678 Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 71 

[Docket No. CDC–2011–0001] 

RIN 0920–AA23 

Requirements for Importers of 

Nonhuman Primates 

AGENCY: Centers for Disease Control and 

Prevention (CDC), U.S. Department of 

Health and Human Services (HHS). 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: CDC is proposing to amend its 

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. Filovirus 

testing will continue to be required only 

for Old World NHPs. CDC also is 

proposing to reduce the frequency at 

which importers of cynomolgus, African 

green, and rhesus monkeys are required 

to renew their registrations, (from every 

180 days to every two years). CDC 

proposes to incorporate existing 

guidelines into the regulations and add 

new provisions to address: NHPs 

imported as part of a trained animal act; 

NHPs imported or transferred by 

zoological societies; The transfer of 

NHPs from approved laboratories; and 

Non-live imported NHP products. CDC 

is also proposing that all NHPs be 

imported only through ports of entry 

where a CDC quarantine station is 

located. 

DATES: Submit written or electronic 

comments by March 7, 2011. 

ADDRESSES: Written comments, 

identified by Docket No. xxx, may be 

submitted to the following address: 

Centers for Disease Control and 

Prevention, Division of Global Migration 

and Quarantine, ATTN: NHP Rule 

Comments, 1600 Clifton Road, NE., 

(E03), Atlanta, GA, 30333. Comments 

will be available for public inspection 

Monday through Friday, except for legal 

holidays, from 9 a.m. until 5 p.m., 

Eastern Time, at 1600 Clifton Road, NE., 

Atlanta, GA 30333. Please call ahead to 

1–866–694–4867 and ask for a 

representative in the Division of Global 

Migration and Quarantine (DGMQ) to 

schedule your visit. Comments also may 

be viewed at http://www.cdc.gov/

ncidod/dq. Written comments may be 

submitted electronically via the Internet 

at http://www.regulations.gov or via email to NHPPublicComments@cdc.gov. 

All comments received will be posted 

publicly without change, including any 

personal or proprietary information 

provided. To download an electronic 

version of the rule, access http://www.

regulations.gov. 

Mail written comments on the 

proposed information collection 

requirements to the following address: 

Office of Information and Regulatory 

Affairs, OMB, New Executive Office 

Building, 725 17th Street, NW., rm. 

10235, Washington, DC 20503, Attn: 

Desk Officer for CDC. 

FOR FURTHER INFORMATION CONTACT: 

Ashley A. Marrone, J.D., U.S. 

Department of Health and Human 

Services, Centers for Disease Control 

and Prevention, Division of Global 

Migration and Quarantine, 1600 Clifton 

Road, NE., Mailstop E–03, Atlanta, GA 

30333, Telephone, 404–498–1600. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. What is the risk to human health from 

nonhuman primates? 

B. What is the legal authority for this 

rulemaking? 

C. What is the history of this rulemaking? 

II. Proposed Rule Requirements 

A. What is the scope of this proposed rule? 

B. Does the proposed rule continue the 

general prohibition on importing live 

NHPs? 

C. What new and revised definitions is 

CDC proposing in regard to importers of 

NHPs? 

D. What expanded requirements apply to 

importers of NHPs? 

E. What is a performance-based standard? 

F. What documentation requirements 

apply to importers of NHPs? 

G. What are the requirements for a worker 

protection plan and personal protection 

equipment? 

H. What are the proposed requirements for 

NHP quarantine? 

I. What are the proposed requirements for 

SOPs and equipment for crating, caging, 

and transporting NHPs? 

J. What are the requirements for ground 

transport vehicles? 

K. What are the requirements for 

recordkeeping and reporting? 

L. What are the requirements for animals 

acts; zoo-to-zoo transfers; and lab-to-lab 

transfers? 

M. What are the requirements for in-transit 

shipments of NHPs? 

N. What procedures are being proposed for 

revocation and reinstatement of an 

importer’s registration? 

O. What are the requirements for importing 

NHP products? 

P. Is there an appeal process for a denied 

application to import? 

III. Regulatory Analyses 

A. Economic Analysis 

1. Objectives and Basis for the Action 

2. The Nature of the Impacts 

3. Baseline 

4. Alternatives 

5. Benefits 

6. Costs 

7. Regulatory Flexibility Analysis 

B. Paperwork Reduction Act Analysis 

C. Federalism Impact 

D. Environmental Impact 

E. Unfunded Mandates Reform Act 

F. Executive Order 12988 

IV. References 

List of Subjects 

I. Background 

A. What is the risk to human health 

from nonhuman primates? 

Nonhuman primates (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 their work, 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, and 

parasitic infections (1). A zoonotic 

disease is any infectious agent or 

communicable disease that is able to be 

transmitted from animals, both wild and 

domestic, to humans. A filovirus is a 

virus that can cause severe hemorrhagic 

fever in humans and nonhuman 

primates, such as Ebola virus and 

Marburg virus. Some Macaca 

fascicularis (cynomolgus), Chlorocebus 

aethiops (African green), and Macaca 

mulatta (rhesus) monkeys imported into 

the United States have been infected 

with a filovirus (2). An epidemiologic 

link between hepatitis A infections in 

NHPs, especially chimpanzees, and 

their caretakers has been demonstrated 

(3). Herpes B virus is a zoonotic agent 

that naturally infects only macaque 

monkeys. However, while Herpes B 

virus infection is generally 

asymptomatic or mild in macaque 

monkeys, it can cause fatal 

encephalomyelitis in humans. 

Previously reported cases of herpes B 

virus disease in humans usually have 

been attributed to NHP bites, scratches, 

or percutaneous (through the skin) 

inoculation with infected materials (4). 

NHPs, especially macaques, are highly 

susceptible to tuberculosis, and most are 

imported from areas of the world with 

a high prevalence of tuberculosis in 

humans and NHPs (5). NHPs may also 

be a source of yellow fever virus, which 

can be transmitted to humans by 

mosquitoes that have fed on an infected 


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NHP (6). In fact, transmission of yellow 

fever to humans in NHP research work 

has occurred in this manner (7). NHPs 

imported into the United States from 

foreign countries often have an 

uncertain health history, and may 

potentially harbor diseases infectious to 

humans. 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 the Secretary deems 

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 further 

provides that such regulations may 

provide for the carrying out and 

enforcement of measures to protect 

public health, including inspection and 

destruction of animals or articles found 

to be so infected or contaminated as to 

constitute dangerous sources of 

infection to humans. 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 if death 

of a person has not resulted from the 

violation or up to $250,000 per violation 

if death of a person has resulted from 

the violation [18 U.S.C. 3559, 3571(b)]. 

Organizations may be fined up to 

$200,000 per violation not resulting in 

death and $500,000 per violation 

resulting in death [18 U.S.C. 3559, 

3571(c)]. These penalties are criminal in 

nature and would be imposed by a 

court, and not administratively by HHS 

or CDC. 

C. What is the history of this 

rulemaking? 

CDC regulations regarding the 

importation of NHPs were developed to 

address the risk NHPs pose to humans. 

Since October 10, 1975, CDC, through 

42 CFR 71.53, has prohibited the 

importation of NHPs except for 

scientific, educational, or exhibition 

purposes. For the purpose of importing 

NHPs, CDC has defined scientific and 

educational purposes as those 

conducted at the university level or 

equivalent (e.g. use in breeding colonies 

and the advancement of medicine). 

Exhibition purposes is defined as the 

use of NHPs as part of a public display 

open to the general public during 

routinely scheduled hours in a facility 

that meets or exceeds the accreditation 

standards of the Association of Zoos and 

Aquariums (AZA), or in a comparable 

facility. For example, if an importer or 

facility proposes to exhibit the NHPs for 

one day a month and only to friends and 

family, this would neither meet nor 

exceed AZA accreditation standards and 

therefore the facility would not qualify 

as an importer for exhibition purposes. 

However, if an importer or facility 

proposes to exhibit the NHPs to the 

general public at a zoo during routinely 

scheduled hours, that importer may 

qualify as an importer for exhibition 

purposes. Some institutions may fall 

under more than one category of 

importer. For example, if an established 

zoo applies for a permit to import a live 

NHP for display, it would be considered 

an importer for exhibition purposes. On 

the other hand, if the zoo employs 

researchers and requests a permit so that 

staff can perform behavioral psychology 

studies, for example, it would be 

considered an importer for scientific 

purposes. 

Under this regulation, NHP importers 

are required to register with CDC; this 

registration must be renewed every two 

years. NHPs are required to be held in 

quarantine for at least 31 days following 

entry into the United States. This 

regulation also requires importers to 

maintain records on imported NHPs and 

to immediately report illness suspected 

of being communicable to humans. 

Importers must make their facilities, 

vehicles, equipment, and business 

records used in the importation of NHPs 

available to CDC during operating 

business days and hours, and at other 

‘‘necessary and reasonable times,’’ to 

enable CDC to ascertain compliance 

with the regulations in this section. 

These ‘‘necessary and reasonable times’’ 

may include an outbreak or other threat 

to public health that requires immediate 

and unobstructed access to an 

importer’s facilities. 

Additional requirements for importers 

of NHPs have been developed and 

implemented in response to specific 

public health threats. On January 19, 

1990, in response to the identification of 

Ebola virus (Reston strain) in NHPs 

imported from the Philippines, CDC 

published interim guidelines for 

handling NHPs during transit and also 

during quarantine (2). Importers were 

informed by letter from the Director on 

March 15, 1990, that they must comply 

with specific isolation and quarantine 

standards for continued registration as 

an importer of NHPs under 42 CFR part 

71 (8). 

On March 23, 1990, CDC invited the 

public to comment on new guidelines 

for the importation of NHPs and the 

potential impact of a temporary ban on 

the importation of cynomolgus monkeys 

into the United States (9). After 

considering information received at this 

public meeting, coupled with an April 

4, 1990, confirmation of asymptomatic 

Ebola virus infection in four NHP 

caretakers and serologic findings 

suggesting that cynomolgus, African 

green, and rhesus monkeys posed a risk 

for human filovirus infection, CDC 

concluded that these three species were 

capable of being an animal host or 

vector of human disease (10). 

On April 20, 1990, CDC published a 

notice in the Federal Register requiring 

a special permit for importing 

cynomolgus, African green, and rhesus 

monkeys (11). To be granted a special 

permit, importers must submit a plan to 

CDC describing specific isolation, 

quarantine, and communicable disease 

control measures. The plan must detail 

the 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. Additional requirements include 

detailed testing procedures for all 

quarantined NHPs to rule out the 

possibility of filovirus infection. When 

importers demonstrate compliance with 

these special-permit requirements, CDC 

authorizes continued shipments under 

the same permit for a period of 180 

days. Certain components of the specialpermit requirement have changed 

slightly in response to surveillance 

findings and the development of 

improved laboratory tests. As indicated 

in the 1990 notice, importers were 

informed of these changes by letter from 

CDC (12). The current special-permit 

notice requires filovirus antigen testing 

on specimens from any NHP that dies 

during quarantine for reasons other than 

trauma. Antibody testing is also 


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required on surviving NHPs that exhibit 

signs of possible filovirus infection 

before the cohort is released from 

quarantine (13). 

On July 30, 1993, CDC published 

guidelines in the Morbidity and 

Mortality Weekly Report (MMWR) for 

tuberculosis testing requirements for 

NHPs, following the recognition of 

tuberculosis in up to 2% of imported 

NHPs and the risk for infection posed to 

caretakers (5). These published 

guidelines include provisions for 

recordkeeping to track and trace 

nonhuman primates and use of personal 

protective equipment by NHP handlers 

to prevent transmission of tuberculosis 

(5). Since publication of the guidelines 

in the MMWR, importers have 

submitted a minimum of three negative 

tuberculin skin tests (TSTs) 

administered at two-week intervals on 

each imported NHP, before CDC has 

agreed to release of any NHPs from 

quarantine. 

II. Proposed Rule Requirements 

A. What is the scope of this proposed 

rule? 

This proposed rule 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. 

Importers must make their facilities, 

vehicles, equipment, and business 

records used in the importation of NHPs 

available to CDC for inspection during 

operating business days and hours, and 

at other necessary and reasonable times, 

to enable CDC to ascertain compliance 

with these regulations. Nothing in this 

proposal supersedes or preempts 

enforcement of emergency response 

requirements imposed by statutes or 

other regulations. 

B. Does the proposed rule continue the 

general prohibition on importing live 

NHPs except for science, education, or 

exhibition purposes? 

Yes, it does. In § 71.53(d), CDC would 

continue the long-standing general 

prohibition in the current regulation on 

importing live NHPs except for science, 

education, or exhibition purposes. This 

prohibition extends to the importation 

of non-human primates intended for use 

as service animals. On July 23, 2010, 

Attorney General Eric Holder signed 

final regulations revising U.S. 

Department of Justice regulations under 

the Americans with Disabilities Act 

(ADA), which included a revised 

definition of ‘‘service animal.’’ Effective 

February, 2011, these regulations limit 

the definition of service animals to dogs. 

Other species of animals, whether wild 

or domestic, trained or untrained, are 

not service animals for the purposes of 

this definition. CDC has carefully 

considered the potential risks associated 

with the use of imported nonhuman 

primates as service animals and agrees 

with the position of the U.S. Department 

of Justice that nonhuman primates 

should not be recognized as service 

animals because of their potential for 

disease transmission and unpredictable 

aggressive behavior. 

C. What new and revised definitions is 

CDC proposing in regard to importers of 

NHPs? 

In this NPRM, CDC has developed a 

list of definitions specific to modern 

importation principles and practices for 

NHPs. These definitions either do not 

appear in the current 42 CFR 71.53, or 

have been revised, and are intended to 

add clarity to the provisions regulating 

the importation of NHPs. CDC is 

soliciting public comment on these 

definitions. Of particular importance to 

this proposal are the definitions for 

animal act, breeding colony, broker, 

cohort, importer, in transit, lab or 

laboratory, medical consultant, 

offspring, Old World NHP, permitted 

purpose, quarantine facility, quarantine 

room, trophy, zoo, and zoonotic disease. 

D. What expanded requirements apply 

to importers of NHPs? 

CDC is proposing to expand the 

isolation, quarantine, and worker 

protection requirements, as well as the 

registration process, currently described 

in the special-permit requirements for 

cynomolgus, African green, and rhesus 

monkeys to all importations of NHPs. 

The proposed changes will simplify 

importer registration procedures by 

eliminating the need for a separate 

category of importer that must request 

special permits (those that import 

cynomolgus macaques, Rhesus 

macaques, and African green monkeys). 

The proposed changes will also provide 

an enhanced measure of worker and 

NHP safety against known and emerging 

zoonotic diseases. Under proposed 

provision (g)(1), to register as an 

importer, an individual must submit to 

CDC a completed application form, a 

completed statement of intent 

describing the number and types of 

NHPs intended for import during the 

registration period, a copy of all written 

Standard Operating Procedures (as 

specified in the NPRM), a copy of any 

current registrations, licenses, and/or 

permits that may be required from the 

U.S. Department of Agriculture and U.S. 

Fish and Wildlife Service, and 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 

these regulations. Upon receiving the 

above application and documentation 

required (as proposed in section (g)(2)), 

CDC will review the application and 

grant or deny the application for 

registration as an importer. The 

timeframe between acceptance of the 

application, and either approval or 

denial, will generally be 30 to 60 

calendar days, during which time CDC 

may consult with the applicant 

regarding any element of the application 

or accompanying documentation. 

E. What is a performance-based 

standard? 

A performance-based standard states 

goals and objectives to be achieved and 

describes methods that can be used to 

demonstrate whether or not processes, 

products, and services meet the 

specified goals and objectives. In 

contrast, a prescriptive standard 

typically prescribes materials, design 

and construction methods without 

stating goals and objectives. A 

performance-based standard focuses on 

desired characteristics of the final 

product, service, or activity rather than 

requirements for the processes to 

produce it. Performance-based 

standards allow users flexibility in 

choosing materials (such as which 

products to use for disinfection), design 

(such as the use of squeeze-back cages 

for controlling animals), and services 

(such as the use of off-site, contractual 

occupational health services for 

workers). An example of a performancebased standard is the Occupational 

Safety and Health Administration’s 

Hazard Communication Standard (HCS), 

29 CFR 1910.1200. CDC proposes to 

primarily use a performance-based 

standard in reviewing and approving 

applications for individuals to become 

registered importers of NHPs into the 

United States and is soliciting public 

comments on this approach. 

F. What documentation requirements 

apply to importers of NHPs? 

The utility of the special permit 

requirements in quickly detecting and 

controlling filovirus was illustrated by 

the early and effective detection of 

Ebola virus in imported cynomolgus 

monkeys in 1996. The special permit 

and other disease control requirements 

were effective in promptly identifying 

the filovirus infection, minimizing NHP 

exposure, and preventing spread of the 

infection beyond the room housing the 

original infected NHP (14). For these 

reasons, CDC is also proposing that 

filovirus testing be expanded to include 


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all Old World NHPs (as defined in 

proposed provision (c)(2)) in quarantine 

that have illness consistent with 

filovirus or that die for any reason other 

than trauma. The proposed changes 

would allow for surveillance of filovirus 

infection in other Old World primates, 

such as chimpanzees, gorillas, baboons, 

drills, and mandrills, which are known 

to be susceptible to infection but are not 

addressed by the current special permit 

requirements (unpublished data, CDC; 

15–18). 

Consistent with the current special 

permit requirements, under proposed 

provision (h), an importer of NHPs must 

have a written policy that imported 

NHPs and their offspring will only be 

used and distributed for permitted 

purposes, as defined in proposed 

subsection (a), and document the 

intended purpose for the imported 

NHPs. An importer must also retain 

records documenting the identity of any 

recipients, the number of NHPs in each 

shipment or sale, and the dates of each 

shipment or sale. An importer must 

keep written certifications 

demonstrating that the NHPs and any 

offspring will continue to be used for 

permitted purposes. CDC is proposing to 

require the importer to maintain such 

documentation to ensure that these 

NHPs are not diverted into the pet trade 

and subsequently place individuals at 

risk of contracting zoonotic diseases. 

This record retention requirement 

would apply to any transfer of the NHP 

from the quarantine facility and any 

subsequent transfers. CDC is soliciting 

public comment on the proposed record 

retention requirement to learn whether 

the burden to importers outweighs the 

benefit to public health. Specifically, 

CDC is soliciting comment on how long 

records should be maintained by the 

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

the NHP. 

Proposed subparagraph (h) also 

proposes to require the importer to 

maintain these records in an organized 

manner and either electronically or in a 

central location, at or in close proximity 

to the NHP facility, to allow CDC to 

inspect the records during CDC site 

visits during regular business hours or 

within one hour of such visits. Before 

distributing or transferring an imported 

NHP, an importer must communicate to 

the recipients of NHPs, in writing, the 

restrictions and definitions of permitted 

purposes and obtain written 

certifications from the intended 

recipient that the NHPs will be used and 

distributed for one of the permitted 

purposes before the NHPs are sent to 

them. CDC is soliciting public 

comments on these proposed 

requirements. 

G. What are the requirements for a 

worker protection plan and personal 

protection equipment? 

In accordance with good public health 

practice, HHS/CDC recommends that all 

workers who are at high risk of exposure 

to NHPs be current on routine 

vaccinations including but not limited 

to Hepatitis B, tetanus, and measles 

vaccines. As part of the NPRM, in 

provision (i), CDC is proposing to 

require that importers have a written 

worker protection plan for anyone 

whose duties may result in exposure to 

NHPs. The proposed protection plan is 

designed to ensure that individuals who 

work in close proximity to NHPs are 

educated on the risks and protected 

from exposure to zoonotic diseases. For 

the purposes of enforcement of this 

provision CDC considers ‘‘exposure’’ to 

be a well-understood term in the NHP 

importing community, generally 

meaning in direct contact or sufficiently 

close proximity to a NHP (≤ 5 feet) that 

NHP bodily fluids could be transferred 

between the NHP and the worker. 

‘‘Exposure’’ also refers to worker 

exposure to respiratory pathogens (e.g., 

Mycobacterium tuberculosis) for 

workers in proximity to a NHP (≤ 5 feet). 

However, CDC is soliciting public 

comment on provisions which use this 

term and welcomes input on ways 

which may add clarification to its 

meaning. Using the performance-based 

standard described above, CDC will 

evaluate the importer’s worker 

protection plan and determine whether 

the proposed worker protection program 

is sufficient to protect workers from 

exposure to zoonotic diseases. 

Under proposed subsection (i) an 

importer must contact CDC immediately 

by telephone to report any instance of 

a worker contracting a potential 

zoonotic disease, and must include 

specific instructions for contacting CDC 

in its worker protection plan. Also 

included in the worker protection plan 

must be procedures to protect and train 

transport workers from exposures to 

communicable disease; hazard 

evaluation and worker communication 

procedures; personal protective 

equipment (PPE) requirements; 

tuberculosis requirements; if applicable, 

SOPs that adhere to requirements 

relating to macaques as described in 

paragraph (i)(7); an infection-prevention 

program; SOPs that include 

requirements for preventing workplace 

infection from potentially contaminated 

needles or other sharp instruments; 

SOPs requiring that used disposable 

sharp items are placed in punctureresistant containers kept as close to the 

work site as practical; SOPs requiring 

that removed, disposable PPE be 

disposed of as biohazardous waste; and 

that nondisposable clothing worn in the 

quarantine facility be disinfected on site 

before laundering. CDC is soliciting 

public comments on these provisions. 

To further ensure worker safety from 

communicable disease, subsection (i) 

also includes certain specific postexposure requirements to be included in 

the worker protection plan, such as 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. 

The worker protection plan also 

places requirements upon the importer 

to provide exposed workers with direct 

and rapid access to a medical 

consultant, and to document the 

frequency of worker training and 

education on potential risks of exposure 

to NHPs. CDC is specifically soliciting 

comment on the appropriate frequency 

of such worker training and education 

programs. As part of the worker 

protection plan described in proposed 

subparagraph (i), an importer must 

establish, implement, and maintain 

hazard evaluation and worker 

communication procedures. Such 

procedures for employees working in 

the quarantine facility shall include the 

following: a description of the known 

zoonotic disease and injury hazards of 

handling NHPs; the need for PPE in 

handling NHPs and training in proper 

use of PPE, including re-training and 

reinforcement of appropriate use; 

procedures for monitoring workers for 

signs of zoonotic illness; and procedures 

for disinfection of garments, supplies, 

equipment, and waste (1–5, 7, 10, 11, 

14, 19–21). 

As part of the worker protection plan 

described in this subsection (i), an 

importer must identify the PPE required 

for each task or working. Proposed 

§ 71.53(i)(5) describes requirements in 

the worker protection plans for PPE, 

including face shields or eye protection 

and respiratory protection (such as N95, 

or powered air-purifying respirator 

(PAPR)) that is compliant with OSHA 

29 CFR § 1910.134 which requires a 

respiratory protection program. Face 

shields are important for preventing 

droplet splashes to the head from 

running down into the eyes and 

preventing mucous membrane exposure 

around the edges (sides, top, and bottom 

to below the chin). 

For tuberculosis protection, CDC is 

proposing that an importer be required 

to ensure that workers in a facility 

housing NHPs have a baseline 

tuberculosis test prior to beginning work 


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with NHPs and, at least annually, a 

tuberculosis skin test. Tuberculosis is an 

illness which can potentially be 

transmitted either from NHP to human, 

or from human to NHP. The purpose of 

this requirement is to protect the NHPs 

from exposure to tuberculosis from the 

workers as well as to monitor potential 

exposure of the workers to tuberculosis 

from the NHPs. A baseline tuberculosis 

test is typically conducted before the 

employee begins working with NHPs to 

ensure that the employee does not 

already have active or latent 

tuberculosis. A Mantoux tuberculosis 

skin test is the most common diagnostic 

test used for humans to detect 

tuberculosis exposure. 

Proposed § 71.53(i)(3)(xii) describes 

herpes B virus post-exposure 

procedures that would be required as 

part of worker protection plans for 

registered importers who import 

macaques. For protection against herpes 

B virus, CDC is proposing in this 

subsection that an importer must 

develop, implement, and adhere to a 

written PPE program to prevent herpes 

B virus transmission. 

CDC is also proposing to require that 

the worker protection program include 

a thorough hazard assessment of all 

work procedures, potential routes of 

exposure (e.g., bites, scratches, or 

mucosal exposures), and potential 

adverse health outcomes. Workers must 

also be assured prompt and direct 

access to a medical consultant, defined 

in the proposed rule as an occupational 

health physician, physician’s assistant 

or a registered nurse, who is 

knowledgeable about the risks to human 

health associated with NHPs. The 

medical consultant in this proposed 

provision may either be an employee of 

the quarantine facility or a contractor, 

but must be readily available and aware 

of the potential zoonotic risks involved 

in working with NHPs. CDC is seeking 

comment on this proposed requirement. 

Additionally, CDC is proposing to 

require all importers to maintain 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 been exposed 

to NHPs in transit or in quarantine. CDC 

is proposing to require that the record 

of febrile illnesses be kept indefinitely 

by the importer as part of the worker’s 

medical records, and is soliciting public 

comment on whether this requirement 

would pose an undue burden upon the 

importer as to outweigh the benefit to 

public health and the health of the 

individual. 

If macaques are being imported under 

this provision, the proposed worker 

protection requirements would also 

include provisions related to exposure 

to herpes B virus (Cercopithecine 

herpesvirus) because of the unique risk 

of herpes B virus transmission 

associated with macaques. Most cases of 

herpes B virus disease in humans have 

been attributed to NHP bites, scratches, 

or percutaneous inoculation with 

infected materials. However, a report of 

a fatal case of herpes B virus infection 

caused by mucosal splash exposure 

occurred in 1998, lead to the 

development of CDC recommendations 

in 1999 for preventing and treating 

herpes B virus exposure (19). 

In addition to complying with the 

proposed requirements of this section, 

an importer must continue to comply 

with all relevant Federal and State 

requirements relating to occupational 

health and safety. CDC is soliciting 

public comment on these additional 

proposed requirements. 

H. What are the proposed requirements 

for NHP quarantine? 

The proposed requirements state that 

importers must quarantine all NHPs for 

at least 31 days after arrival at a 

quarantine facility in the U.S. This time 

period may be extended in the event 

that the NHPs are infected with certain 

communicable diseases (such as 

tuberculosis, shigella, measles, 

campylobacter), the importer or CDC 

suspect a NHP may be infected with 

certain communicable diseases, or if the 

importer or CDC determines that there 

is a need for additional diagnostic 

testing. The NHP will remain in 

quarantine until the CDC determines 

that it no longer poses a threat to human 

health. These requirements minimize 

the risk to persons exposed to imported 

NHPs by preventing an infected NHP 

from premature release from quarantine. 

The proposed rule directly addresses 

the two major reasons for quarantining 

recently imported NHPs. The first major 

reason is to provide the earliest 

recognition of the importation of a 

zoonotic disease with potential public 

health importance. The second is to 

prevent transmitting infectious agents 

between NHPs or from NHPs to humans. 

The proposed procedures and standards 

contained in § 71.53(l) are essential to 

minimize the risk of transmitting 

infectious agents between NHPs and 

from NHPs to humans in quarantine 

facilities. CDC has based these 

procedures and standards on National 

Research Council (NRC) guidelines, 

CDC biosafety guidelines, current 

knowledge of infectious agent 

transmission routes and, experience 

gained from investigating filovirus 

infection outbreaks (14, 22). These 

requirements are in addition to U.S. 

Department of Agriculture (USDA) 

regulations in 9 CFR parts 1 through 3 

on Animal Welfare, and Fish and 

Wildlife Service regulations in 50 CFR 

part 14 on Importation, Exportation, and 

Transportation of Wildlife. Section 

71.53(l)(1)(ii) requires the use of 

commonly accepted industry standards 

for the design and operation of animal 

holding facilities and the care and use 

of laboratory animals. Examples of 

minimum acceptable industry standards 

include those found in the current 

editions of NRC’s ‘‘Guide for the Care 

and Use of Laboratory Animals’’ (20) 

and the CDC/NIH’s ‘‘Biosafety in 

Microbiological and Biomedical 

Laboratories’’ (21). 

We have written the proposed facility 

and procedural requirements to apply to 

all NHP importers. We intend these 

requirements to protect NHPs, facility 

workers, and others from a variety of 

potential pathogens and to be adaptable 

to changing needs. We would further 

require importers to incorporate the 

essential features of each applicable 

proposed requirement into written 

policies and procedures for employees. 

Proposed § 71.53(g)(1) requires an 

importer to establish, implement, and 

maintain documentation and standard 

operating procedures (SOPs) associated 

with the importation of NHPs, and 

proposed § 71.53(b)(3) requires the 

importer to make the records available 

to CDC for inspection during the life of 

the NHP, so that we may ascertain 

compliance with the regulations. To 

facilitate inspection, records should be 

maintained electronically or in a 

location in close proximity to the 

quarantine facility and in an organized 

manner. CDC is specifically soliciting 

comment on these proposed recordkeeping requirements. 

Proposed § 71.53(i) and § 71.53(l) 

address routine veterinary medical care 

and screening for zoonotic diseases of 

NHPs in quarantine and management of 

illnesses and deaths of unknown 

etiology. Appropriate screening or 

diagnostic tests may differ by species, 

country of origin, clinical presentation 

of ill NHPs, and necropsy findings. 

Therefore, in these regulations, it is 

proposed that importers be required to 

maintain direct and immediate access to 

both a veterinarian experienced in the 

care of NHPs and a qualified (i.e., 

licensed or certified) laboratory. CDC is 

soliciting public comments on this 

provision. Specifically, we hope to 

obtain 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 factors constitute a 

‘‘qualified’’ laboratory. This provision 


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also proposes to require that importers 

maintain written protocols for the 

evaluation and diagnostic testing of 

suspect cases of zoonotic disease in 

NHPs. At a minimum, an importer’s 

written protocols must include 

diagnostic testing for the infectious 

agents for which reporting is required 

under these regulations and a plan for 

evaluating unusually high morbidity or 

mortality rates in a shipment of NHPs. 

Proposed section 71.53(l)(1) of the 

quarantine requirements addresses 

monitoring and testing NHPs for 

tuberculosis (TB). In July 1993, CDC 

published in the MMWR a review of TB 

in imported NHPs over a three-year 

period (5). Because TB in captive NHPs 

is both an animal and a human health 

problem, NHP importers routinely 

provide a tuberculin skin test (TST) for 

NHPs and workers. According to the 

MMWR, an importer must consider any 

NHP with a positive TST during import 

quarantine as infectious and as 

representing a high risk for disease 

transmission. Therefore, when an 

importer identifies a quarantined NHP 

as TST-positive, the standard practice 

according to the MMWR 

recommendation is to euthanize the 

NHP, attempt laboratory confirmation of 

TB, and reinstitute tuberculin skin 

testing of all other exposed NHPs at 

two-week intervals, with quarantine 

until five consecutive negative TSTs are 

completed in the quarantined NHPs. 

CDC considers all NHPs to be 

susceptible to TB; virtually all are 

imported from areas of the world with 

high prevalence of TB in humans and 

NHPs. Close confinement of these and 

other NHPs in holding facilities 

(including quarantine) and shipping 

crates fosters conditions where one 

infected NHP might infect many others. 

Therefore, each NHP in a cohort in 

quarantine must complete negative 

TSTs before any are released. 

Because there is the potential for 

transmitting TB and other pathogens 

among NHPs and humans, improved 

surveillance and testing procedures are 

essential in NHP quarantine and 

research facility settings. Paragraphs 

§ 71.53(i)(6) and (l)(2) of the proposed 

rule include worker protection and 

quarantine requirements regarding TB. 

Proposed § 71.53(l)(2)(ix) requires an 

importer to conduct three TSTs, with at 

least two weeks between tests, before 

releasing NHPs from import quarantine. 

If any NHP in the cohort has a positive 

or suspicious TST reaction (as defined 

by Institute of Laboratory Animal 

Resources [ILAR] standards [25]), the 

importer must keep the cohort in 

quarantine and must administer at least 

five additional TSTs following removal 

of the last affected NHP. Proposed 

§ 71.53(l)(5)(iv) provides that for any 

necropsy of an NHP dying during 

quarantine, the importer must ensure 

that the necropsy is performed under 

biosafety level 3 (BSL3) or biosafety 

level 2 (BSL2) with enhanced protective 

equipment and procedures to protect 

against exposure to highly infectious 

agents. 

Proposed § 71.53(m)(6) requires an 

importer to report to CDC within 48 

hours any positive or suspicious TST 

results, necropsy findings, or laboratory 

results. 

I. What are the proposed requirements 

for SOPs and equipment for crating, 

caging, and transporting NHPs? 

In this proposed provision, the 

importer bears responsibility for 

ensuring that all infection control 

measures are in place throughout the 

transportation of the cohort, not just 

after the NHPs reach a licensed 

quarantine facility in the United States. 

Physical custody of NHPs may be 

transferred several times during 

transportation (e.g., from exporter to 

airline to importer). However, because 

the registered importer selects the 

supplier at the country of origin and 

arranges for transportation to the United 

States, CDC expects the importer to 

exert control over the conditions under 

which the NHPs are shipped. CDC 

considers this provision to be part of the 

performance-based approach and the 

intent is for CDC to work with the 

importer to identify procedures that are 

effective in preventing communicable 

disease spread. Proposed § 71.53(j) 

outlines the requirements that the 

importer must meet, either directly or 

by contractual or other arrangement, to 

ensure safe handling of NHPs during 

transportation. In the combined 

proposed requirements for crating, 

caging, and transporting, we emphasize 

the infection control-related aspects of 

shipping NHPs, including procedures to 

prevent contamination of other articles 

and cargo during transportation, to 

provide physical separation of crates 

from other cargo, and to decontaminate 

aircraft, ships, vehicles, and related 

equipment following transport. An 

importer must meet these requirements 

in combination with all applicable 

sections of other Federal and 

international regulations and guidelines, 

such as the International Air Transport 

Association ‘‘Live Animal Regulations,’’ 

which have been adopted by U.S. Fish 

and Wildlife Service (23) and the World 

Health Organization’s ‘‘Transport of 

Infectious Substances’’ (24). Certain 

procedures such as planeside transfers 

and expedited clearances may require 

oversight and/or inspection by CDC to 

ensure implementation of CDC’s 

requirements and guidelines. Therefore, 

in § 71.53(f), CDC proposes to restrict 

entry of NHPs into the United States to 

those ports of entry where CDC 

quarantine stations are located, except 

in limited circumstances approved in 

advance by CDC. These circumstances 

may include situations involving 

ground transport across the U.S. border 

and charter aircraft transport arriving 

through airports that do not have 

quarantine stations. CDC is working 

with the stations to enhance the training 

and response capability of the staff. The 

CDC quarantine stations operational at 

ports of entry and border crossings are 

currently listed at: http://www.cdc.gov/ 

ncidod/dq/quarantine_stations.htm. 

This listing will be updated if more 

stations are added in the future. 

J. What are the requirements for ground 

transport vehicles? 

When a shipment of NHPs arrive at a 

U.S. port of entry via aircraft, special 

vehicles must be used to transport the 

NHPs safely to a quarantine facility and 

ensure that these pre-quarantined NHPs 

do not pose a risk to human health. 

Likewise, a specialized ground 

transportation vehicle should be used 

when a shipment of NHPs enters the 

U.S. via a land border crossing, destined 

for a quarantine facility. To ensure 

vehicles contain proper safeguards, in 

proposed subparagraph (k), CDC is 

proposing that an importer be required 

to establish, implement, maintain, and 

adhere to SOPs for ground transport 

vehicles transporting NHPs. CDC is 

soliciting public comments on these 

proposed requirements. 

K. What are the health reporting 

requirements for NHPs? 

Under proposed § 71.53(m), an 

importer would have to ensure that CDC 

is notified of the occurrence of any of 

six events listed in the paragraph. An 

importer must report to CDC within 24 

hours of discovering the severe illness 

or death of NHPs in a quarantine 

facility; an illness in an NHP that the 

importer reasonably suspects is yellow 

fever, monkey pox, or filovirus disease; 

or of an NHP testing positively for 

filovirus virus antigen or antibody. An 

importer must report to CDC within 48 

hours, any positive or suspicious 

tuberculin skin test results, necropsy 

findings, or laboratory results. These 

reports may be by telephone. 

An importer must report promptly to 

CDC if the mortality for a shipment 

exceeds 5 percent. The period runs from 

the time of embarkation from the 

country of origin to the release of the 


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shipment’s animals from quarantine. 

The report must include the cause of 

death of each NHP. This report may be 

by telephone. Finally, the importer must 

ensure that CDC receives a written 

report from the quarantine facility’s 

licensed veterinarian of the health status 

of a shipment after the quarantine 

period is complete, but before the 

importer releases any NHP, cohort, or 

mixed cohort. 

Any report CDC requires in this 

section must include a copy or summary 

of the individual NHP’s health records. 

L. What are the requirements for 

recordkeeping and reporting? 

In addition to the NHP health 

reporting requirements in § 71.53(m), 

CDC proposes 19 general reporting and 

recordkeeping requirements in 

§ 71.53(n), with which the importer 

must comply in writing at least 7 days 

before it imports a shipment of NHPs. 

Among these requirements is supplying 

information that will help authorities 

identify named individuals, businesses, 

shippers, and carriers importing NHPs 

who are responsible for the NHPs at 

every leg of the transportation process 

from the time a shipment leaves the 

country of origin to the time the animals 

arrive at a licensed quarantine facility. 

CDC also will require importers to 

provide information to identify the 

specific vehicles or aircraft used to 

transport these animals, the quarantine 

facility for which the animals are 

destined, methods of identifying 

individual NHPs, and similar 

information. CDC is soliciting comment 

on these proposed requirements. 

M. What are the requirements for 

animal acts; zoo-to-zoo transfers; and 

lab-to-lab transfers? 

Under proposed § 71.53(o)(1), an 

importer must register with CDC all 

foreign-based animal acts that include a 

NHP. This provision would require the 

importer to provide information and 

documentation to help identify the 

individual animal and to describe the 

conditions under which the NHPs are 

housed in the United States. Other 

requirements include documentation 

signed by a licensed veterinarian 

attesting to the results of physical 

examinations of NHPs. The exams must 

address routine elements and tests for 

conditions specified in the regulations. 

Under proposed § 71.53(o)(2), an 

importer must meet specified 

requirements for U.S.-based animal acts 

containing NHPs when the animal reenters the United States after export. 

The requirements in § 71.53(o) are in 

addition to those documentation 

requirements in proposed § 71.53(g). 

For those NHPs entering the U.S. 

under the zoo-to-zoo and laboratory-tolaboratory transfers exception, proposed 

§ 71.53(p) and (q) require the recipient 

zoo or laboratory within the United 

States to submit veterinary medical 

records documenting a NHP’s current 

and past health history. To qualify for 

these exemptions, both the recipient 

and transferring zoos must be accredited 

by the Association of Zoos and 

Aquariums (AZA) (or equivalent if 

outside of the U.S.) and the labs or 

laboratories must both be accredited by 

the Association for Assessment and 

Accreditation of Laboratory Animal 

Care International (AAALAC) or 

licensed by USDA. In addition to the 

requirement itself, CDC is soliciting 

public comment on these provisions to 

ascertain what standards or factors 

should be considered in reaching the 

determination that a zoo located outside 

of the U.S. is ‘‘equivalent’’ to an AZA 

accredited facility for it to qualify for an 

exemption under this provision. 

Further, § 71.53(q) is available only to 

those NHPs from a lab that has both a 

foreign-based and United States-based 

facility and that are part of an ongoing, 

institutionally approved research 

project. Adequate justification must also 

be provided to CDC describing the 

reason a transfer to a U.S. laboratory is 

necessary (e.g., diagnostic equipment 

only available in the U.S.-based 

laboratory). 

N. What are the requirements for intransit shipments of NHPs? 

Under § 71.53(r), CDC is proposing to 

add requirements for brokers in the 

U.S. regarding the handling of in transit 

shipments of NHPs that have a layover 

or are detained or delayed at a U.S. 

airport. Because there is the potential 

for human exposure or other cargo 

contamination from NHPs with diseases 

of public health concern 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 71.53(j) and 

71.53(k) of this section. CDC is soliciting 

comment on these new proposed 

requirements for brokers. 

O. What procedures are being proposed 

for revocation and reinstatement of an 

importer’s registration? 

Under § 71.53(s), CDC is proposing 

new procedures for revocation and 

reinstatement of an importer’s 

registration. Under these procedures, a 

registration may be revoked upon notice 

to the importer if the Director 

determines that the importer has failed 

to comply with any of the applicable 

provisions of this section. The importer 

may request a written record review by 

the Director by filing a response within 

20 calendar days of receiving our notice. 

The Director will review the written 

record and issue a decision in writing to 

affirm the revocation or reinstate the 

importer’s registration. As a condition of 

reinstating the registration, the Director 

may require inspection of facilities, 

examination of records, and other 

assurances of compliance with CDC’s 

requirements. The Director’s written 

decision shall constitute final agency 

action. 

P. What are the requirements for 

importing NHP products? 

Because of the risk to human health 

of untreated NHP products such as 

carcasses, trophies, blood, and other 

biological samples, CDC is also adding 

a permit requirement under proposed 

§ 71.53(t) for importing these products. 

Under this provision, a permit is not 

required if the product has been 

rendered non-infectious by one of the 

approved methods. HHS/CDC has 

selected this prescribed manner of 

rendering a product non-infectious 

because it has proven to be efficient and 

effective in protecting public health. 

However, a permit will be required if 

the product is untreated. An untreated 

product without an accompanying 

permit will be considered a potential 

health hazard and may be seized for 

destruction upon arrival at the port of 

entry. This permit requirement applies 

to individuals importing trophies for 

their own personal use as well as 

businesses importing trophies for a 

commercial purpose, with the intent to 

resell to the public. 

Q. Is there an appeal process for a 

denied application to import? 

Yes. HHS/CDC proposes new 

subsection (u) to provide importers with 

an opportunity for a written appeal in 

the event that the Director denies a 

request for a permit to import a NHP for 

bona fide scientific, exhibition, or 

educational purposes, NHP products 

that have been rendered noninfectious, 

or an application to become an 

importer. Under the proposal, a person 

who wishes to make such an appeal 

would have two business days after 

receiving the denial to submit the 

appeal. CDC would issue a written 

response, which would constitute final 

Agency action. HHS/CDC invites 

comments on this process. 


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III. Regulatory Analyses 

A. Economic Analysis 

CDC has examined the impacts of the 

proposed rule under Executive Order 

12866, the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits, 

including potential economic, 

environmental, public health and safety, 

and other advantages, distributive 

impacts, and equity. Unless we certify 

that the rule is not expected to have a 

significant economic impact on a 

substantial number of small entities, the 

Regulatory Flexibility Act, as amended 

by the Small Business Regulatory 

Enforcement Fairness Act (SBREFA), 

requires agencies to analyze regulatory 

options that would minimize any 

significant economic impact of a rule on 

small entities. Section 202 of UMRA 

requires that agencies prepare a written 

statement of anticipated costs and 

benefits before proposing any rule that 

may result in expenditure by State, 

local, and Tribal governments in the 

aggregate or by the private sector of 

$100 million in any one year (adjusted 

annually for inflation). CDC has 

analyzed the rule and has determined 

that it is consistent with the principles 

set forth in the Executive Order and 

these statutes. 

This proposed rule is not a significant 

regulatory action as defined by the 

Executive Order. This regulatory action 

is not a major rule under the 

Congressional Review Act. In our 

screening analysis under the Regulatory 

Flexibility Act, CDC also concludes that 

the rule will not have a significant 

economic impact on a substantial 

number of small entities. UMRA does 

not require CDC to prepare a statement 

of costs and benefits for this proposed 

rule because we do not expect the rule 

to result in any one-year expenditure 

that would exceed $100 million 

adjusted for inflation. 

1. Objectives and Basis for the Action 

Our principal objectives in this 

proposed rule are to consolidate and 

codify requirements for infection 

control and worker safety procedures to 

prevent transmitting pathogens from 

NHPs to humans. The proposed 

requirements for developing an 

operating plan and SOPs will ensure 

that facility-specific documents 

outlining quarantine and other 

operations, personnel training, and 

worker health programs are in place 

before NHPs are imported into the 

United States. 

2. The Nature of the Impacts 

The proposed rule would consolidate 

CDC’s import requirements into one 

regulatory section thus easing the 

burden on importers. The rule would 

expand the requirements for importing 

cynomolgus, rhesus, and African green 

monkeys to all NHPs, with the 

exception of filovirus testing, which 

would be required only for Old World 

NHPs, but allow importers of those 

three species to renew their registrations 

every two years, rather than every 180 

days. CDC proposes to incorporate into 

the rule, our interim NHP guidelines, 

requirements for NHP imports as part of 

a circus or trained animal act or a zooto-zoo or laboratory-to-laboratory 

transfer, as well as restrictions on which 

ports of entry an NHP may be imported 

into the United States. 

3. Baseline 

Economic analysis of a regulatory 

action requires as a first step identifying 

a baseline, which is a depiction of the 

world in the absence of any action. CDC 

uses this baseline to calculate the effects 

of new regulation. In this action, CDC 

proposes to codify guidelines, 

registration requirements, notices, and 

permitting procedures that have been in 

effect since 1990. In January 1990, CDC 

published interim guidelines for 

handling NHPs during transit and 

quarantine (2). In March 1990, CDC 

notified all importers that that their 

compliance was required with the 

transit, isolation, and quarantine 

standards for continued registration and 

that CDC would subject registered 

importers to unannounced inspections 

of quarantine facilities. In April 1990, 

CDC implemented a special permitting 

procedure for importing cynomolgus, 

African green, and rhesus monkeys (9). 

These administrative requirements 

differ only slightly from the 

requirements CDC proposes today; the 

proposed rule merely formalizes, 

clarifies, and makes minor changes in 

existing administrative requirements. 

Therefore, the proposed rule has little 

impact on costs and benefits relative to 

the baseline of existing practices. In this 

analysis, CDC estimates incremental 

costs and benefits relative to that 

baseline, and also provides background 

on the health benefits that motivated the 

administrative actions taken in 1990. 

In general, CDC intends that the 

proposed rule will preserve the health 

benefits of current practices, while 

reducing some costs for the regulated 

community. Specifically, the proposed 

rule would reduce costs in two ways. 

First, CDC proposes to reduce the 

frequency of registration renewal for 

importers of cynomolgus, rhesus, and 

African green monkeys from every 180 

days to every 2 years, consistent with 

registration requirements for importers 

of other NHPs. This change would 

reduce administrative cost burdens for 

importers of cynomolgus, rhesus, and 

African green monkeys. 

Second, CDC proposes to eliminate 

the 31-day quarantine requirement for 

transfers of NHPs into the United States 

between accredited zoos, such as those 

accredited by the Association of Zoos 

and Aquariums (AZA) (or its equivalent) 

(i.e., ‘‘zoo-to-zoo transfers’’), and 

transfers of those NHPs from 

laboratories that are accredited by the 

Association for Assessment and 

Accreditation of Laboratory Animal 

Care International (AAALAC) (or its 

equivalent) that have a foreign based 

and a United States based facility and 

the NHP is part of an ongoing research 

project. In such circumstances, CDC 

would require zoos and laboratories to 

maintain detailed records regarding 

NHPs. Because domestic AZAaccredited zoos and established research 

labs are regulated by USDA’s Animal 

Welfare Act, and if receiving Public 

Health Service (PHS) funds are bound 

by the PHS Policy for Humane Care and 

Use of Laboratory Animals, and may 

additionally be accredited by AAALAC, 

to meet strict guidelines regarding 

husbandry and medical care for animals 

and occupational health and safety, CDC 

believes that a records requirement for 

these zoo collections and research 

laboratories effectively provides the 

same health and safety assurance as a 

31-day quarantine. Additionally, since 

zoos are placing imported animals into 

their existing collections, they require a 

quarantine facility for all new NHPs. 

The records requirement will document 

the health of the NHPs over a specified 

period of time, in a monitored setting, 

before the NHPs are transferred between 

zoo collections or research facilities, 

thereby providing the same health and 

safety assurance that quarantine 

provides for other NHP imports. The 

transportation of NHPs for a zoo-to-zoo 

or laboratory-to-laboratory transfer 

would be in accordance with the 

transportation guidelines listed in 

proposed paragraphs (j) and (k). In the 

event that zoo collections or research 

laboratories are unable to comply with 

the requirements regarding proper 

veterinary medical records, all other 

aspects of the importation and 

quarantine requirements will apply. 

The proposed rule could increase 

costs for a small set of importers by 


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requiring that all live NHP imports enter 

through ports of entry where CDC 

quarantine stations are located, except 

in limited circumstances approved in 

advance by CDC. This change could 

increase transportation costs for a small 

number of shipments currently driven 

across the Mexican or Canadian borders. 

Restricting the ports of entry should not 

increase costs for importers shipping by 

air, since currently all shipments are to 

airports with CDC quarantine stations. 

Further, CDC believes the nominal cost 

of this requirement is warranted by the 

health and safety value of ensuring 

proper loading of the NHPs on a flight, 

proper handling of the crates as they are 

unloaded, and adequate disinfection of 

the plane. 

4. Alternatives 

The key alternative to the proposed 

rulemaking would be to not adopt these 

proposed regulations. If the provisions 

described above are not adopted, 

importers of cynomolgus, rhesus, and 

African green monkeys would continue 

to bear an additional administrative 

burden when importing. CDC believes 

that the reductions in administrative 

burden and costs proposed through 

these regulations can be achieved 

without compromising or reducing the 

health and safety benefits of current 

practices. The registration process that 

all importers must complete, detailed in 

subsection (g), will include the 

development of detailed standard 

operating procedures designed to 

protect both the NHPs and the 

individuals at each facility, a signed 

statement of intent, the review and 

approval of these SOPs by the Director, 

and an inspection by CDC. Regular, 

unscheduled site visits ensure that 

facility operations are adequately 

maintained in a manner to prevent the 

transmission of infectious agents from 

NHPs to humans. 

5. Benefits 

In November 1989, a shipment of 

cynomolgus monkeys imported into the 

United States was found to be infected 

with a previously unrecognized Ebolalike filovirus (22). In the 1990 

guidelines, registration requirements 

and permitting procedures were 

established specifying transit, isolation, 

and quarantine standards for importers 

of African green, cynomolgus, and 

rhesus monkeys. These guidelines were 

established to reduce the risks to public 

health that could result from the 

importation of monkeys carrying a 

filovirus. The 1990 CDC actions also 

provided the related benefit of avoiding 

an economic disruption of the NHP 

import market associated with the threat 

of an Ebola-like filovirus. 

Although we propose few changes to 

the existing baseline, this rule would 

provide some further assurance of 

health and safety by requiring that most 

imports of live NHPs arrive at a port of 

entry with a CDC quarantine station, 

where qualified personnel are present to 

monitor the arriving shipments. 

By removing the regulatory cost 

barrier of the quarantine requirement for 

zoos accredited by AZA and laboratories 

accredited by AAALAC or licensed by 

USDA, the proposed rule is expected to 

yield an additional public benefit by 

facilitating transfers from zoo-to-zoo and 

laboratories-to-laboratories. The 

proposed rule would remove obstacles 

to the movement of highly endangered 

NHPs for preservation of a species. 

Additionally, it would allow the 

controlled entry of long-term research 

NHPs for public health studies that 

could only be performed in a U.S.-based 

laboratory. 

6. Costs 

It is difficult to calculate the 

regulatory costs of our 1990 actions 

because the threat of an Ebola-like 

filovirus in the United States may have 

sharply reduced the future importation 

of NHPs. Assuming no complications, 

CDC estimates that the cost for keeping 

an NHP in quarantine for 31 days is 

roughly $500–$600 per NHP, which 

includes the cost of recordkeeping, 

monitoring and testing NHPs for TB. 

These costs are in addition to 

registration and permitting costs per 

importer. However, absent CDC action, 

the economic disruption associated with 

the threat of an Ebola-like filovirus 

could have resulted in higher industry 

costs. From FY 2000 through FY 2007, 

NHP imports increased from 15,433 

NHPs to 26,714 NHPs, indicating that 

CDC’s transit, isolation, and quarantine 

standards for NHP imports have 

provided for an orderly, growing market 

while protecting public health. 

As noted above, the proposed rule 

would have three cost impacts relative 

to the baseline of current practices: 

(1) An administrative cost reduction for 

importers of cynomolgus, rhesus, and 

African green monkeys resulting from a 

2-year registration renewal cycle rather 

than the current 180-day registration 

renewal cycle; (2) a reduction in 

quarantine costs for zoos and 

laboratories that are able to maintain 

detailed records of zoo-to-zoo and 

laboratory-to-laboratory transfers; and 

(3) an increase in transportation costs 

for NHP shipments customarily driven 

across borders that will have to enter 

through ports of entry with CDC 

quarantine facilities or obtain advance 

approval and enter the U.S. by an 

alternate port of entry. 

Based on recent estimates from the 

American College of Laboratory Animal 

Veterinarians and the Bureau of Labor 

Statistics, CDC estimates that the 

average wage for NHP importers is 

$112.00 per hour. Thus, the estimated 

cost of registration renewal is $56.00 (30 

minutes at $112.00 per hour). In late 

2005, eight active commercial importers 

were subject to the 180-day renewal 

cycle for cynomolgus, rhesus, and 

African green monkey importers. The 

change to a 2-year renewal cycle will 

reduce annual regulatory costs for each 

of these importers by $84.00 per year 

($56.00 per renewal times 3 fewer 

renewals every two years), reducing 

total costs for these eight importers by 

$672.00 per year ($84.00 × 8). Other 

registered importers (e.g., zoos) import 

very infrequently and will continue to 

renew their registration once every two 

years, resulting in no net change in 

costs. 

By eliminating quarantine 

requirements for zoo-to-zoo and 

laboratory-to-laboratory NHP transfers 

for zoos and labs that maintain detailed 

records of such transfers, we expect to 

reduce annual regulatory costs by about 

$550 to $1800 per transfer. CDC 

estimates that only one or two zoo-tozoo or laboratory-to-laboratory transfers 

occur each year under current 

requirements, so eliminating the 

quarantine requirement for these 

transfers would yield no substantial 

regulatory cost reduction. 

Requiring importers to send all live 

NHPs through ports of entry with CDC 

quarantine stations could increase 

transportation costs for any NHP 

shipment that might be driven across 

the Mexican or Canadian borders. 

However, we estimate that only three or 

four such overland shipments occur per 

year (or about 2% of all shipments), and 

alternate ports of entry may be allowed 

if approved in advance by CDC. CDC 

expects the total cost to be insignificant 

because of the small number of imports 

affected. 

7. Regulatory Flexibility Analysis 

The Regulatory Flexibility Act 

requires agencies to examine regulatory 

alternatives for small entities if that rule 

may have a significant economic impact 

on a substantial number of small 

entities. 

Objective of the Rule. The 

implementation of the proposed rule 

would preserve the health benefits of 

current practices and standards, while 

yielding net regulatory cost reductions 

for the NHP importers. 


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Small Entity Impacts. A regulatory 

flexibility analysis (RFA) is required to 

estimate the number of small entities to 

which a proposed rule would apply, 

unless a screening analysis shows that 

the rule will not have a significant 

economic impact on a substantial 

number of small entities. A screening 

analysis is adequate for this proposed 

rule because it will yield administrative 

cost reductions for most NHP importers, 

because the 2-year registration renewal 

cycle will replace the 180-day 

registration renewal cycle, and because 

this proposed rule will eliminate 

quarantine costs for zoo-to-zoo and 

laboratory-to-laboratory NHP transfers 

that maintain detailed records. The only 

change from current practices that could 

increase costs is an increase in 

transportation costs for the small 

number of shipments currently driven 

across the Mexican or Canadian borders. 

If approved in advance by CDC, these 

imports may be allowed to enter 

through alternate ports of entry. Thus, 

CDC expects this change to affect a very 

small number of NHP importers of any 

size (a few shipments per year). CDC 

estimates that there are at most only 

three or four such overland shipments 

per year. CDC does not expect the 

increase in cost for these imports to 

represent a significant portion of any 

NHP importer’s total sales. Any 

additional costs are likely to be low, in 

part because there are several CDC 

quarantine stations near the Canadian 

border (Boston, Chicago, Detroit, 

Minneapolis, New York, and Seattle) 

and near the Mexican border (El Paso, 

Houston, and San Diego). Thus, CDC 

does not expect the proposed rule either 

to have a significant impact on any 

small entity or to have a significant 

economic impact on a substantial 

number of small entities. 

Analysis of Alternatives. As stated 

previously, the key alternative of the 

proposed rule is not to adopt each of the 

provisions that affect regulatory costs, 

including the provision that would 

increase costs by requiring NHP 

importation through ports of entry with 

CDC quarantine stations for shipments 

currently imported overland across the 

Mexican or Canadian borders. CDC did 

not accept this alternative because CDC 

believes that the small additional cost is 

warranted by the health and safety value 

of assuring that NHP shipments arrive at 

a port of entry with a CDC quarantine 

station. 

B. Paperwork Reduction Act Analysis 

HHS/CDC has determined that this 

proposed 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 June 30, 

2012). 

In addition, HHS/CDC currently 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, 2011) to collect data from importers 

who wish to apply for a special permit 

to import non-human primates. HHS/ 

CDC plans to submit an extension 

request to OMB for OMB Control No. 

0920–0263 for approval to continue the 

special permit program until HHS/CDC 

promulgates its final rule on non-human 

primates. HHS/CDC requests comment 

from the public on the proposed data 

collection and record keeping 

requirements in the rule. 

C. Federalism Impact 

Under Executive Order 13132, if the 

contemplated 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 proposed 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 

proposed 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, 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 

proposed rule is not expected to result 

in any one-year expenditure that would 

exceed this amount. 

F. Executive Order 12988 

This Notice of Proposed Rulemaking 

has been reviewed under Executive 

Order 12988, Civil Justice Reform. This 

notice of Proposed Rulemaking has been 

reviewed under Executive Order 12988, 

Civil Justice Reform. This rule: (1) 

Would preempt all State and local laws 

and regulations that are inconsistent 

with this rule; (2) would have no 

retroactive effect; and (3) would not 

require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

IV. References 

1. 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. 

2. Centers for Disease Control and 

Prevention. 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 1990; 

39(2):22–24, 29–30. 

3. Robertson, B.H. Viral Hepatitis and 

Primates: Historical and Molecular 

Analysis of Human and Nonhuman 

Primate Hepatitis A, B, and the GB– 

Related Viruses. J Viral Hepatitis. 2001; 

8:233–242. 

4. Cohen, J.I., et al. Recommendations for 

Prevention of and Therapy for Exposure 

to B Virus (Cercopithecine Herpesvirus 

1). Clinical Infectious Diseases 2002; 

35:1191–203. 

5. Centers for Disease Control and 

Prevention. Tuberculosis in Imported 

Nonhuman Primates—United States, 

June 1990–May 1993. Morbidity and 

Mortality Weekly Report MMWR 1993; 

42(39):572–576. 

6. Mansfield, K., N. King. Viral Diseases. 

Nonhuman Primates in Biomedical 

Research, Diseases. B.T. Bennett, C.R. 

Abee, and R. Henrickson, eds. San Diego, 

CA: Academic Press, Inc., 1998. 

7. Richardson, J.H. Basic Considerations in 

Assessing and Preventing Occupational 

Infections in Personnel Working with 


kgrant on DSKGBLS3C1PROD with BILLS
688 Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Proposed Rules 

Nonhuman Primates. J. Med. Primatol. 

1987;16:83–89. 

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

March 15, 1990. Available upon request: 

(404) 639–1600. 

9. 55 FR 10288, March 20, 1990, ‘‘Importation 

of Nonhuman Primates: Meeting.’’ 

10. Centers for Disease Control and 

Prevention. Update: Filovirus Infection 

in Animal Handlers. Morbidity and 

Mortality Weekly Report MMWR 1990; 

39(13):221. 

11. 55 FR 15210, April 20, 1990, Requirement 

for a Special Permit to Import 

Cynomolgus, African Green, or rhesus 

Monkeys into the United States. 

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

October 10, 1991. Available upon 

request: (404) 639–1600. 

13. Tipple, M.A. Dear interested party 

(letter). March 5, 1996. Available upon 

request: (404) 639–1600. 

14. Centers for Disease Control and 

Prevention. Ebola-Reston Virus Infection 

among Quarantined Nonhuman 

Primates—Texas, 1996. Morbidity and 

Mortality Weekly Report MMWR 1996; 

45(15):314–316. 

15. 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. 

16. 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. 

17. 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. 

18. 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. 

19. Centers for Disease Control and 

Prevention. Fatal Cercopithecine Herpes 

Virus 1 (B Virus) Infection Following 

Mucocutaneous Exposure and Interim 

Recommendations for Worker Protection. 

Morbidity and Mortality Weekly Report 

MMWR, 1998; 47(49):1073–1076; 1083. 

20. National Research Council. Guide for the 

Care and Use of Laboratory Animals. 

Institute of Laboratory Animal Resources 

Commission on Life Sciences, National 

Research Council, National Academy 

Press 1996; Washington, DC. 

21. 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. 

Referenced January 7, 2009. Available at 

http://www.cdc.gov/OD/ohs/biosfty/ 

bmbl5/bmbl5toc.htm. 

22. Centers for Disease Control and 

Prevention. Ebola Virus Infection in 

Imported Primates—Virginia. Morbidity 

and Mortality Weekly Report MMWR, 

1989; 38(48):831–832,837–838. 

23. International Air Transport Association. 

Live Animal Regulations. International 

Air Transport Association 2007, Geneva. 

24. World Health Organization, Guidance on 

Regulations for the Transport of 

Infectious Substances, World Health 

Organization 2007–2008. Referenced 

January 7, 2009. http://www.who.int/csr/ 

resources/publications/biosafety/ 

WHO_CDS_EPR_2007_2cc.pdf. 

25. Institute of Laboratory Animal Resources, 

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. 

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 proposes to 

amend 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, including 

pathogens, from nonhuman primates 

(NHPs) imported into the United States, 

or their offspring, to humans. These 

regulations 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 used in the 

importation of NHPs available to CDC 

for inspection during operating business 

days and hours, and at other necessary 

and reasonable times, to enable CDC to 

ascertain compliance with these 

regulations. 

(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. 

CDC means the Centers for Disease 

Control and Prevention, U.S. 

Department of Health and Human 

Services, or an authorized 

representative acting on its behalf. 

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. 

MOT means mammalian old 

tuberculin, a biological product used as 

a diagnostic tool in the evaluation for 

mycobacterial (tuberculosis 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. (2) For purposes of this 

section, the terms listed below shall 

have the following meanings: 

Animal act means any use of NHPs 

for entertainment in which the NHPs are 

trained to perform some behavior or 

action and are part of a show, 

performance, or exhibition. Offspring of 

such NHPs are subject to the 

requirements of this section. 

Breeding colony means a facility 

where NHPs are maintained for 

reproductive purposes. Offspring of 

such NHPs are subject to the 

requirements of this section. 

Broker means a person within the 

United States that acts as an official 

agent of, or intermediary between, 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 in the teaching of a defined 

educational program at the university 

level or equivalent. Offspring of such 

NHPs are subject to the requirements of 

this section. 


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Exhibition purposes means the use of 

NHPs 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. 

Offspring of such NHPs are subject to 

the requirements of this section. 

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 is 

subject to or carries out responsibilities 

in accordance with these regulations. 

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 

accredited by AAALAC or licensed by 

USDA, conducting research using NHPs, 

having foreign and/or United States 

based facilities, and intending to 

transfer or transferring one or more 

NHPs that were originally part of an 

institutionally approved, ongoing 

protocol, into the United States facility 

for purposes related to that specific 

research project. 

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, including animals commonly 

known as chimpanzees, gorillas, 

monkeys, macaques, gibbons, 

orangutans, baboons, marmosets, 

tamarins, lemurs, and lorises. 

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, including 

herpes B virus. 

Permitted Purpose means the use of 

NHPs for scientific, education, or 

exhibition purposes as defined in this 

section. 

Person means any individual or 

partnership, firm, company, 

corporation, association, organization, 

or similar 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, including other 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 for research following a defined 

protocol and other standards for 

research projects as normally conducted 

at the university level. Offspring of such 

NHPs are subject to the requirements of 

this section. 

Trophy means a mount, rug, or other 

display item composed of the hide, hair, 

skull, teeth, bones, or claws of a 

nonhuman primate. 

Zoo means: 

(A) Within the United States, an AZA 

accredited and professionally 

maintained park, garden, or other place 

in which animals are kept for public 

exhibition and viewing; or 

(B) 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 other animals to 

humans or from humans to animals. 

(d) General Prohibition of Excluded 

Nonhuman Primates. (1) A person may 

not import live NHPs into the United 

States unless the person is registered 

with CDC as a NHP importer in 

accordance with this section. (2) A 

person may not import live NHPs into 

the United States or maintain, sell, 

resell, or otherwise distribute imported 

NHPs except for: 

(i) Permitted purposes; 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 import live 

NHPs into the United States or 

maintain, sell, resell, or otherwise 

distribute imported NHPs or 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) 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 purposes other 

than permitted purposes; 

(iii) It is maintained, sold, resold, or 

distributed for purposes 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, 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 to a scientific, 

educational, or exhibition facility as 

approved by the Director. 

(3) If the importer 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 

importer’s expense. 

(4) Pending disposal of any NHPs 

arriving into the United States, the NHP 

will be detained at the importer’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 CDC 

quarantine station is located. Currently, 

the list of CDC quarantine stations can 

be found at http://www.cdc.gov/ 

quarantine/QuarantineStations.html. 

(2) In the event that the importer is 

unable to provide for entry at a port 

where a CDC quarantine station is 

located, the importer may only import 

live NHPs into the United States if 

advance written approval has been 

obtained from the Director. 

(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 of Importers. Before 

importing any live NHP into the United 

States, including those that are part of 

an animal act or those involved in zooto-zoo or laboratory-to-laboratory 

transfers, an importer must register with 

and receive written approval from the 

Director. 


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(1) To register as an importer, a 

person must submit the following 

documents to CDC: 

(i) A completed application form; 

(ii) A completed statement of intent 

describing the number and types of 

NHPs intended for import during the 

registration period; 

(iii) A copy of all written Standard 

Operating Procedures (SOPs) that 

include all elements required in 

paragraphs (h) through (n) of this 

section; 

(iv) A copy of any current 

registrations, licenses, and/or permits 

that may be required from the U.S. 

Department of Agriculture and U.S. Fish 

and Wildlife Service; 

(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 

these regulations. 

(2) Upon receiving the documentation 

required by this section, the Director 

will review the application and either 

grant, in whole or in part, or deny the 

application for registration as an 

importer. CDC may consult with the 

importer regarding any element of the 

application or accompanying 

documentation. 

(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 CDC issues the 

registration certificate. 

(iii) An importer must apply to 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 

have a written policy that imported 

NHPs and their offspring will only be 

used and distributed for permitted 

purposes. 

(1) An importer must document the 

intended purpose for each imported 

NHP and the purpose must comply with 

one of the permitted purposes. 

(2) An importer must retain records 

documenting the identity of any 

recipients, the number of NHPs in each 

shipment or sale, and the dates of each 

shipment or sale. 

(3) An importer must maintain these 

records in an organized manner and 

either electronically or in a central 

location that is at or in close proximity 

to the NHP facility to allow CDC to 

inspect the records during CDC site 

visits during regular business hours or 

within one hour of such visits. 

(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 for one of 

the permitted purposes. 

(5) An importer must keep written 

certifications demonstrating that the 

NHPs and any offspring will continue to 

be used 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. An importer must adhere to the 

plan and SOPs and must ensure that 

each worker covered under the plan also 

adheres to it and SOPs. 

(3) An importer must contact CDC 

immediately by telephone to report any 

instance of a worker exposed to a 

zoonotic illness and must include 

instructions for contacting 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; 

(ii) Hazard evaluation and worker 

communication procedures that adhere 

to those in paragraph (i)(4) of this 

section; 

(iii) Personal protective equipment 

(PPE) requirements that adhere to those 

in paragraph (i)(5) of this section; 

(iv) SOPs that adhere to tuberculosis 

requirements in paragraph (i)(6) of this 

section; 

(v) If applicable, SOPs that adhere to 

requirements relating to macaques as 

described in paragraph (i)(7) 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; 

(vii) 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; 

(viii) 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; 

(ix) 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; 

(x) 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; 

(xi) 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; 

(xii) 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 CDC. 

(B) For potential exposures to 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 CDC. 

(xiii) 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 subparagraph, 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 of 

handling NHPs; 

(ii) The need for PPE in handling 

NHPs and training in proper use of PPE, 

including re-training and reinforcement 

of appropriate use; 

(iii) Procedures for monitoring 

workers for signs of zoonotic illness, 

including procedures that ensure 

reporting to CDC by telephone within 24 

hours of the occurrence of illness in any 

worker suspected of having a zoonotic 

disease acquired from an NHP; and 

(iv) Procedures for disinfection of 

garments, supplies, equipment, and 

waste. 


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(6) As part of the worker protection 

plan described in this paragraph, 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) Disposable NIOSH-approved N95 

or equivalent respirators, in compliance 

with OSHA 29 CFR § 1910.134 which 

requires 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) Long-sleeved shirts and trousers 

that resist minor tears and are 

appropriate for the weather; 

(C) Waterproof shoes or boots; 

(D) NIOSH-approved respiratory 

protection that is compliant with OSHA 

29 CFR § 1910.134, and 

(E) Face shields or eye protection that 

protect the eyes. 

(iv) Workers whose faces may come 

within 5 feet of an NHP must wear 

disposable NIOSH-approved N95 or 

equivalent 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 tuberculosis protection, an 

importer must ensure the following: 

(i) Workers in a facility housing NHPs 

must have a baseline tuberculosis skin 

test prior to working with NHPs and, at 

least annually, a tuberculosis skin test; 

(ii) Prompt and direct access to a 

medical consultant who reads 

tuberculin skin tests and maintains 

records for such tests; 

(iii) If an NHP is found to have 

laboratory-confirmed tuberculosis, any 

worker who had previously entered any 

room where a confirmed NHP has been 

housed must promptly undergo a postexposure tuberculin skin test and 

(A) If that test is negative, the worker 

must undergo another tuberculin skin 

test 3 months after exposure, and 

(B) If that test is reactive, the worker 

must be referred for medical evaluation; 

and 

(C) The CDC must be immediately 

notified of the results by telephone, 

SMS text, or e-mail as specified in the 

importer’s standard operating 

procedures. 

(iv) Compliance with exposure 

control planning elements under 29 CFR 

1910.1030 for workers who will have 

parenteral and other contact with blood 

or other potentially infectious material 

from NHPs and compliance with the 

respiratory protection requirements in 

29 CFR 1910.134. 

(8) 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 CDC by 

telephone 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 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. 

(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, 

qualified veterinarian. NHPs must not 

be removed during transport. 

(4) Whenever possible, workers must 

not handle live NHPs directly. 

(5) Upon arrival into the U.S., only an 

importer or an authorized representative 

may receive the NHPs from a 

conveyance (i.e., airplane, ship, etc). 

(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, 

ventilation systems must direct airflow 

away from individuals and toward the 

compartment housing NHPs to prevent 

the transmission of zoonotic diseases to 

individuals traveling with the shipment; 

any recirculated air must be HEPAfiltered. 

(9) If traveling by plane, crates 

containing NHPs must 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) Documentation must be made of 

the communicable disease-prevention 

procedures carried out in every step of 

the chain of custody, from the time of 

embarkation of the NHPs at the country 

of origin until arrival at the quarantine 

facility. 

(12) Procedures to ensure that aircraft, 

ship, vehicles, and related equipment 

are decontaminated following transport. 

(13) PPE, bedding, or other 

biohazardous waste must be disposed of 

following transport. 

(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, easily 

cleaned and disinfected. 

(3) PPE, bedding, or other 

biohazardous waste must be disposed of 

following ground transport. 


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(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 CDC in writing within 48 hours 

of the time the shipment arrived at the 

quarantine facility. 

(6) As part of the notification of 

arrival in paragraph (k)(4) of this 

section, an importer must inform CDC 

whether suspected or confirmed 

transmission or spread of communicable 

disease occurred during transport, 

including notification of NHPs that died 

or became ill during transport or 

malfunctions associated with disease 

mitigation procedures or equipment. 

(l) Quarantine Facilities. (1) The 

requirements of this paragraph relating 

to quarantine facilities does not apply to 

laboratory-to-laboratory transfers or zooto-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. CDC may extend the quarantine 

period if an importer or CDC finds or 

suspects that an NHP is infected with, 

or has been exposed to, a zoonotic 

disease, or if an importer or 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 quarantine room must have 

a separate air-handling system and 

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 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 

because such procedures pose a risk of 

needle sticks or aerosol exposures to 

employees. 

(ii) Health certificates, shipping 

documents, and NHP health records 

must include the number or code 

required in paragraph (l)(2)(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 or 

tranquilized before handling. 

(iv) 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 

multidose vials (e.g., ketamine). 

(v) Before any contaminated item is 

removed from a quarantine facility an 

importer must ensure all NHP waste, 

bedding, uneaten food, or other possibly 

contaminated items are disinfected, 

autoclaved, or double-bagged for 

disposal as biomedical waste by a 

licensed facility. 

(vi) All cages, feeding bottles, reusable 

items, and other contaminated items 

must be disinfected between uses and 

before disposal. 

(vii) Any equipment used for infusion 

of NHPs must be autoclaved or 

incinerated, as appropriate. 

(viii) During the quarantine period, an 

importer must monitor NHPs for signs 

of any zoonotic illness, including signs 

consistent with yellow fever, 

monkeypox, or filovirus disease. 

(A) If any NHP appears ill during 

quarantine, an importer must monitor 

that NHP for signs of zoonotic illness, 

including filovirus disease, and ensure 

appropriate treatment. 

(B) If an Old World NHP displays 

signs suggestive of filovirus infection 

(e.g., diarrhea with melena or frank 

blood, bleeding from external orifices or 

petechiae, or suffusive hemorrhage), and 

survives, an importer must collect 

serum samples on day 31 of quarantine 

and test these samples for antibodies to 

filovirus while the entire cohort remains 

in quarantine. An importer must test the 

serum for Immunoglobulin G (IgG) 

antibodies to Ebola viruses by using an 

ELISA methodology, or other method 

approved by CDC. 

(C) An importer must not request a 

release from CDC of any NHP from 

quarantine under paragraph (l)(3) of this 

section, if the importer knows or has 

reason to suspect that the NHP is 

infected with or has been exposed to a 

zoonotic disease. 

(ix) For each NHP in a quarantine 

facility, an importer must administer at 

least three tuberculin skin tests on the 

eyelid using old mammalian tuberculin 

(MOT), with at least 2 weeks between 

tests, before the NHP is released from 

import quarantine. Tuberculin skin tests 

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 tuberculosis testing. 

(A) An importer must ensure that any 

cohort with positive or suspicious 

tuberculin reactions remains in 

quarantine and receives at least five 

additional tuberculin skin tests (each 

administered at least two weeks apart) 

following removal of the last NHP with 

a positive TST. 

(B) The validity of tuberculosis test 

results may be compromised if during 

quarantine an NHP contracts a viral 

illness, including measles; a severe 

illness; 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 CDC, depending on 

the illness or treatment in question) 

before tuberculosis tests are performed. 

(C) An importer must retain records of 

all tuberculin skin tests 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. 


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(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 at all 

times will 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 an NHP from 

quarantine, an importer must obtain 

written permission from CDC. 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) 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) CDC confirms that the importer 

has addressed and resolved to CDC’s 

satisfaction any NHP or worker 

communicable disease issues that were 

reported to CDC during shipment. 

(5) If 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 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 State-licensed veterinary pathologist 

or State-licensed veterinarian under 

biosafety level 3 containment. 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 or biosafety level 

2 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 CDC, 

in case other testing is required by 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 tuberculosis 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 during 

quarantine, liver tissue for filovirus 

antigen by using the antigen-capture 

ELISA method must be submitted to a 

laboratory for testing 

(m) Health Reporting Requirements 

for Nonhuman Primates. 

(1) An importer must notify CDC of 

the events listed in this paragraph by 

telephone or as otherwise specified in 

this paragraph. 

(2) An importer must notify CDC 

within 24 hours of the occurrence of 

severe illness or death of NHPs in 

quarantine facilities. 

(3) An importer must report to CDC 

within 24 hours of the occurrence of any 

illness in NHPs that an importer has 

reason to suspect is yellow fever, 

monkey pox, or filovirus disease. 

(4) If mortality for a cohort exceeds 5 

percent, calculated from time of 

embarkation from country of origin to 

release from CDC quarantine, an 

importer must report the circumstances 

to CDC promptly, including the cause of 

death for each NHP. 

(5) 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 CDC in writing of 

the health status of the shipment. 

(6) An importer must notify CDC 

within 24 hours if any NHP tests 

positive for filovirus virus antigen or 

antibody. 

(7) An importer must report to CDC 

within 48 hours, any positive or 

suspicious tuberculin skin test 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 CDC in writing 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 as described by the 

recipient under paragraph (i)(2) of this 

section; 

(vii) Specific itinerary with names, 

dates, flights, times, airports, sea ports, 

and responsible parties to contact at 

every step of travel, including all 

ground transportation; 

(viii) Port of entry; 

(ix) If arriving by flight, the name of 

the airline and its flight number; 

(x) If arriving by vehicle, the name of 

the vehicle’s owner and its license plate 

number; 

(xi) If arriving by ship, the name of 

the ship and its vessel number; 

(xii) Name and address of the 

destination quarantine facility; 

(xiii) Name, address, and contact 

information for shipper, if other than 

the importer; 

(xiv) Name, address, and contact 

information for broker in the United 

States; 

(xv) Name, address, and contact 

information for person 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 foreign-based 

animal acts that include a NHP must be 

registered with CDC in accordance with 

this section prior to entry into the U.S. 

In addition to the requirements in 

paragraph (g) of this section, an 

importer must provide: 

(i) A description of the animal act that 

includes the 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 or microchip. 


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(iv) 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. 

(v) 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, tuberculosis 

testing with MOT and interpreted as 

stated in paragraph (l)(2)(ix); 

(C) NHPs with positive tuberculin 

skin test results must be treated with 

antituberculosis chemotherapy after 

consultation with CDC. 

(D) If the NHP is a chimpanzee, 

serology and antigen testing for hepatitis 

B, serology for hepatitis C, and any 

additional titers 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 U.S., unless 

confirmatory evidence signed by a 

licensed veterinarian shows that there is 

no hepatitis B or hepatitis C virus 

present in the NHP. 

(vi) 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. 

(vii) A copy of a negative tuberculosis 

test conducted within the past 12 

months, or medical documentation that 

the individual is free of clinically active 

tuberculosis, for each trainer and/or 

handler. 

(viii) A copy of each SOP for dealing 

with suspected zoonotic diseases. 

(ix) If macaques are in the animal act, 

a procedure for dealing with potential 

herpes B-virus exposures. 

(2) Requirements for U.S.-based 

animal acts containing NHPs to re-enter 

the United States after export. 

(i) An importer must ensure that the 

NHP contains the unique identifier, 

such as a tattoo or microchip, obtained 

prior to export. 

(ii) Each NHP must be included on an 

approved list of performing NHPs that 

are cleared by CDC to travel outside of 

and return to the U.S. 

(iii) Before re-entry, an importer must 

ensure that CDC receives the itinerary as 

described in paragraph (n)(2). 

(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), (i), (j), (k), (m), (n) of 

this section. 

(2) If a zoo is receiving one or more 

NHPs into the United States from 

another AZA zoo (or AZA-equivalent 

outside of the U.S.), the recipient zoo 

must, before the transfer, submit the 

following information for approval by 

CDC: 

(i) A copy of each NHP’s veterinary 

medical records regular testing for 

tuberculosis from the previous zoo for 

approval by CDC, including a method of 

positive identification such as a tattoo, 

microchip or photograph, and 

(ii) A copy of a current health 

certificate, including documentation of 

a negative tuberculosis test, signed by a 

licensed qualified veterinarian within 

14 days of the transfer documenting that 

the NHP appears healthy and free from 

communicable diseases, and 

(iii) Documentation which verifies 

that the recipient zoo is registered in 

accordance with this section, and 

(iv) 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) Persons who will only be 

transferring NHPs on established 

research protocols from a laboratory 

outside of the U.S. to laboratory within 

the U.S. must comply with all the 

elements listed in paragraphs (g), (h), (i), 

(j), (k), (m), and (n) 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 CDC for approval: 

(i) A copy of each NHP’s veterinary 

medical records, including regular 

testing for tuberculosis from the 

previous lab for 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 stating that the NHP(s) appear 

healthy and are free from communicable 

diseases, including documentation of a 

negative tuberculosis test. The 

certificate must be signed by a State 

licensed veterinarian within 14 days of 

the transfer; and 

(iii) Documentation of the ongoing 

research project and the reason the NHP 

needs to be transported to the U.S. 

laboratory facility. 

(iv) Specific itinerary with names, 

dates, flights, times, airports, sea ports, 

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 paragraph 

(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 CDC of all scheduled in transit 

shipments of NHPs not intended for 

import into the United States and 

provide the following information: 

(i) Number and species of NHPs in the 

shipment; 

(ii) Origin of NHPs, including the 

country, the exporter, and the exporter’s 

address; 

(iii) Name and full address of the final 

destination quarantine facility in the 

importing country; 

(iv) Means of individually identifying 

NHPs, if required by the importing 

country; 

(v) 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) Established SOPs 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. 


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Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Proposed Rules 695 

(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) 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. 

(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 trophies, skins, or skulls 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). 

(2) Non-live NHP products (including 

skulls, skins, bodies, blood, or tissue) 

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 purposes. 

(iii) The product may only 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. 

(u) Appeal of denial for a permit to 

import. (1) If the CDC denies your 

request for a permit under 42 CFR 71.53, 

you may appeal that denial to the CDC 

Director. 

(2) You must submit your appeal in 

writing to the CDC Director, stating the 

reasons for the appeal and showing that 

there is a genuine and substantial issue 

of fact in dispute. 

(3) You must submit the appeal 

within 2 business days after you receive 

the denial. 

(4) CDC will issue a written response 

to the appeal, which shall constitute 

final Agency action. 

Dated: December 15, 2010. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2010–32922 Filed 1–4–11; 8:45 am] 

BILLING CODE 4163–18–P 


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