| 
			Section
			2: Worker Protection Plan and Personal Protective Equipment 
			 | 
	
		| 
			Regulation
			42 CFR §71.53 (i) | 
			Standard
			Operating Procedure Meeting Regulation | 
	
		| 
			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
 | 
	
		| 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
 | 
	
		| Outer
				protective clothing
 | 
	
		| Waterproof
				shoes or boots
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		| NIOSH-approved
				respiratory protection that is compliant with OSHA regulations at
				29
				CFR 1910.134
 | 
	
		| 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;
 | 
	
		| 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 
			 | 
	
		| 
			Regulation
			42 CFR §71.53 (j) | 
			Standard
			Operating Procedure Meeting Regulation | 
	
		| 
			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.
 | 
			
 | 
	
	
	
	
		| 
			Section
			5: Quarantine Facilities 
			 | 
	
		| 
			Regulation
			42 CFR §71.53 (l) | 
			Standard
			Operating Procedure Meeting Regulation | 
	
		| 
			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. | 
			
 | 
	
		| 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.
 | 
			
 | 
	
		| 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.
 | 
			
 | 
	
		| 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:
 | 
			
 | 
	
		| 
			
 | 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.
 | 
			
 | 
	
		| 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.
 | 
			
 | 
	
		| Any
				equipment used for infusion of NHPs must be autoclaved or
				incinerated, as appropriate.
 | 
			
 | 
	
		| 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. | 
			
 | 
	
		| 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. 
 | 
			
 | 
	
		| 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. | 
			
 | 
	
		| 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.
 | 
			
 | 
	
		| The
				importer must provide written notification of the health status
				of the NHPs in the shipment from the quarantine facility's
				licensed veterinarian.
 | 
	
		| 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.
 | 
	
		| 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:
 | 
			
 | 
	
		| 
			
 | 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;
 | 
			
 | 
	
		| A
				necropsy must be performed by a veterinary pathologist or
				state-licensed veterinarian. 
				
 | 
			
 | 
	
		| Each
				necropsy report must address all major organ systems and
				incorporate the following: 
					Clinical
					historyExam
					findings before the animal diedComplete
					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
						systemRespiratory
						systemDigestive
						system (including ancillary organs such as liver and pancreas)Genitourinary
						systemLymphatic
						system (including spleen)Musculoskeletal
						systemEndocrine
						systemIntegumentary
						systemLaboratory
					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;
 | 
			
 | 
	
		| Necropsy
				must be performed under biosafety level 3 (BSL3) or enhanced
				biosafety level 2 “plus” (BSL2 + ) to protect against
				exposure to highly infectious agents;
 | 
			
 | 
	
		| 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;
 | 
			
 | 
	
		| Fresh
				and formalin-fixed tissue specimens, including tracheobronchial
				lymph node, liver, lung, and spleen, regardless of necropsy
				findings, must be collected for laboratory examination;
 | 
			
 | 
	
		| 
				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
 | 
			
 | 
	
		| 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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