64 
research would have to be found to present ”an unreasonable risk of 
injury to health or the environment/' 
The Hazardous Materials Transportation Act (HMTA) and Sec- 
tion 361 of the Public Health Service (PHS) Act give the Department 
of Transportation (DOT) and the Center for Disease Control (CDC), 
respectively, authority to regulate the shipment of hazardous materials 
in interstate commerce. Both the DOT and the CDC, in implementing 
these acts with respect to biological products, have essentially aimed at 
imposing labeling, packaging, and shipping requirements, and were 
found to be wanting for regulation of all recombinant DXA research. 
The Environmental Defense Fund, in November 1976, petitioned the 
DHETV to regulate recombinant DXA research under Section 361 of 
the PHS Act. (The petition is included in Appendix IV.) The Sub- 
committee carefully reviewed this section, which is directed to organ- 
isms that are communicable and cause human disease. Thus, under this 
section, there would have to be a reasonable basis for concluding that 
the products of all recombinant DXA research may cause human dis- 
ease and are communicable. Further, Section 361 does not apply to 
plants, animals, or the general environment. It was the conclusion of 
the Subcommittee that Section 361 lacked the requisiite authority to 
meet all of the requirements set for the regulation of this research. 
The Subcommittee also considered the authority of the CDC to li- 
cense and control the operation of clinical laboratories under Section 
353 of the PHS Act. but this provision was not considered to be ap- 
plicable to research laboratories. 
Other authorities of EPA under the Clean Air Act. the Federal 
Water Pollution Control Act. and the Resource Conservation and Re- 
covery Act of 1976 were considered briefly and thought only to apply, 
if at all. to isolated aspects of recombinant DXA research. The authori- 
ties of the Food and Drug Administration (FDA) were also reviewed, 
but it was concluded that recombinant DXA research has not yet 
reached the stage of commercial application that comes under the 
FDA's jurisdiction. The regulatory powers of the U.S. Department of 
Agriculture (USDA) were also reviewed and found applicable solely 
to nonhuman animals and plants. 
In summary, the group concluded that no single legal authority, or 
combination of authorities, currently exists which would clearly reach 
all recombinant DXA research in a manner deemed necessary by the 
Committee. Although there is existing authoritv that might be broadly 
interpreted to cover most of the research at issue, it was generally 
agreed that regulatory actions taken on the basis of any such interpre- 
tation would probably be subject to legal challenge. 
After completing an analysis of existing legislation, the Subcommit- 
tee on February S. 1977. considered elements which might be included 
in legislation to regulate recombinant DXA research. The Subcom- 
mittee referred the analysis of existing legislation and elements for 
new legislation to the full Committee at a meeting held on February 
25. 1977. The full Committee adopted the report of the Subcommittee 
on existing legislation and agreed that new legislation was required. 
[Appendix B — 323] 
