12 
Dr. Wai tz said that Section VII-B-3 mandates that aerosol release be prevented 
during sample collection, material addition and culture transfer. He said the 
word "prevents" implies an absolute oondition which at the Pl-LS level is neither 
realistic nor necessary. He suggested that the word "minimizes" be substituted 
for the word "prevents". He suggested this modification would be consistent 
with the intent of this section. 
Dr. Waitz then suggested the Physical Containment Recommendations be incorporated 
into the Guidelines as a new Appendix. He said industry believes this action 
will formalize the Recommendations and provide a more efficient mechanism for 
comment on or modification of the Recommendations. He expressed industry's 
concern that failure to take such action may leave a perceived gap in the 
overall regulatory scheme, thereby encouraging the development of conflicting 
regulatory requirements. 
Dialogue Between Industry and the NIH 
Dr. Waitz said Schering-Plough Corporation, like other industrial organizations, 
has considerable experience in recombinant DNA technology, and believes that 
industry can provide valuable assistance and expertise to the NIH and RAC. He 
said industry welcomes the opportunity to participate and hopes that carminica- 
tion between this committee and industry can be formalized. Cne mechanism of 
formalization is the establishment of an advisory group which would include 
suitable industry representatives and would be available to provide expertise 
to the Large-Scale Review Working Group. Such an advisory group could be a 
primary source of the technical expertise so vital bo the work of the committee. 
He said Schering-Plough Corporation prefers this approach (over a single indus- 
trial representative as had been suggested at a previous meeting) as it is 
MP] 
