HOWARD W. CANNON. NEV.. CHAIRMAN 
WARREN G.MAGNUSON. WASH. 
RUSSELL B. LONG. LA. 
CRNCST F. HOLLINGS. S.C. 
DANIEL K. INOUYE. HAWAII 
ADLAI E. STEVENSON. ILL. 
WENDELL H. FORD. KY. 
DONALD W. RIEGLE. JR.. MICH. 
J. JAMES EXON, NEBR. . 
HOWELL HEFLIN, ALA. 
BOB PACKWOOD. OREG. 
BARRY GOLDWATER. ARIZ. 
HARRISON H. SCHMITT. N. MEX. 
JOHN C. DANFORTH. MO. 
NANCY KASSEBAUM, KANS. 
LARRY PRESSLER, S. DAK. 
JOHN W. WARNER, VA. 
QlCruieb pieties Senate 
COMMITTEE ON l^fcflCE. SCIENCE 
AND TRANSPORTATION 
Washington. D.C. 20510 
AUBREY L. SARVIS. STAFF DIRECTOR AND CHIEF COUNSEL 
EDWIN K. HALL. GENERAL COUNSEL 
MALCOLM M. B. ST ER RETT. MINORITY STAFF DIRECTOR 
November 21, 1979 
The Honorable Patricia Roberts Harris 
Secretary 
Department of Health, Education, and Welfare 
Washington, D.C. 20201 
Dear Secretary Harris: 
The Senate Subcommittee on Science, Technology, and Space has been deeply 
interested in the progress of recombinant DNA research since our first 
oversight hearings two years ago. We continue to follow developments 
in the field closely, both to help ensure the protection of public health 
and the environment and to facilitate the orderly development of this 
extremely promising technology. 
I understand that the Director of the National Institutes of Health, Dr. 
Fredrickson, is nearing decisions on two important changes in the NIH 
Recombinant DNA Research Guidelines. The first involves the recommendation 
of the Department's advisory committee to remove all but minimal controls 
on experiments using the E. coli K-12 host-vector system. The second 
proposal is to institute a system of voluntary registration of experiments 
by researchers and institutions not now subject to the Guidelines. I am 
writing to urge your careful review of these proposals. 
I am aware that the so-called exemption of E. coli K-12 experiments is 
controversial even within the scientific community. Some researchers 
and others have questioned whether experiments that have been conducted 
to ascertain the risks of K-12 containing recombinant DNA have been either 
conclusive or exhaustive. I do not presume to question the scientific 
judgment of the committee or the Director, but I do wish to call your 
attention to three important procedural issues which deserve consideration 
before a decision is made. First, is it wise to proceed with so significant 
a relaxation of the Guidelines before completion of the risk assessment 
studies, many of them relating specifically to K-12, outlined by the NIH 
in its Federal Register notice of September 13, 1979? Secondly, does the 
brief experience under the revised Guidelines justify confidence in the 
willingness and ability of local institutional review committees to 
maintain the laboratory standards and practices which the RAC believes 
should still be followed? Finally, if the Director's recommendation differs 
from the RAC's proposal, should there be another opportunity for public 
comment and departmental review? 
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