5 
Liaison Group, FDA has agreed under recently published guidelines ( Federal 
Register , March 28, 1980, pages 20638-20641) to make such information available to 
the other agency. However, The Food, Drug and Cosmetic Act prohibits disclosure 
j of proprietary information outside of the Department of Health and Human Services. 
Report from NIQSH 
i 
At the previous Subcommittee meeting, Dr. Robbins distributed the report of 
a NIOSH walk-through survey conducted at Eli Lilly and Company Research Laboratories. 
He now distributed the reports of NIOSH walk-through surveys conducted at Genentech, 
Inc., South San Francisco, California, on April 8, 1980 (Attachment C), and at Cetus 
Corporation, Berkeley, California, on April 9, 1980 (Attachment D). A fourth survey 
at Burns-Biotec Laboratories, Inc., Elkhorn, Nebraska, on November 24, 1980, has 
been completed; the report is not yet available, although Mr. Elliott and 
Mr. Pauker described to the Subcommittee some of the findings. They said the 
walk-through survey was much more informative when the NIOSH team: (1) had 
received, prior to the visit, copies of the proposal to exceed 10 liters in volume, 
which the company had submitted to the NIH Recombinant DNA Advisory Committee; and 
(2) observed, during the visit, an actual production run. NIOSH may do follow-up 
■ 
surveys at Eli Lilly and Genentech to observe a production run and product 
purification steps. Mr. Pauker noted that there were differences in approaches 
at different companies in such areas as the physical set-up of the production 
|Unit, operational protocols, use of control technology, handling of exhaust air, 
jemployee health system, policy for workers receiving antibiotic therapy, and 
i 
| emergency plans. 
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