Bill Summary
This bill, known as the "Humane Research and Testing Act of 2020," aims to amend the Public Health Service Act in order to establish the National Center for Alternatives to Animals in Research and Testing. The purpose of this center would be to promote and fund alternatives to animal research and testing, as well as develop a plan for reducing the number of animals used in federally funded research. The bill also requires covered reporting entities, which receive federal funds and use animals in research, to report the total number of animals used and to develop a plan for reducing these numbers on an annual basis. The bill highlights the need for more accurate tracking of animal use in research and the potential for alternative methods, such as advanced cell cultures, microphysiological systems, and artificial intelligence, to replace animal testing.
Possible Impacts
1. Researchers may need to change their methods of testing and find alternative ways to carry out their research, which could affect the timeline and progress of their work.
2. Animal rights organizations may see this legislation as a step in the right direction towards reducing the use of animals in research and testing, leading to increased support and advocacy for the bill.
3. Pharmaceutical companies may face increased pressure to produce effective and safe medications using non-animal testing methods, potentially leading to changes in their research and development processes.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8633 Introduced in House (IH)]
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116th CONGRESS
2d Session
H. R. 8633
To amend the Public Health Service Act 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
October 20, 2020
Mr. Hastings (for himself, Mr. Buchanan, Mr. Bishop of Georgia, and Ms.
Sherrill) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Humane Research and Testing Act of
2020''.
SEC. 2. FINDINGS.
The Congress finds as follows:
(1) The mission of the National Institutes of Health (NIH)
is to seek fundamental knowledge about the nature and behavior
of living systems and the application of that knowledge to
enhance health, lengthen life, and reduce illness and
disability.
(2) Much of NIH's research is carried out on animals.
However, the precise number of animals used in research in the
United States is unknown. Estimates range between 17 million
and 100 million animals used annually. Such imprecise numbers
make it impossible to effectively track and reduce the numbers
of animals used, as mandated by the NIH policies to ensure the
smallest possible number of animals are used.
(3) There is widespread agreement among scientists and
regulatory agencies that animal models are poor predictors of
the human response, with over 90 percent of new candidate drugs
never making it to market.
(4) More than 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.
An additional 65 percent of candidate drugs that pass animal
trials fail due to lack of efficacy.
(5) Despite the ever-increasing growth in animal
procedures, there is no corresponding increase in the number of
human medicines making it to the clinic.
(6) Dramatically rising costs and extremely high failure
rates in drug development have led many to re-evaluate the
value of animal studies.
(7) Effective alternatives to animals are available and
growing. Cutting-edge technology has forged new frontiers in
biology and medicine that have produced human-relevant models,
including organoid cell cultures, organs-on-chips, genomics,
induced pluripotent adult stem cells, 3D modeling with human
cells, high throughput technology, molecular imaging, computer
models, in silico trials, digital imaging, artificial
intelligence, and other innovative methods--all of which have
launched a technological revolution in biomedical research.
(8) Despite these cutting-edge, human-relevant methods, a
preponderance of NIH research is carried out on animals. A 2019
news release from NIH indicates that 70 percent of NIH grant
applications relate to studies using mice.
(9) The American public has expressed concern about
subjecting animals to the pain of experimentation. This concern
grows as alternatives to research on animals become available.
(10) Under the system of oversight established by the
National Institutes of Health Revitalization Act of 1993
(Public Law 103-43), NIH is supposed to outline a plan for
reducing the use of animals in research. Section 404C(a)(1) of
the Public Health Service Act (42 U.S.C. 283e(a)(1)), as added
by section 205 of the National Institutes of Health
Revitalization Act of 1993, calls for NIH to ``conduct or
support research into . . . methods of biomedical research and
experimentation that do not require the use of animals and
methods of such research and experimentation that reduce the
number of animals used in such research''.
(11) A dedicated center that provides resources, funding,
and training to encourage researchers to utilize humane, cost-
effective, and scientifically suitable non-animal methods is
needed to fulfill the intent of the National Institutes of
Health Revitalization Act of 1993 (Public Law 103-43).
SEC. 3. NATIONAL CENTER FOR ALTERNATIVES TO ANIMALS IN RESEARCH AND
TESTING.
(a) Addition to List of Institutes and Centers.--Section 401 of the
Public Health Service Act (42 U.S.C. 281) is amended--
(1) by redesignating paragraph (25) as paragraph (26); and
(2) by inserting after paragraph (24) the following new
paragraph:
``(25) National Center for Alternatives to Animals in
Research and Testing.''.
(b) Conforming Change to Number of Institutes and Centers.--Section
401(d)(1) of the Public Health Service Act (42 U.S.C. 281(d)(1)) is
amended by striking ``27'' and inserting ``28''.
(c) Establishment; Duties.--Part E of title IV of the Public Health
Service Act (42 U.S.C. 287 et seq.) is amended by inserting after
subpart 5 of such part E (42 U.S.C. 287c-21) the following new subpart:
``Subpart 6--National Center for Alternatives to Animals in Research
and Testing
``SEC. 485E. ESTABLISHMENT; DUTIES.
``(a) Establishment.--Not later than one year after the date of
enactment of the Humane Research and Testing Act of 2020 the Secretary
shall establish a National Center for Alternatives to Animals in
Research and Testing (in this subpart referred to as the `National
Center') within the National Institutes of Health.
``(b) Purposes.--The sole purposes of the National Center shall
be--
``(1) developing, promoting, and funding alternatives to
animal research and testing; and
``(2) developing a plan for reducing the number of animals
used in federally funded research and testing.
``(c) Duties.--The Director of the National Center shall--
``(1) provide assistance (including funding) to federally
funded researchers to incentivize research and testing without
the use of animals, based on advanced cell cultures or
technology such as 3D organoids, microphysiological systems,
induced pluripotent adult stem cell models, in silico modeling,
advanced imaging systems, artificial intelligence, and other
innovative methods;
``(2) train and inform scientists about these available
methods of research and testing without the use of animals;
``(3) establish collaborations among research scientists to
assist those working in institutions where research and testing
scientists may lack resources (such as bioengineering and
advanced bio-imaging equipment) to carry out new and emerging
high-tech methods of research and testing without the use of
animals; and
``(4) tally and make publicly available information on the
numbers of animals used in federally funded research and
testing in order to implement adequate steps to measure the
reduction of animals so used.''.
SEC. 4. REPORTING BY FEDERALLY FUNDED RESEARCH ENTITIES ON NUMBERS OF
ANIMALS USED IN RESEARCH AND TESTING.
(a) In General.--Each covered reporting entity shall do the
following:
(1) Not later than 1 year after the date of enactment of
this Act, report to the National Center for Alternatives to
Animals in Research and Testing and make publicly available--
(A) the total number of animals used in federally
funded research and testing at any facilities of the
covered reporting entity, disaggregated by species; and
(B) the total number of such animals that were bred
or acquired for research or testing purposes,
disaggregated by species.
(2) Every 2 years thereafter, update the latest report of
the entity under this section and make publicly available such
updated report to measure the progress of the covered reporting
entity in reducing the number of animals used in federally
funded research and testing.
(3) On an annual basis, develop and submit to the National
Center for Alternatives to Animals in Research and Testing and
make publicly available a plan for reducing the numbers
described in subparagraphs (A) and (B) of paragraph (1).
(b) Standardized Process.--The Director of the National Center for
Alternatives to Animals in Research and Testing shall establish a
standardized process for submitting and updating reports and plans
under subsection (a), including for making such reports and plans
publicly available.
(c) Definition.--In this section:
(1) The term ``animal''--
(A) means any vertebrate; and
(B) includes all warm-blooded and cold-blooded
species.
(2) The term ``covered reporting entity'' means--
(A) any entity that--
(i) receives Federal funds for research or
testing; and
(ii) uses animals in research and testing;
and
(B) any Federal department or agency that uses
animals in research or testing.
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