The Honorable Joseph A. Califano 
October'13, 1973 
Page 2 
laboratory production of human insulin by recombinant DNA techniques, 
although far from commercialization, suggests that the time is appropriate 
to issue these regulations, as do the comments of Eli Lilly Company to 
Dr. Fredrickson on the proposed revised guidelines. Lilly states, "Recom- 
binant DNA technology is progressing rapidly from a laboratory phenomenon 
to developmental activities. The necessity for conducting scale-up experi- 
ments (greater than 10-liter volumes) is imminent." 
The fact remains, however, that FDA action will not suffice to put all recom- 
binant DNA research on the same regulatory footing. The provision of the 
proposed revised guidelines which would extend their coverage to privately 
supported research in institutions receiving NIH funds for RDNA work is a 
significant step in that direction, although, as I suggest in my comments on 
the revisions, it should be broadened to include all recombinant DNA research 
at institutions receiving any NIH funds. 
Presumably, this extension of the guidelines' coverage will encompass some 
but not all of the research supported by Federal agencies other than NIH. 
You state in your letter that the Interagency Committee has "served to 
ensure a commonality of standards" among Federal agencies sponsoring recom- 
binant DNA research, but it is my understanding that the Committee has not 
met in nearly a year. The Federal Register documents relating to the proposed 
revised NIH guidelines contain no indication that such agencies as the 
Departments of Energy and Agriculture, the Veterans Administration, and the 
National Science Foundation are prepared to adopt the revisions and require 
compliance with them. A survey of these agencies by the Subcommittee indi- 
cated that their procedures for monitoring compliance with the 1976 guide- 
lines vary enormously; some have procedures comparable to those of NIH while 
others rely on informal assurances by investigators. In the case of the 
Department of Energy, responsible agency officials were not even aware when 
I wrote in March of recombinant DNA projects that were under way in a 
national laboratory under the Department's jurisdiction. Before the final 
revised guidelines are issued, I urge you to obtain the agreement of these 
agencies to follow the review procedures for NIH grantees, including requiring 
submission of the appropriate information to the Office of Recombinant DNA 
Activities. 
The proposed voluntary registration system is a useful but limited addition 
to the guidelines. It will facilitate consultation between NIH and private 
sponsors of research, but apparently it does not resolve their concerns about 
the disclosure of proprietary information. Indeed, Section IV-C-4 of the 
revisions encourages private firms to "consider applying for a patent before 
[A-415] 
