[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]
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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
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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
[[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
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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
[[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