158 • Alternatives to Animal Use in Research, Testing, and Education 
Centers for Disease Control (CDC), the Department 
of Transportation (DOT), the Federal Trade Com- 
mission (FTC), and the U.S. Department of Agri- 
culture (USDA). Animal testing is also funded by 
the Department of Defense. 
Testing is covered by several types of statutes 
and regulations. Most common are laws that re- 
quire a product to be safe and effective. Given the 
state of currently accepted technology and prac- 
tice, such a statute implicitly (although not explic- 
itly) calls for animal testing. Such tests are rou- 
tinely expected as an indication of meeting the 
standard of product safety and effectiveness. A 
second stimulus for animal testing involves pre- 
market approved. Under this authority, testing with 
animals is explicitly required by regulations of the 
agency involved. Or, animal testing may be explic- 
itly required by statute, as in the case of the Fed- 
eral Flazardous Substances Act administered by 
CPSC. As a practical matter, it makes little differ- 
ence whether the tests involving animals occur 
under implicit or explicit statutory or regulatory 
authority: The procedures used are quite similar. 
The specific tests performed and the methodol- 
ogies used may be dictated by informal or formal 
requirements of the agency. These may take the 
form of promulgated regulations, published guide- 
lines, unpublished guidelines, or customary prac- 
tices . Some guidelines and the use of specific tests 
are accepted internationally (see app. A.) 
With these general principles in mind, this dis- 
cussion summarizes current Federal regulatory 
requirements relating to testing with animals (see 
also app. B). This review is not intended to evalu- 
ate the justification of such testing, only to describe 
its scope and magnitude. It is meant to provide 
sufficient background to permit an evaluation of 
the reasons testing is conducted and of the regu- 
latory needs that any alternatives to such testing 
must satisfy. 
Food and Drug Administration 
FDA is responsible for administering several stat- 
utes that regulate animal and human food, animal 
and human drugs, medical devices, cosmetics, 
color additives, and radiological products. This 
regulation takes place primarily under the 1938 
Federal Food, Drug, and Cosmetic Act as amended 
(21 U.S.C. 301 et seq.) and the Public Health Serv- 
ice Act of 1944 (42 U.S.C. 200 et seq.). 
FDA evaluates each product on a case-by-case 
basis. The exact testing regime is determined by 
considering the type of product, the method of 
exposure, the amount and duration of intended 
use, and the potential hazards associated with the 
specific product. In support of its regulatory re- 
sponsibilities and to assure quality testing, FDA 
has issued standards for good laboratory practice 
(see ch. 13) and has developed guidelines and test- 
ing protocols. Although some special guidelines 
or testing protocols are established for specific 
products, most tests are the same as or similar to 
the toxicological tests used by other agencies. Ap- 
pendix A lists the types of tests used. 
The National Center for Toxicological Research 
(NCTR) in Jefferson, AR, and the National Toxicol- 
ogy Program are the research and testing arms 
of FDA. Although NCTR and NTP have no direct 
regulatory responsibilities, they provide informa- 
tion needed to evaluate the safety of chemicals. 
Research that involves the use of animals or alter- 
native methods includes studies of effects of low- 
dose, long-term exposure to chemicals; develop- 
ment of new methodology to investigate toxic ef- 
fects; study of biological mechanisms of toxicity; 
and investigation of methods for estimating human 
health risks using experimental laboratory data. 
The misbranding or adulteration of virtually any 
product regulated by FDA is prohibited. In addi- 
tion, testing is required both to substantiate label- 
ing claims and to demonstrate safety. These re- 
quirements should be assumed to apply to the 
substances and products discussed in this section 
unless otherwise stated. 
Food for Humans 
Under the law, a food additive is defined as a 
food substance that is not “generally recognized 
as safe” (as defined in the Federal Food, Drug, and 
Cosmetic Act) and that has not previously been 
approved as safe by FDA or USDA between 1938 
and 1958. No such additive may be used until it 
has been subjected to extensive toxicity testing, 
a food additive petition has been submitted to FDA, 
and FDA has approved the additive as safe and 
promulgated a food additive regulation govern- 
ing its use. 
