48 
Other statutes providing for the regulation of recombinant DNA 
.also have separate recordkeeping and reporting requirements. While 
certain statutory authorities, such as section 361 of the Public Health 
Service Act, do not explicitly provide for reporting and recordkeep- 
ing, these requirements are presumably within the discretion of the 
Secretary. To the extent that other statutes provide for recordkeeping 
and reporting, the A dminis trator of EPA is admonished in section 
8(a) of TOSCA not to impose requirements which are "unnecessary 
or duplicative.” As Jonathan King pointed out in the subcommittee 
hearings, however, there are presently no techniques for tracking inad- 
vertent contaminations for adverse health or ecological effects. 
Views of the subcommittee 
In examining the anticipated uses of recombinant DNA technology, 
the subcommittee recognizes the limits of present knowledge. Neither 
the course of research and development nor the progress of risk assess- 
ment can be predicted with accuracy. It may be, as Roy Curtiss sug- 
gested, that commercial uses of genetically modified micro-organisms 
will pose no threat to public health or the environment. On the other 
hand, the risks of large-scale production and release of recombinant 
DNA organisms may be greater than those attributed to experimenta- 
tion in research laboratories. 
Congress and the executive branch should anticipate these potential 
hazards before they materialize. With that in mind, the subcommittee 
has studied existing statutes to determine ^ .other they are capable 
of insuring the safe manufacture, processing, use, transportation, and 
disposal of recombinant DNA products. There should be adequate pro- 
visions for premanufacturing or premarketing approval, quality con- 
trols in manufacture, testing of effects, recordkeeping and reporting, 
and appropriate packaging and handling. With the exceptions noted 
above, the subcommittee has found surprisingly few obvious gaps in 
these authorities; effective regulation, however, depends upon their 
proper administration. 
The subcommittee believes that Federal regulation should focus on 
the nature of the prospective uses of recombinant DNA techniques 
rather than on the technology per se. It therefore makes little sense 
to create a new agency or bureaucracy to regulate all activities in- 
volving recombinant DNA when existing agencies have appropriate 
authority and expertise in controlling a variety of chemical hazards, 
insuring drug safety, regulating waste disposal and transportation of 
hazardous materials, and performing similar functions. Thus, author- 
ity over pesticidal uses of recombinant DNA technology should re- 
main with the Environmental Protection Agency. Regulation of phar- 
maceutical and other applications subject to the Federal Food, Drug, 
and Cosmetic Act should remain with the Food and Drug Adminis- 
tration. The same reasoning applies to transportation and plant and 
animal protection. Legislation relating to research should not 
preempt existing authorities that are applicable to commercial uses 
of recombinant DNA. There is a danger, however, of conflicting 
regulation by different agencies. In the case of university and indus- 
trial research activities, this danger is minimized by the limita- 
tions mentioned above in the Occupational Safety and Health Act, 
[Appendix B — 307] 
