Animal Use in Federal Biomedical Research: A Policy Overview

Animal Use in Federal Biomedical Research: A Policy Overview

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Updated December 28, 2023
Animal Use in Federal Biomedical Research: A Policy Overview
Animals commonly are used in federally funded biomedical
Animal
Summary
research for a number of reasons—for example, to better
Swine (Pigs)
Pigs are used to study heart and lung diseases,
understand the biology of disease or to test the safety and
skin conditions, reproduction and fetal
efficacy of medical products. The existing federal policy
development, and organ transplantation.
framework generally seeks to reflect a balance of animal
Source: CRS review of scientific and policy literature. Table is not
welfare considerations with the scientific value of such
exhaustive of all research uses for the selected animals or of all
research. Federal policy also encourages the development
animals used in federal biomedical research.
and use of alternatives to animals where possible. Different
policies apply depending on the type of animals used, the
Animal Welfare Act
entity conducting the research, and the source of funding.
The AWA governs the humane care and treatment of
Many of the policy requirements place the primary
certain animals that are intended for research, bred for
responsibility for ensuring animal welfare on the funded
commercial sale, exhibited to the public, or commercially
research institution (e.g., a university). Separately, enacted
transported. The U.S. Department of Agriculture (USDA)
legislation and other policy efforts have sought to reduce,
Animal and Plant Health Inspection Service (APHIS)
refine, and replace the use of animals in biomedical
develops and administers AWA regulations. These
research (principles known as the “Three Rs”). This In
regulations (9 C.F.R. Part 2) establish minimum standards
Focus provides an overview of certain laws and policies—
of care and treatment for certain animals used in research,
focusing on the Animal Welfare Act (AWA, 7 U.S.C.
among other uses. USDA must consult with the Secretary
§§2131-2156) and the Public Health Service (PHS) Policy
of Health and Human Services (HHS) before issuing AWA
on Humane Care and Use of Laboratory Animals (PHS
regulations.
Policy)—that guide animal use and welfare in federally
funded biomedical research. The Food and Drug
With respect to research, the AWA requires nonfederal
Administration (FDA) also has regulations governing
research facilities to register with APHIS and all research
animal welfare, including for studies on regulated products
facilities (federal and nonfederal) to undergo periodic
(21 C.F.R. Part 58), that are not discussed in detail herein.
inspections, keep records, submit annual reports to APHIS,
Background
and train personnel involved in animal care and treatment
on humane practices. Research facilities, both federal and
Biomedical research frequently incorporates animal models
nonfederal, must establish an Institutional Animal Care and
to study biological processes, diseases, and potential
Use Committee (IACUC), which reviews the facility’s
treatments. Animal models, in this context, refer to living
compliance with AWA regulations and reports violations to
organisms used to simulate aspects of human biology.
APHIS (nonfederal facilities) or the head of the agency
Table 1 provides a summary of selected animals used in
(federal research facilities). A federal agency may revoke a
research and their common uses.
project’s funding if it finds that an AWA violation has not
Table 1. Selected Uses of Animals in Biomedical
been remedied following a warning. Research facilities may
Research
be subject to civil penalties for AWA violations.
Animal
Summary
There are limitations on the application of the AWA to
Mice and Rats Comprise an estimated 95% of all laboratory
research, since it does not authorize USDA to regulate the
animals. Modern genetics has enabled rodent
design, guidelines, or performance of research or to
models for many human diseases and biological
interrupt the conduct of research (7 U.S.C. §2143(a)(6)).
systems.
Nonhuman
Because of biological similarity to humans, used
Types of Animals: The AWA applies to any live or dead
Primates
for studying complex systems for which other
dog, cat, nonhuman primate, guinea pig, hamster, rabbit, or
animals are incomparable, such as immune,
other warm-blooded animal determined by USDA to be
reproductive, and neurological systems.
used for research or exhibition or as a pet. The AWA’s
Constitute an estimated less than 0.5% of all
statutory definition of animal excludes certain animals,
biomedical research animals.
including birds bred for research, and rats (of genus Rattus)
Dogs and
Dogs are used to study cardiovascular disease,
and mice (of genus Mus) bred for research.
Cats
spinal cord injury, medical imaging, diabetes,
neurology, and infectious diseases. Cats are
Covered Entities: Under the AWA, research facilities are
used for neuroscience and infectious diseases.
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.
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Animal Use in Federal Biomedical Research: A Policy Overview
Public Health Service Policy
Covered Entities: The PHS Policy applies to (1) any
The PHS Policy addresses the welfare of animals used in
institution conducting research funded by a PHS agency
research conducted or supported by PHS agencies. These
and (2) institutions conducting research supported by VA,
include the National Institutes of Health (NIH), the Centers
NSF, and NASA (through interagency agreements). The
for Disease Control and Prevention, FDA, and others in
Department of Defense, which supports considerable
HHS. Through interagency agreements, the PHS Policy
biomedical research, has its own animal welfare policy.
also applies to research conducted or supported by the
Department of Veterans Affairs (VA) the National Science
Guide for the Care and Use of Laboratory Animals
Foundation (NSF), and the National Aeronautics and Space
The Guide serves as a commonly accepted standard for
Administration (NASA). The statutory basis for the PHS
recommended laboratory animal and research management
Policy is Public Health Service Act Section 495 (42 U.S.C.
practices, including detailed recommendations based on the
§289d). The policy also is informed by the U.S.
type of animal and procedures involved. The PHS Policy
Government Principles for the Utilization and Care of
requires that institutions base their animal care and use
Vertebrate Animals Used in Testing, Research and
programs on The Guide. Developed by a committee of
Training, promulgated in 1985 by the Office of Science and
scientists and veterinarians, The Guide was first issued in
Technology Policy.
1963 and most recently updated in 2011 by the National
Research Council.
The PHS Policy places requirements on both the institutions
conducting research and the federal agencies that fund such
Number and Types of Animals Used
research. Covered institutions must have an Animal
There is no central public tracking of the number and types
Welfare Assurance on file with the Office of Laboratory
of animals used in all federally funded biomedical research.
Animal Welfare (OLAW) at NIH. Covered institutions also
Based on annual reporting required by the AWA, USDA
must have an IACUC that reviews and inspects all of the
institution’s animal research and facilities
summarizes the number and type of covered animals used
. (This IACUC
or held by federal and AWA-registered research facilities
requirement is separate from AWA IACUC requirements.)
for research, testing, teaching, experimentation, and/or
The IACUC is required to review new and modified
surgery in categories corresponding to the pain and distress
research project proposals at the institution to ensure that
the animals experienced. These data are available at the
they are in accordance with AWA requirements as
APHIS Research Facility Annual Summary & Archive
applicable, they minimize discomfort and distress to
Reports website. The data include animals used in
animals consistent with sound research design, and they
biomedical as well as in other research and do not include
provide adequate veterinary care and living conditions,
mice, rats, and other animals not covered by the AWA.
among other things. The PHS Policy also tasks IACUCs
with ensuring that programs are consistent with the Guide
Policy Efforts to Develop and Promote
for the Care and Use of Laboratory Animals (The Guide)
Alternatives to Animal Use
and certain other guidelines, such as euthanasia guidelines.
Efforts to develop alternatives to animal use, grounded in
Given that both the AWA and the PHS Policy include
the “Three Rs” principles, have been ongoing. Scientific
separate IACUC requirements, many institutions establish
advances have enabled new technologies, such as “tissue
single IACUCs that satisfy both requirements. Institutions
chips,” designed to replicate human organ functions and
are subject to recordkeeping and annual reporting
replace animals in certain research. Federal efforts,
requirements. Noncompliance with the PHS Policy can be
including the Interagency Coordinating Committee on the
reported to and addressed by OLAW.
Validation of Alternative Methods (codified by P.L. 106-
545) and the Toxicology in the 21st Century program, seek
Research project applications to funding agencies involving
to develop and promote the use of alternative methods. A
animal use require a rationale for species, the approximate
2019 Government Accountability Office (GAO) evaluation
number of animals, and a description of procedures.
(GAO-19-629) found that agencies have not consistently
Agencies can establish additional agency-specific policies.
evaluated such efforts, and in particular, some of the
For NIH, the largest federal funder of biomedical research,
alternatives developed have not met regulatory and industry
animal welfare plans are reviewed during the grant review
needs.
process (42 C.F.R. §52h.8). If an award is made, then prior
to conducting any animal activities, the recipient must
Concluding Observations
submit to the NIH awarding institute or center a research
There are conflicting views on the current policy
plan and meet the Animal Welfare Assurance and IACUC
framework and its potential for reform. Some advocates in
requirements of the PHS Policy. There is a similar review
the biomedical science field contend that the existing
process for NIH intramural research.
policies impose administrative challenges on researchers,
Types of Animals: The PHS policy applies to research
leading them to resist additional restrictions or
involving live vertebrate animals, including certain types of
requirements. Others maintain that the current policies fall
animals not covered by the AWA, such as rodents and fish.
short in safeguarding animal welfare and advocate for
Per its policy, NIH does not fund invasive research with
additional restrictions on some or all animal research.
chimpanzees. In September 2023, OLAW issued proposed
Congress may continue to weigh scientific and ethical
guidance for cephalopod (e.g., octopus) research (NOT-
considerations.
OD-23-176), which would require institutions to include
cephalopods in animal research approval and oversight.
Kavya Sekar, Analyst in Health Policy
Eleni G. Bickell, Analyst in Agricultural Policy
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Animal Use in Federal Biomedical Research: A Policy Overview

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