HOWARD W. CANNON", NCV.. CHAIRH* 
WARRtfJ G. MACNUSOH, WASH. 
RUSSELL B. LONG. LA. 
ERNEST F. ROLLINGS, S.C. 
DANIEL K. INOUYE. HAWAII 
AD LAI E. STEVENSON. ILL. 
WENDELL H. FORD, KV. 
JOHN A. DURKIN, N.H. 
EDWARD ZORINSKY, NEBR. 
DONALD W. RIEGLE. JR.. MICH. 
JAMES B. PEARSON. KAN. 
ROOERT P. GRIFFIN. MICH. 
TED STEVfE^S. ALASKA 
BARRY GffLDWATER, ARIZ. 
BOB PACKWOOO. OREG. 
HARRISON H. SCHMITT. N. MEX. 
JOHN C. DANFORTH, MO. 
'UlCmfeb Genetic 
COMMITTEE ON COMMERCE. GfclCNCB. 
AND TRANSPORTATION! 
AUBREY L. SARVIS, STAFF DIRECTOR AND CHIEF COUNSEL 
EDWIN K. HALL, GENERAL COUNSEL 
MALCOLM M. B. STERRETT. MINORITY STAFF DIRECTOR 
Washington. D.C. 20510 
October 13, 1978 
The Honorable Joseph A. Califano 
Secretary 
Department of Health, Education 
and Welfare 
Washington, D.C. 20201 
Dear Mr. Secretary: 
I have received your reply of September 12 to the June 1 inquiry of several 
Senators regarding the use of existing statutory authorities, especially 
Section 361 of the Public Health Service Act, to regulate recombinant DNA 
research. I am writing to support your call for new legislation and to 
recommend several changes in the proposed revised NIH guidelines. 
As you know, the Senate Subcommittee on Science, Technology and Space recently 
issued an oversight report, "Recombinant DNA Research and Its Applications," 
in which the majority observed that, in view of the nature of the concerns 
about recombinant DNA techniques and the history of Section 361, the absence 
of evidence that the products of the research can cause human disease is not 
a conclusive argument against the use of that authority. Neither your reply 
nor the March 1977 report of the Federal Interagency Committee on which you 
rely addresses these points. Nevertheless, I respect your desire for a 
specific legislative mandate and accept your decision not to invoke Section 
361 except in the unlikely event of a demonstrated health emergency. 
I find more puzzling your observation that the Food and Drug Administration 
does not have authority to impose any requirements on recombinant- DNA 
research since it has not yielded any products subject to FDA regulation. 
In your letter to me of February 27, 1978, you stated that FDA ". . could, 
under existing authority, require any firm seeking approval of a product 
which may be the end product of recombinant DNA research to certify to the 
Agency that it has complied with the NIH guidelines on recombinant DNA." 
While FDA may not be able to monitor research in progress, such Regulations 
as you described in your earlier letter would at least put firms on notice 
that noncompliance with the guidelines would be grounds for the agency's 
withholding approval of a product of that research. The recent successful 
[A-414] 
