December 20, 2021
Animal Use in Federal Biomedical Research: A Policy Overview
Animals commonly are used in federally funded biomedical
With respect to research, the AWA requires nonfederal
research for a number of reasons—for example, to better
research facilities to register with APHIS and all research
understand the biology of disease or to test the safety and
facilities (federal and nonfederal) to undergo periodic
efficacy of medical products. The existing federal policy
inspections, keep records, submit annual reports to APHIS,
framework generally reflects a balance of animal welfare
and train personnel involved in animal care and treatment
considerations with the scientific value of such research and
on humane practices. Each research facility must establish
encourages the development and use of alternatives to
an Institutional Animal Care and Use Committee (IACUC),
animals where possible. Various federal statutes and
which reviews the facility’s compliance with AWA
policies seek to ensure the welfare of animals used in such
regulations and reports violations to APHIS (nonfederal
research. Different policies apply depending on the type of
facilities) or the head of the agency (federal research
animals used, the entity conducting the research, and the
facilities). A federal agency may revoke a project’s funding
source of funding. Many of the policy requirements place
if it finds that an AWA violation has not been remedied
the primary responsibility for ensuring animal welfare on
following a warning. Research facilities may be subject to
the funded research institution (e.g., a university).
civil penalties for AWA violations.
Separately, enacted legislation and other policy efforts have
There are limitations on the application of the AWA to
sought to reduce, refine, and replace the use of animals in
research. With few exceptions, the AWA does not authorize
biomedical research (principles known as the “Three Rs”).
USDA to regulate the design, guidelines, or performance of
This report provides an overview of certain laws and
research or to interrupt the conduct of research (7 U.S.C.
policies—focusing on the Animal Welfare Act (AWA, 7
§2143(a)(6)).
U.S.C. §§2131-2156) and the Public Health Service Policy
on the Human Care and Use of Laboratory Animals—
Types of Animals: The AWA applies to any live or dead
relevant to animal use and welfare in federally funded
dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or
biomedical research. It does not address all relevant laws
other warm-blooded animal determined by USDA to be
and policies, such as certain related Food and Drug
used for research or exhibition or as a pet. The AWA’s
Administration (FDA) regulations.
statutory definition of animal excludes certain animals,
including birds, rats, and mice bred for research. There are
Background
restrictions on facilities’ procurement of dogs and cats.
In recent decades, rodents (e.g., mice, rats) have become the
predominate type of animal used in biomedical research,
Covered Entities: Under the AWA, research facilities are
driven by scientific advances that have refined rodent
those entities that use live animals for research, tests, or
models for many types of diseases and biological systems.
experiments and that (1) purchase or transport live animals
Large mammals, such as dogs, swine, and nonhuman
or (2) receive federal funds. These entities include federal
primates, remain useful for certain studies. For example, a
and nonfederal facilities.
2020 National Academies of Sciences, Engineering, and
Medicine review (Necessity, Use, and Care of Laboratory
Research Outside the United States: The AWA and its
Dogs at the U.S. Department of Veterans Affairs) found that
regulations do not directly address federally funded
some experiments with dogs “offer the potential for
research conducted by foreign entities. A 2018 Government
medically important discoveries that cannot currently be
Accountability Office (GAO) report (GAO-18-459) found
obtained elsewhere,” especially for studies related to
that APHIS does not instruct federal research facilities
cardiovascular disease and spinal cord injury.
outside of the United States to report on animal research
activities and concluded that providing such instructions
Animal Welfare Act
would increase AWA reporting consistency.
The AWA governs the humane care and treatment of
certain animals that are intended for research, bred for
Public Health Service Policy
commercial sale, exhibited to the public, or commercially
The Public Health Service Policy on the Humane Care and
transported. The U.S. Department of Agriculture’s
Use of Laboratory Animals (PHS Policy) addresses the
(USDA’s) Animal and Plant Health Inspection Service
welfare of animals used in research conducted or supported
(APHIS) develops and administers AWA regulations.
by Public Health Service (PHS) agencies. (PHS agencies
These regulations (9 C.F.R. Part 2) establish minimum
include the National Institutes of Health [NIH], the Centers
standards of care and treatment for certain animals used in
for Disease Control and Prevention [CDC], FDA, and
research, among other uses. USDA must consult with the
others in HHS). Through interagency agreements, the PHS
Secretary of Health and Human Services (HHS) before
policy also applies to research conducted or supported by
issuing AWA regulations.
the Department of Veterans Affairs (VA), the National
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Animal Use in Federal Biomedical Research: A Policy Overview
Science Foundation (NSF), and the National Aeronautics
the International Guiding Principles for Biomedical
and Space Administration (NASA). The statutory basis for
Research Involving Animals. When a domestic funding
the PHS policy is Public Health Service Act, Section 495
recipient conducts animal research at a foreign site, the
(42 U.S.C. §289d). The policy also is informed by the U.S.
domestic institution is responsible for compliance.
Government Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research and Training
Guide for the Care and Use of Laboratory Animals
promulgated in 1985 by the Office of Science and
The Guide serves as a commonly accepted standard for
Technology Policy.
recommended laboratory animal and research management
practices, including detailed recommendations based on the
Under the PHS Policy, any institution that is subject to the
type of animal and procedures involved. The PHS Policy
PHS Policy and conducts animal research using live
requires that institutions base their animal care and use
vertebrate animals must have an Animal Welfare Assurance
programs on The Guide. Developed by a committee of
on file with the Office of Laboratory Animal Welfare
scientists and veterinarians, The Guide was first issued in
(OLAW) at NIH. Each institution subject to the policy must
1963 and most recently updated in 2011 by the National
have an IACUC that reviews and inspects all of the
institution’s animal research and facilities. The IACUC is
Research Council.
required to review new and modified research project
Number and Types of Animals Used
proposals at the institution to ensure that they are in
There is no central public tracking of the number and types
accordance with AWA requirements as applicable, they
of animals used in all federally funded biomedical research.
minimize discomfort and distress to animals consistent with
Based on annual reporting required by the AWA, USDA
sound research design, and they provide adequate
summarizes the number and type of covered animals used
veterinary care and living conditions, among other things.
or held by federal and AWA-registered research facilities
The PHS Policy also tasks IACUCs with ensuring that
for research, testing, teaching, experimentation, and/or
programs are consistent with the Guide for the Care and
surgery. These data are available at the APHIS Research
Use of Laboratory Animals (The Guide) and certain other
Facility Annual Summary & Archive Reports website. They
guidelines, such as euthanasia guidelines from the
include animals used in research other than biomedical
American Veterinary Medical Association (AVMA). Given
research and do not include mice, rats, and other animals
that both AWA and the PHS Policy include separate
not covered by the AWA.
IACUC requirements, many research institutions establish
single IACUCs that satisfy both requirements.
Policy Efforts to Develop and Promote
Research project applications to funding agencies that
Alternatives to Animal Use
involve the use of animals must include a rationale for the
Over the last several decades, the Three Rs have
species, number of animals used, and the procedures
underpinned laboratory animal welfare standards, such as
involved. Projects are subject to annual reporting
The Guide, as well as policy efforts to promote alternatives
requirements on animal use. Noncompliance with the PHS
to animal use. Scientific advances have enabled the
Policy can be reported to and addressed by OLAW.
development of new technologies, such as “tissue chips,”
Agencies can establish additional agency-specific policies.
designed to replicate the complex functions of human
For NIH, the largest federal funder of biomedical research,
organs that can replace animals in certain research. Several
animal welfare plans are reviewed during the grant review
federal efforts, such as the Interagency Coordinating
process (42 C.F.R. §52h.8). If an award is made, then prior
Committee on the Validation of Alternative Methods
to conducting any animal activities, the recipient must
(codified by P.L. 106-545) and the Toxicology in the 21st
submit to the NIH awarding institute or center a research
Century program, seek to develop and promote the use of
plan and meet the Animal Welfare Assurance and IACUC
alternatives to animals in biomedical research and testing.
requirements of the PHS Policy.
A September 2019 GAO evaluation (GAO-19-629) found
that agencies have not consistently assessed such efforts,
Types of Animals: The PHS policy applies to research
and in particular, some of the alternatives developed have
involving live vertebrate animals, including certain types of
not met the research needs of federal agencies or industry.
animals not covered by the AWA, such as rodents and fish.
Per its policy, NIH does not fund invasive research with
Concluding Observations
chimpanzees. There are also procurement-related
There are conflicting views on the current policy
restrictions for cats and dogs.
framework and the need for reform. Some biomedical
science advocates argue that existing policies create an
Covered Entities: The PHS Policy applies to (1) any
administrative burden for researchers and oppose further
institution conducting research funded by a PHS agency
restrictions. Some animal welfare advocates assert that
and (2) institutions conducting research supported by VA,
current policies do not adequately protect animal welfare
NSF, and NASA (through interagency agreements). The
and argue for further restrictions on some or all animal
Department of Defense, which supports considerable
research. Congress may continue to weigh scientific and
biomedical research, has its own animal welfare policy.
ethical considerations.
Foreign Entities: Foreign entities directly receiving NIH
funding must provide OLAW an Animal Welfare
Kavya Sekar, Analyst in Health Policy
Assurance for Foreign Institutions, which ensures that the
Genevieve K. Croft, Specialist in Agricultural Policy
institution complies with applicable animal welfare laws of
IF12002
the jurisdiction in which the research is conducted and with
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Animal Use in Federal Biomedical Research: A Policy Overview


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