```

[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Rules and Regulations]
[Pages 11521-11545]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03064]

[[Page 11521]]

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

Federal Register / Vol. 78 , No. 32 / Friday, February 15, 2013 / 
Rules and Regulations

[[Page 11522]]

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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)

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: 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:

Table of Contents

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

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

[[Page 11523]]

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 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 31-day quarantine period for any 
reason other than trauma. This provision was initially designated in 
the NPRM at Sec.  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 Sec.  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 
Sec.  71.53(d), the long-standing general prohibition on importing 
NHPs, and to reflect, in Sec.  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 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 Sec.  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

[[Page 11524]]

determined by HHS/CDC, for protecting workers from the risks associated 
with handling NHPs.
    The proposed rule contained quarantine provisions, including a 31-
day 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 Sec.  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 Sec.  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 Sec.  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 Sec.  71.53(f), HHS/CDC 
proposed to restrict entry of NHPs into 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 Sec.  
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 pre-
quarantined NHPs posed no risk to human health. Under proposed Sec.  
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 Sec.  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 Sec.  71.53(m), HHS/CDC proposed 19 general 
reporting and recordkeeping requirements in Sec.  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 Sec.  71.53(h) through (n). 
HHS/CDC proposed additional requirements for animal acts entering and 
re-entering the United States under proposed Sec.  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 Sec.  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 [Sec.  71.53(s)] as well as requirements for importing 
untreated NHP products such as carcasses, trophies, blood, and other 
biological samples were proposed under Sec.  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.

[[Page 11525]]

B. Public Comments Regarding Purpose and Scope

    One commenter said that we should broaden the purpose provision in 
Sec.  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 
Sec.  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 post-importation 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 Sec.  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.''
    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 Sec.  71.53(b) and the general prohibition in Sec.  
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 Sec.  71.53(c) to explicitly include not-
for-profit 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.''
    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\
---------------------------------------------------------------------------

    \1\ http://www.HHS/CDC.gov/animalimportation/lawsregulations/nonhuman-primates/nprm/questions-answers-importers.html.
---------------------------------------------------------------------------

    Other commenters addressed the definitions in Sec.  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 Sec.  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

[[Page 11526]]

in Sec. Sec.  71.53(i) and 71.53(l). This same commenter said that in 
the notification requirements in Sec.  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 Sec.  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 Sec.  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 Sec.  71.53, and a provision like 
paragraph (d)(2) for importers, but instead addressed ``post-
importation'' recipients of NHPs.
    HHS/CDC Response. As noted above, under Sec.  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 Sec.  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 Sec.  71.53(g), each NHP importer must obtain 
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/CDC-registered 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 Sec.  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 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 Sec.  
71.53(b)(1) and (g)(2)(i).)

F. Public Comments Regarding Importer Licensing Requirements

    Commenters addressed the application and permit renewal proposals 
in Sec.  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,

[[Page 11527]]

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 Sec.  71.53(i) for worker protection and Sec.  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 Sec.  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 Sec.  71.53(h), (i), (k), 
(m), and (n).
    An individual suggested that we change paragraph Sec.  71.53(h) to 
require that importers develop and document compliance with a written 
policy; revise Sec.  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 Sec.  71.53(h)(3) how an importer must authenticate electronic 
records, if HHS/CDC would permit such records.
    HHS/CDC Response. Each HHS/CDC-registered 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 Sec.  
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 
USFWS-licensed 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, Sec.  
71.53(h) failed to indicate how long an importer must maintain 
documentation, and suggested a 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 Sec.  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 Sec.  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 Sec.  
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 Sec.  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

[[Page 11528]]

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 Sec.  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 Sec.  
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 Sec.  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 Sec.  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 Sec.  
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.
    Other commenters addressed the proposed health reporting 
requirements in Sec.  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 evidence-based, 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 Sec.  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, Sec.  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, evidence-based reporting 
standard. Further, we have set a more conservative 24-hour requirement 
in Sec.  71.53(m)(7) for notifying the Agency of positive or suspicious 
TST results as most protective of human health. All notification 
periods in Sec.  71.53(m) are now 24 hours.
    These commenters also suggested that notification requirements in 
proposed Sec.  71.53(p)(2)(i) and (ii) for zoo-to-zoo transfers mirror 
the requirements for laboratory-to-laboratory transfers in proposed 
Sec.  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 Sec.  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 Sec.  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

[[Page 11529]]

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.
---------------------------------------------------------------------------

    \2\ http://www.HHS/CDC.gov/vaccines/recs/acip.
---------------------------------------------------------------------------

I. Public Comments Regarding Equipment, Transfer/Transport, and 
Handling

    Commenters discussed the proposed requirements in Sec.  71.53(j) 
and Sec.  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.
    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 disease-prevention SOPs to be carried out throughout the 
chain of custody. In final rule paragraph (j)(12), HHS/CDC has 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 Sec.  
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 Sec.  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 Sec.  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

[[Page 11530]]

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 Sec.  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 Sec.  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 Sec.  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 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 
Sec.  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 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 Sec.  71.53(l)(3)(iv) for importers to describe 
procedures for handling and transporting such samples.
    Three commenters noted that proposed Sec.  71.53(l)(3)(viii)(B) 
would require antibody testing for animals surviving quarantine and 
displaying signs suggestive of a filovirus infection,

[[Page 11531]]

but that paragraph (l)(6)(viii) of the provision would require 
performing filovirus testing using the antigen-capture 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 Sec.  71.53(l)(6)(viii) to require antigen-capture 
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 Sec.  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 Sec.  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 Sec.  
71.53(l)(6)(ii), requiring performance of a necropsy under biosafety 
level (BSL)3 containment, and Sec.  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 Sec.  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 
Sec.  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 Sec.  
71.53(l)(3)(viii)(C) as the commenter 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 Sec.  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 performance-
based 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 Sec.  
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 made to Sec.  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 board-certified 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 Sec.  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-to-Zoo and Laboratory-to-Laboratory 
Transfers; Animal Acts

    Some commenters addressed the proposed requirements for zoo-to-zoo 
and laboratory-to-laboratory transfers in Sec.  71.53(l)(1), which 
would exempt these entities from the quarantine facility requirements 
in this provision provided that the transfer complied with proposed 
Sec.  71.53(p)(2) and Sec.  71.53(q)(2). After stating their strong 
support for paragraph (p)(2), one commenter recommended following 
proposed risk-

[[Page 11532]]

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.
---------------------------------------------------------------------------

    \3\ http://www.aza.org/uploadedFiles/Accreditation/Accreditation%20Standards.pdf.
---------------------------------------------------------------------------

    Another commenter requested that we clarify the Sec.  71.53(p)(2) 
proposed exemption from the 31-day quarantine provision in Sec.  
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 Sec. Sec.  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 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-to-laboratory 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 Sec.  71.53(p)(2) and Sec.  71.53(q)(2) 
provisions permitting NHP transfers between laboratories without 
subjecting the animals to ``certain testing and quarantine 
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 laboratory-to-
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-to-laboratory 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.

[[Page 11533]]

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 Sec.  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 
Sec.  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 formalin-fixed 
tissue and histological 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/CDC-issued permit. Under Sec.  71.53(t)(1) of the final rule, we 
lay out the conditions for importing noninfectious products into the 
United States. In Sec.  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 Sec.  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 Sec.  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, Sec.  
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 
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 Sec.  
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.

[[Page 11534]]

    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, 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 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/
CDC-mandated 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.

[[Page 11535]]

[GRAPHIC] [TIFF OMITTED] TR15FE13.014

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 
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 Sec.  71.53(r).
    HHS/CDC Response. Although there is no requirement for brokers to 
register with the Agency, under Sec.  71.53(r), brokers must notify 
HHS/CDC of in transit shipments before the shipments 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 31-day quarantine period is reported to (and recorded by) HHS/CDC. 
Illness reports and necropsy reports are

[[Page 11536]]

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 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 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

[[Page 11537]]

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 long-term 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 
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.

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

[[Page 11538]]

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.

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:

PART 71--FOREIGN QUARANTINE

0
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).

0
2. Revise Sec.  71.53 to read as follows:

Sec.  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.
    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

[[Page 11539]]

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.
    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 AZA-accredited 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;
    (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;

[[Page 11540]]

    (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 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 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,

[[Page 11541]]

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 NIOSH-approved N95 respirators, in 
compliance with OSHA 29 CFR Sec.  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;
    (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 post-exposure 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 exposure-control 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 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.

[[Page 11542]]

    (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 air-conditioning 
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 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 air-conditioning 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 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 double-bagged 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

[[Page 11543]]

(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 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 antigen-capture 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 morbidity or mortality of NHPs in quarantine 
facilities, or following a zoo-to-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;

[[Page 11544]]

    (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.
    (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
    (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 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 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:

[[Page 11545]]

    (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, 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[deg] 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, 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) Non-human primate importers shall be 
charged a fee for filovirus testing of non-human 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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