Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System, 60410-60430 [E8-23518]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 198 (Friday, October 10, 2008)]
[Rules and Regulations]
[Pages 60410-60430]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23518]



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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

Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / 
Rules and Regulations

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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.

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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

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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

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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

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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 https://www.nap.edu; or view it 
online at https://oacu.od.nih.gov/regs/guide/guidex.htm. You may inspect 
a copy at NIH, NCRR, 1 Democracy Plaza, 6701 Democracy Boulevard, 
Bethesda, MD 20817-4874, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to https://www.archives.gov/
federal_register/code_of_federal_regulations/ibr_locations.html.
    (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 
chi