[Senate Report 112-242]
[From the U.S. Government Publishing Office]
Calendar No. 557
112th Congress Report
SENATE
2d Session 112-242
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GREAT APE PROTECTION AND COST SAVINGS ACT
OF 2011
_______
November 30, 2012.--Ordered to be printed
_______
Mrs. Boxer, from the Committee on Environment and Public Works,
submitted the following
R E P O R T
[To accompany S. 810]
[Including cost estimate of the Congressional Budget Office]
The Committee on Environment and Public Works, to which was
referred a bill (S. 810) to prohibit the conducting of invasive
research on great apes, and for other purposes, having
considered the same, reports favorably thereon with an
amendment and recommends that the bill, as amended, do pass.
GENERAL STATEMENT AND BACKGROUND
While chimpanzee research has helped in the past to address
certain diseases, current research is rapidly moving away from
the use of Chimpanzees. At Congress' request, the National
Institutes of Health (NIH) commissioned the Institute of
Medicine (IOM) to assess the current and anticipated need for
chimpanzee biomedical research. After nine months of
evaluation, discussion and review, which included hearing from
the nation's leading experts in chimpanzee research and many
science and animal advocacy groups, the IOM issued its report
in December 2011, concluding--
``While the chimpanzee has been a valuable animal
model in past research, most current use of chimpanzees
for biomedical research is unnecessary, based on the
criteria established by the committee, except
potentially for two current research uses.''
``The present trajectory indicates a decreasing
scientific need for chimpanzee studies due to the
emergence of non-chimpanzee models and technologies.''
The Great Ape Protection and Cost Savings Act of 2011
includes prohibitions on invasive research on great apes. The
legislation also requires the Secretary of Health and Human
Services (HHS), within three years of enactment, to permanently
retire all great apes that are owned by the federal government
and that are being maintained in any facility for the purpose
of conducting invasive research.
However, the bill as reported also recognizes that new or
emerging diseases could present unique challenges in the future
and establishes a process for future consideration of invasive
research necessary to address a new, emerging, or reemerging
threat.
OBJECTIVES OF THE LEGISLATION
The Great Ape Protection and Cost Savings Act of 2011 seeks
to prohibit the conducting of invasive research on great apes,
except in instances where a determination is made that a new,
emerging or reemerging disease requires the use of great apes
for invasive research.
SECTION-BY-SECTION ANALYSIS
Section 1. Short title
Section 1 provides that this Act may be cited as the
``Great Ape Protection and Cost Savings Act of 2012''.
Section 2. Findings and purpose
Section 2 provides Congressional findings regarding
invasive research on great apes and describes the purposes of
the Act.
Section 3. Definitions
Section 3 defines terms used in the Act.
Section 4. Prohibitions
Section 4 prohibits the following--
invasive research on a great ape;
possession or housing a great ape for the
purpose of conducting invasive research;
use of federal funds for invasive research
on a great ape;
breeding of a great ape for the purpose of
conducting or facilitating invasive research;
transport, move, deliver, receive, lease,
rent, donate, purchase, sell, or borrow a great ape in
interstate or foreign commerce for the purpose of
conducting or facilitating invasive research on a great
ape;
transfer of ownership of a great ape by a
Federal agency to any non-Federal entity other than a
suitable sanctuary
Section 4 includes an exemption provision clarifying that
nothing in the Act limits or prevents individualized medical
care performed on a great ape by a licensed veterinarian or
physician for the well-being of the great ape.
Section 5. Invasive research to address human health threats
Section 5 establishes a process for approval of invasive
research when a new, emerging or reemerging disease or disorder
presents a challenge to treatment, prevention or control that
defies non-great ape models and technologies. If research is
approved under this section, the prohibitions of section 4 do
not apply.
Three years after the date of enactment, the Secretary of
Health and Human Services (Secretary) may issue a preliminary
finding that great apes may be required because a new, emerging
or reemerging disease or disorder presents a challenge to
treatment, prevention or control that defies non-great ape
models and technologies.
If the Secretary makes such a finding, the Secretary must
convene the Great Ape Research Task Force, which consists of--
the Secretary,
the Director of the National Institutes of
Health,
the Secretary of Defense,
the Secretary of the Interior,
the President of the Institute of Medicine,
the Chair of the Association of Zoos and
Aquariums Ape Taxon Advisory Group,
an individual appointed by the Secretary
with scientific expertise in the use of great apes in
areas of research relating to the disease or disorder
for which the Task Force is considering authorizing
invasive research,
an individual appointed by the Secretary
with scientific expertise in the use of research models
that do not use great apes in areas of research
relating to the disease or disorder for which the Task
Force is considering authorizing invasive research, and
an individual appointed by the Secretary who
is a representative of an animal protection
organization.
The Task Force must review proposed research protocols and
determine whether to authorize invasive research on great apes.
In reviewing protocols, the Task Force must consult with the
Animal Welfare Information Center. The Secretary must also
allow public comment on any proposed research protocol prior to
final authorization. The Task Force may issue written
authorization for a person to carry out an approved research
protocol if it determines based on the best scientific evidence
available that the following criteria are met--
for invasive research for biomedical
purposes--there is no suitable model available other
than great apes; the research in question cannot be
performed ethically on human subjects; foregoing the
use of great apes will significantly slow or prevent
important advancements to prevent, control, or treat
life-threatening or debilitating conditions; and the
research has not already been found to be unnecessary
by a committee of the Institute of Medicine
for invasive research for comparative
genomics and behavioral studies--a study using great
apes would provide otherwise unattainable insight; each
experiment is performed on acquiescent animals, using
techniques that are minimally invasive, and in a manner
that minimizes pain and distress; and the research has
not already been found to be unnecessary by a committee
of the Institute of Medicine.
The Task Force must require any person carrying out
authorized research to identify each individual great ape on
which research will be performed, minimize pain and physical
and mental harm or distress to the great ape, and maintain the
great ape in ethologically appropriate physical and social
environments throughout the course of the authorized research
protocol.
Section 5 states that the Federal Advisory Committee Act
does not apply to the Task Force.
This section clarifies that nothing in this section
authorizes research on a great ape retired pursuant to the
Chimpanzee Health Improvement, Maintenance, and Protection Act
(P.L. 106-551).
Section 5 requires the Secretary to submit a report to
Congress detailing the findings and recommendations of the
Working Group on the Use of Chimpanzees in NIH-supported
Research of the Council of Councils of the National Institutes
of Health (Working Group). The report must include any
legislative recommendations relating to the Task Force and the
requirements of this section that are necessary to ensure
consistency with the recommendations of the Working Group.
Section 5 authorizes the Secretary to promulgate
regulations to carry out the findings and recommendations of
the Working Group and the requirements of this section.
Section 6. Retirement
Section 6 requires, within three years after the date of
enactment, the Secretary to effectuate the permanent retirement
of all great apes owned by the Federal Government for the
purposes of breeding, holding for, or conducting invasive
research.
This section requires a federally owned great ape selected
for invasive research authorized under Section 5 to be returned
to a suitable sanctuary immediately after the research is
concluded.
Section 7. Civil penalties
Section 7 authorizes a civil penalty of not more than
$10,000 for each violation of a provision of this Act. This
section also clarifies that each day that a violation of this
Act continues shall constitute a separate offense.
Section 8. Great Ape Sanctuary System Fund
Section 8 establishes a Great Ape Sanctuary System Fund to
receive funds equivalent to amounts collected as penalties
under Section 7. Funds may be used for construction,
renovation, and operation of the sanctuary system established
pursuant to section 404K of the Public Health Service Act (42
U.S.C. 283m).
Section 8 requires the Secretary to submit an annual report
on the deposits into and expenditures from the Fund,
recommendations for additional authorities to fulfill the
purpose of the Fund, and a statement of the balance remaining
in the Fund at the end of each fiscal year.
Section 9. Effective dates
Section 9 states that the prohibition on invasive research
in Section 4(a) takes effect on the date that is three years
after the date of enactment for great apes assigned to an
active protocol on the date of enactment and immediately for
great apes not assigned to an active protocol. The prohibitions
in Section 4(b) and (c) on housing a great ape and providing
Federal funding for great apes takes effect three years after
the date of enactment.
Section 10. Severability
Section 10 states that if any provision of the Act is held
invalid or unenforceable in any respect, it shall not affect
any other provision of this Act.
LEGISLATIVE HISTORY
S. 810 was introduced by Senator Cantwell and 14 co-
sponsors on April 13, 2011. The bill was received, read twice,
and referred to the Committee on Environment and Public Works.
On July 25, 2012, the full Committee on Environment and Public
Works met to consider the bill. The bill was ordered reported
favorably, as amended, by voice vote.
HEARINGS
On April 24th, 2012, the Water and Wildlife Subcommittee of
the Senate Environment and Public Works Committee held a
legislative hearing on multiple bills, including S. 810.
ROLLCALL VOTES
The Committee on Environment and Public Works met to
consider S. 810 on July 25, 2012. The Committee adopted an
amendment offered by Senators Boxer and Cardin by voice vote.
The bill, as amended, was ordered reported favorably by voice
vote with Senators Alexander and Johanns recorded as ``no''.
REGULATORY IMPACT STATEMENT
In compliance with section 11(b) of rule XXVI of the
Standing Rules of the Senate, the committee notes that S. 810
would prohibit invasive research on great apes, unless
authorized by the research task force established in the bill.
The bill will not cause any adverse impact on the personal
privacy of individuals.
MANDATES ASSESSMENT
In compliance with the Unfunded Mandates Reform Act of 1995
(Public Law 104-4), the committee noted that the Congressional
Budget Office has found, ``S. 810 would impose
intergovernmental and private-sector mandates as defined in the
Unfunded Mandates Reform Act (UMRA) by prohibiting invasive
research on great apes, unless authorized by the research task
force established in the bill . . . CBO estimates that the cost
of the mandate would be small and would not exceed the annual
thresholds established in UMRA for intergovernmental or
private-sector mandates.''
CONGRESSIONAL BUDGET OFFICE COST ESTIMATE
U.S. Congress,
Congressional Budget Office,
Washington, DC, November 12, 2012.
Hon. Barbara Boxer,
Chairman, Committee on Environment and Public Works,
U.S. Senate, Washington, DC.
Dear Madam Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for S. 810, the Great Ape
Protection and Cost Savings Act of 2011.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Jamease
Miles.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
S. 810--Great Ape Protection and Cost Savings Act of 2011
Summary: The Great Ape Protection and Cost Savings Act of
2011 would prohibit invasive research on a great ape, as well
as the transport or breeding of great apes to be used in such
research within and outside of the United States. For great
apes that are owned by or are under the control of the federal
government, the bill also would require their permanent
retirement and lifetime care in a suitable sanctuary. In
addition, the bill would establish the Great Ape Sanctuary
System Fund to support the construction, renovation, and
operation of the sanctuary system. Civil monetary penalties
collected as a result of violations of the bill would be used
to endow the Great Ape Sanctuary System Fund.
CBO estimates that implementing S. 810 would cost $56
million over the 2013-2017 period, assuming appropriation of
the necessary amounts. Because fines may be collected as a
result of violations of this legislation, there could be an
increase in revenues and direct spending; therefore, pay-as-
you-go procedures apply. However, CBO estimates that any
effects on revenues and direct spending would be insignificant
for each year.
S. 810 would impose intergovernmental and private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
by prohibiting invasive research on great apes, unless
authorized by the research task force established in the bill.
Based on information from public and private entities,
including research institutions, CBO estimates that the cost of
the mandates would be small and would not exceed the
intergovernmental or private-sector thresholds established in
UMRA ($73 million and $146 million, respectively, in 2012,
adjusted annually for inflation).
Estimated cost to the federal Government: The estimated
budgetary impact of S. 810 is shown in the following table. The
costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------
2013 2014 2015 2016 2017 2013-2017
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CHANGES IN SPENDING SUBJECT TO APPROPRIATIONa
Estimated Authorization Level........................... 30 4 8 7 7 56
Estimated Outlays....................................... 9 25 8 7 7 56
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aEnacting S. 810 could affect revenues and direct spending from the collection and spending of fines, but CBO
estimates that any such effects would be insignificant for each year.
Basis of estimate: At present, CBO understands that the
National Institutes of Health (NIH) is the only federal agency
that provides financial support for research that involves the
use of great apes, namely chimpanzees, for invasive research.
NIH also supports research that involves the use of chimpanzees
for behavioral and observational studies. Under the bill,
chimpanzees intended for use in invasive research would be
retired; other chimpanzees would remain available for
behavioral and observational research. Based on a 2011 report
by the Institute of Medicine and National Research Council of
the National Academies, CBO estimates that about 440
government-owned chimpanzees are available for use in invasive
research.
Implementing S. 810 would require start-up expenditures to
establish a suitable sanctuary with sufficient capacity to
accommodate the retired chimpanzees and transport them to the
sanctuary, as well as ongoing costs for the care of the
chimpanzees in the sanctuary. In addition, the budgetary effect
of S. 810 would include any difference between the cost to NIH
of invasive research that uses chimpanzees and the cost of
alternative methods of conducting such studies.
For this estimate, CBO assumes that S. 810 will be enacted
near the end of calendar year 2012 and that the necessary
amounts will be appropriated near the beginning of calendar
year 2013 and near the start of each subsequent fiscal year.
CBO estimates that implementing S. 810 would cost $56 million
over the 2013-2017 period, assuming appropriations of the
necessary amounts.
It is unclear whether S. 810 would authorize appropriations
for the existing sanctuary program for retired great apes. The
amount authorized for that program is capped at a cumulative
total of $30 million. CBO expects that cap will be reached by
2014. This estimate reflects the incremental cost of expanding
the existing sanctuary program to accommodate chimpanzees
retired under S. 810, but does not incorporate the cost of
continuing to operate the existing program after the cumulative
cap on funding is reached.
The bill would allow civil monetary penalties against any
person who violates the bill three or more years after the date
of enactment. Also, it would permit the expenditure of the
amounts collected without subsequent appropriation action. For
this estimate, CBO assumes that the affected chimpanzees would
be retired and housed in a suitable sanctuary by that deadline.
As a result, CBO estimates that any increases in both revenues
(from civil monetary penalties) and direct spending from the
amounts collected would be insignificant.
Construction and transportation costs
The bill would require that all retired apes be placed in
suitable sanctuaries as outlined in the Chimpanzee Health,
Improvement, Maintenance & Protection (CHIMP) Act of 2000. CBO
has identified only one existing sanctuary that meets the
requirements of the CHIMP Act. However, that sanctuary has
space for less than one-quarter of the chimpanzees expected to
retire under the legislation. CBO estimates that expansion of
that facility and transportation of the retired chimpanzees to
the facility would cost about $30 million over three years,
beginning in 2013. (Transportation costs account for less than
$500,000 of that amount.)
If a new sanctuary were established instead of expanding
the existing sanctuary, the construction costs could be
substantially higher and the three-year deadline for complying
with the requirements of S. 810 probably would not be met. Non-
compliance could result in the collection of substantial civil
monetary penalties and direct spending of the amounts
collected.
Cost of caring for chimpanzees
Under S. 810, CBO assumes that all chimpanzees would be
moved to the sanctuary by December 2015. The estimate assumes
that there is space for less than one-quarter of the
chimpanzees estimated to be retired under the bill. Those
chimpanzees could be moved immediately to the sanctuary upon
enactment of the bill. The remaining chimpanzees would be moved
as suitable living space becomes available. In addition, the
estimate assumes that the costs for care of the chimpanzees
will rise with inflation, but that the population of retired
chimpanzees will decline as a result of chimpanzee mortality.
CBO estimates that caring for the retired chimpanzees in the
sanctuary would cost about $26 million over the 2013-2017
period, assuming the appropriation of the necessary funds.
Cost of alternatives to invasive research
By many estimates, chimpanzees and humans share
approximately 98 percent of their DNA and are susceptible to
many of the same infections. As a result, for some disease
research, the chimpanzee is the only established non-human,
animal model in which to test innovative new medicines and to
understand the immune response to those medicines. While the
National Institutes of Health could seek an exception for the
use of a chimpanzee model in such circumstances from the Great
Ape Research Task Force established under S. 810, it is unclear
if an exception would be granted. The cost of developing and
using alternative models for such research would probably
exceed the cost of testing with existing chimpanzee models.
However, because NIH is not required to develop alternative
models and could either prolong the development of such models
or shift their research priorities, CBO cannot determine what
the net change in research spending might be over the next five
years. As a result, CBO estimates that the provision that would
prohibit invasive research using chimpanzees would not have a
significant net effect on research spending by NIH.
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. CBO estimates that the net changes in revenues and
direct spending that are subject to those pay-as-you-go
procedures under S. 810 would be insignificant.
Intergovernmental and private-sector impact: S. 810 would
impose intergovernmental and private sector mandates as defined
in UMRA by prohibiting invasive research on great apes unless
authorized by the research task force established in the bill.
Public and private entities, including research institutions,
that use, breed, house, or transport great apes for invasive
research would be prohibited from continuing those activities.
Based on information from public and private research
institutions, CBO estimates that the cost of the mandate would
be small and would not exceed the annual thresholds established
in UMRA for intergovernmental or private-sector mandates ($73
million and $146 million, respectively, in 2012, adjusted
annually for inflation).
Estimate prepared by: Federal costs: Jamease Miles and
Martin von Gnechten; Impact on state, local, and tribal
governments: Melissa Merrell and Sandra Trevino; Impact on the
private sector: Danielle Parnass and Amy Petz.
Estimate approved by: Holly Harvey, Deputy Assistant
Director for Budget Analysis.
CHANGES IN EXISTING LAW
Section 12 of rule XXVI of the Standing Rules of the Senate
requires the committee to publish changes in existing law made
by the bill as reported. Passage of this bill will make no
changes to existing law.