APPENDIX J 
and regulation in other areas. The Committee considered whether, in 
the proposed legislation, the regulations should be limited to research. 
As noted above in the analysis of existing legislation, no current single, 
legal authority reaches all research under requirements set for regulation 
by the Committee. However, the Occupational Safety and Health Administration 
and the Environmental Protection Agency do have authority for regulation 
of commercial applications of recombinant DNA molecules. 
Regulation of research alone presents a problem because of the 
difficulty in determining the border between research and pilot production. 
Therefore, the Committee recommends that regulation cover the production 
or use of recombinant DNA molecules. Such language would include research 
activity, and makes immaterial any consideration of whether a given 
activity constitutes research, pilot production, or manufacture. The 
Committee recommends that the Secretary, in consultation with appropriate 
regulatory agencies, be allowed to determine the nature of the activity 
and should defer to a regulatory body he determines is better empowered 
and equipped to deal with it. 
The Committee also recommends as a suggested element for legislation a 
"sunset provision" for the regulatory authority. This provision is intended 
to mandate a review of regulation in light of accumulated scientific and 
safety information. This provision, the Committee wishes to emphasize, 
does not refer to records and other data relevant, for example, to medical, 
occupational, or environmental surveillance. 
(3) Registration : 
There was general agreement by the Committee that registration of 
projects and other activities involving the use or production of recombinant 
Appendix J — 18 
