15 
o Sterilization of wastes prior to disposal; 
o Chcdlenge and validation of safety procedures; 
o Use of a«cocnting systems for. biolog icedly active products consistent 
with good laboratory practices and good manufacturing practices; 
o Health nonitoring programs; and 
o Careful design of procedures and equipment to minimize the possibility 
and effects of himan error. 
Dr. Fildes said some of these practices result frcm regulations to which industry 
is subject. Others result from compliance with the NIH Guidelines and from 
concern for worker and erwiroanental safety. Finally, certain practices result 
from the knowledge gained from extensive experience in the fermentation of 
antibiotics and other biochemicals. 
Dr. Fildes said experience has indicated that the present Ihysical Oontairment 
Recomrendations for large-Scede Uses of Organisms Containing Reconbinant DN^ 
Molecules are reasonable and workable, althoo^ quite stringent for work at the 
Pl-LS level. The desi^ requirements in the Recommendations are sensible and are 
consistent with other regulations relating to the manufacture of products for 
use with hunan subjects. Vtiile it has not ^t been a problem 6or IBA members, 
potential difficulties may arise from the requirement in Section VII-B-2 of 
the Recommendations. This requirement specifies that all reconbinant micro- 
organisms must be inactivated before the pr inary contairment system is opened, 
and it may be very difficult in some processes to do so without compromising 
the product. 
[501] 
