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to decide whether and to what extent it wishes to develop this technology. To 
achieve these goals the regulatory program must : 
1. Apply uniformity to all persous and institutions engaged in recombinant 
activities. 
2. Prevent release of organisms, rather than control emissions or remedy 
environmental damage after it has occurred. A preventive program is es- 
sential, because the consequences of recombinant technology are largely un- 
known, but likely to be irreversible. Licensing which requires containment 
facilities and regulates work practices is the most effective form of preven- 
tive legislation. 
3. Protect the environment as well as human health. 
4. Provide continuing evaluation of risks as more information becomes 
available. 
o. Provide technology assessment of proposed uses of recombinant orga- 
nisms and techniques. 
6. Provide public participation in all phases of regulation. 
7. Require full disclosure of all recombinant DNA research, development, 
manufacturing and use. 
5. Establish civil liability of institutions engaged in recombinant DNA 
activities, for injury to individuals exposed to recombinant DNA organisms. 
The following discussion of statutes focuses on points 1 through 5. Points 6, 
7. and 8 would each require extensive legal research which was not feasible in 
the time available for preparing this memorandum. 
toxic substaxces coxtrol act 
Although the Toxic Substances Control Act (TSCA) is one of the broadest 
regulatory programs available, it does not provide uniform regulation of all chem- 
ical substances. It is explicitly designed to fill in the gaps left by existing statutes. 
Consequently, regulation of recombinant activities under TSCA will only be mean- 
ingful if supplemented by regulation under other statutes. Even if used in com- 
bination with other statutes, TSCA would provide incomplete protection. TSCA 
only provides for selective testing of chemical substances ; many chemicals will 
be marketed without any evaluation of their safety or environmental impact 
because there is no requirement under TSCA that every chemical substance be 
tested for health and environmental impacts before it is used. Any chemical sub- 
stances cau be marketed free of constraints unless EPA takes affirmative action. 
Also, it may be difficult to apply TSCA to recombinant DNA because most of the 
regulatory authority depends on an affirmative finding of unreasonable risk. The 
paucity of concrete information about risks may make it hard to support such a 
finding. Finally, TSCA does not provide effective regulation of research. 
TSCA's strengths are that it provides a vehicle for requiring research into the 
hazards of recombinant organisms and can be used to require reporting and moni- 
toring of recombinant activities by industry. 
Definitions and jurisdiction: Section 3 
The regulatory sections of TSCA (§§ 4-8) apply to chemical substances which 
are manufactured, distributed in commerce, processed or disposed of. A chemical 
substance is defined as: “any organic or inorganic substance of a particular 
molecular structure. - ’ 
Substances subject to the Food, Drug and Cosmetic Act (FDCA) or the Federal 
Insecticide. Fungicide and Rodenticide Act (FIFRA) are excluded from this 
definition. Manufacture means “import . . . produce, or manufacture.” Commerce 
includes any trade or transportation of a chemical substance. Consequently, 
TSCA gives EPA jurisdiction over recombinant DNA molecules, any protein or 
enzyme produced by a recombinant organism as well as restriction enzymes and 
vectors used in recombinant technology. It also provides jurisdiction over all 
activities from research through use. 
Nof/cc of new chemicals , inventory of existing chemicals: Sections J(o) (b) (c) 
(d), (h) (*), 8(a) (6) 
The notice, reporting and inventory provisions of TSCA are central to its ef- 
fectiveness. Unless EPA knows the chemicals it may have to regulate it cannot 
protect the public from their hazards. Under these requirements, the manufac- 
turer of a chemical substance is required to report its identity, intended uses and 
whatever is known about its toxicity and environmental impacts. However, re- 
[ Appendix B — 354] 
