What This Bill Does
This bill changes how the National Institutes of Health handles research using animals. It requires the NIH to prioritize non-animal research methods (like lab-grown cells and computer models) where applicable and feasible. The bill also creates a new National Center for Alternatives to Animals in Research and Testing to help develop and fund these alternative methods.
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Who It Affects
- The National Institutes of Health and its leadership
- Researchers who receive federal funding for research
- Universities and research institutions that use animals in federally funded studies
- Federal agencies that conduct animal research
- The general public (who will have access to data on animal use in research)
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Key Provisions
- The NIH must establish a system of incentives to encourage researchers to use non-animal methods in their research proposals. (Sec. 3)
- Before any animal research is approved, researchers must fully evaluate all scientifically acceptable non-animal methods that could get the same results. (Sec. 3)
- At least one person with expertise in non-animal research methods must review all research proposals, and reviewers must have access to librarians who specialize in finding non-animal alternatives. (Sec. 3)
- A new National Center for Alternatives to Animals in Research and Testing must be established within the NIH within one year of the law taking effect. (Sec. 4)
- Research institutions and federal agencies using animals must report to the National Center every two years on how many animals they use (broken down by species) and create plans to reduce that number. (Sec. 5)
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What Changes
If this becomes law, researchers applying for NIH funding will face new requirements to prove they have considered non-animal alternatives before proposing animal studies. A new government center will provide funding and training to help scientists develop and use non-animal research methods. For the first time, the public will receive standardized reports showing exactly how many animals are used in federally funded research, which the bill states is currently unknown. Research institutions will be required to set goals for reducing their animal use every two years.
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Important Definitions
The bill defines "animal" as any living, nonhuman vertebrate animal or cephalopod (such as an octopus) used or intended for use in research, training, experiments, or biological testing.
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Effective Date
The National Center must be established not later than one year after the date this bill becomes law. Not specified in bill text for other provisions.
I
118TH CONGRESS
1ST SESSION H. R. 1024
To amend the Public Health Service Act to ensure that nonanimal methods
are prioritized, where applicable and feasible, in proposals for all research
to be conducted or supported by the National Institutes of Health,
to provide for the establishment of the National Center for Alternatives
to Animals in Research and Testing, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 14, 2023
Mr. PAPPAS (for himself and Mr. CALVERT) introduced the following bill;
which was referred to the Committee on Energy and Commerce
A BILL
To amend the Public Health Service Act to ensure that
nonanimal methods are prioritized, where applicable and
feasible, in proposals for all research to be conducted
or supported by the National Institutes of Health, to
provide for the establishment of the National Center
for Alternatives to Animals in Research and Testing,
and for other purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
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•HR 1024 IH
SECTION 1. SHORT TITLE.
1
This Act may be cited as the ‘‘Humane and Existing
2
Alternatives in Research and Testing Sciences Act of
3
2022’’ or the ‘‘HEARTS Act of 2022’’.
4
SEC. 2. FINDINGS.
5
Congress finds the following:
6
(1) The National Institutes of Health (NIH)
7
has supported life-saving research that has greatly
8
improved the health and well-being not only of
9
Americans but also of people around the world.
10
(2) Much of this research has relied on animals.
11
It is estimated that between 17,000,000 and
12
100,000,000 animals are used annually in the
13
United States in research, education, and testing.
14
However, the precise number of animals used in re-
15
search in the United States is unknown. Such im-
16
precise numbers make it impossible to effectively
17
track and reduce the numbers of animals used.
18
(3) According to the NIH, ‘‘approximately 30
19
percent of promising medications have failed in
20
human clinical trials because they are found to be
21
toxic despite promising pre-clinical studies in animal
22
models. About 60 percent of candidate drugs fail
23
due to lack of efficacy.’’. These statistics indicate
24
that new, human-focused biology is needed.
25
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(4) The laboratory use of animals has also long
1
been a matter of public concern because, among
2
other things, there is very little publicly available
3
data provided by the NIH about the number and
4
species of animals used in research.
5
(5) Effective alternatives to animals are becom-
6
ing available, and their number is growing. Cutting-
7
edge technologies have forged new frontiers in toxi-
8
cology, biology, and medicine that have produced
9
human-relevant models, including organoid cell cul-
10
tures, multiphysiological systems, genomics, induced
11
pluripotent adult stem cells, 3D modeling with
12
human cells, molecular imaging, computer models, in
13
silico trials, digital imaging, artificial intelligence,
14
and other innovative methods, all of which have
15
launched a technological revolution in biomedical re-
16
search.
17
(6) The Animal Welfare Act (Public Law 89–
18
544) requires researchers to consider alternatives to
19
animal use for painful procedures and stresses that
20
researchers should not unnecessarily duplicate pre-
21
vious experiments. However, oversight is lacking,
22
and these provisions are not implemented the way
23
that Congress intended. As a result, researchers are
24
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not capitalizing on nonanimal models that might
1
more effectively recapitulate human biology.
2
(7) A system of active incentives is needed to
3
encourage researchers to develop and utilize hu-
4
mane, cost-effective, and scientifically suitable non-
5
animal methods based on human biology.
6
(8) Further, under the National Institutes of
7
Health Revitalization Act of 1993 (Public Law 103–
8
43), the NIH is supposed to outline a plan for re-
9
ducing the use of animals in research. Section
10
404C(a)(1) of the Public Health Service Act (42
11
U.S.C. 283e(a)(1)), as added by section 205 of the
12
National Institutes of Health Revitalization Act of
13
1993, calls for the NIH to ‘‘conduct or support re-
14
search into. . . methods of biomedical research and
15
experimentation that do not require the use of ani-
16
mals [and] methods of such research and experimen-
17
tation that reduce the number of animals used in
18
such research’’.
19
(9) A dedicated center that provides resources,
20
funding, and training to encourage researchers to
21
utilize humane, cost-effective, and scientifically suit-
22
able nonanimal methods based on human biology will
23
result in more progress toward understanding
24
human diseases and their treatments and cures. It
25
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•HR 1024 IH
will complete the vision that Congress set out in the
1
National Institutes of Health Revitalization Act of
2
1993 (Public Law 103–43), which has been thwart-
3
ed because of lack of oversight.
4
SEC. 3. ANIMALS IN RESEARCH.
5
Section 495 of the Public Health Service Act (42
6
U.S.C. 289d) is amended—
7
(1) in subsection (a)—
8
(A) in paragraph (2)—
9
(i) in the matter preceding subpara-
10
graph (A), by striking ‘‘paragraph’’ and in-
11
serting ‘‘subparagraph’’; and
12
(ii) by redesignating subparagraphs
13
(A) and (B) as clauses (i) and (ii), respec-
14
tively, and moving the margins of such
15
clauses (as so redesignated) two ems to the
16
right;
17
(B) by redesignating paragraphs (1), (2)
18
(as so amended), and (3) as subparagraphs (A),
19
(B), and (C), respectively, and moving the mar-
20
gins of such subparagraphs (as so redesignated)
21
two ems to the right;
22
(C) in the matter preceding subparagraph
23
(A) (as so redesignated), by striking ‘‘shall es-
24
tablish guidelines for the following:’’ and insert-
25
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•HR 1024 IH
ing the following: ‘‘, with respect to all research
1
conducted or supported by the National Insti-
2
tutes of Health, do the following:
3
‘‘(1) Establish and maintain animal care guide-
4
lines for the following:’’; and
5
(D) by adding at the end the following:
6
‘‘(2) Establish a system of meaningful incen-
7
tives to encourage the use of existing humane and
8
scientifically satisfactory nonanimal methods in re-
9
search proposals.
10
‘‘(3) Ensure that, before any research involving
11
the use of animals is approved or performed all sci-
12
entifically satisfactory nonanimal methods for ob-
13
taining the results sought have been fully evaluated.
14
‘‘(4) Ensure that—
15
‘‘(A) research proposals are reviewed by at
16
least one person who has expertise in nonanimal
17
research methods; and
18
‘‘(B) reviewers of the research proposals
19
have access to a reference librarian with exper-
20
tise in evaluating the adequacy of the searches
21
for nonanimal methods described in the re-
22
search proposals.
23
‘‘(5) Establish and maintain research proposal
24
guidelines for conducting thorough searches for non-
25
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•HR 1024 IH
animal alternatives to the use of animals for bio-
1
medical and behavioral research.’’; and
2
(2) in subsection (c)(1)—
3
(A) in subparagraph (A), by striking
4
‘‘and’’ at the end; and
5
(B) by adding at the end the following:
6
‘‘(C) a statement of assurance that a sci-
7
entifically satisfactory nonanimal method of ob-
8
taining the result sought is not available; and’’.
9
SEC. 4. NATIONAL CENTER FOR ALTERNATIVES TO ANI-
10
MALS IN RESEARCH AND TESTING.
11
(a) ADDITION TO LIST OF INSTITUTES AND CEN-
12
TERS.—Section 401 of the Public Health Service Act (42
13
U.S.C. 281) is amended—
14
(1) by redesignating paragraph (25) as para-
15
graph (26); and
16
(2) by inserting after paragraph (24) the fol-
17
lowing new paragraph:
18
‘‘(25) The National Center for Alternatives to
19
Animals in Research and Testing.’’.
20
(b) CONFORMING CHANGE TO NUMBER OF INSTI-
21
TUTES AND CENTERS.—Section 401(d)(1) of the Public
22
Health Service Act (42 U.S.C. 281(d)(1)) is amended by
23
striking ‘‘27’’ and inserting ‘‘28’’.
24
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•HR 1024 IH
(c) ESTABLISHMENT; DUTIES.—Part E of title IV of
1
the Public Health Service Act (42 U.S.C. 287 et seq.) is
2
amended by inserting after subpart 5 of such part E (42
3
U.S.C. 287c–21) the following new subpart:
4
‘‘Subpart 6—National Center for Alternatives to
5
Animals in Research and Testing
6
‘‘SEC. 485E. ESTABLISHMENT; DUTIES.
7
‘‘(a) ESTABLISHMENT.—Not later than one year
8
after the date of enactment of the Humane and Existing
9
Alternatives in Research and Testing Sciences Act of
10
2022, the Secretary shall establish a National Center for
11
Alternatives to Animals in Research and Testing (in this
12
subpart referred to as the ‘National Center’) within the
13
National Institutes of Health. The Center shall be headed
14
by a director, who shall be appointed by the Secretary.
15
‘‘(b) PURPOSE.—The general purpose of the National
16
Center shall be—
17
‘‘(1) developing, promoting, and funding alter-
18
natives to animal research and testing; and
19
‘‘(2) developing a plan for reducing the number
20
of animals used in federally funded research and
21
testing.
22
‘‘(c) DUTIES.—The Director of the National Center
23
shall—
24
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•HR 1024 IH
‘‘(1) provide assistance (including funding) to
1
federally funded researchers to incentivize the devel-
2
opment and qualification of nonanimal methods,
3
such as advanced cell cultures or technology such as
4
3D organoids, microphysiological systems, induced
5
pluripotent adult stem cell models, in silico mod-
6
eling, advanced imaging systems, artificial intel-
7
ligence, and other innovative methods;
8
‘‘(2) train and inform scientists about the
9
methods developed pursuant to paragraph (1);
10
‘‘(3) establish collaborations among research in-
11
stitutions so that scientists who lack resources (such
12
as bioengineering and advanced bio-imaging equip-
13
ment) can develop and use methods developed pursu-
14
ant to paragraph (1); and
15
‘‘(4) collect information regarding the numbers
16
of animals used in federally funded research and
17
testing, and make such information available to the
18
public in a timely manner.’’.
19
SEC. 5. REPORTING BY FEDERALLY FUNDED RESEARCH
20
ENTITIES ON NUMBERS OF ANIMALS USED IN
21
RESEARCH AND TESTING.
22
(a) IN GENERAL.—Each covered reporting entity
23
shall do the following:
24
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•HR 1024 IH
(1) Not later than 2 years after the date of en-
1
actment of this Act, report to the National Center
2
for Alternatives to Animals in Research and Testing
3
and make publicly available—
4
(A) the number of animals used by the
5
covered reporting entity in federally funded re-
6
search and testing at facilities of the covered
7
reporting entity, disaggregated by species; and
8
(B) the total number of such animals that
9
were bred or acquired by the covered reporting
10
entity
for
research
or
testing
purposes,
11
disaggregated by species.
12
(2) Every 2 years thereafter—
13
(A) update the latest report of the covered
14
reporting entity under this section and make
15
publicly available such updated report to meas-
16
ure the progress of the covered reporting entity
17
in reducing the number of animals used in fed-
18
erally funded research and testing; and
19
(B) develop and submit to the National
20
Center for Alternatives to Animals in Research
21
and Testing and make publicly available a plan
22
for reducing the numbers described in subpara-
23
graphs (A) and (B) of paragraph (1).
24
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•HR 1024 IH
(b) STANDARDIZED PROCESS.—The Director of the
1
National Center for Alternatives to Animals in Research
2
and Testing shall establish a standardized process for sub-
3
mitting and updating reports and plans under subsection
4
(a), including for making such reports and plans publicly
5
available.
6
(c) DEFINITION.—In this section:
7
(1) ANIMAL.—The term ‘‘animal’’ means any
8
live, nonhuman vertebrate animal or cephalopod
9
used or intended for use in research, research train-
10
ing, experimentation, or biological testing, or for re-
11
lated purposes.
12
(2) COVERED REPORTING ENTITY.—The term
13
‘‘covered reporting entity’’ means—
14
(A) any entity that—
15
(i) receives Federal funds for research
16
or testing; and
17
(ii) uses animals in research and test-
18
ing; and
19
(B) any Federal department or agency
20
that uses animals in research or testing.
21
Æ
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