9 
Dr. Logan said that the apparent belief of some RAC members that 
OSHA and NIOSH can certify proposals before they are instituted is a 
misconception. He thought the RAC's proposed change in procedures for 
review of large-scale proposals should perhaps be discussed by this 
Subcommittee, which could consider making a formal recommendation to 
the RAC. Dr. Lewis said he felt that most of the RAC members did not 
have a misconception of OSHA's authorities. He noted that the motion 
passed by the RAC specifically names the Institutional Biosafety Committee 
as responsible for monitoring adherence to the specified containment level, 
and that words dealing with regulatory processes and regulatory agencies 
were specifically deleted from the motion before passage by the RAC. 
Dr. Omenn noted that the RAC has a tradition of relying on IBCs for 
monitoring, and said he felt that this Subcommittee need not deal with 
the issue at this time. 
Report from NIOSH 
Dr. Robbins discussed his June 11 memorandum to Dr, Omenn (appended 
as Attachment C). He said that NIOSH will continue looking at the eight 
items cited in the memorandum, i.e., physical containment design (e.g,, 
fermentors); engineering controls (e.g., ventilation, filter of exhaust 
gases); work practices (e.g., operational protocols, clothing and hygiene 
requirements); validation procedures (e.g,, sterilization and fermentor 
containment); emergency procedures (e.g., spills); environmental monitoring 
medical surveillance (e.g,, serum samples for serologic changes, monitor 
possible physiologic changes related to product exposure); and worker 
education. At the next Subcommittee meeting, a progress report will 
be presented. In developing that, NIOSH may be calling on 
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