UNITED STATES DEPARTMENT OF AGRICULTURE 
SCIENCE AND EDUCATION ADMINISTRATION 
OFFICE OF THE OIRECTOP 
WASHINGTON. D C. 20250 
August 15, 1978 
Dr. Donald S. Fredrickson 
Director, National Institutes of Health 
Department of Health, Education and 
Welfare 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
Thank you for your letter of July 27 to Dr. Jim Nielson transmitting 
the NIH Proposed Revised Guidelines for Recombinant DNA Research and 
the accompanying Decision and Assessment documents. These materials 
are being revieved by the USDA Recombinant DNA Committee, together vith 
Drs. Day and Zaltlin, and their comments on sections dealing with the 
agricultural sciences will be forwarded to you as soon as possible. 
This Interim response pertains to an issue of urgent concern to the 
agriculture research community. 
Details of the issue bothersome to us are covered in a July 27 response 
from you to Dr. Peter Day giving your decision not to approve the risk/ 
benefit assessment experiments as proposed by Dr. M. D. Chilton and 
colleagues and conveyed to you by Dr. Day in a letter of May 10, 1978. 
Whereas your reluctance to approve experiments that are not specifically 
stated in the 1976 Guidelines is appreciated, some questions arise 
concerning recent Interpretations of the guidelines. I refer 
specifically to your recent allowance of self-cloning experiments with 
yeast which appear to involve studies analogous to Dr. Chilton's 
proposed experiment of reintroducing the shrunken T^ plasmid into 
Agrobacterium tumef aciens . Moreover, since the ovalbumin DNA is a 
characterized clone shown to present no biohazard it should be 
acceptable as a eukaryotic marker in the genetic engineering study 
described by Dr. Chilton. We feel the precedent for permitting this 
has been established by the allowance of self-cloning experiments with 
yeast . 
In principle, the risk/benefit assessment experiments described by 
Dr. Chilton represent the type of studies that must be performed before 
the feasibility and significance of recombinant DNA in agriculture can 
be properly and scientifically assessed. USDA feels strongly that the 
experiments, proposed for our high containment facilities such as 
Frederick, Maryland, should begin without delay. The extremely 
restrictive 1976 guidelines have already impeded the application of 
[A-15J 
