DNA/3 
all of the NIH requirements. The responsibility of the American 
government to insure the environmentally sound practice of the export 
of American science and technology has received much attention in a 
variety of different forums. The U.S. Consumer Product Safety Com- 
mission recently banned the export of U.S. made TRIS treated sleepwear. 
TRIS is a carcinogenic flame retardant, originally banned by the Com- 
mission only from children's sleepwear sold in America. The ability 
of U.S. companies to export drugs not approved for sale in the U.S. 
has been the focus of much argument during Congressional consideration 
of the drug reform act of 1978. In that forum EDF supported language 
which would have prevented export of non-approved drugs. FDA regula- 
tions require that foreign generated research submitted for marketing 
license approval must get informed consent from subjects(21 CFR 312.20). 
Finally, the White House is currently deliberating the extent to which 
the National Environmental Policy Act should apply to U.S. funded 
projects overseas. 
I-D. In the document entitled "Decision of the Director,. NIH 
(DD-NIH) , much is made of the fact that the U.S. DNA regulations are 
stricter than those of most other countries. It appears as if this 
comparison is being used by the Director as support for relaxation of 
the existing NIH guidelines. If so, this is completely unjustified. 
Unfortunately, the U.S. has found itself leading the world in a large 
variety of environmental and public health oriented regulations. This 
fact attests not to the radical progressiveness of American regulatory 
agencies but to the failures of foreign regulatory agencies. 
I-D-2 . As presently written, this section does not include any 
criteria for identification of "potent" toxins. The use of ambiguous 
terms such as "potent" is proper in legislation but not in regulations. 
[A-338] 
