187 
DR. MC CARTHY: All of the letters and statements that were turned in 
yesterday are available now in Room 8. 
DR. FREDRICKSON: Dr. Gartland. 
DR. GARTLAND: Thank you. I am going to make some remarks this morn- 
ing on the implementation of the NIH Guidelines, because over the past year 
and a half a rather elaborate structure for their implementation has been 
put into place, and this structure is not evident from inspection of the 
Guidelines. The reason is because these policies and procedures that I am 
going to talk about are promulgated in such places as the NIH Guide for 
Grants and Contracts , which is an organ the NIH uses to communicate with 
invest igators and with grantee institutions. Also, these policies and 
procedures are contained in internal directives to NIH staff. 
Some of the documents that I am going to talk about are duplicated 
in the final Environmental Impact Statement, and as Dr. Fredrickson said, 
I will take them up in chronological order. 
In late 1975 the NIH Institutes sent letters to principal investi- 
gators stating that the Recombinant Advisory Committee was in the process 
of elaborating a detailed set of explicit guidelines. And in the interim 
period the principles and standards of the Asilomar Conference must be 
complied with. The letter went on to cite experiments that were not to be 
done at all. The letter then required investigators to provide a descrip- 
tion of ongoing or proposed experiments involving recombinant DNA work, and 
an assurance that the Asilomar Guidelines would be followed in the conduct 
of these experiments. Furthermore, the letter at that time, which was late 
1975, required assurance that there would be no change in the nature of 
ongoing experiments without the prior approval of the NIH. 
In June of 1976 the Office of Recombinant DNA Activities was estab- 
lished in the National Institute of General Medical Sciences, and among its 
many responsibilities, the Office is responsible for participating in the 
development of policies and procedures for the handling of recombinant DNA 
projects at the NIH. A specific function of the Office of Recombinant DNA 
Activities is to review and approve all recombinant DNA projects prior to 
their funding by any of the Institutes. 
In July of 1976, as you know, the current Guidelines that we are opera- 
ting under were published in the Federal Register . On August 26, 1976, a 
notice was sent to grantee institutions and investigators from the Director, 
NIH, and from the Office of Recombinant DNA Activities stating "procedures 
which must be undertaken immediately if recombinant DNA is being conducted or 
will be conducted in the future." 
Among the requirements which were stated at that time were that an insti- 
tutional biohazards committee must be established and the composition of the 
committee must be reported to the NIH by October 15, 1976. In addition, it 
was stated in that directive that, effective immediately, all experiments 
[ 391 ] 
