5 
Dr. Levin questioned v#)ether the CDC/NIOSH report should address only recom- 
binant OJA practices; worker safety and fennentation technology in general 
might be evaluated. Q:. Bems said the Imrge-Scale Review Working GToup had 
requested a report deeding with recxmibinant ENA issues. 
Or. Miller of the PDA's Bureau cf Drugs reiterated that the NI06H report 
should not focus on reooitbinant ENA. He said singling out reconbinant ENA for 
medical surveillanoe is gratuitous and baseless. He attacked the report as 
unnecessary and flawed. He questioned the cost effectiveness of holding 
large nuiherB of senjn sonples. He also questioned the advisability of 
evaluating in/dequately explained absences from work of 48 hours or longer 
as suggested by the CDC/^I06H document. Cr. Bems said the definition of 
the tern "adequate* would determine how many absences would be investigated. 
cr. Mason again comended Dr. lamdrigan and his group on their initial efforts 
in evaluating medical surveillance in fermentation technology using recombinant 
DNA technology as a model. Cr. Richardson also supported Cr. landrigan's 
use of recombinant ENA technology for evaluating issues in fennentation 
technolcigy. 
Cr. Logan suggested that it is appropriate to oonslder recombinant ENA tech- 
nolcsgy as a distinct subset of fermentation technology; recombinant DNA 
technology will produce potent products, many of vhich cannot be produced in 
any other way, and it can provide large anoints of these produchs. Medical 
serve il lance is necessary in these product areas. Cr. Landrigan's report is 
necessary and highly appropriate. 
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