Humane Research and Testing Act of 2021
This bill establishes the National Center for Alternatives to Animal Research and Testing within the National Institutes of Health to promote alternatives to animal research and testing and to reduce the number of animals used in such research and testing.
In addition, federal departments or agencies and federally funded research entities that use animals for research and testing must develop plans to reduce the use of animals in their activities. They must also annually report the number of animals that they use to the center, and the center must make this information publicly available.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1744 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 1744
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
March 10, 2021
Mr. Hastings (for himself, Mr. Buchanan, Mrs. Beatty, Ms. Roybal-
Allard, and Ms. Brownley) 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
2021''.
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 2021 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.
<all>
Introduced in House
Introduced in House
Sponsor introductory remarks on measure. (CR E221-222)
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
ASSUMING FIRST SPONSORSHIP - Mr. Pappas asked unanimous consent that he may hereafter be considered as the first sponsor of H.R. 1744, a bill originally introduced by Representative Hastings, for the purpose of adding cosponsors and requesting reprintings pursuant to clause 7 of rule XII. Agreed to without objection.
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