Ch. 11— Economic Considerations • 249 
Testing costs vary with the product and its uses. 
Pesticides intended for food crops require much 
more testing than those for other uses. Some of 
the required testing depends on results obtained 
in screening tests. The cost of testing can range 
from $2 million to $5 million for a new active in- 
gredient. This represents a small fraction of the 
total developmental expenses, which may approach 
$100 million (31). Testing costs are incurred pri- 
marily in the beginning of the developmental 
cycle (see fig. 11-2). As the figure illustrates, test- 
ing with animals— during testing for toxicity— is 
an integral part of the development of a new pes- 
ticide. 
Testing and Product Liability 
Toxicological testing of consumer products 
helps keep unsafe products off the market. It also 
may sometimes allow liability for injuries to be 
avoided. The cost of product liability litigation can 
be enormous, and companies are tending to drop 
risky products, as the current situation with vac- 
cines illustrates. 
Most States have "strict liability,” in that a 
manufacturer is liable for whatever injuries its 
products cause. In most jurisdictions, there are 
exceptions, such as when the technology for de- 
termining that a product is unsafe does not ex- 
ist. There are also exceptions when the product 
is known to be dangerous but also to confer a 
great benefit. Such is the case for rabies vaccine. 
A few jurisdictions merely require that a manu- 
facturer not be negligent (see ch. 7.) Manufac- 
turers are unlikely to adopt alternatives to ani- 
mal tests until they believe such methods offer 
a level of assurance of product safety equal to that 
offered by animal testing. 
Testing Costs of Animals 
and the Alternatives 
An estimated 80 percent of the cost of testing, 
whether whole-animal or in vitro, is for labor (6). 
Testing costs vary widely with the assay used and 
somewhat with the facility. The cheapest, such 
as for eye or skin irritation, can be done for un- 
Figure 11-2.— Development of a Typical Pesticide for Agriculture 
(Note the integral role of animal toxicity testing in pesticide development, shown in boldface.) 
Year 
012345678 
Research 
and 
development 
ASynthesis 
A Analytical methods development 
A Preliminary tests for efficacy 
AField trials, product development 
Toxicity 
A Acute and subacute tests, skin and eye sensitization ($25,000) 
A Subchronic tests, fish and bird studies, teratogenicity ($500,000) 
A Chronic effects, carcinogenicity, reproduction ($2-2.5 million) 
A Metabolism and environmental studies ($2 million) 
Registration 
A Apply to EPA for experimental use permit 
ASubmit application for registration to EPA 
Marketing 
A Market research 
A Develop marketing strategy 
A Test market 
Production 
APatent application 
A Process development 
A Design small plant 
A Start up small plant 
A Final plant design 
A Begin construction 
A Start up plant 
Commercialization 
Full 
commercialization 
SOURCE: Office of Technology Assessment, adapted from Haskell Laboratories, E.l. du Pont de Nemours & Company, Wilmington, DE. 1984 
38-750 O 
86 
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