Humane and Existing Alternatives in Research and Testing Sciences Act of 2021 or the HEARTS Act of 2021
This bill expands the responsibilities of the National Institutes of Health (NIH) to promote research methods that do not use animals. Specifically, the NIH must (1) provide incentives for nonanimal research, and (2) require the evaluation of viable nonanimal alternatives before approving any research that involves animals.
Additionally, NIH applications for research grants involving animals must include an assurance that nonanimal methods for such research are not available.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4101 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 4101
To amend the Public Health Service Act to ensure that non-animal
methods are prioritized, where applicable and feasible, in proposals
for all research to be conducted or supported by the National
Institutes of Health, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 23, 2021
Ms. Roybal-Allard (for herself 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 non-animal
methods are prioritized, where applicable and feasible, in proposals
for all research to be conducted or supported by the National
Institutes of Health, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Humane and Existing Alternatives in
Research and Testing Sciences Act of 2021'' or the ``HEARTS Act of
2021''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) The National Institutes of Health has supported life-
saving research that has greatly improved the health and well-
being not only of Americans but also of people around the
world.
(2) Much of this research has relied on animals. It is
estimated that between 17 million and 22 million animals are
used annually in the United States in research, education, and
testing.
(3) At the same time, however, a great deal of research
that utilized animal studies yielded no benefits for humans.
For example, according to NIH itself, ``approximately 30
percent of promising medications have failed in human clinical
trials because they are found to be toxic despite promising
pre-clinical studies in animal models. About 60 percent of
candidate drugs fail due to lack of efficacy''.
(4) The laboratory use of animals has also long been an
issue of public concern because animals will, in most cases,
experience fear, pain, disease or surgery, and early death.
(5) Much more has become known about the unsuitability of
animal models for studying human disease and many more humane,
cost-effective, and scientifically suitable non-animal methods
are available.
(6) Under the system of oversight established by the Animal
Welfare Act (Public Law 89-544), researchers are supposed to
consider alternatives to animal use or painful procedures and
should not unnecessarily duplicate previous experiments.
However, oversight is generally weak and little heed is paid to
the use of non-animal methods or the avoidance of duplication,
thereby unnecessarily subjecting animals to pain, suffering,
and death.
(7) A system of active incentives is needed to encourage
researchers to utilize humane, cost-effective, and
scientifically suitable non-animal methods.
SEC. 3. ANIMALS IN RESEARCH.
Section 495 of the Public Health Service Act (42 U.S.C. 289d) is
amended--
(1) in subsection (a)--
(A) in paragraph (2)--
(i) in the matter preceding subparagraph
(A), by striking ``paragraph'' and inserting
``subparagraph''; and
(ii) by redesignating subparagraphs (A) and
(B) as clauses (i) and (ii), respectively, and
moving the margins of such clauses (as so
redesignated) two ems to the right;
(B) by redesignating paragraphs (1), (2) (as so
amended), and (3) as subparagraphs (A), (B), and (C),
respectively, and moving the margins of such
subparagraphs (as so redesignated) two ems to the
right;
(C) in the matter preceding subparagraph (A) (as so
redesignated), by striking ``shall establish guidelines
for the following:'' and inserting the following: ``,
with respect to all research conducted or supported by
the National Institutes of Health, do the following:
``(1) Establish and maintain animal care guidelines for the
following:''; and
(D) by adding at the end the following:
``(2) Establish a system of meaningful incentives to
encourage the use of existing humane and scientifically
satisfactory non-animal methods in research proposals.
``(3) Ensure that, before any research involving the use of
animals is approved or performed all scientifically
satisfactory non-animal methods for obtaining the results
sought have been fully evaluated.
``(4) Ensure that--
``(A) research proposals are reviewed by at least
one person who has expertise in non-animal research
methods; and
``(B) reviewers of the research proposals have
access to a reference librarian with expertise in
evaluating the adequacy of the searches for non-animal
methods described in the research proposals.
``(5) Establish and maintain research proposal guidelines
for conducting thorough searches for non-animal alternatives to
the use of animals for biomedical and behavioral research.'';
and
(2) in subsection (c)(1)--
(A) in subparagraph (A), by striking ``and'' at the
end; and
(B) by adding at the end the following:
``(C) a statement of assurance that a
scientifically satisfactory non-animal method of
obtaining the result sought is not available; and''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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