7 
states that the Department should include in the regulations implementing 
H.R. 11192 provisions for the protection of proprietary data. 
NIH filed an environmental impact statement on the recombinant DNA 
Guidelines in October 1977, and we are conducting an assessment of the 
environmental impact, if any, of the proposed revisions. Mr. Chairman, 
the National Environmental Policy Act (NEPA) requires that for "major 
federal actions significantly affecting the quality of the human environ- 
ment" a detailed statement by the responsible official must be made. It 
should be noted that in the Commerce Committee's report it is stated: 
"It is the [Commerce] Committee's understanding that the Secretary 
will complete and file an EIS on all guidelines and regulations, as 
expeditiously as practicable, even after promulgation of the 
administrative regulations. . . . "* 
Under NEPA's requirements, it is more precise to say, Mr. Chairman, that 
the Department will conduct an assessment of the environmental impact of 
the standards and regulations. And based on the assessment document, a 
determination will be made on whether an EIS is specifically required. 
Presently, we are moving as rapidly as possible to develop a decision 
document and an environmental impact assessment of the proposed revisions 
in order to put them into effect as rapidly as possible — in accordance 
with the Administrative Procedures Act — so that we can avoid unnecessarily 
heavy regulatory burdens — such as those in the current Guidelines. 
*Page 20 of Report 95-1005, the Report by the Committee on Interstate 
and Foreign Commerce accompanying H.R. 11192. 
[Appendix B — 183] 
