Documentation and Standard Operating Procedures - New Importer

§ 71.53

42 CFR Ch. I (10–1–19 Edition)

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

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

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Public Health Service, HHS

§ 71.53

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 the regulations in this section.
In transit means NHPs located within
the United States that are not intended for import, whether scheduled
or not, as part of the movement of
those NHPs between a foreign country
of departure and foreign country of
final destination.
Lab or laboratory means a facility in
the United States accredited by
AAALAC or licensed by USDA, conducting research using NHPs, having
foreign based facilities, and intending
to transfer or transferring one or more
NHPs that were originally part of an
institutionally approved, ongoing protocol, from its foreign-based facility
into its United States facility for purposes related to that specific research
project.
Licensed veterinarian means a person
who has graduated from a veterinary
school accredited by the American Veterinary Medical Association’s Council
on Education, or has a certificate
issued by the American Veterinary
Medical Association’s Education Commission for Foreign Veterinary Graduates, or has received equivalent formal education as determined by the
HHS/CDC; and has received training
and/or experience in the care and management of nonhuman primates.
Medical consultant means an occupational health physician, physician’s assistant, or registered nurse, who is
knowledgeable about the risks to
human health associated with NHPs.
Nonhuman primate or NHP means all
nonhuman members of the Order Primates.
NHP product or Product means skulls,
skins, bodies, blood, tissues, or other
biological samples from a nonhuman
primate, including trophies, mounts,
rugs, or other display items.
Offspring means the direct offspring
of any live NHPs imported into the

United States and the descendants of
any such offspring.
Old World Nonhuman Primate means
all nonhuman primates endemic to
Asia or Africa.
Pathogen means any organism or substance capable of causing a communicable disease.
Permitted purpose means the use of
NHPs for scientific, educational, or exhibition purposes as defined in this section.
Person means any individual or partnership, firm, company, corporation,
association, organization, including a
not-for-profit organization, such as a
sanctuary, or other legal entity.
Quarantine means the practice of isolating live NHPs for at least 31 days
after arrival in a U.S. quarantine facility where the NHPs are observed for
evidence of infection with communicable disease, and where measures
are in place to prevent transmission of
infection to humans or NHPs within
the cohort.
Quarantine facility means a facility
used by a registered importer of NHPs
for the purpose of quarantining imported NHPs.
Quarantine room means a room in a
registered import facility for housing
imported NHPs during the quarantine
period.
Scientific purposes means the use of
NHPs including offspring for research
following a defined protocol and other
standards for research projects as normally conducted at the university
level.
Zoo means:
(1) Within the United States, an
AZA-accredited
and
professionally
maintained park, garden, or other
place in which animals are kept for
public exhibition and viewing; or
(2) Outside of the United States, a
professionally maintained park, garden, or other place in which animals
are kept for public exhibition and viewing that meets or exceeds the accrediting standards of the AZA.
Zoonotic disease means any infectious
agent or communicable disease that is
capable of being transmitted from animals (both wild and domestic) to humans.
(d) General prohibition on importing
nonhuman primates. (1) A person may

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§ 71.53

42 CFR Ch. I (10–1–19 Edition)

not import live NHPs into the United
States unless the person is registered
with HHS/CDC as a NHP importer in
accordance with this section.
(2) A person may only import live
NHPs into the United States for:
(i) Permitted purposes, as defined
under paragraph (c)(2) of this section;
or
(ii) Use in breeding colonies, provided
that all offspring will be used only as
replacement breeding stock or for permitted purposes.
(3) A person may not accept, maintain, sell, resell, or otherwise distribute imported NHPs (including their
offspring) for use as pets, as a hobby, or
as an avocation with occasional display
to the general public.
(e) Disposal of prohibited or excluded
NHPs. (1) HHS/CDC may seize, examine,
isolate, quarantine, export, treat, or
destroy any NHP if:
(i) It is imported through a location
other than an authorized port of entry;
(ii) It is imported for other than permitted purposes;
(iii) It is maintained, sold, resold, or
distributed for other than permitted
purpose;
(iv) It is imported by a person who is
not a registered importer; or
(v) It is otherwise deemed to constitute a public health threat by the
Director.
(2) For any NHP arriving in the
United States through an unauthorized
location, for other than the permitted
purposes, or by a person who is not a
registered importer, the person attempting to import that NHP, must, as
approved by the Director and at the
person’s own expense, do one of the following:
(i) Export or arrange for destruction
of the NHP, or
(ii) Donate the NHP for a scientific,
educational, or exhibition purpose
after quarantine at a HHS/CDC-registered facility.
(3) If the person attempting to import a NHP fails to dispose of the NHP
by one of the options described in paragraph (e)(2) of this section, the Director will dispose of the NHP at the person’s expense.
(4) Pending disposal of any prohibited
or excluded NHPs, the NHP will be de-

tained at the person’s expense at a location approved by the Director.
(f) Authorized ports of entry for live
NHPs. (1) An importer may import live
NHPs into the United States only
through a port of entry where a HHS/
CDC quarantine station is located. The
list of current HHS/CDC quarantine
stations can be found at http://
www.HHS/CDC.gov/quarantine/
QuarantineStations.html.
(2) In the event that the importer is
unable to provide for entry at a port
where a HHS/CDC quarantine station is
located, the importer may only import
live NHPs into the United States
through another port of entry if the Director provides advance written approval.
(3) If prior written approval is not obtained from the Director, the importer
and excluded NHPs will be subject to
the provisions of paragraph (e) of this
section.
(g) Registration or renewal of importers.
Before importing any live NHP into the
United States, including those that are
part of an animal act or those involved
in zoo-to-zoo or laboratory-to-laboratory transfers, an importer must register with and receive written approval
from the Director.
(1) To register, or to renew a registration certificate, as an importer, a
person must submit the following documents to HHS/CDC:
(i) A completed registration/application form;
(ii) A completed statement of intent
that describes the number and types of
NHPs intended for import during the
registration period, the intended permitted purposes for which the NHPs
will be imported;
(iii) Written SOPs that include all
elements required in paragraphs (h)
through (n) of this section;
(iv) A copy of all federal, state, or
local registrations, licenses, and/or permits; and
(v) A signed, self-certification stating
that the importer is in compliance
with the regulations contained in this
section and agrees to continue to comply with the regulations in this section.
(2) Upon receiving the documentation
required by this section, the Director
will review the application and either

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Public Health Service, HHS

§ 71.53

grant or deny the application for registration as an importer. Applications
that are denied may be appealed under
paragraph (u) of this section.
(i) Before issuing a registration, the
Director may inspect any business
record, facility, vehicle, or equipment
to be used in importing NHPs.
(ii) Unless revoked in accordance
with paragraph (t) of this section, a
registration certificate issued under
this section is effective for two years
beginning from the date HHS/CDC
issues the registration certificate.
(iii) An importer must apply to HHS/
CDC for renewal of the registration
certificate not less than 30 days and
not more than 60 days before the existing registration expires.
(3) All importers must comply with
the requirements of paragraphs (h)
through (n) of this section.
(h) Documentation. An importer must
develop, and document compliance
with, a written policy that states imported NHPs, including their offspring,
will only be used and distributed for
permitted purposes.
(1) An importer must collect or create a record of the intended purpose of
importation for each imported NHP
and the purpose must comply with one
of the permitted purposes. An importer
must retain written certifications demonstrating that the NHPs and their offspring will continue to be used for permitted purposes for three years after
the distribution or transfer of the NHP.
(2) An importer must retain records
regarding each distribution of imported
NHPs. Each record must include the
identity of any recipients, the number
and identity of each NHP in each shipment or sale, and the dates of each
shipment or sale, for three years after
the distribution or transfer of the NHP.
(3) An importer must maintain these
records in an organized manner, either
electronically or in a central location
that is at or in close proximity to the
NHP facility to allow HHS/CDC to easily inspect the records during HHS/CDC
site visits during regular business
hours or within one hour of such visits.
If records are maintained electronically, they must be time-dated in a
manner than cannot be altered, and redundant back-up copies must be made
in a manner that protects against loss.

(4) Before distributing or transferring
an imported NHP, an importer must:
(i) Communicate to the recipients of
NHPs, in writing, the restrictions and
definitions of permitted purposes; and
(ii) Obtain written certifications
from the intended recipient that the
NHPs will be used and distributed only
for permitted purposes.
(i) Worker protection plan and personal
protective Equipment. (1) In addition to
complying with the requirements of
this section, an importer must comply
with all relevant federal and state requirements relating to occupational
health and safety.
(2) Importers must have a written
worker protection plan for anyone
whose duties may result in exposure to
NHPs, including procedures for appropriate response measures in the event
of an emergency. An importer must adhere to the plan and SOPs and must ensure that each worker covered under
the plan also adheres to it and all pertinent SOPs.
(3) An importer must contact HHS/
CDC immediately by telephone, text,
or email, as specified in the importer’s
SOP, to report any instance of a worker exposed to a zoonotic illness and
must include instructions for contacting HHS/CDC in its worker protection plan.
(4) A worker protection plan must include the following:
(i) Procedures to protect and train
transport workers in how to avoid and
respond to zoonotic disease exposures
associated with NHPs, including procedures for appropriate responses in the
event of a vehicle crash or other emergency during transport;
(ii) Hazard evaluation and worker
communication procedures that adhere
to those in paragraph (i)(5) of this section;
(iii) PPE requirements that adhere to
those in paragraph (i)(6) of this section;
(iv) TB-control requirements that adhere to those in paragraph (i)(7) of this
section;
(v) If applicable, SOPs that adhere to
requirements relating to macaques as
described in paragraph (i)(8) of this section;
(vi) An infection-prevention program,
including infection-prevention methods
requiring, at a minimum, PPE and

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§ 71.53

42 CFR Ch. I (10–1–19 Edition)

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

importer must establish, implement,
and maintain hazard evaluation and
worker communication procedures that
include the following:
(i) A description of the known
zoonotic disease and injury hazards associated with handling NHPs;
(ii) The need for PPE when handling
NHPs and training in proper use of
PPE, including re-training and reinforcement of appropriate use;
(iii) Procedures for monitoring workers for signs of zoonotic illness, including procedures that ensure reporting to
HHS/CDC by telephone, text, or email
within 24 hours of the occurrence of illness in any worker suspected of having
a zoonotic disease; and
(iv) Procedures for disinfection of
garments, supplies, equipment, and
waste.
(6) As part of the worker protection
plan described in this paragraph (i), an
importer must identify the PPE required for each task or working area.
Additionally, in this part of the worker
protection plan, an importer must ensure the following:
(i) Any required PPE must be available to workers when needed;
(ii) Workers in direct contact with
NHPs must wear the following:
(A) Gloves of sufficient thickness to
reduce the risk of cuts, scratches, and
punctures;
(B) At a minimum, disposable
NIOSH-approved N95 respirators, in
compliance
with
OSHA
29
CFR
§ 1910.134, which requires a respiratory
protection program;
(C) Face shields or eye protection;
and
(D) Outer protective clothing when
opening crates, removing foreign materials from crates, feeding NHPs, removing dead NHPs, or handling bedding
materials.
(iii) Workers handling crates or pallets containing NHPs must wear the
following:
(A) Elbow-length, reinforced leather
gloves or equivalent gloves that prevent penetration of splinters, other
crating materials, or debris;
(B) Outer protective clothing;
(C) Waterproof shoes or boots;
(D) NIOSH-approved respiratory protection that is compliant with OSHA
regulations at 29 CFR 1910.134, and;

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Public Health Service, HHS

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(E) Face shields or eye protection.
(iv) Workers whose faces may come
within 5 feet of an NHP must wear disposable
NIOSH-approved
N95
respirators and either face shields or eye
protection to protect against aerosol or
droplet transmission of pathogens;
(v) Workers must remove disposable
PPE and discard as a biohazard; and
(vi) Workers must not drink, eat, or
smoke while physically handling NHPs
or cages, crates, or other materials
from such NHPs.
(7) For TB protection, an importer
must ensure the following:
(i) Workers in a facility housing
NHPs must have a baseline evaluation
for TB prior to working with NHPs and
an evaluation at least annually;
(ii) Prompt and direct access to a
medical consultant who is capable of
performing the evaluation and maintaining records for such tests;
(iii) If an NHP is found to have laboratory-confirmed TB, any worker who
had previously entered any room where
a confirmed NHP has been housed must
promptly undergo a post-exposure TB
evaluation and
(A) If that test is negative, the worker must undergo another TB evaluation
3 months later; and
(B) If either test is reactive, the
worker must be referred for medical
evaluation; and
(C) The HHS/CDC must be immediately notified of the results of the
medical evaluation by telephone, text,
or email as specified in the importer’s
SOPs.
(iv) Compliance with exposure-control planning elements under 29 CFR
1910.1030 for workers who will have parenteral and other contact with blood or
other potentially infectious material
from NHPs and compliance with the
respiratory protection requirements in
29 CFR 1910.134.
(8) For importation of macaques, an
importer must develop, implement and
adhere to a written PPE program to
prevent herpes B virus transmission.
The program must be based on a thorough hazard assessment of all work
procedures, potential routes of exposure (e.g., bites, scratches, or mucosal
exposures), and potential adverse
health outcomes.

(9) An importer must keep records of
all serious febrile illnesses (fever greater than 101.3 degrees Fahrenheit [38.5
degrees Celsius] for more than 48
hours) in workers having exposure to
NHPs in transit or in quarantine. The
record must be kept by the importer as
part of the worker’s administrative
records. The importer must promptly
notify HHS/CDC by telephone, text, or
email if such an illness occurs. An importer must ensure that the medical
consultant providing care is informed
that the patient works with and/or has
been exposed to NHPs.
(j) SOP requirements and equipment
standards for crating, caging, and transporting live nonhuman primates. Equipment standards for crating, caging, and
transporting live NHPs must be in accordance with USDA Animal Welfare
regulation standards (9 CFR parts 1, 2,
and 3) and International Air Transport
Association standards, and an importer
must establish, implement, maintain,
and adhere to SOPs that ensure the following requirements are met:
(1) Any crate used to transport NHPs
must be free of sharp projections that
could scratch or otherwise injure workers or NHPs.
(2) Glass items must not be used for
feeding or watering NHPs during transport.
(3) NHPs must only be removed from
crates in an approved quarantine facility under the supervision of a licensed
veterinarian.
(4) NHPs must not be removed from
crates during transport.
(5) Upon arrival into the United
States, only an importer or an authorized representative may receive the
NHPs from a conveyance (e.g., airplane,
ship). The importer must establish an
emergency contingency plan in the unlikely event they are unable to meet
the shipment.
(6) All reusable items must be decontaminated between uses.
(7) At all times during transport,
crates containing NHPs must be separated by a physical barrier from workers, other individuals, and all other
animals and cargo, or by a spatial barrier greater than 5 feet, that prevents
contamination of cargo or individuals
with bodily fluids, feces, or soiled bedding.

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42 CFR Ch. I (10–1–19 Edition)

(8) At all times during transport, individuals traveling with the shipment
must be protected from shared air of
NHPs to prevent the transmission of
zoonotic diseases. Airflow must be
unidirectional from NHP transport
workers to NHPs or, if any air is recirculated to the NHP transport workers,
it must be HEPA-filtered. If a ventilation system is not in place, all NHP
transport workers must wear respiratory protection.
(9) If traveling by plane, crates containing NHPs should be loaded in the
cargo hold last and removed first, must
be placed on plastic that prevents spillage onto the deck of the plane, and
must be placed on pallets or double
crated to ensure separation from other
cargo.
(10) Workers, as well as NHPs, must
be protected from communicable disease exposures at any facility used en
route, including transportation holding
facilities. An importer must maintain
a description of any transportation
holding facilities and document the
communicable
disease
prevention
measures taken to protect workers at
facilities used en route.
(11) For each import, documentation
must be made of the communicable disease-prevention procedures to be carried out in every step of the chain of
custody, from the time of embarkation
of the NHPs at the country of origin
until arrival at the quarantine facility.
(12) Procedures to ensure that aircraft, ship, vehicles, and related equipment are decontaminated following
transport.
(13) Used PPE, bedding, and other potentially contaminated material must
be removed from the ground transport
vehicle upon arrival at the quarantine
facility and disposed of as biohazardous
waste.
(k) Ground transport vehicles. An importer must establish, implement,
maintain, and adhere to SOPs for
ground transport vehicles transporting
NHPs that meet the following requirements.
(1) Ground transport vehicles must
have a separate cargo compartment
with separate heating, ventilation, and
air-conditioning systems.
(2) The interior surfaces of ground
transport vehicle cargo compartments

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

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Public Health Service, HHS

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

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

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least three TSTs on the eyelid using
old mammalian tuberculin (MOT), with
at least 2 weeks between tests, before
the NHP is released from import quarantine. TSTs must be read and recorded at 24, 48, and 72 hours, and a
grading scale for interpretation of
these tests must be listed in an SOP for
TB testing.
(A) An importer must ensure that
any cohort with positive or suspicious
TST reaction remains in quarantine
and receives at least five additional
TSTs (each administered at least two
weeks apart) following removal of the
last affected NHP.
(B) The validity of TB test results
may be compromised if during quarantine an NHP contracts a viral illness, including measles; is treated with
steroids; or is immunized. An importer
must document such occurrence(s) and
hold the NHPs until they have recovered from the illness or are no longer
on treatment, and for a recommended
time after recovery (to be determined
in consultation with HHS/CDC, depending on the illness or treatment in question) before TB tests are performed.
(C) An importer must retain records
of all TSTs performed during the lifetime of each NHP at the facility housing the NHP until the NHP is transferred to another facility. These
records must accompany the NHP during moves to other facilities.
(x) An importer must ensure that different cohorts of NHPs are quarantined
in separate quarantine rooms.
(A) If mixing of cohorts should occur,
an importer must treat the mixed cohort as a single cohort.
(B) All NHPs within that mixed cohort must remain in quarantine until
each NHP in that mixed cohort has
completed the minimum 31-day quarantine period.
(C) Quarantined NHPs must be
housed in such a manner that they do
not expose non-quarantined NHPs to
non-filtered air and other potentially
infectious materials, including soiled
bedding, caging, and other potentially
contaminated items.
(4) Before releasing a NHP from quarantine, an importer must obtain written permission from HHS/CDC. HHS/
CDC may permit the release of a cohort

from quarantine when all the following
conditions have been met:
(i) The 31-day quarantine period, including any required extension of quarantine, has been completed.
(ii) HHS/CDC has confirmed receipt
of written notification of the health
status of the NHPs in the shipment
from the quarantine facility’s licensed
veterinarian as required by paragraph
(m)(4) of this section.
(iii) HHS/CDC confirms that the importer has addressed and resolved to
HHS/CDC’s satisfaction any NHP or
worker communicable disease issues
that were reported to HHS/CDC during
shipment.
(5) If HHS/CDC notifies an importer
of any evidence that NHPs have been
exposed to a zoonotic disease, the importer must, at the importer’s expense,
implement or cooperate in the HHS/
CDC’s implementation of additional
measures to rule out the spread of suspected zoonotic disease before releasing a shipment from quarantine, including examination, additional diagnostic procedures, treatment, detention, isolation, seizure, or destruction
of exposed animals.
(6) An importer must establish, implement, and adhere to SOPs for safe
handling and necropsy of any NHP that
dies in quarantine. The SOPs must ensure the following:
(i) The carcass of the NHP must be
placed in a waterproof double-bag and
properly stored for necropsy, specimen
collection, autoclaving and/or incineration, and disposal;
(ii) A necropsy must be performed by
a veterinary pathologist or state-licensed veterinarian. Each necropsy report must address all major organ systems and incorporate clinical history
and laboratory findings;
(iii) Necropsy and appropriate laboratory testing of the NHP must document the cause of death and/or rule out
zoonotic illness;
(iv) Necropsy must be performed
under biosafety level 3 (BSL3) or enhanced biosafety level 2 ‘‘plus’’ (BSL2 +
) to protect against exposure to highly
infectious agents;
(v) Any samples of tissues, blood,
serum, and/or transudates (bodily fluid)
collected during necropsy must be retained until the NHP shipment has

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been released from quarantine by HHS/
CDC, in case other testing is required
by HHS/CDC;
(vi) Fresh and formalin-fixed tissue
specimens, including tracheobronchial
lymph node, liver, lung, and spleen, regardless of necropsy findings, must be
collected for laboratory examination;
(vii) Any granulomatous lesions
found in any NHP at necropsy, regardless of whether TB in the NHP was previously suspected, must be submitted
to a laboratory for laboratory examination for acid-fast bacilli and for
mycobacterial culture; and
(viii) In the event that an Old World
NHP dies or is euthanized for any reason other than trauma or unexpected
adverse environmental conditions during
quarantine,
liver
tissue
for
filovirus antigen by using the antigencapture ELISA method must be submitted to a qualified laboratory for
testing. The laboratory should provide
documentation of test validation and
records of ongoing quality assurance.
(m) Health reporting requirements for
nonhuman primates. (1) An importer
must notify HHS/CDC of the events
listed in this paragraph (m) by telephone, text, or email.
(2) An importer must notify HHS/
CDC within 24 hours of the occurrence
of any morbidity or mortality of NHPs
in quarantine facilities, or following a
zoo-to-zoo or laboratory-to-laboratory
transfer.
(3) For any morbidity or mortality
from time of embarkation from country of origin to release from HHS/CDC
quarantine, an importer must report
the circumstances to HHS/CDC promptly, including the cause of death for
each NHP.
(4) Upon completion of the quarantine period and before an importer
releases any NHP, cohort, or mixed cohort from quarantine, the importer
must ensure that the quarantine facility’s licensed veterinarian notifies HHS/
CDC in writing of the health status of
the shipment.
(5) An importer must notify HHS/
CDC within 24 hours if any NHP tests
positive for filovirus virus antigen or
antibody.
(6) An importer must report to HHS/
CDC within 24 hours, any positive or
suspicious TST results, necropsy find-

ings, or laboratory results. Any report
required under this section must include a copy or summary of the individual NHP’s health records.
(n) Recordkeeping and reporting requirements for importing NHPs. (1) Before
authorizing the import of any NHPs, an
importer must be in compliance with
all applicable elements of the importer’s SOPs.
(2) At least seven days before importing a shipment of NHPs, an importer
must notify HHS/CDC in writing or by
email of the impending shipment and
provide the following information:
(i) The importer’s name and address;
(ii) Number and species of NHPs
being imported;
(iii) Description of crates;
(iv) Means of individually identifying
NHPs;
(v) Origin of NHPs, including the
country, the exporter, and the exporter’s address;
(vi) Use of NHPs under paragraph (h)
of this section;
(vii) Specific itinerary with names,
dates, flights, times, airports, sea
ports, and responsible parties to contact at every step of travel, including
all ground transportation;
(viii) Port of entry;
(ix) If arriving by flight, the name of
the airline and its flight number;
(x) If arriving by vehicle, the name of
the vehicle’s owner and its license
plate number;
(xi) If arriving by ship, the name of
the ship and its vessel number;
(xii) Name and address of the destination quarantine facility;
(xiii) Name, address, and contact information for shipper, if other than the
importer;
(xiv) If applicable, name, address, and
contact information for broker in the
United States;
(xv) Name, address, and contact information for the person(s) responsible
for off-loading NHPs in the United
States;
(xvi) Name, address, and contact information for any party responsible for
ground transportation from port of
entry to quarantine facility;
(xvii) Expected quarantine facility, if
different from the importer;
(xviii) Master air waybill number for
shipment;

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42 CFR Ch. I (10–1–19 Edition)

(xix) CITES permit number and expiration date.
(o) Animal acts. (1) All animal acts
must be registered with HHS/CDC
under paragraph (g) of this section. In
addition to the requirements in paragraph (g) of this section, which incorporates the requirements in paragraphs
(h) through (m), an importer must provide:
(i) A description of the animal act
that includes each NHP.
(ii) Brochures, advertising materials,
and/or documentation of recent or
planned animal act performances.
(iii) A current list of all NHPs in the
animal act, indicating each NHP’s
name, species, sex, age, distinguishing
physical description, and unique identifier such as a tattoo, microchip, or
other permanent identifier.
(iv) Prior to entry or re-entry into
the United States, specific itinerary
with names, dates, flights, times, airports, sea ports, and responsible parties
to contact at every step of travel, including all ground transportation.
(v) A description, diagram, and photographs of the facilities where the importer houses the NHPs in the animal
act in the United States, including illustrations of the primate caging and/
or enclosures; the relationship of these
cages or enclosures to other structures
on the property and adjoining properties; whether the primate facilities
are open to the air or fully enclosed;
and the physical security measures of
the facility.
(vi) Documentation signed by a licensed veterinarian describing the
physical exam performed on each NHP
in the animal act. Such examinations
must be performed at least once a year.
The physical exam must include the
following:
(A) Routine complete blood counts,
clinical chemistries, fecal exams, and
any additional testing indicated by the
physical exam.
(B) At least once a year, TB testing
with MOT and interpreted as stated in
paragraph (l)(3)(ix) of this section;
(C) NHPs with positive TST results
must be evaluated for potential
antituberculosis chemotherapy in consultation with HHS/CDC.
(D) If the NHP is a chimpanzee, serology and antigen testing for hepatitis B,

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

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

paragraphs (g), (h), (i), (j), (k), (l), (m),
and (n) of this section.
(r) In transit shipments of NHPs. (1)
Before arrival into the United States,
brokers of in transit shipments must
notify HHS/CDC of all scheduled in
transit shipments of NHPs not intended for import into the United
States and provide the following information:
(i) Number and species of NHPs in
the shipment;
(ii) Origin of NHPs, including the
country, the exporter, and the exporter’s address;
(iii) Name and full address of the
final destination quarantine facility in
the importing country;
(iv) Means of individually identifying
NHPs, if required by the importing
country;
(v) A specific itinerary while in the
United States including names, dates,
flights, times, airports, seaports, and
responsible parties to contact at every
step of travel within the United States,
including all ground transportation;
(vi) Description of crates;
(vii) SOPs describing procedures to
protect and train transport workers
from exposure to communicable disease while handling NHPs;
(viii) SOPs describing procedures to
prevent contamination of other articles and cargo during transit, including
physical separation of crates from
other cargo;
(ix) SOPs describing procedures to
decontaminate aircraft, ships, vehicles,
and related equipment following transport; and
(x) Proposed use, if any, of in transit
holding facilities and steps to be taken
to protect workers, as well as NHPs,
from communicable disease exposure
at each facility to be used en route.
(2) While located in the United
States, in transit shipments must be
housed and cared for in a manner consistent with requirements for NHPs intended for import into the United
States as specified in paragraphs (j)
and (k) of this section.
(s) Revocation and reinstatement of an
importer’s registration. (1) If the Director
determines that an importer has failed

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to comply with any applicable provisions of this section, including the importer’s SOPs, the Director may revoke
the importer’s registration.
(2) HHS/CDC will send the importer a
notice of revocation stating the
grounds upon which the proposed revocation is based.
(i) If the importer wishes to contest
the revocation, the importer must file
a written response to the notice within
20 calendar days after receiving the notice.
(A) As part of the response, an importer may request that the Director
review the written record.
(B) If an importer fails to file a response within 20 calendar days, all of
the grounds listed in the proposed revocation will be deemed admitted, in
which case the notice shall constitute
final agency action.
(ii) [Reserved]
(3) If an importer’s response is timely, the Director will review the registration, the notice of revocation, and
the response, and make a decision in
writing based on the written record.
(4) As soon as practicable after completing the written record review, the
Director will issue a decision in writing
that shall constitute final agency action. The Director will serve the importer with a copy of the written decision.
(5) The Director may reinstate a revoked registration after inspecting the
importer’s facility, examining its
records, conferring with the importer,
and receiving information and assurance from the importer of compliance
with the requirements of this section.
(t) Nonhuman primate products. (1)
NHP products may be imported without obtaining a permit under this section if accompanied by documentation
demonstrating that the products have
been rendered noninfectious using one
of the following methods:
(i) Boiling in water for an appropriate time so as to ensure that any
matter other than bone, horns, hooves,
claws, antlers, or teeth is removed; or
(ii) Gamma irradiation at a dose of at
least 20 kilo Gray at room temperature
(20 °C or higher); or
(iii) Soaking, with agitation, in a 4%
(w/v) solution of washing soda (sodium

carbonate, Na2CO3) maintained at pH
11.5 or above for at least 48 hours; or
(iv) Soaking, with agitation, in a formic acid solution (100 kg salt [NaCl]
and 12 kg formic acid per 1,000 liters
water) maintained at below pH 3.0 for
at least 48 hours; wetting and dressing
agents may be added;
(v) In the case of raw hides, salting
for at least 28 days with sea salt containing 2% washing soda (sodium carbonate, Na2CO3);
(vi) Formalin fixation; or
(vii) Another method approved by
HHS/CDC.
(viii) Fully taxidermied products are
considered rendered noninfectious, and
so do not require a permit from the Director.
(2) NHP products that have not been
rendered noninfectious are considered
to pose a potential human health risk
and may only be imported under the
following circumstances:
(i) The product must be accompanied
by a permit issued by the Director. Requests for permits should be accompanied by an explanation of the product’s intended use and a description of
how the product will be handled to ensure that it does not pose a zoonotic
disease threat to humans. The Director
will review the request for a permit,
and accompanying materials, and issue
a decision that shall constitute final
agency action.
(ii) The product may only be imported for bona fide scientific, educational, or exhibition purposes.
(iii) A permit will only be issued if
the product will be received by a facility equipped to handle potentially infectious NHP materials.
(iv) The product must comply with
any other applicable federal requirements, including those relating to
packaging, shipping, and transport of
potentially infectious, biohazardous
substances as well as those for select
agents pursuant to 42 CFR part 73, 7
CFR part 331, and 9 CFR part 121.
(u) Appeal of denial for a permit to import. If the HHS/CDC denies your request for a permit under this section,
you may appeal that denial to the
HHS/CDC Director.

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(1) You must submit your appeal in
writing to the HHS/CDC Director, stating the reasons for the appeal and demonstrating that there is a genuine and
substantial issue of fact in dispute.
(2) You must submit the appeal within 5 business days after you receive the
denial.
(3) HHS/CDC will issue a written response to the appeal, which shall constitute final Agency action.
(v) Filovirus testing fee. (1) Non-human
primate importers shall be charged a
fee for filovirus testing of non-human
primate liver samples submitted to the
Centers for Disease Control and Prevention (CDC).
(2) The fee shall be based on the cost
of reagents and other materials necessary to perform the testing; the use
of the laboratory testing facility; irradiation for inactivation of the sample;
personnel costs associated with performance of the laboratory tests; and
administrative costs for test planning,
review of assay results, and dissemination of test results.
(3) An up-to-date fee schedule is
available from the Division of Global
Migration & Quarantine, Centers for
Disease Control and Prevention, 1600
Clifton Road, Atlanta, Georgia 30333.
Any changes in the fee schedule will be
published in the FEDERAL REGISTER.
(4) The fee must be paid in U.S. dollars at the time that the importer submits the specimens to HHS/CDC for
testing.
[78 FR 11538, Feb. 15, 2013]

§ 71.54 Import regulations for infectious biological agents, infectious
substances, and vectors.
(a) The following definitions apply to
this section:
Animal. Any member of the animal
kingdom except a human including an
animal product (e.g., a mount, rug, or
other display item composed of the
hide, hair, skull, teeth, bones, or
claws).
Diagnostic specimen. Specimens of
human and animal matter (including
tissue, blood, body discharges, fluids,
excretions or similar material), or environmental samples.
Genomic material. Deoxyribonucleic
acid (DNA) or Ribonucleic acid (RNA)
comprising the genome or organism’s

hereditary information, that may be
single-stranded or double-stranded, and
in a linear, circular, or segmented configuration and may be positive sense
(same polarity as mRNA), negative
sense, or ambisense (mixture of the
two).
Infectious biological agent. A microorganism (including, but not limited
to, bacteria (including rickettsiae), viruses, fungi, or protozoa) or prion,
whether naturally occurring, bioengineered, or artificial, or a component of
such microorganism or prion that is
capable of causing communicable disease in a human.
Infectious substance. Any material
that is known or reasonably expected
to contain an infectious biological
agent.
Select agents and toxins. Biological
agents and toxins that could pose a severe threat to public health and safety
as listed in 42 CFR 73.3 and 73.4.
Vector. Any animals (vertebrate or
invertebrate) including arthropods or
any noninfectious self-replicating system (e.g., plasmids or other molecular
vector) or animal products (e.g., a
mount, rug, or other display item composed of the hide, hair, skull, teeth,
bones, or claws of an animal) that are
known to transfer or are capable of
transferring an infectious biological
agent to a human.
(b) Unless excluded pursuant to paragraph (f) of this section, a person may
not import into the United States any
infectious biological agent, infectious
substance, or vector unless:
(1) It is accompanied by a permit
issued by the Centers for Disease Control and Prevention (CDC). The possession of a permit issued by the CDC does
not satisfy permitting requirements
placed on materials by the U.S. Department of Agriculture that may pose hazards to agriculture or agricultural production in addition to hazards to
human health.
(2) The importer is in compliance
with all of the permit requirements
and conditions that are outlined in the
permit issued by the CDC.
(3) The importer has implemented
biosafety measures commensurate with
the hazard posed by the infectious biological agent, infectious substance,

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