162 • Alternatives to Animal Use in Research, Testing, and Education 
Such regulatory actions would be based on toxic- 
ity data and exposure data, as well as on data re- 
garding the beneficial uses of the substance. Reg- 
ulation can be in the form of prohibiting or limiting 
certain actions, requiring warnings or instructions 
for use, or requiring the submission or retention 
of certain records. 
If EPA has reason to believe that a substance 
presents an unreasonable risk but the agency lacks 
sufficient information to make such a finding, it 
can require reporting of existing toxicity or ex- 
posure data. EPA can also require that a substance 
be tested in animals for specific toxic effects. 
Under TSCA, EPA has authority to require test- 
ing of industrial chemicals if testing is needed to 
perform a risk assessment. To aid in identifying 
relevant chemical substances, TSCA authorized 
an interagency testing committee to make sugges- 
tions. EPA must consider these suggestions and 
either initiate rulemaking or publish reasons for 
not doing so. 
TSCA requires that 90 days before the manu- 
facture or import of a “new” chemical (a chemical 
not on the TSCA Inventory of Chemical Substances) 
can begin, a Premanufacture Notification must be 
submitted to EPA. The submitters must provide 
all information in their possession or control re- 
lated to health or environmental effects or to ex- 
posure. EPA can also require hazard or exposure 
information for substances already in commerce. 
Air 
The Clean Air Act (42 U.S.C. 7401 et seq.) requires 
the Federal and State Governments to take cer- 
tain actions to improve or maintain the quality of 
ambient air. Animal testing data support various 
activities under the act. EPA designates certain sub- 
stances as “criteria pollutants” and establishes na- 
tional standards for ambient air based on toxicity 
and other concerns. Under Section 112, EPA also 
designates certain very toxic pollutants as “haz- 
ardous” and establishes standards for their emis- 
sion or other control. 
For registrations of any fuel or fuel additive, the 
EPA Administrator may require the manufacturer 
to conduct tests to determine whether there are 
potential short- or long-term health effects. Tests 
may be for acute effects, chronic effects, immuno- 
toxicity, carcinogenicity, teratogenicity, or muta- 
genicity. 
Radiation 
EPA's authority over radiation was delegated in 
the President’s Reorganization Plan of 1970 (35 FR 
15623), under which EPA makes recommendations 
to other Federal agencies (the Nuclear Regulatory 
Commission, the Department of Energy, and OSHA) 
regarding acceptable levels of emissions for the 
byproducts of producing fuel-grade uranium and 
from other low-level wastes . Most of the data used 
to develop regulatory standards were gathered 
from humans inadvertently exposed to radiation, 
but data from animals are used for genetic and 
other effects, dose-response relationships, and me- 
tabolism. 
Water 
The Clean Water Act (33 U.S.C. 466) requires 
Federal and State efforts to restore and maintain 
the integrity of U.S. waters. Data needed to fulfill 
these requirements are obtained primarily from 
testing fish and other aquatic organisms. 
The 1977 amendments to the act listed toxic sub- 
stances that are commonly referred to as the 126 
priority pollutants, primarily because of their toxic 
effects on humans and animals. These are con- 
trolled through nationally uniform limitations on 
the effluents containing them. Water Quality Cri- 
teria have also been promulgated for permissible 
ambient concentrations of these substances and 
are used to establish State water quality standards. 
Other toxic chemicals will also be regulated under 
the Clean Water Act. 
The Clean Water Act calls for National Water 
Quality Criteria to be derived. The complete data 
set is developed by conducting a series of acute 
and long-term bioassays using organisms from at 
least eight different families. Acute tests are re- 
quired on a salmonid, another family belonging 
to the class Osteichthyes (bony fish), and another 
representative of the phylum Chordata. The long- 
term tests required are chronic tests with one spe- 
cies of fish and a bioconcentration test with one 
aquatic species. 
