[Federal Register Volume 70, Number 7 (Tuesday, January 11, 2005)]
[Proposed Rules]
[Pages 1843-1858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-394]
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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.
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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: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected]. 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
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* 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 http://www.nap.edu; or view it online at http://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 http://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
establish criteria and a fee system for acceptance of non-
governmentally-owned 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 a consent decree for any violation of
the Animal Welfare Act.
Sec. 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
[[Page 1853]]
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 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 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
[[Page 1854]]
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 http://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 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 Sec. 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
vaccine-preventable 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
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 cage-side 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
[[Page 1855]]
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 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 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 http://nap.edu; or view it online at http://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 http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
Sec. 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.
[[Page 1856]]
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.
Sec. 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 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.
Sec. 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 high-quality 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, 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.
Sec. 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
[[Page 1857]]
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-to-day 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
(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 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 http://www.nap.edu; or view it online at http://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 http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
Sec. 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
[[Page 1858]]
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 e-mail, 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).
Sec. 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 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 non-
invasive 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).
Sec. 9.13 Other Federal laws, regulations, policies, and statues that
apply to the Sanctuary.
(a) Animal Welfare Act (7 U.S.C. 2131-2159).
(b) Animal Welfare Regulations, 9 CFR, subchapter A, parts 1 and 2.
Sec. 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