Stat«Univ«r«ity of New York at Buffalo 
BIOeATETY COMMITTEE 
Jamueiry 29, 1982 
Willie J. Gartland, Jr., Fh.D. , Director 
Office of Reoanbinant IKA Activitiee 
Nationed Institutes of Heedth 
B uildin g 31, Roon 4A52 
Bethesda, Maryland 20205 
Dear cr. Geurtland: 
I an writing in response to the two main p^opoe^ds presently being 
considered as a revision of the "NTH Guidelines for Rese 2 u:ch Involving Reccn- 
binamt ONA Molecules". I have spoken with a few menbers of our Bioeadety Ocn- 
mittee and with physicians in the aurea who are experts in infectious diseases. 
M/ feeling is that the RAC proposal may involve a greater change 
than is wise at the present time. The establishnent of the local IBC and 
guidelines for conducting research with reocnbinant CNA have been useful. If 
a looad institution is not required to have an IBC or a Biological Sadety Offi- 
cer there may be no one to TBvieu or supervise aurtivities or to periodicadly 
ronind individual investigators what a code of good praKrtioe shoidd be. When 
guidelines are established, but not made mandatory, then less attention is 
given to them, more caurelessness follows, amd less oonoem %d.U be devoted to 
avoiding and repor t ing accidents. I believe that guidelines for adl micro- 
organisms (as proposed by CDC) could be made mandatary by a local IBC as a 
useful safety regidation. This requirement would be more effective than a 
voluntary code of good practioe. 
My greatest oonoem about the RAC proposal involves the plan to 
eliminate prohibitions. The message that %rill oome across at the locad level 
is that the guidelines auxl all prohibitions -have been abolished; the adronish- 
ments not to do experiments involving drug resistant traits and toxin genes will 
be lost and forgotten. At the very least these latter types of experiments 
should be highlighted, reviewed, approved and supervised by a local IBC, pre- 
ferably with RAC review and NIH approval as stated in the Gottesman propx3saLl. 
In conclusion, I would favor the Gottesman proposal, particularly 
because of the statement on prohibitions (Section I-O) £uxi secondly, to recog- 
nize the present need to oontinue mandatory guidelines and the local IBC. 
Best wishes in your attenpt to resolve these issxies. 
Sincerely yours 
H. Kite, Jr., Ph.D. 
Professor of Microbiology 
Ch 
JHKzjlw 
Wr MICHAEL HALL BUFFALO. NEW YORK U114 TEL fMOBSI-SSOI 
(7371 
