Bill Summary
The Humane and Existing Alternatives in Research and Testing Sciences Act of 2019, also known as the HEARTS Act, aims to amend the Public Health Service Act to prioritize non-animal methods in research proposals funded by the National Institutes of Health. This is due to concerns about the ethical implications and scientific validity of using animals in research, as well as the availability of more humane and cost-effective alternatives. The Act would establish incentives for researchers to use non-animal methods, require thorough evaluations and justifications for any use of animals, and set guidelines for the care and treatment of animals in research. It would also require researchers to receive training in humane practices and awareness of non-animal methods. Failure to comply with these guidelines could result in the suspension or revocation of grants or contracts.
Possible Impacts
1. This legislation could affect researchers and scientists who rely on animals for their research. They may need to change their methods and find non-animal alternatives, which could be more time-consuming and costly.
2. Animal rights activists and organizations may see this as a victory for their cause and could potentially lead to further legislation limiting or banning the use of animals in research.
3. The government may have to allocate more funds to support the development and use of non-animal methods, which could potentially affect taxpayers.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1209 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 1209
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
February 13, 2019
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 2019'' or the ``HEARTS Act of
2019''.
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 to read as follows:
``SEC. 495. ANIMALS IN RESEARCH.
``(a) In General.--The Secretary, acting through the Director of
NIH, shall, with respect to all research conducted or supported by the
National Institutes of Health, do the following:
``(1) Establish a system of meaningful incentives to
encourage the use of existing humane and scientifically
satisfactory non-animal methods in research proposals.
``(2) Ensure that, before any research involving the use of
animals is approved or performed--
``(A) all scientifically satisfactory non-animal
methods for obtaining the results sought have been
fully evaluated; and
``(B) a detailed explanation and an analysis of the
harms and benefits of such use of animals have been
completed.
``(3) 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.
``(4) Establish and maintain research proposal guidelines
for the following:
``(A) Conducting thorough searches for non-animal
alternatives to the use of animals for biomedical and
behavioral research.
``(B) Carrying out analyses of the harms and
benefits of the use of animals in proposed research to
assess whether the harms that would be caused to
animals in terms of suffering, pain, and distress are
justified by the expected outcomes, taking into account
ethical considerations and the expected benefits to
human beings, animals, or the environment.
``(5) Establish and maintain animal care guidelines for the
following:
``(A) The proper care of animals to be used in
biomedical and behavioral research.
``(B) The proper treatment of animals while being
used in such research. Guidelines under this paragraph
shall require--
``(i) the appropriate use of tranquilizers,
analgesics, anesthetics, paralytics, and
euthanasia for animals in such research; and
``(ii) appropriate pre-surgical and post-
surgical veterinary medical and nursing care
for animals in such research.
Such guidelines shall not be construed to prescribe
methods of research.
``(C) The organization and operation of animal care
committees in accordance with subsection (b).
``(b) Animal Care Committees.--
``(1) In general.--The guidelines under subsection
(a)(5)(C) shall require animal care committees at each entity
which conducts biomedical and behavioral research with funds
provided under this Act (including the National Institutes of
Health and the national research institutes) to assure
compliance with the guidelines established under subsection
(a)(5).
``(2) Appointment of members.--Each animal care committee
shall--
``(A) be appointed by the chief executive officer
of the entity for which the committee is established;
``(B) be composed of not fewer than three members;
and
``(C) include at least one individual who has no
association with such entity and at least one doctor of
veterinary medicine.
``(3) Requirements.--Each animal care committee of a
research entity shall--
``(A) review the care and treatment of animals in
all animal study areas and facilities of the research
entity at least semiannually to evaluate compliance
with applicable guidelines established under subsection
(a)(5) for appropriate animal care and treatment;
``(B) keep appropriate records of reviews conducted
under subparagraph (A); and
``(C) for each review conducted under subparagraph
(A), file with the Director of NIH at least annually--
``(i) a certification that the review has
been conducted; and
``(ii) reports of any violations of the
guidelines under subsection (a)(5) or
assurances required under paragraph (1) which
were observed in such review and which have
continued after notice by the committee to the
research entity involved of the violations.
``(4) Minority views.--Reports filed under paragraph (3)(C)
shall include any minority views filed by members of the
committee.
``(c) Applications and Contracts.--
``(1) Contents.--The Director of NIH shall require each
applicant for a grant, contract, or cooperative agreement
involving research on animals which is administered by the
National Institutes of Health or any national research
institute to include in its application or contract proposal--
``(A) assurances satisfactory to the Director of
NIH that--
``(i) the applicant meets the requirements
under paragraphs (2), (3), (4), and (5) of
subsection (a) and has an animal care committee
which meets the requirements of subsection (b);
and
``(ii) scientists, animal technicians, and
other personnel involved with animal care,
treatment, and use by the applicant have
available to them instruction or training in--
``(I) the humane practice of animal
maintenance and experimentation; and
``(II) the concept, availability,
and use of research or testing methods
that replace the use of animals, limit
the use of animals, or limit animal
distress;
``(B) a statement of the reasons for the use of
animals in the research to be conducted with funds
provided under such grant or contract;
``(C) a statement of assurance that a
scientifically satisfactory non-animal method of
obtaining the result sought is not available; and
``(D) an analysis of the harms and benefits of the
use of animals in the proposed research assessing
whether the harms that would be caused to animals in
terms of suffering, pain, and distress is justified by
the expected outcomes, taking into account ethical
considerations and the expected benefits to human
beings, animals, or the environment.
``(2) Regulatory process.--Notwithstanding subsection
(a)(2) of section 553 of title 5, United States Code,
regulations under this subsection shall be promulgated in
accordance with the notice and comment requirements of such
section.
``(d) Suspension or Revocation.--If the Director of NIH determines
that--
``(1) the conditions of animal care, treatment, or use in
an entity which is receiving a grant, contract, or cooperative
agreement involving research on animals under this title do not
meet applicable guidelines established under subsection (a)(5);
``(2) the entity has been notified by the Director of NIH
of such determination and has been given a reasonable
opportunity to take corrective action; and
``(3) no action has been taken by the entity to correct
such conditions,
the Director of NIH shall suspend or revoke such grant, contract, or
cooperative agreement under such conditions as the Director determines
appropriate.
``(e) Protection of Certain Information.--No guideline or
regulation promulgated under subsection (a)(5) or (c) may require a
research entity to disclose publicly trade secrets or commercial or
financial information which is privileged or confidential.''.
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