3 
follow standard good practice oodes; they are adanant oonoerning adherence 
to the NIH Guidelines. Industry's greatest hesitation concerning adherence 
is the fiTictioning of the raechemism by which NIH will protect proprietary 
infomation. Industry is concerned about who would nake a fin^LL deter- 
mination of what is proprietary information, particularly in Freedom of 
Infomation (FOI) requests. Dr. Milewski explained the procedure by which 
confidential submissions were processed by the NIH under the Voluntary Com- 
pliance Program; Part VI of the Guidelines, Voluntary Conpliance , specifies 
procedures to be followed in the event of an POI request. Dr. McKinney said 
that the NIH review system provides industry with third party review of 
projects. 
FDk Views 
Dr. Henry of the Food eux3 Drug Administration (FDA) said his agency favors 
eliminating the 10 liter limit and supports the proposal to convert the NIH 
Guidelines to a voluntary "code of stiuidard practice." If such changes 
should occur, the FDA would continue product review using current FDA pro- 
cedures, which are directed to thoroughly assessing the safety of the finished 
product. He said FDA possesses the authority to inspect production facil- 
ities, but not to inspect or regulate research facilities. FDA is charged 
with regulating the marketing of many of the products of recombinant DNA 
technology. 
NI06H Views 
Dr. West of the National Institute for Occupational Safety and Health (NIOSH) 
said that the concerns of NIOSH were similar to those of the Occupational 
Safety and Heedth Administration (OSHA) . He said NIOSH will evaluate recom- 
binant ENA technology and the ferrcntation industry in genered. At the moment. 
{ 183 ) 
