[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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
* 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