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December 20, 2021
Animal Use in Federal Biomedical Research: A Policy Overview
Animals commonly are used in federally funded biomedical
research for a number of reasons-for example, to better
understand the biology of disease or to test the safety and
efficacy of medical products. The existing federal policy
framework generally reflects a balance of animal welfare
considerations with the scientific value of such research and
encourages the development and use of alternatives to
animals where possible. Various federal statutes and
policies seek to ensure the welfare of animals used in such
research. Different policies apply depending on the type of
animals used, the entity conducting the research, and the
source of funding. Many of the policy requirements place
the primary responsibility for ensuring animal welfare on
the funded research institution (e.g., a university).
Separately, enacted legislation and other policy efforts have
sought to reduce, refine, and replace the use of animals in
biomedical research (principles known as the Three Rs).
This report provides an overview of certain laws and
policies-focusing on the Animal Welfare Act (AWA, 7
U.S.C. §§2131-2156) and the Public Health Service Policy
on the Human Care and Use of Laboratory Animals-
relevant to animal use and welfare in federally funded
biomedical research. It does not address all relevant laws
and policies, such as certain related Food and Drug
Administration (FDA) regulations.
Background
In recent decades, rodents (e.g., mice, rats) have become the
predominate type of animal used in biomedical research,
driven by scientific advances that have refined rodent
models for many types of diseases and biological systems.
Large mammals, such as dogs, swine, and nonhuman
primates, remain useful for certain studies. For example, a
2020 National Academies of Sciences, Engineering, and
Medicine review (Necessity, Use, and Care of Laboratory
Dogs at the U.S. Department of Veterans Affairs) found that
some experiments with dogs offer the potential for
medically important discoveries that cannot currently be
obtained elsewhere, especially for studies related to
cardiovascular disease and spinal cord injury.
Animal Welfare Act
The AWA governs the humane care and treatment of
certain animals that are intended for research, bred for
commercial sale, exhibited to the public, or commercially
transported. The U.S. Department of Agriculture's
(USDA's) Animal and Plant Health Inspection Service
(APHIS) develops and administers AWA regulations.
These regulations (9 C.F.R. Part 2) establish minimum
standards of care and treatment for certain animals used in
research, among other uses. USDA must consult with the
Secretary of Health and Human Services (HHS) before
issuing AWA regulations.
With respect to research, the AWA requires nonfederal
research facilities to register with APHIS and all research
facilities (federal and nonfederal) to undergo periodic
inspections, keep records, submit annual reports to APHIS,
and train personnel involved in animal care and treatment
on humane practices. Each research facility must establish
an Institutional Animal Care and Use Committee (IACUC),
which reviews the facility's compliance with AWA
regulations and reports violations to APHIS (nonfederal
facilities) or the head of the agency (federal research
facilities). A federal agency may revoke a project's funding
if it finds that an AWA violation has not been remedied
following a warning. Research facilities may be subject to
civil penalties for AWA violations.
There are limitations on the application of the AWA to
research. With few exceptions, the AWA does not authorize
USDA to regulate the design, guidelines, or performance of
research or to interrupt the conduct of research (7 U.S.C.
§2143(a)(6)).
Types of Animals: The AWA applies to any live or dead
dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or
other warm-blooded animal determined by USDA to be
used for research or exhibition or as a pet. The AWA's
statutory definition of animal excludes certain animals,
including birds, rats, and mice bred for research. There are
restrictions on facilities' procurement of dogs and cats.
Covered Entities: Under the AWA, research facilities are
those entities that use live animals for research, tests, or
experiments and that (1) purchase or transport live animals
or (2) receive federal funds. These entities include federal
and nonfederal facilities.
Research Outside the United States: The AWA and its
regulations do not directly address federally funded
research conducted by foreign entities. A 2018 Government
Accountability Office (GAO) report (GAO-18-459) found
that APHIS does not instruct federal research facilities
outside of the United States to report on animal research
activities and concluded that providing such instructions
would increase AWA reporting consistency.
Public Health Service Policy
The Public Health Service Policy on the Humane Care and
Use of Laboratory Animals (PHS Policy) addresses the
welfare of animals used in research conducted or supported
by Public Health Service (PHS) agencies. (PHS agencies
include the National Institutes of Health [NIH], the Centers
for Disease Control and Prevention [CDC], FDA, and
others in HHS). Through interagency agreements, the PHS
policy also applies to research conducted or supported by
the Department of Veterans Affairs (VA), the National
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