DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
t 
Food and Drug Administration 
Rockville MD 20857 
OCT 241964 
Dr. William Gartland 
Office of Recombinant DNA Activities 
National Institute for Allergy 
and Infectious Disease 
National Institutes of Health 
Bethesda, MD 20205 
Dear Dr. Gartland: 
As you know, the Assistant Secretary for Health recently convened a group within 
the PHS, the Ad Hoc Oonmittee on Biotechnology, to serve as a focal point for 
PHS deliberations on issues regarding biotechnology. On behalf of that 
committee, we wish to offer comments on two proposals to amend the NIH 
Guidelines on Recombinant ENA Research. These proposals by the Foundation on 
Economic Trends are described in documents designated 1182 and 1183. 
The proposed amendments to the Guidelines would, in essence, prohibit the 
inter-species transfer of "genetic traits" between mammals. In our opinion, 
such prohibitions are not warranted by the canons of science, and could inflict 
incalculable damage on several areas of scientific and medical inquiry ( vide 
infra) . Hence, we urge that the proposed amendments be rejected. These views 
are explicated below. 
First, terms such as "genetic trait" are so vague as to be meaningless in the 
context of transfer of individual genes, which are, of course, merely 
homopolymers of nucleic acid. It is not unusual for experiments to employ genes 
that are hybrids, with regulatory and structural sequences derived from 
different sources, perhaps even including chemically-synthesized regions that do 
not occur in nature. Moreover , the transfer of single genes does not confer 
species identity - or the loss thereof - on an organism. 
Second, the proposed prohibitions would inhibit the study of the role of 
specific genes in susceptibility to disease. For example, the recent 
experiments of Professor Philip Leder with transgenic mice that have begun to 
elucidate the nature of genetic susceptibility to breast cancer would be 
proscribed. 
Third, the proposed prohibitions would confound the new vistas that recombinant 
DNA technology provides for developmental biology. The insertion of 
controllable heterologous genes whose activity is manipulable into embryos will 
provide important insights into the role of various genes in development. 
