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Executive Summary
The use of animate in scientific research has been a controversial
issue for wed over a hundred years. The basic problem can be
stated quite simply: Research with animals has sacred human lives,
lessened human suffering, and advanced scientific understanding,
yet that same research can cause pain and distress for the animals
involved and usually results in their death. It is hardly surprising
that animal experimentation raises complex questions and generates
strong emotions.
Animal experimentation is an essential component of biomedical
and behavioral research, a critical part of efforts to prevent, cure,
and treat a tract range of ailments. As in the past, investigators are
using animals to learn about the most widespread diseases of the age,
including heart disease and cancer, as weD as to gain basic knowledge
in genetics, physiology, and other life sciences. Animals are also
needed to combat new diseases, of which acquired immune deficiency
syndrome (AIDS) is currently the most prorn~nent ex~nple. At the
same time, behavioral researchers are drawing on animal studies to
learn more about such major causes of human suffering as mental
illness, drug addiction, and senility.
The recognition that animals are essential in scientific research
is critical in making decisions about their use, but these decisions
are also made in the broad context of social and ethical values. In
this report, the committee addresses these issues and examines how
1
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2
USE OF LABORATORY ANIMALS
and why animals are used in research and how society oversees that
research.
PATTERNS OF ANIMAL USE
Data about the numbers and species of animals used for scien-
tific experimentation in the United States come primarily from two
sources: the Nations Research Council's Institute for Laboratory
Animal Resources (ALAR) and the U.S. Department of Agriculture's
Animal and Plant Health Inspection Service (APHIS). Though the
information Tom both of these sources ~ incomplete, it provides a
picture of the magnitude of animal experunentation in the United
States. In 1983, an estimated 17 to 22 million animals were used for
research, testing, and education in the United States. In this case,
Animals includes all vertebrates—namely, mammals, birds, rem
tiles, amphibians, and fish. The majority of animals used between
12 million and 15 million were rats and mice. These quantities are
a small fraction of the total of over 5 billion animals used annually
for food, clothing, and other purposes in the United States.
A significant portion of the laboratory anunals used each year
are involved not in research but in testing. Research and testing
are not always separable, but testing generally entails the use of
animals, primarily rats and mice, to "se" the safety or effectiveness
of consumer products such as drugs, chem~c~s, and cosmetics.
The data concerning the numbers of animals used In testing are
not complete. Various sources estimate that anywhere from several
million to more than half of the approximately 20 million animals
used for research and testing in the United States are used for testing.
In contrast, the use of animals in education is relatively small (i.e.,
only an estimated 53,000 animals are used per year in teaching in
medical and veterinary schools) and has been declining in recent
years.
In general, the data concerning animal use in the United States
must be viewed as uncertain. The Office of Technology Assessment
has concluded that it is not even possible to tell from the existing
data whether the total number of animals used each year is increasing
or decreasing. A survey now being planned by ILAR, the fourth in
a series of ILAR surveys conducted since 1962, will provide some of
this information.
Animal research encompasses a wide range of biomedical ~d
behavioral experiments. One field of behavioral research entails
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EXECUTIVE SUMAL4RY
3
observing animals in colonies that simulate their natural enviror~-
ments. Other animals undergo medical procedures such as surgery
to gauge the effectiveness of new techniques Some are exposed to
toxic substances until death or disability results. Others are killed
immediately to obtain an essential organ or tissue for further studies.
Although long-term survival is sometimes the goal of animal experi-
mentation, most research animals are humanely kiDed at some point
during the course of the research.
BENEFITS DERIVED PROM THE USE OF AN=A[S
The use of animals in biomedical and behavioral research has
greatly increased scientific knowledge and has had enormous benefits
for human health. For example, ~ the United States, animal experi-
mentation has contributed to an increase in average life expectancy
of about 25 years since 1900. A few examples give an indication of
the breadth and variety of these contributions.
. Animals have been used to study cardiovascular function and
disease since the early 1600s. Heart-lung machines, which have made
open-heart surgery possible, were developed with animals before
being used with humans. More than 80 percent of all congenital
heart diseases that were formerly fatal can now be cured by surgical
treatment based on animal experiments. Similarly, a wide variety of
surgical techniques and drug treatments, which have extended life
for ganglions of Americans, were first perfected In animate.
Studies of the biology of transplantation in animals have made
it possible to transfer organs between people. Some 30,000 Americans
now alive have transplanted kidneys, which free them from the labori-
ous and uncomfortable dialysis treatments once needed to keep them
alive. Other Americans are now alive because of transplanted heats
or livers, or have had their lives immeasurably improved because of
skin or cornea transplants. Basic research on transplantation has
also contributed greatly to the understanding of immunology, with
wide ramifications for the treatment of many diseases.
Animal research shed light on the nature of polio and has
helped to nearly eliminate the disease from the United States. In the
early 1900s, researchers succeeded in transmitting the polio virus to
monkeys for the first time. In following years, investigators tested
various altered or inactivated forms of the virus in monkeys until
strains were found that could immunize the monkeys without giving
them the disease. This work led to human vaccines that have reduced
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4
.
USE OF LABORATORY ANIMALS
the number of cases of paralytic polio in the United States from
58,000 in 1952, at the height of one epidemic, to 4 in 1984.
Many clinically useful methodologies were first tested on an-
~mals before being used with humans. Examples include computed
axial tomographic (CAT) scans and magnetic resonance imaging
(MRI).
. Animal studies have been essential In probing the functions
clef the brain in health and disease. Investigators have used animals
to understand movement (and the movement dysfunctions caused
by such diseases as epilepsy and multiple sclerosis), vision, memory
(including the severe memory loss that occurs ire 5 percent of persons
over the age of 65), drug addiction, nerve cell regeneration, learning,
and pain.
The use of animals is important if biomedical research is to
continue to lead to the understanding and amelioration of diseases
such as cancer, diabetes, and uncontrolled infectious diseases. It will
also be essential in efforts to understand and control newly emergent
human diseases. For example, researchers have identified viruses
in monkeys and other animals that cause diseases in those species
sirn~lar to AIDS. These animads can therefore act as mode} systems
for the human disease, allowing investigation of possible treatments
and vaccines.
Animal research does not only benefit humans. Much animal re-
search also benefits animals, either directly because animal health is
the subject of research or indirectly because the same procedures and
treatments used in humans can be used in animals. Most of the ani-
mals that benefit from this research are domesticated and therefore
assist humans in some way—as sources of food and fiber, for instance,
or as pets and companions. Vaccines, antibiotics, anesthetics, and
other products have improved the lives of countless animals.
ALTERNATIVE METHODS IN BlOMEDICAI' AND
BEHAVIORAL RESEARCH
Scientists have been and are searching for alternative methods
to the use of animals in biomedical and behavioral research for a
variety of reasons, including an interest in the welfare of animals, a
concern for the increasing costs of purchasing and caring for animals,
and because in some areas alternative methods may be more efficient
and effective research tools. In current usage, the term "alternative
methods" includes replacements for mammals, reductions in the use
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EXECUTIVE SUMMARY
5
of animals, and refinements in experimental protocols that lessen the
pain of the animals involved.
One way to reduce the use of mammals is to modify experi-
mental protocols so that fewer of them are needed. In the field of
testing, for instance, methods have been found to assess toxicity us-
ing fewer mammals than were once thought necessary. In addition,
in some experimental situations, features of mammals can be mod-
eled by nonmammalian vertebrates (birds, reptiles, amphibians, and
fish), invertebrates, plants, organs, tissues, cells, microorganisms,
and nonbiological systems. For example, research conducted on the
fruit fly Drosophila has led to understandings in genetics that apply
to all living things, and mathematical models can increase the effec-
tiveness of experiments by defining variables and checking theories,
thus making experunents on biological systems more effective ~d
econorn~cal. Finally, experunental protocols can be refined to reduce
the pain and suffering experienced by laboratory animals. These
approaches are all referred to as alternatives.
The search for alternatives to the use of animals In research
and testing remains a valid goal of researchers, but the chance that
alternatives wiD completely replace anunals in the foreseeable future
is nil. Nevertheless, successes have occurred in reducing the numbers
of animals used, in developing nonmammalian modem, and In refining
experunental protocols to reduce the pain experienced by anneals,
and work continues In this area.
Recognizing the above, the committee recommends that:
.
Research investigators should consider possible alternative
methods before using animals In experimental procedures.
To enable researchers better to consider alternatives, it is impor-
tant that they have access to relevant information. The committee
therefore recommends that:
~ Databases and knowledge byes should be further developed
and made available for those seeking appropriate experimental mod-
els for use in the design of research protocob.
Furthermore, although the committee's work has focused mainly
on research, it recommends that:
~ Federal regulatory agencies should move rapidly to accept
tests as such tests become validated- that reduce the number of
vertebrates used, insofar as this does not compromise the regulatory
mission of an agency and protection of the public.
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6
USE OF LABORATORY ANIMALS
REGULATORY ISSUES
The laws and regulations governing animal research reflect the
broad ethical considerations surrounding the use of animals by hu-
mans. The most important federal law affecting animal research in
the United States ~ the Animal Welfare Act. Passed in 1966 and
amended in 1970, 1976, and 1985, the act sets minimum standards for
handling, housing, feeding, and watering laboratory animals and es-
tablishes basic leveL of sanitation, ventilation, and shelter Tom tem-
perature and weather extremes. The law covers those warm-blooded
animals designated by the secretary of the U.S. Department of Agri-
culture, the overseer of the Anunal Welfare Act. At present, this
includes dogs, cats, nonhuman primates, rabbits, hamsters, guinea
pigs, and marine marrunals, but not rats, mice, birds, and farm an-
imals used in biomedical research although rats and mice account
for about 85 percent of the animals used in research, education, and
testing.
The most recent amendments to' the Animal Welfare Act, which
took the form of the Improved Standards for Laboratory Animals
Act of 1985, added several important provisions to the law. The law
requires investigators to consider alternative methods that do not
involve animals and to consult with a veterinarian before beginning
any experiment that could cause pain. It also requires that dogs
receive proper exercise, that primates be provided with environments
that promote their psychological well-being, and that ~} animals
used receive adequate presurgical and po~tsurgical care and pain-
relieving drugs. These mnendments also require that each registered
research facility appoint a committee to monitor animal research
in that institution. These committees must include a veterinarian
and a person unaffiliated with the research facility to represent the
community's interests in animal welfare. Committee members must
inspect the facility's animal laboratories twice a year and report
deficiencies to the institution for correction. If the deficiencies are
not corrected promptly, the U.S. Department of Agriculture must be
notified for enforcement, and any funding agency must be informed
so that it can decide whether to suspend or revoke grants or contracts
to the violator.
A second Tong-standing, important document affecting animal
research in the United States is a product not of the federal gov-
ernment but of the scientific community. In 1963, the Animal Care
Panel released the Guide for Laboratory Animal Facilities and Care.
The Guide has been revised five times since then by ILAR, most
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EXECUTIVE SUMMARY
7
recently in 1985, and has been renames] the Guide for the Care and
Use of Laboratory Animal to reflect its broadened scope. Its purpose
is to assist investigators and institutions in caring for and using laW
oratory animals professionally and humanely. It ~ written in general
terms so that it can be used by the wide variety of institutions that
conduct experiments using animals.
A number of other government agencies and private organiza-
tions have drawn on the Guide In establishing standards for animal
research. The 1985 Health Research Extension Act, which reauthm
rized funding for the National Institutes of Health (NIH), requires
that researchers receiving funding from NIH adhere to the standards
of the Guide. In 1986, the Public Health Service (PHS) which
includes NIH, the Food and Drug Administration, the Centers for
Disease Control, and the Alcohol, Drug Abuse, and Mental Health
Administration released the most recent revision of its policy state-
ment on the humane care and use of laboratory animals. This, too,
requires compliance with the Guide. An Interagency Research An-
im~ Committee incorporated the Guide by reference In its 1985
U.S. Government Principles for the Utilization and Care of Vertex
brate Animals Used in Testing, Research, and Raining. On the
nongovernmental side, the American Association for Accreditation
of Laboratory Animal Care uses the Guide in evaluating the animal
facilities of institutions seeking accreditation.
In addition to requiring compliance with the Guide, the PHS
policy statement and 1985 Health Research Extension Act include
several other important statutory and regulatory changes. They re-
quire that each institution receiving funcIs from PHS maintain an
Institutional Animal Care and Use Committee (IACUC) to monitor
animal research. As with the committees required by the Animal
Welfare Act, each lACUC must mclude one veterinarian and one
individual not affiliated with the institution. Investigators who plan
to use animals must submit their research protocols to these com-
mittees, including a justification for the use of a particular kind of
animal and a demonstration that they have considered methods that
do not use animals.
The use of animals for research, testing, and education is also
regulated in other ways in the United States. For example, the Food
and Drug Administration and the Environmental Protection Agency
have established Good Laboratory Practices (GEP) regulations that
affect the use and care of animals.
Even with this abundance of regulatory activity, self-regulation
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8
USE OF LABORATORY ANVILS
is the most ~rnportant determinant of humane treatment of animate.
Professional societies have set up guidelines to be followed by their
members. TO addition, many individual institutions—governmental,
academic, en c] private have established policies governing animal
experimentation and testing. Many institutions now provide in-
formation and instruction to anneal users on the proper care and
handling of research animals. Most important are m~ividual inves-
tigators; under the review of their institutional animal committees,
they ultimately have the greatest control over and responsibility for
how an animal will be cared for and used. At the same time, most
scientists acknowledge the need for regulations to set m~nunum stan-
dards and provide for public accountability.
Although humane care ~d use of laboratory an~rnals charac-
terize the scientific community, there have been from time to time
some members of this community who have been found to care
inadequately for their animals. The committee believes that the mid
treatment or mishandling of animate is not acceptable. Maltreatment
arid Proper care of animate used in research cannot be tolerated,
and individuals responsible for such behavior must be subject to
censure. Without such punishment, the continued use of animals by
aD scientists is threatened, ~ more regulations and restrictions are
imposed by legislative and regulatory authorities in response to their
perception that scientists who commit abuses are not punished.
Many scientists believe, however, that present regulatory proce-
dures can in some instances be disruptive, ~ that they may decrease
efficiency, increase costs, and slow progress. For instance, obtaining
preliminary approval of all research protocob does delay some exper-
iments. On the other hand, protocol review can help the researcher
when it provides an opportunity for the scientists peers to offer
advice and assistance. This advice may result in a better-planned
experiment that not only improves anunal care and minimizes animal
pain but also leads to more instructive results. In any case, more
extensive regulations may have contributed to the increased expense
of animal research, which constrains the research that can be done.
The requirement that investigators strictly comply with the
Guide for the Care and Use of Laboratory Animals has also raised
difficulties. The 1985 Health Research Extension Act essentially im-
parts the force of law to the Guide, but the Guide was not written
to be a legal document. It was designed to provide for flexibility
in interpretation, guided by professional judgment. As such, it has
served the community of individuals using laboratory animals well
OCR for page 9
EXECUTIVE SUMMARY
9
in the more than 20 years since it was first published. Because it is
now being used to set minimum standards for inspection, it may in
some respects be too rigidly interpreted, ~ in the requirement for
multiple separate areas and rooms for performing aseptic surgery.
If the Guide is to act ~ law, it should be carefully examined and
redrafted as needed to ensure that its language satisfies the intent,
as distinct from the letter, of the law.
In the general area of regulation, the committee recommends the
following:
. No additional laws or regulatory measures (except the regu-
lations required by the Improved Standards for Laboratory Animals
Act of 1985) affecting the use of animals in research should be pro-
mulgated until, based on experience, a careful accounting of the
effects of the application of the present body of laws, regulations,
and guidelines has been made and evidence of the need for more
regulation ~ available.
. A mechanism should be established for ongoing review of
the regulatory framework of federal agencies for animal experunen-
tation. It ~ essential that research scientists who must abide by
this regulatory framework be prominently involved In its assessment.
Specifically, the Guide for the Care and Use of Laboratory Animal
should be reviewed as soon as possible to determine whether revisions
are necessary due to new information.
~ Federal standards developed by different agencies for the care
and use of laboratory animals should be congruent with each other.
~ Sufficient federal funds should be appropriated for the inspec-
tions required for the enforcement of the Animal Welfare Act.
. Sufficient federal funds should be appropriated for mainte-
nance and unprovement of animal facilities to allow individuals and
institutions to conduct animal research in compliance with govern-
ment policies, regulations, and laws. It is important that such funds
should be added to ongoing research support.
USE OF POUND AND!~A[S
One of the most controversial areas in the current debate involves
the use of impounded dogs and cats. The emotions engendered have
resulted in the passage of laws by a number of political jurisdictions
that prohibit or restrict the release of impounded animals for use
in research. These laws create a dilemma: the impounded animals
are not released for use in research but are killed by the pound or
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10
USE OF LABORATORY ANNALS
shelter if not claimed. Each year more than 10 million such animals
are destroyed at pounds or shelters, whereas fewer than 200,000
dogs and cats are released from pounds and shelters to scientific
establishments for use in research less than 2 percent of the number
that are destroyed.
A prohibition against the use of pound animals also means that
more animals are used each year. Instead of using one of the 10
million pound animals that will be destroyecI, different animate are
bred for use in research.
Whether a pound animal or a "purpose-bred~ animal Is the
appropriate research mode! depends on the needs of the experiment.
Pound animals are seen as having varied genetic backgrounds. In
some experiments the genetic variability, because it Is much like
that found naturally ~ humans, is an advantage; in other cases it is
necessary to know the genetic background of the animal, requiring an
animal bred for research. For other experiments it may be necessary
to use purpose-bred animals because the health history, physiological
status, and age of pound anneals are not well enough known to ensure
that conditions present in the animals will not interfere with conduct
of the experiment.
Twelve states have passed laws that prohibit the release of im-
pounded animals for use In research. In 11 of these states, researchers
can use animals impounded in other states, which are legally trans-
ported across state lines by dealers. In Massachusetts, a new law that
went into effect ~ 1986 prohibits researchers from using any animals
from pounds, no matter where those animals were unpounded.
A prohibition against the use of pound animals inevitably in-
creases the costs of animal research because the cost of an animal
from a dealer ~ greater than the cost of a pound animal. If the
impounded dogs used each year in research were not available, a sum
stantial additional cost would be incurred! from buying replacement
dogs from dealers.
In addressing the use of pound animals:
.
The committee unanimously recommends that pound animals
be made available for research in which the experimental animals
are used in acute experiments (i.e., in which the animals remain
anesthetized until they are killed). While a majority of the committee
supports the appropriate use of pound animals in all experiments,
a minority opposes the use of pound animals for chronic, survival
experiments.
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BECUTI~YE SUMMARY
11
American society is a pluralistic society in which public policy
takes into account many different perspectives. No single ideology or
theology governs people's ways of thinking. Similarly, Sections in the
United States do not arise unilaterally from authorities. They reflect
a consensus within society, ~ expressed through people's elected
representatives.
Some people wiD continue to contend that animal research should
be eliminated. The committee rejects such a view. Indeed, the
committee concludes that:
. Humans are moraDy obliged to each other to improve the
human condition. In cases in which research with animals is the best
available method to reach that goal, animals should be used.
The committee also recognizes that:
.
Scientists are ethically obliged to ensure the well-being of
animals used in research and to minimize their pain and suffering.
The corrunittee affirms the principle of humane care of all animals
used in research and recommends that:
· All those responsible for the care and use of animals in re-
search should adhere to the principle that these animals be treated
humanely.
Representative terms from entire chapter:
laboratory animals
