 
problems the RAC is not dealing with, 
so that no one thinks this is a global 
statement covering both research and 
industrial risks. Dr. Ahmed suggested 
that language be inserted indicating that 
the report does not address industrial 
scale-up. Dr. Bems noted that the NIH, 
on the advice of the RAC. had issued 
"Physical Containment 
Recommendations for Large-Scale Uses 
of Organisms Containing Recombinant 
DNA Molecules;" RAC. however, is no 
longer evaluating mechanical details in 
individual large-scale applications. Dr. 
Landy opposed Dr. Ahmed's suggestion 
on the introduction of a specific 
statement on industrial considerations 
as it would dilute the general policy 
statement. 
Dr. Pinon moved to table the motion: 
he preferred that ORDA bring these 
items to the attention of the Director, 
NIH, without the necessity of a formal 
motion. By a vote of ten in favor, eight 
opposed, and two abstentions, the 
motion to table carried. 
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