Section
2: Worker Protection Plan and Personal Protective Equipment
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Regulation
42 CFR §71.53 (i)
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Standard
Operating Procedure Meeting Regulation
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Note:
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.
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Please
verify that you 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.
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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. Please describe your procedures to contact CDC.
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Describe
the elements of your worker protection plan that address the
following:
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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;
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An
infection-prevention program, including infection-prevention
methods requiring, at a minimum, PPE and workplace practices for
preventing infection among workers whose duties may result in
exposure to NHPs and;
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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.
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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.
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SOPs
requiring that removable, disposable PPE be autoclaved,
incinerated, or otherwise disposed of as biohazardous waste.
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Nondisposable
clothing worn in the quarantine facility must be disinfected on
site before laundering. Please provide a detailed description of
how quarantine laundry is handled.
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Describe
your 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.
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Describe
your 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.
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Describe
your post-exposure procedures that provide potentially exposed
workers with direct and rapid access to a medical consultant
including:
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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.
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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.
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How
do you document worker training, including for those working in
the quarantine facility?
What
is the frequency of quarantine worker training?
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Describe
how your worker protection program addresses hazard evaluation
and worker communication procedures that include the following:
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A
description of the known zoonotic disease and injury hazards
associated with handling NHPs
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The
need for PPE when handling NHPs and training in proper use of
PPE, including re-training and reinforcement of appropriate use
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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
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Procedures
for disinfection of garments, supplies, equipment, and waste.
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As
part of your worker protection plan, you must identify the PPE
required for each task or working area. Please describe your
procedures for ensuring the following (be sure to describe in
detail the steps for donning, doffing, and discarding or
disinfecting PPE):
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Any
required PPE must be available to workers when needed
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Workers
in direct contact with NHPs must wear the following
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Gloves
of sufficient thickness to reduce the risk of cuts, scratches,
and punctures
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At
a minimum, disposable NIOSH-approved N95 respirators, in
compliance with OSHA 29
CFR §1910.134,
which requires a respiratory protection program
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Face
shields or eye protection
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Outer
protective clothing when opening crates, removing foreign
materials from crates, feeding NHPs, removing dead NHPs, or
handling bedding materials
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Workers
handling crates or pallets containing NHPs must wear the
following
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Elbow-length,
reinforced leather gloves or equivalent gloves that prevent
penetration of splinters, other crating materials, or debris
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Outer
protective clothing
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Waterproof
shoes or boots
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NIOSH-approved
respiratory protection that is compliant with OSHA regulations at
29
CFR 1910.134
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Face
shields or eye protection
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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;
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Workers
must remove disposable PPE and discard as a biohazard
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Describe
procedures to ensure workers do not drink, eat, or smoke while
physically handling NHPs or cages, crates, or other materials
from such NHPs
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Describe
your procedures for ensuring that each item listed below
regarding tuberculosis (TB) is addressed:
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Workers
in a facility housing NHPs must have a baseline evaluation for TB
prior to working with NHPs and an evaluation at least annually
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Personnel
must have prompt and direct access to a medical consultant who is
capable of performing the evaluation and maintaining records for
such tests
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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
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If
that test is negative, the worker must undergo another TB
evaluation 3 months later; and
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If
either test is reactive, the worker must be referred for medical
evaluation; and
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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
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Describe
how you ensure 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.
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Describe
how you will ensure compliance with the respiratory protection
requirements in 29
CFR 1910.134.
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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. If you intend to import macaques during
the 2-year registration period, please provide a description of
your program addressing herpes B.
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Describe
how you will ensure the following requirements are met:
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.
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Section
3: Crating, Caging, and Transport
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Regulation
42 CFR §71.53 (j)
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Standard
Operating Procedure Meeting Regulation
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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. Additionally, importers must establish, implement,
maintain, and adhere to SOPs that ensure the items listed below
are met. Describe the elements of your SOPs that will ensure the
following:
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Any
crate used to transport NHPs must be free of sharp projections
that could scratch or otherwise injure workers or NHPs
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Glass
items must not be used for feeding or watering NHPs during
transport.
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NHPs
must only be removed from crates in an approved quarantine
facility under the supervision of a licensed veterinarian.
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NHPs
must not be removed from crates during transport
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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.
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All
reusable items must be decontaminated between uses.
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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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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.
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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.
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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
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For
each import, documentation must be made of the communicable
disease-prevention procedures to be carried out in every step of
the chain of custody, from the time of embarkation of the NHPs at
the country of origin until arrival at the quarantine facility.
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Procedures
to ensure that aircraft, ship, vehicles, and related equipment
are decontaminated following transport.
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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.
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Section
5: Quarantine Facilities
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Regulation
42 CFR §71.53 (l)
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Standard
Operating Procedure Meeting Regulation
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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.
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For
any quarantine facility established or maintained under this
section, an importer must establish, implement, maintain, and
adhere to SOPs that meet physical security requirements. Please
describe the security measures to ensure the following at your
quarantine facility:
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The
facility must be locked and secure, with access limited to
authorized, trained, and knowledgeable personnel.
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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.
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Describe
your procedures to keep the number of workers involved in the
care, transport, and inspection of NHPs to the minimum necessary
to perform these functions.
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Explain
how the facility is designed and operated in such a manner as to
allow for adequate disinfecting.
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Please
provide a written description or attach diagrams/photos to
support that your facility meets these requirements.
The
facility must have adequate equipment and space for discarding
and disinfecting all equipment, clothing, and caging.
Each
heating ventilation and air-conditioning unit in the quarantine
facility must be designed so that there is no mixing of air
among quarantine rooms.
Each
quarantine room must remain under negative air pressure in
relationship to the common hallway or anteroom(s) adjacent to
the quarantine room.
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.
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An
importer must establish, implement, maintain, and adhere to SOPs
for handling, monitoring, and testing NHPs in quarantine. Please
describe the elements of your SOPs that ensure the following
requirements are met:
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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.
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Health
certificates, shipping documents, and NHP health records must
include the NHP’s identification number, age, sex, and
species.
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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.
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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).
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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.
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All
cages, feeding bottles, reusable items, and other contaminated
items must be disinfected between uses and before disposal.
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Any
equipment used for infusion of NHPs must be autoclaved or
incinerated, as appropriate.
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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.
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.
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.
An
importer must not knowingly request a release from HHS/CDC of any
ill NHP from quarantine.
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Describe
your procedures for administering at least three tuberculin skin
tests (TSTs) on the eyelid of each imported NHP 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
testing.
A.
Please verify that any cohort with positive or suspicious TST
reaction will remain in quarantine and receive 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. Please provide a written
procedure for ensuring such occurrence(s) will be documented and
the affected NHPs will be held 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.
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Please
describe how you will ensure that different cohorts of NHPs are
quarantined in separate quarantine rooms, along with procedures
to address the following:
If
mixing of cohorts should occur, an importer must treat the mixed
cohort as a single cohort.
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.
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.
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Before
requesting release of a NHP from quarantine, an importer must
obtain written permission from HHS/CDC. Provide a protocol for
providing written documentation to HHS/CDC that all the
following conditions have been met when requesting release from
CDC-mandated quarantine:
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The
31-day quarantine period, including any required extension of
quarantine, has been completed.
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The
importer must provide written notification of the health status
of the NHPs in the shipment from the quarantine facility's
licensed veterinarian.
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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.
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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.
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An
importer must establish, implement, and adhere to SOPs for safe
handling and necropsy of any NHP that dies in quarantine. Please
describe elements of your SOPs that ensure the following:
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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;
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A
necropsy must be performed by a veterinary pathologist or
state-licensed veterinarian.
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Each
necropsy report must address all major organ systems and
incorporate the following:
Clinical
history
Exam
findings before the animal died
Complete
description of the gross appearance of all major body system at
the time of necropsy. Major body systems include:
Nervous
system (including brain if indicated by clinical signs)
Cardiovascular
system
Respiratory
system
Digestive
system (including ancillary organs such as liver and pancreas)
Genitourinary
system
Lymphatic
system (including spleen)
Musculoskeletal
system
Endocrine
system
Integumentary
system
Laboratory
findings, including the following:
Histopathology
results from, at a minimum, samples of tracheobronchial lymph
nodes, liver, lung, spleen, and any tissue that exhibited
lesions during gross necropsy examination.
For
any tissues where histopathology results suggested evidence of
infection, results of appropriate microbiological cultures.
A
pathologic diagnosis must be included on each necropsy report.
If cause of death cannot be determined, an explanation regarding
how an infectious disease was ruled out must be included in the
report.
If
an infectious cause of death is suspected, the necropsy report
must document tests conducted to establish the exact etiology of
the infection (e.g., for a pathologic diagnosis of pneumonia,
the necropsy report must include results of histopathological
and microbiological tests conducted to determine the type of
pneumonia, and, if infectious, the etiologic agent).
The
printed name, state license number, state in which licensed, and
signature of the veterinarian who conducted the necropsy.
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Necropsy
and appropriate laboratory testing of the NHP must document the
cause of death and/or rule out zoonotic illness;
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Necropsy
must be performed under biosafety level 3 (BSL3) or enhanced
biosafety level 2 “plus” (BSL2 + ) to protect against
exposure to highly infectious agents;
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Any
samples of tissues, blood, serum, and/or transudates (bodily
fluid) collected during necropsy must be retained until the NHP
shipment has been released from quarantine by HHS/CDC, in case
other testing is required by HHS/CDC;
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Fresh
and formalin-fixed tissue specimens, including tracheobronchial
lymph node, liver, lung, and spleen, regardless of necropsy
findings, must be collected for laboratory examination;
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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
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In
the event that an Old World NHP dies or is euthanized for any
reason other than trauma or unexpected adverse environmental
conditions during quarantine, liver tissue for filovirus antigen
by using the antigen-capture ELISA method must be submitted to a
qualified laboratory for testing. The laboratory should provide
documentation of test validation and records of ongoing quality
assurance.
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