Dr. Donald S. Fredrickson 
November 3, 1980 
Page 2 
Also, the recommendations made by Dr. Maxine Singer 
and Dr. Gottesman during the September RAC meeting, 
which were favorably considered, are indicative of 
the growing feeling of confidence expressed by 
responsible scientists in the day-to-day conduct of 
recombinant DNA research. The acceptance of these 
recommendations indicates a decreased desire for RAC 
oversight and greater reliance by RAC on IBC's. 
(2) It does not appear desirable to create a new sub- 
committee with representatives from a half dozen 
regulatory agencies to complicate the review process 
applicable to large-scale protocols. The proposed 
activities of the subcommittee would certainly dupli- 
cate in part the functions of the Federal Interagency 
Advisory Committee on recombinant DNA research (which 
incidentally has an Industrial Practices Subcommittee). 
The agencies listed as participants in the proposed 
subcommittee are usually present at RAC meetings as 
observers. In addition, industrial applications of 
recombinant DNA technology are by statute subject to 
the laws these agencies administer, £.£. , the Federal 
Food, Drug, and Cosmetic Act for pharmaceutical 
products, the Occupational Health and Safety Act for 
worker safety, and a number of other Federal acts 
administered by the EPA. 
No evidence is presented which points toward the 
need for evaluation of the performance of IBC’s 
which consider large-scale recombinant DNA appli- 
cations. Evaluation, audit, performance standards, 
inspection, or other oversight procedures for IBC's 
should be considered only after a full discussion by 
the RAC of the need for such procedures for all types 
of recombinant DNA research activities. It is our 
understanding that the situation in California which 
may have prompted the RAC's concern did not involve 
a failure to act by the IBC but a failure to adhere 
to communication procedures by staff personnel. 
For the reasons noted above, the creation of the subcommittee as 
proposed will result in duplication in existing oversight and 
advisory mechanisms; for example the RAC has already approved 
large-scale guidelines (Part VII) in addition to an existing 
working group on large-scale recombinant DNA activities. The 
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