Requirements for Importers of Nonhuman Primates, 678-695 [2010-32922]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Proposed Rules]
[Pages 678-695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32922]



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Part IV





Department of Health and Human Services





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42 CFR Part 71



Requirements for Importers of Nonhuman Primates; Proposed Rule

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

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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).

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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 https://www.cdc.gov/ncidod/dq. Written comments may be 
submitted electronically via the Internet at https://www.regulations.gov 
or via e-mail 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 https://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 special-permit 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 Sec.  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 performance-based 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 puncture-resistant 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 post-exposure 
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 Sec.  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 Sec.  
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 Sec.  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 Sec.  
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 Sec.  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 
Sec.  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 record-keeping 
requirements.
    Proposed Sec.  71.53(i) and Sec.  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

[[Page 683]]

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 Sec.  71.53(i)(6) and (l)(2) of the proposed rule 
include worker protection and quarantine requirements regarding TB. 
Proposed Sec.  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 Sec.  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 Sec.  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 Sec.  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 Sec.  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: https://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 Sec.  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

[[Page 684]]

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 Sec.  
71.53(m), CDC proposes 19 general reporting and recordkeeping 
requirements in Sec.  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 Sec.  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 Sec.  71.53(o)(2), an importer must meet 
specified requirements for U.S.-based animal acts containing NHPs when 
the animal re-enters the United States after export. The requirements 
in Sec.  71.53(o) are in addition to those documentation requirements 
in proposed Sec.  71.53(g).
    For those NHPs entering the U.S. under the zoo-to-zoo and 
laboratory-to-laboratory transfers exception, proposed Sec.  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, Sec.  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 in-transit shipments of NHPs?

    Under Sec.  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 Sec.  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 Sec.  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.

[[Page 685]]

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 zoo-to-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 AZA-
accredited 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

[[Page 686]]

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 Ebola-like 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 facilitie