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10 October 2008


[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Rules and Regulations]               
[Page 60409-60430]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc08-12]                         


[[Page 60409]]

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Part II





Department of Health and Human Services





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42 CFR Part 9



Standards of Care for Chimpanzees Held in the Federally Supported 
Chimpanzee Sanctuary System; Final Rule


[[Page 60410]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 9

[Docket No. NIH-2007-0927]
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: Final rule.

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

SUMMARY: The National Institutes of Health (NIH) is issuing 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 (HHS) to develop and 
publish standards of care for chimpanzees held in the sanctuary system 
supported by federal funds authorized under the CHIMP Act. This 
regulation applies to only those facilities receiving federal funds as 
a part of the federally funded chimpanzee sanctuary system.

DATES: This final rule is effective on November 10, 2008. The 
incorporation by reference listed in the rule is approved by the 
Director of the Federal Register as of November 10, 2008.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, 
Office of Management Assessment, National Institutes of Health, 6011 
Executive Boulevard, Suite 601, MSC 7669, Rockville, Maryland 20892, 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, ``CHIMP Act''). Section 1 of 
this law amended the Public Health Service (PHS) Act by adding 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), the Centers for Disease Control and Prevention 
(CDC), 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 the 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, 
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 (HHS) 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 private nonprofit 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. The NCRR/NIH must approve both contractor and subcontractor 
awards and NCRR/NIH will verify contractor and subcontractor (if 
applicable) qualifications through facility site visits, review of 
written documentation submitted to the contractor, and evaluation of 
available and current resources.
    The NCRR/NIH will ensure compliance with the standards of care 
regulation through site visits (at least annually 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 may 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 
this regulation requires the Sanctuary Contractor to register with the 
United States Department of Agriculture (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 or licensed 
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 
final standards of care regulation. 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 this regulation 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 NCRR/NIH. In preparing these 
final 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; the 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 USDA Animal Welfare Regulations codified 
in various parts of title 9, chapter 1, Subchapter A of the Code of 
Federal Regulations (CFR).
    We are amending title 42 of the CFR by adding a new part 9 to 
establish

[[Page 60411]]

standards for operating the sanctuary system to provide for the 
permanent retirement of surplus chimpanzees. These standards of care 
apply to only the sanctuaries that are a part of the federally funded 
chimpanzee Sanctuary system. This final 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.
    We announced our intention to issue the standards of care in the 
notice of proposed rulemaking (NPRM), ``Standards of Care for 
Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary 
System,'' that we published in the Federal Register of January 11, 2005 
(70 FR1843-1858). The NPRM provided for a 60-day public comment period. 
In December 2007, the CHIMP Act was amended by the ``Chimp Haven is 
Home Act'' (Pub. L. 110-170), which terminated the authority for the 
removal of chimpanzees from the sanctuary system for research purposes, 
although noninvasive behavioral studies [``noninvasive research''] as 
defined herein is still permitted on site. Conforming amendments have 
been made to the final regulation.

I. Public Comments--General

    We received 21 responses with 13 additional signatories 
(concurrences). The commenters generally expressed support for the 
regulation while taking the opportunity to comment on specific sections 
and paragraphs. One commenter stated the regulation was unnecessary 
because there are adequate regulations and policies already available 
to cover the care of chimpanzees in the sanctuary. However, the 
commenter expressed support given the fact that the regulation is in 
response to the CHIMP Act. Our consideration of and responses to the 
comments are discussed as follows.

Section 9.2 Definitions

Animal Care and Use Committee
    (Comments) Several commenters objected to having a member of an 
animal protection organization (defined later in this section) on the 
committee, as set forth in the definition. They stated the 
individual(s) would hamper consensus and increase litigation. Another 
commenter noted the definition should clearly state that the 
requirement to have a member of an animal protection organization on 
the Animal Care and Use Committee (ACUC) is unique to this regulation 
and is not required by either the Animal Welfare Regulations or the 
Public Health Service Policy on the Humane Care and Use of Laboratory 
Animals. The commenter also noted the ACUC must also meet the 
requirements of the PHS Policy if non-invasive research is performed at 
the sanctuary.
    (Response) We have revised the definition to indicate that the 
requirement for an animal protection organization member on the ACUC is 
unique to this regulation and is not required by the Animal Welfare 
Regulations or the Public Health Service Policy.
Animal Protection Organization
    (Comments) Several commenters stated the definition allowed animal 
protection organizations to define themselves without any requirements 
for training, experience, or proven performance. The commenters 
expressed concern that these individuals could be appointed to the ACUC 
and the Sanctuary Chimpanzee Care Committee (SCCC) despite a lack of 
nonhuman primate/chimpanzee experience.
    (Response) The intent of the requirement to have a member of an 
animal protection organization is to ensure that an animal advocate is 
on the SCCC. The definition in the proposed regulation accomplishes 
that purpose and is not changed. A representative of such an 
organization is still required to be a member of the ACUC and the SCCC.
Exhibition
    (Comments) Three commenters wrote that this definition needed 
further clarification to address visits by large groups that could be 
disruptive to the chimpanzees. Also, the commenters stated that the 
definition, as written, excludes limited viewing for educational 
purposes. They recommended the definition be modified to state that 
exhibition ``does not include limited viewing for educational 
purposes.''
    (Response) We have modified the definition to state that the term 
exhibition ``does not include limited viewing for educational purposes 
that is not disruptive to the chimpanzees.''
Federally Owned Chimpanzees
    (Comment) One commenter believed the definition should be broadened 
to include chimpanzees leased, loaned, or transferred to other 
biomedical/behavioral research facilities throughout the country.
    (Response) We do not agree with the commenter on this issue. If we 
were to expand the definition to the extent requested, the system would 
be overwhelmed and could not support the federally owned chimpanzees as 
currently defined.
Invasive Research
    (Comment) One commenter noted that example 3 seemed to be a routine 
veterinary medical procedure and therefore should not be included in 
the definition of invasive research.
    (Response) This example was not worded properly in the proposed 
rule. We have changed the example as follows: ``(3) Surgery or 
implantation of devices that are not a part of a veterinary medical 
treatment or colony management practice.''
    (Comment) Another commenter noted that darting (example 8) is 
dangerous for chimpanzees and should only be used as a last resort for 
medical or other emergencies. The commenter also noted that personnel 
familiar to the chimpanzee in question should always be present if 
darting is necessary.
    (Response) We believe the wording in this section appropriately 
addresses these issues and that rewording is unnecessary. Additionally, 
we might consider in the future incorporating into standard operating 
procedures a requirement that a person familiar with the chimpanzee be 
present at the time of darting, but not make it a regulatory 
requirement.

Section 9.3 Sanctuary Policies and Responsibilities

    9.3(a)(4): (Comment) One commenter suggested this paragraph should 
read ``Prohibit any invasive research except as outlined in the CHIMP 
Act, but permit noninvasive studies.''
    (Response) We have modified the wording to incorporate the above 
comment and to reflect the amendment of the CHIMP Act in December 2007 
by the ``Chimp Haven is Home Act,'' which terminated the authority for 
the removal of chimpanzees from the sanctuary system for research 
purposes.
    9.3(a)(5): (Comments) Three commenters felt only educational 
viewing through camcorders or nonintrusive electronic means should be 
allowed. Additionally, they stated the visitor centers should be 
located away from the chimpanzees so they would not disrupt the 
chimpanzees' daily lives. Another individual stated that limited 
viewing should be defined. Another commenter stated facility design 
must include cameras to minimize the impact of visitors.
    (Response) We do not agree the regulation should require facilities 
to install cameras. We believe the sanctuary staff should have the

[[Page 60412]]

flexibility to choose the technology needed to eliminate or reduce the 
impact of visitors on the chimpanzees. We agree that any visitor center 
associated with the sanctuary should be located in a manner that does 
not disrupt the chimpanzees' routine activities. Therefore, we have 
revised this paragraph to end with the phrase, ``that does not 
adversely affect the chimpanzees' routine.''
    9.3(a)(7)(v): (Comments) Two commenters noted there are many Animal 
Protection Organizations (APOs) that focus on animal welfare, farm 
animals, endangered species, etc., and recommended that the individual 
represent an animal advocacy group with specific experience and 
expertise for advocacy for chimpanzees. One Commenter proposed the APO 
position be a rotating one (every three years) from a reputable 
sanctuary with experience in the care of chimpanzees formerly used in 
research. Two commenters stated there was no good reason to provide for 
an ill-defined APO member on the SCCC.
    (Response) We disagree that the restrictions noted by the five 
commenters should be included in this regulation. They are too 
restrictive and would likely limit the ability of the Sanctuary to 
attract a representative that satisfies the needs of their program.
    9.3(a)(vi)(B): (Comments) Two commenters wrote that no program 
should be approved that interferes with the chimpanzees' well-being.
    (Response) We agree. We have revised the sentence to remove that 
statement.
    9.3(7)(vi)(E): (Comments) One commenter stated there is a need to 
clarify the conditions under which the SCCC might function as an Animal 
Care and Use Committee. This commenter also questioned who appoints the 
members and evaluates the SCCC reports. One commenter noted if the ACUC 
reviews noninvasive study proposals, it must be constituted in 
accordance with the provisions of the PHS policy and the Animal Welfare 
Regulations (AWR). The same commenter suggested that anesthesia, 
euthanasia, and review of study proposals be addressed in separate 
paragraphs since study proposals must be reviewed by a PHS/AWR-
sanctioned ACUC.
    (Response) We agree with the commenters that further clarification 
is needed to address the comments raised. We have revised 9.3(a)(vi)(E) 
to effect the desired clarifications, and we have added a new paragraph 
9.3(a)(vi)(F) to address anesthesia and euthanasia.
    9.3(a)(8): (Comments) Two Commenters strongly supported the rule 
requiring the prevention of reproduction in the sanctuary. They noted 
that offspring born in the sanctuary should remain with the mother 
until they are at least 4 years old; and offspring born in the 
sanctuary should belong to the sanctuary, not the Federal Government.
    (Response) The length of time that offspring stay with the mother 
should be addressed in sanctuary operating policy based upon best 
available information rather than in the regulation. We agree that the 
sanctuary should retain ownership of offspring born there. Therefore, 
we have amended 9.5(a) (Chimpanzee ownership, fees, and studies) to add 
a statement to that effect.
    9.3(a)(9): (Comment) One commenter stated chimpanzees should not be 
discharged from the Sanctuary for any reason.
    (Response) In December 2007, the Chimp Act was amended by the 
``CHIMP Haven is Home Act,'' which terminated the authority for the 
removal of chimpanzees from the sanctuary system for research purposes.
    9.3(a)(10): (Comments) Two commenters felt chimpanzees that are 
seropositive for, harbor, or have been exposed to infectious diseases 
should be socially housed with other chimpanzees that have a similar 
profile. One commenter indicated that the behaviorist should have 
experience working with chimpanzees with such exposures as well as 
disabled and old chimpanzees.
    (Response) We appreciate the comments. However, we believe the 
issues raised are adequately covered under this section and, as 
written, the section allows the sanctuary to develop innovative ways to 
address these issues.
    9.3(a)(11): (Comments) One commenter proposed the guidelines 
developed for accepting chimpanzees not owned by the Federal Government 
should be published for public comment.
    (Response) We disagree. The CHIMP Act left this process to the 
Sanctuary Board of Directors with oversight from the Secretary, HHS. 
There was no requirement that guidelines for acceptance of non-
government-owned chimpanzees be published for public comment.
    9.3(a)(12) and (13): (Comments) Two commenters stated the location 
and numbering of this section implies that the Board of Directors (BOD) 
is subservient to the SCCC. They also suggested that we show the lines 
of authority from the BOD and the SCCC.
    (Response) We agree the numbering and wording implies the Sanctuary 
BOD reports to the Sanctuary SCCC. This is not the case. We have 
corrected this error in the final regulation.
    9.3(a)(13)(ii): (Comment) One commenter indicated that we should 
consider seeking input from persons who are experts on chimpanzees in 
the wild not just behavioral experts for captive chimpanzees. This 
description of behaviorist was paraphrased from the CHIMP Act and, as 
written, does not exclude a person with experience in the behavior of 
chimpanzees in the wild. We have decided not to change this paragraph.
    9.3(a)(13)(iii): (Comments) One commenter expressed strong support 
for including a member of an animal protection organization (APO) on 
the SCCC and indicated that the organization represented should have 
demonstrated advocacy for chimpanzees. Two commenters believed the 
inclusion of representation from an APO would be counterproductive and 
should not be mandatory.
    (Response) We consider the representation of an APO on the SCCC 
appropriate. The Sanctuary Director, with the approval of the Board of 
Directors, will select the APO representative with the mission of the 
sanctuary in mind.
    9.3(a)(13)(iv): (Comment) One commenter suggested that a sentence 
be added indicating that any chimpanzee removed from the Sanctuary for 
invasive research in accordance with the CHIMP Act must be placed in a 
PHS-assured facility.
    (Response) In December 2007, the CHIMP Act was amended by the 
``Chimp Haven is Home Act,'' which terminated the authority for the 
removal of chimpanzees from the sanctuary system for research purposes. 
Therefore, this paragraph was deleted in the final rule.
    9.3(a)(14): (Comments) Two commenters stated that chimpanzees 
should not be removed from the sanctuary for any reason. One commenter 
further expressed support for the public comment period and stated that 
it should be extended from 60 to 90 days.
    (Response) In December 2007, the CHIMP Act was amended by the 
``Chimp Haven is Home Act,'' which terminated the authority for the 
removal of chimpanzees from the sanctuary system for research purposes. 
Therefore this paragraph was deleted in the final rule.

Section 9.4 Physical Facility Policy and Design

    (Comments) One commenter stated strong support for the language 
present in the regulation that considers the

[[Page 60413]]

psychological and behavioral well-being and the social needs of all 
chimpanzees transferred from the laboratories. The commenter also 
indicated the regulation should require that chimpanzees formerly 
living in groups should not be sent to the Sanctuary without members of 
that group. Also, volunteer staff should not be allowed contact with 
any chimpanzees until after a six-month training period in order to 
maintain stable human interaction.
    (Response) We agree that the psychological well-being and social 
needs of the chimpanzees are important considerations and have retained 
language in the regulation that considers the psychological well-being 
and social needs of all chimpanzees transferred from the laboratories. 
However, to include provisions in the regulation that would require 
that all chimpanzees residing in a group be sent to the Sanctuary 
together would be overly restrictive to the operations of the 
Sanctuary. Mandating a six-month training period for volunteers also 
restricts the administrative discretion of the staff to determine when 
a volunteer is properly trained and when access to the chimpanzees is 
appropriate.
    (Comment) One commenter strongly supported the need to provide a 
facility with sufficient space for chimpanzees to engage in a full 
range of species-specific activities.
    (Response) We agree. The regulation as written requires such space.
    (Comments) Three commenters noted that the passage ``the safe and 
sanitary equipment for both the chimpanzees and their human 
counterparts'' was duplicative.
    (Response) We agree and have removed the redundant sentence.
    (Comment) One commenter objected to simply stating ``the floor must 
not be slippery'' because some areas may be inherently slippery. The 
commenter suggested that we change the wording to state ``the floor 
must not be dangerously slippery.''
    (Response) We believe that 9.4(a)(ii) necessitates that the 
enclosure ``prevent escape and injury to the chimpanzees''. Therefore, 
phrasing regarding the slipperiness of the floor is redundant and has 
been removed.
    (Comment) One commenter indicated it was unnecessary to limit the 
sanctuary system to a particular climate because there are successful 
chimpanzee sanctuaries in varying climates.
    (Response) We believe that 9.4 necessitates indoor and outdoor 
enclosures that permit natural activities of chimpanzees. Climate is 
therefore incorporated into the expectation of natural activities.
    (Comments) Three commenters indicated that the use of strong chain 
link fencing with curved barbed wire is not a barrier to chimpanzees 
and it should be deleted as an example.
    (Response) We agree. We have removed this example from the final 
regulation.
    (Comments) Two commenters stated that space heaters should not be 
used for closed, indoor quarters because they can lead to fires or 
other health hazards. One commenter stated that support for this 
regulation depends upon the indoor and outdoor housing areas providing 
temperatures that are comfortable for chimpanzees; outdoor areas 
providing shelter to escape extreme temperatures, if necessary; and the 
sanctuary providing mechanical systems to achieve these goals.
    (Response) We believe the regulation as written sufficiently 
addresses the concerns expressed by the commenter. We have revised the 
text to eliminate the reference to space heaters. Methods of providing 
for the comfort of the chimpanzees will likely vary depending upon the 
location of the facility.

Section 9.5 Chimpanzee Ownership, Fees, and Studies

    9.5(a): (Comment) One commenter stated that the ownership of all 
chimpanzees in the federally supported sanctuary should belong to the 
sanctuary, not just the non-Government-owned ones.
    (Response) The CHIMP Act specifically sets forth the requirement to 
transfer the title for non-Government-owned chimpanzees to the 
sanctuary. The Secretary uses the discretionary authority granted by 
the Act to retain Government ownership of federally owned chimpanzees. 
Therefore, we have made no changes in response to the comment.
    9.5(b): (Comment) One commenter wrote that any chimpanzee from the 
four or five current biomedical research facilities currently housing 
chimpanzees for research should be exempt from entry fees.
    (Response) The exemptions noted in this section are stated or 
implied in the CHIMP Act. The only biomedical research centers 
specifically exempted are the National Primate Research Centers.
    9.5(b)(2): (Comments) One commenter suggested this paragraph should 
be amended to state that fees for non-Government-owned chimpanzees 
shall (rather than may) be levied in order to assure that adequate 
financial support is available. The commenter also suggested the 
paragraph should emphasize that the sanctuary is primarily for 
chimpanzees that are no longer needed for federally supported research.
    (Response) We note the concern of this commenter that the taxpayers 
are not committed to supporting chimpanzees from private entities. We 
have revised this paragraph to emphasize that while chimpanzees not 
owned or supported by the Federal Government may be accepted into the 
sanctuary, federal funds may not be used for their support, unless 
authorized by the Secretary or an authorized designee. We do not 
believe it is necessary to modify the current language to reiterate 
that the sanctuary is established primarily for chimpanzees that are no 
longer needed in federally funded biomedical research.
    9.5(c)(3): (Comment) One commenter suggested adding a statement to 
this condition indicating that any chimpanzee owned by the Federal 
Government or a National Primate Research Center (NPRC), and available 
for transport, shall not be excluded from transport to the sanctuary 
because a lack of space exists.
    (Response) It is unclear whether the commenter was implying that 
federally and/or NPRC-owned chimpanzees shall have first priority for 
space in the sanctuary, or whether space must always be available to 
accept chimpanzees from these sources whenever they are made available. 
If it is the former, then the fact that first priority is given to 
federally owned (or supported) and NPRC-owned chimpanzees is stated 
and/or implied elsewhere in this regulation and will be reemphasized 
here. If the reference is to the latter scenario, then the sanctuary 
will not be required to hold space for indefinite periods to 
accommodate unplanned transfer from these sources.
    9.5(e): (Comment) One commenter wrote that the fees for accepting 
chimpanzees not owned by the Federal Government should be clearly 
defined in this regulation.
    (Response) We disagree because any future changes in the fee 
structure would require revision of the regulation. Therefore, we have 
decided not to make any changes in response to the comment.
    9.5(f): (Comments) Three commenters opposed the return to research 
of any chimpanzee in the sanctuary.
    (Response) No invasive research will be allowed on chimpanzees in 
the sanctuary. However, the CHIMP Act does allow for noninvasive 
studies to be conducted in the sanctuary, provided the study does not 
affect the health,

[[Page 60414]]

well-being, and social status of the chimpanzees. In December 2007, the 
CHIMP Act was amended by the ``Chimp Haven is Home Act,'' which 
terminated the authority for the removal of chimpanzees from the 
sanctuary system for research purposes. Therefore, all references to 
the procedures for returning chimpanzees to research were deleted from 
the final rule.

Section 9.6 Animal Care, Well-Being, Husbandry, Veterinary Care, and 
Euthanasia

    9.6(a): (Comment) One commenter indicated support for language that 
considers the psychological and behavioral well-being and the social 
needs of the chimpanzees transferred from research laboratories. The 
commenter also noted the regulation should require that chimpanzees 
that formerly lived in a group should not be sent to the sanctuary 
without all members of that group, and that volunteer staff should be 
trained for at least 6 months before having direct contact with the 
chimpanzees. Actions expressed in the latter statement are deemed 
necessary to maintain stable human-chimpanzee interaction.
    (Response) We do not agree that all chimpanzees belonging to a 
group prior to assignment to the sanctuary must be transported together 
as a group. Mandating the entities involved to follow such strict 
requirements is not practical. Nor do we agree that the regulation 
should set rigid standards mandating 6 month training regarding 
volunteers or other employees. These activities are best handled 
through policies developed by the sanctuary and monitored by the 
appropriate oversight agencies.
    (Comments) Three commenters suggested (1) the reference to a 
cleaning schedule for indoor enclosures be changed to read ``Indoor 
primary enclosures must be cleaned as often as required to maintain a 
clean and healthy environment, with a minimum of once daily''; (2) the 
outdoor enclosure must be monitored and cleaned on a routine basis, 
with routine defined as requiring daily monitoring and cleaning at 
least 3 times weekly; and (3) the phrase ``if appropriate'' should be 
removed as chimpanzees need food, water, and bedding at all times.
    (Response) We believe 9.6(b) as revised addresses these concerns. 
The sanctuary system will gain experience with proper husbandry and 
dietary care, and this regulation provides sufficient flexibility for 
achieving the primary goal of promoting the chimpanzees' well-being. 
Specifically, the revised regulation states that chimpanzees ``must 
have access to food, water, and bedding at all times, unless medical or 
behavioral conditions dictate otherwise.''
    (Comment) One commenter suggested the reference for cleaning, 
feeding, and watering implements should be changed from the ``Guide'' 
to the Animal Welfare Regulations, paragraph 384.
    (Response) The Guide is used as a reference for compliance with the 
Public Health Service Policy on Humane Care and Use of Laboratory 
Animals and thus is appropriate for this regulation. Compliance with 
the Animal Welfare regulations is also mandatory.
    (Comments) Three commenters supported keeping chimpanzees in pairs 
or larger groups and indicated the allowance for solitary needs further 
definition, i.e., specific medical and behavioral conditions that 
require solitary housing should be enumerated. The psychological 
determent must be considered before allowing solitary housing.
    (Response) We agree that chimpanzees should be housed in groups of 
2 or more and that the psychological ramifications of solitary housing 
be considered before it is done. We disagree with the suggestion to 
more specifically define the medical and behavioral conditions that 
require solitary housing. This determination should be made by the 
veterinarian and behaviorist.
    (Comments) Several commenters also suggested that we should include 
running as a species-specific behavior.
    (Response) We agree, and we have added running as a species-
specific behavior.
    (Comments) Three commenters indicated the requirement to have 
outdoor housing that must include elements of natural habitats such as 
trees, shrubs, grasses, potable water for drinking, and natural and 
artificial shelter would not be practical. They suggested this standard 
be applied only to facilities that have outside ranging areas.
    (Response) Section 9.4 addresses the comment that outdoor areas 
provide sufficient space, habitat, and structures.
    (Comments) Three commenters wrote this section did not sufficiently 
address enrichment and stated that more specific details were needed 
such as a list of items to be available, a list of prohibited items, 
and a list of social activities between chimpanzees and caregivers.
    (Response) We do not agree that very specific details are needed in 
the regulation. To do so would be too prescriptive and would discourage 
innovation and variety. We have added a sentence to indicate that 
enrichment techniques used should be those currently accepted 
practices.
    (Comments) Two commenters expressed strong support for the 
requirement that chimpanzees be able to retreat when threatened.
    (Comment) One commenter indicated that the site should have enough 
structures/areas to provide refuge and shade for all group members.
    (Response) We agree. These concerns have been addressed in other 
sections of the regulation.
    (Comments) One commenter supported the requirement to provide 
challenging feeding techniques. Three commenters addressed specific 
areas within this section. These areas were (1) the statement that 
commercial diet should be supplemented by natural foods should be 
revised to read that natural diet should be supplemented by commercial 
diet; (2) the statement that enrichment food must be provided a minimum 
of twice daily to engage chimpanzee interest; and (3) the need to 
include appropriate rodent and pest control measures, especially in a 
semi-tropical and tropical environment.
    (Response) We believe the regulation provides sanctuary staff the 
flexibility to develop and implement innovative enrichment feeding 
schedules that might include an effective once-a-day feeding plan. The 
Facility Director and other staff are expected to provide appropriate 
care for chimpanzees, which would include appropriate rodent and pest 
control. As the regulation requires the sanctuary to be accredited by 
an outside organization, we expect that rodent and pest control will be 
addressed to achieve full accreditation.
    (Comments) Four commenters stated this section should specifically 
outline or define the methods to be used to train chimpanzees to 
present arms for collection of blood collection or maintain previously 
learned related behaviors (more specifics needed on training and 
oversight). Also, commenters indicated that using punishment and 
negative stimuli should not be allowed.
    (Response) We disagree that the regulation should outline specific 
methods that are allowed or not allowed for training chimpanzees to 
participate in certain clinical procedures. The law requires the 
sanctuary to use acceptable methods that represent current practices. 
We agree that physical punishment should be used only in life-
threatening situations and should not be used routinely. We have 
revised the section to include the requirement to use current 
acceptable practices that do

[[Page 60415]]

not include physical punishment except in life-threatening conditions 
involving other chimpanzees or humans.
    (Comments) We received several comments that paragraph 9.6(b)(3) in 
the notice of proposed rulemaking includes one comment indicating that 
information in that paragraph was redundant with information presented 
in section 9.7.
    (Response) We agree the information here is redundant with the 
information presented in section 9.7. Therefore, we have deleted this 
paragraph and have addressed comments on this topic in section 9.7.
    (Comments) Two commenters noted the regulation does not 
specifically address housing individuals with infectious diseases with 
healthy animals. They noted healthy chimpanzees should not be exposed 
or placed at risk by infected animals.
    (Response) We agree. The regulation, as revised, expects the 
facility to be appropriately designed to reduce exposure. Additionally, 
the Facility Veterinarian is expected to have appropriate expertise to 
address infectious diseases.
    (Comments) Five commenters expressed concern that anesthesia, if 
used to perform annual physicals, may place chimpanzees at risk and 
should not be used routinely. Visual observation and medical history 
should be sufficient in most cases. One commenter suggested that if 
anesthesia was necessary, the physical should be done when a chimpanzee 
is anesthetized for other reasons.
    (Response) We agree that there can be risks associated with general 
anesthesia. However, the veterinarian is medically trained to assess 
and accommodate for the risk factors involved. The regulation as 
written does not specify that the physical must be done under general 
anesthesia. However, for safety reasons for both the chimpanzee and the 
individual performing the physical, it may be the logical thing to do. 
The Facility Veterinarian must use sound professional judgment in 
deciding when and if general anesthesia is needed or whether visual and 
historical information is sufficient. A statement to this effect has 
been added to this paragraph.
    (Comment) One commenter stated that complete veterinary records and 
a comprehensive health history must accompany every chimpanzee sent to 
the sanctuary. The commenter noted that records of this sort were not 
required under Section 9.6, Animal care, Well-being, Veterinary care, 
and Euthanasia. We presume the comment is noted in regards to using the 
medical history to determine the frequency and extent of the annual 
physical examination.
    (Response) We disagree. We believe the medical records noted are 
required by this regulation. The requirement to submit complete records 
with chimpanzees accepted into the sanctuary can be found in one or 
more of the following sections: 9.5(d), 9.6, and 9.8(a)(3). We have 
added wording to section 9.6 to further emphasize the need for a 
complete medical history. The CHIMP Act states that the Secretary may 
deny a chimpanzee entry into the sanctuary if the complete medical and 
research history is not available.
    (Comment) One commenter noted euthanasia for a chimpanzee with 
tuberculosis should be done only as a last resort.
    (Response) We agree and believe the current wording encompasses the 
commenter's concern.
    (Comment) One commenter stated that collection and banking of serum 
should only occur if it has a direct effect on the chimpanzees' health 
and not for research.
    (Response) We agree and have added the appropriate wording to this 
paragraph.
    (Comments) One commenter noted that additional tests should only be 
conducted if necessary for the health and safety of the chimpanzees. 
The commenter also suggested the Facility Veterinarian should consult 
with the veterinarian from the donating institution to gain additional 
information in order to eliminate the possible need for anesthesia.
    (Response) We agree that additional tests should only be done for 
the health of the chimpanzee. We have revised this paragraph to clarify 
that point. We believe that requiring the Facility Veterinarian to 
consult with another veterinarian in the case would be inappropriate. 
However, nothing in the regulation precludes the facility veterinarian 
from holding such consultation.
    (Comments) Two commenters stated that abnormal behavior and efforts 
to manage it should be clearly defined. Also, they noted the minimal 
provisions set forth in this paragraph were insufficient.
    (Response) We disagree. The behaviorist and other professionals at 
the Sanctuary must be properly trained and capable of defining and 
implementing the specific plan for each chimpanzee without the 
constraints of specifics in the regulation. The plan and intervention 
will be reviewed by the appropriate federal officials when conducting 
inspections.
    (Comments) One commenter indicated support for the language that 
emphasizes minimizing the use of physical and chemical restraints. Two 
commenters noted we need to explicitly define procedures for training 
chimpanzees to participate in certain activities in order to avoid the 
use of physical constraint. Further, the commenters stated that methods 
must not include any negative stimuli or punishment. Finally, they 
noted physical restraint should be prohibited unless methods are 
approved by the Board of Directors (no approval for research purposes).
    (Response) We do not agree that the regulation must provide 
explicit detailed procedures for training chimpanzees to participate in 
certain activities in order to avoid the use of physical restraint. The 
specific methods are more appropriately left to the Sanctuary 
professional staff with oversight by the Board of Directors and 
appropriate Federal officials. The prior approval of training and 
restraint methods by the Sanctuary Board of Directors is expected to be 
handled by institutional policies and procedures if deemed appropriate 
by the sanctuary administration.
    (Comments) Six commenters raised questions about what constituted 
adequate staff and staffing ratios for emergency, weekend, and holiday 
coverage. Two of these commenters also stated that Sanctuary staff and 
caregivers should be given radios for emergency communication.
    (Response) The issue of appropriate staffing is addressed under 
sections 9.6 and 9.9. Experience will dictate the number and ratio of 
staff needed to provide adequate care for chimpanzees in the sanctuary 
environment. Insurance of communication devices is appropriately 
handled by institutional policies and procedures as opposed to 
specification in this regulation.
    (Comments) Six commenters suggested changes to the paragraph 
regarding euthanasia. Several indicated that the sanctuary should have 
a policy on euthanasia from either the SCCC or the Board of Directors. 
Some stated that with pre-existing endpoints, the veterinarian would 
have some guidance in exercising professional judgment for performing 
euthanasia to relieve pain and/or suffering in a timely manner with 
SCCC review after euthanasia. Three of the commenters believed the 
decision to euthanize a chimpanzee should not be left to an individual 
veterinarian but the regulation should require consensus of at least 
two veterinarians.

[[Page 60416]]

    (Response) We agree that the sanctuary must have a policy on 
euthanasia that, at a minimum, outlines when, why, how, and by whom 
euthanasia will be performed. The requirement to have a policy on 
euthanasia is stated elsewhere in the regulation, but we have added a 
sentence to that effect in this paragraph. However, the decision to 
euthanize a chimpanzee for medical reasons to relieve pain and/or 
suffering for humane reasons remains with the Facility Veterinarian.

Section 9.7 Reproduction

    (Comments) Three commenters stated that offspring accidentally born 
in the sanctuary should be allowed to remain with the mother for a 
period of at least four years (or in one commenter's opinion, for 
life). If this is not possible, then the offspring should be placed 
with a surrogate mother.
    (Response) There was disagreement among the experts who we 
consulted concerning the specific length of time offspring should 
remain with the mother. Therefore, we have added a sentence in this 
paragraph that states, in essence, that the sanctuary must have a 
contingency for handling births in the colony including the length of 
time the offspring should remain with the mother.

Section 9.8 Animal Records

    (Comments) Five commenters raised questions about the method(s) of 
identification of chimpanzees and the need to define which agency will 
track chimpanzees for life and the methods used for identification. 
They noted that identification methods should be noninvasive and 
exclude tattoos unless the chimpanzee is already tattooed.
    (Response) The vast majority of chimpanzees entering the sanctuary 
will already be identified. It is possible that chimpanzees entering 
from a private entity may not be permanently identified. The sanctuary 
must then determine the appropriate method of identification. We have 
decided to retain the wording used in the proposed regulation.
    (Comments) Two commenters questioned whether the records or reports 
will be available to the public. One commenter suggested that reports 
should be published in the Federal Register.
    (Response) There is no requirement in the CHIMP Act to publish 
reports pertaining to the Sanctuary in the Federal Register, and we 
have no plan to do so. The Agency's Sanctuary-related records will only 
be available using existing federal laws for obtaining information from 
federal agencies.
    (Comments) Two commenters stated that all necropsy records should 
be publicly available and published in the Federal Register. One 
commenter noted that the necropsy records should be reasonably 
available to any veterinarian caring for chimpanzees formerly used in 
research. To do otherwise is perceived to not recognize the importance 
of such information for the care and well-being of formerly used or 
supported chimpanzees.
    (Response) The CHIMP Act specifies the distribution of necropsy 
records. We believe the current wording captures the essence of 
congressional intent. Therefore, we have decided not to change the 
wording in this section.

Section 9.9 Facility Staffing

    (Comment) One commenter provided general comments stating that 
reasons for dismissal of staff should be recorded (ethics, attitude, 
misconduct, etc.). Also, rules should prohibit individuals with 
communicable disease from direct contact with chimpanzees.
    (Response) We do not agree that the above items should be a part of 
the regulation. Documentation of actions taken against staff is 
governed by human resources policies that are not appropriate for 
inclusion in the regulation. Identification of communicable diseases 
that could affect chimpanzees and the restriction of staff direct 
contact with chimpanzees are issues best dealt with via the veterinary 
care and occupational health policies and procedures of the sanctuary.
    (Comments) Two commenters indicated that the staffing ratio should 
be sufficient to maintain an effective program of behavioral 
enrichment.
    (Response) We agree and have added a phrase indicating that 
sufficiently trained staff for behavioral enrichment must be available.
    (Comments) Three commenters stated the section on signs of well-
being should be revised to read that staff is trained to recognize all 
forms of distress, not just illness, and that signs of physical and 
psychological well-being are monitored.
    (Response) We do not agree that the sentence in question needs to 
be revised. We believe it encompasses all issues of well-being as 
written.
    (Comments) Two commenters indicated this paragraph should be more 
specific about the number or ratio of veterinarians needed for the 
sanctuary. One of the commenters suggested an explicit ratio should be 
recommended by the Board of Directors.
    (Response) We disagree with the need to provide more specific 
numbers and ratios of veterinarians needed. We believe conditions may 
vary and capturing every possible variation in the regulation is not 
practical. The number needed is best deferred to the sanctuary 
administration that may or may not include recommendations from the 
Board of Directors, and will be assessed by the NIH staff. The adequacy 
of the veterinary care program will be monitored by federal agencies 
and, upon accreditation, the accrediting agency.
    (Comment) One commenter stated the behaviorist's experience must 
also include working specifically with nonhuman primates during the 
introduction and formation of social groups. If they are unsuccessful 
in group formation, then they should consult with chimpanzee experts 
outside of the facility. The behaviorist should have access to the 
donating institution in order to observe behavior of incoming 
chimpanzees and discuss plans with individuals on site.
    (Response) We believe the description of the behaviorist's 
qualifications as described in the existing paragraph is adequate. The 
comments provided are relevant but detailed description of the 
qualifications should be left to Sanctuary administration and staff.

Section 9.13 Other Federal Laws, Regulations, and Policies That Apply 
to This Part

    (Comments) Three commenters noted that a segment of the Animal 
Welfare Regulations applicable to the chimpanzees in the sanctuary was 
omitted from section 9.13. The segment to which the commenters referred 
is AWR Part 3, Subpart D, ``specifications for the humane handling, 
care, treatment, and transport of nonhuman primates.''
    (Response) We agree that a segment of the AWR was inadvertently 
omitted. We have included it in the final regulation.
    (Comment) One commenter strongly suggested we should add State and 
Federal laws relating to human health and safety and environmental 
issues.
    (Response) Any reference to state laws would have to be general 
since the states that may house sanctuary facilities are unknown at 
this time. In regards to federal laws mentioned, several of the laws 
the commenter had in mind are already applicable by virtue of the 
nature of the business of the entity, i.e., OSHA, EPA, etc. Other 
Federal laws or regulations that are applicable to the general nonhuman 
primate community are not applicable to the federally supported 
chimpanzee

[[Page 60417]]

sanctuary system because there will be no importation, invasive 
research, or air transportation of chimpanzees.

II. Changes Made in Response to Comments

    We have made the following changes to the regulation in response to 
the comments that we received following publication of the notice of 
proposed rulemaking.

Section 9.2 Definitions

Animal Care and Use Committee
    We have revised the definition of the term Animal Care and Use 
Committee (ACUC) to indicate that the requirement for a member of an 
animal protection organization member on the Committee is unique to 
this regulation and is not required by the Animal Welfare Regulations 
or the Public Health Service Policy.
Exhibition
    We have revised the definition of Exhibition to state that it does 
not exclude limited viewing for educational purposes that is not 
disruptive to the chimpanzees.
Invasive Research
    The example was not worded correctly in the proposed rule. We have 
modified the example to read as follows: ``(3) Surgery or implantation 
of devices that are not a part of a veterinary medical treatment or 
colony management practice.''
    Additionally, we have deleted our previous reference to the term 
``ISIS'', the acronym for the International Species Information System, 
because the agency no longer tracks chimpanzees in the Sanctuary.

Section 9.3 Sanctuary Policies and Responsibilities

    We have revised paragraph 9.3(a) to read as follows:
    (a) What are the policies and responsibilities governing the 
Sanctuary system? The policies and responsibilities of the Sanctuary 
system are to--
    (1) Appoint a Board of Directors (BOD) responsible for the overall 
governance and direction of the Sanctuary. The BOD shall designate the 
Chief Executive Officer (CEO), who is responsible for the management 
and oversight of the daily operations of the Sanctuary and the 
performance of other delegated tasks. Subcontractors, if applicable, 
shall be governed by the policies that are developed by the Board of 
Directors of the primary contractor. In addition, the BOD shall:
    (i) Ensure that chimpanzees accepted into the Sanctuary are not 
discharged;
    (ii) 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;
    (iii) Ensure that the Board of Directors of the primary contractor 
consists of no more than thirteen (13) individuals, and that the 
conditions governing the terms of the Board members are in compliance 
with the CHIMP Act;
    (iv) Include individuals with the following expertise and 
experience as set forth in the CHIMP Act;
    (A) At least one veterinarian who is qualified in veterinary care 
of nonhuman primates. These qualifications may be met through 
postdoctoral training, experience, or both;
    (B) Individual(s) with expertise and experience in zoological 
science and with knowledge in behavioral primatology;
    (C) Individual(s) with experience in the animal protection field;
    (D) Individual(s) with experience and expertise in the field of 
business and management of nonprofit organizations;
    (E) Individual(s) knowledgeable and experienced in accrediting 
programs of animal care;
    (F) Individual(s) with experience and expertise in containing 
biohazards;
    (v) Ensure that a member of the Board of Directors serves as the 
Chair of the Board of Directors, who may be elected or appointed by the 
Board from among the individuals identified in paragraphs (a)(1)(iv)(A) 
through (F) of this section;
    (vi) Ensure that no member of the board shall have been fined for, 
or signed a consent decree for, any violation of the Animal Welfare 
Act;
    (vii) Ensure that a chimpanzee may not be removed from the 
sanctuary for research purposes;
    (viii) Create a safe and species-appropriate physical and social 
environment for the lifetime care of chimpanzees;
    (ix) Comply with all applicable provisions of the animal welfare 
regulations and other federal, state, and local laws, regulations, and 
policies;
    (x) Achieve accreditations from appropriate accrediting bodies 
within a reasonable timeframe mutually agreed upon by the contractor 
and NCRR;
    (xi) Prohibit any invasive research on the resident chimpanzees, 
but permit noninvasive and behavioral studies. Definitions for the 
terms invasive and noninvasive are set forth in Sec.  9.2 of this part;
    (xii) 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 that does not adversely 
affect the chimpanzees' routine.];
    (xiii) Staff the organization with people with appropriate 
experience; and
    (xiv) Authorize the establishment of a Sanctuary Chimpanzee Care 
Committee (SCCC) that is appointed by and reports to the CEO or 
President of the company or corporation. The SCCC is responsible for 
overseeing the chimpanzee care program and operations to ensure that 
the health and well-being of the chimpanzees and the occupational 
safety of the staff are being addressed. The Committee must consist of 
no fewer than five people who must include:
    (A) A chairperson knowledgeable of the needs of chimpanzees;
    (B) A veterinarian with chimpanzee care experience;
    (C) A behaviorist with experience in chimpanzee behavior;
    (D) A member of the chimpanzee care staff; and
    (E) Member or members from the community, including at least one 
with affiliation or employment with an animal protection organization 
as defined in Sec.  9.2 of this part. (Note, this provision is unique 
to these standards of care and is not required by the Animal Welfare 
Regulations or the PHS Policy.)
    (F) The SCCC will:
    (1) Oversee and evaluate the chimpanzee care and socialization 
program;
    (2) Review and approve proposed education programs. No program 
should be approved that might interfere with the chimpanzees' well-
being or routine activities;
    (3) Conduct a formal review of the program on a semiannual basis 
and submit reports to the Sanctuary director. The reports must be 
available for review by the USDA and NIH representatives during site 
visits;
    (4) Establish a mechanism for receipt and review of concerns 
involving the care of chimpanzees and resolving such concerns;
    (5) Review all such study proposals. 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 
Regulations and the Public

[[Page 60418]]

Health Service Policy on Humane Care and Use of Laboratory Animals;
    (6) Review all euthanasia events. Euthanasia events performed for 
medical or humane reasons must 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 advance review by 
the SCCC shall be reviewed by the SCCC as soon as possible after the 
event to ensure compliance with established policy;
    (7) 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; and
    (8) Develop procedures for maintaining chimpanzees that are 
seropositive for or harboring infectious agents or previously have been 
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.

Section 9.4 Physical Facility Policies and Design

    We have revised the regulation in response to the comments that we 
received following publication of the notice of proposed rulemaking. 
Specifically, to improve the clarity of the regulation, we have made 
several revisions to the proposed 9.4 and renumbered the section 
accordingly. Statements in the proposed section that were determined to 
be redundant or superfluous relative to other sections in the 
regulation have been deleted.
    The revised section reads as follows.
    (a) What standards apply to the facility design and physical plant? 
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. Daily observation of 
chimpanzees within the enclosures is required and shall be accomplished 
with minimal disturbance to the chimpanzees. The facility design and 
physical plant should be in accordance with the recommendation of The 
Guide for the Care and Use of Laboratory Animals (Guide), where 
applicable. The Guide is published by the National Research Council, 
1996, International Standard Book Number 0-309-05377-3. The Guide 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.
    (i) The facility design and physical plant consist 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.
    (ii) 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, facilitate sanitation and 
servicing, and address the psychological well-being and social needs of 
the chimpanzees. Chimpanzees must be able to retreat from areas where 
they feel threatened or agitated by close human encounters or 
encounters with other chimpanzees.
    (iii) Indoor areas shall have special areas for social 
introductions and medical treatment. 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.
    (iv) Outdoor areas must provide sufficient ranging space and either 
natural or artificial structures that chimpanzees can use for shelter 
or nesting areas to sleep, rest, or seek refuge from rain, direct sun, 
wind, and extreme temperatures.
    (v) 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 
laws, regulations or guidelines, as applicable.
    (vi) 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, 
complete physical examinations, and facilities for extended care of 
medical conditions as needed.
    (b) What security measures are required for the sanctuary? The 
sanctuary must provide adequate security against unauthorized entry, 
sabotage, malicious damage, and theft of chimpanzees and property and 
must 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 
(incorporated by reference, see paragraph (a) of section 9.4).
    (c) Is the sanctuary required to develop disaster and escaped 
animal contingency plans? The sanctuary facility must prepare disaster 
and escaped animal contingency plans outlining simple and easy to 
follow plans for dealing with natural and man-made disasters and steps 
to be taken in case a chimpanzee escapes from the compound. The 
sanctuary also must provide adequate security against unauthorized 
entry, sabotage, malicious damage, and theft of chimpanzees and 
property and must minimize any chance of escape by a chimpanzee. 
Primary barriers must be constructed to prevent escape of chimpanzees 
and secondary or perimeter barriers must prevent entry of unauthorized 
persons into the facility, consistent with the recommendations of the 
Guide (incorporated by reference, see paragraph (a) of section 9.4).

Section 9.5 Chimpanzee Ownership, Fees, and Studies

    We have revised paragraph 9.5(b)(2) to emphasize that although 
chimpanzees not owned or supported by the Federal Government may be 
accepted into the sanctuary, federal funds may not be used for their 
support, unless authorized by the Secretary or an authorized designee.

[[Page 60419]]

Section 9.6 Animal Care, Well-Being, Husbandry, Veterinary Care, and 
Euthanasia

    We have revised the regulation in response to the comments that we 
received following publication of the notice of proposed rulemaking. 
Specifically, to improve the clarity of the regulation, we have made 
several revisions to the proposed 9.6 and renumbered the section 
accordingly. Statements in the proposed section that were determined to 
be redundant or superfluous relative to other sections in the 
regulation have been deleted.
    The revised section reads as follows.
    (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.
    (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:
    (i) Chimpanzees must have access to food, water, and bedding 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 in accordance with the Guide (incorporated by reference, 
see paragraph (a) of section 9.4).
    (ii) Indoor primary enclosures must be cleaned as often as required 
to maintain a clean and healthy environment, with a minimum of once 
daily. Outdoor enclosures must be monitored daily and cleaned on a 
routine basis. Outdoor ranging areas will not require a routine 
cleaning schedule but must be monitored for excessive accumulation of 
waste or other unhealthy conditions. 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, running, group 
interactions, sleeping, etc. Feeding and watering implements must be 
sanitized at intervals required to maintain them in a sanitary 
condition, in accordance with the Guide (incorporated by reference, see 
paragraph (a) of section 9.4).
    (iii) The federally supported chimpanzee sanctuary must employ a 
behavioral scientist knowledgable in primate behavior and socialization 
requirements. This individual shall provide primary leadership in 
developing, implementing, and monitoring the chimpanzee behavioral 
guidelines for the sanctuary. Enrichment techniques used shall be 
currently accepted practices. The sanctuary must provide for the 
expertise to plan, administer, and evaluate the effectiveness of the 
well-being program.
    (iv) 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. 
Trainers must use currently acceptable practices that do not include 
physical punishment.
    (c) What are the requirements for an adequate veterinary care and 
animal health program?
    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 (incorporated by reference, 
see paragraph (b) of section 9.4) and in the American College of 
Laboratory Animal Medicine document, ``The Provision of Adequate 
Veterinary Care,'' available on the Internet at http://www.aclam.com.
    (i) If the sanctuary houses chimpanzees with infectious diseases, 
it must have a veterinarian knowledgable 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. Routine observation and the prevention of disease, metabolic 
conditions, abnormal behavior and injury must be a priority focus of 
the Facility Veterinarian and staff.
    (ii) 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 
must 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.
    (iii) The sanctuary must implement appropriate methods for disease 
surveillance and diagnosis of diseases, which may include the 
following:
    (iv) Tuberculin (TB) 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 in which the chimpanzee consequently 
experiences undue pain and suffering that cannot be alleviated. The 
procedures noted under Sec.  9.6(d) must be observed if euthanasia is 
necessary.
    (v) Fecal samples must be checked for parasites and parasitic ova.
    (vi) A complete blood count and serum chemical panel must be 
obtained.
    (vii) Additional serum for banking and/or testing shall be obtained 
as appropriate by the Facility Veterinarian and is considered 
beneficial for chimpanzee health.
    (viii) 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.
    (ix) Additional tests or procedures that are deemed beneficial to 
the chimpanzees' health may be required by the Facility Veterinarian.
    (x) Chimpanzees are susceptible to many of the vaccine preventable 
diseases of human childhood. Appropriate vaccines must be considered 
and administered if deemed necessary, at the discretion of the Facility 
Veterinarian, to protect the chimpanzees in the sanctuary. Methods of 
disease prevention, diagnosis, and therapy must comply with those 
currently accepted in veterinary medical practice. Arrangements with 
diagnostic laboratories must be established before chimpanzees arrive 
at the sanctuary.
    (xi) The sanctuary must minimize the use of physical and chemical 
restraint. Chimpanzees in the Sanctuary shall 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. However, chemical sedation sometimes may be appropriate 
for certain necessary medical interventions or for the safety of the 
chimpanzee and caregivers. If physical restraint measures are 
necessary, due consideration must be given to the temporary or 
permanent effects upon the chimpanzee and human and animal safety 
concerns.
    (xii) Methods used to relieve pain must be documented in the 
chimpanzee medical or surgical records. These

[[Page 60420]]

records will be available for review by USDA and NIH representatives. 
The Facility Veterinarian must ensure that pain management is current 
and in accordance with acceptable veterinary medical practices.
    (xiii) 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. Notification procedures must be documented in the form of 
operating procedures.
    (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 when it is 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. The 
sanctuary must establish a policy on euthanasia that will provide 
conditions that must be met before euthanasia is permitted and guidance 
for performing euthanasia.
    (i) Methods of euthanasia will be consistent with the most recent 
report of the American Veterinary Medical Association Panel on 
Euthanasia (2002), unless more reliable data becomes available. 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.
    (ii) The SCCC will participate in the decision in nonmedical 
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 shall be considered.

Section 9.7 Reproduction

    We have added sentences in this section indicating that the 
sanctuary must have a contingency plan for handling births in the 
colony that includes the length of time the offspring should remain 
with the mother. The sentences also indicate that documentation must be 
provided verifying that a vasectomy was performed and confirmed by 
removing and examining a segment of the Vas Deferens, or using another 
reliable test method to confirm the male is negative for sperm.

Section 9.8 Animal Records

    We have deleted the requirement that all chimpanzees must be 
tracked for life by a single agency. We did this because NIH no longer 
funds this activity and the agency is not obligated to continue the 
tracking activity.

Section 9.9 Facility Staffing

    We have made several revisions to the proposed 9.9 in order to 
improve the clarity of the regulation. Statements that were determined 
to be redundant or superfluous relative to other sections in the 
regulation were removed or modified.
    The revised section reads as follows.
    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 shall be adjusted 
as experience is gained during the operation of the sanctuary. 
Sufficiently trained staff also must be available to maintain adequate 
behavioral enrichment;
    (c) 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;
    (d) 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;
    (e) The remaining staff, which may include part-time, full-time, or 
contractor Facility Veterinarian(s) and Behaviorist(s), must possess 
the skills, knowledge, and/or experience required to perform their 
duties, as elaborated within the regulation.

Section 9.10 Occupational Health and Safety Program (OHSP) and 
Biosafety Requirements

    We have modified this section to improve the clarity of the 
regulation.
    The revised section reads as follows.
    (a) How are employee Occupational Health and Safety Program risks 
and concerns addressed? The sanctuary shall assure that an Occupational 
Health and Safety Program (OHSP) is developed and implemented in 
accordance with current veterinary medical practices and the guidelines 
and standards found in the Guide (incorporated by reference, see 
paragraph (a) of section 9.4);
    (b) How are biosafety concerns addressed? The sanctuary shall 
institute and administer an effective biosafety program that addresses 
the biosafety hazards at that particular site. The program shall 
include identifying biohazards, outlining practices and procedures to 
be followed, providing personal safety equipment or protective clothing 
and equipment, and establishing 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. In establishing a program, the sanctuary 
must use current accepted practices and publications prepared by the 
CDC, NIH, and professional societies specializing in biosafety. The 
input and guidance of personnel trained or experienced in biosafety are 
essential.
    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 (for example, serology, virus 
culture, histology) so that the sanctuary staff is fully aware of the 
health condition of the arriving chimpanzee. The records may be created 
and retained in electronic form.

Section 9.11 Animal Transport

    We have modified section 9.11 to clarify its objective to require

[[Page 60421]]

consistency with existing laws and regulations.
    The revised section reads as follows.
    The transportation of chimpanzees by surface or air must be in 
accordance with the requirements set forth in the Animal Welfare Act 
and Regulations and the International Air Transport Association (IATA) 
Live Animal Regulations and guidelines, as applicable.

Section 9.12 Compliance With the Standards of Care, and USDA and PHS 
Policies and Regulations

    We changed the frequency of site visits from quarterly to annually.

Section 9.13 Other Federal Laws, Regulations, Policies, and Statutes 
That Apply to the Sanctuary

    In section 9.13, we have added ``part 3, subpart D-Specifications 
for the Humane Handling, Care, Treatment, and Transport of Nonhuman 
Primates'' to the Animal Welfare Regulations reference.
    We provide the following as public information.

Executive Order 12866

    NIH has examined the impacts of this final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action under the 
Executive order.

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 final rule 
will not have such impact.

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 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 final rule applies only to a contractor or any 
subcontractor operating under a contract funded by 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 Request for Proposals 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 several 
members of its Board of Directors familiar with chimpanzee care 
standards and had served as consultants to some of the agencies 
publishing such standards. Therefore, the contractor included resources 
needed to potentially comply with anticipated standards in its 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 one 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 percent of the construction cost. We 
do not anticipate the use of subcontractors in the foreseeable future 
because of the considerable amount of unused space available 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 final 
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 final 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 final rule as required under the Order and 
determined that it will not have federalism implications. The Secretary 
certifies that the final rule will not have an effect on the States or 
on the distribution of power and responsibilities among various levels 
of government.

Paperwork Reduction Act

    Sections 9.3(a)(2)(xiv)(F)(3), 9.6(d)(ii), 9.8(a)(4), and 9.12(b) 
of this final 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)(2)(xiv)(F)(3), 9.5(c)(4), 9.5(e), 9.6(c)(xii), 9.6c(xiii), 
9.6d(ii), 9.7, 9.8(a)(1-4), 9.8(b), 9.10(a) , 9.10(b), and 9.12(b) 
contain recordkeeping requirements that also are subject to OMB 
approval under the Paperwork

[[Page 60422]]

Reduction Act. In addition, elements of disclosure are found in 
sections 9.3(a)(2)(vii)(F)(8), 9.4(c), 9.5(c), 9.5(e), 9.5(f)(2), 
9.6(c)(xii), 9.6(c)(xiii), 9.6(d)(ii), 9.7, 9.10(a), and 9.10(b).
    The title, description, and respondent description of the 
information collection and recordkeeping 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) Marilyn Tuttleman, Project Clearance Branch, 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 recordkeeping 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                      Average      Annual burden
                                                        of            Annual          burden         hours per
                                                   respondents *     frequency        (hours)        response
----------------------------------------------------------------------------------------------------------------
Reporting:
    Sec.   9.3(a)(2)(xiv)(F)(3).................             1-3               2               6              12
    Sec.   9.6(d)(ii)...........................             1-3               2             0.5               1
    Sec.   9.8(a)(4)............................             1-3               4               5              20
    Sec.   9.12(b)..............................             1-3               1               6               6
                                                 ---------------------------------------------------------------
        Subtotal................................  ..............               9            17.5              39
                                                 ===============================================================
Recordkeeping:
    Sec.   9.3(a)((2)(xiv)(F)(3 )...............             1-3               2               2               4
    Sec.   9.5(c)(4)............................             1-3               1               2               2
    Sec.   9.5 (e)..............................             1-3               1               4               4
    Sec.   9.6(c)(xii)..........................             1-3               4             0.1             0.4
    Sec.   9.6(c)(xii)..........................             1-3               1               2               2
    Sec.   9.6(d)(ii)...........................             1-3               4               1               4
    Sec.   9.7..................................             1-3               5               2              10
    Sec.   9.8(a)(1-4)..........................             1-3               1             0.5               5
    Sec.   9.8(b)...............................             1-3               5               2              10
    Sec.   9.10(a)..............................             1-3              12             0.2             2.4
    Sec.   9.10(b)..............................             1-3               3             1.5             4.5
    Sec.   9.12(b)..............................          ** 1-3               1               3               3
                                                 ---------------------------------------------------------------
        Subtotal................................  ..............              40            20.3            51.3
                                                 ---------------------------------------------------------------
Disclosure:
    Sec.   9.3(a)(2)(vii) (F)(8)................             1-3               6             0.5               3
    Sec.   9.4(c)...............................             1-3               1               1               1
    Sec.   9.5 (c)..............................             1-3               1             0.1             0.1
    Sec.   9.5(e)...............................             1-3               1               8               8
    Sec.   9.5(f)(2)............................             1-3           *** 1               2               2
    Sec.   9.6(c)(xii)..........................             1-3             0.2               8             1.6
    Sec.   9.6(c)(xiii).........................             1-3               2               2               1
    Sec.   9.6(d)(ii)...........................             1-3               1               1               1
    Sec.   9.7..................................             1-3               5               2              10
    Sec.   9.10(a)..............................             1-3              10             0.2               2
    Sec.   9.10(b)..............................             1-3              10             0.2               2
                                                 ---------------------------------------------------------------
        Subtotal................................  ..............            38.2              25            31.7
                                                 ===============================================================
            Total...............................             1-3            87.2            62.8            122
----------------------------------------------------------------------------------------------------------------
* 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.
** 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-time event.


[[Page 60423]]

List of Subjects in 42 CFR Part 9

    Animal welfare, humane care and treatment of chimpanzees, 
Incorporation by reference.

    Dated: August 12, 2008.
Elias A. Zerhouni,
Director, National Institutes of Health.
    Approved: September 30, 2008.
Michael O. Leavitt,
Secretary.

0
Accordingly, NIH amends 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 (OHSP) 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.

    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 regulation? The Chimpanzee Health Improvement, Maintenance, and 
Protection Act (Pub. L. 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 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 composed of individuals with various backgrounds and interests 
that are 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. The requirement that a member of the ACUC must be from an 
animal protection organization is unique to this part and is not 
required under the Animal Welfare Regulations or the Public Health 
Service Policy on the Humane Care and Use of Laboratory Animals. This 
Committee must be established 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 nonprofessional 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

[[Page 60424]]

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) mean 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. This definition excludes limited viewing for educational 
purposes that are not disruptive to the chimpanzees.
    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 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.
    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, 1996, International 
Standard Book Number 0-309-05377-3.
    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 (for 
example, cages, pens, rooms) for maintaining animals in a controlled 
environment that provides for normal physiological and behavioral 
needs.
    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. Sanctuary 
chimpanzees may not be used in invasive research. This definition 
excludes any invasive procedure that is a part of veterinary, medical, 
or surgical care that is performed by or under the direction of the 
Sanctuary Veterinarian using acceptable veterinary practices. 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 that are not a 
part of a veterinary medical treatment or colony management purposes.
    (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 from 
their social group or addition of individuals in order to conduct 
behavioral research (for example, 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 June 2007, there were eight 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.
    Noninvasive research (studies) means the use of procedures that 
depend upon close observation of chimpanzee behavior or on medical 
information collected during the course of normal veterinary care. 
These procedures do not require removal of the chimpanzees from their 
social group or environment, or require a separate anesthetic or 
sedation event to collect data or record observations. Some examples of 
noninvasive studies are:
    (1) Visual observation;
    (2) Behavioral studies designed to improve the establishment and 
maintenance of social groups. These activities may cause stress as a 
result of novel interactions between chimpanzees and caregivers, but 
they are not considered invasive as long as they are intended to 
maximize the well-being of the chimpanzees;

[[Page 60425]]

    (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.
    Nonfederally 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. Offspring born in the sanctuary is 
owned by the Sanctuary Contractor.
    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 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 NCRR/NIH/HHS 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 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) Appoint a Board of Directors (BOD) responsible 
for the overall governance and direction of the Sanctuary. The BOD 
shall designate the Chief Executive Officer (CEO), who is responsible 
for the management and oversight of the daily operations of the 
sanctuary and the performance of other delegated tasks. Subcontractors, 
if applicable, shall be governed by the policies that are developed by 
the Board of Directors of the primary contractor.
    (2) Direct the BOD to:
    (i) Ensure that chimpanzees accepted into the sanctuary are not 
discharged;
    (ii) 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;
    (iii) Ensure that the Board of Directors of the primary contractor 
consists of no more than thirteen (13) individuals, and that the 
conditions governing the terms of the Board members are in compliance 
with the CHIMP Act;
    (iv) Include individuals with the following expertise and 
experience as set forth in the CHIMP Act;
    (A) At least one veterinarian who is qualified in veterinary care 
of nonhuman primates. These qualifications may be met through 
postdoctoral training, experience, or both;
    (B) Individual(s) with expertise and experience in zoological 
science and with knowledge in behavioral primatology;
    (C) Individual(s) with experience in the animal protection field;
    (D) Individual(s) with experience and expertise in the field of 
business and management of nonprofit organizations;
    (E) Individual(s) knowledgeable and experienced in accrediting 
programs of animal care;
    (F) Individual(s) with experience and expertise in containing 
biohazards;
    (v) Ensure that a member of the Board of Directors serves as the 
Chair of the Board of Directors, who may be elected or appointed by the 
Board from among the individuals identified in paragraphs (a) (1) (iv) 
(A) through (F) of this section;
    (vi) Ensure that no member of the board shall have been fined for, 
or signed a consent decree for, any violation of the Animal Welfare 
Act;
    (vii) Create a safe and species-appropriate physical and social 
environment for the lifetime care of chimpanzees;
    (viii) Comply with all applicable provisions of the animal welfare 
regulations and other federal, state and local laws, regulations, and 
policies;
    (ix) Achieve accreditations from appropriate accrediting bodies 
within a reasonable time frame mutually agreed upon by the Contractor 
and NCRR;
    (x) Prohibit any invasive research on the resident chimpanzees, but 
permit noninvasive studies (Definitions for the terms invasive and non-
invasive are set forth in Sec.  9.2 of this part.);
    (xi) 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 that

[[Page 60426]]

does not adversely affect the chimpanzees' routine.);
    (xii) Staff the organization with people with appropriate 
experience; and
    (xiii) Authorize the establishment of a Sanctuary Chimpanzee Care 
Committee (SCCC) that is appointed by and reports to the CEO or 
President of the company or corporation.
    The SCCC is responsible for overseeing the chimpanzee care program 
and operations to ensure the health and well-being of the chimpanzees 
and the occupational safety of the staff are being addressed. The 
Committee must consist of no fewer than five people who must include:
    (A) A chair (person) knowledgeable of the needs of chimpanzees;
    (B) A veterinarian with chimpanzee care experience;
    (C) A behaviorist with experience in chimpanzee behavior;
    (D) A member of the chimpanzee care staff; and
    (E) Member or members from the community, including at least one 
with affiliation or employment with an animal protection organization 
as defined in Sec.  9.2 of this part.
    (F) The SCCC will:
    (1) Oversee and evaluate the chimpanzee care and socialization 
program;
    (2) Review and approve proposed education programs. No program 
should be approved that might interfere with the chimpanzees' well-
being or routine activities;
    (3) Conduct a formal review of the program on a semiannual basis 
and submit reports to the Sanctuary Director. The reports must be 
available for review by the USDA and NIH representatives during site 
visits;
    (4) Establish a mechanism for receipt and review of concerns 
involving the care of chimpanzees and resolving such concerns;
    (5) Review all noninvasive study proposals. 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, the Public Health Service Policy on Humane Care and Use of 
Laboratory Animals, and these standards of care;
    (6) Review all euthanasia events. Euthanasia events performed for 
medical or humane reasons must 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 advance review by 
the SCCC shall be reviewed by the SCCC as soon as possible after the 
event to ensure compliance with established policy;
    (7) 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; and
    (8) Develop procedures for maintaining chimpanzees that are 
seropositive for or harboring infectious agents or previously have been 
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 
NCRR/NIH for approval.
    (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? 
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. Daily observation of 
chimpanzees within the enclosures is required and shall be accomplished 
with minimal disturbance to the chimpanzees. The facility design and 
physical plant should be in accordance with the recommendation of The 
Guide for the Care and Use of Laboratory Animals (Guide), where 
applicable. The Guide is published by the National Research Council, 
1996, International Standard Book Number 0-309-05377-3. The Guide 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.
    (1) The facility design and physical plant consist 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) 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, facilitate sanitation and 
servicing, and address the psychological well-being and social needs of 
the chimpanzees. Chimpanzees must be able to retreat from areas where 
they feel threatened or agitated by close human encounters or 
encounters with other chimpanzees.
    (3) Indoor areas shall have special areas for social introductions 
and medical treatment. 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.
    (4) Outdoor areas must provide sufficient ranging space and either 
natural or artificial structures that chimpanzees can use for shelter 
or nesting areas to sleep, rest, or seek refuge from rain, direct sun, 
wind, and extreme temperatures.
    (5) 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 
laws, regulations or guidelines, as applicable.
    (6) 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

[[Page 60427]]

procedures, including minor surgery and emergency surgical procedures, 
complete physical examinations, and facilities for extended care of 
medical conditions as needed.
    (b) What security measures are required for the sanctuary? The 
sanctuary must provide adequate security against unauthorized entry, 
sabotage, malicious damage, and theft of chimpanzees and property and 
must 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 (incorporated by 
reference, see paragraph (a) of this section).
    (c) Is the sanctuary required to develop disaster and escaped 
animal contingency plans? The sanctuary facility must prepare disaster 
and escaped animal contingency plans outlining simple and easy to 
follow plans for dealing with natural and man-made disasters and steps 
to be taken in case a chimpanzee escapes from the compound. The 
Sanctuary also must provide adequate security against unauthorized 
entry, sabotage, malicious damage, and theft of chimpanzees and 
property and must minimize any chance of escape by a chimpanzee. 
Primary barriers must be constructed to prevent escape of chimpanzees 
and secondary or perimeter barriers must prevent entry of unauthorized 
persons into the facility, consistent with the recommendations of the 
Guide (incorporated by reference, see paragraph (a) of this section).


Sec.  9.5  Chimpanzee 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 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 by the Sanctuary Contractor 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. While chimpanzees not 
owned or supported by the Federal Government may be admitted to the 
sanctuary, federal funds may not be used for their support unless 
authorized by the Secretary or an authorized designee;
    (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 nongovernmental owned 
chimpanzees transfer to the chimpanzee sanctuary? The following 
additional conditions apply when nongovernmental owned chimpanzees 
transfer to the chimpanzee sanctuary:
    (1) Chimpanzees transferred to the sanctuary sites must be 
permanently incapable of reproduction, for example, by vasectomy, tubal 
ligation, or another reliable procedure;
    (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 nongovernmental owned chimpanzees? The 
chimpanzee Sanctuary Contractor, in conjunction with NCRR, must 
establish criteria and a fee system for acceptance of nongovernmental 
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? In 
December 2007, the CHIMP Act was amended by the ``Chimp Haven is Home 
Act,'' which terminated the authority for the removal of chimpanzees 
from the sanctuary system for research purposes.


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.
    (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) Chimpanzees must have access to food, water, and bedding 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 in accordance with the Guide (incorporated by reference, 
see paragraph (a) of Sec.  9.4).
    (2) Indoor primary enclosures must be cleaned as often as required 
to maintain a clean and healthy environment, with a minimum of once 
daily. Outdoor enclosures must be monitored daily and cleaned on a 
routine basis. Outdoor ranging areas will not require a routine 
cleaning schedule but must be monitored for excessive accumulation of 
waste or other unhealthy conditions. 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, running, group 
interactions, sleeping, etc. Feeding and watering implements must be 
sanitized at intervals required to maintain them in a sanitary 
condition, in accordance with the Guide (incorporated by reference, see 
paragraph (a) of Sec.  9.4).

[[Page 60428]]

    (3) 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. Enrichment techniques used 
shall be currently accepted practices. The sanctuary must provide for 
the expertise to plan, administer, and evaluate the effectiveness of 
the well-being program.
    (4) 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. 
Trainers must use currently acceptable practices that do not include 
physical punishment.
    (c) What are the requirements for an adequate veterinary care and 
animal health program? 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 
(incorporated by reference, see paragraph (b) of Sec.  9.4). For 
additional guidance see the American College of Laboratory Animal 
Medicine document, ``The Provision of Adequate Veterinary Care,'' 
available on the Internet at http://www.aclam.org.
    (1) 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. Routine observation and the prevention of disease, metabolic 
conditions, abnormal behavior and injury must be a priority focus of 
the Facility Veterinarian and staff.
    (2) 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 
must 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.
    (3) The sanctuary must implement appropriate methods for disease 
surveillance and diagnosis of diseases, which may include the 
following:
    (4) Tuberculin (TB) 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 in which the chimpanzee consequently 
experiences undue pain and suffering that cannot be alleviated. The 
procedures noted under Sec.  9.6 (d) must be observed if euthanasia is 
necessary.
    (5) Fecal samples must be checked for parasites and parasitic ova.
    (6) A complete blood count and serum chemical panel must be 
obtained.
    (7) Additional serum for banking and/or testing shall be obtained 
as appropriate by the Facility Veterinarian and is considered 
beneficial for chimpanzee health.
    (8) 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.
    (9) Additional tests or procedures that are deemed beneficial to 
the chimpanzees' health may be required by the Facility Veterinarian.
    (10) Chimpanzees are susceptible to many of the vaccine preventable 
diseases of human childhood. Appropriate vaccines must be considered 
and administered if deemed necessary, at the discretion of the Facility 
Veterinarian, to protect the chimpanzees in the sanctuary. Methods of 
disease prevention, diagnosis, and therapy must comply with those 
currently accepted in veterinary medical practice. Arrangements with 
diagnostic laboratories must be established before chimpanzees arrive 
at the sanctuary.
    (11) The sanctuary must minimize the use of physical and chemical 
restraint. Chimpanzees in the sanctuary shall 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. However, chemical sedation sometimes may be appropriate 
for certain necessary medical interventions or for the safety of the 
chimpanzee and caregivers. If physical restraint measures are 
necessary, due consideration must be given to the temporary or 
permanent effects upon the chimpanzee and human and animal safety 
concerns.
    (12) Methods used to relieve pain must be documented in the 
chimpanzee medical or surgical records. These records will be available 
for review by USDA and NIH representatives. The Facility Veterinarian 
must ensure that pain management is current and in accordance with 
acceptable veterinary medical practices.
    (13) 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. Notification procedures must be documented in the form of 
operating procedures.
    (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 when it is 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. The 
sanctuary must establish a policy on euthanasia that will provide 
conditions that must be met before euthanasia is permitted and guidance 
for performing euthanasia.
    (1) Methods of euthanasia will be consistent with the most recent 
report of the American Veterinary Medical Association Panel on 
Euthanasia (2002), unless more reliable data becomes available. 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.
    (2) The SCCC will participate in the decision in nonmedical 
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

[[Page 60429]]

appropriate counseling and psychological support shall be considered.


Sec.  9.7  Reproduction.

    Chimpanzee reproduction is prohibited in the sanctuary. Therefore, 
all 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 may be 
validated through laboratory testing for 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 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 a 
segment of the Vas Deferens has been removed, or that the test used is 
reliable and is negative for sperm. The sanctuary must have a 
contingency plan for handling accidental births that includes the 
length of time the offspring is expected to remain with the mother.


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. 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) (9 CFR 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 regulation.
    (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 shall be adjusted 
as experience is gained during the operation of the sanctuary. 
Sufficiently trained staff also must be available to maintain adequate 
behavioral enrichment;
    (c) 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;
    (d) 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;
    (e) The remaining staff, which may include part-time, full-time, or 
contractor Facility Veterinarian(s) and Behaviorist(s), must possess 
the skills, knowledge, and/or experience required to perform their 
duties, as elaborated within the regulation.


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? The sanctuary shall assure that an Occupational 
Health and Safety Program (OHSP) is developed and implemented in 
accordance with current veterinary medical practices and the guidelines 
and standards found in the Guide (incorporated by reference, see 
paragraph (a) of section 9.4);
    (b) How are biosafety concerns addressed? The sanctuary shall 
institute and administer an effective biosafety program that addresses 
the biosafety hazards at that particular site. The program shall 
include identifying biohazards, outlining practices and procedures to 
be followed, providing personal safety equipment or protective clothing 
and equipment, and establishing 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. In establishing a program, the Sanctuary 
must use current accepted practices and publications prepared by the 
CDC, NIH, and professional societies specializing in biosafety. The 
input and guidance of personnel trained or experienced in biosafety are 
essential. 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 (for example, 
serology, virus culture, histology) so that the

[[Page 60430]]

sanctuary staff is fully aware of the health condition of the arriving 
chimpanzee. The records may be created and retained in electronic form.


Sec.  9.11  Animal transport.

    The transportation of chimpanzees by surface or air must be in 
accordance with the requirements set forth in the Animal Welfare Act 
and Regulations and the International Air Transport Association (IATA) 
Live Animal Regulations and guidelines, as applicable.


Sec.  9.12  Compliance with the Standards of Care, and 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 
NCRR/NIH/HHS. The NIH/NCRR Project Officer for this contract will 
conduct scheduled site visits at least one time annually (or more often 
if necessary) and review monthly and quarterly reports submitted to the 
Project and Contract 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 (HHS/NIH), or allow 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 NCRR/NIH/HHS. The NCRR 
representative will use facility site visits, reports, personal 
contact, and any other means as appropriate to ensure compliance with 
these standards. The contractor and subcontractors are required to 
obtain and maintain an Animal Welfare Assurance from NIH's Office of 
Laboratory Animal Welfare (OLAW) when chimpanzees are used for 
noninvasive studies as authorized in the CHIMP Act. In addition, the 
sanctuary must achieve accreditation by a nationally recognized animal 
program accrediting body (such as the AAALAC, the AZA, or similar 
recognized body) 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 and statutes 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; 
part 3, subpart D--Specifications for the Humane Handling, Care, 
Treatment, and Transport of Nonhuman Primates.

 [FR Doc. E8-23518 Filed 10-9-08; 8:45 am]

BILLING CODE 4140-01-P