MINUTES OF MEETING - June 5-6 
7 
Dr. Fredrickson said that a proposed alternative method of reviewing 
industrial applications, where subsequent to the RAC setting a P-LS level 
of biological containment, the Director, NIH, would select a panel of con- 
sultants for the purpose of evaluating the details of a company's physical 
containment is, in his opinion, not appropriate. 
Dr. Parkinson said that state OSHA authority extends to university labor- 
atories as well as to industrial workplaces. He said he saw no point in 
visiting a work place if worker safety is not evaluated. Dr. Krimsky 
asked Dr. Fredrickson whether the NIH has a role, under the voluntary 
compliance program, in establishing more rigorous standards of keeping 
health data in industries. Dr. Fredrickson replied that the Industrial 
Practices Subcommittee of the Interagency Committee is considering this 
issue. 
Following Dr. Fredrickson's departure, Dr. Gartland reviewed the history 
of the NIH voluntary compliance program. He said that at the time the 
December 1978 NIH Guidelines were issued, the Food and Drug Administra- 
tion (FDA) announced its intent to propose regulations for recombinant 
ENA research in the private sector. In February 1979, the RAC unanimously 
approved interim procedures for reviewing large-scale applications. In 
May 1979, the RAC was briefed on procedures for the protection of proprie- 
tary information, and a working group was established to examine physical 
containment requirements for large-scale experiments. Responses to the 
FDA's notice of intent to propose regulations questioned the agency's 
legal authority to regulate in this area. In view of these comments, the 
Director, NIH, and the Commissioner, FDA, developed a draft supplement to 
the NIH Guidelines that would extend the Guidelines on a voluntary basis 
to industry. On July 16, 1979, the Federal Interagency Advisory Committee 
on Recombinant ENA Research, which includes all relevant federal regula- 
tory and research agencies, unanimously agreed that NIH should publish 
for comment this proposed supplement to the Guidelines. In September 
1979, the RAC recommended incorporation of the supplement into the Guide- 
lines. The supplement was then published in the November 30, 1979, 
Federal Register for thirty days of additional comment. The revised NIH 
Guidelines, promulgated in January 1980, incorporated thv supplement as 
Part Six, "Voluntary Compliance." The RAC, at the September 1979 meeting, 
also accepted a report of the working group on large-scale procedures. 
This report specified application procedures for large-scale experiments, 
including the types of information to be submitted for review, and a 
statement regarding confidentiality. In September 1979, the RAC went 
into the first closed session to review proprietary information. In 
December 1979, the RAC agreed to review the voluntary compliance program 
at its June 1980 meeting. Draft guidelines for large-scale physical con- 
tainment were also reviewed. The Federal Interagency Advisory Committee, 
in February 1980, recommended the establishment of an Industrial Practices 
Subcommittee to consider what steps, if any, beyond the NIH Guidelines, 
need to be taken regarding occupational health and industrial production 
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