[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Proposed Rules]
[Pages 678-695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32922]
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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
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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 [email protected]. 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 (<= 5 feet) that NHP bodily
fluids could be transferred between the NHP and the worker.
``Exposure'' also refers to worker exposure to respiratory pathogens
(e.g., Mycobacterium tuberculosis) for workers in proximity to a NHP
(<= 5 feet). However, CDC is soliciting public comment on provisions
which use this term and welcomes input on ways which may add
clarification to its meaning. Using the performance-based standard
described above, CDC will evaluate the importer's worker protection
plan and determine whether the proposed worker protection program is
sufficient to protect workers from exposure to zoonotic diseases.
Under proposed subsection (i) an importer must contact CDC
immediately by telephone to report any instance of a worker contracting
a potential zoonotic disease, and must include specific instructions
for contacting CDC in its worker protection plan. Also included in the
worker protection plan must be procedures to protect and train
transport workers from exposures to communicable disease; hazard
evaluation and worker communication procedures; personal protective
equipment (PPE) requirements; tuberculosis requirements; if applicable,
SOPs that adhere to requirements relating to macaques as described in
paragraph (i)(7); an infection-prevention program; SOPs that include
requirements for preventing workplace infection from potentially
contaminated needles or other sharp instruments; SOPs requiring that
used disposable sharp items are placed in puncture-resistant containers
kept as close to the work site as practical; SOPs requiring that
removed, disposable PPE be disposed of as biohazardous waste; and that
nondisposable clothing worn in the quarantine facility be disinfected
on site before laundering. CDC is soliciting public comments on these
provisions.
To further ensure worker safety from communicable disease,
subsection (i) also includes certain specific post-exposure
requirements to be included in the worker protection plan, such as 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.
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