41 
tion would occur with respect to transportation, waste disposal, and 
other problems that may be associated with recombinant DNA 
applications and for which expertise and regulatory responsi- 
bility have already been established. The types of regulatory 
problems presented by recombinant DNA may differ, however, 
from those of conventional materials regulated under existing 
laws and require specialized training or additional personnel 
familiar with the scientific aspects of recombinant DNA. Nonetheless, 
with the exception of regulation of research activities for which HEW 
currently has primary responsibility, consolidation of all authority in 
the Department of HEW or an independent commission would require 
creating a new administrative structure and assembling the expertise 
to deal with the large number of potential applications of recombinant 
DNA technology. 
APPLICABILITY OF EXISTING STATUTES 
Given the speculative nature of the eventual uses of recombinant 
DNA research, it is difficult to identify precisely the different 
kinds of public health and environmental problems that may arise. 
Nonetheless, some observations are appropriate. There are a number of 
substances which may require control as recombinant DNA technology 
becomes commercially feasible. While many of these materials may 
present little or no hazard in and of themselves, the ability to control 
their production, movement, and use in recombinant activities may be 
important control mechanisms. Included are the recombined DNA 
molecules, the enzymes necessary to split DNA molecules and to re- 
combine them, DNA segments to be inserted in host DNA molecules 
and the organisms serving as hosts for insertion of recombined DNA. 
The authority should also exist to control substances produced by 
recombinants. 
With the exceptions noted below, all of the materials associated with 
recombinant DNA applications are apparently subject to one, and 
possibly several, statutes designed to protect health and the environ- 
ment. If the material produced, either an organism or a product of 
an organism, is to be used as a pesticide, the terms of FIFRA apply. 
Pharmaceutical products and manufacturing processes are subject to 
the Federal Food, Drug, and Cosmetic Act — 21 U.S.C. 301, et 
seq. (FDCA). To the extent that the substances necessary to produce 
pesticide products or products subject to the FDCA are not covered 
by those statutes, they are covered by the Toxic Substances Control 
Act — 15 U.S.C. 2601, et seq. (TOSCA). Similarly, Federal laws relat- 
ing to water pollution, waste disposal, air pollution, occupational safety 
and health, and communicable disease all appear applicable to re- 
combinant DNA materials and organisms if they are related to those 
types of hazards. The extent to which these statutes provide adequate 
regulatory authority merits closer examination. 
There is substantial question regarding the control of organisms 
containing recombined DNA under TOSCA. This is particularly im- 
portant when examining requirements for premanufacturing review 
of organisms which are not pesticidal or subject to the FDCA. For 
example, attempts may be made to improve the efficiency of sewage 
[Appendix B — 300] 
