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E. General Federal Regulation of All Such Research 
A number of commentators addressed concerns about the scope of 
the NIH Guidelines and the need for regulation of all recombinant DNA 
research nationally and internationally [11,12,14,17,29]. Two com- 
mentators suggested that a national commission be formed to ensure 
representation beyond the control of the NIH [12,28]. From the time 
the Draft EIS was filed in the Federal Register of September 9, 1976, 
there have been Federal activities directly related to these concerns. 
The Federal Interagency Committee on Recombinant DNA Research was 
created to address these and other important public policy issues. The 
pending legislation directly addresses the need for regulating all recom- 
binant DNA activities. This subsection of the EIS has been expanded to 
cover these and other activities that have taken place over the last 
year. 
Several commentators were concerned about the extent of actual 
compliance with the NIH Guidelines by NIH grantees and contractors 
[20,26]. The Guidelines place responsibility on the investigator and 
the local institution for initial implementation of the safety standards. 
Review by the NIH study sections, the NIH Office of Recombinant DNA 
Activities, and the NIH Recombinant Advisory Committee provides 
further monitoring. At the local level, as noted before, the Guidelines 
recommend broad representation on biohazards committees. The NIH 
in its own intramural program has a biohazards committee to review 
intramural recombinant DNA experiments. This committee now includes 
a representative from the local county health department. Of course, 
if legislation is enacted for the regulation of recombinant DNA activities, 
the NIH and its grantees or contractors, as well as any others conducting 
this research, will be subject to such regulation. 
Several commentators expressed concern about the shipping practices 
required for recombinant DNA molecules [26, 29, 32]. There were two 
primary concerns. One related to the need for a defined approach 
or program to deal effectively with an accidental spill during transit, 
so that any threat to the public health could be minimized. The second 
concern related to the limited scope of existing Federal regulations 
governing transport of potentially hazardous microoganisms. Existing 
regulations apply only to etiologic agents listed by the Public Health 
Service in Section 72.2 5 of Part 72, Title 42, Code of Federal 
Regulations. 
The Guidelines require that all recombinant DNA materials (i.e., 
recombinant DNA molecules, and vectors or hosts containing such 
molecules), regardless of whether or not they are constructed from 
an etiologic agent listed in paragraph (c) of 42 CFR 72.25, be contained 
during shipment in packages that meet the requirements described in 
the cited Federal Regulations. Appropriate packaging methods are 
described in detail in Appendix D, Section X of the Guidelines. 
