6 
A. Additional responsibilities lie in the area of information 
transfer and exchange and international liaison. The NIH 
has created a scientific memorandum that will contain the 
most recent developments in this research area and will be 
distributed to scientists involved. And, as Dr. Fredrickson 
has described, the NIH has developed contacts with a number 
of international scientific organizations to facilitate 
international cooperation. 
Following this review of defined responsibilities under the NIH 
guidelines. Dr. Fredrickson then asked Mr. Richard Riseberg, 
NIH General Counsel, to review briefly potential regulatory roles 
to meet some of the responsibilities outlined above. Among potential 
regulatory authorities are the following: 
1. The Public Health Service in DHEW; 
a. DHEW general regulations might serve to regulate such 
research supported or conducted under DHEW auspices. 
b. The Center for Disease Control has authority to regulate 
communicable diseases, but its authority for recombinant 
DNA research is not clear. 
c. The Food and Drug Administration has authority to regulate 
new drugs and devices but, at this point, this research 
area may not be at the stage for such regulation. 
2. The Department of Transportation: 
The Department has the authority to regulate the shipment of 
hazardous substances and does have an appropriate role to 
play in that regard but its extension to regulation of all 
this research is not clear. 
3. The Environmental Protection Agency: 
The Toxic Substances Control Act confers new authority on 
the EPA to regulate chemical substances, but its extension 
to this research area needs further exploration. 
A. The Occupational Safety and Health Administration: 
OSHA has the authority to enforce health and safety standards 
and seems to be the most relevant to the needs of recombinant 
DNA research. 
5. The Department of Agriculture: 
The USDA representative suggested that the Animal and Plant 
Health Section within the USDA be included as having possible 
regulatory authority in this area as well. 
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