Ch. 7— The Use of Animals in Testing • 169 
a variety of exposures to determine the pos- 
sible production of infertility, miscarriages, 
and birth defects; 
• neurotoxicity— a variety of doses and routes 
to determine toxic effects to nerves, with toxic 
end points such as behavioral changes, lack 
of coordination, or learning disabilities; and 
• mutagenicity— a variety of methods for de- 
termining if genetic material of germ or so- 
matic cells has been changed. 
To aid in the design of tests and in the extrapola- 
tion of results to humans, studies are sometimes 
done to determine the mechanisms by which tox- 
icity occurs or to characterize the processes by 
which the test substance enters, is handled, and 
leaves the body. 
The Federal Government has considerable im- 
pact on testing practices through a variety of laws 
and regulations. Sometimes testing is required for 
premarket approval; more often, it is implied by 
requirements for safe and effective products. In 
only a handful of instances, such as the Federal 
Hazardous Substances Act administered by the 
Consumer Product Safety Commission and the 
Hazardous Materials Transportation Act admin- 
istered by the Department of Transportation, do 
Federal statutes explicitly require animal testing. 
The four agencies with the largest roles are the 
Food and Drug Administration, the Environmental 
Protection Agency, the Consumer Product Safety 
Commission, and the Occupational Safety and 
Health Administration. FDA uses animal testing 
data in the approval of food additives, drugs, bio- 
logies, medical devices, and color additives for hu- 
mans and animals. EPA and State Governments 
use such test results in the registration of pesti- 
cides and the regulation of industrial chemicals, 
as well as in the protection of water and air and 
in the regulation of waste disposal. CPSC relies on 
animal data in identifying and regulating risks to 
consumers, while OSHA indirectly uses them in 
requiring employers to maintain a safe workplace. 
Testing also plays an important role in the liabil- 
ity of a manufacturer for unsafe products. In most 
States, a manufacturer is responsible for any in- 
juries arising from use of its products, regardless 
of how much testing was done. Exceptions may 
be made where suitable tests do not exist or the 
product is known to present risks but those risks 
are preferable to the harm that would occur with- 
out the product, as in the case of rabies vaccine. 
Despite the problems of extrapolating to humans 
and other shortcomings of animal testing tech- 
niques, the use of animals in testing is an integral 
part of the Nation’s attempt to protect human 
health. Ideally, as the practice of toxicology ad- 
vances, there will be less emphasis on numerical 
values in certain tests and more consideration of 
the mechanisms by which toxic effects occur. 
CHAPTER 7 REFERENCES 
1. Altman, P.L. (ed .), Pathology of Laboratory Mice and 
Rats (New York: Pergamon Press, 1985). 
2. Berry, C.L., “Reproductive Toxicity,” Animals and 
Alternatives in Toxicity Testing, M. Balls, R.J. Rid- 
dell, and A.N. Worden (eds.) (New York: Academic 
Press, 1983). 
3. Bichler v. Eli Lilly and Company, 436 N.Y.S.2d 625 
(1981). 
4. Bridges, J.W., Chasseaud, L.F., Cohen, G.M., et al., 
"Application of Pharmacokinetics,” Animals and 
Alternatives in Toxicity Testing, M.Balls, R.J. Rid- 
dell, and A.N. Worden (eds.) (New York: Academic 
Press, 1983). 
5. Brusick, D., Principles of Genetic Toxicology (New 
York: Plenum Press, 1980). 
6. Dewar, A. J., "Neurotoxicity ,” Animals and Alterna- 
tives in Toxicity Testing, M. Balls, R.J. Riddell, and 
A.N. Worden (eds.) (New York: Academic Press, 
1983). 
7. Diszfalusy, E. (ed.), Regulation of Human Fertility- 
Proceedings, Symposium on Advances in Fertility 
Regulation (Geneva: World Health Organization, 
1977). 
8. Doull, J., Klassen, C.D., and Amdur, M.O. (eds.), 
Casarett and Doull s Toxicologv: The Basic Science 
of Poisons (New York: Macmillan Publishing Co., 
2d ed., 1980). 
9. Draize, J.H., Woodward, G., and Calvery, H.O., 
"Method for the Study of Irritation and Toxicity of 
Substances Applied Topically to the Skin and Mu- 
