32 
Dr. Talbot pointed out that this prqposal would give the NIH the option to 
defer to another agency. The proposal does not require the NIH to defer. 
The NIH currently does not have this option. 
Mr. Clarence Styron of Monsanto Company asked whether Dr. Talbot's proposal 
had any implication for IBCs. Dr. Talbot replied it would have no implica- 
tions for IBCs. 
Dr. Miller said FDA feels: "there is now clear redundancy of oversight, 
between FDA and NIH, and US DA and NIH, and EPA and NIH, and FDA is disturbed 
by that." 
Dr. Miller said while FDA supports the concept of relieving this redundancy, 
FDA did not think Dr. Talbot's proposal was the "optimal approach." FDA has 
three reservations: (1) there would be some uncertainty among individual 
investigators or industry about whether an exemption would be granted by 
ORDA; (2) 9ome bureaucracy would be created at NIH and by the investigators 
or companies "to deal with correspondence, phone calls, meetings, requests 
to NIH;" (3) there is some ambiguity about the broadness of the exemption, 
i.e., if an investigator slichtly changed his protocol, would he have to 
ccme back to NIH again. 
Dr. Miller said: 
"...what we would prefer to see is some kind of categorical exemption 
so that an investigator who was being regulated by another federal 
agency would be exempt from oversight by NIH or perhaps it could be 
done more specifically so that oversight under specific federal 
statutes such as the Food, Drug, and Cosmetic Act, the Public Health 
Service Act, the USDA's Virus, Serum, and Toxin Act and perhaps 
others, EPA's statutes for example, would automatically be exempt from 
NIH oversight." 
Dr. Miller said this type of exemption is done with TSCA; EPA is exempted 
from jurisdiction - over products overseen by FDA's statutes. 
Dr. Miller said he will formally prepose this type of exemption in the 
Federal Register announcing the next RAC meeting and was now proposing 
that official action on Dr. Talbot's prcposal be deferred until the next 
RAC meeting. 
Dr. Sue Tolin of the US DA said US DA would like to see Dr. Miller's prcposal 
of a categorical exemption be presented to RAC; and, therefore, feels 
approval of Dr. Talbot's prcposal at the May 3, 1985, meeting would be 
premature particularly in light of the discussions occurring at this time 
in the Cabinet Council Working Group. She supported the request to defer 
action on this proposal. 
Dr. Johnson moved that RAC table Dr. Talbot's prcposal. Dr. Walters seconded 
the motion. 
[152] 
