DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OP HEALTH 
BETHESOA, MARYLAND 20014 
January 28, 1980 
[This letter was sent to the head of each institution 
receiving NIH support for recombinant DNA research.] 
A. Bartlett Giamatti, Ph.D. 
President 
Yale University 
New Haven, CT 06520 
Dear Dr. Giamatti: 
A major change in the NIH Guidelines for Recombinant DNA Research will be 
promulgated this week in the Federal Register . The chairman of your 
institutional biosafety committee (IBC), and all NIH-supported principal 
investigators doing recombinant DNA experiments, will receive direct 
communication concerning the new January 1980 Guidelines from Dr. William 
Gartland, Director of the NIH Office of Recombinant DNA Activities. 
A large subset of experiments involving the bacterium Escherichia coli , 
strain K- 12, will no longer require submission of a Memorandum of Under- 
standing and Agreement to NIH for review and approval. Contrary to reports 
you may have heard, such experiments are not exempted from coverage under 
the Guidelines. They must continue to be registered with and reviewed by 
the IBC. The physical containment for these experiments is to be class PI. 
The new Guidelines represent another step in the shift of responsibility for 
surveillance for recombinant DNA research from the national to the local 
level. This letter is to express my personal concern that the leadership of 
all institutions conducting research under the Guidelines communicate with 
their IBC and staff to ensure that the remaining conditions for conduct of 
this set of experiments are carefully followed. PI containment is not 
"P zero." PI requires strict observance of certain rules. Adherence to the 
Guidelines is a requirement for continued NIH support of recombinant DNA 
research at your institution. 
Sincerely 
Donald S. Fredrickson, M.D. 
Director 
[Two signs were enclosed with this letter, introduced by the following note: 
"Very soon new signs will appear on the walls of many of your laboratories 
where recanbinant DNA techniques are being used. So that you, too, will be 
au courant with PI laboratory practices, I enclose these copies." — DSF] 
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