Form CS 337508-B CS 337508-B Lab-to-Lab Form

Registration Form for NHP Importation
(Part 2 – Lab-to-Lab Standard Operating Procedures)

Form Approved
OMB No. 0920-1383
Expiration Date: 1/31/2026

IMPORTER’S CONTACT INFORMATION
Date of Application:

Name:

Institution:
Address:

State:

County:

Zip Code:

Email:

Phone Number:

Standard Operating Procedures
In sections 1-6, please include the elements of your standard operating procedures (SOPs) that address each regulatory
requirement for importing nonhuman primates under a Lab-to-Lab registration. You may copy and paste applicable sections
of your SOPs or reference the SOP (name AND page number/section) that addresses each element in the spaces provided.
Please attach copies of your SOPs.

SECTION 1: DOCUMENTATION
Regulation 42 CFR §71.53 (h)

Standard Operating Procedure Meeting Regulation

1. Describe your procedures to collect or create a record of
the intended purpose of importation for each imported
NHP. The purpose must comply with one of the regulatory permitted purposes (science, education, or exhibition),
as defined in 42 CFR§71.53 (a).
2. Describe how you will ensure that written certifications
demonstrating that the NHPs and their offspring will
continue to be used for permitted purposes are maintained for three years after the distribution or transfer
of the NHP. 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.
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.
3. Explain how, before distributing or transferring an
imported NHP, you will:
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.

Public reporting burden of this collection of information is estimated to average 120 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid
OMB Control Number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions
for reducing this burden to CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA 0920-1383.
CS 337508-B 4/14/2023

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SECTION 2: WORKER PROTECTION PLAN AND PERSONAL PROTECTIVE EQUIPMENT
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.
Regulation 42 CFR 71.53 (i)

Standard Operating Procedure Meeting Regulation

1. Submit 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.
2. 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.
Describe your procedures to contact CDC.
3. Describe the elements of your worker protection plan
that address 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. An infection-prevention program, including infection-prevention methods requiring, at a minimum,
PPE and workplace practices for preventing infection
among workers whose duties may result in exposure
to NHPs and;

a. SOPs that include requirements for preventing
workplace infection from potentially contaminated
needles or other sharp instruments and that, at a
minimum, prohibit workers from recapping used
needles by hand; removing needles by hand; or
otherwise bending, breaking, or manipulating used
needles by hand.

b. SOPs requiring that used disposable syringes and
needles, scalpel blades, and other sharp items be
placed in puncture-resistant containers kept as
close to the work site as practical and disinfected
and/or disposed of as hazardous waste.

c. SOPs requiring that removable, disposable PPE be
autoclaved, incinerated, or otherwise disposed of
as biohazardous waste.

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Regulation 42 CFR 71.53 (i)

Standard Operating Procedure Meeting Regulation

d. 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.

e. 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.

f.

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.

iii. Describe your 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.

iv. How do you document worker training, including
for those working in the quarantine facility?

v. What is the frequency of quarantine worker training?

4. Describe how your worker protection program addresses 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;

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Regulation 42 CFR 71.53 (i)

Standard Operating Procedure Meeting Regulation

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.

5. 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):
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
d. Outer protective clothing when opening crates,
removing foreign materials from crates, feeding
NHPs, removing dead NHPs, or handling
bedding materials.

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Regulation 42 CFR 71.53 (i)

Standard Operating Procedure Meeting Regulation

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
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.

vi. Describe procedures to ensure workers do not drink,
eat, or smoke while physically handling NHPs or
cages, crates, or other materials from such NHPs.

6. Describe your procedures for ensuring that each item
listed below regarding tuberculosis (TB) is addressed:
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. 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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Regulation 42 CFR 71.53 (i)

Standard Operating Procedure Meeting Regulation

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. 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.

v. Describe how you will ensure compliance with
the respiratory protection requirements in 29 CFR
1910.134.

7. 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.
8. Describe how you will ensure the following requirements are met:
i.

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

ii. The importer must promptly notify HHS/CDC by telephone, text, or email if such an illness occurs
iii. 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
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:
Regulation 42 CFR 71.53 (j)

Standard Operating Procedure Meeting Regulation

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.

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Regulation 42 CFR 71.53 (j)

Standard Operating Procedure Meeting Regulation

7. At all times during transport, crates containing NHPs
must be separated by a physical barrier from workers,
other individuals, and all other animals and cargo, or
by a spatial barrier greater than 5 feet, that prevents
contamination of cargo or individuals with bodily fluids,
feces, or soiled bedding.
8. At all times during transport, individuals traveling with
the shipment must be protected from shared air of
NHPs to prevent the transmission of zoonotic diseases. Airflow must be unidirectional from NHP transport
workers to NHPs or, if any air is recirculated to the NHP
transport workers, it must be HEPA-filtered. If a ventilation system is not in place, all NHP transport workers
must wear respiratory protection.

9. If traveling by plane, crates containing NHPs should be
loaded in the cargo hold last and removed first, must be
placed on plastic that prevents spillage onto the deck
of the plane, and must be placed on pallets or double
crated to ensure separation from other cargo.

10. Workers, as well as NHPs, must be protected from
communicable disease exposures at any facility used
en route, including transportation holding facilities. An
importer must maintain a description of any transportation holding facilities and document the communicable
disease prevention measures taken to protect workers
at facilities used en route.

11. For each import, documentation must be made of the
communicable disease-prevention procedures to be
carried out in every step of the chain of custody, from
the time of embarkation of the NHPs at the country of
origin until arrival at the quarantine facility.

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.

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SECTION 4: GROUND TRANSPORT VEHICLES
An importer must establish, implement, maintain, and adhere to SOPs for ground transport vehicles transporting
NHPs that meet the following requirements. Provide a description of ground transport vehicles you intend to use for
transportation of imported NHPs under CDC-mandated quarantine. You may also attach diagrams or photographs.
Regulation 42 CFR 71.53 (k)

Standard Operating Procedure Meeting Regulation

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. 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.

4. Verify that used PPE, bedding, and other potentially
contaminated material will be removed from the
ground transport vehicle upon arrival at the quarantine
facility and disposed of as biohazardous waste by a
licensed facility.

5. Describe procedures to notify HHS/CDC in writing,
text message, or email, after transport of the NHP
shipment from the port of entry to the quarantine facility. Notification must occur within 48 hours of the time
the shipment arrived at the quarantine facility.

6. As part of the notification of arrival in number five (5)
above, 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. Please describe your SOPs to ensure
this notification occurs.

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SECTION 5: HEALTH REPORTING FOR NHPS
An importer must notify HHS/CDC of the events listed in this section (Section 5) by telephone, text, or email. Please
provide elements of your SOPs that ensure the following:
Regulation 42 CFR 71.53(m)

Standard Operating Procedure Meeting Regulation

1. 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-tozoo or laboratory-to-laboratory transfer.

2. An importer must notify HHS/CDC within 24 hours if any
NHP tests positive for filovirus virus antigen or antibody.

3. An importer must report to HHS/CDC within 24 hours,
any positive or suspicious TST results, necropsy findings, or laboratory results. Any report required under
this section must include a copy or summary of the
individual NHP’s health records.

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SECTION 6: LABORATORY TO LABORATORY TRANSFERS
In addition to the requirements listed in Sections 1-5 above, 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.
Note: Only laboratories transferring NHPs on established research protocols from their foreign-based facilities to their
U.S.-based laboratories are eligible to apply to transfer NHPs from lab to lab under 42 CFR §71.53 (q).
Regulation 42 CFR §71.53 (q)

Standard Operating Procedure Meeting Regulation

1. 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.

2. 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

3. Documentation of the ongoing IACUC-approved
research project and the reason the NHP needs to be
transported to the U.S. laboratory facility.

4. A specific itinerary with names, dates, flights, times,
airports, seaports, and responsible parties to contact at
every step of travel, including all ground transportation.
This must be provided in writing (by email) to HHS/CDC
at least 7 days before shipment arrival.

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