PART II— EEC0MMEXDATI0X3 
Rzcoai:.iexdatioxs for Eegulatiox of Research 
LEGISLATIVE AUTHORITY 
In response to the concern that some recombinant DXA research 
was unregulated, the Secretary of HE'W convened an interagency com- 
mittee in the fall of 1976 under the chairmanship of Director Fredrick 
son. The committee included representatives of the Federal agencies 
and departments sponsoring and conducting recombinant DXA re- 
search and those having regulatory authority that might be applicable 
in this area. Its first task was to consider whether "the extension of 
the guidelines beyond XIH to the public and private sectors could be 
accomplished under existing statutory authority or whether new legis- 
lation was required. Having reviewed the relevant statutes, the Inter- 
agency Committee reported in March 1977 its conclusion that "no 
single legal authority or combination of authorities currently exists 
that would clearly reach all research and other uses of recombinant 
DXA techniques and meet all the requirements.” Dr. Gilbert Omenn, 
Assistant Director of the Office of Science and Technology Policy, 
reiterated this position in his testimony to the subcommittee on 
Xovember 8; and it was generally supported by Marcia Cleveland, 
attorney for the Xatural Resources Defense Council, in a December 
memorandum requested by the chairman of the subcommittee. 
The Interagency Committee rejected use of the Occupational Safety 
and Health Act of 1970, the Toxic Substances Control Act. the 
Hazardous Materials Transportation Act, the authorities of the Food 
and Drug Administration and the Center for Disease Control and 
several more specialized statutes primarily on the grounds that they 
could not be extended to cover all performers or all aspects of research 
with recombinant DXA. For example, the Occupational Safety and 
Health Act defines “employer” to exclude States and their political 
subdivisions unless the OSHA standards are voluntarily adopted. 
Twenty-six States have not done so and thus their public universities 
would not be subject to Federal regulation. Section 5 of the Toxic 
Substances Act exempts from the requirement of registration 'with 
EPA those chemical substances used in small quantities for the pur- 
pose of scientific experimentation or analysis. The Hazardous Ma- 
terials Transportation Act would not apply to the handling of recom- 
binant DXA materials in the laboratory. The licensing authority 
of the Center for Disease Control under section 353 of the Public 
Health Service Act is limited to clinical laboratories. FDA’s author- 
ities are generally interpreted to reach the manufacture only of com- 
mercial products. 
The Interagency Committee found no such obvious deficiencies in 
section 361 of the Public Health Service Act, on which the Environ- 
(23) 
23-S90 — 78- 
3 
[Appendix B — 282] 
