248 • Alternatives to Animal Use in Research, Testing, and Education 
In vitro experiments are sometimes sufficient 
to demonstrate utility for patent purposes. In one 
recent case (7), in vitro tests showed that the 
chemical to be patented, an imidazole derivative, 
inhibited thromboxane synthetase in blood plate- 
lets. The activity of thromboxane synthetase was 
thought to be related to hypertension, pulmonary 
vasoconstriction, and other cardiovascular dis- 
eases, and the demonstration of the chemical’s 
ability to inhibit it was sufficient to show utility. 
Data showing therapeutic use were not required 
in showing that an invention had taken place. In 
another case, the fact that the inventor had given 
a detailed description of how the substance to be 
patented would behave was enough to support 
a showing of utility, thus fixing the date of inven- 
tion (24). 
Although the use of alternatives to support pat- 
ents is interesting, it does not have much practi- 
cal effect on the use of animals in developing med- 
ical products because safety and efficacy must be 
demonstrated to satisfy regulatory requirements 
(see ch. 7). These patent cases might have some 
application, however, in demonstrating the suffi- 
ciency of alternatives in other areas. 
COSTS AND BENEFITS IN TESTING 
There are several major economic benefits to 
using animals in toxicological testing. Drugs, food 
additives, pesticides, and many consumer prod- 
ucts are tested for toxicity or other kinds of haz- 
ards before they can be marketed and begin to 
generate income for the manufacturer. This is 
often done to meet regulatory requirements, but 
the tests are also done to avoid marketing unsafe 
products. In addition, testing is done to confirm 
that a product does in fact confer a benefit. 
Testing Pesticides for Toxicity 
Over a billion pounds of pesticides are used in 
the United States annually, corresponding to over 
$4 billion in sales. About 130 firms produce the 
active ingredients in pesticides. Thirty of these 
produce common products in high volume; the 
others tend to produce specialty pesticides . Most 
of the pesticides are used in the agricultural sec- 
tor. About 7 percent are purchased by consumers 
for home and garden use, while industrial and 
institutional use account for about 20 percent (31). 
Because pesticides are designed to be biologi- 
cal poisons, they are among the most toxic sub- 
stances commercially available. Most of the haz- 
ards result from chronic, low-level exposure. 
Exposure and the risk of it are widespread. About 
2 million commercial farms in the United States 
use pesticides, some of which remain in or on the 
food and are eventually consumed. About 40,000 
commercial applicators use pesticides to treat 
structures and facilities. The Environmental Pro- 
tection Agency (EPA) estimates that 90 percent 
of all households regularly use or have used pes- 
ticides in the home, garden, or yard (31). The re- 
sults of tests on animals are used by EPA to iden- 
tify hazards and to develop acceptable exposure 
levels and safe handling and disposal practices (see 
ch. 7). Thus, animal testing plays an important 
role in the protection of virtually the entire U.S. 
population. 
Acute poisonings have been estimated to cost 
over $15 million annually (1980 dollars), exclud- 
ing the value of saving lives or avoiding suffer- 
ing. The estimated cost of each death due to pes- 
ticide poisoning is $112,000, whereas the average 
cost of a nonfatal poisoning is $200 (23,31). The 
costs of cancer, the most important chronic ef- 
fect, is over $34 billion in 1980 dollars, with each 
cancer costing $52,000 (31). One research goal is 
to find new pesticides that are less toxic and more 
effective than those now in use, a search that en- 
tails animal testing. 
There are over 48,000 registered pesticide for- 
mulations, with an estimated 1,400 to 1,500 ac- 
tive ingredients (5). There are between 5 and 20 
new registrations for active ingredients issued an- 
nually, each requiring a complete toxicological 
evaluation based on animal testing and other data. 
Another 1,500 to 2,000 new formulations or uses 
are also registered annually (5,31). These require 
little additional testing, as a rule, and often rely 
on data in EPA’s files. 
