.83 
production of milk, and standards for water in a way that clearly establishes 
the preference for prevention of the occurrence of any risk, rather than control 
of the spread of infection. It is our understanding that the XIH Guidelines on 
Recombinant DNA Activities are directed at exactly the same objective : to 
assure that risks of infection being released be eliminated by stringent control 
over practices and facilities. 
Thus, we have raised to an interagency group, including representatives of 
the Office of the General Counsel of DHEW. the potential applicability of Sec- 
tion 361 in the event that the Congress decides that legislation specific to DXA 
research cannot be agreed upon and that use of Section 3G1 is necessary. This 
single authority, with DHEW the clear lead agency, might well be adequate. 
We do agree with HEW, of course, that Section 361 was not written for the 
purpose of regulation of research or even of research applications and that 
extensive justification and detailed regulations would be required. Such regula- 
tions would be required under proposed legislation, as well. We understand 
that HEW prefers specific Congressional authorization and that Congressman 
Rogers is reviewing the Administration’s proposals along with other alternatives. 
Xow let me turn to the other two issues you raised. 
Issue No. 2 
The Department of Commerce activities are progressing satisfactorily. Staff 
from their Office of General Counsel and from the Office of Environmental Affairs, 
under Assistant Secretary Baruch, and staff from my Office have met several 
times with representatives of the Pharmaceutical Manufacturers Association and 
certain industrial firms. Meetings with labor officials and with representatives 
of environmental groups are being scheduled. The activity I mentioned above 
about use of Section 361 and the discussion of new legislation in the Congress 
has complicated the context of their inquiries, but they are going ahead. Sur- 
veillance mechanisms under discussion include registration, biohazards/biosafety 
committees with public members, and sanctions for violations of guidelines. 
Issue No. 3 
The preemptions provided in S. 1217 (now withdrawn by Senator Kennedy) 
and in Amendment 754 by Senator Xelson were introduced, I presume, to clarify 
responsibility for establishing regulations under any new legislation pertaining 
to DXA activities. Since the Secretary of HEW wouid be charged with the 
implementation of the Act. the Secretary could instruct FDA to require evidence 
of compliance with DX T A regulations in order to approve new drug applications. 
The XIH Guidelines, as revised, will meet the needs of the Department of Agri- 
culture, we are advised. OSHA reserves the possibility of entering into this 
matter later, if evidence of significant hazard to employees should arise. XIH 
guidelines and any regulations developed under new legislation or under Section 
361 seem adequate for the workplace at present. 
Therefore, we see no present need for changes in other statutes. X T or is there 
any apparent need to preempt existing statutes. 
In closing, let me add that the recombinant DXA work seems to be progressing 
well and safely, with additional information during the past year that has per- 
mitted more sober and realistic discussion of the potential risks. These risks 
now seem sufficiently low and the XIH Guidelines sufficiently stringent that the 
public should be much reassured. Furthermore, I believe that the XIH has very 
effectively engendered public discussion, and I see little indication for a public 
commission to enhance or possibly reignite the debate of the past few years on 
this subject. 
We are eager to work with you and with other Committees of the Congress in 
following the development of this research and its applications, 
l’ours sincerely, 
Attachment 
Frank Press, Director. 
Covington & Burling, 
Washington, D.C., January 6, 1978. 
Gilbert S. Omenn, Ph. D., M.D., 
Assistant Director for Human Resources and Social and Economic Services, 
Office of Science and Technology Policy, Washington, D.G. 
Dear Gil: As you requested, I have reviewed the background of Section 361 
of the Public Health Service Act (42 U.S.C. 264), its interpretation and appli- 
cation by the Food and Drug Administration and the Public Health Service over 
[Appendix B — 342] 
