Ch. 8— Alternative to Animal Use in Testing • 189 
• Regulatory schemes, product liability law, and 
patent law also incorporate notions of animal 
models. 
• A large body of animal testing information al- 
ready exists that is useful in interpreting new 
testing data. 
• There are substantial costs and delays associ- 
ated with the development and adoption of 
alternatives . One study indicated that it takes 
about 20 years for an in vitro test to be devel- 
oped, validated, adopted, and implemented 
(92). 
At the same time, there are several factors 
facilitating the development and implementation 
of alternatives: 
• Rapid progress is being made in techniques 
for culturing mammalian cells and organs, in 
instruments for detecting and quantifying 
cellular and molecular changes, and in the 
understanding of the cellular and molecular 
processes underlying toxicity. Improved un- 
derstanding is leading to the ability to predict 
long-term effects and carcinogenicity from 
short-term biochemical and morphological 
changes. 
• As such advances are made, the research lab- 
oratories that have developed the expertise 
are often willing to apply it to the develop- 
ment of new testing methods, and can do so 
efficiently (42). 
• Organizations such as The Johns Hopkins Cen- 
ter for Alternatives to Animal Testing and the 
Rockefeller University laboratory have been 
set up to facilitate and coordinate research 
on alternatives (see ch. 12). 
• Many organizations have been established to 
pressure those who conduct animal testing 
or use data based on it to adopt alternatives 
or conduct research that will lead to alter- 
natives. 
Strategies to speed the development and adop- 
tion of alternatives will depend on the needs and 
resources of the organization involved. The fol- 
lowing recommendations encompass a variety of 
perspectives. They were promulgated by the Tox- 
icity Committee of the Fund for the Replacement 
of Animals in Medical Experiments, which met 
from 1979 through 1982 (40). Some involve re- 
assessment of testing needs and priorities; others 
involve technical strategies thought to be likely to 
lead to better methods, both in testing and in evalu- 
ating results: 
• Provide a mechanism for reviewing the need 
for a given test. 
• Investigate the consequences of not requir- 
ing or possessing testing data other than what 
already exists. Particular attention should be 
given to widely used tests such as the LD 50 
and skin and eye irritation tests with a view 
toward eliminating unnecessary requirements . 
• Encourage flexible use of testing guidelines 
and frequent reappraisal of them in light of 
new knowledge. 
• Strive for broader-based international har- 
monization and mutual recognition of data 
from other countries so that duplicative test- 
ing can be avoided. 
• Encourage detailed publication of all testing 
results, particularly for costly or painful tests 
or those requiring many animals. 
• Investigate the possibility of time limits on the 
confidentiality of test results. 
• Make greater use of studies on absorption, 
distribution, biotransformation, and excretion 
in humans, as well as in test animals, to select 
the most relevant exposure conditions, to aid 
in extrapolation of results, and to improve the 
reliability of test results. 
• Perform preliminary studies before undertak- 
ing long-term studies so that results can be 
as useful as possible. 
• Make greater use of the structural and con- 
formational computer models used in devel- 
oping drugs for the prediction of toxicity. 
• Standardize screening tests based on in vitro 
and nonanimal tests, both to promote efficient 
use of testing resources and to evaluate the 
predictiveness of these tests. 
• Try to predict toxic reactions before testing, 
both as a means for improving prediction tech- 
niques and to avoid testing highly irritating 
substances, particularly in the eye, if possible. 
• Conduct research on the mechanisms bv which 
toxic effects occur to facilitate the develop- 
ment of new testing methods. 
• Develop more accurate, reproducible instru- 
mentation for measuring toxic effects, avoid- 
