3 
is biological oontainraent, and the third is medical surveillance for a number 
of years sufficient to detect problems. He emph^isi 2 ed that vrod^rs may have 
little experience and training with reccmbinant DNA and medical surveillance 
of workers is sin(>ly prucSent medical practice in ^d.l neu technologies. 
Dr. landrigan then introduced Mr. Elliott. Mr. Elliott said the six walk- 
throughs in which he had participated were one or two day visits. Three of 
the six fims have extensive experience in fermentation technology. These 
firms have ettensive ocmprehensive medical safety and health programs. Sane 
of the firas have more extensive medical surveillance programs than that out- 
lined in the CXC/NIC6H document. Three firms new to the field had not develcped 
comprehensive programs} indeed one of the firms had no safety program. This 
firm believed that a safety progron was not necessary as their emp3loyees are 
Eh. Da who should have been exposed to good work practices through education. 
In summary, an enormous gap in sophistication in safety controls and medical 
surveillance exists between the three experienced canpanies and the three 
new canpanies. Mr. Elliott noted that five of the cxmpmnies followed the 
NIH Physical Containment Recamendations for Large-Scale Uses of Organisms 
Containing Reccmbinant DA Molecules (45 PR 24968). These five conpmnies 
ccnplied with the NIH Guidelines for Research Involving Recombinant DtA 
Molecules. The sixth canpany did not; they had no medicud. surveillance 
program, and did not follow the NIH Ehysical Oontaiment Reccmmendations 
for large-scale Ubes of Organisms Containing Recanbinant DA Molecaoles. 
cr. Mason conmended the NI06H effort in evalimting medicml surveillanoe in 
recombinant DA. He asked whether envirormental surveillance e.g., air 
sampling, had been ocxisidered, or periodic culturing to determine if wDr)cers 
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