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OCR for page 18
2
Patterns of Animal Use
Animals are used for a variety of purposes in the United States-
for food and other products; in sports and entertainment; for com-
panionship; for the production of enzymes, hormones, and other
biological products; and in research, testing, and education. The
largest use of anyone Is in food and fiber production, accounting for
over 5 billion vertebrates each year (U.S. Department of Agriculture,
1985~. An estimated 110 million dogs and cats are household pets
in the United States. Between 17 million and 22 million animals are
estimated to be used annually In the United States in research, edu-
cation, and testing. About 85 percent of these are rats and mice, and
less than 2 percent are cats, dogs, and nonhuman primates (O~ce of
Technology Assessment, 1986~.
Animals are used in research to improve the health and welfare
of humans and animals and to gain basic knowledge that cannot be
gained in other ways. Research conducted on animals varies widely in
its impact on the animal subjects themselves. One field of behavioral
research consists of observations of animals living in colonies that
simulate their natural environments but with adequate food supplies
and no predators. In some research projects, animals are subjected to
experimental procedures and then receive supportive care, because
their long-term survival and the validation of methods are the goals
of treatment (examples include the development of organ transplan-
tation and chronic toxicology). Some research animals are subjected
18
OCR for page 19
PATTERNS OF ANNEAL USE
19
to toxic substances and painful procedures until they are disabled or
die, as when determining the lethal dose of radiation used ~ cancer
therapy. Some are killed to obtain an essential organ, such as the
liver, to be used in further studies. Others are anesthetized, sum
jected to an experimental procedure, and killed without regaining
consciousness.
Not only is there considerable variation in how anunals are used,
but there is variation in how many and what types of animus are
used in experiments.
NUMBERS OF ANNALS USED
In 1952 the National Research Council established the Institute
for Laboratory Animal Resources (ALAR) to serve as a coord~nat-
ing agency and an information resource on the use of laboratory
animals. In 1962, 196S, and 197B, ILAR conducted major surveys
of laboratory animal facilities and resources, with the results of the
1978 survey being published by the U.S. Department of Health and
Human Services (National Research Council, 1980~. The 1968 and
1978 ILAR surveys included most of the entities that use animals in
biomedical research, including nonprofit, commercial, rn~litazy, ~d
federal organizations. ILAR is currently planning a fourth survey.
The Animal and Plant Health Inspection Service (APHIS) of
the U.S. Department of Agriculture (USDA) also collects data on
the extent of animal use. Each year APHIS prepares an Animal
Welfare Enforcement Report, which summarizes the annual reports
filed with APHIS by registered research facilities that use animals in
research (U.S. Department of Agriculture, 1972-1987~. All registered
research facilities are required to submit these reports. Institutions
are not required to report on their use of rats, mice, birds, and
domestic farm animals used for research, but the annual report form
has space for voluntary reporting on the use of rats and mice.
Table 1 summarizes information from the lI.AR and APHIS
surveys and from estunates prepared by Health Designs, Inc., for
the Office of Technology Assessment (1986~. As demonstrated by
the table, data from various sources show a lack of consistency. It
should be noted that a considerable decrease was observed between
1967 and 1978 ~ the numbers of animals used as measured by ILAR.
Recent annual reports from APHIS, however, have shown that the
total number of animals used in experimentation (excluding rats,
mice, birds, and wall animals) increased from 1,571,693 In 1983
OCR for page 20
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OCR for page 22
22
USE OF LABORATORY AN~ALS
to 1,633,933 in 1986 (U.S. Department of Agriculture, 1972-1987~.
The Office of Technology Assessment (1986), in evaluating all the
data, has concluded that the available data are too imprecise to
allow any conclusions to be made regarding recent trends in overall
animal use. The ILAR survey being planned will provide more current
information on animal use.
USE OF ANIMALS IN ILESEARCH BY THE
FEDERAL GOVE11NME:NT
The federal government ~ a major user of research annnab.
Specifically, the following departments and agencies use animak for
intramural research and testing (Office of Technology Assessment,
1986).
~ The U.S. Department of Agric?dlure conducts research with
animals to improve animal health and the quality of animal products,
such as food and fiber.
. The U.S. Department of Defense conducts experimental ret
search in a wide variety of areas, with animus being used by the Air
Force, the Army, the Navy, the Uniformed Services University of the
Health Sciences, the Defense Nuclear Agency, and the Armed Forces
Institute of Pathology.
The U.S. Department of Energy conducts research on the
health en c] environmental effects of energy technologies and pro-
grams. Most of this research takes place at the privately man-
aged national laboratories~uch as Brookhaven National Labora-
tory, Oak Ridge National Laboratory, and the Pacific Northwest
I,aboratories and through contracts and grants to scientists em-
ployed at universities snot other research facilities.
The U.S. Department of Health and Human Services carries
out intramural animal research or testing within four of its com-
ponents: the National Institutes of Health (NTH); the Food and
Drug Adnunistration (FDA); the National Institute on Drug Abuse
(NIDA), which ~ part of the Alcohol, Drug Abuse, and Mental
Health Administration (ADAMHA); and the National Institute for
Occupational Safety and Health (NTOSH), which is part of the Cen-
ters for Disease Control. NIH is the largest of these four components
and uses more animals than any other federal department or agency.
The U.S. Department of the Interior, in cooperation with
state and private organizations, conducts research and education
programs to improve fish and wildlife resource management.
OCR for page 23
PATTERNS OF ANIMAL USE
.
23
The U.S. Department of Transportation conducts research
on transportation safety using animals under the authority of the
Hazardous Transportation Act of 1974 and the National Traffic arid
Motor Vehicle Safety Act of 1966.
~ The Consumer Product Safely Commission (CPSC) conducts
tests to determine the toxic potential of consumer products.
The Environmental Protection Agency (EPA) performs re-
search involving animals under the statutory and regulatory author-
ity of the Toxic Substances Control Act and the Federal Insecticide,
Fungicide, and Rodenticide Act.
. The National Aeronautics and Space Administration (NASA)
conducts research with animals to acquire knowledge that can be
used to protect the health of astronauts, both during their rn~ssions
in space and after their return to earth.
The Veterans Administration (VA) uses animals in its ret
search and development divisions and in its education programs.
The Office of Technology Assessment (1986) has estimated that
the total federal use of animate in 1983 was 1.6 million, with about
90 percent of these animals being rats and mice.
USE O1? ANIMALS IN EDUCATION
The number of animus used in education is unknown, but most
observers think that it is relatively small. For example, an estimated
53,000 animals are used annually for teaching in medico and vet-
erinary schools (Office of Technology Assessment, 1986~. However,
animal use in high schools and colleges might be most people's only
contact with laboratory animals, making it an important determi-
nant of how the public feels about such use. This topic is outside
the charge of the committee, but the recent report by the Office of
Technology Assessment (1986) examines the msue in some detail.
USE OF ANNALS IN TESTING
Animals are used extensively to test the safety and efficacy of
compounds produced by the chemical, cosmetic, and drug industries.
The use of so many animals, particularly rats and mice, in testin
cannot be ignored even though the committee was charged primarily
with looking at the use of animals in research. Government regu-
latory agencies, such as FDA, EPA, CPSC, and the Occupational
Safety and Health Administration (OSHA), often explicitly require
OCR for page 24
24
USE OF LABORATORY ANIALALS
the use of an~rnab in testing. A list of some commonly used tests
follows (Office of Technology Assessment, 1986~. Descriptions of
possible alternative methods can be found in Chapter 4.
.
Acute toxicity tests consist of single doses at concentrations
high enough to produce toxic effects or death. They are often used to
screen substances for relative toxicity. The LDso, which is the dose
of a test substance at which half the test an~mais can be expected to
die, Is one such test.
Eye an`] skin irritation tests, which usually consist of a single
exposure, are generally used to develop warnings for handling and
to predict the toxicity of accidental exposure. The most common
method used to test eye irritation is the Druze test, in which a test
substance is applied to one eye of an adult rabbit, with the untreated
eye serving as a control Drape et al., 1944~.
Repeated-dose chronic toxicity tests entail repeated exposures
to substances for periods of two weeks to more than a year to de-
termine the possible effects of long-term exposure. Rats are most
commonly used for these tests.
.
CaTcinogenicity tests involve repeated exposures to sum
stances for most of an animal's lifespan to detect possible human
carcinogens.
. .
Developmental and reproductive toxicity tests consist of a va-
riety of procedures to determine the potential of foreign substances
to cause infertility, miscarriages, and birth defects. Rats and rabbits
are the most commonly used animal subjects.
. Neurotozicity tests use a variety of doses and exposures to
determine toxic effects on the nervous system. Toxic end points
include behavioral changes, lack of coordination, motor disorders,
and learning disabilities in animals.
. Mutagenicity tests include a variety of methods for deter-
m~n~ng whether genetic material of germ or somatic cells has been
changed.
Biological screening tests investigate the biological activity of
organic compounds. Animals may be used in these tests depending
on the type of biological activity being investigated.
Most of the above-mentioned tests require the use of large num-
bers of animals. However, as mentioned earlier, the number of an-
imals used in testing is not known. Most testing Is thought to be
conducted in private commercial establishrr~ents that use primarily
rats and mice, which under current regulations are not subject to the
OCR for page 25
PATTERNS OF ANIMAL USE
25
reporting requirements of the Animal Welfare Act. A recent estunate
of the total number of animals used in testing was "several" moon
(Office of Technology Assessment, 1986~. Another report (Theta
Corporation, 1986) estimated that the use of animals In testing and
industrial research is considerably greater than that, with organi-
zations outside of government and academia accounting for over 75
percent of the estimated 22 million laboratory anunab used annually.
Of these animals, rodents by far are used In the greatest numbers.
1
NEW TECHNOLOGIES AND FUTU1tE [ABO}tATO}lY
USE O1? AN~A[S
The new and rapidly expanding field of biotechnology will have
an impact on the species and numbers of laboratory animate used,
but it is too early to predict precisely its ultunate effects. In some
cases, the number of an~rnab used knight be reduced as biotechnology
provides new testing methods acceptable to governmental regulatory
authorities. In other cases, biotechnology might cause a need for
more animals as wed as shifts ~ the relative numbers of various
species of animals used. At present, the biotechnology industry in
the United States purchases an estunated I! percent of all laboratory
rodents sold, about 5 percent of the swine, and about 2 percent of
the rabbits and dogs, but few prunates or cats (Theta Corporation,
1986~.
Several effects of biotechnology can already be seen. Rabies
virus is widely distributed in nature. It was initially studied by
infecting live laboratory animals with the virus, which led to vaccines
produced using live animals. Recently, new diagnostic tests have been
developed that use monoclonal antibodies produced by cell cultures,
and vaccines are being produced with recombinant DNA technology
(Ereiherr, 1986~. These changes have greatly reduced the use of
animals for this purpose.
Protean such as growth hormone and insulin can now be made
using bioengineering techniques. Although this method of produc-
tion will not eliminate the use of an~rnab, it may reduce the number
used per product, because safety tests can then be performed with
larger batches of a uniform product.
The increasing sophistication in determining molecular structure
and using it to predict biochemical function may reduce the use of
animals. Scientists can use advances in technology to determine the
active sites of molecules and even the attachment sites of viruses.
OCR for page 26
26
USE; OF LABORATORY AN~ALS
Such information may permit drug synthesis to proceed in a more
directed fashion. New compounds developed in this way anti still
require safety and efficacy testing In animate. Animals will also still
be needed for the validation of predicted results.
The numbers of particular animals used could change. For ex-
ample, more mice night be used, because transgenic mice produced
by the m~croinjection of DNA into fertilized mouse eggs constitute
a powerful system for the study of specific genes (Bieberich and
Scangos, 1986~.
SUMMARY
i:
No comprehensive data on the use of animate for research, test-
ng, and education in the private sector are available, and trends
in this use are difficult to gauge. Federal in-house use amounts to
about I.6 million anunab, or best than 10 percent of the estimated 17
million to 22 million animals used annually for research, education,
and testing in the United States. A uniform system of reporting,
while costly, would help to determine more accurately the numbers
of animals used In research, which would make it possible to assess
the impact of policy on trends ~ animal use. Animab are used ex-
tensively in testing the safety and efficacy of compounds produced by
the chemical, cosmetic, and drug industries. Commonly used tests
include those for acute toxicity, eye and skin irritation, repeated-
dose chronic toxicity, carcinogenicity, developmental and reproduc-
tive toxicity, neurotoxicity, mutagenicity, and biological screening.
Future technologies might afford ways of reducing animal use, or
they might lead to a need for more animals or to shifts in the relative
numbers of different species used.
Representative terms from entire chapter:
toxicity tests
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