Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System, 1843-1858 [05-394]
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FOR FURTHER INFORMATION CONTACT:
Michael Infurna, Division of
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Environmental Planning and Protection,
EPA Region 2, 290 Broadway, 22nd
floor, New York, NY 10007; telephone
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SUPPLEMENTARY INFORMATION:
Dated: Novemer 23, 2004.
Kathleen C. Callahan,
Acting Regional Administrator, Region 2.
[FR Doc. 05–503 Filed 1–10–05; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
42 CFR Part 9
RIN 0925–AA31
Standards of Care for Chimpanzees
Held in the Federally Supported
Chimpanzee Sanctuary System
National Institutes of Health,
Department of Health and Human
Services.
ACTION: Notice of proposed rulemaking.
AGENCY:
SUMMARY: The National Institutes of
Health (NIH) proposes to issue
standards to implement provisions of
the Chimpanzee Health Improvement,
Maintenance, and Protection Act
(CHIMP Act) authorizing the Secretary
of the Department of Health and Human
Services (DHHS) to develop and publish
standards of care for chimpanzees held
in the Sanctuary system supported by
Federal funds authorized under the
CHIMP Act. These regulations will
apply to only those facilities receiving
Federal funds as a part of the federally
funded chimpanzee Sanctuary system.
DATES: Comments must be received on
or before March 14, 2005 in order to
assure that NIH will be able to consider
comments in preparing the final rule.
ADDRESSES: You may submit comments,
identified by RIN number 0925–AA31,
by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• E-mail: jm40z@nih.gov. Indicate
RIN number 0925–AA31 in the subject
line of the message.
• Fax: 301–402–0169.
• Mail: Jerry Moore, NIH Regulations
Officer, Office of Management
Assessment, National Institutes of
PO 00000
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1843
Health, 6011 Executive Boulevard, Suite
601, MSC 7669, Rockville, Maryland
20892.
• Hand Delivery/Courier: 6011
Executive Boulevard, Suite 601, MSC
7669, Rockville, Maryland 20892.
FOR FURTHER INFORMATION CONTACT: Jerry
Moore at the address given in the
ADDRESSES section, or telephone 301–
496–4607 (not a toll-free number).
SUPPLEMENTARY INFORMATION: On
December 20, 2000, the United States
Congress enacted the Chimpanzee
Health Improvement, Maintenance, and
Protection Act of 2000 (Pub. L. 106–
551). Section 1 of this law amended the
Public Health Service (PHS) Act by
adding a new section 481C (42 U.S.C.
287a–3a). Section 481C authorizes the
Secretary to provide for the
establishment and operation of a
sanctuary system to provide for the
lifetime care of chimpanzees that have
been used, or were bred or purchased
for use, in research conducted or
supported by the National Institutes of
Health (NIH), the Food and Drug
Administration (FDA), Center for
Disease Control and Prevention, or other
agencies of the Federal Government,
and with respect to which it has been
determined by the Secretary that the
chimpanzees are not needed for such
research (i.e., surplus chimpanzees).
Section 481C (d) directs the Secretary to
establish by regulation standards of care
for operating the Sanctuary system to
provide for the permanent retirement of
surplus chimpanzees. These standards
of care for chimpanzees must ensure the
well-being of animals and the health
and safety of the animals and the people
caring for them. On April 5, 2001, the
Secretary delegated to the Director, NIH,
the authorities to establish and operate
the sanctuary system. Subsequently, the
Director, NIH, delegated the authorities
to the National Center for Research
Resources (NCRR). Consequently, NCRR
has the lead responsibility for
coordinating all efforts on behalf of the
Department of Health and Human
Services (DHHS) concerning the
Sanctuary system for surplus
chimpanzees from both Federal and
non-Federal sources. Section 481C (e)
authorizes the Secretary to make an
award of a contract to a nonprofit
private entity (i.e., Sanctuary
Contractor) under which the entity has
the responsibility of operating (and
establishing, as applicable) the
Sanctuary system and awarding
subcontracts to individual Sanctuary
facilities that meet established
standards. NCRR/NIH must approve
both contractor and subcontractor
awards and NCRR/NIH will verify
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contractor and subcontractor (if
applicable) qualifications through
facility site visits, review of written
documentation submitted to the
contractor, and evaluating available and
current resources.
NCRR/NIH will assure compliance
with the Standards of Care Regulations
through on site visits (at least quarterly
or more often if necessary), review of
quarterly and annual reports, and any
other measures deemed appropriate by
the NCRR/NIH Project or Contracts
Officer. Noncompliance with these
standards or any other federal or state
regulations will result in the NCRR/NIH
invoking the provisions of the contract
that allows the government to terminate
the contract and/or provide a
management team to bring the
Sanctuary back into compliance. The
Sanctuary is covered by the Animal
Welfare Regulations only if covered
activities are performed. The CHIMP
Act requires compliance with the
Animal Welfare Act and the Federal
Contract and these regulations require
the Sanctuary Contractor to register with
the USDA and agree to compliance
inspections. Therefore, the USDA
Inspectors responsible for enforcing the
Animal Welfare Regulations will
perform inspections for compliance
with the Animal Welfare Regulations at
a frequency and time determined by the
USDA staff. Once the contractor
becomes a Registered Facility the USDA
will report noncompliance to NCRR/
NIH as appropriate. The NCRR/NIH
representative will review USDA
inspection reports during on-site visits
in order to monitor compliance with
these proposed Standards of Care
Regulations. The Sanctuary must also
adhere to U.S. Public Health Service
Policy on the Humane Care and Use of
Laboratory Animals. If and when any
noninvasive studies allowed under the
CHIMP Act and these regulations are
proposed for chimpanzees in the
Sanctuary, the Sanctuary Contractor
must obtain an Animal Welfare
Assurance from the NIH Office of
Laboratory Animal Welfare (OLAW) and
comply with the provisions of the
policy. Finally, the Sanctuary must
obtain accreditation or certification by a
nationally or internationally recognized
body that performs such services. The
Sanctuary must achieve accreditation or
certification within a reasonable period
of time as determined by the NCRR/
NIH.
In preparing these proposed standards
of care, we considered the
recommendations of the Board of
Directors of the Sanctuary contractor
and the NCRR Chimpanzee Sanctuary
Working Group, and the applicable
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recommendations of the National
Research Council made in its 1997
report entitled, ‘‘Chimpanzees in
Research—Strategies for Their Ethical
Care, Management, and Use.’’
Individuals involved in developing
recommendations from these groups
represented a variety of professional
areas including veterinary medicine,
chimpanzee behavior, animal
protection, facility management, and
nonhuman primate research and care.
We also consulted other publications,
including: ‘‘The Guide for the Care and
Use of Laboratory Animals,’’ published
by the National Research Council (NRC),
‘‘The Psychological Well-Being of
Nonhuman Primates,’’ also an NRC
publication, ‘‘Public Health Service
Policy on Humane Care and Use of
Laboratory Animals,’’ the accreditation
guidelines used by the Association for
the Assessment and Accreditation of
Laboratory Animal Care, International,
and the American Zoological and
Aquarium Association, and the United
States Department of Agriculture
(USDA), Animal Welfare Regulations
codified in various parts of title 9,
chapter 1, Subchapter A of the Code of
Federal Regulations (CFR).
We propose to amend title 42 of the
CFR by adding a new part 9 to establish
standards for operating the Sanctuary
system to provide for the permanent
retirement of surplus chimpanzees.
These standards of care will apply to
only the sanctuaries that are a part of
the federally funded chimpanzee
Sanctuary system. The proposed rule
specifies the scope and specific
standards that must be met by all
contractors (primary or subcontractors)
operating under the federally supported
Chimpanzee Sanctuary system. The
purpose of this notice is to invite public
comment on the proposed standards of
care.
The following is provided as public
information.
Executive Order 12866
Executive Order 12866, ‘‘Regulatory
Planning and Review,’’ requires that all
regulatory actions reflect consideration
of the costs and benefits they generate,
and that they meet certain standards,
such as avoiding the imposition of
unnecessary burdens on the affected
public. Executive Order 12866 classifies
a rule as a significant regulatory action
if it meets any one of a number of
specific conditions. We determined that
this proposed rule is a ‘‘significant
regulatory action,’’ as defined under
Executive Order 12866, because it raises
novel legal or policy issues. Therefore,
we submitted the proposed rule to the
Office of Information and Regulatory
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Affairs for review prior to publication in
accordance with the requirements of
Executive Order 12866.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5
U.S.C. chapter 6) requires that we
analyze regulatory proposals to
determine whether they create a
significant impact on a substantial
number of small entities. Based on the
analysis that follows, the Secretary
certifies that this proposed rule will not
have such impact when the final rule is
issued.
1. Number and Type of Small Entities
Affected
There are several small entities that
privately fund nonhuman primate
sanctuaries. However, the federally
supported, contractor operated
Chimpanzee Sanctuary System,
established by the CHIMP Act and
covered under the proposed standards
of care, is the only one of its kind in
existence. Congress established the
Sanctuary to provide lifetime care for
chimpanzees that are no longer needed
in federally supported research. The
proposed rule applies only to a
contractor or any subcontractor
operating under a contract funded by
the NIH/NCRR for the Sanctuary. Only
one contractor is identified in the
proposed rule as the prime contractor
for the Sanctuary system. The NCRR
awarded this contract in September
2002. Additionally, a few subcontractors
might be added in future years if the
need arises. The subcontractors would
be selected by the prime contractor
(contingent upon NIH/NCRR approval),
and report to the prime contractor.
Approximately four or five biomedical
research centers with chimpanzees will
be responsible for the transport of
animals to the Sanctuary. The entities
shipping chimpanzees to the Sanctuary
are required to comply with existing
Animal Welfare Regulations
administered by the USDA.
2. Net Cost of Compliance With the
Proposed Rule
At the time NIH/NCRR awarded the
contract in 2002, the contractor was
aware of its role in establishing and
complying with the proposed standards
of care pursuant to the CHIMP Act. The
costs necessary to comply with the
standards of care were anticipated by
the CHIMP Act and subsequent contract
negotiations. The RFP and Statement of
Work noted that Standards of Care
would be developed in consultation
with the selected contractor and that the
contractor must comply with these
standards. The contractor selected had
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several members of their Board of
Directors familiar with chimpanzee care
standards and had served as consultants
to some of the agencies publishing such
standards. Therefore, they included
resources needed to potentially comply
with anticipated standards in their
contract and construction grant
proposals. There could be some
additional unanticipated costs but they
are not obvious at this time. Under the
terms of the contract, the Federal
Government assumes responsibility for
seventy-five percent of the operational
cost that includes compliance with the
proposed standards of care. The net
costs to the contractor are twenty-five
percent of the total costs of care and
maintenance of the chimpanzees,
including compliance with the
proposed standards of care. We estimate
that this will amount to $875,000 to $1
million per year for the contractor. We
anticipate no net increase in the costs as
a result of compliance with the
standards of care. We estimate that five
or six research facilities might incur
expenses in transporting animals to the
Sanctuary, and thus will incur minor
shipping costs (approximately $10,000
to $20,000 for 1 shipment for a total of
six shipments/year.) Subcontractors will
likely have existing facilities and staff
though some might need to be
upgraded. They would be eligible to
compete for NIH Construction Grants
the same as the prime contractor and
thus match 10% of the construction
cost. The use of subcontractors is not
anticipated in the foreseeable future
because of the availability of a
considerable amount of unused space at
the primary contractor. When the need
arises for subcontractors in the
operation of the Sanctuary, they will be
selected by, and report to the prime
contractor, with verification of
qualifications by NCRR/NIH.
3. The Percentage Cost of Compliance
With the Proposed Rule
We estimate that the percentage cost
for complying with the proposed rule is
less than three percent of the total
operational cost of the Sanctuary. We
anticipate that no additional staff is
needed to comply with the proposed
standards of care. The staffing under the
terms of the contract is based upon the
requirement to provide quality care and
maintenance for the chimpanzees as
required by the CHIMP Act and the
contract.
Executive Order 13132
Executive Order 13132, ‘‘Federalism,’’
requires that Federal agencies consult
with State and local government
officials in the development of
regulatory policies with federalism
implications. The Secretary reviewed
this proposed rule as required under the
Order and determined that it will not
have federalism implications. The
Secretary certifies that the proposed rule
will not have an effect on the States or
on the distribution of power and
responsibilities among various levels of
government when the final rule is
issued.
Paperwork Reduction Act
Sections 9.3(a)(7)(v)(C), 9.6(c)(6),
9.6(d), 9.8(a)(4), 9.11(a), 9.11(b)(1)(ii),
and 9.12(b) of this proposed rule
contain reporting information collection
requirements that are subject to OMB
approval under the Paperwork
Reduction Act of 1995, as amended (44
U.S.C. chapter 35). Sections 9.3(a)(11),
9.4(c)(1), 9.4(c)(3), 9.5(c)(4), 9.5(e),
9.6(c)(8), 9.6(c)(10), 9.8(a)(1–4), 9.8(b),
9.9(c), 9.10(a)(1), 9.10(a)(2), 9.10(b)(1),
9.11(a), 9.12(b), contain record keeping
requirements which also are subject to
OMB approval under the Paperwork
Reduction Act. In addition, elements of
disclosure are found in sections
9.3(a)(13), 9.4(c)(2), 9.5(c), 9.5(e),
9.5(f)(2), 9.6(c)(10), 9.9(a)(3), 9.10(a)(1),
9.10(b)(1), and 9.11(a). The title,
description, and respondent description
of the information collection and record
keeping requirements contained in the
proposed rule have been submitted to
OMB for review. Other organizations
and individuals desiring to submit
comments on the information collection
and record keeping requirements should
send their comments to (1) Dr. Charles
MacKay, Project Clearance Officer,
National Institutes of Health, Rockledge
Centre 1, 6705 Rockledge Drive, Room
3509 Bethesda, Maryland 20817,
telephone 301–435–0978 (not a toll-free
number); and (2) the Office of
Information and Regulatory Affairs,
OMB, New Executive Office Building,
Room 10235, 725 17th Street, NW.,
Washington, DC 20503. Attention: Desk
Officer for the National Institutes of
Health, Department of Health and
Human Services. After we obtain OMB
approval, we will publish the OMB
control number in the Federal Register.
Title: Standards of Care for
Chimpanzees Held in the Federallysupported Chimpanzee Sanctuary
System.
Description: The information
collections and record keeping will be
used by NIH and the Sanctuary
contractor and subcontractors to
document proper and adequate care,
identification, accountability, billing,
regulatory compliance, and adherence
to contract specifications and terms.
Respondent Description: Private
nonprofit entities or institutions
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Annual
number of
respondents*
Annual
burden
hours per
response
Avereage
burden
(hours)
Annual
frequency
Reporting:
§ 9.3(a)(7)(v)(C) ........................................................................................
§ 9.6(c)(6) ..................................................................................................
§ 9.6(d) ......................................................................................................
§ 9.8(a)(4) .................................................................................................
§ 9.11(a) ....................................................................................................
§ 9.11(b)(1)(ii) ...........................................................................................
§ 9.12(b) ....................................................................................................
1–3
1–3
1–3
1–3
**1–3
**1–3
1–3
2
3
2
4
1
6
1
6
2
0.5
5
1
2
6
12
6
1
20
12
12
6
Subtotal .............................................................................................
........................
19
22.5
69
Recordkeeping:
§ 9.3(a)(7)(v)(c) .........................................................................................
§ 9.3(a)(10) ...............................................................................................
§ 9.3(a)(11) ...............................................................................................
§ 9.4(c)(1) ..................................................................................................
§ 9.4(c)(3) ..................................................................................................
1–3
**1–3
**1–3
1–3
1–3
2
1
1
1
1
2
8
8
1
6
4
8
8
1
6
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ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN—Continued
Annual
number of
respondents*
Avereage
burden
(hours)
Annual
frequency
Annual
burden
hours per
response
§ 9.5(c)(4) ..................................................................................................
§ 9.5 (e) .....................................................................................................
§ 9.6(c)(8) ..................................................................................................
1–3
1–3
1–3
1
1
5
2
4
0.05
2
4
0.25
Subtotal .............................................................................................
........................
13.00
31.05
33.25
§ 9.6(c)(10) ................................................................................................
§ 9.8(a)(1–4) .............................................................................................
§ 9.8(b) ......................................................................................................
§ 9.9(c) ......................................................................................................
§ 9.10(a)(1) ...............................................................................................
§ 9.10(a)(2) ...............................................................................................
§ 9.10(b)(1) ...............................................................................................
§ 9.11(a) ....................................................................................................
§ 9.12(b) ....................................................................................................
1–3
1–3
1–3
1–3
1–3
1–3
1–3
***1–3
***1–3
4
1
5
12
12
4
3
6
1
0.1
0.5
2
0.2
0.2
3
1.5
1
3
0.4
5
10
2.4
2.4
12
4.5
6
3
Subtotal .............................................................................................
........................
48
11.50
43.30
Disclosure:
§ 9.3(a)(10)** .............................................................................................
§ 9.3(a)(11)** .............................................................................................
§ 9.3(a)(13) ...............................................................................................
§ 9.4(c)(2) ..................................................................................................
§ 9.5 (c) .....................................................................................................
§ 9.5(e) ......................................................................................................
§ 9.5(f)(2) ..................................................................................................
§ 9.6(c)(10) ................................................................................................
§ 9.9(c) ......................................................................................................
§ 9.10(a)(1) ...............................................................................................
§ 9.10(b)(1) ...............................................................................................
§ 9.11(a)*** ................................................................................................
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
1–3
6
1
1
1
1
****1
0.2
4
10
10
1
2
0.5
0.5
1
0.1
8
2
8
0.1
0.2
0.2
0.2
1
3
1
1
0.1
8
2
1.6
0.4
2
2
0.2
2
Subtotal .............................................................................................
........................
38.2
21.8
23.3
Total ...................................................................................................
1–3
118.2
.85
168.25
* Presently, there is only one (1) respondent, the Contractor for the federally supported Chimpanzee Sanctuary System. The estimates are
based upon a maximum of three (3) respondents in the future.
** See also §§ 9.5(c) & 9.5(e).
*** The reporting requirements for these sections vary because it is estimated that chimpanzees will be shipped six (6) times per year. This requires 6 notifications of shipment notices to the Project Officer. While not anticipated, it is possible that approximately one (1) of these shipments
might require reporting because of undesirable conditions, a death, failure to provide adequate food or water, or other conditions affecting animal
welfare. Such incidents must be reported immediately to the NCRR Project Officer who will in turn work with the USDA representatives in investigating the matter.
**** 1 × event.
9.1
9.2
9.3
9.4
9.5
List of Subjects in 42 CFR Part 9
Animal welfare, Humane care and
treatment of chimpanzees.
Dated: April 28, 2004.
Elias A. Zerhouni,
Director, National Institutes of Health.
Approved: September 29, 2004.
Tommy G. Thompson,
Secretary.
Accordingly, NIH proposes to amend
title 42 of the Code of Federal
Regulations by adding part 9 to read as
follows:
PART 9—STANDARDS OF CARE FOR
CHIMPANZEES HELD IN THE
FEDERALLY SUPPORTED
SANCTUARY SYSTEM
Applicability and purpose.
Definitions.
Sanctuary policies and responsibilities.
Physical facility policies and design.
Chimpanzee ownership, fees, and
studies.
9.6 Animal care, well-being, husbandry,
veterinary care, and euthanasia.
9.7 Reproduction.
9.8 Animal records.
9.9 Facility staffing.
9.10 Occupational Health and Safety
Program and biosafety requirements.
9.11 Animal transport.
9.12 Compliance with the Standards of
Care, USDA and PHS policies and
regulations.
9.13 Other Federal laws, regulations, and
policies that apply to this part.
9.14 Authority of the Secretary of Health
and Human Services to amend or issue
additional standards of care regulations.
Sec.
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Authority: 42 U.S.C. 216, 287a–3a.
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§ 9.1
Applicability and purpose.
(a) General. The standards of care set
forth in this part apply to the
chimpanzee sanctuaries that are
contracted (or subcontracted) to the
Federal Government to operate the
federally supported chimpanzee
Sanctuary system authorized by section
481C of the Public Health Service (PHS)
Act, as amended (42 U.S.C. 287a—3a).
(b) What is the purpose of the
federally supported chimpanzee
Sanctuary system and the authority for
establishing these standards of care
regulations? The Chimpanzee Health
Improvement, Maintenance, and
Protection Act (Public Law 106–551,
referred to as the ‘‘CHIMP Act’’ or
‘‘Chimpanzee Retirement Act’’) was
enacted by Congress to provide for the
establishment and operation of a
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Sanctuary system to provide lifetime
care for chimpanzees that have been
used, or were bred or purchased for use,
in research conducted or supported by
the agencies of the Federal Government,
and that are determined to be no longer
needed for such research. The CHIMP
Act also mandates that standards of care
for chimpanzees in the Sanctuary shall
be developed to ensure the well-being of
chimpanzees and the health and safety
of the chimpanzees.
(c) To what chimpanzee sanctuaries
do the standards of care in this part
apply? The standards of care set forth in
this part apply to only those sanctuaries
that are contracted or subcontracted to
the Federal Government to operate the
federally supported chimpanzee
Sanctuary system.
§ 9.2
Definitions.
As used in this part:
Adequate veterinary care means a
program directed by a veterinarian
qualified through training and/or
experience to provide professional
medical care to the chimpanzees within
the Sanctuary and with the appropriate
authority to provide this care. The
program also provides guidance to all
caregivers on all matters relating to the
health and well-being of the
chimpanzees.
American Zoo and Aquarium
Association (AZA) means the
professional society comprised of
individuals with various backgrounds
and interests that is devoted to
advancing the knowledge and
understanding of zoo animals and the
management of zoos in the United
States.
American Zoo and Aquarium
Association (AZA) Accreditation
Standards are those standards
developed by the AZA that are used to
review, evaluate, and accredit zoos or
zoological gardens. These standards
cover a variety of areas including
facilities, policies and procedures,
training, staff qualifications, medical
and animal care, husbandry and wellbeing procedures, and conservation,
along with other specific areas.
Animal Care and Use Committee
means the Institutional Animal Care and
Use Committee established under
section 13(b) of the Animal Welfare Act
of 1985 and the Health Research
Extension Act of 1985. For the purpose
of these Standards of Care, it shall
consist of at least five (5) members
including the Chairperson, a Doctor of
Veterinary Medicine (D.V.M. or V.M.D.)
knowledgeable in nonhuman primate
care and diseases and with delegated
program responsibility, a member not
affiliated with the Sanctuary, a scientist,
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and a member of the animal protection
community. This Committee is required
if research as defined by the Animal
Welfare Act Regulations and the Public
Health Service Policy (research,
teaching, testing, exhibition) is to be
conducted at the Sanctuary.
Animal protection organization
means a nonprofit organization whose
primary mission is protection of animals
through positive advocacy and action.
Animal Resource Manager (or Animal
Resource Supervisor) means the
individual employee responsible for
managing the non-professional staff
providing care for the chimpanzees at
the Sanctuary. This individual may
perform other duties as assigned by the
Sanctuary contractor.
Animal Welfare Act/Regulations
means the Act of August 24, 1966 (Pub.
L. 89–544), (commonly known as the
Laboratory Animal Welfare Act) as
amended by the Act of December 24,
1970 (Pub. L. 91–579), (the Animal
Welfare Act of 1970), the Act of April
22, 1976 (Pub. L. 94–279), (the Animal
Welfare Act of 1976), and the Act of
December 23, 1985 (Pub. L. 99–198),
(the Food Security Act of 1985), and as
may be subsequently amended, and the
United States Department of Agriculture
(USDA) regulations implementing the
Animal Welfare Act in title 9, chapter 1,
subchapter A of the CFR.
Animal Welfare Assurance means the
documentation from an institution
assuring compliance with the PHS
Policy on Humane Care and Use of
Laboratory Animals. This policy is
administered by the Office of Laboratory
Animal Welfare (OLAW), National
Institutes of Health.
Association for Assessment and
Accreditation of Laboratory Animal
Care, International (AAALAC) means
the nonprofit organization that is
recognized in the United States and
abroad as being the body responsible for
the accreditation of laboratory animal
programs.
Behaviorist means a person hired by
the Sanctuary to administer or oversee
the enrichment and behavioral program
for the chimpanzees at the Sanctuary.
This individual must be qualified
through training or experience.
Biosafety Officer means the individual
responsible for establishing and
monitoring workplace safety procedures
designed to minimize or prevent injury
or loss due to biohazards in accordance
with policies established by the
Sanctuary administration.
Board of Directors (BOD) means the
individuals selected by the Contractor to
govern the nonprofit institution
responsible for operating the federally
supported chimpanzee Sanctuary
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system. The board members must meet
the qualifications and criteria stated in
the CHIMP Act.
Chair of the Board of Directors means
the individual chosen by the BOD or
other legally empowered entity to carry
out such action, who is responsible for
chairing meetings and acting on behalf
of the board. This individual reports
directly to the board.
Chief Executive Officer (CEO) means
the principal person responsible for
overall accomplishment of the mission
of the chimpanzee Sanctuary.
CHIMP Act means the Chimpanzee
Health Improvement, Maintenance, and
Protection Act of December 20, 2000
(Pub. L. 106–551) commonly known as
the ‘‘CHIMP Act’’ or ‘‘Chimpanzee
Retirement Act,’’ and any future
amendments.
Chimpanzee means a member of Pan
troglodytes. It excludes the pygmy
chimpanzee (Pan paniscus or bonobo).
Chimpanzee caregivers (caregivers)
means all Sanctuary technical and
husbandry staff providing long term
care and services for the chimpanzees.
Contractor/Primary Contractor/
Sanctuary Contractor means the
nonprofit entity awarded a contract by
the Federal Government to establish and
operate the chimpanzee Sanctuary
system.
Euthanasia means the humane death
of a chimpanzee accomplished by a
method that produces rapid
unconsciousness and subsequent death
without evidence of pain or distress.
The method must be consistent with the
recommendations of the American
Veterinary Medical Association Panel
on Euthanasia.
Exhibition means exhibiting
chimpanzees to the public for
compensation. It specifically excludes
limited viewing for educational
purposes.
Facility director means the individual
responsible for directing the overall
activities at the Sanctuary site.
Facility Veterinarian means a person
who has graduated from a veterinary
school accredited by the American
Veterinary Medical Association (AVMA)
Council on Education, or who has a
certificate issued by the AVMA’s
Education Commission for Foreign
Veterinary Graduates; has training and/
or experience in the care and
management of nonhuman primates;
and has direct or delegated authority for
activities involving chimpanzees at the
federally funded chimpanzee Sanctuary.
Federal agency means an executive
agency as such term is defined in
section 105 of title 5, United States
Code, and refers to the agency from
which the research facility receives a
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Federal award for projects involving
animals.
Federal Acquisition Regulations
(FAR) means the codified rules
applicable to contracts, specifically
those sections of the FAR (48 CFR
chapter 1, part 52) that are applicable to
contracts between the Federal
Government and a contractor (in this
case a private, nonprofit entity under
contract to operate the chimpanzee
sanctuary system).
Federally-owned chimpanzees mean
chimpanzees that have been purchased
by, bred by, or donated to a Federal
agency for use in biomedical/behavioral
research. Chimpanzees whose
ownership was subsequently transferred
from Federal ownership via written
transfer agreements are no longer
federally-owned. Newborn chimpanzees
generally belong to the same entity that
owned the mother at the time of the
baby’s birth.
Guide means the ‘‘Guide for the Care
and Use of Laboratory Animals’’
published by the National Academy of
Sciences, Institute for Laboratory
Animal Research of the National
Research Council.
Housing facility means any land,
premises, shed, barn, building, trailer,
or other structure or area housing
intended to house chimpanzees.
Indoor housing facility refers to any
structure or enclosure (e.g., cages, pens,
rooms) for maintaining animals in a
controlled environment that provides
for normal physiological and behavioral
needs.
International Species Information
System (ISIS) means the organization
that provides the chimpanzees in zoos,
research facilities, exhibitors, etc., with
a unique identification number that can
be used to track and account for
chimpanzees around the world.
Interstate air transport live animals
(IATA) regulations means those
regulations and standards covering the
air transportation of nonhuman
primates developed and implemented
by the International Air Transportation
Association.
Invasive research (studies) utilizes
those procedures that cause more than
momentary pain, distress, fear,
discomfort, injury, or other negative
modalities to a chimpanzee. Any
procedure that enters or exposes a body
cavity is considered to be invasive.
Except as outlined in the CHIMP Act,
Sanctuary chimpanzees may not be used
in invasive research. Some examples of
invasive studies are:
(1) Experimental exposure to a
substance that may be detrimental to a
chimpanzee’s health (e.g., infectious
disease, radiation). This does not
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include accidental exposures to
infectious diseases transmitted from
cage mates, or from radiation or other
exposures at the time of regularly
scheduled or necessary veterinary
examinations and treatments;
(2) Any invasion of a body cavity;
(3) Surgery and surgical implantation
of devices. Procedures of this nature
performed for non research or study
purposes are allowable when the
Sanctuary staff determine they are
needed for veterinary medical or colony
management purposes and is in the best
interest of the chimpanzee or the
chimpanzee colony;
(4) Behavioral studies that cause
distress or discomfort, such as induction
of a fear response;
(5) Testing of any drug;
(6) Purposeful manipulation of social
groups or the removal or addition of
individuals in order to conduct
behavioral research (e.g., on aggression).
Creation and refinement of social groups
will be necessary when the animals
arrive at the Sanctuary and this should
take place only when necessary in
regards to colony management and
should not be driven by independently
initiated research studies;
(7) Restraint unless it is in
conjunction with the annual exam or
clinical care; and
(8) Darting or anesthesia induction
other than at annual exam or in the case
of an emergency in which the
chimpanzee’s well-being is at stake.
National Primate Research Center
(NPRC) means those centers supported
by the National Center for Research
Resources, National Institutes of Health,
Department of Health and Human
Services, as national resources for
providing high-quality nonhuman
primate research resources and
facilities. As of November 2003, there
were 8 such centers.
National Research Council means the
component of the National Academy of
Sciences that advises the Federal
Government on matters related to
science, research, and research
resources.
Non-invasive research (studies) means
the use of procedures that depend upon
close observation of chimpanzee
behavior or on medical information
collected during the course of normal
veterinary care. These procedures do
not require removal of the chimpanzees
from their social group or environment,
or require a separate anesthetic or
sedation event to collect data or record
observations. Some examples of noninvasive studies are:
(1) Visual observation;
(2) Behavioral studies designed to
improve the establishment and
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maintenance of social groups. These
activities may cause stress as a result of
novel interactions between chimpanzees
and between chimpanzees and
caregivers, but they are not considered
invasive as long as they are intended to
maximize the well-being of the
chimpanzees;
(3) Medical examinations as deemed
necessary to oversee the health of the
chimpanzees, in the least invasive
manner possible. Collection of samples
routinely obtained during a physical
examination for processing during this
time is also considered noninvasive
since a separate event is not required;
(4) Administration and evaluation of
environmental enrichment used to
promote the psychological well-being of
the chimpanzees; and
(5) Actions taken to provide essential
medical treatment to an individual
chimpanzee exhibiting symptoms of
illness. This applies only to serious
illness that cannot be treated while the
chimpanzee remains within the colony.
Non-federally owned chimpanzees
mean chimpanzees that have not been
purchased by, bred by, or donated to the
Federal Government for use in federally
supported research projects. In
accordance with the CHIMP Act,
chimpanzees owned on the date of
passage of the CHIMP Act by a National
Primate Research Center may enter the
Sanctuary system without requiring the
NPRC to pay a fee.
Outdoor housing facility (area) means
corrals, Primadomes (a prefabricated
outdoor housing unit), fenced open
areas, or similar structures or areas, for
maintaining chimpanzees with access to
adequate protection from the extremes
of environmental elements and harsh
weather conditions.
Outdoor ranging area means an area
that allows chimpanzees greater ranging
space than corrals or other outdoor
housing area, and includes a variety of
vegetation, shrubbery, grasses and trees,
thereby providing for a fairly
unrestricted natural setting for the
chimpanzees to engage in species
appropriate activities. The area is
secured by an outer perimeter barrier.
Project Officer means the individual
designated by the Federal Government
to represent the contracting officer and
interests of the Federal agency, within
defined areas, in monitoring and
overseeing the chimpanzee Sanctuary
system contract.
Sanctuary or federally supported
chimpanzee Sanctuary system means
the Sanctuary or Sanctuary system
established by the Federal Government
through contracting with a private,
nonprofit entity, for the purpose of
carrying out the provisions of the
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CHIMP Act of 2000. The system
includes a primary Contractor and may
include additional subcontractors as
required. This Sanctuary system is
supported primarily from funds
allocated by the NCRR/NIH/DHHS with
some matching funds from the nonprofit
contractor.
Sanctuary Chimpanzee Care
Committee (SCCC) or similar designated
committee means the group of
individuals designated by the CEO of
the Sanctuary that reviews and monitors
adherence to the policies, procedures,
and regulations at the Sanctuary.
Sanctuary Contractor means the
nonprofit, private entities selected by
the NCRR/NIH to develop and operate
the chimpanzee Sanctuary system. This
Contractor is also known as the
‘‘primary contractor’’ for the Sanctuary
system.
Sanctuary Director means the
individual who provides day to day
direction and oversight to the
employees responsible for performing
the daily tasks at the facility.
Secretary means the Secretary of
Health and Human Services or his/her
designee.
Subcontractor means a private,
nonprofit entity selected by the primary
contractor to provide additional
Sanctuary services.
Surplus chimpanzees means
chimpanzees that are no longer needed
in research, and that were used, or were
bred or purchased for use in research
conducted or supported by the Federal
Government.
USDA licensed intermediate handler/
carrier means any person, including a
department, agency, or instrumentality
of the United States or of any State or
local government, who is engaged in
any business in which it receives
custody of animals in connection with
their transportation in commerce and
who is licensed by the USDA.
Zoonotic disease(s) means diseases
that are transmissible from chimpanzees
to humans.
§ 9.3 Sanctuary policies and
responsibilities.
(a) What are the policies and
responsibilities governing the Sanctuary
system? It will be the policies and
responsibilities of the Sanctuary system
to:
(1) Create a safe and speciesappropriate physical and social
environment for the lifetime care of
chimpanzees;
(2) Comply with all applicable
provisions of the animal welfare
regulations and other Federal, State and
local laws, regulations and policies;
(3) Achieve accreditation from
appropriate accrediting bodies within a
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reasonable time frame mutually agreed
upon by the contractor and NCRR;
(4) Prohibit any invasive research on
the resident chimpanzees but permit
non-invasive studies (as authorized in
42 U.S.C. 287a-3a) that do not
compromise the well-being of the
chimpanzees and that are approved by
an appropriate Sanctuary Chimpanzee
Care Committee. Definitions for the
terms ‘‘invasive’’ and ‘‘non-invasive’’
are set forth in § 9.2 of this part;
(5) Prohibit exhibition of chimpanzees
in the Sanctuary. This policy does not
prohibit educational activities that may
involve limited viewing of chimpanzees
in their environment and that are
designed to promote an understanding
of chimpanzee behavior, well-being, or
importance to the ecological system;
(6) Staff the organization with people
with appropriate training and
experience; and
(7) Establish a Sanctuary Chimpanzee
Care Committee (SCCC) responsible for
oversight of the facility programs and
operations to ensure the health and
well-being of the chimpanzees and the
occupational safety of the staff. The
Committee must consist of no fewer
than five people who should include the
sets of experiences or qualifications in
the following paragraphs (a)(7)(i)
through (v):
(i) A chair (person) knowledgeable of
the needs of chimpanzees;
(ii) A veterinarian with chimpanzee
care experience;
(iii) A behaviorist with experience in
chimpanzee behavior;
(iv) A member of the chimpanzee care
staff; and
(v) Member or members from the
community, including at least one with
affiliation or employment with an
animal protection organization as
defined in section 9.2 of this part.
(vi) The Sanctuary Chimpanzee Care
Committee will:
(A) Oversee and evaluate the
chimpanzee care and socialization
program;
(B) Review and approve proposed
education programs that might interfere
with the chimpanzees’ well-being or
routine activities;
(C) Conduct a formal review of the
program on a semiannual basis and
submit reports to the Sanctuary director
and Board of Directors. The reports
must be available for review by the
USDA and NIH representatives during
site visits;
(D) Establish a mechanism for receipt
and review of concerns involving the
care of chimpanzees and resolving such
concerns; and
(E) Review all study proposals and all
euthanasia events. The SCCC
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membership may require additional
qualified individuals to perform the
functions of an Animal Care and Use
Committee (ACUC) if and when the
need arises. The contractor may
establish a separate ACUC. The ACUC
must be established in accordance with
the applicable provisions of the Animal
Welfare Act regulations. Euthanasia
events performed for medical or
humane reasons will be based upon
sound professional veterinary judgment
that conforms to current veterinary
medical practices and must be in the
best interest of the chimpanzee.
Euthanasia performed for emergency
reasons without an advance review by
the SCCC shall be reviewed by the SCCC
as soon as possible after the event to
assure compliance with established
policy.
(8) Establish procedures to prevent
any reproduction in the colony through
appropriate permanent birth control,
preferably by vasectomy of all sexually
mature male chimpanzees in the
Sanctuary;
(9) Assure that chimpanzees accepted
into the Sanctuary are not discharged
for any reason, except as provided for in
section 481C(d)(3) of the Public Health
Service Act as added by section 2 of the
CHIMP Act;
(10) Develop procedures for
chimpanzees that are seropositive for or
harboring infectious agents, or have
been previously exposed to infectious
agents (whether experimentally-induced
or naturally-occurring), that will allow
them to be accepted by the Sanctuary
and properly housed; the procedures
must be submitted to the NCRR for
approval;
(11) Develop guidelines for accepting
chimpanzees not owned by the Federal
Government into the Sanctuary if the
conditions are met as outlined in 42
U.S.C. 287;
(12) Assure that the Board of Directors
of the primary contractor consist of no
more than thirteen (13) individuals and
that the conditions governing the terms
of the board members comply with the
CHIMP Act. The Board of Directors
must include individuals with the
following expertise and experience as
set forth in the CHIMP Act.
Subcontractors, if applicable, shall be
governed by the policies developed by
the Board of Directors of the primary
contractor:
(i) At least one veterinarian that is
qualified in veterinary care of
nonhuman primates. These
qualifications may be met through
postdoctoral training, experience, or
both;
(ii) Individuals with expertise and
experience in zoological science and
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with knowledge in behavioral
primatology;
(iii) Individuals with experience in
the animal protection field;
(iv) Individuals with experience and
expertise in the field of business and
management of nonprofit organizations;
(v) Individuals knowledgeable and
experienced in accrediting programs of
animal care;
(vi) Individuals with experience and
expertise in containing biohazards;
(vii) A member who serves as the
Chair of the Board of Directors. This
member may be elected or appointed by
the Board from individuals identified in
paragraphs (a)(12)(i) through (vi) of this
section; and
(viii) No member of the board shall
have been fined for, or signed a consent
decree, for any violation of the Animal
Welfare Act.
(13) Assure that a chimpanzee may be
removed from the Sanctuary for
research purposes only if the Secretary
determines that the provisions of the
CHIMP Act are met. In accordance with
the provisions of the CHIMP Act, the
removal of a chimpanzee from the
Sanctuary for research requires a
recommendation from the contractor’s
Board of Directors, and publication in
the Federal Register of a notice of intent
for public comment for a period not less
than 60 days. The final decision rests
with the Secretary. Ownership of
chimpanzees removed for that purpose
remains with the Sanctuary (or the
Federal Government) and all
chimpanzees removed for research must
be returned to the Sanctuary when the
studies are completed.
(b) Who is responsible for developing
or revising Sanctuary policies? (1) The
Sanctuary contractor is responsible for
developing, revising, and implementing
policies affecting the Sanctuary.
(2) The Federal agency (NCRR/NIH)
designated by the Secretary must concur
with any changes that substantially
change existing policies. The Secretary,
or designee, will determine if a policy
change will have a substantial impact
upon current policy after consultation
with the Sanctuary contractor.
§ 9.4
Physical facility policies and design.
(a) What standards apply to the
facility design and physical plant? (1)
The chimpanzee Sanctuary facility must
be designed to provide sufficient space
and variety of natural or artificial
objects to accommodate natural
activities of chimpanzees while
restricting their movement and range to
the defined area. Cages, compounds,
and all housing areas shall be designed
to withstand the continuous and harsh
assaults common when chimpanzees are
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confined. It is highly recommended that
the Sanctuary administrators engage a
design firm that is experienced in
designing chimpanzee facilities or
demonstrates the capability to involve
individuals possessing such experience.
Housing areas appropriate for the
complex social behavior of chimpanzees
should allow them to express a full
range of species typical behavior. The
facility design and physical plant
consists of the following components:
indoor design features; outdoor design
features; construction and construction
materials; physical barriers; shelter;
service support space, including storage
areas for food, supplies, and equipment;
personnel and administrative support
space; quarantine and isolation
facilities; treatment area; heating,
ventilation, and air conditioning
(HVAC); food preparation area; and
animal waste treatment.
(2) Primary enclosures must promote
chimpanzee well-being and provide a
safe and sanitary environment for both
the chimpanzees and their human
caregivers and attendants, safe and
sanitary environment for both the
chimpanzees and their human
caregivers and attendants, and allow for
behavioral needs of the species. Daily
observation of chimpanzees within the
enclosures is required and shall be
accomplished with minimal disturbance
to the chimpanzees. A housing system
shall include indoor and outdoor
enclosures that must be kept in good
repair to prevent escape and injury to
the chimpanzees, promote physical
comfort, and facilitate sanitation and
servicing:
(i) Indoor areas shall have special
areas for social introductions and
medical treatment. Indoor design
features will generally include rooms,
units, gates and passage corridors to
allow for transferring and isolating
chimpanzees for medical procedures,
protection from aggression, etc. The
floor surfaces must not be slippery; and
the floors and walls should be sealed to
facilitate proper sanitation. Doors to the
chimpanzee housing areas shall not
open directly to the outside, unless they
open into enclosed outdoor housing or
free-ranging areas. Indoor containment
materials must be well anchored,
durable, and free of sharp or jagged
edges to prevent escape or injury to the
chimpanzees. Light fixtures must be
sealed to prevent the introduction of
moisture. Lighting must be adequate for
appropriate animal care and
observation, but not disruptive or
harmful to the chimpanzees.
Furnishings for climbing, resting,
swinging, and sleeping must be durable,
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nontoxic, comfortable and easily
sanitized or replaceable when soiled;
(ii) Primary housing in a Sanctuary
must include large outdoor compounds,
corrals, or other ranging areas. The
Sanctuary should be in an area with a
climate suitable for chimpanzees to
reduce the need for long-term, indoor
housing. Outdoor ranging areas must
provide enough space for the formation
of social groups of varying sizes, ages
and sexes. Chimpanzee facilities must
have areas for social introductions and
medical treatment. During the design
and construction of the facility, special
consideration must be given to plans for
removing chimpanzees from the ranging
area for emergency and routine
procedures. Primary barriers must be
constructed to prevent escape of
chimpanzees and secondary or
perimeter barriers should prevent entry
of unauthorized persons into the
facility. Grasses, hay, bamboo, or other
material suitable for nest building
should be available in the ranging area
and artificial objects that simulate or
enhance the natural environment may
be used to further promote chimpanzee
well being;
(iii) Primary enclosures must be
constructed with materials that balance
the needs of the chimpanzees with the
ability to provide for sanitation. They
must have smooth impervious surfaces
with minimal ledges, angles, corners,
and overlapping surfaces so that
accumulation of dirt, debris, and
moisture is reduced and satisfactory
cleaning and disinfecting are possible.
Less durable material, such as non
pressure treated wood, can provide a
more appropriate environment in some
situations (such as runs, pens, and
outdoor corrals) and can be used to
construct perches, climbing structures,
resting areas, and perimeter fences for
primary enclosures. Wooden items must
be replaced when they become damaged
or difficult to sanitize. All primary
enclosures must be kept in good repair
to prevent escape of and injury to
chimpanzees, promote physical comfort,
and facilitate sanitation and servicing.
Damaged, rusting or oxidized
equipment that threatens the health or
safety of the chimpanzees must be
repaired or replaced;
(iv) Physical barriers must be
designed to contain the chimpanzees
within the Sanctuary grounds and to
prevent the intrusion of unauthorized
persons. Some examples of barrier
structures include properly and safely
designed water moats, strong chain link
fencing with curved or ‘‘V’’ shaped
barbed wire topping, solid concrete,
brick, or pre-cast concrete walls, and
electrical fences. Each Sanctuary site
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may choose the type of barrier that is
suitable for that location;
(v) Outdoor facilities must provide
either natural or artificial structures that
chimpanzees can use for shelter to
escape rain, direct sun, wind, and
extreme temperatures. Indoor and
outdoor housing units can serve this
purpose when chimpanzees are
confined to smaller outdoor facilities;
(vi) Personnel and administrative
support space must be appropriately
designed and provided to adequately
accommodate the technical, managerial,
professional, and administrative staff;
(vii) Quarantine and isolation
facilities are required for the Sanctuary.
These facilities must be designed to
prevent the spread of undesirable agents
from quarantine and isolation rooms to
other parts of the facility. These
facilities may also be used to isolate
incoming chimpanzees to evaluate and
to assess their behavior before
assimilation into the resident
population. Sufficient space must be
designed in the area to accommodate a
station that provides protective
equipment for the staff and others to be
worn when entering areas housing the
chimpanzees. Shower, toilet and locker
facilities must be located within or near
the quarantine and isolation areas for
preventative health and sanitation
reasons. Provisions for enrichment in
quarantine areas must also be made;
(viii) An area for treatment of and
performing veterinary clinical
procedures on chimpanzees must be
provided at each Sanctuary site. This
area must be constructed and
provisioned to perform emergency
procedures, including minor surgery
and emergency surgical procedures if
needed, and complete physical
examinations. The Sanctuary must
provide facilities for extended care of
medical conditions as the need arises.
Emergency treatment carts must be
available for emergency situations when
a chimpanzee requires on-site treatment.
Aging chimpanzees present special
medical challenges that should be
addressed in the preventative medicine
and animal health plan; and
(ix) Heating, ventilation, and airconditioning (HVAC) must comply with
the standards of the Guide when
chimpanzees must be confined to
closed, indoor quarters for isolation,
treatment or other situations on a shortterm basis. It is critical to provide
ventilation that allows chimpanzees to
seek a thermo-neutral zone that fits their
needs. In general, the design of the
Sanctuary facility can be such that the
mechanical systems may not be
required, except in tightly closed areas.
The use of shelters, nesting materials,
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circulating fans, and space heaters are
examples of means that address the
comfort needs of the chimpanzees.
(x) Support facilities must be
appropriate for the goals of the facility.
In accordance with the Guide and the
Animal Welfare Regulations, and
currently available data, several types of
functional support areas are required,
including veterinary treatment and
surgery, quarantine, food storage,
bedding storage (if used), dry storage,
administrative space, and equipment.
(xi) Animal waste from the Sanctuary
must be properly treated to remove
known hazardous agents before
discharging it into the environment in
accordance with currently acceptable
and effective waste treatment
procedures including current industry
standards and Federal, State, and Local
governmental guidelines and
regulations.
(b) What security measures are
required for the Sanctuary? The
Sanctuary must provide adequate
security against unauthorized entry,
sabotage, malicious damage, theft of
chimpanzees and property, and
minimize any chance of escape by a
chimpanzee. The security staff must
have training and/or experience in
methods and equipment designed to
detect possible security breaches and
the ability to respond to security events
in a timely and effective manner.
Perimeter containment shall be used to
protect the compound housing the
chimpanzees consistent with the
recommendations of the Guide.
(c) Is the Sanctuary required to
develop disaster and escaped animal
contingency plans? (1) The Sanctuary
facility must prepare contingency plans
outlining simple and easy to follow
plans for dealing with natural and
manmade disasters and steps to be taken
in case a chimpanzee escapes from the
compound. Separate plans will be
developed for disasters and recovery of
escaped chimpanzees. These plans must
be prepared prior to the arrival of
chimpanzees at the facility. All
employees with responsibilities under
the plans must be familiar with the
contents of each plan and able to
execute the plans when a situation
occurs. Incidents and actions taken
must be documented for future
reference.
(2) As a minimum, the disaster plan
must identify disasters likely to occur in
the area, including severe rainstorms,
crippling snowstorms, forest fires,
sabotage and hurricanes, that may
endanger the lives of the chimpanzees
or staff, the names and telephone
numbers of persons to contact in the
event of an emergency, procedures to be
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followed in collecting and securing
chimpanzees, local or state services that
may be required, and the person or
persons responsible for determining
final action. Personnel required to
respond to a disaster must obtain any
special identification cards needed to
report to duty. Other elements
considered appropriate to addressing
disasters should be added by the
Sanctuary contractor if necessary.
(3) The design of the perimeter
security must be such that chance for
escape of a chimpanzee is minimized. A
well-prepared, properly crafted plan can
lead to decisive actions being taken to
recapture the chimpanzee in a timely
fashion. The plan must be designed to
minimize or eliminate injury to the
chimpanzee and the persons attempting
to gain control of the escaped
chimpanzee. Details must include stepby-step procedure options for capture,
person(s) to contact, person(s) or
organizational unit(s) required to
respond to an alert due to an escape,
transportation back to the Sanctuary
facility, and how corrective actions will
be implemented to prevent future
incidents.
(d) Incorporation by reference. The
Guide for the Care and Use of
Laboratory Animals published by the
National Research Council (Guide),
1996, International Standard Book
Number 0–309–05377–3, is
incorporated by reference in this
section. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain a copy of the publication from
the National Academy Press, 2101
Constitution Avenue, NW., Lockbox
285,Washington, DC 20055; or you may
order it electronically via the Internet at
https://www.nap.edu; or view it online at
https://oacu.od.nih.gov/regs/guide/
guidex.htm. You may inspect a copy at
NIH, NCRR, 1 Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD
20817–4874, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to https://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
§ 9.5 Chimpanzees ownership, fees, and
studies.
(a) Who owns the chimpanzees in the
federally supported Sanctuary? The
Federal government retains ownership
of chimpanzees owned by the Federal
government at the time they enter the
Sanctuary system. Non-federally owned
or supported chimpanzees will be
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owned by the Sanctuary. The
chimpanzees shall continue to be
maintained in the Sanctuary throughout
their lifetime and shall not be
discharged from the Sanctuary except as
specifically indicated in the CHIMP Act.
(b) Is there a charge for placing
chimpanzees in the Sanctuary? No fees
shall be charged for federally owned or
supported chimpanzees entering the
Sanctuary. Chimpanzees that were
owned by a NPRC when the CHIMP Act
became effective are also admitted
without payment of fees. Fees for
maintenance of the chimpanzees
alluded to above are provided for in the
contract between the Federal
Government and the Sanctuary
contractor.
(c) May the Sanctuary agree to accept
chimpanzees that are not owned by the
Federal Government? The Sanctuary
may accept chimpanzees that are not
owned by the Federal Government
subject to the following conditions:
(1) Ownership of the chimpanzee
must be transferred to the Sanctuary;
(2) Fees for these chimpanzees may be
levied based on a range of
considerations that include most
importantly, the well-being of the
chimpanzee, and secondarily factors
that include (but are not limited to) the
resources available to support the
chimpanzee, the health, age and social
history of the chimpanzee, and other
relevant factors affecting the cost of
caring for the chimpanzee;
(3) Available space exists in the
Sanctuary; and
(4) An agreement exists between the
Sanctuary system and the NCRR/NIH
documenting that the chimpanzee may
be brought into the Sanctuary.
(d) What additional conditions apply
when non-governmentally-owned
chimpanzees transfer to the chimpanzee
Sanctuary? The following additional
conditions apply when nongovernmentally-owned chimpanzees
transfer to the chimpanzee Sanctuary:
(1) Chimpanzees transferred to the
Sanctuary sites must be permanently
incapable of reproduction, for example,
by vasectomy or tubal ligation;
(2) Complete histories must
accompany each chimpanzee. Any
chimpanzee missing documentation for
any period of research or other use may
not be transferred to the Sanctuary
without the concurrent authorization of
the Sanctuary contractor’s Board of
Directors and the NCRR; the records
may be created and retained in
electronic form; and
(3) Appropriate screening of each
chimpanzee must be performed to
assess the likelihood of the chimpanzee
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being a health or safety threat to the care
staff, and/or other chimpanzees.
(e) What are the criteria for
acceptance and the fees for admission
into the Sanctuary for nongovernmentally-owned chimpanzees?
The chimpanzee Sanctuary contractor,
in conjunction with the NCRR, must
establish criteria and a fee system for
acceptance of non-governmentallyowned chimpanzees. Funds collected
for this purpose must be accounted for
and used to help defray the expenses
incurred in operating the Sanctuary.
(f) Under what circumstances might a
chimpanzee from the Sanctuary be
returned to research at a United States
research facility? (1) The CHIMP Act
provides details for the return of
chimpanzees to research for a specific
need as determined by the Secretary.
While the likelihood of a chimpanzee
from the Sanctuary being returned to
research is remote based upon current
consensus, the CHIMP Act does provide
for such event. The Act lists several
conditions that must be met prior to
initiating any research on a chimpanzee
in the Sanctuary and before the
Secretary can grant approval. These
conditions are:
(i) The chimpanzee in question
possesses unique characteristics (based
upon prior use or medical history) that
are not found in other chimpanzees
outside of the Sanctuary;
(ii) Technological or medical
advances have occurred that were not
available at the time the chimpanzee
was accepted into the Sanctuary and
that such advancement can and will be
used in the research;
(iii) The research is essential to an
important public health need;
(iv) The research design involves
minimal pain, physical or psychological
harm, distress, and disturbance to the
chimpanzee or social group.
(2) The evaluation by the Board of
Directors of the Sanctuary of whether
the proposed research satisfies the
criteria above will be forwarded to the
Secretary for a final determination. Prior
to rendering a final decision, the
Secretary will publish in the Federal
Register the proposed findings of the
Secretary, the findings of the Board of
Directors, and the evaluation by the
Secretary. The Secretary will solicit
public comment on the proposal for not
less than 60 days before making a final
decision. This process is designed to
ensure a thorough review of the
proposal, including input from the
public, and to reduce or eliminate
arbitrary findings by the Board of
Directors. An additional condition for
approved use is that the applicant for
such use has not been fined or signed
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a consent decree for any violation of the
Animal Welfare Act.
§ 9.6 Animal care, well-being, husbandry,
veterinary care, and euthanasia.
(a) What are the requirements for
promoting the well-being of Sanctuary
chimpanzees? The goal of chimpanzee
housing and management in the
Sanctuary is to promote the
chimpanzees’ well-being. Long-term
care staff shall have the expertise and
the commitment to plan, administer,
and evaluate the effectiveness of the
well-being program. The staff
behaviorist will evaluate the well-being
of individual chimpanzees and develop
programs to improve the life of
Sanctuary chimpanzees in general.
(b) What are the provisions for daily
chimpanzee husbandry and care?
Adequate and proper care for
chimpanzees in the Sanctuary must be
provided with respect to physical
environment, housing and husbandry,
behavioral management, and population
management and control. Specific
requirements include the following:
(1) Physical Environment/Husbandry/
Housing. (i) Husbandry. Chimpanzees
must have access to food, water, and
bedding (if appropriate) at all times,
unless medical or behavioral conditions
dictate otherwise. Husbandry
procedures shall represent current
policies and practices and conform to
standards set by a nationally recognized
accrediting association. Indoor primary
enclosures must be cleaned at least once
daily or as often as required to maintain
a clean and healthful environment.
Outdoor enclosures must be monitored
and, if necessary, a plan to handle
excessive waste accumulation must be
established and implemented as needed.
Outdoor ranging areas as a rule will not
require a routine cleaning schedule, but
must be monitored and maintained if
there is an excessive accumulation of
waste that is unsanitary, or when other
potentially unhealthy conditions exist.
Feeding and watering implements must
be sanitized at intervals required to
maintain them in a sanitary condition.
The minimum interval shall be as stated
in the ‘‘Guide;’’
(ii) Indoor housing. Indoor housing
areas shall provide sufficient space for
chimpanzees to perform species-typical
behavior and expression. Examples of
such activities include but are not
limited to natural movements, climbing,
swinging, resting, group interactions,
sleeping, etc. At a minimum,
chimpanzees confined to cages, runs, or
similar enclosures shall be housed in
pairs or larger groups unless
contraindicated for medical, behavioral
or other justifiable reasons. These
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enclosures must be designed to allow
any member of the group to disengage
from aggression by other chimpanzees
through the provision of climbing
devices, resting boards, sufficient space,
or accessibility to adjoining cages or
outdoor cages. Visual, tactile, and
auditory contact should be maintained
where possible. Primary enclosures
must be constructed of sturdy materials
that will properly contain chimpanzees.
Cages and holding rooms, or similar
units, must be capable of being readily
sanitized. Primary enclosures will be
cleaned as often as required to provide
a clean and healthful environment. The
Sanctuary must have special areas for
social introductions and medical
treatment. The design of primary
enclosures must be such to allow for
shifting of chimpanzees during cleaning
procedures to prevent them from being
injured during the sanitation process;
(iii) Outdoor housing. Primary
housing in the Sanctuary must include
outdoor compounds or other ranging
areas. Enclosures must minimize the
potential for escape of chimpanzees and
entry of unauthorized persons into the
facility. The design must include an
area for staff persons to separate
themselves from chimpanzee enclosures
and the outer perimeter. Outdoor spaces
in the Sanctuary must include some
element of their natural habitat such as
trees, shrubs, grasses, hills, water for
drinking, and natural or artificial shelter
for retreat from inclement weather.
Outdoor ranging areas should provide
enough space for the formation of
groups or families of varying sizes, ages,
and sexes; and
(iv) Housing conditions. All indoor
and outdoor enclosures must be kept in
good repair to prevent escape or injury
to the chimpanzees, promote physical
comfort, and facilitate sanitation and
servicing. Damaged, rusting or oxidized
equipment that threatens the health or
safety of the chimpanzees must be
repaired or replaced promptly.
(2) Behavioral management. (i) The
federally supported chimpanzee
Sanctuary must employ a behavioral
scientist knowledgeable in primate
behavior and socialization
requirements. This individual shall
provide primary leadership in
developing, implementing, and
monitoring the chimpanzee behavioral
guidelines for the Sanctuary. Each site
must provide sufficient staff technician
time to adequately monitor and oversee
the activities of the resident
chimpanzees;
(ii) Environmental enrichment and
animal well-being. The staff behaviorist
will evaluate the well-being of
individual chimpanzees, and develop
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programs to improve the life of
Sanctuary chimpanzees in general.
Enrichment of the environment for
chimpanzees is required within a
federally supported Sanctuary. The goal
of all chimpanzee housing and
management is to promote a high degree
of well-being. The Sanctuary must
provide for the expertise to plan,
administer, and evaluate the
effectiveness of the well-being program.
The staff behaviorist will evaluate the
well-being of individual chimpanzees,
and develop programs when needed to
improve the life of Sanctuary
chimpanzees in general. In delvoping
such programs the behaviorist will
access individual chimpanzee
experimental and housing history. An
environmental enrichment program
must be in place to encourage the
expression of natural behavior such as
social interaction, locomotion, climbing,
foraging, resting, playing, manipulating
objects, and nest building. Enrichment
should be emphasized for chimpanzees
that must be confined to smaller, indoor
spaces. Chimpanzees must be able to
retreat from areas where they feel
threatened or agitated by close human
encounters or encounters with other
chimpanzees;
(iii) Socialization. The Sanctuary
shall provide an environment that
provides the opportunity for
chimpanzees to live in a social setting
that is compatible with their social
needs. In most cases, social housing is
an important means of enriching
chimpanzee activities. Chimpanzees
may be housed individually only if
required for quarantine, medical
reasons, or behavioral reasons, such as
for chimpanzees that have failed several
socialization attempts;
(iv) Nesting, sleeping, and resting.
The Sanctuary must contain sufficient
outdoor or ranging space and structures
(natural or artificial) for the
chimpanzees to build nesting areas for
sleeping and resting. The site shall not
be located in an area where it is noisy
or frequently interrupted by human
activity;
(v) Feeding. In the native
environment, chimpanzee diets consist
mainly of fruits and vegetables, insects
and occasional small mammals.
Chimpanzee foraging and feeding
activities occupy a large portion of their
waking hours, and these critical
behaviors must be accommodated in the
Sanctuary facilities. The Sanctuary
ranging area should include some of the
natural diet consumed in the wild
where possible (e.g., leaves, wild fruit,
and insects). The chimpanzees must be
supplied with a commercially prepared
diet, even when the chimpanzees are
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housed in outside areas, to ensure
proper nutrition. Diets shall be
supplemented with natural foods when
housed indoors or in indoor/outdoor
enclosures. This supplementation may
also be desirable for chimpanzees
housed in large ranging areas. Feeding
techniques that are challenging to the
chimpanzees are recommended to add
variety and enrichment opportunities.
Aggressive behavior during feeding
must be anticipated and managed to
prevent serious injury to the
chimpanzees. The special needs of aged
chimpanzees must be considered and
addressed as they may be sick, have
limited movement capabilities, or have
other conditions that require special
considerations;
(vi) Play activities. The Sanctuary
must provide ample space or objects for
chimpanzees to engage in play activities
that are considered appropriate for the
species; and
(vii) Chimpanzee training. Many
chimpanzees can be trained through
positive reinforcement to cooperate with
a variety of veterinary and chimpanzee
care procedures. Efforts must be made to
develop or maintain this capability for
chimpanzees housed in the Sanctuary to
the extent possible.
(3) Population management and
control. Reproduction of chimpanzees is
prohibited in the Sanctuary. Therefore,
males must be sterilized by vasectomy
before acceptance into the Sanctuary
facility or housed apart from females
until they are sterilized. Vasectomies are
preferable because of their minimal
invasiveness and because vasectomies
can be validated through laboratory
testing of semen. Seminal collection
techniques must be carefully evaluated
to avoid painful stimuli. Other proven
methods of birth control may be used
under special conditions deemed
appropriate by the Facility Veterinarian
and SCCC. The Facility Veterinarian
will determine the appropriate test(s) to
use to validate sterility. The vasectomy
should be performed by a veterinarian
experienced in performing vasectomies
in chimpanzees. Documentation must
accompany each male accepted by the
Sanctuary system attesting to the fact
that the male has been vasectomized
and laboratory tests are negative for
sperm. In instances where it is not
possible to perform a vasectomy before
arrival at the Sanctuary due to
extenuating circumstances (such as a
lack of on-site expertise), that particular
male must be isolated at the Sanctuary
from the females until the procedure is
performed and the required tests are
performed and found to be acceptable.
(c) What are the requirements for an
adequate veterinary care and animal
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health program? (1) Veterinary care.
The Sanctuary staff must provide
sufficient resources of personnel,
equipment, supplies, and facilities to
enable the provision of adequate
veterinary care as set forth in the Guide
and in the American College of
Laboratory Animal Medicine document
on ‘‘The Provision of Adequate
Veterinary Care’’ available on the
Internet at https://www.aclam.com. The
Sanctuary must provide adequate
veterinary care to assure the health of
the chimpanzees. If the Sanctuary
houses chimpanzees with infectious
diseases, it must have a veterinarian
knowledgeable in the infectious
diseases and care of chimpanzees. The
Facility Veterinarian is responsible for
establishing and implementing a health
monitoring system specifically designed
to meet the health requirements of
chimpanzees in the Sanctuary. The
veterinarian must use appropriate
professional judgment based upon
current veterinary practices when
dealing with the health and well-being
of the chimpanzees in the Sanctuary.
(2) Preventative medicine and animal
health program. The prevention of
disease, metabolic conditions, and
injury must be a priority focus of the
Facility Veterinarian, managers, and
caregivers staff. A quality preventative
medicine and animal health program
requires the participation of all
employees having direct contact with
the chimpanzees in the Sanctuary. The
goal of this program shall be to maintain
the chimpanzees in good health, taking
into consideration each animal’s age,
medical history, experimental history,
behavior patterns, prognosis for
recovery, and current veterinary
medical practices. It shall be the
responsibility of the Facility
Veterinarian to develop and implement
the preventive medicine and animal
health program. Other persons may
perform some aspects of the program
under the direction of the veterinarian.
The veterinarian must provide guidance
to all personnel involved in the care of
chimpanzees to ensure appropriate
handling, observation, treatment and
oversight of surgery, post-surgical care,
immobilization, sedation, analgesia, and
anesthesia. Chimpanzees must receive
an annual physical examination unless
the Facility Veterinarian determines that
a different interval is needed.
(3) Quarantine and stabilization of
newly arrived animals. Newly received
chimpanzees must be quarantined for a
period for physiological, psychological,
and nutritional stabilization before their
introduction to the rest of the group.
The stabilization period should be
lengthened appropriately if the
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chimpanzee has a significant medical
problem or if abnormal medical findings
are detected during the quarantine
period. If the chimpanzee has not been
given a complete physical examination
within six months, an examination must
be conducted during the stabilization
period. During this period, the following
additional procedures will be
performed:
(i) Tuberculin tests must be negative
for two (2) consecutive tests before the
chimpanzee is released from quarantine.
Any chimpanzee that is suspected of
harboring the TB organism, or that is
diagnosed with TB will be isolated and
treated until determined by the Facility
Veterinarian to be of no health risk to
other chimpanzees or humans. The
Facility Veterinarian may recommend
euthanasia in those cases that do not
respond to therapy and consequently
the chimpanzee experiences undue pain
and suffering that cannot be alleviated.
The procedures noted under § 9.6(d)
must be observed if euthanasia is
necessary.
(ii) Fecal samples must be checked for
parasites and parasitic ova.
(iii) A complete blood count and
serum chemical panel must be obtained.
(iv) Additional serum for banking
and/or testing shall be obtained as
appropriate by the Facility Veterinarian.
(v) If the donating facility did not test
for the appropriate viruses, the
Sanctuary must perform a viral panel
and serology for the various chronic
hepatitis viruses and HIV.
(vi) Additional tests or procedures
may be required if deemed necessary by
the Facility Veterinarian.
(4) Vaccination. Chimpanzees are
susceptible to many of the vaccinepreventable diseases of human
childhood. Appropriate vaccines should
be considered and administered if
deemed necessary to protect the
chimpanzees in the Sanctuary. Measles,
mumps, and rubella occur
predominantly as asymptomatic
diseases. Vaccination protocols should
be changed with the introduction of
new vaccines and with the expanding
knowledge of chimpanzee disease
susceptibility. Additional vaccines may
be warranted under specific conditions
(e.g., rabies, influenza,
encephalomyocarditis virus vaccine).
The need for adjusting or changing the
vaccines will be determined at the
discretion of the Facility Veterinarian.
(5) Parasite detection, control, and
treatment. Parasite control is an
important aspect of a preventative
medicine program for chimpanzees.
Prophylactic de-worming must be
considered and provided for newly
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arrived chimpanzees if deemed
appropriate by the Facility Veterinarian.
(6) Observation, diagnosis, prevention
and treatment of illness and injury. The
Sanctuary must implement appropriate
methods for disease surveillance and
diagnosis of diseases. Upon diagnosis of
disease, treatment must be initiated
unless the Facility Veterinarian
determines that treatment is
inappropriate for medical, ethical, or
humane reasons. A person trained to
recognize signs of disease must observe
chimpanzees for signs of illness, injury,
or abnormal behavior. The Facility
Veterinarian must approve all
medication or therapy plans. The staff
behaviorist will develop and implement
plans addressing abnormal behavior in
chimpanzees. Observations must be
made at least once every day including
holidays and weekends. More frequent
observations are warranted during
postoperative recovery or when
chimpanzees are ill or have an injury.
Professional judgment should be used to
determine the adequate frequency and
quality of observations. If an entire
group of chimpanzees is known or
believed to be exposed to an infectious
agent (e.g., Mycobacterium
tuberculosis), the group may be kept
intact during the process of diagnosis,
treatment, and control. Methods of
disease prevention, diagnosis, and
therapy must comply with those
currently accepted in veterinary medical
practice. Diagnostic laboratory services
facilitate veterinary medical care and
can include gross and microscopic
pathology, clinical pathology,
hematology, microbiology, clinical
chemistry, and serology. It is important
that arrangements with diagnostic
laboratories be established before
chimpanzees arrive at the Sanctuary.
(7) Physical and chemical restraint.
The Sanctuary should minimize the use
of physical and chemical restraint.
Chimpanzees in the Sanctuary should
be trained to permit certain procedures
with minimal or no restraint. Such
procedures may include injections,
dosing or other treatments, and cageside health observations. Due to the
strength of chimpanzees, consideration
must always be given to the safety of the
caregivers. For this reason, as well as
the requirement for certain necessary
interventions (e.g., complete exams,
treatments, tissue collections, and
transfer), chemical sedation may
sometimes be necessary. A qualified
individual must continuously monitor
recovery from chemical restraint until
the chimpanzee has regained full
ambulatory capability and is alert
enough to move about the cage and is
alert enough to avoid injury. Padding of
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the enclosure may be required if there
is a danger of injury (falling) while
recovering from anesthesia or heavy
sedation. In most instances,
chimpanzees should be isolated from
their cage mates during the sedation
process which is to include recovery.
Physical restraint should rarely be
necessary in the Sanctuary. When it is
necessary to use physical restraint
measures, due consideration must be
given to the temporary or permanent
effects upon the chimpanzee and human
and animal safety concerns.
Chimpanzees should be physically
restrained only for the time required to
complete the task at hand.
(8) Surgery and post-surgical care.
Surgery on Sanctuary chimpanzees may
be required to improve their health or
repair injuries. Except for emergency
situations in the following paragraph,
survival surgery on Sanctuary
chimpanzees must be performed under
aseptic conditions and in facilities that
meet the requirements of the accrediting
association and must be under the
direction and supervision of a
veterinarian qualified to perform
surgery on nonhuman primates. When
emergency situations require immediate
surgical intervention under less than
aseptic conditions, veterinary medical
judgment must be employed with the
best possible technique practiced.
During the post-surgical recovery
period, the chimpanzee must be in a
clean, dry area free from objects that
might cause inadvertent harm to the
chimpanzee. The chimpanzee must be
constantly monitored by trained
personnel until fully recovered from the
anesthesia and fully ambulatory.
Particular attention must be given to
thermoregulation, cardiovascular and
respiratory function, and postoperative
pain or discomfort during recovery from
anesthesia. Detailed medical and
surgical records must be maintained
including observations, any drugs or
supportive care given, and times and
dosage of medications given to the
chimpanzee. The records may be
created and retained in electronic forms.
After anesthetic recovery, monitoring
may be less intense but should include
attention to basic biologic functions of
intake and elimination, behavioral signs
of postoperative pain, monitoring for
post-surgical infections and care of the
surgical incision, bandaging, and timely
removal of skin sutures, clips, or
staples.
(9) Analgesia. Relief of pain is a
component of adequate veterinary care
that must be provided to chimpanzees
in the Sanctuary. The responsibility for
assuring that pain management is
current and in accordance with
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acceptable veterinary medical practices
rests with the Facility Veterinarian.
Sanctuary caregivers must be properly
trained to recognize when a chimpanzee
is in pain, and provide the appropriate
response to alleviate or report the
condition to veterinarian or, in the
absence of the veterinarian, to another
individual capable of initiating the
procedures necessary to reduce or
eliminate the pain. Methods used to
relieve the pain must be in accordance
with current veterinary or medical
practices, and documented in the
chimpanzee medical or surgical records.
These records will be available for
review by USDA and NIH
representatives. The records may be
created and retained in electronic form.
(10) Emergency, weekend, and
holiday care. Chimpanzees must be
cared for by qualified personnel on a
daily basis, including weekends and
holidays, to safeguard their well-being.
Emergency veterinary care must also be
available during these times. In the
event of an emergency, Sanctuary
security should be able to reach
someone that can adequately respond to
such emergency. Notification
procedures must be documented in the
form of operating procedures and a list
of persons to call. The list must include
home and/or mobile telephone
numbers. The operating procedure and
phone numbers must be placed in a
location that it is available to the
appropriate individuals when needed. A
copy of the disaster plan must also be
available in a location that makes it
readily available to the staff when
needed.
(d) Under what circumstances is
euthanasia permitted? As stated in
section 481C(d)(2)(I) of the Public
Health Service Act as added by section
2 of the CHIMP Act, none of the
chimpanzees may be subjected to
euthanasia except as in the best interest
of the chimpanzee involved as
determined by the SCCC and the
Facility Veterinarian. Therefore,
euthanasia for medical or humane
reasons is permitted. Euthanasia may be
permitted for reasons of health or
quality of life of the individual
chimpanzee, including for disease, in
connection with trauma, complications
of aging, or for other humane reasons.
Methods of euthanasia must be
consistent with the most recent report of
the American Veterinary Medical
Association Panel on Euthanasia (2002).
When euthanasia is performed, the
veterinarian will determine the
appropriate agent and it will be
administered only by properly trained
personnel under the direction of the
Facility Veterinarian. The decision to
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1855
perform euthanasia will be made by the
veterinarian in consultation with the
Facility Director or Deputy Director. The
SCCC will participate in the decision in
non-medical emergencies. All
euthanasia decisions must be reviewed
by the SCCC, preferably prior to
euthanasia. In emergencies, where
euthanasia has to be performed
immediately by the Facility
Veterinarian, the circumstances and the
decision by the Facility Veterinarian
will be presented at the next scheduled
or special meeting of the SCCC. The
NCRR Project Officer must be notified of
the euthanasia event within 72 hours by
electronic or telephonic means.
Euthanasia of individual chimpanzees
may negatively affect the care staff and
appropriate counseling and
psychological support should be
considered.
(e) Incorporation by reference. The
Guide for the Care and Use of
Laboratory Animals published by the
National Research Council (Guide),
1996, International Standard Book
Number 0–309–05377–3, is
incorporated by reference in this
section. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain a copy of the publication from
the National Academy Press, 2101
Constitution Avenue, NW., Lockbox
285,Washington, DC 20055; or you may
order it electronically via the Internet at
https://nap.edu; or view it online at
https://oacu.od.nih.gov/regs/guide/
guidex.htm. You may inspect a copy at
NIH, NCRR, 1 Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD
20817–4874, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to https://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
§ 9.7
Reproduction.
Chimpanzee reproduction is
prohibited in the Sanctuary. Therefore,
males must be sterilized by vasectomy
before acceptance into the system, or, as
a temporary measure, housed apart from
females until they are sterilized.
Vasectomies are advisable because they
are minimally invasive and because
effectiveness of the vasectomy can be
validated through laboratory testing of
semen. Seminal collection techniques
must be carefully evaluated to avoid
painful stimuli. Other proven methods
of birth control may be used under
special conditions deemed appropriate
by the Facility Veterinarian and SCCC.
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The Facility Veterinarian must
determine the appropriate test(s) to use
to validate sterility. A veterinarian
experienced in performing vasectomies
in chimpanzees should perform the
operation. Documentation must
accompany each male accepted to the
Sanctuary system attesting to the fact
that the male has been vasectomized
and laboratory tests confirm that semen
samples are negative for sperm.
§ 9.8
Animal records.
(a) What records must be maintained
for chimpanzees in the Sanctuary and
how are they managed? (1) Contractors
and Subcontractors operating the
Federal chimpanzee Sanctuary system
must maintain appropriate records to
allow for accountability and disposition
of chimpanzees under their care as
required by the USDA Animal Welfare
Regulations (9 CFR 2.35). The records
may be created and retained in
electronic form.
(2) The animal records currently
required by the USDA Animal Welfare
Regulations are also required for these
standards. All chimpanzees must be
tracked for life by a single agency with
demonstrated expertise and capability
in this area. Chimpanzees must be
individually and permanently
identifiable.
(3) Retrievable records must be
maintained for a minimum of three
years beyond the disposition or death of
each chimpanzee in accordance with
the Animal Welfare Regulations section
2.35(f). Original records or a copy must
be transferred if the chimpanzee moves
to a different facility. The records must
include standard information, including
permanent individual identification,
research use(s), reproductive status (past
and present), a summary or copy of the
medical and behavioral history, the
sire’s identification number (if
available), the dam’s identification
number, birth date, sex, and date
acquired by the Sanctuary. The
disposition date must also be noted, if
applicable, including whether the
chimpanzee died or was transferred to
another site in the Federal Sanctuary
system. The records may be created and
retained in electronic form.
(4) The contractor and any
subcontractor(s) operating the federally
supported chimpanzee Sanctuary must
provide special, quarterly and annual
progress reports to the designated
Federal officials as identified in the
contract. The annual report must also
contain a statement that certifies the
Sanctuary is in full compliance with
these Standards of Care regulations.
(b) What are the rules governing the
disposition of necropsy records? The
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CHIMP Act requires that necropsy
records from chimpanzees previously
used in federally funded research
projects be made available on a
reasonable basis to investigators
engaged in biomedical or behavioral
research. In order to comply with this
provision, the contractor for the
Sanctuary system must devise a plan
that will allow interested parties to
contact the Sanctuary and receive
necropsy records when they become
available. Records may be provided free
of charge but requesters may be required
to pay for packaging and shipping costs.
The records may be created and retained
in electronic form.
§ 9.9
Facility staffing.
How many personnel are required to
staff the chimpanzee Sanctuary and
what qualifications and training must
the staff possess?
(a) The professional, managerial, and
support staff must be sufficient to
support the scope and diversity of the
activities and chimpanzee population of
the Sanctuary. The level of staffing shall
be adequate to ensure that the
chimpanzees receive appropriate health
care, are well cared for, and the
administrative and fiscal operations are
sound and in keeping with current
practices required by NCRR, NIH;
(b) There must be a sufficient number
of appropriately trained animal care and
technical personnel to provide
appropriate care to the chimpanzees at
all times, including evenings, weekends
and holidays. The number of animal
care staff to chimpanzee ratio should be
adjusted as experience is gained during
the operation of the Sanctuary;
(c) Animal care personnel must be
properly trained or experienced in
providing care for the chimpanzees.
Caregivers must have experience or be
trained in the daily care of
chimpanzees, including husbandry,
enrichment techniques and observation
for illness. Personnel must be familiar
with regulations, guidelines and
policies that relate to their duties,
including basic emergency care. The
Sanctuary must provide for formal or
on-the-job training to facilitate the
effective implementation of a highquality and humane care program for
the chimpanzees. The Sanctuary CEO is
responsible for assuring that staff hired
to care for the chimpanzees have a
working knowledge of the physiological
and behavioral needs of chimpanzees. A
formal training program for new
employees shall be developed and
implemented. The Sanctuary shall
develop a mechanism to document
employee-training activities that include
chimpanzee biology, husbandry,
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behavior, signs of well-being vs. illness
or maladaption, zoonoses, and
enrichment and socialization
techniques, among other relevant
subject areas. Training must be
documented and available for review by
regulatory, accrediting, and other
agencies with a need to know;
(d) The veterinarian(s) responsible for
providing veterinary medical care must
be knowledgeable of nonhuman primate
health care needs through training or
experience and capable of providing
appropriate care to the chimpanzees in
the Sanctuary. Sufficient veterinarians
must be available to administer the
veterinary medical program;
(e) The Facility Director must be a
person with experience in chimpanzee
care and socialization techniques. In
addition, the Director must have
management and administrative
experience;
(f) The Behaviorist(s) must be
qualified through training and
experience. The person must have
formal training in one of the behavioral
sciences and experience working with
and observing nonhuman primates, or
have developed expertise through at
least four years of experience working
with chimpanzees;
(g) The Biosafety Officer must have
experience in developing and
monitoring biohazards and dealing with
biosafety issues related to captive
nonhuman primates. Experience in
these areas dealing specifically with
chimpanzees is desirable;
(h) Animal Resource Managers or
Supervisors must have experience
working with nonhuman primates and
demonstrate the skills and ability to
supervise personnel; and
(i) The remaining support staff must
possess the skills, knowledge and/or
experience required to perform their
duties.
§ 9.10 Occupational Health and Safety
Program (OHSP) and biosafety
requirements.
(a) How are employee Occupational
Health and Safety Program risks and
concerns addressed? (1) It is the
responsibility of the Chief Executive
Officer (CEO) of the Sanctuary to assure
that an Occupational Health and Safety
Program (OHSP) program is developed
and implemented. The CEO or other
responsible person may delegate
responsibility for the monitoring
activities associated with oversight and
monitoring of the program. The
Sanctuary must design and implement a
plan that is consistent with current
veterinary medical practices. A plan
shall be considered adequate and
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appropriate if it meets the guidelines
and standards found in the Guide.
(2) An effective OHSP must be
established at each federally supported
chimpanzee sanctuary site. The program
must be designed to protect all
personnel, including visitors, from
occupational and accidental exposure to
known hazards associated with
providing care or other services for
chimpanzees. A health professional
knowledgeable in occupational health
as it relates to staff working with
nonhuman primates must provide input
for the OHSP. Employees in managerial
and supervisory positions are obligated
to provide sufficient training and
oversight as necessary to minimize or
eliminate exposure to occupational
hazards. Employees providing day-today care shall follow the procedures
established by the Sanctuary to avoid
occupational health hazards and
accidental exposures or injuries. An
effective program is based upon several
factors. These include knowing the
hazards involved (risks), avoiding and
controlling exposures (preventative
measures), training and education,
establishing rules and guidelines
(standard operating procedures),
consistency, record keeping and
monitoring (documentation), and
institutional and individual
commitment and coordination. The
Sanctuary OHSP must be reviewed with
each employee at risk, and an
acknowledgment of this review must be
signed or initialed by the supervisor or
training officer (or equivalent) and the
employee.
(3) Qualified individuals with
experience and training in OHSP must
oversee the development of this
program. The program may be directed
and coordinated by the contractor’s staff
or consultants, or a combination of both.
At a minimum, the program must
address the following:
(i) An overview of the program and
the institutional commitment to the
OHSP;
(ii) OHSP training and education for
employees working with or having
exposure to chimpanzees;
(iii) Facility design and operation as
needed to address occupational health
and safety issues;
(iv) Hazard identification and risk
assessment;
(v) Personal protective equipment;
(vi) Prevention and treatment
procedures;
(vii) Personal hygiene;
(viii) Rules and guidelines for
avoiding exposures;
(ix) Record keeping and monitoring
procedures; and
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(x) Monitoring overall performance of
these areas.
(b) How are biosafety concerns
addressed? (1) The chimpanzees may
contract natural infections of zoonotic
importance that can contaminate the
environment or otherwise present
biohazards to humans and other
chimpanzees. Certain chemicals used in
the routine sanitation of facilities and
equipment can be hazardous if not
properly used or disposed. Other
conditions may also occur where
temporary or permanent hazards are
present. Appropriate operating
procedures and policies must be
established to address these areas. The
contractor for the Sanctuary system is
responsible for instituting and
administering an effective biosafety
program that addresses the biosafety
hazards at that particular site. The
program should include: identifying
biohazards, outlining practices and
procedures to be followed, providing
personal safety equipment or protective
clothing and equipment, and a
description of the facility requirements
for working with hazardous agents or
materials. Policies and procedures must
be implemented to avoid exposure to
environmental and animal hazards.
Biosafety must be included in the
training program for all Sanctuary
employees. The Sanctuary must use
current accepted practices and
publications prepared by the CDC, NIH,
and professional societies specializing
in biosafety in establishing a program.
The input and guidance of personnel
trained or experienced in biosafety are
essential.
(2) Biosafety issues in the chimpanzee
Sanctuary are likely reduced compared
to those encountered in a biomedical
research environment since research
involving toxicity testing, or
radioisotopes are prohibited at the
Sanctuary. For those chimpanzees that
arrive in the Sanctuary that are
chronically infected with viruses, blood
sampling and health assessments will be
needed, but no invasive research will be
allowed at the Sanctuary. The major
biosafety concerns relate to
chimpanzees that were exposed to
experimental agents prior to arriving at
the Sanctuary and that still present a
hazard due to chronic infection (e.g.,
persistent bacteremia or viremia).
Complete records of both clinical and
experimental agent exposure must
accompany each chimpanzee sent to the
Sanctuary. The donating facility must
also provide recent testing, e.g.,
serology, virus culture, histology, so that
the Sanctuary staff are fully aware of the
health condition of the arriving
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1857
chimpanzee. The records may be
created and retained in electronic form.
(c) Incorporation by reference. The
Guide for the Care and Use of
Laboratory Animals published by the
National Research Council (Guide),
1996, International Standard Book
Number 0–309–05377–3, is
incorporated by reference in this
section. The Director of the Federal
Register approves this incorporation by
reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may
obtain a copy of the publication from
the National Academy Press, 2101
Constitution Avenue, NW., Lockbox
285, Washington, DC 20055; or you may
order it electronically via the Internet at
https://www.nap.edu; or view it online at
https://oacu.od.nih.gov/regs/guide/
guidex.htm. You may inspect a copy at
NIH, NCRR, 1 Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD
20817–4874, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to https://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
§ 9.11
Animal transport.
(a) What are the standards for
transporting chimpanzees between other
facilities and the Sanctuary? The
transportation of chimpanzees from the
facility where they are housed to the
Sanctuary by surface or air must be in
accordance with the requirements set
forth in the Animal Welfare Regulations
(9 CFR part 3, subpart F) and
international air transportation
regulations and guidelines. Because the
size of chimpanzees varies greatly, the
transportation vehicle and/or primary
enclosure must provide adequate space
for the chimpanzee to make postural
adjustments and provide adequate
ventilation. Adequate ventilation is
interpreted to mean the chimpanzee is
able to maintain normal respiratory
function and body temperature
regulation. The Sanctuary Contractor
must ascertain that the firm transporting
the chimpanzees has the proper
equipment, personnel, and experience
to safely transport the chimpanzees. It is
the responsibility of the donating
institution in collaboration with the
Sanctuary to validate this capability
before releasing the chimpanzees for
transport. The Sanctuary must report
any undesirable problems involved with
transportation to the donating
institution and the transportation
company. The NCRR representative will
be notified telephonically and or
electronically of the nature of the
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incident, factors contributing to the
incident, outcome, and measures taken
to prevent future incidents. A record of
such incident and action taken shall be
available for review by representatives
of the USDA and NIH. All records
associated with the transportation of
chimpanzees to or from the Sanctuary
must be maintained for at least one year
after the movement is completed in
accordance with the current
requirements set forth in the Animal
Welfare Regulations (9 CFR 2.80).
(b) What other transport regulations
apply to the federally supported
chimpanzee Sanctuary system? (1)
General requirements and regulations
applicable to animal transport into and
among Sanctuary sites include:
(i) The contractor will maintain
contact with carrier personnel in order
to ensure their compliance with proper
care of chimpanzees during transit; and
(ii) The contractor must submit to the
Project Officer by telephone, fax, or email, the actual shipment schedule and
proposed method of transport no less
than 10 days prior to shipment. The
Project Officer must be immediately
informed of any changes or delays in
this schedule in accordance with the
terms of the current contract between
NCRR and the Sanctuary contractor.
(2) Additional requirements and
regulations applicable to ground
transportation include:
(i) Transport must be provided by a
USDA licensed intermediate handler;
and
(ii) Transport must adhere to
provisions of the Interstate Commerce
Commission Authority Animal
Transportation Regulations.
(3) Additional requirements and
regulations applicable to air
transportation include:
(i) The International Air Transport
Association (IATA) Live Animal
Regulations if air transportation is
utilized, and
(ii) Delivery to and from the airports
must be provided in an environmentally
controlled truck per USDA Animal
Welfare Regulations, (9 CFR part 3,
subpart F).
(4) Requirements and regulations
applicable to shipping units mandate
that chimpanzees must be delivered in
properly ventilated, escape-proof units,
and each compartmentalized unit must
have separate water and feed containers
(9 CFR part 3, subpart F).
§ 9.12 Compliance with the Standards of
Care, USDA and PHS policies and
regulations.
(a) How will compliance with the
standards set forth in this part be
monitored and what are the
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consequences of noncompliance with
the standards? The federally supported
chimpanzee Sanctuary must comply
with the standards of care set forth in
this part and include a statement in the
Annual Progress Report certifying
compliance with these standards of care
in accordance with the terms of the
current contract between NCRR and the
Sanctuary contractor. A designated
representative of the Secretary will
monitor compliance. The responsibility
to monitor compliance with the
standards is delegated to the NCRR/
NIH/DHHS. The NIH/NCRR Project
Officer for this contract will conduct
scheduled site visits at least one time
quarterly (or more often if necessary),
review monthly and quarterly reports
submitted to the Project and Contracts
Officer, Subcontractors are subjected to
the same provisions. Failure to comply
with the standards set forth in this part
or to correct deficiencies noted within
the allowable time period could result
in termination of the contract by the
Federal Government (DHHS/NIH),
allowing the Secretary to correct the
deficiencies according to the terms and
conditions outlined in the contract. The
Secretary may impose additional
sanctions on the contractor up to, and
including, authorizing assumption or
reassignment of the management of the
Sanctuary contract.
(b) To what type of outside review or
inspection will the federally supported
Sanctuary be subjected? As noted in
paragraph (a) of this section, the
contractor for the Sanctuary will be
monitored on a regularly scheduled
basis by representatives of the NCRR/
NIH/DHHS. The NCRR representative
will use facility site visits, reports,
personal contact, and any other means
as appropriate to assure compliance
with these standards. The contractor
and subcontractors are required to
obtain and maintain an Animal Welfare
Assurance from NIH’s Office of
Laboratory Animal Welfare (OLAW)
when chimpanzees are used for noninvasive studies as authorized in the
CHIMP Act. involving chimpanzees. In
addition, the Sanctuary must achieve
accreditation by a nationally recognized
animal program accrediting body (such
as the AAALAC, or the AZA) within a
time frame to be determined by NCRR/
NIH. The federally supported Sanctuary
must comply with the requirements set
forth in the Animal Welfare Regulations
(9 CFR parts 1 through 3).
§ 9.13 Other Federal laws, regulations,
policies, and statues that apply to the
Sanctuary.
(a) Animal Welfare Act (7 U.S.C.
2131–2159).
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(b) Animal Welfare Regulations, 9
CFR, subchapter A, parts 1 and 2.
§ 9.14 Authority of the Secretary of Health
and Human Services to amend or issue
additional standards of care regulations.
The Secretary of the Department of
Health and Human Services (or
designated Federal agency) may amend,
rescind, or promulgate new regulations
if deemed necessary and appropriate to
assure compliance with the CHIMP Act.
Any such proposed changes must be
published in the Federal Register for
public comment for a minimum of 60
days.
[FR Doc. 05–394 Filed 1–10–05; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
RIN 1018—AI79
Endangered and Threatened Wildlife
and Plants; Proposed Removal of the
Plant Agave arizonica (Arizona agave)
From the Federal List of Endangered
and Threatened Plants
Fish and Wildlife Service,
Interior.
ACTION: Proposed rule.
AGENCY:
SUMMARY: We, the U.S. Fish and
Wildlife Service (Service), under the
Endangered Species Act of 1973, as
amended (Act), propose to remove the
plant Agave arizonica (Arizona agave)
from the Federal List of Endangered and
Threatened Plants. Agave arizonica was
listed as endangered on June 18, 1984,
due to threats of habitat modification
and collection. Evidence collected
subsequent to the listing indicates that
plants attributed to Agave arizonica do
not constitute a distinct species but
rather are individuals that have resulted
from recent and sporadic instances of
hybridization between two species.
Current taxonomic practice is not to
recognize such groups of individuals as
a species. The term ‘‘species,’’ as
defined by the Act, only includes
species, subspecies, and distinct
population segments. Since Agave
arizonica is not recognized as a species,
it no longer qualifies for protection
under the Act.
DATES: Comments on the proposed rule
must be received on or before March 14,
2005 to ensure our consideration. Public
hearing requests must be received by
February 25, 2005.
ADDRESSES: Comments and materials
concerning this proposal should be sent
E:\FR\FM\11JAP1.SGM
11JAP1
Agencies
[Federal Register Volume 70, Number 7 (Tuesday, January 11, 2005)]
[Proposed Rules]
[Pages 1843-1858]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-394]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
42 CFR Part 9
RIN 0925-AA31
Standards of Care for Chimpanzees Held in the Federally Supported
Chimpanzee Sanctuary System
AGENCY: National Institutes of Health, Department of Health and Human
Services.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The National Institutes of Health (NIH) proposes to issue
standards to implement provisions of the Chimpanzee Health Improvement,
Maintenance, and Protection Act (CHIMP Act) authorizing the Secretary
of the Department of Health and Human Services (DHHS) to develop and
publish standards of care for chimpanzees held in the Sanctuary system
supported by Federal funds authorized under the CHIMP Act. These
regulations will apply to only those facilities receiving Federal funds
as a part of the federally funded chimpanzee Sanctuary system.
DATES: Comments must be received on or before March 14, 2005 in order
to assure that NIH will be able to consider comments in preparing the
final rule.
ADDRESSES: You may submit comments, identified by RIN number 0925-AA31,
by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: jm40z@nih.gov. Indicate RIN number 0925-AA31 in
the subject line of the message.
Fax: 301-402-0169.
Mail: Jerry Moore, NIH Regulations Officer, Office of
Management Assessment, National Institutes of Health, 6011 Executive
Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892.
Hand Delivery/Courier: 6011 Executive Boulevard, Suite
601, MSC 7669, Rockville, Maryland 20892.
FOR FURTHER INFORMATION CONTACT: Jerry Moore at the address given in
the ADDRESSES section, or telephone 301-496-4607 (not a toll-free
number).
SUPPLEMENTARY INFORMATION: On December 20, 2000, the United States
Congress enacted the Chimpanzee Health Improvement, Maintenance, and
Protection Act of 2000 (Pub. L. 106-551). Section 1 of this law amended
the Public Health Service (PHS) Act by adding a new section 481C (42
U.S.C. 287a-3a). Section 481C authorizes the Secretary to provide for
the establishment and operation of a sanctuary system to provide for
the lifetime care of chimpanzees that have been used, or were bred or
purchased for use, in research conducted or supported by the National
Institutes of Health (NIH), the Food and Drug Administration (FDA),
Center for Disease Control and Prevention, or other agencies of the
Federal Government, and with respect to which it has been determined by
the Secretary that the chimpanzees are not needed for such research
(i.e., surplus chimpanzees). Section 481C (d) directs the Secretary to
establish by regulation standards of care for operating the Sanctuary
system to provide for the permanent retirement of surplus chimpanzees.
These standards of care for chimpanzees must ensure the well-being of
animals and the health and safety of the animals and the people caring
for them. On April 5, 2001, the Secretary delegated to the Director,
NIH, the authorities to establish and operate the sanctuary system.
Subsequently, the Director, NIH, delegated the authorities to the
National Center for Research Resources (NCRR). Consequently, NCRR has
the lead responsibility for coordinating all efforts on behalf of the
Department of Health and Human Services (DHHS) concerning the Sanctuary
system for surplus chimpanzees from both Federal and non-Federal
sources. Section 481C (e) authorizes the Secretary to make an award of
a contract to a nonprofit private entity (i.e., Sanctuary Contractor)
under which the entity has the responsibility of operating (and
establishing, as applicable) the Sanctuary system and awarding
subcontracts to individual Sanctuary facilities that meet established
standards. NCRR/NIH must approve both contractor and subcontractor
awards and NCRR/NIH will verify
[[Page 1844]]
contractor and subcontractor (if applicable) qualifications through
facility site visits, review of written documentation submitted to the
contractor, and evaluating available and current resources.
NCRR/NIH will assure compliance with the Standards of Care
Regulations through on site visits (at least quarterly or more often if
necessary), review of quarterly and annual reports, and any other
measures deemed appropriate by the NCRR/NIH Project or Contracts
Officer. Noncompliance with these standards or any other federal or
state regulations will result in the NCRR/NIH invoking the provisions
of the contract that allows the government to terminate the contract
and/or provide a management team to bring the Sanctuary back into
compliance. The Sanctuary is covered by the Animal Welfare Regulations
only if covered activities are performed. The CHIMP Act requires
compliance with the Animal Welfare Act and the Federal Contract and
these regulations require the Sanctuary Contractor to register with the
USDA and agree to compliance inspections. Therefore, the USDA
Inspectors responsible for enforcing the Animal Welfare Regulations
will perform inspections for compliance with the Animal Welfare
Regulations at a frequency and time determined by the USDA staff. Once
the contractor becomes a Registered Facility the USDA will report
noncompliance to NCRR/NIH as appropriate. The NCRR/NIH representative
will review USDA inspection reports during on-site visits in order to
monitor compliance with these proposed Standards of Care Regulations.
The Sanctuary must also adhere to U.S. Public Health Service Policy on
the Humane Care and Use of Laboratory Animals. If and when any
noninvasive studies allowed under the CHIMP Act and these regulations
are proposed for chimpanzees in the Sanctuary, the Sanctuary Contractor
must obtain an Animal Welfare Assurance from the NIH Office of
Laboratory Animal Welfare (OLAW) and comply with the provisions of the
policy. Finally, the Sanctuary must obtain accreditation or
certification by a nationally or internationally recognized body that
performs such services. The Sanctuary must achieve accreditation or
certification within a reasonable period of time as determined by the
NCRR/NIH.
In preparing these proposed standards of care, we considered the
recommendations of the Board of Directors of the Sanctuary contractor
and the NCRR Chimpanzee Sanctuary Working Group, and the applicable
recommendations of the National Research Council made in its 1997
report entitled, ``Chimpanzees in Research--Strategies for Their
Ethical Care, Management, and Use.'' Individuals involved in developing
recommendations from these groups represented a variety of professional
areas including veterinary medicine, chimpanzee behavior, animal
protection, facility management, and nonhuman primate research and
care. We also consulted other publications, including: ``The Guide for
the Care and Use of Laboratory Animals,'' published by the National
Research Council (NRC), ``The Psychological Well-Being of Nonhuman
Primates,'' also an NRC publication, ``Public Health Service Policy on
Humane Care and Use of Laboratory Animals,'' the accreditation
guidelines used by the Association for the Assessment and Accreditation
of Laboratory Animal Care, International, and the American Zoological
and Aquarium Association, and the United States Department of
Agriculture (USDA), Animal Welfare Regulations codified in various
parts of title 9, chapter 1, Subchapter A of the Code of Federal
Regulations (CFR).
We propose to amend title 42 of the CFR by adding a new part 9 to
establish standards for operating the Sanctuary system to provide for
the permanent retirement of surplus chimpanzees. These standards of
care will apply to only the sanctuaries that are a part of the
federally funded chimpanzee Sanctuary system. The proposed rule
specifies the scope and specific standards that must be met by all
contractors (primary or subcontractors) operating under the federally
supported Chimpanzee Sanctuary system. The purpose of this notice is to
invite public comment on the proposed standards of care.
The following is provided as public information.
Executive Order 12866
Executive Order 12866, ``Regulatory Planning and Review,'' requires
that all regulatory actions reflect consideration of the costs and
benefits they generate, and that they meet certain standards, such as
avoiding the imposition of unnecessary burdens on the affected public.
Executive Order 12866 classifies a rule as a significant regulatory
action if it meets any one of a number of specific conditions. We
determined that this proposed rule is a ``significant regulatory
action,'' as defined under Executive Order 12866, because it raises
novel legal or policy issues. Therefore, we submitted the proposed rule
to the Office of Information and Regulatory Affairs for review prior to
publication in accordance with the requirements of Executive Order
12866.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that
we analyze regulatory proposals to determine whether they create a
significant impact on a substantial number of small entities. Based on
the analysis that follows, the Secretary certifies that this proposed
rule will not have such impact when the final rule is issued.
1. Number and Type of Small Entities Affected
There are several small entities that privately fund nonhuman
primate sanctuaries. However, the federally supported, contractor
operated Chimpanzee Sanctuary System, established by the CHIMP Act and
covered under the proposed standards of care, is the only one of its
kind in existence. Congress established the Sanctuary to provide
lifetime care for chimpanzees that are no longer needed in federally
supported research. The proposed rule applies only to a contractor or
any subcontractor operating under a contract funded by the NIH/NCRR for
the Sanctuary. Only one contractor is identified in the proposed rule
as the prime contractor for the Sanctuary system. The NCRR awarded this
contract in September 2002. Additionally, a few subcontractors might be
added in future years if the need arises. The subcontractors would be
selected by the prime contractor (contingent upon NIH/NCRR approval),
and report to the prime contractor. Approximately four or five
biomedical research centers with chimpanzees will be responsible for
the transport of animals to the Sanctuary. The entities shipping
chimpanzees to the Sanctuary are required to comply with existing
Animal Welfare Regulations administered by the USDA.
2. Net Cost of Compliance With the Proposed Rule
At the time NIH/NCRR awarded the contract in 2002, the contractor
was aware of its role in establishing and complying with the proposed
standards of care pursuant to the CHIMP Act. The costs necessary to
comply with the standards of care were anticipated by the CHIMP Act and
subsequent contract negotiations. The RFP and Statement of Work noted
that Standards of Care would be developed in consultation with the
selected contractor and that the contractor must comply with these
standards. The contractor selected had
[[Page 1845]]
several members of their Board of Directors familiar with chimpanzee
care standards and had served as consultants to some of the agencies
publishing such standards. Therefore, they included resources needed to
potentially comply with anticipated standards in their contract and
construction grant proposals. There could be some additional
unanticipated costs but they are not obvious at this time. Under the
terms of the contract, the Federal Government assumes responsibility
for seventy-five percent of the operational cost that includes
compliance with the proposed standards of care. The net costs to the
contractor are twenty-five percent of the total costs of care and
maintenance of the chimpanzees, including compliance with the proposed
standards of care. We estimate that this will amount to $875,000 to $1
million per year for the contractor. We anticipate no net increase in
the costs as a result of compliance with the standards of care. We
estimate that five or six research facilities might incur expenses in
transporting animals to the Sanctuary, and thus will incur minor
shipping costs (approximately $10,000 to $20,000 for 1 shipment for a
total of six shipments/year.) Subcontractors will likely have existing
facilities and staff though some might need to be upgraded. They would
be eligible to compete for NIH Construction Grants the same as the
prime contractor and thus match 10% of the construction cost. The use
of subcontractors is not anticipated in the foreseeable future because
of the availability of a considerable amount of unused space at the
primary contractor. When the need arises for subcontractors in the
operation of the Sanctuary, they will be selected by, and report to the
prime contractor, with verification of qualifications by NCRR/NIH.
3. The Percentage Cost of Compliance With the Proposed Rule
We estimate that the percentage cost for complying with the
proposed rule is less than three percent of the total operational cost
of the Sanctuary. We anticipate that no additional staff is needed to
comply with the proposed standards of care. The staffing under the
terms of the contract is based upon the requirement to provide quality
care and maintenance for the chimpanzees as required by the CHIMP Act
and the contract.
Executive Order 13132
Executive Order 13132, ``Federalism,'' requires that Federal
agencies consult with State and local government officials in the
development of regulatory policies with federalism implications. The
Secretary reviewed this proposed rule as required under the Order and
determined that it will not have federalism implications. The Secretary
certifies that the proposed rule will not have an effect on the States
or on the distribution of power and responsibilities among various
levels of government when the final rule is issued.
Paperwork Reduction Act
Sections 9.3(a)(7)(v)(C), 9.6(c)(6), 9.6(d), 9.8(a)(4), 9.11(a),
9.11(b)(1)(ii), and 9.12(b) of this proposed rule contain reporting
information collection requirements that are subject to OMB approval
under the Paperwork Reduction Act of 1995, as amended (44 U.S.C.
chapter 35). Sections 9.3(a)(11), 9.4(c)(1), 9.4(c)(3), 9.5(c)(4),
9.5(e), 9.6(c)(8), 9.6(c)(10), 9.8(a)(1-4), 9.8(b), 9.9(c), 9.10(a)(1),
9.10(a)(2), 9.10(b)(1), 9.11(a), 9.12(b), contain record keeping
requirements which also are subject to OMB approval under the Paperwork
Reduction Act. In addition, elements of disclosure are found in
sections 9.3(a)(13), 9.4(c)(2), 9.5(c), 9.5(e), 9.5(f)(2), 9.6(c)(10),
9.9(a)(3), 9.10(a)(1), 9.10(b)(1), and 9.11(a). The title, description,
and respondent description of the information collection and record
keeping requirements contained in the proposed rule have been submitted
to OMB for review. Other organizations and individuals desiring to
submit comments on the information collection and record keeping
requirements should send their comments to (1) Dr. Charles MacKay,
Project Clearance Officer, National Institutes of Health, Rockledge
Centre 1, 6705 Rockledge Drive, Room 3509 Bethesda, Maryland 20817,
telephone 301-435-0978 (not a toll-free number); and (2) the Office of
Information and Regulatory Affairs, OMB, New Executive Office Building,
Room 10235, 725 17th Street, NW., Washington, DC 20503. Attention: Desk
Officer for the National Institutes of Health, Department of Health and
Human Services. After we obtain OMB approval, we will publish the OMB
control number in the Federal Register.
Title: Standards of Care for Chimpanzees Held in the Federally-
supported Chimpanzee Sanctuary System.
Description: The information collections and record keeping will be
used by NIH and the Sanctuary contractor and subcontractors to document
proper and adequate care, identification, accountability, billing,
regulatory compliance, and adherence to contract specifications and
terms.
Respondent Description: Private nonprofit entities or institutions
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual number Annual burden
of Annual Avereage hours per
respondents* frequency burden (hours) response
----------------------------------------------------------------------------------------------------------------
Reporting:
Sec. 9.3(a)(7)(v)(C)...................... 1-3 2 6 12
Sec. 9.6(c)(6)............................ 1-3 3 2 6
Sec. 9.6(d)............................... 1-3 2 0.5 1
Sec. 9.8(a)(4)............................ 1-3 4 5 20
Sec. 9.11(a).............................. **1-3 1 1 12
Sec. 9.11(b)(1)(ii)....................... **1-3 6 2 12
Sec. 9.12(b).............................. 1-3 1 6 6
-----------------
Subtotal................................ .............. 19 22.5 69
=================
Recordkeeping:
Sec. 9.3(a)(7)(v)(c)...................... 1-3 2 2 4
Sec. 9.3(a)(10)........................... **1-3 1 8 8
Sec. 9.3(a)(11)........................... **1-3 1 8 8
Sec. 9.4(c)(1)............................ 1-3 1 1 1
Sec. 9.4(c)(3)............................ 1-3 1 6 6
[[Page 1846]]
Sec. 9.5(c)(4)............................ 1-3 1 2 2
Sec. 9.5 (e).............................. 1-3 1 4 4
Sec. 9.6(c)(8)............................ 1-3 5 0.05 0.25
-----------------
Subtotal................................ .............. 13.00 31.05 33.25
=================
Sec. 9.6(c)(10)........................... 1-3 4 0.1 0.4
Sec. 9.8(a)(1-4).......................... 1-3 1 0.5 5
Sec. 9.8(b)............................... 1-3 5 2 10
Sec. 9.9(c)............................... 1-3 12 0.2 2.4
Sec. 9.10(a)(1)........................... 1-3 12 0.2 2.4
Sec. 9.10(a)(2)........................... 1-3 4 3 12
Sec. 9.10(b)(1)........................... 1-3 3 1.5 4.5
Sec. 9.11(a).............................. ***1-3 6 1 6
Sec. 9.12(b).............................. ***1-3 1 3 3
-----------------
Subtotal................................ .............. 48 11.50 43.30
=================
Disclosure:
Sec. 9.3(a)(10)**......................... 1-3 6 0.5 3
Sec. 9.3(a)(11)**......................... 1-3 1 0.5 1
Sec. 9.3(a)(13)........................... 1-3 1 1 1
Sec. 9.4(c)(2)............................ 1-3 1 0.1 0.1
Sec. 9.5 (c).............................. 1-3 1 8 8
Sec. 9.5(e)............................... 1-3 ****1 2 2
Sec. 9.5(f)(2)............................ 1-3 0.2 8 1.6
Sec. 9.6(c)(10)........................... 1-3 4 0.1 0.4
Sec. 9.9(c)............................... 1-3 10 0.2 2
Sec. 9.10(a)(1)........................... 1-3 10 0.2 2
Sec. 9.10(b)(1)........................... 1-3 1 0.2 0.2
Sec. 9.11(a)***........................... 1-3 2 1 2
-----------------
Subtotal................................ .............. 38.2 21.8 23.3
=================
Total................................... 1-3 118.2 .85 168.25
----------------------------------------------------------------------------------------------------------------
* Presently, there is only one (1) respondent, the Contractor for the federally supported Chimpanzee Sanctuary
System. The estimates are based upon a maximum of three (3) respondents in the future.
** See also Sec. Sec. 9.5(c) & 9.5(e).
*** The reporting requirements for these sections vary because it is estimated that chimpanzees will be shipped
six (6) times per year. This requires 6 notifications of shipment notices to the Project Officer. While not
anticipated, it is possible that approximately one (1) of these shipments might require reporting because of
undesirable conditions, a death, failure to provide adequate food or water, or other conditions affecting
animal welfare. Such incidents must be reported immediately to the NCRR Project Officer who will in turn work
with the USDA representatives in investigating the matter.
**** 1 x event.
List of Subjects in 42 CFR Part 9
Animal welfare, Humane care and treatment of chimpanzees.
Dated: April 28, 2004.
Elias A. Zerhouni,
Director, National Institutes of Health.
Approved: September 29, 2004.
Tommy G. Thompson,
Secretary.
Accordingly, NIH proposes to amend title 42 of the Code of Federal
Regulations by adding part 9 to read as follows:
PART 9--STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY
SUPPORTED SANCTUARY SYSTEM
Sec.
9.1 Applicability and purpose.
9.2 Definitions.
9.3 Sanctuary policies and responsibilities.
9.4 Physical facility policies and design.
9.5 Chimpanzee ownership, fees, and studies.
9.6 Animal care, well-being, husbandry, veterinary care, and
euthanasia.
9.7 Reproduction.
9.8 Animal records.
9.9 Facility staffing.
9.10 Occupational Health and Safety Program and biosafety
requirements.
9.11 Animal transport.
9.12 Compliance with the Standards of Care, USDA and PHS policies
and regulations.
9.13 Other Federal laws, regulations, and policies that apply to
this part.
9.14 Authority of the Secretary of Health and Human Services to
amend or issue additional standards of care regulations.
Authority: 42 U.S.C. 216, 287a-3a.
Sec. 9.1 Applicability and purpose.
(a) General. The standards of care set forth in this part apply to
the chimpanzee sanctuaries that are contracted (or subcontracted) to
the Federal Government to operate the federally supported chimpanzee
Sanctuary system authorized by section 481C of the Public Health
Service (PHS) Act, as amended (42 U.S.C. 287a--3a).
(b) What is the purpose of the federally supported chimpanzee
Sanctuary system and the authority for establishing these standards of
care regulations? The Chimpanzee Health Improvement, Maintenance, and
Protection Act (Public Law 106-551, referred to as the ``CHIMP Act'' or
``Chimpanzee Retirement Act'') was enacted by Congress to provide for
the establishment and operation of a
[[Page 1847]]
Sanctuary system to provide lifetime care for chimpanzees that have
been used, or were bred or purchased for use, in research conducted or
supported by the agencies of the Federal Government, and that are
determined to be no longer needed for such research. The CHIMP Act also
mandates that standards of care for chimpanzees in the Sanctuary shall
be developed to ensure the well-being of chimpanzees and the health and
safety of the chimpanzees.
(c) To what chimpanzee sanctuaries do the standards of care in this
part apply? The standards of care set forth in this part apply to only
those sanctuaries that are contracted or subcontracted to the Federal
Government to operate the federally supported chimpanzee Sanctuary
system.
Sec. 9.2 Definitions.
As used in this part:
Adequate veterinary care means a program directed by a veterinarian
qualified through training and/or experience to provide professional
medical care to the chimpanzees within the Sanctuary and with the
appropriate authority to provide this care. The program also provides
guidance to all caregivers on all matters relating to the health and
well-being of the chimpanzees.
American Zoo and Aquarium Association (AZA) means the professional
society comprised of individuals with various backgrounds and interests
that is devoted to advancing the knowledge and understanding of zoo
animals and the management of zoos in the United States.
American Zoo and Aquarium Association (AZA) Accreditation Standards
are those standards developed by the AZA that are used to review,
evaluate, and accredit zoos or zoological gardens. These standards
cover a variety of areas including facilities, policies and procedures,
training, staff qualifications, medical and animal care, husbandry and
well-being procedures, and conservation, along with other specific
areas.
Animal Care and Use Committee means the Institutional Animal Care
and Use Committee established under section 13(b) of the Animal Welfare
Act of 1985 and the Health Research Extension Act of 1985. For the
purpose of these Standards of Care, it shall consist of at least five
(5) members including the Chairperson, a Doctor of Veterinary Medicine
(D.V.M. or V.M.D.) knowledgeable in nonhuman primate care and diseases
and with delegated program responsibility, a member not affiliated with
the Sanctuary, a scientist, and a member of the animal protection
community. This Committee is required if research as defined by the
Animal Welfare Act Regulations and the Public Health Service Policy
(research, teaching, testing, exhibition) is to be conducted at the
Sanctuary.
Animal protection organization means a nonprofit organization whose
primary mission is protection of animals through positive advocacy and
action.
Animal Resource Manager (or Animal Resource Supervisor) means the
individual employee responsible for managing the non-professional staff
providing care for the chimpanzees at the Sanctuary. This individual
may perform other duties as assigned by the Sanctuary contractor.
Animal Welfare Act/Regulations means the Act of August 24, 1966
(Pub. L. 89-544), (commonly known as the Laboratory Animal Welfare Act)
as amended by the Act of December 24, 1970 (Pub. L. 91-579), (the
Animal Welfare Act of 1970), the Act of April 22, 1976 (Pub. L. 94-
279), (the Animal Welfare Act of 1976), and the Act of December 23,
1985 (Pub. L. 99-198), (the Food Security Act of 1985), and as may be
subsequently amended, and the United States Department of Agriculture
(USDA) regulations implementing the Animal Welfare Act in title 9,
chapter 1, subchapter A of the CFR.
Animal Welfare Assurance means the documentation from an
institution assuring compliance with the PHS Policy on Humane Care and
Use of Laboratory Animals. This policy is administered by the Office of
Laboratory Animal Welfare (OLAW), National Institutes of Health.
Association for Assessment and Accreditation of Laboratory Animal
Care, International (AAALAC) means the nonprofit organization that is
recognized in the United States and abroad as being the body
responsible for the accreditation of laboratory animal programs.
Behaviorist means a person hired by the Sanctuary to administer or
oversee the enrichment and behavioral program for the chimpanzees at
the Sanctuary. This individual must be qualified through training or
experience.
Biosafety Officer means the individual responsible for establishing
and monitoring workplace safety procedures designed to minimize or
prevent injury or loss due to biohazards in accordance with policies
established by the Sanctuary administration.
Board of Directors (BOD) means the individuals selected by the
Contractor to govern the nonprofit institution responsible for
operating the federally supported chimpanzee Sanctuary system. The
board members must meet the qualifications and criteria stated in the
CHIMP Act.
Chair of the Board of Directors means the individual chosen by the
BOD or other legally empowered entity to carry out such action, who is
responsible for chairing meetings and acting on behalf of the board.
This individual reports directly to the board.
Chief Executive Officer (CEO) means the principal person
responsible for overall accomplishment of the mission of the chimpanzee
Sanctuary.
CHIMP Act means the Chimpanzee Health Improvement, Maintenance, and
Protection Act of December 20, 2000 (Pub. L. 106-551) commonly known as
the ``CHIMP Act'' or ``Chimpanzee Retirement Act,'' and any future
amendments.
Chimpanzee means a member of Pan troglodytes. It excludes the pygmy
chimpanzee (Pan paniscus or bonobo).
Chimpanzee caregivers (caregivers) means all Sanctuary technical
and husbandry staff providing long term care and services for the
chimpanzees.
Contractor/Primary Contractor/Sanctuary Contractor means the
nonprofit entity awarded a contract by the Federal Government to
establish and operate the chimpanzee Sanctuary system.
Euthanasia means the humane death of a chimpanzee accomplished by a
method that produces rapid unconsciousness and subsequent death without
evidence of pain or distress. The method must be consistent with the
recommendations of the American Veterinary Medical Association Panel on
Euthanasia.
Exhibition means exhibiting chimpanzees to the public for
compensation. It specifically excludes limited viewing for educational
purposes.
Facility director means the individual responsible for directing
the overall activities at the Sanctuary site.
Facility Veterinarian means a person who has graduated from a
veterinary school accredited by the American Veterinary Medical
Association (AVMA) Council on Education, or who has a certificate
issued by the AVMA's Education Commission for Foreign Veterinary
Graduates; has training and/or experience in the care and management of
nonhuman primates; and has direct or delegated authority for activities
involving chimpanzees at the federally funded chimpanzee Sanctuary.
Federal agency means an executive agency as such term is defined in
section 105 of title 5, United States Code, and refers to the agency
from which the research facility receives a
[[Page 1848]]
Federal award for projects involving animals.
Federal Acquisition Regulations (FAR) means the codified rules
applicable to contracts, specifically those sections of the FAR (48 CFR
chapter 1, part 52) that are applicable to contracts between the
Federal Government and a contractor (in this case a private, nonprofit
entity under contract to operate the chimpanzee sanctuary system).
Federally-owned chimpanzees mean chimpanzees that have been
purchased by, bred by, or donated to a Federal agency for use in
biomedical/behavioral research. Chimpanzees whose ownership was
subsequently transferred from Federal ownership via written transfer
agreements are no longer federally-owned. Newborn chimpanzees generally
belong to the same entity that owned the mother at the time of the
baby's birth.
Guide means the ``Guide for the Care and Use of Laboratory
Animals'' published by the National Academy of Sciences, Institute for
Laboratory Animal Research of the National Research Council.
Housing facility means any land, premises, shed, barn, building,
trailer, or other structure or area housing intended to house
chimpanzees.
Indoor housing facility refers to any structure or enclosure (e.g.,
cages, pens, rooms) for maintaining animals in a controlled environment
that provides for normal physiological and behavioral needs.
International Species Information System (ISIS) means the
organization that provides the chimpanzees in zoos, research
facilities, exhibitors, etc., with a unique identification number that
can be used to track and account for chimpanzees around the world.
Interstate air transport live animals (IATA) regulations means
those regulations and standards covering the air transportation of
nonhuman primates developed and implemented by the International Air
Transportation Association.
Invasive research (studies) utilizes those procedures that cause
more than momentary pain, distress, fear, discomfort, injury, or other
negative modalities to a chimpanzee. Any procedure that enters or
exposes a body cavity is considered to be invasive. Except as outlined
in the CHIMP Act, Sanctuary chimpanzees may not be used in invasive
research. Some examples of invasive studies are:
(1) Experimental exposure to a substance that may be detrimental to
a chimpanzee's health (e.g., infectious disease, radiation). This does
not include accidental exposures to infectious diseases transmitted
from cage mates, or from radiation or other exposures at the time of
regularly scheduled or necessary veterinary examinations and
treatments;
(2) Any invasion of a body cavity;
(3) Surgery and surgical implantation of devices. Procedures of
this nature performed for non research or study purposes are allowable
when the Sanctuary staff determine they are needed for veterinary
medical or colony management purposes and is in the best interest of
the chimpanzee or the chimpanzee colony;
(4) Behavioral studies that cause distress or discomfort, such as
induction of a fear response;
(5) Testing of any drug;
(6) Purposeful manipulation of social groups or the removal or
addition of individuals in order to conduct behavioral research (e.g.,
on aggression). Creation and refinement of social groups will be
necessary when the animals arrive at the Sanctuary and this should take
place only when necessary in regards to colony management and should
not be driven by independently initiated research studies;
(7) Restraint unless it is in conjunction with the annual exam or
clinical care; and
(8) Darting or anesthesia induction other than at annual exam or in
the case of an emergency in which the chimpanzee's well-being is at
stake.
National Primate Research Center (NPRC) means those centers
supported by the National Center for Research Resources, National
Institutes of Health, Department of Health and Human Services, as
national resources for providing high-quality nonhuman primate research
resources and facilities. As of November 2003, there were 8 such
centers.
National Research Council means the component of the National
Academy of Sciences that advises the Federal Government on matters
related to science, research, and research resources.
Non-invasive research (studies) means the use of procedures that
depend upon close observation of chimpanzee behavior or on medical
information collected during the course of normal veterinary care.
These procedures do not require removal of the chimpanzees from their
social group or environment, or require a separate anesthetic or
sedation event to collect data or record observations. Some examples of
non-invasive studies are:
(1) Visual observation;
(2) Behavioral studies designed to improve the establishment and
maintenance of social groups. These activities may cause stress as a
result of novel interactions between chimpanzees and between
chimpanzees and caregivers, but they are not considered invasive as
long as they are intended to maximize the well-being of the
chimpanzees;
(3) Medical examinations as deemed necessary to oversee the health
of the chimpanzees, in the least invasive manner possible. Collection
of samples routinely obtained during a physical examination for
processing during this time is also considered noninvasive since a
separate event is not required;
(4) Administration and evaluation of environmental enrichment used
to promote the psychological well-being of the chimpanzees; and
(5) Actions taken to provide essential medical treatment to an
individual chimpanzee exhibiting symptoms of illness. This applies only
to serious illness that cannot be treated while the chimpanzee remains
within the colony.
Non-federally owned chimpanzees mean chimpanzees that have not been
purchased by, bred by, or donated to the Federal Government for use in
federally supported research projects. In accordance with the CHIMP
Act, chimpanzees owned on the date of passage of the CHIMP Act by a
National Primate Research Center may enter the Sanctuary system without
requiring the NPRC to pay a fee.
Outdoor housing facility (area) means corrals, Primadomes (a
prefabricated outdoor housing unit), fenced open areas, or similar
structures or areas, for maintaining chimpanzees with access to
adequate protection from the extremes of environmental elements and
harsh weather conditions.
Outdoor ranging area means an area that allows chimpanzees greater
ranging space than corrals or other outdoor housing area, and includes
a variety of vegetation, shrubbery, grasses and trees, thereby
providing for a fairly unrestricted natural setting for the chimpanzees
to engage in species appropriate activities. The area is secured by an
outer perimeter barrier.
Project Officer means the individual designated by the Federal
Government to represent the contracting officer and interests of the
Federal agency, within defined areas, in monitoring and overseeing the
chimpanzee Sanctuary system contract.
Sanctuary or federally supported chimpanzee Sanctuary system means
the Sanctuary or Sanctuary system established by the Federal Government
through contracting with a private, nonprofit entity, for the purpose
of carrying out the provisions of the
[[Page 1849]]
CHIMP Act of 2000. The system includes a primary Contractor and may
include additional subcontractors as required. This Sanctuary system is
supported primarily from funds allocated by the NCRR/NIH/DHHS with some
matching funds from the nonprofit contractor.
Sanctuary Chimpanzee Care Committee (SCCC) or similar designated
committee means the group of individuals designated by the CEO of the
Sanctuary that reviews and monitors adherence to the policies,
procedures, and regulations at the Sanctuary.
Sanctuary Contractor means the nonprofit, private entities selected
by the NCRR/NIH to develop and operate the chimpanzee Sanctuary system.
This Contractor is also known as the ``primary contractor'' for the
Sanctuary system.
Sanctuary Director means the individual who provides day to day
direction and oversight to the employees responsible for performing the
daily tasks at the facility.
Secretary means the Secretary of Health and Human Services or his/
her designee.
Subcontractor means a private, nonprofit entity selected by the
primary contractor to provide additional Sanctuary services.
Surplus chimpanzees means chimpanzees that are no longer needed in
research, and that were used, or were bred or purchased for use in
research conducted or supported by the Federal Government.
USDA licensed intermediate handler/carrier means any person,
including a department, agency, or instrumentality of the United States
or of any State or local government, who is engaged in any business in
which it receives custody of animals in connection with their
transportation in commerce and who is licensed by the USDA.
Zoonotic disease(s) means diseases that are transmissible from
chimpanzees to humans.
Sec. 9.3 Sanctuary policies and responsibilities.
(a) What are the policies and responsibilities governing the
Sanctuary system? It will be the policies and responsibilities of the
Sanctuary system to:
(1) Create a safe and species-appropriate physical and social
environment for the lifetime care of chimpanzees;
(2) Comply with all applicable provisions of the animal welfare
regulations and other Federal, State and local laws, regulations and
policies;
(3) Achieve accreditation from appropriate accrediting bodies
within a reasonable time frame mutually agreed upon by the contractor
and NCRR;
(4) Prohibit any invasive research on the resident chimpanzees but
permit non-invasive studies (as authorized in 42 U.S.C. 287a-3a) that
do not compromise the well-being of the chimpanzees and that are
approved by an appropriate Sanctuary Chimpanzee Care Committee.
Definitions for the terms ``invasive'' and ``non-invasive'' are set
forth in Sec. 9.2 of this part;
(5) Prohibit exhibition of chimpanzees in the Sanctuary. This
policy does not prohibit educational activities that may involve
limited viewing of chimpanzees in their environment and that are
designed to promote an understanding of chimpanzee behavior, well-
being, or importance to the ecological system;
(6) Staff the organization with people with appropriate training
and experience; and
(7) Establish a Sanctuary Chimpanzee Care Committee (SCCC)
responsible for oversight of the facility programs and operations to
ensure the health and well-being of the chimpanzees and the
occupational safety of the staff. The Committee must consist of no
fewer than five people who should include the sets of experiences or
qualifications in the following paragraphs (a)(7)(i) through (v):
(i) A chair (person) knowledgeable of the needs of chimpanzees;
(ii) A veterinarian with chimpanzee care experience;
(iii) A behaviorist with experience in chimpanzee behavior;
(iv) A member of the chimpanzee care staff; and
(v) Member or members from the community, including at least one
with affiliation or employment with an animal protection organization
as defined in section 9.2 of this part.
(vi) The Sanctuary Chimpanzee Care Committee will:
(A) Oversee and evaluate the chimpanzee care and socialization
program;
(B) Review and approve proposed education programs that might
interfere with the chimpanzees' well-being or routine activities;
(C) Conduct a formal review of the program on a semiannual basis
and submit reports to the Sanctuary director and Board of Directors.
The reports must be available for review by the USDA and NIH
representatives during site visits;
(D) Establish a mechanism for receipt and review of concerns
involving the care of chimpanzees and resolving such concerns; and
(E) Review all study proposals and all euthanasia events. The SCCC
membership may require additional qualified individuals to perform the
functions of an Animal Care and Use Committee (ACUC) if and when the
need arises. The contractor may establish a separate ACUC. The ACUC
must be established in accordance with the applicable provisions of the
Animal Welfare Act regulations. Euthanasia events performed for medical
or humane reasons will be based upon sound professional veterinary
judgment that conforms to current veterinary medical practices and must
be in the best interest of the chimpanzee. Euthanasia performed for
emergency reasons without an advance review by the SCCC shall be
reviewed by the SCCC as soon as possible after the event to assure
compliance with established policy.
(8) Establish procedures to prevent any reproduction in the colony
through appropriate permanent birth control, preferably by vasectomy of
all sexually mature male chimpanzees in the Sanctuary;
(9) Assure that chimpanzees accepted into the Sanctuary are not
discharged for any reason, except as provided for in section 481C(d)(3)
of the Public Health Service Act as added by section 2 of the CHIMP
Act;
(10) Develop procedures for chimpanzees that are seropositive for
or harboring infectious agents, or have been previously exposed to
infectious agents (whether experimentally-induced or naturally-
occurring), that will allow them to be accepted by the Sanctuary and
properly housed; the procedures must be submitted to the NCRR for
approval;
(11) Develop guidelines for accepting chimpanzees not owned by the
Federal Government into the Sanctuary if the conditions are met as
outlined in 42 U.S.C. 287;
(12) Assure that the Board of Directors of the primary contractor
consist of no more than thirteen (13) individuals and that the
conditions governing the terms of the board members comply with the
CHIMP Act. The Board of Directors must include individuals with the
following expertise and experience as set forth in the CHIMP Act.
Subcontractors, if applicable, shall be governed by the policies
developed by the Board of Directors of the primary contractor:
(i) At least one veterinarian that is qualified in veterinary care
of nonhuman primates. These qualifications may be met through
postdoctoral training, experience, or both;
(ii) Individuals with expertise and experience in zoological
science and
[[Page 1850]]
with knowledge in behavioral primatology;
(iii) Individuals with experience in the animal protection field;
(iv) Individuals with experience and expertise in the field of
business and management of nonprofit organizations;
(v) Individuals knowledgeable and experienced in accrediting
programs of animal care;
(vi) Individuals with experience and expertise in containing
biohazards;
(vii) A member who serves as the Chair of the Board of Directors.
This member may be elected or appointed by the Board from individuals
identified in paragraphs (a)(12)(i) through (vi) of this section; and
(viii) No member of the board shall have been fined for, or signed
a consent decree, for any violation of the Animal Welfare Act.
(13) Assure that a chimpanzee may be removed from the Sanctuary for
research purposes only if the Secretary determines that the provisions
of the CHIMP Act are met. In accordance with the provisions of the
CHIMP Act, the removal of a chimpanzee from the Sanctuary for research
requires a recommendation from the contractor's Board of Directors, and
publication in the Federal Register of a notice of intent for public
comment for a period not less than 60 days. The final decision rests
with the Secretary. Ownership of chimpanzees removed for that purpose
remains with the Sanctuary (or the Federal Government) and all
chimpanzees removed for research must be returned to the Sanctuary when
the studies are completed.
(b) Who is responsible for developing or revising Sanctuary
policies? (1) The Sanctuary contractor is responsible for developing,
revising, and implementing policies affecting the Sanctuary.
(2) The Federal agency (NCRR/NIH) designated by the Secretary must
concur with any changes that substantially change existing policies.
The Secretary, or designee, will determine if a policy change will have
a substantial impact upon current policy after consultation with the
Sanctuary contractor.
Sec. 9.4 Physical facility policies and design.
(a) What standards apply to the facility design and physical plant?
(1) The chimpanzee Sanctuary facility must be designed to provide
sufficient space and variety of natural or artificial objects to
accommodate natural activities of chimpanzees while restricting their
movement and range to the defined area. Cages, compounds, and all
housing areas shall be designed to withstand the continuous and harsh
assaults common when chimpanzees are confined. It is highly recommended
that the Sanctuary administrators engage a design firm that is
experienced in designing chimpanzee facilities or demonstrates the
capability to involve individuals possessing such experience. Housing
areas appropriate for the complex social behavior of chimpanzees should
allow them to express a full range of species typical behavior. The
facility design and physical plant consists of the following
components: indoor design features; outdoor design features;
construction and construction materials; physical barriers; shelter;
service support space, including storage areas for food, supplies, and
equipment; personnel and administrative support space; quarantine and
isolation facilities; treatment area; heating, ventilation, and air
conditioning (HVAC); food preparation area; and animal waste treatment.
(2) Primary enclosures must promote chimpanzee well-being and
provide a safe and sanitary environment for both the chimpanzees and
their human caregivers and attendants, safe and sanitary environment
for both the chimpanzees and their human caregivers and attendants, and
allow for behavioral needs of the species. Daily observation of
chimpanzees within the enclosures is required and shall be accomplished
with minimal disturbance to the chimpanzees. A housing system shall
include indoor and outdoor enclosures that must be kept in good repair
to prevent escape and injury to the chimpanzees, promote physical
comfort, and facilitate sanitation and servicing:
(i) Indoor areas shall have special areas for social introductions
and medical treatment. Indoor design features will generally include
rooms, units, gates and passage corridors to allow for transferring and
isolating chimpanzees for medical procedures, protection from
aggression, etc. The floor surfaces must not be slippery; and the
floors and walls should be sealed to facilitate proper sanitation.
Doors to the chimpanzee housing areas shall not open directly to the
outside, unless they open into enclosed outdoor housing or free-ranging
areas. Indoor containment materials must be well anchored, durable, and
free of sharp or jagged edges to prevent escape or injury to the
chimpanzees. Light fixtures must be sealed to prevent the introduction
of moisture. Lighting must be adequate for appropriate animal care and
observation, but not disruptive or harmful to the chimpanzees.
Furnishings for climbing, resting, swinging, and sleeping must be
durable, nontoxic, comfortable and easily sanitized or replaceable when
soiled;
(ii) Primary housing in a Sanctuary must include large outdoor
compounds, corrals, or other ranging areas. The Sanctuary should be in
an area with a climate suitable for chimpanzees to reduce the need for
long-term, indoor housing. Outdoor ranging areas must provide enough
space for the formation of social groups of varying sizes, ages and
sexes. Chimpanzee facilities must have areas for social introductions
and medical treatment. During the design and construction of the
facility, special consideration must be given to plans for removing
chimpanzees from the ranging area for emergency and routine procedures.
Primary barriers must be constructed to prevent escape of chimpanzees
and secondary or perimeter barriers should prevent entry of
unauthorized persons into the facility. Grasses, hay, bamboo, or other
material suitable for nest building should be available in the ranging
area and artificial objects that simulate or enhance the natural
environment may be used to further promote chimpanzee well being;
(iii) Primary enclosures must be constructed with materials that
balance the needs of the chimpanzees with the ability to provide for
sanitation. They must have smooth impervious surfaces with minimal
ledges, angles, corners, and overlapping surfaces so that accumulation
of dirt, debris, and moisture is reduced and satisfactory cleaning and
disinfecting are possible. Less durable material, such as non pressure
treated wood, can provide a more appropriate environment in some
situations (such as runs, pens, and outdoor corrals) and can be used to
construct perches, climbing structures, resting areas, and perimeter
fences for primary enclosures. Wooden items must be replaced when they
become damaged or difficult to sanitize. All primary enclosures must be
kept in good repair to prevent escape of and injury to chimpanzees,
promote physical comfort, and facilitate sanitation and servicing.
Damaged, rusting or oxidized equipment that threatens the health or
safety of the chimpanzees must be repaired or replaced;
(iv) Physical barriers must be designed to contain the chimpanzees
within the Sanctuary grounds and to prevent the intrusion of
unauthorized persons. Some examples of barrier structures include
properly and safely designed water moats, strong chain link fencing
with curved or ``V'' shaped barbed wire topping, solid concrete, brick,
or pre-cast concrete walls, and electrical fences. Each Sanctuary site
[[Page 1851]]
may choose the type of barrier that is suitable for that location;
(v) Outdoor facilities must provide either natural or artificial
structures that chimpanzees can use for shelter to escape rain, direct
sun, wind, and extreme temperatures. Indoor and outdoor housing units
can serve this purpose when chimpanzees are confined to smaller outdoor
facilities;
(vi) Personnel and administrative support space must be
appropriately designed and provided to adequately accommodate the
technical, managerial, professional, and administrative staff;
(vii) Quarantine and isolation facilities are required for the
Sanctuary. These facilities must be designed to prevent the spread of
undesirable agents from quarantine and isolation rooms to other parts
of the facility. These facilities may also be used to isolate incoming
chimpanzees to evaluate and to assess their behavior before
assimilation into the resident population. Sufficient space must be
designed in the area to accommodate a station that provides protective
equipment for the staff and others to be worn when entering areas
housing the chimpanzees. Shower, toilet and locker facilities must be
located within or near the quarantine and isolation areas for
preventative health and sanitation reasons. Provisions for enrichment
in quarantine areas must also be made;
(viii) An area for treatment of and performing veterinary clinical
procedures on chimpanzees must be provided at each Sanctuary site. This
area must be constructed and provisioned to perform emergency
procedures, including minor surgery and emergency surgical procedures
if needed, and complete physical examinations. The Sanctuary must
provide facilities for extended care of medical conditions as the need
arises. Emergency treatment carts must be available for emergency
situations when a chimpanzee requires on-site treatment. Aging
chimpanzees present special medical challenges that should be addressed
in the preventative medicine and animal health plan; and
(ix) Heating, ventilation, and air-conditioning (HVAC) must comply
with the standards of the Guide when chimpanzees must be confined to
closed, indoor quarters for isolation, treatment or other situations on
a short-term basis. It is critical to provide ventilation that allows
chimpanzees to seek a thermo-neutral zone that fits their needs. In
general, the design of the Sanctuary facility can be such that the
mechanical systems may not be required, except in tightly closed areas.
The use of shelters, nesting materials, circulating fans, and space
heaters are examples of means that address the comfort needs of the
chimpanzees.
(x) Support facilities must be appropriate for the goals of the
facility. In accordance with the Guide and the Animal Welfare
Regulations, and currently available data, several types of functional
support areas are required, including veterinary treatment and surgery,
quarantine, food storage, bedding storage (if used), dry storage,
administrative space, and equipment.
(xi) Animal waste from the Sanctuary must be properly treated to
remove known hazardous agents before discharging it into the
environment in accordance with currently acceptable and effective waste
treatment procedures including current industry standards and Federal,
State, and Local governmental guidelines and regulations.
(b) What security measures are required for the Sanctuary? The
Sanctuary must provide adequate security against unauthorized entry,
sabotage, malicious damage, theft of chimpanzees and property, and
minimize any chance of escape by a chimpanzee. The security staff must
have training and/or experience in methods and equipment designed to
detect possible security breaches and the ability to respond to
security events in a timely and effective manner. Perimeter containment
shall be used to protect the compound housing the chimpanzees
consistent with the recommendations of the Guide.
(c) Is the Sanctuary required to develop disaster and escaped
animal contingency plans? (1) The Sanctuary facility must prepare
contingency plans outlining simple and easy to follow plans for dealing
with natural and manmade disasters and steps to be taken in case a
chimpanzee escapes from the compound. Separate plans will be developed
for disasters and recovery of escaped chimpanzees. These plans must be
prepared prior to the arrival of chimpanzees at the facility. All
employees with responsibilities under the plans must be familiar with
the contents of each plan and able to execute the plans when a
situation occurs. Incidents and actions taken must be documented for
future reference.
(2) As a minimum, the disaster plan must identify disasters likely
to occur in the area, including severe rainstorms, crippling
snowstorms, forest fires, sabotage and hurricanes, that may endanger
the lives of the chimpanzees or staff, the names and telephone numbers
of persons to contact in the event of an emergency, procedures to be
followed in collecting and securing chimpanzees, local or state
services that may be required, and the person or persons responsible
for determining final action. Personnel required to respond to a
disaster must obtain any special identification cards needed to report
to duty. Other elements considered appropriate to addressing disasters
should be added by the Sanctuary contractor if necessary.
(3) The design of the perimeter security must be such that chance
for escape of a chimpanzee is minimized. A well-prepared, properly
crafted plan can lead to decisive actions being taken to recapture the
chimpanzee in a timely fashion. The plan must be designed to minimize
or eliminate injury to the chimpanzee and the persons attempting to
gain control of the escaped chimpanzee. Details must include step-by-
step procedure options for capture, person(s) to contact, person(s) or
organizational unit(s) required to respond to an alert due to an
escape, transportation back to the Sanctuary facility, and how
corrective actions will be implemented to prevent future incidents.
(d) Incorporation by reference. The Guide for the Care and Use of
Laboratory Animals published by the National Research Council (Guide),
1996, International Standard Book Number 0-309-05377-3, is incorporated
by reference in this section. The Director of the Federal Register
approves this incorporation by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may obtain a copy of the publication from
the National Academy Press, 2101 Constitution Avenue, NW., Lockbox
285,Washington, DC 20055; or you may order it electronically via the
Internet at https://www.nap.edu; or view it online at https://
oacu.od.nih.gov/regs/guide/guidex.htm. You may inspect a copy at NIH,
NCRR, 1 Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20817-
4874, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to https://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
Sec. 9.5 Chimpanzees ownership, fees, and studies.
(a) Who owns the chimpanzees in the federally supported Sanctuary?
The Federal government retains ownership of chimpanzees owned by the
Federal government at the time they enter the Sanctuary system. Non-
federally owned or supported chimpanzees will be
[[Page 1852]]
owned by the Sanctuary. The chimpanzees shall continue to be maintained
in the Sanctuary throughout their lifetime and shall not be discharged
from the Sanctuary except as specifically indicated in the CHIMP Act.
(b) Is there a charge for placing chimpanzees in the Sanctuary? No
fees shall be charged for federally owned or supported chimpanzees
entering the Sanctuary. Chimpanzees that were owned by a NPRC when the
CHIMP Act became effective are also admitted without payment of fees.
Fees for maintenance of the chimpanzees alluded to above are provided
for in the contract between the Federal Government and the Sanctuary
contractor.
(c) May the Sanctuary agree to accept chimpanzees that are not
owned by the Federal Government? The Sanctuary may accept chimpanzees
that are not owned by the Federal Government subject to the following
conditions:
(1) Ownership of the chimpanzee must be transferred to the
Sanctuary;
(2) Fees for these chimpanzees may be levied based on a range of
considerations that include most importantly, the well-being of the
chimpanzee, and secondarily factors that include (but are not limited
to) the resources available to support the chimpanzee, the health, age
and social history of the chimpanzee, and other relevant factors
affecting the cost of caring for the chimpanzee;
(3) Available space exists in the Sanctuary; and
(4) An agreement exists between the Sanctuary system and the NCRR/
NIH documenting that the chimpanzee may be brought into the Sanctuary.
(d) What additional conditions apply when non-governmentally-owned
chimpanzees transfer to the chimpanzee Sanctuary? The following
additional conditions apply when non-governmentally-owned chimpanzees
transfer to the chimpanzee Sanctuary:
(1) Chimpanzees transferred to the Sanctuary sites must be
permanently incapable of reproduction, for example, by vasectomy or
tubal ligation;
(2) Complete histories must accompany each chimpanzee. Any
chimpanzee missing documentation for any period of research or other
use may not be transferred to the Sanctuary without the concurrent
authorization of the Sanctuary contractor's Board of Directors and the
NCRR; the records may be created and retained in electronic form; and
(3) Appropriate screening of each chimpanzee must be performed to
assess the likelihood of the chimpanzee being a health or safety threat
to the care staff, and/or other chimpanzees.
(e) What are the criteria for acceptance and the fees for admission
into the Sanctuary for non-governmentally-owned chimpanzees? The
chimpanzee Sanctuary contractor, in conjunction with the NCRR, must