Requirements for Importers of nonhuman primates

Vol. 78

Friday,

No. 32

February 15, 2013

Part VI

Department of Health and Human Services

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42 CFR Part 71
Control of Communicable Disease; Foreign—Requirements for Importers of
Nonhuman Primates (NHP); Final Rule

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 71
[Docket No. HHS/CDC–2011–0001]
RIN 0920–AA23

Control of Communicable Disease;
Foreign—Requirements for Importers
of Nonhuman Primates (NHP)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Final rule.
AGENCY:

The Centers for Disease
Control and Prevention (CDC), located
within the Department of Health and
Human Services (HHS), is amending
regulations for the importation of live
nonhuman primates (NHPs) by
extending existing requirements for the
importation of Macaca fascicularis
(cynomolgus), Chlorocebus aethiops
(African green), and Macaca mulatta
(rhesus) monkeys to all NHPs with the
exception of the filovirus testing
requirement. Filovirus testing will only
be required for Old World NHPs in
quarantine that have illness consistent
with filovirus infection or that die for
any reason other than trauma during
quarantine. HHS/CDC is also finalizing
a provision to reduce the frequency at
which importers of cynomolgus, African
green, and rhesus monkeys are required
to renew their special permits (from
every 180 days to every 2 years). HHS/
CDC is incorporating existing guidelines
into the regulations and adding new
provisions to address the following:
NHPs imported as part of an animal act;
NHPs imported or transferred by
zoological societies; the transfer of
NHPs from approved laboratories; and
non-live imported NHP products.
Finally, HHS/CDC is also requiring that
all NHPs be imported only through
ports of entry where a HHS/CDC
quarantine station is located.
DATES: This final rule is effective April
16, 2013.
FOR FURTHER INFORMATION CONTACT:
Ashley A. Marrone, J.D., Division of
Global Migration and Quarantine,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE.,
Mailstop E–03, Atlanta, Georgia 30333,
telephone, 404–498–1600.
SUPPLEMENTARY INFORMATION: This final
rule is organized as follows:

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SUMMARY:

Table of Contents
I. Background
A. What is the risk to human health from
NHPs?
B. What is the legal authority for this
rulemaking?

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C. What is the history of this rulemaking?
II. Summary of the Proposed Rule
Requirements
III. Comment Summary and Responses
A. General Opposition and Support
B. Public Comments Regarding Purpose
and Scope
C. Public Comments Regarding Definitions
D. Public Comments Regarding Prohibition
on Importing NHPs
E. Public Comments Regarding Authorized
Points of Entry
F. Public Comments Regarding Importer
Licensing Requirements
G. Public Comments Regarding
Recordkeeping, Reporting, and
Notification Requirements
H. Public Comments Regarding Worker
Protection Requirements
I. Public Comments Regarding Equipment,
Transfer/Transport, and Handling
J. Public Comments Regarding Quarantine
Facility Requirements
K. Public Comments Regarding
Requirements for Veterinarians and
Veterinary Pathologists
L. Public Comments Regarding Zoo-to-Zoo
and Laboratory-to-Laboratory Transfers;
Animal Acts
M. Public Comments Regarding NHP
Products
N. Public Comments Regarding Appeals
O. Public Comments Regarding HHS/CDC
Monitoring and Enforcement
P. Miscellaneous Comments
IV. Alternatives Considered
V. Regulatory Analyses
A. Economic Analysis
B. Paperwork Reduction Act Analysis
C. Federalism Impact
D. Environmental Impact
E. Unfunded Mandates Reform Act
F. Plain Language Act of 2010
VI. References

I. Background
A. What is the risk to human health
from NHPs?
NHPs, particularly those recently
captured in the wild, may harbor agents
infectious to humans. Although such
infectious agents, if present, are usually
detectable in the NHP’s blood, they also
may be detected in secreted bodily
fluids such as urine, feces, or saliva.
Due to the nature of the job, persons
working in temporary and long-term
holding facilities and those involved in
transporting NHPs (e.g., cargo handlers
and inspectors) are especially at risk for
infection. NHPs are a potential source of
pathogens and communicable or
zoonotic disease that may be fatal to
humans, including filoviruses, hepatitis,
herpes B virus, tuberculosis (TB), and
parasitic infections (National Research
Council, 2003). Quarantine
requirements for imported NHPs are
designed to reduce this communicable
disease risk.

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B. What is the legal authority for this
rulemaking?
Section 361 of the Public Health
Service Act (PHSA) (42 U.S.C. 264)
authorizes the Secretary of the
Department of Health and Human
Services (HHS) to make and enforce
regulations as may be necessary to
prevent the introduction, transmission,
or spread of communicable diseases
from foreign countries into the United
States or from one State or possession to
another. Section 361 of the PHSA also
provides that, as the Secretary deems
necessary, such regulations may provide
for inspection and destruction of
animals or articles found to be infected
or contaminated as a source of
dangerous infection. Section 361 of the
PHSA serves as the primary legal
authority for 42 CFR 71.53, regarding
the importation of NHPs.
Section 368 of the PHSA (42 U.S.C.
271) sets forth penalties for violations of
any regulations prescribed under
section 361 of the PHSA. Under section
368(a) of the PHSA, any person who
violates a regulation prescribed under
section 361 of the PHSA may be
punished by a fine up to $1,000 or by
imprisonment for up to 1 year, or both
[42 U.S.C. 271(a)]. These penalties are
strengthened under the sentencing
classification provisions of 18 U.S.C.
sections 3559 and 3571, which provide
for more strict penalties for criminal
violations that would otherwise be
classified as Class A misdemeanors.
Individuals may be punished by a fine
of up to $100,000 per violation not
resulting in the death of an individual,
or up to $250,000 per violation resulting
in the death of an individual [18 U.S.C.
3559, 3571(b)]. Organizations may be
fined up to $200,000 per violation not
resulting in the death of an individual
and $500,000 per violation resulting in
the death of an individual [18 U.S.C.
3559, 3571(c)]. These penalties are
criminal in nature and would thus be
imposed by a court, not administratively
by HHS or HHS/CDC.
C. What is the history of this
rulemaking?
To address the risk NHPs pose to
humans, since October 10, 1975, HHS/
CDC has prohibited the importation of
NHPs except for scientific, educational,
or exhibition purposes (42 CFR 71.53).
NHP importers have been required to
register with HHS/CDC, renew this
registration every 2 years, and hold
NHPs in quarantine for a minimum of
31 days following entry into the United
States. Importers also must maintain
records on imported NHPs; immediately
report illness suspected of being

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communicable to humans; and make
their facilities, vehicles, equipment, and
business records used in the
importation of NHPs available to HHS/
CDC during operating business days and
hours, and at other ‘‘necessary and
reasonable times,’’ to enable HHS/CDC
to ascertain compliance with the
regulations in this section.
Additional requirements for importers
of NHPs have been developed and
implemented in response to specific
public health threats, including interim
guidelines for handling NHPs during
transit and quarantine (HHS/CDC
Update: Ebola-Related, 1990) issued
following a 1990 incident involving
identification of Ebola virus (Reston
strain) among NHPs imported from the
Philippines. As a result of this incident,
HHS/CDC concluded that cynomolgus,
African green, and rhesus monkeys were
capable of being an animal host or
vector of filovirus which may pose a
threat to human health. On April 20,
1990, HHS/CDC published a notice in
the Federal Register requiring a special
permit for importing cynomolgus,
African green, and rhesus monkeys (55
FR 15210, April 20, 1990), with
enhanced requirements for the granting
of a special permit to import these
species, including submitting a plan to
HHS/CDC every 180 days describing
specific isolation, quarantine, and
disease control measures and detailing
measures to be carried out at every step
of the chain of custody, from
embarkation at the country of origin,
through delivery of the NHPs and the
completion of the required quarantine
period. Importers also were required to
describe and implement testing
procedures for all quarantined NHPs to
rule out the possibility of filovirus
infection.
Over time, HHS/CDC revised
components of the special permit
requirement in response to surveillance
findings and the development of
improved laboratory tests. HHS/CDC
informed covered importers of these
changes by letter in 1991 (Roper, 1991).
The special permit notice required
filovirus antigen-capture testing on
specimens from any NHP that died
during quarantine for reasons other than
trauma, and filovirus antibody testing of
a serum sample taken at the end of
quarantine before a cohort is released
from quarantine on any NHPs that
recover from illness consistent with a
possible filovirus infection during
quarantine (Tipple, 1996).
On July 30, 1993, HHS/CDC
published guidelines in the Morbidity
and Mortality Weekly Report (MMWR)
for TB testing requirements for NHPs,
following the recognition of TB in up to

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2% of imported NHPs and the risk for
TB infection posed to caretakers (HHS/
CDC, 1993). These published
requirements included provisions for
recordkeeping to track and trace NHPs
and for use of personal protective
equipment (PPE) by NHP handlers to
prevent transmission of TB (HHS/CDC,
1993). Since publishing the guidelines
in the MMWR, HHS/CDC has required a
minimum of three negative tuberculin
skin tests (TSTs) administered at 2-week
intervals, on each imported NHP before
approving release of any NHPs from
quarantine.
On February 12, 2013, HHS/CDC
published a final rule at 78 FR 9828
establishing a user fee for filovirus
testing of all nonhuman primates that
die during the HHS/CDC-required 31day quarantine period for any reason
other than trauma. This provision was
initially designated in the NPRM at
§ 71.53(j). Because HHS/CDC had
already published its proposal for a
filovirus user fee, we did not solicit or
receive additional comment on this
proposal through this current
rulemaking. Through today’s final rule,
we are renumbering the filovirus user
fee provision as § 71.53(v). HHS/CDC is
making this non-substantive change to
increase the functionality and ease of
use of these regulations.
II. Summary of the Proposed Rule
Requirements
In the January 5, 2011, NPRM, HHS/
CDC proposed to continue, in § 71.53(d),
the long-standing general prohibition on
importing NHPs, and to reflect, in
§ 71.53(e), its authority to require
disposal of prohibited or excluded
NHPs. HHS/CDC also proposed a list of
definitions specific to modern
importation principles and practices for
NHPs, including adding new definitions
and revising existing ones, to add clarity
to the provisions regulating the
importation of NHPs.
Additionally, HHS/CDC proposed to
expand the isolation, quarantine, and
worker protection requirements; and to
expand the registration process
described in the special permit
requirements for cynomolgus, African
green, and rhesus monkeys to all
importations of NHPs. HHS/CDC
intended that the proposed changes
would simplify importer registration
procedures and provide an enhanced
measure of worker and NHP safety
against known and emerging zoonotic
diseases.
HHS/CDC intended to achieve its
regulatory objectives through a
performance-based standard focusing on
desired characteristics of the regulated
activities, rather than a prescriptive

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standard for conducting those activities.
The Agency endeavored to allow
regulated entities flexibility in choosing
how to meet the standard’s goals and
objectives.
To extend the public health benefits
of the special permit requirements
regarding identifying filovirus
infections, HHS/CDC proposed
extending filovirus testing to include all
Old World NHPs in quarantine that
have illness consistent with filovirus
infection or that die for any reason other
than trauma during quarantine. This
requirement was proposed because Old
World NHPs are susceptible to filovirus
infection and they originate from areas
of the world where filoviruses have
caused fatal disease in NHPs.
Consequently, surveillance for filovirus
infection would include not just the
species covered under the special
permit requirements, but all newly
imported Old World primates
(unpublished data, HHS/CDC;
Formenty, et al., 1999; Rollin, et al.,
1999, Rouquet, et al., 2005; Leroy, et al.,
2004).
Also in keeping with the special
permit requirements, HHS/CDC
proposed under paragraph (h) to require
that NHP importers develop a written
policy for ensuring that imported NHPs
and their offspring would be used and
distributed only for the permitted
purposes defined in the regulation.
HHS/CDC proposed requiring importers
to keep written certifications that would
follow the NHP for life and demonstrate
the continued use of the NHPs and any
offspring only for permitted purposes.
The intended purpose of this
requirement was to ensure that NHPs
are not diverted into the pet trade,
subsequently placing individuals at risk
of contracting zoonotic diseases that
NHPs may carry.
Under proposed paragraph (h)
importers would be required to
maintain these records in an organized
manner, and in a central location, which
is at or in close proximity to the NHP
facility, to allow HHS/CDC to inspect
the records during regular business
hours or within one hour of HHS/CDC
site visits. Proposed § 71.53(g)(1) would
require any importer to establish,
implement, and maintain
documentation and standard operating
procedures (SOPs) associated with the
importation of NHPs. HHS/CDC’s
proposal included performance-based
requirements for worker education
concerning risks, exposure notification
and reporting, PPE, development of
SOPs, TB and other diagnostic testing,
post-exposure procedures, and other
requirements for the development and
implementation of a plan sufficient, as

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determined by HHS/CDC, for protecting
workers from the risks associated with
handling NHPs.
The proposed rule contained
quarantine provisions, including a 31day period of quarantine at a U.S.
quarantine facility, with possible
extensions of quarantine if the NHPs
showed infection with certain
communicable diseases, if the importer
or HHS/CDC suspected that an NHP was
infected with certain communicable
diseases, or if the importer or HHS/CDC
determined that there was a need for
additional diagnostic testing.
Additionally, HHS/CDC proposed to
eliminate the 31-day quarantine
requirement and associated restrictions
for transfers of NHPs into the United
States between Association of Zoos and
Aquariums (AZA)-accredited zoos.
HHS/CDC proposed a similar quarantine
exception for transfers of NHPs from
laboratories accredited by the
Association for Assessment and
Accreditation of Laboratory Animal
Care International (AAALAC) or its
equivalent, if the laboratory has a
foreign-based and a U.S.-based facility
and the NHP is part of an ongoing
research project. The proposed
procedures and standards contained in
§ 71.53(l) were based on procedures and
standards of the National Research
Council (NRC), HHS/CDC biosafety
guidelines, current knowledge of
infectious agent transmission routes,
and experience gained from
investigating filovirus infection
outbreaks (HHS/CDC, 1996; HHS/CDC,
1989).
Other quarantine requirements
proposed in § 71.53(l) addressed routine
veterinary medical care and screening
for zoonotic diseases of NHPs in
quarantine, management of illnesses
and deaths of unknown etiology, written
protocols for the evaluation and
diagnostic testing of suspect cases of
zoonotic disease in NHPs, and improved
surveillance and testing procedures in
NHP quarantine and research facility
settings. The proposed requirements for
SOPs and equipment for crating, caging,
and transporting NHPs in § 71.53(j)
outlined the requirements that the
importer must meet, either directly or
by contractual or other arrangement, to
ensure safe handling of NHPs during
transportation. The proposed
procedures included preventing
contamination of other articles and
cargo during transportation; providing
physical separation of crates from other
cargo; and ensuring decontamination of
aircraft, ships, vehicles, and related
equipment following NHP transport. In
addition, in § 71.53(f), HHS/CDC
proposed to restrict entry of NHPs into

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the United States to those ports of entry
where HHS/CDC quarantine stations are
located, except in limited circumstances
approved in advance by HHS/CDC. In
§ 71.53(k), HHS/CDC proposed that an
importer establish, implement,
maintain, and adhere to SOPs for
ground vehicles to ensure the safe
transport of NHPs to quarantine
facilities, and ensure that prequarantined NHPs posed no risk to
human health. Under proposed
§ 71.53(m), an importer would have to
notify HHS/CDC of certain events listed
in the paragraph within the designated
time period. For example, proposed
§ 71.53(m)(6) would require an importer
to report to HHS/CDC within 48 hours
any positive or suspicious TST results,
necropsy findings, or laboratory results.
In addition to the NHP health-reporting
requirements in § 71.53(m), HHS/CDC
proposed 19 general reporting and
recordkeeping requirements in
§ 71.53(n), with which the importer
would have to comply.
Paragraph (g) Registration or Renewal
of Importers requires all animal acts to
comply with requirements in § 71.53(h)
through (n). HHS/CDC proposed
additional requirements for animal acts
entering and re-entering the United
States under proposed § 71.53(o). Under
proposed paragraph (o)(1) of the animal
act provision, a foreign-based importer
would have to provide additional
information and documentation to help
identify the individual NHP and to
describe the conditions under which the
NHPs are housed in the United States,
and maintain documentation signed by
a licensed veterinarian attesting to the
results of physical examinations for
NHPs. Under proposed paragraph (o)(2)
of that provision, the importer of a U.S.based animal act would meet additional
specified requirements when the
animals re-enter the United States.
For those NHPs entering the United
States under the zoo-to-zoo and
laboratory-to-laboratory transfers
exception, proposed § 71.53(p) and (q)
set requirements for the recipient zoo or
laboratory within the United States,
including registration, submission of
veterinary medical records that
document an NHP’s current and past
health history, accreditation standards,
and equivalency standards for zoos and
aquariums. HHS/CDC also proposed
requirements for brokers in the United
States handling in-transit shipments of
NHPs that have a layover or are
detained or delayed at a U.S. airport.
Finally, HHS/CDC proposed new
procedures for revocation and
reinstatement of an importer’s
registration [§ 71.53(s)] as well as
requirements for importing untreated

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NHP products such as carcasses,
trophies, blood, and other biological
samples were proposed under § 71.53(t).
III. Comment Summary and Responses
A. General Opposition and Support
HHS/CDC received public comments
from 23 individuals and entities to the
January 5, 2011, NPRM. One commenter
opposed the rule in its entirety,
asserting that all imports of NHPs
should be banned, irrespective of the
purpose for which the NHP was
imported. However, if such imports
were permitted, this commenter said we
should require a physical inspection of
the importer’s premise, the importer’s
fingerprints and picture identification,
and posting of the importer’s
application forms on the web for public
inspection.
HHS/CDC response. HHS/CDC is
obligated to regulate animal imports to
best protect public health and is
satisfied that this final rule achieves this
goal. Further, HHS/CDC maintains a
very efficient and effective registration
and oversight program for the
importation of NHPs and the protection
of public health, which includes a
thorough review of all records and
unannounced inspection of the
premises in which the NHPs are kept
during quarantine. We do not believe
the addition of fingerprinting or picture
identification is necessary or would
improve oversight. Further, an
importer’s application contains
proprietary information and therefore
would not be appropriate for public
display.
Several commenters expressed
support for portions of the proposed
rule. Eight commenters approved of
extending the import requirements for
special permit NHP importers to all
importers, and four supported extending
the period for permit renewal from 6
months to 2 years. Four commenters
also supported easing the quarantine
restrictions for zoo-to-zoo transfers of
NHPs between zoos accredited by the
AZA or an equivalent organization, and
laboratory-to-laboratory transfers where
the importer can document that the
animals are part of a research project
following Institutional Animal Care and
Use Committee (IACUC)-approved
protocols. One commenter supported
the proposal to import shipments of
NHPs only through ports of entry with
HHS/CDC quarantine stations, and
another supported the animal act
provisions.
HHS/CDC Response. HHS/CDC has
reviewed and considered all details of
these comments and will discuss each
in turn.

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B. Public Comments Regarding Purpose
and Scope
One commenter said that we should
broaden the purpose provision in
§ 71.53(a) to include not only preventing
the transmission of communicable
disease and pathogens from imported
NHPs to humans, but also preventing
the importation of diseases and
pathogens themselves.
HHS/CDC Response. NHPs are only
one of the imports that HHS/CDC
regulates to prevent the introduction of
communicable disease. Specifically, the
importation of pathogens is regulated
under 42 CFR 71.54, Etiological agents,
hosts, and vectors. Further, the HHS/
CDC Director has broad general
authority under 42 CFR 71.32(b) to take
measures with regard to any carrier,
article, or thing that may be
contaminated with a communicable
disease. Therefore, HHS/CDC does not
believe it necessary to broaden the
purpose and scope of this section.
This same commenter said we should
broaden the scope provision in
§ 71.53(b) to include post-importation
recipients of NHPs and the offspring of
these NHPs, arguing that the proposal
placed ‘‘an unreasonable indirect
enforcement burden on registered
importers’’ by requiring them to
question their customers’ intended use
of the importer’s products. The
commenter recommended requiring
prospective recipients of postimportation NHPs and their offspring to
register with HHS/CDC, and maintain
records regarding the use, distribution,
and disposition of these animals.
HHS/CDC Response. Under § 71.53,
HHS/CDC regulates the initial
importation of NHPs into the United
States. To be approved to register as an
importer, an importer must agree to only
distribute NHPs for a permitted
purpose. The requirement that an
importer retain records of distribution
allows HHS/CDC to monitor this
agreement to ensure importers are
adhering to the distribution restrictions.
Therefore, HHS/CDC believes that the
current practice of holding the initial
importer responsible for the transfer of
an NHP for a permitted purpose is
sufficient to protect the public’s health
and will remain in place.
Finally, a commenter suggested
requiring that ‘‘sanctuaries’’ obtain a
U.S. Department of Agriculture (USDA)
license, HHS/CDC registration, or both,
if the sanctuary is to receive or possess
previously imported NHPs. The
commenter asserted that such entities
‘‘must agree not otherwise (to) dispose
(of) or distribute said primates.’’

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HHS/CDC Response. HHS/CDC does
not have the authority to require USDA
to issue a license to an individual or
entity. A ‘‘sanctuary’’ would fall under
the definition of ‘‘person,’’ which means
such entities fall under § 71.53(b) and
the general prohibition in § 71.53 (d)
against receiving, maintaining, or
distributing an NHP for other than a
permitted purpose. For clarity, we have
revised the definition of ‘‘person’’ in
§ 71.53(c) to explicitly include not-forprofit organizations, such as sanctuaries.
Finally, we note that in keeping with
current practices, any ‘‘person’’ may
submit an application to HHS/CDC to
become a registered importer, including
a sanctuary.
C. Public Comments Regarding
Definitions
One commenter supported the
definition of ‘‘education and scientific
purposes,’’ saying that they had
experienced problems with importers
abusing the concept and endeavoring to
bring NHPs into the United States by
claiming the animals were purchased
for a thesis. This commenter said that
the proposed definition would ‘‘prevent
such an abuse.’’ However, this
commenter also noted that our proposed
definition of ‘‘trophy’’ was broader than
the same definition of this term in 50
CFR 23.74(b). Whereas the U.S. Fish and
Wildlife Service (USFWS) defines a
trophy as ‘‘items taken as a result of
sport-hunting,’’ the commenter asserted
that HHS/CDC’s proposed definition
included any such items ‘‘purchased
abroad that are display items,’’ and
noted that under the Convention on
International Trade in Endangered
Species (CITES), only an item resulting
from a ‘‘personal sport-hunt’’ would be
a trophy.
HHS/CDC Response. Regarding the
comment on CITES requirements for
any product defined by that agency as
a ‘‘sports-hunted trophy,’’ we note that
today’s final rule provisions do not
negate other federal requirements.
However, we note, too, that our mandate
to protect public health is different from
the CITES program objective and
requires targeting a broader class of
imported NHP products. However, CDC
agrees that our proposed definition of
‘‘trophy’’ may cause confusion among
the regulated communities; therefore,
we have introduced a new definition for
product that includes sports-hunted
trophies. Under this final rule, a
‘‘product’’ is defined as ‘‘skulls, skins,
bodies, blood, tissues, or other
biological samples from a nonhuman
primate, including trophies, mounts,
rugs, or other display items.’’

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Any untreated NHP product poses a
risk to human health, irrespective of
whether the product is a trophy from a
‘‘personal sport-hunt’’ or from
commercial or other activity, and would
require the importer to obtain a permit
from HHS/CDC before bringing the
product into the United States. To
import any NHP product, an importer
must render the product noninfectious
under a HHS/CDC approved method, or
obtain a permit in advance from the
Director of HHS/CDC.1
Other commenters addressed the
definitions in § 71.53(c). Two argued
that we should change the definition of
‘‘zoonotic disease’’ because the
proposed definition was inconsistent
with the background information in the
NPRM and with the medical dictionary
definition of the term. Instead, these
commenters suggested we define the
term as ‘‘any infectious agent or
communicable disease that is able to be
transmitted from animals, both wild and
domestic, to humans.’’
Another commenter suggested
revising four proposed definitions. First,
the commenter recommended revising
‘‘broker’’ by adding ‘‘of NHP from
another country, or as an intermediary
between such an’’ immediately
following ‘‘official agent of an exporter’’
and before ‘‘exporter and an importer of
NHPs.’’ Second, the commenter
recommended a new definition of
‘‘cohort’’ as ‘‘a shipment or shipments of
NHP that shared a confined space or
close proximity (within 5 feet) during
import into the United States and/or
transit to the importer quarantine
facility.’’ Third, for clarity and
specificity, this commenter said we
should consider changing the term ‘‘in
transit’’ to ‘‘in international transit’’ or
‘‘in international transit within the
U.S.’’ Asserting that the definition for
‘‘offspring’’ lacked documentation
criteria, the commenter suggested the
fourth change of specifying minimum
verification documentation in the
definition.
HHS/CDC Response. To clarify many
of the terms used in § 71.53, HHS/CDC
has adopted most of the above
commenter’s suggestions. We did not
change the term ‘‘in transit’’ because we
believe the definition adequately
specifies and clarifies HHS/CDC’s
intent.
A fifth commenter suggested adding a
definition of ‘‘unusually high
morbidity,’’ which the commenter
argued was inadequately defined in the
proposed documentation requirements
1 http://www.HHS/CDC.gov/animalimportation/
lawsregulations/nonhuman-primates/nprm/
questions-answers-importers.html.

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in §§ 71.53(i) and 71.53(l). This same
commenter said that in the notification
requirements in § 71.53(m), ‘‘the
definition of ‘severe’ illness in this
section is ambiguous.’’
HHS/CDC Response. Regarding the
comment on defining ‘‘unusually high
morbidity,’’ we note that HHS/CDC did
not propose use of the term in the
regulatory text and therefore we do not
believe that it is necessary to define it.
Regarding the comment on notification
requirements in § 71.53 (m), HHS/CDC
has removed ‘‘severe illness’’ from this
provision in the final rule to alleviate
any ambiguity.
D. Public Comments Regarding
Prohibition on Importing NHPs
Two commenters said we should
expand the general prohibition on
importing NHPs in § 71.53(d). One
argued that expanding the prohibition
would relieve the burdensome
requirements imposed on importers.
This commenter suggested adding a
provision to prohibit persons from
receiving ‘‘post-importation NHPs’’
unless the recipient was registered with
HHS/CDC under § 71.53, and a
provision like paragraph (d)(2) for
importers, but instead addressed ‘‘postimportation’’ recipients of NHPs.
HHS/CDC Response. As noted above,
under § 71.53, HHS/CDC regulates the
initial importation of NHPs into the
United States. To be approved to
register as an importer, an importer
must agree to only distribute NHPs for
a permitted purpose. The requirement
that an importer retain records of
distribution allows HHS/CDC to
monitor this agreement to ensure
importers are adhering to the
distribution restrictions. Therefore, the
current practice of holding the initial
importer responsible for the initial
transfer of an NHP for a permitted
purpose will remain in place.
One commenter suggested that we
should expressly prohibit the
importation of wild and feral NHPs
because these animals represent serious
risks to public health and animal
welfare.
HHS/CDC Response. In § 71.53(d) of
the final rule, HHS/CDC retains the
general prohibition on the importation
of live NHPs except for certain limited
purposes. No matter its origin, there can
be no question of an NHP coming into
the United States without prior HHS/
CDC review and issuance of a
registration certificate, regardless of
whether the animal is caught in the wild
or raised in captivity, because live NHPs
present the same potential for infectious
disease outbreaks. Under § 71.53(g),
each NHP importer must obtain

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registration from HHS/CDC before
importing these animals.
HHS/CDC notes that since we
established quarantine restrictions for
NHPs in 1975, the number of HHS/CDCregistered NHP importers went from 140
(according to a 1989 review) to 27 in
1999 (Roberts, 2008), and the mortality
rates for NHPs imported under a special
permit during shipment and quarantine
went from 20 percent to less than 1
percent (Roberts, 2008; DeMarcus, 1999)
and has remained there (ILAR, 2006).
These data indicate the efficacy of our
certification process for NHP importers.
Further, allowing NHP imports for
specific and limited purposes under
HHS/CDC authorization is consistent
with the Executive Order 13656 section
1 directive of protecting public health
with the ‘‘least burdensome tools for
achieving regulatory ends.’’
E. Public Comments Regarding
Authorized Points of Entry
Comments were received regarding
the proposal in § 71.53(f) to require
importation of live NHPs into the
United States only through ports of
entry with a HHS/CDC quarantine
station, unless the importer received
advance written approval from HHS/
CDC for some other port of entry. One
commenter asked that the preamble to
the final rule discuss requirements in 50
CFR part 14 for NHP importers to obtain
from USFWS a port-exception permit
before a shipment entered the United
States at Detroit, Dulles, El Paso,
Minneapolis, San Diego, or San Juan.
This commenter also noted that there
are no USFWS staff at the port of entry
in Philadelphia.
HHS/CDC Response. HHS/CDC is
adopting the proposal that, absent prior
approval, a shipment of live NHPs into
the United States must come through
ports of entry with a HHS/CDC
quarantine station. In response to the
comment on USFWS’s requirements
under 50 CFR part 14, in promulgating
this final rule, HHS/CDC does not
intend to supersede—and believes that
these requirements are not inconsistent
with—any applicable USFWS or USDA
regulation nor any applicable state
regulation. An importer must have a
CITES permit to bring NHPs into the
United States, and an importer in
violation of otherwise applicable
regulations is prohibited from importing
NHPs. We will continue working with
federal partners at ports of entry to
ensure that the administrative burden
on partner agencies is not unreasonable.
Another commenter opposed what
they viewed as an exception for NHP
shipments entering the United States at
‘‘certain border crossing[s] from Canada

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and Mexico.’’ Such an exception,
asserted the commenters, ran contrary to
our stated purpose for the port-of-entry
requirement. These commenters said
further that including shipments coming
from U.S. border countries in the
paragraph (f) requirement was logical,
would have little economic impact
given the few importers who ship NHPs
across those borders, and would
maintain public health and safety at the
cost of a small inconvenience to
importers.
HHS/CDC Response. HHS/CDC notes
that there is no exception in the final
rule from the port-of-entry requirement
for over-the-road (OTR) shipments of
NHPs coming from Canada or Mexico. A
person importing NHPs from those
countries either must bring the animals
through ports of entry with a HHS/CDC
quarantine station, or obtain prior
Agency approval for bringing the
shipment through an alternate U.S. port
of entry. Further, HHS/CDC maintains
public health safety through direct
oversight of the importation, because a
candidate for registration certification or
renewal must allow HHS/CDC to
inspect records, facilities, transport
vehicles, and equipment during
operating days and hours, and at other
necessary and reasonable times. (See
§ 71.53(b)(1) and (g)(2)(i).)
F. Public Comments Regarding Importer
Licensing Requirements
Commenters addressed the
application and permit renewal
proposals in § 71.53(g). Two
commenters opposed eliminating the
180-day registration renewal
requirement for special permit holders.
Presenting several examples of alleged
noncompliance and Animal Welfare Act
violations by ‘‘top NHP importation
companies in the United States,’’ one
commenter argued that reducing
government oversight of companies
‘‘with documented histories of
noncompliance’’ would pose a serious
threat to public health. Further, argued
the commenter, there was no evidence
in the record that the species subject to
special permit requirements
(cynomolgus, African green, and rhesus
monkeys) present less of a threat to
human health than they did when we
first established the requirements in
1990. The same commenter asserted we
failed to make the case that moving to
a 2-year renewal period would be in the
best interest of public health.
HHS/CDC Response. HHS/CDC is
adopting the proposal to extend the time
for special permit renewal from every
180 days to every 2 years. We believe
that the concern about the reduction in
government oversight is misplaced,

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because registration is only part of the
oversight of importers. Importers must
continue to notify HHS/CDC of all
shipments and we will continue to
perform regular site visits, including the
review of importer SOPs.
Indeed, there is constant
communication between HHS/CDC and
importers. Further, extending the
renewal period is consistent with the
directive in Executive Order 13653
section 1 that we apply the least
burdensome tools for achieving
regulatory ends.
An individual commenter suggested
changes to three of the proposed
paragraphs in (g)(1). The first suggestion
was to change paragraph (g)(1)(ii) to
state that an applicant must submit a
completed statement of the intended
permitted purpose for which an NHP is
imported and must name any ‘‘intended
prospective post-importation
recipients.’’ The second was to remove
the requirement in proposed (g)(1)(iii)
for applicants to submit ‘‘a copy of all’’
SOPs. The final suggestion was to add
in proposed (g)(1)(iv) a requirement for
applicants to submit ‘‘copies of all
Federal, State, or local registrations.’’
HHS/CDC Response. HHS/CDC does
not believe it is reasonable to require
importers to submit ‘‘prospective’’
recipients of NHPs. HHS/CDC routinely
audits importer records to verify that
distribution is for permitted purposes.
As part of this oversight, HHS/CDC will
continue to require importers to submit
copies of all SOPs. However, in
response to the commenter’s third
suggestion, the final rule will require a
copy of all federal, state, or local
registrations, licenses, and/or permits.
Another commenter said that HHS/
CDC should require applicants for an
importer license or license renewal to
submit the documentation required
under § 71.53(i) for worker protection
and § 71.53(l) quarantine facilities as
part of the permit application process.
HHS/CDC Response. We have added
clarifying language to the title and
throughout § 71.53(g) of the final rule to
make it clear that the same
documentation is needed to apply for
registration or renewing a registration
certificate for importing NHPs.
G. Public Comments Regarding
Recordkeeping, Reporting, and
Notification Requirements
Several commenters discussed
various proposed recordkeeping,
reporting, and notification requirements
in § 71.53(h), (i), (k), (m), and (n).
An individual suggested that we
change paragraph § 71.53(h) to require
that importers develop and document
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§ 71.53(h)(2) to require that importers
collect or create records of the intended
purpose for imported NHPs and
maintain records regarding each
distribution of imported primates; and
clarify in § 71.53(h)(3) how an importer
must authenticate electronic records, if
HHS/CDC would permit such records.
HHS/CDC Response. Each HHS/CDCregistered NHP importer is subjected to
periodic, mandatory site visits. During
these site visits, HHS/CDC staff assesses
compliance with recordkeeping
requirements. Importers are also
required to provide HHS/CDC staff with
an intended-use statement for each NHP
that was distributed following HHS/
CDC quarantine. Failure to comply with
these recordkeeping requirements may
result in suspension or forfeiture of an
importer’s HHS/CDC registration. HHS/
CDC also agrees that there should be a
requirement for time-dating of
electronic records in a manner that
cannot be altered, and for back-up
copies of such records. We have revised
§ 71.53(h)(3) accordingly.
One commenter expressed general
support for the proposed reporting
requirements and asked that we notify
USFWS if we receive disease reports
from importers that might raise
concerns about its wildlife inspections.
HHS/CDC Response. With regard to
the commenter’s request that USFWS
‘‘receive disease reports from importers
that might raise concerns about its
wildlife inspections,’’ HHS/CDC
routinely informs USFWS of ongoing
potentially life-threatening disease
outbreaks occurring among USFWSlicensed facilities.
The same commenter strongly
recommended that HHS/CDC require
tattoos or microchip numbers for NHPs
to better identify animals involved in a
transfer or transaction.
HHS/CDC Response. Paragraph
(l)(3)(i) of this final rule requires
importers to ensure that all NHPs are
identified individually with a unique
number or alphanumeric code
permanently applied to the NHP.
However, consistent with our intent to
set performance-based requirements, the
rule does not require one specific
identification yet allows the importer to
select a ‘‘tattoo, microchip, or other
permanent identifier.’’ This requirement
ensures that NHPs may be identified in
any transfer or transaction.
The January 2011 NPRM specifically
solicited public comment on how long
records should be maintained by the
importer, e.g., for the expected life of
the NHP. One commenter said that, as
written, § 71.53(h) failed to indicate
how long an importer must maintain
documentation, and suggested a

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11527

retention period similar to existing
USDA requirements (i.e., 3 years after
disposition). Two commenters asserted
that the retention period under
paragraph (h) should be at least for the
life of the animal, plus a post-mortem
period to investigate disease outbreaks
or rules violations. One commenter
agreed that the retention period for
§ 71.53(h) documentation should be for
the life of the NHP.
HHS/CDC Response. HHS/CDC agrees
with commenters’ concern that there
should be a specified period for which
an importer must keep the written
certifications required under
§ 71.53(h)(1), and has revised the final
rule to specify the period of record
retention as 3 years after distribution or
transfer of the animal. In § 71.53(h)(2) of
the final rule, HHS/CDC also clarifies its
intention for importers to maintain
records regarding each distribution of
primates for the required 3-year period,
including information identifying each
animal in a shipment. We believe these
retention periods are sufficient for
protecting public health and tracking
NHPs after their release from
quarantine, and that it is overly
burdensome to require record retention
for the life of an NHP and a period after
death, as some commenters suggested.
Another commenter asked whether
importers must document the intended
purpose for the life of the NHP, what the
effects would be if there were
subsequent movements of the NHP
within the United States, and whether
paragraph (h) applied to offspring of
imported NHPs.
HHS/CDC Response. HHS/CDC has
revised § 71.53(h) to state expressly that
an importer must develop and
document compliance with a written
policy for use and distribution of NHPs
and their offspring. Paragraph (h)(1) also
makes clear that it is the importer’s
obligation to collect a signed record of
the intended purpose for which NHPs
are imported from the customer, and to
take reasonable steps to ensure that its
customers will use NHPs in accordance
with Part 71. These records must be
retained for three years after
distribution. The original importer is
not responsible for documenting
subsequent movements of the NHP
beyond the initial transfer. Again, this is
a codification of the accepted current
practice that importers only distribute
NHPs for scientific, educational, or
exhibition purposes as defined in this
final rule.
One commenter requested
clarification on proposed required
certifications under paragraph (h)(5),
and asked how HHS/CDC would
monitor, track, and record these

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certifications; how often the importer
should provide us with certifications;
and how subsequent movement of NHPs
and their offspring would affect the
certifications. Another commenter said
they were uncertain whether the sellers
needed to verify the authority of the
person who certifies use of primates at
the purchasing institution, and said they
were against imposing a requirement on
the seller other than maintaining
certification from the consignee.
HHS/CDC Response. Regarding the
comment on how we would receive and
track certifications under proposed
§ 71.53(h)(5) (not adopted under the
final rule), we note that the intent of the
final requirements under paragraph (h)
is for the importer to retain the records,
not to send them to HHS/CDC. HHS/
CDC will review certifications in person
and regularly through an audit process
yet does not expect importers to certify
the authority of the signatory beyond
normal due diligence. An example of
due diligence would be for the importer
to include a statement of authority on
the certification form.
Two commenters commented on the
proposed requirement in § 71.53(i)(3) on
notification to HHS/CDC of a worker’s
exposure to a zoonotic illness. The
commenters said we should change this
provision to make it consistent with
other, similar reporting requirements.
Specifically, said the commenters, the
provision should read, ‘‘An importer
must immediately contact HHS/CDC by
telephone, SMS text, or email, as
specified in the importer’s standard
operating procedures, to report any
instance of a worker exposed to a
zoonotic illness and must include
instructions for contacting HHS/CDC in
its worker protection plan.’’ For the
same reason, the commenters suggested
revising the sentence on notification in
§ 71.53(i)(9) to read as follows: ‘‘The
importer must promptly notify HHS/
CDC by telephone, SMS text, or email as
specified in the importer’s standard
operating procedures if such illness
occurs.’’
These same commenters suggested
revising § 71.53(k)(5) to permit notifying
HHS/CDC of the arrival of an NHP
shipment by SMS text or email as
specified in the importer’s SOPs. They
also requested that HHS/CDC should
permit written notice by email in
notification requirements before
authorizing the import of NHPs in
§ 71.53(n)(2).
HHS/CDC Response. HHS/CDC agrees
with the commenters and has revised
the text of the final rule to expressly
permit notifying the Agency by
telephone, text message, or email of
worker exposure to a zoonotic illness.

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Other commenters addressed the
proposed health reporting requirements
in § 71.53(m). One commenter
questioned the proposal in paragraph
(m)(4) that an importer must notify
HHS/CDC if the mortality of an NHP
cohort exceeds 5 percent. The
commenter said this threshold could
preclude the earliest detection of
outbreaks or identification of
associations between cases, and argued
that we should establish an evidencebased, risk-averse threshold through
epidemiological analysis and other
available data.
Regarding the proposal in paragraph
(m)(7) that an importer notify HHS/CDC
within 48 hours if an NHP exhibits signs
of TB, four commenters asserted the
reporting period should be 24 hours.
These commenters said that because TB
is extremely communicable and highly
dangerous to humans, it was
‘‘nonsensical’’ to have a reporting
period that is double that for reporting
other zoological diseases. The
commenter said that although paragraph
(m) stated proposed notification
requirements for six events, the failure
to define what would constitute a
‘‘severe’’ illness made the provision
ambiguous, and difficult to either
comply with or enforce.
HHS/CDC Response. In § 71.53(m)(2),
the final rule requires notifying the
Agency of any morbidity or mortality of
animals in quarantine, rather than of
‘‘severe illness or death’’ as proposed.
Similarly, § 71.53(m)(4) of the final rule
removes the 5 percent threshold for
notifying HHS/CDC of morbidity or
mortality in a shipment between
embarkation from the county of origin
through release from quarantine in the
United States. Instead, as with
paragraph (m)(2), the rule requires
notification of any morbidity or
mortality during the period described.
As to the comment that we set an
evidenced-based threshold for reporting
mortality, we noted previously that the
mortality rates for special permit
process NHPs during shipment and
quarantine has been less than 1 percent
over the last 5 years (Roberts, 2008;
DeMarcus, 1999). Therefore, requiring
notification of any morbidity or
mortality sets a conservative, evidencebased reporting standard. Further, we
have set a more conservative 24-hour
requirement in § 71.53(m)(7) for
notifying the Agency of positive or
suspicious TST results as most
protective of human health. All
notification periods in § 71.53(m) are
now 24 hours.
These commenters also suggested that
notification requirements in proposed
§ 71.53(p)(2)(i) and (ii) for zoo-to-zoo

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transfers mirror the requirements for
laboratory-to-laboratory transfers in
proposed § 71.53(q)(2)(i) and (ii).
HHS/CDC Response. HHS/CDC agrees
that notification requirements should be
the same for laboratory-to-laboratory
transfers as for zoo-to-zoo transfers and
has edited the text of the final rule
accordingly.
H. Public Comments Regarding Worker
Protection Requirements
Commenters addressed the training,
notification, and SOP requirements in
proposed § 71.53(i). One commenter
said HHS/CDC should specify a
maximum interval between training
sessions. Two commenters said we
should require employee training on
post-exposure procedures when the
employee is hired and at least annually
thereafter. One commenter suggested
that worker training include
contingency plans to prevent exposure
to NHPs during transit.
HHS/CDC Response. HHS/CDC agrees
with the comment that worker training
requirements should specify when
workers should receive initial training
and the maximum acceptable interval
between trainings. NHP workers should
receive initial training when they are
hired or before receiving a shipment of
NHPs, and refresher training at least
annually. However, because each
facility varies in size and importation
frequency, we have decided to evaluate
training frequency upon review of
importer application and SOPs, in
keeping performance based standard of
review. This policy of review also
addresses another commenter’s concern
for refresher training on post-exposure
procedures. As stated in § 71.53(i)(4)(i),
worker protection plan training must
include how to avoid and respond to
disease exposures associated with
NHPs. Plans for refresher and
contingency training should also be
included in these SOPs.
One commenter fully supported the
proposed plans for importers, and
especially noted his or her appreciation
of the worker PPE requirements for
employees who handle live NHPs,
which the commenter said, would
benefit USFWS inspectors. This
commenter added a request that we
notify the USFWS-Office of Law
Enforcement of our concerns with their
inspectors who might be responsible for
inspecting a shipment of wildlife later
found to be a source of TB exposure.
HHS/CDC Response. We will
continue to work with and
communicate with our federal partners
whose employees may be exposed to
NHPs while inspecting animal
shipments to ensure awareness of any

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health concerns, including the potential
for exposure to TB. We note that
USFWS inspectors, as with all
individuals, should be wearing
appropriate eye and respiratory
protection when handling or within five
feet of the live NHP shipments.
Another commenter asked why we
recommended hepatitis B vaccine rather
than hepatitis A vaccine, asserting that
animals frequently arrive in quarantine
with naturally occurring positive titers
of hepatitis A, and that hepatitis A is a
disease commonly found throughout the
world, including the United States.
HHS/CDC Response. In the NPRM,
CDC did not recommend specific
vaccines as part of the worker protection
plan. HHS/CDC recommends that all
workers who are at high risk of exposure
to NHPs be current on routine
vaccinations, in accordance with good
public health practice and as reflected
in the Advisory Committee on
Immunization Practices 2
recommendations.

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I. Public Comments Regarding
Equipment, Transfer/Transport, and
Handling
Commenters discussed the proposed
requirements in § 71.53(j) and § 71.53(k)
for NHP equipment, processing,
transport, and identification. An
individual commenter made several
comments concerning these proposed
provisions. The commenter described as
‘‘unrealistic’’ the proposed requirement
in paragraph (j)(5) that only an importer
or an authorized representative could
receive a shipment of NHPs. For
airplanes, said the commenter, a plane
will not wait if there is no one present
who has authority to take receipt of the
shipment under this requirement.
Instead, said the commenter, HHS/CDC
should require a contingency plan to
address Agency concerns.
HHS/CDC Response. HHS/CDC made
a number of changes to the final rule in
response to comments on the proposed
standard operating requirements and
equipment standards for crating, caging,
and transporting live NHPs. We have
deleted proposed paragraph (j)(4), and
renumbered proposed paragraphs (j)(5)
through (j)(13) as (j)(4) through (j)(12) in
the final rule. Paragraph (j)(4) of the
final rule requires an importer to
establish an emergency contingency
plan in the unlikely event that the
importer or its representative is unable
to meet the conveyance transporting an
NHP shipment. This change makes clear
HHS/CDC’s intent that importers should
anticipate and plan for contingencies.
2 http://www.HHS/CDC.gov/vaccines/recs/acip.

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Similarly, the commenter described as
‘‘unrealistic’’ our proposal in paragraph
(j)(8) that during NHP transport,
recirculated air in the NHP
compartment must be HEPA-filtered,
given that neither planes nor
commercial OTR trucks commonly are
equipped with such air-filter systems for
cargo. Regarding our proposal in
paragraph (j)(9) concerning cargo
loading of NHP shipments, this
individual said importers have little
control over aircraft loading procedures,
and cannot enforce loading
requirements. The individual suggested
we work with the International Air
Transport Association (IATA). For
paragraph (j)(11), the commenter
suggested beginning the provision with,
‘‘For each importation itinerary,’’
arguing that without this language, we
would require monitoring and
certification during each shipment.
Finally, regarding paragraphs (j)(13) and
(k)(3), this individual suggested we
expressly require the removal of
potentially contaminated material from
ground transport vehicles ‘‘upon arrival
at the quarantine facility,’’ and the
appropriate disposal of biohazardous
waste.
HHS/CDC Response. HHS/CDC
recognizes that while the importer may
not have control over how a plane is
loaded at the port of destination,
importer SOPs should include
information for training of airport cargo
handlers regarding the importance of
loading NHPs into aircraft to assure that
no contamination of other cargo occurs
and that any issues with the shipment
be easily determined and corrected.
Further, we have revised the
requirement proposed in paragraph
(j)(8) (codified in the final rule as
paragraph (j)(7)) to give importers the
option of either ensuring an adequate
ventilation system is in place, with
HEPA filtration for airflow circulating
between NHPs and passengers traveling
with a shipment of live NHPs, or
providing NHP transport workers with
respiratory PPE if there is not an
adequate ventilation system. The
Agency believes this change makes the
provision less prescriptive while
offering adequate protection against
transmitting zoonotic diseases from
NHPs to humans traveling on the same
conveyance.
We have also revised proposed
paragraph (j)(11) (paragraph (j)(10) of
the final rule) to make clear that before
beginning operations, or ‘‘for each
import,’’ importers must establish and
document the communicable diseaseprevention SOPs to be carried out
throughout the chain of custody. In final
rule paragraph (j)(12), HHS/CDC has

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adopted the commenter suggestion to
state expressly that importers must
ensure SOPs for both the removal from
transport vehicles and proper disposal
of biohazardous waste following a
shipment of live NHPs.
An individual said we should
consider requiring at least two transport
workers for over-the-road (OTR) NHP
shipments, written contingency plans,
and signage on the transport vehicle
warning the public to call a designated
number before entering a vehicle
transporting live NHPs. The commenter
suggested further that we require OTR
shippers to register with HHS/CDC and
undergo training specific to transport
workers. Another commenter suggested
having OTR transporters register with
HHS/CDC. This same commenter also
suggested GPS-equipped vehicles that
meet ‘‘certain minimum standards,’’ and
with operators possessing ‘‘all
applicable licenses/permits to operate as
a commercial transporter.’’
HHS/CDC Response. In response to
the comment that we require two
transport workers per OTR transport
shipment of NHPs, and that these
transport workers and vehicles be
subject to certain additional
requirements, we note that HHS/CDC
has not traditionally regulated transport
workers, but rather NHP importers.
Accordingly, we believe that continuing
to regulate NHP importers, rather than
placing new requirements on transport
workers is the best way to protect public
health. However, we agree with the
commenter that importers should plan
for contingencies in OTR transport, and
have revised § 71.53(i)(4)(i) to clarify
that worker protection plans should
address procedures for responding to
emergencies during transport.
J. Public Comments Regarding
Quarantine Facility Requirements
Commenters addressed the proposed
provisions on quarantine requirements
in § 71.53(l) for importers not otherwise
exempted under this provision (i.e.,
authorized zoo-to-zoo and lab-to-lab
transfers).
Two commenters commented on the
proposed air-handling system
requirements in § 71.53(l)(2)(v) and (vi)
that would mandate a separate system
for each quarantine room, which would
remain under negative pressure relative
to the common hallway or anterooms.
One commenter said the requirement
needed further explanation, given that
inhibiting air mixture between rooms
could be accomplished with separate
exhaust equipment for each room or a
dedicated exhaust system that pools
adjacent rooms. The commenter noted
that exhaust systems are on emergency

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generator power and supply-side air to
quarantine rooms is often provided with
a common HVAC (heating, ventilation,
and air conditioning) system. Regarding
the airflow indicator, the other
commenter asked whether it would
suffice to confirm negative pressure in
the wards and no air circulation out of
the ward, if the importer mounted a
pressure monitor in the wall indicating
negative pressure in the ward compared
to the exterior.
HHS/CDC Response. HHS/CDC agrees
with the commenter’s concerns above
and has edited the text of the final rule
to better explain the intent of the
provision.
One commenter asked whether under
proposed § 71.53(l)(3)(iii), HHS/CDC
should permit veterinary discretion
within a quarantine room to use nets or
gloves to recapture a small NHP rather
than anesthetizing or tranquilizing the
animal ‘‘before handling.’’ The
commenter said that the proposed text
would preclude the use of these
alternative capture methods—even
where experienced personnel would be
involved in the recapture—and the size,
species, or clinical soundness of the
animal would warrant a non-chemical
restraint.
HHS/CDC Response. To address the
comment that HHS/CDC should permit
the use of methods other than
anesthesia or tranquilizer before
handling a live NHP, we have revised
§ 71.53(l)(3)(iii) to allow handling where
an animal is ‘‘otherwise restrained.’’
Because anesthetizing or tranquilizing a
live animal before handling is most
protective of human health and safety,
those are the preferred methods under
the regulation. However, we recognize
that using an alternative restraint
method may be appropriate where the
restraint is part of the facility’s SOPs
and is the last resort for obtaining quick
capture and veterinary handling of a
live NHP.
There were several observations and
suggestions from commenters
concerning the proposed necropsy and
diagnostic testing requirements under
§ 71.53(l), with most commenters
addressing TB testing and procedures.
One commenter recommended
replacing the proposed TB testing
procedures. Another commenter said
that current TB testing methods used in
NHP screening are inadequate, and that
the proposed changes to these methods
‘‘do not go far enough’’ to protect public
and NHP health and welfare. And
another commenter suggested we
reconsider the decision to rely on TB
skin testing using the mammalian old
tuberculin (MOT) method. The
commenter said that skin testing is ‘‘a

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poorly performing test in many NHPs,’’
that the current requirements for
multiple testing at 2-week intervals is
‘‘physiologically demanding’’ on the
animals, and that there is an inherent
risk to animals and humans each time
an NHP must be immobilized for such
testing. The same commenter argued
alternatively for ‘‘currently available
confirmatory tests, which can be
utilized in conjunction with skin
testing, minimizing repeat
immobilization procedures.’’
Another commenter said that there is
a diagnostic TB test other than the
intradermal TST and HHS/CDC’s failure
to recognize the alternative test has
hampered sales. The commenter
asserted that the alternative test permits
use of the same blood sample drawn
during a health examination and
provides results in minutes rather than
days. This commenter said that TST
measured only cell-mediated immunity,
which might be suppressed in a latent
infection, and that combining TST with
measures of humoral immune response
would increase diagnostic power and
could reduce the possibility of failing to
detect latent infection during
quarantine. This commenter further
asserted that there was no proof of TST
working in all NHP species, that there
is no requirement to test new
production batches of TST on primates,
and that imposing the same testing
requirements on all NHPs is an
approach based on tradition, not
scientific merit. Another commenter
also objected to maintaining the TST,
saying that given the poor reliability of
TST results in NHPs, we should
strengthen the proposed requirements to
reflect the best available science and
practices for test methods and regimens.
Yet another commenter recommended
‘‘replacing the (proposed) tuberculin
testing procedures.’’ The commenter
also said that rather than rely solely on
‘‘poorly-performing screening tests in
quarantine,’’ HHS/CDC should require
‘‘currently available confirmatory tests
and then rigorous, ongoing bio-security
and surveillance once in the managed
zoo collection.’’ Noting the proposed
requirement for including in the SOPs a
grading scale interpretation of TSTs for
NHPs in quarantine, this commenter
suggested removing this requirement
from § 71.53(l)(3)(ix), and instead,
grading reactive animals in import
quarantine either as negative or positive.
The commenter asserted that although
quarantine facilities might use such a
scale during import quarantine, many
‘‘do not recognize ‘questionable’
responses,’’ and prefer to err ‘‘on the
side of caution.’’ Similarly, another
commenter said it preferred to grade

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reactions for animals in import
quarantine as positive or negative. The
commenter asserted that that the TB test
itself is imperfect, and that ‘‘any range
of abnormal display may be seen on an
individual that is truly infected.’’
HHS/CDC Response. HHS/CDC does
not accept the assertions that there are
currently TB tests more appropriate
than the required MOT, but believes
that a more improved test may be
developed in the future. The currently
approved test for the diagnosis of TB in
NHPs is the TST performed using MOT,
0.1cc injected intradermally in the
palpebrum and observed at 24, 48, and
72 hours (ILAR, 1980). Other TB tests
have been evaluated but it has been
noted that ‘‘no single screening test will
meet all the requirements for
surveillance and diagnosis of TB in
nonhuman primates. Instead, the use of
several tests in combination can
increase the overall sensitivity and
specificity of screening and surveillance
programs and likely represents the
future of TB testing in nonhuman
primates’’ (Lerche, 2008). HHS/CDC will
continue to require the TST until an
improved testing procedure is
developed. Until then, if test results are
positive, the importer may elect a
battery of tests to confirm the TST
finding, and in consultation with HHS/
CDC, may choose either to treat or
euthanize the animals. Further,
concerning grading scales for animals
with ‘‘questionable’’ responses, HHS/
CDC appreciates that many NHP
importers consider any MOT reaction as
positive. Again, our regulations are
influenced by the ILAR guidelines
(ILAR, 1980), which do allow subjecting
NHPs to further testing in a ‘‘suspect’’
case of TB. HHS/CDC believes that it is
permissible for an importer to interpret
the TST according to the importer’s
approved standard operating procedure
and to do further diagnostic testing for
NHPs with a suspect TB reaction as
defined by the SOP.
A commenter noted that paragraph
(l)(3) should spell out steps for
removing samples from the quarantine
ward to perform laboratory analyses.
HHS/CDC Response. In response to
the commenter’s observation that there
was no language in the proposed rule
describing procedures for removing
samples from the quarantine ward,
HHS/CDC has added a requirement in
§ 71.53(l)(3)(iv) for importers to describe
procedures for handling and
transporting such samples.
Three commenters noted that
proposed § 71.53(l)(3)(viii)(B) would
require antibody testing for animals
surviving quarantine and displaying
signs suggestive of a filovirus infection,

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but that paragraph (l)(6)(viii) of the
provision would require performing
filovirus testing using the antigencapture enzyme-linked immunosorbent
assay (ELISA) method on the liver of
any animal that dies or is euthanized for
reasons other than trauma. The
commenters suggested we modify
§ 71.53(l)(6)(viii) to require antigencapture testing of liver tissue only from
animals that died or were euthanized
and exhibited potential signs of a
filovirus infection.
HHS/CDC Response. In accordance
with the intent of the provision, HHS/
CDC has clarified the proposed language
in § 71.53(l)(6)(viii) to specify that
antigen-capture testing is required for
NHPs that die or are euthanized for any
other reason than trauma or adverse
environmental conditions.
A commenter asked whether an
exemption from a BSL3 type quarantine
still would require adhering to proposed
paragraphs § 71.53(i), (j) and (k). The
commenter suggested worker protection,
crating, and transport at a BSL1 or BSL2
for NHPs with well-documented
medical histories prior to import. Also,
this commenter and another asked HHS/
CDC to clarify the apparent
inconsistency between proposed
§ 71.53(l)(6)(ii), requiring performance
of a necropsy under biosafety level
(BSL)3 containment, and
§ 71.53(l)(6)(iv), requiring necropsy
under BSL3 or BSL2 containment.
HHS/CDC Response. To address
commenter requests for clarification
regarding the appropriate biosafety level
procedures for necropsy requirements
under § 71.53(l)(6), we deleted the
reference to BSL3 in paragraph (l)(6)(ii).
We revised paragraph (l)(6)(iv) to
require BSL3 or BSL2+ precautions for
necropsies only. However, HHS/CDC
acknowledges that all NHPs pose a
potential risk to human health and
should therefore be handled while
wearing recommended PPE, as dictated
in the approved SOPs. BSL2+ is a
hybrid level of precautions that requires
at least the use of a BSL2 facility with
BSL3 containment equipment and
practices. (HHS/CDC and NIH, 2007).
An individual commented that we
should modify or delete proposed
§ 71.53(l)(3)(vii)(C) that would prohibit
an importer from releasing an animal
from quarantine if the importer knows
or has reason to suspect the NHP has a
zoonotic exposure or infection. The
commenter said we should not consider
zoonotic agents such as herpes B virus
in the same category as TB, yellow
fever, or filovirus.
HHS/CDC Response. HHS/CDC has
also revised paragraph
§ 71.53(l)(3)(viii)(C) as the commenter

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requested to clarify that an importer
must not request a release of an NHP
from quarantine if the animal is ‘‘visibly
ill.’’
Referencing proposed paragraphs
§ 71.53(i)(5), (j)(6), (j)(12) and (13),
(k)(3), and (l)(2); a commenter said we
should clarify acceptable procedures for
disinfecting, autoclaving, or disposing
of animal wastes, bedding, and uneaten
food. The commenter also said we
should clarify disinfection requirements
for vehicles. This same commenter said
that when dealing with imports of large
species or large numbers of primates,
the cost of disposing of bedding and
medical wastes could be prohibitive for
zoos, and autoclaving could be
impractical or impossible.
HHS/CDC Response. Regarding the
commenter’s request that HHS/CDC
clarify acceptable procedures for
disinfecting animal wastes, bedding,
and uneaten food, we note that all
methods that meet the performancebased standard will be considered. One
example for handling of animal waste,
bedding, and uneaten food other than
autoclaving or disposal by a biohazard
company would be to put the waste into
the sanitary sewer system. Also, trucks
can be cleaned of gross debris to be
properly disposed of and then sprayed
or fogged with a tuberculocidal,
virucidal, or bactericidal disinfectant for
an adequate contact time and then
cleaned.
K. Public Comments Regarding
Requirements for Veterinarians and
Veterinary Pathologists
The January 2011 NPRM specifically
asked for feedback on what factors
should be taken into consideration in
the determination of whether a
veterinarian is sufficiently
‘‘experienced’’ in the care of NHPs and
what constitutes a ‘‘qualified’’
laboratory. A few commenters discussed
the requirements for veterinarians and
veterinary pathologists. One commenter
said that in requiring quarantine
facilities to have access to a qualified
veterinarian, proposed § 71.53(i) and (l)
should specify that such personnel be
on duty and on site during business
hours; and that there be appropriate
veterinary coverage for evenings,
weekends, and holidays. This
commenter said further that the
requirements should specify a number
of available and qualified veterinarians
commensurate with the number of
NHPs.
HHS/CDC Response. While HHS/CDC
may agree that these are good
requirements for a facility, these do not
help to define qualifications of a
veterinarian. Thus, no changes were

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made to § 71.53(i) and (l) based upon
these comments.
A commenter asserted that the rule
should include as minimum
requirements for veterinarians: A
current veterinary license, USDA
accreditation, and experience with
NHPs. Another commenter also stated
that HHS/CDC should define ‘‘qualified
veterinarian’’ similar to USDA.
HHS/CDC response. HHS/CDC agrees
that these would be the ideal minimal
requirements for a licensed veterinarian
working with NHPs. In response, we
have added a definition for licensed
veterinarian to the text of the regulation
to clarify that these individuals must
have experience working with NHPs.
A commenter asked why HHS/CDC
would require a veterinary pathologist
to have a state license, which would
preclude other qualified professionals
from conducting procedures such as
necropsy. The commenter said that
because veterinary pathologists do not
‘‘practice,’’ most do not obtain or
maintain state licenses. The commenter
also suggested that we require the
performance of necropsies by a boardcertified veterinary pathologist or a
state-licensed veterinarian.
HHS/CDC response. HHS/CDC agrees
that requiring a veterinary pathologist to
perform necropsy is not always
necessary and may be too limiting to an
NHP import facility, but that just any
state-licensed veterinarian may not be
familiar with the public health risk
associated with performing necropsies
on imported NHPs. We have removed
‘‘state-licensed veterinary pathologist’’
from § 71.53(l)(6)(ii) and edited the
language to reflect a requirement for the
performance of necropsies by a
veterinary pathologist or a state-licensed
veterinarian with knowledge and
experience with the disease risks
associated with performing these
necropsies. Additionally, the veterinary
pathologist or licensed veterinarian
must be familiar with the precautions
and level of containment that should be
used to perform these necropsies.
L. Public Comments Regarding Zoo-toZoo and Laboratory-to-Laboratory
Transfers; Animal Acts
Some commenters addressed the
proposed requirements for zoo-to-zoo
and laboratory-to-laboratory transfers in
§ 71.53(l)(1), which would exempt these
entities from the quarantine facility
requirements in this provision provided
that the transfer complied with
proposed § 71.53(p)(2) and § 71.53(q)(2).
After stating their strong support for
paragraph (p)(2), one commenter
recommended following proposed risk-

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reduction procedures irrespective of
whether quarantine is required.
HHS/CDC Response. Regarding the
recommendation for a defined disease
risk assessment for NHPs imported by
AZA-accredited zoos, HHS/CDC does
not believe further risk reduction
procedures are necessary, because a zoo
must conform to AZA standards as a
condition of being excepted from
otherwise applicable quarantine
requirements.
In response to the commenter’s
request that we clarify HHS/CDC criteria
for determining that a zoo outside the
United States is ‘‘AZA equivalent,’’
HHS/CDC will consider a facility as
meeting this standard if it is accredited
by an organization that has standards
comparable to those in the AZA
Accreditation Standards and Related
Policies.3 These standards include
performance-based procedures
addressing appropriate veterinary care,
quarantine and necropsy, and public
exposure to animals. This approach
allows individual institutions to decide
on the best procedures within their
institutional capabilities to reach the
desired results.
Another commenter requested that we
clarify the § 71.53(p)(2) proposed
exemption from the 31-day quarantine
provision in § 71.53(l)(1) for zoo-to-zoo
transfers. The commenter stated that
importers involved in zoo-to-zoo
transfers of NHPs still would have to
comply with proposed §§ 71.53(i)
(worker protection and PPE), 71.53(j)
(SOPs for NHP crating, caging, and
transport), and 71.53(k) (ground
transport requirements). The same
commenter asserted that as written,
these subsections indicate that if an
NHP with a known medical history
were the subject of a zoo-to-zoo transfer,
the animal still would be handled under
BSL3 protocols until its arrival at a U.S.
zoo, where it then would be exempt
from any type of quarantine. The
commenter said there appeared to be an
inconsistency.
HHS/CDC Response. HHS/CDC
clarifies the intent of the regulation by
emphasizing that qualified zoos and
labs under paragraphs (p) and (q) are not
exempt from the worker protection,
ground transportation, or SOP
requirements under this regulation.
Further, the only BSL2+ or BSL3
requirements in this regulation are for
necropsies. However, HHS/CDC
acknowledges that all NHPs pose a
potential risk to human health and
should therefore be handled while
3 http://www.aza.org/uploadedFiles/
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wearing recommended PPE, as dictated
in the approved SOPs.
One commenter said it was unclear
why there was inconsistency in the
standards for documentation of negative
TB tests for animal acts, zoo-to-zoo
transfers, and laboratory-to-laboratory
transfers. The commenter suggested that
the standard for all three should be the
higher one, which is the laboratory-tolaboratory transfer standard. Two
commenters suggested that we have the
same standard for medical records and
certificates for zoo-to-zoo and
laboratory-to-laboratory transfers from
outside the United States.
HHS/CDC Response. Regarding the
differing TB standards for zoo-to-zoo,
laboratory-to-laboratory, and animal
acts, HHS/CDC believes the commenter
may have misinterpreted the proposed
provisions. Neither the proposed
language nor final rule language
specifies a more stringent standard for
one group. However, each group will be
expected to present documentation of
regular TB testing and good health.
One commenter recommended that
NHPs imported through AZA-accredited
zoos go through a defined risk
assessment and decision analysis before
importation and release from
quarantine. This commenter also asked
what criteria HHS/CDC would use to
determine that a zoo outside the United
States was an AZA-equivalent zoo.
HHS/CDC Response. Although we are
easing some of the quarantine
requirements for zoo-to-zoo and
laboratory-to-laboratory transfers, these
entities still will be regulated and
required to follow risk-reduction
procedures. Further, as explained in the
regulatory analyses section for this rule,
importers transferring NHPs between
qualifying zoos and qualifying
laboratories already are regulated by
USDA, may be bound by the Public
Health Service (PHS) policy for humane
treatment of laboratory animals, and
must meet guidelines for animal care
and occupational health and safety from
accrediting organizations. For zoos, that
means providing a quarantine facility
for animals new to the collection.
Considering all these factors, we believe
that our registration, records, and
oversight requirements; the
requirements of accrediting
organizations; and oversight by other
federal entities provides health and
safety assurance equivalent to what the
31-day quarantine period provides for
other importers.
One commenter opposed § 71.53(p)(2)
and § 71.53(q)(2) provisions permitting
NHP transfers between laboratories
without subjecting the animals to
‘‘certain testing and quarantine

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requirements.’’ More specifically, the
commenter said the proposed change
would result in risks to public health
and animal health and welfare, and
would create the potential for abuse.
Another commenter also opposed easing
quarantine requirements for laboratoryto-laboratory transfers of NHPs. Citing
published papers to support the
proposition that neither new shipments
nor established colonies of NHPs are
immune from infectious diseases, the
commenter said we should not
eliminate quarantine requirements for
any reason.
HHS/CDC Response. HHS/CDC
disagrees with these commenters and
emphasizes that such transfers will not
be without oversight. For laboratory-tolaboratory transfers of NHPs, importers
must have protocols approved by the
IACUC, a self-regulating entity required
under U.S. law for institutions using
laboratory animals for research and
instruction. Further, the importer must
demonstrate that the animals are part of
long-term, established studies with
specific study protocols. Sending
laboratories must submit records
showing TB testing, number of NHPs,
current health certificates,
documentation of the research project,
and travel itineraries.
One commenter said that because
NHPs in zoos and in many professional
animal acts live in uncontrolled
environments where interaction with
humans may be unlimited, imported
NHPs in zoo populations and animal
acts leaving and then returning to the
United States should have no special
import exemptions. This commenter
suggested maintaining the 31-day
quarantine requirements for both
categories of NHPs. Two commenters
both agreed we should maintain the
quarantine period for zoo-to-zoo
transfers.
HHS/CDC Response. HHS/CDC agrees
with the comment that transfers of NHP
from facilities outside the United States
should be subject to the same medical
records and health certificate
requirements—irrespective of whether
the transfer is between qualified zoos or
laboratories. Although these groups will
not be required to undergo the 31-day
quarantine, these importers still are
subject to registration with the Agency
before bringing animals into the United
States. The final rule will also hold
importers of U.S.-based animal acts to
the same requirements for entry as
foreign-based animal acts; all such
NHPs will be subject to a quarantine
period regardless of where the animals
are based.

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M. Public Comments Regarding NHP
Products
One commenter said we should better
define ‘‘the scope, requirements or
duration’’ of the permit process to help
importers of NHP blood and tissue
samples ensure that shipments of such
products would not be degraded or
destroyed and lose their scientific value.
The commenter questioned the
necessity for further permit
requirements given that importers of
these products already must obtain a
CITES permit.
HHS/CDC Response. Under § 71.53(t),
Nonhuman primate products, importers
are required to obtain a permit from
HHS/CDC prior to shipment of these
products. However, this final rule does
not change the current and longstanding
practice of obtaining such a permit.
HHS/CDC recognizes the need for
timely shipment of such products and
will expedite all requested permits to
ensure that no products are degraded or
destroyed.
Two commenters made remarks on
proposed requirements for permits for
importing NHP products, including
blood and biological samples. One
commenter asked us to indicate that a
HHS/CDC permit covers NHP products
not intended for commercial use.
HHS/CDC Response. In response, a
HHS/CDC permit is required and will
cover any NHP product (personal or
commercial) unless it has been rendered
noninfectious, as defined in the final
text of the regulation.
A commenter asked us also to clarify
that although a product importer may
not need a HHS/CDC permit for some
products, there may be other non-HHS/
CDC permits required for import.
Asserting that proposed § 71.53(t) would
cover blood and tissue samples from
NHPs, another commenter noted that
importing these materials already
requires holding a CITES permit, which
HHS/CDC may use to track these
importers and materials.
HHS/CDC Response. At present, HHS/
CDC does not have the resources to
track permits issued by other federal
agencies. Furthermore, such outside
permits are reviewed and issued for
purposes other than to protect public
health.
The commenter also noted that the
requirement to render biological
samples noninfectious could destroy
their scientific value. This commenter
further asked whether formalin-treated
NHP tissues and slides containing such
tissue would require a permit for
importation. The same commenter said
it was important to distinguish between
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preparations of slides and blocks from
formalin-fixed tissue. The commenter
described slides and blocks as subject to
disinfecting in the form of serial
exposure to extractive solvents (e.g.,
alcohol) and heat during tissue
processing and block preparation. It said
that penetration of thin slices of tissue
used on slides permits excellent
penetration of solvents, and that the
preparation of paraffin-embedded
blocks and slides provides a physical
barrier that minimizes potential
exposure. The commenter said that
these materials are for scientific
purposes, that knowledgeable people
handle the materials in laboratories
equipped for handling potentially
infectious samples from humans or
animals, and that the value of permits
for such materials is questionable. The
commenter said that should HHS/CDC
require importers of blood and tissue
samples to obtain a permit, that it must
define and structure the process to
avoid delays that may adversely affect
the scientific quality of samples.
HHS/CDC Response. As noted earlier,
although some importers of NHP
products are subject to the CITES
program, HHS/CDC’s mandate is to
protect public health, and any untreated
NHP product poses a risk to human
health. However, items which may be
compromised by rendering them
noninfectious may still enter the United
States if accompanied by a HHS/CDCissued permit. Under § 71.53(t)(1) of the
final rule, we lay out the conditions for
importing noninfectious products into
the United States. In § 71.53(t)(2) of the
final rule, we clarify that it may be
permissible to import infectious blood
and tissue samples for bona fide
scientific, educational, and exhibition
purposes under conditions set out in
that provision. Timely requests for
importing these products are processed
expeditiously. As the final rule makes
clear in § 71.53(t)(1), an NHP product
importer may use formalin fixation or
any method approved by HHS/CDC to
render products noninfectious.
N. Public Comments Regarding Appeals
Regarding the appeals process in
proposed § 71.53(u), four commenters
asserted that the proposed time for
appeal was too short, the process was
undefined, and a rationale for so short
a period was absent. Commenters
suggested expanding appeals to 5 days.
HHS/CDC Response. HHS/CDC agrees
that importers who are denied a permit
should have more time to appeal the
denial. Therefore, § 71.53(u)(2) extends
the time for appeal from 2 to 5 days.
Regarding the process itself, we believe
that an appeal of a permit denial to the

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HHS/CDC Director is unambiguous and
provides sufficient procedural
safeguards against erroneous permit
denials.
O. Public Comments Regarding HHS/
CDC Monitoring and Enforcement
An individual commenter stated that
our proposal said little about facility
inspection, importer compliance,
number of personnel, program funding,
and enforcement actions. The
commenter questioned how we would
ensure consistent monitoring and
enforcement. Another commenter
referenced what it called ‘‘obvious
disincentives’’ for reporting
noncompliance by overseas suppliers
and shippers, and the apparent lack of
a mechanism for HHS/CDC to assess
compliance before an NHP shipment
arrives in the United States. Calling the
proposed procedures in § 71.53(j)
‘‘inadequate,’’ and given what the
commenter said was the failure of NHP
breeding farms outside the United States
to match our health and welfare
standards, this commenter said we
should ‘‘directly monitor’’ NHP overseas
operations. This commenter suggested
that the Agency take a direct, active role
in risk management, by follow the
approach the United Kingdom now
employs. In the alternative, said the
commenter, we could prohibit NHP
imports altogether.
HHS/CDC Response. HHS/CDC does
not have the authority to regulate
foreign NHP facilities. However,
enforcement of the regulations for U.S.
facilities will remain as it is currently,
and the same penalties apply for
violations. For compliance and
inspections, HHS/CDC will continue to
make unannounced visits for U.S.-based
importers, as these importers must make
records, facilities, vehicles, and
equipment available for HHS/CDC
inspection during operating business
days and hours, and at other necessary
and reasonable times.
Another commenter asked whether
inspection of NHP importers would
include importers of blood and tissue
samples, and asked what criteria we
would use for such inspections.
HHS/CDC Response. Because of the
extensive resources that would be
required for such inspections, the
Agency will not perform site visits but
will rely on HHS/CDC quarantine
station inspections of incoming
shipments for compliance with these
requirements.
Another commenter also suggested we
add ‘‘employee health and safety
records’’ and ‘‘animal health records’’ to
the list of things an importer must make
available for HHS/CDC inspection.

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HHS/CDC Response. HHS/CDC agrees
with this comment and has inserted the
suggested language into paragraph
(b)(1).
Regarding a change in the special
permit-renewal period from every 180
days to every two years, one commenter
said this change would ‘‘vastly reduc[e]
regulatory oversight of importers’’
without evidence that the health risk
posed by these importers has changed.
This commenter further asserted that we
provided no justification for changing
the renewal period other than easing the
$84/year burden on the regulated
community, and that such a goal alone
is insufficient ‘‘to justify the serious
threat to the public posed by relaxing
standards for importation of these
species of NHPs.’’
HHS/CDC Response. HHS/CDC
believes that the commenter’s concern
about the reduction in government
oversight is misplaced. We did not
propose a reduction in oversight, but in
administrative burden. Importers must
continue to notify HHS/CDC of all
shipments and the Agency will continue
to perform regular site visits, including
the review of importer standard
operating procedures. Indeed, there is
constant communication between HHS/
CDC and importers. Extending the
renewal period for special permit
species will not result in less oversight,
and is consistent with the directive in
Executive Order 13653 section 1 that we
apply the least burdensome tools for
achieving regulatory ends. Further,

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although one objective of this rule is to
reduce the compliance burden on
special permit species importers; the
principal goals of this rulemaking are to
extend special permit species
requirements to all NHP imports, to
improve Agency oversight through a
general requirement that NHP
shipments enter the United States
through ports of entry with a HHS/CDC
quarantine facility, and to codify
existing guidelines. We have extended
the registration renewal period for
special permit species importers not just
to reduce the burden on the regulated
community, as the commenter asserts,
but because the reduction and
continuing low morbidity and mortality
rates for these species in transit and
quarantine demonstrate that a 2-year
renewal period would be sufficiently
protective of public health.
Concerning the change in timeframe
for renewal of importer licenses, HHS/
CDC would like to emphasize that we
have incorporated all provisions of the
old 180-day permit requirement into the
new regulation and have strengthened
these requirements by requiring
filovirus testing on all Old World
Monkeys. All currently registered
importers of the three special-permit
species (cynomolgus and rhesus
macaques, and African green monkeys)
have been importing these animals since
the special permit first went into effect
in 1990. There have been no legal
challenges to any of the provisions of
the special permit. We received only

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positive feedback from the public
during the comment period for the
NPRM. Compliance with provisions of
the 180-day special permit has been
excellent. Any potential for
misinterpretation of the provisions is
identified during the at-least biannual
review of the importer’s standard
operating procedures and annual site
visits.
The NHP import industry has
changed vastly during the 22 years since
the 180-day special permit final rule
was promulgated. Before the
requirements of the special permit were
introduced, there were hundreds of
NHP importers and high levels of NHP
mortality during import. Many of these
operations were poorly equipped and
quickly dropped out of the industry in
response to the special permit
regulation and other HHS/CDCmandated provisions concerning
tuberculosis. Currently there are only 24
NHP importers registered with CDC: 11
commercial importers; 7 zoos; 4
national primate research centers; 1
university; 1 private research facility.
This number has decreased from 27
registered importers in 2004. There are
now only 8 importers who routinely
import NHP covered by the special
permit.
The number of NHPs imported
annually has decreased dramatically
over the last several years, as shown in
the Figure 1 below.

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Factors for this decrease include
difficulties encountered in international
transportation of NHPs (fewer airlines
allow transport each year), as well as
decreased demand.
When an importer requests renewal of
the special permit, the importer submits
an email, and CDC re-authorizes the
special permit, provided there have
been no changes in the importer’s
standard operating procedures and no
uncorrected procedural violations. In
the last 8 years of program oversight,
there has never been an instance where
a special permit has not been renewed
promptly. Any deficiencies on the part
of the importer are: Noted during
quarantine station oversight when the
shipment reaches the United States;
self-reported during quarantine by the
importer; picked up on biannual review
of the importer’s registration
application; or identified during routine
site visits. All special permit NHP
importers are visited annually.
HHS/CDC’s rulemaking is in keeping
with Executive Order 13563, Improving
Regulation and Regulatory Review,
which states that regulations must
‘‘identify and use the best, most
innovative and least burdensome tools
for achieving regulatory ends. [The
regulations] must take into account
benefits and costs, both quantitative and
qualitative.’’ Renewing the special
permits every 180 days expends

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taxpayer resources (i.e., staff time) to
review and approve renewal
applications, when there is no current
evidence to suggest that such a
frequency of scrutiny contributes
appreciably to protecting public health.
As stated above, regulations should
impose the smallest reasonable burden
on the regulated entities in order to
accomplish the purpose of the
regulations; we are acting in the spirit
of that principle by reducing the burden
on the NHP importers because there is
no evidence that requiring them to
renew their special permits every 180
days is necessary to accomplish the
purpose of the regulations.
It is our opinion based on extensive
experience that the 180-day special
permit final rule was promulgated
during a much different phase of the
import industry. Changes in the
industry since then lead us to believe
firmly that it has no appreciable benefits
public health benefits over a two-year
timeframe.
An individual asked how we will
monitor compliance and apply penalties
for brokers given there were no apparent
requirements for them to register with
HHS/CDC under § 71.53(r).
HHS/CDC Response. Although there
is no requirement for brokers to register
with the Agency, under § 71.53(r),
brokers must notify HHS/CDC of in
transit shipments before the shipments

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arrive in the United States, which
includes providing detailed information
on the animals; the in transit itinerary;
equipment used in transport, housing
and decontamination procedures; and
other performance-based procedures to
reduce the risk of exposing the public to
health hazards presented by NHPs.
Further, the same penalties apply to
brokers as to other entities subject to
these regulations.
P. Miscellaneous Comments
Asserting that proposed reporting of
NHP illnesses and deaths upon arrival
and in quarantine would reveal ‘‘only a
fraction’’ of morbidity and mortality for
these animals, a commenter asked that
we provide an analysis of such cases
from the recent past before continuing
with this rulemaking. The commenter
said we should report on the precise
nature of illnesses and deaths, and
include laboratory and post-mortem
results. According to one comment,
such an analysis would ensure that the
public appreciated and understood any
risks and benefits of the changes we
proposed.
HHS/CDC Response. HHS/CDC
disagrees with this comment. All
morbidity and mortality in a shipment
of NHPs upon arrival and during the 31day quarantine period is reported to
(and recorded by) HHS/CDC. Illness
reports and necropsy reports are

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reviewed before any NHPs are released
from the required quarantine.
Additionally, veterinary medical
records are reviewed during the regular,
unannounced site visits.
One commenter recommended that in
the final rule preamble or the rule itself,
we discuss whether the rule would
apply retroactively to NHPs imported
before issuance of the final rule. The
agency expressed particular interest in
rule provisions addressing an importer’s
ability to maintain, sell, resell, or
otherwise distribute imported NHPs or
the offspring of imported NHPs.
HHS/CDC Response. Regarding the
question of retroactive applicability,
HHS/CDC notes that the new rule does
not apply to animals or the offspring of
animals imported into the country
before 1975. For decades, there have
been prohibitions on importing NHPs
except for scientific, exhibition, or
educational purposes; or for using the
offspring of imported NHPs for reasons
other than scientific, exhibition, or
educational purposes. The revised rule
continues these prohibitions.
IV. Alternatives Considered
Executive Order 13563 recommends
that the regulatory impact analysis
consider all feasible alternatives to
current practice and the rule as
proposed. The main impact of the rule
is to unify existing regulations and
codify and professional guidance
regarding infection control and worker
safety procedures to prevent
transmitting pathogens from NHPs to
humans. As explained in II. Summary of
the Proposed Rule Requirements, HHS/
CDC proposed a number of changes in
the NPRM that would achieve its
regulatory objectives through
performance-based standards rather
than promulgating prescriptive
standards for importers. HHS/CDC
endeavored to allow regulated entities
flexibility in choosing how to meet the
standards. We have provided flexibility
regarding recordkeeping requirements,
standard operating procedures, and
worker protection requirements.
HHS/CDC reviewed the 31-day
quarantine requirement and associated
restrictions for transfers of NHPs into
the United States between Association
of Zoos and Aquariums (AZA)accredited zoos and proposed to
eliminate that requirement. Similarly,
HHS/CDC proposed a quarantine
exception for transfers of NHPs from
laboratories accredited by the
Association for Assessment and
Accreditation of Laboratory Animal
Care International (AAALAC) or its
equivalent, if the laboratory has a
foreign-based and a U.S.-based facility

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and the NHP is part of an ongoing
research project.
V. Regulatory Analyses
A. Executive Orders 12866 and 13563
HHS/CDC has examined the impacts
of the proposed rule under Executive
Order 12866, Regulatory Planning and
Review (58 FR 51735, October 4, 1993)
and Executive Order 13563, Improving
Regulation and Regulatory Review, (76
FR 3821, January 21, 2011). Both
Executive Orders direct agencies to
evaluate any rule prior to promulgation
to determine the regulatory impact in
terms of costs and benefits to United
States populations and businesses.
Further, together, the two Executive
Orders set the following bars: quantify
costs and benefits where the new
regulation creates a change in current
practice; define qualitative costs and
benefits; choose approaches that
maximize benefits; support regulations
that protect public health and safety;
and minimize the impact of regulation.
HHS/CDC has analyzed the rule as
required by these Executive Orders and
has determined that it is consistent with
the principles set forth in the Executive
Orders and the Regulatory Flexibility
Act, as amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA) and that the rule will not
create enough change in current practice
to have a measurable, quantifiable
impact.
This rule is not being treated as a
significant regulatory action as defined
by Executive Order 12866. As such, it
has not been reviewed by the Office of
Management and Budget. This
regulatory action is not a major rule
under the Congressional Review Act. In
our screening analysis under the
Regulatory Flexibility Act, HHS/CDC
also concludes that the rule will not
have a significant economic impact on
a substantial number of small entities.
HHS/CDC has determined that the
main impact of the rule will be to unify
existing regulations and codify
professional guidance regarding
infection control and worker safety
procedures to prevent transmitting
pathogens from NHPs to humans. All
stakeholders involved in the
importation and maintenance of NHPs
will now be subject to the same set of
rules and guidelines. This rule
combines a disparate set of professional
recommendations and rules that were
published or established in various
formats between 1975 and 1993 (see C.
What is the History of this
Rulemaking?). This rule clarifies
definitions of terms and requirements
for developing plans and SOPs for

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quarantine, other operations, personnel
training, and worker health programs
prior to importation of NHPs; although
the rule does not add new terms or
requirements. The regulation also
allows stakeholders to exercise their
own good judgment in implementing
the regulatory guidelines through
performance-based standards, rather
than dictating prescriptive compliance.
The rule impact will be unification of
existing rules and codification
professional guidance. The rule will
create qualitative costs and benefits for
all NHP importation stakeholders and
the United State public as explained
below.
Benefits. There are benefits to the rule
that accrue to: (1) The public in the form
of protecting public health; (2) business
stakeholders in the form of investment
protection and a reduction in time
needed to be spent on regulatory
compliance leading to a benefit of
avoided costs; (3) the NHP workforce;
and (4) the scientific community.
Public health benefits:
• Reduction in risk of transmission of
a variety of zoonotic infections
including filoviruses, TB, herpes B
virus, and parasites.
• Entry through quarantine stations
where qualified personnel examine the
NHP to ascertain any potential exposure
to the public through direct contact or
contaminated cargo.
• Certifying the health of NHPs in
animal acts will reduce the risk of
spectators coming in contact with ill
animals.
Business stakeholders benefits
(reduction in time spent on regulatory
compliance, or avoided costs, and
investment protection):
• Investment protection—Certifying
the health of NHP will reduce the
potential transmission of disease
between NHP and reduce the costs to
the business of caring for other ill
animals, or in the worst case, stop the
loss of investment through death.
• Regulatory reduction (avoided
cost)—The registration renewal time for
all NHPs will now be 2 years.
Previously, importers of cynomolgus,
African green, and rhesus monkeys were
required to renew their special permit
registration every 180 days, or two times
a year. According to HHS/CDC records,
special-permit holders are about a third
of all NHP importers (20 of a total of 60).
This is a four-fold reduction in
paperwork for registration renewal for
about a third of all NHP importers.
• Regulatory reduction (avoided
cost)—More specific definitions and
uniform application of rules and
standards will make it much easier for
businesses to reliably forecast the time

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Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations
they need to spend complying with
regulation.
• Regulatory reduction (avoided
cost)—The rule eradicates the 31-day
quarantine period for animals being
transferred between zoos and
laboratories when the facilities have
been approved by professional
organizations (AZA for zoos and
AAALAC for laboratories). CDC
professionals indicate that there are
between three and five such transfers a
year. Professional opinion and
discussion with zoos and laboratories
indicates that this would result in
avoided costs of about $500 to $1,800
per transfer, depending on the facility
costs for quarantine.
Scientific benefits:
• Obstacles to the movement of
highly endangered NHPs will be
removed to protect the species.
• Controlled entry of NHPs for longterm research will be allowed when the
research can only be performed in
United States laboratories.
NHP workers benefits:
• The regulation now defines the
types of personal protective gear that
workers must wear in order to protect
the worker from the potential
transmission of infectious agents.
• Guidelines for regular TB testing
have been established to ensure that
workers are tested and diagnosed in a
timely manner.
• Guidelines are now established for
access to medical care in the event of
zoonotic-human illness transmission to
ensure that workers are tested and
diagnosed in a timely manner.
Costs. The current regulation is
primarily definitional and changes very
little actual current practice. The only
part of the new regulation that will
create an additional cost will be the
requirement that all NHPs being
imported enter the country through a
port of entry or airport with a
quarantine station. At the current time
the majority of, as much as 95%
according to CDC subject matter experts,
of NHPs enter the country at ports with
quarantine stations because they arrive
on airlines that frequent those ports of
entry. The remaining NHPs that are
transported into the United States come
in by truck across smaller border
crossings between Mexico and the
United States or Canada and the United
States. Professionals in CDC’s
Quarantine Branch estimate that this
amounts to approximately one shipment
per year, or less than 5% of all NHP
imported to the United States. HHS/
CDC also notes that arrangements can be
made in advance for alternative ports of
entry if the importers contact HHS/CDC.
Thus, HHS/CDC believes there is very

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little additional cost impact to the
importer.
Cost-Benefit comparison. Benefits and
avoided costs as enumerated in the
benefits section appear to outweigh the
additional transportation cost of
additional travel for one or two
importers each year that will need to
enter through points with quarantine
station.
B. Paperwork Reduction Act Analysis
HHS/CDC has determined that this
rule contains data collection and record
keeping requirements that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3420). HHS/CDC already has
approval from OMB for the collection of
registration information from importers
and record keeping requirements under
OMB Control No. 0920–0134: Foreign
Quarantine Regulations (expiration date
July 31, 2015).
In addition, HHS/CDC has approval
from OMB under OMB Control No.
0920–0263: Requirements for a Special
Permit to Import Cynomolgus, African
Green, or Rhesus Monkeys into the
United States (expiration date June 30,
2014) to collect data from importers
who wish to apply for a special permit
to import non-human primates.
C. Federalism Impact
Under Executive Order 13132, if the
rule would limit or preempt State
authorities, then a Federalism analysis
is required. The agency must consult
with State and local officials to
determine whether the rule would have
a substantial direct effect on State or
local governments, as well as whether it
would either preempt State law or
impose a substantial direct cost of
compliance.
In accordance with section 361(e) of
the PHSA [42 U.S.C. 264(e)], nothing in
this rule would supersede any
provisions of State or local law except
to the extent that such a provision
conflicts with this rule. For example,
the rule would not prevent a State from
taking stronger measures to deal with
infected or possibly infected NHPs or to
cover additional species. Further, our
rule will not supersede state
requirements not in conflict with the
federal rule’s provisions. However, in
accordance with section 361(e) of the
PHSA, any state or local law that would
permit any activity prohibited under
this rule would conflict with this rule
and, therefore, would be superseded.
The rule would not have a substantial
direct effect on State or local
governments or impose a substantial
direct cost of compliance on them.

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D. Environmental Impact
In the absence of an applicable
categorical exclusion, the Director,
HHS/CDC, has determined that
provisions amending 42 CFR 71.53 will
not have a significant impact on the
human environment.
E. Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
at 2 U.S.C. 1532 requires that agencies
prepare an assessment of anticipated
costs and benefits before developing any
rule that may result in expenditure by
State, local, or tribal governments, in the
aggregate, or by the private sector of
$100 million or more (adjusted for
inflation) in any given year. This rule is
not expected to result in any one-year
expenditure that would exceed this
amount, therefore HHS/CDC has not
prepared a table of quantified costs and
benefits.
F. Plain Language Act of 2010
Under Public Law 111–274 (October
13, 2010), executive Departments and
Agencies are required to use plain
language in documents that explain to
the public how to comply with a
requirement the Federal Government
administers or enforces. HHS/CDC has
attempted to use plain language in
promulgating this rule consistent with
the Federal Plain Writing Act
guidelines.
VI. References
National Research Council. ‘‘Occupational
Health and Safety in the Care and Use of
Nonhuman Primates.’’ Institute for
Laboratory Animal Research, Division of
Earth and Life Studies, National
Research Council, The National
Academies Press 2003, Washington, DC.
HHS/CDC (Centers for Disease Control and
Prevention). 1990. Update: Ebola-Related
Filovirus Infection in Nonhuman
Primates and Interim Guidelines for
Handling Nonhuman Primates during
Transit and Quarantine. Morbidity and
Mortality Weekly Report (MMWR).
39(2):22–24, 29–30.
HHS/CDC (Centers for Disease Control and
Prevention). 1990. Update: Filovirus
Infection in Animal Handlers. Morbidity
and Mortality Weekly Report (MMWR).
39(13):221.
55 FR 15210, April 20, 1990, Requirements
for a Special Permit to Import
Cynomolgus, African Green, or rhesus
Monkeys into the United States.
Roper, W.L. Dear interested party (letter).
October 10, 1991. Available upon
request: (404) 639–1600.
Tipple, M.A. Dear interested party (letter).
March 5, 1996. Available upon request:
(404) 639–1600.
HHS/CDC (Centers for Disease Control and
Prevention). 1993. Tuberculosis in
Imported Nonhuman Primates—United
States, June 1990–May 1993. Morbidity

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and Mortality Weekly Report (MMWR).
42(39):572–576.
Formenty, P., et al. Ebola Virus Outbreak
among Wild Chimpanzees Living in a
Rain Forest of Cote d’Ivoire. J. Infect. Dis.
1999; 179(Suppl 1):S120–126.
Rollin PE, et al. Ebola (Subtype Reston) Virus
among Quarantined Nonhuman Primates
Recently Imported from the Philippines
to the United States. J Infect Dis., 1999;
179(Suppl 1):S108–14.
Rouquet P, et al. Wild Animal Mortality
Monitoring and Human Ebola Outbreaks,
Gabon and Republic of Congo 2001–
2003. Emerg Infect Dis., 2005; 11:283–90.
Leroy EM, Telfer P, Kumulungui B, et al.
Serological Survey of Ebola Virus
Infection in Central African Nonhuman
Primates. J Infect Dis., 2004; 190:1895–9.
HHS/CDC (Centers for Disease Control and
Prevention). 1996. Ebola-Reston Virus
Infection among Quarantined Nonhuman
Primates—Texas, 1996. Morbidity and
Mortality Weekly Report (MMWR).
45(15):314–316.
HHS/CDC (Centers for Disease Control and
Prevention). 1989. Ebola Virus Infection
in Imported Primates—Virginia.
Morbidity and Mortality Weekly Report
(MMWR). 38(48):831–832, 837–838.
Roberts, J.A., Andrews, A. Nonhuman
Primate Quarantine: Its Evolution and
Practice. 2008. Institute for Laboratory
Animal Research (ILAR) Journal. 49(2).
DeMarcus, T.A., Tipple, A., Ostrowski, S.R.
US Policy for Disease Control among
imported nonhuman primates. 1999. J
Infect Dis. 179:S281–S82.
Institute for Laboratory Animal Research
(ILAR. 2006 Citing Mullan R.J.
Nonhuman Primate Importation and
Quarantine: United States. Presentation
at Annual Meeting of the Association of
Primate Veterinarians, Park City, Utah,
October 12–14.
Lerche NW., Yee JL, Capuano SV, Flynn JL.
New approaches to tuberculosis
surveillance in nonhuman primates.
ILAR J. 2008;49(2):170–8.
ILAR Subcommittee on Care and Use,
Committee on Nonhuman Primates.
Laboratory Animal Management:
Nonhuman Primates. ILAR News
XXIII:2–3:28–29; National Academy
Press 1980; Washington, DC.
Centers for Disease Control and Prevention
and National Institutes of Health.
Biosafety in Microbiological and
Biomedical Laboratories. U.S.
Department of Health and Human
Services, Fifth Edition, 2007; U.S.
Government Printing Office,
Washington, DC, March 31, 2008.

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List of Subjects in 42 CFR Part 71
Airports, Animals, Communicable
diseases, Harbors, Imports, Pesticides
and pests, Public health, Quarantine,
Reporting and recordkeeping
requirements.
For the reasons discussed in the
preamble, the Centers for Disease
Control and Prevention amends 42 CFR
part 71 as follows:

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PART 71—FOREIGN QUARANTINE
1. The authority citation for 42 CFR
part 71 continues to read as follows:

■

Authority: Sec. 311 of the Public Health
Service (PHS) Act, as amended (42 U.S.C.
243), secs. 361–369, PHS Act, as amended
(42 U.S.C. 264–272).
■

2. Revise § 71.53 to read as follows:

§ 71.53 Requirements for importers of
nonhuman primates.

(a) Purpose. The purpose of this
section is to prevent the transmission of
communicable disease from nonhuman
primates (NHPs) imported into the
United States, or their offspring, to
humans. The regulations in this section
are in addition to other regulations
promulgated by the Secretary to prevent
the introduction, transmission, and
spread of communicable diseases under
42 CFR part 71, subpart A and 42 CFR
part 70.
(b) Scope. This section applies to any
person importing a live NHP into the
United States, including existing
importers, any person applying to
become a registered importer, and any
person importing NHP products.
(1) Importers must make their
facilities, vehicles, equipment, and
business records, including employee
health records and animal health
records, used in the importation of
NHPs, available to HHS/CDC for
inspection during operating business
days and hours, and at other necessary
and reasonable times, to enable HHS/
CDC to ascertain compliance with the
regulations in this section.
(2) Nothing in this section supersedes
or preempts enforcement of emergency
response requirements imposed by
statutes or other regulations.
(c) Acronyms, initialisms, and
definitions.
(1) For the purposes of this section:
AAALAC means the Association for
Assessment and Accreditation of
Laboratory Animal Care International.
AZA means the Association of Zoos
and Aquariums.
CITES means the Convention on
International Trade in Endangered
Species.
ELISA means enzyme-linked
immunosorbent assay, a type of
laboratory test that measures antibodies
or detects antigens for specific
pathogens.
HHS/CDC means U.S. Department of
Health and Human Services, Centers for
Disease Control and Prevention, or an
authorized representative acting on its
behalf.
IACUC means Institutional Animal
Care and Use Committee.

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MOT means mammalian old
tuberculin, a biological product used as
a diagnostic tool in the evaluation for
mycobacterial (TB and related bacteria)
infections.
NIOSH means the National Institute
for Occupational Safety and Health,
Centers for Disease Control and
Prevention, U.S. Department of Health
and Human Services.
PPE means personal protective
equipment, such as gloves, respirators,
and other devices used in preventing
the spread of communicable diseases.
SOPs means standard operating
procedures.
TB means tuberculosis.
TST means tuberculin skin test.
USDA means United States
Department of Agriculture.
(2) For purposes of this section, the
terms listed below shall have the
following meanings:
Animal act means any use of NHPs,
including offspring, for entertainment in
which the NHPs are trained to perform
some behavior or action and are part of
a routinely scheduled show,
performance, or exhibition, open to the
general public.
Breeding colony means a facility
where NHPs, including offspring, are
maintained for reproductive purposes.
Broker means a person or organization
within the United States that acts as an
official agent of an exporter of NHPs
from another country, or as an
intermediary between such an exporter
and an importer of NHPs.
Cohort means a group of NHPs
imported together into the United
States.
Director means the Director of the
Centers for Disease Control and
Prevention, U.S. Department of Health
and Human Services, or an authorized
representative.
Educational purpose means the use of
NHPs, including offspring, in the
teaching of a defined educational
program at the university level or
equivalent.
Exhibition purposes means the use of
NHPs, including offspring, as part of a
public display open to the general
public during routinely scheduled hours
in a facility that meets or exceeds AZA
accreditation standards.
Importer means any person importing,
or attempting to import, a live NHP into
the United States, including an
applicant to become a registered
importer. Within the meaning of this
section, ‘‘importer’’ includes any person
maintaining a facility or institution
housing NHPs during quarantine.
Within the meaning of this section,
‘‘importer’’ also includes the agent of
any animal act, laboratory, or zoo that

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is subject to or carries out
responsibilities in accordance with the
regulations in this section.
In transit means NHPs located within
the United States that are not intended
for import, whether scheduled or not, as
part of the movement of those NHPs
between a foreign country of departure
and foreign country of final destination.
Lab or laboratory means a facility in
the United States accredited by
AAALAC or licensed by USDA,
conducting research using NHPs, having
foreign based facilities, and intending to
transfer or transferring one or more
NHPs that were originally part of an
institutionally approved, ongoing
protocol, from its foreign-based facility
into its United States facility for
purposes related to that specific
research project.
Licensed veterinarian means a person
who has graduated from a veterinary
school accredited by the American
Veterinary Medical Association’s
Council on Education, or has a
certificate issued by the American
Veterinary Medical Association’s
Education Commission for Foreign
Veterinary Graduates, or has received
equivalent formal education as
determined by the HHS/CDC; and has
received training and/or experience in
the care and management of nonhuman
primates.
Medical consultant means an
occupational health physician,
physician’s assistant, or registered
nurse, who is knowledgeable about the
risks to human health associated with
NHPs.
Nonhuman primate or NHP means all
nonhuman members of the Order
Primates.
NHP product or Product means skulls,
skins, bodies, blood, tissues, or other
biological samples from a nonhuman
primate, including trophies, mounts,
rugs, or other display items.
Offspring means the direct offspring
of any live NHPs imported into the
United States and the descendants of
any such offspring.
Old World Nonhuman Primate means
all nonhuman primates endemic to Asia
or Africa.
Pathogen means any organism or
substance capable of causing a
communicable disease.
Permitted purpose means the use of
NHPs for scientific, educational, or
exhibition purposes as defined in this
section.
Person means any individual or
partnership, firm, company,
corporation, association, organization,
including a not-for-profit organization,
such as a sanctuary, or other legal
entity.

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Quarantine means the practice of
isolating live NHPs for at least 31 days
after arrival in a U.S. quarantine facility
where the NHPs are observed for
evidence of infection with
communicable disease, and where
measures are in place to prevent
transmission of infection to humans or
NHPs within the cohort.
Quarantine facility means a facility
used by a registered importer of NHPs
for the purpose of quarantining
imported NHPs.
Quarantine room means a room in a
registered import facility for housing
imported NHPs during the quarantine
period.
Scientific purposes means the use of
NHPs including offspring for research
following a defined protocol and other
standards for research projects as
normally conducted at the university
level.
Zoo means:
(1) Within the United States, an AZAaccredited and professionally
maintained park, garden, or other place
in which animals are kept for public
exhibition and viewing; or
(2) Outside of the United States, a
professionally maintained park, garden,
or other place in which animals are kept
for public exhibition and viewing that
meets or exceeds the accrediting
standards of the AZA.
Zoonotic disease means any
infectious agent or communicable
disease that is capable of being
transmitted from animals (both wild and
domestic) to humans.
(d) General prohibition on importing
nonhuman primates. (1) A person may
not import live NHPs into the United
States unless the person is registered
with HHS/CDC as a NHP importer in
accordance with this section.
(2) A person may only import live
NHPs into the United States for:
(i) Permitted purposes, as defined
under paragraph (c)(2) of this section; or
(ii) Use in breeding colonies, provided
that all offspring will be used only as
replacement breeding stock or for
permitted purposes.
(3) A person may not accept,
maintain, sell, resell, or otherwise
distribute imported NHPs (including
their offspring) for use as pets, as a
hobby, or as an avocation with
occasional display to the general public.
(e) Disposal of prohibited or excluded
NHPs. (1) HHS/CDC may seize,
examine, isolate, quarantine, export,
treat, or destroy any NHP if:
(i) It is imported through a location
other than an authorized port of entry;
(ii) It is imported for other than
permitted purposes;

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(iii) It is maintained, sold, resold, or
distributed for other than permitted
purpose;
(iv) It is imported by a person who is
not a registered importer; or
(v) It is otherwise deemed to
constitute a public health threat by the
Director.
(2) For any NHP arriving in the
United States through an unauthorized
location, for other than the permitted
purposes, or by a person who is not a
registered importer, the person
attempting to import that NHP, must, as
approved by the Director and at the
person’s own expense, do one of the
following:
(i) Export or arrange for destruction of
the NHP, or
(ii) Donate the NHP for a scientific,
educational, or exhibition purpose after
quarantine at a HHS/CDC-registered
facility.
(3) If the person attempting to import
a NHP fails to dispose of the NHP by
one of the options described in
paragraph (e)(2) of this section, the
Director will dispose of the NHP at the
person’s expense.
(4) Pending disposal of any prohibited
or excluded NHPs, the NHP will be
detained at the person’s expense at a
location approved by the Director.
(f) Authorized ports of entry for live
NHPs. (1) An importer may import live
NHPs into the United States only
through a port of entry where a HHS/
CDC quarantine station is located. The
list of current HHS/CDC quarantine
stations can be found at http://
www.HHS/CDC.gov/quarantine/
QuarantineStations.html.
(2) In the event that the importer is
unable to provide for entry at a port
where a HHS/CDC quarantine station is
located, the importer may only import
live NHPs into the United States
through another port of entry if the
Director provides advance written
approval.
(3) If prior written approval is not
obtained from the Director, the importer
and excluded NHPs will be subject to
the provisions of paragraph (e) of this
section.
(g) Registration or renewal of
importers. Before importing any live
NHP into the United States, including
those that are part of an animal act or
those involved in zoo-to-zoo or
laboratory-to-laboratory transfers, an
importer must register with and receive
written approval from the Director.
(1) To register, or to renew a
registration certificate, as an importer, a
person must submit the following
documents to HHS/CDC:
(i) A completed registration/
application form;

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(ii) A completed statement of intent
that describes the number and types of
NHPs intended for import during the
registration period, the intended
permitted purposes for which the NHPs
will be imported;
(iii) Written SOPs that include all
elements required in paragraphs (h)
through (n) of this section;
(iv) A copy of all federal, state, or
local registrations, licenses, and/or
permits; and
(v) A signed, self-certification stating
that the importer is in compliance with
the regulations contained in this section
and agrees to continue to comply with
the regulations in this section.
(2) Upon receiving the documentation
required by this section, the Director
will review the application and either
grant or deny the application for
registration as an importer. Applications
that are denied may be appealed under
paragraph (u) of this section.
(i) Before issuing a registration, the
Director may inspect any business
record, facility, vehicle, or equipment to
be used in importing NHPs.
(ii) Unless revoked in accordance
with paragraph (t) of this section, a
registration certificate issued under this
section is effective for two years
beginning from the date HHS/CDC
issues the registration certificate.
(iii) An importer must apply to HHS/
CDC for renewal of the registration
certificate not less than 30 days and not
more than 60 days before the existing
registration expires.
(3) All importers must comply with
the requirements of paragraphs (h)
through (n) of this section.
(h) Documentation. An importer must
develop, and document compliance
with, a written policy that states
imported NHPs, including their
offspring, will only be used and
distributed for permitted purposes.
(1) An importer must collect or create
a record of the intended purpose of
importation for each imported NHP and
the purpose must comply with one of
the permitted purposes. An importer
must retain written certifications
demonstrating that the NHPs and their
offspring will continue to be used for
permitted purposes for three years after
the distribution or transfer of the NHP.
(2) An importer must retain records
regarding each distribution of imported
NHPs. Each record must include the
identity of any recipients, the number
and identity of each NHP in each
shipment or sale, and the dates of each
shipment or sale, for three years after
the distribution or transfer of the NHP.
(3) An importer must maintain these
records in an organized manner, either
electronically or in a central location

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that is at or in close proximity to the
NHP facility to allow HHS/CDC to easily
inspect the records during HHS/CDC
site visits during regular business hours
or within one hour of such visits. If
records are maintained electronically,
they must be time-dated in a manner
than cannot be altered, and redundant
back-up copies must be made in a
manner that protects against loss.
(4) Before distributing or transferring
an imported NHP, an importer must:
(i) Communicate to the recipients of
NHPs, in writing, the restrictions and
definitions of permitted purposes; and
(ii) Obtain written certifications from
the intended recipient that the NHPs
will be used and distributed only for
permitted purposes.
(i) Worker protection plan and
personal protective Equipment. (1) In
addition to complying with the
requirements of this section, an
importer must comply with all relevant
federal and state requirements relating
to occupational health and safety.
(2) Importers must have a written
worker protection plan for anyone
whose duties may result in exposure to
NHPs, including procedures for
appropriate response measures in the
event of an emergency. An importer
must adhere to the plan and SOPs and
must ensure that each worker covered
under the plan also adheres to it and all
pertinent SOPs.
(3) An importer must contact HHS/
CDC immediately by telephone, text, or
email, as specified in the importer’s
SOP, to report any instance of a worker
exposed to a zoonotic illness and must
include instructions for contacting
HHS/CDC in its worker protection plan.
(4) A worker protection plan must
include the following:
(i) Procedures to protect and train
transport workers in how to avoid and
respond to zoonotic disease exposures
associated with NHPs, including
procedures for appropriate responses in
the event of a vehicle crash or other
emergency during transport;
(ii) Hazard evaluation and worker
communication procedures that adhere
to those in paragraph (i)(5) of this
section;
(iii) PPE requirements that adhere to
those in paragraph (i)(6) of this section;
(iv) TB-control requirements that
adhere to those in paragraph (i)(7) of
this section;
(v) If applicable, SOPs that adhere to
requirements relating to macaques as
described in paragraph (i)(8) of this
section;
(vi) An infection-prevention program,
including infection-prevention methods
requiring, at a minimum, PPE and
workplace practices for preventing

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infection among workers whose duties
may result in exposure to NHPs and:
(A) SOPs that include requirements
for preventing workplace infection from
potentially contaminated needles or
other sharp instruments and that, at a
minimum, prohibit workers from
recapping used needles by hand;
removing needles by hand; or otherwise
bending, breaking, or manipulating used
needles by hand.
(B) SOPs requiring that used
disposable syringes and needles, scalpel
blades, and other sharp items be placed
in puncture-resistant containers kept as
close to the work site as practical and
disinfected and/or disposed of as
hazardous waste.
(C) SOPs requiring that removable,
disposable PPE be autoclaved,
incinerated, or otherwise disposed of as
biohazardous waste. Nondisposable
clothing worn in the quarantine facility
must be disinfected on site before
laundering.
(D) An infection-prevention program
that requires NHP handlers to cleanse
all bites, scratches, and/or mucosal
surfaces or abraded skin exposed to
blood or body fluids immediately and
thoroughly.
(E) Infection-prevention procedures
that require workers to immediately
flush their eyes with water for at least
15 minutes following an exposure of
blood or body fluids to the eye.
(vii) Post-exposure procedures that
provide potentially exposed workers
with direct and rapid access to a
medical consultant including:
(A) Procedures ensuring that exposed
workers have direct and immediate
access to a medical consultant who has
been previously identified in the SOPs
to HHS/CDC.
(B) For potential exposures to herpes
B virus, post-exposure procedures that
require the routing of diagnostic
specimens to the National B Virus
Resource Center located at Georgia State
University in Atlanta, Georgia, or
another location as specified by HHS/
CDC.
(viii) Procedures for documenting the
frequency of worker training, including
for those working in the quarantine
facility.
(5) As part of the worker protection
plan described in this paragraph (i), an
importer must establish, implement,
and maintain hazard evaluation and
worker communication procedures that
include the following:
(i) A description of the known
zoonotic disease and injury hazards
associated with handling NHPs;
(ii) The need for PPE when handling
NHPs and training in proper use of PPE,

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including re-training and reinforcement
of appropriate use;
(iii) Procedures for monitoring
workers for signs of zoonotic illness,
including procedures that ensure
reporting to HHS/CDC by telephone,
text, or email within 24 hours of the
occurrence of illness in any worker
suspected of having a zoonotic disease;
and
(iv) Procedures for disinfection of
garments, supplies, equipment, and
waste.
(6) As part of the worker protection
plan described in this paragraph (i), an
importer must identify the PPE required
for each task or working area.
Additionally, in this part of the worker
protection plan, an importer must
ensure the following:
(i) Any required PPE must be
available to workers when needed;
(ii) Workers in direct contact with
NHPs must wear the following:
(A) Gloves of sufficient thickness to
reduce the risk of cuts, scratches, and
punctures;
(B) At a minimum, disposable NIOSHapproved N95 respirators, in
compliance with OSHA 29 CFR
§ 1910.134, which requires a respiratory
protection program;
(C) Face shields or eye protection; and
(D) Outer protective clothing when
opening crates, removing foreign
materials from crates, feeding NHPs,
removing dead NHPs, or handling
bedding materials.
(iii) Workers handling crates or pallets
containing NHPs must wear the
following:
(A) Elbow-length, reinforced leather
gloves or equivalent gloves that prevent
penetration of splinters, other crating
materials, or debris;
(B) Outer protective clothing;
(C) Waterproof shoes or boots;
(D) NIOSH-approved respiratory
protection that is compliant with OSHA
regulations at 29 CFR 1910.134, and;
(E) Face shields or eye protection.
(iv) Workers whose faces may come
within 5 feet of an NHP must wear
disposable NIOSH-approved N95
respirators and either face shields or eye
protection to protect against aerosol or
droplet transmission of pathogens;
(v) Workers must remove disposable
PPE and discard as a biohazard; and
(vi) Workers must not drink, eat, or
smoke while physically handling NHPs
or cages, crates, or other materials from
such NHPs.
(7) For TB protection, an importer
must ensure the following:
(i) Workers in a facility housing NHPs
must have a baseline evaluation for TB
prior to working with NHPs and an
evaluation at least annually;

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(ii) Prompt and direct access to a
medical consultant who is capable of
performing the evaluation and
maintaining records for such tests;
(iii) If an NHP is found to have
laboratory-confirmed TB, any worker
who had previously entered any room
where a confirmed NHP has been
housed must promptly undergo a postexposure TB evaluation and
(A) If that test is negative, the worker
must undergo another TB evaluation 3
months later; and
(B) If either test is reactive, the worker
must be referred for medical evaluation;
and
(C) The HHS/CDC must be
immediately notified of the results of
the medical evaluation by telephone,
text, or email as specified in the
importer’s SOPs.
(iv) Compliance with exposurecontrol planning elements under 29 CFR
1910.1030 for workers who will have
parenteral and other contact with blood
or other potentially infectious material
from NHPs and compliance with the
respiratory protection requirements in
29 CFR 1910.134.
(8) For importation of macaques, an
importer must develop, implement and
adhere to a written PPE program to
prevent herpes B virus transmission.
The program must be based on a
thorough hazard assessment of all work
procedures, potential routes of exposure
(e.g., bites, scratches, or mucosal
exposures), and potential adverse health
outcomes.
(9) An importer must keep records of
all serious febrile illnesses (fever greater
than 101.3 degrees Fahrenheit [38.5
degrees Celsius] for more than 48 hours)
in workers having exposure to NHPs in
transit or in quarantine. The record
must be kept by the importer as part of
the worker’s administrative records. The
importer must promptly notify HHS/
CDC by telephone, text, or email if such
an illness occurs. An importer must
ensure that the medical consultant
providing care is informed that the
patient works with and/or has been
exposed to NHPs.
(j) SOP requirements and equipment
standards for crating, caging, and
transporting live nonhuman primates.
Equipment standards for crating, caging,
and transporting live NHPs must be in
accordance with USDA Animal Welfare
regulation standards (9 CFR parts 1, 2,
and 3) and International Air Transport
Association standards, and an importer
must establish, implement, maintain,
and adhere to SOPs that ensure the
following requirements are met:
(1) Any crate used to transport NHPs
must be free of sharp projections that

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could scratch or otherwise injure
workers or NHPs.
(2) Glass items must not be used for
feeding or watering NHPs during
transport.
(3) NHPs must only be removed from
crates in an approved quarantine facility
under the supervision of a licensed
veterinarian.
(4) NHPs must not be removed from
crates during transport.
(5) Upon arrival into the United
States, only an importer or an
authorized representative may receive
the NHPs from a conveyance (e.g.,
airplane, ship). The importer must
establish an emergency contingency
plan in the unlikely event they are
unable to meet the shipment.
(6) All reusable items must be
decontaminated between uses.
(7) At all times during transport,
crates containing NHPs must be
separated by a physical barrier from
workers, other individuals, and all other
animals and cargo, or by a spatial barrier
greater than 5 feet, that prevents
contamination of cargo or individuals
with bodily fluids, feces, or soiled
bedding.
(8) At all times during transport,
individuals traveling with the shipment
must be protected from shared air of
NHPs to prevent the transmission of
zoonotic diseases. Airflow must be
unidirectional from NHP transport
workers to NHPs or, if any air is
recirculated to the NHP transport
workers, it must be HEPA-filtered. If a
ventilation system is not in place, all
NHP transport workers must wear
respiratory protection.
(9) If traveling by plane, crates
containing NHPs should be loaded in
the cargo hold last and removed first,
must be placed on plastic that prevents
spillage onto the deck of the plane, and
must be placed on pallets or double
crated to ensure separation from other
cargo.
(10) Workers, as well as NHPs, must
be protected from communicable
disease exposures at any facility used en
route, including transportation holding
facilities. An importer must maintain a
description of any transportation
holding facilities and document the
communicable disease prevention
measures taken to protect workers at
facilities used en route.
(11) For each import, documentation
must be made of the communicable
disease-prevention procedures to be
carried out in every step of the chain of
custody, from the time of embarkation
of the NHPs at the country of origin
until arrival at the quarantine facility.

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(12) Procedures to ensure that aircraft,
ship, vehicles, and related equipment
are decontaminated following transport.
(13) Used PPE, bedding, and other
potentially contaminated material must
be removed from the ground transport
vehicle upon arrival at the quarantine
facility and disposed of as biohazardous
waste.
(k) Ground transport vehicles. An
importer must establish, implement,
maintain, and adhere to SOPs for
ground transport vehicles transporting
NHPs that meet the following
requirements.
(1) Ground transport vehicles must
have a separate cargo compartment with
separate heating, ventilation, and airconditioning systems.
(2) The interior surfaces of ground
transport vehicle cargo compartments
must be of smooth construction, easy to
clean and disinfect.
(3) Used PPE, bedding, and other
potentially contaminated material must
be removed from the ground transport
vehicle upon arrival at the quarantine
facility and disposed of as biohazardous
waste by a licensed facility.
(4) Ground transport vehicle cargo
compartments must be large enough to
allow safe stowage of NHP crates in a
manner that allows ready access to each
NHP during transit without unloading
any crates.
(5) After transport of the NHP
shipment from the port of entry to the
quarantine facility, the importer must
notify HHS/CDC in writing, text
message, or email as specified within
the SOP, within 48 hours of the time the
shipment arrived at the quarantine
facility.
(6) As part of the notification of
arrival in paragraph (k)(5) of this
section, an importer must inform HHS/
CDC whether suspected or confirmed
transmission or spread of communicable
disease occurred during transport,
including notification of NHPs that
died, became ill, or were injured during
transport, or malfunctions associated
with disease-mitigation procedures or
equipment.
(l) Quarantine facilities. (1) The
requirements of this paragraph (l)
relating to quarantine facilities do not
apply to laboratory-to-laboratory
transfers or zoo-to-zoo transfers that are
in compliance with paragraphs (p)(2)
and (q)(2) of this section, respectively.
(2) An importer must maintain a
quarantine facility for holding a cohort
during the required quarantine period.
NHPs must be quarantined for 31 days
after arrival at the importer’s quarantine
facility. HHS/CDC may extend the
quarantine period if an importer or
HHS/CDC finds or suspects that an NHP

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is infected with, or has been exposed to,
a zoonotic disease, or if an importer or
HHS/CDC finds a need for additional
diagnostic testing.
(i) For any quarantine facility
established or maintained under this
section, an importer must establish,
implement, maintain, and adhere to
SOPs that meet the following physical
security requirements:
(A) The facility must be locked and
secure, with access limited to
authorized, trained, and knowledgeable
personnel.
(B) An importer must limit access to
NHP quarantine areas to authorized
personnel who are responsible for the
transport, study, care, or treatment of
the NHPs.
(ii) An importer must keep the
number of workers involved in the care,
transport, and inspection of NHPs to the
minimum necessary to perform these
functions.
(iii) The facility must be designed and
operated in such a manner as to allow
for adequate disinfecting.
(iv) The facility must have adequate
equipment and space for discarding and
disinfecting all equipment, clothing,
and caging.
(v) Each heating ventilation and airconditioning unit in the quarantine
facility must be designed so that there
is no mixing of air among quarantine
rooms and each quarantine room must
remain under negative air pressure in
relationship to the common hallway or
anteroom(s) adjacent to the quarantine
room.
(vi) Each quarantine room must have
air flow indicators (pressure gauges or
visual flow indicators) that are affixed
outside the quarantine room that
indicate the direction of airflow into or
out of quarantine rooms and adjoining
common hallways and anterooms.
(3) An importer must establish,
implement, maintain, and adhere to
SOPs for handling, monitoring, and
testing NHPs in quarantine that meet the
following requirements:
(i) An importer must ensure that all
NHPs are identified individually with a
unique number or alphanumeric code
permanently applied to the NHP by
tattoo, microchip, or other permanent
identifier before importation or after the
31-day quarantine. Tattoos, microchips,
or other permanent identifiers must not
be applied during the quarantine period.
(ii) Health certificates, shipping
documents, and NHP health records
must include the number or code
required in paragraph (l)(3)(i) of this
section, as well as the age, sex, and
species of the NHP.
(iii) An importer must ensure NHPs
are confined in a squeeze-back cage

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whenever possible and that any
individual NHP is anesthetized,
tranquilized, or otherwise restrained
before handling.
(iv) A description of handling and
transporting samples. For any procedure
involving the use of a syringe, a
separate, disposable needle and syringe
must be used, including a sterile needle
and syringe for withdrawing medication
from any multi-dose vials (e.g.,
ketamine).
(v) Before any contaminated item is
removed from a quarantine facility, an
importer must ensure that all NHP
waste, bedding, uneaten food, or other
possibly contaminated items are
disinfected, autoclaved, or doublebagged for disposal as biomedical waste
by a licensed facility.
(vi) All cages, feeding bottles, reusable
items, and other contaminated items
must be disinfected between uses and
before disposal.
(vii) Any equipment used for infusion
of NHPs must be autoclaved or
incinerated, as appropriate.
(viii) During the quarantine period, an
importer must monitor NHPs for signs
of any zoonotic illness, including signs
consistent with yellow fever,
monkeypox, or filovirus disease.
(A) If any NHP appears ill during
quarantine, an importer must monitor
that NHP for signs of zoonotic illness,
including filovirus disease, and ensure
appropriate treatment.
(B) If an Old World NHP displays
signs suggestive of filovirus infection
(e.g., diarrhea with melena or frank
blood, bleeding from external orifices or
petechiae, or suffusive hemorrhage), and
survives, an importer must collect
serum samples on day 31 of quarantine
and test these samples for antibodies to
filovirus while the entire cohort remains
in quarantine. An importer must test the
serum for immunoglobulin G (IgG)
antibodies to filovirus by using an
ELISA methodology, or other method
approved by HHS/CDC.
(C) An importer must not knowingly
request a release from HHS/CDC of any
ill NHP from quarantine under
paragraph (l)(4) of this section.
(ix) For each NHP in a quarantine
facility, an importer must administer at
least three TSTs on the eyelid using old
mammalian tuberculin (MOT), with at
least 2 weeks between tests, before the
NHP is released from import quarantine.
TSTs must be read and recorded at 24,
48, and 72 hours, and a grading scale for
interpretation of these tests must be
listed in an SOP for TB testing.
(A) An importer must ensure that any
cohort with positive or suspicious TST
reaction remains in quarantine and
receives at least five additional TSTs

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(each administered at least two weeks
apart) following removal of the last
affected NHP.
(B) The validity of TB test results may
be compromised if during quarantine an
NHP contracts a viral illness, including
measles; is treated with steroids; or is
immunized. An importer must
document such occurrence(s) and hold
the NHPs until they have recovered
from the illness or are no longer on
treatment, and for a recommended time
after recovery (to be determined in
consultation with HHS/CDC, depending
on the illness or treatment in question)
before TB tests are performed.
(C) An importer must retain records of
all TSTs performed during the lifetime
of each NHP at the facility housing the
NHP until the NHP is transferred to
another facility. These records must
accompany the NHP during moves to
other facilities.
(x) An importer must ensure that
different cohorts of NHPs are
quarantined in separate quarantine
rooms.
(A) If mixing of cohorts should occur,
an importer must treat the mixed cohort
as a single cohort.
(B) All NHPs within that mixed
cohort must remain in quarantine until
each NHP in that mixed cohort has
completed the minimum 31-day
quarantine period.
(C) Quarantined NHPs must be
housed in such a manner that they do
not expose non-quarantined NHPs to
non-filtered air and other potentially
infectious materials, including soiled
bedding, caging, and other potentially
contaminated items.
(4) Before releasing a NHP from
quarantine, an importer must obtain
written permission from HHS/CDC.
HHS/CDC may permit the release of a
cohort from quarantine when all the
following conditions have been met:
(i) The 31-day quarantine period,
including any required extension of
quarantine, has been completed.
(ii) HHS/CDC has confirmed receipt of
written notification of the health status
of the NHPs in the shipment from the
quarantine facility’s licensed
veterinarian as required by paragraph
(m)(4) of this section.
(iii) HHS/CDC confirms that the
importer has addressed and resolved to
HHS/CDC’s satisfaction any NHP or
worker communicable disease issues
that were reported to HHS/CDC during
shipment.
(5) If HHS/CDC notifies an importer of
any evidence that NHPs have been
exposed to a zoonotic disease, the
importer must, at the importer’s
expense, implement or cooperate in the
HHS/CDC’s implementation of

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additional measures to rule out the
spread of suspected zoonotic disease
before releasing a shipment from
quarantine, including examination,
additional diagnostic procedures,
treatment, detention, isolation, seizure,
or destruction of exposed animals.
(6) An importer must establish,
implement, and adhere to SOPs for safe
handling and necropsy of any NHP that
dies in quarantine. The SOPs must
ensure the following:
(i) The carcass of the NHP must be
placed in a waterproof double-bag and
properly stored for necropsy, specimen
collection, autoclaving and/or
incineration, and disposal;
(ii) A necropsy must be performed by
a veterinary pathologist or state-licensed
veterinarian. Each necropsy report must
address all major organ systems and
incorporate clinical history and
laboratory findings;
(iii) Necropsy and appropriate
laboratory testing of the NHP must
document the cause of death and/or rule
out zoonotic illness;
(iv) Necropsy must be performed
under biosafety level 3 (BSL3) or
enhanced biosafety level 2 ‘‘plus’’
(BSL2+) to protect against exposure to
highly infectious agents;
(v) Any samples of tissues, blood,
serum, and/or transudates (bodily fluid)
collected during necropsy must be
retained until the NHP shipment has
been released from quarantine by HHS/
CDC, in case other testing is required by
HHS/CDC;
(vi) Fresh and formalin-fixed tissue
specimens, including tracheobronchial
lymph node, liver, lung, and spleen,
regardless of necropsy findings, must be
collected for laboratory examination;
(vii) Any granulomatous lesions
found in any NHP at necropsy,
regardless of whether TB in the NHP
was previously suspected, must be
submitted to a laboratory for laboratory
examination for acid-fast bacilli and for
mycobacterial culture; and
(viii) In the event that an Old World
NHP dies or is euthanized for any
reason other than trauma or unexpected
adverse environmental conditions
during quarantine, liver tissue for
filovirus antigen by using the antigencapture ELISA method must be
submitted to a qualified laboratory for
testing. The laboratory should provide
documentation of test validation and
records of ongoing quality assurance.
(m) Health reporting requirements for
nonhuman primates. (1) An importer
must notify HHS/CDC of the events
listed in this paragraph (m) by
telephone, text, or email.
(2) An importer must notify HHS/CDC
within 24 hours of the occurrence of any

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morbidity or mortality of NHPs in
quarantine facilities, or following a zooto-zoo or laboratory-to-laboratory
transfer.
(3) For any morbidity or mortality
from time of embarkation from country
of origin to release from HHS/CDC
quarantine, an importer must report the
circumstances to HHS/CDC promptly,
including the cause of death for each
NHP.
(4) Upon completion of the quarantine
period and before an importer releases
any NHP, cohort, or mixed cohort from
quarantine, the importer must ensure
that the quarantine facility’s licensed
veterinarian notifies HHS/CDC in
writing of the health status of the
shipment.
(5) An importer must notify HHS/CDC
within 24 hours if any NHP tests
positive for filovirus virus antigen or
antibody.
(6) An importer must report to HHS/
CDC within 24 hours, any positive or
suspicious TST results, necropsy
findings, or laboratory results. Any
report required under this section must
include a copy or summary of the
individual NHP’s health records.
(n) Recordkeeping and reporting
requirements for importing NHPs. (1)
Before authorizing the import of any
NHPs, an importer must be in
compliance with all applicable elements
of the importer’s SOPs.
(2) At least seven days before
importing a shipment of NHPs, an
importer must notify HHS/CDC in
writing or by email of the impending
shipment and provide the following
information:
(i) The importer’s name and address;
(ii) Number and species of NHPs
being imported;
(iii) Description of crates;
(iv) Means of individually identifying
NHPs;
(v) Origin of NHPs, including the
country, the exporter, and the exporter’s
address;
(vi) Use of NHPs under paragraph (h)
of this section;
(vii) Specific itinerary with names,
dates, flights, times, airports, sea ports,
and responsible parties to contact at
every step of travel, including all
ground transportation;
(viii) Port of entry;
(ix) If arriving by flight, the name of
the airline and its flight number;
(x) If arriving by vehicle, the name of
the vehicle’s owner and its license plate
number;
(xi) If arriving by ship, the name of
the ship and its vessel number;
(xii) Name and address of the
destination quarantine facility;

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(xiii) Name, address, and contact
information for shipper, if other than
the importer;
(xiv) If applicable, name, address, and
contact information for broker in the
United States;
(xv) Name, address, and contact
information for the person(s)
responsible for off-loading NHPs in the
United States;
(xvi) Name, address, and contact
information for any party responsible
for ground transportation from port of
entry to quarantine facility;
(xvii) Expected quarantine facility, if
different from the importer;
(xviii) Master air waybill number for
shipment;
(xix) CITES permit number and
expiration date.
(o) Animal acts. (1) All animal acts
must be registered with HHS/CDC under
paragraph (g) of this section. In addition
to the requirements in paragraph (g) of
this section, which incorporates the
requirements in paragraphs (h) through
(m), an importer must provide:
(i) A description of the animal act that
includes each NHP.
(ii) Brochures, advertising materials,
and/or documentation of recent or
planned animal act performances.
(iii) A current list of all NHPs in the
animal act, indicating each NHP’s name,
species, sex, age, distinguishing
physical description, and unique
identifier such as a tattoo, microchip, or
other permanent identifier.
(iv) Prior to entry or re-entry into the
United States, specific itinerary with
names, dates, flights, times, airports, sea
ports, and responsible parties to contact
at every step of travel, including all
ground transportation.
(v) A description, diagram, and
photographs of the facilities where the
importer houses the NHPs in the animal
act in the United States, including
illustrations of the primate caging and/
or enclosures; the relationship of these
cages or enclosures to other structures
on the property and adjoining
properties; whether the primate
facilities are open to the air or fully
enclosed; and the physical security
measures of the facility.
(vi) Documentation signed by a
licensed veterinarian describing the
physical exam performed on each NHP
in the animal act. Such examinations
must be performed at least once a year.
The physical exam must include the
following:
(A) Routine complete blood counts,
clinical chemistries, fecal exams, and
any additional testing indicated by the
physical exam.

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(B) At least once a year, TB testing
with MOT and interpreted as stated in
paragraph (l)(3)(ix) of this section;
(C) NHPs with positive TST results
must be evaluated for potential
antituberculosis chemotherapy in
consultation with HHS/CDC.
(D) If the NHP is a chimpanzee,
serology and antigen testing for hepatitis
B, serology for hepatitis C, and any
additional titers must be performed as
indicated by clinical history or exam. A
chimpanzee found serologically positive
for hepatitis B and/or hepatitis C is
ineligible for entry or re-entry into the
United States, unless confirmatory
evidence signed by a licensed
veterinarian shows that there is no
hepatitis B or hepatitis C virus present
in the NHP.
(vii) SOPs for transporting the NHPs
internationally, including the shipping
crates or enclosures, the type of
conveyance, and measures to minimize
human exposure to the NHPs.
(viii) A copy of a negative TST
conducted within the past 12 months, or
medical documentation that the
individual is free of clinically active TB,
for each trainer and/or handler.
(ix) A copy of each SOP for
responding to suspected zoonotic
diseases.
(x) If macaques are in the animal act,
an SOP for responding to potential
herpes B-virus exposures.
(p) Zoo-to-zoo transfers. (1) Persons
who will only be importing live NHPs
into the United States through transfer
from one zoo to another must comply
with all the elements listed in
paragraphs (g), (h), (n), (i)(1) through (5),
(i)(6)(i), (i)(6)(v), (i)(6)(vi), (i)(7) through
(9); (j)(1), (j)(2), (j)(5), (j)(10) through
(12); (k)(5) and (k)(6); and (m)(1), (m)(2),
(m)(5), and (m)(6) of this section.
(2) If a zoo is importing one or more
NHPs into the United States from
another zoo, the recipient zoo must,
before the transfer, submit the following
information for approval by HHS/CDC:
(i) A copy of each NHP’s veterinary
medical records, including regular
testing for TB from the previous zoo for
HHS/CDC’s approval. The medical
record should include a positive
identification of the NHP, such as a
tattoo, microchip, or photograph.
(ii) A copy of a current health
certificate, including documentation of
a negative TB test, signed by a state
licensed veterinarian within 14 days of
the transfer stating that the NHP(s)
appear healthy and are free from
communicable diseases; and
(iii) Documentation which verifies
that the recipient zoo is registered in
accordance with this section, and

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(iv) A specific itinerary with names,
dates, flights, times, airports, seaports,
and responsible parties to contact at
every step of travel, including all
ground transportation.
(3) Persons importing live NHPs that
are transferred from one zoo to another,
who are not able to meet the
requirements listed in paragraphs
(p)(2)(i) and (ii) of this section, must
comply with all the elements in
paragraphs (g), (h), (i), (j), (k), (l), (m),
and (n) of this section.
(q) Laboratory-to-laboratory transfers.
(1) A laboratory transferring NHPs on an
established research protocol from its
foreign-based facility to its U.S.-based
laboratory must comply with all the
elements listed in paragraphs (g), (h), (i),
(j), (k), and (n) of this section; and
paragraphs (m)(1), (m)(2), (m)(5), and
(m)(6) of this section.
(2) If a lab is receiving one or more
NHPs for purposes related to an ongoing
research project from another
established research facility outside the
United States, the recipient facility
must, before the transfer, submit the
following to HHS/CDC for approval:
(i) A copy of each NHP’s veterinary
medical records, including regular
testing for TB from the previous lab for
HHS/CDC’s approval. The medical
record should include a positive
identification of the NHP, such as a
tattoo, microchip, or photograph.
(ii) A copy of a current health
certificate(s), including documentation
of a negative TST, signed by a statelicensed veterinarian within 14 days of
the transfer stating that the NHP(s)
appear healthy and are free from
communicable diseases; and
(iii) Documentation of the ongoing
IACUC-approved research project and
the reason the NHP needs to be
transported to the U.S. laboratory
facility.
(iv) A specific itinerary with names,
dates, flights, times, airports, seaports,
and responsible parties to contact at
every step of travel, including all
ground transportation.
(3) Persons importing live NHPs that
are transferred from one lab to another,
who are not able to meet the
requirements listed in paragraphs
(q)(2)(i), (ii), and (iii) of this section,
must comply with all the elements in
paragraphs (g), (h), (i), (j), (k), (l), (m),
and (n) of this section.
(r) In transit shipments of NHPs. (1)
Before arrival into the United States,
brokers of in transit shipments must
notify HHS/CDC of all scheduled in
transit shipments of NHPs not intended
for import into the United States and
provide the following information:

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(i) Number and species of NHPs in the
shipment;
(ii) Origin of NHPs, including the
country, the exporter, and the exporter’s
address;
(iii) Name and full address of the final
destination quarantine facility in the
importing country;
(iv) Means of individually identifying
NHPs, if required by the importing
country;
(v) A specific itinerary while in the
United States including names, dates,
flights, times, airports, seaports, and
responsible parties to contact at every
step of travel within the United States,
including all ground transportation;
(vi) Description of crates;
(vii) SOPs describing procedures to
protect and train transport workers from
exposure to communicable disease
while handling NHPs;
(viii) SOPs describing procedures to
prevent contamination of other articles
and cargo during transit, including
physical separation of crates from other
cargo;
(ix) SOPs describing procedures to
decontaminate aircraft, ships, vehicles,
and related equipment following
transport; and
(x) Proposed use, if any, of in transit
holding facilities and steps to be taken
to protect workers, as well as NHPs,
from communicable disease exposure at
each facility to be used en route.
(2) While located in the United States,
in transit shipments must be housed
and cared for in a manner consistent
with requirements for NHPs intended
for import into the United States as
specified in paragraphs (j) and (k) of this
section.
(s) Revocation and reinstatement of
an importer’s registration. (1) If the
Director determines that an importer has
failed to comply with any applicable
provisions of this section, including the
importer’s SOPs, the Director may
revoke the importer’s registration.
(2) HHS/CDC will send the importer
a notice of revocation stating the
grounds upon which the proposed
revocation is based.
(i) If the importer wishes to contest
the revocation, the importer must file a
written response to the notice within 20
calendar days after receiving the notice.
(A) As part of the response, an
importer may request that the Director
review the written record.
(B) If an importer fails to file a
response within 20 calendar days, all of
the grounds listed in the proposed
revocation will be deemed admitted, in
which case the notice shall constitute
final agency action.
(ii) [Reserved]
(3) If an importer’s response is timely,
the Director will review the registration,

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the notice of revocation, and the
response, and make a decision in
writing based on the written record.
(4) As soon as practicable after
completing the written record review,
the Director will issue a decision in
writing that shall constitute final agency
action. The Director will serve the
importer with a copy of the written
decision.
(5) The Director may reinstate a
revoked registration after inspecting the
importer’s facility, examining its
records, conferring with the importer,
and receiving information and
assurance from the importer of
compliance with the requirements of
this section.
(t) Nonhuman primate products. (1)
NHP products may be imported without
obtaining a permit under this section if
accompanied by documentation
demonstrating that the products have
been rendered noninfectious using one
of the following methods:
(i) Boiling in water for an appropriate
time so as to ensure that any matter
other than bone, horns, hooves, claws,
antlers, or teeth is removed; or
(ii) Gamma irradiation at a dose of at
least 20 kilo Gray at room temperature
(20° C or higher); or
(iii) Soaking, with agitation, in a 4%
(w/v) solution of washing soda (sodium
carbonate, Na2CO3) maintained at pH
11.5 or above for at least 48 hours; or
(iv) Soaking, with agitation, in a
formic acid solution (100 kg salt [NaCl]
and 12 kg formic acid per 1,000 liters
water) maintained at below pH 3.0 for
at least 48 hours; wetting and dressing
agents may be added;
(v) In the case of raw hides, salting for
at least 28 days with sea salt containing
2% washing soda (sodium carbonate,
Na2CO3);
(vi) Formalin fixation; or
(vii) Another method approved by
HHS/CDC.
(viii) Fully taxidermied products are
considered rendered noninfectious, and
so do not require a permit from the
Director.
(2) NHP products that have not been
rendered noninfectious are considered
to pose a potential human health risk
and may only be imported under the
following circumstances:
(i) The product must be accompanied
by a permit issued by the Director.
Requests for permits should be
accompanied by an explanation of the
product’s intended use and a
description of how the product will be
handled to ensure that it does not pose
a zoonotic disease threat to humans.
The Director will review the request for
a permit, and accompanying materials,

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and issue a decision that shall constitute
final agency action.
(ii) The product may only be imported
for bona fide scientific, educational, or
exhibition purposes.
(iii) A permit will only be issued if
the product will be received by a facility
equipped to handle potentially
infectious NHP materials.
(iv) The product must comply with
any other applicable federal
requirements, including those relating
to packaging, shipping, and transport of
potentially infectious, biohazardous
substances as well as those for select
agents pursuant to 42 CFR part 73, 7
CFR part 331, and 9 CFR part 121.
(u) Appeal of denial for a permit to
import. If the HHS/CDC denies your
request for a permit under this section,
you may appeal that denial to the HHS/
CDC Director.
(1) You must submit your appeal in
writing to the HHS/CDC Director,
stating the reasons for the appeal and
demonstrating that there is a genuine
and substantial issue of fact in dispute.
(2) You must submit the appeal
within 5 business days after you receive
the denial.
(3) HHS/CDC will issue a written
response to the appeal, which shall
constitute final Agency action.
(v) Filovirus testing fee. (1) Nonhuman primate importers shall be
charged a fee for filovirus testing of nonhuman primate liver samples submitted
to the Centers for Disease Control and
Prevention (CDC).
(2) The fee shall be based on the cost
of reagents and other materials
necessary to perform the testing; the use
of the laboratory testing facility;
irradiation for inactivation of the
sample; personnel costs associated with
performance of the laboratory tests; and
administrative costs for test planning,
review of assay results, and
dissemination of test results.
(3) An up-to-date fee schedule is
available from the Division of Global
Migration & Quarantine, Centers for
Disease Control and Prevention, 1600
Clifton Road, Atlanta, Georgia 30333.
Any changes in the fee schedule will be
published in the Federal Register.
(4) The fee must be paid in U.S.
dollars at the time that the importer
submits the specimens to HHS/CDC for
testing.
Dated: February 6, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2013–03064 Filed 2–14–13; 8:45 am]
BILLING CODE 4163–18–P

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