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Researchers know that the care and treatment of laboratory animals is of
prime importance for both ethical and scientific reasons. A comprehensive
system of federal, state, and local agencies have provided consistently high
standards for using animals in research. The following provides an outline
for many of the laws, regulations, and guidelines that must be followed
when using laboratory animals.
U.S. Government Principles for the Utilization and Care of Vertebrate
Animals Used in Testing, Research, and Training
In 1984 the Interagency Research Animal Committee (IRAC) issued nine principles
(see chart below) that underlie our current system of federal regulation for activities
involving vertebrate laboratory animals. IRAC is comprised of representatives from
the following: U.S. Departments of Agriculture, Defense, Energy, Interior, Health and
Human Services, State, Transportation, Veterans Affairs; the Consumer Products Safety
Commission; the Environmental Protection Agency; the National Aeronautics and
Space Administration; the National Science Foundation; the Smithsonian Institution;
U.S. Agency for International Development; Centers for Disease Control and
Prevention; the Food and Drug Administration; the National Institutes of Health;
and the Office of International and Refugee Health.
U.S. Government Principles
- The transportation, care, and use of animals should be in accordance with the Animal Welfare Act
and other applicable federal laws, guidelines, and policies.
- Procedures involving animals should be designed and performed with due consideration of their
relevance to human or animal health, the advancement of knowledge, or the good of society.
- The animals selected for a procedure should be of an appropriate species and quality and the
minimum number required to obtain valid results. Methods such as mathematical models, computer
simulation, and in vitro biological systems should he considered.
- Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain
when consistent with sound scientific practices, is imperative. Unless the contrary is established,
investigators should consider that procedures that cause pain or distress in human beings may cause
pain or distress in other animals.
- Procedures with animals that may cause more than momentary or slight pain or distress should
be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures
should not be performed on unanesthetized animals paralyzed by chemical agents.
- Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved
should be painlessly killed at the end of the procedure or, if appropriate, during the procedure.
- The living conditions of animals should be appropriate for their species and contribute to their
health and comfort. Normally, the housing, feeding, and care of all animals used for biomedical purposes
must be directed by a veterinarian or other scientist trained and experienced in the proper care,
handling, and use of the species being maintained or studied. In any case, veterinary care shall be
provided as indicated.
- Investigators and other personnel shall be appropriately qualified and experienced for conducting
procedures on living animals. Adequate arrangements shall be made for their inservice training,
including the proper and humane care and use of laboratory animals.
- Where exceptions are required in relation to the provisions of these Principles, the decisions should
not rest with the investigators directly concerned but should be made with due regard to Principle 2, by
an appropriate review group such as an institutional animal care and use committee. Such exceptions
should not be made solely for the purpose of teaching or demonstration.
Federal Animal Welfare Act
The Act applies to all research facilities that use animal
species designated by the Secretary of Agriculture.
Facilities must register with the U.S. Department of
Agriculture (USDA) and comply with USDA animal
welfare regulations and guidelines, including: minimal
pain or distress for the animals; adequate veterinary
care including appropriate use of anesthetic, analgesic,
tranquilizing or euthanasia agents; consideration
of alternatives to using animals; not unnecessarily
duplicating previous experiments; adequately trained
personnel; extensive record keeping available upon
inspections; and appropriate care and housing for the
animals. The USDA has unannounced inspections at
least annually of each registered facility. The facilities
are also required to have an Institutional Animal Care
and Use Committee (IACUC) that reviews and
approves procedures in advance. At least one member
of the IACUC must be a veterinarian and another a
``public'' member, a nonscientist not affiliated with
the institution, who represents the interests of the
general community. Noncompliance with any of the
above may result in fines, suspension or revocation
of licenses, and ceaseanddesist orders.
Public Health Service Act
The Health Research Extension Act created a federal
mandate for longstanding policies governing the use
of animals supported by U.S. Public Health Service
(PHS) funds. The PHS includes: the Centers for
Disease Control, the Food and Drug Administration,
the National Institutes of Health, and other programs
of the Office of the Assistant Secretary for Health,
Department of Health and Human Services. The legal
requirements are consistent with and similar to the
Animal Welfare Act and apply to all PHSconducted or
supported research, training, and testing activities
involving the use of vertebrate animals. The Public
Health Service Policy on Humane Care and Use of
Laboratory Animals implements and supplements the
Public Health Service Act and general U.S. Government
Principles. A provision of the Policy is the filing and
annual updating of an Animal Welfare Assurance. It
must fully describe the institution's animal care and
use program and comply with the Animal Welfare Act
and the Guide for the Care and Use of Laboratory
Animals. The NIH Office for Protection from Research
Risks (OPRR) administers the Policy on behalf of
the PHS.
Guide for the Care and Use of
Laboratory Animals
The Guide is widely accepted as the primary reference
on animal care and use. It was compiled by veterinary
and other scientific experts assembled by the Institute
of Laboratory Animal Resources (ILAR) and the
Commission on Life Sciences of the National Research
Council, with the purpose being to assist institutions
in caring for and using animals in a scientifically,
technically, and humanely appropriate manner.
Sections of the Guide include: institutional policies
and responsibilities, animal environment, housing
and management, veterinary medical care, and the
physical plant (facilities).
Good Laboratory Practice Standards
The Food and Drug Administration (FDA) and the
Environmental Protection Agency (EPA) enforce
``Good Laboratory Practice'' (GLP) rules. The GLPs
for both agencies address all reviews of laboratory
operations. Noncompliance with GLPs may result in
the FDA's refusal to consider a study, disqualification
of the testing facility, and recommendation for
criminal prosecution in case of alleged fraud.
Association for the Assessment and
Accreditation of Laboratory Animal
Care International
AAALAC is a voluntary accreditation organization that
works with institutions and researchers to ensure the
highest standards in the care and use of animals. An
accreditation demonstrates an institution is meeting
the minimum requirements by law and also going the
extra step to adhere to excellence in animal wellbeing.
Endangered Species Act
There are many federal and international laws and
agreements that exist to protect animals. The
Endangered Species Act prohibits or controls
acquisition of wild or captivebred, domestic, and
nondomestic animals classified as endangered
or threatened.
State Laws
The typical state requirements relevant to laboratory
animals fall in the following categories: regulation of
research facilities, availability of pound animals for
research, and animal cruelty prevention.
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