9 
"NIH [will] recommend the revisions in the guidelines, review and 
clarify the technical issues, and handle, if you will, the standard 
setting, the philosophy, the scientific input, and then turn over 
to CDC the functions of licensing facilities and maintaining the 
registry and operating and promulgating standards. Both organizations 
would obviously have to be involved in training workers and in 
working with those outside the Federal Establishment as well as 
inside that are involved in recombinant DNA research."* 
Indeed NIH, for the past 18 months, has worked closely with the Center 
for Disease Control (CDC) concerning safety aspects of the Guidelines. 
For example, NIH, in conjunction with CDC, has been developing mechanisms 
for assisting institutions in managing possible laboratory emergencies 
and for providing direct assistance when appropriate. Also, NIH and CDC 
have been reviewing packaging and shipping requirements relevant to 
recombinant DNA activities. Further, NIH and CDC have collaborated 
closely in revising the CDC Classifications of Etiologic Agents on the 
Basis of Hazard. This classification scheme underpins some of the 
safety requirements of the Guidelines. Close coordination and consultation 
with the Food and Drug Administration and the Environmental Protection 
Agency will be essential since these agencies' regulatory authorities 
will come into play when recombinant DNA research inventions are ready 
for commercial development. The Occupational Safety and Health Administration 
will exercise its regulatory authority in the workplace. 
*Page 92 of the published hearing record dated April 6, 1977, on the 
Recombinant DNA Regulation Act. 
[Appendix B — 185] 
