Vol. 78 Friday, 

No. 32 February 15, 2013 

Part VI 

Department of Health and Human Services 

42 CFR Part 71 

Control of Communicable Disease; Foreign—Requirements for Importers of 

Nonhuman Primates (NHP); Final Rule 


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11522 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 71 

[Docket No. HHS/CDC–2011–0001] 

RIN 0920–AA23 

Control of Communicable Disease; 

Foreign—Requirements for Importers 

of Nonhuman Primates (NHP) 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Final rule. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS), is amending 

regulations for the importation of live 

nonhuman primates (NHPs) by 

extending existing requirements for the 

importation of Macaca fascicularis 

(cynomolgus), Chlorocebus aethiops 

(African green), and Macaca mulatta 

(rhesus) monkeys to all NHPs with the 

exception of the filovirus testing 

requirement. Filovirus testing will only 

be required for Old World NHPs in 

quarantine that have illness consistent 

with filovirus infection or that die for 

any reason other than trauma during 

quarantine. HHS/CDC is also finalizing 

a provision to reduce the frequency at 

which importers of cynomolgus, African 

green, and rhesus monkeys are required 

to renew their special permits (from 

every 180 days to every 2 years). HHS/ 

CDC is incorporating existing guidelines 

into the regulations and adding new 

provisions to address the following: 

NHPs imported as part of an animal act; 

NHPs imported or transferred by 

zoological societies; the transfer of 

NHPs from approved laboratories; and 

non-live imported NHP products. 

Finally, HHS/CDC is also requiring that 

all NHPs be imported only through 

ports of entry where a HHS/CDC 

quarantine station is located. 

DATES: This final rule is effective April 

16, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Ashley A. Marrone, J.D., Division of 

Global Migration and Quarantine, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE., 

Mailstop E–03, Atlanta, Georgia 30333, 

telephone, 404–498–1600. 

SUPPLEMENTARY INFORMATION: This final 

rule is organized as follows: 

Table of Contents 

I. Background 

A. What is the risk to human health from 

NHPs? 

B. What is the legal authority for this 

rulemaking? 

C. What is the history of this rulemaking? 

II. Summary of the Proposed Rule 

Requirements 

III. Comment Summary and Responses 

A. General Opposition and Support 

B. Public Comments Regarding Purpose 

and Scope 

C. Public Comments Regarding Definitions 

D. Public Comments Regarding Prohibition 

on Importing NHPs 

E. Public Comments Regarding Authorized 

Points of Entry 

F. Public Comments Regarding Importer 

Licensing Requirements 

G. Public Comments Regarding 

Recordkeeping, Reporting, and 

Notification Requirements 

H. Public Comments Regarding Worker 

Protection Requirements 

I. Public Comments Regarding Equipment, 

Transfer/Transport, and Handling 

J. Public Comments Regarding Quarantine 

Facility Requirements 

K. Public Comments Regarding 

Requirements for Veterinarians and 

Veterinary Pathologists 

L. Public Comments Regarding Zoo-to-Zoo 

and Laboratory-to-Laboratory Transfers; 

Animal Acts 

M. Public Comments Regarding NHP 

Products 

N. Public Comments Regarding Appeals 

O. Public Comments Regarding HHS/CDC 

Monitoring and Enforcement 

P. Miscellaneous Comments 

IV. Alternatives Considered 

V. Regulatory Analyses 

A. Economic Analysis 

B. Paperwork Reduction Act Analysis 

C. Federalism Impact 

D. Environmental Impact 

E. Unfunded Mandates Reform Act 

F. Plain Language Act of 2010 

VI. References 

I. Background 

A. What is the risk to human health 

from NHPs? 

NHPs, particularly those recently 

captured in the wild, may harbor agents 

infectious to humans. Although such 

infectious agents, if present, are usually 

detectable in the NHP’s blood, they also 

may be detected in secreted bodily 

fluids such as urine, feces, or saliva. 

Due to the nature of the job, persons 

working in temporary and long-term 

holding facilities and those involved in 

transporting NHPs (e.g., cargo handlers 

and inspectors) are especially at risk for 

infection. NHPs are a potential source of 

pathogens and communicable or 

zoonotic disease that may be fatal to 

humans, including filoviruses, hepatitis, 

herpes B virus, tuberculosis (TB), and 

parasitic infections (National Research 

Council, 2003). Quarantine 

requirements for imported NHPs are 

designed to reduce this communicable 

disease risk. 

B. What is the legal authority for this 

rulemaking? 

Section 361 of the Public Health 

Service Act (PHSA) (42 U.S.C. 264) 

authorizes the Secretary of the 

Department of Health and Human 

Services (HHS) to make and enforce 

regulations as may be necessary to 

prevent the introduction, transmission, 

or spread of communicable diseases 

from foreign countries into the United 

States or from one State or possession to 

another. Section 361 of the PHSA also 

provides that, as the Secretary deems 

necessary, such regulations may provide 

for inspection and destruction of 

animals or articles found to be infected 

or contaminated as a source of 

dangerous infection. Section 361 of the 

PHSA serves as the primary legal 

authority for 42 CFR 71.53, regarding 

the importation of NHPs. 

Section 368 of the PHSA (42 U.S.C. 

271) sets forth penalties for violations of 

any regulations prescribed under 

section 361 of the PHSA. Under section 

368(a) of the PHSA, any person who 

violates a regulation prescribed under 

section 361 of the PHSA may be 

punished by a fine up to $1,000 or by 

imprisonment for up to 1 year, or both 

[42 U.S.C. 271(a)]. These penalties are 

strengthened under the sentencing 

classification provisions of 18 U.S.C. 

sections 3559 and 3571, which provide 

for more strict penalties for criminal 

violations that would otherwise be 

classified as Class A misdemeanors. 

Individuals may be punished by a fine 

of up to $100,000 per violation not 

resulting in the death of an individual, 

or up to $250,000 per violation resulting 

in the death of an individual [18 U.S.C. 

3559, 3571(b)]. Organizations may be 

fined up to $200,000 per violation not 

resulting in the death of an individual 

and $500,000 per violation resulting in 

the death of an individual [18 U.S.C. 

3559, 3571(c)]. These penalties are 

criminal in nature and would thus be 

imposed by a court, not administratively 

by HHS or HHS/CDC. 

C. What is the history of this 

rulemaking? 

To address the risk NHPs pose to 

humans, since October 10, 1975, HHS/ 

CDC has prohibited the importation of 

NHPs except for scientific, educational, 

or exhibition purposes (42 CFR 71.53). 

NHP importers have been required to 

register with HHS/CDC, renew this 

registration every 2 years, and hold 

NHPs in quarantine for a minimum of 

31 days following entry into the United 

States. Importers also must maintain 

records on imported NHPs; immediately 

report illness suspected of being 


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Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 11523 

communicable to humans; and make 

their facilities, vehicles, equipment, and 

business records used in the 

importation of NHPs available to HHS/ 

CDC 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. 

Additional requirements for importers 

of NHPs have been developed and 

implemented in response to specific 

public health threats, including interim 

guidelines for handling NHPs during 

transit and quarantine (HHS/CDC 

Update: Ebola-Related, 1990) issued 

following a 1990 incident involving 

identification of Ebola virus (Reston 

strain) among NHPs imported from the 

Philippines. As a result of this incident, 

HHS/CDC concluded that cynomolgus, 

African green, and rhesus monkeys were 

capable of being an animal host or 

vector of filovirus which may pose a 

threat to human health. On April 20, 

1990, HHS/CDC published a notice in 

the Federal Register requiring a special 

permit for importing cynomolgus, 

African green, and rhesus monkeys (55 

FR 15210, April 20, 1990), with 

enhanced requirements for the granting 

of a special permit to import these 

species, including submitting a plan to 

HHS/CDC every 180 days describing 

specific isolation, quarantine, and 

disease control measures and detailing 

measures to be carried out at every step 

of the chain of custody, from 

embarkation at the country of origin, 

through delivery of the NHPs and the 

completion of the required quarantine 

period. Importers also were required to 

describe and implement testing 

procedures for all quarantined NHPs to 

rule out the possibility of filovirus 

infection. 

Over time, HHS/CDC revised 

components of the special permit 

requirement in response to surveillance 

findings and the development of 

improved laboratory tests. HHS/CDC 

informed covered importers of these 

changes by letter in 1991 (Roper, 1991). 

The special permit notice required 

filovirus antigen-capture testing on 

specimens from any NHP that died 

during quarantine for reasons other than 

trauma, and filovirus antibody testing of 

a serum sample taken at the end of 

quarantine before a cohort is released 

from quarantine on any NHPs that 

recover from illness consistent with a 

possible filovirus infection during 

quarantine (Tipple, 1996). 

On July 30, 1993, HHS/CDC 

published guidelines in the Morbidity 

and Mortality Weekly Report (MMWR) 

for TB testing requirements for NHPs, 

following the recognition of TB in up to 

2% of imported NHPs and the risk for 

TB infection posed to caretakers (HHS/ 

CDC, 1993). These published 

requirements included provisions for 

recordkeeping to track and trace NHPs 

and for use of personal protective 

equipment (PPE) by NHP handlers to 

prevent transmission of TB (HHS/CDC, 

1993). Since publishing the guidelines 

in the MMWR, HHS/CDC has required a 

minimum of three negative tuberculin 

skin tests (TSTs) administered at 2-week 

intervals, on each imported NHP before 

approving release of any NHPs from 

quarantine. 

On February 12, 2013, HHS/CDC 

published a final rule at 78 FR 9828 

establishing a user fee for filovirus 

testing of all nonhuman primates that 

die during the HHS/CDC-required 31- 

day quarantine period for any reason 

other than trauma. This provision was 

initially designated in the NPRM at 

§ 71.53(j). Because HHS/CDC had 

already published its proposal for a 

filovirus user fee, we did not solicit or 

receive additional comment on this 

proposal through this current 

rulemaking. Through today’s final rule, 

we are renumbering the filovirus user 

fee provision as § 71.53(v). HHS/CDC is 

making this non-substantive change to 

increase the functionality and ease of 

use of these regulations. 

II. Summary of the Proposed Rule 

Requirements 

In the January 5, 2011, NPRM, HHS/ 

CDC proposed to continue, in § 71.53(d), 

the long-standing general prohibition on 

importing NHPs, and to reflect, in 

§ 71.53(e), its authority to require 

disposal of prohibited or excluded 

NHPs. HHS/CDC also proposed a list of 

definitions specific to modern 

importation principles and practices for 

NHPs, including adding new definitions 

and revising existing ones, to add clarity 

to the provisions regulating the 

importation of NHPs. 

Additionally, HHS/CDC proposed to 

expand the isolation, quarantine, and 

worker protection requirements; and to 

expand the registration process 

described in the special permit 

requirements for cynomolgus, African 

green, and rhesus monkeys to all 

importations of NHPs. HHS/CDC 

intended that the proposed changes 

would simplify importer registration 

procedures and provide an enhanced 

measure of worker and NHP safety 

against known and emerging zoonotic 

diseases. 

HHS/CDC intended to achieve its 

regulatory objectives through a 

performance-based standard focusing on 

desired characteristics of the regulated 

activities, rather than a prescriptive 

standard for conducting those activities. 

The Agency endeavored to allow 

regulated entities flexibility in choosing 

how to meet the standard’s goals and 

objectives. 

To extend the public health benefits 

of the special permit requirements 

regarding identifying filovirus 

infections, HHS/CDC proposed 

extending filovirus testing to include all 

Old World NHPs in quarantine that 

have illness consistent with filovirus 

infection or that die for any reason other 

than trauma during quarantine. This 

requirement was proposed because Old 

World NHPs are susceptible to filovirus 

infection and they originate from areas 

of the world where filoviruses have 

caused fatal disease in NHPs. 

Consequently, surveillance for filovirus 

infection would include not just the 

species covered under the special 

permit requirements, but all newly 

imported Old World primates 

(unpublished data, HHS/CDC; 

Formenty, et al., 1999; Rollin, et al., 

1999, Rouquet, et al., 2005; Leroy, et al., 

2004). 

Also in keeping with the special 

permit requirements, HHS/CDC 

proposed under paragraph (h) to require 

that NHP importers develop a written 

policy for ensuring that imported NHPs 

and their offspring would be used and 

distributed only for the permitted 

purposes defined in the regulation. 

HHS/CDC proposed requiring importers 

to keep written certifications that would 

follow the NHP for life and demonstrate 

the continued use of the NHPs and any 

offspring only for permitted purposes. 

The intended purpose of this 

requirement was to ensure that NHPs 

are not diverted into the pet trade, 

subsequently placing individuals at risk 

of contracting zoonotic diseases that 

NHPs may carry. 

Under proposed paragraph (h) 

importers would be required to 

maintain these records in an organized 

manner, and in a central location, which 

is at or in close proximity to the NHP 

facility, to allow HHS/CDC to inspect 

the records during regular business 

hours or within one hour of HHS/CDC 

site visits. Proposed § 71.53(g)(1) would 

require any importer to establish, 

implement, and maintain 

documentation and standard operating 

procedures (SOPs) associated with the 

importation of NHPs. HHS/CDC’s 

proposal included performance-based 

requirements for worker education 

concerning risks, exposure notification 

and reporting, PPE, development of 

SOPs, TB and other diagnostic testing, 

post-exposure procedures, and other 

requirements for the development and 

implementation of a plan sufficient, as 


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11524 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 

determined by HHS/CDC, for protecting 

workers from the risks associated with 

handling NHPs. 

The proposed rule contained 

quarantine provisions, including a 31- 

day period of quarantine at a U.S. 

quarantine facility, with possible 

extensions of quarantine if the NHPs 

showed infection with certain 

communicable diseases, if the importer 

or HHS/CDC suspected that an NHP was 

infected with certain communicable 

diseases, or if the importer or HHS/CDC 

determined that there was a need for 

additional diagnostic testing. 

Additionally, HHS/CDC proposed to 

eliminate the 31-day quarantine 

requirement and associated restrictions 

for transfers of NHPs into the United 

States between Association of Zoos and 

Aquariums (AZA)-accredited zoos. 

HHS/CDC proposed a similar quarantine 

exception for transfers of NHPs from 

laboratories accredited by the 

Association for Assessment and 

Accreditation of Laboratory Animal 

Care International (AAALAC) or its 

equivalent, if the laboratory has a 

foreign-based and a U.S.-based facility 

and the NHP is part of an ongoing 

research project. The proposed 

procedures and standards contained in 

§ 71.53(l) were based on procedures and 

standards of the National Research 

Council (NRC), HHS/CDC biosafety 

guidelines, current knowledge of 

infectious agent transmission routes, 

and experience gained from 

investigating filovirus infection 

outbreaks (HHS/CDC, 1996; HHS/CDC, 

1989). 

Other quarantine requirements 

proposed in § 71.53(l) addressed routine 

veterinary medical care and screening 

for zoonotic diseases of NHPs in 

quarantine, management of illnesses 

and deaths of unknown etiology, written 

protocols for the evaluation and 

diagnostic testing of suspect cases of 

zoonotic disease in NHPs, and improved 

surveillance and testing procedures in 

NHP quarantine and research facility 

settings. The proposed requirements for 

SOPs and equipment for crating, caging, 

and transporting NHPs in § 71.53(j) 

outlined the requirements that the 

importer must meet, either directly or 

by contractual or other arrangement, to 

ensure safe handling of NHPs during 

transportation. The proposed 

procedures included preventing 

contamination of other articles and 

cargo during transportation; providing 

physical separation of crates from other 

cargo; and ensuring decontamination of 

aircraft, ships, vehicles, and related 

equipment following NHP transport. In 

addition, in § 71.53(f), HHS/CDC 

proposed to restrict entry of NHPs into 

the United States to those ports of entry 

where HHS/CDC quarantine stations are 

located, except in limited circumstances 

approved in advance by HHS/CDC. In 

§ 71.53(k), HHS/CDC proposed that an 

importer establish, implement, 

maintain, and adhere to SOPs for 

ground vehicles to ensure the safe 

transport of NHPs to quarantine 

facilities, and ensure that prequarantined NHPs posed no risk to 

human health. Under proposed 

§ 71.53(m), an importer would have to 

notify HHS/CDC of certain events listed 

in the paragraph within the designated 

time period. For example, proposed 

§ 71.53(m)(6) would require an importer 

to report to HHS/CDC within 48 hours 

any positive or suspicious TST results, 

necropsy findings, or laboratory results. 

In addition to the NHP health-reporting 

requirements in § 71.53(m), HHS/CDC 

proposed 19 general reporting and 

recordkeeping requirements in 

§ 71.53(n), with which the importer 

would have to comply. 

Paragraph (g) Registration or Renewal 

of Importers requires all animal acts to 

comply with requirements in § 71.53(h) 

through (n). HHS/CDC proposed 

additional requirements for animal acts 

entering and re-entering the United 

States under proposed § 71.53(o). Under 

proposed paragraph (o)(1) of the animal 

act provision, a foreign-based importer 

would have to provide additional 

information and documentation to help 

identify the individual NHP and to 

describe the conditions under which the 

NHPs are housed in the United States, 

and maintain documentation signed by 

a licensed veterinarian attesting to the 

results of physical examinations for 

NHPs. Under proposed paragraph (o)(2) 

of that provision, the importer of a U.S.- 

based animal act would meet additional 

specified requirements when the 

animals re-enter the United States. 

For those NHPs entering the United 

States under the zoo-to-zoo and 

laboratory-to-laboratory transfers 

exception, proposed § 71.53(p) and (q) 

set requirements for the recipient zoo or 

laboratory within the United States, 

including registration, submission of 

veterinary medical records that 

document an NHP’s current and past 

health history, accreditation standards, 

and equivalency standards for zoos and 

aquariums. HHS/CDC also proposed 

requirements for brokers in the United 

States handling in-transit shipments of 

NHPs that have a layover or are 

detained or delayed at a U.S. airport. 

Finally, HHS/CDC proposed new 

procedures for revocation and 

reinstatement of an importer’s 

registration [§ 71.53(s)] as well as 

requirements for importing untreated 

NHP products such as carcasses, 

trophies, blood, and other biological 

samples were proposed under § 71.53(t). 

III. Comment Summary and Responses 

A. General Opposition and Support 

HHS/CDC received public comments 

from 23 individuals and entities to the 

January 5, 2011, NPRM. One commenter 

opposed the rule in its entirety, 

asserting that all imports of NHPs 

should be banned, irrespective of the 

purpose for which the NHP was 

imported. However, if such imports 

were permitted, this commenter said we 

should require a physical inspection of 

the importer’s premise, the importer’s 

fingerprints and picture identification, 

and posting of the importer’s 

application forms on the web for public 

inspection. 

HHS/CDC response. HHS/CDC is 

obligated to regulate animal imports to 

best protect public health and is 

satisfied that this final rule achieves this 

goal. Further, HHS/CDC maintains a 

very efficient and effective registration 

and oversight program for the 

importation of NHPs and the protection 

of public health, which includes a 

thorough review of all records and 

unannounced inspection of the 

premises in which the NHPs are kept 

during quarantine. We do not believe 

the addition of fingerprinting or picture 

identification is necessary or would 

improve oversight. Further, an 

importer’s application contains 

proprietary information and therefore 

would not be appropriate for public 

display. 

Several commenters expressed 

support for portions of the proposed 

rule. Eight commenters approved of 

extending the import requirements for 

special permit NHP importers to all 

importers, and four supported extending 

the period for permit renewal from 6 

months to 2 years. Four commenters 

also supported easing the quarantine 

restrictions for zoo-to-zoo transfers of 

NHPs between zoos accredited by the 

AZA or an equivalent organization, and 

laboratory-to-laboratory transfers where 

the importer can document that the 

animals are part of a research project 

following Institutional Animal Care and 

Use Committee (IACUC)-approved 

protocols. One commenter supported 

the proposal to import shipments of 

NHPs only through ports of entry with 

HHS/CDC quarantine stations, and 

another supported the animal act 

provisions. 

HHS/CDC Response. HHS/CDC has 

reviewed and considered all details of 

these comments and will discuss each 

in turn. 


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1http://www.HHS/CDC.gov/animalimportation/ 

lawsregulations/nonhuman-primates/nprm/ 

questions-answers-importers.html. 

B. Public Comments Regarding Purpose 

and Scope 

One commenter said that we should 

broaden the purpose provision in 

§ 71.53(a) to include not only preventing 

the transmission of communicable 

disease and pathogens from imported 

NHPs to humans, but also preventing 

the importation of diseases and 

pathogens themselves. 

HHS/CDC Response. NHPs are only 

one of the imports that HHS/CDC 

regulates to prevent the introduction of 

communicable disease. Specifically, the 

importation of pathogens is regulated 

under 42 CFR 71.54, Etiological agents, 

hosts, and vectors. Further, the HHS/ 

CDC Director has broad general 

authority under 42 CFR 71.32(b) to take 

measures with regard to any carrier, 

article, or thing that may be 

contaminated with a communicable 

disease. Therefore, HHS/CDC does not 

believe it necessary to broaden the 

purpose and scope of this section. 

This same commenter said we should 

broaden the scope provision in 

§ 71.53(b) to include post-importation 

recipients of NHPs and the offspring of 

these NHPs, arguing that the proposal 

placed ‘‘an unreasonable indirect 

enforcement burden on registered 

importers’’ by requiring them to 

question their customers’ intended use 

of the importer’s products. The 

commenter recommended requiring 

prospective recipients of postimportation NHPs and their offspring to 

register with HHS/CDC, and maintain 

records regarding the use, distribution, 

and disposition of these animals. 

HHS/CDC Response. Under § 71.53, 

HHS/CDC regulates the initial 

importation of NHPs into the United 

States. To be approved to register as an 

importer, an importer must agree to only 

distribute NHPs for a permitted 

purpose. The requirement that an 

importer retain records of distribution 

allows HHS/CDC to monitor this 

agreement to ensure importers are 

adhering to the distribution restrictions. 

Therefore, HHS/CDC believes that the 

current practice of holding the initial 

importer responsible for the transfer of 

an NHP for a permitted purpose is 

sufficient to protect the public’s health 

and will remain in place. 

Finally, a commenter suggested 

requiring that ‘‘sanctuaries’’ obtain a 

U.S. Department of Agriculture (USDA) 

license, HHS/CDC registration, or both, 

if the sanctuary is to receive or possess 

previously imported NHPs. The 

commenter asserted that such entities 

‘‘must agree not otherwise (to) dispose 

(of) or distribute said primates.’’ 

HHS/CDC Response. HHS/CDC does 

not have the authority to require USDA 

to issue a license to an individual or 

entity. A ‘‘sanctuary’’ would fall under 

the definition of ‘‘person,’’ which means 

such entities fall under § 71.53(b) and 

the general prohibition in § 71.53 (d) 

against receiving, maintaining, or 

distributing an NHP for other than a 

permitted purpose. For clarity, we have 

revised the definition of ‘‘person’’ in 

§ 71.53(c) to explicitly include not-forprofit organizations, such as sanctuaries. 

Finally, we note that in keeping with 

current practices, any ‘‘person’’ may 

submit an application to HHS/CDC to 

become a registered importer, including 

a sanctuary. 

C. Public Comments Regarding 

Definitions 

One commenter supported the 

definition of ‘‘education and scientific 

purposes,’’ saying that they had 

experienced problems with importers 

abusing the concept and endeavoring to 

bring NHPs into the United States by 

claiming the animals were purchased 

for a thesis. This commenter said that 

the proposed definition would ‘‘prevent 

such an abuse.’’ However, this 

commenter also noted that our proposed 

definition of ‘‘trophy’’ was broader than 

the same definition of this term in 50 

CFR 23.74(b). Whereas the U.S. Fish and 

Wildlife Service (USFWS) defines a 

trophy as ‘‘items taken as a result of 

sport-hunting,’’ the commenter asserted 

that HHS/CDC’s proposed definition 

included any such items ‘‘purchased 

abroad that are display items,’’ and 

noted that under the Convention on 

International Trade in Endangered 

Species (CITES), only an item resulting 

from a ‘‘personal sport-hunt’’ would be 

a trophy. 

HHS/CDC Response. Regarding the 

comment on CITES requirements for 

any product defined by that agency as 

a ‘‘sports-hunted trophy,’’ we note that 

today’s final rule provisions do not 

negate other federal requirements. 

However, we note, too, that our mandate 

to protect public health is different from 

the CITES program objective and 

requires targeting a broader class of 

imported NHP products. However, CDC 

agrees that our proposed definition of 

‘‘trophy’’ may cause confusion among 

the regulated communities; therefore, 

we have introduced a new definition for 

product that includes sports-hunted 

trophies. Under this final rule, a 

‘‘product’’ is defined as ‘‘skulls, skins, 

bodies, blood, tissues, or other 

biological samples from a nonhuman 

primate, including trophies, mounts, 

rugs, or other display items.’’ 

Any untreated NHP product poses a 

risk to human health, irrespective of 

whether the product is a trophy from a 

‘‘personal sport-hunt’’ or from 

commercial or other activity, and would 

require the importer to obtain a permit 

from HHS/CDC before bringing the 

product into the United States. To 

import any NHP product, an importer 

must render the product noninfectious 

under a HHS/CDC approved method, or 

obtain a permit in advance from the 

Director of HHS/CDC.1

Other commenters addressed the 

definitions in § 71.53(c). Two argued 

that we should change the definition of 

‘‘zoonotic disease’’ because the 

proposed definition was inconsistent 

with the background information in the 

NPRM and with the medical dictionary 

definition of the term. Instead, these 

commenters suggested we define the 

term as ‘‘any infectious agent or 

communicable disease that is able to be 

transmitted from animals, both wild and 

domestic, to humans.’’ 

Another commenter suggested 

revising four proposed definitions. First, 

the commenter recommended revising 

‘‘broker’’ by adding ‘‘of NHP from 

another country, or as an intermediary 

between such an’’ immediately 

following ‘‘official agent of an exporter’’ 

and before ‘‘exporter and an importer of 

NHPs.’’ Second, the commenter 

recommended a new definition of 

‘‘cohort’’ as ‘‘a shipment or shipments of 

NHP that shared a confined space or 

close proximity (within 5 feet) during 

import into the United States and/or 

transit to the importer quarantine 

facility.’’ Third, for clarity and 

specificity, this commenter said we 

should consider changing the term ‘‘in 

transit’’ to ‘‘in international transit’’ or 

‘‘in international transit within the 

U.S.’’ Asserting that the definition for 

‘‘offspring’’ lacked documentation 

criteria, the commenter suggested the 

fourth change of specifying minimum 

verification documentation in the 

definition. 

HHS/CDC Response. To clarify many 

of the terms used in § 71.53, HHS/CDC 

has adopted most of the above 

commenter’s suggestions. We did not 

change the term ‘‘in transit’’ because we 

believe the definition adequately 

specifies and clarifies HHS/CDC’s 

intent. 

A fifth commenter suggested adding a 

definition of ‘‘unusually high 

morbidity,’’ which the commenter 

argued was inadequately defined in the 

proposed documentation requirements 


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in §§ 71.53(i) and 71.53(l). This same 

commenter said that in the notification 

requirements in § 71.53(m), ‘‘the 

definition of ‘severe’ illness in this 

section is ambiguous.’’ 

HHS/CDC Response. Regarding the 

comment on defining ‘‘unusually high 

morbidity,’’ we note that HHS/CDC did 

not propose use of the term in the 

regulatory text and therefore we do not 

believe that it is necessary to define it. 

Regarding the comment on notification 

requirements in § 71.53 (m), HHS/CDC 

has removed ‘‘severe illness’’ from this 

provision in the final rule to alleviate 

any ambiguity. 

D. Public Comments Regarding 

Prohibition on Importing NHPs 

Two commenters said we should 

expand the general prohibition on 

importing NHPs in § 71.53(d). One 

argued that expanding the prohibition 

would relieve the burdensome 

requirements imposed on importers. 

This commenter suggested adding a 

provision to prohibit persons from 

receiving ‘‘post-importation NHPs’’ 

unless the recipient was registered with 

HHS/CDC under § 71.53, and a 

provision like paragraph (d)(2) for 

importers, but instead addressed ‘‘postimportation’’ recipients of NHPs. 

HHS/CDC Response. As noted above, 

under § 71.53, HHS/CDC regulates the 

initial importation of NHPs into the 

United States. To be approved to 

register as an importer, an importer 

must agree to only distribute NHPs for 

a permitted purpose. The requirement 

that an importer retain records of 

distribution allows HHS/CDC to 

monitor this agreement to ensure 

importers are adhering to the 

distribution restrictions. Therefore, the 

current practice of holding the initial 

importer responsible for the initial 

transfer of an NHP for a permitted 

purpose will remain in place. 

One commenter suggested that we 

should expressly prohibit the 

importation of wild and feral NHPs 

because these animals represent serious 

risks to public health and animal 

welfare. 

HHS/CDC Response. In § 71.53(d) of 

the final rule, HHS/CDC retains the 

general prohibition on the importation 

of live NHPs except for certain limited 

purposes. No matter its origin, there can 

be no question of an NHP coming into 

the United States without prior HHS/ 

CDC review and issuance of a 

registration certificate, regardless of 

whether the animal is caught in the wild 

or raised in captivity, because live NHPs 

present the same potential for infectious 

disease outbreaks. Under § 71.53(g), 

each NHP importer must obtain 

registration from HHS/CDC before 

importing these animals. 

HHS/CDC notes that since we 

established quarantine restrictions for 

NHPs in 1975, the number of HHS/CDCregistered NHP importers went from 140 

(according to a 1989 review) to 27 in 

1999 (Roberts, 2008), and the mortality 

rates for NHPs imported under a special 

permit during shipment and quarantine 

went from 20 percent to less than 1 

percent (Roberts, 2008; DeMarcus, 1999) 

and has remained there (ILAR, 2006). 

These data indicate the efficacy of our 

certification process for NHP importers. 

Further, allowing NHP imports for 

specific and limited purposes under 

HHS/CDC authorization is consistent 

with the Executive Order 13656 section 

1 directive of protecting public health 

with the ‘‘least burdensome tools for 

achieving regulatory ends.’’ 

E. Public Comments Regarding 

Authorized Points of Entry 

Comments were received regarding 

the proposal in § 71.53(f) to require 

importation of live NHPs into the 

United States only through ports of 

entry with a HHS/CDC quarantine 

station, unless the importer received 

advance written approval from HHS/ 

CDC for some other port of entry. One 

commenter asked that the preamble to 

the final rule discuss requirements in 50 

CFR part 14 for NHP importers to obtain 

from USFWS a port-exception permit 

before a shipment entered the United 

States at Detroit, Dulles, El Paso, 

Minneapolis, San Diego, or San Juan. 

This commenter also noted that there 

are no USFWS staff at the port of entry 

in Philadelphia. 

HHS/CDC Response. HHS/CDC is 

adopting the proposal that, absent prior 

approval, a shipment of live NHPs into 

the United States must come through 

ports of entry with a HHS/CDC 

quarantine station. In response to the 

comment on USFWS’s requirements 

under 50 CFR part 14, in promulgating 

this final rule, HHS/CDC does not 

intend to supersede—and believes that 

these requirements are not inconsistent 

with—any applicable USFWS or USDA 

regulation nor any applicable state 

regulation. An importer must have a 

CITES permit to bring NHPs into the 

United States, and an importer in 

violation of otherwise applicable 

regulations is prohibited from importing 

NHPs. We will continue working with 

federal partners at ports of entry to 

ensure that the administrative burden 

on partner agencies is not unreasonable. 

Another commenter opposed what 

they viewed as an exception for NHP 

shipments entering the United States at 

‘‘certain border crossing[s] from Canada 

and Mexico.’’ Such an exception, 

asserted the commenters, ran contrary to 

our stated purpose for the port-of-entry 

requirement. These commenters said 

further that including shipments coming 

from U.S. border countries in the 

paragraph (f) requirement was logical, 

would have little economic impact 

given the few importers who ship NHPs 

across those borders, and would 

maintain public health and safety at the 

cost of a small inconvenience to 

importers. 

HHS/CDC Response. HHS/CDC notes 

that there is no exception in the final 

rule from the port-of-entry requirement 

for over-the-road (OTR) shipments of 

NHPs coming from Canada or Mexico. A 

person importing NHPs from those 

countries either must bring the animals 

through ports of entry with a HHS/CDC 

quarantine station, or obtain prior 

Agency approval for bringing the 

shipment through an alternate U.S. port 

of entry. Further, HHS/CDC maintains 

public health safety through direct 

oversight of the importation, because a 

candidate for registration certification or 

renewal must allow HHS/CDC to 

inspect records, facilities, transport 

vehicles, and equipment during 

operating days and hours, and at other 

necessary and reasonable times. (See 

§ 71.53(b)(1) and (g)(2)(i).) 

F. Public Comments Regarding Importer 

Licensing Requirements 

Commenters addressed the 

application and permit renewal 

proposals in § 71.53(g). Two 

commenters opposed eliminating the 

180-day registration renewal 

requirement for special permit holders. 

Presenting several examples of alleged 

noncompliance and Animal Welfare Act 

violations by ‘‘top NHP importation 

companies in the United States,’’ one 

commenter argued that reducing 

government oversight of companies 

‘‘with documented histories of 

noncompliance’’ would pose a serious 

threat to public health. Further, argued 

the commenter, there was no evidence 

in the record that the species subject to 

special permit requirements 

(cynomolgus, African green, and rhesus 

monkeys) present less of a threat to 

human health than they did when we 

first established the requirements in 

1990. The same commenter asserted we 

failed to make the case that moving to 

a 2-year renewal period would be in the 

best interest of public health. 

HHS/CDC Response. HHS/CDC is 

adopting the proposal to extend the time 

for special permit renewal from every 

180 days to every 2 years. We believe 

that the concern about the reduction in 

government oversight is misplaced, 


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because registration is only part of the 

oversight of importers. Importers must 

continue to notify HHS/CDC of all 

shipments and we will continue to 

perform regular site visits, including the 

review of importer SOPs. 

Indeed, there is constant 

communication between HHS/CDC and 

importers. Further, extending the 

renewal period is consistent with the 

directive in Executive Order 13653 

section 1 that we apply the least 

burdensome tools for achieving 

regulatory ends. 

An individual commenter suggested 

changes to three of the proposed 

paragraphs in (g)(1). The first suggestion 

was to change paragraph (g)(1)(ii) to 

state that an applicant must submit a 

completed statement of the intended 

permitted purpose for which an NHP is 

imported and must name any ‘‘intended 

prospective post-importation 

recipients.’’ The second was to remove 

the requirement in proposed (g)(1)(iii) 

for applicants to submit ‘‘a copy of all’’ 

SOPs. The final suggestion was to add 

in proposed (g)(1)(iv) a requirement for 

applicants to submit ‘‘copies of all 

Federal, State, or local registrations.’’ 

HHS/CDC Response. HHS/CDC does 

not believe it is reasonable to require 

importers to submit ‘‘prospective’’ 

recipients of NHPs. HHS/CDC routinely 

audits importer records to verify that 

distribution is for permitted purposes. 

As part of this oversight, HHS/CDC will 

continue to require importers to submit 

copies of all SOPs. However, in 

response to the commenter’s third 

suggestion, the final rule will require a 

copy of all federal, state, or local 

registrations, licenses, and/or permits. 

Another commenter said that HHS/ 

CDC should require applicants for an 

importer license or license renewal to 

submit the documentation required 

under § 71.53(i) for worker protection 

and § 71.53(l) quarantine facilities as 

part of the permit application process. 

HHS/CDC Response. We have added 

clarifying language to the title and 

throughout § 71.53(g) of the final rule to 

make it clear that the same 

documentation is needed to apply for 

registration or renewing a registration 

certificate for importing NHPs. 

G. Public Comments Regarding 

Recordkeeping, Reporting, and 

Notification Requirements 

Several commenters discussed 

various proposed recordkeeping, 

reporting, and notification requirements 

in § 71.53(h), (i), (k), (m), and (n). 

An individual suggested that we 

change paragraph § 71.53(h) to require 

that importers develop and document 

compliance with a written policy; revise 

§ 71.53(h)(2) to require that importers 

collect or create records of the intended 

purpose for imported NHPs and 

maintain records regarding each 

distribution of imported primates; and 

clarify in § 71.53(h)(3) how an importer 

must authenticate electronic records, if 

HHS/CDC would permit such records. 

HHS/CDC Response. Each HHS/CDCregistered NHP importer is subjected to 

periodic, mandatory site visits. During 

these site visits, HHS/CDC staff assesses 

compliance with recordkeeping 

requirements. Importers are also 

required to provide HHS/CDC staff with 

an intended-use statement for each NHP 

that was distributed following HHS/ 

CDC quarantine. Failure to comply with 

these recordkeeping requirements may 

result in suspension or forfeiture of an 

importer’s HHS/CDC registration. HHS/ 

CDC also agrees that there should be a 

requirement for time-dating of 

electronic records in a manner that 

cannot be altered, and for back-up 

copies of such records. We have revised 

§ 71.53(h)(3) accordingly. 

One commenter expressed general 

support for the proposed reporting 

requirements and asked that we notify 

USFWS if we receive disease reports 

from importers that might raise 

concerns about its wildlife inspections. 

HHS/CDC Response. With regard to 

the commenter’s request that USFWS 

‘‘receive disease reports from importers 

that might raise concerns about its 

wildlife inspections,’’ HHS/CDC 

routinely informs USFWS of ongoing 

potentially life-threatening disease 

outbreaks occurring among USFWSlicensed facilities. 

The same commenter strongly 

recommended that HHS/CDC require 

tattoos or microchip numbers for NHPs 

to better identify animals involved in a 

transfer or transaction. 

HHS/CDC Response. Paragraph 

(l)(3)(i) of this final rule requires 

importers to ensure that all NHPs are 

identified individually with a unique 

number or alphanumeric code 

permanently applied to the NHP. 

However, consistent with our intent to 

set performance-based requirements, the 

rule does not require one specific 

identification yet allows the importer to 

select a ‘‘tattoo, microchip, or other 

permanent identifier.’’ This requirement 

ensures that NHPs may be identified in 

any transfer or transaction. 

The January 2011 NPRM specifically 

solicited public comment on how long 

records should be maintained by the 

importer, e.g., for the expected life of 

the NHP. One commenter said that, as 

written, § 71.53(h) failed to indicate 

how long an importer must maintain 

documentation, and suggested a 

retention period similar to existing 

USDA requirements (i.e., 3 years after 

disposition). Two commenters asserted 

that the retention period under 

paragraph (h) should be at least for the 

life of the animal, plus a post-mortem 

period to investigate disease outbreaks 

or rules violations. One commenter 

agreed that the retention period for 

§ 71.53(h) documentation should be for 

the life of the NHP. 

HHS/CDC Response. HHS/CDC agrees 

with commenters’ concern that there 

should be a specified period for which 

an importer must keep the written 

certifications required under 

§ 71.53(h)(1), and has revised the final 

rule to specify the period of record 

retention as 3 years after distribution or 

transfer of the animal. In § 71.53(h)(2) of 

the final rule, HHS/CDC also clarifies its 

intention for importers to maintain 

records regarding each distribution of 

primates for the required 3-year period, 

including information identifying each 

animal in a shipment. We believe these 

retention periods are sufficient for 

protecting public health and tracking 

NHPs after their release from 

quarantine, and that it is overly 

burdensome to require record retention 

for the life of an NHP and a period after 

death, as some commenters suggested. 

Another commenter asked whether 

importers must document the intended 

purpose for the life of the NHP, what the 

effects would be if there were 

subsequent movements of the NHP 

within the United States, and whether 

paragraph (h) applied to offspring of 

imported NHPs. 

HHS/CDC Response. HHS/CDC has 

revised § 71.53(h) to state expressly that 

an importer must develop and 

document compliance with a written 

policy for use and distribution of NHPs 

and their offspring. Paragraph (h)(1) also 

makes clear that it is the importer’s 

obligation to collect a signed record of 

the intended purpose for which NHPs 

are imported from the customer, and to 

take reasonable steps to ensure that its 

customers will use NHPs in accordance 

with Part 71. These records must be 

retained for three years after 

distribution. The original importer is 

not responsible for documenting 

subsequent movements of the NHP 

beyond the initial transfer. Again, this is 

a codification of the accepted current 

practice that importers only distribute 

NHPs for scientific, educational, or 

exhibition purposes as defined in this 

final rule. 

One commenter requested 

clarification on proposed required 

certifications under paragraph (h)(5), 

and asked how HHS/CDC would 

monitor, track, and record these 


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11528 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 

certifications; how often the importer 

should provide us with certifications; 

and how subsequent movement of NHPs 

and their offspring would affect the 

certifications. Another commenter said 

they were uncertain whether the sellers 

needed to verify the authority of the 

person who certifies use of primates at 

the purchasing institution, and said they 

were against imposing a requirement on 

the seller other than maintaining 

certification from the consignee. 

HHS/CDC Response. Regarding the 

comment on how we would receive and 

track certifications under proposed 

§ 71.53(h)(5) (not adopted under the 

final rule), we note that the intent of the 

final requirements under paragraph (h) 

is for the importer to retain the records, 

not to send them to HHS/CDC. HHS/ 

CDC will review certifications in person 

and regularly through an audit process 

yet does not expect importers to certify 

the authority of the signatory beyond 

normal due diligence. An example of 

due diligence would be for the importer 

to include a statement of authority on 

the certification form. 

Two commenters commented on the 

proposed requirement in § 71.53(i)(3) on 

notification to HHS/CDC of a worker’s 

exposure to a zoonotic illness. The 

commenters said we should change this 

provision to make it consistent with 

other, similar reporting requirements. 

Specifically, said the commenters, the 

provision should read, ‘‘An importer 

must immediately contact HHS/CDC by 

telephone, SMS text, or email, as 

specified in the importer’s standard 

operating procedures, 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.’’ For the 

same reason, the commenters suggested 

revising the sentence on notification in 

§ 71.53(i)(9) to read as follows: ‘‘The 

importer must promptly notify HHS/ 

CDC by telephone, SMS text, or email as 

specified in the importer’s standard 

operating procedures if such illness 

occurs.’’ 

These same commenters suggested 

revising § 71.53(k)(5) to permit notifying 

HHS/CDC of the arrival of an NHP 

shipment by SMS text or email as 

specified in the importer’s SOPs. They 

also requested that HHS/CDC should 

permit written notice by email in 

notification requirements before 

authorizing the import of NHPs in 

§ 71.53(n)(2). 

HHS/CDC Response. HHS/CDC agrees 

with the commenters and has revised 

the text of the final rule to expressly 

permit notifying the Agency by 

telephone, text message, or email of 

worker exposure to a zoonotic illness. 

Other commenters addressed the 

proposed health reporting requirements 

in § 71.53(m). One commenter 

questioned the proposal in paragraph 

(m)(4) that an importer must notify 

HHS/CDC if the mortality of an NHP 

cohort exceeds 5 percent. The 

commenter said this threshold could 

preclude the earliest detection of 

outbreaks or identification of 

associations between cases, and argued 

that we should establish an evidencebased, risk-averse threshold through 

epidemiological analysis and other 

available data. 

Regarding the proposal in paragraph 

(m)(7) that an importer notify HHS/CDC 

within 48 hours if an NHP exhibits signs 

of TB, four commenters asserted the 

reporting period should be 24 hours. 

These commenters said that because TB 

is extremely communicable and highly 

dangerous to humans, it was 

‘‘nonsensical’’ to have a reporting 

period that is double that for reporting 

other zoological diseases. The 

commenter said that although paragraph 

(m) stated proposed notification 

requirements for six events, the failure 

to define what would constitute a 

‘‘severe’’ illness made the provision 

ambiguous, and difficult to either 

comply with or enforce. 

HHS/CDC Response. In § 71.53(m)(2), 

the final rule requires notifying the 

Agency of any morbidity or mortality of 

animals in quarantine, rather than of 

‘‘severe illness or death’’ as proposed. 

Similarly, § 71.53(m)(4) of the final rule 

removes the 5 percent threshold for 

notifying HHS/CDC of morbidity or 

mortality in a shipment between 

embarkation from the county of origin 

through release from quarantine in the 

United States. Instead, as with 

paragraph (m)(2), the rule requires 

notification of any morbidity or 

mortality during the period described. 

As to the comment that we set an 

evidenced-based threshold for reporting 

mortality, we noted previously that the 

mortality rates for special permit 

process NHPs during shipment and 

quarantine has been less than 1 percent 

over the last 5 years (Roberts, 2008; 

DeMarcus, 1999). Therefore, requiring 

notification of any morbidity or 

mortality sets a conservative, evidencebased reporting standard. Further, we 

have set a more conservative 24-hour 

requirement in § 71.53(m)(7) for 

notifying the Agency of positive or 

suspicious TST results as most 

protective of human health. All 

notification periods in § 71.53(m) are 

now 24 hours. 

These commenters also suggested that 

notification requirements in proposed 

§ 71.53(p)(2)(i) and (ii) for zoo-to-zoo 

transfers mirror the requirements for 

laboratory-to-laboratory transfers in 

proposed § 71.53(q)(2)(i) and (ii). 

HHS/CDC Response. HHS/CDC agrees 

that notification requirements should be 

the same for laboratory-to-laboratory 

transfers as for zoo-to-zoo transfers and 

has edited the text of the final rule 

accordingly. 

H. Public Comments Regarding Worker 

Protection Requirements 

Commenters addressed the training, 

notification, and SOP requirements in 

proposed § 71.53(i). One commenter 

said HHS/CDC should specify a 

maximum interval between training 

sessions. Two commenters said we 

should require employee training on 

post-exposure procedures when the 

employee is hired and at least annually 

thereafter. One commenter suggested 

that worker training include 

contingency plans to prevent exposure 

to NHPs during transit. 

HHS/CDC Response. HHS/CDC agrees 

with the comment that worker training 

requirements should specify when 

workers should receive initial training 

and the maximum acceptable interval 

between trainings. NHP workers should 

receive initial training when they are 

hired or before receiving a shipment of 

NHPs, and refresher training at least 

annually. However, because each 

facility varies in size and importation 

frequency, we have decided to evaluate 

training frequency upon review of 

importer application and SOPs, in 

keeping performance based standard of 

review. This policy of review also 

addresses another commenter’s concern 

for refresher training on post-exposure 

procedures. As stated in § 71.53(i)(4)(i), 

worker protection plan training must 

include how to avoid and respond to 

disease exposures associated with 

NHPs. Plans for refresher and 

contingency training should also be 

included in these SOPs. 

One commenter fully supported the 

proposed plans for importers, and 

especially noted his or her appreciation 

of the worker PPE requirements for 

employees who handle live NHPs, 

which the commenter said, would 

benefit USFWS inspectors. This 

commenter added a request that we 

notify the USFWS-Office of Law 

Enforcement of our concerns with their 

inspectors who might be responsible for 

inspecting a shipment of wildlife later 

found to be a source of TB exposure. 

HHS/CDC Response. We will 

continue to work with and 

communicate with our federal partners 

whose employees may be exposed to 

NHPs while inspecting animal 

shipments to ensure awareness of any 


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2http://www.HHS/CDC.gov/vaccines/recs/acip. 

health concerns, including the potential 

for exposure to TB. We note that 

USFWS inspectors, as with all 

individuals, should be wearing 

appropriate eye and respiratory 

protection when handling or within five 

feet of the live NHP shipments. 

Another commenter asked why we 

recommended hepatitis B vaccine rather 

than hepatitis A vaccine, asserting that 

animals frequently arrive in quarantine 

with naturally occurring positive titers 

of hepatitis A, and that hepatitis A is a 

disease commonly found throughout the 

world, including the United States. 

HHS/CDC Response. In the NPRM, 

CDC did not recommend specific 

vaccines as part of the worker protection 

plan. HHS/CDC recommends that all 

workers who are at high risk of exposure 

to NHPs be current on routine 

vaccinations, in accordance with good 

public health practice and as reflected 

in the Advisory Committee on 

Immunization Practices 2

recommendations. 

I. Public Comments Regarding 

Equipment, Transfer/Transport, and 

Handling 

Commenters discussed the proposed 

requirements in § 71.53(j) and § 71.53(k) 

for NHP equipment, processing, 

transport, and identification. An 

individual commenter made several 

comments concerning these proposed 

provisions. The commenter described as 

‘‘unrealistic’’ the proposed requirement 

in paragraph (j)(5) that only an importer 

or an authorized representative could 

receive a shipment of NHPs. For 

airplanes, said the commenter, a plane 

will not wait if there is no one present 

who has authority to take receipt of the 

shipment under this requirement. 

Instead, said the commenter, HHS/CDC 

should require a contingency plan to 

address Agency concerns. 

HHS/CDC Response. HHS/CDC made 

a number of changes to the final rule in 

response to comments on the proposed 

standard operating requirements and 

equipment standards for crating, caging, 

and transporting live NHPs. We have 

deleted proposed paragraph (j)(4), and 

renumbered proposed paragraphs (j)(5) 

through (j)(13) as (j)(4) through (j)(12) in 

the final rule. Paragraph (j)(4) of the 

final rule requires an importer to 

establish an emergency contingency 

plan in the unlikely event that the 

importer or its representative is unable 

to meet the conveyance transporting an 

NHP shipment. This change makes clear 

HHS/CDC’s intent that importers should 

anticipate and plan for contingencies. 

Similarly, the commenter described as 

‘‘unrealistic’’ our proposal in paragraph 

(j)(8) that during NHP transport, 

recirculated air in the NHP 

compartment must be HEPA-filtered, 

given that neither planes nor 

commercial OTR trucks commonly are 

equipped with such air-filter systems for 

cargo. Regarding our proposal in 

paragraph (j)(9) concerning cargo 

loading of NHP shipments, this 

individual said importers have little 

control over aircraft loading procedures, 

and cannot enforce loading 

requirements. The individual suggested 

we work with the International Air 

Transport Association (IATA). For 

paragraph (j)(11), the commenter 

suggested beginning the provision with, 

‘‘For each importation itinerary,’’ 

arguing that without this language, we 

would require monitoring and 

certification during each shipment. 

Finally, regarding paragraphs (j)(13) and 

(k)(3), this individual suggested we 

expressly require the removal of 

potentially contaminated material from 

ground transport vehicles ‘‘upon arrival 

at the quarantine facility,’’ and the 

appropriate disposal of biohazardous 

waste. 

HHS/CDC Response. HHS/CDC 

recognizes that while the importer may 

not have control over how a plane is 

loaded at the port of destination, 

importer SOPs should include 

information for training of airport cargo 

handlers regarding the importance of 

loading NHPs into aircraft to assure that 

no contamination of other cargo occurs 

and that any issues with the shipment 

be easily determined and corrected. 

Further, we have revised the 

requirement proposed in paragraph 

(j)(8) (codified in the final rule as 

paragraph (j)(7)) to give importers the 

option of either ensuring an adequate 

ventilation system is in place, with 

HEPA filtration for airflow circulating 

between NHPs and passengers traveling 

with a shipment of live NHPs, or 

providing NHP transport workers with 

respiratory PPE if there is not an 

adequate ventilation system. The 

Agency believes this change makes the 

provision less prescriptive while 

offering adequate protection against 

transmitting zoonotic diseases from 

NHPs to humans traveling on the same 

conveyance. 

We have also revised proposed 

paragraph (j)(11) (paragraph (j)(10) of 

the final rule) to make clear that before 

beginning operations, or ‘‘for each 

import,’’ importers must establish and 

document the communicable diseaseprevention SOPs to be carried out 

throughout the chain of custody. In final 

rule paragraph (j)(12), HHS/CDC has 

adopted the commenter suggestion to 

state expressly that importers must 

ensure SOPs for both the removal from 

transport vehicles and proper disposal 

of biohazardous waste following a 

shipment of live NHPs. 

An individual said we should 

consider requiring at least two transport 

workers for over-the-road (OTR) NHP 

shipments, written contingency plans, 

and signage on the transport vehicle 

warning the public to call a designated 

number before entering a vehicle 

transporting live NHPs. The commenter 

suggested further that we require OTR 

shippers to register with HHS/CDC and 

undergo training specific to transport 

workers. Another commenter suggested 

having OTR transporters register with 

HHS/CDC. This same commenter also 

suggested GPS-equipped vehicles that 

meet ‘‘certain minimum standards,’’ and 

with operators possessing ‘‘all 

applicable licenses/permits to operate as 

a commercial transporter.’’ 

HHS/CDC Response. In response to 

the comment that we require two 

transport workers per OTR transport 

shipment of NHPs, and that these 

transport workers and vehicles be 

subject to certain additional 

requirements, we note that HHS/CDC 

has not traditionally regulated transport 

workers, but rather NHP importers. 

Accordingly, we believe that continuing 

to regulate NHP importers, rather than 

placing new requirements on transport 

workers is the best way to protect public 

health. However, we agree with the 

commenter that importers should plan 

for contingencies in OTR transport, and 

have revised § 71.53(i)(4)(i) to clarify 

that worker protection plans should 

address procedures for responding to 

emergencies during transport. 

J. Public Comments Regarding 

Quarantine Facility Requirements 

Commenters addressed the proposed 

provisions on quarantine requirements 

in § 71.53(l) for importers not otherwise 

exempted under this provision (i.e., 

authorized zoo-to-zoo and lab-to-lab 

transfers). 

Two commenters commented on the 

proposed air-handling system 

requirements in § 71.53(l)(2)(v) and (vi) 

that would mandate a separate system 

for each quarantine room, which would 

remain under negative pressure relative 

to the common hallway or anterooms. 

One commenter said the requirement 

needed further explanation, given that 

inhibiting air mixture between rooms 

could be accomplished with separate 

exhaust equipment for each room or a 

dedicated exhaust system that pools 

adjacent rooms. The commenter noted 

that exhaust systems are on emergency 


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generator power and supply-side air to 

quarantine rooms is often provided with 

a common HVAC (heating, ventilation, 

and air conditioning) system. Regarding 

the airflow indicator, the other 

commenter asked whether it would 

suffice to confirm negative pressure in 

the wards and no air circulation out of 

the ward, if the importer mounted a 

pressure monitor in the wall indicating 

negative pressure in the ward compared 

to the exterior. 

HHS/CDC Response. HHS/CDC agrees 

with the commenter’s concerns above 

and has edited the text of the final rule 

to better explain the intent of the 

provision. 

One commenter asked whether under 

proposed § 71.53(l)(3)(iii), HHS/CDC 

should permit veterinary discretion 

within a quarantine room to use nets or 

gloves to recapture a small NHP rather 

than anesthetizing or tranquilizing the 

animal ‘‘before handling.’’ The 

commenter said that the proposed text 

would preclude the use of these 

alternative capture methods—even 

where experienced personnel would be 

involved in the recapture—and the size, 

species, or clinical soundness of the 

animal would warrant a non-chemical 

restraint. 

HHS/CDC Response. To address the 

comment that HHS/CDC should permit 

the use of methods other than 

anesthesia or tranquilizer before 

handling a live NHP, we have revised 

§ 71.53(l)(3)(iii) to allow handling where 

an animal is ‘‘otherwise restrained.’’ 

Because anesthetizing or tranquilizing a 

live animal before handling is most 

protective of human health and safety, 

those are the preferred methods under 

the regulation. However, we recognize 

that using an alternative restraint 

method may be appropriate where the 

restraint is part of the facility’s SOPs 

and is the last resort for obtaining quick 

capture and veterinary handling of a 

live NHP. 

There were several observations and 

suggestions from commenters 

concerning the proposed necropsy and 

diagnostic testing requirements under 

§ 71.53(l), with most commenters 

addressing TB testing and procedures. 

One commenter recommended 

replacing the proposed TB testing 

procedures. Another commenter said 

that current TB testing methods used in 

NHP screening are inadequate, and that 

the proposed changes to these methods 

‘‘do not go far enough’’ to protect public 

and NHP health and welfare. And 

another commenter suggested we 

reconsider the decision to rely on TB 

skin testing using the mammalian old 

tuberculin (MOT) method. The 

commenter said that skin testing is ‘‘a 

poorly performing test in many NHPs,’’ 

that the current requirements for 

multiple testing at 2-week intervals is 

‘‘physiologically demanding’’ on the 

animals, and that there is an inherent 

risk to animals and humans each time 

an NHP must be immobilized for such 

testing. The same commenter argued 

alternatively for ‘‘currently available 

confirmatory tests, which can be 

utilized in conjunction with skin 

testing, minimizing repeat 

immobilization procedures.’’ 

Another commenter said that there is 

a diagnostic TB test other than the 

intradermal TST and HHS/CDC’s failure 

to recognize the alternative test has 

hampered sales. The commenter 

asserted that the alternative test permits 

use of the same blood sample drawn 

during a health examination and 

provides results in minutes rather than 

days. This commenter said that TST 

measured only cell-mediated immunity, 

which might be suppressed in a latent 

infection, and that combining TST with 

measures of humoral immune response 

would increase diagnostic power and 

could reduce the possibility of failing to 

detect latent infection during 

quarantine. This commenter further 

asserted that there was no proof of TST 

working in all NHP species, that there 

is no requirement to test new 

production batches of TST on primates, 

and that imposing the same testing 

requirements on all NHPs is an 

approach based on tradition, not 

scientific merit. Another commenter 

also objected to maintaining the TST, 

saying that given the poor reliability of 

TST results in NHPs, we should 

strengthen the proposed requirements to 

reflect the best available science and 

practices for test methods and regimens. 

Yet another commenter recommended 

‘‘replacing the (proposed) tuberculin 

testing procedures.’’ The commenter 

also said that rather than rely solely on 

‘‘poorly-performing screening tests in 

quarantine,’’ HHS/CDC should require 

‘‘currently available confirmatory tests 

and then rigorous, ongoing bio-security 

and surveillance once in the managed 

zoo collection.’’ Noting the proposed 

requirement for including in the SOPs a 

grading scale interpretation of TSTs for 

NHPs in quarantine, this commenter 

suggested removing this requirement 

from § 71.53(l)(3)(ix), and instead, 

grading reactive animals in import 

quarantine either as negative or positive. 

The commenter asserted that although 

quarantine facilities might use such a 

scale during import quarantine, many 

‘‘do not recognize ‘questionable’ 

responses,’’ and prefer to err ‘‘on the 

side of caution.’’ Similarly, another 

commenter said it preferred to grade 

reactions for animals in import 

quarantine as positive or negative. The 

commenter asserted that that the TB test 

itself is imperfect, and that ‘‘any range 

of abnormal display may be seen on an 

individual that is truly infected.’’ 

HHS/CDC Response. HHS/CDC does 

not accept the assertions that there are 

currently TB tests more appropriate 

than the required MOT, but believes 

that a more improved test may be 

developed in the future. The currently 

approved test for the diagnosis of TB in 

NHPs is the TST performed using MOT, 

0.1cc injected intradermally in the 

palpebrum and observed at 24, 48, and 

72 hours (ILAR, 1980). Other TB tests 

have been evaluated but it has been 

noted that ‘‘no single screening test will 

meet all the requirements for 

surveillance and diagnosis of TB in 

nonhuman primates. Instead, the use of 

several tests in combination can 

increase the overall sensitivity and 

specificity of screening and surveillance 

programs and likely represents the 

future of TB testing in nonhuman 

primates’’ (Lerche, 2008). HHS/CDC will 

continue to require the TST until an 

improved testing procedure is 

developed. Until then, if test results are 

positive, the importer may elect a 

battery of tests to confirm the TST 

finding, and in consultation with HHS/ 

CDC, may choose either to treat or 

euthanize the animals. Further, 

concerning grading scales for animals 

with ‘‘questionable’’ responses, HHS/ 

CDC appreciates that many NHP 

importers consider any MOT reaction as 

positive. Again, our regulations are 

influenced by the ILAR guidelines 

(ILAR, 1980), which do allow subjecting 

NHPs to further testing in a ‘‘suspect’’ 

case of TB. HHS/CDC believes that it is 

permissible for an importer to interpret 

the TST according to the importer’s 

approved standard operating procedure 

and to do further diagnostic testing for 

NHPs with a suspect TB reaction as 

defined by the SOP. 

A commenter noted that paragraph 

(l)(3) should spell out steps for 

removing samples from the quarantine 

ward to perform laboratory analyses. 

HHS/CDC Response. In response to 

the commenter’s observation that there 

was no language in the proposed rule 

describing procedures for removing 

samples from the quarantine ward, 

HHS/CDC has added a requirement in 

§ 71.53(l)(3)(iv) for importers to describe 

procedures for handling and 

transporting such samples. 

Three commenters noted that 

proposed § 71.53(l)(3)(viii)(B) would 

require antibody testing for animals 

surviving quarantine and displaying 

signs suggestive of a filovirus infection, 


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but that paragraph (l)(6)(viii) of the 

provision would require performing 

filovirus testing using the antigencapture enzyme-linked immunosorbent 

assay (ELISA) method on the liver of 

any animal that dies or is euthanized for 

reasons other than trauma. The 

commenters suggested we modify 

§ 71.53(l)(6)(viii) to require antigencapture testing of liver tissue only from 

animals that died or were euthanized 

and exhibited potential signs of a 

filovirus infection. 

HHS/CDC Response. In accordance 

with the intent of the provision, HHS/ 

CDC has clarified the proposed language 

in § 71.53(l)(6)(viii) to specify that 

antigen-capture testing is required for 

NHPs that die or are euthanized for any 

other reason than trauma or adverse 

environmental conditions. 

A commenter asked whether an 

exemption from a BSL3 type quarantine 

still would require adhering to proposed 

paragraphs § 71.53(i), (j) and (k). The 

commenter suggested worker protection, 

crating, and transport at a BSL1 or BSL2 

for NHPs with well-documented 

medical histories prior to import. Also, 

this commenter and another asked HHS/ 

CDC to clarify the apparent 

inconsistency between proposed 

§ 71.53(l)(6)(ii), requiring performance 

of a necropsy under biosafety level 

(BSL)3 containment, and 

§ 71.53(l)(6)(iv), requiring necropsy 

under BSL3 or BSL2 containment. 

HHS/CDC Response. To address 

commenter requests for clarification 

regarding the appropriate biosafety level 

procedures for necropsy requirements 

under § 71.53(l)(6), we deleted the 

reference to BSL3 in paragraph (l)(6)(ii). 

We revised paragraph (l)(6)(iv) to 

require BSL3 or BSL2+ precautions for 

necropsies only. However, HHS/CDC 

acknowledges that all NHPs pose a 

potential risk to human health and 

should therefore be handled while 

wearing recommended PPE, as dictated 

in the approved SOPs. BSL2+ is a 

hybrid level of precautions that requires 

at least the use of a BSL2 facility with 

BSL3 containment equipment and 

practices. (HHS/CDC and NIH, 2007). 

An individual commented that we 

should modify or delete proposed 

§ 71.53(l)(3)(vii)(C) that would prohibit 

an importer from releasing an animal 

from quarantine if the importer knows 

or has reason to suspect the NHP has a 

zoonotic exposure or infection. The 

commenter said we should not consider 

zoonotic agents such as herpes B virus 

in the same category as TB, yellow 

fever, or filovirus. 

HHS/CDC Response. HHS/CDC has 

also revised paragraph 

§ 71.53(l)(3)(viii)(C) as the commenter 

requested to clarify that an importer 

must not request a release of an NHP 

from quarantine if the animal is ‘‘visibly 

ill.’’ 

Referencing proposed paragraphs 

§ 71.53(i)(5), (j)(6), (j)(12) and (13), 

(k)(3), and (l)(2); a commenter said we 

should clarify acceptable procedures for 

disinfecting, autoclaving, or disposing 

of animal wastes, bedding, and uneaten 

food. The commenter also said we 

should clarify disinfection requirements 

for vehicles. This same commenter said 

that when dealing with imports of large 

species or large numbers of primates, 

the cost of disposing of bedding and 

medical wastes could be prohibitive for 

zoos, and autoclaving could be 

impractical or impossible. 

HHS/CDC Response. Regarding the 

commenter’s request that HHS/CDC 

clarify acceptable procedures for 

disinfecting animal wastes, bedding, 

and uneaten food, we note that all 

methods that meet the performancebased standard will be considered. One 

example for handling of animal waste, 

bedding, and uneaten food other than 

autoclaving or disposal by a biohazard 

company would be to put the waste into 

the sanitary sewer system. Also, trucks 

can be cleaned of gross debris to be 

properly disposed of and then sprayed 

or fogged with a tuberculocidal, 

virucidal, or bactericidal disinfectant for 

an adequate contact time and then 

cleaned. 

K. Public Comments Regarding 

Requirements for Veterinarians and 

Veterinary Pathologists 

The January 2011 NPRM specifically 

asked for feedback on what factors 

should be taken into consideration in 

the determination of whether a 

veterinarian is sufficiently 

‘‘experienced’’ in the care of NHPs and 

what constitutes a ‘‘qualified’’ 

laboratory. A few commenters discussed 

the requirements for veterinarians and 

veterinary pathologists. One commenter 

said that in requiring quarantine 

facilities to have access to a qualified 

veterinarian, proposed § 71.53(i) and (l) 

should specify that such personnel be 

on duty and on site during business 

hours; and that there be appropriate 

veterinary coverage for evenings, 

weekends, and holidays. This 

commenter said further that the 

requirements should specify a number 

of available and qualified veterinarians 

commensurate with the number of 

NHPs. 

HHS/CDC Response. While HHS/CDC 

may agree that these are good 

requirements for a facility, these do not 

help to define qualifications of a 

veterinarian. Thus, no changes were 

made to § 71.53(i) and (l) based upon 

these comments. 

A commenter asserted that the rule 

should include as minimum 

requirements for veterinarians: A 

current veterinary license, USDA 

accreditation, and experience with 

NHPs. Another commenter also stated 

that HHS/CDC should define ‘‘qualified 

veterinarian’’ similar to USDA. 

HHS/CDC response. HHS/CDC agrees 

that these would be the ideal minimal 

requirements for a licensed veterinarian 

working with NHPs. In response, we 

have added a definition for licensed 

veterinarian to the text of the regulation 

to clarify that these individuals must 

have experience working with NHPs. 

A commenter asked why HHS/CDC 

would require a veterinary pathologist 

to have a state license, which would 

preclude other qualified professionals 

from conducting procedures such as 

necropsy. The commenter said that 

because veterinary pathologists do not 

‘‘practice,’’ most do not obtain or 

maintain state licenses. The commenter 

also suggested that we require the 

performance of necropsies by a boardcertified veterinary pathologist or a 

state-licensed veterinarian. 

HHS/CDC response. HHS/CDC agrees 

that requiring a veterinary pathologist to 

perform necropsy is not always 

necessary and may be too limiting to an 

NHP import facility, but that just any 

state-licensed veterinarian may not be 

familiar with the public health risk 

associated with performing necropsies 

on imported NHPs. We have removed 

‘‘state-licensed veterinary pathologist’’ 

from § 71.53(l)(6)(ii) and edited the 

language to reflect a requirement for the 

performance of necropsies by a 

veterinary pathologist or a state-licensed 

veterinarian with knowledge and 

experience with the disease risks 

associated with performing these 

necropsies. Additionally, the veterinary 

pathologist or licensed veterinarian 

must be familiar with the precautions 

and level of containment that should be 

used to perform these necropsies. 

L. Public Comments Regarding Zoo-toZoo and Laboratory-to-Laboratory 

Transfers; Animal Acts 

Some commenters addressed the 

proposed requirements for zoo-to-zoo 

and laboratory-to-laboratory transfers in 

§ 71.53(l)(1), which would exempt these 

entities from the quarantine facility 

requirements in this provision provided 

that the transfer complied with 

proposed § 71.53(p)(2) and § 71.53(q)(2). 

After stating their strong support for 

paragraph (p)(2), one commenter 

recommended following proposed riskVerDate Mar<15>2010 19:42 Feb 14, 2013 Jkt 229001 PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 E:\FR\FM\15FER5.SGM 15FER5

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Accreditation/Accreditation%20Standards.pdf. 

reduction procedures irrespective of 

whether quarantine is required. 

HHS/CDC Response. Regarding the 

recommendation for a defined disease 

risk assessment for NHPs imported by 

AZA-accredited zoos, HHS/CDC does 

not believe further risk reduction 

procedures are necessary, because a zoo 

must conform to AZA standards as a 

condition of being excepted from 

otherwise applicable quarantine 

requirements. 

In response to the commenter’s 

request that we clarify HHS/CDC criteria 

for determining that a zoo outside the 

United States is ‘‘AZA equivalent,’’ 

HHS/CDC will consider a facility as 

meeting this standard if it is accredited 

by an organization that has standards 

comparable to those in the AZA 

Accreditation Standards and Related 

Policies.3 These standards include 

performance-based procedures 

addressing appropriate veterinary care, 

quarantine and necropsy, and public 

exposure to animals. This approach 

allows individual institutions to decide 

on the best procedures within their 

institutional capabilities to reach the 

desired results. 

Another commenter requested that we 

clarify the § 71.53(p)(2) proposed 

exemption from the 31-day quarantine 

provision in § 71.53(l)(1) for zoo-to-zoo 

transfers. The commenter stated that 

importers involved in zoo-to-zoo 

transfers of NHPs still would have to 

comply with proposed §§ 71.53(i) 

(worker protection and PPE), 71.53(j) 

(SOPs for NHP crating, caging, and 

transport), and 71.53(k) (ground 

transport requirements). The same 

commenter asserted that as written, 

these subsections indicate that if an 

NHP with a known medical history 

were the subject of a zoo-to-zoo transfer, 

the animal still would be handled under 

BSL3 protocols until its arrival at a U.S. 

zoo, where it then would be exempt 

from any type of quarantine. The 

commenter said there appeared to be an 

inconsistency. 

HHS/CDC Response. HHS/CDC 

clarifies the intent of the regulation by 

emphasizing that qualified zoos and 

labs under paragraphs (p) and (q) are not 

exempt from the worker protection, 

ground transportation, or SOP 

requirements under this regulation. 

Further, the only BSL2+ or BSL3 

requirements in this regulation are for 

necropsies. However, HHS/CDC 

acknowledges that all NHPs pose a 

potential risk to human health and 

should therefore be handled while 

wearing recommended PPE, as dictated 

in the approved SOPs. 

One commenter said it was unclear 

why there was inconsistency in the 

standards for documentation of negative 

TB tests for animal acts, zoo-to-zoo 

transfers, and laboratory-to-laboratory 

transfers. The commenter suggested that 

the standard for all three should be the 

higher one, which is the laboratory-tolaboratory transfer standard. Two 

commenters suggested that we have the 

same standard for medical records and 

certificates for zoo-to-zoo and 

laboratory-to-laboratory transfers from 

outside the United States. 

HHS/CDC Response. Regarding the 

differing TB standards for zoo-to-zoo, 

laboratory-to-laboratory, and animal 

acts, HHS/CDC believes the commenter 

may have misinterpreted the proposed 

provisions. Neither the proposed 

language nor final rule language 

specifies a more stringent standard for 

one group. However, each group will be 

expected to present documentation of 

regular TB testing and good health. 

One commenter recommended that 

NHPs imported through AZA-accredited 

zoos go through a defined risk 

assessment and decision analysis before 

importation and release from 

quarantine. This commenter also asked 

what criteria HHS/CDC would use to 

determine that a zoo outside the United 

States was an AZA-equivalent zoo. 

HHS/CDC Response. Although we are 

easing some of the quarantine 

requirements for zoo-to-zoo and 

laboratory-to-laboratory transfers, these 

entities still will be regulated and 

required to follow risk-reduction 

procedures. Further, as explained in the 

regulatory analyses section for this rule, 

importers transferring NHPs between 

qualifying zoos and qualifying 

laboratories already are regulated by 

USDA, may be bound by the Public 

Health Service (PHS) policy for humane 

treatment of laboratory animals, and 

must meet guidelines for animal care 

and occupational health and safety from 

accrediting organizations. For zoos, that 

means providing a quarantine facility 

for animals new to the collection. 

Considering all these factors, we believe 

that our registration, records, and 

oversight requirements; the 

requirements of accrediting 

organizations; and oversight by other 

federal entities provides health and 

safety assurance equivalent to what the 

31-day quarantine period provides for 

other importers. 

One commenter opposed § 71.53(p)(2) 

and § 71.53(q)(2) provisions permitting 

NHP transfers between laboratories 

without subjecting the animals to 

‘‘certain testing and quarantine 

requirements.’’ More specifically, the 

commenter said the proposed change 

would result in risks to public health 

and animal health and welfare, and 

would create the potential for abuse. 

Another commenter also opposed easing 

quarantine requirements for laboratoryto-laboratory transfers of NHPs. Citing 

published papers to support the 

proposition that neither new shipments 

nor established colonies of NHPs are 

immune from infectious diseases, the 

commenter said we should not 

eliminate quarantine requirements for 

any reason. 

HHS/CDC Response. HHS/CDC 

disagrees with these commenters and 

emphasizes that such transfers will not 

be without oversight. For laboratory-tolaboratory transfers of NHPs, importers 

must have protocols approved by the 

IACUC, a self-regulating entity required 

under U.S. law for institutions using 

laboratory animals for research and 

instruction. Further, the importer must 

demonstrate that the animals are part of 

long-term, established studies with 

specific study protocols. Sending 

laboratories must submit records 

showing TB testing, number of NHPs, 

current health certificates, 

documentation of the research project, 

and travel itineraries. 

One commenter said that because 

NHPs in zoos and in many professional 

animal acts live in uncontrolled 

environments where interaction with 

humans may be unlimited, imported 

NHPs in zoo populations and animal 

acts leaving and then returning to the 

United States should have no special 

import exemptions. This commenter 

suggested maintaining the 31-day 

quarantine requirements for both 

categories of NHPs. Two commenters 

both agreed we should maintain the 

quarantine period for zoo-to-zoo 

transfers. 

HHS/CDC Response. HHS/CDC agrees 

with the comment that transfers of NHP 

from facilities outside the United States 

should be subject to the same medical 

records and health certificate 

requirements—irrespective of whether 

the transfer is between qualified zoos or 

laboratories. Although these groups will 

not be required to undergo the 31-day 

quarantine, these importers still are 

subject to registration with the Agency 

before bringing animals into the United 

States. The final rule will also hold 

importers of U.S.-based animal acts to 

the same requirements for entry as 

foreign-based animal acts; all such 

NHPs will be subject to a quarantine 

period regardless of where the animals 

are based. 


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M. Public Comments Regarding NHP 

Products 

One commenter said we should better 

define ‘‘the scope, requirements or 

duration’’ of the permit process to help 

importers of NHP blood and tissue 

samples ensure that shipments of such 

products would not be degraded or 

destroyed and lose their scientific value. 

The commenter questioned the 

necessity for further permit 

requirements given that importers of 

these products already must obtain a 

CITES permit. 

HHS/CDC Response. Under § 71.53(t), 

Nonhuman primate products, importers 

are required to obtain a permit from 

HHS/CDC prior to shipment of these 

products. However, this final rule does 

not change the current and longstanding 

practice of obtaining such a permit. 

HHS/CDC recognizes the need for 

timely shipment of such products and 

will expedite all requested permits to 

ensure that no products are degraded or 

destroyed. 

Two commenters made remarks on 

proposed requirements for permits for 

importing NHP products, including 

blood and biological samples. One 

commenter asked us to indicate that a 

HHS/CDC permit covers NHP products 

not intended for commercial use. 

HHS/CDC Response. In response, a 

HHS/CDC permit is required and will 

cover any NHP product (personal or 

commercial) unless it has been rendered 

noninfectious, as defined in the final 

text of the regulation. 

A commenter asked us also to clarify 

that although a product importer may 

not need a HHS/CDC permit for some 

products, there may be other non-HHS/ 

CDC permits required for import. 

Asserting that proposed § 71.53(t) would 

cover blood and tissue samples from 

NHPs, another commenter noted that 

importing these materials already 

requires holding a CITES permit, which 

HHS/CDC may use to track these 

importers and materials. 

HHS/CDC Response. At present, HHS/ 

CDC does not have the resources to 

track permits issued by other federal 

agencies. Furthermore, such outside 

permits are reviewed and issued for 

purposes other than to protect public 

health. 

The commenter also noted that the 

requirement to render biological 

samples noninfectious could destroy 

their scientific value. This commenter 

further asked whether formalin-treated 

NHP tissues and slides containing such 

tissue would require a permit for 

importation. The same commenter said 

it was important to distinguish between 

formalin-fixed tissue and histological 

preparations of slides and blocks from 

formalin-fixed tissue. The commenter 

described slides and blocks as subject to 

disinfecting in the form of serial 

exposure to extractive solvents (e.g., 

alcohol) and heat during tissue 

processing and block preparation. It said 

that penetration of thin slices of tissue 

used on slides permits excellent 

penetration of solvents, and that the 

preparation of paraffin-embedded 

blocks and slides provides a physical 

barrier that minimizes potential 

exposure. The commenter said that 

these materials are for scientific 

purposes, that knowledgeable people 

handle the materials in laboratories 

equipped for handling potentially 

infectious samples from humans or 

animals, and that the value of permits 

for such materials is questionable. The 

commenter said that should HHS/CDC 

require importers of blood and tissue 

samples to obtain a permit, that it must 

define and structure the process to 

avoid delays that may adversely affect 

the scientific quality of samples. 

HHS/CDC Response. As noted earlier, 

although some importers of NHP 

products are subject to the CITES 

program, HHS/CDC’s mandate is to 

protect public health, and any untreated 

NHP product poses a risk to human 

health. However, items which may be 

compromised by rendering them 

noninfectious may still enter the United 

States if accompanied by a HHS/CDCissued permit. Under § 71.53(t)(1) of the 

final rule, we lay out the conditions for 

importing noninfectious products into 

the United States. In § 71.53(t)(2) of the 

final rule, we clarify that it may be 

permissible to import infectious blood 

and tissue samples for bona fide 

scientific, educational, and exhibition 

purposes under conditions set out in 

that provision. Timely requests for 

importing these products are processed 

expeditiously. As the final rule makes 

clear in § 71.53(t)(1), an NHP product 

importer may use formalin fixation or 

any method approved by HHS/CDC to 

render products noninfectious. 

N. Public Comments Regarding Appeals 

Regarding the appeals process in 

proposed § 71.53(u), four commenters 

asserted that the proposed time for 

appeal was too short, the process was 

undefined, and a rationale for so short 

a period was absent. Commenters 

suggested expanding appeals to 5 days. 

HHS/CDC Response. HHS/CDC agrees 

that importers who are denied a permit 

should have more time to appeal the 

denial. Therefore, § 71.53(u)(2) extends 

the time for appeal from 2 to 5 days. 

Regarding the process itself, we believe 

that an appeal of a permit denial to the 

HHS/CDC Director is unambiguous and 

provides sufficient procedural 

safeguards against erroneous permit 

denials. 

O. Public Comments Regarding HHS/ 

CDC Monitoring and Enforcement 

An individual commenter stated that 

our proposal said little about facility 

inspection, importer compliance, 

number of personnel, program funding, 

and enforcement actions. The 

commenter questioned how we would 

ensure consistent monitoring and 

enforcement. Another commenter 

referenced what it called ‘‘obvious 

disincentives’’ for reporting 

noncompliance by overseas suppliers 

and shippers, and the apparent lack of 

a mechanism for HHS/CDC to assess 

compliance before an NHP shipment 

arrives in the United States. Calling the 

proposed procedures in § 71.53(j) 

‘‘inadequate,’’ and given what the 

commenter said was the failure of NHP 

breeding farms outside the United States 

to match our health and welfare 

standards, this commenter said we 

should ‘‘directly monitor’’ NHP overseas 

operations. This commenter suggested 

that the Agency take a direct, active role 

in risk management, by follow the 

approach the United Kingdom now 

employs. In the alternative, said the 

commenter, we could prohibit NHP 

imports altogether. 

HHS/CDC Response. HHS/CDC does 

not have the authority to regulate 

foreign NHP facilities. However, 

enforcement of the regulations for U.S. 

facilities will remain as it is currently, 

and the same penalties apply for 

violations. For compliance and 

inspections, HHS/CDC will continue to 

make unannounced visits for U.S.-based 

importers, as these importers must make 

records, facilities, vehicles, and 

equipment available for HHS/CDC 

inspection during operating business 

days and hours, and at other necessary 

and reasonable times. 

Another commenter asked whether 

inspection of NHP importers would 

include importers of blood and tissue 

samples, and asked what criteria we 

would use for such inspections. 

HHS/CDC Response. Because of the 

extensive resources that would be 

required for such inspections, the 

Agency will not perform site visits but 

will rely on HHS/CDC quarantine 

station inspections of incoming 

shipments for compliance with these 

requirements. 

Another commenter also suggested we 

add ‘‘employee health and safety 

records’’ and ‘‘animal health records’’ to 

the list of things an importer must make 

available for HHS/CDC inspection. 


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11534 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 

HHS/CDC Response. HHS/CDC agrees 

with this comment and has inserted the 

suggested language into paragraph 

(b)(1). 

Regarding a change in the special 

permit-renewal period from every 180 

days to every two years, one commenter 

said this change would ‘‘vastly reduc[e] 

regulatory oversight of importers’’ 

without evidence that the health risk 

posed by these importers has changed. 

This commenter further asserted that we 

provided no justification for changing 

the renewal period other than easing the 

$84/year burden on the regulated 

community, and that such a goal alone 

is insufficient ‘‘to justify the serious 

threat to the public posed by relaxing 

standards for importation of these 

species of NHPs.’’ 

HHS/CDC Response. HHS/CDC 

believes that the commenter’s concern 

about the reduction in government 

oversight is misplaced. We did not 

propose a reduction in oversight, but in 

administrative burden. Importers must 

continue to notify HHS/CDC of all 

shipments and the Agency will continue 

to perform regular site visits, including 

the review of importer standard 

operating procedures. Indeed, there is 

constant communication between HHS/ 

CDC and importers. Extending the 

renewal period for special permit 

species will not result in less oversight, 

and is consistent with the directive in 

Executive Order 13653 section 1 that we 

apply the least burdensome tools for 

achieving regulatory ends. Further, 

although one objective of this rule is to 

reduce the compliance burden on 

special permit species importers; the 

principal goals of this rulemaking are to 

extend special permit species 

requirements to all NHP imports, to 

improve Agency oversight through a 

general requirement that NHP 

shipments enter the United States 

through ports of entry with a HHS/CDC 

quarantine facility, and to codify 

existing guidelines. We have extended 

the registration renewal period for 

special permit species importers not just 

to reduce the burden on the regulated 

community, as the commenter asserts, 

but because the reduction and 

continuing low morbidity and mortality 

rates for these species in transit and 

quarantine demonstrate that a 2-year 

renewal period would be sufficiently 

protective of public health. 

Concerning the change in timeframe 

for renewal of importer licenses, HHS/ 

CDC would like to emphasize that we 

have incorporated all provisions of the 

old 180-day permit requirement into the 

new regulation and have strengthened 

these requirements by requiring 

filovirus testing on all Old World 

Monkeys. All currently registered 

importers of the three special-permit 

species (cynomolgus and rhesus 

macaques, and African green monkeys) 

have been importing these animals since 

the special permit first went into effect 

in 1990. There have been no legal 

challenges to any of the provisions of 

the special permit. We received only 

positive feedback from the public 

during the comment period for the 

NPRM. Compliance with provisions of 

the 180-day special permit has been 

excellent. Any potential for 

misinterpretation of the provisions is 

identified during the at-least biannual 

review of the importer’s standard 

operating procedures and annual site 

visits. 

The NHP import industry has 

changed vastly during the 22 years since 

the 180-day special permit final rule 

was promulgated. Before the 

requirements of the special permit were 

introduced, there were hundreds of 

NHP importers and high levels of NHP 

mortality during import. Many of these 

operations were poorly equipped and 

quickly dropped out of the industry in 

response to the special permit 

regulation and other HHS/CDCmandated provisions concerning 

tuberculosis. Currently there are only 24 

NHP importers registered with CDC: 11 

commercial importers; 7 zoos; 4 

national primate research centers; 1 

university; 1 private research facility. 

This number has decreased from 27 

registered importers in 2004. There are 

now only 8 importers who routinely 

import NHP covered by the special 

permit. 

The number of NHPs imported 

annually has decreased dramatically 

over the last several years, as shown in 

the Figure 1 below. 


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Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 11535 

Factors for this decrease include 

difficulties encountered in international 

transportation of NHPs (fewer airlines 

allow transport each year), as well as 

decreased demand. 

When an importer requests renewal of 

the special permit, the importer submits 

an email, and CDC re-authorizes the 

special permit, provided there have 

been no changes in the importer’s 

standard operating procedures and no 

uncorrected procedural violations. In 

the last 8 years of program oversight, 

there has never been an instance where 

a special permit has not been renewed 

promptly. Any deficiencies on the part 

of the importer are: Noted during 

quarantine station oversight when the 

shipment reaches the United States; 

self-reported during quarantine by the 

importer; picked up on biannual review 

of the importer’s registration 

application; or identified during routine 

site visits. All special permit NHP 

importers are visited annually. 

HHS/CDC’s rulemaking is in keeping 

with Executive Order 13563, Improving 

Regulation and Regulatory Review, 

which states that regulations must 

‘‘identify and use the best, most 

innovative and least burdensome tools 

for achieving regulatory ends. [The 

regulations] must take into account 

benefits and costs, both quantitative and 

qualitative.’’ Renewing the special 

permits every 180 days expends 

taxpayer resources (i.e., staff time) to 

review and approve renewal 

applications, when there is no current 

evidence to suggest that such a 

frequency of scrutiny contributes 

appreciably to protecting public health. 

As stated above, regulations should 

impose the smallest reasonable burden 

on the regulated entities in order to 

accomplish the purpose of the 

regulations; we are acting in the spirit 

of that principle by reducing the burden 

on the NHP importers because there is 

no evidence that requiring them to 

renew their special permits every 180 

days is necessary to accomplish the 

purpose of the regulations. 

It is our opinion based on extensive 

experience that the 180-day special 

permit final rule was promulgated 

during a much different phase of the 

import industry. Changes in the 

industry since then lead us to believe 

firmly that it has no appreciable benefits 

public health benefits over a two-year 

timeframe. 

An individual asked how we will 

monitor compliance and apply penalties 

for brokers given there were no apparent 

requirements for them to register with 

HHS/CDC under § 71.53(r). 

HHS/CDC Response. Although there 

is no requirement for brokers to register 

with the Agency, under § 71.53(r), 

brokers must notify HHS/CDC of in 

transit shipments before the shipments 

arrive in the United States, which 

includes providing detailed information 

on the animals; the in transit itinerary; 

equipment used in transport, housing 

and decontamination procedures; and 

other performance-based procedures to 

reduce the risk of exposing the public to 

health hazards presented by NHPs. 

Further, the same penalties apply to 

brokers as to other entities subject to 

these regulations. 

P. Miscellaneous Comments 

Asserting that proposed reporting of 

NHP illnesses and deaths upon arrival 

and in quarantine would reveal ‘‘only a 

fraction’’ of morbidity and mortality for 

these animals, a commenter asked that 

we provide an analysis of such cases 

from the recent past before continuing 

with this rulemaking. The commenter 

said we should report on the precise 

nature of illnesses and deaths, and 

include laboratory and post-mortem 

results. According to one comment, 

such an analysis would ensure that the 

public appreciated and understood any 

risks and benefits of the changes we 

proposed. 

HHS/CDC Response. HHS/CDC 

disagrees with this comment. All 

morbidity and mortality in a shipment 

of NHPs upon arrival and during the 31- 

day quarantine period is reported to 

(and recorded by) HHS/CDC. Illness 

reports and necropsy reports are 


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11536 Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 

reviewed before any NHPs are released 

from the required quarantine. 

Additionally, veterinary medical 

records are reviewed during the regular, 

unannounced site visits. 

One commenter recommended that in 

the final rule preamble or the rule itself, 

we discuss whether the rule would 

apply retroactively to NHPs imported 

before issuance of the final rule. The 

agency expressed particular interest in 

rule provisions addressing an importer’s 

ability to maintain, sell, resell, or 

otherwise distribute imported NHPs or 

the offspring of imported NHPs. 

HHS/CDC Response. Regarding the 

question of retroactive applicability, 

HHS/CDC notes that the new rule does 

not apply to animals or the offspring of 

animals imported into the country 

before 1975. For decades, there have 

been prohibitions on importing NHPs 

except for scientific, exhibition, or 

educational purposes; or for using the 

offspring of imported NHPs for reasons 

other than scientific, exhibition, or 

educational purposes. The revised rule 

continues these prohibitions. 

IV. Alternatives Considered 

Executive Order 13563 recommends 

that the regulatory impact analysis 

consider all feasible alternatives to 

current practice and the rule as 

proposed. The main impact of the rule 

is to unify existing regulations and 

codify and professional guidance 

regarding infection control and worker 

safety procedures to prevent 

transmitting pathogens from NHPs to 

humans. As explained in II. Summary of 

the Proposed Rule Requirements, HHS/ 

CDC proposed a number of changes in 

the NPRM that would achieve its 

regulatory objectives through 

performance-based standards rather 

than promulgating prescriptive 

standards for importers. HHS/CDC 

endeavored to allow regulated entities 

flexibility in choosing how to meet the 

standards. We have provided flexibility 

regarding recordkeeping requirements, 

standard operating procedures, and 

worker protection requirements. 

HHS/CDC reviewed the 31-day 

quarantine requirement and associated 

restrictions for transfers of NHPs into 

the United States between Association 

of Zoos and Aquariums (AZA)- 

accredited zoos and proposed to 

eliminate that requirement. Similarly, 

HHS/CDC proposed a quarantine 

exception for transfers of NHPs from 

laboratories accredited by the 

Association for Assessment and 

Accreditation of Laboratory Animal 

Care International (AAALAC) or its 

equivalent, if the laboratory has a 

foreign-based and a U.S.-based facility 

and the NHP is part of an ongoing 

research project. 

V. Regulatory Analyses 

A. Executive Orders 12866 and 13563 

HHS/CDC has examined the impacts 

of the proposed rule under Executive 

Order 12866, Regulatory Planning and 

Review (58 FR 51735, October 4, 1993) 

and Executive Order 13563, Improving 

Regulation and Regulatory Review, (76 

FR 3821, January 21, 2011). Both 

Executive Orders direct agencies to 

evaluate any rule prior to promulgation 

to determine the regulatory impact in 

terms of costs and benefits to United 

States populations and businesses. 

Further, together, the two Executive 

Orders set the following bars: quantify 

costs and benefits where the new 

regulation creates a change in current 

practice; define qualitative costs and 

benefits; choose approaches that 

maximize benefits; support regulations 

that protect public health and safety; 

and minimize the impact of regulation. 

HHS/CDC has analyzed the rule as 

required by these Executive Orders and 

has determined that it is consistent with 

the principles set forth in the Executive 

Orders and the Regulatory Flexibility 

Act, as amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA) and that the rule will not 

create enough change in current practice 

to have a measurable, quantifiable 

impact. 

This rule is not being treated as a 

significant regulatory action as defined 

by Executive Order 12866. As such, it 

has not been reviewed by the Office of 

Management and Budget. This 

regulatory action is not a major rule 

under the Congressional Review Act. In 

our screening analysis under the 

Regulatory Flexibility Act, HHS/CDC 

also concludes that the rule will not 

have a significant economic impact on 

a substantial number of small entities. 

HHS/CDC has determined that the 

main impact of the rule will be to unify 

existing regulations and codify 

professional guidance regarding 

infection control and worker safety 

procedures to prevent transmitting 

pathogens from NHPs to humans. All 

stakeholders involved in the 

importation and maintenance of NHPs 

will now be subject to the same set of 

rules and guidelines. This rule 

combines a disparate set of professional 

recommendations and rules that were 

published or established in various 

formats between 1975 and 1993 (see C. 

What is the History of this 

Rulemaking?). This rule clarifies 

definitions of terms and requirements 

for developing plans and SOPs for 

quarantine, other operations, personnel 

training, and worker health programs 

prior to importation of NHPs; although 

the rule does not add new terms or 

requirements. The regulation also 

allows stakeholders to exercise their 

own good judgment in implementing 

the regulatory guidelines through 

performance-based standards, rather 

than dictating prescriptive compliance. 

The rule impact will be unification of 

existing rules and codification 

professional guidance. The rule will 

create qualitative costs and benefits for 

all NHP importation stakeholders and 

the United State public as explained 

below. 

Benefits. There are benefits to the rule 

that accrue to: (1) The public in the form 

of protecting public health; (2) business 

stakeholders in the form of investment 

protection and a reduction in time 

needed to be spent on regulatory 

compliance leading to a benefit of 

avoided costs; (3) the NHP workforce; 

and (4) the scientific community. 

Public health benefits: 

• Reduction in risk of transmission of 

a variety of zoonotic infections 

including filoviruses, TB, herpes B 

virus, and parasites. 

• Entry through quarantine stations 

where qualified personnel examine the 

NHP to ascertain any potential exposure 

to the public through direct contact or 

contaminated cargo. 

• Certifying the health of NHPs in 

animal acts will reduce the risk of 

spectators coming in contact with ill 

animals. 

Business stakeholders benefits 

(reduction in time spent on regulatory 

compliance, or avoided costs, and 

investment protection): 

• Investment protection—Certifying 

the health of NHP will reduce the 

potential transmission of disease 

between NHP and reduce the costs to 

the business of caring for other ill 

animals, or in the worst case, stop the 

loss of investment through death. 

• Regulatory reduction (avoided 

cost)—The registration renewal time for 

all NHPs will now be 2 years. 

Previously, importers of cynomolgus, 

African green, and rhesus monkeys were 

required to renew their special permit 

registration every 180 days, or two times 

a year. According to HHS/CDC records, 

special-permit holders are about a third 

of all NHP importers (20 of a total of 60). 

This is a four-fold reduction in 

paperwork for registration renewal for 

about a third of all NHP importers. 

• Regulatory reduction (avoided 

cost)—More specific definitions and 

uniform application of rules and 

standards will make it much easier for 

businesses to reliably forecast the time 


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Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Rules and Regulations 11537 

they need to spend complying with 

regulation. 

• Regulatory reduction (avoided 

cost)—The rule eradicates the 31-day 

quarantine period for animals being 

transferred between zoos and 

laboratories when the facilities have 

been approved by professional 

organizations (AZA for zoos and 

AAALAC for laboratories). CDC 

professionals indicate that there are 

between three and five such transfers a 

year. Professional opinion and 

discussion with zoos and laboratories 

indicates that this would result in 

avoided costs of about $500 to $1,800 

per transfer, depending on the facility 

costs for quarantine. 

Scientific benefits: 

• Obstacles to the movement of 

highly endangered NHPs will be 

removed to protect the species. 

• Controlled entry of NHPs for longterm research will be allowed when the 

research can only be performed in 

United States laboratories. 

NHP workers benefits: 

• The regulation now defines the 

types of personal protective gear that 

workers must wear in order to protect 

the worker from the potential 

transmission of infectious agents. 

• Guidelines for regular TB testing 

have been established to ensure that 

workers are tested and diagnosed in a 

timely manner. 

• Guidelines are now established for 

access to medical care in the event of 

zoonotic-human illness transmission to 

ensure that workers are tested and 

diagnosed in a timely manner. 

Costs. The current regulation is 

primarily definitional and changes very 

little actual current practice. The only 

part of the new regulation that will 

create an additional cost will be the 

requirement that all NHPs being 

imported enter the country through a 

port of entry or airport with a 

quarantine station. At the current time 

the majority of, as much as 95% 

according to CDC subject matter experts, 

of NHPs enter the country at ports with 

quarantine stations because they arrive 

on airlines that frequent those ports of 

entry. The remaining NHPs that are 

transported into the United States come 

in by truck across smaller border 

crossings between Mexico and the 

United States or Canada and the United 

States. Professionals in CDC’s 

Quarantine Branch estimate that this 

amounts to approximately one shipment 

per year, or less than 5% of all NHP 

imported to the United States. HHS/ 

CDC also notes that arrangements can be 

made in advance for alternative ports of 

entry if the importers contact HHS/CDC. 

Thus, HHS/CDC believes there is very 

little additional cost impact to the 

importer. 

Cost-Benefit comparison. Benefits and 

avoided costs as enumerated in the 

benefits section appear to outweigh the 

additional transportation cost of 

additional travel for one or two 

importers each year that will need to 

enter through points with quarantine 

station. 

B. Paperwork Reduction Act Analysis 

HHS/CDC has determined that this 

rule contains data collection and record 

keeping requirements that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3420). HHS/CDC already has 

approval from OMB for the collection of 

registration information from importers 

and record keeping requirements under 

OMB Control No. 0920–0134: Foreign 

Quarantine Regulations (expiration date 

July 31, 2015). 

In addition, HHS/CDC has approval 

from OMB under OMB Control No. 

0920–0263: Requirements for a Special 

Permit to Import Cynomolgus, African 

Green, or Rhesus Monkeys into the 

United States (expiration date June 30, 

2014) to collect data from importers 

who wish to apply for a special permit 

to import non-human primates. 

C. Federalism Impact 

Under Executive Order 13132, if the 

rule would limit or preempt State 

authorities, then a Federalism analysis 

is required. The agency must consult 

with State and local officials to 

determine whether the rule would have 

a substantial direct effect on State or 

local governments, as well as whether it 

would either preempt State law or 

impose a substantial direct cost of 

compliance. 

In accordance with section 361(e) of 

the PHSA [42 U.S.C. 264(e)], nothing in 

this rule would supersede any 

provisions of State or local law except 

to the extent that such a provision 

conflicts with this rule. For example, 

the rule would not prevent a State from 

taking stronger measures to deal with 

infected or possibly infected NHPs or to 

cover additional species. Further, our 

rule will not supersede state 

requirements not in conflict with the 

federal rule’s provisions. However, in 

accordance with section 361(e) of the 

PHSA, any state or local law that would 

permit any activity prohibited under 

this rule would conflict with this rule 

and, therefore, would be superseded. 

The rule would not have a substantial 

direct effect on State or local 

governments or impose a substantial 

direct cost of compliance on them. 

D. Environmental Impact 

In the absence of an applicable 

categorical exclusion, the Director, 

HHS/CDC, has determined that 

provisions amending 42 CFR 71.53 will 

not have a significant impact on the 

human environment. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

at 2 U.S.C. 1532 requires that agencies 

prepare an assessment of anticipated 

costs and benefits before developing any 

rule that may result in expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector of 

$100 million or more (adjusted for 

inflation) in any given year. This rule is 

not expected to result in any one-year 

expenditure that would exceed this 

amount, therefore HHS/CDC has not 

prepared a table of quantified costs and 

benefits. 

F. Plain Language Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS/CDC has 

attempted to use plain language in 

promulgating this rule consistent with 

the Federal Plain Writing Act 

guidelines. 

VI. References 

National Research Council. ‘‘Occupational 

Health and Safety in the Care and Use of 

Nonhuman Primates.’’ Institute for 

Laboratory Animal Research, Division of 

Earth and Life Studies, National 

Research Council, The National 

Academies Press 2003, Washington, DC. 

HHS/CDC (Centers for Disease Control and 

Prevention). 1990. Update: Ebola-Related 

Filovirus Infection in Nonhuman 

Primates and Interim Guidelines for 

Handling Nonhuman Primates during 

Transit and Quarantine. Morbidity and 

Mortality Weekly Report (MMWR). 

39(2):22–24, 29–30. 

HHS/CDC (Centers for Disease Control and 

Prevention). 1990. Update: Filovirus 

Infection in Animal Handlers. Morbidity 

and Mortality Weekly Report (MMWR). 

39(13):221. 

55 FR 15210, April 20, 1990, Requirements 

for a Special Permit to Import 

Cynomolgus, African Green, or rhesus 

Monkeys into the United States. 

Roper, W.L. Dear interested party (letter). 

October 10, 1991. Available upon 

request: (404) 639–1600. 

Tipple, M.A. Dear interested party (letter). 

March 5, 1996. Available upon request: 

(404) 639–1600. 

HHS/CDC (Centers for Disease Control and 

Prevention). 1993. Tuberculosis in 

Imported Nonhuman Primates—United 

States, June 1990–May 1993. Morbidity 


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and Mortality Weekly Report (MMWR). 

42(39):572–576. 

Formenty, P., et al. Ebola Virus Outbreak 

among Wild Chimpanzees Living in a 

Rain Forest of Cote d’Ivoire. J. Infect. Dis. 

1999; 179(Suppl 1):S120–126. 

Rollin PE, et al. Ebola (Subtype Reston) Virus 

among Quarantined Nonhuman Primates 

Recently Imported from the Philippines 

to the United States. J Infect Dis., 1999; 

179(Suppl 1):S108–14. 

Rouquet P, et al. Wild Animal Mortality 

Monitoring and Human Ebola Outbreaks, 

Gabon and Republic of Congo 2001– 

2003. Emerg Infect Dis., 2005; 11:283–90. 

Leroy EM, Telfer P, Kumulungui B, et al. 

Serological Survey of Ebola Virus 

Infection in Central African Nonhuman 

Primates. J Infect Dis., 2004; 190:1895–9. 

HHS/CDC (Centers for Disease Control and 

Prevention). 1996. Ebola-Reston Virus 

Infection among Quarantined Nonhuman 

Primates—Texas, 1996. Morbidity and 

Mortality Weekly Report (MMWR). 

45(15):314–316. 

HHS/CDC (Centers for Disease Control and 

Prevention). 1989. Ebola Virus Infection 

in Imported Primates—Virginia. 

Morbidity and Mortality Weekly Report 

(MMWR). 38(48):831–832, 837–838. 

Roberts, J.A., Andrews, A. Nonhuman 

Primate Quarantine: Its Evolution and 

Practice. 2008. Institute for Laboratory 

Animal Research (ILAR) Journal. 49(2). 

DeMarcus, T.A., Tipple, A., Ostrowski, S.R. 

US Policy for Disease Control among 

imported nonhuman primates. 1999. J 

Infect Dis. 179:S281–S82. 

Institute for Laboratory Animal Research 

(ILAR. 2006 Citing Mullan R.J. 

Nonhuman Primate Importation and 

Quarantine: United States. Presentation 

at Annual Meeting of the Association of 

Primate Veterinarians, Park City, Utah, 

October 12–14. 

Lerche NW., Yee JL, Capuano SV, Flynn JL. 

New approaches to tuberculosis 

surveillance in nonhuman primates. 

ILAR J. 2008;49(2):170–8. 

ILAR Subcommittee on Care and Use, 

Committee on Nonhuman Primates. 

Laboratory Animal Management: 

Nonhuman Primates. ILAR News 

XXIII:2–3:28–29; National Academy 

Press 1980; Washington, DC. 

Centers for Disease Control and Prevention 

and National Institutes of Health. 

Biosafety in Microbiological and 

Biomedical Laboratories. U.S. 

Department of Health and Human 

Services, Fifth Edition, 2007; U.S. 

Government Printing Office, 

Washington, DC, March 31, 2008. 

List of Subjects in 42 CFR Part 71 

Airports, Animals, Communicable 

diseases, Harbors, Imports, Pesticides 

and pests, Public health, Quarantine, 

Reporting and recordkeeping 

requirements. 

For the reasons discussed in the 

preamble, the Centers for Disease 

Control and Prevention amends 42 CFR 

part 71 as follows: 

PART 71—FOREIGN QUARANTINE 

■ 1. The authority citation for 42 CFR 

part 71 continues to read as follows: 

Authority: Sec. 311 of the Public Health 

Service (PHS) Act, as amended (42 U.S.C. 

243), secs. 361–369, PHS Act, as amended 

(42 U.S.C. 264–272). 

■ 2. Revise § 71.53 to read as follows: 

§ 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 diagnostic 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 

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 


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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 AZAaccredited 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 

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 

detained 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; 


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(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 

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 

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, 


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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 NIOSHapproved 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; 

(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 postexposure 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 exposurecontrol 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. 

(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. 


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(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 airconditioning 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: 

(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 doublebagged 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 

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 


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(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 

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 zooto-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 

findings, or laboratory results. Any 

report required under this section must 

include a copy or summary of the 

individual NHP’s health records. 

(n) Recordkeeping and reporting 

requirements for importing NHPs. (1) 

Before authorizing the import of any 

NHPs, an importer must be in 

compliance with all applicable elements 

of the importer’s SOPs. 

(2) At least seven days before 

importing a shipment of NHPs, an 

importer must notify 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; 


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(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; 

(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 

(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 statelicensed 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: 


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(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 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. 

(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) Nonhuman primate importers shall be 

charged a fee for filovirus testing of nonhuman 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. 

Dated: February 6, 2013. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2013–03064 Filed 2–14–13; 8:45 am] 

BILLING CODE 4163–18–P 


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