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[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Proposed Rules]
[Pages 678-695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32922]

[[Page 677]]

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Part IV

Department of Health and Human Services

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42 CFR Part 71

Requirements for Importers of Nonhuman Primates; Proposed Rule

Federal Register / Vol. 76 , No. 3 / Wednesday, January 5, 2011 / 
Proposed Rules

[[Page 678]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 71

[Docket No. CDC-2011-0001]
RIN 0920-AA23

Requirements for Importers of Nonhuman Primates

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: CDC is proposing to amend its 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. Filovirus testing will continue to be required only for Old World 
NHPs. CDC also is proposing to reduce the frequency at which importers 
of cynomolgus, African green, and rhesus monkeys are required to renew 
their registrations, (from every 180 days to every two years). CDC 
proposes to incorporate existing guidelines into the regulations and 
add new provisions to address: NHPs imported as part of a trained 
animal act; NHPs imported or transferred by zoological societies; The 
transfer of NHPs from approved laboratories; and Non-live imported NHP 
products. CDC is also proposing that all NHPs be imported only through 
ports of entry where a CDC quarantine station is located.

DATES: Submit written or electronic comments by March 7, 2011.

ADDRESSES: Written comments, identified by Docket No. xxx, may be 
submitted to the following address: Centers for Disease Control and 
Prevention, Division of Global Migration and Quarantine, ATTN: NHP Rule 
Comments, 1600 Clifton Road, NE., (E03), Atlanta, GA, 30333. Comments 
will be available for public inspection Monday through Friday, except 
for legal holidays, from 9 a.m. until 5 p.m., Eastern Time, at 1600 
Clifton Road, NE., Atlanta, GA 30333. Please call ahead to 1-866-694-
4867 and ask for a representative in the Division of Global Migration 
and Quarantine (DGMQ) to schedule your visit. Comments also may be 
viewed at http://www.cdc.gov/ncidod/dq. Written comments may be 
submitted electronically via the Internet at http://www.regulations.gov 
or via e-mail to NHPPublicComments@cdc.gov. All comments received will 
be posted publicly without change, including any personal or 
proprietary information provided. To download an electronic version of 
the rule, access http://www.regulations.gov.
    Mail written comments on the proposed information collection 
requirements to the following address: Office of Information and 
Regulatory Affairs, OMB, New Executive Office Building, 725 17th 
Street, NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer for 
CDC.

FOR FURTHER INFORMATION CONTACT: Ashley A. Marrone, J.D., U.S. 
Department of Health and Human Services, Centers for Disease Control 
and Prevention, Division of Global Migration and Quarantine, 1600 
Clifton Road, NE., Mailstop E-03, Atlanta, GA 30333, Telephone, 404-
498-1600.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. What is the risk to human health from nonhuman primates?
    B. What is the legal authority for this rulemaking?
    C. What is the history of this rulemaking?
II. Proposed Rule Requirements
    A. What is the scope of this proposed rule?
    B. Does the proposed rule continue the general prohibition on 
importing live NHPs?
    C. What new and revised definitions is CDC proposing in regard 
to importers of NHPs?
    D. What expanded requirements apply to importers of NHPs?
    E. What is a performance-based standard?
    F. What documentation requirements apply to importers of NHPs?
    G. What are the requirements for a worker protection plan and 
personal protection equipment?
    H. What are the proposed requirements for NHP quarantine?
    I. What are the proposed requirements for SOPs and equipment for 
crating, caging, and transporting NHPs?
    J. What are the requirements for ground transport vehicles?
    K. What are the requirements for recordkeeping and reporting?
    L. What are the requirements for animals acts; zoo-to-zoo 
transfers; and lab-to-lab transfers?
    M. What are the requirements for in-transit shipments of NHPs?
    N. What procedures are being proposed for revocation and 
reinstatement of an importer's registration?
    O. What are the requirements for importing NHP products?
    P. Is there an appeal process for a denied application to 
import?
III. Regulatory Analyses
    A. Economic Analysis
    1. Objectives and Basis for the Action
    2. The Nature of the Impacts
    3. Baseline
    4. Alternatives
    5. Benefits
    6. Costs
    7. Regulatory Flexibility Analysis
    B. Paperwork Reduction Act Analysis
    C. Federalism Impact
    D. Environmental Impact
    E. Unfunded Mandates Reform Act
    F. Executive Order 12988
IV. References
List of Subjects

I. Background

A. What is the risk to human health from nonhuman primates?

    Nonhuman primates (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 their work, 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, 
and parasitic infections (1). A zoonotic disease is any infectious 
agent or communicable disease that is able to be transmitted from 
animals, both wild and domestic, to humans. A filovirus is a virus that 
can cause severe hemorrhagic fever in humans and nonhuman primates, 
such as Ebola virus and Marburg virus. Some Macaca fascicularis 
(cynomolgus), Chlorocebus aethiops (African green), and Macaca mulatta 
(rhesus) monkeys imported into the United States have been infected 
with a filovirus (2). An epidemiologic link between hepatitis A 
infections in NHPs, especially chimpanzees, and their caretakers has 
been demonstrated (3). Herpes B virus is a zoonotic agent that 
naturally infects only macaque monkeys. However, while Herpes B virus 
infection is generally asymptomatic or mild in macaque monkeys, it can 
cause fatal encephalomyelitis in humans. Previously reported cases of 
herpes B virus disease in humans usually have been attributed to NHP 
bites, scratches, or percutaneous (through the skin) inoculation with 
infected materials (4). NHPs, especially macaques, are highly 
susceptible to tuberculosis, and most are imported from areas of the 
world with a high prevalence of tuberculosis in humans and NHPs (5). 
NHPs may also be a source of yellow fever virus, which can be 
transmitted to humans by mosquitoes that have fed on an infected

[[Page 679]]

NHP (6). In fact, transmission of yellow fever to humans in NHP 
research work has occurred in this manner (7). NHPs imported into the 
United States from foreign countries often have an uncertain health 
history, and may potentially harbor diseases infectious to humans. 
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 the Secretary deems 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 further 
provides that such regulations may provide for the carrying out and 
enforcement of measures to protect public health, including inspection 
and destruction of animals or articles found to be so infected or 
contaminated as to constitute dangerous sources of infection to humans. 
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 if death of a person 
has not resulted from the violation or up to $250,000 per violation if 
death of a person has resulted from the violation [18 U.S.C. 3559, 
3571(b)]. Organizations may be fined up to $200,000 per violation not 
resulting in death and $500,000 per violation resulting in death [18 
U.S.C. 3559, 3571(c)]. These penalties are criminal in nature and would 
be imposed by a court, and not administratively by HHS or CDC.

C. What is the history of this rulemaking?

    CDC regulations regarding the importation of NHPs were developed to 
address the risk NHPs pose to humans. Since October 10, 1975, CDC, 
through 42 CFR 71.53, has prohibited the importation of NHPs except for 
scientific, educational, or exhibition purposes. For the purpose of 
importing NHPs, CDC has defined scientific and educational purposes as 
those conducted at the university level or equivalent (e.g. use in 
breeding colonies and the advancement of medicine). Exhibition purposes 
is defined as the use of NHPs as part of a public display open to the 
general public during routinely scheduled hours in a facility that 
meets or exceeds the accreditation standards of the Association of Zoos 
and Aquariums (AZA), or in a comparable facility. For example, if an 
importer or facility proposes to exhibit the NHPs for one day a month 
and only to friends and family, this would neither meet nor exceed AZA 
accreditation standards and therefore the facility would not qualify as 
an importer for exhibition purposes. However, if an importer or 
facility proposes to exhibit the NHPs to the general public at a zoo 
during routinely scheduled hours, that importer may qualify as an 
importer for exhibition purposes. Some institutions may fall under more 
than one category of importer. For example, if an established zoo 
applies for a permit to import a live NHP for display, it would be 
considered an importer for exhibition purposes. On the other hand, if 
the zoo employs researchers and requests a permit so that staff can 
perform behavioral psychology studies, for example, it would be 
considered an importer for scientific purposes.
    Under this regulation, NHP importers are required to register with 
CDC; this registration must be renewed every two years. NHPs are 
required to be held in quarantine for at least 31 days following entry 
into the United States. This regulation also requires importers to 
maintain records on imported NHPs and to immediately report illness 
suspected of being communicable to humans. Importers must make their 
facilities, vehicles, equipment, and business records used in the 
importation of NHPs available to CDC during operating business days and 
hours, and at other ``necessary and reasonable times,'' to enable CDC 
to ascertain compliance with the regulations in this section. These 
``necessary and reasonable times'' may include an outbreak or other 
threat to public health that requires immediate and unobstructed access 
to an importer's facilities.
    Additional requirements for importers of NHPs have been developed 
and implemented in response to specific public health threats. On 
January 19, 1990, in response to the identification of Ebola virus 
(Reston strain) in NHPs imported from the Philippines, CDC published 
interim guidelines for handling NHPs during transit and also during 
quarantine (2). Importers were informed by letter from the Director on 
March 15, 1990, that they must comply with specific isolation and 
quarantine standards for continued registration as an importer of NHPs 
under 42 CFR part 71 (8).
    On March 23, 1990, CDC invited the public to comment on new 
guidelines for the importation of NHPs and the potential impact of a 
temporary ban on the importation of cynomolgus monkeys into the United 
States (9). After considering information received at this public 
meeting, coupled with an April 4, 1990, confirmation of asymptomatic 
Ebola virus infection in four NHP caretakers and serologic findings 
suggesting that cynomolgus, African green, and rhesus monkeys posed a 
risk for human filovirus infection, CDC concluded that these three 
species were capable of being an animal host or vector of human disease 
(10).
    On April 20, 1990, CDC published a notice in the Federal Register 
requiring a special permit for importing cynomolgus, African green, and 
rhesus monkeys (11). To be granted a special permit, importers must 
submit a plan to CDC describing specific isolation, quarantine, and 
communicable disease control measures. The plan must detail the 
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. Additional 
requirements include detailed testing procedures for all quarantined 
NHPs to rule out the possibility of filovirus infection. When importers 
demonstrate compliance with these special-permit requirements, CDC 
authorizes continued shipments under the same permit for a period of 
180 days. Certain components of the special-permit requirement have 
changed slightly in response to surveillance findings and the 
development of improved laboratory tests. As indicated in the 1990 
notice, importers were informed of these changes by letter from CDC 
(12). The current special-permit notice requires filovirus antigen 
testing on specimens from any NHP that dies during quarantine for 
reasons other than trauma. Antibody testing is also

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required on surviving NHPs that exhibit signs of possible filovirus 
infection before the cohort is released from quarantine (13).
    On July 30, 1993, CDC published guidelines in the Morbidity and 
Mortality Weekly Report (MMWR) for tuberculosis testing requirements 
for NHPs, following the recognition of tuberculosis in up to 2% of 
imported NHPs and the risk for infection posed to caretakers (5). These 
published guidelines include provisions for recordkeeping to track and 
trace nonhuman primates and use of personal protective equipment by NHP 
handlers to prevent transmission of tuberculosis (5). Since publication 
of the guidelines in the MMWR, importers have submitted a minimum of 
three negative tuberculin skin tests (TSTs) administered at two-week 
intervals on each imported NHP, before CDC has agreed to release of any 
NHPs from quarantine.

II. Proposed Rule Requirements

A. What is the scope of this proposed rule?

    This proposed rule 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. 
Importers must make their facilities, vehicles, equipment, and business 
records used in the importation of NHPs available to CDC for inspection 
during operating business days and hours, and at other necessary and 
reasonable times, to enable CDC to ascertain compliance with these 
regulations. Nothing in this proposal supersedes or preempts 
enforcement of emergency response requirements imposed by statutes or 
other regulations.

B. Does the proposed rule continue the general prohibition on importing 
live NHPs except for science, education, or exhibition purposes?

    Yes, it does. In Sec.  71.53(d), CDC would continue the long-
standing general prohibition in the current regulation on importing 
live NHPs except for science, education, or exhibition purposes. This 
prohibition extends to the importation of non-human primates intended 
for use as service animals. On July 23, 2010, Attorney General Eric 
Holder signed final regulations revising U.S. Department of Justice 
regulations under the Americans with Disabilities Act (ADA), which 
included a revised definition of ``service animal.'' Effective 
February, 2011, these regulations limit the definition of service 
animals to dogs. Other species of animals, whether wild or domestic, 
trained or untrained, are not service animals for the purposes of this 
definition. CDC has carefully considered the potential risks associated 
with the use of imported nonhuman primates as service animals and 
agrees with the position of the U.S. Department of Justice that 
nonhuman primates should not be recognized as service animals because 
of their potential for disease transmission and unpredictable 
aggressive behavior.

C. What new and revised definitions is CDC proposing in regard to 
importers of NHPs?

    In this NPRM, CDC has developed a list of definitions specific to 
modern importation principles and practices for NHPs. These definitions 
either do not appear in the current 42 CFR 71.53, or have been revised, 
and are intended to add clarity to the provisions regulating the 
importation of NHPs. CDC is soliciting public comment on these 
definitions. Of particular importance to this proposal are the 
definitions for animal act, breeding colony, broker, cohort, importer, 
in transit, lab or laboratory, medical consultant, offspring, Old World 
NHP, permitted purpose, quarantine facility, quarantine room, trophy, 
zoo, and zoonotic disease.

D. What expanded requirements apply to importers of NHPs?

    CDC is proposing to expand the isolation, quarantine, and worker 
protection requirements, as well as the registration process, currently 
described in the special-permit requirements for cynomolgus, African 
green, and rhesus monkeys to all importations of NHPs. The proposed 
changes will simplify importer registration procedures by eliminating 
the need for a separate category of importer that must request special 
permits (those that import cynomolgus macaques, Rhesus macaques, and 
African green monkeys). The proposed changes will also provide an 
enhanced measure of worker and NHP safety against known and emerging 
zoonotic diseases. Under proposed provision (g)(1), to register as an 
importer, an individual must submit to CDC a completed application 
form, a completed statement of intent describing the number and types 
of NHPs intended for import during the registration period, a copy of 
all written Standard Operating Procedures (as specified in the NPRM), a 
copy of any current registrations, licenses, and/or permits that may be 
required from the U.S. Department of Agriculture and U.S. Fish and 
Wildlife Service, and 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 these regulations. Upon 
receiving the above application and documentation required (as proposed 
in section (g)(2)), CDC will review the application and grant or deny 
the application for registration as an importer. The timeframe between 
acceptance of the application, and either approval or denial, will 
generally be 30 to 60 calendar days, during which time CDC may consult 
with the applicant regarding any element of the application or 
accompanying documentation.

E. What is a performance-based standard?

    A performance-based standard states goals and objectives to be 
achieved and describes methods that can be used to demonstrate whether 
or not processes, products, and services meet the specified goals and 
objectives. In contrast, a prescriptive standard typically prescribes 
materials, design and construction methods without stating goals and 
objectives. A performance-based standard focuses on desired 
characteristics of the final product, service, or activity rather than 
requirements for the processes to produce it. Performance-based 
standards allow users flexibility in choosing materials (such as which 
products to use for disinfection), design (such as the use of squeeze-
back cages for controlling animals), and services (such as the use of 
off-site, contractual occupational health services for workers). An 
example of a performance-based standard is the Occupational Safety and 
Health Administration's Hazard Communication Standard (HCS), 29 CFR 
1910.1200. CDC proposes to primarily use a performance-based standard 
in reviewing and approving applications for individuals to become 
registered importers of NHPs into the United States and is soliciting 
public comments on this approach.

F. What documentation requirements apply to importers of NHPs?

    The utility of the special permit requirements in quickly detecting 
and controlling filovirus was illustrated by the early and effective 
detection of Ebola virus in imported cynomolgus monkeys in 1996. The 
special permit and other disease control requirements were effective in 
promptly identifying the filovirus infection, minimizing NHP exposure, 
and preventing spread of the infection beyond the room housing the 
original infected NHP (14). For these reasons, CDC is also proposing 
that filovirus testing be expanded to include

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all Old World NHPs (as defined in proposed provision (c)(2)) in 
quarantine that have illness consistent with filovirus or that die for 
any reason other than trauma. The proposed changes would allow for 
surveillance of filovirus infection in other Old World primates, such 
as chimpanzees, gorillas, baboons, drills, and mandrills, which are 
known to be susceptible to infection but are not addressed by the 
current special permit requirements (unpublished data, CDC; 15-18).
    Consistent with the current special permit requirements, under 
proposed provision (h), an importer of NHPs must have a written policy 
that imported NHPs and their offspring will only be used and 
distributed for permitted purposes, as defined in proposed subsection 
(a), and document the intended purpose for the imported NHPs. An 
importer must also retain records documenting the identity of any 
recipients, the number of NHPs in each shipment or sale, and the dates 
of each shipment or sale. An importer must keep written certifications 
demonstrating that the NHPs and any offspring will continue to be used 
for permitted purposes. CDC is proposing to require the importer to 
maintain such documentation to ensure that these NHPs are not diverted 
into the pet trade and subsequently place individuals at risk of 
contracting zoonotic diseases. This record retention requirement would 
apply to any transfer of the NHP from the quarantine facility and any 
subsequent transfers. CDC is soliciting public comment on the proposed 
record retention requirement to learn whether the burden to importers 
outweighs the benefit to public health. Specifically, CDC is soliciting 
comment on how long records should be maintained by the importer, e.g., 
for the expected life of the NHP.
    Proposed subparagraph (h) also proposes to require the importer to 
maintain these records in an organized manner and either electronically 
or in a central location, at or in close proximity to the NHP facility, 
to allow CDC to inspect the records during CDC site visits during 
regular business hours or within one hour of such visits. Before 
distributing or transferring an imported NHP, an importer must 
communicate to the recipients of NHPs, in writing, the restrictions and 
definitions of permitted purposes and obtain written certifications 
from the intended recipient that the NHPs will be used and distributed 
for one of the permitted purposes before the NHPs are sent to them. CDC 
is soliciting public comments on these proposed requirements.

G. What are the requirements for a worker protection plan and personal 
protection equipment?

    In accordance with good public health practice, HHS/CDC recommends 
that all workers who are at high risk of exposure to NHPs be current on 
routine vaccinations including but not limited to Hepatitis B, tetanus, 
and measles vaccines. As part of the NPRM, in provision (i), CDC is 
proposing to require that importers have a written worker protection 
plan for anyone whose duties may result in exposure to NHPs. The 
proposed protection plan is designed to ensure that individuals who 
work in close proximity to NHPs are educated on the risks and protected 
from exposure to zoonotic diseases. For the purposes of enforcement of 
this provision CDC considers ``exposure'' to be a well-understood term 
in the NHP importing community, generally meaning in direct contact or 
sufficiently close proximity to a NHP (or mucosal surfaces or abraded skin exposed to 
blood or body fluids immediately and thoroughly.
    The worker protection plan also places requirements upon the 
importer to provide exposed workers with direct and rapid access to a 
medical consultant, and to document the frequency of worker training 
and education on potential risks of exposure to NHPs. CDC is 
specifically soliciting comment on the appropriate frequency of such 
worker training and education programs. As part of the worker 
protection plan described in proposed subparagraph (i), an importer 
must establish, implement, and maintain hazard evaluation and worker 
communication procedures. Such procedures for employees working in the 
quarantine facility shall include the following: a description of the 
known zoonotic disease and injury hazards of handling NHPs; the need 
for PPE in handling NHPs and training in proper use of PPE, including 
re-training and reinforcement of appropriate use; procedures for 
monitoring workers for signs of zoonotic illness; and procedures for 
disinfection of garments, supplies, equipment, and waste (1-5, 7, 10, 
11, 14, 19-21).
    As part of the worker protection plan described in this subsection 
(i), an importer must identify the PPE required for each task or 
working. Proposed Sec.  71.53(i)(5) describes requirements in the 
worker protection plans for PPE, including face shields or eye 
protection and respiratory protection (such as N95, or powered air-
purifying respirator (PAPR)) that is compliant with OSHA 29 CFR Sec.  
1910.134 which requires a respiratory protection program. Face shields 
are important for preventing droplet splashes to the head from running 
down into the eyes and preventing mucous membrane exposure around the 
edges (sides, top, and bottom to below the chin).
    For tuberculosis protection, CDC is proposing that an importer be 
required to ensure that workers in a facility housing NHPs have a 
baseline tuberculosis test prior to beginning work

[[Page 682]]

with NHPs and, at least annually, a tuberculosis skin test. 
Tuberculosis is an illness which can potentially be transmitted either 
from NHP to human, or from human to NHP. The purpose of this 
requirement is to protect the NHPs from exposure to tuberculosis from 
the workers as well as to monitor potential exposure of the workers to 
tuberculosis from the NHPs. A baseline tuberculosis test is typically 
conducted before the employee begins working with NHPs to ensure that 
the employee does not already have active or latent tuberculosis. A 
Mantoux tuberculosis skin test is the most common diagnostic test used 
for humans to detect tuberculosis exposure.
    Proposed Sec.  71.53(i)(3)(xii) describes herpes B virus post-
exposure procedures that would be required as part of worker protection 
plans for registered importers who import macaques. For protection 
against herpes B virus, CDC is proposing in this subsection that an 
importer must develop, implement, and adhere to a written PPE program 
to prevent herpes B virus transmission.
    CDC is also proposing to require that the worker protection program 
include a thorough hazard assessment of all work procedures, potential 
routes of exposure (e.g., bites, scratches, or mucosal exposures), and 
potential adverse health outcomes. Workers must also be assured prompt 
and direct access to a medical consultant, defined in the proposed rule 
as an occupational health physician, physician's assistant or a 
registered nurse, who is knowledgeable about the risks to human health 
associated with NHPs. The medical consultant in this proposed provision 
may either be an employee of the quarantine facility or a contractor, 
but must be readily available and aware of the potential zoonotic risks 
involved in working with NHPs. CDC is seeking comment on this proposed 
requirement. Additionally, CDC is proposing to require all importers to 
maintain 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 been exposed to NHPs in transit or in quarantine. CDC 
is proposing to require that the record of febrile illnesses be kept 
indefinitely by the importer as part of the worker's medical records, 
and is soliciting public comment on whether this requirement would pose 
an undue burden upon the importer as to outweigh the benefit to public 
health and the health of the individual.
    If macaques are being imported under this provision, the proposed 
worker protection requirements would also include provisions related to 
exposure to herpes B virus (Cercopithecine herpesvirus) because of the 
unique risk of herpes B virus transmission associated with macaques. 
Most cases of herpes B virus disease in humans have been attributed to 
NHP bites, scratches, or percutaneous inoculation with infected 
materials. However, a report of a fatal case of herpes B virus 
infection caused by mucosal splash exposure occurred in 1998, lead to 
the development of CDC recommendations in 1999 for preventing and 
treating herpes B virus exposure (19).
    In addition to complying with the proposed requirements of this 
section, an importer must continue to comply with all relevant Federal 
and State requirements relating to occupational health and safety. CDC 
is soliciting public comment on these additional proposed requirements.

H. What are the proposed requirements for NHP quarantine?

    The proposed requirements state that importers must quarantine all 
NHPs for at least 31 days after arrival at a quarantine facility in the 
U.S. This time period may be extended in the event that the NHPs are 
infected with certain communicable diseases (such as tuberculosis, 
shigella, measles, campylobacter), the importer or CDC suspect a NHP 
may be infected with certain communicable diseases, or if the importer 
or CDC determines that there is a need for additional diagnostic 
testing. The NHP will remain in quarantine until the CDC determines 
that it no longer poses a threat to human health. These requirements 
minimize the risk to persons exposed to imported NHPs by preventing an 
infected NHP from premature release from quarantine.
    The proposed rule directly addresses the two major reasons for 
quarantining recently imported NHPs. The first major reason is to 
provide the earliest recognition of the importation of a zoonotic 
disease with potential public health importance. The second is to 
prevent transmitting infectious agents between NHPs or from NHPs to 
humans. The proposed procedures and standards contained in Sec.  
71.53(l) are essential to minimize the risk of transmitting infectious 
agents between NHPs and from NHPs to humans in quarantine facilities. 
CDC has based these procedures and standards on National Research 
Council (NRC) guidelines, CDC biosafety guidelines, current knowledge 
of infectious agent transmission routes and, experience gained from 
investigating filovirus infection outbreaks (14, 22). These 
requirements are in addition to U.S. Department of Agriculture (USDA) 
regulations in 9 CFR parts 1 through 3 on Animal Welfare, and Fish and 
Wildlife Service regulations in 50 CFR part 14 on Importation, 
Exportation, and Transportation of Wildlife. Section 71.53(l)(1)(ii) 
requires the use of commonly accepted industry standards for the design 
and operation of animal holding facilities and the care and use of 
laboratory animals. Examples of minimum acceptable industry standards 
include those found in the current editions of NRC's ``Guide for the 
Care and Use of Laboratory Animals'' (20) and the CDC/NIH's ``Biosafety 
in Microbiological and Biomedical Laboratories'' (21).
    We have written the proposed facility and procedural requirements 
to apply to all NHP importers. We intend these requirements to protect 
NHPs, facility workers, and others from a variety of potential 
pathogens and to be adaptable to changing needs. We would further 
require importers to incorporate the essential features of each 
applicable proposed requirement into written policies and procedures 
for employees. Proposed Sec.  71.53(g)(1) requires an importer to 
establish, implement, and maintain documentation and standard operating 
procedures (SOPs) associated with the importation of NHPs, and proposed 
Sec.  71.53(b)(3) requires the importer to make the records available 
to CDC for inspection during the life of the NHP, so that we may 
ascertain compliance with the regulations. To facilitate inspection, 
records should be maintained electronically or in a location in close 
proximity to the quarantine facility and in an organized manner. CDC is 
specifically soliciting comment on these proposed record-keeping 
requirements.
    Proposed Sec.  71.53(i) and Sec.  71.53(l) address routine 
veterinary medical care and screening for zoonotic diseases of NHPs in 
quarantine and management of illnesses and deaths of unknown etiology. 
Appropriate screening or diagnostic tests may differ by species, 
country of origin, clinical presentation of ill NHPs, and necropsy 
findings. Therefore, in these regulations, it is proposed that 
importers be required to maintain direct and immediate access to both a 
veterinarian experienced in the care of NHPs and a qualified (i.e., 
licensed or certified) laboratory. CDC is soliciting public comments on 
this provision. Specifically, we hope to obtain 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 factors constitute a ``qualified'' laboratory. This 
provision

[[Page 683]]

also proposes to require that importers maintain written protocols for 
the evaluation and diagnostic testing of suspect cases of zoonotic 
disease in NHPs. At a minimum, an importer's written protocols must 
include diagnostic testing for the infectious agents for which 
reporting is required under these regulations and a plan for evaluating 
unusually high morbidity or mortality rates in a shipment of NHPs.
    Proposed section 71.53(l)(1) of the quarantine requirements 
addresses monitoring and testing NHPs for tuberculosis (TB). In July 
1993, CDC published in the MMWR a review of TB in imported NHPs over a 
three-year period (5). Because TB in captive NHPs is both an animal and 
a human health problem, NHP importers routinely provide a tuberculin 
skin test (TST) for NHPs and workers. According to the MMWR, an 
importer must consider any NHP with a positive TST during import 
quarantine as infectious and as representing a high risk for disease 
transmission. Therefore, when an importer identifies a quarantined NHP 
as TST-positive, the standard practice according to the MMWR 
recommendation is to euthanize the NHP, attempt laboratory confirmation 
of TB, and reinstitute tuberculin skin testing of all other exposed 
NHPs at two-week intervals, with quarantine until five consecutive 
negative TSTs are completed in the quarantined NHPs.
    CDC considers all NHPs to be susceptible to TB; virtually all are 
imported from areas of the world with high prevalence of TB in humans 
and NHPs. Close confinement of these and other NHPs in holding 
facilities (including quarantine) and shipping crates fosters 
conditions where one infected NHP might infect many others. Therefore, 
each NHP in a cohort in quarantine must complete negative TSTs before 
any are released.
    Because there is the potential for transmitting TB and other 
pathogens among NHPs and humans, improved surveillance and testing 
procedures are essential in NHP quarantine and research facility 
settings. Paragraphs Sec.  71.53(i)(6) and (l)(2) of the proposed rule 
include worker protection and quarantine requirements regarding TB. 
Proposed Sec.  71.53(l)(2)(ix) requires an importer to conduct three 
TSTs, with at least two weeks between tests, before releasing NHPs from 
import quarantine. If any NHP in the cohort has a positive or 
suspicious TST reaction (as defined by Institute of Laboratory Animal 
Resources [ILAR] standards [25]), the importer must keep the cohort in 
quarantine and must administer at least five additional TSTs following 
removal of the last affected NHP. Proposed Sec.  71.53(l)(5)(iv) 
provides that for any necropsy of an NHP dying during quarantine, the 
importer must ensure that the necropsy is performed under biosafety 
level 3 (BSL3) or biosafety level 2 (BSL2) with enhanced protective 
equipment and procedures to protect against exposure to highly 
infectious agents.
    Proposed Sec.  71.53(m)(6) requires an importer to report to CDC 
within 48 hours any positive or suspicious TST results, necropsy 
findings, or laboratory results.

I. What are the proposed requirements for SOPs and equipment for 
crating, caging, and transporting NHPs?

    In this proposed provision, the importer bears responsibility for 
ensuring that all infection control measures are in place throughout 
the transportation of the cohort, not just after the NHPs reach a 
licensed quarantine facility in the United States. Physical custody of 
NHPs may be transferred several times during transportation (e.g., from 
exporter to airline to importer). However, because the registered 
importer selects the supplier at the country of origin and arranges for 
transportation to the United States, CDC expects the importer to exert 
control over the conditions under which the NHPs are shipped. CDC 
considers this provision to be part of the performance-based approach 
and the intent is for CDC to work with the importer to identify 
procedures that are effective in preventing communicable disease 
spread. Proposed Sec.  71.53(j) outlines the requirements that the 
importer must meet, either directly or by contractual or other 
arrangement, to ensure safe handling of NHPs during transportation. In 
the combined proposed requirements for crating, caging, and 
transporting, we emphasize the infection control-related aspects of 
shipping NHPs, including procedures to prevent contamination of other 
articles and cargo during transportation, to provide physical 
separation of crates from other cargo, and to decontaminate aircraft, 
ships, vehicles, and related equipment following transport. An importer 
must meet these requirements in combination with all applicable 
sections of other Federal and international regulations and guidelines, 
such as the International Air Transport Association ``Live Animal 
Regulations,'' which have been adopted by U.S. Fish and Wildlife 
Service (23) and the World Health Organization's ``Transport of 
Infectious Substances'' (24). Certain procedures such as planeside 
transfers and expedited clearances may require oversight and/or 
inspection by CDC to ensure implementation of CDC's requirements and 
guidelines. Therefore, in Sec.  71.53(f), CDC proposes to restrict 
entry of NHPs into the United States to those ports of entry where CDC 
quarantine stations are located, except in limited circumstances 
approved in advance by CDC. These circumstances may include situations 
involving ground transport across the U.S. border and charter aircraft 
transport arriving through airports that do not have quarantine 
stations. CDC is working with the stations to enhance the training and 
response capability of the staff. The CDC quarantine stations 
operational at ports of entry and border crossings are currently listed 
at: http://www.cdc.gov/ncidod/dq/quarantine_stations.htm. This listing 
will be updated if more stations are added in the future.

J. What are the requirements for ground transport vehicles?

    When a shipment of NHPs arrive at a U.S. port of entry via 
aircraft, special vehicles must be used to transport the NHPs safely to 
a quarantine facility and ensure that these pre-quarantined NHPs do not 
pose a risk to human health. Likewise, a specialized ground 
transportation vehicle should be used when a shipment of NHPs enters 
the U.S. via a land border crossing, destined for a quarantine 
facility. To ensure vehicles contain proper safeguards, in proposed 
subparagraph (k), CDC is proposing that an importer be required to 
establish, implement, maintain, and adhere to SOPs for ground transport 
vehicles transporting NHPs. CDC is soliciting public comments on these 
proposed requirements.

K. What are the health reporting requirements for NHPs?

    Under proposed Sec.  71.53(m), an importer would have to ensure 
that CDC is notified of the occurrence of any of six events listed in 
the paragraph. An importer must report to CDC within 24 hours of 
discovering the severe illness or death of NHPs in a quarantine 
facility; an illness in an NHP that the importer reasonably suspects is 
yellow fever, monkey pox, or filovirus disease; or of an NHP testing 
positively for filovirus virus antigen or antibody. An importer must 
report to CDC within 48 hours, any positive or suspicious tuberculin 
skin test results, necropsy findings, or laboratory results. These 
reports may be by telephone.
    An importer must report promptly to CDC if the mortality for a 
shipment exceeds 5 percent. The period runs from the time of 
embarkation from the country of origin to the release of the

[[Page 684]]

shipment's animals from quarantine. The report must include the cause 
of death of each NHP. This report may be by telephone. Finally, the 
importer must ensure that CDC receives a written report from the 
quarantine facility's licensed veterinarian of the health status of a 
shipment after the quarantine period is complete, but before the 
importer releases any NHP, cohort, or mixed cohort.
    Any report CDC requires in this section must include a copy or 
summary of the individual NHP's health records.

L. What are the requirements for recordkeeping and reporting?

    In addition to the NHP health reporting requirements in Sec.  
71.53(m), CDC proposes 19 general reporting and recordkeeping 
requirements in Sec.  71.53(n), with which the importer must comply in 
writing at least 7 days before it imports a shipment of NHPs. Among 
these requirements is supplying information that will help authorities 
identify named individuals, businesses, shippers, and carriers 
importing NHPs who are responsible for the NHPs at every leg of the 
transportation process from the time a shipment leaves the country of 
origin to the time the animals arrive at a licensed quarantine 
facility.
    CDC also will require importers to provide information to identify 
the specific vehicles or aircraft used to transport these animals, the 
quarantine facility for which the animals are destined, methods of 
identifying individual NHPs, and similar information. CDC is soliciting 
comment on these proposed requirements.

M. What are the requirements for animal acts; zoo-to-zoo transfers; and 
lab-to-lab transfers?

    Under proposed Sec.  71.53(o)(1), an importer must register with 
CDC all foreign-based animal acts that include a NHP. This provision 
would require the importer to provide information and documentation to 
help identify the individual animal and to describe the conditions 
under which the NHPs are housed in the United States. Other 
requirements include documentation signed by a licensed veterinarian 
attesting to the results of physical examinations of NHPs. The exams 
must address routine elements and tests for conditions specified in the 
regulations. Under proposed Sec.  71.53(o)(2), an importer must meet 
specified requirements for U.S.-based animal acts containing NHPs when 
the animal re-enters the United States after export. The requirements 
in Sec.  71.53(o) are in addition to those documentation requirements 
in proposed Sec.  71.53(g).
    For those NHPs entering the U.S. under the zoo-to-zoo and 
laboratory-to-laboratory transfers exception, proposed Sec.  71.53(p) 
and (q) require the recipient zoo or laboratory within the United 
States to submit veterinary medical records documenting a NHP's current 
and past health history. To qualify for these exemptions, both the 
recipient and transferring zoos must be accredited by the Association 
of Zoos and Aquariums (AZA) (or equivalent if outside of the U.S.) and 
the labs or laboratories must both be accredited by the Association for 
Assessment and Accreditation of Laboratory Animal Care International 
(AAALAC) or licensed by USDA. In addition to the requirement itself, 
CDC is soliciting public comment on these provisions to ascertain what 
standards or factors should be considered in reaching the determination 
that a zoo located outside of the U.S. is ``equivalent'' to an AZA 
accredited facility for it to qualify for an exemption under this 
provision. Further, Sec.  71.53(q) is available only to those NHPs from 
a lab that has both a foreign-based and United States-based facility 
and that are part of an ongoing, institutionally approved research 
project. Adequate justification must also be provided to CDC describing 
the reason a transfer to a U.S. laboratory is necessary (e.g., 
diagnostic equipment only available in the U.S.-based laboratory).

N. What are the requirements for in-transit shipments of NHPs?

    Under Sec.  71.53(r), CDC is proposing to add requirements for 
brokers in the U.S. regarding the handling of in transit shipments of 
NHPs that have a layover or are detained or delayed at a U.S. airport. 
Because there is the potential for human exposure or other cargo 
contamination from NHPs with diseases of public health concern 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 71.53(j) 
and 71.53(k) of this section. CDC is soliciting comment on these new 
proposed requirements for brokers.

O. What procedures are being proposed for revocation and reinstatement 
of an importer's registration?

    Under Sec.  71.53(s), CDC is proposing new procedures for 
revocation and reinstatement of an importer's registration. Under these 
procedures, a registration may be revoked upon notice to the importer 
if the Director determines that the importer has failed to comply with 
any of the applicable provisions of this section. The importer may 
request a written record review by the Director by filing a response 
within 20 calendar days of receiving our notice. The Director will 
review the written record and issue a decision in writing to affirm the 
revocation or reinstate the importer's registration. As a condition of 
reinstating the registration, the Director may require inspection of 
facilities, examination of records, and other assurances of compliance 
with CDC's requirements. The Director's written decision shall 
constitute final agency action.

P. What are the requirements for importing NHP products?

    Because of the risk to human health of untreated NHP products such 
as carcasses, trophies, blood, and other biological samples, CDC is 
also adding a permit requirement under proposed Sec.  71.53(t) for 
importing these products. Under this provision, a permit is not 
required if the product has been rendered non-infectious by one of the 
approved methods. HHS/CDC has selected this prescribed manner of 
rendering a product non-infectious because it has proven to be 
efficient and effective in protecting public health. However, a permit 
will be required if the product is untreated. An untreated product 
without an accompanying permit will be considered a potential health 
hazard and may be seized for destruction upon arrival at the port of 
entry. This permit requirement applies to individuals importing 
trophies for their own personal use as well as businesses importing 
trophies for a commercial purpose, with the intent to resell to the 
public.

Q. Is there an appeal process for a denied application to import?

    Yes. HHS/CDC proposes new subsection (u) to provide importers with 
an opportunity for a written appeal in the event that the Director 
denies a request for a permit to import a NHP for bona fide scientific, 
exhibition, or educational purposes, NHP products that have been 
rendered noninfectious, or an application to become an importer. Under 
the proposal, a person who wishes to make such an appeal would have two 
business days after receiving the denial to submit the appeal. CDC 
would issue a written response, which would constitute final Agency 
action. HHS/CDC invites comments on this process.

[[Page 685]]

III. Regulatory Analyses

A. Economic Analysis

    CDC has examined the impacts of the proposed rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits, including 
potential economic, environmental, public health and safety, and other 
advantages, distributive impacts, and equity. Unless we certify that 
the rule is not expected to have a significant economic impact on a 
substantial number of small entities, the Regulatory Flexibility Act, 
as amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA), requires agencies to analyze regulatory options that would 
minimize any significant economic impact of a rule on small entities. 
Section 202 of UMRA requires that agencies prepare a written statement 
of anticipated costs and benefits before proposing any rule that may 
result in expenditure by State, local, and Tribal governments in the 
aggregate or by the private sector of $100 million in any one year 
(adjusted annually for inflation). CDC has analyzed the rule and has 
determined that it is consistent with the principles set forth in the 
Executive Order and these statutes.
    This proposed rule is not a significant regulatory action as 
defined by the Executive Order. This regulatory action is not a major 
rule under the Congressional Review Act. In our screening analysis 
under the Regulatory Flexibility Act, CDC also concludes that the rule 
will not have a significant economic impact on a substantial number of 
small entities. UMRA does not require CDC to prepare a statement of 
costs and benefits for this proposed rule because we do not expect the 
rule to result in any one-year expenditure that would exceed $100 
million adjusted for inflation.
1. Objectives and Basis for the Action
    Our principal objectives in this proposed rule are to consolidate 
and codify requirements for infection control and worker safety 
procedures to prevent transmitting pathogens from NHPs to humans. The 
proposed requirements for developing an operating plan and SOPs will 
ensure that facility-specific documents outlining quarantine and other 
operations, personnel training, and worker health programs are in place 
before NHPs are imported into the United States.
2. The Nature of the Impacts
    The proposed rule would consolidate CDC's import requirements into 
one regulatory section thus easing the burden on importers. The rule 
would expand the requirements for importing cynomolgus, rhesus, and 
African green monkeys to all NHPs, with the exception of filovirus 
testing, which would be required only for Old World NHPs, but allow 
importers of those three species to renew their registrations every two 
years, rather than every 180 days. CDC proposes to incorporate into the 
rule, our interim NHP guidelines, requirements for NHP imports as part 
of a circus or trained animal act or a zoo-to-zoo or laboratory-to-
laboratory transfer, as well as restrictions on which ports of entry an 
NHP may be imported into the United States.
3. Baseline
    Economic analysis of a regulatory action requires as a first step 
identifying a baseline, which is a depiction of the world in the 
absence of any action. CDC uses this baseline to calculate the effects 
of new regulation. In this action, CDC proposes to codify guidelines, 
registration requirements, notices, and permitting procedures that have 
been in effect since 1990. In January 1990, CDC published interim 
guidelines for handling NHPs during transit and quarantine (2). In 
March 1990, CDC notified all importers that that their compliance was 
required with the transit, isolation, and quarantine standards for 
continued registration and that CDC would subject registered importers 
to unannounced inspections of quarantine facilities. In April 1990, CDC 
implemented a special permitting procedure for importing cynomolgus, 
African green, and rhesus monkeys (9).
    These administrative requirements differ only slightly from the 
requirements CDC proposes today; the proposed rule merely formalizes, 
clarifies, and makes minor changes in existing administrative 
requirements. Therefore, the proposed rule has little impact on costs 
and benefits relative to the baseline of existing practices. In this 
analysis, CDC estimates incremental costs and benefits relative to that 
baseline, and also provides background on the health benefits that 
motivated the administrative actions taken in 1990.
    In general, CDC intends that the proposed rule will preserve the 
health benefits of current practices, while reducing some costs for the 
regulated community. Specifically, the proposed rule would reduce costs 
in two ways. First, CDC proposes to reduce the frequency of 
registration renewal for importers of cynomolgus, rhesus, and African 
green monkeys from every 180 days to every 2 years, consistent with 
registration requirements for importers of other NHPs. This change 
would reduce administrative cost burdens for importers of cynomolgus, 
rhesus, and African green monkeys.
    Second, CDC proposes to eliminate the 31-day quarantine requirement 
for transfers of NHPs into the United States between accredited zoos, 
such as those accredited by the Association of Zoos and Aquariums (AZA) 
(or its equivalent) (i.e., ``zoo-to-zoo transfers''), and transfers of 
those NHPs from laboratories that are accredited by the Association for 
Assessment and Accreditation of Laboratory Animal Care International 
(AAALAC) (or its equivalent) that have a foreign based and a United 
States based facility and the NHP is part of an ongoing research 
project. In such circumstances, CDC would require zoos and laboratories 
to maintain detailed records regarding NHPs. Because domestic AZA-
accredited zoos and established research labs are regulated by USDA's 
Animal Welfare Act, and if receiving Public Health Service (PHS) funds 
are bound by the PHS Policy for Humane Care and Use of Laboratory 
Animals, and may additionally be accredited by AAALAC, to meet strict 
guidelines regarding husbandry and medical care for animals and 
occupational health and safety, CDC believes that a records requirement 
for these zoo collections and research laboratories effectively 
provides the same health and safety assurance as a 31-day quarantine. 
Additionally, since zoos are placing imported animals into their 
existing collections, they require a quarantine facility for all new 
NHPs. The records requirement will document the health of the NHPs over 
a specified period of time, in a monitored setting, before the NHPs are 
transferred between zoo collections or research facilities, thereby 
providing the same health and safety assurance that quarantine provides 
for other NHP imports. The transportation of NHPs for a zoo-to-zoo or 
laboratory-to-laboratory transfer would be in accordance with the 
transportation guidelines listed in proposed paragraphs (j) and (k). In 
the event that zoo collections or research laboratories are unable to 
comply with the requirements regarding proper veterinary medical 
records, all other aspects of the importation and quarantine 
requirements will apply.
    The proposed rule could increase costs for a small set of importers 
by

[[Page 686]]

requiring that all live NHP imports enter through ports of entry where 
CDC quarantine stations are located, except in limited circumstances 
approved in advance by CDC. This change could increase transportation 
costs for a small number of shipments currently driven across the 
Mexican or Canadian borders. Restricting the ports of entry should not 
increase costs for importers shipping by air, since currently all 
shipments are to airports with CDC quarantine stations. Further, CDC 
believes the nominal cost of this requirement is warranted by the 
health and safety value of ensuring proper loading of the NHPs on a 
flight, proper handling of the crates as they are unloaded, and 
adequate disinfection of the plane.
4. Alternatives
    The key alternative to the proposed rulemaking would be to not 
adopt these proposed regulations. If the provisions described above are 
not adopted, importers of cynomolgus, rhesus, and African green monkeys 
would continue to bear an additional administrative burden when 
importing. CDC believes that the reductions in administrative burden 
and costs proposed through these regulations can be achieved without 
compromising or reducing the health and safety benefits of current 
practices. The registration process that all importers must complete, 
detailed in subsection (g), will include the development of detailed 
standard operating procedures designed to protect both the NHPs and the 
individuals at each facility, a signed statement of intent, the review 
and approval of these SOPs by the Director, and an inspection by CDC. 
Regular, unscheduled site visits ensure that facility operations are 
adequately maintained in a manner to prevent the transmission of 
infectious agents from NHPs to humans.
5. Benefits
    In November 1989, a shipment of cynomolgus monkeys imported into 
the United States was found to be infected with a previously 
unrecognized Ebola-like filovirus (22). In the 1990 guidelines, 
registration requirements and permitting procedures were established 
specifying transit, isolation, and quarantine standards for importers 
of African green, cynomolgus, and rhesus monkeys. These guidelines were 
established to reduce the risks to public health that could result from 
the importation of monkeys carrying a filovirus. The 1990 CDC actions 
also provided the related benefit of avoiding an economic disruption of 
the NHP import market associated with the threat of an Ebola-like 
filovirus.
    Although we propose few changes to the existing baseline, this rule 
would provide some further assurance of health and safety by requiring 
that most imports of live NHPs arrive at a port of entry with a CDC 
quarantine station, where qualified personnel are present to monitor 
the arriving shipments.
    By removing the regulatory cost barrier of the quarantine 
requirement for zoos accredited by AZA and laboratories accredited by 
AAALAC or licensed by USDA, the proposed rule is expected to yield an 
additional public benefit by facilitating transfers from zoo-to-zoo and 
laboratories-to-laboratories. The proposed rule would remove obstacles 
to the movement of highly endangered NHPs for preservation of a 
species. Additionally, it would allow the controlled entry of long-term 
research NHPs for public health studies that could only be performed in 
a U.S.-based laboratory.
6. Costs
    It is difficult to calculate the regulatory costs of our 1990 
actions because the threat of an Ebola-like filovirus in the United 
States may have sharply reduced the future importation of NHPs. 
Assuming no complications, CDC estimates that the cost for keeping an 
NHP in quarantine for 31 days is roughly $500-$600 per NHP, which 
includes the cost of recordkeeping, monitoring and testing NHPs for TB. 
These costs are in addition to registration and permitting costs per 
importer. However, absent CDC action, the economic disruption 
associated with the threat of an Ebola-like filovirus could have 
resulted in higher industry costs. From FY 2000 through FY 2007, NHP 
imports increased from 15,433 NHPs to 26,714 NHPs, indicating that 
CDC's transit, isolation, and quarantine standards for NHP imports have 
provided for an orderly, growing market while protecting public health.
    As noted above, the proposed rule would have three cost impacts 
relative to the baseline of current practices: (1) An administrative 
cost reduction for importers of cynomolgus, rhesus, and African green 
monkeys resulting from a 2-year registration renewal cycle rather than 
the current 180-day registration renewal cycle; (2) a reduction in 
quarantine costs for zoos and laboratories that are able to maintain 
detailed records of zoo-to-zoo and laboratory-to-laboratory transfers; 
and (3) an increase in transportation costs for NHP shipments 
customarily driven across borders that will have to enter through ports 
of entry with CDC quarantine facilities or obtain advance approval and 
enter the U.S. by an alternate port of entry.
    Based on recent estimates from the American College of Laboratory 
Animal Veterinarians and the Bureau of Labor Statistics, CDC estimates 
that the average wage for NHP importers is $112.00 per hour. Thus, the 
estimated cost of registration renewal is $56.00 (30 minutes at $112.00 
per hour). In late 2005, eight active commercial importers were subject 
to the 180-day renewal cycle for cynomolgus, rhesus, and African green 
monkey importers. The change to a 2-year renewal cycle will reduce 
annual regulatory costs for each of these importers by $84.00 per year 
($56.00 per renewal times 3 fewer renewals every two years), reducing 
total costs for these eight importers by $672.00 per year ($84.00 x 8). 
Other registered importers (e.g., zoos) import very infrequently and 
will continue to renew their registration once every two years, 
resulting in no net change in costs.
    By eliminating quarantine requirements for zoo-to-zoo and 
laboratory-to-laboratory NHP transfers for zoos and labs that maintain 
detailed records of such transfers, we expect to reduce annual 
regulatory costs by about $550 to $1800 per transfer. CDC estimates 
that only one or two zoo-to-zoo or laboratory-to-laboratory transfers 
occur each year under current requirements, so eliminating the 
quarantine requirement for these transfers would yield no substantial 
regulatory cost reduction.
    Requiring importers to send all live NHPs through ports of entry 
with CDC quarantine stations could increase transportation costs for 
any NHP shipment that might be driven across the Mexican or Canadian 
borders. However, we estimate that only three or four such overland 
shipments occur per year (or about 2% of all shipments), and alternate 
ports of entry may be allowed if approved in advance by CDC. CDC 
expects the total cost to be insignificant because of the small number 
of imports affected.
7. Regulatory Flexibility Analysis
    The Regulatory Flexibility Act requires agencies to examine 
regulatory alternatives for small entities if that rule may have a 
significant economic impact on a substantial number of small entities.
    Objective of the Rule. The implementation of the proposed rule 
would preserve the health benefits of current practices and standards, 
while yielding net regulatory cost reductions for the NHP importers.

[[Page 687]]

    Small Entity Impacts. A regulatory flexibility analysis (RFA) is 
required to estimate the number of small entities to which a proposed 
rule would apply, unless a screening analysis shows that the rule will 
not have a significant economic impact on a substantial number of small 
entities. A screening analysis is adequate for this proposed rule 
because it will yield administrative cost reductions for most NHP 
importers, because the 2-year registration renewal cycle will replace 
the 180-day registration renewal cycle, and because this proposed rule 
will eliminate quarantine costs for zoo-to-zoo and laboratory-to-
laboratory NHP transfers that maintain detailed records. The only 
change from current practices that could increase costs is an increase 
in transportation costs for the small number of shipments currently 
driven across the Mexican or Canadian borders. If approved in advance 
by CDC, these imports may be allowed to enter through alternate ports 
of entry. Thus, CDC expects this change to affect a very small number 
of NHP importers of any size (a few shipments per year). CDC estimates 
that there are at most only three or four such overland shipments per 
year. CDC does not expect the increase in cost for these imports to 
represent a significant portion of any NHP importer's total sales. Any 
additional costs are likely to be low, in part because there are 
several CDC quarantine stations near the Canadian border (Boston, 
Chicago, Detroit, Minneapolis, New York, and Seattle) and near the 
Mexican border (El Paso, Houston, and San Diego). Thus, CDC does not 
expect the proposed rule either to have a significant impact on any 
small entity or to have a significant economic impact on a substantial 
number of small entities.
    Analysis of Alternatives. As stated previously, the key alternative 
of the proposed rule is not to adopt each of the provisions that affect 
regulatory costs, including the provision that would increase costs by 
requiring NHP importation through ports of entry with CDC quarantine 
stations for shipments currently imported overland across the Mexican 
or Canadian borders. CDC did not accept this alternative because CDC 
believes that the small additional cost is warranted by the health and 
safety value of assuring that NHP shipments arrive at a port of entry 
with a CDC quarantine station.

B. Paperwork Reduction Act Analysis

    HHS/CDC has determined that this proposed 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 June 30, 2012).
    In addition, HHS/CDC currently 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, 2011) to collect data from importers who wish 
to apply for a special permit to import non-human primates. HHS/CDC 
plans to submit an extension request to OMB for OMB Control No. 0920-
0263 for approval to continue the special permit program until HHS/CDC 
promulgates its final rule on non-human primates. HHS/CDC requests 
comment from the public on the proposed data collection and record 
keeping requirements in the rule.

C. Federalism Impact

    Under Executive Order 13132, if the contemplated 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 proposed 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 proposed 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, 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 
proposed rule is not expected to result in any one-year expenditure 
that would exceed this amount.

F. Executive Order 12988

    This Notice of Proposed Rulemaking has been reviewed under 
Executive Order 12988, Civil Justice Reform. This notice of Proposed 
Rulemaking has been reviewed under Executive Order 12988, Civil Justice 
Reform. This rule: (1) Would preempt all State and local laws and 
regulations that are inconsistent with this rule; (2) would have no 
retroactive effect; and (3) would not require administrative 
proceedings before parties may file suit in court challenging this 
rule.

IV. References

1. 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.
2. Centers for Disease Control and Prevention. 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 1990; 39(2):22-24, 29-30.
3. Robertson, B.H. Viral Hepatitis and Primates: Historical and 
Molecular Analysis of Human and Nonhuman Primate Hepatitis A, B, and 
the GB-Related Viruses. J Viral Hepatitis. 2001; 8:233-242.
4. Cohen, J.I., et al. Recommendations for Prevention of and Therapy 
for Exposure to B Virus (Cercopithecine Herpesvirus 1). Clinical 
Infectious Diseases 2002; 35:1191-203.
5. Centers for Disease Control and Prevention. Tuberculosis in 
Imported Nonhuman Primates--United States, June 1990-May 1993. 
Morbidity and Mortality Weekly Report MMWR 1993; 42(39):572-576.
6. Mansfield, K., N. King. Viral Diseases. Nonhuman Primates in 
Biomedical Research, Diseases. B.T. Bennett, C.R. Abee, and R. 
Henrickson, eds. San Diego, CA: Academic Press, Inc., 1998.
7. Richardson, J.H. Basic Considerations in Assessing and Preventing 
Occupational Infections in Personnel Working with

[[Page 688]]

Nonhuman Primates. J. Med. Primatol. 1987;16:83-89.
8. Roper, W.L. Dear interested party (letter). March 15, 1990. 
Available upon request: (404) 639-1600.
9. 55 FR 10288, March 20, 1990, ``Importation of Nonhuman Primates: 
Meeting.''
10. Centers for Disease Control and Prevention. Update: Filovirus 
Infection in Animal Handlers. Morbidity and Mortality Weekly Report 
MMWR 1990; 39(13):221.
11. 55 FR 15210, April 20, 1990, Requirement for a Special Permit to 
Import Cynomolgus, African Green, or rhesus Monkeys into the United 
States.
12. Roper, W.L. Dear interested party (letter). October 10, 1991. 
Available upon request: (404) 639-1600.
13. Tipple, M.A. Dear interested party (letter). March 5, 1996. 
Available upon request: (404) 639-1600.
14. Centers for Disease Control and Prevention. Ebola-Reston Virus 
Infection among Quarantined Nonhuman Primates--Texas, 1996. 
Morbidity and Mortality Weekly Report MMWR 1996; 45(15):314-316.
15. 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.
16. 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.
17. 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.
18. 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.
19. Centers for Disease Control and Prevention. Fatal Cercopithecine 
Herpes Virus 1 (B Virus) Infection Following Mucocutaneous Exposure 
and Interim Recommendations for Worker Protection. Morbidity and 
Mortality Weekly Report MMWR, 1998; 47(49):1073-1076; 1083.
20. National Research Council. Guide for the Care and Use of 
Laboratory Animals. Institute of Laboratory Animal Resources 
Commission on Life Sciences, National Research Council, National 
Academy Press 1996; Washington, DC.
21. 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. Referenced January 7, 2009. Available at http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm.
22. Centers for Disease Control and Prevention. Ebola Virus 
Infection in Imported Primates--Virginia. Morbidity and Mortality 
Weekly Report MMWR, 1989; 38(48):831-832,837-838.
23. International Air Transport Association. Live Animal 
Regulations. International Air Transport Association 2007, Geneva.
24. World Health Organization, Guidance on Regulations for the 
Transport of Infectious Substances, World Health Organization 2007-
2008. Referenced January 7, 2009. http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2007_2cc.pdf.
25. Institute of Laboratory Animal Resources, 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.

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 proposes to amend 42 CFR part 71 as follows:

PART 71--FOREIGN QUARANTINE

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

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

    2. Revise 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, including pathogens, from 
nonhuman primates (NHPs) imported into the United States, or their 
offspring, to humans. These regulations 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 used in the importation of NHPs available to CDC for 
inspection during operating business days and hours, and at other 
necessary and reasonable times, to enable CDC to ascertain compliance 
with these regulations.
    (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.
    CDC means the Centers for Disease Control and Prevention, U.S. 
Department of Health and Human Services, or an authorized 
representative acting on its behalf.
    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.
    MOT means mammalian old tuberculin, a biological product used as a 
diagnostic tool in the evaluation for mycobacterial (tuberculosis 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. (2) For purposes of this 
section, the terms listed below shall have the following meanings:
    Animal act means any use of NHPs for entertainment in which the 
NHPs are trained to perform some behavior or action and are part of a 
show, performance, or exhibition. Offspring of such NHPs are subject to 
the requirements of this section.
    Breeding colony means a facility where NHPs are maintained for 
reproductive purposes. Offspring of such NHPs are subject to the 
requirements of this section.
    Broker means a person within the United States that acts as an 
official agent of, or intermediary between, 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 in the teaching of a 
defined educational program at the university level or equivalent. 
Offspring of such NHPs are subject to the requirements of this section.

[[Page 689]]

    Exhibition purposes means the use of NHPs 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. Offspring 
of such NHPs are subject to the requirements of this section.
    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 is 
subject to or carries out responsibilities in accordance with these 
regulations.
    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 accredited by AAALAC or licensed 
by USDA, conducting research using NHPs, having foreign and/or United 
States based facilities, and intending to transfer or transferring one 
or more NHPs that were originally part of an institutionally approved, 
ongoing protocol, into the United States facility for purposes related 
to that specific research project.
    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, including animals commonly known as chimpanzees, gorillas, 
monkeys, macaques, gibbons, orangutans, baboons, marmosets, tamarins, 
lemurs, and lorises.
    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, including herpes B virus.
    Permitted Purpose means the use of NHPs for scientific, education, 
or exhibition purposes as defined in this section.
    Person means any individual or partnership, firm, company, 
corporation, association, organization, or similar 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, including other 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 for research following a 
defined protocol and other standards for research projects as normally 
conducted at the university level. Offspring of such NHPs are subject 
to the requirements of this section.
    Trophy means a mount, rug, or other display item composed of the 
hide, hair, skull, teeth, bones, or claws of a nonhuman primate.
    Zoo means:
    (A) 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
    (B) 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 other animals to humans or 
from humans to animals.
    (d) General Prohibition of Excluded Nonhuman Primates. (1) A person 
may not import live NHPs into the United States unless the person is 
registered with CDC as a NHP importer in accordance with this section. 
(2) A person may not import live NHPs into the United States or 
maintain, sell, resell, or otherwise distribute imported NHPs except 
for:
    (i) Permitted purposes; 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 import live NHPs into the United States or 
maintain, sell, resell, or otherwise distribute imported NHPs or 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) 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 purposes other than permitted purposes;
    (iii) It is maintained, sold, resold, or distributed for purposes 
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, 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 to a scientific, educational, or exhibition 
facility as approved by the Director.
    (3) If the importer 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 importer's expense.
    (4) Pending disposal of any NHPs arriving into the United States, 
the NHP will be detained at the importer'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 CDC quarantine station is located. Currently, the list of CDC 
quarantine stations can be found at http://www.cdc.gov/quarantine/QuarantineStations.html.
    (2) In the event that the importer is unable to provide for entry 
at a port where a CDC quarantine station is located, the importer may 
only import live NHPs into the United States if advance written 
approval has been obtained from the Director.
    (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 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.

[[Page 690]]

    (1) To register as an importer, a person must submit the following 
documents to CDC:
    (i) A completed application form;
    (ii) A completed statement of intent describing the number and 
types of NHPs intended for import during the registration period;
    (iii) A copy of all written Standard Operating Procedures (SOPs) 
that include all elements required in paragraphs (h) through (n) of 
this section;
    (iv) A copy of any current registrations, licenses, and/or permits 
that may be required from the U.S. Department of Agriculture and U.S. 
Fish and Wildlife Service;
    (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 these regulations.
    (2) Upon receiving the documentation required by this section, the 
Director will review the application and either grant, in whole or in 
part, or deny the application for registration as an importer. CDC may 
consult with the importer regarding any element of the application or 
accompanying documentation.
    (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 CDC issues the 
registration certificate.
    (iii) An importer must apply to 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 have a written policy that 
imported NHPs and their offspring will only be used and distributed for 
permitted purposes.
    (1) An importer must document the intended purpose for each 
imported NHP and the purpose must comply with one of the permitted 
purposes.
    (2) An importer must retain records documenting the identity of any 
recipients, the number of NHPs in each shipment or sale, and the dates 
of each shipment or sale.
    (3) An importer must maintain these records in an organized manner 
and either electronically or in a central location that is at or in 
close proximity to the NHP facility to allow CDC to inspect the records 
during CDC site visits during regular business hours or within one hour 
of such visits.
    (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 for one of the permitted 
purposes.
    (5) An importer must keep written certifications demonstrating that 
the NHPs and any offspring will continue to be used 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. An importer must adhere to 
the plan and SOPs and must ensure that each worker covered under the 
plan also adheres to it and SOPs.
    (3) An importer must contact CDC immediately by telephone to report 
any instance of a worker exposed to a zoonotic illness and must include 
instructions for contacting 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;
    (ii) Hazard evaluation and worker communication procedures that 
adhere to those in paragraph (i)(4) of this section;
    (iii) Personal protective equipment (PPE) requirements that adhere 
to those in paragraph (i)(5) of this section;
    (iv) SOPs that adhere to tuberculosis requirements in paragraph 
(i)(6) of this section;
    (v) If applicable, SOPs that adhere to requirements relating to 
macaques as described in paragraph (i)(7) 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;
    (vii) 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;
    (viii) 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;
    (ix) 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;
    (x) 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;
    (xi) 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;
    (xii) 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 CDC.
    (B) For potential exposures to 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 CDC.
    (xiii) 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 
subparagraph, 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 
of handling NHPs;
    (ii) The need for PPE in handling NHPs and training in proper use 
of PPE, including re-training and reinforcement of appropriate use;
    (iii) Procedures for monitoring workers for signs of zoonotic 
illness, including procedures that ensure reporting to CDC by telephone 
within 24 hours of the occurrence of illness in any worker suspected of 
having a zoonotic disease acquired from an NHP; and
    (iv) Procedures for disinfection of garments, supplies, equipment, 
and waste.

[[Page 691]]

    (6) As part of the worker protection plan described in this 
paragraph, 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) Disposable NIOSH-approved N95 or equivalent respirators, in 
compliance with OSHA 29 CFR Sec.  1910.134 which requires 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) Long-sleeved shirts and trousers that resist minor tears and 
are appropriate for the weather;
    (C) Waterproof shoes or boots;
    (D) NIOSH-approved respiratory protection that is compliant with 
OSHA 29 CFR Sec.  1910.134, and
    (E) Face shields or eye protection that protect the eyes.
    (iv) Workers whose faces may come within 5 feet of an NHP must wear 
disposable NIOSH-approved N95 or equivalent 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 tuberculosis protection, an importer must ensure the 
following:
    (i) Workers in a facility housing NHPs must have a baseline 
tuberculosis skin test prior to working with NHPs and, at least 
annually, a tuberculosis skin test;
    (ii) Prompt and direct access to a medical consultant who reads 
tuberculin skin tests and maintains records for such tests;
    (iii) If an NHP is found to have laboratory-confirmed tuberculosis, 
any worker who had previously entered any room where a confirmed NHP 
has been housed must promptly undergo a post-exposure tuberculin skin 
test and
    (A) If that test is negative, the worker must undergo another 
tuberculin skin test 3 months after exposure, and
    (B) If that test is reactive, the worker must be referred for 
medical evaluation; and
    (C) The CDC must be immediately notified of the results by 
telephone, SMS text, or e-mail as specified in the importer's standard 
operating procedures.
    (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) 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 CDC 
by telephone 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 
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.
    (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, qualified veterinarian. 
NHPs must not be removed during transport.
    (4) Whenever possible, workers must not handle live NHPs directly.
    (5) Upon arrival into the U.S., only an importer or an authorized 
representative may receive the NHPs from a conveyance (i.e., airplane, 
ship, etc).
    (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, ventilation systems must direct 
airflow away from individuals and toward the compartment housing NHPs 
to prevent the transmission of zoonotic diseases to individuals 
traveling with the shipment; any recirculated air must be HEPA-
filtered.
    (9) If traveling by plane, crates containing NHPs must 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) Documentation must be made of the communicable disease-
prevention procedures 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.
    (12) Procedures to ensure that aircraft, ship, vehicles, and 
related equipment are decontaminated following transport.
    (13) PPE, bedding, or other biohazardous waste must be disposed of 
following transport.
    (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, easily cleaned and 
disinfected.
    (3) PPE, bedding, or other biohazardous waste must be disposed of 
following ground transport.

[[Page 692]]

    (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 CDC in writing within 
48 hours of the time the shipment arrived at the quarantine facility.
    (6) As part of the notification of arrival in paragraph (k)(4) of 
this section, an importer must inform CDC whether suspected or 
confirmed transmission or spread of communicable disease occurred 
during transport, including notification of NHPs that died or became 
ill during transport or malfunctions associated with disease mitigation 
procedures or equipment.
    (l) Quarantine Facilities. (1) The requirements of this paragraph 
relating to quarantine facilities does 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. CDC 
may extend the quarantine period if an importer or CDC finds or 
suspects that an NHP is infected with, or has been exposed to, a 
zoonotic disease, or if an importer or 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 quarantine room must have a separate air-handling system 
and 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 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 because such procedures pose a risk of needle sticks 
or aerosol exposures to employees.
    (ii) Health certificates, shipping documents, and NHP health 
records must include the number or code required in paragraph (l)(2)(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 or 
tranquilized before handling.
    (iv) 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 multidose vials (e.g., 
ketamine).
    (v) Before any contaminated item is removed from a quarantine 
facility an importer must ensure 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 Ebola viruses by using an ELISA 
methodology, or other method approved by CDC.
    (C) An importer must not request a release from CDC of any NHP from 
quarantine under paragraph (l)(3) of this section, if the importer 
knows or has reason to suspect that the NHP is infected with or has 
been exposed to a zoonotic disease.
    (ix) For each NHP in a quarantine facility, an importer must 
administer at least three tuberculin skin tests on the eyelid using old 
mammalian tuberculin (MOT), with at least 2 weeks between tests, before 
the NHP is released from import quarantine. Tuberculin skin tests 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 tuberculosis 
testing.
    (A) An importer must ensure that any cohort with positive or 
suspicious tuberculin reactions remains in quarantine and receives at 
least five additional tuberculin skin tests (each administered at least 
two weeks apart) following removal of the last NHP with a positive TST.
    (B) The validity of tuberculosis test results may be compromised if 
during quarantine an NHP contracts a viral illness, including measles; 
a severe illness; 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 CDC, depending on the illness or treatment in question) before 
tuberculosis tests are performed.
    (C) An importer must retain records of all tuberculin skin tests 
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.

[[Page 693]]

    (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 at 
all times will 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 an NHP from quarantine, an importer must 
obtain written permission from CDC. 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) 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) CDC confirms that the importer has addressed and resolved to 
CDC's satisfaction any NHP or worker communicable disease issues that 
were reported to CDC during shipment.
    (5) If 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 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 State-licensed veterinary 
pathologist or State-licensed veterinarian under biosafety level 3 
containment. 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 or 
biosafety level 2 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 CDC, in case other 
testing is required by 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 tuberculosis 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 during quarantine, liver tissue for 
filovirus antigen by using the antigen-capture ELISA method must be 
submitted to a laboratory for testing
    (m) Health Reporting Requirements for Nonhuman Primates.
    (1) An importer must notify CDC of the events listed in this 
paragraph by telephone or as otherwise specified in this paragraph.
    (2) An importer must notify CDC within 24 hours of the occurrence 
of severe illness or death of NHPs in quarantine facilities.
    (3) An importer must report to CDC within 24 hours of the 
occurrence of any illness in NHPs that an importer has reason to 
suspect is yellow fever, monkey pox, or filovirus disease.
    (4) If mortality for a cohort exceeds 5 percent, calculated from 
time of embarkation from country of origin to release from CDC 
quarantine, an importer must report the circumstances to CDC promptly, 
including the cause of death for each NHP.
    (5) 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 CDC in writing of the health status of the shipment.
    (6) An importer must notify CDC within 24 hours if any NHP tests 
positive for filovirus virus antigen or antibody.
    (7) An importer must report to CDC within 48 hours, any positive or 
suspicious tuberculin skin test 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 CDC in writing 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 as described by the recipient under paragraph 
(i)(2) 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;
    (xiii) Name, address, and contact information for shipper, if other 
than the importer;
    (xiv) Name, address, and contact information for broker in the 
United States;
    (xv) Name, address, and contact information for person 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 foreign-based animal acts that include a 
NHP must be registered with CDC in accordance with this section prior 
to entry into the U.S. In addition to the requirements in paragraph (g) 
of this section, an importer must provide:
    (i) A description of the animal act that includes the 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 or microchip.

[[Page 694]]

    (iv) 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.
    (v) 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, tuberculosis testing with MOT and 
interpreted as stated in paragraph (l)(2)(ix);
    (C) NHPs with positive tuberculin skin test results must be treated 
with antituberculosis chemotherapy after consultation with CDC.
    (D) If the NHP is a chimpanzee, serology and antigen testing for 
hepatitis B, serology for hepatitis C, and any additional titers 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 U.S., unless confirmatory evidence signed by a 
licensed veterinarian shows that there is no hepatitis B or hepatitis C 
virus present in the NHP.
    (vi) 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.
    (vii) A copy of a negative tuberculosis test conducted within the 
past 12 months, or medical documentation that the individual is free of 
clinically active tuberculosis, for each trainer and/or handler.
    (viii) A copy of each SOP for dealing with suspected zoonotic 
diseases.
    (ix) If macaques are in the animal act, a procedure for dealing 
with potential herpes B-virus exposures.
    (2) Requirements for U.S.-based animal acts containing NHPs to re-
enter the United States after export.
    (i) An importer must ensure that the NHP contains the unique 
identifier, such as a tattoo or microchip, obtained prior to export.
    (ii) Each NHP must be included on an approved list of performing 
NHPs that are cleared by CDC to travel outside of and return to the 
U.S.
    (iii) Before re-entry, an importer must ensure that CDC receives 
the itinerary as described in paragraph (n)(2).
    (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), (i), (j), (k), (m), (n) of this section.
    (2) If a zoo is receiving one or more NHPs into the United States 
from another AZA zoo (or AZA-equivalent outside of the U.S.), the 
recipient zoo must, before the transfer, submit the following 
information for approval by CDC:
    (i) A copy of each NHP's veterinary medical records regular testing 
for tuberculosis from the previous zoo for approval by CDC, including a 
method of positive identification such as a tattoo, microchip or 
photograph, and
    (ii) A copy of a current health certificate, including 
documentation of a negative tuberculosis test, signed by a licensed 
qualified veterinarian within 14 days of the transfer documenting that 
the NHP appears healthy and free from communicable diseases, and
    (iii) Documentation which verifies that the recipient zoo is 
registered in accordance with this section, and
    (iv) 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) Persons who will only 
be transferring NHPs on established research protocols from a 
laboratory outside of the U.S. to laboratory within the U.S. must 
comply with all the elements listed in paragraphs (g), (h), (i), (j), 
(k), (m), and (n) 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 CDC for approval:
    (i) A copy of each NHP's veterinary medical records, including 
regular testing for tuberculosis from the previous lab for 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 stating that the NHP(s) 
appear healthy and are free from communicable diseases, including 
documentation of a negative tuberculosis test. The certificate must be 
signed by a State licensed veterinarian within 14 days of the transfer; 
and
    (iii) Documentation of the ongoing research project and the reason 
the NHP needs to be transported to the U.S. laboratory facility.
    (iv) Specific itinerary with names, dates, flights, times, 
airports, sea ports, 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 
paragraph (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 CDC of all 
scheduled in transit shipments of NHPs not intended for import into the 
United States and provide the following information:
    (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) 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) Established SOPs 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.

[[Page 695]]

    (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) 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.
    (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 trophies, skins, or skulls 
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).
    (2) Non-live NHP products (including skulls, skins, bodies, blood, 
or tissue) 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 
purposes.
    (iii) The product may only 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.
    (u) Appeal of denial for a permit to import. (1) If the CDC denies 
your request for a permit under 42 CFR 71.53, you may appeal that 
denial to the CDC Director.
    (2) You must submit your appeal in writing to the CDC Director, 
stating the reasons for the appeal and showing that there is a genuine 
and substantial issue of fact in dispute.
    (3) You must submit the appeal within 2 business days after you 
receive the denial.
    (4) CDC will issue a written response to the appeal, which shall 
constitute final Agency action.

    Dated: December 15, 2010.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2010-32922 Filed 1-4-11; 8:45 am]
BILLING CODE 4163-18-P
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