Dr. Logan of OSHA opined that prior review of physical facilities serves 
an important function. He said the legal counsel of the Department of 
Labor (DOL) believes that OSHA does not have the authority to conduct 
such prior review. He further stated that the Federal Interagency Advisory 
Committee on Recombinant ENA has no mandate to conduct this type of prior 
review. He said that if the RAC does not accept Dr. Krimsky's proposal, 
large-scale prior review of physical facilities will not occur. Q:. Berns 
asked if representatives of the various federal agencies would be able 
to legally vote in the proposed subcommittee. Dr. Logan said the legal 
counsel of the Department of Labor would have to determine the propriety 
of OSHA participation. Dr. Gottesman reminded the Committee that under 
the proposal previously voted, the RAC will continue to review biological 
aspects of applications. Dr. Ahmed said that while he personally did 
not wish to participate in the review of confidential material, he thought 
the prior review system was valuable. He supported Dr. Krimsky's proposal. 
Dr. McGarrity asked hew other federal agencies view recomb inant DNA experi- 
ments and products. Er. Miller of FDA said it is likely there will be 
some linkage between the FDA product approval process and compliance with 
other federal guidelines, including the NIH Guidelines for Research In- 
volving Recombinant DNA Molecules. Dr. Logan said that NIOSH and OSHA 
were working closely to develop a plan for possible regulation, or at 
least procedures to protect safety and health. 
Dr. Campbell said that the RAC has certain responsibilities. Che such 
responsibility is to set and to revise standards, e.g., what constitutes 
Pl-LS. A second responsibility is to monitor the functioning of the 
system. He said he would support Dr. Krimsky's proposal if the subcom- 
mittee was constituted to gather information and to advise RAC on large- 
scale technology, but not to perform review of individual projects. 
Dr. Gottesman moved that the motion be amended to read as follows: 
"An industrial review subcommittee of the RAC shall be esta- 
blished with the responsibility for advising the full RAC 
on procedures and facilities design pertaining to applica- 
tions for large-scale operations. The subcommittee shall 
invite participation from NIH's biosafety staff plus OSHA, 
NIOSH, CDC, EPA, and USDA." 
The subcommittee would not review individual proposals, but would review 
standards. Dr. Berns suggested that Dr. Gottesman' s proposed language be 
amended to change the name of the subcommittee to the "Large-Scale Review 
Subcommittee." Dr. Gottesman accepted this amendment. Mr. Thornton asked 
Dr. Krimsky if he would accept Dr. Gottesman 's amended language a£ an 
amendment to his original motion. Dr. Krimsky declined. Instead, 
Dr. Krimsky moved to amend Dr. Gottesman' s amendment to read as follows: 
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