16 
Might be used as a preatnble tx> the introduction of the new Guidelines by 
the NIH Director. Dr. Holioes raoved that the Director is requested to consider 
the "Surmary Analysis of Risks" (46 FR 59390) as he detemines a preanttle 
to the revised Guidelines. Dr. Nightingale seconded the notion. She 
CR^ivasized that her earlier motion for adoption of the Deconber 1 , 1981, 
propoB^Ll was based on the document "Evaluation of the Risks Associated 
with Reconbinant ENA Researdi." She atpected this docunent would be pub- 
lished as an integral part of the decision doctnent. Cr. Nason hoped the 
dooxnent would note the different options considered by the RAC. 
Ns. King suggested Dr. Holmes' motion be amended to cedi the attention of the 
NIH Director not just to the "Summary Analysis of Ris)cs" (46 FR 59390) but 
also the motion %#ii(±i originally established the Wor)cing Qroup on Revision 
of the Guidelines, the working Group's agenda, and its conplete report. 
Dr. Talbot as)ced if the motion might not be withdravn, with the assiaremce 
that NIH staff would bring all of these items to the Director's attention 
without the necessity of a motion. Hs. Ring said she would prefer a 
specific motion since the Working Group 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 surnoary infonretion discussed 
be included in the EHrector's preamble. Dr. Nightingale, %fio had seconded 
Dr. Holmes' earlier motion, also agreed. 
Ik*. Wright said that if there were to be a genered statement on risks, then 
it should be made clear industrial problans the RAC is not dealing with, 
so that no one thinks this is a global statement covering both research and 
industrial risks. Ek. Abned suggested that language be inserted indioating 
that the report does not address industrial scale-up. Ek. Bems noted 
that the NIH, on the advice of the RAC, had issued "Physical Contairarent 
Recamendations for large-scale Ubes of Organisms Containing Recombinant 
Dt^ Molecules;" RAC, however, is no longer evaluating mechanical details 
in individual large-scale ipplications. Dr. Eandy opiposed Dr. Ahmed's 
suggestion on the introducti^ of a specific statement on industrial 
considerations as it would dilute the general policy statement. 
Ek. Pinon moved to table the motion; he preferred that OREA bring these 
itere 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 tzble carried. 
After a brief recess. Dr. Kason moved to reconsider the action in order to 
provide the Director with a clear indication of RAC intent. He felt the 
previous vote revol>^ about procedural issues rather than intent. By a 
vote of ten in favor, fou: opposed, and three abstentions, the motion to 
reconsider was adopted. 
( 345 ) 
