60410 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 9 

[Docket No. NIH–2007–0927] 

RIN 0925–AA31 

Standards of Care for Chimpanzees 

Held in the Federally Supported 

Chimpanzee Sanctuary System 

AGENCY: National Institutes of Health, 

Department of Health and Human 

Services. 

ACTION: Final rule. 

SUMMARY: The National Institutes of 

Health (NIH) is issuing standards to 

implement provisions of the 

Chimpanzee Health Improvement, 

Maintenance, and Protection Act 

(CHIMP Act) authorizing the Secretary 

of the Department of Health and Human 

Services (HHS) to develop and publish 

standards of care for chimpanzees held 

in the sanctuary system supported by 

federal funds authorized under the 

CHIMP Act. This regulation applies to 

only those facilities receiving federal 

funds as a part of the federally funded 

chimpanzee sanctuary system. 

DATES: This final rule is effective on 

November 10, 2008. The incorporation 

by reference listed in the rule is 

approved by the Director of the Federal 

Register as of November 10, 2008. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Moore, NIH Regulations Officer, Office 

of Management Assessment, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 601, MSC 7669, 

Rockville, Maryland 20892, or 

telephone 301–496–4607 (not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: On 

December 20, 2000, the United States 

Congress enacted the Chimpanzee 

Health Improvement, Maintenance, and 

Protection Act of 2000 (Pub. L. 106–551, 

‘‘CHIMP Act’’). Section 1 of this law 

amended the Public Health Service 

(PHS) Act by adding section 481C (42 

U.S.C. 287a–3a). Section 481C 

authorizes the Secretary to provide for 

the establishment and operation of a 

sanctuary system to provide for the 

lifetime care of chimpanzees that have 

been used, or were bred or purchased 

for use, in research conducted or 

supported by the National Institutes of 

Health (NIH), the Food and Drug 

Administration (FDA), the Centers for 

Disease Control and Prevention (CDC), 

or other agencies of the Federal 

Government, and with respect to which 

it has been determined by the Secretary 

that the chimpanzees are not needed for 

such research (i.e., surplus 

chimpanzees). 

Section 481C(d) directs the Secretary 

to establish, by regulation, standards of 

care for operating the sanctuary system 

to provide for the permanent retirement 

of surplus chimpanzees. These 

standards of care for chimpanzees must 

ensure the well-being of the animals and 

the health and safety of the animals and 

the people caring for them. On April 5, 

2001, the Secretary delegated to the 

Director, NIH, authorities to establish 

and operate the sanctuary system. 

Subsequently, the Director, NIH, 

delegated the authorities to the National 

Center for Research Resources (NCRR). 

Consequently, NCRR has the lead 

responsibility for coordinating all efforts 

on behalf of the Department of Health 

and Human Services (HHS) concerning 

the sanctuary system for surplus 

chimpanzees from both Federal and 

non-Federal sources. Section 481C(e) 

authorizes the Secretary to make an 

award of a contract to a private 

nonprofit entity (i.e., Sanctuary 

Contractor) under which the entity has 

the responsibility of operating (and 

establishing, as applicable) the 

sanctuary system and awarding 

subcontracts to individual sanctuary 

facilities that meet established 

standards. The NCRR/NIH must approve 

both contractor and subcontractor 

awards and NCRR/NIH will verify 

contractor and subcontractor (if 

applicable) qualifications through 

facility site visits, review of written 

documentation submitted to the 

contractor, and evaluation of available 

and current resources. 

The NCRR/NIH will ensure 

compliance with the standards of care 

regulation through site visits (at least 

annually or more often if necessary), 

review of quarterly and annual reports, 

and any other measures deemed 

appropriate by the NCRR/NIH Project or 

Contracts Officer. Noncompliance with 

these standards or any other federal or 

state regulations may result in the 

NCRR/NIH invoking the provisions of 

the contract that allows the Government 

to terminate the contract and/or provide 

a management team to bring the 

sanctuary back into compliance. The 

sanctuary is covered by the Animal 

Welfare Regulations only if covered 

activities are performed. The CHIMP 

Act requires compliance with the 

Animal Welfare Act and the Federal 

contract and this regulation requires the 

Sanctuary Contractor to register with the 

United States Department of Agriculture 

(USDA) and agree to compliance 

inspections. Therefore, the USDA 

Inspectors responsible for enforcing the 

Animal Welfare Regulations will 

perform inspections for compliance 

with the Animal Welfare Regulations at 

a frequency and time determined by the 

USDA staff. Once the contractor 

becomes a Registered or licensed 

Facility, the USDA will report 

noncompliance to NCRR/NIH as 

appropriate. The NCRR/NIH 

representative will review USDA 

inspection reports during on-site visits 

in order to monitor compliance with 

these final standards of care regulation. 

The sanctuary must also adhere to U.S. 

Public Health Service Policy on the 

Humane Care and Use of Laboratory 

Animals. If and when any noninvasive 

studies allowed under the CHIMP Act 

and this regulation are proposed for 

chimpanzees in the sanctuary, the 

Sanctuary Contractor must obtain an 

Animal Welfare Assurance from the NIH 

Office of Laboratory Animal Welfare 

(OLAW) and comply with the 

provisions of the policy. Finally, the 

sanctuary must obtain accreditation or 

certification by a nationally or 

internationally recognized body that 

performs such services. The sanctuary 

must achieve accreditation or 

certification within a reasonable period 

of time as determined by NCRR/NIH. In 

preparing these final standards of care, 

we considered the recommendations of 

the Board of Directors of the Sanctuary 

Contractor and the NCRR Chimpanzee 

Sanctuary Working Group and the 

applicable recommendations of the 

National Research Council made in its 

1997 report entitled, ‘‘Chimpanzees in 

Research—Strategies for Their Ethical 

Care, Management, and Use.’’ 

Individuals involved in developing 

recommendations from these groups 

represented a variety of professional 

areas including, veterinary medicine, 

chimpanzee behavior, animal 

protection, facility management, and 

nonhuman primate research and care. 

We also consulted other publications, 

including: The Guide for the Care and 

Use of Laboratory Animals, published 

by the National Research Council (NRC), 

The Psychological Well-Being of 

Nonhuman Primates, also an NRC 

publication; the Public Health Service 

Policy on Humane Care and Use of 

Laboratory Animals; the accreditation 

guidelines used by the Association for 

the Assessment and Accreditation of 

Laboratory Animal Care, International, 

and the American Zoological and 

Aquarium Association; and the USDA 

Animal Welfare Regulations codified in 

various parts of title 9, chapter 1, 

Subchapter A of the Code of Federal 

Regulations (CFR). 

We are amending title 42 of the CFR 

by adding a new part 9 to establish 


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standards for operating the sanctuary 

system to provide for the permanent 

retirement of surplus chimpanzees. 

These standards of care apply to only 

the sanctuaries that are a part of the 

federally funded chimpanzee Sanctuary 

system. This final rule specifies the 

scope and specific standards that must 

be met by all contractors (primary or 

subcontractors) operating under the 

federally supported chimpanzee 

sanctuary system. 

We announced our intention to issue 

the standards of care in the notice of 

proposed rulemaking (NPRM), 

‘‘Standards of Care for Chimpanzees 

Held in the Federally Supported 

Chimpanzee Sanctuary System,’’ that 

we published in the Federal Register of 

January 11, 2005 (70 FR1843–1858). The 

NPRM provided for a 60-day public 

comment period. In December 2007, the 

CHIMP Act was amended by the 

‘‘Chimp Haven is Home Act’’ (Pub. L. 

110–170), which terminated the 

authority for the removal of 

chimpanzees from the sanctuary system 

for research purposes, although 

noninvasive behavioral studies 

[‘‘noninvasive research’’] as defined 

herein is still permitted on site. 

Conforming amendments have been 

made to the final regulation. 

I. Public Comments—General 

We received 21 responses with 13 

additional signatories (concurrences). 

The commenters generally expressed 

support for the regulation while taking 

the opportunity to comment on specific 

sections and paragraphs. One 

commenter stated the regulation was 

unnecessary because there are adequate 

regulations and policies already 

available to cover the care of 

chimpanzees in the sanctuary. However, 

the commenter expressed support given 

the fact that the regulation is in 

response to the CHIMP Act. Our 

consideration of and responses to the 

comments are discussed as follows. 

Section 9.2 Definitions 

Animal Care and Use Committee 

(Comments) Several commenters 

objected to having a member of an 

animal protection organization (defined 

later in this section) on the committee, 

as set forth in the definition. They stated 

the individual(s) would hamper 

consensus and increase litigation. 

Another commenter noted the definition 

should clearly state that the requirement 

to have a member of an animal 

protection organization on the Animal 

Care and Use Committee (ACUC) is 

unique to this regulation and is not 

required by either the Animal Welfare 

Regulations or the Public Health Service 

Policy on the Humane Care and Use of 

Laboratory Animals. The commenter 

also noted the ACUC must also meet the 

requirements of the PHS Policy if noninvasive research is performed at the 

sanctuary. 

(Response) We have revised the 

definition to indicate that the 

requirement for an animal protection 

organization member on the ACUC is 

unique to this regulation and is not 

required by the Animal Welfare 

Regulations or the Public Health Service 

Policy. 

Animal Protection Organization 

(Comments) Several commenters 

stated the definition allowed animal 

protection organizations to define 

themselves without any requirements 

for training, experience, or proven 

performance. The commenters 

expressed concern that these 

individuals could be appointed to the 

ACUC and the Sanctuary Chimpanzee 

Care Committee (SCCC) despite a lack of 

nonhuman primate/chimpanzee 

experience. 

(Response) The intent of the 

requirement to have a member of an 

animal protection organization is to 

ensure that an animal advocate is on the 

SCCC. The definition in the proposed 

regulation accomplishes that purpose 

and is not changed. A representative of 

such an organization is still required to 

be a member of the ACUC and the 

SCCC. 

Exhibition 

(Comments) Three commenters wrote 

that this definition needed further 

clarification to address visits by large 

groups that could be disruptive to the 

chimpanzees. Also, the commenters 

stated that the definition, as written, 

excludes limited viewing for 

educational purposes. They 

recommended the definition be 

modified to state that exhibition ‘‘does 

not include limited viewing for 

educational purposes.’’ 

(Response) We have modified the 

definition to state that the term 

exhibition ‘‘does not include limited 

viewing for educational purposes that is 

not disruptive to the chimpanzees.’’ 

Federally Owned Chimpanzees 

(Comment) One commenter believed 

the definition should be broadened to 

include chimpanzees leased, loaned, or 

transferred to other biomedical/ 

behavioral research facilities throughout 

the country. 

(Response) We do not agree with the 

commenter on this issue. If we were to 

expand the definition to the extent 

requested, the system would be 

overwhelmed and could not support the 

federally owned chimpanzees as 

currently defined. 

Invasive Research 

(Comment) One commenter noted that 

example 3 seemed to be a routine 

veterinary medical procedure and 

therefore should not be included in the 

definition of invasive research. 

(Response) This example was not 

worded properly in the proposed rule. 

We have changed the example as 

follows: ‘‘(3) Surgery or implantation of 

devices that are not a part of a 

veterinary medical treatment or colony 

management practice.’’ 

(Comment) Another commenter noted 

that darting (example 8) is dangerous for 

chimpanzees and should only be used 

as a last resort for medical or other 

emergencies. The commenter also noted 

that personnel familiar to the 

chimpanzee in question should always 

be present if darting is necessary. 

(Response) We believe the wording in 

this section appropriately addresses 

these issues and that rewording is 

unnecessary. Additionally, we might 

consider in the future incorporating into 

standard operating procedures a 

requirement that a person familiar with 

the chimpanzee be present at the time 

of darting, but not make it a regulatory 

requirement. 

Section 9.3 Sanctuary Policies and 

Responsibilities 

9.3(a)(4): (Comment) One commenter 

suggested this paragraph should read 

‘‘Prohibit any invasive research except 

as outlined in the CHIMP Act, but 

permit noninvasive studies.’’ 

(Response) We have modified the 

wording to incorporate the above 

comment and to reflect the amendment 

of the CHIMP Act in December 2007 by 

the ‘‘Chimp Haven is Home Act,’’ which 

terminated the authority for the removal 

of chimpanzees from the sanctuary 

system for research purposes. 

9.3(a)(5): (Comments) Three 

commenters felt only educational 

viewing through camcorders or 

nonintrusive electronic means should 

be allowed. Additionally, they stated 

the visitor centers should be located 

away from the chimpanzees so they 

would not disrupt the chimpanzees’ 

daily lives. Another individual stated 

that limited viewing should be defined. 

Another commenter stated facility 

design must include cameras to 

minimize the impact of visitors. 

(Response) We do not agree the 

regulation should require facilities to 

install cameras. We believe the 

sanctuary staff should have the 


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flexibility to choose the technology 

needed to eliminate or reduce the 

impact of visitors on the chimpanzees. 

We agree that any visitor center 

associated with the sanctuary should be 

located in a manner that does not 

disrupt the chimpanzees’ routine 

activities. Therefore, we have revised 

this paragraph to end with the phrase, 

‘‘that does not adversely affect the 

chimpanzees’ routine.’’ 

9.3(a)(7)(v): (Comments) Two 

commenters noted there are many 

Animal Protection Organizations (APOs) 

that focus on animal welfare, farm 

animals, endangered species, etc., and 

recommended that the individual 

represent an animal advocacy group 

with specific experience and expertise 

for advocacy for chimpanzees. One 

Commenter proposed the APO position 

be a rotating one (every three years) 

from a reputable sanctuary with 

experience in the care of chimpanzees 

formerly used in research. Two 

commenters stated there was no good 

reason to provide for an ill-defined APO 

member on the SCCC. 

(Response) We disagree that the 

restrictions noted by the five 

commenters should be included in this 

regulation. They are too restrictive and 

would likely limit the ability of the 

Sanctuary to attract a representative that 

satisfies the needs of their program. 

9.3(a)(vi)(B): (Comments) Two 

commenters wrote that no program 

should be approved that interferes with 

the chimpanzees’ well-being. 

(Response) We agree. We have revised 

the sentence to remove that statement. 

9.3(7)(vi)(E): (Comments) One 

commenter stated there is a need to 

clarify the conditions under which the 

SCCC might function as an Animal Care 

and Use Committee. This commenter 

also questioned who appoints the 

members and evaluates the SCCC 

reports. One commenter noted if the 

ACUC reviews noninvasive study 

proposals, it must be constituted in 

accordance with the provisions of the 

PHS policy and the Animal Welfare 

Regulations (AWR). The same 

commenter suggested that anesthesia, 

euthanasia, and review of study 

proposals be addressed in separate 

paragraphs since study proposals must 

be reviewed by a PHS/AWR-sanctioned 

ACUC. 

(Response) We agree with the 

commenters that further clarification is 

needed to address the comments raised. 

We have revised 9.3(a)(vi)(E) to effect 

the desired clarifications, and we have 

added a new paragraph 9.3(a)(vi)(F) to 

address anesthesia and euthanasia. 

9.3(a)(8): (Comments) Two 

Commenters strongly supported the rule 

requiring the prevention of reproduction 

in the sanctuary. They noted that 

offspring born in the sanctuary should 

remain with the mother until they are at 

least 4 years old; and offspring born in 

the sanctuary should belong to the 

sanctuary, not the Federal Government. 

(Response) The length of time that 

offspring stay with the mother should be 

addressed in sanctuary operating policy 

based upon best available information 

rather than in the regulation. We agree 

that the sanctuary should retain 

ownership of offspring born there. 

Therefore, we have amended 9.5(a) 

(Chimpanzee ownership, fees, and 

studies) to add a statement to that effect. 

9.3(a)(9): (Comment) One commenter 

stated chimpanzees should not be 

discharged from the Sanctuary for any 

reason. 

(Response) In December 2007, the 

Chimp Act was amended by the 

‘‘CHIMP Haven is Home Act,’’ which 

terminated the authority for the removal 

of chimpanzees from the sanctuary 

system for research purposes. 

9.3(a)(10): (Comments) Two 

commenters felt chimpanzees that are 

seropositive for, harbor, or have been 

exposed to infectious diseases should be 

socially housed with other chimpanzees 

that have a similar profile. One 

commenter indicated that the 

behaviorist should have experience 

working with chimpanzees with such 

exposures as well as disabled and old 

chimpanzees. 

(Response) We appreciate the 

comments. However, we believe the 

issues raised are adequately covered 

under this section and, as written, the 

section allows the sanctuary to develop 

innovative ways to address these issues. 

9.3(a)(11): (Comments) One 

commenter proposed the guidelines 

developed for accepting chimpanzees 

not owned by the Federal Government 

should be published for public 

comment. 

(Response) We disagree. The CHIMP 

Act left this process to the Sanctuary 

Board of Directors with oversight from 

the Secretary, HHS. There was no 

requirement that guidelines for 

acceptance of non-government-owned 

chimpanzees be published for public 

comment. 

9.3(a)(12) and (13): (Comments) Two 

commenters stated the location and 

numbering of this section implies that 

the Board of Directors (BOD) is 

subservient to the SCCC. They also 

suggested that we show the lines of 

authority from the BOD and the SCCC. 

(Response) We agree the numbering 

and wording implies the Sanctuary BOD 

reports to the Sanctuary SCCC. This is 

not the case. We have corrected this 

error in the final regulation. 

9.3(a)(13)(ii): (Comment) One 

commenter indicated that we should 

consider seeking input from persons 

who are experts on chimpanzees in the 

wild not just behavioral experts for 

captive chimpanzees. This description 

of behaviorist was paraphrased from the 

CHIMP Act and, as written, does not 

exclude a person with experience in the 

behavior of chimpanzees in the wild. 

We have decided not to change this 

paragraph. 

9.3(a)(13)(iii): (Comments) One 

commenter expressed strong support for 

including a member of an animal 

protection organization (APO) on the 

SCCC and indicated that the 

organization represented should have 

demonstrated advocacy for 

chimpanzees. Two commenters believed 

the inclusion of representation from an 

APO would be counterproductive and 

should not be mandatory. 

(Response) We consider the 

representation of an APO on the SCCC 

appropriate. The Sanctuary Director, 

with the approval of the Board of 

Directors, will select the APO 

representative with the mission of the 

sanctuary in mind. 

9.3(a)(13)(iv): (Comment) One 

commenter suggested that a sentence be 

added indicating that any chimpanzee 

removed from the Sanctuary for 

invasive research in accordance with 

the CHIMP Act must be placed in a 

PHS-assured facility. 

(Response) In December 2007, the 

CHIMP Act was amended by the 

‘‘Chimp Haven is Home Act,’’ which 

terminated the authority for the removal 

of chimpanzees from the sanctuary 

system for research purposes. Therefore, 

this paragraph was deleted in the final 

rule. 

9.3(a)(14): (Comments) Two 

commenters stated that chimpanzees 

should not be removed from the 

sanctuary for any reason. One 

commenter further expressed support 

for the public comment period and 

stated that it should be extended from 

60 to 90 days. 

(Response) In December 2007, the 

CHIMP Act was amended by the 

‘‘Chimp Haven is Home Act,’’ which 

terminated the authority for the removal 

of chimpanzees from the sanctuary 

system for research purposes. Therefore 

this paragraph was deleted in the final 

rule. 

Section 9.4 Physical Facility Policy 

and Design 

(Comments) One commenter stated 

strong support for the language present 

in the regulation that considers the 


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psychological and behavioral well-being 

and the social needs of all chimpanzees 

transferred from the laboratories. The 

commenter also indicated the regulation 

should require that chimpanzees 

formerly living in groups should not be 

sent to the Sanctuary without members 

of that group. Also, volunteer staff 

should not be allowed contact with any 

chimpanzees until after a six-month 

training period in order to maintain 

stable human interaction. 

(Response) We agree that the 

psychological well-being and social 

needs of the chimpanzees are important 

considerations and have retained 

language in the regulation that considers 

the psychological well-being and social 

needs of all chimpanzees transferred 

from the laboratories. However, to 

include provisions in the regulation that 

would require that all chimpanzees 

residing in a group be sent to the 

Sanctuary together would be overly 

restrictive to the operations of the 

Sanctuary. Mandating a six-month 

training period for volunteers also 

restricts the administrative discretion of 

the staff to determine when a volunteer 

is properly trained and when access to 

the chimpanzees is appropriate. 

(Comment) One commenter strongly 

supported the need to provide a facility 

with sufficient space for chimpanzees to 

engage in a full range of species-specific 

activities. 

(Response) We agree. The regulation 

as written requires such space. 

(Comments) Three commenters noted 

that the passage ‘‘the safe and sanitary 

equipment for both the chimpanzees 

and their human counterparts’’ was 

duplicative. 

(Response) We agree and have 

removed the redundant sentence. 

(Comment) One commenter objected 

to simply stating ‘‘the floor must not be 

slippery’’ because some areas may be 

inherently slippery. The commenter 

suggested that we change the wording to 

state ‘‘the floor must not be dangerously 

slippery.’’ 

(Response) We believe that 9.4(a)(ii) 

necessitates that the enclosure ‘‘prevent 

escape and injury to the chimpanzees’’. 

Therefore, phrasing regarding the 

slipperiness of the floor is redundant 

and has been removed. 

(Comment) One commenter indicated 

it was unnecessary to limit the 

sanctuary system to a particular climate 

because there are successful 

chimpanzee sanctuaries in varying 

climates. 

(Response) We believe that 9.4 

necessitates indoor and outdoor 

enclosures that permit natural activities 

of chimpanzees. Climate is therefore 

incorporated into the expectation of 

natural activities. 

(Comments) Three commenters 

indicated that the use of strong chain 

link fencing with curved barbed wire is 

not a barrier to chimpanzees and it 

should be deleted as an example. 

(Response) We agree. We have 

removed this example from the final 

regulation. 

(Comments) Two commenters stated 

that space heaters should not be used 

for closed, indoor quarters because they 

can lead to fires or other health hazards. 

One commenter stated that support for 

this regulation depends upon the indoor 

and outdoor housing areas providing 

temperatures that are comfortable for 

chimpanzees; outdoor areas providing 

shelter to escape extreme temperatures, 

if necessary; and the sanctuary 

providing mechanical systems to 

achieve these goals. 

(Response) We believe the regulation 

as written sufficiently addresses the 

concerns expressed by the commenter. 

We have revised the text to eliminate 

the reference to space heaters. Methods 

of providing for the comfort of the 

chimpanzees will likely vary depending 

upon the location of the facility. 

Section 9.5 Chimpanzee Ownership, 

Fees, and Studies 

9.5(a): (Comment) One commenter 

stated that the ownership of all 

chimpanzees in the federally supported 

sanctuary should belong to the 

sanctuary, not just the non-Governmentowned ones. 

(Response) The CHIMP Act 

specifically sets forth the requirement to 

transfer the title for non-Governmentowned 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 nonGovernment-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, 


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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’ wellbeing. 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 semitropical 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 lifethreatening situations and should not be 

used routinely. We have revised the 

section to include the requirement to 

use current acceptable practices that do 


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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. 


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(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 Sanctuaryrelated 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 


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


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60418 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

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 manmade 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. 


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


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60420 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

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 


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


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60422 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

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 recordkeeping 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 of 

respondents * 

Annual 

frequency 

Average 

burden 

(hours) 

Annual burden 

hours per 

response 

Reporting: 

§ 9.3(a)(2)(xiv)(F)(3) .................................................................................. 1–3 2 6 12 

§ 9.6(d)(ii) .................................................................................................. 1–3 2 0.5 1 

§ 9.8(a)(4) ................................................................................................. 1–3 4 5 20 

§ 9.12(b) .................................................................................................... 1–3 1 6 6 

Subtotal ............................................................................................. ........................ 9 17.5 39 

Recordkeeping: 

§ 9.3(a)((2)(xiv)(F)(3 ) ............................................................................... 1–3 2 2 4 

§ 9.5(c)(4) .................................................................................................. 1–3 1 2 2 

§ 9.5 (e) ..................................................................................................... 1–3 1 4 4 

§ 9.6(c)(xii) ................................................................................................ 1–3 4 0.1 0.4 

§ 9.6(c)(xii) ................................................................................................ 1–3 1 2 2 

§ 9.6(d)(ii) .................................................................................................. 1–3 4 1 4 

§ 9.7 .......................................................................................................... 1–3 5 2 10 

§ 9.8(a)(1–4) ............................................................................................. 1–3 1 0.5 5 

§ 9.8(b) ...................................................................................................... 1–3 5 2 10 

§ 9.10(a) .................................................................................................... 1–3 12 0.2 2.4 

§ 9.10(b) .................................................................................................... 1–3 3 1.5 4.5 

§ 9.12(b) .................................................................................................... ** 1–3 1 3 3 

Subtotal ............................................................................................. ........................ 40 20.3 51.3 

Disclosure: 

§ 9.3(a)(2)(vii) (F)(8) ................................................................................. 1–3 6 0.5 3 

§ 9.4(c) ...................................................................................................... 1–3 1 1 1 

§ 9.5 (c) ..................................................................................................... 1–3 1 0.1 0.1 

§ 9.5(e) ...................................................................................................... 1–3 1 8 8 

§ 9.5(f)(2) .................................................................................................. 1–3 *** 1 2 2 

§ 9.6(c)(xii) ................................................................................................ 1–3 0.2 8 1.6 

§ 9.6(c)(xiii) ............................................................................................... 1–3 2 2 1 

§ 9.6(d)(ii) .................................................................................................. 1–3 1 1 1 

§ 9.7 .......................................................................................................... 1–3 5 2 10 

§ 9.10(a) .................................................................................................... 1–3 10 0.2 2 

§ 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. 


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

■ 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. 

§ 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. 

§ 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 wellbeing 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 


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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; 


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(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 speciesappropriate 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. 

§ 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 speciesappropriate 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 § 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 


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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 § 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. 

§ 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 


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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 manmade 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). 

§ 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. 

§ 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 § 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 § 9.4). 


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(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 § 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 § 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 cageside 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 


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Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 60429 

appropriate counseling and 

psychological support shall be 

considered. 

§ 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. 

§ 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. 

§ 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. 

§ 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 


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60430 Federal Register / Vol. 73, No. 198 / Friday, October 10, 2008 / Rules and Regulations 

sanctuary staff is fully aware of the 

health condition of the arriving 

chimpanzee. The records may be 

created and retained in electronic form. 

§ 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. 

§ 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). 

§ 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 


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