15 
Er. Masai spoke against D:. McGarrity's proposal, as it runs comter to 
usual regulatory practice, in which states and localities may regulate as long 
as their requirements are at least as stringent as Federal requirements. 
He added that RAC's reconmendation 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 bic^azards associated with recombinant 
M^A are laiique or different fron biohazards associated with 
other work with pathogenic organisms; therefore, RAC encourages 
local Institutional Biosafety Committees to establish procedures 
for review of experiitents not involving recombinant ENA, vhich, 
nonetheless, involve bidiazards such as those addressed in 
Section III of the Guidelines." 
Dr. Fedoroff seconded the motion. Dr. Landy suggested that a different state- 
ment be substituted for Dr. Holmes' proposed language to the effect that: 
"The Rsconbinant ENA Advisory Committee wants to point out the 
absence of doronstrated risk or danger posed by recombinant 
ENA research. Hie 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 ri^. 
E)r. Ahmed asked vhether NIH has the authority to expand the purview of the 
IBCs as in Dr. Holmes' statement. Dr. Talbot replied that such a statement 
ccxild be sent to the IBCs as a recommendation. 
Dr. Goldstein said that he thought Dr. Dandy's proposal could "stir up a 
hornet's nest," regenerating the situation of previous i^ars with recom- 
binant MJA. Ms. King said she could not support Dr. landy 's proposal as 
she questioned the fhrase "absence of demonstrated ride." Dr. Bems moved 
to table Dr. Holmes' 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 
Asscx:iated with Recombinant DNA Research" and particularly fert IV-A of 
the report, "Sumnary Analysis of Risks" (46 FR 59390). He said the con- 
clusioi is that most potential recombinant DNA risks envisaged in 1975 are 
now considered nonexistent. Ms. King said RAC should emphasize that 
available data cited in that report support and justify RAC's reconmendation 
of the December 7, 1981, proposal. She suggested the RAC might formally 
reaffirm the "Summary Analysis of Risks." Dr. Martin suggested this text 
[ 344 ] 
