63 
The Subcommittee was charged to determine whether existing 
legislative authority would permit the regulation of all recombinant 
DXA research in the United States (whether or not Federally funded) 
and would include at least the following regulatory requirements: 
(1) review of such research by an institutional biohazards 
committee before it is undertaken. 
(2) compliance with physical and biological containment 
standards and prohibitions in the XIH Guidelines, 
(3) registration of such research with a national registry at 
the time the research is undertaken (subject to appropriate safe- 
guards to protect proprietary interests) , and 
(4) enforcement of the above requirements through monitor- 
ing. inspection, and sanctions. 
It was the conclusion of the Subcommittee that present law could 
permit imposition of some of the above requirements on much recom- 
binant DXA laboratory research, but 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. The complete Subcommittee analysis is included 
in Appendix III. The Subcommittee, in reaching this conclusion, 
reviewed the following laws that were deemed most deserving of 
detailed consideration : 
(1) the Occupational Safety and Health Act of 1970 (Public 
Law 91-596) . 
(2) the Toxic Substances Control Act (Public Law 94-469), 
(3) the Hazardous Materials Transportation Act (Public Law 
93-633), 
(4) Section 361 of the Public Health Service Act (42 U.S.C. 
Sec. 264). . 
The Occupational Safety and Health Act gives the Occupational 
Safety and Health Administration (OSHA) broad powers to require 
employers to provide a safe workplace for their employees. The term 
“employer ’ in the Act, however, is defined in such a way as to exclude 
States and their political subdivisions unless the OSHA standards are 
voluntarily adopted. Twenty- four States have adopted the standards, 
but twenty-six states are not subject to them. Further, the OSHA 
standards do not cover self-employed persons. For these reasons it was 
determined that OSHA at present could not regulate all recombinant 
DXA research. 
The Environmental Protection Agency, under the Toxic Substances 
Control Act, is directed to control chemicals that may present an 
“unreasonable risk of injury to the health or the environment.’’ The 
Subcommittee determined that the materials used in recombinant 
DXA research would appear to be covered in most cases by the Act's 
definition of “chemical substance.’’ Section 5 of the Act, however, 
explicitly exempts registration of chemical substances used in small 
quantities for the purposes of scientific experimentation or analysis. 
This represents a most serious deficiency, as the registration of activ- 
ities was thought to be an essential element of any regulatory effort. 
Also, in order to meet the specifications of the Act, recombinant DXA 
[Appendix B — 322] 
