Ch. 12— Public and Private Funding Toward the Development of Alternatives • 265 
of program plans and results to the public (22,23). 
Figure 12-3 illustrates the relative priorities of these 
activities and their components with reference to 
spending in fiscal year 1985. Testing activities con- 
sume by far the largest share of resources. Within 
each of the three divisions, efforts are divided into 
four major areas: mutagenesis (cellular and genetic 
toxicology), carcinogenesis, toxicological charac- 
terization, and fertility and reproduction (repro- 
ductive and developmental toxicology). 
According to the NTP’s "Fiscal Year 1984 Annual 
Plan” (22), planning activities are directed toward 
reducing the number of chemicals that require 
chronic testing through the development, valida- 
tion, and application of more efficient and more 
sensitive testing systems. It is in this area— estab- 
lishing new batteries of tests and subsequently 
validating them— that the development of alter- 
natives is most likely to occur. 
NIEHS directs between $18 million and $20 mil- 
lion toward testing and research related to alter- 
native test systems, especially short-term indica- 
tors of intoxication. Approximately 85 percent of 
this money is channeled through NTP in the form 
of grants for research and testing, R&D contracts 
for testing and development, and in-house re- 
search. These funds cover the actual testing in addi- 
tion to methods validation and evaluation of alter- 
natives. Test systems receiving the bulk of attention 
include bacteria, yeast, insects, and cultured cells 
from mammalian tissues including humans (10). 
Figure 12-3.— Funding Levels of National 
Toxicology Program Activities, Fiscal Year 1985 
(dollars in millions) 
Methods development $13.2 
Carcinogenesis 2.0 
Toxic characterization 4.2 
Mutagenesis 5.5 
Fertility and reproduction ... . 1.5 
Validation $ 5.0 
Carcinogenesis 0.6 
Toxic characterization 1.5 
Mutagenesis 0.9 
Fertility and reproduction ... . ^.0 
Testing $54.5 
Carcinogenesis 28.4 
Toxic characterization 17.0 
Mutagenesis 6.9 
Fertility and reproduction ... . 2.2 
SOURCE: L.G. Hart, Assistant to the Director, National Toxicology Program, 
Research Triangle Park, NC, personal communication, July 1985. 
Beyond NCI, NIEHS, NCTR, and NIOSH (the four 
constituent agencies of NTP), DHHS support for 
research related to toxicology is also found within 
the Alcohol, Drug Abuse, and Mental Health Ad- 
ministration, CDC, FDA, and NIH. Substantial Fed- 
eral support for toxicological research and testing 
is also provided by the Environmental Protection 
Agency (see ch. 11, table 11-3). 
Food and Drug Administration 
FDA conducts primarily mission-oriented, ap- 
plied research. Its interest in alternatives derives 
from FDA requirements for product testing. Al- 
though intramural funds are not allocated on a 
project-by-project basis, the agency has tried to 
estimate expenditures on the basis of person-years 
involved in the work (4). Assuming a person-year 
is $40,000 (salary, overhead, and benefits), in- 
tramural research into alternatives to testing with 
animals was estimated at 35 person-years, an ex- 
penditure of roughly $1.2 million. Extramural 
work consists of one project, valued at $87,000, 
to develop an in vitro model as a primary screen 
to detect active agents against Dirofilaria immitis 
larvae (a heartworm found in the dog, wolf, and 
fox) and microfilariae (the prelarval stage of a para- 
sitic roundworm). For the most part, these in vitro 
models have been developed elsewhere, and these 
projects involve the application to FDA-regulated 
products. Tables 12-2 and 12-3 list alternative tests 
currently under development and in use at the 
Food and Drug Administration. 
Private Funding 
Private sector motivation to develop alternatives 
in testing ranges from scientific concerns through 
economic and political ones. Investors in this sec- 
tor account for perhaps the most diverse group 
of supporters of this type of research. 
Trade and Industrial Groups 
The development of alternatives in testing is sup- 
ported by trade groups and industry for several 
reasons, mostly linked economically to the finan- 
cial health of the company or industry. Commer- 
cial concerns find alternative methods generally 
take less time and labor and are therefore less ex- 
pensive to perform than standard animal-based 
