Announcement of Agency Decision: Recommendations on the Use of Chimpanzees in NIH-Supported Research, 39741-39757 [2013-15791]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39741-39757]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of Agency Decision: Recommendations on the Use of 
Chimpanzees in NIH-Supported Research

SUMMARY: This notice announces the responses to public comments and 
decisions of the National Institutes of Health (NIH) regarding the use 
of chimpanzees in research. In February 2012, the NIH charged a working 
group of the Council of Councils, a federal advisory committee, to 
provide advice on implementing recommendations made by the Institute of 
Medicine (IOM) Committee on the Use of Chimpanzees in Biomedical and 
Behavioral Research in its 2011 report, Chimpanzees in Biomedical and 
Behavioral Research: Assessing the Necessity. On January 22, 2013, the 
NIH Council of Councils (Council) accepted recommendations presented by 
the Working Group on the Use of Chimpanzees in NIH-Supported Research 
and provided these recommendations to the NIH. The NIH subsequently 
issued a request for comments to obtain broad public input on the 28 
Council recommendations that the NIH is considering as it determines 
how to implement the IOM Committee's recommendations. This notice 
summarizes the comments received in response to the request for 
comments and announces the agency's decisions with respect to the 
Council recommendations. The NIH plans to prepare subsequent procedural 
guidance and technical assistance, as appropriate, to implement some of 
these decisions. Investigators should continue to follow existing 
guidance (see NOT-OD-12-025 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-025.html) regarding the submission of 
applications, proposals, or protocols for research involving 
chimpanzees until the NIH announces the procedural guidance.

FOR FURTHER INFORMATION CONTACT: The Division of Program Coordination, 
Planning, and Strategic Initiatives, Office of the Director, National 
Institutes of Health at dpcpsi@od.nih.gov.

SUPPLEMENTARY INFORMATION: 

Background

    The use of animals in biomedical and behavioral research has 
enabled scientists to identify new ways to treat illness, extend life, 
and improve health and well-being. Chimpanzees are our closest 
relatives in the animal kingdom, providing exceptional insights into 
human biology and requiring special consideration and respect. Although 
used very selectively and in limited numbers for biomedical research, 
chimpanzees have served an important role in advancing human health. 
However, new methods and technologies developed by the biomedical 
research community have provided alternatives to the use of chimpanzees 
in several areas of research.
    In December 2010, the National Institutes of Health (NIH) 
commissioned a study by the Institute of Medicine (IOM) to assess 
whether chimpanzees are or will be necessary for NIH-funded biomedical 
and behavioral research. On December 15, 2011, the IOM Committee on the 
Use of Chimpanzees in Biomedical and Behavioral Research (IOM 
Committee) issued its findings along with a primary recommendation that 
a set of principles and criteria guide

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the use of chimpanzees in biomedical and behavioral research in its 
report, Chimpanzees in Biomedical and Behavioral Research: Assessing 
the Necessity (https://iom.edu/Reports/2011/Chimpanzees-in-Biomedical-and-Behavioral-Research-Assessing-the-Necessity.aspx). The three 
principles that the IOM Committee proposed to assess the use of 
chimpanzees in current and potential future biomedical and behavioral 
research supported by the NIH were:
    1. The knowledge gained must be necessary to advance the public's 
health;
    2. There must be no other research model by which the knowledge 
could be obtained, and the research cannot be ethically performed on 
human subjects; and
    3. The animals used in the proposed research must be maintained 
either in ethologically appropriate physical and social environments or 
in natural habitats.
    The IOM Committee also developed two separate sets of criteria for 
assessing the necessity of using chimpanzees for biomedical research 
and for comparative genomics and behavioral research. Based on its 
deliberations, the IOM Committee concluded that, ``While the chimpanzee 
has been a valuable animal model in past research, most current use of 
chimpanzees for biomedical research is unnecessary . . .''
    The IOM Committee considered case studies of current chimpanzee use 
in research to provide examples of its vision for applying its 
criteria. Based on these case studies, the IOM Committee concluded that 
the use of chimpanzees might continue to be required for some ongoing 
research on monoclonal antibody therapies; comparative genomics; and 
social and behavioral factors that affect the development, prevention, 
or treatment of disease. The IOM Committee was unable to reach 
consensus on the necessity of using chimpanzees to develop a 
prophylactic hepatitis C virus vaccine. It also acknowledged that new, 
emerging, or reemerging diseases could present challenges that might 
require the use of chimpanzees.
    In December 2011, the NIH accepted the recommendations in the IOM 
Committee's report (https://www.nih.gov/news/health/dec2011/od-15.htm) 
and issued an interim agency policy in notice NOT-OD-12-025 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-025.html). This 
notice indicated that the NIH would not fund any new or other competing 
projects (renewal and revisions) for research involving chimpanzees and 
would not allow any new projects to go forward with NIH-owned (i.e., 
chimpanzees directly owned by the agency) or -supported research 
chimpanzees (i.e., chimpanzees not owned by the NIH but supported 
through NIH awards, such as grants and contracts). However, the NIH 
permitted currently funded research involving chimpanzees to continue. 
The policy remains in effect until the NIH issues a future notice in 
the NIH Guide for Grants and Contracts regarding research applications, 
proposals, and protocols requesting to use chimpanzees in accordance 
with the IOM Committee's recommendations.
    The NIH established the Working Group on the Use of Chimpanzees in 
NIH-Supported Research (Council Working Group) within the Council of 
Councils, a federal advisory committee, on February 1, 2012, to provide 
advice on implementing the IOM Committee's recommendations and to 
consider the size and placement of the active and inactive populations 
of NIH-owned or -supported research chimpanzees. Research-active 
chimpanzees are currently used for research, whereas research-inactive 
chimpanzees are not currently used in research protocols but might be 
used for new projects that meet the IOM principles and criteria. The 
NIH charged the Council Working Group with: (1) Developing a plan for 
implementation of the IOM's guiding principles and criteria, (2) 
analyzing currently active NIH-supported research using chimpanzees to 
advise on which studies currently meet the principles and criteria 
defined by the IOM report and advising on the process for closing 
studies if any do not comply with the IOM recommendations, (3) advising 
on the size and placement of active and inactive populations of NIH-
owned or -supported chimpanzees that may need to be considered as a 
result of implementing the IOM recommendations, and (4) developing a 
review process for considering whether potential future use of the 
chimpanzee in NIH-supported research is scientifically necessary and 
consistent with the IOM principles.
    In developing its recommendations, the Council Working Group 
considered the scientific use of chimpanzees in research currently 
supported by the NIH and public comments received in response to a 
previous request for information (see summary at https://dpcpsi.nih.gov/council/working_group.aspx#Summary) in NOT-OD-12-052 (https://grants.nih.gov/grants/guide/notice-files/not-od-12-052.html) dated 
February 10, 2012, and a Federal Register notice dated February 23, 
2012 (https://www.gpo.gov/fdsys/pkg/FR-2012-02-23/pdf/2012-4269.pdf); 
obtained advice from external experts; and visited several facilities 
that house and care for chimpanzees. The Council Working Group's 
efforts culminated in a report containing 28 recommendations, available 
at https://dpcpsi.nih.gov/council/pdf/FNL_Report_WG_Chimpanzees.pdf, 
which the group submitted to the NIH Council of Councils on January 22, 
2013. The NIH Council of Councils accepted these recommendations and 
provided them as advice to the NIH on January 22, 2013. The NIH 
subsequently issued a request for comments in the Federal Register, 
available at https://www.gpo.gov/fdsys/pkg/FR-2013-02-05/html/2013-02507.html, and the NIH Guide for Grants and Contracts, available at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-026.html, to 
obtain broad public input on the 28 Council recommendations.

Public Comments, NIH Responses to These Comments, and NIH Decisions 
Regarding the Council Recommendations

    This section lists the recommendations made by the Council of 
Councils, summarizes the public comments that the NIH received, and 
provides the agency's responses and decisions with respect to the 
recommendations. More than 12,500 individuals submitted comments in 
response to the request for comments issued in the NIH Guide for Grants 
and Contracts and the Federal Register. The discussion of comments 
below provides an overview of responses received during the public 
comment period and is not intended to capture the details of every 
comment. Responses received during the public comment period are 
available for public inspection at the NIH On-site FOIA Library, 
Building 31, Room 5B35, 9000 Rockville Pike, Bethesda, MD 20892, which 
is open 10:00 a.m. to 4:00 p.m. Monday through Friday and is closed on 
federal holidays. Those who plan to view the records must contact the 
NIH Freedom of Information Office at nihfoia@mail.nih.gov in advance.

A. Ethologically Appropriate Physical and Social Environments

    Throughout its report, the IOM Committee used the term 
``ethologically appropriate physical and social environments'' as a 
central principle for housing research-active and research-inactive 
chimpanzees. Because the IOM did not define this term, the Council 
defined ``ethologically appropriate physical and social environments'' 
as

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``captive environments that do not simply allow but also, importantly, 
promote a full range of behaviors that are natural for chimpanzees.'' 
The Council offered 10 recommendations on ethologically appropriate 
physical and social environments. This section provides these 10 
recommendations, a summary of public comments on these recommendations, 
and the NIH responses to the comments and decisions regarding the 
Council recommendations.
    The NIH believes that it is important to describe the guidance 
currently used for the housing and care of NIH-owned or -supported 
research chimpanzees. Facilities housing chimpanzees owned by the NIH 
or used in NIH-supported research must comply with the recommendations 
in the Guide for the Care and Use of Laboratory Animals, Eighth Edition 
(https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf), an internationally accepted primary reference 
on animal care and use whose contents form the foundation for the 
development of comprehensive animal care and use programs. The Guide 
provides: (1) A framework for institutional policies, management, and 
oversight of institutional animal care and use programs; (2) 
recommendations for housing, environmental enrichment, and animal well-
being; (3) recommendations on space and social housing for nonhuman 
primates and the physical characteristics of animal facilities, 
including special facilities for behavioral studies and imaging; and 
(4) guidance on veterinary care and maintaining the health and well-
being of laboratory animals. The Guide also addresses the regulatory 
requirements that govern animal research activities in the United 
States, including the federal Animal Welfare Act and regulations and 
the Public Health Service Policy on Humane Care and Use of Laboratory 
Animals.
    Any Council recommendations accepted by the NIH will not replace 
the body of laws, regulations, and policies that already govern the 
care and housing of the NIH research chimpanzees but, instead, will 
supplement existing policies.
1. Size of Social Groupings (Recommendation EA1)
    Recommendation EA1 states: ``Chimpanzees must have the opportunity 
to live in sufficiently large, complex, multi-male, multi-female social 
groupings, ideally consisting of at least 7 individuals. Unless 
dictated by clearly documented medical or social circumstances, no 
chimpanzee should be required to live alone for extended periods of 
time. Pairs, trios, and even small groups of 4 to 6 individuals do not 
provide the social complexity required to meet the social needs of this 
cognitively advanced species. When chimpanzees need to be housed in 
groupings that are smaller than ideal for longer than necessary, for 
example, during routine veterinary examinations or when they are 
introduced to a new social group, this need should be regularly 
reviewed and documented by a veterinarian* and a primate behaviorist.
    ``*In this context, the Working Group defines a ``veterinarian'' as 
a licensed, graduate veterinarian with demonstrated expertise in the 
clinical care and welfare of nonhuman primates (preferably chimpanzees) 
and who is directly responsible for the routine clinical care of the 
animal(s) in question.''
    Comments: A large number of commenters supported Recommendation 
EA1. Many believed that implementing this recommendation would enable 
facilities to replicate the social environments of chimpanzees in the 
wild or in sanctuaries. Others noted that ethologically appropriate 
housing conditions could make chimpanzees a more valuable research 
model and enhance the validity of results derived from research using 
them by enabling chimpanzees to express more fully species-appropriate 
behaviors.
    Other commenters expressed concern that the Council recommended 
arbitrary standards instead of recommending housing conditions that 
target such outcomes as chimpanzee physical and mental well-being. For 
example, a number of commenters noted that elderly or infirm 
chimpanzees might benefit from long-term housing in smaller groups to 
accommodate their individual medical or social needs.
    A large number of commenters favored social groups of at least 7 
chimpanzees, with rare exceptions for single or pair housing. Some 
stated that 7 chimpanzees might be too few for a social group and 
recommended that group sizes be similar to those in the wild, which, 
according to commenters, include more than 7 chimpanzees. Other 
commenters supported the recommendation to house chimpanzees in groups 
of at least 7 members in theory but indicated that captive chimpanzees 
might not have the complete set of social skills needed to function 
safely in larger groups.
    A few commenters questioned the scientific basis for the 
recommended group size of at least 7 animals. Some stated that the 
average party size of wild chimpanzee groups is more than 7 members. 
Others pointed to studies that document group sizes as small as 3 or 4 
members and recommended that the NIH determine group size based on 
individual chimpanzee behavioral characteristics, existing social group 
composition and compatibility, and the professional judgment of 
chimpanzee behaviorists or veterinarians familiar with the animals. 
These commenters agreed on the importance of achieving a balance 
between the needs of social groupings and individual chimpanzees. Some 
commenters did not support the recommendation to house chimpanzees in 
social groups that have fewer than 7 animals under certain 
circumstances, even with proper documentation of the need for such 
conditions by a veterinarian and primate behaviorist. These commenters 
wanted more details concerning the ``clearly documented medical or 
social circumstances'' and ``extended periods of time'' that would 
warrant smaller group sizes. Others stated that research chimpanzees 
should never be housed singly or in pairs or should never be housed in 
such conditions for more than a week. It was also suggested that 
veterinarians are not sufficiently sensitive to chimpanzees' 
psychological needs to assess their suitability for group versus 
individual housing. A few commenters recommended requiring consultation 
with a behavioral primatologist to determine whether a plan to house 
chimpanzees singly or in pairs is appropriate. Others wondered why the 
Council defined ``veterinarian'' but not ``primate behaviorist'' and 
suggested that the NIH define this term.
    Response: The NIH accepts Recommendation EA1. We agree that 
chimpanzees should have the opportunity to live in sufficiently large 
and complex groups of 7 chimpanzees or more. Unless compelling factors 
prevent social housing, the chimpanzees owned or supported by the NIH 
already live in compatible social groups of varying sizes depending on 
the individual chimpanzee characteristics, the facility, and the nature 
of the research conducted, if any. We also believe that housing 
chimpanzees in larger groups has the potential to offer greater social 
complexity and more environmental stimuli than housing them in smaller 
groups. At the same time, the agency believes that chimpanzee 
facilities should evaluate individual chimpanzees to determine their 
suitability for successful integration into larger social groups. We 
agree with the Council recommendation that facility staff knowledgeable 
about

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chimpanzee well-being (i.e., veterinarians and primate behaviorists) 
are well-positioned to determine a chimpanzee's suitability for group 
versus single housing based on that chimpanzee's best interests. The 
agency disagrees with the comment that veterinarians are not 
sufficiently sensitive to chimpanzees' psychological needs to make such 
determinations.
    The NIH believes that the recommendation is sufficiently flexible 
and permits facilities to adjust the sizes of research chimpanzee 
social groups as necessary, as long as these facilities support any 
downward adjustments with proper documentation and regular reviews by a 
veterinarian and a primate behaviorist. Experts in chimpanzee well-
being, such as primate behaviorists and veterinarians, currently use 
their professional judgment to balance the needs of individual 
chimpanzees with those of chimpanzee social groups. The agency expects 
that facilities will continue to do so.
    In the context of this recommendation, the NIH defines a ``primate 
behaviorist'' to include a behavioral scientist knowledgeable in 
primate behavior and socialization requirements.
2. Primary Living Space and Climbing Height (Recommendations EA2 and 
EA4)
    Recommendation EA2 states: ``The density of the primary living 
space of chimpanzees should be at least 1,000 ft\2\ (93 m\2\) per 
individual. Therefore, the minimum outdoor enclosure size for a group 
of 7 animals should be 7,000 ft\2\ (651 m\2\).''
    Comments: A large number of commenters who discussed Recommendation 
EA2 supported this recommendation. Some commenters emphasized that the 
amount of space recommended is the minimum area needed, and larger 
enclosures that more closely replicate the amount of space available to 
chimpanzees in the wild (suggestions ranged from 2,000 ft\2\ to several 
acres) are preferable. Other commenters encouraged the NIH to identify 
data in the scientific literature on the appropriate area for 
chimpanzee housing.
    In contrast, several commenters argued that the recommended 1,000 
ft\2\ area is arbitrary and unnecessary, is not based on or is contrary 
to the published literature, and does not accurately reflect the 
opinions of some of the experts consulted by the Council Working Group. 
Several commenters pointed out that certain publications cited by the 
Council Working Group pertain to gorillas or to spaces smaller than 
1,000 ft\2\. In the absence of sufficient supporting scientific 
evidence, these commenters did not believe that larger housing 
environments would improve chimpanzee well-being. Others suggested that 
rather than establishing minimum space requirements, the NIH should 
consider the complexity and quality of the environment, including the 
opportunity for chimpanzees to take temporary refuge from other members 
of their group.
    Commenters also expressed concerns about whether any facility could 
meet the proposed space recommendation; some asserted that the federal 
sanctuary system does not provide this amount of space to all of its 
chimpanzees. In general, these commenters were concerned that the 
recommendation would set a bar that is too high for research facilities 
to meet as a way to ban the use of chimpanzees in NIH-supported 
research. A suggestion was that research facilities might satisfy this 
recommendation by rotating chimpanzees between smaller and larger 
enclosures every few weeks.
    Several commenters, including some who supported the 
recommendations on ethologically appropriate environments and some who 
did not, were concerned about the construction costs for facilities to 
comply with the recommendation and the recommendation's inflexible 
specifications. A few commenters suggested tactics to minimize the 
costs of upgrading primate research facilities, including adapting 
current facilities so that they could be used as sanctuaries at a later 
time. Others suggested expanding the existing federal sanctuary system, 
arranging with other existing sanctuaries to house NIH-owned 
chimpanzees, or moving all NIH-owned chimpanzees to privately owned 
locations rather than NIH-supported institutions.
    Response: The NIH does not accept Recommendation EA2. Although the 
NIH agrees that sufficient square footage is needed for chimpanzees to 
travel, patrol, coexist in social groups of 7 or more members, and 
sometimes separate from others, the agency is concerned about the lack 
of scientific consensus on the recommended square footage and is 
especially concerned about whether the published literature supports 
1,000 ft\2\ per chimpanzee. We agree that the scientific literature on 
ethologically appropriate physical and social environments for captive 
chimpanzees appears to be scant. However, determining the appropriate 
housing space density is important because, according to this 
recommendation, the amount of space should increase linearly with the 
number of chimpanzees housed in the area (see Recommendation EA2) and 
because spaces of this size might be costly to construct. We also note 
that the Association of Zoos and Aquariums (AZA) and the Global 
Federation of Animal Sanctuaries recommend space densities that differ 
from each other and from the one in Recommendation EA2. In addition, 
the area recommended by these other groups does not scale linearly with 
the number of chimpanzees.
    We agree with commenters that constructing spaces offering 1,000 
ft\2\ per chimpanzee might be difficult and costly and would likely 
require substantial government funding. We appreciate the examples 
given of alternative ways to provide the recommended square footage, 
such as rotating chimpanzees into larger enclosures on a regular basis, 
and other suggestions to conserve costs.
    We recognize the diligence of the Council Working Group in defining 
and recommending parameters for the new concept of ``ethologically 
appropriate.'' However, because of concerns about the scientific basis 
for this recommendation and the expected costs of implementing it, the 
agency will review the space density requirements with respect to the 
promotion of species-appropriate behavior.
    Recommendation EA4 states: ``Chimpanzees should have the 
opportunity to climb at least 20 ft. (6.1 m) vertically. Moreover, 
their environment must provide enough climbing opportunities and space 
to allow all members of larger groups to travel, feed, and rest in 
elevated spaces.''
    Comments: A large number of commenters who responded to this topic 
agreed with Recommendation EA4. A few commenters indicated that the NIH 
should provide natural climbing structures (e.g., trees) that allow 
more than 1 chimpanzee to climb or descend at the same time and to rest 
on multiple tiers of the structures. Others suggested that the NIH 
specify the types of climbing structures that facilities must provide 
(e.g., trees, playground equipment, ropes, and vines) and require 
facilities to place climbing structures far enough from walls to 
prevent chimpanzees from jumping out of open-air housing areas.
    Other commenters expressed concern that this recommendation was too 
specific, research supporting the 20 ft. climbing height is lacking, 
and the published literature cited by the Council Working Group 
supports structures that are closer to 10 ft. than 20 ft. high.

[[Page 39745]]

Others noted that the ideal climbing height should depend on the 
habitat, which varies among chimpanzees in the wild (i.e., forest-
dwelling chimpanzees spend more time off the ground than those living 
in savanna or woodland environments). These commenters and others 
encouraged the NIH to require facilities to provide climbing 
opportunities that promote species-specific behavior and accommodate 
the needs of individual chimpanzees, including physically challenged 
chimpanzees that require lower structures, rather than attempting to 
replicate specific aspects of forested environments.
    Response: The NIH accepts Recommendation EA4. The recommended 
structures offer environmental complexity and encourage species-
appropriate behaviors, including foraging, nesting, ranging, 
interacting, exercising, and separating from social groups. The NIH 
disagrees with commenters' suggestion to reduce or remove the 
recommended climbing height or not to require facilities to provide 
climbing opportunities. Although some chimpanzees in savanna or 
woodland environments might not have access to natural structures that 
are 20 ft. high, implementing this recommendation will provide 
opportunities for species-appropriate behavior, environmental 
complexity, and interacting with or separating from group members. The 
agency notes that some facilities already offer apparatus that is at 
least 20 ft. high for certain populations of captive chimpanzees.
3. Environmental Complexity, Nutrition, and Enrichment (Recommendations 
EA3, EA5-7)
    Recommendation EA3 states: ``Chimpanzees must be housed in 
environments that provide outdoor access year round. They should have 
access to natural substrates, such as grass, dirt, and mulch, to 
enhance environmental complexity.''
    Comments: A large number of commenters on Recommendation EA3 agreed 
with it or stated that its provisions serve as minimum requirements. 
Many indicated that natural substrates mimic wild conditions. A 
suggestion was to conduct research on the optimal composition of the 
natural substrates. Others indicated that using more durable synthetic 
materials instead of natural substrates could enhance environmental 
complexity.
    Some commenters believed that the recommendation does not 
adequately address key elements of chimpanzees' natural environment, 
including trees, rocks, fresh water, and structures for exercise. 
Others argued that the NIH should also require facilities to provide 
shelter from the outdoors, access to sleeping dens, and the freedom to 
move to and from an indoor enclosure. Some noted that chimpanzees 
accustomed to artificial substrates, such as concrete floors, might not 
be comfortable with natural substrates and might need an acclimation 
period to become accustomed to the new environment. A few commenters 
wondered why the Council Working Group did not recommend dome-type 
structures, noting that the IOM Committee had described these 
structures as ethologically appropriate. Others expressed concern that 
this recommendation prohibits the use of synthetic structures and 
material.
    Response: The NIH accepts Recommendation EA3 and believes that 
research chimpanzees need year-round access to natural substrates and 
the outdoors to enhance their environmental complexity. We believe that 
the recommendation does not need to list all possible natural 
substrates because such a list could not be exhaustive and would be 
unnecessarily prescriptive. We do not interpret the recommendation as 
precluding the use of synthetic materials (e.g., non-natural flooring) 
and structures (e.g., geodesic domes) but, instead, as ensuring that 
chimpanzees have access to various natural substrates intended to 
enhance their environment. The agency believes that Recommendation EA3 
does not prevent facilities from accommodating the needs of chimpanzees 
that are accustomed to concrete flooring and have had limited prior 
exposure to natural substrates.
    The NIH interprets this recommendation as calling for outdoor 
access without excluding the provision of indoor space. The NIH already 
requires facilities housing NIH research chimpanzees to comply with the 
Guide for the Care and Use of Laboratory Animals, Eighth Edition 
(https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf) and the federal Animal Welfare Act and 
regulations. These standards require that facilities provide 
appropriate sheltered housing facilities necessary to protect the 
animals from extreme weather and to provide for their health and well-
being.
    Recommendation EA5 states: ``Progressive and ethologically 
appropriate management of chimpanzees must include provision of 
foraging opportunities and of diets that are varied, nutritious, and 
challenging to obtain and process.''
    Comments: Commenters generally supported Recommendation EA5. 
However, some commenters believed that the NIH should specify the 
frequency of feeding and types of food that facilities must provide, 
require facilities to feed chimpanzees a diet that is natural or 
tailored to their health needs, and make all necessary nutrients 
available. Others recommended specific strategies for ensuring that 
chimpanzees are challenged when they collect food.
    Response: The NIH accepts Recommendation EA5 and disagrees with the 
requested changes to this recommendation. We believe that dictating 
types of food, nutrients, feeding modalities, and feeding frequency for 
research chimpanzees would be overly prescriptive. Facilities that 
house research chimpanzees are in the best position to understand the 
specific health and dietary needs and preferences of the chimpanzees 
they house.
    Recommendation EA6 states: ``Chimpanzees must be provided with 
materials to construct new nests on a daily basis.''
    Comments: A large number of commenters who responded to this topic 
agreed with this recommendation. Some believed that the NIH should 
specify the types of materials that facilities should make available 
and the need to refresh these materials daily. Some identified the 
types of nesting materials, both natural and synthetic (e.g., blankets, 
newspaper, and other nondurable, nontoxic substances), that facilities 
should provide. A suggestion was that the NIH implement this 
recommendation only for chimpanzees that live primarily indoors because 
providing new, daily nesting materials would be unnecessary for 
chimpanzees with unlimited outdoor access. Others were concerned that 
the costs of materials and staff time required to provide new nesting 
materials daily would be prohibitive for facilities. Some commenters 
argued that some of the references cited to support this recommendation 
focused on other nonhuman primates (not chimpanzees) or did not mention 
nesting and that one reference was to a study in which a facility 
provided nesting materials daily for only a few days and not on a long-
term basis. Others recommended that the types of nesting materials that 
are appropriate for captive chimpanzees be determined by research.
    Response: The NIH accepts Recommendation EA6. We disagree with 
commenters' suggestion to specify the types of materials that 
facilities must

[[Page 39746]]

provide for nest construction or to require the daily provision of 
fresh materials. Research chimpanzee facilities are in the best 
position to gauge the kinds of nesting materials preferred by their 
chimpanzees and when these materials need to be refreshed or 
supplemented. Facilities that offer unlimited access to an outdoor 
environment that makes nest-building materials (e.g., trees, foliage, 
and grasses) readily available might already satisfy this 
recommendation. The NIH does not believe that research to determine the 
appropriate types of nesting materials for captive chimpanzees needs to 
be conducted and published before the NIH accepts this recommendation; 
doing so would unnecessarily delay the recommendation's implementation.
    Recommendation EA7 states: ``The environmental enrichment program 
developed for chimpanzees must provide relevant opportunities for 
choice and self-determination.''
    Comments: A large number of commenters who responded to this topic 
strongly supported this recommendation as a way to ensure both the 
complexity of the captive environment and chimpanzees' ability to 
exercise volition with respect to activity, social groupings, and other 
opportunities. A suggestion was to revise the wording of Recommendation 
EA7 to remove ``self-determination'' and provide more specifics on the 
choices that chimpanzees should be able to exercise, such as to select 
their social groups. It was noted that chimpanzee experts could help 
refine this recommendation to include, for example, a list of possible 
enrichment activities, such as puzzles, games, devices for retrieving 
foods, and perhaps touch-screen technologies, which might also be 
useful for certain types of noninvasive behavioral research. Another 
suggestion was for the NIH to implement this recommendation to the 
fullest extent possible without compromising human safety.
    Response: The NIH accepts Recommendation EA7. We do not believe 
that the recommendation requires additional specificity because this 
could have the unintended consequence of omitting important activities 
or opportunities that would otherwise satisfy this recommendation.
4. Management (Recommendations EA8-EA10)
    Recommendation EA8 states: ``Chimpanzee management staff must 
include experienced and trained behaviorists, animal trainers, and 
enrichment specialists to foster positive human-animal relationships 
and provide cognitive stimulation. Given the importance of trainer/
animal ratios in maintaining trained behaviors, a chimpanzee population 
of 50 should have at least 2 dedicated staff members with this type of 
expertise. Positive reinforcement training is the only acceptable 
method of modifying behaviors to facilitate animal care and fulfillment 
of management needs. Training plans should be developed for each 
animal, and progress toward achieving established benchmarks should be 
documented.''
    Comments: A large number of commenters agreed with Recommendation 
EA8. Agreement was almost uniform concerning the use of positive 
reinforcement for the stated purposes. However, a few commenters 
disagreed that positive reinforcement training alone would be 
sufficient for the stated purposes and suggested permitting the use of 
operant conditioning training and the use of timeouts, for example, to 
help modify behaviors that cannot be modified through positive 
reinforcement.
    Others raised several additional concerns. Some suggested that the 
NIH specify the qualifications of the behaviorists mentioned in the 
recommendation, including an advanced degree (e.g., a Ph.D.) with 
several years of experience and/or experience with chimpanzees in both 
the wild and captivity. Suggestions for staff recruitment and retention 
included creating a chimpanzee husbandry internship, developing 
retention incentives for trained staff to minimize turnover, and having 
senior staff members mentor new employees. Another recommendation was 
that facilities conduct background checks to ensure that applicants for 
jobs at chimpanzee facilities have not violated laws, such as the 
federal Animal Welfare Act and regulations or NIH policies. Other 
commenters believed that 2 staff members would not be sufficient to 
care for 50 research chimpanzees and that the ratio should be increased 
(e.g., to 4 or 5 trained staff members for 50 research chimpanzees) to 
prevent excessive staff workloads. Another suggestion, based on the 
commenters' experience or opinion that the published literature does 
not support a specific staff-to-chimpanzee ratio, was that the NIH 
determine its staffing requirements for research chimpanzee facilities 
based on a performance outcome. Others expressed concern about the 
availability of funding to implement this recommendation.
    Response: The NIH accepts Recommendation EA8. We believe that 
personnel working with NIH-owned and -supported research chimpanzees 
must include experienced and trained behaviorists and enrichment 
specialists to foster positive human-animal relationships and provide 
cognitive stimulation. Facilities that house and care for NIH-owned and 
-supported chimpanzees currently offer a level of staffing and 
expertise that is similar to the recommended level. Likewise, research 
facilities commonly use positive reinforcement training to habituate 
chimpanzees to husbandry and experimental procedures. The Guide for the 
Care and Use of Laboratory Animals, Eighth Edition (https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf) and the federal Animal Welfare Act and regulations allow 
facilities to set performance standards to address the psychological 
well-being of chimpanzees.
    Recommendation EA9 states: ``All personnel working with chimpanzees 
must receive training in core institutional values promoting 
psychological and behavioral well-being of chimpanzees in their care. 
These institutional core values should be publicly accessible.''
    Comments: A large number of commenters agreed that all personnel 
working with chimpanzees must be trained in values promoting chimpanzee 
well-being. Some suggested that individuals working with chimpanzees 
have both training and experience in working with chimpanzees. Others 
expressed the concern that the recommendation does not address the need 
to monitor compliance with these values, such as through the use of 
cameras and NIH audits. Some commenters suggested credentials that 
trainers should have and noted the importance of ensuring that all 
staff members have received all required human vaccinations.
    Response: The NIH accepts Recommendation EA9. We believe that 
personnel working with NIH-owned and -supported research chimpanzees 
must receive training in institutional values that promote the 
psychological and behavioral well-being of chimpanzees. Facilities that 
house and care for NIH-owned and -supported research chimpanzees 
provide such training, and the agency expects this practice to 
continue. We disagree with those who suggested that the recommendation 
specify the credentials that trainers must have. Individual 
institutions are sufficiently knowledgeable about and capable of 
designing staff training

[[Page 39747]]

programs that promote their core values. The NIH also notes that the 
Guide for the Care and Use of Laboratory Animals, Eighth Edition has 
established training and vaccination requirements for personnel working 
with chimpanzees (https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf). The agency believes that each 
facility should have the discretion to decide whether to use cameras or 
other compliance-monitoring methods. We discuss the NIH's role in 
enforcing the accepted recommendations in the ``Other Comments'' 
section at the end of this document.
    Recommendation EA10 states: ``Chimpanzee records must document 
detailed individual animal social, physical, behavioral, and 
psychological requirements and these requirements should be used to 
design appropriate individualized chimpanzee management in the captive 
research environment.''
    Comments: A large number of commenters strongly agreed with 
Recommendation EA10. Several gave examples of the types of information 
that facilities should collect or suggested expanding the 
recommendation to specify the frequency of documentation and record 
reviews, the types of observations to be recorded, and the 
qualifications of individuals who conduct these reviews. Public access 
to these records was also requested. In addition, a few argued that 
because humans cannot know the psychological requirements of individual 
chimpanzees, the recommendation should not mention these requirements.
    Response: The NIH accepts Recommendation EA10. Facilities that 
house and care for NIH-owned or -supported research chimpanzees keep 
and use documentation on the chimpanzees' needs and welfare to satisfy 
accreditation and existing federal requirements. The NIH expects these 
facilities to continue this practice. We disagree with the suggestion 
to remove the mention of chimpanzees' psychological requirements from 
this recommendation. As discussed in the agency's response to 
Recommendation EA9, the training for personnel working with research 
chimpanzees should include an emphasis on chimpanzees' psychological 
well-being to prepare staff to keep proper records. Similarly, the 
agency disagrees with the suggestion to specify the types of 
documentation that facilities must retain, the information they must 
capture, and the qualifications of staff who review the records. 
Facilities that house and care for NIH-owned and -supported research 
chimpanzees are required to keep records on the chimpanzee colonies 
pursuant to existing laws, regulations, and policies. The Guide for the 
Care and Use of Laboratory Animals, Eighth Edition (https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf) and the federal Animal Welfare Act and regulations require 
facilities to keep records on the behavioral management of their 
chimpanzees. Restating these existing requirements in this 
recommendation would be unnecessarily duplicative.
5. Other Issues Related to Ethologically Appropriate Physical and 
Social Environments
    Comments: Several commenters expressed concern that the 
recommendations apply only to research-active and research-inactive 
chimpanzees and not to other categories of NIH-owned chimpanzees (e.g., 
retired chimpanzees). Several recommended that the NIH require 
facilities housing NIH-supported chimpanzees to comply with the housing 
condition, enrichment, and training practices described in the AZA 
Chimpanzee Care Manual (https://www.aza.org/uploadedFiles/Animal_Care_and_Management/Husbandry,_Health,_and_Welfare/Husbandry_and_Animal_Care/ChimpanzeeCareManual2010.pdf) or in scientific or other 
journals. Some commenters believed that the NIH should specify minimum 
veterinary care requirements to maximize chimpanzee welfare.
    Response: The NIH clarifies that any implemented Council 
recommendations will apply to research-active and -inactive populations 
of chimpanzees owned or supported by the NIH and any research using 
them, irrespective of who funds it. The implemented recommendations 
will also apply to NIH-supported research using chimpanzees, regardless 
of whether the agency owns or supports these animals. The Council 
recommendations do not apply to chimpanzees that are retired or 
permanently ineligible for biomedical research.
    The NIH appreciates the suggested references to aid in the care and 
behavioral management of NIH-owned or -supported chimpanzees. We 
believe that facilities that house research chimpanzees are 
sufficiently knowledgeable about the current literature, including the 
AZA Chimpanzee Care Manual used by zoos that house chimpanzees. The NIH 
also notes that the Guide for the Care and Use of Laboratory Animals, 
Eighth Edition (https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf) and the federal Animal Welfare Act 
and regulations have requirements regarding veterinary care for 
nonhuman primates, including chimpanzees.

B. Size and Placement of Research-Active and Research-Inactive 
Populations of NIH-Owned and NIH-Supported Chimpanzees

    The Council provided 9 recommendations on the size and placement of 
research-active and research-inactive populations of NIH-owned and -
supported research chimpanzees in the context of the IOM Committee's 
recommendations. The Council based these recommendations, in part, on 
the number of chimpanzees used in NIH-supported projects. Below are the 
recommendations on this topic, a summary of public comments on these 
recommendations, and the agency's response to these comments and 
decisions regarding the Council recommendations.
1. Chimpanzee Retirement (Recommendation SP1)
    Recommendation SP1 states: ``The majority of NIH-owned chimpanzees 
should be designated for retirement and transferred to the federal 
sanctuary system. Planning should start immediately to expand current 
facilities to accommodate these chimpanzees. The federal sanctuary 
system is the most species-appropriate environment currently available 
and thus is the preferred environment for long-term housing of 
chimpanzees no longer required for research.''
    Comments: Many commenters agreed with this recommendation, although 
most endorsed the retirement of all chimpanzees and not just a 
majority. Furthermore, a large number of commenters agreed that the 
federal sanctuary system is the most species-appropriate environment 
and should be expanded to accommodate the chimpanzees currently used in 
research. Another suggestion was that the federal sanctuary be subject 
to regulations to ensure the well-being of the research chimpanzees.
    Others questioned the quality of care provided by sanctuaries or 
found the recommendation vague. In addition, a concern was that 
sanctuaries do not provide an appropriate level of care for research 
chimpanzees that have health conditions. Other commenters suggested 
that the NIH consider moving chimpanzees to sanctuaries, including 
sanctuaries that are not part of the federal sanctuary system, as long 
as they satisfy applicable standard of care

[[Page 39748]]

requirements, such as those followed by members of the North American 
Primate Sanctuary Alliance or required for accreditation by the Global 
Federation of Animal Sanctuaries.
    A few commenters did not agree with the recommendation, partly 
because the Council Working Group presented no evidence that the 
federal sanctuary system is the ``most species-appropriate 
environment'' for research chimpanzees.
    The need to fund chimpanzee retirement was a common theme in many 
comments on Recommendation SP1. Several commenters suggested asking 
Congress and other entities to allocate the funds necessary to 
construct additional sanctuary space for research chimpanzees. Others 
stated that cost should not be a factor in deciding whether to retire 
additional chimpanzees. It was also noted that the funding limits of 
the Chimpanzee Health Improvement Maintenance and Protection (CHIMP) 
Act of 2000--the law that authorizes the NIH to establish and maintain 
a system of sanctuaries for the lifetime care of chimpanzees no longer 
needed for research--could affect the agency's decisions about retiring 
chimpanzees no longer needed for research.
    Response: The NIH partially accepts SP1 and intends to implement 
the following: ``Subject to the availability of additional sanctuary 
space and the elimination of funding restrictions on the federal 
sanctuary system imposed by the CHIMP Act, the majority of NIH-owned 
chimpanzees will be designated for retirement and transferred to the 
federal sanctuary system. Planning to expand current facilities to 
accommodate the additional chimpanzees will continue once the funding 
restrictions have been eliminated.''
    We agree that the majority of chimpanzees that the NIH owns could 
be eligible for retirement, but the federal sanctuary system needs 
additional capacity. Although the federal sanctuary system plans to use 
private funding to construct additional space to house chimpanzees from 
the New Iberia Research Center, these new areas will not be sufficient 
to accommodate the majority of NIH-owned chimpanzees that the Council 
recommended retiring. The NIH is currently unable to fund expansion of 
the sanctuary due to funding limitations in the CHIMP Act.
    The NIH believes that adding standards to Recommendation SP1 or 
specifying the nature of the veterinary care that sanctuaries provide 
would be unnecessarily duplicative. The standards of care for 
chimpanzees held in the federally supported sanctuary system (42 CFR 
Part 9), which have been in effect since October 2008, govern the 
facilities that have contracts or subcontracts with the federal 
government to operate the federally supported chimpanzee sanctuary 
system. In addition, these regulations and the standards in the Guide 
for the Care and Use of Laboratory Animals, Eighth Edition (https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf) govern the veterinary care of chimpanzees in the federal 
sanctuary system.
    Because of funding limitations and the lack of available space in 
the federal sanctuary system to house additional chimpanzees, the NIH 
is not in a position to implement Recommendation SP1. Instead, the 
agency agrees with the recommendation subject to the availability of 
additional sanctuary space and the elimination of funding restrictions 
so that the agency can provide additional funding to the federal 
sanctuary system.
2. Maintaining 50 Chimpanzees for Research (Recommendations SP2 and 
SP3)
    Recommendation SP2 states: ``A small population of chimpanzees 
should be maintained for future potential research that meets the IOM 
principles and criteria. Based on an assessment of current research 
protocols and interviews with content experts and current research 
facility administrators, this colony is estimated to require 
approximately 50 chimpanzees. The size and placement of this colony 
should be reassessed on a frequent basis (approximately every 5 years) 
to ensure that such a colony is still actually needed and that the 
animals are not overused.''
    Comments: A large number of commenters strongly disagreed with 
Recommendation SP2, asserting that no chimpanzees should be retained 
for future research that meets the IOM principles and criteria and/or 
that chimpanzees might be needed for noninvasive research only. Among 
other things, they argued that the genetic and physiologic differences 
between humans and chimpanzees render the chimpanzee a poor scientific 
model for studying human diseases. Several commenters cited HIV studies 
that ultimately showed that the chimpanzee model had limited utility 
for studying this virus. Those who disagreed with this recommendation 
believed that no scientific basis or public health need exists for 
keeping a reserve population for research and/or that using chimpanzees 
in research is unethical. Some noted that discontinuing chimpanzee 
research would align U.S. policies with those of other nations that 
prohibit chimpanzee use in research. Others added that stopping 
chimpanzee use in research would conserve funds. In general, these and 
other commenters asserted that all research involving chimpanzees 
should end and that the NIH should not keep 50 chimpanzees for 
research.
    In contrast, several commenters strongly supported keeping 50 
chimpanzees available for research, although a suggestion was that 25 
chimpanzees would suffice because 50 is too many. Those supporting 
Recommendation SP2 argued that due to the similarities between 
chimpanzees and humans, the chimpanzee model has been key to scientific 
advancements, including the development of interventions to treat or 
prevent certain diseases. These commenters noted that this model could 
continue to serve as a useful, and in some cases the only, animal model 
for studying certain human diseases, such as emerging diseases or other 
public health threats, the hepatitis C virus, and human behavior.
    Some commenters were concerned about the potential loss of the 
chimpanzee model for studying hepatitis C. They indicated that neither 
cell culture systems nor other animal models can replace chimpanzees in 
studies of the hepatitis C virus. Commenters noted that although cell 
cultures are useful for studying the hepatitis C virus life cycle and 
evaluating therapeutic drug candidates, they cannot be used for vaccine 
development. Commenters also noted that two mouse models for hepatitis 
C virus infection are currently in use but have limitations. The 
commenters noted that vaccine safety and efficacy must be tested in 
models with a working immune system, but the existing mouse models lack 
an intact immune system or are immune deficient and, therefore, cannot 
be used to test hepatitis C virus vaccines. A few commenters 
recommended that the NIH establish a new committee to consider the need 
for chimpanzees in hepatitis C research.
    Several commenters expressed concern that 50 chimpanzees would be 
insufficient to meet possible demands resulting from the need to 
address known and emerging biomedical and other public health threats. 
These commenters urged the NIH to reconsider the population size needed 
for future research on the hepatitis C virus and other conditions 
because chimpanzees used in research will age, will develop age-related 
illnesses, or could be exposed to viruses that would make

[[Page 39749]]

them unsuitable for biomedical research. It was, instead, recommended 
that the NIH maintain a population of 200 chimpanzees that are 
available for research, in part due to concerns that the NIH would be 
prohibited from replacing chimpanzees in the group of 50 reserved for 
research.
    Several commenters believed that 5-year reassessments are too 
infrequent and, instead, recommended conducting assessments more 
frequently. In addition, several commenters wondered how the NIH would 
select the research animals, how many projects these animals would be 
involved in, and/or whether the healthiest chimpanzees would be 
prevented from retiring. Others expressed concern that the 50 
chimpanzees selected would experience negative emotional and/or social 
effects if they were separated from their social groups.
    Response: The NIH accepts Recommendation SP2. In accepting the IOM 
Committee's recommendations, the NIH agreed that although most current 
uses of chimpanzees for biomedical research are unnecessary, some 
ongoing research might be necessary but any such research must be 
consistent with the IOM principles and criteria. The NIH recognizes 
that one matter left unsettled by the IOM Committee was the use of 
chimpanzees to develop a prophylactic vaccine for the hepatitis C 
virus. The agency believes that the hepatitis C virus is an example of 
research that warrants the further use of chimpanzees as long as this 
research is consistent with the IOM Committee's principles and 
criteria.
    The agency disagrees that the number of chimpanzees for future 
research needs to be reconsidered at this time. Those who suggested 
fewer chimpanzees (e.g., 25) did not provide a rationale for this 
number other than to say that 50 chimpanzees seemed to be too many. 
Although the NIH appreciates the argument to keep up to 200 chimpanzees 
available for research and understands the concern that the NIH might 
not be able to replenish the proposed population of approximately 50 
chimpanzees, the NIH finds the Council Working Group's rationale for 
this recommendation to be compelling.
    The NIH would like to clarify its strategy for selecting the 
approximately 50 chimpanzees to maintain for research. Our intent is to 
consult with scientists, veterinarians, and primate facility directors 
who oversee the research-active and -inactive chimpanzees owned or 
supported by the NIH. These individuals are familiar with these 
particular chimpanzees, their social groupings, their health status, 
and other characteristics that could determine their suitability for 
research. We understand and share concerns about separating chimpanzees 
from their social groups. Social groups will be among the many 
important factors that the NIH will consider to select NIH-owned or -
supported chimpanzees that will be maintained for future research. The 
NIH intends to review its decision to retain approximately 50 
chimpanzees for research at least every 5 years.
    In addition, the Council advised continuing several comparative 
genomics or behavioral research projects involving 290 chimpanzees, 
many of which are not owned or supported by the NIH; meaning that a 
currently active project may continue until the end of the current 
project period but is not eligible for a no-cost extension or other 
means to extend the original project term (see Council Working Group 
report, at https://dpcpsi.nih.gov/council/working_group_message.aspx, 
for further clarification of this concept). However, the Council 
Working Group concluded that the NIH should not maintain a large 
reserve colony of chimpanzees for minimally invasive research because 
many of these research needs could be met in nontraditional research 
settings, such as accredited sanctuaries or zoos. The NIH would like to 
clarify that researchers may request NIH funding for minimally invasive 
research using chimpanzees that are not part of the research colony of 
approximately 50 NIH-owned or -supported chimpanzees, but the NIH will 
review these applications, proposals, and protocols for consistency 
with the IOM principles and criteria. See the discussion of the Council 
recommendations regarding this review process below under ``Review 
Process for Future Requests to Use Chimpanzees in NIH-Supported 
Research.'' In addition, the environments in which NIH-supported 
research involving chimpanzees is conducted must be consistent with the 
NIH accepted recommendations for ethologically appropriate 
environments.
    Recommendation SP3 states: ``This small chimpanzee colony should be 
maintained at a facility that has the characteristics of ethologically 
appropriate physical and social environments described in this report. 
Thus, plans should be made now to ensure that ethologically appropriate 
physical and social housing conditions will be available within 3 to 5 
years. Maintaining the chimpanzee colony at a single facility could be 
advantageous to minimize costs and maximize management flexibility.''
    Comments: Although a few commenters believed that creating a 
separate colony of chimpanzees for research would be fiscally 
irresponsible, many commenters on Recommendation SP3 agreed with this 
recommendation. In addition, several suggested that the NIH require 
changes to chimpanzee housing conditions immediately and not within 3 
to 5 years as recommended. In contrast, others stated that 3 to 5 years 
might not be enough time to construct or renovate chimpanzee 
facilities.
    Several commenters voiced concern that housing all 50 chimpanzees 
in a single facility could put the animals at risk of contracting 
contagious diseases, such as tuberculosis. Others strongly opposed the 
use of any chimpanzees in research and suggested retiring all NIH-owned 
and -supported chimpanzees to a sanctuary. Another suggestion was to 
house any colony of chimpanzees retained for research in accredited 
sanctuaries or sanctuary-like settings in which only noninvasive or 
minimally invasive behavioral research is permitted.
    Response: The NIH partially accepts Recommendation SP3, subject to 
further consideration of the data supporting the recommended space 
density (see previous discussion on Recommendation EA2). We believe 
that the 3-to-5-year timeframe recommended by the Council should be 
sufficient for planning, designing, obtaining permits for, and 
constructing facilities that are consistent with the recommendation.
    In determining whether to keep the research chimpanzee colony in 
one facility or several facilities, the NIH will carefully consider 
such factors as the cost and management benefits of both options and 
safeguards to protect the chimpanzees from colony-wide infections. The 
agency acknowledges the suggestion that the NIH house the chimpanzees 
available for research in sanctuary settings that permit limited types 
of behavioral research. Although the agency agrees that observational 
research can occur in the federal sanctuary system, this type of 
research will not satisfy all of the needs noted in the reports of the 
IOM Committee or Council. Thus, we do not believe that the 
approximately 50 research chimpanzees could be housed in the federal 
sanctuary system.
3. Demographic Constitution of Colony and Breeding (Recommendations SP4 
and SP7)
    Recommendation SP4 states: ``The demographic constitution of this 
small chimpanzee colony is important to maximize its utility for 
research. Ideally, the colony should be age and sex

[[Page 39750]]

stratified, have an approximately 50:50 sex ratio, and be composed 
primarily of animals that are healthy and younger than 30 years. At 
least half of this population should be physiologically na[iuml]ve to 
infection (e.g., hepatitis or HIV). When this colony is formed, best 
practices should be used for maintaining current social groupings, 
whenever possible, to minimize adverse stress.''
    Comments: Many of the commenters who addressed this recommendation 
agreed with the proposed colony composition. Others supported the 
recommendation as long as the recommended demographic constitution is 
best for the animals and the colony or stated that the group cannot be 
age stratified if all of the animals are under age 30. In addition, 
some commenters were concerned that if some of the chimpanzees are 
na[iuml]ve to infection and others become or are infected, the colony 
would be further subdivided and might therefore not comply with the 
other Council recommendations, including the recommendation pertaining 
to group size (see Recommendation EA1). Some expressed concern that 
housing equal numbers of animals of both sexes in groups could lead to 
injuries and deaths. It was also suggested that chimpanzees younger 
than 3 years or those with compromised health be retired and not be 
available for research. The remaining commenters generally disagreed 
with the recommendation, stating that no colony of chimpanzees should 
be kept for research.
    Response: The NIH accepts Recommendation SP4. The NIH intends to 
use the Council recommendation and the best available data to guide its 
selection of the most appropriate animals to maintain for current and 
anticipated future research. Consideration of social group 
requirements, stratification concerns, and possible unintended 
consequences (e.g., aggression or compromised health of na[iuml]ve 
chimpanzees) will be among the many important factors that the agency 
will use to select the chimpanzees to maintain for future research. The 
agency also intends to select only healthy chimpanzees for this colony, 
as the Council suggests. The NIH does not own or support any research-
active or research-inactive chimpanzees younger than 3 years.
    Recommendation SP7 states: ``The NIH should not, on its own, 
revitalize breeding strategies to derive a population of chimpanzees 
for any research, including for new, emerging, or reemerging disease 
research.''
    Comments: Nearly all commenters on Recommendation SP7 agreed that 
the NIH should not revitalize breeding strategies. Several commenters 
suggested the use of contraception to prevent accidental breeding 
within the research chimpanzee colony, and others suggested that no new 
chimpanzees be added to the NIH-owned population and be used for 
research. A few added that revitalizing breeding would incur additional 
costs and exacerbate existing space concerns.
    In contrast, a few commenters who supported the availability of 
chimpanzees for research believed that a limited breeding program 
should be reestablished to repopulate the colony after research 
chimpanzees currently owned or supported by the NIH age, expire, or 
become otherwise unsuitable for research.
    Response: The NIH accepts Recommendation SP7. We do not agree with 
some commenters that a chimpanzee-breeding program needs to be 
reestablished at this time. The cost of caring for a chimpanzee over 
its lifetime can range from $300,000 to $500,000. This cost alone is a 
considerable deterrent to revitalizing the breeding of NIH-owned or -
supported research chimpanzees. Furthermore, as the IOM Committee 
observed, alternatives to the use of chimpanzees in some areas of 
research are now available, and the NIH expects that additional 
alternative research models will continue to be developed.
4. Funding Priorities for Behavioral and Comparative Genomics Research 
(Recommendation SP5)
    Recommendation SP5 states: ``The NIH should review its funding 
priorities for comparative behavioral, cognitive, and genomics studies 
using chimpanzees. The NIH should consider targeting funding for low-
burden projects that can be conducted in nontraditional research 
settings that can maintain ethologically appropriate environments or 
projects that use materials collected during routine veterinary 
examinations.''
    Comments: Many commenters stated that chimpanzees should not be 
used in any research (even noninvasive or minimally invasive research) 
and, as a result, disagreed with this recommendation. However, some of 
these commenters agreed that materials collected from chimpanzees 
during routine veterinary exams could be used for research. Others 
stated that the recommendation was unclear but disagreed with it in 
general because they believe that all chimpanzee and/or other animal 
research should stop. For the most part, however, commenters on this 
recommendation favored a review by the NIH of its funding priorities 
for comparative genomics and behavioral research using chimpanzees.
    Several commenters wondered why this recommendation addresses 
behavioral research partly because the tasks associated with behavioral 
research can be enriching for captive chimpanzees. These commenters 
emphasized the scientific value of chimpanzees for behavioral and 
neuroscience research due to their cognitive skills, including basic 
language, self-recognition, and empathy, as well as similarities 
between chimpanzee and human brain structure and function.
    Commenters familiar with behavioral research stated that 
nontraditional settings, such as sanctuaries, might allow only 
noninvasive behavioral research and would not be conducive to or would 
not allow some other types of cognitive and behavioral research. It was 
also suggested that sanctuaries would not make behavioral research a 
priority. Another suggestion was that if the NIH relocates most of its 
chimpanzees to a sanctuary where some behavioral research could occur, 
a research advocate should be appointed to the sanctuary's board of 
directors to promote the creative use of chimpanzees in ways that do 
not disturb the animals' retirement.
    Response: The NIH accepts Recommendation SP5. We acknowledge that 
many commenters disagreed with this recommendation because of their 
belief that the use of chimpanzees in research is unnecessary. However, 
the agency does not share this view.
    In response to questions about why the Council addressed behavioral 
research in its recommendations, the NIH has funded behavioral research 
using chimpanzees, so this type of research was within the group's 
purview. During its review, the Council Working Group found that most 
of the chimpanzees used in NIH-supported research are enrolled in 
behavioral research protocols. In its report, the Council Working Group 
concluded that the need for chimpanzees in behavioral research is not 
negligible but that the NIH should reexamine its programmatic 
priorities in this area. We appreciate the detailed information that 
some commenters supplied about behavioral, neuroscience, and related 
research for the agency's consideration.
    The NIH agrees with those commenters who noted that the regulations 
governing the federal sanctuary system permit only noninvasive 
behavioral studies in these

[[Page 39751]]

facilities, so some invasive types of behavioral research would not be 
permitted in the federal sanctuary system. Non-observational, NIH-
funded behavioral research might be permissible in other settings, such 
as zoos; however, the extent to which these entities could satisfy the 
ethologically appropriate conditions that the NIH plans to implement is 
unknown. As the agency considers its priorities in behavioral and 
comparative genomics research, it will take into account both the types 
of behavioral, neuroscience, and related research that might be 
conducted using chimpanzees and the relevant regulations that could 
limit this kind of research in nontraditional settings.
5. New, Emerging, and/or Reemerging Diseases and the Use of Alternative 
Animal Models (Recommendations SP6, SP8, and SP9)
    Recommendation SP6 states: ``The NIH should not support any long-
term maintenance of chimpanzees intended for research on new, emerging, 
or reemerging diseases in animal biosafety level 2 or greater 
biocontainment-level facilities.''
    Comments: A large number of commenters agreed that the NIH should 
not support any long-term maintenance of chimpanzees intended for 
research on new, emerging, or reemerging diseases. Many did not support 
any research on chimpanzees. Others agreed that biomedical research 
using chimpanzees should stop but found the wording of this 
recommendation confusing, especially the reference to ``level 2 or 
greater biocontainment-level facilities.'' Some commenters believed 
that implementing Recommendation SP6 would threaten national security 
in the event of an outbreak, while others wondered what would 
constitute a ``national security risk.'' A few commenters stated that 
future research on the hepatitis C virus would necessitate biosafety 
level 2 (BSL-2) facilities and disagreed with Recommendation SP6 
because it would prevent hepatitis C virus research. Another concern 
was that chimpanzees, which are typically held in BSL-2 facilities 
because they are very susceptible to human respiratory viruses and 
bacterial infections, could no longer be held at this biosafety level 
if the NIH accepted this recommendation.
    Response: The NIH accepts Recommendation SP6 and will not support 
the long-term maintenance of chimpanzees for the stated research 
purposes. Information about biosafety and BSLs is available at https://www.cdc.gov/training/QuickLearns/biosafety/.
    The NIH strongly disagrees with the view that this recommendation 
would prohibit facilities from continuing to practice BSL-2 precautions 
and possibly other safeguards that are already in place to protect the 
health of the chimpanzees and facility personnel. The agency reiterates 
that the Council recommendations do not alter existing safety 
regulations, requirements, and policies that dictate the precautions 
that must be taken for the safe handling of, care of, interaction with, 
and other exposures of NIH-owned and -supported research chimpanzees to 
protect the health and safety of both the chimpanzees and the 
individuals in charge of their care. The agency expects facilities 
housing NIH-owned and -supported research chimpanzees to continue 
taking the applicable safety and health precautions.
    The NIH also does not interpret this recommendation as prohibiting 
research on the hepatitis C virus using chimpanzees, which is conducted 
in BSL-2 facilities due to the nature of the virus and because 
facilities use BSL-2 precautions as a best practice in chimpanzee 
colonies. Furthermore, the chimpanzee is a longstanding and informative 
model for this research. The agency interprets Recommendation SP6 as 
discouraging long-term plans to use chimpanzees for research in higher 
containment conditions on new, emerging, or reemerging diseases.
    The NIH does not agree with commenters who stated that implementing 
this recommendation would threaten national security. Chimpanzees are 
not used for research conducted in high-biocontainment conditions (BSL-
3 or BSL-4). Only other nonhuman primates, other animal models, or non-
animal-based technologies have been used for research to address public 
health threats requiring high-biocontainment conditions.
    Recommendation SP8 states: ``The NIH should collaborate with other 
federal agencies (i.e., Centers for Disease Control and Prevention and 
Food and Drug Administration) and departments (i.e., Department of 
Defense and Department of Homeland Security) when considering any 
future plan for placement, maintenance, and use of chimpanzees in 
research in response to a new, emerging, or reemerging disease that 
could represent a national security risk to the United States.''
    Comments: Of the commenters who responded to Recommendation SP8, 
many disagreed with the recommendation, mainly due to the opinion that 
all chimpanzee and/or other animal research should end. However, other 
commenters agreed with Recommendation SP8. Some of these commenters 
desired more restrictions on such future use. Others desired fewer 
restrictions.
    Response: The NIH accepts Recommendation SP8. We do not believe 
that adding restrictions on the use of chimpanzees for new, emerging, 
or reemerging diseases would be helpful in achieving our public health 
mission.
    Recommendation SP9 states: ``In light of evidence suggesting that 
research involving chimpanzees has rarely accelerated new discoveries 
or the advancement of human health for infectious diseases, with a few 
notable exceptions such as the hepatitis viruses, the NIH should 
emphasize the development and refinement of other approaches, 
especially alternative animal models (e.g., genetically altered mice), 
for research on new, emerging, and reemerging diseases.''
    Comments: Many commenters supported Recommendation SP9, agreeing 
that the development of alternative animal models is a step toward 
eliminating the use of chimpanzees in research. These commenters, 
however, emphasized that the NIH should only select an alternate animal 
model after considering whether the human health benefits of the 
research justify this model's use. In contrast, many commenters 
disagreed with Recommendation SP9 because they believed that no animals 
should be used in research. Others stated that the recommendation 
marginalizes the contributions of chimpanzees to scientific research.
    Response: The NIH accepts Recommendation SP9 and plans to continue 
to support research to develop and validate non-animal-based models to 
help further reduce the use of other animal models in research. 
Research using chimpanzees has prevented hundreds of thousands of human 
deaths and illnesses due to hepatitis A and B and has resulted in 
advances in the development of the hepatitis C and polio vaccines and 
treatments for leukemia, other cancers, and other devastating diseases. 
Our position is that the chimpanzee has been a valuable research model 
for improving human health.

C. Review Process for Future Requests To Use Chimpanzees in NIH-
Supported Research

    The final element of the Council Working Group's charge was to 
develop a process for considering whether the potential future use of 
chimpanzees in

[[Page 39752]]

NIH-supported research is scientifically necessary and consistent with 
the IOM principles and criteria. The Council offered 9 recommendations 
in this area. Below are these recommendations, summaries of comments on 
these recommendations, the agency's response to these comments, and its 
decisions regarding this set of recommendations.
    In some of these recommendations, the Council called for the NIH to 
create an ``independent Oversight Committee for Proposals Using 
Chimpanzees in NIH-supported Research (Oversight Committee)'' to advise 
the NIH on whether the proposed use of chimpanzees in research is 
consistent with the IOM principles and criteria. In its January 22, 
2013, deliberations, the Council of Councils encouraged the agency to 
consider various options for placing the Panel's consideration of 
research involving chimpanzees. The NIH notes that the recommended 
Oversight Committee must abide by applicable federal laws, regulations, 
and policies and, thus, must play an advisory role only and cannot have 
decision-making authority. Decisions about funding for NIH-supported 
research are made solely by the NIH and not its advisory bodies. For 
these reasons, the NIH is not able to accept portions of some 
recommendations on the review process for future requests to use 
chimpanzees in NIH-supported research. Instead, the NIH partially 
accepts some of these recommendations and provides language for 
implementing the portions of the recommendations that satisfy 
applicable laws, regulations, and policies. For example, to be 
consistent with certain laws and regulations, the NIH refers to the 
``Oversight Committee'' as the ``Chimpanzee Research Use Panel'' (the 
Panel). In addition, the NIH has decided to use a single process to 
assess the consistency with the IOM principles and criteria of grant 
applications, contract proposals, intramural research protocols, and 
third-party research requests involving chimpanzees.
    The NIH proposes to establish the Panel as a working group of the 
Council of Councils, a federal advisory committee. The Panel will 
consider whether requests to the NIH to use chimpanzees in research are 
consistent with the IOM principles and criteria. Panel members will 
convene before the NIH makes funding decisions but after the NIH peer 
review or technical evaluation processes are completed for grant 
applications, contract proposals, and intramural research protocols. In 
accordance with laws governing the federal advisory committee process, 
the Panel will present its recommendations to the Council of Councils, 
which, in turn, will make recommendations to the appropriate NIH 
Institute or Center director(s).
1. Oversight Committee Composition (Recommendations RP1 and RP3)
    Recommendation RP1 states: ``The NIH should replace the Interagency 
Animal Models Committee with an independent Oversight Committee for 
Proposals Using Chimpanzees in NIH-supported Research (Oversight 
Committee) to advise on the proposed use of chimpanzees in research. 
The current Interagency Animal Models Committee is not considered 
independent from other individuals and bodies that review and approve 
grant applications to the NIH, contains no members of the public, and 
thus does not fully meet the spirit of the IOM principles and 
criteria.''
    Comments: Many of those who commented on this topic agreed with the 
recommendation. Among those who disagreed with this recommendation, 
some were concerned that the proposed Oversight Committee could stifle 
behavioral research. One suggestion was that the NIH not charge this 
new committee with reviewing behavioral research but, instead, consider 
the institutional animal care and use committee's approval to be 
sufficient. In addition, a few asked why research with chimpanzees 
would be subject to more scrutiny than research with other animals and 
noted that this type of oversight committee duplicates the activities 
of the existing NIH peer review system used to evaluate grant 
applications. Some commenters raised the concern that animal rights 
advocacy groups would seek a separate type of review for proposed 
research using other species if the NIH implements Recommendation RP1. 
Others stated that all chimpanzees used in research should be moved to 
the federal sanctuary system or were not sufficiently familiar with the 
Interagency Animal Models Committee to provide an opinion on this 
recommendation.
    Response: The NIH partially accepts Recommendation RP1 and intends 
to implement the following: ``The NIH will replace the Interagency 
Animal Models Committee with the independent Chimpanzee Research Use 
Panel to advise on the proposed use of chimpanzees in research.''
    The Interagency Animal Models Committee was a federal group 
chartered to oversee all federally supported biomedical research 
involving chimpanzees. The agency plans to replace this committee with 
the Panel, which will function independently of review processes 
currently used to assess grant applications, contract proposals, and 
intramural research protocols. The Panel will include members of the 
public and will consider whether requests to the NIH to use chimpanzees 
in research are consistent with the IOM principles and criteria.
    The NIH disagrees with some commenters' suggestions to exclude 
behavioral research involving chimpanzees from the Panel's 
consideration of whether proposed research is consistent with the IOM 
Committee's principles and criteria. Verifying whether proposed 
research meets the IOM Committee's criteria for behavioral research 
will help the NIH determine whether that research is consistent with 
the IOM Committee's recommendations. The agency disagrees with 
commenters that using the Panel to consider whether proposed behavioral 
research meets the IOM principles and criteria will stifle research in 
this field.
    Recommendation RP3 states: ``The Oversight Committee should be 
comprised of individuals with the specific scientific, biomedical, and 
behavioral expertise needed to properly evaluate whether a grant, 
intramural program, contract, or other award mechanism supporting 
research using chimpanzees complies with the IOM principles and 
criteria.''
    Comments: Many commenters who responded to this recommendation 
strongly agreed with it. Among those who agreed, several suggested that 
the NIH not compensate Oversight Committee members for their reviews 
and that this committee include at least one animal welfare 
representative, members of animal protection groups (such as Jane 
Goodall), experts in chimpanzee conservation, and/or scientists with 
disease-specific expertise. Some also wanted the NIH to expand the 
number of public representatives on the committee. Several voiced 
concern that including only scientific members on the committee would 
not be in the best interests of the chimpanzees. For those who 
disagreed with the recommendation, the main concerns were the 
composition of this committee and the belief that all research 
chimpanzees should be retired.
    Response: The NIH partially accepts Recommendation RP3 and intends 
to implement the following: ``The Chimpanzee Research Use Panel will be 
comprised of individuals with the specific scientific, biomedical, and 
behavioral expertise needed to properly

[[Page 39753]]

evaluate whether requests to use chimpanzees in research that is 
supported by a grant, intramural program, contract, or other award 
mechanism are consistent with the IOM principles and criteria.''
    In addition, the NIH agrees with the Council recommendation 
regarding the Panel membership, namely, that it should consist of 1 or 
more scientists, veterinarians, primatologists, bioethicists, and 
statisticians; and 2 or more public representatives. NIH officials will 
advise on process issues and provide information but will not be 
members of the Panel.
2. Review Process (Recommendations RP4-RP6)
    Recommendation RP4 states: ``Investigators seeking NIH funding to 
conduct research using chimpanzees must explain in their application 
how their proposed research complies with the IOM principles and 
criteria. This supplemental information must address all of the 
questions posed in the decision-making algorithm in this report and 
provide sufficient detail for consideration by the Oversight Committee. 
This information is in addition to the vertebrate animal section and/or 
applicable animal study protocol. The NIH might wish to develop a form 
or other suggested template for investigators to use for this 
purpose.''
    Comments: Many commenters on this topic supported Recommendation 
RP4 and requested that the template have, and that researchers adhere 
to, strict guidelines. Commenters suggested that investigators be 
required to justify the need to use chimpanzees by explaining how the 
proposed research would contribute substantially to human health and by 
specifying which other animal models or alternatives have been tested 
or considered.
    Several commenters stated that the proposed decision-making process 
is ambiguous and needs clear-cut criteria. Some of the wording in the 
Council Working Group's decision-making algorithm was also of concern 
because it could be interpreted to mean that research cannot be 
conducted in chimpanzees if it can be conducted in humans. More 
specifically, a concern was that research to compare the chimpanzee's 
genome to a human's genome would not be permitted.
    In general, those who disagreed with Recommendation RP4 did so 
because they believed that all chimpanzees should be retired from 
research. Others argued that because of the IOM Committee's finding 
that using chimpanzees in research is largely unnecessary, the process 
described in Recommendation RP4 is not needed.
    Response: The NIH partially accepts Recommendation RP4 and intends 
to implement the following: ``Investigators proposing to the NIH to 
conduct research using chimpanzees must demonstrate that their proposed 
research is consistent with the IOM principles and criteria. The 
supplemental information that these investigators provide must address 
all of the questions posed in the decision-making algorithm in the 
Council Working Group report and provide sufficient details for 
consideration by the Chimpanzee Research Use Panel. This information is 
in addition to the vertebrate animal section and/or applicable animal 
study protocol.''
    The NIH plans to develop a form or other suggested template for 
investigators to use for this purpose. In addition, the agency will 
determine the timing and most appropriate format for collecting the 
supplemental information that investigators proposing to use 
chimpanzees in research will need to submit. The existing technical 
and/or peer review processes applicable to grant applications, contract 
proposals, or intramural research protocols will continue without 
modification. The Panel will function separately from these existing 
processes.
    The NIH does not interpret the recommendations of the IOM Committee 
or the Council or the Council Working Group's decision-making algorithm 
as prohibiting comparative genomics research or other research that 
compares biology or behavior in humans and chimpanzees to answer a 
scientifically meritorious question. The IOM Committee provided 
explicit criteria to guide comparative genomics and behavioral research 
that proposes to use chimpanzees for those purposes.
    Recommendation RP5 states: ``To ensure that the scientific use of 
chimpanzees is justified, the animal numbers and group sizes must be 
statistically justified before the NIH approves any proposed research 
project involving the use of chimpanzees.''
    Comments: Many commenters on this topic agreed that researchers 
must statistically justify the requested sample size of chimpanzees for 
the proposed research. However, some commenters wondered what the term 
``statistically justified'' means. Others were concerned about who 
would decide when the use of chimpanzees is or is not statistically 
justified.
    Those who disagreed with Recommendation RP5 generally believed that 
the NIH should not fund any chimpanzee research and that the scientific 
use of chimpanzees is never justified. Others stated that not all 
experimental designs involving chimpanzees require statistical analyses 
of animal numbers and group sizes. A suggestion was that a chimpanzee 
might concurrently serve as its own control in, for example, studies to 
determine the dose of a drug that maximally binds to a target or the 
half-life of a test compound.
    Response: The NIH partially accepts Recommendation RP5 and intends 
to implement the following: ``To ensure that the scientific use of 
chimpanzees is justified, the proposed animal numbers and group sizes 
must be statistically or scientifically justified before the NIH 
approves any proposed research project involving the use of 
chimpanzees.''
    We believe that the intent of this recommendation is to ensure that 
the number of chimpanzees proposed for a study is sufficient to yield 
meaningful results. Mathematical calculations, often described as 
statistical power analyses, are commonly used to ensure that studies 
include enough test subjects to provide confidence that the observed 
results would not have occurred by chance.
    The NIH appreciates the view that researchers must statistically 
justify the numbers of chimpanzees that they propose to study. At the 
same time, the NIH wishes to prevent the use of more chimpanzees than 
are needed for a study. The NIH is willing to consider applications, 
proposals, and protocols for research that request to use fewer 
chimpanzees than the statistically justified number if doing so can 
appropriately meet the scientific need.
    Recommendation RP6 states: ``Investigators need not include 
supplemental information on chimpanzee use for proposals involving the 
following, and these proposals will be exempt from Oversight Committee 
review:
     The use of any biomaterials, including pathological 
specimens, collected and/or stored prior to submission of the research 
proposal, or as part of a research grant or contract that has undergone 
Oversight Committee review and approval, or as part of regular 
veterinary (health) examinations;
     Other observational or non-interventional studies, such as 
behavioral observations in the wild that do not result in contact or 
otherwise interfere with the chimpanzees being observed; or
     Noninvasive collection of samples from the wild in a 
manner that does not result in contact or otherwise interfere

[[Page 39754]]

with the chimpanzees during the collection.''
    Comments: Many commenters agreed with Recommendation RP6. Several 
also supported the use of chimpanzee specimens collected and stored 
post mortem as well as development of a chimpanzee tissue-sharing 
network among researchers to facilitate comparative genomics and other 
research. A few commenters found the wording of this recommendation 
unclear. As with the other review process recommendations, those who 
disagreed generally did so because they did not believe that 
chimpanzees should be used in any research.
    Response: The NIH partially accepts Recommendation RP6 but will use 
the Chimpanzee Research Use Panel described above instead of an 
Oversight Committee. In addition, NIH understands ``proposals'' to 
include research applications, proposals, or protocols. Thus, NIH 
intends to implement the following: ``Investigators need not include 
supplemental information on chimpanzee use for research applications, 
proposals, or protocols involving the following because they will be 
exempt from Chimpanzee Research Use Panel consideration:
     The use of any biomaterials, including pathological 
specimens, collected and/or stored prior to submission of the research 
application, proposal, or protocol, as part of a research project that 
has undergone Chimpanzee Research Use Panel consideration and 
subsequent NIH approval, or as part of regular veterinary (health) 
examinations;
     Other observational or non-interventional studies, such as 
behavioral observations in the wild that do not result in contact or 
otherwise interfere with the chimpanzees being observed; or
     Noninvasive collection of samples from the wild in a 
manner that does not result in contact or otherwise interfere with the 
chimpanzees during the collection.''
    The agency plans to issue a future notice in the NIH Guide for 
Grants and Contracts with procedural guidance for implementing these 
decisions.
3. Placement of the ``Oversight Committee'' Review (Recommendations RP2 
and RP7-RP9)
    Recommendation RP2 states: ``The Oversight Committee should be 
separate from extramural initial review groups, intramural scientific 
program personnel, and Institute or Center directors. In addition, the 
Oversight Committee's reviews should take place after the standard 
reviews and approvals by these entities. The Oversight Committee's 
reviews will focus on whether the proposed research is consistent with 
the IOM principles and criteria for the use of chimpanzees in 
research.''
    Comments: Many commenters on this topic agreed with Recommendation 
RP2. A prevailing sentiment was that the Oversight Committee members 
should have no vested interest in or potential financial gain from 
using chimpanzees for research. Several repeated that public members 
with no ties to research should be part of this committee. Others held 
the opinion that this separate committee would be better positioned 
than an existing NIH committee to give priority to the animals' well-
being during these reviews.
    Those who disagreed that the NIH should establish an additional 
committee for this purpose were concerned that members would oppose 
research for nonscientific reasons. These commenters raised concerns 
about the potential that the Oversight Committee would duplicate 
scientific reviews at the NIH and delay approvals of grants, contracts, 
and intramural projects. Several disagreed with the recommendation 
because they believed that chimpanzees should not be used in research 
and, therefore, that the NIH does not need a committee of this sort. 
Some commenters wondered how members of this committee would be 
selected.
    Response: The NIH partially accepts Recommendation RP2 and intends 
to implement the following: ``The Chimpanzee Research Use Panel will be 
separate from extramural peer review groups, contract evaluation 
panels, and intramural scientific review procedures. In addition, the 
Chimpanzee Research Use Panel's considerations will take place after 
the standard reviews (e.g., after the reviews by peer review panels, 
technical evaluation panels, and NIH Institute and Center advisory 
councils) and will focus on whether the proposed research is consistent 
with the IOM principles and criteria for the use of chimpanzees in 
research.''
    Recommendation RP7 states: ``The Oversight Committee review should 
take place after the Center or Institute director approves a proposal 
so that the key elements of the review are publicly accessible to the 
extent allowable by federal regulations. The Oversight Committee should 
review all requests for grants, contracts, intramural projects, and 
third-party projects rather than establishing a separate review process 
for each mechanism. Funding of an award for research involving the use 
of chimpanzees that has received an Institute or Center director's 
approval will be conditional and subject to the subsequent evaluation 
by the Oversight Committee.''
    Comments: Many commenters agreed with Recommendation RP7 and 
emphasized the need for full disclosure and transparency of the 
Oversight Committee's activities. Some commenters suggested that the 
Oversight Committee proceedings be open to the public. Another 
suggestion was that the Oversight Committee's reviews occur before the 
NIH peer review or after the peer review but before the NIH approves 
the project for funding. Those who disagreed with Recommendation RP7 
believed that all research chimpanzees should be sent to a sanctuary 
and that the NIH should not fund any chimpanzee and/or other animal 
research.
    Response: The NIH partially accepts Recommendation RP7 and intends 
to implement the following: ``The NIH will convene the Chimpanzee 
Research Use Panel after completing the standard review processes for 
grant applications, contract proposals, and intramural research 
protocols. The NIH will charge the Chimpanzee Research Use Panel with 
considering grant applications, contract proposals, intramural research 
protocols, and third-party research requests rather than establishing a 
separate review process for each mechanism.''
    The agency acknowledges commenters' requests that the Panel's 
activities be open to the public or otherwise transparent. However, to 
protect the confidentiality of research applications and proposals, 
proprietary interests, and researcher privacy, discussions and 
recommendations about specific applications or proposals are not 
available to the public. Standard information about funded research 
will continue to be available at https://projectreporter.nih.gov/reporter.cfm. The NIH intends to provide the public with details about 
general processes that the Panel will follow, the criteria for 
selecting its members, and the decision-making algorithm that the Panel 
will use in applying the IOM principles and criteria.
    Recommendation RP8 states: ``The Oversight Committee will base its 
reviews on the supplemental information provided by investigators on 
how the proposed research complies with the IOM principles and criteria 
and all relevant documents (including animal study protocols and grant 
applications) required to make informed determinations for all funding 
requests (grants, contracts, and intramural

[[Page 39755]]

projects) and other requests to use chimpanzees (e.g., third-party 
projects).''
    Comments: Many commenters strongly agreed with Recommendation RP8. 
A suggestion was to allow the Oversight Committee to hold onsite 
inspections although, ideally, the use of chimpanzees in research would 
be banned entirely. Those who disagreed with Recommendation RP8 
disapproved of using chimpanzees for research and believed that the 
animals should be sent to a sanctuary.
    Response: The NIH partially accepts Recommendation RP8 and intends 
to implement the following: ``The Chimpanzee Research Use Panel will 
base its assessments on the supplemental information provided by 
investigators that explains how the proposed research is consistent 
with the IOM principles and criteria and all relevant documents 
(including animal study protocols and grant applications) necessary to 
provide informed recommendations about requests to NIH to use 
chimpanzees in research (i.e., NIH-sponsored grants, contracts, 
intramural projects, and third-party projects).''
    Recommendation RP9 states: ``The Oversight Committee will determine 
whether each application meets or does not meet the IOM principles and 
criteria based on the votes of a majority of all voting members. At its 
members' discretion, the Oversight Committee may vote on whether 
different components or parts of an application meet or do not meet the 
IOM principles and criteria.''
    Comments: Many commenters who responded agreed with Recommendation 
RP9. One suggestion was to require a favorable three-fourths majority 
vote before the Oversight Committee determines that the research meets 
the IOM principles and criteria. Others disagreed with the 
recommendation because they believed that chimpanzees should not be 
used for research or because the composition of the Oversight Committee 
is unknown.
    Response: The NIH partially accepts Recommendation RP9. The agency 
intends to implement the following: ``The Chimpanzee Research Use Panel 
will advise on whether each application, proposal, and protocol meets 
or does not meet the IOM principles and criteria based on the votes of 
a majority of all voting members. At its members' discretion, the 
Chimpanzee Research Use Panel may vote on whether different components 
or parts of an application, proposal, or protocol meet or do not meet 
the IOM principles and criteria.''

D. Review of NIH-Supported Research Projects Using Chimpanzees

    The NIH requested public comments on a summary in the Council 
Working Group's report of the group's reviews of 30 research projects 
involving the use of NIH-owned or -supported chimpanzees. The Council 
recommended ending 6 of 9 biomedical research projects, 5 of 13 
comparative genomic and behavioral research projects, 1 colony housing 
and care project, and the research components of 3 of the remaining 7 
colony housing and care projects. The report did not identify the 30 
projects. The NIH asked for input on the outcomes of the project 
reviews summarized in the report.
    Comments: Of the commenters who addressed this topic, a small 
subset favored the Council recommendations regarding research projects 
using chimpanzees. Most commenters opposed the continuation of any 
research involving chimpanzees, stating that all experimentation on 
chimpanzees should end and all research chimpanzees should be relocated 
to a sanctuary. Others opposed only the recommendations to continue 
biomedical research and believed that the behavioral research studies 
should continue. Several commenters noted their difficulty providing 
input on the Council Working Group's reviews of research projects 
because the report did not include project details; these respondents 
requested that the NIH make the details on these projects public.
    In an effort to preserve the scientific integrity of chimpanzee-
based research projects that the Council's recommended ending, a 
suggestion was to encourage the researchers to use another research 
model to achieve the scientific objectives of their original projects. 
A concern was that it would be unfair to change the rules and interrupt 
current research; it was argued that ongoing projects should be allowed 
to continue and to maintain their original level of funding and 
timeframe. A few commenters questioned whether the Council Working 
Group had the requisite expertise to review some of the research.
    Response: The NIH accepts the recommendations on the research 
projects reviewed by the Council Working Group. The NIH intends to 
phase out the projects that the Council recommended ending in such a 
way as to avoid causing unacceptable losses to research programs or an 
impact on the animals, as the IOM Committee suggested. The agency 
appreciates the comments received on the summary-level information 
provided and those suggesting that certain projects not end as a result 
of the Council recommendations. The NIH's acceptance of the IOM 
Committee's report and any Council recommendations reflects a shift in 
the agency's scientific priorities away from chimpanzee research that 
does not critically need this model. This announcement does not 
prohibit researchers affected by the Council recommendation from 
disclosing the details of their research.
    The NIH does not agree with those who suggested that the Council 
Working Group lacked the expertise required to review research 
involving chimpanzees. The Council Working Group members and 
consultants included experts in behavioral sciences; infectious 
diseases, including hepatitis; use of alternative models; neuroscience 
and cognition; colony management; and veterinary medicine.

E. Other Comments

    This section summarizes comments that were not directed at a 
specific Council recommendation or address topics not discussed 
previously. Commenters discussed ending animal-based research, the 
recommendations' applicability to other animal models, funding for 
alternatives to chimpanzees, funding for and enforcement of any 
implemented recommendations, and the composition of the Council Working 
Group. A number of commenters commended the NIH for accepting public 
input and convening the Council Working Group. Many applauded the 
Council recommendations and the group members for their work and 
careful consideration of the issues.
1. Ending All Animal-Based Research and Testing
    Comments: Many commenters asked the NIH to end all chimpanzee and/
or animal-based research and to use alternative approaches instead. 
Some commenters based this opinion on the perceived inefficiencies of 
animal-based research for solving human health problems, but, in most 
cases, these commenters argued that the use of animals in research is 
inhumane, unfair, and unethical. For example, some stated that the 
laboratory environment cannot meet the complex intellectual, social, 
psychological, and emotional needs of chimpanzees. Others believed that 
chimpanzees, because of their genetic similarity to humans, experience 
the world in a similar manner to humans and, therefore, should be 
treated more like humans (e.g., should provide consent before 
participating in research

[[Page 39756]]

and have the opportunity to pursue happiness). Many argued that 
currently available non-animal alternatives, such as computer 
simulations, should facilitate the phasing out of animal-based 
research. Other commenters suggested that rather than fund animal-based 
studies, the NIH should allocate more funds toward developing and 
expanding these non-animal alternatives, which, in their opinion, might 
be more cost effective than animal-based experiments. Many commenters 
did not want their tax dollars used for chimpanzee and/or other animal-
based experiments.
    Response: The NIH emphasizes that the use of animals in research 
continues to be central to understanding, treating, and preventing many 
diseases and conditions that cause human suffering and death. Although 
we believe that ceasing all animal research at this time would be 
imprudent, the NIH maintains high standards for the use of animals in 
research. In addition, the agency is a major proponent of the U.S. 
Government Principles for the Utilization and Care of Vertebrate 
Animals Used in Testing, Research, and Training (Principles), which 
provide an ethical framework for the use of live animals in research. 
Scientists must adhere to the Principles in their conduct of research, 
testing, and training that is funded by the NIH. The Principles require 
that procedures involving animals be designed and performed with due 
consideration of their relevance to human or animal health, the 
advancement of knowledge, or the good of society. Researchers must 
select animal models for procedures that are of an appropriate species 
and quality and must use the minimum number of animals required to 
obtain valid results. Furthermore, researchers must consider the use of 
alternative methods to animal models, such as mathematical models, 
computer simulations, and in vitro biological systems.
    The agency also funds efforts to develop alternative ways to 
conduct research without using animal models. These technologies 
include improved molecular analysis techniques to study various 
diseases and three-dimensional chips with living cells and tissues that 
might accurately model the structure and function of human organs.
2. Applying the Recommendations beyond the NIH and to Other Animal 
Models
    Comments: Several commenters suggested that the recommendations 
apply beyond the NIH to other agencies of the federal government, 
private industry, and private laboratories. A concern was that the use 
of privately owned chimpanzees might increase if the NIH-owned 
chimpanzees were no longer available for research; expanding the reach 
of the recommendations would help mitigate some of these concerns. 
Others wished the NIH to apply the recommendations to other animal 
models.
    Response: Any Council recommendations implemented by the NIH will 
apply to research-active and -inactive populations of chimpanzees owned 
or supported by the NIH and any research using them, irrespective of 
who funds it. The implemented recommendations will also apply to NIH-
supported research using chimpanzees, regardless of whether the agency 
owns or supports these animals. However, the NIH lacks authority to 
apply the Council recommendations to other agencies of the federal 
government, private industry, or private laboratories.
3. Enforcing the Accepted Recommendations
    Comments: One suggestion was for the NIH to create a new entity, 
separate from the Oversight Committee that the Council Working Group 
recommended, to enforce the other recommendations, especially those 
regarding ethologically appropriate housing, that the NIH accepts. Some 
believed that this entity should conduct frequent inspections (i.e., 
more than once yearly) of facilities that house research chimpanzees 
and have the legal authority to terminate unacceptable practices.
    Response: The NIH believes that the Council recommendations provide 
the NIH with sufficient guidance without the need for additional 
external oversight. NIH-funded institutions must comply with the 
federal Animal Welfare Act and regulations, the Public Health Service 
Policy, and the Guide for the Care and Use of Laboratory Animals, 
Eighth Edition (https://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf). Any recommendations regarding the 
use of chimpanzees in research that the NIH implements will supplement 
these existing statutes and policies. The NIH Office of Laboratory 
Animal Welfare (OLAW) oversees all NIH-supported research activities 
that involve animals. OLAW monitors NIH-funded institutions to ensure 
their compliance with animal welfare laws and policies. OLAW also 
investigates allegations of animal welfare abuses and inappropriate 
animal care in NIH-funded studies.
4. Funding for Chimpanzee Retirement and Facility Construction
    Comments: Several commenters expressed concern about funding to 
implement the Council recommendations. They stated that the current 
national fiscal climate will probably limit the amount of money made 
available to fund new construction or other facets of the Council 
recommendations.
    Several commenters suggested ways that the NIH could financially 
support the implementation of the recommendations. One suggestion from 
numerous commenters was for the NIH to transfer the funds currently 
used to support chimpanzees in laboratories to sanctuaries. Others 
recommended fundraising to pay for construction and other costs. Some 
asserted that caring for chimpanzees in sanctuaries rather than 
research facilities might save money or suggested supporting 
chimpanzees through for-profit entities or by retiring the chimpanzees 
in place.
    Another concern was that funding would be diverted from important 
research to pay for the recommendations' implementation and for 
additional chimpanzee housing when the size of the population is 
decreasing. Some stated that existing facilities offer high-quality 
conditions and care and have trained staff to provide enrichment and 
health care, and keeping chimpanzees in these facilities would save 
transportation costs.
    Response: The agency understands commenters' concerns about the 
prospect of future expenditures to implement the Council 
recommendations. As the NIH gains a better understanding of the 
resources needed to implement the recommendations, it will explore 
options for funding their implementation.
5. Composition and Impartiality of the Council Working Group
    Comments: Certain commenters expressed concern about the 
composition of the Council Working Group. A few stated that the Council 
Working Group seemed to be biased in favor of scientific research. 
However, many commenters on this topic stated that certain Council 
Working Group members were biased against research and the group lacked 
the necessary scientific diversity to reach the stated conclusions 
about behavioral and neuroscience research. Several commenters were 
also concerned that 1 or more Council Working Group members had 
conflicts of interest that

[[Page 39757]]

prevented them from being impartial and that these members might have 
swayed the group to recommend the retirement of most chimpanzees. 
Others who expressed knowledge of the Council Working Group's 
activities commented that the members failed to seek diverse input on a 
range of matters, including certain scientific issues and U.S. 
laboratory facilities. These commenters stated that the group should 
have included NIH-funded experts in chimpanzee behavior and chimpanzee 
research in general. Some commenters believed that the NIH should 
appoint a new committee to consider the use of chimpanzees in research.
    Response: The agency believes that the composition of the Council 
Working Group and consultants was appropriately balanced to provide 
advice to the Council on NIH-supported research involving chimpanzees 
and implementing the IOM Committee's recommendations. Members and 
consultants included experts in behavioral sciences; infectious 
diseases, including hepatitis; use of alternative models; neuroscience; 
cognition; colony management; and veterinary medicine. The Council 
Working Group was charged with providing recommendations on how to 
implement the IOM Committee's recommendations. The NIH had already 
accepted the IOM recommendation that most current use of chimpanzees in 
research is unnecessary.
6. Additional Comments
    Comments: A few commenters expressed confusion about the number of 
chimpanzees currently used in NIH-supported and other research. Some 
had difficulty aligning the number of chimpanzees in NIH-supported 
research with the census data on NIH-owned or -supported research 
chimpanzees. Others commented on captive chimpanzee conservation and 
captive chimpanzees' status as a threatened species. A number of 
commenters disliked the length of the request for comments form and 
would have preferred a different format, such as checkboxes to indicate 
agreement or disagreement with the Council recommendations.
    Response: The census of chimpanzees on page 32 of the Council 
Working Group report includes only the chimpanzees that the NIH owns or 
supports. This table is not a census of all chimpanzees available for 
research in the United States. According to the IOM Committee's report 
(https://iom.edu/Reports/2011/Chimpanzees-in-Biomedical-and-Behavioral-Research-Assessing-the-Necessity.aspx), approximately 300 additional 
chimpanzees available for research are privately owned and housed in 
research facilities not supported by the NIH. The research projects 
that the Council Working Group reviewed involved chimpanzees owned or 
supported by the NIH and chimpanzees that are privately owned and not 
supported by the agency.
    The NIH recognizes that on June 12, 2013 the U.S. Fish and Wildlife 
Service proposed a rule that would list captive chimpanzees as 
endangered rather than threatened (https://www.fws.gov/policy/library/2013/2013-14007.pdf). The NIH will prepare for a potential final rule 
that lists captive chimpanzees as endangered and intends to adapt its 
policies on research projects using chimpanzees to comply with the 
guidelines that the U.S. Fish & Wildlife Service will establish in its 
final rule. In addition, we acknowledge concerns about the length of 
the request for comments form and appreciate the suggestions for easing 
comment entry in the future.

Conclusion

    The NIH expresses its appreciation for the comments it received on 
the Council recommendations on the use of chimpanzees in NIH-supported 
research. The agency used these comments to inform its decisions about 
these recommendations and explained its rationale in its responses to 
the comments in this notice. The NIH recognizes the Council Working 
Group for its diligence in responding to its charge to advise the NIH 
on implementing the IOM Committee's recommendations. The NIH intends to 
prepare procedural guidance and technical assistance for researchers, 
facility staff, and agency staff to ensure proper implementation of 
these decisions. Investigators should continue to follow existing 
guidance (see NOT-OD-12-025 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-025.html) regarding the submission of 
applications, proposals, or protocols for research involving 
chimpanzees until the NIH announces the procedural guidance.

    Dated: June 26, 2013.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2013-15791 Filed 7-1-13; 8:45 am]
BILLING CODE 4140-01-P