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searchers are not required to give notice of new substances and small businesses 
may not be required to report on existing substances. Non-commercial institu- 
tions, such as universities, are exempt from both requirements. 
Testing orders: Section 4 
If EPA concludes that a chemical substance “may present an unreasonable risk 
of injury to health or the environment” or "may reasonably be expected to enter 
the environment in substantial quantities or . . . there is or may be significant 
or substantial human exposure,” it can issue an order requiring testing. The 
terms “unreasonable risk,” “substantial quantities,” “significant exposure” are 
not defined precisely in the statute. However, the legislative history indicates that 
the Administrator is to have broad authority to issue testing orders and that he 
will necessarily have to act on incomplete information about risks. Given the 
breadth of the authority under this section, the Administrator would be able to 
require research into the hazards of recombinant DNA. If such research involves 
the use of recombinant techniques, the Administrator could use his authority to 
set testing protocols and require that strict safety procedures be followed. 
Interim regulation : Section 5 
EPA has the authority to regulate toxic substances while testing is being con- 
ducted, but this authority does not apply to persons and institutions exempt from 
the notice requirements of § 5. This means that TSCA does not authorize any 
interim regulation of research or non-commercial institutions since they are not 
subject to the notice requirements. 
Permanent regulation under Section 6 
Once EPA finds that a chemical substance “will present an unreasonable risk 
of injury to health or the environment,” it can issue a wide variety of orders to 
prevent that harm. However, the “will present” standard may require more infor- 
mation about the risks of recombinant DNA than is now available and therefore 
may not allow preventive regulations until far more is known about the conse- 
quences of recombinant technology. Also it is not clear that EPA could establish 
a facilities licensing system or regulate work practices under § 6. However, § 
can be applied to research and non-commercial activities. 
THE FOOD, DBUG AXD COSMETIC ACT 
The regulatory system of the Food, Drug and Cosmetic Act is based on pre- 
marketing approval — i.e. the requirement that a manufacturer demonstrate the 
safety of his product before it is marketed. Although this is one of the most 
powerful regulatory tools for protecting human health, it provides only incom- 
plete protection against the hazards of recombinant DNA. First, the FDCA is only 
designed to protect human and animal health, not the environment. Second, its 
regulatory provisions apply only at the point that a product is marketed or after ; 
non-commercial activities are not covered at all. Third, only a limited number 
of products — food additives, color additives, new drugs, new animal drugs, de- 
vices and pesticide residues — are subject to premarketing approval. Other sub- 
stances covered by the act — food, environmental contaminants or other impuri- 
ties in food and cosmetics — can only be regulated after the fact, if FDA has 
evidence that they are unsafe. Finally, the FDCA provides no technology assess- 
ment. If a product meets the safety and efficacy requirements of the Act. it must 
be approved regardless of whether risks outweigh benefits or alternatives are 
available. 
Jurisdiction over recombinant organisms or products: Sections 201, SOI, 402, 
501, 601 
The FDCA prohibits the sale in interstate commerce of any adulterated food, 
drug, device or cosmetic (§ 301(a) ). Food is considered adulterated if it “bears 
or contains any poisonous or deleterious substance which may render it injurious 
to health” or contains an additive, or residue which does not comply with 
premarketing approval requirements or tolerances (§402). Similarly, drugs and 
devices are adulterated if they are “injurious to health” or have not complied 
with approval and quality control requirements or contain unapproved color 
additives. Cosmetics are adulterated if they contain any “poisonous or deleterious 
substances” or are not manufactured according to quality control requirements. 
If recombinant organisms or recombinant DNA molecules themselves are ever 
used as food, drugs or cosmetics, they could be prohibited under the Act if they 
[Appendix B — 355] 
