98 
and provide their employees a place of employment “free from recognized 
hazards that are causing or are likely to cause death or serious physical harm 
to his employees.” States can administer the Act within their borders, as long 
as they have approved programs at least as strict as the federal program. The 
principal limitation of OSHA is that it only protects employee health, the health 
of the general public and the environment are not within scope of the Act and 
employees of states which do not administer their own OSHA programs are 
exempt from the Act. This means that researchers at some state universities can- 
not be covered by OSHA standards. Also, OSHA is designed to apply to health 
hazards, for which information is already available. Unlike the premarket test- 
ing statutes, it is not designed to compel research on hazards which are either 
unknown or poorly understood. Finally, OSHA contains no provisions for tech- 
nology assessment. Indeed, it requires that standards promulgated under the Act 
be feasible. This feasibility requirement presumes that at some point the health 
of workers may be compromised to insure the continued availability of their 
products. This kind of compromise should not be available in the regulation of 
recombinant DNA. 
One feature of OSHA is sound and should be incorporated into any regulatory 
program for recombinant DNA. Standards promulgated under OSHA can require 
an employer to install control technology, modify work practices and give his 
employees protective clothing and equipment, changing rooms, showers and 
lunch rooms. OSHA is the only statute which provides for control of workplace 
design and work practices. 
THE CLEAN AIR ACT AND THE FEDERAL WATER POLLUTION CONTROL ACT 
These two acts are primarily designed to remedy existing pollution problems. 
They establish national standards, which define maximum ambient levels for 
pollutants and limit discharges from each source. These standards are achieved 
either by federal enforcement programs or by state programs pursuant to ap- 
proved plans. Although both these statutes provide comprehensive regulatory 
programs, they are poorly suited to regulating recombinant DNA. They are de- 
signed to regulate pollutants, the health and environmental impacts of which 
are relatively well understood, rather than a technology the consequences of 
which are largely unknown. Both the air and water acts place limitations on the 
discharge of pollutants based on the control technology which is either available 
or can be developed. They are not designed to completely prevent discharge as 
is necessary with recombinant DNA. Unlike OSHA they do not regulate work 
practices, but rather focus on controlling emissions. 
THE PUBLIC HEALTH SERVICES ACT 
§ 361 of the Public Health Services Act gives the Secretary of Health, Educa- 
tion and Welfare broad dicretion to regulate recombinant DNA technology to 
protect human health. It empowers the Secretary to : “. . . make and enforce 
such regulations as in his judgment are necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries into 
the States or possessions, or from one State or possession into any other State or 
possession . . .” 
It further provides that: “for purposes of carrying out and enforcing such 
regulations, the [Secretary] may provide for such inspection, . . . disinfection 
. . . and other measures, as in his judgment may be necessary.” 
The problem with the PHSA is that it does not explicitly provide for protec- 
tion of the environment. In other regulations under this section a communicable 
disease is defined as “an illness due to an infectious agent or its toxic product 
. . .” transmitted by persons, animals, plants or the inanimate environment. (42 
C.F.R. §§ 71.1(b), 72.1(b)). Another weakness of §361 is that it leaves the 
regulatory structure for enforcement to the discretion of the Secretary. 
THE NATIONAL ENVIRONMENTAL POLICY ACT 
NEPA is the only federal statute that provides for technology assessment. 
NEPA requires all federal agencies to consider the impact their activities will 
have on the environment and the alternatives to a proposed action. But even 
NEPA does not require that nonessential technology be avoided or that the 
environmentally least damaging alternative must be chosen. Furthermore, NEPA 
[Appendix B — 357] 
