6 
of live vaccines to the population. This projected application will create a 
great deal of pressure on the preposed oversight scheme. 
Dr. W&lters said as a private citizen he felt the proposed review mechanism 
presents a great danger of fragmentation in cversight of recombinant ENA tech- 
nology and an eventual loss of oversight. He felt a centralized oversight 
structure would be far more effective and efficient than the preposed loose 
federation of agency advisory ccnmittees. 
Dr. Walters said a sense of continuity is necessary if an expanded oversight 
scheme is to work. A successful oversight scheme would require an experienced 
staff, an institutional memory, and dedicated committee members. The preposed 
loose federation of agencies cannot provide all of these necessary components, 
nor can it provide the press and public a single focus for biotechnology over- 
sight. 
Dr. Walters said the December 31, 1984, Federal Register does not consider the 
role of the public. Many of the questions facing society in the application 
of this technology have a moral and ethical component as well as a scientific 
component. Any proposed oversight scheme should incorporate societal value 
judgments. The cversight committees should function to the extent possible in 
the public arena, and members representing the public should be part of any 
committee. These oversight committees should also play a role in public 
education. If the oversight system for biotechnology is decentralized and 
goes underground, the public will be confused and suspicious. 
Dr. Walters said under the proposed oversight scheme, problems may arise with 
proposals which do not clearly fit under the purview of a single agency. If 
proposals are submitted to a central review body which might forward the pro- 
posal to working groups for consideration, this type of proposal will not 
present a difficulty. 
Dr. Walters added that Occupational Safety and Health Administration (OSHA) 
does not offer a policy statement in the December 31, 1984, Federal Register ; 
this agency should participate in any consideration of oversight of biotechnology. 
Dr. Walters offered an alternative oversight scheme. He suggested the creation 
of a "third generation" RAC. This RAC would be essentially the current RAC 
with supplementation of expertise in areas such as ethics, public policy, and 
science. An oversight committee must have representation in these areas to 
permit a broad evaluation of proposals. A subcommittee /working group structure 
such as that used by the current RAC could provide additional expertise in areas 
where the "third generation" RAC's expertise is not of sufficient depth. The 
"third generation RAC" might be situated in the Office of the Secretary of 
Health and Human Services. This cormittee should be prepared to report its 
activities to Congress and the public. 
Dr. Pirone said the US DA policy statement in the Federal Register announcement is 
reasonable. He said the Federal Register announcement does not, however, address 
the question of what constitutes agricultural research and what constitutes 
agricultural application. The December 31, 1984, Federal Register simply indi- 
cates NSF will review "environmentally- related" proposals when testing begins 
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