6 
explicit statement to that effect. Dr. Baltimore said that if RAC felt it 
MBS necessary, he Mould support an enendment to the Decentser 4 , 1981, 
proposal to acoonplish that aim. 
Finally, Dr. Bedtimore suggested the language of Section InA might be 
■odified to include a strong statement that although voluntary, adherence 
to the Guidelines is strongly reconmended. He said the December 4, 1981, 
proposal with these amendments would be responsive to corments received. 
He then mcved the proposal appearing in the December 4, 1981, Federal 
Register (46 FR 59368) eis an item for discussion. The motion was seconded 
by Dr. MoGarrity. 
Dr. Baltimore made an additionad statement in response to certain written 
ccnments received. He said that he has never hidden his affiliation with 
the oonp3any. Collaborative Reseaurdi, of Wad them, Massachusetts. He stressed, 
however, that if he were acting for the compjany, he would not be supporting 
the December 4, 1981, pxroposad because he said it is not in the interests 
of amy institution in the Boston area, as it might lead to nore stringent 
regulation at the locad level. He said he supported the December 4, 1981, 
proposal because he believes it is correct. 
Dr. Nightingade said that letters conmenting on the prcposads indicate 
many remaining concerns in both the scientific au^d public sectors. In her 
view, these concerns are not adequately addressed by the December 4, 
1981, prcposad even if that proposal were modified as just suggested by 
Dr. Badtinore. 
Dr. Nightingade said that there is not a clear consensus for eliminating 
the mandatory nature of the Guidelines or eliminating the requirement 
for IBCs. She said the issue of scale-up needs further discussion. She 
expressed the belief that removing the n^uvdatory nature of the Guidelines 
would stimulate a variety of legislative actions across the country, possibly 
resulting in regulatory variation from location to location. She adso 
suggested that although the probability of an event with disastrous 
consequences is v^ry small, one must acknowledge that gaps in scientific 
knowledge exist; if such a very rare event should occur, there could be 
tremendous backlash against the scientific canmxiity. 
Dr. Nightingale said the December 7, 1981 (46 FR 59734, fert 7, •'Gottesman" ) , 
proposal would simplify the Guidelines and remove nany restrictions. 
Dr. Nightingade said she had a list of at least six ways in which the 
Gottesman proposal could be further simplified, and restrictions further 
rancved, by the next RAC meeting. Dr. Nightingade then moved acceptance of 
the December 7, 1981, "Gottesman" proposal as a substitute motion with a 
conmitment to oontirue to review, reorganize, simplify, and remove restric- 
tions from the Guidelines as expi^itiously as pxssible. cr. Fedoroff 
seconded the motion. 
Dr. Bems said that the current Guidelines are cumbersome and ocmplex. The 
RAC has severad options. The most significant issue is the mandatory nature 
of the Guidelines. He thought having IBCs is good, and reconmended keeping 
the RAC. He stated a preference for readily understandable Guidelines. 
[ 335 ] 
