17 
ayDout unnecessary disclosure of proprietary infiomation; these concerns may be 
a problem with an IBC. The IBA believes that these internal safety conmittees 
are a good example of a useful addition bo IBC review; an addition that can 
inprove the overall monitoring process. General safety committees are industry 
practice now and, are useful not only to supplement IBC review but are also 
valuable in assessing and controlling safety r isles of a more general nature. 
Such cormittees might typicedly review the use of flammable solvents, the 
design and safety of particular itans of equipment, fire safety, emergency 
procedures and similar safety issues. Because of IBA views on the safety 
of recombinant CNA research per se, many IBA members see the conventional 
safety issues as the more si^ificant ones to be aissessed and controlled. 
Dr. Fildes said the IBA has no problems with 10 liter volumes being the 
boundary between large and small scale experiments. The IBA does feel that 10 
liters is an arbitrary boundary and certainly does not reflect industry practice. 
Most industrial pilot plant derations, for exanple, occur at the 250-3,000 
liter size. As addition^d experience is accumulated with industrial applications, 
the IBA feels the conmittee will find it logicaQly conpelling bo adjust the 
large-scale tlxreshold upward. 
Virtually adl IBA n«nbers have instituted medicad surveillance programs. Common 
bo most of these programs are medical check-up», storage of serum samples, and 
follcw-up in cases of extended or serious illnesses. The IBCs are charged 
with reviewing medical monitoring programs as part of their responsibility 
ux3er the Guidelines, and existing medical surveillance programs can be supple- 
mented by the IBC for particular expar iments . Thus, if any spacial require- 
ments are appropriate for a particular procedure, the IBC can require special 
[503] 
