MINUTES OF MEETING - March 6-7 
29 
I 
i 
- 
Barkley, and Johnson described the program including annual physical exam- 
ination and serum collection. 
i 
Dr. Parkinson asked if any environmental monitoring procedures had been 
implemented in the plant. Mr. Young replied that during operation of 
the 150-liter fermentor, a monitoring program measures both the exhaust 
gases of the fermentors and the roan environment twice a week. He said 
these operations were initiated in October 1979, and no recombinant organ- 
isms have been found to date. Dr. Goldstein asked how frequently the 
fermentors are used. Mr. Young replied that these fermentors were cycled 
at the rate of four harvests per week. Dr. Young asked if either concen- 
trated air samples or plate samples are examined in the survey. Mr. Young 
said both types of collection were used. Dr. Baltimore asked how negative 
pressure in the fermentors was maintained. Mr. Young replied that a 
vacuum source and a built-in sensor control unit maintain negative pressure. 
Dr. Parkinson asked whether worker education manuals dealing with emer- 
gencies or with other potential health-related hazards are available in 
the plant. Dr. Walters said emergency procedures are specified in the 
documentation provided to the group by Eli Lilly. In addition, a detailed 
manual for recombinant DNA projects, including emergency procedures, was 
available. 
Dr. Krimsky asked if the group considered it essential that RAC represen- 
tatives inspect industrial facilities. Mr. Thornton replied he believed it 
important that the Director of NIH have the right to designate representa- 
tives to visit an industrial site. He recommended that this procedure be 
continued with other large-scale approvals, not that an inspection would 
necessarily occur in every case, but that NIH has the authority to do so 
by consent of the company making the application. Dr. Baltimore agreed 
with Mr. Thornton's position and asked whether the group felt that the 
large-scale standards should be flexible. Dr. Walters replied that the 
revision of the draft standards included a shortening and a simplification. 
Dr. Goldstein pointed out that a difference between GMAG and the RAC is 
that ®1AG has labor and worker representatives. Dr. Parkinson said those 
who had gone on the January 28 visit demonstrated naivete of the industrial 
world, and that he had never yet cone across non-unionized workers who are 
prepared to make aggressive statements about their workplace conditions. 
Dr. Baltimore said the January 28 visit was not intended to be a regulatory 
inspection. 
XXI. CONTAINMENT STANDARDS FOR LARGE-SCALE RESEARCH AND PRODUCTION 
Dr. Walters noted that tab 862 is a revised draft of the proposed physical 
containment standards for large-scale work. He then introduced Dr. Burnett 
Barkley who reported on comments received (tab 835-840, 850, 851, 861) 
[ 64 ] 
