6 
Dr. Naacxi said! the use of biotechnology will e)qplode. Although the hazards 
asaociatedi with fermentation technology not be new, the hazards must 
be considered in the context of large nunbers of inexperienced workers. 
Dr. Miller said the situation will be analogous to that faced by FDA with 
generic drug producers. Vhen generic drugs laws changed, the number of 
firms involved in generic production exploded; some c€ these fions did not 
meet FDA specifications and FDA has taken action. FDA clearly has the power 
to regulate the reconbinant DMA products area. Dr. Tolin pointed out that 
FDA's mandate is limited, and many potential products of reccrobinant DNA 
technology may not be subject to FDA regulation. 
Dr. Daniel Liberman of the Nassadiusetts Institute of Tie<hnology said the city 
of Cambridge, Massachusetts reguires health sirveillanoe of worloers using 
recombinant DNA. m his experioice, it is most iiiqportant to define medical 
surveillance. He said the OC/NIOSH reoanmendations are primarily epidemio- 
logical; such a program will protect future generations of worloers but provides 
little or no protection to worloers currently in the field. He then offered 
some criticisms of the CDC/NI06H document. (1) He requested that potentizd 
zmd actual hazards be stated in the doament. (2) He noted that it is the 
"hands-on* worloer, i.e., the labc»nitory researcher, who currently is at 
greatest rialc of exposure. 
Dr. Tblin pointed out that in cxhtrast to chemical exposure where workers may 
acamulate damage, the phenomenon <3f a threshold dosage exists in exposure 
to microbes. A threshold amount of orgwism must be administered in any one 
exposure to cause any effect. 
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