of compliance including creation of institutional biohazards committees 
and memoranda of understanding and agreement (assurance of familiarity 
and compliance with the Guidelines) and subsequently requiring prior 
approval from NIH for all new, or continuing research activities 
involving recombinant DNA technology. ORDA also developed procedures 
designed to facilitate processing of the documents by NIH staff. 
Dr. LeRoy Walters (RAC) then described the proposed changes 
in the Roles and Responsibilities section. The RAC recommended 
that; 1) institutional biohazards committees include individuals 
who represent community involvement 2) institutions with P3 and P4 
level experiments appoint a biological safety officer who would have 
oversight functions, 3) certification of host-vector systems proceed 
through a mechanism including review by an expert subcommittee of the 
RAC, concurrence by the RAC, and final approval by the Director, NIH, 
who would have ultimate responsibility, and 4) an administrative 
mechanism be developed * for exemptions to the Guidelines in which 
a procedure similar to certification would apply. In discussion 
with members of the DAC, Dr. Walters indicated that the Guidelines 
do not address the question of voluntary compliance for non- 
governmental funded research. 
The public witnesses addressed the issue of enforcement. 
Representatives of the AFL-CIO indicated that although the Guidelines 
have set standards for good personnel practices, they believed 
that the Occupational Safety and Health Administration (OSHA) had 
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