THE SECRETARY OF HEALTH. EDUCATION. AND WELFARE 
WASHINGTON. O C. 20201 
dec 1 5 1978 
The Honorable Douglas M. Costle 
Administrator 
Environmental Protection Agency 
Washington, D.C. 20460 
Dear Doug: 
I am announcing today several steps we are taking with 
respect to the future course of recombinant DNA research in 
this country. Our objective is to permit the maximum 
freedom for scientific inquiry consistent with protection of 
public health and the environment, and with the profound 
ethical concerns raised by recombinant DNA research. 
As noted in the public statement v/hich is enclosed, I am 
today, (1) approving revised guidelines prepared by the 
National Institutes of Health governing safety requirements 
for the conduct of recombinant DNA research by institutions 
receiving NIH funding for such research; (2) directing NIH 
to increase its studies on the extent of risk associated 
with such research; (3) broadening substantially public 
representation on the HEW advisory committee which will 
assist NIH in administering the revised guidelines; and 
(4) increasing significantly public access to information 
about recombinant DNA research and public participation in 
administration of the guidelines in local areas. 
If the health, environmental and ethical concerns raised by 
recombinant DNA research are to be accommodated effectively, 
these actions by government, and by those who receive 
government support for recombinant DNA research, will not be 
enough. It is also necessary that research conducted by the 
private sector comply with the NIH guidelines. 
To this end, I have directed the Food and Drug Administration 
to use its regulatory authority to require that all recombi- 
nant DNA research submitted to FDA to satisfy its regulatory 
requirements comply with the NIH guidelines. I have 
enclosed FDA's Notice of Intent to Propose Regulations for 
this purpose. 
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