Page 2 of Attachment C 
Page 2 - Dr. Gilbert S. Omenn 
5) emergency procedures (e.g., spills) 
61 environmental monitoring 
7) medical surveillance Ce-g-, serum samples for serologic changes; monitor 
possible physiologic changes related to product exposure) 
8) worker education 
It will be necessary to request directly from the companies proposing work, 
those submissions which have been made under the NIH voluntary compliance 
program (J5ee Attachment) . These submissions describe the design of the 
physical containment facilities, work practices and biological systems 
which are intended to ensure safe operation of the production process. 
As NIH can attest, adequate safety evaluation is impossible without this 
information. 
In order to support our evaluation, we will seek information about 
fermentation processes which use similar equipment to that proposed for 
recombinant DNA fermentation application. Data obtained on fermenter 
reliability and effectiveness, accidents and possible routes of exposures 
should help us to determine whether potential health hazards in other 
biotechnology applications need assessment. 
Appropriate medical surveillance has been discussed by different groups. 
The Recombinant DNA Advisory Committee has discussed the need for medical 
surveillance and NIOSH has been asked for recommendations by some of the 
companies we have visited. The varied nature of proposed host-vector 
systems and the multitude of possible biologically active products and 
byproducts make the determination of appropriate and effective medical 
surveillance a complex issue. To help address this need, NIOSH, together 
with other CDC experts in infectious disease, epidemiology and molecular 
biology will expeditiously develop guidelines for medical surveillance 
techniques. 
It would be helpful if those companies proceeding with "large-scale" 
recombinant DNA applications inform NIOSH, so that the Federal agencies 
charged with the protection of public health will have basic information 
upon which to act in the event hazards unexpectedly emerge. This notifica- 
tion to NIOSH should at a minimum contain the name and location of the 
company, the host-vector system utilized, and the product which will be 
produced. The companies should also maintain internally complete records 
of their projects. The records should detail such information as the 
biological system, physical containment level, design and configuration, 
and identification of workers with their time associated with the projects. 
It is important to bear in mind that the retention of this type of 
information by the companies should not be unduly burdensome, because they 
would invariably be needed for the project development. This information 
would be necessary to evaluate any hazards which might unexpectedly emerge. 
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