46 
Of the three principal statutes which might be used to control the 
commercial products of recombinant DNA technology (FIFE A. 
TOSCA, and FDCA), only the FDCA may contain sufficient author- 
ity to insure that products subject to that act are manufactured in a 
safe manner. Section 701(a) gives the Secretary of HEW authority 
to issue general rules for the efficient enforcement of the act. This 
broad grant of authority may be sufficient to reach the manufacture 
of recombinant DNA. 
FIFEA, while providing ample authority to protect against hazards 
associated with the products of manufacture, contains no authority 
which would enable the Administrator of EPA to impose require- 
ments with respect to the manner of manufacture. Likewise. TOSCA, 
while providing broad authority to deal with recombinant DNA mole- 
cules and other chemical substances, contains only limited authority 
to specify the manner of manufacture. Section 6(b) of TOSCA en- 
ables the Administrator to order that quality control procedures be 
invoked in the event a chemical substance or mixture is manufactured 
or processed in a manner which unintentionally causes it to present 
unreasonable risks to health or the environment. In addition, in im- 
posing quality control procedures, the Administrator is required to 
undertake a potentially time-consuming and laborious adjudicator}' 
procedure in order to impose requirements. While other statutes, 
such as section 361 of the Public Health Service Act and perhaps the 
plant and animal quarantine laws, may be construed to provide this 
kind of authority, an explicit statutory declaration of the authority 
would be desirable. 
Many of the problems associated with manufacture are similar to 
those associated with conducting research with recombinant DNA 
molecules. The scale is larger and, arguably, the opportunity for 
environmental damage is greater in manufacturing situations than 
in research because of differences in personnel training, volume of 
matei-ials used, and methods of production. Nonetheless, the types of 
controls necessary to protect workers in the environment and com- 
mercial manufacture are similar to those that may be imposed in the 
laboratory. 
Hazaras to health and the environment that may occur after com- 
mercial manufacture present different problems that must be ad- 
dressed separately. While tests to determine health and environmental 
effects may be similar, the control mechanisms developed to prevent 
hazards in transportation, use, and disposal of the material will be 
very different in character than those applied inside the laboratory 
or manufacturing plant. The latter controls will be characterized 
largely by biological and physical containment requirements similar 
to those in the NIH guidelines and future regulations governing 
experimentation. 
TESTING REQUIREMENTS 
It is implicit in any premanufacturing review system that decisions 
to approve the manufacture of recombinant DNA or derived prod- 
ucts will be made intelligently with as full knowledge as possible of 
the risks. This means that test data relating to health and environ- 
mental effects must be available in the premanufacturing review 
[Appendix B — 305] 
