WARREN O. MAGNUSON, WASH.. CHAIRMAN 
HOWARD W. CANNON. NEV. 
RUSSELL B. LONG. LA. 
JAMES B. PEARSON. KANS 
ROBERT P. GRIFFIN. MICH 
TED STEVENS. ALASKA 
BARRY GOLOWATER. ARIZ. 
BOB PACKWOOO. OREG. 
HARRISON H. SCHMITT. N MEX. 
JOHN C. OANFORTH. MO. 
ERNEST F. HOLLINGS. S.C. 
DANIEL K. INOUYE. HAWAII 
AOLAI E. STEVENSON. ILL 
WENDELL H. FORD. KY. 
^Cmied -Sialcs J&cruxle 
JOHN A. DURKIN. N.H . 
EDWARO ZORINSKY. NEBR. 
DONALD W. RIEGLE. JR.. MICH 
JOHN MELCHER. MONT 
COMMITTEE ON COMMERCE. SCIENCE, 
AND TRANSPORTATION 
Washington. D.C. 20510 
November 30, 1977 
Dr. Donald S. Fredrickson 
Director 
National Institutes of Health 
Department of Health, Education 
and Wei fare 
9000 Rockville Pike 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
Thank you for participating in our Subcommittee hearings on the 
regulation of recombinant DNA activities. Your testimony, responses 
to questions, and information to be supplied for the record will be 
very helpful in formulating recommendations for legislation and the 
administration of existing statutory authorities. 
In that connection, I would appreciate your commenting further on four 
issues related to the unauthorized use of a plasmid vector by 
researchers at the University of California at San Francisco. These 
questions underscore the need for greater accountability in the present 
or any future system of regulation. 
First, the UCSF incident demonstrates the difficulty of establishing 
responsibility when procedures are uncertain and communication is 
lacking. As you pointed out in your testimony, the language of the 
NIH guidelines is misleading in failing to mention the role of the 
Director in the certification of EK2 and EK3 vectors. Some kind of 
formal notification to researchers might have compensated in part for 
this oversight. Drs. Boyer and Rutter testified, however, that the 
certification of plasmids "... was never made known to us in any 
form of writing. It was all by word of mouth." 
The Subcommittee has received numerous assurances that the procedure 
is now much "tighter" and "more businesslike." Does this mean that, 
apart from the proposed revisions recently circulated for comment prior 
to their adoption, researchers have been informed in detail about the 
process and criteria for certifying vectors? Are applicants for 
approval of these plasmids now informed in writing of actions by the 
Advisory Committee and by the Director? Are other interested 
researchers formally notified when a vector has been certified? What 
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