Ch. 7— The Use of Animals in Testing • 161 
Environmental Protection Agency 
In fulfilling its statutory responsibilities, EPA 
uses toxicity data derived from animal testing in 
a variety of ways. EPA has the authority to require 
such data be submitted under laws it administers, 
but data are obtained through other means as well. 
They are submitted voluntarily by those who con- 
duct or sponsor testing and are obtained from the 
open literature, from other government agencies, 
through contracts and grants, and from EPA lab- 
oratories. 
This section describes the regulatory programs 
for which animal testing data are needed and the 
authorities under which existing data or testing 
can be required. (EPA's testing guidelines are de- 
scribed in app. A.) 
Pesticides 
The Federal Insecticide, Fungicide, and Rodenti- 
cide Act (FIFRA) (Public Law 92-516, 7 U.S.C. 136 
et seq.) is designed to protect human health and 
the environment from adverse effects of pesticides 
while allowing the benefits of their use. This is 
done by granting or denying registrations; approv- 
ing labeling; setting maximum residue levels on 
or in raw agricultural commodities; and establish- 
ing procedures for safe application, storage, and 
disposal. In registering the approximately 50,000 
formulations of “pesticide products,” EPA uses 
comprehensive registration standards that include 
animal testing data, as well as physical properties, 
analytical methods, and descriptions of manufac- 
turing and use conditions. 
EPA also relies on animal toxicity data when it 
issues emergency exemptions, experimental-use 
permits, and temporary tolerances for experi- 
mental purposes in response to unexpected and 
temporary food or health emergencies. Emergency 
exemptions may be granted to State or Federal 
agencies for uses not included in the registration. 
Experimental-use permits allow large-scale test- 
ing of new pesticides or new uses of a registered 
pesticide. 
The Agency's Data Requirements for Pesticide 
Registration specify the kinds of material that must 
be submitted to EPA to support registration of each 
pesticide under Section 3 of FIFRA. EPA uses the 
information to determine the identity and com- 
position of pesticides and to evaluate their poten- 
tial adverse effects and environmental fate. Tests 
are either "required” or "conditionally required” 
depending on such factors as the results of pre- 
liminary tests, whether the pesticide use is for a 
food crop, whether the use is experimental, where 
and how the pesticide is to be applied, and the fate 
of the pesticide residue . Certain tests are required 
for new products, and guidelines for conducting 
these tests have also been developed (40 CFR 158, 
49 FR 42856). Many are conditionally required 
through "tiered testing,” whereby the results of 
the first tier of tests determine the need for addi- 
tional ones. Three tiers have been described. 
There is some flexibility in the application of 
these testing requirements, but EPA is to be con- 
sulted if test protocols other than those described 
are to be used. Additional flexibility in the testing 
requirements is available through EPA’s proce- 
dures for waivers and for minor uses (40 CFR 158). 
Virtually all data are submitted in the context 
of obtaining, maintaining, or renewing a registra- 
tion. Another requirement is that the registrant 
must submit any health or safety information that 
would be of interest to EPA regarding a registered 
pesticide. This includes the submission of ongoing 
or completed studies for pesticides subject to regis- 
tration standards, cancellation, or review; incidents 
involving adverse effects to human or nontarget 
organisms resulting from exposure; or incidents 
regarding lack of efficacy that could indirectly pose 
a hazard to human life. 
Industrial Chemicals 
The Toxic Substances Control Act (TSCA) (15 
U.S.C. 2601) authorizes EPA to regulate chemical 
substances that present an "unreasonable risk” of 
injury to health or the environment and to require 
the reporting or development of data necessary 
for EPA to assess risks posed by a given substance. 
Toxicological testing data derived from animals 
form the basis for risk assessment and subsequent 
regulatory actions taken by EPA in implementing 
TSCA. 
If a chemical substance presents an unreason- 
able risk, EPA can regulate its manufacturing, proc- 
essing, distribution in commerce, use, or disposal. 
