Control of Communicable Diseases; Foreign Quarantine: Importation of Dogs and Cats, 43978-44029 [2023-14343]
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 71
[CDC Docket No. CDC–2023–0051]
RIN 0920–AA82
Control of Communicable Diseases;
Foreign Quarantine: Importation of
Dogs and Cats
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of proposed rulemaking.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), in the
Department of Health and Human
Services (HHS), proposes to amend its
foreign quarantine regulation to provide
additional clarity and safeguards to
address the public health risk of dogmaintained rabies virus variant
(DMRVV) associated with the
importation of dogs into the United
States. The United States has been
DMRVV-free since 2007, and
reintroduction poses significant risk to
human and animal health. The close
relationship between dogs and people
means there is a direct public health
risk to individuals that interact with
inadequately vaccinated dogs imported
from countries at high risk of DMRVV
(high-risk countries). The notice of
proposed rulemaking (NPRM) also
addresses the importation of cats
because both dogs and cats are included
in the current regulation. Cats are not
required to have proof of rabies
vaccination and CDC is not proposing
new substantive changes relating to the
importation of cats.
DATES: Written or electronic comments
on the NPRM must be received by
September 8, 2023.
Written comments on the proposed
data collection requirements under the
Paperwork Reduction Act must be
received by September 8, 2023.
ADDRESSES:
For the NPRM: You may submit
comments, identified by Docket No.
CDC–2023–0051 or RIN 0920–AA82, by
either of the following ways:
• Federal Rulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Division of Global Migration
and Quarantine, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS H16–4, Atlanta, GA
30329.
Instructions: All submissions received
must include the agency name and
docket number or Regulatory
Information Number (RIN) for this
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SUMMARY:
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action. All relevant comments received,
including any personal information
provided, will be posted without change
to https://www.regulations.gov/. Do not
submit comments by email. CDC does
not accept comments by email.
To request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
FOR FURTHER INFORMATION CONTACT:
Ashley C. Altenburger, J.D., Division of
Global Migration and Quarantine,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H16–4, Atlanta, GA 30329. Telephone:
1–800–232–4636. For information
regarding CDC operations and
importations related to this NPRM,
please contact Dr. Emily Pieracci,
D.V.M., Division of Global Migration
and Quarantine, Centers for Disease
Control and Prevention, 1600 Clifton
Road NE, MS H16–4, Atlanta, GA
30329; Telephone: 1–800–232–4636.
The
NPRM is organized as follows:
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Purpose of This Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Public Participation
III. Background
A. Legal Authority
B. Historical Background
C. Current Process
IV. Summary of Proposed Changes
V. Alternatives Considered
VI. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act of 1995
D. National Environmental Policy Act
(NEPA)
E. Executive Order 12988: Civil Justice
Reform
F. Executive Order 13132: Federalism
G. Plain Language Act of 2010
I. Executive Summary
A. Purpose of This Regulatory Action
Through this NPRM, HHS/CDC
proposes to revise its regulation at 42
CFR 71.51 to prevent the reintroduction
and spread of dog-maintained rabies
virus variant (DMRVV) in the United
States. HHS/CDC also proposes
amendments to 42 CFR 71.50, which
contains definitions applicable to
animal importations under 42 CFR part
71, subpart F. The United States was
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declared DMRVV-free in 2007.1 The
importation of just one dog infected
with DMRVV risks re-introduction of
the virus into the United States; such a
public health threat could result in the
loss of human and animal life and
consequential economic impact.2 3 4 The
rabies virus can infect any mammal,
and, once clinical signs appear, the
disease is almost always fatal.5 A
DMRVV-infected dog can transmit the
virus to humans, domestic pets,
livestock, or wildlife. Importing
inadequately vaccinated dogs from
countries at high risk of DMRVV (highrisk countries) 6 involves a significant
public health risk to people who
directly interact with those dogs. In
2019, the importation of a DMRVVinfected dog cost the affected State
governments more than $400,000 U.S.
dollars (USD) for the ensuing public
health investigations and rabies postexposure prophylaxis (PEP) treatments
administered to exposed persons.7 8
Through this proposed rulemaking,
HHS/CDC also seeks to prevent and
deter the importation of dogs with
falsified or fraudulent rabies vaccine
documentation. In 2020, CDC observed
a 52 percent increase in the number of
dogs that were ineligible for admission
due to falsified or fraudulent
documentation, as compared to 2018
and 2019 (450 dogs compared to the
previous baseline of 300 dogs per year).9
This troubling trend continued in 2021,
with an additional 24 percent increase
of dogs ineligible for admission in just
1 Centers for Disease Control and Prevention. US
Declared Canine-Rabies Free. https://www.cdc.gov/
media/pressrel/2007/r070907.htm. Accessed June 1,
2023.
2 World Bank (2012). People, Pathogens and Our
Planet: The Economics of One Health. Retrieved
from https://openknowledge.worldbank.org/handle/
10986/11892.
3 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. MMWR Morb Mort Wkly Rep
2020; 69 (38): 1374–1377.
4 Jeon S, Cleaton J, Meltzer M, et al. Determining
the post-elimination level of vaccination needed to
prevent re-establishment of dog rabies. PLoS Neg
Trop Dis 2019; 13 (12): e0007869.
5 Fooks AR, Banyard AC, Horton DL, Johnson N,
McElhinney LM, Jackson AC. Current status of
rabies and prospects for elimination. Lancet
2014;384:1389–99.
6 A complete list of countries with high risk of
DMRVV is available at ‘‘High-Risk Countries for
Dog Rabies.’’ https://www.cdc.gov/importation/
bringing-an-animal-into-the-united-states/highrisk.html. Accessed June 8, 2023.
7 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. MMWR Morb Mort Wkly Rep
2020; 69 (38): 1374–1377.
8 Centers for Disease Control and Prevention
(2022). Rabies Postexposure Prophylaxis. Retrieved
from https://www.cdc.gov/rabies/medical_care/
index.html.
9 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog importation data, 2018–2020.
Accessed: 15 February 2021.
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the first half of the year, compared to
the full 2020 calendar year (January–
December) (approximately 560 dogs
with falsified or fraudulent
documentation).10
The use of a single false rabies
vaccination certificate (RVC) 11 or rabies
vaccination documents as part of a
larger shipment of multiple dogs raises
suspicion that the other rabies
vaccination documents for the
remaining dogs may also be false and
creates an additional burden on CDC
and State health departments to track,
test, and evaluate the remaining dogs in
the shipment. CDC and U.S. Customs
and Border Protection (CBP) have
documented numerous importations
every year in which flight parents 12
transport dogs for the purpose of resale,
adoption, or transfer of ownership that
do not meet CDC’s entry requirements.
These flight parents often claim the dogs
are their personal pets to avoid U.S.
Department of Agriculture (USDA)
Animal Care entry requirements and
potential tariffs or fees under CBP
regulations. Even when well-meaning,
these importers jeopardize public
health, as many of them do not know
the history of the animals they are
transporting. Deterring individuals who
serve as flight parents from supporting
fraudulent dog importations has proven
difficult despite the existence of CBP
penalties relating to aiding unlawful
importations and fraudulent conduct.
See 19 U.S.C. 1592 and 19 U.S.C. 1595a.
The documented increase in
fraudulent vaccine documentation and
importers circumventing dog import
regulations was shortly followed by the
advent of the coronavirus disease 2019
(COVID–19) pandemic. Many public
health resources were redirected to the
COVID–19 response, reducing the
availability of resources to respond to
dog importation issues. In light of this
confluence of events, in June 2021, CDC
published a temporary suspension of
dogs entering the United States from
DMRVV high-risk countries.13 The
temporary suspension created a system
that, among other things, implemented
10 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog importation data, January 1,
2021–July 14, 2021. Accessed: 01 October 2021.
11 Centers for Disease Control and Prevention.
What is a valid rabies vaccination certificate?
Available at: www.cdc.gov/importation/bringing-ananimal-into-the-united-states/vaccinecertificate.html.
12 A flight parent refers to a person accompanying
an animal into the country. Flight parents are often
solicited through social media, not affiliated with
the sponsoring dog rescue organization, and usually
compensated with an airline ticket or other funds.
13 Temporary Suspension of Dogs Entering the
United States from High-Risk Rabies Countries.
Federal Register, 86 FR 32041 (June 16, 2021).
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the use of standardized forms, required
titer test results demonstrating the
presence of rabies antibodies in dogs,
and developed a reservation system
allowing for the rapid quarantine of
dogs from DMRVV high-risk countries
arriving with inadequate proof of titers.
During the temporary suspension, CDC
has documented decreased instances of
fraud, fewer dogs being denied
admission into the country, fewer sick
and dead dogs arriving in the United
States, and fewer federal and state
agency resources devoted to addressing
issues related to inadequately
vaccinated dogs upon arrival. This
NPRM proposes a similar regulatory
framework based on the documented
successes of the temporary suspension.
In parallel with the publication of this
NPRM, CDC has published an extension
of the temporary suspension through
July 31, 2024. A suspension remains
necessary to protect the public’s health
against the reintroduction of DMRVV
into the United States because there is
a continued threat posed by dogs from
DMRVV high-risk countries that are
unvaccinated or inadequately
vaccinated against rabies. This
continued threat is due to various
factors, including: a high volume of
dogs being imported into the United
States contemporaneous with
insufficient veterinary controls in
DMRVV high-risk countries to prevent
the export of inadequately vaccinated
dogs, inadequate veterinary supply
chains for vaccines and related
materials, and persistent workforce
capacity shortages, particularly in
DMRVV high-risk countries that export
dogs to the United States.
This NPRM proposes to incorporate
practices used during the temporary
suspension period that CDC found
effective to better protect the public’s
health from introductions of DMRVV
from high-risk countries and reduce
potential instances of fraudulent
documentation. The NPRM outlines a
framework and set of operations that
CDC believes would mitigate the need
for suspending dog imports from highrisk countries should these procedures
be adopted. We welcome feedback from
the public on all proposals contained
within this NRPM.
B. Summary of Major Provisions
In this NPRM, HHS/CDC proposes to
align U.S. import requirements for dogs
with the importation requirements of
other DMRVV-free countries by
requiring proof of rabies vaccination
and adequate serologic test results from
a CDC-approved laboratory. This NPRM
proposes for all dog imports: a
microchip, six-month minimum age
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requirement for admission, importer
submission of a CDC import form (CDC
Import Submission Form), and
requirements for airlines to confirm
documentation, provide safe housing,
and assist public health officials in
determining animal cause of death.
HHS/CDC proposes all importers of
dogs that have been in a DMRVV highrisk country in the past six months,
regardless of whether foreign- or U.S.vaccinated, would be required to submit
a standardized vaccination form
verifying the rabies vaccination status of
dogs. For dogs that have been in a
DMRVV high-risk country in the past
six months and have a valid U.S.-issued
rabies vaccination certificate, this
NPRM proposes that the dog be required
to arrive at a U.S. airport with a CDC
quarantine station. For dogs that have
been in a DMRVV high-risk country in
the past six months, and were
vaccinated in a foreign country, this
NPRM proposes that the dog be required
to arrive a U.S. airport with a CDC
quarantine station and a CDC-registered
Animal Care Facility. This NPRM
further proposes that dogs imported
from DMRVV-free or DMRVV low-risk
countries be eligible to arrive at any U.S.
port. In lieu of a CDC vaccination form,
which would be required for dogs
imported from DMRVV high-risk
countries, these importers may instead
provide proof that the dogs have only
been in DMRVV-free or DMRVV lowrisk countries during the previous six
months prior to arriving in the United
States.
HHS/CDC also proposes to require
that all dogs arriving from any country,
including dogs returning to the United
States after traveling abroad, be properly
microchipped with an International
Standards Organization (ISO)compatible microchip prior to travel
into the United States. The microchip
information would be included on
importation documents to help ensure
that dogs presented for admission are
the same dogs as those listed on the
rabies vaccination records. Microchips
are already used globally and required
for importation in many DMRVV-free
countries. Microchips are recommended
by the international veterinary
community and animal rescue and
welfare organizations to reunite lost
animals with their owners and ensure
the veterinary records for an animal can
be linked to the animal.14
The microchip requirement will also
promote greater confidence in the
14 American Veterinary Medical Association.
Microchipping FAQ. https://www.avma.org/
resources-tools/pet-owners/petcare/microchipsreunite-pets-families/microchipping-faq. Accessed
June 1, 2023.
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information recorded on the rabies
vaccination records. CDC has
documented several instances of
importers attempting to present records
of vaccinated dogs that became ill or
died before travel as the vaccination
records for dogs that lacked appropriate
veterinary paperwork, presenting the
original dogs’ vaccination records for
the replacement dogs and attempting to
import the unvaccinated dogs into the
United States without detection.15
Because microchips are not currently
required for entry into the United States
and the dogs in question were not
microchipped, the public health
investigation to confirm the identity of
these dogs was both resource intensive
and challenging. Further, during CDC’s
temporary suspension of dogs entering
the United States from DMRVV highrisk countries, CDC documented that 99
percent (>20,000) of permit applications
received were for dogs that had
microchips implanted prior to the
announcement of the suspension.
Microchips are frequently used by pet
owners and required for international
transit by many foreign countries.
Therefore, CDC’s proposed requirement
would have minimal impact on dog
importations, although costs to some
importers would still be incurred. We
welcome feedback on this proposal.
To address concerns about
importations of puppies that are too
young to be properly vaccinated against
rabies, through this NPRM, HHS/CDC
proposes requiring that any dog arriving
in the United States be at least six
months of age. Dogs cannot be
vaccinated effectively against rabies
before 12 weeks of age and are not
considered fully vaccinated until 28
days after vaccination.16 Establishing a
six-month minimum age requirement
for the import of dogs aligns with
current USDA requirements for
commercial dog imports under the
Animal Welfare Act 17 and will better
protect the public’s health from rabies.
Under this proposal, an exception
would be included to permit an owner
to import a maximum of three
individual (personal pet) dogs under six
months of age in the same calendar year
(January–December) if arriving in the
United States via a U.S. land port
through Canada or Mexico, provided the
dogs have not been in a DMRVV high15 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog importation data, 2018–2020.
Accessed: February 15, 2021.
16 National Association of State Public Health
Veterinarians. Compendium of animal rabies
prevention and control, 2016. JAVMA 2016; 248
(5):505–517.
17 7 U.S.C. 2148.
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risk or DMRVV-restricted country since
birth. CDC notes that both Canada and
Mexico are currently DMRVV-free
countries, and a limited exception to
accommodate personal pet owners who
travel by land between the U.S. and
Canada or Mexico is unlikely to threaten
the public’s health. HHS/CDC
specifically welcomes public comment
this proposal.
In this NPRM, HHS/CDC also
proposes to require all dog importers to
submit a CDC Import Submission Form
(i.e., an online form that includes the
importers’ contact information and
information related to each dog being
imported) via a CDC-approved system
prior to travel to the United States. This
proposed requirement would apply to
all imported dogs (including dogs
arriving from DMRVV-free and DMRVV
low-risk countries) arriving in the
United States by air, land, or sea. Upon
arrival at a U.S. port,18 importers will
present a receipt confirming they
submitted a completed CDC Import
Submission Form; additionally,
importers arriving by air will present
the receipt to the airline prior to
boarding. The receipt will contain the
information submitted on the CDC
Import Submission Form, which will
allow government officials to verify that
the details from the CDC Import
Submission Form match the dog being
presented for entry. CDC’s import
submission system would operate as a
free online system. Requiring
documentation for all imported dogs
would allow CDC to track the total
number of dog importations (including
the number imported from DMRVV
high-risk countries), something CDC is
unable to do currently.
HHS/CDC further proposes that an
airline, prior to accepting a dog for
transport, must confirm that the dog
possess all required import
documentation based on the country of
origin. Airlines must also ensure dogs
from DMRVV high-risk countries will
only be entering the United States
through a designated U.S. airport with
a CDC quarantine station (if U.S.vaccinated) or a U.S. airport with both
a CDC quarantine station and a CDCregistered Animal Care Facility (if
foreign-vaccinated) and that the
importer possesses a reservation with
the CDC-registered Animal Care Facility
for examination, vaccination, and
quarantine (if required). As needed,
CDC will coordinate with the airline
regarding transport of the dog to the
CDC-registered Animal Care Facility.
18 U.S. Port means any seaport, airport, or border
crossing point under the control of the United
States. 42 CFR 71.1(b).
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These regulatory actions (if finalized as
proposed) would help ensure that dogs
arriving in the United States from
DMRVV high-risk countries are
adequately protected against rabies and
do not pose a public health threat. We
welcome feedback from the public on
this proposal.
HHS/CDC proposes to require that
airlines return dogs or cats denied
admission to the country of departure
within 72 hours after arrival. The
responsibility for a dog or cat pending
admission into the United States or
awaiting return to the country of
departure has been a point of confusion
for many airlines, resulting in delayed
care and improper housing for
numerous animals. Delays in returning
dogs to their countries of departure also
potentially threaten U.S. public health
by exposing people to dogs with
unknown rabies vaccination status.
HHS/CDC proposes that the airline on
which a dog or cat is brought to the
United States must arrange for and
ensure transportation and care until the
animal is either returned to the county
of departure or cleared for entry into the
United States.
HHS/CDC also proposes a provision
regarding dogs and cats that die en route
to the United States or that die while
detained pending determination of their
admissibility. This provision is
primarily directed at airlines and would
require that they transport deceased
dogs and cats and arrange for necropsy
requiring gross and histopathologic
examination and any subsequent
infectious disease testing based on the
findings. The importer is responsible for
all costs associated with necropsy and
testing. The airline would also be
required to notify the CDC quarantine
station of jurisdiction 19 prior to
transporting a dead dog or cat for a
necropsy to determine whether rabies
testing is required and provide the
quarantine station with the final
necropsy report and all test results.
These measures will help CDC rule out
foreign animal diseases of public health
concern 20 as a potential cause of death
and will protect both animal and human
health. The provisions of this paragraph
may also be applied to other carriers
transporting such dogs and cats in the
very rare event when the death of a dog
or cat occurs en route to the United
19 CDC quarantine station jurisdictions, available
at: www.cdc.gov/quarantine/
quarantinestationsjurisdictionscounties.html.
20 U.S. Department of Agriculture. Notifiable
Diseases and Conditions. https://
www.aphis.usda.gov/aphis/ourfocus/animalhealth/
nvap/NVAP-Reference-Guide/Animal-HealthEmergency-Management/Notifiable-Diseases-andConditions.
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Proposed Rules
States, or the animal dies while
detained pending determination of their
admissibility. HHS/CDC welcomes
public comment specifically on these
proposed requirements.
Through this NPRM, HHS/CDC
proposes to remove the current
requirement for a valid RVC in 42 CFR
71.51(c) and replace it with new rabies
vaccination forms for dogs imported
from DMRVV high-risk countries. The
proposed rabies vaccination forms
would include the rabies vaccination
status of the dog and other required
information similar to the current valid
RVC requirement. However, unlike the
current requirement for a valid RVC, the
proposed rabies vaccination forms
would be standardized.
The rabies vaccination form for
foreign-vaccinated dogs would also be
certified by a government official in the
exporting country, as an added measure
to prevent falsification. The acceptable
rabies vaccination form to fulfill this
requirement for foreign-vaccinated dogs
from DMRVV high-risk countries would
be titled ‘‘CDC Import Certification of
Rabies Vaccination and Microchip
Required for Live Dog Importations into
the United States.’’ This proposed
change would help ensure that foreignvaccinated dogs imported from DMRVV
high-risk countries meet CDC entry
requirements prior to traveling to the
United States and allow for follow-up
with the exporting country’s
government officials if repeated import
violations occur. HHS/CDC welcomes
public comment on this proposed
requirement.
Under the proposed rule, importers of
U.S.-vaccinated dogs presenting for reentry into the United States from
countries at high risk for DMRVV would
be required to arrive at a U.S. airport
with a CDC quarantine station.
Additionally, prior to traveling out of
the United States, a USDA-Accredited
Veterinarian would need to complete
and sign a form titled ‘‘Certification of
U.S.-issued Rabies Vaccination for Live
Dog Re-entry into the United States.’’
This form would then be certified by a
USDA Official Veterinarian prior to
departing the United States and would
need to be presented by the importer to
the airline to board the dog on its return
flight to the United States. The importer
would also need to present this form
when requested to do so by U.S.
government officials upon arrival. The
use of this form would decrease the
likelihood of falsification or fraud
because it would include information in
a standardized format and rely on
USDA’s existing veterinary
accreditation system. Dogs arriving with
this form would not be subject to the
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requirement for veterinary examination
(unless ill, injured, or exposed),
revaccination, verification of adequate
rabies serologic tests, and/or postvaccination quarantine at a CDCregistered Animal Care Facility.
In this NPRM, CDC/HHS proposes to
require importers of foreign-vaccinated
dogs from DMRVV high-risk countries
to enter the United States through an
airport with a CDC quarantine station
and a CDC-registered Animal Care
Facility. The importer would also need
to obtain a rabies serologic test from a
CDC-approved laboratory for their
foreign-vaccinated dogs demonstrating
adequate titer levels. In addition, the
importer would also need to have a
reservation at the CDC-registered
Animal Care Facility and have their
dog(s) undergo a veterinary exam and
revaccination with a USDA-licensed
rabies vaccine at the CDC-registered
Animal Care Facility. Importers of
foreign-vaccinated dogs who cannot
obtain serologic test results prior to
importation would be required to have
their dog remain under quarantine at the
facility for 28 days after revaccination or
until verification of adequate rabies
serologic test from a CDC-approved
laboratory is obtained, whichever occurs
first. HHS/CDC is requesting comment
on this proposed process.
HHS/CDC proposes a narrow
exception for both U.S.- and foreignvaccinated service dogs that have been
in a DMRVV high-risk country within
the last six months. This exception
would allow such dogs to enter the U.S.
at a U.S. seaport if the dog is at least six
months of age, has a microchip, has
either a complete, accurate, and valid
Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States form or a complete,
accurate, and valid CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States
form, as appropriate, and has sufficient
and valid titer results from a CDCapproved laboratory (if the dog is
foreign-vaccinated). To be considered a
valid service dog, the dog would need
to meet the definition of a ‘‘service
animal’’ under 14 CFR 382.3, be
accompanied by an ‘‘individual with a
disability’’ as defined under 14 CFR
382.3, and work or perform tasks
directly related to that individual’s
disability. HHS/CDC is requesting
comment on this proposed exception.
HHS/CDC also proposes to prohibit or
otherwise restrict importation of dogs
into the United States from certain
countries that have a history of
exporting dogs infected with DMRVV to
other countries or have demonstrated a
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lack of appropriate veterinary controls
to prevent the exportation of rabid dogs.
To implement this provision, HHS/CDC
proposes to maintain a ‘‘List of DMRVVRestricted Countries’’ from which the
importation of dogs into the United
States would be prohibited. The list of
DMRVV-restricted countries would be
maintained on CDC’s website. Additions
or removals of countries would also be
announced in notices published in the
Federal Register. Under this proposal,
CDC would retain the ability to issue a
special exemption on an extremely
limited basis for dogs that have been in
a DMRVV-restricted country in the six
months prior to their importation into
the United States (e.g., for dogs
imported for scientific purposes, for use
as a trained service animal for
individuals with disabilities,21 or in
furtherance of an important government
interest). HHS/CDC welcomes public
comment on public health standards
and evidence used to maintain a list of
DMRVV-restricted countries and the
length of time or conditions to be met
before a country is added or eligible for
removal from the list. Additionally,
HHS/CDC welcomes public comment on
how the list will be maintained and
whether publication on CDC’s website
and through Federal Register notices
would be sufficient to adequately
inform importers.
HHS/CDC proposes that airlines be
required to confirm prior to boarding
that the dog is scheduled to arrive at an
approved U.S. airport and, if foreignvaccinated, that the importer has
documentation confirming a reservation
at the CDC-registered Animal Care
Facility. This will ensure that CDC and
USDA can follow up with airlines more
easily to ensure animals are being
properly handled (e.g., not left in cargo
warehouses for prolonged periods of
time that endanger the health of the
animal). Additionally, to address
concerns relating to the movement of
dogs or cats that are sick or dead upon
arrival, HHS/CDC proposes to require
that airlines transport all sick or dead
animals (regardless of vaccination status
and country of origin) to a CDCregistered Animal Care Facility or,
under certain conditions, to other CDCor USDA-approved veterinary clinic
within six hours of arrival. CDC
acknowledges that extraordinary
circumstances, such as extreme weather,
may delay the transport of animals
beyond the six-hour window. Under
21 Emotional support animals are not recognized
as service animals. U.S. Department of
Transportation. Service Animals. https://
www.transportation.gov/individuals/aviationconsumer-protection/service-animals, last updated
June 9, 2021.
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such circumstances, CDC will work
closely with airlines to address these
rare and unforeseen events while
ensuring the safe handling of animals.
CDC also will work with importers who
arrive at unapproved U.S. ports based
on circumstances beyond their control
(e.g., re-routing of their flight due to
extreme weather). CDC quarantine
station staff are available 24 hours a day
to assist streamlined coordination and
processing of dog and cat importation at
U.S. ports and provide coverage for
geographic areas beyond the U.S. port in
which the CDC quarantine station is
located.
HHS/CDC also proposes establishing
requirements for businesses that wish to
become CDC-registered Animal Care
Facilities. Requirements would include
a USDA intermediate handlers license
and approval by CBP to act as a CBPbonded facility with an active Facilities
Information and Resource Management
System (FIRMS) code. This will ensure
dogs and cats receive appropriate
veterinary care and are housed in a way
that prevents the spread of infectious
diseases while protecting the safety of
the animals.
The requirements HHS/CDC is
proposing in this NPRM for dog
importation into the United States are
summarized below in Table 1. Since
HHS/CDC is not proposing substantial
changes to cat importation
requirements, Table 1 does not apply to
cats.
TABLE 1—SUMMARY TABLE OF PROPOSED IMPORTATION REQUIREMENTS FOR DOGS BASED ON VACCINATION STATUS
AND COUNTRY OF ORIGIN
Requirements for admission
ISOcompatible
microchip
Age
U.S.-Vaccinated Dog from DMRVV
High-Risk Country.
At least six months
of age.
Yes .............
Foreign-Vaccinated Dog from
DMRVV High-Risk Country.
At least six months
of age.
Yes .............
Dog from Rabies-Free or DMRVV
Low-Risk Country.
At least six months
of age **.
Yes .............
U.S.- or Foreign-Vaccinated Dog
from DMRVV-Restricted Country.
At least six months
of age.
Yes .............
Documentation
Approved U.S. ports
Valid Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United States
Form and CDC Import Submission Form receipt.
Reservation with a CDC-registered Animal Care Facility, CDC Import Certification of Rabies Vaccination and Microchip Required for Live Dog Importations into the United States Form, CDC Import
Submission Form receipt, titer results from a
CDC-approved laboratory (dogs without titer results will be required to quarantine).
There are no vaccination requirements, however,
written documentation that the dog has resided or
otherwise been only in a DMRVV low-risk or rabies-free country for the six months prior to the
attempted entry and CDC Import Submission
Form receipt.
CDC Dog Import Permit for limited groups of dogs
(i.e., service animals, government-owned animals).
Only U.S. airports with a CDC
quarantine station.*
Only U.S. airports with a CDC
quarantine station and a CDCregistered Animal Care Facility.*
All U.S. ports.
Only U.S. airports with a CDC
quarantine station and a CDCregistered Animal Care Facility.
* Dogs arriving at U.S. land ports that have been in DMRVV high-risk countries within the last six months will be denied admission. All service dogs entering at U.S.
seaports must be six months of age, have an ISO-compatible microchip, and have a receipt confirming submission of a CDC Import Submission Form. Service dogs
that have been in DMRVV high-risk countries within the last six months may enter the United States at U.S. seaports if they have either a valid Certification of U.S.issued Rabies Vaccination for Live Dog Re-entry into the United States Form or both a valid CDC Import Certification of Rabies Vaccination and Microchip Required
for Live Dog Importations into the United States Form and sufficient and valid titer results from a CDC-approved laboratory.
** Dogs arriving at U.S. land ports are subject to the six-month minimum age requirement. However, an importer may import up to three dogs younger than six
months of age in a calendar year if the dogs have not been in a DMRVV high-risk country since birth.
The forms HHS/CDC is proposing be
required in this NPRM for dog
importation into the United States are
summarized below in Table 2. Since
HHS/CDC is not proposing substantial
changes to cat importation
requirements, Table 2 does not apply to
cats.
TABLE 2—SUMMARY TABLE OF PROPOSED FORMS REQUIRED FROM IMPORTERS OF DOGS BASED ON VACCINATION
STATUS AND COUNTRY OF ORIGIN
Form
CDC Import Submission Form ..............................................................................
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry into the
United States Form.
CDC Import Certification of Rabies Vaccination and Microchip Required for Live
Dog Importations into the United States Form.
Application for Special Exemption for a Permitted Dog Import Form ...................
Dog from rabiesfree or DMRVV
low-risk country
U.S.-vaccinated
dog from DMRVV
high-risk country
Foreign-vaccinated
dog from DMRVV
high-risk country
U.S.-vaccinated
dog from DMRVVrestricted country
Required ...............
Not Required ........
Required ...............
Required ...............
Required ...............
N/A .......................
Required.
Required.
Not Required ........
N/A .......................
Required ...............
N/A.
Not Required ........
Not Required ........
Not Required ........
Required.
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* Importers of foreign-vaccinated dogs from DMRVV high-risk countries will also be required to provide additional information to the CDC-registered Animal Care Facilities to make a reservation for their dog prior to arrival in the United States.
The documentation HHS/CDC is
proposing in this NPRM be presented at
the U.S. port upon arrival for dog
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importation into the United States is
summarized below in Table 3. Since
HHS/CDC is not proposing substantial
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changes to cat importation
requirements, Table 3 does not apply to
cats.
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43983
TABLE 3—SUMMARY TABLE OF PROPOSED REQUIRED DOCUMENTATION TO BE PRESENTED AT U.S. PORT UPON ARRIVAL
FOR DOGS BASED ON VACCINATION STATUS AND COUNTRY OF ORIGIN
Documentation to be presented at U.S. port upon arrival
lotter on DSK11XQN23PROD with PROPOSALS4
CDC Import Submission Form Receipt .................................................................
Written documentation that the animal has resided or otherwise been only in a
rabies-free or DMRVV low-risk country for the six months prior to the attempted entry.
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry into the
United States Form.
Reservation with a CDC-registered Animal Care Facility .....................................
CDC Dog Import Permit ........................................................................................
C. Costs and Benefits
CDC conducted an analysis to
estimate the distributions of costs and
benefits that may be incurred if a final
rule is published in the future with the
requirements proposed in this NPRM.
The provisions of this NPRM (if
finalized as proposed) are not likely to
have an effect on the economy of $200
million or more in any one year,
although there is considerable
uncertainty around the number of dogs
imported at baseline, including the
number of dogs imported from DMRVV
high-risk countries. HHS/CDC is
soliciting public comment on costs to
importers, airlines and other carriers,
and State and local health departments
of the proposed requirements in this
NPRM to improve the accuracy of cost
and benefit estimates for a future final
rule.
The provisions of this NPRM (if
finalized as proposed) will address the
market inefficiency in which dog
importers do not account for the
potential detrimental impacts to public
health that may result from the
importation of ill dogs, especially dogs
infected with DMRVV. Federal
regulation is necessary to mitigate the
risk of importing infected dogs. Federal
action allows risks to be addressed prior
to dogs’ arrival in the United States and
for dogs to be evaluated, revaccinated,
and possibly quarantined (if required) in
controlled conditions after their arrival
in the United States. The regulatory
changes proposed in this NPRM (if
finalized as proposed) are expected to
affect the following categories of
interested parties and implementing
partners:
• Importers of dogs from countries
that are DMRVV-free or are low risk for
DMRVV;
• Importers of dogs from countries
that are at high risk of DMRVV;
• Airlines and other carriers;
• CBP;
• CDC;
• USDA; and
• State and local public health and
animal health departments.
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Dog from rabiesfree or DMRVV
low-risk country
U.S.-vaccinated
dog from DMRVV
high-risk country
Foreign-vaccinated
dog from DMRVV
high-risk country
U.S.-vaccinated
dog from DMRVVrestricted country
Required ...............
Required ...............
Required ...............
N/A .......................
Required ...............
N/A .......................
Required.
N/A.
Not Required ........
Required ...............
N/A .......................
Not Required.
Not Required ........
N/A .......................
Not Required ........
N/A .......................
Required ...............
N/A .......................
May be required.
Required.
The changes proposed in the NPRM
incorporate different requirements for
dogs imported from DMRVV high-risk
countries than those imported from
DMRVV-free or DMRVV low-risk
countries. The annualized and present
value estimates of monetized costs and
benefits over the 10-year period from
2023 through 2032 using three percent
and seven percent discount rates are
summarized below. The annualized,
monetized costs (2020 USD) of the
provisions in the NPRM (if finalized as
proposed) are estimated to be $29
million (range: $7.7 to $87 million)
using a three percent discount rate; the
estimated monetized costs using a seven
percent discount rate are largely the
same.
Most monetized costs are expected to
be incurred by importers (84 percent of
costs is the most likely estimate). The
estimated monetized costs are about 3.8
times greater for importers of dogs from
DMRVV high-risk countries compared
to importers of dogs from DMRVV-free
or low-risk countries. The provisions
proposed in the NPRM estimated to
result in the greatest increase in costs
for importers of dogs are those
associated with the veterinary
examination and revaccination against
rabies at a CDC-registered Animal Care
Facility for foreign-vaccinated dogs from
DMRVV high-risk countries in proposed
section 71.51(k), costs for titer testing of
foreign-vaccinated dogs from DMRVV
high-risk countries, additional costs
associated with the proposed CDC
Import Submission Form requirements
and including the information from the
form for all dogs in CDC data systems
prior to or upon entry, the proposed
minimum age for imported dogs, and
the proposed microchip requirements
for all imported dogs. Other costs
include (1) an expected reduction in the
number of dogs imported from DMRVV
high-risk countries, (2) the proposed
requirements to arrive at one of 18 U.S.
airports with a CDC quarantine station
such that some travelers would need to
arrange their travel plans to arrive at
these approved U.S. airports (required
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for U.S.-vaccinated dogs arriving from
DMRVV high-risk countries) or a more
limited number of U.S. airports with
CDC-registered Animal Care Facilities
(required for foreign-vaccinated dogs
arriving from DMRVV high-risk
countries) rather than other airports
without CDC staff, and (3) the proposed
requirement of obtaining a CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States
Form or a Certification of U.S.-issued
Rabies Vaccination for Live Dog Reentry into the United States Form with
certification by an Official Government
Veterinarian for all dogs from DMRVV
high-risk countries.
Airlines are estimated to absorb about
8.7 percent of the estimated annualized
costs associated with the NPRM (if
finalized as proposed). Most airline
costs would result from ensuring that all
transported dogs comply with the new
requirements in the NPRM (if finalized
as proposed) and from a small reduction
in the number of dogs transported.
CDC is estimated to incur about 6.9
percent of the annualized, monetized
costs (most likely estimate) associated
with the provisions of this NPRM (if
finalized as proposed). Most CDC costs
would be associated with the oversight
of animal care facilities, which must be
approved by and registered with CDC,
and the establishment of a laboratory
proficiency testing program to support
serologic testing for foreign-vaccinated
dogs imported from DMRVV high-risk
countries. CBP is expected to incur
about 0.5 percent of the annualized
costs (most likely estimate) associated
with the provisions of this NPRM (if
finalized as proposed). Most CBP costs
would result from training on the
proposed new requirements.
The annualized monetized benefits of
the provisions in the NPRM (if finalized
as proposed) are estimated to be about
$1.9 million (range: $0.80 to $4.2
million) using a three percent or seven
percent discount rate. Most benefits
would accrue to importers (46 percent
of the most likely estimates) and to CBP
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(41 percent of the most likely estimate).
Some of the benefits estimated for both
importers and CBP would result from
reduced time spent on screening dogs
from high-risk countries at U.S. ports.
The requirements in the NPRM (if
finalized as proposed) are estimated to
reduce the amount of time required to
verify admissibility per dog at U.S. ports
because it is assumed that rabies
vaccination documentation will be
included in standardized forms for
importers of dogs from DMRVV highrisk countries. The provisions in this
NPRM (if finalized as proposed) are also
estimated to reduce the number of dogs
arriving ill or dead and the number of
dogs denied entry, with benefits
estimated for importers, airlines, and
CDC.
The wide range between the lowerbound and upper-bound cost and
benefit estimates demonstrates that
there is considerable uncertainty in
these results. At present, the number of
dogs imported into the United States is
neither accurately nor completely
tracked by any data system, and the
uncertainty in the cost and benefit
estimates reflect uncertainty in both the
total number of dogs imported and the
number of dogs imported from DMRVV
high-risk countries, as well as the cost
of the new requirements in the NPRM
(if finalized as proposed). The net
annualized, monetized costs (total cost
estimate ¥ total benefit estimate) were
estimated to be about $26 million per
year (range: $6.9 to $83 million) using
a three percent discount rate. The
annualized estimates were relatively
unaffected by using a seven percent
discount rate.
The importation of just one dog
infected with DMRVV risks
reintroduction of the virus into the
United States, which could result in loss
of human and animal life and
substantial public health response
costs.22 23 24 The average cost per
importation of a single DMRVV-infected
dog is estimated to be $320,000 (range:
$220,000 to $520,000) for conducting
public health investigations and
administering rabies PEP to exposed
persons. The primary public health
benefit of the provisions in the NPRM
(if finalized as proposed) is the reduced
risk that a dog with DMRVV will be
22 Smith J, le Gall F, Stephenson S, et al. People,
pathogens and our planet. The Economics of One
Health 2012;2.
23 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. MMWR Morb Mort Wkly Rep
2020; 69 (38): 1374–1377.
24 Jeon S, Cleaton J, Meltzer M, et al. Determining
the post-elimination level of vaccination needed to
prevent re-establishment of dog rabies. PLoS Neg
Trop Dis 2019; 13 (12): e0007869.
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imported from a DMRVV high-risk
country. The above estimate of the cost
of importation of a dog with DMRVV
does not account for the worst-case
outcomes, which include (1)
transmission of rabies to a person who
dies from the disease, and (2) ongoing
transmission to other domestic and
wildlife species in the United States.
The cost of re-introduction could be
especially high if DMRVV spreads to
other species of U.S. wildlife. Reestablishment of DMRVV in the United
States could result in costly efforts over
several years to eliminate the virus
again. The costs to contain any
reintroduction would depend on the
time period before the reintroduction
was realized, the wildlife species in
which DMRVV was transmitted, and the
geographic area over which
reintroduction occurs.
An increase in human deaths from
DMRVV could occur following the reintroduction of DMRVV to the United
States, as the risk of exposure would
increase. Human deaths from rabies
continue to occur in the United States
after exposures to wild animals, and
there have been eight deaths among U.S.
residents bitten by rabid dogs while
traveling abroad in DMRVV high-risk
countries since 2009.25 CDC uses the
value of statistical life (VSL) to support
quantifying benefits for interventions
that can result in mortality risk
reductions. HHS recommends using a
median estimate of $11.6 million and a
range of $5.5 to $17.7 million (2020
USD).26 CDC is unable to estimate the
potential magnitude of the mortality risk
reduction associated with the proposed
rule. Based on the median VSL, averting
three human deaths per year would
mean the benefits of the NPRM (if
finalized as proposed) would exceed its
costs.
CDC and other Federal government
agencies do not know with precision the
number of dogs imported each year or
the countries from which the dogs
originate. More comprehensive data on
where dogs are imported from may
benefit public health investigations.
Arrival data on animals exposed to a
dog with DMRVV on U.S.-bound flights,
for example, would expedite follow-up
of exposed dogs in the United States.
The lack of data received from
implementing the current regulations
also inhibits the Federal government’s
25 Human Rabies. https://www.cdc.gov/rabies/
location/usa/surveillance/human_rabies.html.
26 U.S. Department of Health and Human
Services, 2016. Office of the Assistant Secretary for
Planning and Evaluation. Guidelines for Regulatory
Impact Analysis. https://aspe.hhs.gov/sites/default/
files/private/pdf/242926/HHS_RIAGuidance.pdf.
Accessed: April 20, 2020.
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ability to target interventions for dogs
imported from specific countries. Of
note, the COVID–19 pandemic
weakened rabies control programs in
some DMRVV high-risk countries,
increasing the risk that imported dogs
may be infected with DMRVV.27 The
provisions of this NPRM (if finalized as
proposed) would be of particular public
health benefit in light of the ongoing
resource concerns for global rabies
vaccination campaigns in the wake of
the pandemic.
These data would also benefit
agencies such as USDA’s Animal and
Plant Health Inspection Service
(APHIS), which have an interest in
regulating dog imports with the intent of
reducing the risk of introduction of
diseases that may affect U.S. livestock.
For example, in 2021, APHIS issued a
Federal Order 28 that established
additional post-entry requirements on
dogs for resale imported from countries
with ongoing African swine fever
transmission, which poses a significant
risk to U.S. pork producers.29 The
potential economic benefits of reducing
the risk of the importation of African
swine fever could be significant; in fact,
a recent outbreak in China in 2019 was
estimated to have total economic losses
equivalent to 0.78 percent of China’s
gross domestic product.30 Thus, some of
the requirements in this NPRM (if
finalized as proposed) may mitigate the
risks of introduction and transmission
of diseases that impact livestock in
addition to reducing the risk of dogs
being imported while infected with
DMRVV.
II. Public Participation
Interested persons or organizations
are invited to participate in this
proposed rulemaking by submitting
written views, recommendations, and
27 A Kunkel, Jeon S, Haim, Dilius CJP, Crowdis
K, Meltzer MI, Wallace R (2021) The urgency of
resuming disrupted dog rabies vaccination
campaigns: a modeling and cost-effectiveness
analysis. Scientific Reports (2021) 11:12476. https://
doi.org/10.1038/s41598-021-92067-5.
28 USDA/APHIS (2021) Federal Order for
Importation of Live Dogs for Resale from Regions
Where African Swine Fever Exists or is Reasonably
Believed to Exist. https://www.aphis.usda.gov/
import_export/downloads/vs-federal-order-asf.pdf
and https://www.aphis.usda.gov/aphis/newsroom/
news/sa_by_date/sa-2021/asf-dog-imports.
Accessed June 5, 2023.
29 Animal and Plant Health Inspection Service
(Aug. 4, 2021) USDA Announces Requirements for
Importing Dogs from Countries Affected with
African Swine Fever. https://www.aphis.usda.gov/
aphis/newsroom/news/sa_by_date/sa-2021/asf-dogimports. Accessed: February 5, 2022.
30 Shibing You, Tingyi Liu, Miao Zhang, Xue
Zhao, Yizhe Dong, Bi Wu, Yanzhen Wang, Juan Li,
Xinjie Wei and Baofeng Shi (2021). African swine
fever outbreaks in China led to gross domestic
product and economic losses. Nature Food; 2: 802–
808.
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data on all aspects of the proposed rule
notice. Comments received should
reference a specific portion of the
notice. Attachments and other
supporting materials are part of the
public record and subject to public
disclosure. Submitters should not
include any information in their
comments or supporting materials that
they consider confidential or
inappropriate for public disclosure.
HHS/CDC welcome comments on all
aspects of this proposed rule, including
the use of any forms or information
collected and whether proposed
requirements should be modified in any
way.
HHS/CDC will carefully review,
consider, and address all comments
submitted and may revise the content of
the rule as appropriate at the final
rulemaking stage. HHS/CDC will
publish a final rule after the comment
period that reflects any content changes
made because of comments received.
III. Background
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A. Legal Authority
HHS/CDC has reviewed this rule
under Executive Order 12988 on Civil
Justice Reform and determines that this
proposed rule meets the standard in the
Executive Order. In this action, HHS/
CDC proposes to revise 42 CFR 71.50
and 71.51.
The primary legal authority
supporting this proposed rulemaking is
section 361 of the Public Health Service
Act (PHS Act) (42 U.S.C. 264). Under
section 361, the Secretary of HHS
(Secretary) may make and enforce such
regulations as in the Secretary’s
judgment are necessary to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the United States and
from one State or possession into any
other State or possession.31 It also
authorizes the Secretary to promulgate
and enforce a variety of public health
regulations to prevent the spread of
communicable diseases, including
through inspection, fumigation,
disinfection, sanitation, pest
extermination, destruction of animals or
articles found to be sources of
dangerous infection to human beings,
and other measures. Since at least 1956,
Federal quarantine regulations
(currently found at 42 CFR 71.51) have
31 Although the statute assigns authority to the
Surgeon General, all statutory powers and functions
of the Surgeon General were transferred to the
Secretary of HHS in 1966, 31 FR 8855, 80 Stat. 1610
(June 25, 1966), see also Public Law 96–88, 509(b),
October 17, 1979, 93 Stat. 695 (codified at 20 U.S.C.
3508(b)). The Secretary has retained these
authorities despite the reestablishment of the Office
of the Surgeon General in 1987.
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controlled the entry of dogs and cats
into the United States.32
In addition to section 361, other
sections of the PHS Act relevant to this
proposed rulemaking are section 362 (42
U.S.C. 265), section 365 (42 U.S.C. 268),
section 367 (42 U.S.C. 270), and section
368 (42 U.S.C. 271). Section 362, among
other things, authorizes the Secretary to
promulgate regulations prohibiting, in
whole or in part, the introduction of
property from foreign countries or
places, for such period of time and as
necessary for such purpose, to avert the
serious danger of introducing
communicable disease into the United
States. Section 365 provides that it shall
be the duty of customs officers and of
Coast Guard officers to aid in the
enforcement of quarantine rules and
regulations.33 Through this statutory
provision, CBP provides critical
assistance in enforcing Federal
quarantine regulations at U.S. ports.
Section 367 (42 U.S.C. 270) also
authorizes the application of certain
sections of the PHS Act to air navigation
and aircraft to such extent and upon
such conditions as deemed necessary
for safeguarding public health and
authorizes the promulgation of
regulations, including provisions for
penalties and forfeitures for violations.
Section 368 of the PHS Act provides
that any person who violates regulations
implementing sections 361 or 362 is
subject to imprisonment of not more
than one year, a fine, or both. Pursuant
to 18 U.S.C. 3559 and 3571, an
individual may face a fine of up to
$100,000 for a violation not resulting in
death and up to $250,000 for a violation
resulting in death. Under section 368,
HHS/CDC may refer violators to the U.S.
Department of Justice for criminal
prosecution. HHS/CDC does not have
independent authority under section
368 to impose criminal fines or
imprison violators.
21 FR 9870 (Dec. 12, 1956).
U.S.C. 268(b). The terms ‘‘officer of the
customs’’ and ‘‘customs officer’’ are defined by
statute to mean, ‘‘any officer of the United States
Customs Service of the Treasury Department (also
hereinafter referred to as the ‘‘Customs Service’’) or
any commissioned, warrant, or petty officer of the
Coast Guard, or any agent or other person,
including foreign law enforcement officers,
authorized by law or designated by the Secretary of
the Treasury to perform any duties of an officer of
the Customs Service.’’ 19 U.S.C. 1401(i). Although
this provision refers to the Secretary of the
Treasury, the Homeland Security Act transferred to
the Secretary of Homeland Security all ‘‘the
functions, personnel, assets, and liabilities of . . .
the United States Customs Service of the
Department of the Treasury, including the functions
of the Secretary of the Treasury relating thereto . . .
[,]’’ 6 U.S.C. 203(1), such that reference to the
Secretary of the Treasury should be read to
reference the Secretary of Homeland Security.
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33 42
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Through this NPRM, HHS/CDC
proposes new language advising
individuals and organizations that it
may request that DHS/CBP take
additional action pursuant to 19 U.S.C.
1592 and 19 U.S.C. 1595a. Specifically,
CDC may request that DHS/CBP issue
additional fines, citations, or penalties
to importers or carriers whenever the
CDC Director (Director) has reason to
believe that an importer or carrier has
violated any of the provisions of this
section or otherwise engaged in conduct
contrary to law. HHS/CDC stresses that
it does not administer Title 19, and
decisions regarding whether to issue
such fines, citations, or other penalties
would be entirely at the discretion of
DHS/CBP and subject to its policies and
procedures. Notwithstanding, HHS/CDC
believes it important to include this
language to advise individuals and
organizations that it may request that
DHS/CBP pursue such actions.
Through this NPRM, HHS/CDC
further clarifies that there is no agency
policy of using the ‘‘least restrictive
means’’ (as that concept is typically
understood and applied in cases
involving interests protected by the U.S.
Constitution) in regard to animal
importations under 42 CFR part 71.
‘‘The Due Process Clause of the
Fourteenth Amendment imposes
procedural constraints on governmental
decisions that deprive individuals of
liberty or property interests.’’ Nozzi v.
Hous. Auth. of City of Los Angeles, 806
F.3d 1178, 1190 (9th Cir. 2015).
However, ‘‘[d]ue process protections
extend only to deprivations of protected
interests.’’ Shinault v. Hawks, 782 F.3d
1053, 1057 (9th Cir. 2015). Because
individuals have no protected property
or liberty interest in importing dogs or
other animals into the United States, it
is HHS/CDC’s policy to not employ a
constitutional analysis of ‘‘least
restrictive means’’ in regard to animal
imports under 42 CFR part 71. See
Ganadera Ind. v. Block, 727 F.2d 1156,
1160 (D.C. Cir. 1984) (‘‘no
constitutionally-protected right to
import into the United States’’); see also
Arjay Assoc. v. Bush, 891 F.2d. 894, 896
(Fed. Cir. 1989) (‘‘It is beyond cavil that
no one has a constitutional right to
conduct foreign commerce in products
excluded by Congress.’’). Members of
the public are invited to comment
regarding this clarification to HHS/
CDC’s animal import policy.
B. Historical Background
Rabies is one of the deadliest zoonotic
diseases and accounts for an estimated
59,000 human deaths globally each
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year.34 Over 98 percent of those deaths
are due to DMRVV.35 The rabies virus
can infect any mammal and, once
clinical signs appear, the disease is
almost always fatal.36 In September
2007, at the Inaugural World Rabies Day
Symposium, HHS/CDC declared the
United States to be free of DMRVV.37
While bat rabies lyssaviruses and
multiple terrestrial variants of rabies
continue circulating in wildlife species
(e.g., fox, raccoon, and skunk) in the
United States, the country has been free
of DMRVV since 2007 and focuses its
regulatory efforts on preventing the
reintroduction of this rabies virus
variant. The close relationship between
dogs and people means there is a direct
public health risk to individuals that
interact with inadequately vaccinated
dogs imported from countries at high
risk of DMRVV. One of CDC’s principal
goals is to prevent the reintroduction
and spread of DMRVV in the United
States.
DMRVV is still a serious public health
threat in the more than 100 countries
where it remains enzootic.38 DMRVV
has been highly successful at adapting
to new host species, particularly
wildlife, that can further transmit the
virus.39 Although the U.S. Government
does not precisely track the total
number of dogs imported each year,
CDC previously estimated that
approximately 1 million dogs are
imported into the United States
annually, of which 100,000 dogs are
from DMRVV high-risk countries.40 This
estimate was based on information
34 World Health Organization (2018). WHO Expert
Consultation on Rabies (WHO Technical Report
Series 1012). Retrieved from https://www.who.int/
publications/i/item/WHO-TRS-1012.
35 Hampson K, Coudeville L, Lembo T, et al.;
Global Alliance for Rabies Control Partners for
Rabies Prevention. Estimating the global burden of
endemic canine rabies. PLoS Negl Trop Dis
2015;9:e0003709. https://doi.org/10.1371/
journal.pntd.0003709.
36 Fooks, A.R., Banyard, A.C., Horton, D.L.,
Johnson, N., McElhinney, L.M., and Jackson, A.C.
(2014) Current status of rabies and prospects for
elimination. Lancet, 384(9951), 1389–1399. doi:
10.1016/S0140–6736(13)62707–5.
37 Velasco-Villa, A., Mauldin, M., Shi, M.,
Escobar, L., Gallardo-Romero, N., Damon, I.,
Emerson, G. (2017) The history of rabies in the
Western Hemisphere. Antiviral Res, 146, 221–232.
doi:10.1016/j.antiviral.2017.03.013.
38 Hampson K, Coudeville L, Lembo T, et al.;
Global Alliance for Rabies Control Partners for
Rabies Prevention. Estimating the global burden of
endemic canine rabies. PLoS Negl Trop Dis
2015;9:e0003709. https://doi.org/10.1371/journal.
pntd.0003709.
39 Velasco-Villa A, Mauldin MR, Shi M, et al. The
history of rabies in the Western Hemisphere.
Antiviral Res. 2017;146:221–232. doi:10.1016/
j.antiviral.2017.03.013.
40 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. 84 FR
724,724–730 (Jan. 31, 2019).
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provided by airlines, CBP, and a public
health study conducted at a U.S.-Mexico
land border crossing.41
Preventing the entry of animals
infected with DMRVV into the United
States is a public health priority. When
it is discovered that a rabid dog has
been imported into the United States, a
multi-agency response is required. This
can involve CDC, USDA, CBP, State and
local health departments and animal
health officials, and veterinarians in the
local community. Local, State, and
Federal government agencies primarily
incur the costs of investigation, testing,
and response efforts. Since 2015 there
have been four known rabid dogs
imported into the United States. Each of
the dogs was imported by a different
animal rescue organization for the
purposes of U.S. adoption. These four
cases, discussed in detail below,
highlight the vast amount of public
health resources that are required to
investigate, respond to, and mitigate the
public health threat posed by the
importation of a rabid dog.
In 2015, a rabid dog was part of a
group of eight dogs and 27 cats
imported from Egypt by an animal
rescue group. The dog had an unhealed
leg fracture and began showing signs of
rabies four days after arrival. Following
the DMRVV diagnosis, animal rescue
workers in Egypt admitted that the dog’s
rabies vaccination documentation had
been intentionally falsified to evade
CDC entry requirements.42 As a result of
this single importation, public health
officials recommended that 18 people
receive rabies PEP, seven dogs
underwent a six-month quarantine, and
eight additional dogs housed in the
same home as the rabid dog had to
receive rabies booster vaccinations and
undergo a 45-day monitoring period.43
In 2017, a flight parent imported four
dogs from Egypt on behalf of an animal
rescue organization. One of the dogs
appeared agitated and bit the flight
parent prior to the flight. A U.S.
veterinarian examined the dog one day
after its arrival and then euthanized and
tested the dog for rabies. A post-mortem
rabies test showed that the dog was
41 McQuiston, J.H., et al., Importation of dogs into
the United States: risks from rabies and other
zoonotic diseases. Zoonoses Public Health, 2008.
55(8–10): p. 421–6.
42 Sinclair JR, Wallace RM, Gruszynski K, et al.
Rabies in a dog imported from Egypt with a falsified
rabies vaccination certificate—Virginia, 2015.
MMWR Morb Mort Wkly Rep 2015;64:1359–62.
https://doi.org/10.15585/mmwr.mm6449a2.
43 Quarantine periods for animals exposed to
rabies can vary between 30 days to six months
based on several factors, including vaccination
history, serologic titers or prospective serologic
monitoring results, or jurisdictional requirements.
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positive for DMRVV.44 Public health
officials recommended that at least four
people receive rabies PEP, and the
remaining three dogs underwent
quarantine periods ranging from 30 days
to six months. An investigation revealed
the possibility of falsified rabies
vaccination documentation presented
on entry to the United States.45
Another example in 2019 involved 26
dogs that were imported into the United
States from Egypt by a rescue
organization. All dogs had rabies
vaccination documentation and
serologic documentation indicating the
presence of rabies antibodies in
response to immunization, based on
results from an Egyptian governmentaffiliated rabies laboratory. However,
one dog developed signs of rabies three
weeks after arrival and, when
euthanized, tested positive for DMRVV.
The resulting public health
investigation raised suspicions that the
rabies vaccination documents and
serological test results were falsified for
all 26 dogs in the shipment because 18
dogs in the shipment lacked serologic
evidence of vaccination when re-tested
in the United States. Due to this event,
44 people were required to receive PEP
and the 25 other dogs imported on the
same flight underwent re-vaccination
and quarantines that ranged from four to
six months. The rabid dog had been
released into an individual’s home
because of its false paperwork and
subsequently had contact with an
additional 12 dogs, all of which had to
be revaccinated and undergo quarantine
periods ranging from 45 days to six
months.46 The public health
investigations and administration of
rabies PEP to exposed persons in this
case cost more than $400,000 in state
resources.47 48 As a result of the rabid
dog importations that occurred in 2015,
2017, and 2019, CDC issued a temporary
suspension for dogs entering the United
States from Egypt.49 50
44 The diagnosis of rabies requires laboratory
confirmation on the basis of a positive result for the
direct fluorescent antibody test performed on CNS
tissue collected post-mortem. National Association
of State Public Health Veterinarians. Compendium
of animal rabies prevention and control, 2016.
JAVMA 2016; 248 (5):505–517.
45 Hercules Y, Bryant NJ, Wallace RM, et al.
Rabies in a dog imported from Egypt—Connecticut,
2017. MMWR Morb Mort Wkly Rep 2018; 67:1388–
91. https://doi.org/10.15585/mmwr.mm6750a3.
46 Raybern, C et al. Rabies in a dog imported from
Egypt—Kansas, 2019. MMWR Morb Mort Wkly Rep
2020; 69 (38): 1374–1377.
47 Id.
48 Centers for Disease Control and Prevention
(2022). Rabies Postexposure Prophylaxis. Retrieved
from https://www.cdc.gov/rabies/medical_care/
index.html.
49 84 FR 20628 (May 10, 2019).
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In June 2021, 33 dogs and one cat
were imported into the United States
from Azerbaijan by an animal rescue
organization. All dogs had rabies
vaccination documents that appeared
valid upon arrival in the United States.
Three days after arrival, one dog
developed signs of rabies and was
euthanized. CDC confirmed the dog was
infected with DMRVV known to
circulate in the Caucasus Mountains
region of Azerbaijan. The remaining
rescue animals exposed to the rabid dog
during travel were quickly dispersed
across nine states, leading to what is
believed to be the largest, multi-state,
imported rabid dog investigation in U.S.
history.51 Eighteen people received PEP
to prevent rabies because of exposure to
the rabid dog. CDC performed the test
known as the ‘‘Prospective Serologic
Monitoring’’ test on the remaining dogs
and the public health investigation
revealed that improper vaccination
practices by the veterinarian in
Azerbaijan likely contributed to the
inadequate vaccination response
documented in 48 percent of the
imported animals, including the rabid
dog.52 The 33 exposed animals were
revaccinated and placed in quarantine
for periods ranging from 45 days to six
months.53
CDC estimates a range of costs for
public health investigations and
subsequent cost of care for people
exposed to rabid dogs to be between
$220,00 and $520,000 per importation
event, as summarized in Section VI.54 55
This cost estimate does not include the
cost to evaluate, vaccinate, test, and
quarantine exposed animals. This cost
estimate also does not account for the
50 CDC implemented this suspension because of
the lack of veterinary controls available in Egypt to
prevent the exportation of rabid dogs. With limited
exceptions, CDC began requiring a CDC Dog Import
Permit and documentation of the dog’s rabies
serologic tests from World Organisation for Animal
Health (WOAH)-approved laboratories for eligible
importers. Since these permit and serologic test
requirements were implemented, no rabid dogs
have been imported from Egypt.
51 Whitehill F, Bonaparte S, Hartloge C, et al.
Rabies in a Dog Imported from Azerbaijan—
Pennsylvania, 2021. MMWR Morb Mortal Wkly Rep
2022; 71: 686–689.
52 Centers for Disease Control and Prevention
(2021). CDC responds to a case of rabies in an
imported dog. Retrieved from https://www.cdc.gov/
worldrabiesday/disease-detectives/rabies-importeddog.html.
53 Whitehill F, Bonaparte S, Hartloge C, et al.
Rabies in a Dog Imported from Azerbaijan—
Pennsylvania, 2021. MMWR Morb Mort Wkly Rep
2022; 71: 686–689.
54 Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. MMWR Morb Mort Wkly Rep
2020; 69 (38): 1374–1377.
55 CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. 84 FR
724 (Jan. 31, 2019).
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worst-case outcomes, which include: (1)
transmission of rabies to a person who
dies from the disease; and (2) ongoing
transmission to other domestic and
wildlife species in the United States.
DMRVV becoming re-established in
the United States would result in costly
efforts over several years to eliminate
the virus again. The extraordinary cost
of re-introduction of DMRVV is
demonstrated by an instance of
reintroduction that occurred in Texas,
where DMRVV had been previously
eliminated. The reintroduction resulted
in several human deaths; the subsequent
re-elimination of DMRVV cost $60
million (in 2022 USD) and required over
10 years of effort.56 57
Historically, approximately 60 to 70
percent of CDC’s dog entry denials (or
about 200 cases annually) have been
based on fraudulent, incomplete, or
inaccurate paperwork.58 However,
between January 2020 and July 2021
(i.e., during the COVID–19 pandemic,
prior to the temporary suspension), CDC
documented more than 1,000 instances
of incomplete, inadequate, or fraudulent
rabies vaccination certificates for dogs
arriving from DMRVV high-risk
countries.59 These cases resulted in dogs
being denied entry into the United
States and ultimately returned to their
country of origin.
The significant increase in the
number of dogs from DMRVV high-risk
countries arriving with incomplete,
inadequate, or fraudulent rabies
vaccination documentation observed in
2020 and 2021 coincided with increased
interest in purchasing dogs from the
international rescues and breeders
during the COVID–19 pandemic.60 61 62
56 Thomas, S., Wilson, P., Moore, G., Oertli, E.,
Hicks, B., Rohde, R., Johnston, D. (2005). Evaluation
of oral rabies vaccination programs for control of
rabies epizootics in coyotes and gray foxes: 1995–
2003. Journal of the American Veterinary Medicine
Association, 227(5),785–92. doi: 10.2460/
javma.2005.227.785.
57 Sterner, R., Meltzer, M., Shwiff, S., Slate, D.
(2009). Tactics and Economics of Wildlife Oral
Rabies Vaccination, Canada and the United States.
Emerging Infectious Diseases, 15(8), 1176–1184.
doi: 10.3201/eid1508.081061.
58 Centers for Disease Control and Prevention
(2021). Quarantine Activity Reporting System
(version 4.9.8.8.2.2A). Dog Importation data, 2010–
2019. Accessed 1 October 2022.
59 Pieracci, E., Williams, C., Wallace, R.,
Kalapura, C., Brown, C. U.S. dog importations
during the COVID–19 pandemic: Do we have an
erupting problem? PLoS ONE,16(9), e0254287. doi:
10.1371/journal.pone.0254287.
60 Id.
61 Wynne E. Dog lovers find prices rise steeply
amid COVID-fueled demand. Australian
Broadcasting Corporation News. May 20, 2021.
62 Morgan L, Protopopova A, Birkler RID, ItinShwatz B, Sutton G, Gamliel A, et al. Human-dog
relationships during the COVID–19 pandemic:
booming dog adoption during social isolation.
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Since 2021, the demand for puppies and
rescue dogs has remained high. The
trend in purchasing and rescuing dogs
from abroad has been noted in many
countries, including the United
States.63 64 65 66 Internationally, there has
been significant growth within the
companion animal breeding industry
with increasing international trade.67
Multiple international and U.S.
investigations have identified
importations of puppies that were too
young to meet rabies vaccination
requirements.68 69 70 71 In addition, there
is growing evidence that criminal
networks are becoming involved in the
lucrative dog trade, and the illegal
puppy trade was reported to have
increased during the pandemic.72 73 74
Humanities and Social Science Communications.
2021; 7(150): 1–11.
63 Pieracci, E., Williams, C., Wallace, R.,
Kalapura, C., Brown, C. U.S. dog importations
during the COVID–19 pandemic: Do we have an
erupting problem? PLoS ONE,16(9), e0254287. doi:
10.1371/journal.pone.0254287.
64 Wynne E. Dog lovers find prices rise steeply
amid COVID-fueled demand. Australian
Broadcasting Corporation News. May 20, 2021.
65 Morgan L, Protopopova A, Birkler RID, ItinShwatz B, Sutton G, Gamliel A, et al. Human-dog
relationships during the COVID–19 pandemic:
booming dog adoption during social isolation.
Humanities and Social Science Communications.
2021; 7(150): 1–11.
66 Velez M. I adopted my dog Cannoli from
overseas. It’s easier than you think. 9/20/2020.
Available at: https://www.thedailybeast.com/iadopted-my-dog-cannoli-from-overseas-its-easierthan-you-think.
67 Maher J, Wyatt T. European illegal puppy trade
and organized crime. Trends in Organized Crime.
2021; 24(4) 506–525.
68 Pieracci, E., Williams, C., Wallace, R.,
Kalapura, C., Brown, C. U.S. dog importations
during the COVID–19 pandemic: Do we have an
erupting problem? PLoS ONE,16(9), e0254287. doi:
10.1371/journal.pone.0254287.
69 Zucca P, Rossman MC, Osorio JE, Karem K, De
Benedictis P, Haifsl J, et al. The ‘bio-crime model’
of cross-border cooperation among veterinary
public health, justice, law enforcements, and
customs to tackle the illegal animal trade/bioterrorism and to prevent the spread of zoonotic
diseases among human population. Frontiers in
Veterinary Science. 2020; 7: 1–13.
70 Cocchi M, Danesi P, DeZan G, Leati M,
Gagliazzo L, et al. A three-year biocrime sanitary
surveillance on illegally imported companion
animals. Pathogens. 2021; 10(80):1–12.
71 Houle MK. Perspective from the field: Illegal
puppy imports uncovered at JFK airport. 2017.
Available at: www.cdc.gov/ncezid/dgmq/featurestories/operation-dog-catcher.html.
72 Maher J, Wyatt T. Rural-urban dynamics in the
UK illegal puppy trade: trafficking and trade in
man’s best friend. International Journal of Rural
Law and Policy. 2019; 9 (2): 1–20.
73 Zucca P, Rossman MC, Osorio JE, Karem K, De
Benedictis P, Haifsl J, et al. The ‘bio-crime model’
of cross-border cooperation among veterinary
public health, justice, law enforcements, and
customs to tackle the illegal animal trade/bioterrorism and to prevent the spread of zoonotic
diseases among human population. Frontiers in
Veterinary Science. 2020; 7: 1–13.
74 British Broadcasting Corporation. Illegal puppy
trade warning as sales boom during the COVID
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Because imported dogs will typically
encounter multiple people, pets, and
other animals throughout their
journey—beginning at the airport in the
country of departure and continuing
with the airline, through the U.S. port,
and pet adoption and pet socialization
process—an increase in inadequately
vaccinated dogs likewise increases the
risk of human and animal exposure.75
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Temporary Suspension of the
Importation of Dogs From DMRVV
High-Risk Countries
In light of these concerns, on June 16,
2021, CDC announced a temporary
suspension of the importation of dogs
from DMRVV high-risk countries to
protect the public’s health. The
temporary suspension was issued
because public health resources were
being diverted to the response to the
COVID–19 pandemic, which limited the
availability of resources to respond to
dog importation issues. This diversion
of resources coincided with the
documented increase in fraudulent
vaccine documentation and importers
circumventing dog import regulations.
To address these concerns, CDC
developed a framework for dog
importation requiring importers to
apply for special permission to import
a dog into the United States. Importers
were required to submit an Application
for Special Exemption for a Permitted
Dog Import form 76 and obtain a CDC
Dog Import Permit prior to importing a
dog into the United States. To obtain a
permit, an importer had to demonstrate
that the dog was at least six months old,
had a microchip, had proof of rabies
vaccination, and had obtained a
serologic titer test from a CDC-approved
laboratory if the dog was vaccinated
outside the United States.
From July 14, 2021, to June 9, 2022,
CDC issued CDC Dog Import Permits on
a limited basis, for persons permanently
relocating to the United States,
importers of government-owned
working dogs, or owners of service
animals 77 to alleviate the potential
burden of the temporary suspension for
these categories of importers. On
pandemic. 18 NOV 2020. British Broadcasting
Corporation News.
75 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog importation data, 2018–2020.
Accessed: February 15, 2021.
76 Approved under OMB Control Number 0920–
1383 Importation Regulations (42 CFR 71 Subpart
F) (exp. 1/31/2026, or as revised).
77 A service dog must meet the definition of a
‘‘service animal’’ under 14 CFR 382.3, be
accompanied by an ‘‘individual with a disability’’
as defined under 14 CFR 382.3, and work or
perform tasks directly related to that individual’s
disability.
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December 1, 2021, consistent with
public health standards of practice, CDC
eased some of the temporary suspension
restrictions. CDC allowed dogs six
months of age or older that were
microchipped and accompanied by
valid U.S. RVCs to re-enter the United
States without a CDC Dog Import
Permit. Because these dogs were
vaccinated in the United States, CDC
determined that allowing them to enter
without a CDC Dog Import Permit
would be unlikely to endanger the
public’s health. To provide additional
resources for importers of foreignvaccinated dogs, CDC expanded the
number of approved rabies serologic
testing laboratories from five to 60
laboratories.78 CDC also reduced the
wait time following collection of a
serologic sample to permit dogs to be
eligible to enter the United States after
only 45 days, rather than the previous
90-day waiting period. In addition,
based on data from the latter part of
2021 showing a significant decrease in
the arrival of ill dogs and dogs being
denied entry, CDC allowed imported
dogs from DMRVV high-risk countries
to enter through any of the 18 U.S.
airports with a CDC quarantine
station.79 80
Even with the temporary suspension
in place, CDC documented multiple
instances of importers attempting to
circumvent entry requirements by using
fraudulent rabies vaccination
documents that had been fabricated to
make them appear as if they had been
issued in the United States. CDC also
documented instances of importers
presenting fraudulent rabies vaccination
documents purporting to be from
DMRVV-free countries to import young
puppies from DMRVV high-risk
countries into the United States,
presumably for resale. These factors
highlight the need for rabies vaccination
documentation to be standardized for all
dogs arriving from DMRVV high-risk
countries to reduce the likelihood of
falsified documentation in the future.
On June 1, 2022, CDC announced that
effective June 10, 2022, it would modify
and extend the temporary suspension
78 List of CDC-approved labs can be found at
www.cdc.gov/importation/bringing-an-animal-intothe-United-States/approved-labs.html.
79 List of U.S. ports with a CDC quarantine station
available at: www.cdc.gov/quarantine/
quarantinestationcontactlistfull.html.
80 At the time the Federal Register announcing
the temporary suspension was published, dogs
imported from high-risk countries were only
allowed to enter the United States through the one
port of entry with an animal care facility. However,
CDC’s review of dog importation data from July 14–
November 30, 2021, noted a significant decrease in
the arrival of ill dogs and dogs denied entry,
reducing the need for dogs to enter only through
U.S. ports with an animal care facility.
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through January 31, 2023.81 The
suspension was extended based on the
continued risk of the reintroduction of
DMRVV into the United States and the
ongoing need to commit global public
health resources towards the COVID–19
pandemic. Between the temporary
suspension going into effect on July 14,
2021, and June 1, 2022, CDC
documented a decrease in dog
importation issues that existed prior to
the suspension (e.g., the number of
suspected fraudulent rabies vaccination
documents, the number of dogs that
were sick or dead upon arrival). CDC’s
ability to track and monitor dog imports
from DMRVV high-risk countries also
improved during this timeframe. For
these reasons, CDC modified the terms
of the temporary suspension to allow
more dog imports into the United States
by a wider range of importers building
upon the requirements that had already
been in place and had been successful
in reducing dog importation issues. On
February 1, 2023, CDC extended the
temporary suspension without
modifications through July 31, 2023,
because of a continued risk of
reintroduction of DMRVV due to
insufficient veterinary controls in
DMRVV high-risk countries to prevent
the export of inadequately vaccinated
dogs and veterinary supply chain and
workforce capacity shortages that have
persisted since the global COVID–19
pandemic.82
In parallel with the publication of this
NPRM, CDC has published an extension
of the temporary suspension through
July 31, 2024. A suspension remains
necessary to protect the public’s health
against the reintroduction of DMRVV
into the United States because there is
a continued threat posed by dogs from
high-risk countries that are
unvaccinated or inadequately
vaccinated against rabies. This
continued threat is due to various
factors, including: a high volume of
dogs being imported into the United
States contemporaneous with
insufficient veterinary controls in highrisk countries to prevent the export of
inadequately vaccinated dogs,
inadequate veterinary supply chains for
vaccines and related materials, and
persistent workforce capacity shortages,
particularly in high-risk countries that
export dogs to the United States.
Through this NPRM, HHS/CDC
proposes to address the various
concerns with the importation of dogs
81 Notice of Extension and Modification of
Temporary Suspension of Dogs Entering the United
States From High-Risk Rabies Countries. 87 FR
33158 (June 1, 2022).
82 88 FR 5348 (Jan. 27, 2023).
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observed in recent years by establishing
a regulatory framework based on the
documented successes of the temporary
suspension. In addition, the
requirements and standards proposed in
the rule would help ensure the health
and safety of imported animals while
also protecting the public’s health and
preventing the reintroduction of
DMRVV into the United States.
There are numerous challenges
associated with reviewing rabies
vaccination documentation from around
the world, including the lack of a
standardized rabies vaccination
documents, different required elements
on a rabies vaccination documents,
differences in who can vaccinate and
issue rabies vaccination documents, and
limited to no accountability for
unlicensed or unauthorized vaccinators.
CDC has documented numerous
instances of fraudulent or erroneous
paperwork for dogs based on various
factors. These include:
• Dogs that were younger than the age
indicated on their rabies vaccination
paperwork (based on dental
examination by U.S. veterinarians);
• Differences between the breed, sex,
color, or microchip number listed on the
rabies vaccination documents and the
dog presented for admission;
• Suspicious veterinary stamps and
inconsistent signatures across veterinary
paperwork;
• Inconsistent dates of rabies
vaccination between different veterinary
documents; and
• Vaccines administered after the
expiration date of the vaccine lot.
The international public health
community has recognized that rabies
vaccination documentation alone is no
longer sufficient to ensure adequate
protection against rabies.83 84 Numerous
DMRVV-free countries, including
Australia, New Zealand, and European
Union member states, already require a
two-step verification of rabies
vaccination status for dogs imported
from DMRVV high-risk countries (when
direct importation is allowed), by which
a valid RVC and proof of adequate
rabies serologic test are required for
importation. The international standard
is to capture any required information
for movement of animals via an ‘‘import
(movement) certificate.’’ Import
83 World Organisation for Animal Health.
Terrestrial Code Online Access—WOAH—World
Organisation for Animal Health, Chapter 2.1.17 and
8.14. https://www.woah.org/en/what-we-do/
standards/codes-and-manuals/terrestrial-codeonline-access/?id=169&L=1&htmfile=chapitre_
certif_rabies.htm.
84 World Health Organization. Expert
Consultation on Rabies, Third Report. Geneva,
Switzerland. 2018.
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certificates can be standardized, which
helps to ensure all required information
is included and the information is
verified by an Official Government
Veterinarian in the exporting country
prior to the animal’s shipment to the
United States. Implementing the use of
standardized import certificates, which
have long been used for the
international movement of animals and
are well understood by foreign
governments, would enhance
compliance with CDC entry
requirements and ensure that follow-up
with the exporting country can occur if
import violations are noted.85
In addition to issues with fraudulent
or incomplete rabies vaccination
documents, CDC has observed in recent
years a number of practices that raised
concerns relating to how airlines
transport and house animals. Some
airlines have chosen to leave dogs
denied admission or pending
determination of admissibility in cargo
warehouses, which can create an unsafe
environment for workers exposed to
dogs with zoonotic diseases (such as
rabies, brucellosis, leptospirosis, and
numerous intestinal or external
parasites). Workers also risk bites,
scratches, and other injuries, as they are
not trained to handle live animals and
are required to feed, water, and provide
breaks or cage cleaning for the animals
in accordance with USDA Animal
Welfare Act standards. As a result,
many animals are left in crates for
extended periods of time without
immediate supervision while warehouse
workers conduct routine duties. These
conditions are often unsafe for dogs due
to the prolonged periods of time
between flights, inadequate cooling and
heating, non-compliant cleaning and
sanitization of crates, and the inability
to physically separate the animals from
areas of the warehouse where other
equipment, machinery, and goods are
used and stored.
CDC has documented numerous
instances of dogs housed under
inadequate conditions while in the care
of airlines. For example, during the
COVID–19 pandemic, fewer
international flights worldwide 86 87
resulted in delayed returns for dogs
denied admission to the United States.
85 https://www.aphis.usda.gov/aphis/ourfocus/
animalhealth/export/iregs-for-animal-exports/ct_
iregs_animal_exports_home.
86 https://www.cnbc.com/2020/04/02/
coronavirus-update-american-airlines-cutssummer-international-flights-by-60percent-asdemand-suffers.html.
87 https://news.aa.com/news/news-details/2020/
American-Airlines-Announces-AdditionalSchedule-Changes-in-Response-to-CustomerDemand-Related-to-COVID-19-031420-OPS-DIS-03/
default.aspx.
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43989
In August 2020, a dog died in the
custody of an airline at Chicago O’Hare
International Airport after CDC denied
admission to a group of dogs based on
falsified rabies vaccination
documentation. Despite CDC’s request
to find appropriate housing at a local
kennel or veterinary clinic, the airline
left 18 dogs in a cargo warehouse
without food and water for more than 48
hours contributing to the death of one
dog.88 In March 2023, a dog arrived at
a U.S airport without a CDC-registered
Animal Care Facility. The dog was later
found dead in the airline’s cargo
warehouse.89
Because there are insufficient
numbers of animal care facilities with a
USDA intermediate handlers license
and a CBP-issued FIRMS code available
to house dogs that are denied
admission, CDC worked with USDA,
CBP, and local businesses to identify
and approve five new animal care
facilities in 2021 and 2022 as part of the
strategic shift towards safer importation
controls. As of June 1, 2023, there are
five CDC-registered Animal Care
Facilities with a USDA intermediate
handlers license and a FIRMS code
issued by CBP. The five facilities are
located at Atlanta Hartsfield-Jackson
International Airport, John F. Kennedy
International Airport (New York), Los
Angeles International Airport, Miami
International Airport, and Washington
Dulles International Airport
(Washington DC Metropolitan Area).
While airlines are ultimately
responsible for finding appropriate
housing for dogs denied admission, the
inadequate number of facilities with a
CBP-issued FIRMS code and USDA
intermediate handlers license for
holding and providing care for live
animals creates significant
administrative and financial burdens for
Federal, State, and local governments.
To address these concerns, this NPRM
proposes that if a CDC-registered
Animal Care Facility with a CBP-issued
FIRMS code and USDA intermediate
handlers license is not available to hold
a dog while the U.S. Government
determines admissibility, the airline
that has transported the dog would be
required to, at a minimum, arrange
transfer of the animal to a veterinary
clinic or kennel that meets USDA
Animal Welfare Act standards 90 and is
approved by CDC.
88 https://www.cbsnews.com/chicago/news/dogdies-at-ohare-airport-warehouse-17-others-savedafter-being-left-without-food-or-water-for-3-days/.
89 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System. March 2023.
90 U.S. Department of Agriculture. Animal
Welfare Regulations; Part 3, Subpart A:
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While costs associated with housing,
caring for dogs, and returning dogs are
the responsibility of the importer (or
airline if the importer abandons the
dog), some importers and airlines have
been reluctant to pay these costs,
requiring the Federal government to
find appropriate interim housing
facilities, and veterinary care. The cost
to house, care for, and return
inadequately vaccinated dogs ranges
between $1,000 and $4,000 per dog,
depending on the location and time
required until the next available return
flight. The Federal government has been
required to find individualized
solutions to ensure appropriate
accommodations for prolonged periods
of time for these animals pending return
to their countries of departure and has
been left to bear the costs for such
housing, care, and return of dogs when
airlines and importers have not. The
increasing demand to vaccinate and
quarantine dogs that have been denied
admission presents an increasing
burden to Federal, State, and local
public health agencies.91 92 The
increased need for inspections,
veterinary medical care, and appropriate
quarantine of dogs inadequately
vaccinated against rabies has financially
burdened Federal and State agencies
while also putting the public’s health at
risk.
Additionally, an increasing number of
dogs being imported do not meet age
requirements of multiple agencies. CDC
has noted that 61 percent (890/1463) of
dogs denied admission and 46 percent
of ill or dead dogs arriving in the United
States from 2019 to 2021 were under six
months of age. During the first six
months of 2021, CDC investigated 35
instances of sick or dead puppies under
six months of age. CDC has also
documented an increase in fraudulent
rabies vaccination documentation from
importers claiming the dogs were over
four months of age.93 Many of these
dogs were imported into the United
Transportation Standards. Sections 3.14–3.20. July
2020. Available at: https://www.aphis.usda.gov/
animal_welfare/downloads/AC_BlueBook_AWA_
508_comp_version.pdf.
91 Pieracci EG, Maskery B, Stauffer K, Gertz A,
Brown C. Risk factors for death and illness in dogs
imported into the United States, 2010–2018.
Transbound Emerg Dis 2022. DOI: 10.1111/
tbed.14510.
92 Pieracci EG, Williams CE, Wallace RM,
Kalapura CR, Brown CM (2021) U.S. dog
importations during the COVID–19 pandemic: Do
we have an erupting problem? PLoS ONE 16(9):
e0254287. https://doi.org/10.1371/journal.pone.
0254287.
93 Pieracci, EG; Williams, CE; Wallace, RM;
Kalapura, CR; Brown CM. U.S. dog importations
during the COVID–19 pandemic: Do we have an
erupting problem? PLoS ONE 2021;16 (9):
e0254287.
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States for resale or adoption. USDA
requires any dog entering the United
States for resale or adoption to be six
months of age; however, many
importers claim the animals as personal
pets to avoid the age requirement
because younger dogs may be sold for
more money.94 This has led to multiple
instances where young puppies, some as
young as six weeks of age, were
transported in violation of the Animal
Welfare Act, which requires dogs to be
at least eight weeks of age to be eligible
to fly, in an attempt to circumvent the
entry requirements of multiple agencies.
Updated and standardized vaccination
information collection and minimum
age requirements will help address
these issues.
The requirements proposed in this
NPRM, if adopted, would also help
address public health concerns
regarding sick or dead animals being
imported to the United States. If an
animal arrives in the United States and
appears ill or is dead, a public health
investigation is required to ensure the ill
or dead animal does not present a
public health threat. The overall health
of an animal can play a significant role
in whether it can maintain core body
functions (i.e., body temperature
regulation and glucose levels) during
prolonged flights. Stressed,
malnourished, and young animals are
more likely to become ill and can
transmit communicable diseases that
can affect humans; 95 96 therefore, safety
and welfare concerns for the transport of
dogs have a public health impact that
requires a degree of oversight from
public health agencies to ensure human
and animal health is protected.97
Additionally, diagnostic testing or
necropsy of ill or dead animals,
respectively, is critical to understand
the underlying cause of illness or death
and ensure the animals do not pose a
public health risk.
The creation of standards for CDCregistered Animal Care Facilities; the
requirement that all foreign-vaccinated
dogs be examined, vaccinated, and
quarantined (when applicable) at one of
94 Id.
95 Galanis E et al. Brucellosis and other diseases
imported with dogs. BCMJ 2019; 61 (4): 177–190.
Available at: https://bcmj.org/bccdc/brucellosisand-other-diseases-imported-dogs.
96 Denstedt E. Echinococcus multilocularis as an
emerging public health threat in Canada: A
knowledge synthesis and needs assessment.
Accessed: 28 February 2019. Available at:
www.ncceh.ca/sites/default/files/Guelph-Denstedt2017.pdf.
97 Pieracci EG, Maskery B, Stauffer K, Gertz A,
Brown C. Risk factors for death and illness in dogs
imported into the United States, 2010–2018.
Transbound Emerg Dis 2022. DOI: 10.1111/
tbed.14510.
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these facilities prior to entry into the
United States; and the prevention
measures in this proposed rule will
mitigate the need for future broadly
applied suspensions and help ensure
the health and safety of imported
animals while also serving to protect
public health and prevent the
reintroduction of DMRVV into the
United States.
C. Current Process
Currently, per regulation at 42 CFR
71.51(c), there is no standard form used
to capture rabies vaccination
information. However, importers must
present valid RVCs which must include
all of the following information to be
valid:
• Identifies a dog on the basis of
breed, sex, age, color, markings, and
other identifying information.
• Specifies a date of rabies
vaccination at least 30 days before the
date of arrival of the dog at a U.S. port.
• Specifies a date of expiration which
is after the date of arrival of the dog at
a U.S. port. If no date of expiration is
specified, then the date of vaccination
shall be no more than 12 months before
the date of arrival at a U.S. port.
• Bears the signature of a licensed
veterinarian.
Upon the dog’s arrival in the United
States, Federal officials examine the
RVC and ensure the description of the
dog listed on the paperwork matches the
dog presented. For a rabies vaccine to be
effective, the dog must be at least 12
weeks (84 days) of age at the time of
administration. A dog’s initial vaccine
must also be administered at least four
weeks (28 days) before arrival in the
United States.
Under HHS/CDC’s regulatory
authority, dogs arriving from DMRVV
high-risk countries without appropriate
RVCs are denied admission and
returned to the country of departure on
the next available flight.98 CDC
currently recommends that airlines
house dogs awaiting return to their
country of departure at a USDAaccredited facility that meets the
USDA’s Animal Welfare Act standards
during transit. However, these facilities
are often cargo warehouses that are not
equipped to house live animals for more
than several hours.
The transportation, care, and payment
for sick or dead animals are highly
variable and depend on whether the
animal is suspected of having rabies.
Ideally, local veterinarians are consulted
98 Guidance Regarding Agency Interpretation of
‘‘Rabies-Free’’ as it Relates to the Importation of
Dogs into the United States, 84 FR 724 (Jan. 31,
2019).
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immediately to provide care for sick
animals; however, importers and
owners frequently refuse to pay for the
care of sick animals resulting in
confusion and delayed care for often
critically ill animals. When owners have
refused to pay for the care of their sick
animals, the responsibility has been
transferred to the airline that
transported the animals into the United
States, but some airlines have been
reluctant to pay costs associated with
the care and housing of animals. While
State health departments and CDC will
test blood samples free of charge when
rabies is suspected, in some instances,
CDC has been left to cover the costs of
animal care.
HHS/CDC believes that clarifying the
regulatory requirements delineating
importer and carrier responsibilities
would streamline the animal
importation process and help ensure
sick animals receive timely veterinary
care upon arrival in the United States if
needed. We welcome input from the
public on all proposals contained
herein.
IV. Summary of Proposed Changes
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Proposed Changes to 71.50
Section 71.50(b) contains definitions
applicable to animal importations under
subpart F of 42 CFR part 71. The
definitions contained in paragraph (b)
are of general scientific applicability
and thus would apply to different
animal imports, not just dogs and cats.
HHS/CDC proposes adding the
following definitions to 42 CFR
71.50(b): Authorized Veterinarian,
histopathology, in-transit shipments,
microchip, necropsy, Official
Government Veterinarian.
Authorized Veterinarian means an
individual who has obtained both an
advanced degree and valid license and
is authorized to practice animal
medicine in the exporting country.
Histopathology means the study of
changes in animal tissue caused by
disease.
In-Transit Shipment means a cargo
shipment originating in a foreign
country that is moved through one or
more U.S. ports while transiting through
the United States to a third-country
destination.
Microchip means an implanted radiofrequency device placed under the skin
of an animal that contains a unique
identification tag that meets the
International Standards Organization
(ISO) compatibility through ISO 11784
or ISO 11785, or similar technologies as
approved by the Director.
Necropsy means an animal autopsy in
which the cause of death may be
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determined through the examination
and collection of tissues, organs, or
bodily fluids post-mortem.
Official Government Veterinarian
means a veterinarian who performs
work on behalf of an exporting country’s
government and can verify the license
or credentials of an Authorized
Veterinarian.
HHS/CDC also proposes adding a new
subsection at 42 CFR 71.50(c)
addressing the legal severability of
provisions found in 42 CFR part 71
Subpart F—Importations. Because the
provisions relating to importations
under Subpart F are designed to protect
the public’s health from various
zoonotic disease threats, HHS/CDC
intends that these provisions have
maximum legal effect. Accordingly,
HHS/CDC proposes adding language
that in the event any provision of this
subpart is held by a reviewing court of
law to be invalid or unenforceable by its
terms, or as applied to any person or
circumstance, that the provision be
construed so as to continue to give the
maximum effect to the provision
permitted by law. If a reviewing court
should hold that a provision is utterly
invalid or unenforceable, then HHS/
CDC intends that the provision be
severable from Subpart F and not affect
the remainder or the application of the
provision to persons not similarly
situated or to dissimilar circumstances.
HHS/CDC seeks public comment
regarding this and other proposed
changes to 71.50.
Proposed Changes to 71.51
(a) Definitions.
Section 71.51(a) contains definitions
specifically applicable to importations
of dogs and cats under this section.
Among other things, HHS/CDC proposes
definitions for animal, CDC-registered
Animal Care Facility, CDC Import
Submission Form, conditional release,
confinement, DMRVV-free countries,
DMRVV high-risk countries, DMRVV
low-risk countries, DMRVV-restricted
countries, importer, SAFE TraQ,
serologic testing, USDA-Accredited
Veterinarian, and USDA Official
Veterinarian. Some of these definitions
were previously published in
guidance.99
Animal means all domestic cats (Felis
catus) or domestic dogs (Canis
familiaris).
CDC-registered Animal Care Facility
means a facility registered by CDC for
the purpose of providing veterinary care
99 CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. 84 FR
724 (Jan. 31, 2019).
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43991
and housing to animals imported into
the United States.
CDC Import Submission Form means
an OMB-approved declaration 100
submitted to CDC through an online
portal that includes the importer’s name
and contact information; description of
the dog, including microchip number,
current photographs of the dog’s face
and body; purpose of importation; travel
information, including dates of
departure and arrival, country of
departure, countries visited in the past
six months, and U.S. port of entry; and
other information as described in CDC
technical instructions. A receipt
confirming successful submission of
this form must accompany all dogs
departing foreign locations for travel to
the United States. For dogs departing
from airports overseas with a U.S. final
destination, the responsible airline must
confirm the receipt prior to dogs being
loaded onto departing aircraft.
Conditional release, when applied to
a dog or cat, means the temporary
release of a dog or cat from the custody
of a carrier into the care of a licensed
veterinarian approved by CDC for the
purpose of receiving emergency medical
care or a public health evaluation,
pending removal of the dog or cat from
the United States. Dogs and cats must be
returned immediately to the carrier’s
custody upon the conclusion of such
medical care or evaluation for removal
from the United States.
Confinement, when applied to a dog
or cat, means restriction to a building or
other enclosure at a U.S. port or other
location approved by CDC, including en
route to a destination, in isolation from
other dogs and cats, and from persons
except for contact necessary for its care.
If the animal is allowed out of the
enclosure, it must be muzzled and kept
on a leash.
DMRVV-free countries means
countries assessed by CDC based on
internationally accepted standards as
not having DMRVV present.
DMRVV low-risk countries means
countries assessed by CDC as low risk
for DMRVV transmission based on
factors such as the virus being limited
to a localized area, adequacy of
surveillance and dog vaccination
programs to prevent further geographic
distribution of the virus, and the virus
being in a controlled status with the
country or countries heading toward
eventual DMRVV-free status.
DMRVV high-risk countries means
countries assessed by CDC as high risk
for DMRVV transmission based on
factors such as the presence and
100 Current OMB approval no. 0920–1383 (exp. 1/
31/26).
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geographic distribution of the virus or
low quality of or low confidence in
rabies surveillance systems or dog
vaccination programs.
DMRVV-restricted countries means
countries for which the export of dogs
into the United States has been
prohibited or otherwise restricted based
on the countries’ export of dogs infected
with DMRVV to any other countries
within a period determined by CDC or
based on evidence of lacking adequate
controls, as determined by CDC, to
monitor and prevent the export of dogs
to the United States with falsified or
fraudulent vaccine credentials, invalid
rabies vaccination forms, or other
fraudulent, inaccurate, or invalid
importation documents.
Importer of dogs or cats means any
person importing or attempting to
import a dog or cat into the United
States, including the animal’s legal
owner or a person acting on behalf of
the importer, such as a broker licensed
with CBP. Individuals compensated or
hired to transport animals on behalf of
the importer must have a valid USDA
license or registration. CDC believes that
requiring that individuals who are
compensated or hired to transport
animals have a valid USDA license or
registration pursuant to the Animal
Welfare Act would help deter
fraudulent conduct.
HHS/CDC is also providing a new
definition for what constitutes proof of
rabies vaccination. These definitions are
needed to provide clarity regarding
HHS/CDC’s proposed admission
requirements.
CDC Import Certification of Rabies
Vaccination and Microchip Required for
Live Dog Importations into the United
States Form means the OMB-approved
form 101 that must be: (1) completed by
an Authorized Veterinarian in the
exporting country, which may include
an Official Government Veterinarian in
the exporting country; and (2) reviewed
and certified by an Official Government
Veterinarian in the exporting country
attesting that the information listed is
true and correct.
Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States Form means the OMBapproved form 102 that must be
completed by a USDA-Accredited
Veterinarian and certified by a USDA
Official Veterinarian prior to exporting
a dog from the United States in order to
demonstrate compliance with
101 OMB
approval no. 0920–1383 (exp. 1/31/26).
approval no. 0579–0020, 0036, 0048,
0101, 0156, 0278, 0432.
102 OMB
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admissibility requirements upon
returning to the United States.
SAFE TraQ means the System for
Animal Facilities Electronic Tracking of
Quarantine or other system as approved
by the Director for tracking the
quarantine of animals approved for
admission into the United States.
Serologic Testing, when applied to an
imported animal, means an antibody
titration test performed by a CDCapproved rabies laboratory using a CDCapproved technique. The serology
sample must be drawn and submitted in
accordance with CDC technical
instructions. The current list of CDCapproved laboratories is available
online.
USDA-Accredited Veterinarian is
defined in 9 CFR 160.1 and is an
Accredited Veterinarian who has
completed formal training from the
National Veterinary Accreditation
Program in the State in which they are
licensed to practice as a veterinarian.
USDA Official Veterinarian is a
USDA/APHIS veterinarian who is
assigned by the USDA Administrator to
supervise and perform official work of
APHIS in a State or group of states.
(b) Authorized U.S. airports for dogs
and cats.
Dogs from DMRVV-free or DMRVV
low-risk countries that have not been in
any DMRVV high-risk country within
the last six months and all cats may
continue to enter through any U.S. port.
CDC does not currently have any
restrictions on the U.S. ports for dogs
arriving in the United States from
DMRVV high-risk countries. Through
this NPRM, HHS/CDC proposes that if a
U.S.-vaccinated dog has been in a
DMRVV high-risk country in the
previous six months, the dog must
arrive at an airport with a CDC
quarantine station. The importer would
also be required to have a USDAAccredited Veterinarian complete the
Certification of U.S.-Issued Rabies
Vaccination For Live Dog Re-entry into
the United States Form and present this
form to the airline prior to boarding. All
foreign-vaccinated dogs that have been
in a DMRVV high-risk country in the
previous six months would be required
to enter the United States at a U.S.
airport with a CDC quarantine station
and a CDC-registered Animal Care
Facility. The importer would also be
required to have an Authorized
Veterinarian complete the CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States
Form and present this form to the
airline prior to boarding.
This requirement that dogs from
DMRVV high-risk countries arrive at
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specified airports is being proposed to
ensure dogs can be evaluated by CDC
quarantine station staff or a USDAAccredited Veterinarian upon arrival to
confirm they have all required
documentation for admission and do
not appear ill. Visual examinations of
animals may be conducted by CDC
quarantine station staff to look for overt
signs of illness (i.e., vomiting, diarrhea,
bleeding, seizures, or ocular or nasal
discharge). Animals showing signs of
illness will not be released for entry
until a USDA-Accredited Veterinarian
completes a physical exam and
administers a USDA-licensed rabies
vaccine (if applicable). As of June 1,
2023, five U.S. airports have CDCregistered Animal Care Facilities. The
CDC-registered Animal Care Facilities
will help to ensure animals that arrive
ill, or must be detained, will be held in
a facility that meets CDC requirements,
USDA Animal Welfare Act
Standards,103 and maintains an active
CBP FIRMS code. This requirement
would further help ensure that facilities
have staff who are properly trained to
provide food, water, shelter, and
veterinary care to animals if needed.
CDC will continue to register liveanimal care facilities at the remaining
13 U.S. airports with CDC quarantine
stations to protect the health and safety
of airline and warehouse staff, as well
as the health and safety of animals
arriving in the United States at these
ports.
(c) Authorized U.S. land ports for
dogs and cats.
HHS/CDC is not proposing any
changes to the authorized U.S. land
ports for dogs arriving to the United
States from DMRVV low-risk or
DMRVV-free countries that have not
been in a DMRVV high-risk country
within the last six months. There are
also no proposed changes for cats; cats
may continue to enter through any U.S.
port, including land ports. CDC is
proposing to prohibit entry into the
United States through any U.S. land
port for dogs that have been in a
DMRVV high-risk country within the
last six months. There are no CDCregistered Animal Care Facilities along
the U.S-Mexico and U.S.-Canada
borders that can safely house or
quarantine dogs arriving from DMRVV
high-risk countries. Additionally, local
and State animal and public health
authorities do not have capacity on a
routine basis to house and quarantine
dogs arriving from DMRVV high-risk
countries without additional burdens
being placed on local public health
resources.
103 7
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(d) Authorized U.S. seaports for dogs
and cats.
HHS/CDC is not proposing any
changes to the authorized U.S. seaports
for dogs arriving to the United States
from DMRVV low-risk or DMRVV-free
countries that have not been in any
DMRVV high-risk country within the
last six months. There are also no
proposed changes for cats; cats may
continue to enter through any U.S. port,
including seaports. HHS/CDC is
proposing to prohibit entry into the
United States through any U.S. seaport
for dogs that have been in a DMRVV
high-risk country within the last six
months. There are no CDC-registered
Animal Care Facilities at U.S. seaports
that can safely house or quarantine dogs
arriving from DMRVV high-risk
countries. Additionally, local and State
animal and public health authorities do
not have capacity on a routine basis to
house and quarantine dogs arriving from
DMRVV high-risk countries without
additional burdens being placed on
local public health resources.
However, HHS/CDC is proposing an
exception for dogs meeting the
definition of a ‘‘service animal’’ under
14 CFR 382.3 that have been in a
DMRVV high-risk country within the
last six months. HHS/CDC would permit
entry if the dog is accompanied by an
‘‘individual with a disability’’ as
defined under 14 CFR 382.3 and the dog
does work or performs tasks that are
directly related to the individual’s
disability. CDC believes this exception
would apply to a small number of
individuals who require that their
service dog accompany them on cruise
ships with U.S. destination ports. The
dog must be otherwise admissible under
this section and would be allowed entry
if:
1. The dog was vaccinated against
rabies in the United States and is
accompanied by a valid Certification of
U.S.-issued Rabies Vaccination for Live
Dog Re-entry into the United States
Form; or
2. The dog was vaccinated against
rabies in a foreign country and is
accompanied by both a valid foreignissued CDC Import Certification of
Rabies Vaccination and Microchip
Required for Live Dog Importations into
the United States Form and a valid
serologic titer from a CDC-approved
laboratory.
(e) Limitation on U.S. ports for dogs
and cats.
HHS/CDC is proposing to explicitly
authorize the Director to limit the times,
U.S. ports, and/or conditions under
which dogs or cats may arrive at and be
admitted to the United States based on
an importer’s or carrier’s failure to
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comply with the provisions of this
section or as needed to protect the
public’s health. If the Director
determines such a limitation is required,
the Director will notify importers or
carriers in writing of the specific times,
U.S. ports, and/or conditions under
which dogs and cats may be permitted
to arrive at and be admitted to the
United States.
(f) Age requirement for all dogs.
Through this NPRM, HHS/CDC
proposes that all dogs arriving into the
United States (regardless of whether
from DMRVV-free, DMRVV low-risk, or
DMRVV high-risk countries) be, at
minimum, six months of age. HHS/CDC
currently requires dogs to be at least
four months of age to enter the United
States if arriving from a DMRVV highrisk country because this is the age at
which a dog can be considered
adequately vaccinated for rabies.
Verification of a dog’s age is made via
dental examination, with dogs six
months of age or older being easily
identified by the presence of adult
incisors and canine teeth. HHS/CDC is
proposing to require imported dogs be at
least six months of age, which would
allow veterinarians to more easily
estimate the ages of young dogs to
ensure adequate DMRVV vaccination.
The proposed requirement that all
dogs arriving into the United States be
at least six months of age will align with
USDA/APHIS Animal Care
requirements for the importation of dogs
that are being imported for rescue or
resale and will help ensure pet dogs can
be safely transported without risk to
their health and welfare. HHS/CDC is
proposing as an exception to allow an
importer to import a maximum of three
personal pet dogs under six months of
age in a calendar year if arriving via a
U.S. land port from Canada or Mexico
if the dog has not been in a DMRVV
high-risk country in the previous six
months.
Based on communication with
Federal partner agencies and data in
CDC’s quarantine activity reporting
system, persons importing three or more
dogs in a calendar year are less likely to
be doing so in connection with their
personal pet ownership and more likely
to be associated with commercial
importations of animals, including
importers attempting to circumvent
HHS/CDC entry requirements by
transporting dogs from DMRVV highrisk countries through Canada and
Mexico for resale or adoption in the
United States. Therefore, HHS/CDC
proposes this age requirement to protect
public health, as well as the health and
safety of young puppies being
purchased and sold internationally.
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(g) Microchip requirements for all
dogs.
HHS/CDC does not currently require
a microchip for importation of dogs into
the United States. Requiring a
microchip for all dogs would help
ensure that veterinary paperwork and
animal identification can be verified. It
will also align with the admission
requirements of other DMRVV-free
countries and bring the United States
into international alignment with the
World Organisation for Animal Health
(WOAH) standards that all dogs have
permanent identification or marking for
international movement.104 HHS/CDC
proposes to require that all dogs have an
Individual Standards Organization
(ISO)-compliant microchip prior to
arrival in the United States or prior to
traveling out of the United States and
returning.
(h) CDC Import Submission Form for
all dogs.
CDC and Federal partners have
documented numerous instances of
importers moving dogs from DMRVV
high-risk countries through DMRVV
low-risk country to circumvent U.S. dog
entry requirements.105 106 HHS/CDC
proposes requiring that importers
submit a CDC Import Submission Form
via a CDC-approved system for each
imported dog to help mitigate the risk
of importers presenting dogs from
DMRVV high-risk countries at U.S. ports
that have traveled through DMRVV lowrisk countries for short periods of time
(less than six months) and do not meet
CDC entry requirements. The CDC
Import Submission Form must be
submitted to CDC prior to a dog’s
departure from the foreign country.
(i) Inspection requirements for
admission of dogs and cats.
HHS/CDC currently requires that all
dogs and cats arriving in the United
States be inspected to ensure they
appear healthy. While the requirement
for inspection of dogs and cats is not
new, HHS/CDC proposes clarifying that
dogs and cats may be denied admission
if an importer refuses to consent to the
required screening. HHS/CDC believes
that this additional clarification is
104 World Organisation for Animal Health.
Terrestrial Code Online Access—WOAH—World
Organisation for Animal Health: https://
www.woah.org/en/what-we-do/standards/codesand-manuals/terrestrial-code-online-access/
?id=169&L=1&htmfile=chapitre_certif_rabies.htm.
105 The importer of the rabid dog into the United
States in 2019 first flew into Canada before crossing
a land border into the United States. See Raybern,
C et al. Rabies in a dog imported from EgyptKansas, 2019. MMWR Morb Mort Wkly Rep 2020;
69 (38): 1374–1377.
106 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog importation data, 2018–2020.
Accessed: February 15, 2021.
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needed because of numerous
documented instances of confusion
among importers and some carriers
regarding CDC’s ability to mandate a
public health evaluation of a dog or cat
prior to admission. Additionally, CDC
may coordinate with other federal and
state partners to engage in routine
disease surveillance of animals arriving
in the United States.
(j) Examination by a USDAAccredited Veterinarian and
confinement of exposed dogs and cats or
those that appear unhealthy.
HHS/CDC currently requires
examination by a veterinarian and
confinement if, upon examination, a dog
or cat appears unhealthy upon arrival,
and such measures are needed to protect
the public’s health. While the
requirement for examination and
confinement are not new, this proposed
provision is primarily intended to
require airlines to assume responsibility
for housing and caring for dogs and cats
that arrive sick in the event the importer
abandons the shipment. CDC has
documented numerous instances of sick
animals not receiving care in a timely
manner and animals denied admission
being left by airlines in unacceptable
housing conditions.
HHS/CDC proposes, in the event a
dog or cat arrives ill, is denied
admission, or is exposed to a sick
animal in transit,107 108 that the airline
arrange for confinement in a CDCapproved veterinary clinic and that the
importer bears the expenses of such
confinement, examination, testing, and
treatment. If an importer fails to pay for
such expenses, then the animal may be
considered abandoned, and the airline
will be required to assume financial
responsibility. This provision is needed
to help ensure airlines assume
responsibility for sick or exposed dogs
and cats and that such animals do not
remain in unsafe conditions for
prolonged periods of time (e.g., longer
than six hours). The proposed rule
further clarifies an airline’s
responsibilities in the event an importer
abandons a dog or cat. This provision
may also be applied to other carriers
transporting dogs and cats in the rare
circumstances where it is necessary for
public health reasons to require that the
107 National Association of State Public Health
Veterinarians. Compendium of animal rabies
prevention and control, 2016. JAVMA 2016; 248
(5):505–517.
108 Manning SE, Rupprecht CE, Fishbein D, et al.
Human rabies prevention—United States, 2008:
recommendations of the Advisory Committee on
Immunization Practices. MMWR Recomm Rep
2008;57(RR–3):1–28.
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carrier arrange for examination and
confinement.
(k) Veterinary examination and
revaccination against rabies at a CDCregistered Animal Care Facility for
foreign-vaccinated dogs.
HHS/CDC proposes to require all dogs
arriving from DMRVV high-risk
countries without a valid Certification
of U.S.-Issued Rabies Vaccination for
Live Dog Re-entry into the United States
Form to have a valid CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States
Form and undergo veterinary
examination and revaccination against
rabies at a CDC-registered Animal Care
Facility upon arrival.
The importer would be responsible
for making a reservation and all
arrangements relating to the
examination, revaccination, and
quarantine (if quarantine is required) of
dogs with a CDC-registered Animal Care
Facility prior to the dogs’ arrival in the
United States. Airlines must deny
boarding to dogs if the importer fails to
present a receipt of the completed CDC
Import Certification of Rabies
Vaccination and Microchip Required for
Live Dog Importations into the United
States Form. The costs of examination,
vaccination, and quarantine (if required)
would be borne by the importer and not
the United States Government. Animals
that are abandoned before meeting
requirements outlined below become
the legal responsibility of the airline.
HHS/CDC proposes that the dogs
remain in the custody of a CDCregistered Animal Care Facility until all
of the following requirements are met:
(i) Veterinary health examination by a
USDA-Accredited Veterinarian for signs
of disease. Suspected or confirmed
zoonotic or foreign animal diseases
would be required to be reported to
CDC, USDA, the State or County Public
Health Veterinarian, and the State
Veterinarian prior to release of the
animals.
(ii) Vaccination against rabies with a
USDA-licensed rabies vaccine and
administered by a USDA-Accredited
Veterinarian.
(iii) Confirmation of microchip
number.
(iv) Confirmation of age through
dental examination by a USDAAccredited Veterinarian.
(v) Verification of adequate rabies
serologic test from a CDC-approved
laboratory. To be considered valid,
serologic tests must be drawn prior to
arrival within an established timeframe
and display results within parameters as
specified in CDC technical
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instructions.109 Currently, this means
that serologic tests must be drawn 45 to
365 days before arrival and have a result
greater than or equal to 0.5 IU/mL. Dogs
that arrive without an adequate rabies
serologic test results from a CDCapproved laboratory would be housed at
the CDC-registered Animal Care Facility
for a 28-day quarantine following
administration of the U.S. rabies vaccine
or until an adequate rabies serologic test
from a CDC-approved laboratory is
confirmed.
(l) Registration or renewal of CDCregistered Animal Care Facilities.
Through this NPRM, HHS/CDC
proposes to establish a registration
mechanism for CDC-registered Animal
Care Facilities used in the importation
of foreign-vaccinated dogs arriving in
the United States from DMRVV highrisk countries. Before housing any
imported live dog in the United States,
an animal care facility would be
required to register with and receive
written approval from CDC, USDA, and
CBP to submit their facility application.
The applicant would need to provide
written standard operating procedures
outlining how CDC’s regulatory
requirements will be met and the health
and safety of animals and staff will be
ensured. A copy of all Federal, State, or
local registrations, licenses, or permits
would also be required to be submitted
to CDC. Additionally, CDC would
require the facility to have a USDA
intermediate handlers license and a
FIRMS code issued by CBP. The facility
would be subject to inspection by CDC
at least annually and required to renew
their registration every two years.
Animal health records, facilities,
vehicles, or equipment to be used in
receiving, examining, and processing
imported animals would also be subject
to inspection.
(m) Record-keeping requirements at
CDC-registered Animal Care Facilities.
HHS/CDC proposes to require that
any CDC-registered Animal Care
Facilities retain records regarding each
imported animal for three years after the
distribution or transfer of the animal.
Each record must include:
(i) The bill of lading for each
shipment;
(ii) The name, address, phone
number, and email address of the
importer and owner (if different from
the importer);
(iii) The number of animals in each
shipment;
(iv) The identity of each animal in
each shipment, including name,
109 CDC Technical Instructions will be posted to
CDC’s website (www.cdc.gov/dogtravel) upon
publication of the final rule.
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microchip number, date of birth, sex,
breed, and coloring;
(v) The airline, flight number, date of
arrival, and port of each shipment; and
(vi) Veterinary medical records for
each animal, including:
(a) CDC Import Certification of Rabies
Vaccination and Microchip Required for
Live Dog Importations into the United
States Form and rabies serology
obtained before arrival in the United
States (if applicable);
(b) The USDA-licensed rabies vaccine
administered upon arrival;
(c) Veterinary exam records upon
arrival and while in quarantine;
(d) Rabies serology performed while
in quarantine in the United States (if
applicable); and
(e) All diagnostic test, histopathology
and necropsy results performed during
quarantine (if applicable).
The facility would be required to
maintain these records electronically
and allow CDC to inspect the records.
(n) Worker protection plan and
personal protective equipment (PPE).
HHS/CDC proposes to require that a
CDC-registered Animal Care Facility
establish and maintain a worker
protection plan with standards
comparable to those in CDC’s National
Institute for Occupational Safety and
Health (NIOSH) Veterinary Safety and
Health guidelines 110 and the National
Association of Public Health
Veterinarians (NASPHV) Compendium
of Veterinary Standard Precautions for
Zoonotic Disease Prevention in
Veterinary Personnel.111 Such a worker
protection plan must include rabies preexposure prophylaxis for workers
handling imported animals in
quarantine, post-exposure procedures
that provide potentially exposed
workers with direct and rapid access to
a medical consultant, and procedures
for documenting the frequency of
worker training, including for those
working in the quarantine area. As part
of the worker protection plan, a facility
would also need to establish,
implement, and maintain hazard
evaluation and worker communication
procedures that include descriptions of
the known zoonotic disease and injury
hazards associated with handling
animals, the need for PPE when
handling animals and training in the
proper use of PPE, and procedures for
disinfection of garments, supplies,
equipment, and waste.
(o) CDC-registered Animal Care
Facility standard operating procedures,
110 https://www.cdc.gov/niosh/topics/veterinary/
biological.html.
111 https://www.nasphv.org/Documents/
VeterinaryStandardPrecautions.pdf.
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requirements, and equipment standards
for crating, caging, and transporting live
animals.
HHS/CDC proposes to outline
equipment standards for crating, caging,
and transporting live animals for CDCregistered Animal Care Facilities. The
standards must be in accordance with
USDA Animal Welfare regulation
standards 112 (9 CFR parts 1, 2, and 3)
and International Air Transport
Association standards.113 Violations of
the USDA Animal Welfare Act may
result in immediate revocation of an
animal care facility’s status as a CDCregistered Animal Care Facility.
(p) Health reporting requirements for
animals at CDC-registered Animal Care
Facilities.
HHS/CDC proposes to establish health
reporting requirements for all dogs
being evaluated at a CDC-registered
Animal Care Facility. A facility would
need to provide the following services
for each dog from a DMRVV high-risk
country with a foreign-issued rabies
vaccine upon arrival and ensure each
animal meets CDC, USDA, and state and
local entry requirements prior to release
from the facility:
(i) Veterinary examination by a
USDA-Accredited Veterinarian within
one business day of arrival;
(ii) Verification of microchip and
confirmation that the microchip number
matches the animal’s health records;
(iii) Verification of animal’s age via a
dental examination;
(iv) Vaccination against rabies using a
USDA-licensed vaccine; and
(v) Verification of an adequate
serologic test from a CDC-approved
laboratory OR 28-day quarantine after
administration of the USDA-licensed
rabies vaccine.
HHS/CDC further proposes that the
facility notify CDC within 24 hours of
the occurrence of any morbidity or
mortality of animals in the facility. Any
animal that dies at a CDC-registered
Animal Care Facility would be required
to undergo a necropsy and diagnostic
testing to determine the cause of death.
An animal that arrives ill or becomes ill
while at the CDC-registered Animal Care
Facility would need to be examined by
a USDA-Accredited Veterinarian
immediately and undergo diagnostic
testing to determine the cause of illness
prior to release from the facility.
Suspected or confirmed zoonotic
diseases would need to be reported to
112 U.S. Department of Agriculture. Animal
Welfare Act. https://www.aphis.usda.gov/aphis/
ourfocus/animalwelfare/sa_awa. Accessed June 7,
2023.
113 International Air Transport Association. Live
Animals. https://www.iata.org/en/programs/cargo/
live-animals. Accessed June 7, 2023.
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CDC and the State or County Public
Health Veterinarian within 24 hours of
identification. Suspected or confirmed
foreign animal diseases or infectious
animal diseases would be reported to
USDA and the State or County
Veterinarian within 24 hours of
identification.114
(q) Quarantine requirements for CDCregistered Animal Care Facilities.
HHS/CDC proposes to establish
requirements for the quarantine area at
CDC-registered Animal Care Facilities to
ensure animals are safely housed and do
not present a public health risk to
humans or other animals. The proposed
requirements include building security
to prevent unintended public exposure
to quarantined animals, cleaning and
disinfection standards, and diagnostic
testing or necropsy for ill or deceased
animals.
(r) Revocation and reinstatement of a
CDC-registered Animal Care Facility’s
registration.
HHS/CDC proposes procedures to
revoke a CDC-registered Animal Care
Facility’s registration if the Director
determines that it has failed to comply
with any applicable provisions of this
section. CDC would send the facility a
notice of revocation stating the grounds
upon which the proposed revocation is
based. If the facility contested the
revocation, the facility would be
required to file a written response to the
notice within five business days after
receiving the notice. All the grounds
listed in the proposed revocation would
be deemed admitted if the facility failed
to respond.
If a facility’s response is timely, the
Director will review the registration, the
notice of revocation, and the response.
The Director would then decide
whether to revoke the facility’s
registration based on the written record
and communicate this decision in
writing to the facility. The Director
could reinstate a revoked registration
after inspecting the facility, examining
its records, conferring with the facility,
and receiving information and
assurance from the facility of
compliance with the requirements of
this section.
(s) Requirement for the CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States
Form to import a foreign-vaccinated dog
from DMRVV high-risk countries.
HHS/CDC currently requires in 42
CFR 71.51(c) that importers of dogs
114 Zoonotic disease are diseases that can spread
from animals to people; infectious animal diseases
spread only between animals; foreign animal
diseases are not present in the United States and
may or may not be zoonotic.
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arriving from DMRVV high-risk
countries provide a valid RVC, as
defined in 42 CFR 71.51(a), upon
arrival; this includes proof of
vaccination but importers are not
required to use a standardized form.
Without a standardized form, there is
tremendous variation among countries
in documenting proof of vaccination.
This lack of standardization creates
confusion for port staff who are
responsible for reviewing the rabies
proof of vaccination.
Through this NPRM, HHS/CDC
proposes to require a new, standardized
rabies vaccination form for all foreignvaccinated dogs arriving from DMRVV
high-risk countries. This rabies
vaccination form will be standardized
and help importers and Federal agencies
ensure dogs being imported from
DMRVV high-risk countries are
imported with all the required
information on one form. This
requirement will reduce confusion and
ensure Official Government
Veterinarians in the exporting country
have reviewed the veterinary records
and examined dogs prior to travel. HHS/
CDC proposes that this form replace the
current valid RVC requirement, which
was not aligned with internationally
accepted standards for the international
movement of animals. This form will
also permit CDC and other U.S.
Government agencies to confirm the
accuracy of documentation with
exporting country officials if
discrepancies in the forms are noted.
All foreign-vaccinated dogs from
DMRVV high-risk countries will be
required to be examined by a USDAAccredited Veterinarian and
revaccinated with a USDA-licensed
vaccine at a CDC-registered Animal Care
Facility upon arrival to align with State
rabies vaccination requirements and
recommendations from the NASPHV.115
Dogs arriving without a Certification of
U.S.-issued Rabies Vaccination for Live
Dog Re-entry into the United States form
will be required to present the CDC
Import Certification of Rabies
Vaccination and Microchip Required for
Live Dog Importations into the United
States form to the CDC-registered
Animal Care Facility along with a valid
serologic test from a CDC-approved
laboratory (if applicable).
To be considered valid, serologic tests
must be drawn prior to arrival within a
timeframe and display results within
parameters as specified in CDC
technical instructions. Currently, to be
115 National Association of State Public Health
Veterinarians. Compendium of Animal Rabies
Prevention and Control, 2016. JAVMA 2016; 248
(5): 505–517.
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considered valid, serologic tests must be
drawn within a timeframe of 45 to 365
days before arrival and have a result
greater than or equal to 0.5 IU/ml. Dogs
that arrive without an adequate rabies
serologic test from a CDC-approved
laboratory will be subject to a
mandatory 28-day quarantine after
revaccination at a CDC-registered
Animal Care Facility at the importer’s
expense. HHS/CDC is requesting public
comments on all aspects of this proposal
as it relates to persons traveling abroad
with their dogs.
(t) Requirement for Certification of
U.S.-Issued Rabies Vaccination for Live
Dog Re-entry into the United States
Form for importers seeking to import
U.S.-vaccinated dogs from DMRVV
high-risk countries.
HHS/CDC proposes to require that
U.S.-vaccinated dogs re-entering the
United States from DMRVV high-risk
countries arrive at a U.S. airport with a
CDC quarantine station and be
accompanied by a Certification of U.S.issued Rabies Vaccination for Live Dog
Re-entry into the United States Form.
The form must be completed by a
USDA-Accredited Veterinarian and
signed by a USDA Official Veterinarian
prior to the animal departing the United
States. Importers returning to the United
States from a DMRVV high-risk country
with this form may present their dog for
admission without a rabies serologic test
from a CDC-approved laboratory,
without the dog undergoing veterinary
examination (unless ill, injured, or
exposed), and without revaccination
against rabies at a CDC-registered
Animal Care Facility. People who leave
the United States with their dogs
without first obtaining this form will be
required to have their dogs re-enter the
United States as if they are foreignvaccinated dogs and be required to meet
all the requirements as outlined in
section (s) for the dogs to be eligible for
re-entry from a DRMVV high-risk
country. HHS/CDC solicits feedback on
this proposed process.
(u) Requirement for proof that a dog
has only been in a DMRVV low-risk or
DMRVV-free country.
HHS/CDC proposes to require that
dogs being imported from DMRVV lowrisk or DMRVV-free countries be
accompanied by appropriate written
documentation demonstrating that they
have not been in any DMRVV high-risk
country during the past six months. An
importer would need to provide written
documentation, such as veterinary
medical records, upon request
confirming that the dog is at least six
months of age, is microchipped, and has
been only in a DMRVV low-risk or
DMRVV-free country for the six months
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prior to importation into the United
States. There are no proposed changes
for cat rabies vaccination importation
requirements. CDC recommends
importers comply with State or
Territorial requirements for rabies
vaccination in cats. The CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States form
would not be required for importers able
to meet the requirements of this
paragraph. HHS/CDC is requesting
public comment on whether a
standardized form should be required
for dogs arriving from DMRVV-free and
DMRVV low-risk countries in order to
avoid potential fraud. HHS/CDC is
requesting public comment on all
aspects of this proposal as it relates to
cats and dogs.
(v) Denial of admission of dogs and
cats.
This proposed section outlines the
circumstances under which CDC can
deny admission to a dog or cat being
presented for admission into the United
States. CDC shall notify CBP in writing
to enforce this action. This includes:
• Any dog arriving from a DMRVV
low-risk or DMRVV-free country
without written documentation that the
dog has resided in a DMRVV low-risk or
rabies-free country for the six months
prior to the attempted entry, or if the
Director reasonably suspects fraud.
• Any dog that is not accompanied by
a receipt confirming that a CDC Import
Submission Form has been submitted to
CDC through a CDC-approved system.
• Any dog arriving at a U.S. airport
for which a bill of lading has not been
created by the airline prior to arrival.
• Any dog arriving at a U.S. land port
that has been in a DMRVV high-risk
country within the last six months prior
to the attempted entry.
• Any dog arriving at a U.S. seaport
that has been in a DMRVV high-risk
country within the last six months prior
to the attempted entry, except for a dog
qualifying as a service animal that is
otherwise admissible under this section.
• Any dog imported by an importer
who refuses to comply with the
requirement (if applicable) for the dog to
undergo disease surveillance screening,
veterinary examination, revaccination,
provide proof of sufficient rabies
serologic tests, or quarantine at a CDCregistered Animal Care Facility upon
arrival.
• Any dog that has been in a DMRVV
high-risk country in the previous six
months and arrives without a valid
Certification of U.S.-Issued Rabies
Vaccination for Live Dog Re-entry into
the United States Form or a valid CDC
Import Certification of Rabies
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Vaccination and Microchip Required for
Live Dog Importations into the United
States Form.
• Any dog that has been in a DMRVV
high-risk country in the previous six
months and does not arrive via air at a
U.S. airport with a CDC quarantine
station or via air at a U.S. airport with
a CDC-registered Animal Care Facility
(if applicable).
• Any dog imported from a DMRVV
high-risk country that arrives without a
reservation at a CDC-registered Animal
Care Facility (if applicable).
• Any dog from a DMRVV-restricted
country that arrives without a valid CDC
Dog Import Permit.
• Any dog imported from a DMRVV
high-risk country if the Director
reasonably suspects fraud in any
documentation required for admission
or if such documentation is otherwise
untruthful, inaccurate, or incomplete.
• Any dog or cat, regardless of
country of departure, that poses a public
health risk, including dogs or cats that
appear unhealthy upon arrival or
demonstrate signs or symptoms of
communicable disease.
• Any dog under six months of age
that is arriving at a U.S. airport or
seaport, or any dog under six months of
age that is arriving at a U.S. land port
if the importer has imported three or
more individual dogs under six months
of age in the same calendar year
(January–December).
HHS/CDC solicits public comment
regarding this proposed paragraph,
including whether the grounds for the
proposed denial of admission are
sufficient to protect the public’s health.
(w) Disposal or disposition of dogs
and cats denied admission or
abandoned prior to admission that were
transported to the United States.
Through this NPRM, HHS/CDC
proposes an operational framework
primarily applicable to airlines
regarding how dogs denied admission
would be handled by carriers and
importers. HHS/CDC clarifies that
airlines must provide housing for
animals awaiting return to their country
of departure at a CDC-registered Animal
Care Facility or a CDC-approved animal
facility if a CDC-registered Animal Care
Facility is not available. Airlines are
required to return animals denied
admission to the country of departure
within 72 hours of arrival, regardless of
carrier or route. This is to ensure
airlines do not leave animals in
warehouses unattended for prolonged
periods of time. As proposed, airlines
would be able to request extensions for
an animal’s return in the event the
animal is not medically fit for travel.
This proposed operational framework
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provides that importers are responsible
for all associated costs relating to the
housing, care, and treatment of a dog or
cat denied admission pending return to
its country of departure. However, if an
importer fails to pay any costs or fails
to comply with any requirements, the
animal will be considered abandoned,
and the relevant carrier would be
required to assume responsibility.
In instances where a dog or cat is
fatally ill or injured, the importer or
airline may choose a humane euthanasia
option in accordance with the standards
of the American Veterinary Medical
Association 116 performed by a licensed
veterinarian. The importer or airline
must notify CDC and CBP in writing of
this decision. This decision does not
relieve the importer or airline of the
obligation to obtain and report results of
necropsy or diagnostic testing required
by CDC.
In the case of dogs and cats denied
admission to the United States upon
arrival at a U.S. seaport, the vessel’s
master or operator would be required to
reembark the animal immediately and
return it to its country of departure on
the next voyage. In the case of dogs and
cats denied admission to the United
States upon arrival at a U.S. land port,
the importer or carrier would be
required to immediately return it to its
country of departure.
CDC does not expect the above
operational framework relating to
housing, care, and treatment of a dog or
cat denied admission to be applied on
a routine basis to carriers or importers
arriving with dogs or cats at U.S. land
or seaports because the circumstances
leading to a delay in returning a dog or
cat to its country of departure are not
typically present at these U.S. ports.
However, CDC acknowledges that there
may be rare and unforeseen
circumstances where it may be
necessary to apply such procedures.
Accordingly, CDC has added language
authorizing it to apply these provisions
in circumstances where a dog or cat is
denied entry at a U.S. land or seaport
and cannot be immediately returned to
its country of departure (e.g., because it
is unfit to travel). HHS/CDC specifically
solicits public comment regarding the
possible application of these measures
to dogs and cat arriving in the United
States at U.S. land or seaports.
(x) Appeals of CDC denials to admit
a dog or a cat upon arrival into the
United States.
This section proposes an appeal
process for importers of dogs and cats in
the event their animals are denied
116 https://www.avma.org/resources-tools/avmapolicies/avma-guidelines-euthanasia-animals.
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43997
admission to the United States upon
arrival.
If CDC denies admission to a dog or
cat under this section, the importer may
appeal that denial to the Director. The
importer must submit the appeal in
writing to the Director that states the
reasons for the appeal and demonstrates
that there is a genuine and substantial
issue of fact in dispute. The importer
must submit the appeal within one
business day of the denial. Submitting
an appeal will not delay the return of
the animal to the country of departure.
CDC will issue a written response,
which shall constitute final agency
action.
Because denial of admission to dogs
and cats under these limited
circumstances is likely to occur at a
port, HHS/CDC proposes that any
appeal be submitted within one
business day so as not to unnecessarily
prolong the appeal process and allow
for expedited decision-making regarding
whether an animal should be returned
to its country of departure. Pending a
determination regarding the appeal the
animal will remain the legal
responsibility of the carrier. HHS/CDC
solicits public comment regarding this
proposal.
(y) Record of death of dogs and cats
while en route to the United States and
disposition of dead animals.
The requirement that carriers
maintain a record of sickness or death
for any animals that die during transit
is longstanding. Through this NPRM,
HHS/CDC proposes to require necropsy
and diagnostic testing for any dog or cat
that dies en route to the United States
or at a U.S. port prior to admission to
determine the cause of death. Consistent
with current requirements, carriers
would be required to report deaths to
the CDC quarantine station of
jurisdiction. HHS/CDC proposes these
amendments to ensure it can detect,
provide referrals to appropriate
agencies, and respond to potential
zoonotic disease importation risks in a
timely manner. Importers would be
responsible for the costs unless they
abandon the animal, in which case the
airline or master or operator of a vessel
would assume responsibility for the
costs.
(z) Abandoned shipments of dogs and
cats.
Through this NPRM, HHS/CDC
proposes an operational framework
primarily applicable to airlines for when
a dog or cat would be considered
abandoned prior to admission and thus
require the carrier to assume
responsibility for the shipment. CDC has
documented several instances in which
importers have chosen to abandon dogs.
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Federal and State public health agencies
have incurred financial costs because of
importers abandoning dogs and the
subsequent refusal by airlines to provide
safe housing and return for dogs. HHS/
CDC proposes that an animal shipment
be deemed abandoned under the
following circumstances:
• When explicitly stated by the
importer verbally or in writing to the
carrier, CDC, or CBP; or
• If the importer fails to cooperate
with or respond to the carrier’s attempts
to comply with the regulations listed in
42 CFR 71.51 within 24 hours; or
• If the importer refuses payment
within 24 hours for CDC-mandated
examinations, testing, holding, or
treatment needed to ensure the safe
importation of animals into the United
States.
The provisions of this paragraph may
also be applied to other carriers
transporting such dogs and cats in the
rare circumstances where the dog or cat
is abandoned by the importer at a U.S.
land port or seaport and other options
are not available.
(aa) Sanitation of cages and containers
of dogs and cats.
The requirement that animal cages
and containers be kept in a sanitary
condition is long-standing. This
language appears as a separate
paragraph in the proposed regulation,
but HHS/CDC is not proposing any
changes to the existing language, which
requires that animals be transported in
clean crates or cages. CDC is
republishing this section to provide
context and for the convenience of the
reader.
(bb) Requirements for in-transit
shipments of dogs and cats.
HHS/CDC proposes to clarify the
definition of an in-transit shipment and
outlines the requirements for dogs and
cats that transit the United States as part
of an in-transit shipment. CDC’s
definition would align with that of the
USDA, and HHS/CDC clarifies that dogs
and cats cannot be considered in transit
if they are transported as hand-carried
baggage or checked baggage. In-transit
shipments may only be transported as
cargo.
(cc) Bill of lading and other airline
requirements for dogs.
To help mitigate the risk of importers
presenting dogs from DMRVV high-risk
countries at U.S. airports that have
traveled through DMRVV low-risk
countries for short periods of time (less
than six months) and do not meet CDC
entry requirements, this NPRM proposes
to require that airlines create a bill of
lading accounting for all live dog
imports through a U.S. airport,
regardless of whether the dogs are
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transported as cargo, checked baggage,
or hand-carried baggage, or otherwise
accompany a traveler arriving in the
United States on their person. Requiring
airlines to create a bill of lading
specifically for all live dog imports
arriving at a U.S. airport will also help
ensure airlines are accountable for the
safety of the dog upon arrival in the
United States. Dogs that do not have
bills of lading by an airline are more
likely to be left by the airline in unsafe
conditions, and airlines often refuse to
take responsibility for the safety and
entry requirements for dogs flown as
checked-baggage or hand-carried
baggage.117
CDC also proposes to require that
airlines confirm that all importers have
a receipt of a completed CDC Import
Submission Form prior to boarding. For
U.S.-vaccinated dogs, CDC proposes that
airlines confirm that importers have a
valid Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States Form. For foreignvaccinated dogs, CDC proposes that
airlines confirm that importers have a
reservation at a CDC-registered Animal
Care Facility. For dogs from DMRVVfree or low-risk countries, CDC proposes
that airlines confirm that the importer
has documentation showing that the dog
is over six months of age, has a
microchip, and has not been in a
DMRVV high-risk country in the
previous six months.
CDC is also proposing that a
representative of an airline transporting
live dogs into the United States be onsite at the U.S. airport and available to
coordinate the entry/clearance of the
dogs with federal government officials
until all live dogs transported on an
arriving flight into the United States
have either been cleared for admission
or arrangements have been made to
transport the dogs to a CDC-registered
Animal Care Facility or other facility
(e.g., veterinary clinic or kennel)
approved by CDC pending admissibility
determination.
HHS/CDC is seeking public comment
on whether airline staff should be
required to present dogs for entry and be
available until all dogs have been
cleared for entry or arrangements have
been made to transport the dogs to a
CDC-registered Animal Care Facility or
other facility (e.g., veterinary clinic or
kennel) approved by CDC pending an
admissibility determination. HHS/CDC
is also seeking public comment on how
airlines can present dogs for inspection
117 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog importation data, 2018–2020.
Accessed: February 15, 2021.
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in the cargo area, except dogs meeting
the definition of a ‘‘service animal’’
under 14 CFR 382.3.
(dd) Order prohibiting carriers from
transporting dogs and cats.
HHS/CDC proposes procedures for the
Director to issue an order revoking a
carrier’s permission to transport live
dogs and cats into the United States if
a carrier has endangered the public
health of the United States by acting or
failing to act to prevent the introduction
of DMRVV, as would occur by failing to
comply with the provisions of this
section. HHS/CDC believes that the
circumstances giving rise to such an
order would be exceedingly rare, such
that HHS/CDC would issue an order
only after repeated attempts to consult
with and obtain voluntary compliance
and remedial action from the carrier
have failed. The Director would rescind
the order after working with the carrier
to obtain remedial action, such as:
inspecting the carrier’s facilities;
examining its records; conferring with
the carrier’s owners or operators,
contractors, or staff; or after receiving
information and written assurances
from the carrier owner or operator that
it has taken remedial steps to ensure
future compliance with HHS/CDC dog
and cat importation requirements. Such
an order would be subject to an
administrative appeal. The appeal must
be in writing, addressed to the Director,
state the reasons for the appeal, and
demonstrate that there is a genuine and
substantial issue of fact in dispute. As
soon as practicable after completing the
appeal review, the Director will issue a
decision in writing that would
constitute final agency action. The
Director will serve the carrier owners or
operators with a copy of the written
decision.
(ee) Prohibition on imports of dogs
from DMRVV-restricted countries.
Through this NPRM, HHS/CDC
proposes to prohibit or otherwise
restrict the import of dogs into the
United States from certain countries that
have repeatedly exported rabid dogs to
any other country or that lack adequate
controls to monitor and prevent the
export of dogs to the United States with
falsified or fraudulent vaccine
credentials. Such a prohibition or other
restriction would remain in place until
CDC was satisfied that sufficient
controls had been established to prevent
the reintroduction of DMRVV into the
United States, including preventing the
use of falsified or fraudulent vaccine
credentials. To implement this
provision, this NPRM proposes that
HHS/CDC maintain a list of DMRVVrestricted countries. The list would be
maintained on CDC’s website and
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updated annually. Amendments to the
list of DMRVV-restricted countries
would be published as a notice in the
Federal Register. Under this proposal,
CDC may allow the importation of
certain categories of dogs from DMRVVrestricted countries, such as service
animals or government-owned animals.
HHS/CDC solicits comment as to
whether such Federal Register notices
would be sufficient to inform the public.
(ff) Request for issuance of additional
fines or penalties.
Under 42 U.S.C. 268(b), CBP and
Coast Guard officers may aid in the
enforcement of HHS/CDC’s quarantine
rules and regulations. HHS/CDC is
proposing to add a paragraph
recognizing that HHS/CDC may request
that CBP pursue enforcement actions
using CBP’s existing authorities under
19 U.S.C. 1592 and 19 U.S.C. 1595a
against importers, brokers, or carriers
who violate HHS/CDC’s dog and cat
importation requirements. This
provision does not create new authority.
Its purpose is to inform the public of
actions that CDC may take to request
CBP assistance in enforcing HHS/CDC’s
dog and cat importation requirements.
HHS/CDC stresses that it does not
administer Title 19, and decisions
regarding whether to pursue
enforcement actions under Title 19
would be entirely at the discretion of
DHS/CBP and subject to its policies and
procedures.
V. Alternatives Considered
In developing this NPRM, HHS/CDC
considered more and less restrictive
policy alternatives. The provisions
included in the NPRM were determined
to minimize the cost and burden of the
43999
proposed regulatory provisions while
protecting and reducing risks to the
public’s health. To reduce the costs
associated with the provisions of the
NPRM, many proposed requirements
only apply to dogs imported from
DMRVV high-risk countries, and some
apply only to dogs vaccinated outside
the United States imported from
DMRVV high-risk countries.
Table 4 summarizes alternatives to
selected proposed requirements
expected to be associated with most of
the monetized costs and benefits for this
NPRM (if finalized as proposed) relative
to the current status quo. A semiquantitative analysis of the costs and
benefits is available in Section F of an
Appendix found in the Supplemental
Materials tab of the docket.
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TABLE 4—SUMMARY TABLE OF IMPORTANT CHANGES TO REGULATORY REQUIREMENTS BASED ON THE PROVISIONS OF
THIS NPRM AND ALTERNATIVES CONSIDERED
NPRM requirement
(proposed)
Current requirements 118
(baseline)
Proposed 71.51(f) ..............
Dogs must be at least six
months of age to be imported from a DMRVV
high-risk country.
Dogs must be at least six
months of age to arrive
via aircraft regardless of
country origin.
Only three or fewer dogs
less than six months of
age may be imported at
land ports by an importer/owner (per calendar year). Dogs that
have been in DMRVV
high-risk countries are
not eligible to arrive at
land ports.
DMRVV High-risk countries: Dogs must be at
least four months of age
(based on the earliest
age at which a dog
could be considered fully
vaccinated against rabies).
No requirement for
DMRVV-free or DMRVV
low-risk countries since
rabies vaccination documentation is not currently required for these
dogs.
Proposed section 71.51(g)
All dogs must have a
microchip regardless of
country of origin.
No dog-identification requirement other than a
description on the rabies
vaccination documentation.
118 The current requirements do not take account
of the temporary suspension of dogs from DMRVV
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Option 1—more restrictive
Option 2—less restrictive
Justification
Dogs must be at least six
months of age regardless of country of origin
or type of conveyance.
Dogs must be at least four
months of age to arrive
via aircraft regardless of
country of origin, which
is the youngest age a
dog may be considered
fully vaccinated against
rabies.
No limit to the number of
dogs that may be imported at land ports.
All dogs must be implanted with microchips
and have tattoos for
identification purposes.
Either no identification requirement or allow use
of tattoos or other dogidentifying technology instead of requiring
microchips.
The increased age requirement will improve health
and safety for dogs
being transported and
result in fewer public
health investigations of
dogs found to be ill or to
have died during air
travel. The 6-month
versus 4-month age requirement will also make
it easier to estimate the
age of dogs based on
examination of their
teeth. This age requirement will also improve
alignment with USDA
import requirements (7
CFR 2148) for dogs imported for resale.
This requirement is needed to confirm that the arriving dogs match their
paperwork because
CDC has documented a
dramatic increase in the
number of dogs arriving
with falsified rabies vaccination documentation.
The microchip requirement will allow for
matching microchip information (obtained by
scanning the dog) with
the microchip number
documented on the
dog’s proof of rabies
vaccination.
high-risk countries, because it is a temporary
measure.
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TABLE 4—SUMMARY TABLE OF IMPORTANT CHANGES TO REGULATORY REQUIREMENTS BASED ON THE PROVISIONS OF
THIS NPRM AND ALTERNATIVES CONSIDERED—Continued
NPRM requirement
(proposed)
Current requirements 118
(baseline)
Proposed section 71.51(h)
Require importers to submit advance data for
each dog via a CDC-approved system and require airlines to create
bill of lading for all live
dog imports.
No requirement for dog importers to submit data
with CDC and no requirement for airlines to
create a bill of lading for
all live dog imports.
Proposed 71.51 (t) ............
Require standardized rabies vaccination information using a CDC form:
Certification of U.S.issued Rabies Vaccination for Live Dog Reentry into the United
States Form for dogs
originating in the United
States and wanting to
re-enter the U.S. after
traveling to a DMRVV
high-risk country.
Rabies vaccine certificates
are required for dogs imported from DMRVV
high-risk countries and
do not need to be entered into a standardized
form or certified by an
Official Government Veterinarian.
Proposed 71.51(k) .............
Requirement for veterinary
examination and revaccination against rabies at
a CDC-registered Animal
Care Facility for foreignvaccinated dogs from
DMRVV high-risk countries, no requirement for
dogs imported from
DMRVV-free or DMRVV
low-risk countries or
U.S.-vaccinated dogs
from DMRVV high-risk
countries if U.S.-vaccinated dogs are healthy
and meet all other requirements.
The laboratory testing requirements in proposed
71.51(k)(4)(v) are addressed separately
below.
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Option 2—less restrictive
Justification
Require importers to use
the more complicated
and costly CBP formal
entry requirements.
Only require dogs from
DMRVV high-risk countries to submit data via a
CDC-approved system
and require airlines to
create a bill of lading for
all live dog imports.
Require Certification of
U.S.-issued Rabies Vaccination for Live Dog
Re-entry into the United
States form be certified
by a USDA Official Veterinarian for all dogs
leaving the U.S. with
planned re-entry into the
U.S.
Require veterinarians to fill
out the Certification of
U.S.-issued Rabies Vaccination for Live Dog
Re-entry into the United
States Form, but do not
require certification by
an Official Government
Veterinarian.
No follow-up examination
Require veterinary examor revaccination required.
ination and revaccination
for all dogs imported
from DMRVV high-risk
countries, including dogs
with valid U.S.-issued
rabies vaccinations.
In lieu of requiring followup at a CDC-registered
Animal Care Facility,
allow dogs imported
from DMRVV high-risk
countries that were vaccinated outside the
United States to visit
any licensed U.S. veterinarian for examination
and revaccination.
This requirement will help
Federal agencies detect
dogs that move from
DMRVV high-risk to
DMRVV low-risk countries to avoid U.S. requirements.
This requirement will also
support Federal agencies’ targeting of interventions for dogs arriving from countries presenting significant risks
to human or animal
health.
At present, the information
on rabies vaccination
documents is not standardized; different formats
are used in different
countries and even within the U.S. Lack of a
standardized format may
lead to dogs from
DMRVV high-risk countries arriving at a U.S.
port with rabies vaccination documentation s
that does not align with
current CDC requirements and subsequent
entry denials. This provision will also align the
United States with import/export requirements
commonly required in
other countries.
This process will better
align U.S. requirements
with existing requirements of other DMRVVfree countries
This requirement for veterinary examination and
revaccination will reduce
the risk of dogs potentially infecting people or
wildlife with DMRVV and
potentially other zoonotic
diseases or diseases
which impact livestock in
the United States.
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44001
TABLE 4—SUMMARY TABLE OF IMPORTANT CHANGES TO REGULATORY REQUIREMENTS BASED ON THE PROVISIONS OF
THIS NPRM AND ALTERNATIVES CONSIDERED—Continued
Current requirements 118
(baseline)
NPRM requirement
(proposed)
Option 2—less restrictive
Justification
This laboratory testing provision will better align
U.S. requirements with
existing requirements of
other DMRVV-free countries that require laboratory confirmation because rabies vaccination
documentation alone is
considered insufficient
as proof of rabies immunity. However, this requirement is still less restrictive than many
DMRVV-free countries
because there is no serologic test requirement
for U.S.-vaccinated
dogs.
This requirement will ensure dogs denied entry
or placed on hold have
safe housing locations
available and/or CDC
oversight. This will reduce the risk that dogs
pending or denied entry
will be placed in cargo
warehouses or other unsafe locations while
awaiting CDC determination or return to
their countries of origin.
This would ensure appropriate veterinary follow up for foreign-vaccinated dogs from
DMRVV high-risk countries.
Proposed 71.51(k)(4) ........
Foreign-vaccinated dogs
from DMRVV high-risk
countries must have serologic test results from
a CDC-approved laboratory with a waiting period, or such time period
as specified in CDC
technical instructions,
before entry or be quarantined for 28 days after
revaccination with a
USDA-licensed rabies
vaccine.
No laboratory testing requirement for dog imports from any country.
Serologic test from a CDCapproved laboratory with
a longer, e.g., 90-day
waiting period before
entry for dogs vaccinated outside the
United States and arriving from DMRVV highrisk countries or all dogs
imported from DMRVV
high-risk countries require serologic test results.
Allow serologic test results
for dogs imported from
DMRVV high-risk countries with foreign-issued
rabies vaccinations from
any laboratory (i.e., not
limited to CDC-approved
laboratories).
Proposed 71.51(b) .............
U.S.-vaccinated dogs imported from DMRVV
high-risk countries must
enter through one of 18
U.S. airports with a CDC
quarantine station. Foreign-vaccinated dogs
from DMRVV high-risk
countries must arrive at
a U.S. port with a CDCregistered Animal Care
Facility. Such facilities
must have an active custodial bond and a FIRMS
code issued by CBP,
and a USDA intermediate handlers license. Five U.S. ports
currently have facilities
that meet this standard.
No U.S. port requirement ..
For all dogs from DMRVV
high-risk countries, limit
entry to U.S. port with
CDC-registered Animal
Care Facilities. Five U.S.
ports currently have facilities that meet this
standard.
Allow foreign-vaccinated
dogs imported from
DMRVV high-risk countries to enter at any U.S.
port with a CDC quarantine station and allow
U.S.-vaccinated dogs
from any country to
enter at any U.S. port.
VI. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
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Option 1—more restrictive
Under Executive Order 12866 (E.O.
12866), Regulatory Planning and Review
(58 FR 51735, October 4, 1993), HHS/
CDC is required to determine whether
this regulatory action would be
‘‘significant’’ and therefore subject to
review by the Office of Management and
Budget (OMB) and the requirements of
the Executive Order. E.O. 12866, as
amended by Executive Order 14094,
defines ‘‘significant regulatory action’’
as an action that is likely to result in a
rule:
• Having an annual effect on the
economy of $200 million or more
(adjusted every 3 years by the
Administrator of OIRA for changes in
gross domestic product), or adversely
affect in a material way the economy, a
sector of the economy, productivity,
competition, jobs, the environment,
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public health or safety, or State, local,
territorial, or tribal governments or
communities;
• Creating a serious inconsistency or
otherwise interfere with an action taken
or planned by another agency;
• Materially altering the budgetary
impact of entitlements, grants, user fees,
or loan programs or the rights and
obligations of recipients thereof; or
• Raising legal or policy issues for
which centralized review would
meaningfully further the President’s
priorities, or the principles set forth in
E.O. 12866, as specifically authorized in
a timely manner by the Administrator of
OIRA in each case.
OMB’s Office of Information and
Regulatory Affairs has determined that
this rulemaking is ‘‘significant’’.
The provisions of this NPRM (if
finalized as proposed) are not likely to
have an annual effect on the economy
of $200 million or more, although there
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is considerable uncertainty around the
number of dogs imported at baseline,
including the number of dogs imported
from DMRVV high-risk countries. HHS/
CDC conducted an analysis to estimate
the costs and benefits of the proposed
provisions of this NPRM relative to a
baseline without any change in
requirements. To conduct this analysis,
CDC assumed the NPRM would be
finalized as proposed. HHS/CDC
requests public comment on costs
associated with these changes to
importers, airlines, and State and local
health departments to improve the
accuracy of cost and benefit estimates.
More details on the assumptions used to
develop this analysis are included in an
Appendix found in the Supplemental
Materials tab of the docket, including
more specific solicitations for public
comment.
The economic baseline is based on the
provisions included in the existing 42
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CFR 71.51. The baseline analysis does
not incorporate the impact of the
temporary suspension of dogs imported
from DMRVV high-risk countries that
has been in effect since July 14, 2021.119
The economic baseline does not account
for the temporary suspension but does
account for a change to the definition of
rabies-free country published in
2019.120 This baseline is used as a
comparator to assess the impact of the
provisions of the NPRM if finalized as
proposed.
The provisions of this NPRM (if
finalized as proposed) would address
the market inefficiency in which dog
importers do not consider the potential
detrimental impacts to the public’s
health that may result from the
importation of ill dogs, especially dogs
infected with DMRVV. Regulation at the
Federal level is necessary to address the
risk of unhealthy dog imports upon
entry to the United States. Federal
action allows risks to be addressed prior
to dogs’ arrival in the United States. The
provisions of this NPRM (if finalized as
proposed) are expected to affect the
following categories of interested parties
and implementing partners:
• Importers of dogs from countries
that are DMRVV-free or at low risk for
DMRVV;
• Importers of dogs from countries
that are at high risk of DMRVV;
• Airlines and other carriers;
• CBP;
• CDC;
• USDA; and
• State and local public health and
animal health departments.
As discussed above, the changes
proposed in the NPRM incorporate
different requirements depending on
whether dogs are imported from
DMRVV high-risk countries compared
to countries that are DMRVV-free or
DMRVV low-risk. Proposed
requirements for dogs from DMRVV
high-risk countries are further
differentiated depending on whether
imported dogs have received their rabies
vaccines in the United States or in
another country. Dogs imported from
DMRVV high-risk countries would have
119 On June 14, 2021, CDC published the ‘‘Notice
of Temporary Suspension of Dogs Entering the
United States from High-Risk Rabies Countries.’’
Through this notice, CDC informed the public that,
effective July 14, 2021, it was temporarily
suspending the importation of dogs from: countries
classified by CDC as high risk for DMRVV; AND
countries that are NOT at high risk if the dogs have
been in high-risk countries during the previous six
months. See 86 FR 32041 (June 16, 2021). The
suspension was extended effective June 10, 2022.
See 87 FR 33158 (June 1, 2022).
120 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. 84 FR
724 (Jan. 31, 2019).
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to arrive at one of five airports with a
CDC-registered Animal Care Facility
(foreign-vaccinated dogs) or at one of 18
airports with a CDC quarantine station
(U.S.-vaccinated dogs). Importers of
foreign-vaccinated dogs from DMRVV
high-risk countries would make
reservations with a CDC-registered
Animal Care Facility for a veterinary
examination and revaccination prior to
arrival. As part of the proposed entry
requirements in the NPRM (if finalized
as proposed), importers would either
agree to a 28-day quarantine period for
the dog or submit samples of the dog’s
blood to a CDC-approved laboratory for
serologic testing to demonstrate
immunity to rabies virus. CDC assumes
that most importers would choose
serologic testing in lieu of the
quarantine period. All importers of dogs
from DMRVV high-risk countries would
submit the CDC Import Certification of
Rabies Vaccination and Microchip
Required for All Live Dog Importations
into the United States Form or
Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States Form, which require
certification by an Official Government
Veterinarian. However, dogs imported
from DMRVV-free or DMRVV low-risk
countries do not require evaluation at
CDC-registered Animal Care Facilities
and are eligible to arrive at any U.S.
port. In lieu of the CDC Import
Certification of Rabies Vaccination and
Microchip Required for All Live Dog
Importations into the United States
Form or Certification of U.S.-issued
Rabies Vaccination for Live Dog Reentry into the United States Form,
importers may provide proof that the
dogs have only been in DMRVV-free or
DMRVV low-risk countries during the
six months prior to arriving in the
United States (i.e., to demonstrate the
dog had not been in a high-risk
country).
All dog imports arriving on aircraft
conveyances, regardless of whether they
arrive from countries that are DMRVVfree or at low- or high-risk for DMRVV,
are subject to a six-month minimum age
requirement. Dog imports arriving at
land ports are only subject to the sixmonth minimum age requirement if an
importer needs to import three or more
dogs younger than six months of age in
a calendar year. In addition, all dogs
would need to be implanted with
microchips for identification purposes
(if the NPRM is finalized as proposed).
All dogs, regardless of country of origin,
would be listed on a bill of lading by the
airline, if entering the U.S. via air. All
importers of dogs arriving at an air,
land, or seaport would have to submit
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Fmt 4701
Sfmt 4702
a CDC Import Submission Form to CDC
via a CDC-approved system prior to the
dog’s departure from the foreign
country. The form would need to be
presented to the airline or other carrier
prior to boarding and upon arrival in the
United States.
The annualized and present value
estimates of monetized costs and
benefits over the 10-year period from
2023 through 2032 using three percent
and seven percent discount rates are
summarized in Tables 5 and 6. The
annualized, monetized costs (2020 USD)
of the provisions in the NPRM (if
finalized as proposed) are estimated to
be $29 million (range: $7.8 to $88
million) using a three percent discount
rate, and the results were almost
unchanged using a seven percent
discount rate. Most monetized costs are
expected to be incurred by importers (84
percent for the most likely estimate).
The estimated monetized costs are
expected to be less for importers of dogs
from DMRVV-free or DMRVV low-risk
countries compared to importers of dogs
from DMRVV high-risk countries. The
proposed provisions estimated to result
in the greatest increase in costs for
importers of dogs imported from
DMRVV-free countries were associated
with the additional costs associated
with the minimum age, and with the
microchip requirements, and
completing the new CDC Import
Submission Form.
The provisions estimated to result in
the greatest increase in costs for
importers of dogs from DMRVV highrisk countries were associated with the
requirements regarding use of a CDCregistered Animal Care Facility for
foreign-vaccinated dogs from DMRVV
high-risk countries in proposed section
71.51(k). Other costs included: (1)
laboratory testing, (2) an expected
reduction in the number of dogs
imported from DMRVV high-risk
countries, (3) the need for some
travelers to re-route travel to an airport
with a CDC quarantine station or airport
with a CDC-registered Animal Care
Facility, and (4) the costs with
providing a CDC Import Certification of
Rabies Vaccination and Microchip
Required for All Live Dog Importations
into the United States Form or
Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States Form (certified by an
Official Government Veterinarian).
Airlines are expected to incur the
greatest costs among carriers and their
costs are estimated to comprise about
8.7 percent of the estimated annualized,
monetized costs, with most of their
costs associated with ensuring that all
transported dogs comply with the bill of
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lading requirements of the NPRM (if
finalized as proposed) and a reduction
in the number of dogs transported.
HHS/CDC was unable to estimate costs
from other types of carriers of dogs
arriving by land or sea and welcomes
public comment on their potential costs.
CDC is estimated to incur about 6.9
percent of the annualized, monetized
costs (most likely estimate) associated
with the provisions of this NPRM (if
finalized as proposed). Most CDC costs
would be associated with the oversight
of animal care facilities and laboratory
proficiency testing programs for dogs
imported from high-risk countries. CBP
is expected to incur about 0.5 percent of
the annualized costs (most likely
estimate) associated with the provisions
of this NPRM (if finalized as proposed).
Most CBP costs would result from
training personnel to implement the
proposed requirements.
The annualized monetized benefits of
the provisions in the NPRM (if finalized
The wide range between the lowerbound and upper-bound cost and
benefit estimates demonstrates that
there is considerable uncertainty in
these results. More details on the input
parameters and assumptions used to
generate these estimates may be found
in the Appendix under the
Supplemental Materials tab of the
docket. At present, the number of dogs
imported into the United States is
neither accurately nor completely
tracked by any data system, and the
uncertainty in the cost and benefit
estimates reflect uncertainty in both the
total number of dogs imported and the
number of dogs imported from DMRVV
high-risk countries, as well as the cost
of the new requirements included in the
NPRM (if finalized as proposed). The
net annualized, monetized costs (total
cost estimate¥total benefit estimate) are
estimated to be about $26 million per
year (range: $6.9 to $83 million) using
a three percent discount rate.
as proposed) are estimated to be about
$1.9 million (range: $0.80 to $4.0
million) using a three percent or seven
percent discount rate, with most of the
benefits accruing to importers (46
percent of the most likely estimates) and
to CBP (33 percent of the most likely
estimates). Some of the benefits
estimated for both importers and CBP
would result from reduced time spent
on screening dogs from high-risk
countries at U.S. ports. The amount of
time required per dog at U.S. ports
would be reduced because it is assumed
that the CDC standardized vaccination
forms would be easier to review
compared to non-standardized
documentation for dogs arriving from
DMRVV high-risk countries. The
provisions in this NPRM (if finalized as
proposed) are also estimated to reduce
the number of dogs denied entry or
arriving ill or dead, with benefits
estimated for importers, airlines, CBP,
and CDC.
TABLE 5—ANNUALIZED, MONETIZED COSTS AND BENEFITS SUMMARY TABLE
[In 2020 million dollars, over a 10-year time horizon relative to baseline, three percent or seven percent discount rate]
Most likely
estimate
Lower bound
Upper bound
Source
(RIA section)
Annualized, monetized benefits (reduced costs)
Three percent discount rate:
Importer benefits ......................................................................................
Airline benefits ..........................................................................................
DHS/CBP benefits ....................................................................................
HHS/CDC benefits ...................................................................................
State and local health department benefits .............................................
$0.89
0.18
0.65
0.22
0.05
$0.37
0.038
0.30
0.090
0.0
$1.8
0.59
0.95
0.59
0.022
Total benefits (A1) .............................................................................
1.9
0.8
4.0
Seven percent discount rate:
Importer benefits ......................................................................................
Airline benefits ..........................................................................................
DHS/CBP benefits ....................................................................................
HHS/CDC benefits ...................................................................................
State and local health department benefits .............................................
0.89
0.18
0.65
0.22
0.005
0.37
0.038
0.30
0.090
0.0
1.8
0.59
0.95
0.59
0.022
Total benefits (A2) .............................................................................
1.9
0.80
4.0
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Quantified, but unmonetized, benefits .............................................................
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The response costs associated with a dog
imported while infected with DMRVV were
estimated to be about $320,000, ranging from
$220,000 to $520,000. The requirements in the
NPRM (if finalized as proposed) reduce the risk
of imported dogs arriving with DMRVV, and the
costs associated with rabies response activities
will decrease.
Sfmt 4702
E:\FR\FM\10JYP4.SGM
10JYP4
B1, B2, B3.
B4.
B5.
B6.
B7.
B1, B2, B3.
B4.
B5.
B6.
B7.
C1.
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TABLE 5—ANNUALIZED, MONETIZED COSTS AND BENEFITS SUMMARY TABLE—Continued
[In 2020 million dollars, over a 10-year time horizon relative to baseline, three percent or seven percent discount rate]
Most likely
estimate
Qualitative (unquantified) benefits ...................................................................
Lower bound
Upper bound
With each importation of a dog infected with
DMRVV, there is a risk that a person may
become infected and die or that DMRVV may be
re-introduced in the U.S. wildlife population,
which could dramatically increase costs relative
to the public health response cost summarized
above. In addition, by obtaining high-quality data
on the number of dogs imported by country, CDC
and other Federal agencies, including USDA, will
improve preparedness for outbreaks of new and
emerging infectious disease threats to humans
(e.g., DMRVV) and animals (e.g., African swine
fever). The provisions of the NPRM (if finalized
as proposed) will also ensure that dogs that are
denied entry or arrive ill will receive the
veterinary care needed to protect their health and
safety.
Source
(RIA section)
D1.
Annualized, monetized costs
Three percent discount rate:
Importer costs ...........................................................................................
Airline costs ..............................................................................................
DHS/CBP costs ........................................................................................
HHS/CDC costs ........................................................................................
23.8
2.5
0.1
1.9
5.2
1.0
0.05
1.4
79.1
5.2
0.3
2.5
Total costs (B1) .................................................................................
28.3
7.7
87.1
Seven percent discount rate:
Importer costs ...........................................................................................
Airline costs ..............................................................................................
DHS/CBP costs ........................................................................................
HHS/CDC costs ........................................................................................
23.9
2.5
0.2
2.0
5.3
1.0
0.06
1.4
79.6
5.2
0.4
2.6
Total costs (B2) .................................................................................
28.6
7.8
87.8
Quantified, but unmonetized, costs .................................................................
Not applicable.
C2.
Qualitative (unquantified) costs .......................................................................
CDC would monitor countries and may suspend
entry of dogs from countries with repeated
instances of dogs with falsified or fraudulent
rabies vaccination documentation. The lost value
of these imports would impact some U.S.
businesses and dog purchasers. In addition, the
duration of any suspensions for these countries
is highly uncertain and may be ended in the
event of improvement of those countries’ dog
export controls. CDC is proposing the authority to
issue orders to revoke a carrier’s or importer’s
permission to transport live dogs and cats if
either has endangered the public’s health;
however, CDC does not have any plans to
suspend any carriers or importers at this time.
Owners of dogs that undergo a 28-day
quarantine period may suffer qualitative costs
from being separated from their dogs during
quarantine.
D2.
B1, B2, B3.
B4.
B5.
B6.
B1, B2, B3.
B4.
B5.
B6.
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Net annualized costs
Total (three percent discount rate), (B1)–(A1) ................................................
Total (seven percent discount rate), (B1)–(A1) ...............................................
The present value of the estimated
monetized cost over a 10-year period for
the provisions in the NPRM (if finalized
as proposed) is estimated to be $240
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26.4
26.6
million (range: $65 to $740 million)
using a three percent discount or $200
million (range: $53 to $610 million)
using a seven percent discount rate. The
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Fmt 4701
Sfmt 4702
6.9
7.0
83.1
83.8
present value of monetized benefits over
a 10-year period of the provisions in the
NPRM (if finalized as proposed) is
estimated at $17 million (range: $6.9 to
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$34 million) using a three percent
discount rate or $14 million (range: $5.7
to $28 million) using a seven percent
discount rate. The net annualized
monetized cost (total costs¥total
benefits) is estimated at $230 million
per year (range: $58 to $700 million)
using a three percent discount rate and
$190 million per year (range: $48 to
$580 million) using a seven percent
discount rate.
TABLE 6—PRESENT VALUE OF COSTS AND BENEFITS SUMMARY TABLE
[In 2020 million dollars, over a 10-year time horizon relative to baseline, three percent or seven percent discount rate]
Most likely
estimate
Lower bound
Upper bound
Source
(RIA section)
Present value of monetized benefits (reduced costs)
Three percent discount rate:
Importer benefits ......................................................................................
Airline benefits ..........................................................................................
DHS/CBP benefits ....................................................................................
HHS/CDC benefits ...........................................................................................
State and local health department benefits .............................................
$7.6
1.5
5.5
1.9
0.042
$3.2
0.32
2.6
0.77
0.0
$16
5.0
8.1
5.0
0.19
Total benefits (A) ...............................................................................
17
6.9
34
Seven percent discount rate:
Importer benefits ......................................................................................
Airline benefits ..........................................................................................
DHS/CBP benefits ....................................................................................
HHS/CDC benefits ...................................................................................
State and local health department benefits .............................................
6.3
1.2
4.6
1.6
0.034
2.6
0.27
2.1
0.63
0.0
13
4.1
6.7
4.1
0.16
Total benefits .....................................................................................
14
5.7
28
B1, B2, B3.
B4.
B5.
B6.
B7.
B1, B2, B3.
B4.
B5.
B6.
B7.
Quantified, but unmonetized, benefits .............................................................
The response costs associated with a dog
imported while infected with DMRVV were
estimated to be about $320,000, ranging from
$220,000 to $520,000. The requirements in the
NPRM (if finalized as proposed) reduce the risk
of imported dogs arriving with DMRVV, and the
costs associated with rabies response activities
will decrease.
C1.
Qualitative (unquantified) benefits ...................................................................
With each importation of a dog infected with
DMRVV, there is a risk that a person may
become infected and die or that DMRVV may be
re-introduced in the U.S. wildlife population,
which could dramatically increase costs relative
to the public health response cost summarized
above. In addition, by obtaining high-quality data
on the number of dogs imported by country, CDC
and other Federal agencies, including USDA, will
improve preparedness for outbreaks of new and
emerging infectious disease threats to humans
(e.g., DMRVV) and animals (e.g., African swine
fever). The provisions of the NPRM (if finalized
as proposed) will also ensure that dogs that are
denied entry or arrive ill will receive the
veterinary care needed to protect their health and
safety.
D1.
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Present value of monetized costs
Three percent discount rate:
Importer costs ...........................................................................................
Airline costs ..............................................................................................
DHS/CBP costs ........................................................................................
CDC costs ................................................................................................
203
21
1.1
17
45
8
0.4
11
675
41
2.6
18
Total costs (B) ...................................................................................
242
64
737
Seven percent discount rate:
Importer costs ...........................................................................................
Airline costs ..............................................................................................
DHS/CBP costs ........................................................................................
CDC costs ................................................................................................
168
17
1.1
14
37
6.6
0.4
9.3
559
33
2.4
14
Total costs .........................................................................................
200
53
608
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Sfmt 4702
E:\FR\FM\10JYP4.SGM
10JYP4
B1, B2, B3.
B4.
B5.
B6.
B1, B2, B3.
B4.
B5.
B6.
44006
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TABLE 6—PRESENT VALUE OF COSTS AND BENEFITS SUMMARY TABLE—Continued
[In 2020 million dollars, over a 10-year time horizon relative to baseline, three percent or seven percent discount rate]
Most likely
estimate
Lower bound
Upper bound
Source
(RIA section)
Quantified, but unmonetized, costs .................................................................
Not applicable.
C2.
Qualitative (unquantified) costs .......................................................................
CDC would monitor countries and may suspend
entry of dogs from countries with repeated
instances of dogs with falsified or fraudulent
vaccine credentials or invalid rabies vaccination
documentation. The lost value of these imports
would impact some U.S. businesses and dog
purchasers. In addition, the duration of any
suspensions for these countries is highly
uncertain and may be ended in the event of
improvement of those countries’ dog export
controls. CDC is proposing the authority to issue
orders to revoke a carrier’s or importer’s
permission to transport live dogs and cats if
either has endangered the public’s health;
however, CDC does not have any plans to
suspend any carriers or importers at this time.
Owners of dogs that undergo a 28-day
quarantine period may suffer qualitative costs
from being separated from their dogs during
quarantine.
D2.
Net annualized costs
Total (three percent discount rate), (B1)–(A1) ................................................
Total (seven percent discount rate), (B1)–(A1) ...............................................
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The United States was declared
DMRVV-free in 2007. Importing dogs
from DMRVV high-risk countries
involves a significant public health risk.
The proposed provisions of this NPRM
(if finalized as proposed) would better
align U.S. dog importation requirements
with those of other countries that have
been declared DMRVV-free. Further, the
serologic testing requirements are
consistent with recommendations in the
WOAH Terrestrial Manual for dogs
imported from DMRVV high-risk
countries to DMRVV-free countries.121
One DMRVV-infected dog may cause
transmission to humans, domestic pets,
livestock, or wildlife. The average cost
per importation of a DMRVV-infected
dog was estimated to be $320,000
(range: $220,000 to $520,000) to conduct
public health investigations and
administer rabies PEP to exposed
persons.
Historically, CDC’s has denied entry
to approximately 200 dogs annually due
to fraudulent, incomplete, or inaccurate
paperwork.122 However, between
121 WOAH Terrestrial Animal Health Code.
Chapter 5.11. Available at: Access online: WOAH—
World Organisation for Animal Health https://
www.woah.org/en/what-we-do/standards/codesand-manuals/terrestrial-code-online-access/
?id=169&L=0&htmfile=chapitre_certif_rabies.htm.
122 Centers for Disease Control and Prevention
(2021). Quarantine Activity Reporting System
(version 4.9.8.8.2.2A). Dog Importation data, 2010–
2019. Accessed October 1, 2022.
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187
January 2020 and July 2021 (i.e., during
the COVID–19 pandemic, prior to the
temporary suspension), CDC
documented more than 1000 instances
of incomplete, inadequate, or fraudulent
rabies vaccination certificates for dogs
arriving from DMRVV high-risk
countries.123 The diversion of public
health resources globally to COVID–19
response activities has contributed to a
lapse in canine rabies vaccination
efforts and a related increase in the
prevalence of dogs infected with
DMRVV in some high-risk countries.
The combination of an increasing
number of dogs imported without
adequate documentation of rabies
vaccination,124 in addition to the
potential increase in the prevalence of
DMRVV in high-risk countries,125
would increase the risk of importation
of dogs that are infected with DMRVV.
This combination of factors would
123 Pieracci, E., Williams, C., Wallace, R.,
Kalapura, C., Brown, C. U.S. dog importations
during the COVID–19 pandemic: Do we have an
erupting problem? PLoS ONE, 16(9), e0254287. doi:
10.1371/journal.pone.0254287.
124 Centers for Disease Control and Prevention.
Quarantine Activity Reporting System (version
4.9.8.8.2.2A). Dog importation data, 2018–2020.
Accessed: 15 February 2021.
125 A Kunkel, Jeon S, Haim, Dilius CJP, Crowdis
K, Meltzer MI, Wallace R. (2021) The urgency of
resuming disrupted dog rabies vaccination
campaigns: a modeling and cost-effectiveness
analysis. Scientific Reports; 11:12476. https://
https://doi.org/10.1038/s41598-021-92067-5.
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48
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increase the likelihood of DMRVVimportation events relative to the timeperiod before the COVID–19 pandemic.
CDC is unable to predict future trends
with or without the proposed provisions
included in this NPRM to estimate how
many dogs infected with DMRVV may
be imported. Two rabid dog imports
(both from Iran) have been reported in
Canada within a seven-month period
(specifically July 2021 and January
2022) at around the same time the
United States implemented a temporary
suspension of dogs imported from
DMRVV high-risk countries. Prior to
these two imports, Canada had not
reported a dog infected with DMRVV
since the 1960s.126 Given the limited
number of reported dogs with DMRVV,
this observation may be indicative of a
higher risk for dogs imported from
DMRVV high-risk countries during the
COVID–19 pandemic or could be
anomalous occurrences in Canada.
However, the provisions included in the
NPRM (if finalized as proposed) is
expected to substantively reduce the
risk of importation of dogs infected with
DMRVV relative to baseline.
The primary public health benefit of
this NPRM (if finalized as proposed) is
126 Outbreak News Today (Feb. 10, 2022) Rabies
case reported in Toronto in a dog imported from
Iran. https://outbreaknewstoday.com/rabies-casereported-in-toronto-in-a-dog-imported-from-iran46958. Accessed: February 14, 2022.
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the reduced risk that a dog infected with
DMRVV will be imported from a highrisk country. Using the most likely
estimates of the net monetized cost
estimate ($26.4 million) and the most
likely estimate of the potential benefit of
averting the importation of one dog with
DMRVV from a high-risk country
($320,000), it is possible to calculate the
change in the number of imported dogs
infected with DMRVV if the provisions
of the NPRM are finalized as proposed
relative to the baseline such that the
benefit would equal cost. The net cost
($26.4 million) divided by the cost per
importation ($320,000) suggests that the
provisions of the NPRM (if finalized as
proposed) relative to baseline would
have to avert the importation of 82 dogs
infected with DMRVV for the benefit to
exceed the cost. This would require an
increase in the number of dogs imported
into the United States while infected
with DMRVV, which could only occur
because of widespread failures of rabies
control programs in multiple countries.
However, this analysis does not
consider the potential for fatal rabies
cases in people or the risk of
reintroduction of DMRVV in the United
States, as analyzed below.
The above estimate of the cost of an
importation of a dog with DMRVV does
not account for the worst-case
outcomes, which include (1)
transmission of rabies to a person who
dies from the disease, or (2) ongoing
transmission to other domestic and
wildlife species in the United States.
The cost of re-introduction could be
especially high if DMRVV spreads to
other species of U.S. wildlife. Reestablishment of DMRVV in the United
States could result in costly efforts over
several years to eliminate the virus
again. Both worst-case outcomes may be
more likely to occur after the COVID–19
pandemic because public health
resources were diverted to COVID–19
response activities and disruptions in
rabies control programs in high-risk
countries. Disruptions to rabies control
programs in DMRVV high-risk countries
may contribute to elevated risks even as
the COVID–19 pandemic wanes.
Human deaths from rabies continue to
occur in the United States after
exposure to wild animals; however, no
U.S. resident has died after exposure to
an imported dog with DMRVV in at
least 20 years. CDC uses the value of
statistical life (VSL) to assign a value to
interventions that can result in mortality
risk reductions. For fatal cases, HHS
recommends the use of the value of
statistical life to estimate the potential
benefits of averted deaths, an estimate of
$11.6 million in 2020 USD and a range
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of $5.5 to $17.7 million.127 However,
CDC is unable to estimate the potential
magnitude of the mortality risk
reduction associated with the proposed
rule. Based on the median VSL, the
provisions of the NPRM (if finalized as
proposed) would need to help avert
three or more human deaths per year for
the benefits to exceed costs (or an
average of 2.3 deaths per year over
multiple years).
Efforts to eliminate DMRVV if reestablished in the United States would
also prove costly. A previous campaign
to eliminate domestic dog-coyote rabies
virus variant jointly with gray fox
(Texas fox) rabies virus variant in Texas
over the period from 1995 through 2003
cost $34 million,128 129 or $55 million in
2022 USD. The costs to contain any
reintroduction would depend on the
time-period before the reintroduction
was realized, the wildlife species in
which DMRVV was transmitted, and the
geographic area over which
reintroduction occurs. The above
estimate is limited to the cost of rabies
vaccination programs for targeted
wildlife and does not include the costs
to administer PEP to any persons
exposed after the reintroduction has
been identified. Human deaths from
DMRVV could increase following the reintroduction of DMRVV to the United
States as the risk of exposure would
increase.
The provisions of the NPRM (if
finalized as proposed) would also
ensure that dogs that are denied
admission or arrive ill will be housed
appropriately and receive the veterinary
care needed to protect their health and
safety. This will reduce the likelihood
that dogs may be left in unsafe
conditions in cargo warehouses for
extended periods of time (i.e., longer
than six hours) with the potential to
expose workers who are not trained to
handle live animals safely.130
Under the current baseline, the
number of dogs imported into the
United States is neither accurately nor
completely tracked. The more
127 U.S. Department of Health and Human
Services, 2016. Office of the Assistant Secretary for
Planning and Evaluation. Guidelines for Regulatory
Impact Analysis. https://aspe.hhs.gov/system/files/
pdf/242926/HHS_RIAGuidance.pdf. Accessed:
April 20, 2020.
128 TJ Sidwa et al. (2005) Evaluation of oral rabies
vaccination programs for control of rabies
epizootics in coyotes and gray foxes: 1995–2003.
Journal of the American Veterinary Medicine
Association; 227(5):785–92.
129 R.T. Sterner et al. (2009) Tactics and
Economics of Wildlife Oral Rabies Vaccination,
Canada and the United States. Emerging Infectious
Diseases; 15(8), 1176–1184.
130 https://www.cbsnews.com/chicago/news/dogdies-at-ohare-airport-warehouse-17-others-savedafter-being-left-without-food-or-water-for-3-days/.
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comprehensive data collection proposed
in this NPRM through the CDC Import
Submission Form would benefit public
health investigations and enable better
and more timely contact tracing of all
animals exposed to an imported dog
with DMRVV. The current lack of data
also inhibits the Federal government’s
ability to target interventions for dogs
imported from specific countries. The
collection of data from the CDC Import
Submission Form as proposed in this
NPRM may also benefit other agencies
such as USDA/APHIS that may want to
regulate dog imports based on the risk
of introduction of diseases that may
affect U.S. livestock. For example, in
2021, APHIS regulated importers of
dogs for resale based on whether the
dogs were imported from countries
where African swine fever exists.131 The
potential economic benefits of reducing
the risk of the importation of African
swine fever could be significant. For
example, a recent African swine fever
outbreak in China was estimated to have
total economic losses equivalent to 0.78
percent of China’s gross domestic
product in 2019.132 The requirement in
the NPRM (if finalized as proposed) to
report all dogs to CDC via a CDCapproved system would reduce the risk
of importation of infected dogs from
countries with ongoing disease
outbreaks that may affect livestock.
Viruses exploiting new host species
have led to some of the most devastating
disease epidemics, such as influenza,
Ebola, and the HIV/AIDS pandemic.133
Viruses continually evolve in their
animal hosts. This has been observed in
viruses such as avian and swine
influenza viruses, constituting a
permanent pandemic threat to
humans.134 Although CDC cannot
predict when future zoonotic diseases
may emerge or whether future zoonotic
diseases may be associated with
transmission from dogs to humans, such
events remain a possibility. Future dog131 Animal and Plant Health Inspection Service
(Aug. 4, 2021) USDA Announces Requirements for
Importing Dogs from Countries Affected with
African Swine Fever. https://www.aphis.usda.gov/
aphis/newsroom/news/sa_by_date/sa-2021/asf-dogimports. Accessed: 05 February 2022.
132 Shibing You, Tingyi Liu, Miao Zhang, Xue
Zhao, Yizhe Dong, Bi Wu, Yanzhen Wang, Juan Li,
Xinjie Wei and Baofeng Shi (2021) African swine
fever outbreaks in China led to gross domestic
product and economic losses. Nature Food; 2: 802–
808.
133 Woolhouse M, Haydon D, Antia R. Emerging
pathogens: the epidemiology and evolution of
species jumps. Trends in Ecology & Evolution 2005;
20 (5): 238–244. https://doi.org/10.1016/j.tree.
2005.02.009.
134 Woolhouse M, Haydon D, Antia R. Emerging
pathogens: the epidemiology and evolution of
species jumps. Trends in Ecology & Evolution 2005;
20 (5): 238–244. https://doi.org/10.1016/j.tree.
2005.02.009.
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mediated zoonotic diseases may pose an
acute risk to the public’s health because,
in contrast to other animal imports,
most dogs are imported as pets and will
be in close contact with their owners.
During the COVID–19 pandemic a
variant of the SARS–CoV–2 virus was
detected in mink populations in Europe
and entered human populations from
this animal host. Between February 18,
2020, and December 15, 2021, 457 mink
farms in 12 countries experienced
SARS–CoV–2 outbreaks135 and mink-tohuman transmission of the SARS–CoV–
2 virus was documented on mink farms
in the Netherlands, Denmark, Poland,
and the United States.136 137 138 In
August and September of 2020,
Denmark documented a mink-associated
SARS–CoV–2 variant strain found in 12
people, eight of whom had links to the
mink farming industry. Due to concerns
about transmissibility, immunity, and
potential impacts on vaccine efficacy,
the Danish government ordered that all
15–17 million minks in the country be
culled. Following a risk assessment of
live mink importations from the
Western European region to the United
States, CDC determined additional
regulatory action to prohibit live mink
importations was unnecessary due to
public health prevention measures
taken by mink importers and the low
numbers of imported mink. In
comparison, CDC would not have the
same data available to conduct a risk
assessment for dog imports in the event
of a future dog-mediated zoonotic
disease outbreak because dog imports
are neither accurately nor completely
tracked in any government data system
in the absence of the dog import
submission data requirement proposed
in this NPRM.
The proposed reporting of dog import
volumes by country in an approved CDC
import submission data system provides
an opportunity to target interventions
for dogs imported from specific
135 Koopmans M. SARS–CoV–2 and the humananimal interface: outbreaks on mink farms. The
Lancet Infectious Diseases 2021; 21 (1): 18–19.
136 Hammer AS, Quaade ML, Rasmussen TB, et al.
SARS–CoV–2 Transmission between Mink
(Neovison vison) and Humans, Denmark. Emerg
Infect Dis. 2021 Feb;27(2):547–551. doi: 10.3201/
eid2702.203794. Epub 2020 Nov 18. PMID:
33207152; PMCID: PMC7853580.
137 Oude Munnink BB, Sikkema RS,
Nieuwenhuijse DF, et al. Transmission of SARS–
CoV–2 on mink farms between humans and mink
and back to humans. Science. 2021 Jan
8;371(6525):172–177. doi: 10.1126/science.abe5901.
Epub 2020 Nov 10. PMID: 33172935; PMCID:
PMC7857398.
138 Rabalski L, Kosinki M, Mazur-Panasiuk N, et
al. Zoonotic spillover of SARS–CoV–2: minkadapted virus in humans. Available at: https://
www.biorxiv.org/content/10.1101/2021.03.05.
433713v1.full.pdf.
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countries. Such reporting as proposed in
42 CFR 71.51(h) would allow CDC or
other Federal agencies to more easily
implement preventive measures to
mitigate the risk of introductions of new
zoonotic diseases targeted to specific
countries of concern. The import
submission data requirement may also
help CDC and other Federal agencies, as
well as State and local health
departments, retrospectively inspect
shipments from specific countries. This
would reduce the costs of future
interventions; however, CDC is not able
to quantify future savings.
The provisions of the NPRM (if
finalized as proposed) are expected to
reduce the risk of dogs arriving while
ill. If an animal arrives in the United
States and appears ill or is dead, a
public health investigation is required
to ensure the ill or dead animal does not
present a public health threat. The
overall health of an animal can play a
significant role in whether it can
maintain core body functions (i.e., body
temperature regulation and glucose
levels) during prolonged flights.
Stressed, malnourished, and young
animals are more likely to become ill
and can transmit communicable
diseases that can affect humans; 139 140
therefore, safety and welfare concerns
for the transport of dogs have a public
health impact that requires a degree of
oversight from public health agencies to
ensure human and animal health is
protected.141
In addition to the unmonetized
benefits described above, there may be
additional unmonetized costs. CDC
plans to monitor countries and may
suspend entry of dogs from countries
with repeated instances of falsified or
fraudulent dog vaccine credentials or
invalid rabies vaccination documents.
The lost value of imports from DMRVVrestricted countries would impact some
U.S. businesses and dog purchasers.
However, the duration of any
suspensions for these countries is highly
uncertain and may be ended in the
event of improvement of those
countries’ export controls.
139 Galanis E et al. Brucellosis and other diseases
imported with dogs. BCMJ 2019; 61 (4): 177–190.
Available at: https://bcmj.org/bccdc/brucellosisand-other-diseases-imported-dogs.
140 Denstedt E. Echinococcus multilocularis as an
emerging public health threat in Canada: A
knowledge synthesis and needs assessment.
Accessed: February 28, 2019. Available at:
www.ncceh.ca/sites/default/files/Guelph-Denstedt2017.pdf.
141 Pieracci EG, Maskery B, Stauffer K, Gertz A,
Brown C. Risk factors for death and illness in dogs
imported into the United States, 2010–2018.
Transbound Emerg Dis. 2022 Mar 15. doi: 10.1111/
tbed.14510.
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HHS/CDC is proposing the authority
to issue orders to revoke a carrier’s
permission to transport live dogs and
cats if a carrier has endangered the
public’s health; however, CDC does not
have plans to suspend any carriers at
this time.
CDC lacks data on the cost to airlines
of ensuring that a representative of an
airline transporting live dogs into the
United States be on-site at the U.S. port
and available to coordinate the entry/
clearance of the dogs with Federal
government officials until all live dogs
on an arriving flight into the United
States have either been cleared for entry
or arrangements have been made to
transport the dogs to a CDC-registered
Animal Care Facility or other facility
(e.g., veterinary clinic or kennel)
approved by CDC pending admissibility
determination. CDC believes this will
only incur additional costs on occasion
since airline staff are typically available
on-site. However, HHS/CDC requests
public comment to provide more data to
estimate costs associated with this
proposed requirement.
Impact of the NPRM (if Finalized as
Proposed) on Dog Import Volumes
Although the U.S. Government does
not precisely track the total number of
dogs imported each year, it was
previously estimated that approximately
1 million dogs are imported into the
United States annually, of which
100,000 dogs are from DMRVV high-risk
countries.142 This estimate was based on
information provided by airlines, CBP,
and a zoonoses public health study
conducted at a U.S.-Mexico land border
crossing.143
CBP does record, by country, the
number of dogs imported with formal
entry under Harmonized Tariff
Schedule (HTS) code 0106.19.91.20 and
HTS Description: Other live animals,
other, other, dogs. CDC used these data
from CBP to update its estimates of the
annual number of imported dogs. The
total number of dogs imported into the
United States from all countries under
this HTS category varied from 25,232 in
2018 to 58,540 in 2020. The number of
dogs from DMRVV high-risk countries
under this HTS category averaged
16,390 and varied from 9,966 to 24,031
over this three-year period. Over the
three-year period, 43,000 dogs on
average were imported per year, with
142 HHS/CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. 84 FR
724 (Jan. 31, 2019).
143 McQuiston, J.H., et al., Importation of dogs
into the United States: risks from rabies and other
zoonotic diseases. Zoonoses Public Health, 2008.
55(8–10): p. 421–6.
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about 38 percent arriving from DMRVV
high-risk countries. The number of dogs
reported under this HTS category does
not include dogs imported as checked
baggage, hand-carried in airplane
cabins, or crossing land borders without
formal entry. Thus, the number
underestimates the true number of dogs
imported into the United States. The
fraction of dogs with this HTS code
arriving from DMRVV high-risk
countries (38 percent) is much greater
than the fraction estimated by CBP field
staff (15 percent) in a previous data
collection.144 This could result if the
composition of dogs imported for resale
or adoption under the HTS code is
different than the full distribution of
imported dogs. In other words, more
individuals may travel internationally
with their personal pets or relocate to
the United States from DMRVV-free or
DMRVV low-risk countries. CDC
adjusted for the difference in the
fraction of dogs imported from DMRVVfree or DMRVV low-risk countries based
on estimates from CBP field staff of this
fraction and then re-estimated the
number of imported dogs arriving at
airports, as summarized in Section A2
of the Regulatory Impact Analysis.
CDC used previously reported
estimates of the number of dogs arriving
at the land ports with Canada and
Mexico.145 The updated estimates for
dog imports under the baseline are
summarized in Table 7. In total, CDC
estimated that under the current
regulatory baseline, about 800,000
imported dogs would arrive in the
44009
United States each year and that about
500 dogs from DMRVV high-risk
countries would be denied admission.
The number denied entry is based on
CDC data from 2020 and the first six
months of 2021 prior to the suspension
of dog imports from DMRVV high-risk
countries. This approach may
overestimate the number of dogs denied
entry in the future if the COVID–19
pandemic was associated with a
significant increase in dogs denied
admission due to pandemic-associated
factors. Since dog rabies vaccine
certificates are not currently required for
dogs from DMRVV-free or DMRVV lowrisk countries, CDC did not assume any
dogs from these countries would be
denied admission under the baseline.
TABLE 7—ESTIMATED ANNUAL NUMBERS OF DOGS IMPORTED INTO THE UNITED STATES UNDER THE CURRENT
REGULATORY BASELINE
Most likely
estimate
Lower bound
Upper bound
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Baseline estimate of dog imports
From DMRVV-free or DMRVV low-risk countries under baseline, total .....................................
Airports .................................................................................................................................
Land ports .............................................................................................................................
Canada-U.S. land ports 146 ...........................................................................................
Mexico-U.S. land ports 147 .............................................................................................
Dogs temporarily denied admission ............................................................................................
From DMRVV high-risk countries ................................................................................................
Dogs approved entry with adequate rabies vaccination documentation .............................
Dogs denied admission ........................................................................................................
733,787
371,507
362,280
120,780
241,500
0
65,560
65,060
500
619,229
297,205
322,024
96,624
225,400
0
32,780
32,480
300
848,344
445,808
402,536
144,936
257,600
0
98,340
97,590
750
Total dog imports at baseline ................................................................................
798,847
651,709
945,934
The provisions of the NPRM (if
finalized as proposed) that are expected
to reduce the number of dog imports
include: (1) age restrictions on air travel
for all dogs under six months of age,
including dogs from both DMRVV highrisk and DMRVV low-risk countries; (2)
restricting the number of dogs under six
months of age allowed to enter the
United States at land ports to three or
fewer; and (3) the additional costs of
fulfilling the requirements for follow-up
and revaccination at CDC-registered
Animal Care Facilities for foreignvaccinated dogs from DMRVV high-risk
countries. At the same time, CDC
believes that the number of dogs denied
admission and returned to their
countries of origin would decrease if the
provisions included in the NPRM are
finalized as proposed.
The estimated impact of the NPRM (if
finalized as proposed) on the number of
dog imports is summarized in Table 8.
CDC lacks data on what fraction of dogs
arriving by air are less than six months
old under the baseline. In the absence
of this information, CDC assumes five
percent (range: three to eight percent) of
dogs currently arriving by air are less
than six months and would not be
eligible to be imported into the United
States under the NPRM (if finalized as
proposed). CDC also lacks data on the
importers who would want to bring in
more than three dogs less than six
months of age within a calendar year,
which would no longer be allowed with
the NPRM (if finalized as proposed).
CDC notes that these provisions should
primarily impact individuals traveling
with their personal pets because the
importation of dogs for resale or
adoption that are less than six months
of age is already prohibited by USDA
regulations (7 CFR 2148). Another
144 CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. 84 FR
724 (Jan. 31, 2019).
145 CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
Importation of Dogs Into the United States. 84 FR
724 (Jan. 31, 2019).
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provision of the NPRM (if finalized as
proposed) would require importers of
dogs from DMRVV low-risk countries to
submit written documentation, such as
veterinary medical records,
documenting that the animal has been
in a DMRVV low-risk or DMRVV-free
country for the six months prior to
importation into the United States. CDC
does not anticipate denying admission
to dogs that may arrive from DMRVV
low-risk countries without such
documentation if the NPRM is finalized
as proposed, but there may be delays at
U.S. ports while CDC confirms dogs
from DMRVV low-risk countries have
not been in a DMRVV high-risk country
within the previous six months.
CDC assumes that the additional costs
associated with importing dogs from
DMRVV high-risk countries with
foreign-issued rabies vaccination
documentation would reduce the
146 Id.
147 Id.
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number of imports by about 20 percent
(range: 10 to 30 percent) if the NPRM is
finalized as proposed. In addition, CDC
believes the number of dogs from
DMRVV high-risk countries that are
denied entry will decrease if the
provisions of the NPRM are finalized as
proposed because CDC will be able to
require the use of standardized forms to
confirm rabies vaccination and animal
care facility follow-up requirements
should be clear to importers. Based in
part on the number of dogs denied entry
during CDC’s temporary suspension,
CDC estimated that about 50 dogs from
DMRVV high-risk countries would be
denied entry under the provisions of the
NPRM (if finalized as proposed).
Overall, the provisions in the NPRM (if
finalized as proposed) are expected to
have a small impact on the total number
of dogs imported (from about 799,000 at
baseline to 770,000 with the provisions
of the NPRM in effect and finalized as
proposed).
TABLE 8—ESTIMATED AVERAGE ANNUAL NUMBERS OF DOG IMPORTS BY DMRVV RISK CATEGORY AND BY IMMUNIZATION
STATUS
Best
estimate
Lower
bound b
Upper
bound c
Baseline estimate of dog imports
From rabies-free, DMRVV-free, or DMRVV low-risk countries under previous guidance
Total .............................................................................................................................................
Airports .....................................................................................................................................
Land ports ................................................................................................................................
Canada-U.S. land ports 148 ...............................................................................................
Mexico-U.S. land ports 149 ................................................................................................
Dogs denied entry from rabies-free, DMRVV-free, or low-risk ................................................
733,787
371,507
362,280
120,780
241,500
0
619,229
297,205
322,024
96,624
225,400
0
848,344
445,808
402,536
144,936
257,600
0
65,560
65,060
32,780
32,480
98,340
97,590
50%
32,530
32,530
500
798,847
65%
21,112
11,368
300
651,709
35%
34,157
63,434
750
945,934
5%
352,931
352,578
353
3%
288,289
288,145
144
8%
410,143
409,528
615
1.0%
358,657
119,572
119,453
120
239,085
238,846
239
712
0.5%
320,414
96,141
96,093
48
224,273
224,161
112
304
1.5%
396,498
142,762
142,548
214
253,736
253,355
381
1,210
20%
58,554
32,530
25,974
58,504
50
770,093
798,847
30%
29,070
21,112
7,928
29,040
30
637,743
651,709
10%
91,247
34,157
57,090
91,172
75
897,813
945,934
Dogs from countries at high risk of DMRVV
Total .............................................................................................................................................
Dogs approved entry with rabies vaccination documentation .................................................
Estimated fraction of imported dogs from DMRVV high-risk countries that are U.S.vaccinated .....................................................................................................................
Estimated U.S.-vaccinated dogs .......................................................................................
Estimated foreign-vaccinated dogs ...................................................................................
Dogs denied entry a ..................................................................................................................
Total imported dogs a ...................................................................................................................
With NPRM (if finalized as proposed)
From rabies-free, DMRVV-free, or low-risk countries
Fraction of dogs who are unable to be imported with NPRM (if finalized as proposed) at airports (due to age restrictions) ..................................................................................................
Airports .....................................................................................................................................
Dogs approved entry ........................................................................................................
Dogs temporarily denied entry ..........................................................................................
Fraction of dogs unable to be imported with NPRM (if finalized as proposed) at land ports
(due to age restrictions) ...........................................................................................................
Land ports ................................................................................................................................
Canada-U.S. land ports ....................................................................................................
Dogs approved entry .................................................................................................
Dogs temporarily denied entry ..................................................................................
Mexico-U.S. land ports .....................................................................................................
Dogs approved entry .................................................................................................
Dogs temporarily denied entry ..................................................................................
Dogs temporarily denied entry from rabies-free, DMRVV-free, or low-risk (total) ..................
lotter on DSK11XQN23PROD with PROPOSALS4
Dogs from countries at high risk of DMRVV
Fraction of dog imports that would not occur under the provisions of the NPRM (if finalized
as proposed) due to the higher costs associated with importing foreign-vaccinated dogs
from DMRVV high-risk countries .............................................................................................
Total .............................................................................................................................................
Number of U.S.-vaccinated dogs approved entry ...................................................................
Number of foreign-vaccinated dogs approved entry ...............................................................
Total dogs approved entry ...........................................................................................................
Dogs denied entry and returned to country-of-origin a .............................................................
Total imported dogs (with NPRM, if finalized as proposed) a .....................................................
Total imported dogs (Baseline) a .................................................................................................
a Since
these dogs are denied entry and returned to their countries of origin, they are not included in the total number of imports.
148 CDC. Guidance Regarding Agency
Interpretation of ‘‘Rabies-Free’’ as It Relates to the
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Importation of Dogs Into the United States. 84 FR
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149 Id.
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CDC did not attempt to project future
changes to the volume of dogs imported
annually because of insufficient data.
CDC believed that introducing another
factor to project future volumes was not
prudent. HHS/CDC requests public
comment from airlines on whether the
number of imported dogs has increased,
decreased, or remained relatively
constant in recent years. Such data may
be available to airlines if they track the
number of dogs transported each year.
While CDC observed an increase in the
number of dogs arriving with fraudulent
paperwork prior to implementing the
temporary suspension, this may not
correspond to changes in the total
number of dogs imported, of which only
a small fraction arrive with fraudulent
paperwork.
The most likely estimates of the
annual monetized costs and benefits for
each interested party or implementing
partner are summarized in Table 9 over
a 10-year period from 2023 through
2032 using the estimated values
presented in Sections B1 through B8 of
the Appendix found in the
Supplemental Materials tab of the
docket. The most likely estimate of
monetized costs across interested
parties is $39 million in the first year
and $27 million in subsequent years.
The most likely estimate of monetized
benefits across interested parties was
estimated to be $1.9 million each year.
The annual costs and benefits for
importers are split into importers of
dogs from DMRVV-free or DMRVV lowrisk countries versus importers of dogs
from DMRVV high-risk countries.
However, it is likely that some
importers of dogs from DMRVV highrisk countries may also be importers of
dogs from DMRVV-free or low-risk
countries. In addition, the provisions of
the NPRM (if finalized as proposed) may
result in some importers switching from
importing dogs from DMRVV high-risk
countries to those from DMRVV-free or
low-risk countries.
As a percentage of total costs,
importers were estimated to incur 79 to
85 percent of the total costs (most likely
estimates), with a higher fraction of total
costs incurred in the subsequent years
after the first year of implementation.
Importer costs are approximately 3.8
times greater for dogs imported from
DMRVV high-risk countries compared
to dogs from DMRVV-free or low-risk
countries. In addition, it is important to
note that more than 10 times as many
dogs are estimated to be imported from
DMRVV-free or low-risk countries.
Thus, the cost per dog for importers of
dogs from DMRVV high-risk countries is
significantly greater than for importers
of dogs from DMRVV-free or low-risk
countries. This is especially true for
foreign-vaccinated dogs from DMRVV
high-risk countries.
The costs to airlines are expected to
comprise 8.0 to 8.8 percent of total
costs. Among Federal government
agency costs for the provisions included
in the NPRM (if finalized as proposed),
CBP’s additional costs (0.5 to 2.8
percent of the total) are expected to be
less than CDC’s additional costs (6.2 to
10.4 percent of the total).
TABLE 9—MOST LIKELY ESTIMATES OF ANNUAL MONETIZED COSTS AND BENEFITS BY AFFECTED PARTY OR
IMPLEMENTING PARTNER FROM 2023–2032 RELATIVE TO BASELINE IN 2020 USD
Importers of
dogs from
DMRVV
high-risk
countries
Year
Importers of
dogs from
DMRVV-free
or low-risk
countries
Airlines
Customs
and Border
Protection
Centers for
Disease
Control and
Prevention
State/local
public health
and animal
health
departments
Total
Annual monetized costs (million)
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
$24.6
18.1
18.1
18.1
18.1
18.1
18.1
18.1
18.1
18.1
$6.5
4.8
4.8
4.8
4.8
4.8
4.8
4.8
4.8
4.8
$3.2
2.4
2.4
2.4
2.4
2.4
2.4
2.4
2.4
2.4
$1.1
0.004
0.004
0.004
0.004
0.004
0.004
0.004
0.004
0.004
$4.1
1.7
1.7
1.7
1.7
1.7
1.7
1.7
1.7
1.7
$0
0
0
0
0
0
0
0
0
0
$39
27
27
27
27
27
27
27
27
27
0.65
0.65
0.65
0.65
0.65
0.65
0.65
0.65
0.65
0.65
0.22
0.22
0.22
0.22
0.22
0.22
0.22
0.22
0.22
0.22
0.0049
0.0049
0.0049
0.0049
0.0049
0.0049
0.0049
0.0049
0.0049
0.0049
1.9
1.9
1.9
1.9
1.9
1.9
1.9
1.9
1.9
1.9
Annual monetized benefits (million)
lotter on DSK11XQN23PROD with PROPOSALS4
2023
2024
2025
2026
2027
2028
2029
2030
2031
2032
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
0.81
0.81
0.81
0.81
0.81
0.81
0.81
0.81
0.81
0.81
The greatest fractions of the most
likely estimates of the monetized
benefits associated with the provisions
in the NPRM (if finalized as proposed)
would accrue to importers of dogs from
DMRVV high-risk countries (41 percent)
and to CBP (33 percent). For both
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0.088
0.088
0.088
0.088
0.088
0.088
0.088
0.088
0.088
0.088
0.18
0.18
0.18
0.18
0.18
0.18
0.18
0.18
0.18
0.18
groups, the costs of screening dogs at
U.S. ports would be reduced since
documentation of rabies vaccination
would be standardized. This would
result in cost savings for both groups at
U.S. ports, although costs for importers
to obtain the standardized forms would
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increase (as documented in the cost
estimates). Additional benefits are
estimated to accrue to importers of dogs
from DMRVV high-risk countries,
airlines, CBP, and CDC from a reduction
in the number of dogs denied entry and
returned to their countries of origin.
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The estimates included in this
economic impact analysis are highly
uncertain. HHS/CDC requests comments
on several parameter estimates and
assumptions in the Appendix found in
the Supplemental Materials tab of the
docket. Specifically, HHS/CDC is
requesting comment from the public on
the topics listed below:
• Procedures applicable at U.S. land
and seaports and whether and how
procedures for U.S. land or seaports
should differ from procedures for U.S.
airports.
• The numbers of dogs imported each
year and the numbers of dogs imported
from DMRVV high-risk countries. Such
data may be available from airline
operating data for air imports. Public
comment about dogs imported at land or
seaports could help to improve
estimates.
• The impact of the requirements of
this NPRM (if finalized as proposed) to
reduce the number of dogs imported
from DMRVV high-risk countries.
• The fraction of imported dogs
arriving on air conveyances that are less
than six months of age.
• The number of importers that bring
in more than three dogs at land or
seaports that are less than six months of
age during a calendar year.
• Data showing whether the number
of imported dogs has increased,
decreased, or remained relatively
constant in recent years. Such data may
be available to airlines if they track the
number of dogs transported each year.
• The number of dogs imported at
one time or as part of one shipment on
average and if the requirements of this
NPRM (if finalized as proposed) would
impact how dogs are imported (e.g.,
would importers wait to import a larger
group of dogs in a single shipment).
• The number of times individuals
who travel internationally with their
dogs enter the United States each year.
• How this proposed rulemaking
would impact the ability of individuals
with foreign-vaccinated service dogs to
enter the United States.
• How frequently importers of dogs
for adoption or resale import dogs (i.e.,
among businesses that import dogs for
commercial purposes, how many
shipments are received each year on
average). This information would be
used to improve CDC’s estimate of the
number of repeat importers.
• Costs to owners of young dogs who
would have to forego international
travel with their pets.
• The additional travel costs and
travel time associated with re-routing
travel through an airport with a CDC
quarantine station or an airport with a
CDC-registered Animal Care Facility.
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• The average cost to return a dog to
the country of departure after denial of
entry and the cost to importers whose
dogs have been denied entry.
• The appropriate range of estimates
from airlines for the profit margin per
dog imported on international flights.
• The cost to airlines if they were
prevented from transporting dogs on
flights in the future.
• The cost to CDC-registered Animal
Care Facilities to comply with proposed
CDC requirements for these facilities.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act,
as amended by the Small Business
Regulatory Enforcement Fairness Act
(SBREFA), agencies are required to
analyze regulatory options to minimize
the significant economic impact of a
rule on small businesses, small
governmental units, and small not-forprofit organizations. CDC examined the
potential impact of the provisions of
this NPRM (if finalized as proposed) on
small entities, including small
businesses that may import dogs for
commercial purposes as well as airlines
that transport dogs internationally.
HHS/CDC lacks key data on the number
of dogs imported and requests public
comment from airlines and small
businesses on the number of dogs
imported and the impact of the
provisions of the NPRM (if finalized as
proposed) on their standard practices. In
the absence of data on the number of
dogs imported, CDC made several
assumptions to estimate revenues from
small businesses for different categories
of businesses that may import dogs and
used these revenue estimates to
calculate how many dogs could be
imported such that the costs associated
with the provisions of this NPRM (if
finalized as proposed) would be less
than two percent of estimated revenues.
Based on these analyses, CDC believes
that the only small entities for which
this NPRM (if finalized as proposed)
would have significant impacts would
be those that specialize in importing
dogs from DMRVV high-risk countries.
The provisions of this NPRM (if
finalized as proposed) would not have
a significant economic impact on small
airlines and probably would not have a
significant impact on small entities that
import dogs from DMRVV-free or
DMRVV low-risk countries. CDC notes
that the importation of dogs less than
six months of age for resale or adoption
in the United States is already
prohibited by USDA regulations (7 CFR
2148). Thus, the minimum age
requirements in this proposed NPRM (if
finalized as proposed) should not
impact entities that sell or resell
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imported dogs but may impact entities
that import young dogs for commercial
purposes other than resale. The NPRM
(if finalized as proposed) does not
include provisions that would reduce
costs for small entities relative to other
categories of importers.
As part of the economic impact
analysis, CDC calculated the marginal
cost associated with the proposed
provisions in the NPRM per dog
imported from DMRVV-free or DMRVV
low-risk countries ($9.10, range: $2.60
to $25 per imported dog). The marginal
cost associated with the proposed
provisions in the NPRM per dog
imported from DMRVV high-risk
countries was further subdivided
between foreign-vaccinated dogs
(vaccinated outside the United States)
($810, range: $550 to $1,180) compared
to U.S.-vaccinated dogs ($110, range:
$44 to $510). These estimates cover the
first year of implementation after a final
rule is published, assuming the NPRM
requirements are finalized as proposed.
Marginal costs in the second year and
later are estimated to be about 25
percent less per dog compared to the
first year of implementation.
The estimates summarized below are
subject to a great degree of uncertainty.
CDC does not know how many dogs any
small individual entity currently
imports or the average number of
imported dogs across entities. However,
based on the relative estimates of annual
revenues by type of entity and
subdivided by the number of
employees, CDC calculated how many
dogs each entity could import before
this NPRM (if finalized as proposed)
would have a significant economic
impact on their businesses. HHS/CDC
welcomes public comments to improve
and refine these estimates.
Small Entities That Import Dogs for
Commercial Purposes
The estimated revenues of small
businesses likely to import and resell
dogs are summarized in Table 10. Since
there are no specific codes in the North
American Industry Classification
System (NAICS) specific to dog
importers, CDC used the codes 115210,
423820, 424990, 485991, 812910, and
813312 to estimate the revenue of the
small businesses that may import and
resell dogs. The businesses affected by
the NPRM (if finalized as proposed)
would be a fraction of the firms
summarized in Table 10, as CDC does
not know how many dog importers are
in these categories. Small business
status was determined based on either
firms’ revenue or the numbers of
employees, according to the Small
Business Association’s (SBA) table of
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small business size standards.150 The
revenue of firms in each business
category subdivided by the number of
employees was not available. Using
annual payroll data from the Statistics
of U.S. Businesses (SUSB),151 CDC
estimated the revenue based on the
assumption that each firm’s payroll
expense would be approximately 15 to
30 percent.152
TABLE 10—ESTIMATED REVENUE OF SMALL BUSINESSES THAT MAY IMPORT DOGS FOR COMMERCIAL PURPOSES, 2020
USD
NAICS
code
Description
Number of
employees
115210 .....
Support Activities for Animal Production ....................................
423820 .....
Farm and Garden Machinery and Equipment Merchant Wholesalers.
424990 .....
Other Miscellaneous Nondurable Goods Merchant Wholesalers
485991 .....
Special Needs Transportation .....................................................
812910 .....
Pet Care (except Veterinary) Services .......................................
813312 .....
Environment, Conservation and Wildlife Organizations .............
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
Firms
3,633
585
238
118
1,808
958
835
820
7,068
1,493
791
670
1,553
554
500
611
12,257
4,026
2,580
1,213
3,575
1,262
922
745
Annual
payroll per
firm
(thousand
USD)
Revenue per firm
(thousand USD) a
Lower
bound
(payroll/
30%)
$48
181
406
1,259
90
308
693
2,094
75
299
657
1,755
55
148
338
1,050
43
140
280
663
75
263
516
1,551
$161
605
1,355
4,197
300
1,026
2,309
6,980
249
996
2,191
5,850
184
493
1,127
3,500
142
466
932
2,210
249
875
1,720
5,169
Upper
bound
(payroll/
15%)
$321
1,210
2,709
8,394
599
2,053
4,619
13,960
499
1,992
4,383
11,700
368
986
2,254
6,999
283
931
1,863
4,421
498
1,751
3,441
10,338
Most likely
estimate
(midpoint)
$241
907
2,032
6,296
450
1,539
3,464
10,470
374
1,494
3,287
8,775
276
740
1,691
5,249
213
698
1,398
3,316
373
1,313
2,580
7,754
lotter on DSK11XQN23PROD with PROPOSALS4
a Revenue was estimated from the annual payroll reported in the 2019 SUSB Annual Data Tables by Establishment Industry (https://www.census.gov/data/tables/
2019/econ/susb/2019-susb-annual.html). Estimated were updated to 2020 USD using the Consumer Price Index for All Urban Consumers (CPI–U).
CDC assumes that the costs associated
with the proposed provisions of the
NPRM (if finalized as proposed) would
be significant if the additional costs
would exceed two percent of the
estimated revenue shown in Table 10 by
category. Unless a small entity only
specialized in importing dogs for resale
or adoption, the costs associated with
dog importation would only constitute a
portion of each firm’s operational costs.
Other operational costs by an entity
should be unaffected by the proposed
provisions included in this NPRM (if
finalized as proposed). CDC is unaware
of the proportion of dog import costs
relative to all the other activities for
each type of entity. Thus, CDC was not
able to directly estimate the impact of
the NPRM (if finalized as proposed) as
a fraction of total revenue. Instead, CDC
calculated a threshold for each category
representing the number of imported
dogs at which the cost of the provisions
in the NPRM to importers (if finalized
as proposed) would begin to exceed two
percent of the revenue of firms in each
category. To calculate the number of
dogs at which point the costs associated
with the NPRM (if finalized as
proposed) would be likely to exceed two
percent of revenue for each category of
the firm, the category-specific revenue
per firm in Table 10 (most likely
estimate, lower bound, and upper
bound) were multiplied by 2 percent
and then divided by the marginal cost
per foreign-vaccinated dog from highrisk countries ($810, range: $550 to
$1,180). This was repeated for U.S.vaccinated dogs from DMRVV high-risk
countries ($110, range: $44 to $510) and
dogs from DMRVV-free or DMRVV lowrisk countries ($9.10, range: $2.60 to
$25). The estimated thresholds for the
number of imported dogs per firm for
each small business category are
summarized in Tables 11a and 11b. For
example, if a Wildlife Organization
(NAICS code 813312) with fewer than
five employees import more than ten
foreign-vaccinated dogs (most likely
NPRM cost estimate and midpoint
revenue estimate) from high-risk
countries, the costs associated with the
NPRM (if finalized as proposed) would
be expected to exceed two percent of
revenue. For U.S.-vaccinated dogs, the
threshold would increase from about ten
dog imports to 68 dog imports using the
most likely cost estimate and midpoint
revenue estimate. This NAICS category
may include dog rescue organizations
that are likely to work with dogs
imported from DMRVV high-risk
countries, most or all of which would be
foreign-vaccinated. Because the
marginal cost estimate per dog imported
from DMRVV-free or DMRVV low-risk
countries (assuming the NPRM is
finalized as proposed) is much less than
per dog imported from DMRVV highrisk countries, the threshold numbers of
dogs that may be imported from
DMRVV-free or DMRVV low-risk
countries are much greater than for
DMRVV high-risk countries. The values
shown in Tables 11a and 11b are
estimated by assuming that all dogs
imported by each firm are either from
DMRVV-free or DMRVV low-risk
150 SBA, Table of small business size standards.
Effective August 19, 2019. https://www.sba.gov/
document/support-table-size-standards.
151 2019 SUSB Annual Data Tables by
Establishment Industry. https://www.census.gov/
data/tables/2019/econ/susb/2019-susbannual.html.
152 How to figure the gross percent of payroll.
https://smallbusiness.chron.com/figure-grosspercent-payroll-66395.html.
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countries or, alternatively, from DMRVV
high-risk countries. Some firms may
import dogs from both types of
countries, in which case, the threshold
values would be in between the two sets
of estimates. The difference in costs may
also cause some entities to shift from
importing dogs from DMRVV high-risk
high-risk countries to 823 dogs imported
from DMRVV-free or DMRVV low-risk
countries (both thresholds calculated
using most likely NPRM cost estimate
and midpoint revenue estimate). HHS/
CDC welcomes public comments from
the dog importation industry to improve
these threshold estimates.
countries to dogs imported from
DMRVV-free or DMRVV low-risk
countries if the NPRM is finalized as
proposed. In this case, for a business
with NAICS code of 813312, the
estimated threshold number of dogs
would increase from ten imported
foreign-vaccinated dogs from DMRVV
TABLE 11a—ESTIMATED THRESHOLD FOR THE NUMBER OF IMPORTED DOGS FROM DMRVV HIGH-RISK COUNTRIES PER
FIRM AT WHICH NPRM COSTS (IF FINALIZED AS PROPOSED) WOULD EXCEED TWO PERCENT OF REVENUE DURING
THE FIRST YEAR OF IMPLEMENTATION OF THE PROPOSED REQUIREMENTS
Foreign-vaccinated dogs from high-risk countries
Number of
employees
NAICS code
Most likely
estimate
Marginal NPRM cost per dog (USD, if finalized as proposed)
$810
Lower bound
$553
Upper bound
U.S.-vaccinated dogs from high-risk countries
Most likely
estimate
$1,178
Lower bound
Upper bound
$110
$44
$507
Number of imported dogs per year at which NPRM cost >2 percent of revenue
115210, Support Activities for Animal Production .......................................................
423820, Farm and Garden Machinery and
Equipment Merchant Wholesalers ............
424990, Other Miscellaneous Nondurable
Goods Merchant Wholesalers ...................
485991, Special Needs Transportation ........
812910, Pet Care (except Veterinary) Services ............................................................
813312, Environment, Conservation and
Wildlife Organizations ................................
<5
5–9
10–19
20–99
6
23
51
156
6
22
49
152
6
21
46
143
44
164
366
1,132
72
271
606
1,876
13
48
106
328
<5
5–9
10–19
20–99
12
38
86
259
11
37
84
252
11
35
79
237
81
277
623
1,882
134
459
1,032
3,119
24
81
181
545
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
10
37
82
217
7
19
42
130
9
36
79
211
7
18
41
127
9
34
75
199
7
17
39
119
68
269
591
1,577
50
133
304
944
112
445
979
2,614
83
221
504
1,564
20
78
172
457
15
39
88
274
<5
5–9
10–19
20–99
6
18
35
82
6
17
34
80
5
16
32
75
39
126
252
596
64
208
417
988
12
37
73
173
<5
5–9
10–19
20–99
10
33
64
192
9
32
62
187
9
30
59
176
68
236
464
1,394
112
392
769
2,310
20
69
135
404
TABLE 11b—ESTIMATED THRESHOLD FOR THE NUMBER OF IMPORTED DOGS FROM DMRVV-FREE OR DMRVV LOW-RISK
COUNTRIES PER FIRM AT WHICH NPRM COSTS (IF FINALIZED AS PROPOSED) WOULD EXCEED TWO PERCENT OF
REVENUE DURING THE FIRST YEAR OF IMPLEMENTATION OF THE PROPOSED REQUIREMENTS
Number of
employees
NAICS code
Foreign-vaccinated dogs from
high-risk countries
Most likely
estimate
Marginal NPRM cost per dog (if finalized as proposed, USD) .............................................................................
Lower
bound
Upper
bound
$9.10
$2.60
$25
531
1,999
4,476
13,867
991
3,391
7,630
23,061
824
3,291
7,240
19,327
1,257
4,736
10,605
32,856
2,347
8,034
18,079
54,641
1,953
7,797
17,155
45,794
258
973
2,177
6,744
482
1,649
3,711
11,215
401
1,601
3,522
9,400
Number of imported dogs per year at which NPRM cost > two percent of revenue
lotter on DSK11XQN23PROD with PROPOSALS4
115210, Support Activities for Animal Production .........................................................................
423820, Farm and Garden Machinery and Equipment Merchant Wholesalers ............................
424990, Other Miscellaneous Nondurable Goods Merchant Wholesalers ...................................
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<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Proposed Rules
TABLE 11b—ESTIMATED THRESHOLD FOR THE NUMBER OF IMPORTED DOGS FROM DMRVV-FREE OR DMRVV LOW-RISK
COUNTRIES PER FIRM AT WHICH NPRM COSTS (IF FINALIZED AS PROPOSED) WOULD EXCEED TWO PERCENT OF
REVENUE DURING THE FIRST YEAR OF IMPLEMENTATION OF THE PROPOSED REQUIREMENTS—Continued
Number of
employees
NAICS code
485991, Special Needs Transportation .........................................................................................
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
<5
5–9
10–19
20–99
812910, Pet Care (except Veterinary) Services ............................................................................
813312, Environment, Conservation and Wildlife Organizations ..................................................
The marginal cost per dog imported
(if the NPRM is finalized as proposed)
relative to the reported commercial
values of imported dogs were estimated
using data from CBP for dogs imported
under Harmonized Tariff Schedule code
0106.19.91.20, Other live animals, other,
other, dogs is shown in Table 12. The
estimated ratio of the marginal cost of
NPRM requirements (if finalized as
proposed) relative to the reported value
of the commercially imported dogs from
DMRVV-free or DMRVV low-risk
countries is 1.2 percent (range: 0.33
percent to 3.2 percent). Based on this
ratio, the expected marginal increase in
cost per dog imported should not
change much for dogs imported from
DMRVV-free or low-risk countries.
However, for the foreign-vaccinated
dogs imported from DMRVV high-risk
countries, the estimated ratio is 227
percent (range: 155 percent to 330
percent). This ratio is much larger both
because the marginal cost per dog
imported (assuming the NPRM is
finalized as proposed) is much greater
and because the reported commercial
value of dogs imported from DMRVV
high-risk countries is lower compared to
dogs imported from DMRVV-free or
low-risk countries. Since CBP’s
commercial values of imported dogs
only provide a comparison of the
estimated marginal cost of the NPRM (if
Foreign-vaccinated dogs from
high-risk countries
Most likely
estimate
Lower
bound
608
1,630
3,725
11,562
469
1,539
3,079
7,303
823
2,893
5,684
17,078
1,441
3,860
8,825
27,396
1,110
3,645
7,294
17,305
1,949
6,853
13,468
40,466
Upper
bound
296
793
1,812
5,623
228
749
1,497
3,552
401
1,407
2,765
8,306
finalized as proposed) to reported
commercial value, these ratios cannot be
directly compared to the revenue
estimates by firm since the costs
associated with dog imports would only
be a portion of each firm’s operational
cost. However, it does provide an
estimate of the potential increase in cost
per dog imported from either DMRVVfree or low countries or from DMRVV
high-risk countries if the NPRM is
finalized as proposed. For this analysis,
CDC assumes that most of the dogs
imported from DMRVV high-risk
countries for commercial purposes
would have been vaccinated outside the
United States.
TABLE 12—ESTIMATED IMPACT OF THE NPRM (IF FINALIZED AS PROPOSED) ON THE COST PER DOG IMPORTED FOR
COMMERCIALLY IMPORTED DOGS
[2020 USD]
Most likely
estimate
Lower bound
Upper bound
57,860
$777
$44,957,220
......................
......................
......................
......................
......................
......................
$9.08
$2.55
$24.89
$525,369
1.17%
$147,543
0.33%
$1,440,135
3.20%
43,382
$357
$15,487,374
......................
......................
......................
......................
......................
......................
$810
$553
$1,178
$35,139,420
$23,990,246
$51,103,996
Importers from DMRVV-free or low-risk countries
Baseline: a
—Total dogs imported (A) ..............................................................................................................
—Average commercial value per dog (B) .....................................................................................
—Total commercial value (C) = (A) × (B) ......................................................................................
With NPRM (if finalized as proposed):
—Estimated marginal NPRM cost per dog imported (if finalized as proposed) (D) .....................
—Total marginal NPRM costs for dogs imported for commercial purposes (if finalized as proposed) (E) = (D) × (A) ................................................................................................................
Estimated ratio of marginal NPRM costs to commercial value of imported dogs (E)/(C) ................
lotter on DSK11XQN23PROD with PROPOSALS4
Importers from high-risk countries of foreign-vaccinated dogs
Baseline: a
—Total dogs imported (F) ..............................................................................................................
—Average commercial value per dog (G) .....................................................................................
—Total commercial value (H) = (F) × (G) ......................................................................................
With NPRM (if finalized as proposed):
—Estimated marginal NPRM costs per dog imported (if finalized as proposed) (I) .....................
—Total marginal NPRM costs for dogs imported for commercial purposes (if finalized as proposed) (J) = (I) × (F) ...................................................................................................................
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Proposed Rules
TABLE 12—ESTIMATED IMPACT OF THE NPRM (IF FINALIZED AS PROPOSED) ON THE COST PER DOG IMPORTED FOR
COMMERCIALLY IMPORTED DOGS—Continued
[2020 USD]
Most likely
estimate
Estimated ratio of marginal NPRM costs to commercial value of imported dogs (J)/(H) .................
a Baseline
Lower bound
Upper bound
155%
330%
227%
values were based on the data received from CBP, not publicly available (HTS code 0106.19.91.20).
U.S. Airlines
The provisions of this NPRM (if
finalized as proposed) would affect U.S.
airlines conducting international flight
operations arriving in the United States.
Of the 60 U.S. airlines with
international flights in 2020, 35 airlines
can be identified as small business
entities. This is based on the size
standard of ‘‘fewer than 1,500
employees’’ from the SBA for small
businesses within NAICS Code 481111,
Scheduled Passenger Air
Transportation, and those within NAICS
Code 481211, Nonscheduled Chartered
Passenger Air Transportation in 2019.153
For the analysis, airline employee
counts were estimated from the U.S.
Department of Transportation’s Bureau
of Transportation Statistics.154 Monthly
average numbers of employees in 2019,
including part- and full-time
employment, were used for U.S.
airlines.
The annual revenue per U.S. airline
was estimated based on the 2019
revenue of each airline.155 Lower-bound
and upper-bound estimates were
calculated by multiplying by 75 and 125
percent (Table 13). Among the selected
35 airlines, seven had zero U.S.
international arrivals in 2019.156
TABLE 13—ESTIMATED ANNUAL REVENUE OF SMALL BUSINESS U.S. AIRLINES
Total revenue
(million USD)
2019 U.S.
arrivals
Airline
Most likely
estimate
lotter on DSK11XQN23PROD with PROPOSALS4
1 .......................................................................................................................
2 .......................................................................................................................
3 .......................................................................................................................
4 .......................................................................................................................
5 .......................................................................................................................
6 .......................................................................................................................
7 .......................................................................................................................
8 .......................................................................................................................
9 .......................................................................................................................
10 .....................................................................................................................
11 .....................................................................................................................
12 .....................................................................................................................
13 .....................................................................................................................
14 .....................................................................................................................
15 .....................................................................................................................
16 .....................................................................................................................
17 .....................................................................................................................
18 .....................................................................................................................
19 .....................................................................................................................
20 .....................................................................................................................
21 .....................................................................................................................
22 .....................................................................................................................
23 .....................................................................................................................
24 .....................................................................................................................
25 .....................................................................................................................
26 .....................................................................................................................
27 .....................................................................................................................
28 .....................................................................................................................
29 .....................................................................................................................
30 .....................................................................................................................
31 .....................................................................................................................
32 .....................................................................................................................
33 .....................................................................................................................
34 .....................................................................................................................
153 Small Business Association (SBA), Table of
small business size standards. Effective August 19,
2019. https://www.sba.gov/document/support-tablesize-standards. Accessed: February 21, 2022.
154 Bureau of Transportation Statistics. Air Carrier
Financial Reports (Form 41 Financial Data). Air
Carrier Financial: Schedule P–1(a) Employees.
Bureau of Transportation Statistics. https://
www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_
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$290
78
112
241
38
44
230
541
218
115
558
1,296
42
52
169
37
104
147
265
7
40
2
105
59
20
19
9
313
12
115
117
13
10
21
VQ=GEF&QO_fu146_anzr=Nv4percent20
Pn44vr4percent20Sv0n0pvny Accessed: February
21, 2022.
155 Bureau of Transportation Statistics. Air Carrier
Financial Reports (Form 41 Financial Data). Air
Carrier Financial: Schedule P–1.1, and P–1.2
Operating revenues. https://www.transtats.bts.gov/
DL_SelectFields.asp?gnoyr_VQ=FMD&QO_fu146_
anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny;
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Lower bound
$218
58
84
181
28
33
173
406
164
87
419
972
31
39
127
28
78
110
199
6
30
1
79
44
15
14
7
235
9
86
88
10
7
16
Upper bound
$363
97
140
301
47
55
288
677
273
144
698
1,620
52
66
212
46
130
183
331
9
50
2
131
74
25
23
12
391
14
143
146
16
12
27
317
279
169
136
116
114
113
111
96
86
80
75
73
57
57
55
49
46
45
41
40
31
18
13
12
6
2
1
0
0
0
0
0
0
and https://www.transtats.bts.gov/DL_SelectFields.
asp?gnoyr_VQ=FMI&QO_fu146_anzr=
Nv4percent20Pn44vr4percent20Sv0n0pvny.
Accessed: February 21, 2022.
156 Air Carriers: T–100 International Market (U.S.
Carriers Only) https://www.transtats.bts.gov/DL_
SelectFields.asp?gnoyr_VQ=GDJ&QO_fu146_
anzr=Nv4percent20Pn44vr45. Accessed: February
21, 2022.
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Proposed Rules
TABLE 13—ESTIMATED ANNUAL REVENUE OF SMALL BUSINESS U.S. AIRLINES—Continued
Total revenue
(million USD)
2019 U.S.
arrivals
Airline
Most likely
estimate
35 .....................................................................................................................
The threshold numbers of dogs that
may be transported by each airline such
that the costs associated with the
provisions of this NPRM (if finalized as
proposed) to airlines would be less than
two percent of annual revenue were
estimated using the same methodology
as for the dog importers above.
However, the annualized marginal cost
per dog transported by airlines was only
estimated to be about $6.00 per dog
(range: $3.20 to $10.30 per dog) if the
requirements in the NPRM are finalized
as proposed. This was calculated based
on the annualized costs to airlines
divided by the number of dogs
transported. However, costs were
estimated to be higher in the first year
of implementation and some airlines
Lower bound
19
Upper bound
14
may be disproportionately affected if
their customers are proportionally more
likely to reduce the number of dogs
transported to the United States. The
estimated number of dogs was
calculated by multiplying the revenue
per airline in Table 13 by 2 percent and
then dividing by the marginal airline
cost per dog imported if the NPRM is
finalized as proposed. As shown in
Table 14, the estimated numbers of dogs
that each airline could transport were
significantly greater than the number of
international passengers reported in
2019 and, in most cases, greater than the
total estimated number of dogs
estimated to be imported into the
United States each year. CDC did not
separately estimate marginal costs to
23
0
airlines for dogs imported from
DMRVV-free or DMRVV low-risk
countries versus dogs imported from
DMRVV high-risk countries. The
estimated marginal cost per dog may be
higher for airlines to transport dogs
imported from DMRVV high-risk
countries because dogs from these
countries are more likely to be denied
entry and abandoned by importers.
Thus, marginal costs may be slightly
higher for airlines that specialize in
travel to DMRVV high-risk countries.
However, the general finding still holds
that the provisions of this NPRM (if
finalized as proposed) should not have
a significant impact on airlines.
TABLE 14—ESTIMATED THRESHOLD OF THE ANNUAL NUMBER OF IMPORTED DOGS PER AIRLINE AT WHICH THE MARGINAL
COSTS OF THE NPRM (IF FINALIZED AS PROPOSED) BEGIN TO EXCEED 2 PERCENT OF ANNUAL REVENUE
Most likely
estimate
Airline
Marginal NPRM cost per dog (if finalized as proposed) .................................................
$6.00
Lower
bound
Upper
bound
$3.20
2019 U.S.
arrivals
$10.30
....................
35,242,718
9,417,476
13,592,233
29,223,301
4,563,107
5,339,806
27,961,165
65,728,155
26,504,854
13,980,583
67,766,990
157,281,553
5,048,544
6,407,767
20,582,524
4,466,019
12,621,359
17,766,990
32,135,922
873,786
4,854,369
194,175
12,718,447
7,184,466
2,427,184
2,233,010
1,165,049
37,961,165
1,359,223
13,883,495
14,174,757
1,553,398
1,165,049
317
279
169
136
116
114
113
111
96
86
80
75
73
57
57
55
49
46
45
41
40
31
18
13
12
6
2
1
0
0
0
0
0
lotter on DSK11XQN23PROD with PROPOSALS4
Annual number of transported dogs at which NPRM cost >2 percent of annual revenue
1 .......................................................................................................................................
2 .......................................................................................................................................
3 .......................................................................................................................................
4 .......................................................................................................................................
5 .......................................................................................................................................
6 .......................................................................................................................................
7 .......................................................................................................................................
8 .......................................................................................................................................
9 .......................................................................................................................................
10 .....................................................................................................................................
11 .....................................................................................................................................
12 .....................................................................................................................................
13 .....................................................................................................................................
14 .....................................................................................................................................
15 .....................................................................................................................................
16 .....................................................................................................................................
17 .....................................................................................................................................
18 .....................................................................................................................................
19 .....................................................................................................................................
20 .....................................................................................................................................
21 .....................................................................................................................................
22 .....................................................................................................................................
23 .....................................................................................................................................
24 .....................................................................................................................................
25 .....................................................................................................................................
26 .....................................................................................................................................
27 .....................................................................................................................................
28 .....................................................................................................................................
29 .....................................................................................................................................
30 .....................................................................................................................................
31 .....................................................................................................................................
32 .....................................................................................................................................
33 .....................................................................................................................................
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48,333,333
13,000,000
18,666,667
40,166,667
6,333,333
7,333,333
38,333,333
90,166,667
36,333,333
19,166,667
93,000,000
216,000,000
7,000,000
8,666,667
28,166,667
6,166,667
17,333,333
24,500,000
44,166,667
1,166,667
6,666,667
333,333
17,500,000
9,833,333
3,333,333
3,166,667
1,500,000
52,166,667
2,000,000
19,166,667
19,500,000
2,166,667
1,666,667
E:\FR\FM\10JYP4.SGM
68,125,000
18,125,000
26,250,000
56,562,500
8,750,000
10,312,500
54,062,500
126,875,000
51,250,000
27,187,500
130,937,500
303,750,000
9,687,500
12,187,500
39,687,500
8,750,000
24,375,000
34,375,000
62,187,500
1,875,000
9,375,000
312,500
24,687,500
13,750,000
4,687,500
4,375,000
2,187,500
73,437,500
2,812,500
26,875,000
27,500,000
3,125,000
2,187,500
10JYP4
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Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 / Proposed Rules
TABLE 14—ESTIMATED THRESHOLD OF THE ANNUAL NUMBER OF IMPORTED DOGS PER AIRLINE AT WHICH THE MARGINAL
COSTS OF THE NPRM (IF FINALIZED AS PROPOSED) BEGIN TO EXCEED 2 PERCENT OF ANNUAL REVENUE—Continued
Most likely
estimate
Airline
lotter on DSK11XQN23PROD with PROPOSALS4
34 .....................................................................................................................................
35 .....................................................................................................................................
C. Paperwork Reduction Act of 1995
HHS/CDC has determined that this
NPRM includes proposed information
collections and recordkeeping
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.
3501–3520). A description of these
proposed provisions is given below,
with an estimate of the annual reporting
and recordkeeping burden. Included in
the estimate is the time for reviewing
instructions, searching existing data
sources, gathering and maintaining the
data needed, and completing and
reviewing each collection of
information. Comments are invited on
the following subjects:
• Whether the proposed collection of
information is necessary for the proper
performance of the functions of CDC,
including whether the information will
have practical utility.
• The accuracy of CDC’s estimate of
the burden of the collection of
information.
• Ways to enhance the quality, utility,
and clarity of the information to be
collected.
• Ways to minimize the burden of the
collection of information on
respondents, including by using
information technology.
Under the PRA, Federal agencies must
obtain approval from OMB for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of an existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a revised data
collection as described below.
OMB is particularly interested in
comments that will help:
1. Evaluate whether the revised
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
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3,166,667
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology
(e.g., permitting electronic submissions
of responses); and,
5. Assess information collection costs.
Proposed Project
Importation Regulations (42 CFR 71
Subpart F)—Revised Information
Collection—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
This information collection is a
revision to OMB Control Number 0920–
1383 related to the importation of
animals, animal products, and human
remains. HHS/CDC is amending the
CDC Import Certification of Rabies
Vaccination and Microchip Record
Form and renaming it CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States
Form. HHS/CDC is instituting a new
import submission system that will
collect information similar to what is
currently approved to be collected for
the Application for Special Exemption
for a Permitted Dog Import form. CDC is
also proposing to require per 42 CFR
71.51 that importers of dogs have either
a CDC Import Certification of Rabies
Vaccination and Microchip Required for
Live Dog Importations into the United
States Form or a Certification of U.S.issued Rabies Vaccination for Live Dog
Re-entry into the United States Form,
which is a form approved under OMB
Control No. 0579- 0020, 0036, 0048,
0101, 0156, 0278, and 0432. The
Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States Form will be revised
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Sfmt 4702
Lower
bound
Upper
bound
5,000,000
4,375,000
2,621,359
2,233,010
2019 U.S.
arrivals
0
0
as part of information collection OMB
Control No. 0579–0020, 0036, 0048,
0101, 0156, 0278, and 0432.
Section 361 of the PHS Act (42 U.S.C.
264) authorizes the Secretary of HHS to
make and enforce regulations necessary
to prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the United States. The
existing regulations governing foreign
quarantine activities (42 CFR 71)
authorize quarantine officers and other
personnel to inspect and undertake
necessary control measures with respect
to conveyances, persons, shipments of
animals, articles, and other items to
protect the public’s health.
CDC regulations govern the
importation of animals and animal
products capable of causing human
disease. Animals that are regulated by
CDC include dogs, cats, turtles,
nonhuman primates (NHPs), civets,
African rodents, and bats. CDC controls
the importation of these animals to
ensure that these animals, or animal
products, being imported into the
United States meet CDC regulations.
CDC does this through a permitting
process for certain animals.
The currently approved form
(Application for Special Exemption for
a Permitted Dog Import) for individuals
to apply for a CDC Dog Import Permit
is an online form that includes a series
of questions. It also requires applicants
to upload proof of eligibility to import
under the current requirements,
serology results, a proof of rabies
vaccination, and photos of their dog’s
teeth.
The process for dog importation
under the provisions of the NPRM (if
finalized as proposed) will require
issuing far fewer CDC Dog Import
Permits compared to the currently
approved information collection, since
only people seeking approval to import
dogs from DMRVV-restricted countries
would need to apply. Under the
currently approved information
collection, importers of foreignvaccinated dogs from high-risk
countries can apply for a CDC Dog
Import Permit in lieu of making a
reservation with a CDC-approved
animal care facility. The option to apply
for a CDC Dog Import Permit for
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importers of foreign-vaccinated dogs
from high-risk countries, however, is
not being proposed in this NPRM. At
this time, CDC is not including any
countries on the DMRVV-restricted
countries list; therefore, the annual
burden in the burden table reflects a
change in burden hours to zero hours
for the Application for Special
Exemption for a Permitted Dog Import
form. The most significant changes to
the current information collection will
be the requirement to complete a
standardized form for U.S.-vaccinated
dogs (Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States; approved under OMB
Control No. 0579–0020, 0036, 0048,
0101, 0156, 0278, and 0432) or an
amended standardized form for foreignvaccinated dogs (CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States) and
a new CDC Import Submission Form.
The CDC Import Submission Form will
contain similar information to the
current Application for Special
Exemption for a Permitted Dog Import
form and is proposed to be required for
all dog importations.
The standardized rabies vaccination
forms will be completed by the
importers’ veterinarian to ensure all
required information is on the form and
signed by a government official.
Currently, to be valid, rabies vaccination
documentation must include the name
and address of the owner; dog’s breed,
sex, date of birth, color, and markings;
microchip number; date of vaccination
and vaccine product information,
including product expiration date; date
the vaccination expires; and name,
license number, address, and signature
of the veterinarian who administered
the vaccination. CDC found that despite
these being requirements for
importation, many people submitted
incomplete rabies vaccination
documentation, which both delayed the
issuance of the requestor’s permit and
used staff time for multiple
communications with requestors to
ensure they obtained complete rabies
vaccination documentation. It also
meant some requestors made multiple
requests to their veterinarian, increasing
the time burden on them as well. CDC
is attempting to solve this issue by
requiring that importers have their
veterinarian complete one of the
standardized CDC forms that contains
all the required information and have it
verified by a government official,
making the form harder to falsify.
Additionally, CDC proposes to require
importers to submit a CDC Import
Submission Form online via a new CDC
import submission system for each dog
being imported. Importers would submit
contact information and details about
the dog similar to what is currently
collected in the Application for Special
Exemption for a Permitted Dog Import
form. The new information that would
be collected in this system compared to
what is currently approved to be
collected in the Application for Special
Exemption for a Permitted Dog Import
form is: whether the submission is a
new CDC submission or a change to an
existing submission; the method by
which someone is traveling to the
United States (air, sea, or land); and, if
they marked change to an existing
submission, an explanation of that
change. It would also not require that an
importer upload their rabies vaccination
documentation.
The burden table below has been
updated to reflect the burden hours on
veterinarians to complete the rabies
vaccination forms and the total amount
of time it will take an importer to
complete the online import submission
form.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Form name
Dog Importers with Foreign-vaccinated dogs .........
Importers of Dogs from DMRVV-restricted Countries.
All dog importers .....................................................
Animal Care Facilities .............................................
CDC Import Certification of Rabies Vaccination
and Microchip Required for Live Dog Importations into the United States.
CDC Import Certification of Rabies Vaccination
and Microchip Required for Live Dog Importations into the United States.
CDC Import Certification of Rabies Vaccination
and Microchip Required for Live Dog Importations into the United States.
Certification of U.S.-issued Rabies Vaccination for
Live Dog Re-entry into the United States.
Certification of U.S.-issued Rabies Vaccination for
Live Dog Re-entry into the United States.
Application for Special Exemption for a Permitted
Dog Import.
CDC Import Submission Form ................................
Application ...............................................................
Total .................................................................
.................................................................................
Veterinarians for Foreign-vaccinated dogs .............
Official Government Veterinarian in Exporting
Country.
Importers of U.S.-vaccinated dogs ..........................
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Veterinarians for U.S.-vaccinated dogs ..................
Number of
responses per
respondent
13,671
1
15/60
3,418
13,671
1
15/60
3,418
13,671
1
15/60
3,418
17,121
1
15/60
4,280
17,121
1
15/60
4,280
0
0
60/60
0
800,000
10
1
1
7/60
60/60
93,333
10
....................
........................
....................
112,157
D. National Environmental Policy Act
(NEPA)
E. Executive Order 12988: Civil Justice
Reform
HHS/CDC has determined that
amendments to 42 CFR part 71 will not
have a significant impact on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
needed.
HHS/CDC has reviewed this rule
under Executive Order 12988 on Civil
Justice Reform and determines that this
NPRM meets the standard in the
Executive Order.
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F. Executive Order 13132: Federalism
Under Executive Order 13132, if the
rulemaking would limit or preempt
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Average
burden per
response
(in hours)
Number of
respondents
Total
burden
(in hours)
State, local, or tribal authorities, then a
federalism analysis is required. The
agency must consult with State, local,
and tribal 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 on them.
HHS/CDC has determined that this
NPRM will not have sufficient
federalism implications to warrant the
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preparation of a federalism summary
impact statement.
G. Plain Language Act of 2010
Under 63 FR 31883 (June 10, 1998),
Executive Departments and Agencies
are required to use plain language in all
proposed and final rules. HHS/CDC has
attempted to use plain language in this
proposed rulemaking to make our
intentions and rationale clear and
requests input from the public in this
regard.
List of Subjects in 71.50, 71.51
Airline, animal, border, canine rabies
virus variant, carrier, cat, communicable
diseases, confinement, DMRVV,
Director, dog, exemption, importation,
importer, microchip, necropsy, permit,
public health, quarantine, rabies, rabies
vaccination, rabies virus, serologic
testing, valid rabies vaccination
certificate, zoonotic diseases.
For the reasons discussed in the
preamble, we propose to amend 42 CFR
part 71 as follows:
PART 71—FOREIGN QUARANTINE
1. The authority citation for part 71
continues to read as follows:
■
Authority: Secs. 215 and 311 of Public
Health Service (PHS) Act. as amended (42
U.S.C. 216, 243); secs. 361–369, PHS Act, as
amended (42 U.S.C. 264–272).
2. Amend § 71.50 by:
a. Adding in alphabetical order to
paragraph (b) definitions for
‘‘Authorized veterinarian’’, ‘‘Cat’’,
‘‘Dog’’, ‘‘Histopathology’’, ‘‘In-transit
shipment’’, ‘‘Microchip’’, ‘‘Necropsy’’,
and ‘‘Official government veterinarian’’;
and
■ b. Adding paragraph (c).
The additions read as follows:
■
■
§ 71.50
Scope and definitions.
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*
*
*
*
*
(b) * * *
Authorized veterinarian means an
individual who has obtained both an
advanced degree and valid license and
is authorized to practice animal
medicine in the exporting country.
*
*
*
*
*
Cat means all domestic cats (Felis
catus).
*
*
*
*
*
Dog means all domestic dogs (Canis
familiaris).
*
*
*
*
*
Histopathology means the study of
changes in human or animal tissue
caused by disease.
*
*
*
*
*
In-transit shipment means a cargo
shipment originating in a foreign
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country that is moved through one or
more U.S. ports of entry while transiting
through the United States to a thirdcountry destination. In-transit
shipments pass through a U.S. port of
entry and a U.S. port of exit, which may
be in the same location, or which may
involve numerous stopping points.
*
*
*
*
*
Microchip means an implanted radiofrequency device placed under the skin
of an animal that contains a unique
identification tag that meets the
International Standards Organization
(ISO) compatibility through ISO 11784
or ISO 11785, or similar technologies as
approved by the Director.
Necropsy means an animal autopsy in
which the cause of death may be
determined through the examination
and collection of tissues, organs, or
bodily fluids post-mortem.
Official government veterinarian
means a veterinarian who performs
work on behalf of an exporting country’s
government and can verify the license
or credentials of an Authorized
Veterinarian.
*
*
*
*
*
(c) Any provision of this subpart held
to be invalid or unenforceable by its
terms, or as applied to any person or
circumstance, shall be construed so as
to continue to give the maximum effect
to the provision permitted by law,
unless such holding shall be one of utter
invalidity or unenforceability, in which
event the provision shall be severable
from this subpart and shall not affect the
remainder thereof or the application of
the provision to persons not similarly
situated or to dissimilar circumstances.
■ 3. Amend § 71.51:
■ a. In paragraph (a) by:
■ i. Adding in alphabetical order
definitions for ‘‘Animal’’, CDCregistered animal care facility’’, ‘‘CDC
import submission form’’, ‘‘CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States’’,
‘‘Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States’’, and ‘‘Conditional
release’’;
■ ii. Revising the definition of
‘‘Confinement’’;
■ iii. Adding in alphabetical order
definitions for ‘‘DMRVV’’, ‘‘DMRVV-free
countries’’, ‘‘DMRVV high-risk
countries’’, ‘‘DMRVV low-risk
countries’’, ‘‘DMRVV-restricted
countries’’, ‘‘Importer’’, ‘‘SAFE TraQ’’,
‘‘Serologic testing’’, ‘‘USDA-accredited
veterinarian’’, and ‘‘USDA official
veterinarian’’; and
■ iv. Redesignating paragraphs (1)
through (4) in the definition of ‘‘Valid
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rabies vaccination certificate’’ as
paragraphs (i) through (iv);
■ d. By revising paragraphs (b) through
(g); and
■ e. By adding paragraphs (h) through
(ff).
The additions and revisions read as
follows:
§ 71.51
Dogs and cats.
(a) * * *
Animal means, for purposes of this
section, all domestic cats (Felis catus) or
domestic dogs (Canis familiaris).
*
*
*
*
*
CDC-registered animal care facility
means a facility registered by CDC for
the purpose of providing veterinary care
and housing to animals imported into
the United States.
CDC import submission form means
an OMB-approved declaration
submitted to CDC through an online
portal that includes the importer’s name
and contact information; description of
the dog, including microchip number
and current photographs of the dog’s
face and body; purpose of importation;
travel information, including dates of
departure and arrival, country of
departure, countries visited in the past
six months, and U.S. port of entry; and
other information as described in CDC
technical instructions.
CDC Import Certification of Rabies
Vaccination and Microchip Required for
Live Dog Importations into the United
States means the OMB-approved form
that must be:
(i) Completed by an authorized
veterinarian in the exporting country,
which may include an official
government veterinarian in the
exporting country; and
(ii) Reviewed and signed by an official
government veterinarian in the
exporting country attesting that the
information listed is true and correct.
Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States means the OMBapproved form that must be completed
by a U.S. Department of Agriculture
(USDA)-accredited veterinarian and
certified by a USDA official veterinarian
prior to exporting the dog from the
United States in order to demonstrate
compliance with admissibility
requirements upon returning to the
United States.
Conditional release, when applied to
an animal, means the temporary release
of an animal from the custody of a
carrier into the care of a licensed
veterinarian approved by the Director
for the purpose of receiving emergency
medical care or a public health
evaluation, pending removal of the
animal from the United States. The
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licensed veterinarian must return
animals immediately to the carrier’s
custody upon the conclusion of such
medical care or evaluation for removal
from the United States.
Confinement, when applied to an
animal, means restriction to a building
or other enclosure at a U.S. port or other
location approved by the Director,
including en route to a destination,
separate from other animals, and from
persons except for contact necessary for
its care. If the animal is allowed out of
the enclosure, it must be muzzled and
kept on a leash.
DMRVV means dog-maintained rabies
virus variant and includes any rabies
virus variant that is known or suspected
to have an enzootic transmission cycle
in which dogs are essential for the
maintenance of the viral variant. This
includes epidemiologic situations in
which dogs are the only recognized
reservoir species, as well as situations in
which dogs and other species (typically
wildlife) both play an epidemiologically
relevant role in maintaining enzootic
transmission.
DMRVV-free countries mean countries
determined by the Director as not
having DMRVV present based on
internationally accepted standards.
DMRVV high-risk countries mean
countries determined by the Director as
having high risk for DMRVV
transmission based on factors such as
the presence and geographic
distribution of the virus or low quality
of or low confidence in rabies
surveillance systems or dog vaccination
programs.
DMRVV low-risk countries mean
countries determined by the Director as
having low risk for DMRVV
transmission based on factors such as
the virus being limited to a localized
area, adequacy of surveillance and dog
vaccination programs to prevent further
geographic distribution of the virus, and
the virus being in a controlled status
with the country or countries heading
toward eventual DMRVV-free status.
DMRVV-restricted countries means
countries for which the export of dogs
into the United States has been
prohibited or otherwise restricted based
on the countries’ export of dogs infected
with DMRVV to any other countries
within a timeframe determined by the
Director or based on the countries’
lacking adequate controls, as
determined by the Director, to monitor
and prevent the export of dogs to the
United States with falsified or
fraudulent vaccine credentials, invalid
rabies vaccination documentation, or
other fraudulent, inaccurate, or invalid
importation documents.
*
*
*
*
*
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Importer for purposes of this section
means any person importing or
attempting to import an animal into the
United States, including an owner or a
person acting on behalf of an importer,
such as a broker registered with U.S.
Customs and Border Protection (CBP).
Individuals compensated or hired to
transport animals must have a valid
USDA license or registration.
*
*
*
*
*
SAFE TraQ means the System for
Animal Facilities Electronic Tracking of
Quarantine or other system as approved
by the Director for tracking the
quarantine of animals approved for
admission into the United States.
Serologic testing, when applied to an
imported animal, means a rabies
antibody titration test performed by a
CDC-approved rabies laboratory using a
CDC-approved technique. The serology
sample must be drawn, submitted and
tested in accordance with CDC technical
instructions. The current list of CDCapproved laboratories is available online
on CDC’s website. CDC will update its
website as needed.
USDA-accredited veterinarian shall
have the same definition as accredited
veterinarian under 9 CFR 160.1.
USDA official veterinarian means the
Animal and Plant Health Inspection
Service (APHIS) veterinarian who is
assigned by the USDA Administrator to
supervise and perform the official work
of APHIS in any U.S. State or several
U.S. States.
*
*
*
*
*
(b) Authorized U.S. airports for dogs
and cats. (1) Cats may arrive at and be
admitted into the United States through
any U.S. airport.
(2) Dogs arriving to the United States
from DMRVV low-risk or DMRVV-free
countries that have not been in any
DMRVV high-risk country within the
last six months may arrive at and be
admitted into the United States through
any U.S. airport.
(3) Dogs that have been in a DMRVV
high-risk country within the last six
months and were vaccinated against
rabies in the United States must arrive
at and may only be admitted through a
U.S. airport with a CDC quarantine
station.
(4) Dogs that have been in a DMRVV
high-risk country within the last six
months and were vaccinated against
rabies in a foreign country must arrive
at and may only be admitted through a
U.S. airport with a CDC quarantine
station and a CDC-registered Animal
Care Facility.
(5) Dogs that have been in a DMRVV
high-risk country within the last six
months that arrive at an unauthorized
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44021
U.S. airport shall be denied admission
and returned to their countries of
departure via air pursuant to paragraph
(v) of this section.
(6) The current list of U.S. airports
with CDC quarantine stations is
available on CDC’s website. CDC also
maintains a list of U.S. airports with
CDC-registered Animal Care Facilities
on its website. CDC will update these
lists as needed.
(c) Authorized U.S. land ports for
dogs and cats. (1) Cats may arrive at and
be admitted into the United States
through any U.S. land port.
(2) Dogs arriving to the United States
from DMRVV low-risk or DMRVV-free
countries that have not been in any
DMRVV high-risk country within the
last six months may arrive at and be
admitted into the United States through
any U.S. land port.
(3) Dogs that have been in a DMRVV
high-risk country within the last six
months are not authorized to enter the
United States through any U.S. land
port and shall be denied admission into
the United States.
(d) Authorized U.S. seaports for dogs
and cats. (1) Cats may arrive at and be
admitted into the United States through
any U.S. seaport.
(2) Dogs arriving to the United States
from DMRVV low-risk or DMRVV-free
countries that have not been in any
DMRVV high-risk country within the
last six months may arrive at and be
admitted into the United States through
any U.S. seaport.
(3) Dogs that have been in a DMRVV
high-risk country within the last six
months are not authorized to enter the
United States through any U.S. seaport
and shall be denied admission into the
United States.
(4) Notwithstanding paragraph (d)(3)
of this section, a dog meeting the
definition of a ‘‘service animal’’ under
14 CFR 382.3 that has been in a DMRVV
high-risk country within the last six
months may be admitted through a U.S.
seaport if:
(i) The dog is accompanied by an
‘‘individual with a disability’’ as
defined under 14 CFR 382.3 and the dog
does work or performs tasks that are
directly related to the individual’s
disability; and
(ii) The dog was vaccinated against
rabies in the United States and is
accompanied by a valid Certification of
U.S.-issued Rabies Vaccination for Live
Dog Re-entry into the United States
form; or
(iii) The dog was vaccinated against
rabies in a foreign country and is
accompanied by a valid foreign-issued
CDC Import Certification of Rabies
Vaccination and Microchip Required for
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Live Dog Importations into the United
States form and a valid serologic titer
from a CDC-approved laboratory.
(e) Limitation on U.S. ports for dogs
and cats. The Director may limit the
times, U.S. ports, or conditions under
which dogs or cats may arrive at and be
admitted to the United States based on
an importer’s or carrier’s failure to
comply with the provisions of this
section or as needed to protect the
public’s health. If the Director
determines a limitation is required, the
Director will notify importers or carriers
in writing of the specific times, U.S.
ports, or conditions under which dogs
and cats may be permitted to arrive at
and be admitted to the United States.
(f) Age requirement for all dogs. All
dogs presented for admission into the
United States must be at least six (6)
months old at the time of arrival into the
United States. However, an importer
may present for admission up to three
(3) individual dogs within the same
calendar year below the age of six (6)
months if the dogs are arriving in the
United States by land from Canada or
Mexico and the dogs have not been in
a DMRVV high-risk or DMRVVrestricted country since birth.
(g) Microchip requirements for all
dogs. (1) All dogs presented for
admission into the United States must
have a microchip implanted prior to
arrival at the U.S. port.
(2) The microchip number must be
documented on the CDC Import
Certification of Rabies Vaccination and
Microchip Required for All Live Dog
Importations into the United States form
or the Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States form or documented
on the veterinary health records of the
dog if arriving from a DMRVV low-risk
or DMRVV-free country. The microchip
number must also be documented on
the CDC import submission form.
(3) The importer must consent to the
scanning of the dog’s microchip upon
arrival by CDC quarantine public health
officers or their representatives.
(4) Dogs arriving in the United States
without a microchip, with a microchip
that cannot be detected, with a
microchip that does not match the
accompanying documentation, or if the
importer refuses to have the dogs’
microchip scanned, may be denied
admission and returned to the country
of departure pursuant to paragraph (v)
of this section.
(h) CDC Import Submission Form for
all dogs. (1) All importers of dogs into
the United States must submit a CDC
Import Submission Form to CDC via a
CDC-registered system prior to the dogs’
arrival. This includes accompanied or
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unaccompanied dogs arriving by air,
land, and sea regardless of whether
arriving as cargo, checked-baggage, or
hand-carried baggage.
(2) Dogs that arrive without a
complete and accurate CDC import
submission form filed prior to arrival
may be denied admission and returned
to the country of departure pursuant to
paragraph (v) of this section, regardless
of the value of the shipment.
(3) Dogs arriving by air without a
complete and accurate CDC import
submission form may be held on a
space-available basis for up to 24 hours
after arrival in the care of a CDCregistered animal care facility or a
licensed veterinarian if the animal care
facility cannot house the dog until the
form is filed or if the dog arrives at an
airport without a CDC-registered animal
care facility. The importer (or airline if
the importer abandons the animal) is
responsible for making all necessary
arrangements with a CDC-registered
animal care facility or a veterinary clinic
if the animal care facility cannot house
the dog or is not available at the airport,
including arranging transportation to
the facility. The airline may require
reimbursement from an importer for any
associated costs incurred by the airline
on the importer’s behalf.
(4) Dogs arriving by sea without a
complete and accurate CDC import
submission form may be held onboard
the vessel until the form is filed. The
vessel’s owner or operator may require
reimbursement from an importer for any
associated costs incurred by the vessel
on the importer’s behalf.
(5) Dogs arriving by land without a
complete and accurate CDC import
submission form shall be denied
admission and returned immediately to
the dogs’ country of departure, but such
denial does not prevent the importer
from reapplying for admission of the
dogs after the form is filed.
(6) A receipt confirming submission
of the form to CDC must accompany all
dogs departing foreign locations for
travel to the United States. For dogs
departing from foreign airports to the
United States, the airline must deny
boarding to dogs unless the importer has
presented this receipt prior to boarding.
(7) Airlines are required to create a
bill of lading for all dogs arriving in the
United States prior to arrival. This
includes dogs transported as cargo,
checked-baggage, or hand-carried
baggage.
(8) Dogs arriving by air for which a
bill of lading has not been filed prior to
arrival in the United States may be
denied admission and returned to the
country of departure pursuant to
paragraph (v) of this section.
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(i) Inspection requirements for
admission of all dogs and cats. (1) All
animals arriving at a U.S. port shall be
inspected upon arrival, and only those
animals that show no signs of
communicable disease as defined in 42
CFR 71.1 shall be admitted into the
United States.
(2) All animals presented for
admission into the United States may be
subject to additional examination and
disease surveillance screening for the
purpose of communicable disease
surveillance. Ill animals may be
required to undergo additional
diagnostic testing prior to release of the
animal; such testing is not considered
surveillance screening.
(3) The Director may require
confinement of an animal and
examination by a veterinarian when
necessary to determine whether the
animal is admissible into the United
States, for instance, if dental
examination would assist in
determining the animal’s age.
(4) Importers who refuse to consent to
inspection, examination, or disease
surveillance screening of the animal
upon arrival may have the animal
denied admission and returned to its
country of departure pursuant to
paragraph (v) of this section.
(j) Examination by a USDA-accredited
veterinarian and confinement of
exposed dogs and cats or those that
appear unhealthy. (1) If an animal, upon
inspection, does not appear to be in
good health (e.g., it has symptoms such
as emaciation, lesions of the skin,
discharge of the eyes or nose, coughing,
sneezing, nervous system disturbances,
inability to stand or walk, difficulty
breathing, jaundice, vomiting, or
diarrhea), or appears healthy but, during
shipment, may have been exposed to a
sick or dead animal (including an
animal other than a dog or cat)
suspected of having a communicable
disease, the Director may require
prompt confinement and veterinary
examination.
(2) In the case of animals that appear
unhealthy or those that were potentially
exposed and arriving by air or sea, the
Director may require the airline or
vessel’s master or operator to arrange for
a licensed veterinarian to examine the
animal and give or arrange for any tests
or treatment indicated. In the case of
animals that appear unhealthy or those
that were potentially exposed and
arriving by land, the Director may deny
admission, but such denial does not
prevent the importer from reapplying
for admission after providing the
Director with satisfactory evidence that
a licensed veterinarian has examined
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the animal and administered any tests
or treatment as needed.
(3) Carriers shall maintain a record of
sickness of animals occurring while en
route to the United States and shall
submit the record upon arrival to the
CDC quarantine station with jurisdiction
for the U.S. port.
(4) Animals that become sick while en
route or on arrival shall be separated
from other animals (including an animal
other than a dog or cat) as soon as the
sickness is discovered and shall be held
in confinement pending any necessary
examination as determined by the
Director.
(5) Airlines (in the case of arrivals by
air) or a vessel’s master or operator (in
the case of arrivals by sea) shall
immediately arrange for medical
evaluation by a licensed veterinarian of
any animals that arrive sick and for
transportation as needed to a facility for
confinement or medical evaluation of
any sick animals. In the case of sick
animals arriving by land, the Director
may deny admission, but such denial
does not prevent the importer from
reapplying for admission after providing
the Director with satisfactory evidence
of confinement (as needed) and
examination by a licensed veterinarian.
(6) The Director will consider the
findings of the examination and tests in
determining whether the animal may
have a communicable disease.
(7) The airline or vessel’s master or
operator shall arrange for confinement
at a CDC-registered animal care facility
or CDC-approved veterinary clinic
which, in the judgment of the Director,
affords protection against transmission
of any communicable disease and
suitable housing in accordance with the
Animal Welfare Act (7 U.S.C. 2131 et
seq., as may be amended).
(8) The importer shall bear the
expenses of confinement, examination,
tests, and treatment under this
paragraph. If an importer fails to arrange
for or pay for such expenses or
cooperate with any CDC-mandated
public health evaluations, then the
animal will be considered abandoned,
and the carrier shall assume financial
responsibility pursuant to paragraph (z)
of this section.
(9) Confinement shall be subject to
conditions specified by the Director to
protect the public’s health.
(10) CDC may request that CBP
conditionally release animals in need of
medical evaluation or treatment.
Animals eligible for conditional release
shall remain under the legal custody of
the carrier or CDC-registered animal
care facility for the purpose of receiving
emergency veterinary medical care or
examination. Such animals must be
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returned immediately to a CDCregistered animal care facility or other
CDC-approved kennel or veterinary
facility (if a CDC-registered animal care
facility is not available) once medical
treatment is no longer required or upon
request by either CDC or CBP.
(11) If an importer (or carrier if the
animal is abandoned by the importer)
opts to have an animal euthanatized
(e.g., under circumstances where the
animal is fatally ill or injured), the
importer or carrier shall promptly
communicate this decision to CDC and
CBP in writing and prior to euthanasia.
Euthanasia does not relieve importers or
carriers of the obligation to arrange and
pay for testing and necropsy required by
CDC.
(k) Veterinary examination and
revaccination against rabies at a CDCregistered animal care facility for
foreign-vaccinated dogs. (1) All dogs
arriving from DMRVV high-risk
countries that do not have a valid
certification of U.S.-issued rabies
vaccination for live dog re-entry into the
United States form shall undergo
veterinary examination and
revaccination against rabies at a CDCregistered animal care facility upon
arrival.
(2) The importer is responsible for
making all arrangements relating to the
examination, revaccination, and
quarantine of dogs with a CDCregistered animal care facility prior to
arrival in the United States. The costs of
examination, vaccination, or quarantine
shall be borne by the importer and not
at the government’s expense.
(3) Importers are required to present
to airlines documentation confirming
their reservation at a CDC-registered
animal care facility prior to their dogs
boarding a flight to the United States.
Airlines must deny boarding to dogs if
the importer fails to present such
documentation.
(4) Prior to granting a reservation,
CDC-registered animal care facilities
must ensure they have received the
following:
(i) The completed CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States
form;
(ii) Serologic test results collected in
accordance with CDC’s technical
instruction from a CDC-approved
laboratory (if applicable);
(iii) Photos of the dog’s teeth to assist
with age verification;
(iv) The travel itinerary for the dog
confirming that the dog will only be
arriving at a U.S. airport with a CDC
quarantine station and a CDC-registered
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animal care facility and will not be
arriving at any other U.S. port; and
(v) A receipt confirming submission
of the CDC import submission form.
(5) Airlines must deny boarding to
any foreign-vaccinated dog for which
the importer has not presented a receipt
confirming submission of the CDC
import submission form and proof of a
reservation at a CDC-registered animal
care facility, or that is being presented
for travel to an unauthorized U.S.
airport.
(6) The airline shall arrange for dogs
to be transported by a CBP-bonded
transporter to a CDC-registered animal
care facility immediately upon arrival at
the U.S. airport.
(7) The dog shall remain in the
custody of the CDC-registered animal
care facility until the following
requirements are met:
(i) Veterinary health examination by a
USDA-accredited veterinarian for signs
of illness. All illnesses must be
documented in SAFE TraQ. CDC will
review these illness case reports and
determine admissibility prior to the
animal’s release. Suspected or
confirmed zoonotic or foreign animal
diseases, including the presence of ectoparasites (i.e., ticks and fleas), must be
reported to CDC, USDA, the State or
county public health veterinarian, and
the State veterinarian prior to release of
the animal.
(ii) Vaccination against rabies with a
USDA-licensed rabies vaccine that is
administered by a USDA-accredited
veterinarian.
(iii) Confirmation of microchip
number.
(iv) Confirmation of age through
dental examination by a USDAaccredited veterinarian.
(v) Verification of adequate rabies
serologic test from a CDC-approved
laboratory. Serologic tests must be
drawn within a timeframe as specified
in CDC technical instructions. Dogs that
arrive without an adequate rabies
serologic test results from a CDCapproved laboratory, or with a serologic
test result drawn outside the acceptable
timeframe, or with serologic test results
outside acceptable parameters, shall be
housed, at the CDC-registered animal
care facility for a 28-day quarantine
period following administration of the
USDA-licensed rabies vaccine.
(l) Registration or renewal of CDCregistered animal care facilities. (1)
Before housing any live dog imported
into the United States, a facility must
register with and receive written
approval from the Director to function
as a CDC-registered animal care facility.
Applications and all required
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documents must be submitted to
cdcanimalimports@cdc.gov.
(2) To register or to renew a
registration certificate, a facility must
submit the following documents to CDC:
(i) A completed registration/
application form;
(ii) A statement of intent that
describes the number and types of
animals the facility can house at one
time, including the number of animals
that can be housed in the quarantine
area;
(iii) Written standard operating
procedures that include all elements
required in paragraphs (k) through (q) of
this section;
(iv) A copy of all Federal, State, or
local registrations, licenses, and/or
permits; a facility must have a USDA
Class H intermediate handlers license
(and any additional class licenses or
registrations as deemed appropriate by
USDA) and a CBP Facilities Information
and Resource Management System
(FIRMS) code.
(v) A self-certification signed by the
owner or manager of the CDC-registered
Animal Care Facility stating that the
facility is in compliance and agrees to
continue to comply with the regulations
in this section.
(3) Upon receiving the documentation
required by this section, the Director
will review the application and either
grant or deny the application for
registration as a CDC-registered Animal
Care Facility. Applications that are
denied may be appealed under
paragraph (r) of this section.
(i) Before issuing a registration, the
Director may inspect any animal health
record, facility, vehicle, or equipment to
be used in management, examination,
and clearance of imported animals.
Thereafter, animal health records,
facilities, vehicles, and equipment used
in importing animals may be inspected
during annual site inspection visits or
when otherwise needed to protect the
public’s health.
(ii) Unless revoked in accordance
with paragraph (r) 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) A CDC-registered animal care
facility must apply to CDC for renewal
of the registration certificate not less
than 60 days and not more than 90 days
before the existing registration expires.
(4) The Director may deny an
application to register, renew, or
reinstate a facility as a CDC-registered
animal care facility if the registrant has
had a previous registration revoked in
accordance with paragraph (r) of this
section within the last five years.
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(5) All CDC-registered animal care
facilities must comply with the
requirements of paragraphs (k) through
(q) of this section.
(m) Record-keeping requirements at
CDC-registered animal care facilities. (1)
A CDC-registered animal care facility
must retain records regarding each
imported animal for three years after the
distribution or transfer of the animal.
Each record must include:
(i) The bill of lading for each
shipment;
(ii) The name, address, phone
number, and email address of the
importer and owner (if different from
the importer);
(iii) The number of animals in each
shipment;
(iv) The identity of each animal in
each shipment, including name,
microchip number, date of birth, sex,
breed, and coloring;
(v) The airline, flight number, date of
arrival, and port of arrival of each
shipment;
(vi) Veterinary medical records for
each animal, including:
(A) CDC import certification of rabies
vaccination and microchip required for
live dog importations into the United
States form and rabies serology obtained
before arrival in the United States (if
applicable);
(B) The USDA-licensed rabies vaccine
administered upon arrival;
(C) Veterinary examination records
upon arrival and while in quarantine;
(D) Rabies serology performed while
in quarantine in the United States (if
applicable);
(E) All diagnostic test results
performed during quarantine; and
(F) Necropsy reports for imported
animals that die while in the care of the
CDC-registered animal care facility.
(2) A CDC-registered animal care
facility must maintain these records
electronically in SAFE TraQ.
(i) Copies of all records must be
entered directly into or uploaded into
SAFE TraQ;
(ii) Records must be uploaded and
complete prior to the animal’s release
from the facility; and
(iii) CDC will audit records remotely
as needed and in-person during the
annual site inspection visit(s) at the
facility.
(n) Worker protection plan and
personal protective equipment (PPE). (1)
A CDC-registered Animal Care Facility
must establish and maintain a worker
protection plan with standards
comparable to those in the National
Institute for Occupational Safety and
Health (NIOSH) Veterinary Safety and
Health guidelines and the National
Association of Public Health
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Veterinarians (NASPHV) Compendium
of Veterinary Standard Precautions for
Zoonotic Disease Prevention in
Veterinary Personnel.
(2) In addition to complying with the
requirements of this section, a facility
must comply with all relevant Federal
and State requirements relating to
occupational health and safety.
(3) Rabies pre-exposure prophylaxis is
required for workers handling imported
animals in rabies quarantine.
(4) Post-exposure procedures that
provide potentially exposed workers
with direct and rapid access to a
medical consultant.
(5) Procedures for documenting the
frequency of worker training, including
for those working in the quarantine area.
(6) As part of the worker protection
plan, a facility must establish,
implement, and maintain hazard
evaluation and worker communication
procedures that include the following:
(i) Descriptions of the known zoonotic
disease and injury hazards associated
with handling animals;
(ii) The need for PPE when handling
animals and training in the proper use
of PPE, including re-training and
reinforcement of appropriate use; and
(iii) Procedures for disinfection of
garments, supplies, equipment, and
waste.
(o) CDC-registered animal care facility
standard operating procedures,
requirements, and equipment standards
for crating, caging, and transporting live
animals. (1) Equipment standards for
crating, caging, and transporting live
animals must be in accordance with
USDA Animal Welfare regulation
standards (9 CFR parts 1, 2, and 3) and
International Air Transport Association
standards.
(2) Animals must not be removed
from crates during transport.
(3) Used PPE, bedding, and other
potentially contaminated material must
be removed from the ground transport
vehicle upon arrival at the animal care
facility and disposed of or disinfected in
a manner that would destroy potential
pathogens of concern.
(p) Health reporting requirements for
animals at CDC-registered animal care
facilities. (1) A CDC-registered animal
care facility must provide the following
services for each animal upon arrival
and ensure each animal meets CDC
entry requirements prior to release from
the facility:
(i) Veterinary examination by a
USDA-accredited veterinarian within
one business day of arrival;
(ii) Verification of microchip and
confirmation that the microchip number
matches the animal’s health records;
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(iii) Verification of animal’s age via a
dental examination;
(iv) Revaccination against rabies using
a USDA-licensed vaccine; and
(v) Verification of a valid serology test
from a CDC-approved laboratory drawn
from a dog prior to arrival within a
timeframe and results within parameters
as specified in CDC technical
instructions or 28-day quarantine after
administration of the USDA-licensed
rabies vaccine.
(2) A CDC-registered animal care
facility must provide the following
services upon the occurrence of any
morbidity or mortality in an imported
animal in the facility:
(i) Notification to CDC within 24
hours of the arrival of an ill animal or
occurrence of any illness or death
occurring in an animal.
(ii) Examination by a USDAaccredited veterinarian immediately
upon detection of illness and diagnostic
testing to determine the cause of illness.
All costs associated with examination
and diagnostics are the responsibility of
the importer.
(iii) Reporting of suspected or
confirmed zoonotic diseases and ectoparasites to CDC and the State or county
public health veterinarian within 24
hours of identification. Suspected or
confirmed foreign animal diseases or
infectious animal diseases must be
reported to USDA and the State or
county veterinarian within 24 hours of
identification.
(iv) Necropsy and diagnostic testing to
determine the cause of death. The
importer is responsible for all costs
associated with necropsy and testing.
(3) Upon completion of the quarantine
period and before a facility releases any
animal from quarantine, the facility
must ensure that the facility’s USDAaccredited veterinarian has verified the
health status of the animal and all
required paperwork is uploaded into
SAFE TraQ.
(4) Any report required under this
paragraph must be uploaded to SAFE
TraQ prior to the release of the animal.
(q) Quarantine requirements for
animals at CDC-registered animal care
facilities. (1) A CDC-registered animal
care facility must maintain a quarantine
area for holding dogs during the
required quarantine period. Dogs must
be quarantined for 28 days after
revaccination with a USDA-licensed
rabies vaccine at the facility if they do
not have a valid rabies serologic test
from a CDC-approved laboratory. CDC
may extend the quarantine period if a
facility or CDC finds or suspects that a
dog is infected with, or has been
exposed to, a zoonotic disease or if a
facility or CDC determines that
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additional diagnostic testing is
warranted.
(2) For any quarantine area
established or maintained under this
section, a facility must establish,
implement, maintain, and adhere to
standard operating procedures that meet
the following physical security
requirements:
(i) The CDC-registered animal care
facility must be locked and secure, with
access limited to authorized, trained,
and knowledgeable personnel.
(ii) A CDC-registered animal care
facility must limit access to animal
quarantine areas to authorized
personnel responsible for the transport,
care, or treatment of the animals.
(3) During the quarantine period, a
CDC-registered animal care facility must
monitor animals for signs of any
zoonotic illness, including, but not
limited to, signs consistent with rabies,
brucellosis, leptospirosis, leishmaniasis,
or ecto- or endo-parasites.
(4) If any animals appear ill during
quarantine, the CDC-registered animal
care facility must notify CDC through
SAFE TraQ and monitor that animal for
signs of zoonotic illness and ensure
appropriate treatment. Suspected or
confirmed zoonotic diseases in animals
or facility workers must be reported to
CDC within 48 hours.
(5) A CDC-registered animal care
facility must not knowingly release any
ill animal from quarantine under
paragraph (q)(3) of this section without
prior consultation with and written
approval from CDC.
(6) Quarantined animals must be
housed in such a manner that they do
not expose non-quarantined animals
(including an animal other than a dog or
cat) to other potentially infectious
materials, including soiled bedding,
caging, and other potentially
contaminated items.
(7) If CDC notifies a CDC-registered
animal care facility of any evidence that
animals have been exposed to a
zoonotic disease, the facility must, at
the facility’s expense, implement or
cooperate in the CDC’s implementation
of additional measures to rule out the
spread of suspected zoonotic disease
before releasing an animal or shipment
of animals from quarantine, including
examination, additional diagnostic
procedures, treatment, detention,
isolation, seizure, or destruction of
exposed animals.
(8) A CDC-registered animal care
facility must establish, implement, and
adhere to standard operating procedures
for safe handling and necropsy of any
animal that dies in quarantine.
(r) Revocation and reinstatement of a
CDC-registered animal care facility’s
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44025
registration. (1) If the Director
determines that a CDC-registered animal
care facility has failed to comply with
any applicable provisions of this
section, including failure to abide by the
facility’s standard operating procedures,
the Director may revoke the facility’s
registration.
(2) CDC will send the CDC-registered
animal care facility a notice of
revocation stating the grounds upon
which the proposed revocation is based.
(3) If the CDC-registered animal care
facility wishes to contest the revocation,
the facility must file a written response
to the notice within five business days
after receiving the notice.
(4) As part of the response, a CDCregistered animal care facility may
request that the Director review the
written record.
(5) If a CDC-registered animal care
facility fails to file a response within
five business days, all of the grounds
listed in the proposed revocation will be
deemed admitted, in which case the
notice shall constitute final agency
action.
(6) If a CDC-registered animal care
facility’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.
(7) 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 provide the
facility with a copy of the written
decision.
(8) The Director may reinstate a
revoked registration after inspecting the
facility, examining its records,
conferring with the facility, and
receiving information and assurance
from the facility of compliance with the
requirements of this section.
(s) Requirement for the CDC Import
Certification of Rabies Vaccination and
Microchip Required for Live Dog
Importations into the United States form
to import foreign-vaccinated dogs from
DMRVV high-risk countries. (1)
Importers of foreign-vaccinated dogs
from DMRVV high-risk countries must
submit the CDC Import Certification of
Rabies Vaccination and Microchip
Required for Live Dog Importations into
the United States form to the CDCregistered animal care facility in order
to make a reservation at that facility.
(2) Importers must present
documentation confirming the dog’s
reservation at a CDC-registered animal
care facility to the airline prior to
boarding and to CBP upon arrival at a
U.S. port for admission of foreign-
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vaccinated dogs from DMRVV high-risk
countries.
(3) The CDC Import Certification of
Rabies Vaccination and Microchip
Required for Live Dog Importations into
the United States form must be truthful
and accurate, completed in English, and
include:
(i) The name of person importing the
dog (consignee), physical address,
phone number, email address, passport
number and date of birth;
(ii) The owner’s name, phone number,
and email address;
(iii) The destination address (physical
address) where the dog will reside upon
arrival in the United States;
(iv) The dog’s name, microchip
number, microchip implant date, breed,
sex, date of birth or approximate age if
the date of birth is unknown, and color
or markings of the dog;
(v) Rabies vaccination information for
the dog administered within a
timeframe and in accordance with the
vaccination schedule as specified in
CDC technical instructions;
(vi) Rabies vaccine product
information (product name,
manufacturer, lot number, and product
expiration date);
(vii) Rabies vaccine expiration date
(date when next vaccine is due), which
must be after the dog’s date of arrival at
a U.S. port;
(viii) The name, license number or
official stamp, address, telephone
number, email address, and signature of
the authorized veterinarian or official
government veterinarian that examined
the dog in the exporting country; and
(ix) The name, address, official seal or
stamp, and signature of an official
government veterinarian attesting that
the authorized veterinarian is licensed
or authorized to practice veterinary
medicine in the exporting country and
further attesting that the information
listed on the form is true and correct.
(4) Importers who fail or refuse to
present the CDC Import Certification of
Rabies Vaccination and Microchip
Required for Live Dog Importations into
the United States form or present a form
that is untruthful, inaccurate, and
incomplete may result in the dog denied
admission and returned to the country
of departure pursuant to paragraph (v)
of this section.
(t) Requirement for Certification Of
U.S.-Issued Rabies Vaccination for Live
Dog Re-entry into the United States form
for importers seeking to import U.S.vaccinated dogs from DMRVV high-risk
countries. (1) Importers returning to the
United States from a DMRVV high-risk
country with their U.S.-vaccinated dog
may present their dog for admission
without a rabies serologic test from a
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CDC-approved laboratory, without the
dog undergoing veterinary examination
(unless ill, injured, or exposed), and
without revaccination against rabies at a
CDC-registered animal care facility upon
arrival under the following
circumstances:
(i) The importer presents a
Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States form that is truthful,
complete, and accurate.
(ii) The dog must arrive by air and
entry must be made through a U.S.
airport with a CDC quarantine station.
(iii) The importer presents a valid
Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into
the United States form that sufficiently
and reliably demonstrates that a USDAlicensed rabies vaccine was
administered within a timeframe and
age parameters as specified in CDC
technical instructions.
(2) The Certification of U.S.-issued
Rabies Vaccination for Live Dog Reentry into the United States form must
be completed prior to the dog leaving
the United States and cannot be
completed upon arrival at a U.S. port or
after the dog has left the United States.
(3) Importers returning to the United
States from a DMRVV high-risk country
with their U.S.-vaccinated dog that are
unable to meet the requirements of this
paragraph (t) shall have the dog treated
as if it was vaccinated in a foreign
country in accordance with the
provisions of paragraph (k) of this
section and this paragraph (t) or,
alternatively, have the dog denied
admission and returned to the country
of departure pursuant to the paragraph
(v) of this section.
(4) If an importer fails to immediately
(within 24 hours of arrival) arrange for
the dog’s return to the country of
departure, then the animal will be
considered abandoned pursuant to
paragraph (z) of this section.
(u) Requirement for proof that a dog
has only been in a DMRVV low-risk or
DMRVV-free country. Dogs arriving,
including those returning to the United
States, from a DMRVV low-risk or
DMRVV-free country may be admitted
into the United States subject to the
requirements in this section if the
importer submits written
documentation (i.e., veterinary records,
veterinary import/export certificate)
satisfactory to the Director that for the
six months before arrival, the dog has
been only in a DMRVV low-risk or
DMRVV-free country.
(v) Denial of admission of dogs and
cats. (1) The Director may deny
admission to the following categories of
animals:
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(i) Any dog arriving from a DMRVV
low-risk or DMRVV-free country
without written documentation (i.e.,
veterinary records, veterinary import/
export certificate) that the dog has only
been in a DMRVV low-risk or DMRVVfree country for the six months prior to
the attempted entry, or if the Director
reasonably suspects fraud.
(ii) Any dog that is not accompanied
by a receipt confirming that a CDC
import submission form has been
submitted to CDC through a CDCapproved system.
(iii) Any dog arriving by air for which
a bill of lading has not been created by
the airline prior to arrival.
(iv) Any dog arriving by land to the
United States from DMRVV high-risk
countries.
(v) Any dog arriving by sea to the
United States from DMRVV high-risk
countries, except for a dog qualifying as
a service animal and meeting the
standards set forth in paragraph (d)(4) of
this section.
(vi) Any dog imported by an importer
who refuses to comply with the
requirement (if applicable) to undergo
disease surveillance screening,
microchip scanning, veterinary
examination, revaccination, provide
proof of sufficient rabies serologic tests,
or quarantine at a CDC-registered animal
care facility or other CDC-approved
facility (if a CDC-registered Animal Care
Facility is not available) upon arrival.
(vii) Any dog that has been in a
DMRVV high-risk country in the
previous six months and arrives without
a valid Certification of U.S.-issued
Rabies Vaccination for Live Dog Reentry into the United States form or a
valid CDC import certification of rabies
vaccination and microchip required for
live dog importations into the United
States form.
(viii) Any dog that has been in a
DMRVV high-risk country in the
previous six months and does not arrive
via air at a U.S. airport with a CDC
quarantine station and a CDC-registered
animal care facility, except for a dog
arriving by sea that qualifies as a service
animal and meets the standards set forth
in paragraph (d)(4) of this section.
(ix) Any dog imported from a DMRVV
high-risk country that arrives without a
reservation at a CDC-registered animal
care facility (if applicable).
(x) Any dog from a DMRVV-restricted
country that arrives without a valid CDC
dog import permit.
(xi) Any dog imported from a DMRVV
high-risk country if the Director
reasonably suspects fraud in any
documentation required for admission
or if such documentation is otherwise
untruthful, inaccurate, or incomplete.
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(xii) Any animal, regardless of
country of departure, that poses a public
health risk, including animals that
appear unhealthy upon arrival or
demonstrate signs or symptoms of
communicable disease.
(xiii) Any dog under six months of age
that is arriving via air or sea into the
United States, or any dog under six
months of age imported via a land port
if the importer has imported more than
three individual dogs under six months
of age in the same calendar year
(January-December).
(2) Animals arriving by air that are
awaiting an admissibility determination
or denied admission must be held in
CDC-registered animal care facilities or
other CDC- or USDA-approved
veterinary clinics (if a CDC-registered
animal care facility is not available) in
such a way as to prevent the potential
spread of communicable diseases.
(3) Pursuant to 9 CFR 3.14(f), animals
arriving by air that are denied admission
must be transported to a CDC-registered
animal care facility (or other boarding,
kennel, or veterinary clinic approved by
CDC if a CDC-registered animal care
facility is not available) by the airline
within six hours of denial of admission
into the United States while awaiting
return to the country of departure,
excluding animals transiting through
the United States. Animals arriving by
sea that are denied admission must
remain on the vessel while awaiting
return to the country of departure.
(4) An importer must meet the
admission requirements of all U.S.
Government agencies for the admission
of an animal into the United States.
Satisfaction of CDC’s requirements for
the admission of animals does not fulfill
the admission requirements of other
U.S. Government agencies.
(w) Disposal or disposition of dogs
and cats denied admission to the United
States. (1) Animals shall be subject to
such additional requirements, including
denial of admission, as may be deemed
necessary by the Director to protect the
public’s health or suspension of entry
under 42 CFR 71.63.
(2) Animals denied admission to the
United States that were transported to
the United States via air must be
returned by the airline to the country of
departure at the importer’s expense on
the next available outbound flight (no
later than 72 hours after arrival),
regardless of airline or route, if fit to
travel. Pending the animal’s return, the
animal shall be detained at the
importer’s expense in the custody of the
carrier at a CDC-registered animal care
facility (or other boarding, kennel, or
veterinary clinic approved by CDC if a
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CDC-registered animal care facility is
not available).
(3) Animals denied admission to the
United States that were transported to
the United States via sea shall be
reembarked immediately by the vessel’s
master or operator and returned to its
country of departure on the next voyage.
(4) Animals denied admission to the
United States that were transported to
the United States via land shall be
returned immediately by importer or
carrier to their country of departure.
(5) If an animal is not fit to travel,
poses a public health risk, or would
pose a risk to other animals, then the
carrier shall arrange for the animal to be
transported to a CDC-registered animal
care facility or a CDC- approved
veterinary clinic (if a CDC-registered
animal care facility is not available) for
either housing and treatment by a
licensed veterinarian until approved for
travel by CDC or humanely euthanized
(e.g., under circumstances where the
animal is fatally ill or injured) by a
licensed veterinarian. The importer
shall be responsible for all costs
associated with the denial, veterinary
evaluation, care, or disposal of the
animal. If the importer refuses to pay for
any costs associated with the denial,
evaluation, care, or disposal of the
animal, then it will be considered
abandoned, and the carrier shall assume
custody and financial responsibility for
these costs.
(6) If humane euthanasia is
recommended by a veterinarian or
chosen by an importer or carrier (e.g.,
under circumstances where the animal
is fatally ill or injured), the animal must
be euthanized by a U.S.-licensed
veterinarian in accordance with
American Veterinary Medical
Association guidelines. Euthanasia does
not relieve carriers or importers of the
obligation to arrange and pay for testing
and necropsy required by CDC.
(7) The Director may grant temporary
extensions of returns for animals that
are not fit for travel as determined by a
CDC veterinarian, but the importer (or
carrier in the case of abandonment)
must arrange for the return of the animal
to its country of departure as soon as
CDC notifies the carrier that the animal
is fit for travel.
(8) The requirements of this paragraph
shall additionally apply to dogs or cats
abandoned by the importer prior to the
dogs’ or cats’ admission into the United
States. A dog or cat may be deemed
abandoned pursuant to the provisions of
paragraph (z) of this section.
(9) Carriers must provide
transportation to/from and holding at a
CDC-registered animal care facility (or
other boarding, kennel, or veterinary
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Fmt 4701
Sfmt 4702
44027
clinic approved by CDC if a CDCregistered animal care facility is not
available) while determining
admissibility, undergoing veterinary
evaluation or care, or upon denial of
entry. Carriers may require
reimbursement from an importer for any
costs incurred on behalf of the importer.
(10) Importers must comply with CDC
requirements for the return of an animal
or for the veterinary assessment of an
animal. Refusal to cooperate, including
refusal to pay any associated veterinary
fees, will result in the animal being
considered abandoned by the importer,
and custody of the animal will be
transferred to the carrier who will
assume financial responsibility for costs
relating to the denial, evaluation, care,
or disposal of the animal.
(11) A carrier may enter into
contractual arrangements with an
importer or a third party relating to the
expenses of returning an animal to its
country of departure, for veterinary care,
or otherwise disposing of an animal,
provided that no government costs are
incurred. The return of an animal to its
country of departure or the initiation of
veterinary care shall not be delayed
while the carrier attempts to enter into
or negotiate contractual arrangements.
(12) The provisions of this paragraph
may be applied to importers of animals
and to carriers transporting such
animals in circumstances where an
animal is denied entry at a land port or
seaport of the United States and the
animal cannot be immediately returned
to its country of departure (e.g., because
it is unfit to travel).
(x) Appeals of CDC denials to admit
a dog or a cat upon arrival into the
United States. (1) If CDC denies
admission to an animal upon arrival,
then the importer may appeal that
denial to the Director.
(2) The importer must submit the
appeal in writing to the Director, stating
the reasons for the appeal and
demonstrating that there is a genuine
and substantial issue of fact in dispute.
(3) The importer must submit the
appeal within one (1) business day of
the denial by emailing
CDCAnimalImports@cdc.gov.
(4) Submitting an appeal will not
delay the return of the animal to the
country of departure.
(5) The Director will issue a written
response to the appeal, which shall
constitute final agency action.
(y) Record of death of dogs and cats
en route to the United States and
disposition of dead animals. (1) Carriers
shall maintain a record of the death of
animals occurring while en route to the
United States and shall submit the
record to the CDC quarantine station of
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jurisdiction for the U.S. port upon
arrival.
(2) Animals that become sick or die en
route or are identified as sick or dead
upon arrival shall be separated from
other animals (including animals other
than dogs or cats) as soon as the
sickness or death is discovered and
shall be held in confinement pending
any necessary examination as
determined by the Director. Sick
animals shall be examined pursuant to
the provisions of paragraph (j) of this
section or disposed of pursuant to the
provisions of paragraph (w) of this
section.
(3) The carrier shall arrange for any
animals that die en route to the United
States or that die while detained
pending determination of their
admissibility to undergo a necropsy
(gross and histopathologic examination
are required), and any subsequent
infectious disease testing based on gross
or histopathology findings or as
determined by CDC. The carrier or CDCregistered animal care facility must
contact the CDC quarantine station of
jurisdiction prior to transporting an
animal for necropsy to determine
whether rabies testing is required. In the
event an importer abandons an animal,
the carrier will become the owner and
shall assume responsibility for all
expenses described in this paragraph
(y)(3).
(4) The carrier shall send copies of the
final necropsy report and all test results
to the CDC quarantine station of
jurisdiction.
(5) Pursuant to paragraphs (p) and (w)
of this section, the importer is
responsible for costs associated with the
necropsy, testing, and disposal of the
body. In the event an importer abandons
an animal, then pursuant to paragraph
(z) of this section, the carrier will
become the owner and shall assume
responsibility for all expenses described
in paragraph (y)(3) of this section.
(z) Abandoned shipments of dogs and
cats. (1) In the event an importer
abandons an animal under this section,
the carrier will become the owner and
shall assume responsibility for all
expenses described in this section.
(2) An animal shipment will be
deemed abandoned under the following
circumstances:
(i) When explicitly stated by the
importer verbally or in writing to the
carrier, CDC, or CBP; or
(ii) If the importer fails to cooperate
with or respond to the carrier’s attempts
to comply with the provisions of this
section within 24 hours; or
(iii) If the importer refuses payment
within 24 hours for CDC-mandated
examinations, testing, holding, or
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treatment needed to ensure the safe
importation of dogs and cats into the
United States.
(aa) Sanitation of cages and
containers of dogs and cats. When the
Director finds that the cages or other
containers of animals arriving in the
United States are in an unsanitary or
other condition that may constitute a
communicable disease risk, the animals
shall not be admitted in such containers
unless the carrier has the containers
cleaned and disinfected or the animals
are removed and placed in clean
containers in accordance with USDA
and, in the case of airlines, the
International Air Transport Association
(IATA) shipping requirements.
Discarded containers must be cleaned
and disinfected or destroyed in
accordance with carrier policies. CDC
may require documentation of crate
disinfection or destruction by the
carrier.
(bb) Requirements for in-transit
shipments of dogs and cats. (1) Intransit shipments of live animals are not
eligible for release into the United
States.
(2) In-transit shipments must be
maintained under continuous
confinement with USDA APHIS
oversight onboard a conveyance until
export or off-loaded and maintained
under continuous confinement and
APHIS oversight at a USDA APHISpreapproved holding facility with a
CBP-issued FIRMS code while awaiting
a connecting conveyance, and then
loaded and maintained under USDA
APHIS oversight onboard the
connecting conveyance until export.
(3) The provisions of this section shall
apply to animals transiting through the
United States from one foreign country
to another, except as provided in
paragraphs (bb)(3)(i) and (ii) of this
section:
(i) Animals that appear healthy but
have been exposed to a sick or dead
animal (including an animal other than
a dog or cat) suspected of having a
communicable disease are not required
to undergo examination or tests as
provided in paragraph (j) of this section
if the Director determines that the
conditions under which the animals are
being transported afford adequate
protection against introduction of
communicable disease into the United
States.
(ii) The CDC Import Certification of
Rabies Vaccination and Microchip
Required For Live Dog Importations into
the United States form or Certification
Of U.S.-Issued Rabies Vaccination For
Live Dog Re-entry into the United States
form is not required for dogs that are
transported by aircraft and are being
PO 00000
Frm 00052
Fmt 4701
Sfmt 4702
transited through the United States if
retained in the custody of the airline
under conditions that would prevent
transmission of communicable diseases.
(cc) Bill of lading and other airline
requirements for dogs. (1) Airlines are
required to create a bill of lading for all
dogs arriving in the United States prior
to arrival. This includes dogs
transported as cargo, checked-baggage,
or hand-carried baggage.
(2) Dogs arriving by air for which a
bill of lading has not been filed prior to
arrival in the United States may be
denied admission and returned to the
country of departure pursuant to
paragraph (v) of this section.
(3) Airlines must deny boarding to
any dogs for which the importer has not
presented to the airline before boarding
a receipt confirming submission of the
CDC import submission form. Airlines
must also deny boarding if the dog
presented for travel does not match the
description on the receipt of the CDC
import submission form.
(4) For U.S.-vaccinated dogs that have
been in a DMRVV high-risk country
within the last six months, airlines must
deny boarding unless the importer
presents prior to boarding a valid
certification of U.S.-issued rabies
vaccination for live dog re-entry into the
United States form. Airlines must also
deny boarding if the dog presented for
travel does not match the description on
the Certification of U.S.-Issued Rabies
Vaccination for Live Dog Re-entry into
the United States form or if the dog is
scheduled to arrive in the United States
at a U.S. airport that does not have a
CDC quarantine station.
(5) For foreign-vaccinated dogs that
have been in a DMRVV high-risk
country within the last six months,
airlines must deny boarding unless the
importer presents documentation to the
airline before boarding of a reservation
at a CDC-registered animal care facility
and the dog is scheduled to arrive in the
United States at the U.S. airport where
the CDC-registered animal care facility
is located.
(6) For dogs from DMRVV-free or lowrisk countries, airlines must deny
boarding unless the importer presents
documentation to the airline before
boarding by showing that the dog is over
six months of age, has a microchip, and
has not been in a DMRVV high-risk
country in the previous six months.
Airlines must also deny boarding if the
dog presented for travel does not match
the description on the documents
presented by the importer for travel.
(7) A representative of an airline
transporting live dogs into the United
States must be on-site at the U.S. airport
and available to coordinate the entry/
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clearance of the dogs with Federal
Government officials until all live dogs
transported on an arriving flight into the
United States have either been cleared
for entry or arrangements have been
made to transport the dogs to a CDCregistered animal care facility or other
facility (e.g., veterinary clinic or kennel)
approved by CDC pending an
admissibility determination.
(dd) Order prohibiting carriers from
transporting dogs and cats. (1) If the
Director determines that a carrier has
endangered the public health of the
United States by acting or failing to act
to prevent the introduction of DMRVV,
as would occur through failure to
comply with any applicable provisions
of this section, the Director may issue an
order revoking the carrier’s permission
to transport live animals into the United
States, which shall be served on the
carrier’s owner or operator.
(2) The Director may rescind the order
after inspecting the carrier’s facilities;
examining its records; conferring with
the carrier’s owners or operators, its
contractors, or staff; or receiving
information and written assurances
from the carrier owner or operator that
it has taken remedial steps to ensure
future compliance with the
requirements of this section.
(3) A carrier owner or operator may
appeal a revocation of a carrier’s
permission to transport live animals
into the United States. The appeal shall
be in writing, addressed to the Director,
state the reasons for the appeal, and
demonstrate that there is a genuine and
substantial issue of fact in dispute. The
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appeal must be submitted via email to
CDCAnimalImports@cdc.gov
(4) As soon as practicable after
completing the appeal review, the
Director will issue a decision in writing
that shall constitute final agency action.
The Director will serve the carrier with
a copy of the written decision.
(ee) Prohibition on imports of dogs
from DMRVV-restricted countries. (1)
The Director may prohibit or otherwise
restrict the import of dogs into the
United States from certain countries
designated as DMRVV-restricted
countries. CDC will maintain a list of
DMRVV-restricted countries for which
the import of dogs into the United States
has been prohibited or otherwise
restricted based on the countries’ prior
export of dogs infected with DMRVV to
any other countries within a time frame
determined by CDC or based on
inadequate controls, as determined by
CDC, in the countries to monitor and
prevent the export of dogs to the United
States with falsified or fraudulent rabies
vaccine credentials, invalid rabies
vaccination certificates, or other
fraudulent, inaccurate, or invalid
exportation/importation documents.
(2) DMRVV-restricted countries may
be subject to additional restrictions,
including a complete prohibition on the
importation of dogs into the United
States from those countries as needed to
prevent the reintroduction of DMRVV.
(3) The Director may maintain such
additional restrictions or prohibitions in
place until the Director is satisfied that
the DMRVV-restricted country has
established sufficient controls to
prevent the reintroduction of DMRVV
into the United States, including
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Sfmt 9990
44029
measures to prevent the use of falsified
or fraudulent vaccine credentials or
invalid rabies vaccination certificates.
(4) The addition or removal of
DMRVV-restricted countries from the
list shall be announced through
notification in the Federal Register, and
a list will be maintained on CDC’s
website.
(5) Notwithstanding the prohibition
on imports of dogs from DMRVVrestricted countries, the Director may
allow the importation of dogs for
scientific purposes, when used as a
service animal (as defined in 14 CFR
382.3) for individuals with disabilities,
or in furtherance of an important
government interest. In such instances
CDC will issue a CDC dog import permit
for the importation of dogs from
DMRVV-restricted countries.
Instructions for how to apply for a
permit will be included in CDC
technical instructions.
(ff) Request for issuance of additional
fines or penalties. CDC may request that
U.S. Customs and Border Protection
(CBP), pursuant to 19 U.S.C. 1592 and
19 U.S.C. 1595a, issue additional fines,
citations, or penalties to importers,
brokers, or carriers when the Director
has reason to believe that an importer,
broker, or carrier has violated any of the
provisions of this section or otherwise
engaged in conduct contrary to law.
Dated: June 30, 2023.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2023–14343 Filed 7–6–23; 4:15 pm]
BILLING CODE 4163–18–P
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]]>Agencies
[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Proposed Rules]
[Pages 43978-44029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14343]
[[Page 43977]]
Vol. 88
Monday,
No. 130
July 10, 2023
Part VI
Department of Health and Human Services
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42 CFR Part 71
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Control of Communicable Diseases; Foreign Quarantine: Importation of
Dogs and Cats; Proposed Rule
Federal Register / Vol. 88, No. 130 / Monday, July 10, 2023 /
Proposed Rules
[[Page 43978]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 71
[CDC Docket No. CDC-2023-0051]
RIN 0920-AA82
Control of Communicable Diseases; Foreign Quarantine: Importation
of Dogs and Cats
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), in the
Department of Health and Human Services (HHS), proposes to amend its
foreign quarantine regulation to provide additional clarity and
safeguards to address the public health risk of dog-maintained rabies
virus variant (DMRVV) associated with the importation of dogs into the
United States. The United States has been DMRVV-free since 2007, and
reintroduction poses significant risk to human and animal health. The
close relationship between dogs and people means there is a direct
public health risk to individuals that interact with inadequately
vaccinated dogs imported from countries at high risk of DMRVV (high-
risk countries). The notice of proposed rulemaking (NPRM) also
addresses the importation of cats because both dogs and cats are
included in the current regulation. Cats are not required to have proof
of rabies vaccination and CDC is not proposing new substantive changes
relating to the importation of cats.
DATES: Written or electronic comments on the NPRM must be received by
September 8, 2023.
Written comments on the proposed data collection requirements under
the Paperwork Reduction Act must be received by September 8, 2023.
ADDRESSES:
For the NPRM: You may submit comments, identified by Docket No.
CDC-2023-0051 or RIN 0920-AA82, by either of the following ways:
Federal Rulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: Division of Global Migration and Quarantine, Centers
for Disease Control and Prevention, 1600 Clifton Road NE, MS H16-4,
Atlanta, GA 30329.
Instructions: All submissions received must include the agency name
and docket number or Regulatory Information Number (RIN) for this
action. All relevant comments received, including any personal
information provided, will be posted without change to https://www.regulations.gov/. Do not submit comments by email. CDC does not
accept comments by email.
To request more information on the proposed project or to obtain a
copy of the information collection plan and instruments, contact
Jeffrey M. Zirger, Information Collection Review Office Centers for
Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8,
Atlanta, Georgia 30329; Telephone: 404-639-7570; Email: [email protected].
FOR FURTHER INFORMATION CONTACT: Ashley C. Altenburger, J.D., Division
of Global Migration and Quarantine, Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS H16-4, Atlanta, GA 30329.
Telephone: 1-800-232-4636. For information regarding CDC operations and
importations related to this NPRM, please contact Dr. Emily Pieracci,
D.V.M., Division of Global Migration and Quarantine, Centers for
Disease Control and Prevention, 1600 Clifton Road NE, MS H16-4,
Atlanta, GA 30329; Telephone: 1-800-232-4636.
SUPPLEMENTARY INFORMATION: The NPRM is organized as follows:
I. Executive Summary
A. Purpose of This Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Public Participation
III. Background
A. Legal Authority
B. Historical Background
C. Current Process
IV. Summary of Proposed Changes
V. Alternatives Considered
VI. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act of 1995
D. National Environmental Policy Act (NEPA)
E. Executive Order 12988: Civil Justice Reform
F. Executive Order 13132: Federalism
G. Plain Language Act of 2010
I. Executive Summary
A. Purpose of This Regulatory Action
Through this NPRM, HHS/CDC proposes to revise its regulation at 42
CFR 71.51 to prevent the reintroduction and spread of dog-maintained
rabies virus variant (DMRVV) in the United States. HHS/CDC also
proposes amendments to 42 CFR 71.50, which contains definitions
applicable to animal importations under 42 CFR part 71, subpart F. The
United States was declared DMRVV-free in 2007.\1\ The importation of
just one dog infected with DMRVV risks re-introduction of the virus
into the United States; such a public health threat could result in the
loss of human and animal life and consequential economic
impact.2 3 4 The rabies virus can infect any mammal, and,
once clinical signs appear, the disease is almost always fatal.\5\ A
DMRVV-infected dog can transmit the virus to humans, domestic pets,
livestock, or wildlife. Importing inadequately vaccinated dogs from
countries at high risk of DMRVV (high-risk countries) \6\ involves a
significant public health risk to people who directly interact with
those dogs. In 2019, the importation of a DMRVV-infected dog cost the
affected State governments more than $400,000 U.S. dollars (USD) for
the ensuing public health investigations and rabies post-exposure
prophylaxis (PEP) treatments administered to exposed
persons.7 8
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\1\ Centers for Disease Control and Prevention. US Declared
Canine-Rabies Free. https://www.cdc.gov/media/pressrel/2007/r070907.htm. Accessed June 1, 2023.
\2\ World Bank (2012). People, Pathogens and Our Planet: The
Economics of One Health. Retrieved from https://openknowledge.worldbank.org/handle/10986/11892.
\3\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
\4\ Jeon S, Cleaton J, Meltzer M, et al. Determining the post-
elimination level of vaccination needed to prevent re-establishment
of dog rabies. PLoS Neg Trop Dis 2019; 13 (12): e0007869.
\5\ Fooks AR, Banyard AC, Horton DL, Johnson N, McElhinney LM,
Jackson AC. Current status of rabies and prospects for elimination.
Lancet 2014;384:1389-99.
\6\ A complete list of countries with high risk of DMRVV is
available at ``High-Risk Countries for Dog Rabies.'' https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html. Accessed June 8, 2023.
\7\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
\8\ Centers for Disease Control and Prevention (2022). Rabies
Postexposure Prophylaxis. Retrieved from https://www.cdc.gov/rabies/medical_care/.
---------------------------------------------------------------------------
Through this proposed rulemaking, HHS/CDC also seeks to prevent and
deter the importation of dogs with falsified or fraudulent rabies
vaccine documentation. In 2020, CDC observed a 52 percent increase in
the number of dogs that were ineligible for admission due to falsified
or fraudulent documentation, as compared to 2018 and 2019 (450 dogs
compared to the previous baseline of 300 dogs per year).\9\ This
troubling trend continued in 2021, with an additional 24 percent
increase of dogs ineligible for admission in just
[[Page 43979]]
the first half of the year, compared to the full 2020 calendar year
(January-December) (approximately 560 dogs with falsified or fraudulent
documentation).\10\
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\9\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2020. Accessed: 15 February 2021.
\10\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, January 1, 2021-July 14, 2021. Accessed: 01 October 2021.
---------------------------------------------------------------------------
The use of a single false rabies vaccination certificate (RVC) \11\
or rabies vaccination documents as part of a larger shipment of
multiple dogs raises suspicion that the other rabies vaccination
documents for the remaining dogs may also be false and creates an
additional burden on CDC and State health departments to track, test,
and evaluate the remaining dogs in the shipment. CDC and U.S. Customs
and Border Protection (CBP) have documented numerous importations every
year in which flight parents \12\ transport dogs for the purpose of
resale, adoption, or transfer of ownership that do not meet CDC's entry
requirements. These flight parents often claim the dogs are their
personal pets to avoid U.S. Department of Agriculture (USDA) Animal
Care entry requirements and potential tariffs or fees under CBP
regulations. Even when well-meaning, these importers jeopardize public
health, as many of them do not know the history of the animals they are
transporting. Deterring individuals who serve as flight parents from
supporting fraudulent dog importations has proven difficult despite the
existence of CBP penalties relating to aiding unlawful importations and
fraudulent conduct. See 19 U.S.C. 1592 and 19 U.S.C. 1595a.
---------------------------------------------------------------------------
\11\ Centers for Disease Control and Prevention. What is a valid
rabies vaccination certificate? Available at: www.cdc.gov/importation/bringing-an-animal-into-the-united-states/vaccine-certificate.html.
\12\ A flight parent refers to a person accompanying an animal
into the country. Flight parents are often solicited through social
media, not affiliated with the sponsoring dog rescue organization,
and usually compensated with an airline ticket or other funds.
---------------------------------------------------------------------------
The documented increase in fraudulent vaccine documentation and
importers circumventing dog import regulations was shortly followed by
the advent of the coronavirus disease 2019 (COVID-19) pandemic. Many
public health resources were redirected to the COVID-19 response,
reducing the availability of resources to respond to dog importation
issues. In light of this confluence of events, in June 2021, CDC
published a temporary suspension of dogs entering the United States
from DMRVV high-risk countries.\13\ The temporary suspension created a
system that, among other things, implemented the use of standardized
forms, required titer test results demonstrating the presence of rabies
antibodies in dogs, and developed a reservation system allowing for the
rapid quarantine of dogs from DMRVV high-risk countries arriving with
inadequate proof of titers. During the temporary suspension, CDC has
documented decreased instances of fraud, fewer dogs being denied
admission into the country, fewer sick and dead dogs arriving in the
United States, and fewer federal and state agency resources devoted to
addressing issues related to inadequately vaccinated dogs upon arrival.
This NPRM proposes a similar regulatory framework based on the
documented successes of the temporary suspension.
---------------------------------------------------------------------------
\13\ Temporary Suspension of Dogs Entering the United States
from High-Risk Rabies Countries. Federal Register, 86 FR 32041 (June
16, 2021).
---------------------------------------------------------------------------
In parallel with the publication of this NPRM, CDC has published an
extension of the temporary suspension through July 31, 2024. A
suspension remains necessary to protect the public's health against the
reintroduction of DMRVV into the United States because there is a
continued threat posed by dogs from DMRVV high-risk countries that are
unvaccinated or inadequately vaccinated against rabies. This continued
threat is due to various factors, including: a high volume of dogs
being imported into the United States contemporaneous with insufficient
veterinary controls in DMRVV high-risk countries to prevent the export
of inadequately vaccinated dogs, inadequate veterinary supply chains
for vaccines and related materials, and persistent workforce capacity
shortages, particularly in DMRVV high-risk countries that export dogs
to the United States.
This NPRM proposes to incorporate practices used during the
temporary suspension period that CDC found effective to better protect
the public's health from introductions of DMRVV from high-risk
countries and reduce potential instances of fraudulent documentation.
The NPRM outlines a framework and set of operations that CDC believes
would mitigate the need for suspending dog imports from high-risk
countries should these procedures be adopted. We welcome feedback from
the public on all proposals contained within this NRPM.
B. Summary of Major Provisions
In this NPRM, HHS/CDC proposes to align U.S. import requirements
for dogs with the importation requirements of other DMRVV-free
countries by requiring proof of rabies vaccination and adequate
serologic test results from a CDC-approved laboratory. This NPRM
proposes for all dog imports: a microchip, six-month minimum age
requirement for admission, importer submission of a CDC import form
(CDC Import Submission Form), and requirements for airlines to confirm
documentation, provide safe housing, and assist public health officials
in determining animal cause of death.
HHS/CDC proposes all importers of dogs that have been in a DMRVV
high-risk country in the past six months, regardless of whether
foreign- or U.S.-vaccinated, would be required to submit a standardized
vaccination form verifying the rabies vaccination status of dogs. For
dogs that have been in a DMRVV high-risk country in the past six months
and have a valid U.S.-issued rabies vaccination certificate, this NPRM
proposes that the dog be required to arrive at a U.S. airport with a
CDC quarantine station. For dogs that have been in a DMRVV high-risk
country in the past six months, and were vaccinated in a foreign
country, this NPRM proposes that the dog be required to arrive a U.S.
airport with a CDC quarantine station and a CDC-registered Animal Care
Facility. This NPRM further proposes that dogs imported from DMRVV-free
or DMRVV low-risk countries be eligible to arrive at any U.S. port. In
lieu of a CDC vaccination form, which would be required for dogs
imported from DMRVV high-risk countries, these importers may instead
provide proof that the dogs have only been in DMRVV-free or DMRVV low-
risk countries during the previous six months prior to arriving in the
United States.
HHS/CDC also proposes to require that all dogs arriving from any
country, including dogs returning to the United States after traveling
abroad, be properly microchipped with an International Standards
Organization (ISO)-compatible microchip prior to travel into the United
States. The microchip information would be included on importation
documents to help ensure that dogs presented for admission are the same
dogs as those listed on the rabies vaccination records. Microchips are
already used globally and required for importation in many DMRVV-free
countries. Microchips are recommended by the international veterinary
community and animal rescue and welfare organizations to reunite lost
animals with their owners and ensure the veterinary records for an
animal can be linked to the animal.\14\
---------------------------------------------------------------------------
\14\ American Veterinary Medical Association. Microchipping FAQ.
https://www.avma.org/resources-tools/pet-owners/petcare/microchips-reunite-pets-families/microchipping-faq. Accessed June 1, 2023.
---------------------------------------------------------------------------
The microchip requirement will also promote greater confidence in
the
[[Page 43980]]
information recorded on the rabies vaccination records. CDC has
documented several instances of importers attempting to present records
of vaccinated dogs that became ill or died before travel as the
vaccination records for dogs that lacked appropriate veterinary
paperwork, presenting the original dogs' vaccination records for the
replacement dogs and attempting to import the unvaccinated dogs into
the United States without detection.\15\ Because microchips are not
currently required for entry into the United States and the dogs in
question were not microchipped, the public health investigation to
confirm the identity of these dogs was both resource intensive and
challenging. Further, during CDC's temporary suspension of dogs
entering the United States from DMRVV high-risk countries, CDC
documented that 99 percent (>20,000) of permit applications received
were for dogs that had microchips implanted prior to the announcement
of the suspension. Microchips are frequently used by pet owners and
required for international transit by many foreign countries.
Therefore, CDC's proposed requirement would have minimal impact on dog
importations, although costs to some importers would still be incurred.
We welcome feedback on this proposal.
---------------------------------------------------------------------------
\15\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2020. Accessed: February 15, 2021.
---------------------------------------------------------------------------
To address concerns about importations of puppies that are too
young to be properly vaccinated against rabies, through this NPRM, HHS/
CDC proposes requiring that any dog arriving in the United States be at
least six months of age. Dogs cannot be vaccinated effectively against
rabies before 12 weeks of age and are not considered fully vaccinated
until 28 days after vaccination.\16\ Establishing a six-month minimum
age requirement for the import of dogs aligns with current USDA
requirements for commercial dog imports under the Animal Welfare Act
\17\ and will better protect the public's health from rabies. Under
this proposal, an exception would be included to permit an owner to
import a maximum of three individual (personal pet) dogs under six
months of age in the same calendar year (January-December) if arriving
in the United States via a U.S. land port through Canada or Mexico,
provided the dogs have not been in a DMRVV high-risk or DMRVV-
restricted country since birth. CDC notes that both Canada and Mexico
are currently DMRVV-free countries, and a limited exception to
accommodate personal pet owners who travel by land between the U.S. and
Canada or Mexico is unlikely to threaten the public's health. HHS/CDC
specifically welcomes public comment this proposal.
---------------------------------------------------------------------------
\16\ National Association of State Public Health Veterinarians.
Compendium of animal rabies prevention and control, 2016. JAVMA
2016; 248 (5):505-517.
\17\ 7 U.S.C. 2148.
---------------------------------------------------------------------------
In this NPRM, HHS/CDC also proposes to require all dog importers to
submit a CDC Import Submission Form (i.e., an online form that includes
the importers' contact information and information related to each dog
being imported) via a CDC-approved system prior to travel to the United
States. This proposed requirement would apply to all imported dogs
(including dogs arriving from DMRVV-free and DMRVV low-risk countries)
arriving in the United States by air, land, or sea. Upon arrival at a
U.S. port,\18\ importers will present a receipt confirming they
submitted a completed CDC Import Submission Form; additionally,
importers arriving by air will present the receipt to the airline prior
to boarding. The receipt will contain the information submitted on the
CDC Import Submission Form, which will allow government officials to
verify that the details from the CDC Import Submission Form match the
dog being presented for entry. CDC's import submission system would
operate as a free online system. Requiring documentation for all
imported dogs would allow CDC to track the total number of dog
importations (including the number imported from DMRVV high-risk
countries), something CDC is unable to do currently.
---------------------------------------------------------------------------
\18\ U.S. Port means any seaport, airport, or border crossing
point under the control of the United States. 42 CFR 71.1(b).
---------------------------------------------------------------------------
HHS/CDC further proposes that an airline, prior to accepting a dog
for transport, must confirm that the dog possess all required import
documentation based on the country of origin. Airlines must also ensure
dogs from DMRVV high-risk countries will only be entering the United
States through a designated U.S. airport with a CDC quarantine station
(if U.S.-vaccinated) or a U.S. airport with both a CDC quarantine
station and a CDC-registered Animal Care Facility (if foreign-
vaccinated) and that the importer possesses a reservation with the CDC-
registered Animal Care Facility for examination, vaccination, and
quarantine (if required). As needed, CDC will coordinate with the
airline regarding transport of the dog to the CDC-registered Animal
Care Facility. These regulatory actions (if finalized as proposed)
would help ensure that dogs arriving in the United States from DMRVV
high-risk countries are adequately protected against rabies and do not
pose a public health threat. We welcome feedback from the public on
this proposal.
HHS/CDC proposes to require that airlines return dogs or cats
denied admission to the country of departure within 72 hours after
arrival. The responsibility for a dog or cat pending admission into the
United States or awaiting return to the country of departure has been a
point of confusion for many airlines, resulting in delayed care and
improper housing for numerous animals. Delays in returning dogs to
their countries of departure also potentially threaten U.S. public
health by exposing people to dogs with unknown rabies vaccination
status. HHS/CDC proposes that the airline on which a dog or cat is
brought to the United States must arrange for and ensure transportation
and care until the animal is either returned to the county of departure
or cleared for entry into the United States.
HHS/CDC also proposes a provision regarding dogs and cats that die
en route to the United States or that die while detained pending
determination of their admissibility. This provision is primarily
directed at airlines and would require that they transport deceased
dogs and cats and arrange for necropsy requiring gross and
histopathologic examination and any subsequent infectious disease
testing based on the findings. The importer is responsible for all
costs associated with necropsy and testing. The airline would also be
required to notify the CDC quarantine station of jurisdiction \19\
prior to transporting a dead dog or cat for a necropsy to determine
whether rabies testing is required and provide the quarantine station
with the final necropsy report and all test results. These measures
will help CDC rule out foreign animal diseases of public health concern
\20\ as a potential cause of death and will protect both animal and
human health. The provisions of this paragraph may also be applied to
other carriers transporting such dogs and cats in the very rare event
when the death of a dog or cat occurs en route to the United
[[Page 43981]]
States, or the animal dies while detained pending determination of
their admissibility. HHS/CDC welcomes public comment specifically on
these proposed requirements.
---------------------------------------------------------------------------
\19\ CDC quarantine station jurisdictions, available at:
www.cdc.gov/quarantine/quarantinestationsjurisdictionscounties.html.
\20\ U.S. Department of Agriculture. Notifiable Diseases and
Conditions. https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-Reference-Guide/Animal-Health-Emergency-Management/Notifiable-Diseases-and-Conditions.
---------------------------------------------------------------------------
Through this NPRM, HHS/CDC proposes to remove the current
requirement for a valid RVC in 42 CFR 71.51(c) and replace it with new
rabies vaccination forms for dogs imported from DMRVV high-risk
countries. The proposed rabies vaccination forms would include the
rabies vaccination status of the dog and other required information
similar to the current valid RVC requirement. However, unlike the
current requirement for a valid RVC, the proposed rabies vaccination
forms would be standardized.
The rabies vaccination form for foreign-vaccinated dogs would also
be certified by a government official in the exporting country, as an
added measure to prevent falsification. The acceptable rabies
vaccination form to fulfill this requirement for foreign-vaccinated
dogs from DMRVV high-risk countries would be titled ``CDC Import
Certification of Rabies Vaccination and Microchip Required for Live Dog
Importations into the United States.'' This proposed change would help
ensure that foreign-vaccinated dogs imported from DMRVV high-risk
countries meet CDC entry requirements prior to traveling to the United
States and allow for follow-up with the exporting country's government
officials if repeated import violations occur. HHS/CDC welcomes public
comment on this proposed requirement.
Under the proposed rule, importers of U.S.-vaccinated dogs
presenting for re-entry into the United States from countries at high
risk for DMRVV would be required to arrive at a U.S. airport with a CDC
quarantine station. Additionally, prior to traveling out of the United
States, a USDA-Accredited Veterinarian would need to complete and sign
a form titled ``Certification of U.S.-issued Rabies Vaccination for
Live Dog Re-entry into the United States.'' This form would then be
certified by a USDA Official Veterinarian prior to departing the United
States and would need to be presented by the importer to the airline to
board the dog on its return flight to the United States. The importer
would also need to present this form when requested to do so by U.S.
government officials upon arrival. The use of this form would decrease
the likelihood of falsification or fraud because it would include
information in a standardized format and rely on USDA's existing
veterinary accreditation system. Dogs arriving with this form would not
be subject to the requirement for veterinary examination (unless ill,
injured, or exposed), revaccination, verification of adequate rabies
serologic tests, and/or post-vaccination quarantine at a CDC-registered
Animal Care Facility.
In this NPRM, CDC/HHS proposes to require importers of foreign-
vaccinated dogs from DMRVV high-risk countries to enter the United
States through an airport with a CDC quarantine station and a CDC-
registered Animal Care Facility. The importer would also need to obtain
a rabies serologic test from a CDC-approved laboratory for their
foreign-vaccinated dogs demonstrating adequate titer levels. In
addition, the importer would also need to have a reservation at the
CDC-registered Animal Care Facility and have their dog(s) undergo a
veterinary exam and revaccination with a USDA-licensed rabies vaccine
at the CDC-registered Animal Care Facility. Importers of foreign-
vaccinated dogs who cannot obtain serologic test results prior to
importation would be required to have their dog remain under quarantine
at the facility for 28 days after revaccination or until verification
of adequate rabies serologic test from a CDC-approved laboratory is
obtained, whichever occurs first. HHS/CDC is requesting comment on this
proposed process.
HHS/CDC proposes a narrow exception for both U.S.- and foreign-
vaccinated service dogs that have been in a DMRVV high-risk country
within the last six months. This exception would allow such dogs to
enter the U.S. at a U.S. seaport if the dog is at least six months of
age, has a microchip, has either a complete, accurate, and valid
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry
into the United States form or a complete, accurate, and valid CDC
Import Certification of Rabies Vaccination and Microchip Required for
Live Dog Importations into the United States form, as appropriate, and
has sufficient and valid titer results from a CDC-approved laboratory
(if the dog is foreign-vaccinated). To be considered a valid service
dog, the dog would need to meet the definition of a ``service animal''
under 14 CFR 382.3, be accompanied by an ``individual with a
disability'' as defined under 14 CFR 382.3, and work or perform tasks
directly related to that individual's disability. HHS/CDC is requesting
comment on this proposed exception. HHS/CDC also proposes to prohibit
or otherwise restrict importation of dogs into the United States from
certain countries that have a history of exporting dogs infected with
DMRVV to other countries or have demonstrated a lack of appropriate
veterinary controls to prevent the exportation of rabid dogs. To
implement this provision, HHS/CDC proposes to maintain a ``List of
DMRVV-Restricted Countries'' from which the importation of dogs into
the United States would be prohibited. The list of DMRVV-restricted
countries would be maintained on CDC's website. Additions or removals
of countries would also be announced in notices published in the
Federal Register. Under this proposal, CDC would retain the ability to
issue a special exemption on an extremely limited basis for dogs that
have been in a DMRVV-restricted country in the six months prior to
their importation into the United States (e.g., for dogs imported for
scientific purposes, for use as a trained service animal for
individuals with disabilities,\21\ or in furtherance of an important
government interest). HHS/CDC welcomes public comment on public health
standards and evidence used to maintain a list of DMRVV-restricted
countries and the length of time or conditions to be met before a
country is added or eligible for removal from the list. Additionally,
HHS/CDC welcomes public comment on how the list will be maintained and
whether publication on CDC's website and through Federal Register
notices would be sufficient to adequately inform importers.
---------------------------------------------------------------------------
\21\ Emotional support animals are not recognized as service
animals. U.S. Department of Transportation. Service Animals. https://www.transportation.gov/individuals/aviation-consumer-protection/service-animals, last updated June 9, 2021.
---------------------------------------------------------------------------
HHS/CDC proposes that airlines be required to confirm prior to
boarding that the dog is scheduled to arrive at an approved U.S.
airport and, if foreign-vaccinated, that the importer has documentation
confirming a reservation at the CDC-registered Animal Care Facility.
This will ensure that CDC and USDA can follow up with airlines more
easily to ensure animals are being properly handled (e.g., not left in
cargo warehouses for prolonged periods of time that endanger the health
of the animal). Additionally, to address concerns relating to the
movement of dogs or cats that are sick or dead upon arrival, HHS/CDC
proposes to require that airlines transport all sick or dead animals
(regardless of vaccination status and country of origin) to a CDC-
registered Animal Care Facility or, under certain conditions, to other
CDC- or USDA-approved veterinary clinic within six hours of arrival.
CDC acknowledges that extraordinary circumstances, such as extreme
weather, may delay the transport of animals beyond the six-hour window.
Under
[[Page 43982]]
such circumstances, CDC will work closely with airlines to address
these rare and unforeseen events while ensuring the safe handling of
animals. CDC also will work with importers who arrive at unapproved
U.S. ports based on circumstances beyond their control (e.g., re-
routing of their flight due to extreme weather). CDC quarantine station
staff are available 24 hours a day to assist streamlined coordination
and processing of dog and cat importation at U.S. ports and provide
coverage for geographic areas beyond the U.S. port in which the CDC
quarantine station is located.
HHS/CDC also proposes establishing requirements for businesses that
wish to become CDC-registered Animal Care Facilities. Requirements
would include a USDA intermediate handlers license and approval by CBP
to act as a CBP-bonded facility with an active Facilities Information
and Resource Management System (FIRMS) code. This will ensure dogs and
cats receive appropriate veterinary care and are housed in a way that
prevents the spread of infectious diseases while protecting the safety
of the animals.
The requirements HHS/CDC is proposing in this NPRM for dog
importation into the United States are summarized below in Table 1.
Since HHS/CDC is not proposing substantial changes to cat importation
requirements, Table 1 does not apply to cats.
Table 1--Summary Table of Proposed Importation Requirements for Dogs Based on Vaccination Status and Country of
Origin
----------------------------------------------------------------------------------------------------------------
Requirements for admission
-------------------------------------------------------------------------------
ISO- compatible Approved U.S.
Age microchip Documentation ports
----------------------------------------------------------------------------------------------------------------
U.S.-Vaccinated Dog from DMRVV At least six months Yes.............. Valid Only U.S. airports
High-Risk Country. of age. Certification of with a CDC
U.S.-issued quarantine
Rabies station.*
Vaccination for
Live Dog Re-entry
into the United
States Form and
CDC Import
Submission Form
receipt.
Foreign-Vaccinated Dog from At least six months Yes.............. Reservation with a Only U.S. airports
DMRVV High-Risk Country. of age. CDC-registered with a CDC
Animal Care quarantine
Facility, CDC station and a CDC-
Import registered Animal
Certification of Care Facility.*
Rabies
Vaccination and
Microchip
Required for Live
Dog Importations
into the United
States Form, CDC
Import Submission
Form receipt,
titer results
from a CDC-
approved
laboratory (dogs
without titer
results will be
required to
quarantine).
Dog from Rabies-Free or DMRVV At least six months Yes.............. There are no All U.S. ports.
Low-Risk Country. of age **. vaccination
requirements,
however, written
documentation
that the dog has
resided or
otherwise been
only in a DMRVV
low-risk or
rabies-free
country for the
six months prior
to the attempted
entry and CDC
Import Submission
Form receipt.
U.S.- or Foreign-Vaccinated Dog At least six months Yes.............. CDC Dog Import Only U.S. airports
from DMRVV-Restricted Country. of age. Permit for with a CDC
limited groups of quarantine
dogs (i.e., station and a CDC-
service animals, registered Animal
government-owned Care Facility.
animals).
----------------------------------------------------------------------------------------------------------------
* Dogs arriving at U.S. land ports that have been in DMRVV high-risk countries within the last six months will
be denied admission. All service dogs entering at U.S. seaports must be six months of age, have an ISO-
compatible microchip, and have a receipt confirming submission of a CDC Import Submission Form. Service dogs
that have been in DMRVV high-risk countries within the last six months may enter the United States at U.S.
seaports if they have either a valid Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry
into the United States Form or both a valid CDC Import Certification of Rabies Vaccination and Microchip
Required for Live Dog Importations into the United States Form and sufficient and valid titer results from a
CDC-approved laboratory.
** Dogs arriving at U.S. land ports are subject to the six-month minimum age requirement. However, an importer
may import up to three dogs younger than six months of age in a calendar year if the dogs have not been in a
DMRVV high-risk country since birth.
The forms HHS/CDC is proposing be required in this NPRM for dog
importation into the United States are summarized below in Table 2.
Since HHS/CDC is not proposing substantial changes to cat importation
requirements, Table 2 does not apply to cats.
Table 2--Summary Table of Proposed Forms Required From Importers of Dogs Based on Vaccination Status and Country of Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dog from rabies-free or U.S.-vaccinated dog from Foreign-vaccinated dog from U.S.-vaccinated dog from
Form DMRVV low-risk country DMRVV high-risk country DMRVV high-risk country DMRVV-restricted country
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDC Import Submission Form.......... Required................... Required................... Required................... Required.
Certification of U.S.-issued Rabies Not Required............... Required................... N/A........................ Required.
Vaccination for Live Dog Re-entry
into the United States Form.
CDC Import Certification of Rabies Not Required............... N/A........................ Required................... N/A.
Vaccination and Microchip Required
for Live Dog Importations into the
United States Form.
Application for Special Exemption Not Required............... Not Required............... Not Required............... Required.
for a Permitted Dog Import Form.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Importers of foreign-vaccinated dogs from DMRVV high-risk countries will also be required to provide additional information to the CDC-registered
Animal Care Facilities to make a reservation for their dog prior to arrival in the United States.
The documentation HHS/CDC is proposing in this NPRM be presented at
the U.S. port upon arrival for dog importation into the United States
is summarized below in Table 3. Since HHS/CDC is not proposing
substantial changes to cat importation requirements, Table 3 does not
apply to cats.
[[Page 43983]]
Table 3--Summary Table of Proposed Required Documentation To Be Presented at U.S. Port Upon Arrival for Dogs Based on Vaccination Status and Country of
Origin
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation to be presented at Dog from rabies-free or U.S.-vaccinated dog from Foreign-vaccinated dog from U.S.-vaccinated dog from
U.S. port upon arrival DMRVV low-risk country DMRVV high-risk country DMRVV high-risk country DMRVV-restricted country
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDC Import Submission Form Receipt.. Required................... Required................... Required................... Required.
Written documentation that the Required................... N/A........................ N/A........................ N/A.
animal has resided or otherwise
been only in a rabies-free or DMRVV
low-risk country for the six months
prior to the attempted entry.
Certification of U.S.-issued Rabies Not Required............... Required................... N/A........................ Not Required.
Vaccination for Live Dog Re-entry
into the United States Form.
Reservation with a CDC-registered Not Required............... Not Required............... Required................... May be required.
Animal Care Facility.
CDC Dog Import Permit............... N/A........................ N/A........................ N/A........................ Required.
--------------------------------------------------------------------------------------------------------------------------------------------------------
C. Costs and Benefits
CDC conducted an analysis to estimate the distributions of costs
and benefits that may be incurred if a final rule is published in the
future with the requirements proposed in this NPRM. The provisions of
this NPRM (if finalized as proposed) are not likely to have an effect
on the economy of $200 million or more in any one year, although there
is considerable uncertainty around the number of dogs imported at
baseline, including the number of dogs imported from DMRVV high-risk
countries. HHS/CDC is soliciting public comment on costs to importers,
airlines and other carriers, and State and local health departments of
the proposed requirements in this NPRM to improve the accuracy of cost
and benefit estimates for a future final rule.
The provisions of this NPRM (if finalized as proposed) will address
the market inefficiency in which dog importers do not account for the
potential detrimental impacts to public health that may result from the
importation of ill dogs, especially dogs infected with DMRVV. Federal
regulation is necessary to mitigate the risk of importing infected
dogs. Federal action allows risks to be addressed prior to dogs'
arrival in the United States and for dogs to be evaluated,
revaccinated, and possibly quarantined (if required) in controlled
conditions after their arrival in the United States. The regulatory
changes proposed in this NPRM (if finalized as proposed) are expected
to affect the following categories of interested parties and
implementing partners:
Importers of dogs from countries that are DMRVV-free or
are low risk for DMRVV;
Importers of dogs from countries that are at high risk of
DMRVV;
Airlines and other carriers;
CBP;
CDC;
USDA; and
State and local public health and animal health
departments.
The changes proposed in the NPRM incorporate different requirements
for dogs imported from DMRVV high-risk countries than those imported
from DMRVV-free or DMRVV low-risk countries. The annualized and present
value estimates of monetized costs and benefits over the 10-year period
from 2023 through 2032 using three percent and seven percent discount
rates are summarized below. The annualized, monetized costs (2020 USD)
of the provisions in the NPRM (if finalized as proposed) are estimated
to be $29 million (range: $7.7 to $87 million) using a three percent
discount rate; the estimated monetized costs using a seven percent
discount rate are largely the same.
Most monetized costs are expected to be incurred by importers (84
percent of costs is the most likely estimate). The estimated monetized
costs are about 3.8 times greater for importers of dogs from DMRVV
high-risk countries compared to importers of dogs from DMRVV-free or
low-risk countries. The provisions proposed in the NPRM estimated to
result in the greatest increase in costs for importers of dogs are
those associated with the veterinary examination and revaccination
against rabies at a CDC-registered Animal Care Facility for foreign-
vaccinated dogs from DMRVV high-risk countries in proposed section
71.51(k), costs for titer testing of foreign-vaccinated dogs from DMRVV
high-risk countries, additional costs associated with the proposed CDC
Import Submission Form requirements and including the information from
the form for all dogs in CDC data systems prior to or upon entry, the
proposed minimum age for imported dogs, and the proposed microchip
requirements for all imported dogs. Other costs include (1) an expected
reduction in the number of dogs imported from DMRVV high-risk
countries, (2) the proposed requirements to arrive at one of 18 U.S.
airports with a CDC quarantine station such that some travelers would
need to arrange their travel plans to arrive at these approved U.S.
airports (required for U.S.-vaccinated dogs arriving from DMRVV high-
risk countries) or a more limited number of U.S. airports with CDC-
registered Animal Care Facilities (required for foreign-vaccinated dogs
arriving from DMRVV high-risk countries) rather than other airports
without CDC staff, and (3) the proposed requirement of obtaining a CDC
Import Certification of Rabies Vaccination and Microchip Required for
Live Dog Importations into the United States Form or a Certification of
U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United
States Form with certification by an Official Government Veterinarian
for all dogs from DMRVV high-risk countries.
Airlines are estimated to absorb about 8.7 percent of the estimated
annualized costs associated with the NPRM (if finalized as proposed).
Most airline costs would result from ensuring that all transported dogs
comply with the new requirements in the NPRM (if finalized as proposed)
and from a small reduction in the number of dogs transported.
CDC is estimated to incur about 6.9 percent of the annualized,
monetized costs (most likely estimate) associated with the provisions
of this NPRM (if finalized as proposed). Most CDC costs would be
associated with the oversight of animal care facilities, which must be
approved by and registered with CDC, and the establishment of a
laboratory proficiency testing program to support serologic testing for
foreign-vaccinated dogs imported from DMRVV high-risk countries. CBP is
expected to incur about 0.5 percent of the annualized costs (most
likely estimate) associated with the provisions of this NPRM (if
finalized as proposed). Most CBP costs would result from training on
the proposed new requirements.
The annualized monetized benefits of the provisions in the NPRM (if
finalized as proposed) are estimated to be about $1.9 million (range:
$0.80 to $4.2 million) using a three percent or seven percent discount
rate. Most benefits would accrue to importers (46 percent of the most
likely estimates) and to CBP
[[Page 43984]]
(41 percent of the most likely estimate). Some of the benefits
estimated for both importers and CBP would result from reduced time
spent on screening dogs from high-risk countries at U.S. ports. The
requirements in the NPRM (if finalized as proposed) are estimated to
reduce the amount of time required to verify admissibility per dog at
U.S. ports because it is assumed that rabies vaccination documentation
will be included in standardized forms for importers of dogs from DMRVV
high-risk countries. The provisions in this NPRM (if finalized as
proposed) are also estimated to reduce the number of dogs arriving ill
or dead and the number of dogs denied entry, with benefits estimated
for importers, airlines, and CDC.
The wide range between the lower-bound and upper-bound cost and
benefit estimates demonstrates that there is considerable uncertainty
in these results. At present, the number of dogs imported into the
United States is neither accurately nor completely tracked by any data
system, and the uncertainty in the cost and benefit estimates reflect
uncertainty in both the total number of dogs imported and the number of
dogs imported from DMRVV high-risk countries, as well as the cost of
the new requirements in the NPRM (if finalized as proposed). The net
annualized, monetized costs (total cost estimate - total benefit
estimate) were estimated to be about $26 million per year (range: $6.9
to $83 million) using a three percent discount rate. The annualized
estimates were relatively unaffected by using a seven percent discount
rate.
The importation of just one dog infected with DMRVV risks
reintroduction of the virus into the United States, which could result
in loss of human and animal life and substantial public health response
costs.22 23 24 The average cost per importation of a single
DMRVV-infected dog is estimated to be $320,000 (range: $220,000 to
$520,000) for conducting public health investigations and administering
rabies PEP to exposed persons. The primary public health benefit of the
provisions in the NPRM (if finalized as proposed) is the reduced risk
that a dog with DMRVV will be imported from a DMRVV high-risk country.
The above estimate of the cost of importation of a dog with DMRVV does
not account for the worst-case outcomes, which include (1) transmission
of rabies to a person who dies from the disease, and (2) ongoing
transmission to other domestic and wildlife species in the United
States. The cost of re-introduction could be especially high if DMRVV
spreads to other species of U.S. wildlife. Re-establishment of DMRVV in
the United States could result in costly efforts over several years to
eliminate the virus again. The costs to contain any reintroduction
would depend on the time period before the reintroduction was realized,
the wildlife species in which DMRVV was transmitted, and the geographic
area over which reintroduction occurs.
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\22\ Smith J, le Gall F, Stephenson S, et al. People, pathogens
and our planet. The Economics of One Health 2012;2.
\23\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
\24\ Jeon S, Cleaton J, Meltzer M, et al. Determining the post-
elimination level of vaccination needed to prevent re-establishment
of dog rabies. PLoS Neg Trop Dis 2019; 13 (12): e0007869.
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An increase in human deaths from DMRVV could occur following the
re-introduction of DMRVV to the United States, as the risk of exposure
would increase. Human deaths from rabies continue to occur in the
United States after exposures to wild animals, and there have been
eight deaths among U.S. residents bitten by rabid dogs while traveling
abroad in DMRVV high-risk countries since 2009.\25\ CDC uses the value
of statistical life (VSL) to support quantifying benefits for
interventions that can result in mortality risk reductions. HHS
recommends using a median estimate of $11.6 million and a range of $5.5
to $17.7 million (2020 USD).\26\ CDC is unable to estimate the
potential magnitude of the mortality risk reduction associated with the
proposed rule. Based on the median VSL, averting three human deaths per
year would mean the benefits of the NPRM (if finalized as proposed)
would exceed its costs.
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\25\ Human Rabies. https://www.cdc.gov/rabies/location/usa/surveillance/human_rabies.html.
\26\ U.S. Department of Health and Human Services, 2016. Office
of the Assistant Secretary for Planning and Evaluation. Guidelines
for Regulatory Impact Analysis. https://aspe.hhs.gov/sites/default/files/private/pdf/242926/HHS_RIAGuidance.pdf. Accessed: April 20,
2020.
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CDC and other Federal government agencies do not know with
precision the number of dogs imported each year or the countries from
which the dogs originate. More comprehensive data on where dogs are
imported from may benefit public health investigations. Arrival data on
animals exposed to a dog with DMRVV on U.S.-bound flights, for example,
would expedite follow-up of exposed dogs in the United States. The lack
of data received from implementing the current regulations also
inhibits the Federal government's ability to target interventions for
dogs imported from specific countries. Of note, the COVID-19 pandemic
weakened rabies control programs in some DMRVV high-risk countries,
increasing the risk that imported dogs may be infected with DMRVV.\27\
The provisions of this NPRM (if finalized as proposed) would be of
particular public health benefit in light of the ongoing resource
concerns for global rabies vaccination campaigns in the wake of the
pandemic.
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\27\ A Kunkel, Jeon S, Haim, Dilius CJP, Crowdis K, Meltzer MI,
Wallace R (2021) The urgency of resuming disrupted dog rabies
vaccination campaigns: a modeling and cost-effectiveness analysis.
Scientific Reports (2021) 11:12476. https://doi.org/10.1038/s41598-021-92067-5.
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These data would also benefit agencies such as USDA's Animal and
Plant Health Inspection Service (APHIS), which have an interest in
regulating dog imports with the intent of reducing the risk of
introduction of diseases that may affect U.S. livestock. For example,
in 2021, APHIS issued a Federal Order \28\ that established additional
post-entry requirements on dogs for resale imported from countries with
ongoing African swine fever transmission, which poses a significant
risk to U.S. pork producers.\29\ The potential economic benefits of
reducing the risk of the importation of African swine fever could be
significant; in fact, a recent outbreak in China in 2019 was estimated
to have total economic losses equivalent to 0.78 percent of China's
gross domestic product.\30\ Thus, some of the requirements in this NPRM
(if finalized as proposed) may mitigate the risks of introduction and
transmission of diseases that impact livestock in addition to reducing
the risk of dogs being imported while infected with DMRVV.
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\28\ USDA/APHIS (2021) Federal Order for Importation of Live
Dogs for Resale from Regions Where African Swine Fever Exists or is
Reasonably Believed to Exist. https://www.aphis.usda.gov/import_export/downloads/vs-federal-order-asf.pdf and https://www.aphis.usda.gov/aphis/newsroom/news/sa_by_date/sa-2021/asf-dog-imports. Accessed June 5, 2023.
\29\ Animal and Plant Health Inspection Service (Aug. 4, 2021)
USDA Announces Requirements for Importing Dogs from Countries
Affected with African Swine Fever. https://www.aphis.usda.gov/aphis/newsroom/news/sa_by_date/sa-2021/asf-dog-imports. Accessed: February
5, 2022.
\30\ Shibing You, Tingyi Liu, Miao Zhang, Xue Zhao, Yizhe Dong,
Bi Wu, Yanzhen Wang, Juan Li, Xinjie Wei and Baofeng Shi (2021).
African swine fever outbreaks in China led to gross domestic product
and economic losses. Nature Food; 2: 802-808.
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II. Public Participation
Interested persons or organizations are invited to participate in
this proposed rulemaking by submitting written views, recommendations,
and
[[Page 43985]]
data on all aspects of the proposed rule notice. Comments received
should reference a specific portion of the notice. Attachments and
other supporting materials are part of the public record and subject to
public disclosure. Submitters should not include any information in
their comments or supporting materials that they consider confidential
or inappropriate for public disclosure. HHS/CDC welcome comments on all
aspects of this proposed rule, including the use of any forms or
information collected and whether proposed requirements should be
modified in any way.
HHS/CDC will carefully review, consider, and address all comments
submitted and may revise the content of the rule as appropriate at the
final rulemaking stage. HHS/CDC will publish a final rule after the
comment period that reflects any content changes made because of
comments received.
III. Background
A. Legal Authority
HHS/CDC has reviewed this rule under Executive Order 12988 on Civil
Justice Reform and determines that this proposed rule meets the
standard in the Executive Order. In this action, HHS/CDC proposes to
revise 42 CFR 71.50 and 71.51.
The primary legal authority supporting this proposed rulemaking is
section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264).
Under section 361, the Secretary of HHS (Secretary) may make and
enforce such regulations as in the Secretary's judgment are necessary
to prevent the introduction, transmission, or spread of communicable
diseases from foreign countries into the United States and from one
State or possession into any other State or possession.\31\ It also
authorizes the Secretary to promulgate and enforce a variety of public
health regulations to prevent the spread of communicable diseases,
including through inspection, fumigation, disinfection, sanitation,
pest extermination, destruction of animals or articles found to be
sources of dangerous infection to human beings, and other measures.
Since at least 1956, Federal quarantine regulations (currently found at
42 CFR 71.51) have controlled the entry of dogs and cats into the
United States.\32\
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\31\ Although the statute assigns authority to the Surgeon
General, all statutory powers and functions of the Surgeon General
were transferred to the Secretary of HHS in 1966, 31 FR 8855, 80
Stat. 1610 (June 25, 1966), see also Public Law 96-88, 509(b),
October 17, 1979, 93 Stat. 695 (codified at 20 U.S.C. 3508(b)). The
Secretary has retained these authorities despite the reestablishment
of the Office of the Surgeon General in 1987.
\32\ See 21 FR 9870 (Dec. 12, 1956).
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In addition to section 361, other sections of the PHS Act relevant
to this proposed rulemaking are section 362 (42 U.S.C. 265), section
365 (42 U.S.C. 268), section 367 (42 U.S.C. 270), and section 368 (42
U.S.C. 271). Section 362, among other things, authorizes the Secretary
to promulgate regulations prohibiting, in whole or in part, the
introduction of property from foreign countries or places, for such
period of time and as necessary for such purpose, to avert the serious
danger of introducing communicable disease into the United States.
Section 365 provides that it shall be the duty of customs officers and
of Coast Guard officers to aid in the enforcement of quarantine rules
and regulations.\33\ Through this statutory provision, CBP provides
critical assistance in enforcing Federal quarantine regulations at U.S.
ports. Section 367 (42 U.S.C. 270) also authorizes the application of
certain sections of the PHS Act to air navigation and aircraft to such
extent and upon such conditions as deemed necessary for safeguarding
public health and authorizes the promulgation of regulations, including
provisions for penalties and forfeitures for violations.
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\33\ 42 U.S.C. 268(b). The terms ``officer of the customs'' and
``customs officer'' are defined by statute to mean, ``any officer of
the United States Customs Service of the Treasury Department (also
hereinafter referred to as the ``Customs Service'') or any
commissioned, warrant, or petty officer of the Coast Guard, or any
agent or other person, including foreign law enforcement officers,
authorized by law or designated by the Secretary of the Treasury to
perform any duties of an officer of the Customs Service.'' 19 U.S.C.
1401(i). Although this provision refers to the Secretary of the
Treasury, the Homeland Security Act transferred to the Secretary of
Homeland Security all ``the functions, personnel, assets, and
liabilities of . . . the United States Customs Service of the
Department of the Treasury, including the functions of the Secretary
of the Treasury relating thereto . . . [,]'' 6 U.S.C. 203(1), such
that reference to the Secretary of the Treasury should be read to
reference the Secretary of Homeland Security.
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Section 368 of the PHS Act provides that any person who violates
regulations implementing sections 361 or 362 is subject to imprisonment
of not more than one year, a fine, or both. Pursuant to 18 U.S.C. 3559
and 3571, an individual may face a fine of up to $100,000 for a
violation not resulting in death and up to $250,000 for a violation
resulting in death. Under section 368, HHS/CDC may refer violators to
the U.S. Department of Justice for criminal prosecution. HHS/CDC does
not have independent authority under section 368 to impose criminal
fines or imprison violators.
Through this NPRM, HHS/CDC proposes new language advising
individuals and organizations that it may request that DHS/CBP take
additional action pursuant to 19 U.S.C. 1592 and 19 U.S.C. 1595a.
Specifically, CDC may request that DHS/CBP issue additional fines,
citations, or penalties to importers or carriers whenever the CDC
Director (Director) has reason to believe that an importer or carrier
has violated any of the provisions of this section or otherwise engaged
in conduct contrary to law. HHS/CDC stresses that it does not
administer Title 19, and decisions regarding whether to issue such
fines, citations, or other penalties would be entirely at the
discretion of DHS/CBP and subject to its policies and procedures.
Notwithstanding, HHS/CDC believes it important to include this language
to advise individuals and organizations that it may request that DHS/
CBP pursue such actions.
Through this NPRM, HHS/CDC further clarifies that there is no
agency policy of using the ``least restrictive means'' (as that concept
is typically understood and applied in cases involving interests
protected by the U.S. Constitution) in regard to animal importations
under 42 CFR part 71. ``The Due Process Clause of the Fourteenth
Amendment imposes procedural constraints on governmental decisions that
deprive individuals of liberty or property interests.'' Nozzi v. Hous.
Auth. of City of Los Angeles, 806 F.3d 1178, 1190 (9th Cir. 2015).
However, ``[d]ue process protections extend only to deprivations of
protected interests.'' Shinault v. Hawks, 782 F.3d 1053, 1057 (9th Cir.
2015). Because individuals have no protected property or liberty
interest in importing dogs or other animals into the United States, it
is HHS/CDC's policy to not employ a constitutional analysis of ``least
restrictive means'' in regard to animal imports under 42 CFR part 71.
See Ganadera Ind. v. Block, 727 F.2d 1156, 1160 (D.C. Cir. 1984) (``no
constitutionally-protected right to import into the United States'');
see also Arjay Assoc. v. Bush, 891 F.2d. 894, 896 (Fed. Cir. 1989)
(``It is beyond cavil that no one has a constitutional right to conduct
foreign commerce in products excluded by Congress.''). Members of the
public are invited to comment regarding this clarification to HHS/CDC's
animal import policy.
B. Historical Background
Rabies is one of the deadliest zoonotic diseases and accounts for
an estimated 59,000 human deaths globally each
[[Page 43986]]
year.\34\ Over 98 percent of those deaths are due to DMRVV.\35\ The
rabies virus can infect any mammal and, once clinical signs appear, the
disease is almost always fatal.\36\ In September 2007, at the Inaugural
World Rabies Day Symposium, HHS/CDC declared the United States to be
free of DMRVV.\37\ While bat rabies lyssaviruses and multiple
terrestrial variants of rabies continue circulating in wildlife species
(e.g., fox, raccoon, and skunk) in the United States, the country has
been free of DMRVV since 2007 and focuses its regulatory efforts on
preventing the reintroduction of this rabies virus variant. The close
relationship between dogs and people means there is a direct public
health risk to individuals that interact with inadequately vaccinated
dogs imported from countries at high risk of DMRVV. One of CDC's
principal goals is to prevent the reintroduction and spread of DMRVV in
the United States.
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\34\ World Health Organization (2018). WHO Expert Consultation
on Rabies (WHO Technical Report Series 1012). Retrieved from https://www.who.int/publications/i/item/WHO-TRS-1012.
\35\ Hampson K, Coudeville L, Lembo T, et al.; Global Alliance
for Rabies Control Partners for Rabies Prevention. Estimating the
global burden of endemic canine rabies. PLoS Negl Trop Dis
2015;9:e0003709. https://doi.org/10.1371/journal.pntd.0003709.
\36\ Fooks, A.R., Banyard, A.C., Horton, D.L., Johnson, N.,
McElhinney, L.M., and Jackson, A.C. (2014) Current status of rabies
and prospects for elimination. Lancet, 384(9951), 1389-1399. doi:
10.1016/S0140-6736(13)62707-5.
\37\ Velasco-Villa, A., Mauldin, M., Shi, M., Escobar, L.,
Gallardo-Romero, N., Damon, I., Emerson, G. (2017) The history of
rabies in the Western Hemisphere. Antiviral Res, 146, 221-232.
doi:10.1016/j.antiviral.2017.03.013.
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DMRVV is still a serious public health threat in the more than 100
countries where it remains enzootic.\38\ DMRVV has been highly
successful at adapting to new host species, particularly wildlife, that
can further transmit the virus.\39\ Although the U.S. Government does
not precisely track the total number of dogs imported each year, CDC
previously estimated that approximately 1 million dogs are imported
into the United States annually, of which 100,000 dogs are from DMRVV
high-risk countries.\40\ This estimate was based on information
provided by airlines, CBP, and a public health study conducted at a
U.S.-Mexico land border crossing.\41\
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\38\ Hampson K, Coudeville L, Lembo T, et al.; Global Alliance
for Rabies Control Partners for Rabies Prevention. Estimating the
global burden of endemic canine rabies. PLoS Negl Trop Dis
2015;9:e0003709. https://doi.org/10.1371/journal.pntd.0003709.
\39\ Velasco-Villa A, Mauldin MR, Shi M, et al. The history of
rabies in the Western Hemisphere. Antiviral Res. 2017;146:221-232.
doi:10.1016/j.antiviral.2017.03.013.
\40\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. 84 FR 724,724-730 (Jan. 31, 2019).
\41\ McQuiston, J.H., et al., Importation of dogs into the
United States: risks from rabies and other zoonotic diseases.
Zoonoses Public Health, 2008. 55(8-10): p. 421-6.
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Preventing the entry of animals infected with DMRVV into the United
States is a public health priority. When it is discovered that a rabid
dog has been imported into the United States, a multi-agency response
is required. This can involve CDC, USDA, CBP, State and local health
departments and animal health officials, and veterinarians in the local
community. Local, State, and Federal government agencies primarily
incur the costs of investigation, testing, and response efforts. Since
2015 there have been four known rabid dogs imported into the United
States. Each of the dogs was imported by a different animal rescue
organization for the purposes of U.S. adoption. These four cases,
discussed in detail below, highlight the vast amount of public health
resources that are required to investigate, respond to, and mitigate
the public health threat posed by the importation of a rabid dog.
In 2015, a rabid dog was part of a group of eight dogs and 27 cats
imported from Egypt by an animal rescue group. The dog had an unhealed
leg fracture and began showing signs of rabies four days after arrival.
Following the DMRVV diagnosis, animal rescue workers in Egypt admitted
that the dog's rabies vaccination documentation had been intentionally
falsified to evade CDC entry requirements.\42\ As a result of this
single importation, public health officials recommended that 18 people
receive rabies PEP, seven dogs underwent a six-month quarantine, and
eight additional dogs housed in the same home as the rabid dog had to
receive rabies booster vaccinations and undergo a 45-day monitoring
period.\43\
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\42\ Sinclair JR, Wallace RM, Gruszynski K, et al. Rabies in a
dog imported from Egypt with a falsified rabies vaccination
certificate--Virginia, 2015. MMWR Morb Mort Wkly Rep 2015;64:1359-
62. https://doi.org/10.15585/mmwr.mm6449a2.
\43\ Quarantine periods for animals exposed to rabies can vary
between 30 days to six months based on several factors, including
vaccination history, serologic titers or prospective serologic
monitoring results, or jurisdictional requirements.
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In 2017, a flight parent imported four dogs from Egypt on behalf of
an animal rescue organization. One of the dogs appeared agitated and
bit the flight parent prior to the flight. A U.S. veterinarian examined
the dog one day after its arrival and then euthanized and tested the
dog for rabies. A post-mortem rabies test showed that the dog was
positive for DMRVV.\44\ Public health officials recommended that at
least four people receive rabies PEP, and the remaining three dogs
underwent quarantine periods ranging from 30 days to six months. An
investigation revealed the possibility of falsified rabies vaccination
documentation presented on entry to the United States.\45\
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\44\ The diagnosis of rabies requires laboratory confirmation on
the basis of a positive result for the direct fluorescent antibody
test performed on CNS tissue collected post-mortem. National
Association of State Public Health Veterinarians. Compendium of
animal rabies prevention and control, 2016. JAVMA 2016; 248 (5):505-
517.
\45\ Hercules Y, Bryant NJ, Wallace RM, et al. Rabies in a dog
imported from Egypt--Connecticut, 2017. MMWR Morb Mort Wkly Rep
2018; 67:1388-91. https://doi.org/10.15585/mmwr.mm6750a3.
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Another example in 2019 involved 26 dogs that were imported into
the United States from Egypt by a rescue organization. All dogs had
rabies vaccination documentation and serologic documentation indicating
the presence of rabies antibodies in response to immunization, based on
results from an Egyptian government-affiliated rabies laboratory.
However, one dog developed signs of rabies three weeks after arrival
and, when euthanized, tested positive for DMRVV. The resulting public
health investigation raised suspicions that the rabies vaccination
documents and serological test results were falsified for all 26 dogs
in the shipment because 18 dogs in the shipment lacked serologic
evidence of vaccination when re-tested in the United States. Due to
this event, 44 people were required to receive PEP and the 25 other
dogs imported on the same flight underwent re-vaccination and
quarantines that ranged from four to six months. The rabid dog had been
released into an individual's home because of its false paperwork and
subsequently had contact with an additional 12 dogs, all of which had
to be revaccinated and undergo quarantine periods ranging from 45 days
to six months.\46\ The public health investigations and administration
of rabies PEP to exposed persons in this case cost more than $400,000
in state resources.47 48 As a result of the rabid dog
importations that occurred in 2015, 2017, and 2019, CDC issued a
temporary suspension for dogs entering the United States from
Egypt.49 50
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\46\ Raybern, C et al. Rabies in a dog imported from Egypt--
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
\47\ Id.
\48\ Centers for Disease Control and Prevention (2022). Rabies
Postexposure Prophylaxis. Retrieved from https://www.cdc.gov/rabies/medical_care/.
\49\ 84 FR 20628 (May 10, 2019).
\50\ CDC implemented this suspension because of the lack of
veterinary controls available in Egypt to prevent the exportation of
rabid dogs. With limited exceptions, CDC began requiring a CDC Dog
Import Permit and documentation of the dog's rabies serologic tests
from World Organisation for Animal Health (WOAH)-approved
laboratories for eligible importers. Since these permit and
serologic test requirements were implemented, no rabid dogs have
been imported from Egypt.
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[[Page 43987]]
In June 2021, 33 dogs and one cat were imported into the United
States from Azerbaijan by an animal rescue organization. All dogs had
rabies vaccination documents that appeared valid upon arrival in the
United States. Three days after arrival, one dog developed signs of
rabies and was euthanized. CDC confirmed the dog was infected with
DMRVV known to circulate in the Caucasus Mountains region of
Azerbaijan. The remaining rescue animals exposed to the rabid dog
during travel were quickly dispersed across nine states, leading to
what is believed to be the largest, multi-state, imported rabid dog
investigation in U.S. history.\51\ Eighteen people received PEP to
prevent rabies because of exposure to the rabid dog. CDC performed the
test known as the ``Prospective Serologic Monitoring'' test on the
remaining dogs and the public health investigation revealed that
improper vaccination practices by the veterinarian in Azerbaijan likely
contributed to the inadequate vaccination response documented in 48
percent of the imported animals, including the rabid dog.\52\ The 33
exposed animals were revaccinated and placed in quarantine for periods
ranging from 45 days to six months.\53\
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\51\ Whitehill F, Bonaparte S, Hartloge C, et al. Rabies in a
Dog Imported from Azerbaijan--Pennsylvania, 2021. MMWR Morb Mortal
Wkly Rep 2022; 71: 686-689.
\52\ Centers for Disease Control and Prevention (2021). CDC
responds to a case of rabies in an imported dog. Retrieved from
https://www.cdc.gov/worldrabiesday/disease-detectives/rabies-imported-dog.html.
\53\ Whitehill F, Bonaparte S, Hartloge C, et al. Rabies in a
Dog Imported from Azerbaijan--Pennsylvania, 2021. MMWR Morb Mort
Wkly Rep 2022; 71: 686-689.
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CDC estimates a range of costs for public health investigations and
subsequent cost of care for people exposed to rabid dogs to be between
$220,00 and $520,000 per importation event, as summarized in Section
VI.54 55 This cost estimate does not include the cost to
evaluate, vaccinate, test, and quarantine exposed animals. This cost
estimate also does not account for the worst-case outcomes, which
include: (1) transmission of rabies to a person who dies from the
disease; and (2) ongoing transmission to other domestic and wildlife
species in the United States.
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\54\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
\55\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United
States. 84 FR 724 (Jan. 31, 2019).
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DMRVV becoming re-established in the United States would result in
costly efforts over several years to eliminate the virus again. The
extraordinary cost of re-introduction of DMRVV is demonstrated by an
instance of reintroduction that occurred in Texas, where DMRVV had been
previously eliminated. The reintroduction resulted in several human
deaths; the subsequent re-elimination of DMRVV cost $60 million (in
2022 USD) and required over 10 years of effort.56 57
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\56\ Thomas, S., Wilson, P., Moore, G., Oertli, E., Hicks, B.,
Rohde, R., Johnston, D. (2005). Evaluation of oral rabies
vaccination programs for control of rabies epizootics in coyotes and
gray foxes: 1995-2003. Journal of the American Veterinary Medicine
Association, 227(5),785-92. doi: 10.2460/javma.2005.227.785.
\57\ Sterner, R., Meltzer, M., Shwiff, S., Slate, D. (2009).
Tactics and Economics of Wildlife Oral Rabies Vaccination, Canada
and the United States. Emerging Infectious Diseases, 15(8), 1176-
1184. doi: 10.3201/eid1508.081061.
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Historically, approximately 60 to 70 percent of CDC's dog entry
denials (or about 200 cases annually) have been based on fraudulent,
incomplete, or inaccurate paperwork.\58\ However, between January 2020
and July 2021 (i.e., during the COVID-19 pandemic, prior to the
temporary suspension), CDC documented more than 1,000 instances of
incomplete, inadequate, or fraudulent rabies vaccination certificates
for dogs arriving from DMRVV high-risk countries.\59\ These cases
resulted in dogs being denied entry into the United States and
ultimately returned to their country of origin.
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\58\ Centers for Disease Control and Prevention (2021).
Quarantine Activity Reporting System (version 4.9.8.8.2.2A). Dog
Importation data, 2010-2019. Accessed 1 October 2022.
\59\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C.,
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we
have an erupting problem? PLoS ONE,16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
---------------------------------------------------------------------------
The significant increase in the number of dogs from DMRVV high-risk
countries arriving with incomplete, inadequate, or fraudulent rabies
vaccination documentation observed in 2020 and 2021 coincided with
increased interest in purchasing dogs from the international rescues
and breeders during the COVID-19 pandemic.60 61 62 Since
2021, the demand for puppies and rescue dogs has remained high. The
trend in purchasing and rescuing dogs from abroad has been noted in
many countries, including the United States.63 64 65 66
Internationally, there has been significant growth within the companion
animal breeding industry with increasing international trade.\67\
Multiple international and U.S. investigations have identified
importations of puppies that were too young to meet rabies vaccination
requirements.68 69 70 71 In addition, there is growing
evidence that criminal networks are becoming involved in the lucrative
dog trade, and the illegal puppy trade was reported to have increased
during the pandemic.72 73 74
[[Page 43988]]
Because imported dogs will typically encounter multiple people, pets,
and other animals throughout their journey--beginning at the airport in
the country of departure and continuing with the airline, through the
U.S. port, and pet adoption and pet socialization process--an increase
in inadequately vaccinated dogs likewise increases the risk of human
and animal exposure.\75\
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\60\ Id.
\61\ Wynne E. Dog lovers find prices rise steeply amid COVID-
fueled demand. Australian Broadcasting Corporation News. May 20,
2021.
\62\ Morgan L, Protopopova A, Birkler RID, Itin-Shwatz B, Sutton
G, Gamliel A, et al. Human-dog relationships during the COVID-19
pandemic: booming dog adoption during social isolation. Humanities
and Social Science Communications. 2021; 7(150): 1-11.
\63\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C.,
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we
have an erupting problem? PLoS ONE,16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
\64\ Wynne E. Dog lovers find prices rise steeply amid COVID-
fueled demand. Australian Broadcasting Corporation News. May 20,
2021.
\65\ Morgan L, Protopopova A, Birkler RID, Itin-Shwatz B, Sutton
G, Gamliel A, et al. Human-dog relationships during the COVID-19
pandemic: booming dog adoption during social isolation. Humanities
and Social Science Communications. 2021; 7(150): 1-11.
\66\ Velez M. I adopted my dog Cannoli from overseas. It's
easier than you think. 9/20/2020. Available at: https://www.thedailybeast.com/i-adopted-my-dog-cannoli-from-overseas-its-easier-than-you-think.
\67\ Maher J, Wyatt T. European illegal puppy trade and
organized crime. Trends in Organized Crime. 2021; 24(4) 506-525.
\68\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C.,
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we
have an erupting problem? PLoS ONE,16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
\69\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P,
Haifsl J, et al. The `bio-crime model' of cross-border cooperation
among veterinary public health, justice, law enforcements, and
customs to tackle the illegal animal trade/bio-terrorism and to
prevent the spread of zoonotic diseases among human population.
Frontiers in Veterinary Science. 2020; 7: 1-13.
\70\ Cocchi M, Danesi P, DeZan G, Leati M, Gagliazzo L, et al. A
three-year biocrime sanitary surveillance on illegally imported
companion animals. Pathogens. 2021; 10(80):1-12.
\71\ Houle MK. Perspective from the field: Illegal puppy imports
uncovered at JFK airport. 2017. Available at: www.cdc.gov/ncezid/dgmq/feature-stories/operation-dog-catcher.html.
\72\ Maher J, Wyatt T. Rural-urban dynamics in the UK illegal
puppy trade: trafficking and trade in man's best friend.
International Journal of Rural Law and Policy. 2019; 9 (2): 1-20.
\73\ Zucca P, Rossman MC, Osorio JE, Karem K, De Benedictis P,
Haifsl J, et al. The `bio-crime model' of cross-border cooperation
among veterinary public health, justice, law enforcements, and
customs to tackle the illegal animal trade/bio-terrorism and to
prevent the spread of zoonotic diseases among human population.
Frontiers in Veterinary Science. 2020; 7: 1-13.
\74\ British Broadcasting Corporation. Illegal puppy trade
warning as sales boom during the COVID pandemic. 18 NOV 2020.
British Broadcasting Corporation News.
\75\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2020. Accessed: February 15, 2021.
---------------------------------------------------------------------------
Temporary Suspension of the Importation of Dogs From DMRVV High-Risk
Countries
In light of these concerns, on June 16, 2021, CDC announced a
temporary suspension of the importation of dogs from DMRVV high-risk
countries to protect the public's health. The temporary suspension was
issued because public health resources were being diverted to the
response to the COVID-19 pandemic, which limited the availability of
resources to respond to dog importation issues. This diversion of
resources coincided with the documented increase in fraudulent vaccine
documentation and importers circumventing dog import regulations. To
address these concerns, CDC developed a framework for dog importation
requiring importers to apply for special permission to import a dog
into the United States. Importers were required to submit an
Application for Special Exemption for a Permitted Dog Import form \76\
and obtain a CDC Dog Import Permit prior to importing a dog into the
United States. To obtain a permit, an importer had to demonstrate that
the dog was at least six months old, had a microchip, had proof of
rabies vaccination, and had obtained a serologic titer test from a CDC-
approved laboratory if the dog was vaccinated outside the United
States.
---------------------------------------------------------------------------
\76\ Approved under OMB Control Number 0920-1383 Importation
Regulations (42 CFR 71 Subpart F) (exp. 1/31/2026, or as revised).
---------------------------------------------------------------------------
From July 14, 2021, to June 9, 2022, CDC issued CDC Dog Import
Permits on a limited basis, for persons permanently relocating to the
United States, importers of government-owned working dogs, or owners of
service animals \77\ to alleviate the potential burden of the temporary
suspension for these categories of importers. On December 1, 2021,
consistent with public health standards of practice, CDC eased some of
the temporary suspension restrictions. CDC allowed dogs six months of
age or older that were microchipped and accompanied by valid U.S. RVCs
to re-enter the United States without a CDC Dog Import Permit. Because
these dogs were vaccinated in the United States, CDC determined that
allowing them to enter without a CDC Dog Import Permit would be
unlikely to endanger the public's health. To provide additional
resources for importers of foreign-vaccinated dogs, CDC expanded the
number of approved rabies serologic testing laboratories from five to
60 laboratories.\78\ CDC also reduced the wait time following
collection of a serologic sample to permit dogs to be eligible to enter
the United States after only 45 days, rather than the previous 90-day
waiting period. In addition, based on data from the latter part of 2021
showing a significant decrease in the arrival of ill dogs and dogs
being denied entry, CDC allowed imported dogs from DMRVV high-risk
countries to enter through any of the 18 U.S. airports with a CDC
quarantine station.79 80
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\77\ A service dog must meet the definition of a ``service
animal'' under 14 CFR 382.3, be accompanied by an ``individual with
a disability'' as defined under 14 CFR 382.3, and work or perform
tasks directly related to that individual's disability.
\78\ List of CDC-approved labs can be found at www.cdc.gov/importation/bringing-an-animal-into-the-United-States/approved-labs.html.
\79\ List of U.S. ports with a CDC quarantine station available
at: www.cdc.gov/quarantine/quarantinestationcontactlistfull.html.
\80\ At the time the Federal Register announcing the temporary
suspension was published, dogs imported from high-risk countries
were only allowed to enter the United States through the one port of
entry with an animal care facility. However, CDC's review of dog
importation data from July 14-November 30, 2021, noted a significant
decrease in the arrival of ill dogs and dogs denied entry, reducing
the need for dogs to enter only through U.S. ports with an animal
care facility.
---------------------------------------------------------------------------
Even with the temporary suspension in place, CDC documented
multiple instances of importers attempting to circumvent entry
requirements by using fraudulent rabies vaccination documents that had
been fabricated to make them appear as if they had been issued in the
United States. CDC also documented instances of importers presenting
fraudulent rabies vaccination documents purporting to be from DMRVV-
free countries to import young puppies from DMRVV high-risk countries
into the United States, presumably for resale. These factors highlight
the need for rabies vaccination documentation to be standardized for
all dogs arriving from DMRVV high-risk countries to reduce the
likelihood of falsified documentation in the future.
On June 1, 2022, CDC announced that effective June 10, 2022, it
would modify and extend the temporary suspension through January 31,
2023.\81\ The suspension was extended based on the continued risk of
the reintroduction of DMRVV into the United States and the ongoing need
to commit global public health resources towards the COVID-19 pandemic.
Between the temporary suspension going into effect on July 14, 2021,
and June 1, 2022, CDC documented a decrease in dog importation issues
that existed prior to the suspension (e.g., the number of suspected
fraudulent rabies vaccination documents, the number of dogs that were
sick or dead upon arrival). CDC's ability to track and monitor dog
imports from DMRVV high-risk countries also improved during this
timeframe. For these reasons, CDC modified the terms of the temporary
suspension to allow more dog imports into the United States by a wider
range of importers building upon the requirements that had already been
in place and had been successful in reducing dog importation issues. On
February 1, 2023, CDC extended the temporary suspension without
modifications through July 31, 2023, because of a continued risk of
reintroduction of DMRVV due to insufficient veterinary controls in
DMRVV high-risk countries to prevent the export of inadequately
vaccinated dogs and veterinary supply chain and workforce capacity
shortages that have persisted since the global COVID-19 pandemic.\82\
---------------------------------------------------------------------------
\81\ Notice of Extension and Modification of Temporary
Suspension of Dogs Entering the United States From High-Risk Rabies
Countries. 87 FR 33158 (June 1, 2022).
\82\ 88 FR 5348 (Jan. 27, 2023).
---------------------------------------------------------------------------
In parallel with the publication of this NPRM, CDC has published an
extension of the temporary suspension through July 31, 2024. A
suspension remains necessary to protect the public's health against the
reintroduction of DMRVV into the United States because there is a
continued threat posed by dogs from high-risk countries that are
unvaccinated or inadequately vaccinated against rabies. This continued
threat is due to various factors, including: a high volume of dogs
being imported into the United States contemporaneous with insufficient
veterinary controls in high-risk countries to prevent the export of
inadequately vaccinated dogs, inadequate veterinary supply chains for
vaccines and related materials, and persistent workforce capacity
shortages, particularly in high-risk countries that export dogs to the
United States. Through this NPRM, HHS/CDC proposes to address the
various concerns with the importation of dogs
[[Page 43989]]
observed in recent years by establishing a regulatory framework based
on the documented successes of the temporary suspension. In addition,
the requirements and standards proposed in the rule would help ensure
the health and safety of imported animals while also protecting the
public's health and preventing the reintroduction of DMRVV into the
United States.
There are numerous challenges associated with reviewing rabies
vaccination documentation from around the world, including the lack of
a standardized rabies vaccination documents, different required
elements on a rabies vaccination documents, differences in who can
vaccinate and issue rabies vaccination documents, and limited to no
accountability for unlicensed or unauthorized vaccinators. CDC has
documented numerous instances of fraudulent or erroneous paperwork for
dogs based on various factors. These include:
Dogs that were younger than the age indicated on their
rabies vaccination paperwork (based on dental examination by U.S.
veterinarians);
Differences between the breed, sex, color, or microchip
number listed on the rabies vaccination documents and the dog presented
for admission;
Suspicious veterinary stamps and inconsistent signatures
across veterinary paperwork;
Inconsistent dates of rabies vaccination between different
veterinary documents; and
Vaccines administered after the expiration date of the
vaccine lot.
The international public health community has recognized that
rabies vaccination documentation alone is no longer sufficient to
ensure adequate protection against rabies.83 84 Numerous
DMRVV-free countries, including Australia, New Zealand, and European
Union member states, already require a two-step verification of rabies
vaccination status for dogs imported from DMRVV high-risk countries
(when direct importation is allowed), by which a valid RVC and proof of
adequate rabies serologic test are required for importation. The
international standard is to capture any required information for
movement of animals via an ``import (movement) certificate.'' Import
certificates can be standardized, which helps to ensure all required
information is included and the information is verified by an Official
Government Veterinarian in the exporting country prior to the animal's
shipment to the United States. Implementing the use of standardized
import certificates, which have long been used for the international
movement of animals and are well understood by foreign governments,
would enhance compliance with CDC entry requirements and ensure that
follow-up with the exporting country can occur if import violations are
noted.\85\
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\83\ World Organisation for Animal Health. Terrestrial Code
Online Access--WOAH--World Organisation for Animal Health, Chapter
2.1.17 and 8.14. https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/?id=169&L=1&htmfile=chapitre_certif_rabies.htm.
\84\ World Health Organization. Expert Consultation on Rabies,
Third Report. Geneva, Switzerland. 2018.
\85\ https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/iregs-for-animal-exports/ct_iregs_animal_exports_home.
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In addition to issues with fraudulent or incomplete rabies
vaccination documents, CDC has observed in recent years a number of
practices that raised concerns relating to how airlines transport and
house animals. Some airlines have chosen to leave dogs denied admission
or pending determination of admissibility in cargo warehouses, which
can create an unsafe environment for workers exposed to dogs with
zoonotic diseases (such as rabies, brucellosis, leptospirosis, and
numerous intestinal or external parasites). Workers also risk bites,
scratches, and other injuries, as they are not trained to handle live
animals and are required to feed, water, and provide breaks or cage
cleaning for the animals in accordance with USDA Animal Welfare Act
standards. As a result, many animals are left in crates for extended
periods of time without immediate supervision while warehouse workers
conduct routine duties. These conditions are often unsafe for dogs due
to the prolonged periods of time between flights, inadequate cooling
and heating, non-compliant cleaning and sanitization of crates, and the
inability to physically separate the animals from areas of the
warehouse where other equipment, machinery, and goods are used and
stored.
CDC has documented numerous instances of dogs housed under
inadequate conditions while in the care of airlines. For example,
during the COVID-19 pandemic, fewer international flights worldwide
86 87 resulted in delayed returns for dogs denied admission
to the United States. In August 2020, a dog died in the custody of an
airline at Chicago O'Hare International Airport after CDC denied
admission to a group of dogs based on falsified rabies vaccination
documentation. Despite CDC's request to find appropriate housing at a
local kennel or veterinary clinic, the airline left 18 dogs in a cargo
warehouse without food and water for more than 48 hours contributing to
the death of one dog.\88\ In March 2023, a dog arrived at a U.S airport
without a CDC-registered Animal Care Facility. The dog was later found
dead in the airline's cargo warehouse.\89\
---------------------------------------------------------------------------
\86\ https://www.cnbc.com/2020/04/02/coronavirus-update-american-airlines-cuts-summer-international-flights-by-60percent-as-demand-suffers.html.
\87\ https://news.aa.com/news/news-details/2020/American-Airlines-Announces-Additional-Schedule-Changes-in-Response-to-Customer-Demand-Related-to-COVID-19-031420-OPS-DIS-03/default.aspx.
\88\ https://www.cbsnews.com/chicago/news/dog-dies-at-ohare-airport-warehouse-17-others-saved-after-being-left-without-food-or-water-for-3-days/.
\89\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System. March 2023.
---------------------------------------------------------------------------
Because there are insufficient numbers of animal care facilities
with a USDA intermediate handlers license and a CBP-issued FIRMS code
available to house dogs that are denied admission, CDC worked with
USDA, CBP, and local businesses to identify and approve five new animal
care facilities in 2021 and 2022 as part of the strategic shift towards
safer importation controls. As of June 1, 2023, there are five CDC-
registered Animal Care Facilities with a USDA intermediate handlers
license and a FIRMS code issued by CBP. The five facilities are located
at Atlanta Hartsfield-Jackson International Airport, John F. Kennedy
International Airport (New York), Los Angeles International Airport,
Miami International Airport, and Washington Dulles International
Airport (Washington DC Metropolitan Area).
While airlines are ultimately responsible for finding appropriate
housing for dogs denied admission, the inadequate number of facilities
with a CBP-issued FIRMS code and USDA intermediate handlers license for
holding and providing care for live animals creates significant
administrative and financial burdens for Federal, State, and local
governments. To address these concerns, this NPRM proposes that if a
CDC-registered Animal Care Facility with a CBP-issued FIRMS code and
USDA intermediate handlers license is not available to hold a dog while
the U.S. Government determines admissibility, the airline that has
transported the dog would be required to, at a minimum, arrange
transfer of the animal to a veterinary clinic or kennel that meets USDA
Animal Welfare Act standards \90\ and is approved by CDC.
---------------------------------------------------------------------------
\90\ U.S. Department of Agriculture. Animal Welfare Regulations;
Part 3, Subpart A: Transportation Standards. Sections 3.14-3.20.
July 2020. Available at: https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_508_comp_version.pdf.
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[[Page 43990]]
While costs associated with housing, caring for dogs, and returning
dogs are the responsibility of the importer (or airline if the importer
abandons the dog), some importers and airlines have been reluctant to
pay these costs, requiring the Federal government to find appropriate
interim housing facilities, and veterinary care. The cost to house,
care for, and return inadequately vaccinated dogs ranges between $1,000
and $4,000 per dog, depending on the location and time required until
the next available return flight. The Federal government has been
required to find individualized solutions to ensure appropriate
accommodations for prolonged periods of time for these animals pending
return to their countries of departure and has been left to bear the
costs for such housing, care, and return of dogs when airlines and
importers have not. The increasing demand to vaccinate and quarantine
dogs that have been denied admission presents an increasing burden to
Federal, State, and local public health agencies.91 92 The
increased need for inspections, veterinary medical care, and
appropriate quarantine of dogs inadequately vaccinated against rabies
has financially burdened Federal and State agencies while also putting
the public's health at risk.
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\91\ Pieracci EG, Maskery B, Stauffer K, Gertz A, Brown C. Risk
factors for death and illness in dogs imported into the United
States, 2010-2018. Transbound Emerg Dis 2022. DOI: 10.1111/
tbed.14510.
\92\ Pieracci EG, Williams CE, Wallace RM, Kalapura CR, Brown CM
(2021) U.S. dog importations during the COVID-19 pandemic: Do we
have an erupting problem? PLoS ONE 16(9): e0254287. https://doi.org/10.1371/journal.pone.0254287.
---------------------------------------------------------------------------
Additionally, an increasing number of dogs being imported do not
meet age requirements of multiple agencies. CDC has noted that 61
percent (890/1463) of dogs denied admission and 46 percent of ill or
dead dogs arriving in the United States from 2019 to 2021 were under
six months of age. During the first six months of 2021, CDC
investigated 35 instances of sick or dead puppies under six months of
age. CDC has also documented an increase in fraudulent rabies
vaccination documentation from importers claiming the dogs were over
four months of age.\93\ Many of these dogs were imported into the
United States for resale or adoption. USDA requires any dog entering
the United States for resale or adoption to be six months of age;
however, many importers claim the animals as personal pets to avoid the
age requirement because younger dogs may be sold for more money.\94\
This has led to multiple instances where young puppies, some as young
as six weeks of age, were transported in violation of the Animal
Welfare Act, which requires dogs to be at least eight weeks of age to
be eligible to fly, in an attempt to circumvent the entry requirements
of multiple agencies. Updated and standardized vaccination information
collection and minimum age requirements will help address these issues.
---------------------------------------------------------------------------
\93\ Pieracci, EG; Williams, CE; Wallace, RM; Kalapura, CR;
Brown CM. U.S. dog importations during the COVID-19 pandemic: Do we
have an erupting problem? PLoS ONE 2021;16 (9): e0254287.
\94\ Id.
---------------------------------------------------------------------------
The requirements proposed in this NPRM, if adopted, would also help
address public health concerns regarding sick or dead animals being
imported to the United States. If an animal arrives in the United
States and appears ill or is dead, a public health investigation is
required to ensure the ill or dead animal does not present a public
health threat. The overall health of an animal can play a significant
role in whether it can maintain core body functions (i.e., body
temperature regulation and glucose levels) during prolonged flights.
Stressed, malnourished, and young animals are more likely to become ill
and can transmit communicable diseases that can affect humans;
95 96 therefore, safety and welfare concerns for the
transport of dogs have a public health impact that requires a degree of
oversight from public health agencies to ensure human and animal health
is protected.\97\ Additionally, diagnostic testing or necropsy of ill
or dead animals, respectively, is critical to understand the underlying
cause of illness or death and ensure the animals do not pose a public
health risk.
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\95\ Galanis E et al. Brucellosis and other diseases imported
with dogs. BCMJ 2019; 61 (4): 177-190. Available at: https://bcmj.org/bccdc/brucellosis-and-other-diseases-imported-dogs.
\96\ Denstedt E. Echinococcus multilocularis as an emerging
public health threat in Canada: A knowledge synthesis and needs
assessment. Accessed: 28 February 2019. Available at: www.ncceh.ca/
sites/default/files/Guelph-Denstedt-2017.pdf.
\97\ Pieracci EG, Maskery B, Stauffer K, Gertz A, Brown C. Risk
factors for death and illness in dogs imported into the United
States, 2010-2018. Transbound Emerg Dis 2022. DOI: 10.1111/
tbed.14510.
---------------------------------------------------------------------------
The creation of standards for CDC-registered Animal Care
Facilities; the requirement that all foreign-vaccinated dogs be
examined, vaccinated, and quarantined (when applicable) at one of these
facilities prior to entry into the United States; and the prevention
measures in this proposed rule will mitigate the need for future
broadly applied suspensions and help ensure the health and safety of
imported animals while also serving to protect public health and
prevent the reintroduction of DMRVV into the United States.
C. Current Process
Currently, per regulation at 42 CFR 71.51(c), there is no standard
form used to capture rabies vaccination information. However, importers
must present valid RVCs which must include all of the following
information to be valid:
Identifies a dog on the basis of breed, sex, age, color,
markings, and other identifying information.
Specifies a date of rabies vaccination at least 30 days
before the date of arrival of the dog at a U.S. port.
Specifies a date of expiration which is after the date of
arrival of the dog at a U.S. port. If no date of expiration is
specified, then the date of vaccination shall be no more than 12 months
before the date of arrival at a U.S. port.
Bears the signature of a licensed veterinarian.
Upon the dog's arrival in the United States, Federal officials
examine the RVC and ensure the description of the dog listed on the
paperwork matches the dog presented. For a rabies vaccine to be
effective, the dog must be at least 12 weeks (84 days) of age at the
time of administration. A dog's initial vaccine must also be
administered at least four weeks (28 days) before arrival in the United
States.
Under HHS/CDC's regulatory authority, dogs arriving from DMRVV
high-risk countries without appropriate RVCs are denied admission and
returned to the country of departure on the next available flight.\98\
CDC currently recommends that airlines house dogs awaiting return to
their country of departure at a USDA-accredited facility that meets the
USDA's Animal Welfare Act standards during transit. However, these
facilities are often cargo warehouses that are not equipped to house
live animals for more than several hours.
---------------------------------------------------------------------------
\98\ Guidance Regarding Agency Interpretation of ``Rabies-Free''
as it Relates to the Importation of Dogs into the United States, 84
FR 724 (Jan. 31, 2019).
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The transportation, care, and payment for sick or dead animals are
highly variable and depend on whether the animal is suspected of having
rabies. Ideally, local veterinarians are consulted
[[Page 43991]]
immediately to provide care for sick animals; however, importers and
owners frequently refuse to pay for the care of sick animals resulting
in confusion and delayed care for often critically ill animals. When
owners have refused to pay for the care of their sick animals, the
responsibility has been transferred to the airline that transported the
animals into the United States, but some airlines have been reluctant
to pay costs associated with the care and housing of animals. While
State health departments and CDC will test blood samples free of charge
when rabies is suspected, in some instances, CDC has been left to cover
the costs of animal care.
HHS/CDC believes that clarifying the regulatory requirements
delineating importer and carrier responsibilities would streamline the
animal importation process and help ensure sick animals receive timely
veterinary care upon arrival in the United States if needed. We welcome
input from the public on all proposals contained herein.
IV. Summary of Proposed Changes
Proposed Changes to 71.50
Section 71.50(b) contains definitions applicable to animal
importations under subpart F of 42 CFR part 71. The definitions
contained in paragraph (b) are of general scientific applicability and
thus would apply to different animal imports, not just dogs and cats.
HHS/CDC proposes adding the following definitions to 42 CFR 71.50(b):
Authorized Veterinarian, histopathology, in-transit shipments,
microchip, necropsy, Official Government Veterinarian.
Authorized Veterinarian means an individual who has obtained both
an advanced degree and valid license and is authorized to practice
animal medicine in the exporting country.
Histopathology means the study of changes in animal tissue caused
by disease.
In-Transit Shipment means a cargo shipment originating in a foreign
country that is moved through one or more U.S. ports while transiting
through the United States to a third-country destination.
Microchip means an implanted radio-frequency device placed under
the skin of an animal that contains a unique identification tag that
meets the International Standards Organization (ISO) compatibility
through ISO 11784 or ISO 11785, or similar technologies as approved by
the Director.
Necropsy means an animal autopsy in which the cause of death may be
determined through the examination and collection of tissues, organs,
or bodily fluids post-mortem.
Official Government Veterinarian means a veterinarian who performs
work on behalf of an exporting country's government and can verify the
license or credentials of an Authorized Veterinarian.
HHS/CDC also proposes adding a new subsection at 42 CFR 71.50(c)
addressing the legal severability of provisions found in 42 CFR part 71
Subpart F--Importations. Because the provisions relating to
importations under Subpart F are designed to protect the public's
health from various zoonotic disease threats, HHS/CDC intends that
these provisions have maximum legal effect. Accordingly, HHS/CDC
proposes adding language that in the event any provision of this
subpart is held by a reviewing court of law to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, that the provision be construed so as to continue to give
the maximum effect to the provision permitted by law. If a reviewing
court should hold that a provision is utterly invalid or unenforceable,
then HHS/CDC intends that the provision be severable from Subpart F and
not affect the remainder or the application of the provision to persons
not similarly situated or to dissimilar circumstances. HHS/CDC seeks
public comment regarding this and other proposed changes to 71.50.
Proposed Changes to 71.51
(a) Definitions.
Section 71.51(a) contains definitions specifically applicable to
importations of dogs and cats under this section. Among other things,
HHS/CDC proposes definitions for animal, CDC-registered Animal Care
Facility, CDC Import Submission Form, conditional release, confinement,
DMRVV-free countries, DMRVV high-risk countries, DMRVV low-risk
countries, DMRVV-restricted countries, importer, SAFE TraQ, serologic
testing, USDA-Accredited Veterinarian, and USDA Official Veterinarian.
Some of these definitions were previously published in guidance.\99\
---------------------------------------------------------------------------
\99\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United
States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------
Animal means all domestic cats (Felis catus) or domestic dogs
(Canis familiaris).
CDC-registered Animal Care Facility means a facility registered by
CDC for the purpose of providing veterinary care and housing to animals
imported into the United States.
CDC Import Submission Form means an OMB-approved declaration \100\
submitted to CDC through an online portal that includes the importer's
name and contact information; description of the dog, including
microchip number, current photographs of the dog's face and body;
purpose of importation; travel information, including dates of
departure and arrival, country of departure, countries visited in the
past six months, and U.S. port of entry; and other information as
described in CDC technical instructions. A receipt confirming
successful submission of this form must accompany all dogs departing
foreign locations for travel to the United States. For dogs departing
from airports overseas with a U.S. final destination, the responsible
airline must confirm the receipt prior to dogs being loaded onto
departing aircraft.
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\100\ Current OMB approval no. 0920-1383 (exp. 1/31/26).
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Conditional release, when applied to a dog or cat, means the
temporary release of a dog or cat from the custody of a carrier into
the care of a licensed veterinarian approved by CDC for the purpose of
receiving emergency medical care or a public health evaluation, pending
removal of the dog or cat from the United States. Dogs and cats must be
returned immediately to the carrier's custody upon the conclusion of
such medical care or evaluation for removal from the United States.
Confinement, when applied to a dog or cat, means restriction to a
building or other enclosure at a U.S. port or other location approved
by CDC, including en route to a destination, in isolation from other
dogs and cats, and from persons except for contact necessary for its
care. If the animal is allowed out of the enclosure, it must be muzzled
and kept on a leash.
DMRVV-free countries means countries assessed by CDC based on
internationally accepted standards as not having DMRVV present.
DMRVV low-risk countries means countries assessed by CDC as low
risk for DMRVV transmission based on factors such as the virus being
limited to a localized area, adequacy of surveillance and dog
vaccination programs to prevent further geographic distribution of the
virus, and the virus being in a controlled status with the country or
countries heading toward eventual DMRVV-free status.
DMRVV high-risk countries means countries assessed by CDC as high
risk for DMRVV transmission based on factors such as the presence and
[[Page 43992]]
geographic distribution of the virus or low quality of or low
confidence in rabies surveillance systems or dog vaccination programs.
DMRVV-restricted countries means countries for which the export of
dogs into the United States has been prohibited or otherwise restricted
based on the countries' export of dogs infected with DMRVV to any other
countries within a period determined by CDC or based on evidence of
lacking adequate controls, as determined by CDC, to monitor and prevent
the export of dogs to the United States with falsified or fraudulent
vaccine credentials, invalid rabies vaccination forms, or other
fraudulent, inaccurate, or invalid importation documents.
Importer of dogs or cats means any person importing or attempting
to import a dog or cat into the United States, including the animal's
legal owner or a person acting on behalf of the importer, such as a
broker licensed with CBP. Individuals compensated or hired to transport
animals on behalf of the importer must have a valid USDA license or
registration. CDC believes that requiring that individuals who are
compensated or hired to transport animals have a valid USDA license or
registration pursuant to the Animal Welfare Act would help deter
fraudulent conduct.
HHS/CDC is also providing a new definition for what constitutes
proof of rabies vaccination. These definitions are needed to provide
clarity regarding HHS/CDC's proposed admission requirements.
CDC Import Certification of Rabies Vaccination and Microchip
Required for Live Dog Importations into the United States Form means
the OMB-approved form \101\ that must be: (1) completed by an
Authorized Veterinarian in the exporting country, which may include an
Official Government Veterinarian in the exporting country; and (2)
reviewed and certified by an Official Government Veterinarian in the
exporting country attesting that the information listed is true and
correct.
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\101\ OMB approval no. 0920-1383 (exp. 1/31/26).
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Certification of U.S.-issued Rabies Vaccination for Live Dog Re-
entry into the United States Form means the OMB-approved form \102\
that must be completed by a USDA-Accredited Veterinarian and certified
by a USDA Official Veterinarian prior to exporting a dog from the
United States in order to demonstrate compliance with admissibility
requirements upon returning to the United States.
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\102\ OMB approval no. 0579-0020, 0036, 0048, 0101, 0156, 0278,
0432.
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SAFE TraQ means the System for Animal Facilities Electronic
Tracking of Quarantine or other system as approved by the Director for
tracking the quarantine of animals approved for admission into the
United States.
Serologic Testing, when applied to an imported animal, means an
antibody titration test performed by a CDC-approved rabies laboratory
using a CDC-approved technique. The serology sample must be drawn and
submitted in accordance with CDC technical instructions. The current
list of CDC-approved laboratories is available online.
USDA-Accredited Veterinarian is defined in 9 CFR 160.1 and is an
Accredited Veterinarian who has completed formal training from the
National Veterinary Accreditation Program in the State in which they
are licensed to practice as a veterinarian.
USDA Official Veterinarian is a USDA/APHIS veterinarian who is
assigned by the USDA Administrator to supervise and perform official
work of APHIS in a State or group of states.
(b) Authorized U.S. airports for dogs and cats.
Dogs from DMRVV-free or DMRVV low-risk countries that have not been
in any DMRVV high-risk country within the last six months and all cats
may continue to enter through any U.S. port. CDC does not currently
have any restrictions on the U.S. ports for dogs arriving in the United
States from DMRVV high-risk countries. Through this NPRM, HHS/CDC
proposes that if a U.S.-vaccinated dog has been in a DMRVV high-risk
country in the previous six months, the dog must arrive at an airport
with a CDC quarantine station. The importer would also be required to
have a USDA-Accredited Veterinarian complete the Certification of U.S.-
Issued Rabies Vaccination For Live Dog Re-entry into the United States
Form and present this form to the airline prior to boarding. All
foreign-vaccinated dogs that have been in a DMRVV high-risk country in
the previous six months would be required to enter the United States at
a U.S. airport with a CDC quarantine station and a CDC-registered
Animal Care Facility. The importer would also be required to have an
Authorized Veterinarian complete the CDC Import Certification of Rabies
Vaccination and Microchip Required for Live Dog Importations into the
United States Form and present this form to the airline prior to
boarding.
This requirement that dogs from DMRVV high-risk countries arrive at
specified airports is being proposed to ensure dogs can be evaluated by
CDC quarantine station staff or a USDA-Accredited Veterinarian upon
arrival to confirm they have all required documentation for admission
and do not appear ill. Visual examinations of animals may be conducted
by CDC quarantine station staff to look for overt signs of illness
(i.e., vomiting, diarrhea, bleeding, seizures, or ocular or nasal
discharge). Animals showing signs of illness will not be released for
entry until a USDA-Accredited Veterinarian completes a physical exam
and administers a USDA-licensed rabies vaccine (if applicable). As of
June 1, 2023, five U.S. airports have CDC-registered Animal Care
Facilities. The CDC-registered Animal Care Facilities will help to
ensure animals that arrive ill, or must be detained, will be held in a
facility that meets CDC requirements, USDA Animal Welfare Act
Standards,\103\ and maintains an active CBP FIRMS code. This
requirement would further help ensure that facilities have staff who
are properly trained to provide food, water, shelter, and veterinary
care to animals if needed. CDC will continue to register live-animal
care facilities at the remaining 13 U.S. airports with CDC quarantine
stations to protect the health and safety of airline and warehouse
staff, as well as the health and safety of animals arriving in the
United States at these ports.
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\103\ 7 U.S.C. 2148.
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(c) Authorized U.S. land ports for dogs and cats.
HHS/CDC is not proposing any changes to the authorized U.S. land
ports for dogs arriving to the United States from DMRVV low-risk or
DMRVV-free countries that have not been in a DMRVV high-risk country
within the last six months. There are also no proposed changes for
cats; cats may continue to enter through any U.S. port, including land
ports. CDC is proposing to prohibit entry into the United States
through any U.S. land port for dogs that have been in a DMRVV high-risk
country within the last six months. There are no CDC-registered Animal
Care Facilities along the U.S-Mexico and U.S.-Canada borders that can
safely house or quarantine dogs arriving from DMRVV high-risk
countries. Additionally, local and State animal and public health
authorities do not have capacity on a routine basis to house and
quarantine dogs arriving from DMRVV high-risk countries without
additional burdens being placed on local public health resources.
[[Page 43993]]
(d) Authorized U.S. seaports for dogs and cats.
HHS/CDC is not proposing any changes to the authorized U.S.
seaports for dogs arriving to the United States from DMRVV low-risk or
DMRVV-free countries that have not been in any DMRVV high-risk country
within the last six months. There are also no proposed changes for
cats; cats may continue to enter through any U.S. port, including
seaports. HHS/CDC is proposing to prohibit entry into the United States
through any U.S. seaport for dogs that have been in a DMRVV high-risk
country within the last six months. There are no CDC-registered Animal
Care Facilities at U.S. seaports that can safely house or quarantine
dogs arriving from DMRVV high-risk countries. Additionally, local and
State animal and public health authorities do not have capacity on a
routine basis to house and quarantine dogs arriving from DMRVV high-
risk countries without additional burdens being placed on local public
health resources.
However, HHS/CDC is proposing an exception for dogs meeting the
definition of a ``service animal'' under 14 CFR 382.3 that have been in
a DMRVV high-risk country within the last six months. HHS/CDC would
permit entry if the dog is accompanied by an ``individual with a
disability'' as defined under 14 CFR 382.3 and the dog does work or
performs tasks that are directly related to the individual's
disability. CDC believes this exception would apply to a small number
of individuals who require that their service dog accompany them on
cruise ships with U.S. destination ports. The dog must be otherwise
admissible under this section and would be allowed entry if:
1. The dog was vaccinated against rabies in the United States and
is accompanied by a valid Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into the United States Form; or
2. The dog was vaccinated against rabies in a foreign country and
is accompanied by both a valid foreign-issued CDC Import Certification
of Rabies Vaccination and Microchip Required for Live Dog Importations
into the United States Form and a valid serologic titer from a CDC-
approved laboratory.
(e) Limitation on U.S. ports for dogs and cats.
HHS/CDC is proposing to explicitly authorize the Director to limit
the times, U.S. ports, and/or conditions under which dogs or cats may
arrive at and be admitted to the United States based on an importer's
or carrier's failure to comply with the provisions of this section or
as needed to protect the public's health. If the Director determines
such a limitation is required, the Director will notify importers or
carriers in writing of the specific times, U.S. ports, and/or
conditions under which dogs and cats may be permitted to arrive at and
be admitted to the United States.
(f) Age requirement for all dogs.
Through this NPRM, HHS/CDC proposes that all dogs arriving into the
United States (regardless of whether from DMRVV-free, DMRVV low-risk,
or DMRVV high-risk countries) be, at minimum, six months of age. HHS/
CDC currently requires dogs to be at least four months of age to enter
the United States if arriving from a DMRVV high-risk country because
this is the age at which a dog can be considered adequately vaccinated
for rabies. Verification of a dog's age is made via dental examination,
with dogs six months of age or older being easily identified by the
presence of adult incisors and canine teeth. HHS/CDC is proposing to
require imported dogs be at least six months of age, which would allow
veterinarians to more easily estimate the ages of young dogs to ensure
adequate DMRVV vaccination.
The proposed requirement that all dogs arriving into the United
States be at least six months of age will align with USDA/APHIS Animal
Care requirements for the importation of dogs that are being imported
for rescue or resale and will help ensure pet dogs can be safely
transported without risk to their health and welfare. HHS/CDC is
proposing as an exception to allow an importer to import a maximum of
three personal pet dogs under six months of age in a calendar year if
arriving via a U.S. land port from Canada or Mexico if the dog has not
been in a DMRVV high-risk country in the previous six months.
Based on communication with Federal partner agencies and data in
CDC's quarantine activity reporting system, persons importing three or
more dogs in a calendar year are less likely to be doing so in
connection with their personal pet ownership and more likely to be
associated with commercial importations of animals, including importers
attempting to circumvent HHS/CDC entry requirements by transporting
dogs from DMRVV high-risk countries through Canada and Mexico for
resale or adoption in the United States. Therefore, HHS/CDC proposes
this age requirement to protect public health, as well as the health
and safety of young puppies being purchased and sold internationally.
(g) Microchip requirements for all dogs.
HHS/CDC does not currently require a microchip for importation of
dogs into the United States. Requiring a microchip for all dogs would
help ensure that veterinary paperwork and animal identification can be
verified. It will also align with the admission requirements of other
DMRVV-free countries and bring the United States into international
alignment with the World Organisation for Animal Health (WOAH)
standards that all dogs have permanent identification or marking for
international movement.\104\ HHS/CDC proposes to require that all dogs
have an Individual Standards Organization (ISO)-compliant microchip
prior to arrival in the United States or prior to traveling out of the
United States and returning.
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\104\ World Organisation for Animal Health. Terrestrial Code
Online Access--WOAH--World Organisation for Animal Health: https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/?id=169&L=1&htmfile=chapitre_certif_rabies.htm.
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(h) CDC Import Submission Form for all dogs.
CDC and Federal partners have documented numerous instances of
importers moving dogs from DMRVV high-risk countries through DMRVV low-
risk country to circumvent U.S. dog entry
requirements.105 106 HHS/CDC proposes requiring that
importers submit a CDC Import Submission Form via a CDC-approved system
for each imported dog to help mitigate the risk of importers presenting
dogs from DMRVV high-risk countries at U.S. ports that have traveled
through DMRVV low-risk countries for short periods of time (less than
six months) and do not meet CDC entry requirements. The CDC Import
Submission Form must be submitted to CDC prior to a dog's departure
from the foreign country.
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\105\ The importer of the rabid dog into the United States in
2019 first flew into Canada before crossing a land border into the
United States. See Raybern, C et al. Rabies in a dog imported from
Egypt-Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-
1377.
\106\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2020. Accessed: February 15, 2021.
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(i) Inspection requirements for admission of dogs and cats.
HHS/CDC currently requires that all dogs and cats arriving in the
United States be inspected to ensure they appear healthy. While the
requirement for inspection of dogs and cats is not new, HHS/CDC
proposes clarifying that dogs and cats may be denied admission if an
importer refuses to consent to the required screening. HHS/CDC believes
that this additional clarification is
[[Page 43994]]
needed because of numerous documented instances of confusion among
importers and some carriers regarding CDC's ability to mandate a public
health evaluation of a dog or cat prior to admission. Additionally, CDC
may coordinate with other federal and state partners to engage in
routine disease surveillance of animals arriving in the United States.
(j) Examination by a USDA-Accredited Veterinarian and confinement
of exposed dogs and cats or those that appear unhealthy.
HHS/CDC currently requires examination by a veterinarian and
confinement if, upon examination, a dog or cat appears unhealthy upon
arrival, and such measures are needed to protect the public's health.
While the requirement for examination and confinement are not new, this
proposed provision is primarily intended to require airlines to assume
responsibility for housing and caring for dogs and cats that arrive
sick in the event the importer abandons the shipment. CDC has
documented numerous instances of sick animals not receiving care in a
timely manner and animals denied admission being left by airlines in
unacceptable housing conditions.
HHS/CDC proposes, in the event a dog or cat arrives ill, is denied
admission, or is exposed to a sick animal in transit,107 108
that the airline arrange for confinement in a CDC-approved veterinary
clinic and that the importer bears the expenses of such confinement,
examination, testing, and treatment. If an importer fails to pay for
such expenses, then the animal may be considered abandoned, and the
airline will be required to assume financial responsibility. This
provision is needed to help ensure airlines assume responsibility for
sick or exposed dogs and cats and that such animals do not remain in
unsafe conditions for prolonged periods of time (e.g., longer than six
hours). The proposed rule further clarifies an airline's
responsibilities in the event an importer abandons a dog or cat. This
provision may also be applied to other carriers transporting dogs and
cats in the rare circumstances where it is necessary for public health
reasons to require that the carrier arrange for examination and
confinement.
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\107\ National Association of State Public Health Veterinarians.
Compendium of animal rabies prevention and control, 2016. JAVMA
2016; 248 (5):505-517.
\108\ Manning SE, Rupprecht CE, Fishbein D, et al. Human rabies
prevention--United States, 2008: recommendations of the Advisory
Committee on Immunization Practices. MMWR Recomm Rep 2008;57(RR-
3):1-28.
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(k) Veterinary examination and revaccination against rabies at a
CDC-registered Animal Care Facility for foreign-vaccinated dogs.
HHS/CDC proposes to require all dogs arriving from DMRVV high-risk
countries without a valid Certification of U.S.-Issued Rabies
Vaccination for Live Dog Re-entry into the United States Form to have a
valid CDC Import Certification of Rabies Vaccination and Microchip
Required for Live Dog Importations into the United States Form and
undergo veterinary examination and revaccination against rabies at a
CDC-registered Animal Care Facility upon arrival.
The importer would be responsible for making a reservation and all
arrangements relating to the examination, revaccination, and quarantine
(if quarantine is required) of dogs with a CDC-registered Animal Care
Facility prior to the dogs' arrival in the United States. Airlines must
deny boarding to dogs if the importer fails to present a receipt of the
completed CDC Import Certification of Rabies Vaccination and Microchip
Required for Live Dog Importations into the United States Form. The
costs of examination, vaccination, and quarantine (if required) would
be borne by the importer and not the United States Government. Animals
that are abandoned before meeting requirements outlined below become
the legal responsibility of the airline.
HHS/CDC proposes that the dogs remain in the custody of a CDC-
registered Animal Care Facility until all of the following requirements
are met:
(i) Veterinary health examination by a USDA-Accredited Veterinarian
for signs of disease. Suspected or confirmed zoonotic or foreign animal
diseases would be required to be reported to CDC, USDA, the State or
County Public Health Veterinarian, and the State Veterinarian prior to
release of the animals.
(ii) Vaccination against rabies with a USDA-licensed rabies vaccine
and administered by a USDA-Accredited Veterinarian.
(iii) Confirmation of microchip number.
(iv) Confirmation of age through dental examination by a USDA-
Accredited Veterinarian.
(v) Verification of adequate rabies serologic test from a CDC-
approved laboratory. To be considered valid, serologic tests must be
drawn prior to arrival within an established timeframe and display
results within parameters as specified in CDC technical
instructions.\109\ Currently, this means that serologic tests must be
drawn 45 to 365 days before arrival and have a result greater than or
equal to 0.5 IU/mL. Dogs that arrive without an adequate rabies
serologic test results from a CDC-approved laboratory would be housed
at the CDC-registered Animal Care Facility for a 28-day quarantine
following administration of the U.S. rabies vaccine or until an
adequate rabies serologic test from a CDC-approved laboratory is
confirmed.
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\109\ CDC Technical Instructions will be posted to CDC's website
(www.cdc.gov/dogtravel) upon publication of the final rule.
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(l) Registration or renewal of CDC-registered Animal Care
Facilities.
Through this NPRM, HHS/CDC proposes to establish a registration
mechanism for CDC-registered Animal Care Facilities used in the
importation of foreign-vaccinated dogs arriving in the United States
from DMRVV high-risk countries. Before housing any imported live dog in
the United States, an animal care facility would be required to
register with and receive written approval from CDC, USDA, and CBP to
submit their facility application. The applicant would need to provide
written standard operating procedures outlining how CDC's regulatory
requirements will be met and the health and safety of animals and staff
will be ensured. A copy of all Federal, State, or local registrations,
licenses, or permits would also be required to be submitted to CDC.
Additionally, CDC would require the facility to have a USDA
intermediate handlers license and a FIRMS code issued by CBP. The
facility would be subject to inspection by CDC at least annually and
required to renew their registration every two years. Animal health
records, facilities, vehicles, or equipment to be used in receiving,
examining, and processing imported animals would also be subject to
inspection.
(m) Record-keeping requirements at CDC-registered Animal Care
Facilities.
HHS/CDC proposes to require that any CDC-registered Animal Care
Facilities retain records regarding each imported animal for three
years after the distribution or transfer of the animal. Each record
must include:
(i) The bill of lading for each shipment;
(ii) The name, address, phone number, and email address of the
importer and owner (if different from the importer);
(iii) The number of animals in each shipment;
(iv) The identity of each animal in each shipment, including name,
[[Page 43995]]
microchip number, date of birth, sex, breed, and coloring;
(v) The airline, flight number, date of arrival, and port of each
shipment; and
(vi) Veterinary medical records for each animal, including:
(a) CDC Import Certification of Rabies Vaccination and Microchip
Required for Live Dog Importations into the United States Form and
rabies serology obtained before arrival in the United States (if
applicable);
(b) The USDA-licensed rabies vaccine administered upon arrival;
(c) Veterinary exam records upon arrival and while in quarantine;
(d) Rabies serology performed while in quarantine in the United
States (if applicable); and
(e) All diagnostic test, histopathology and necropsy results
performed during quarantine (if applicable).
The facility would be required to maintain these records
electronically and allow CDC to inspect the records.
(n) Worker protection plan and personal protective equipment (PPE).
HHS/CDC proposes to require that a CDC-registered Animal Care
Facility establish and maintain a worker protection plan with standards
comparable to those in CDC's National Institute for Occupational Safety
and Health (NIOSH) Veterinary Safety and Health guidelines \110\ and
the National Association of Public Health Veterinarians (NASPHV)
Compendium of Veterinary Standard Precautions for Zoonotic Disease
Prevention in Veterinary Personnel.\111\ Such a worker protection plan
must include rabies pre-exposure prophylaxis for workers handling
imported animals in quarantine, post-exposure procedures that provide
potentially exposed workers with direct and rapid access to a medical
consultant, and procedures for documenting the frequency of worker
training, including for those working in the quarantine area. As part
of the worker protection plan, a facility would also need to establish,
implement, and maintain hazard evaluation and worker communication
procedures that include descriptions of the known zoonotic disease and
injury hazards associated with handling animals, the need for PPE when
handling animals and training in the proper use of PPE, and procedures
for disinfection of garments, supplies, equipment, and waste.
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\110\ https://www.cdc.gov/niosh/topics/veterinary/biological.html.
\111\ https://www.nasphv.org/Documents/VeterinaryStandardPrecautions.pdf.
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(o) CDC-registered Animal Care Facility standard operating
procedures, requirements, and equipment standards for crating, caging,
and transporting live animals.
HHS/CDC proposes to outline equipment standards for crating,
caging, and transporting live animals for CDC-registered Animal Care
Facilities. The standards must be in accordance with USDA Animal
Welfare regulation standards \112\ (9 CFR parts 1, 2, and 3) and
International Air Transport Association standards.\113\ Violations of
the USDA Animal Welfare Act may result in immediate revocation of an
animal care facility's status as a CDC-registered Animal Care Facility.
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\112\ U.S. Department of Agriculture. Animal Welfare Act.
https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa_awa.
Accessed June 7, 2023.
\113\ International Air Transport Association. Live Animals.
https://www.iata.org/en/programs/cargo/live-animals. Accessed June
7, 2023.
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(p) Health reporting requirements for animals at CDC-registered
Animal Care Facilities.
HHS/CDC proposes to establish health reporting requirements for all
dogs being evaluated at a CDC-registered Animal Care Facility. A
facility would need to provide the following services for each dog from
a DMRVV high-risk country with a foreign-issued rabies vaccine upon
arrival and ensure each animal meets CDC, USDA, and state and local
entry requirements prior to release from the facility:
(i) Veterinary examination by a USDA-Accredited Veterinarian within
one business day of arrival;
(ii) Verification of microchip and confirmation that the microchip
number matches the animal's health records;
(iii) Verification of animal's age via a dental examination;
(iv) Vaccination against rabies using a USDA-licensed vaccine; and
(v) Verification of an adequate serologic test from a CDC-approved
laboratory OR 28-day quarantine after administration of the USDA-
licensed rabies vaccine.
HHS/CDC further proposes that the facility notify CDC within 24
hours of the occurrence of any morbidity or mortality of animals in the
facility. Any animal that dies at a CDC-registered Animal Care Facility
would be required to undergo a necropsy and diagnostic testing to
determine the cause of death. An animal that arrives ill or becomes ill
while at the CDC-registered Animal Care Facility would need to be
examined by a USDA-Accredited Veterinarian immediately and undergo
diagnostic testing to determine the cause of illness prior to release
from the facility. Suspected or confirmed zoonotic diseases would need
to be reported to CDC and the State or County Public Health
Veterinarian within 24 hours of identification. Suspected or confirmed
foreign animal diseases or infectious animal diseases would be reported
to USDA and the State or County Veterinarian within 24 hours of
identification.\114\
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\114\ Zoonotic disease are diseases that can spread from animals
to people; infectious animal diseases spread only between animals;
foreign animal diseases are not present in the United States and may
or may not be zoonotic.
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(q) Quarantine requirements for CDC-registered Animal Care
Facilities.
HHS/CDC proposes to establish requirements for the quarantine area
at CDC-registered Animal Care Facilities to ensure animals are safely
housed and do not present a public health risk to humans or other
animals. The proposed requirements include building security to prevent
unintended public exposure to quarantined animals, cleaning and
disinfection standards, and diagnostic testing or necropsy for ill or
deceased animals.
(r) Revocation and reinstatement of a CDC-registered Animal Care
Facility's registration.
HHS/CDC proposes procedures to revoke a CDC-registered Animal Care
Facility's registration if the Director determines that it has failed
to comply with any applicable provisions of this section. CDC would
send the facility a notice of revocation stating the grounds upon which
the proposed revocation is based. If the facility contested the
revocation, the facility would be required to file a written response
to the notice within five business days after receiving the notice. All
the grounds listed in the proposed revocation would be deemed admitted
if the facility failed to respond.
If a facility's response is timely, the Director will review the
registration, the notice of revocation, and the response. The Director
would then decide whether to revoke the facility's registration based
on the written record and communicate this decision in writing to the
facility. The Director could reinstate a revoked registration after
inspecting the facility, examining its records, conferring with the
facility, and receiving information and assurance from the facility of
compliance with the requirements of this section.
(s) Requirement for the CDC Import Certification of Rabies
Vaccination and Microchip Required for Live Dog Importations into the
United States Form to import a foreign-vaccinated dog from DMRVV high-
risk countries.
HHS/CDC currently requires in 42 CFR 71.51(c) that importers of
dogs
[[Page 43996]]
arriving from DMRVV high-risk countries provide a valid RVC, as defined
in 42 CFR 71.51(a), upon arrival; this includes proof of vaccination
but importers are not required to use a standardized form. Without a
standardized form, there is tremendous variation among countries in
documenting proof of vaccination. This lack of standardization creates
confusion for port staff who are responsible for reviewing the rabies
proof of vaccination.
Through this NPRM, HHS/CDC proposes to require a new, standardized
rabies vaccination form for all foreign-vaccinated dogs arriving from
DMRVV high-risk countries. This rabies vaccination form will be
standardized and help importers and Federal agencies ensure dogs being
imported from DMRVV high-risk countries are imported with all the
required information on one form. This requirement will reduce
confusion and ensure Official Government Veterinarians in the exporting
country have reviewed the veterinary records and examined dogs prior to
travel. HHS/CDC proposes that this form replace the current valid RVC
requirement, which was not aligned with internationally accepted
standards for the international movement of animals. This form will
also permit CDC and other U.S. Government agencies to confirm the
accuracy of documentation with exporting country officials if
discrepancies in the forms are noted.
All foreign-vaccinated dogs from DMRVV high-risk countries will be
required to be examined by a USDA-Accredited Veterinarian and
revaccinated with a USDA-licensed vaccine at a CDC-registered Animal
Care Facility upon arrival to align with State rabies vaccination
requirements and recommendations from the NASPHV.\115\ Dogs arriving
without a Certification of U.S.-issued Rabies Vaccination for Live Dog
Re-entry into the United States form will be required to present the
CDC Import Certification of Rabies Vaccination and Microchip Required
for Live Dog Importations into the United States form to the CDC-
registered Animal Care Facility along with a valid serologic test from
a CDC-approved laboratory (if applicable).
---------------------------------------------------------------------------
\115\ National Association of State Public Health Veterinarians.
Compendium of Animal Rabies Prevention and Control, 2016. JAVMA
2016; 248 (5): 505-517.
---------------------------------------------------------------------------
To be considered valid, serologic tests must be drawn prior to
arrival within a timeframe and display results within parameters as
specified in CDC technical instructions. Currently, to be considered
valid, serologic tests must be drawn within a timeframe of 45 to 365
days before arrival and have a result greater than or equal to 0.5 IU/
ml. Dogs that arrive without an adequate rabies serologic test from a
CDC-approved laboratory will be subject to a mandatory 28-day
quarantine after revaccination at a CDC-registered Animal Care Facility
at the importer's expense. HHS/CDC is requesting public comments on all
aspects of this proposal as it relates to persons traveling abroad with
their dogs.
(t) Requirement for Certification of U.S.-Issued Rabies Vaccination
for Live Dog Re-entry into the United States Form for importers seeking
to import U.S.-vaccinated dogs from DMRVV high-risk countries.
HHS/CDC proposes to require that U.S.-vaccinated dogs re-entering
the United States from DMRVV high-risk countries arrive at a U.S.
airport with a CDC quarantine station and be accompanied by a
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry
into the United States Form. The form must be completed by a USDA-
Accredited Veterinarian and signed by a USDA Official Veterinarian
prior to the animal departing the United States. Importers returning to
the United States from a DMRVV high-risk country with this form may
present their dog for admission without a rabies serologic test from a
CDC-approved laboratory, without the dog undergoing veterinary
examination (unless ill, injured, or exposed), and without
revaccination against rabies at a CDC-registered Animal Care Facility.
People who leave the United States with their dogs without first
obtaining this form will be required to have their dogs re-enter the
United States as if they are foreign-vaccinated dogs and be required to
meet all the requirements as outlined in section (s) for the dogs to be
eligible for re-entry from a DRMVV high-risk country. HHS/CDC solicits
feedback on this proposed process.
(u) Requirement for proof that a dog has only been in a DMRVV low-
risk or DMRVV-free country.
HHS/CDC proposes to require that dogs being imported from DMRVV
low-risk or DMRVV-free countries be accompanied by appropriate written
documentation demonstrating that they have not been in any DMRVV high-
risk country during the past six months. An importer would need to
provide written documentation, such as veterinary medical records, upon
request confirming that the dog is at least six months of age, is
microchipped, and has been only in a DMRVV low-risk or DMRVV-free
country for the six months prior to importation into the United States.
There are no proposed changes for cat rabies vaccination importation
requirements. CDC recommends importers comply with State or Territorial
requirements for rabies vaccination in cats. The CDC Import
Certification of Rabies Vaccination and Microchip Required for Live Dog
Importations into the United States form would not be required for
importers able to meet the requirements of this paragraph. HHS/CDC is
requesting public comment on whether a standardized form should be
required for dogs arriving from DMRVV-free and DMRVV low-risk countries
in order to avoid potential fraud. HHS/CDC is requesting public comment
on all aspects of this proposal as it relates to cats and dogs.
(v) Denial of admission of dogs and cats.
This proposed section outlines the circumstances under which CDC
can deny admission to a dog or cat being presented for admission into
the United States. CDC shall notify CBP in writing to enforce this
action. This includes:
Any dog arriving from a DMRVV low-risk or DMRVV-free
country without written documentation that the dog has resided in a
DMRVV low-risk or rabies-free country for the six months prior to the
attempted entry, or if the Director reasonably suspects fraud.
Any dog that is not accompanied by a receipt confirming
that a CDC Import Submission Form has been submitted to CDC through a
CDC-approved system.
Any dog arriving at a U.S. airport for which a bill of
lading has not been created by the airline prior to arrival.
Any dog arriving at a U.S. land port that has been in a
DMRVV high-risk country within the last six months prior to the
attempted entry.
Any dog arriving at a U.S. seaport that has been in a
DMRVV high-risk country within the last six months prior to the
attempted entry, except for a dog qualifying as a service animal that
is otherwise admissible under this section.
Any dog imported by an importer who refuses to comply with
the requirement (if applicable) for the dog to undergo disease
surveillance screening, veterinary examination, revaccination, provide
proof of sufficient rabies serologic tests, or quarantine at a CDC-
registered Animal Care Facility upon arrival.
Any dog that has been in a DMRVV high-risk country in the
previous six months and arrives without a valid Certification of U.S.-
Issued Rabies Vaccination for Live Dog Re-entry into the United States
Form or a valid CDC Import Certification of Rabies
[[Page 43997]]
Vaccination and Microchip Required for Live Dog Importations into the
United States Form.
Any dog that has been in a DMRVV high-risk country in the
previous six months and does not arrive via air at a U.S. airport with
a CDC quarantine station or via air at a U.S. airport with a CDC-
registered Animal Care Facility (if applicable).
Any dog imported from a DMRVV high-risk country that
arrives without a reservation at a CDC-registered Animal Care Facility
(if applicable).
Any dog from a DMRVV-restricted country that arrives
without a valid CDC Dog Import Permit.
Any dog imported from a DMRVV high-risk country if the
Director reasonably suspects fraud in any documentation required for
admission or if such documentation is otherwise untruthful, inaccurate,
or incomplete.
Any dog or cat, regardless of country of departure, that
poses a public health risk, including dogs or cats that appear
unhealthy upon arrival or demonstrate signs or symptoms of communicable
disease.
Any dog under six months of age that is arriving at a U.S.
airport or seaport, or any dog under six months of age that is arriving
at a U.S. land port if the importer has imported three or more
individual dogs under six months of age in the same calendar year
(January-December).
HHS/CDC solicits public comment regarding this proposed paragraph,
including whether the grounds for the proposed denial of admission are
sufficient to protect the public's health.
(w) Disposal or disposition of dogs and cats denied admission or
abandoned prior to admission that were transported to the United
States.
Through this NPRM, HHS/CDC proposes an operational framework
primarily applicable to airlines regarding how dogs denied admission
would be handled by carriers and importers. HHS/CDC clarifies that
airlines must provide housing for animals awaiting return to their
country of departure at a CDC-registered Animal Care Facility or a CDC-
approved animal facility if a CDC-registered Animal Care Facility is
not available. Airlines are required to return animals denied admission
to the country of departure within 72 hours of arrival, regardless of
carrier or route. This is to ensure airlines do not leave animals in
warehouses unattended for prolonged periods of time. As proposed,
airlines would be able to request extensions for an animal's return in
the event the animal is not medically fit for travel. This proposed
operational framework provides that importers are responsible for all
associated costs relating to the housing, care, and treatment of a dog
or cat denied admission pending return to its country of departure.
However, if an importer fails to pay any costs or fails to comply with
any requirements, the animal will be considered abandoned, and the
relevant carrier would be required to assume responsibility.
In instances where a dog or cat is fatally ill or injured, the
importer or airline may choose a humane euthanasia option in accordance
with the standards of the American Veterinary Medical Association \116\
performed by a licensed veterinarian. The importer or airline must
notify CDC and CBP in writing of this decision. This decision does not
relieve the importer or airline of the obligation to obtain and report
results of necropsy or diagnostic testing required by CDC.
---------------------------------------------------------------------------
\116\ https://www.avma.org/resources-tools/avma-policies/avma-guidelines-euthanasia-animals.
---------------------------------------------------------------------------
In the case of dogs and cats denied admission to the United States
upon arrival at a U.S. seaport, the vessel's master or operator would
be required to reembark the animal immediately and return it to its
country of departure on the next voyage. In the case of dogs and cats
denied admission to the United States upon arrival at a U.S. land port,
the importer or carrier would be required to immediately return it to
its country of departure.
CDC does not expect the above operational framework relating to
housing, care, and treatment of a dog or cat denied admission to be
applied on a routine basis to carriers or importers arriving with dogs
or cats at U.S. land or seaports because the circumstances leading to a
delay in returning a dog or cat to its country of departure are not
typically present at these U.S. ports. However, CDC acknowledges that
there may be rare and unforeseen circumstances where it may be
necessary to apply such procedures. Accordingly, CDC has added language
authorizing it to apply these provisions in circumstances where a dog
or cat is denied entry at a U.S. land or seaport and cannot be
immediately returned to its country of departure (e.g., because it is
unfit to travel). HHS/CDC specifically solicits public comment
regarding the possible application of these measures to dogs and cat
arriving in the United States at U.S. land or seaports.
(x) Appeals of CDC denials to admit a dog or a cat upon arrival
into the United States.
This section proposes an appeal process for importers of dogs and
cats in the event their animals are denied admission to the United
States upon arrival.
If CDC denies admission to a dog or cat under this section, the
importer may appeal that denial to the Director. The importer must
submit the appeal in writing to the Director that states the reasons
for the appeal and demonstrates that there is a genuine and substantial
issue of fact in dispute. The importer must submit the appeal within
one business day of the denial. Submitting an appeal will not delay the
return of the animal to the country of departure. CDC will issue a
written response, which shall constitute final agency action.
Because denial of admission to dogs and cats under these limited
circumstances is likely to occur at a port, HHS/CDC proposes that any
appeal be submitted within one business day so as not to unnecessarily
prolong the appeal process and allow for expedited decision-making
regarding whether an animal should be returned to its country of
departure. Pending a determination regarding the appeal the animal will
remain the legal responsibility of the carrier. HHS/CDC solicits public
comment regarding this proposal.
(y) Record of death of dogs and cats while en route to the United
States and disposition of dead animals.
The requirement that carriers maintain a record of sickness or
death for any animals that die during transit is longstanding. Through
this NPRM, HHS/CDC proposes to require necropsy and diagnostic testing
for any dog or cat that dies en route to the United States or at a U.S.
port prior to admission to determine the cause of death. Consistent
with current requirements, carriers would be required to report deaths
to the CDC quarantine station of jurisdiction. HHS/CDC proposes these
amendments to ensure it can detect, provide referrals to appropriate
agencies, and respond to potential zoonotic disease importation risks
in a timely manner. Importers would be responsible for the costs unless
they abandon the animal, in which case the airline or master or
operator of a vessel would assume responsibility for the costs.
(z) Abandoned shipments of dogs and cats.
Through this NPRM, HHS/CDC proposes an operational framework
primarily applicable to airlines for when a dog or cat would be
considered abandoned prior to admission and thus require the carrier to
assume responsibility for the shipment. CDC has documented several
instances in which importers have chosen to abandon dogs.
[[Page 43998]]
Federal and State public health agencies have incurred financial costs
because of importers abandoning dogs and the subsequent refusal by
airlines to provide safe housing and return for dogs. HHS/CDC proposes
that an animal shipment be deemed abandoned under the following
circumstances:
When explicitly stated by the importer verbally or in
writing to the carrier, CDC, or CBP; or
If the importer fails to cooperate with or respond to the
carrier's attempts to comply with the regulations listed in 42 CFR
71.51 within 24 hours; or
If the importer refuses payment within 24 hours for CDC-
mandated examinations, testing, holding, or treatment needed to ensure
the safe importation of animals into the United States.
The provisions of this paragraph may also be applied to other
carriers transporting such dogs and cats in the rare circumstances
where the dog or cat is abandoned by the importer at a U.S. land port
or seaport and other options are not available.
(aa) Sanitation of cages and containers of dogs and cats.
The requirement that animal cages and containers be kept in a
sanitary condition is long-standing. This language appears as a
separate paragraph in the proposed regulation, but HHS/CDC is not
proposing any changes to the existing language, which requires that
animals be transported in clean crates or cages. CDC is republishing
this section to provide context and for the convenience of the reader.
(bb) Requirements for in-transit shipments of dogs and cats.
HHS/CDC proposes to clarify the definition of an in-transit
shipment and outlines the requirements for dogs and cats that transit
the United States as part of an in-transit shipment. CDC's definition
would align with that of the USDA, and HHS/CDC clarifies that dogs and
cats cannot be considered in transit if they are transported as hand-
carried baggage or checked baggage. In-transit shipments may only be
transported as cargo.
(cc) Bill of lading and other airline requirements for dogs.
To help mitigate the risk of importers presenting dogs from DMRVV
high-risk countries at U.S. airports that have traveled through DMRVV
low-risk countries for short periods of time (less than six months) and
do not meet CDC entry requirements, this NPRM proposes to require that
airlines create a bill of lading accounting for all live dog imports
through a U.S. airport, regardless of whether the dogs are transported
as cargo, checked baggage, or hand-carried baggage, or otherwise
accompany a traveler arriving in the United States on their person.
Requiring airlines to create a bill of lading specifically for all live
dog imports arriving at a U.S. airport will also help ensure airlines
are accountable for the safety of the dog upon arrival in the United
States. Dogs that do not have bills of lading by an airline are more
likely to be left by the airline in unsafe conditions, and airlines
often refuse to take responsibility for the safety and entry
requirements for dogs flown as checked-baggage or hand-carried
baggage.\117\
---------------------------------------------------------------------------
\117\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2020. Accessed: February 15, 2021.
---------------------------------------------------------------------------
CDC also proposes to require that airlines confirm that all
importers have a receipt of a completed CDC Import Submission Form
prior to boarding. For U.S.-vaccinated dogs, CDC proposes that airlines
confirm that importers have a valid Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into the United States Form. For
foreign-vaccinated dogs, CDC proposes that airlines confirm that
importers have a reservation at a CDC-registered Animal Care Facility.
For dogs from DMRVV-free or low-risk countries, CDC proposes that
airlines confirm that the importer has documentation showing that the
dog is over six months of age, has a microchip, and has not been in a
DMRVV high-risk country in the previous six months.
CDC is also proposing that a representative of an airline
transporting live dogs into the United States be on-site at the U.S.
airport and available to coordinate the entry/clearance of the dogs
with federal government officials until all live dogs transported on an
arriving flight into the United States have either been cleared for
admission or arrangements have been made to transport the dogs to a
CDC-registered Animal Care Facility or other facility (e.g., veterinary
clinic or kennel) approved by CDC pending admissibility determination.
HHS/CDC is seeking public comment on whether airline staff should
be required to present dogs for entry and be available until all dogs
have been cleared for entry or arrangements have been made to transport
the dogs to a CDC-registered Animal Care Facility or other facility
(e.g., veterinary clinic or kennel) approved by CDC pending an
admissibility determination. HHS/CDC is also seeking public comment on
how airlines can present dogs for inspection in the cargo area, except
dogs meeting the definition of a ``service animal'' under 14 CFR 382.3.
(dd) Order prohibiting carriers from transporting dogs and cats.
HHS/CDC proposes procedures for the Director to issue an order
revoking a carrier's permission to transport live dogs and cats into
the United States if a carrier has endangered the public health of the
United States by acting or failing to act to prevent the introduction
of DMRVV, as would occur by failing to comply with the provisions of
this section. HHS/CDC believes that the circumstances giving rise to
such an order would be exceedingly rare, such that HHS/CDC would issue
an order only after repeated attempts to consult with and obtain
voluntary compliance and remedial action from the carrier have failed.
The Director would rescind the order after working with the carrier to
obtain remedial action, such as: inspecting the carrier's facilities;
examining its records; conferring with the carrier's owners or
operators, contractors, or staff; or after receiving information and
written assurances from the carrier owner or operator that it has taken
remedial steps to ensure future compliance with HHS/CDC dog and cat
importation requirements. Such an order would be subject to an
administrative appeal. The appeal must be in writing, addressed to the
Director, state the reasons for the appeal, and demonstrate that there
is a genuine and substantial issue of fact in dispute. As soon as
practicable after completing the appeal review, the Director will issue
a decision in writing that would constitute final agency action. The
Director will serve the carrier owners or operators with a copy of the
written decision.
(ee) Prohibition on imports of dogs from DMRVV-restricted
countries.
Through this NPRM, HHS/CDC proposes to prohibit or otherwise
restrict the import of dogs into the United States from certain
countries that have repeatedly exported rabid dogs to any other country
or that lack adequate controls to monitor and prevent the export of
dogs to the United States with falsified or fraudulent vaccine
credentials. Such a prohibition or other restriction would remain in
place until CDC was satisfied that sufficient controls had been
established to prevent the reintroduction of DMRVV into the United
States, including preventing the use of falsified or fraudulent vaccine
credentials. To implement this provision, this NPRM proposes that HHS/
CDC maintain a list of DMRVV-restricted countries. The list would be
maintained on CDC's website and
[[Page 43999]]
updated annually. Amendments to the list of DMRVV-restricted countries
would be published as a notice in the Federal Register. Under this
proposal, CDC may allow the importation of certain categories of dogs
from DMRVV-restricted countries, such as service animals or government-
owned animals. HHS/CDC solicits comment as to whether such Federal
Register notices would be sufficient to inform the public.
(ff) Request for issuance of additional fines or penalties.
Under 42 U.S.C. 268(b), CBP and Coast Guard officers may aid in the
enforcement of HHS/CDC's quarantine rules and regulations. HHS/CDC is
proposing to add a paragraph recognizing that HHS/CDC may request that
CBP pursue enforcement actions using CBP's existing authorities under
19 U.S.C. 1592 and 19 U.S.C. 1595a against importers, brokers, or
carriers who violate HHS/CDC's dog and cat importation requirements.
This provision does not create new authority. Its purpose is to inform
the public of actions that CDC may take to request CBP assistance in
enforcing HHS/CDC's dog and cat importation requirements. HHS/CDC
stresses that it does not administer Title 19, and decisions regarding
whether to pursue enforcement actions under Title 19 would be entirely
at the discretion of DHS/CBP and subject to its policies and
procedures.
V. Alternatives Considered
In developing this NPRM, HHS/CDC considered more and less
restrictive policy alternatives. The provisions included in the NPRM
were determined to minimize the cost and burden of the proposed
regulatory provisions while protecting and reducing risks to the
public's health. To reduce the costs associated with the provisions of
the NPRM, many proposed requirements only apply to dogs imported from
DMRVV high-risk countries, and some apply only to dogs vaccinated
outside the United States imported from DMRVV high-risk countries.
Table 4 summarizes alternatives to selected proposed requirements
expected to be associated with most of the monetized costs and benefits
for this NPRM (if finalized as proposed) relative to the current status
quo. A semi-quantitative analysis of the costs and benefits is
available in Section F of an Appendix found in the Supplemental
Materials tab of the docket.
---------------------------------------------------------------------------
\118\ The current requirements do not take account of the
temporary suspension of dogs from DMRVV high-risk countries, because
it is a temporary measure.
Table 4--Summary Table of Important Changes to Regulatory Requirements Based on the Provisions of This NPRM and
Alternatives Considered
----------------------------------------------------------------------------------------------------------------
Current
NPRM requirement (proposed) requirements \118\ Option 1--more Option 2--less Justification
(baseline) restrictive restrictive
----------------------------------------------------------------------------------------------------------------
Proposed 71.51(f)............... DMRVV High-risk Dogs must be at Dogs must be at The increased age
Dogs must be at least six months countries: Dogs least six months least four months requirement will
of age to be imported from a must be at least of age regardless of age to arrive improve health
DMRVV high-risk country. four months of of country of via aircraft and safety for
Dogs must be at least six months age (based on the origin or type of regardless of dogs being
of age to arrive via aircraft earliest age at conveyance. country of transported and
regardless of country origin. which a dog could origin, which is result in fewer
Only three or fewer dogs less be considered the youngest age public health
than six months of age may be fully vaccinated a dog may be investigations of
imported at land ports by an against rabies). considered fully dogs found to be
importer/owner (per calendar No requirement for vaccinated ill or to have
year). Dogs that have been in DMRVV-free or against rabies. died during air
DMRVV high-risk countries are DMRVV low-risk No limit to the travel. The 6-
not eligible to arrive at land countries since number of dogs month versus 4-
ports. rabies that may be month age
vaccination imported at land requirement will
documentation is ports. also make it
not currently easier to
required for estimate the age
these dogs. of dogs based on
examination of
their teeth. This
age requirement
will also improve
alignment with
USDA import
requirements (7
CFR 2148) for
dogs imported for
resale.
Proposed section 71.51(g)....... No dog- All dogs must be Either no This requirement
All dogs must have a microchip identification implanted with identification is needed to
regardless of country of origin. requirement other microchips and requirement or confirm that the
than a have tattoos for allow use of arriving dogs
description on identification tattoos or other match their
the rabies purposes. dog-identifying paperwork because
vaccination technology CDC has
documentation. instead of documented a
requiring dramatic increase
microchips. in the number of
dogs arriving
with falsified
rabies
vaccination
documentation.
The microchip
requirement will
allow for
matching
microchip
information
(obtained by
scanning the dog)
with the
microchip number
documented on the
dog's proof of
rabies
vaccination.
[[Page 44000]]
Proposed section 71.51(h)....... No requirement for Require importers Only require dogs This requirement
Require importers to submit dog importers to to use the more from DMRVV high- will help Federal
advance data for each dog via a submit data with complicated and risk countries to agencies detect
CDC-approved system and require CDC and no costly CBP formal submit data via a dogs that move
airlines to create bill of requirement for entry CDC-approved from DMRVV high-
lading for all live dog imports. airlines to requirements. system and risk to DMRVV low-
create a bill of require airlines risk countries to
lading for all to create a bill avoid U.S.
live dog imports. of lading for all requirements.
live dog imports. This requirement
will also support
Federal agencies'
targeting of
interventions for
dogs arriving
from countries
presenting
significant risks
to human or
animal health.
Proposed 71.51 (t).............. Rabies vaccine Require Require At present, the
Require standardized rabies certificates are Certification of veterinarians to information on
vaccination information using a required for dogs U.S.-issued fill out the rabies
CDC form: Certification of U.S.- imported from Rabies Certification of vaccination
issued Rabies Vaccination for DMRVV high-risk Vaccination for U.S.-issued documents is not
Live Dog Re-entry into the countries and do Live Dog Re-entry Rabies standardized;
United States Form for dogs not need to be into the United Vaccination for different formats
originating in the United entered into a States form be Live Dog Re-entry are used in
States and wanting to re-enter standardized form certified by a into the United different
the U.S. after traveling to a or certified by USDA Official States Form, but countries and
DMRVV high-risk country. an Official Veterinarian for do not require even within the
Government all dogs leaving certification by U.S. Lack of a
Veterinarian. the U.S. with an Official standardized
planned re-entry Government format may lead
into the U.S. Veterinarian. to dogs from
DMRVV high-risk
countries
arriving at a
U.S. port with
rabies
vaccination
documentation s
that does not
align with
current CDC
requirements and
subsequent entry
denials. This
provision will
also align the
United States
with import/
export
requirements
commonly required
in other
countries.
Proposed 71.51(k)............... No follow-up Require veterinary In lieu of This process will
Requirement for veterinary examination or examination and requiring follow- better align U.S.
examination and revaccination revaccination revaccination for up at a CDC- requirements with
against rabies at a CDC- required. all dogs imported registered Animal existing
registered Animal Care Facility from DMRVV high- Care Facility, requirements of
for foreign-vaccinated dogs risk countries, allow dogs other DMRVV-free
from DMRVV high-risk countries, including dogs imported from countries
no requirement for dogs with valid U.S.- DMRVV high-risk This requirement
imported from DMRVV-free or issued rabies countries that for veterinary
DMRVV low-risk countries or vaccinations. were vaccinated examination and
U.S.-vaccinated dogs from DMRVV outside the revaccination
high-risk countries if U.S.- United States to will reduce the
vaccinated dogs are healthy and visit any risk of dogs
meet all other requirements. licensed U.S. potentially
The laboratory testing veterinarian for infecting people
requirements in proposed examination and or wildlife with
71.51(k)(4)(v) are addressed revaccination. DMRVV and
separately below. potentially other
zoonotic diseases
or diseases which
impact livestock
in the United
States.
[[Page 44001]]
Proposed 71.51(k)(4)............ No laboratory Serologic test Allow serologic This laboratory
Foreign-vaccinated dogs from testing from a CDC- test results for testing provision
DMRVV high-risk countries must requirement for approved dogs imported will better align
have serologic test results dog imports from laboratory with a from DMRVV high- U.S. requirements
from a CDC-approved laboratory any country. longer, e.g., 90- risk countries with existing
with a waiting period, or such day waiting with foreign- requirements of
time period as specified in CDC period before issued rabies other DMRVV-free
technical instructions, before entry for dogs vaccinations from countries that
entry or be quarantined for 28 vaccinated any laboratory require
days after revaccination with a outside the (i.e., not laboratory
USDA-licensed rabies vaccine. United States and limited to CDC- confirmation
arriving from approved because rabies
DMRVV high-risk laboratories). vaccination
countries or all documentation
dogs imported alone is
from DMRVV high- considered
risk countries insufficient as
require serologic proof of rabies
test results. immunity.
However, this
requirement is
still less
restrictive than
many DMRVV-free
countries because
there is no
serologic test
requirement for
U.S.-vaccinated
dogs.
Proposed 71.51(b)............... No U.S. port For all dogs from Allow foreign- This requirement
U.S.-vaccinated dogs imported requirement. DMRVV high-risk vaccinated dogs will ensure dogs
from DMRVV high-risk countries countries, limit imported from denied entry or
must enter through one of 18 entry to U.S. DMRVV high-risk placed on hold
U.S. airports with a CDC port with CDC- countries to have safe housing
quarantine station. Foreign- registered Animal enter at any U.S. locations
vaccinated dogs from DMRVV high- Care Facilities. port with a CDC available and/or
risk countries must arrive at a Five U.S. ports quarantine CDC oversight.
U.S. port with a CDC-registered currently have station and allow This will reduce
Animal Care Facility. Such facilities that U.S.-vaccinated the risk that
facilities must have an active meet this dogs from any dogs pending or
custodial bond and a FIRMS code standard. country to enter denied entry will
issued by CBP, and a USDA at any U.S. port. be placed in
intermediate handlers license. cargo warehouses
Five U.S. ports currently have or other unsafe
facilities that meet this locations while
standard. awaiting CDC
determination or
return to their
countries of
origin. This
would ensure
appropriate
veterinary follow
up for foreign-
vaccinated dogs
from DMRVV high-
risk countries.
----------------------------------------------------------------------------------------------------------------
VI. Required Regulatory Analyses
A. Executive Orders 12866 and 13563
Under Executive Order 12866 (E.O. 12866), Regulatory Planning and
Review (58 FR 51735, October 4, 1993), HHS/CDC is required to determine
whether this regulatory action would be ``significant'' and therefore
subject to review by the Office of Management and Budget (OMB) and the
requirements of the Executive Order. E.O. 12866, as amended by
Executive Order 14094, defines ``significant regulatory action'' as an
action that is likely to result in a rule:
Having an annual effect on the economy of $200 million or
more (adjusted every 3 years by the Administrator of OIRA for changes
in gross domestic product), or adversely affect in a material way the
economy, a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, territorial, or
tribal governments or communities;
Creating a serious inconsistency or otherwise interfere
with an action taken or planned by another agency;
Materially altering the budgetary impact of entitlements,
grants, user fees, or loan programs or the rights and obligations of
recipients thereof; or
Raising legal or policy issues for which centralized
review would meaningfully further the President's priorities, or the
principles set forth in E.O. 12866, as specifically authorized in a
timely manner by the Administrator of OIRA in each case.
OMB's Office of Information and Regulatory Affairs has determined
that this rulemaking is ``significant''.
The provisions of this NPRM (if finalized as proposed) are not
likely to have an annual effect on the economy of $200 million or more,
although there is considerable uncertainty around the number of dogs
imported at baseline, including the number of dogs imported from DMRVV
high-risk countries. HHS/CDC conducted an analysis to estimate the
costs and benefits of the proposed provisions of this NPRM relative to
a baseline without any change in requirements. To conduct this
analysis, CDC assumed the NPRM would be finalized as proposed. HHS/CDC
requests public comment on costs associated with these changes to
importers, airlines, and State and local health departments to improve
the accuracy of cost and benefit estimates. More details on the
assumptions used to develop this analysis are included in an Appendix
found in the Supplemental Materials tab of the docket, including more
specific solicitations for public comment.
The economic baseline is based on the provisions included in the
existing 42
[[Page 44002]]
CFR 71.51. The baseline analysis does not incorporate the impact of the
temporary suspension of dogs imported from DMRVV high-risk countries
that has been in effect since July 14, 2021.\119\ The economic baseline
does not account for the temporary suspension but does account for a
change to the definition of rabies-free country published in 2019.\120\
This baseline is used as a comparator to assess the impact of the
provisions of the NPRM if finalized as proposed.
---------------------------------------------------------------------------
\119\ On June 14, 2021, CDC published the ``Notice of Temporary
Suspension of Dogs Entering the United States from High-Risk Rabies
Countries.'' Through this notice, CDC informed the public that,
effective July 14, 2021, it was temporarily suspending the
importation of dogs from: countries classified by CDC as high risk
for DMRVV; AND countries that are NOT at high risk if the dogs have
been in high-risk countries during the previous six months. See 86
FR 32041 (June 16, 2021). The suspension was extended effective June
10, 2022. See 87 FR 33158 (June 1, 2022).
\120\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------
The provisions of this NPRM (if finalized as proposed) would
address the market inefficiency in which dog importers do not consider
the potential detrimental impacts to the public's health that may
result from the importation of ill dogs, especially dogs infected with
DMRVV. Regulation at the Federal level is necessary to address the risk
of unhealthy dog imports upon entry to the United States. Federal
action allows risks to be addressed prior to dogs' arrival in the
United States. The provisions of this NPRM (if finalized as proposed)
are expected to affect the following categories of interested parties
and implementing partners:
Importers of dogs from countries that are DMRVV-free or at
low risk for DMRVV;
Importers of dogs from countries that are at high risk of
DMRVV;
Airlines and other carriers;
CBP;
CDC;
USDA; and
State and local public health and animal health
departments.
As discussed above, the changes proposed in the NPRM incorporate
different requirements depending on whether dogs are imported from
DMRVV high-risk countries compared to countries that are DMRVV-free or
DMRVV low-risk. Proposed requirements for dogs from DMRVV high-risk
countries are further differentiated depending on whether imported dogs
have received their rabies vaccines in the United States or in another
country. Dogs imported from DMRVV high-risk countries would have to
arrive at one of five airports with a CDC-registered Animal Care
Facility (foreign-vaccinated dogs) or at one of 18 airports with a CDC
quarantine station (U.S.-vaccinated dogs). Importers of foreign-
vaccinated dogs from DMRVV high-risk countries would make reservations
with a CDC-registered Animal Care Facility for a veterinary examination
and revaccination prior to arrival. As part of the proposed entry
requirements in the NPRM (if finalized as proposed), importers would
either agree to a 28-day quarantine period for the dog or submit
samples of the dog's blood to a CDC-approved laboratory for serologic
testing to demonstrate immunity to rabies virus. CDC assumes that most
importers would choose serologic testing in lieu of the quarantine
period. All importers of dogs from DMRVV high-risk countries would
submit the CDC Import Certification of Rabies Vaccination and Microchip
Required for All Live Dog Importations into the United States Form or
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-entry
into the United States Form, which require certification by an Official
Government Veterinarian. However, dogs imported from DMRVV-free or
DMRVV low-risk countries do not require evaluation at CDC-registered
Animal Care Facilities and are eligible to arrive at any U.S. port. In
lieu of the CDC Import Certification of Rabies Vaccination and
Microchip Required for All Live Dog Importations into the United States
Form or Certification of U.S.-issued Rabies Vaccination for Live Dog
Re-entry into the United States Form, importers may provide proof that
the dogs have only been in DMRVV-free or DMRVV low-risk countries
during the six months prior to arriving in the United States (i.e., to
demonstrate the dog had not been in a high-risk country).
All dog imports arriving on aircraft conveyances, regardless of
whether they arrive from countries that are DMRVV-free or at low- or
high-risk for DMRVV, are subject to a six-month minimum age
requirement. Dog imports arriving at land ports are only subject to the
six-month minimum age requirement if an importer needs to import three
or more dogs younger than six months of age in a calendar year. In
addition, all dogs would need to be implanted with microchips for
identification purposes (if the NPRM is finalized as proposed). All
dogs, regardless of country of origin, would be listed on a bill of
lading by the airline, if entering the U.S. via air. All importers of
dogs arriving at an air, land, or seaport would have to submit a CDC
Import Submission Form to CDC via a CDC-approved system prior to the
dog's departure from the foreign country. The form would need to be
presented to the airline or other carrier prior to boarding and upon
arrival in the United States.
The annualized and present value estimates of monetized costs and
benefits over the 10-year period from 2023 through 2032 using three
percent and seven percent discount rates are summarized in Tables 5 and
6. The annualized, monetized costs (2020 USD) of the provisions in the
NPRM (if finalized as proposed) are estimated to be $29 million (range:
$7.8 to $88 million) using a three percent discount rate, and the
results were almost unchanged using a seven percent discount rate. Most
monetized costs are expected to be incurred by importers (84 percent
for the most likely estimate). The estimated monetized costs are
expected to be less for importers of dogs from DMRVV-free or DMRVV low-
risk countries compared to importers of dogs from DMRVV high-risk
countries. The proposed provisions estimated to result in the greatest
increase in costs for importers of dogs imported from DMRVV-free
countries were associated with the additional costs associated with the
minimum age, and with the microchip requirements, and completing the
new CDC Import Submission Form.
The provisions estimated to result in the greatest increase in
costs for importers of dogs from DMRVV high-risk countries were
associated with the requirements regarding use of a CDC-registered
Animal Care Facility for foreign-vaccinated dogs from DMRVV high-risk
countries in proposed section 71.51(k). Other costs included: (1)
laboratory testing, (2) an expected reduction in the number of dogs
imported from DMRVV high-risk countries, (3) the need for some
travelers to re-route travel to an airport with a CDC quarantine
station or airport with a CDC-registered Animal Care Facility, and (4)
the costs with providing a CDC Import Certification of Rabies
Vaccination and Microchip Required for All Live Dog Importations into
the United States Form or Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into the United States Form
(certified by an Official Government Veterinarian). Airlines are
expected to incur the greatest costs among carriers and their costs are
estimated to comprise about 8.7 percent of the estimated annualized,
monetized costs, with most of their costs associated with ensuring that
all transported dogs comply with the bill of
[[Page 44003]]
lading requirements of the NPRM (if finalized as proposed) and a
reduction in the number of dogs transported. HHS/CDC was unable to
estimate costs from other types of carriers of dogs arriving by land or
sea and welcomes public comment on their potential costs. CDC is
estimated to incur about 6.9 percent of the annualized, monetized costs
(most likely estimate) associated with the provisions of this NPRM (if
finalized as proposed). Most CDC costs would be associated with the
oversight of animal care facilities and laboratory proficiency testing
programs for dogs imported from high-risk countries. CBP is expected to
incur about 0.5 percent of the annualized costs (most likely estimate)
associated with the provisions of this NPRM (if finalized as proposed).
Most CBP costs would result from training personnel to implement the
proposed requirements.
The annualized monetized benefits of the provisions in the NPRM (if
finalized as proposed) are estimated to be about $1.9 million (range:
$0.80 to $4.0 million) using a three percent or seven percent discount
rate, with most of the benefits accruing to importers (46 percent of
the most likely estimates) and to CBP (33 percent of the most likely
estimates). Some of the benefits estimated for both importers and CBP
would result from reduced time spent on screening dogs from high-risk
countries at U.S. ports. The amount of time required per dog at U.S.
ports would be reduced because it is assumed that the CDC standardized
vaccination forms would be easier to review compared to non-
standardized documentation for dogs arriving from DMRVV high-risk
countries. The provisions in this NPRM (if finalized as proposed) are
also estimated to reduce the number of dogs denied entry or arriving
ill or dead, with benefits estimated for importers, airlines, CBP, and
CDC.
The wide range between the lower-bound and upper-bound cost and
benefit estimates demonstrates that there is considerable uncertainty
in these results. More details on the input parameters and assumptions
used to generate these estimates may be found in the Appendix under the
Supplemental Materials tab of the docket. At present, the number of
dogs imported into the United States is neither accurately nor
completely tracked by any data system, and the uncertainty in the cost
and benefit estimates reflect uncertainty in both the total number of
dogs imported and the number of dogs imported from DMRVV high-risk
countries, as well as the cost of the new requirements included in the
NPRM (if finalized as proposed). The net annualized, monetized costs
(total cost estimate-total benefit estimate) are estimated to be about
$26 million per year (range: $6.9 to $83 million) using a three percent
discount rate.
Table 5--Annualized, Monetized Costs and Benefits Summary Table
[In 2020 million dollars, over a 10-year time horizon relative to baseline, three percent or seven percent
discount rate]
----------------------------------------------------------------------------------------------------------------
Most likely
estimate Lower bound Upper bound Source (RIA section)
----------------------------------------------------------------------------------------------------------------
Annualized, monetized benefits (reduced costs)
----------------------------------------------------------------------------------------------------------------
Three percent discount rate:
Importer benefits............... $0.89 $0.37 $1.8 B1, B2, B3.
Airline benefits................ 0.18 0.038 0.59 B4.
DHS/CBP benefits................ 0.65 0.30 0.95 B5.
HHS/CDC benefits................ 0.22 0.090 0.59 B6.
State and local health 0.05 0.0 0.022 B7.
department benefits.
---------------------------------------------------------------------------
Total benefits (A1)......... 1.9 0.8 4.0
----------------------------------------------------------------------------------------------------------------
Seven percent discount rate:
Importer benefits............... 0.89 0.37 1.8 B1, B2, B3.
Airline benefits................ 0.18 0.038 0.59 B4.
DHS/CBP benefits................ 0.65 0.30 0.95 B5.
HHS/CDC benefits................ 0.22 0.090 0.59 B6.
State and local health 0.005 0.0 0.022 B7.
department benefits.
---------------------------------------------------------------------------
Total benefits (A2)......... 1.9 0.80 4.0
----------------------------------------------------------------------------------------------------------------
Quantified, but unmonetized, The response costs associated with a dog C1.
benefits. imported while infected with DMRVV were
estimated to be about $320,000, ranging from
$220,000 to $520,000. The requirements in the
NPRM (if finalized as proposed) reduce the
risk of imported dogs arriving with DMRVV, and
the costs associated with rabies response
activities will decrease.
----------------------------------------------------------------------------------------------------------------
[[Page 44004]]
Qualitative (unquantified) benefits. With each importation of a dog infected with D1.
DMRVV, there is a risk that a person may
become infected and die or that DMRVV may be
re-introduced in the U.S. wildlife population,
which could dramatically increase costs
relative to the public health response cost
summarized above. In addition, by obtaining
high-quality data on the number of dogs
imported by country, CDC and other Federal
agencies, including USDA, will improve
preparedness for outbreaks of new and emerging
infectious disease threats to humans (e.g.,
DMRVV) and animals (e.g., African swine
fever). The provisions of the NPRM (if
finalized as proposed) will also ensure that
dogs that are denied entry or arrive ill will
receive the veterinary care needed to protect
their health and safety.
----------------------------------------------------------------------------------------------------------------
Annualized, monetized costs
----------------------------------------------------------------------------------------------------------------
Three percent discount rate:
Importer costs.................. 23.8 5.2 79.1 B1, B2, B3.
Airline costs................... 2.5 1.0 5.2 B4.
DHS/CBP costs................... 0.1 0.05 0.3 B5.
HHS/CDC costs................... 1.9 1.4 2.5 B6.
---------------------------------------------------------------------------
Total costs (B1)............ 28.3 7.7 87.1
----------------------------------------------------------------------------------------------------------------
Seven percent discount rate:
Importer costs.................. 23.9 5.3 79.6 B1, B2, B3.
Airline costs................... 2.5 1.0 5.2 B4.
DHS/CBP costs................... 0.2 0.06 0.4 B5.
HHS/CDC costs................... 2.0 1.4 2.6 B6.
---------------------------------------------------------------------------
Total costs (B2)............ 28.6 7.8 87.8
----------------------------------------------------------------------------------------------------------------
Quantified, but unmonetized, costs.. Not applicable. C2.
----------------------------------------------------------------------------------------------------------------
Qualitative (unquantified) costs.... CDC would monitor countries and may suspend D2.
entry of dogs from countries with repeated
instances of dogs with falsified or fraudulent
rabies vaccination documentation. The lost
value of these imports would impact some U.S.
businesses and dog purchasers. In addition,
the duration of any suspensions for these
countries is highly uncertain and may be ended
in the event of improvement of those
countries' dog export controls. CDC is
proposing the authority to issue orders to
revoke a carrier's or importer's permission to
transport live dogs and cats if either has
endangered the public's health; however, CDC
does not have any plans to suspend any
carriers or importers at this time. Owners of
dogs that undergo a 28-day quarantine period
may suffer qualitative costs from being
separated from their dogs during quarantine.
----------------------------------------------------------------------------------------------------------------
Net annualized costs
----------------------------------------------------------------------------------------------------------------
Total (three percent discount rate), 26.4 6.9 83.1
(B1)-(A1).
Total (seven percent discount rate), 26.6 7.0 83.8
(B1)-(A1).
----------------------------------------------------------------------------------------------------------------
The present value of the estimated monetized cost over a 10-year
period for the provisions in the NPRM (if finalized as proposed) is
estimated to be $240 million (range: $65 to $740 million) using a three
percent discount or $200 million (range: $53 to $610 million) using a
seven percent discount rate. The present value of monetized benefits
over a 10-year period of the provisions in the NPRM (if finalized as
proposed) is estimated at $17 million (range: $6.9 to
[[Page 44005]]
$34 million) using a three percent discount rate or $14 million (range:
$5.7 to $28 million) using a seven percent discount rate. The net
annualized monetized cost (total costs-total benefits) is estimated at
$230 million per year (range: $58 to $700 million) using a three
percent discount rate and $190 million per year (range: $48 to $580
million) using a seven percent discount rate.
Table 6--Present Value of Costs and Benefits Summary Table
[In 2020 million dollars, over a 10-year time horizon relative to baseline, three percent or seven percent
discount rate]
----------------------------------------------------------------------------------------------------------------
Most likely
estimate Lower bound Upper bound Source (RIA section)
----------------------------------------------------------------------------------------------------------------
Present value of monetized benefits (reduced costs)
----------------------------------------------------------------------------------------------------------------
Three percent discount rate:
Importer benefits............... $7.6 $3.2 $16 B1, B2, B3.
Airline benefits................ 1.5 0.32 5.0 B4.
DHS/CBP benefits................ 5.5 2.6 8.1 B5.
HHS/CDC benefits.................... 1.9 0.77 5.0 B6.
State and local health 0.042 0.0 0.19 B7.
department benefits.
---------------------------------------------------------------------------
Total benefits (A).......... 17 6.9 34
----------------------------------------------------------------------------------------------------------------
Seven percent discount rate:
Importer benefits............... 6.3 2.6 13 B1, B2, B3.
Airline benefits................ 1.2 0.27 4.1 B4.
DHS/CBP benefits................ 4.6 2.1 6.7 B5.
HHS/CDC benefits................ 1.6 0.63 4.1 B6.
State and local health 0.034 0.0 0.16 B7.
department benefits.
---------------------------------------------------------------------------
Total benefits.............. 14 5.7 28
----------------------------------------------------------------------------------------------------------------
Quantified, but unmonetized, The response costs associated with a dog C1.
benefits. imported while infected with DMRVV were
estimated to be about $320,000, ranging from
$220,000 to $520,000. The requirements in the
NPRM (if finalized as proposed) reduce the
risk of imported dogs arriving with DMRVV, and
the costs associated with rabies response
activities will decrease.
----------------------------------------------------------------------------------------------------------------
Qualitative (unquantified) benefits. With each importation of a dog infected with D1.
DMRVV, there is a risk that a person may
become infected and die or that DMRVV may be
re-introduced in the U.S. wildlife population,
which could dramatically increase costs
relative to the public health response cost
summarized above. In addition, by obtaining
high-quality data on the number of dogs
imported by country, CDC and other Federal
agencies, including USDA, will improve
preparedness for outbreaks of new and emerging
infectious disease threats to humans (e.g.,
DMRVV) and animals (e.g., African swine
fever). The provisions of the NPRM (if
finalized as proposed) will also ensure that
dogs that are denied entry or arrive ill will
receive the veterinary care needed to protect
their health and safety.
----------------------------------------------------------------------------------------------------------------
Present value of monetized costs
----------------------------------------------------------------------------------------------------------------
Three percent discount rate:
Importer costs.................. 203 45 675 B1, B2, B3.
Airline costs................... 21 8 41 B4.
DHS/CBP costs................... 1.1 0.4 2.6 B5.
CDC costs....................... 17 11 18 B6.
---------------------------------------------------------------------------
Total costs (B)............. 242 64 737
----------------------------------------------------------------------------------------------------------------
Seven percent discount rate:
Importer costs.................. 168 37 559 B1, B2, B3.
Airline costs................... 17 6.6 33 B4.
DHS/CBP costs................... 1.1 0.4 2.4 B5.
CDC costs....................... 14 9.3 14 B6.
---------------------------------------------------------------------------
Total costs................. 200 53 608
----------------------------------------------------------------------------------------------------------------
[[Page 44006]]
Quantified, but unmonetized, costs.. Not applicable. C2.
----------------------------------------------------------------------------------------------------------------
Qualitative (unquantified) costs.... CDC would monitor countries and may suspend D2.
entry of dogs from countries with repeated
instances of dogs with falsified or fraudulent
vaccine credentials or invalid rabies
vaccination documentation. The lost value of
these imports would impact some U.S.
businesses and dog purchasers. In addition,
the duration of any suspensions for these
countries is highly uncertain and may be ended
in the event of improvement of those
countries' dog export controls. CDC is
proposing the authority to issue orders to
revoke a carrier's or importer's permission to
transport live dogs and cats if either has
endangered the public's health; however, CDC
does not have any plans to suspend any
carriers or importers at this time. Owners of
dogs that undergo a 28-day quarantine period
may suffer qualitative costs from being
separated from their dogs during quarantine.
----------------------------------------------------------------------------------------------------------------
Net annualized costs
----------------------------------------------------------------------------------------------------------------
Total (three percent discount rate), 225 58 702
(B1)-(A1).
Total (seven percent discount rate), 187 48 581
(B1)-(A1).
----------------------------------------------------------------------------------------------------------------
The United States was declared DMRVV-free in 2007. Importing dogs
from DMRVV high-risk countries involves a significant public health
risk. The proposed provisions of this NPRM (if finalized as proposed)
would better align U.S. dog importation requirements with those of
other countries that have been declared DMRVV-free. Further, the
serologic testing requirements are consistent with recommendations in
the WOAH Terrestrial Manual for dogs imported from DMRVV high-risk
countries to DMRVV-free countries.\121\ One DMRVV-infected dog may
cause transmission to humans, domestic pets, livestock, or wildlife.
The average cost per importation of a DMRVV-infected dog was estimated
to be $320,000 (range: $220,000 to $520,000) to conduct public health
investigations and administer rabies PEP to exposed persons.
---------------------------------------------------------------------------
\121\ WOAH Terrestrial Animal Health Code. Chapter 5.11.
Available at: Access online: WOAH--World Organisation for Animal
Health https://www.woah.org/en/what-we-do/standards/codes-and-manuals/terrestrial-code-online-access/?id=169&L=0&htmfile=chapitre_certif_rabies.htm.
---------------------------------------------------------------------------
Historically, CDC's has denied entry to approximately 200 dogs
annually due to fraudulent, incomplete, or inaccurate paperwork.\122\
However, between January 2020 and July 2021 (i.e., during the COVID-19
pandemic, prior to the temporary suspension), CDC documented more than
1000 instances of incomplete, inadequate, or fraudulent rabies
vaccination certificates for dogs arriving from DMRVV high-risk
countries.\123\ The diversion of public health resources globally to
COVID-19 response activities has contributed to a lapse in canine
rabies vaccination efforts and a related increase in the prevalence of
dogs infected with DMRVV in some high-risk countries. The combination
of an increasing number of dogs imported without adequate documentation
of rabies vaccination,\124\ in addition to the potential increase in
the prevalence of DMRVV in high-risk countries,\125\ would increase the
risk of importation of dogs that are infected with DMRVV. This
combination of factors would increase the likelihood of DMRVV-
importation events relative to the time-period before the COVID-19
pandemic.
---------------------------------------------------------------------------
\122\ Centers for Disease Control and Prevention (2021).
Quarantine Activity Reporting System (version 4.9.8.8.2.2A). Dog
Importation data, 2010-2019. Accessed October 1, 2022.
\123\ Pieracci, E., Williams, C., Wallace, R., Kalapura, C.,
Brown, C. U.S. dog importations during the COVID-19 pandemic: Do we
have an erupting problem? PLoS ONE, 16(9), e0254287. doi: 10.1371/
journal.pone.0254287.
\124\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2020. Accessed: 15 February 2021.
\125\ A Kunkel, Jeon S, Haim, Dilius CJP, Crowdis K, Meltzer MI,
Wallace R. (2021) The urgency of resuming disrupted dog rabies
vaccination campaigns: a modeling and cost-effectiveness analysis.
Scientific Reports; 11:12476. https://https://doi.org/10.1038/s41598-021-92067-5.
---------------------------------------------------------------------------
CDC is unable to predict future trends with or without the proposed
provisions included in this NPRM to estimate how many dogs infected
with DMRVV may be imported. Two rabid dog imports (both from Iran) have
been reported in Canada within a seven-month period (specifically July
2021 and January 2022) at around the same time the United States
implemented a temporary suspension of dogs imported from DMRVV high-
risk countries. Prior to these two imports, Canada had not reported a
dog infected with DMRVV since the 1960s.\126\ Given the limited number
of reported dogs with DMRVV, this observation may be indicative of a
higher risk for dogs imported from DMRVV high-risk countries during the
COVID-19 pandemic or could be anomalous occurrences in Canada. However,
the provisions included in the NPRM (if finalized as proposed) is
expected to substantively reduce the risk of importation of dogs
infected with DMRVV relative to baseline.
---------------------------------------------------------------------------
\126\ Outbreak News Today (Feb. 10, 2022) Rabies case reported
in Toronto in a dog imported from Iran. https://outbreaknewstoday.com/rabies-case-reported-in-toronto-in-a-dog-imported-from-iran-46958. Accessed: February 14, 2022.
---------------------------------------------------------------------------
The primary public health benefit of this NPRM (if finalized as
proposed) is
[[Page 44007]]
the reduced risk that a dog infected with DMRVV will be imported from a
high-risk country. Using the most likely estimates of the net monetized
cost estimate ($26.4 million) and the most likely estimate of the
potential benefit of averting the importation of one dog with DMRVV
from a high-risk country ($320,000), it is possible to calculate the
change in the number of imported dogs infected with DMRVV if the
provisions of the NPRM are finalized as proposed relative to the
baseline such that the benefit would equal cost. The net cost ($26.4
million) divided by the cost per importation ($320,000) suggests that
the provisions of the NPRM (if finalized as proposed) relative to
baseline would have to avert the importation of 82 dogs infected with
DMRVV for the benefit to exceed the cost. This would require an
increase in the number of dogs imported into the United States while
infected with DMRVV, which could only occur because of widespread
failures of rabies control programs in multiple countries. However,
this analysis does not consider the potential for fatal rabies cases in
people or the risk of reintroduction of DMRVV in the United States, as
analyzed below.
The above estimate of the cost of an importation of a dog with
DMRVV does not account for the worst-case outcomes, which include (1)
transmission of rabies to a person who dies from the disease, or (2)
ongoing transmission to other domestic and wildlife species in the
United States. The cost of re-introduction could be especially high if
DMRVV spreads to other species of U.S. wildlife. Re-establishment of
DMRVV in the United States could result in costly efforts over several
years to eliminate the virus again. Both worst-case outcomes may be
more likely to occur after the COVID-19 pandemic because public health
resources were diverted to COVID-19 response activities and disruptions
in rabies control programs in high-risk countries. Disruptions to
rabies control programs in DMRVV high-risk countries may contribute to
elevated risks even as the COVID-19 pandemic wanes.
Human deaths from rabies continue to occur in the United States
after exposure to wild animals; however, no U.S. resident has died
after exposure to an imported dog with DMRVV in at least 20 years. CDC
uses the value of statistical life (VSL) to assign a value to
interventions that can result in mortality risk reductions. For fatal
cases, HHS recommends the use of the value of statistical life to
estimate the potential benefits of averted deaths, an estimate of $11.6
million in 2020 USD and a range of $5.5 to $17.7 million.\127\ However,
CDC is unable to estimate the potential magnitude of the mortality risk
reduction associated with the proposed rule. Based on the median VSL,
the provisions of the NPRM (if finalized as proposed) would need to
help avert three or more human deaths per year for the benefits to
exceed costs (or an average of 2.3 deaths per year over multiple
years).
---------------------------------------------------------------------------
\127\ U.S. Department of Health and Human Services, 2016. Office
of the Assistant Secretary for Planning and Evaluation. Guidelines
for Regulatory Impact Analysis. https://aspe.hhs.gov/system/files/pdf/242926/HHS_RIAGuidance.pdf. Accessed: April 20, 2020.
---------------------------------------------------------------------------
Efforts to eliminate DMRVV if re-established in the United States
would also prove costly. A previous campaign to eliminate domestic dog-
coyote rabies virus variant jointly with gray fox (Texas fox) rabies
virus variant in Texas over the period from 1995 through 2003 cost $34
million,128 129 or $55 million in 2022 USD. The costs to
contain any reintroduction would depend on the time-period before the
reintroduction was realized, the wildlife species in which DMRVV was
transmitted, and the geographic area over which reintroduction occurs.
The above estimate is limited to the cost of rabies vaccination
programs for targeted wildlife and does not include the costs to
administer PEP to any persons exposed after the reintroduction has been
identified. Human deaths from DMRVV could increase following the re-
introduction of DMRVV to the United States as the risk of exposure
would increase.
---------------------------------------------------------------------------
\128\ TJ Sidwa et al. (2005) Evaluation of oral rabies
vaccination programs for control of rabies epizootics in coyotes and
gray foxes: 1995-2003. Journal of the American Veterinary Medicine
Association; 227(5):785-92.
\129\ R.T. Sterner et al. (2009) Tactics and Economics of
Wildlife Oral Rabies Vaccination, Canada and the United States.
Emerging Infectious Diseases; 15(8), 1176-1184.
---------------------------------------------------------------------------
The provisions of the NPRM (if finalized as proposed) would also
ensure that dogs that are denied admission or arrive ill will be housed
appropriately and receive the veterinary care needed to protect their
health and safety. This will reduce the likelihood that dogs may be
left in unsafe conditions in cargo warehouses for extended periods of
time (i.e., longer than six hours) with the potential to expose workers
who are not trained to handle live animals safely.\130\
---------------------------------------------------------------------------
\130\ https://www.cbsnews.com/chicago/news/dog-dies-at-ohare-airport-warehouse-17-others-saved-after-being-left-without-food-or-water-for-3-days/.
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Under the current baseline, the number of dogs imported into the
United States is neither accurately nor completely tracked. The more
comprehensive data collection proposed in this NPRM through the CDC
Import Submission Form would benefit public health investigations and
enable better and more timely contact tracing of all animals exposed to
an imported dog with DMRVV. The current lack of data also inhibits the
Federal government's ability to target interventions for dogs imported
from specific countries. The collection of data from the CDC Import
Submission Form as proposed in this NPRM may also benefit other
agencies such as USDA/APHIS that may want to regulate dog imports based
on the risk of introduction of diseases that may affect U.S. livestock.
For example, in 2021, APHIS regulated importers of dogs for resale
based on whether the dogs were imported from countries where African
swine fever exists.\131\ The potential economic benefits of reducing
the risk of the importation of African swine fever could be
significant. For example, a recent African swine fever outbreak in
China was estimated to have total economic losses equivalent to 0.78
percent of China's gross domestic product in 2019.\132\ The requirement
in the NPRM (if finalized as proposed) to report all dogs to CDC via a
CDC-approved system would reduce the risk of importation of infected
dogs from countries with ongoing disease outbreaks that may affect
livestock.
---------------------------------------------------------------------------
\131\ Animal and Plant Health Inspection Service (Aug. 4, 2021)
USDA Announces Requirements for Importing Dogs from Countries
Affected with African Swine Fever. https://www.aphis.usda.gov/aphis/newsroom/news/sa_by_date/sa-2021/asf-dog-imports. Accessed: 05
February 2022.
\132\ Shibing You, Tingyi Liu, Miao Zhang, Xue Zhao, Yizhe Dong,
Bi Wu, Yanzhen Wang, Juan Li, Xinjie Wei and Baofeng Shi (2021)
African swine fever outbreaks in China led to gross domestic product
and economic losses. Nature Food; 2: 802-808.
---------------------------------------------------------------------------
Viruses exploiting new host species have led to some of the most
devastating disease epidemics, such as influenza, Ebola, and the HIV/
AIDS pandemic.\133\ Viruses continually evolve in their animal hosts.
This has been observed in viruses such as avian and swine influenza
viruses, constituting a permanent pandemic threat to humans.\134\
Although CDC cannot predict when future zoonotic diseases may emerge or
whether future zoonotic diseases may be associated with transmission
from dogs to humans, such events remain a possibility. Future dog-
[[Page 44008]]
mediated zoonotic diseases may pose an acute risk to the public's
health because, in contrast to other animal imports, most dogs are
imported as pets and will be in close contact with their owners.
---------------------------------------------------------------------------
\133\ Woolhouse M, Haydon D, Antia R. Emerging pathogens: the
epidemiology and evolution of species jumps. Trends in Ecology &
Evolution 2005; 20 (5): 238-244. https://doi.org/10.1016/j.tree.2005.02.009.
\134\ Woolhouse M, Haydon D, Antia R. Emerging pathogens: the
epidemiology and evolution of species jumps. Trends in Ecology &
Evolution 2005; 20 (5): 238-244. https://doi.org/10.1016/j.tree.2005.02.009.
---------------------------------------------------------------------------
During the COVID-19 pandemic a variant of the SARS-CoV-2 virus was
detected in mink populations in Europe and entered human populations
from this animal host. Between February 18, 2020, and December 15,
2021, 457 mink farms in 12 countries experienced SARS-CoV-2 outbreaks
\135\ and mink-to-human transmission of the SARS-CoV-2 virus was
documented on mink farms in the Netherlands, Denmark, Poland, and the
United States.136 137 138 In August and September of 2020,
Denmark documented a mink-associated SARS-CoV-2 variant strain found in
12 people, eight of whom had links to the mink farming industry. Due to
concerns about transmissibility, immunity, and potential impacts on
vaccine efficacy, the Danish government ordered that all 15-17 million
minks in the country be culled. Following a risk assessment of live
mink importations from the Western European region to the United
States, CDC determined additional regulatory action to prohibit live
mink importations was unnecessary due to public health prevention
measures taken by mink importers and the low numbers of imported mink.
In comparison, CDC would not have the same data available to conduct a
risk assessment for dog imports in the event of a future dog-mediated
zoonotic disease outbreak because dog imports are neither accurately
nor completely tracked in any government data system in the absence of
the dog import submission data requirement proposed in this NPRM.
---------------------------------------------------------------------------
\135\ Koopmans M. SARS-CoV-2 and the human-animal interface:
outbreaks on mink farms. The Lancet Infectious Diseases 2021; 21
(1): 18-19.
\136\ Hammer AS, Quaade ML, Rasmussen TB, et al. SARS-CoV-2
Transmission between Mink (Neovison vison) and Humans, Denmark.
Emerg Infect Dis. 2021 Feb;27(2):547-551. doi: 10.3201/
eid2702.203794. Epub 2020 Nov 18. PMID: 33207152; PMCID: PMC7853580.
\137\ Oude Munnink BB, Sikkema RS, Nieuwenhuijse DF, et al.
Transmission of SARS-CoV-2 on mink farms between humans and mink and
back to humans. Science. 2021 Jan 8;371(6525):172-177. doi: 10.1126/
science.abe5901. Epub 2020 Nov 10. PMID: 33172935; PMCID:
PMC7857398.
\138\ Rabalski L, Kosinki M, Mazur-Panasiuk N, et al. Zoonotic
spillover of SARS-CoV-2: mink-adapted virus in humans. Available at:
https://www.biorxiv.org/content/10.1101/2021.03.05.433713v1.full.pdf.
---------------------------------------------------------------------------
The proposed reporting of dog import volumes by country in an
approved CDC import submission data system provides an opportunity to
target interventions for dogs imported from specific countries. Such
reporting as proposed in 42 CFR 71.51(h) would allow CDC or other
Federal agencies to more easily implement preventive measures to
mitigate the risk of introductions of new zoonotic diseases targeted to
specific countries of concern. The import submission data requirement
may also help CDC and other Federal agencies, as well as State and
local health departments, retrospectively inspect shipments from
specific countries. This would reduce the costs of future
interventions; however, CDC is not able to quantify future savings.
The provisions of the NPRM (if finalized as proposed) are expected
to reduce the risk of dogs arriving while ill. If an animal arrives in
the United States and appears ill or is dead, a public health
investigation is required to ensure the ill or dead animal does not
present a public health threat. The overall health of an animal can
play a significant role in whether it can maintain core body functions
(i.e., body temperature regulation and glucose levels) during prolonged
flights. Stressed, malnourished, and young animals are more likely to
become ill and can transmit communicable diseases that can affect
humans; 139 140 therefore, safety and welfare concerns for
the transport of dogs have a public health impact that requires a
degree of oversight from public health agencies to ensure human and
animal health is protected.\141\
---------------------------------------------------------------------------
\139\ Galanis E et al. Brucellosis and other diseases imported
with dogs. BCMJ 2019; 61 (4): 177-190. Available at: https://bcmj.org/bccdc/brucellosis-and-other-diseases-imported-dogs.
\140\ Denstedt E. Echinococcus multilocularis as an emerging
public health threat in Canada: A knowledge synthesis and needs
assessment. Accessed: February 28, 2019. Available at: www.ncceh.ca/
sites/default/files/Guelph-Denstedt-2017.pdf.
\141\ Pieracci EG, Maskery B, Stauffer K, Gertz A, Brown C. Risk
factors for death and illness in dogs imported into the United
States, 2010-2018. Transbound Emerg Dis. 2022 Mar 15. doi: 10.1111/
tbed.14510.
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In addition to the unmonetized benefits described above, there may
be additional unmonetized costs. CDC plans to monitor countries and may
suspend entry of dogs from countries with repeated instances of
falsified or fraudulent dog vaccine credentials or invalid rabies
vaccination documents. The lost value of imports from DMRVV-restricted
countries would impact some U.S. businesses and dog purchasers.
However, the duration of any suspensions for these countries is highly
uncertain and may be ended in the event of improvement of those
countries' export controls.
HHS/CDC is proposing the authority to issue orders to revoke a
carrier's permission to transport live dogs and cats if a carrier has
endangered the public's health; however, CDC does not have plans to
suspend any carriers at this time.
CDC lacks data on the cost to airlines of ensuring that a
representative of an airline transporting live dogs into the United
States be on-site at the U.S. port and available to coordinate the
entry/clearance of the dogs with Federal government officials until all
live dogs on an arriving flight into the United States have either been
cleared for entry or arrangements have been made to transport the dogs
to a CDC-registered Animal Care Facility or other facility (e.g.,
veterinary clinic or kennel) approved by CDC pending admissibility
determination. CDC believes this will only incur additional costs on
occasion since airline staff are typically available on-site. However,
HHS/CDC requests public comment to provide more data to estimate costs
associated with this proposed requirement.
Impact of the NPRM (if Finalized as Proposed) on Dog Import Volumes
Although the U.S. Government does not precisely track the total
number of dogs imported each year, it was previously estimated that
approximately 1 million dogs are imported into the United States
annually, of which 100,000 dogs are from DMRVV high-risk
countries.\142\ This estimate was based on information provided by
airlines, CBP, and a zoonoses public health study conducted at a U.S.-
Mexico land border crossing.\143\
---------------------------------------------------------------------------
\142\ HHS/CDC. Guidance Regarding Agency Interpretation of
``Rabies-Free'' as It Relates to the Importation of Dogs Into the
United States. 84 FR 724 (Jan. 31, 2019).
\143\ McQuiston, J.H., et al., Importation of dogs into the
United States: risks from rabies and other zoonotic diseases.
Zoonoses Public Health, 2008. 55(8-10): p. 421-6.
---------------------------------------------------------------------------
CBP does record, by country, the number of dogs imported with
formal entry under Harmonized Tariff Schedule (HTS) code 0106.19.91.20
and HTS Description: Other live animals, other, other, dogs. CDC used
these data from CBP to update its estimates of the annual number of
imported dogs. The total number of dogs imported into the United States
from all countries under this HTS category varied from 25,232 in 2018
to 58,540 in 2020. The number of dogs from DMRVV high-risk countries
under this HTS category averaged 16,390 and varied from 9,966 to 24,031
over this three-year period. Over the three-year period, 43,000 dogs on
average were imported per year, with
[[Page 44009]]
about 38 percent arriving from DMRVV high-risk countries. The number of
dogs reported under this HTS category does not include dogs imported as
checked baggage, hand-carried in airplane cabins, or crossing land
borders without formal entry. Thus, the number underestimates the true
number of dogs imported into the United States. The fraction of dogs
with this HTS code arriving from DMRVV high-risk countries (38 percent)
is much greater than the fraction estimated by CBP field staff (15
percent) in a previous data collection.\144\ This could result if the
composition of dogs imported for resale or adoption under the HTS code
is different than the full distribution of imported dogs. In other
words, more individuals may travel internationally with their personal
pets or relocate to the United States from DMRVV-free or DMRVV low-risk
countries. CDC adjusted for the difference in the fraction of dogs
imported from DMRVV-free or DMRVV low-risk countries based on estimates
from CBP field staff of this fraction and then re-estimated the number
of imported dogs arriving at airports, as summarized in Section A2 of
the Regulatory Impact Analysis.
---------------------------------------------------------------------------
\144\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United
States. 84 FR 724 (Jan. 31, 2019).
---------------------------------------------------------------------------
CDC used previously reported estimates of the number of dogs
arriving at the land ports with Canada and Mexico.\145\ The updated
estimates for dog imports under the baseline are summarized in Table 7.
In total, CDC estimated that under the current regulatory baseline,
about 800,000 imported dogs would arrive in the United States each year
and that about 500 dogs from DMRVV high-risk countries would be denied
admission. The number denied entry is based on CDC data from 2020 and
the first six months of 2021 prior to the suspension of dog imports
from DMRVV high-risk countries. This approach may overestimate the
number of dogs denied entry in the future if the COVID-19 pandemic was
associated with a significant increase in dogs denied admission due to
pandemic-associated factors. Since dog rabies vaccine certificates are
not currently required for dogs from DMRVV-free or DMRVV low-risk
countries, CDC did not assume any dogs from these countries would be
denied admission under the baseline.
---------------------------------------------------------------------------
\145\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United
States. 84 FR 724 (Jan. 31, 2019).
Table 7--Estimated Annual Numbers of Dogs Imported Into the United States Under the Current Regulatory Baseline
----------------------------------------------------------------------------------------------------------------
Most likely
estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
Baseline estimate of dog imports
----------------------------------------------------------------------------------------------------------------
From DMRVV-free or DMRVV low-risk countries under baseline, 733,787 619,229 848,344
total..........................................................
Airports.................................................... 371,507 297,205 445,808
Land ports.................................................. 362,280 322,024 402,536
Canada-U.S. land ports \146\............................ 120,780 96,624 144,936
Mexico-U.S. land ports \147\............................ 241,500 225,400 257,600
Dogs temporarily denied admission............................... 0 0 0
From DMRVV high-risk countries.................................. 65,560 32,780 98,340
Dogs approved entry with adequate rabies vaccination 65,060 32,480 97,590
documentation..............................................
Dogs denied admission....................................... 500 300 750
-----------------------------------------------
Total dog imports at baseline....................... 798,847 651,709 945,934
----------------------------------------------------------------------------------------------------------------
The provisions of the NPRM (if finalized as proposed) that are
expected to reduce the number of dog imports include: (1) age
restrictions on air travel for all dogs under six months of age,
including dogs from both DMRVV high-risk and DMRVV low-risk countries;
(2) restricting the number of dogs under six months of age allowed to
enter the United States at land ports to three or fewer; and (3) the
additional costs of fulfilling the requirements for follow-up and
revaccination at CDC-registered Animal Care Facilities for foreign-
vaccinated dogs from DMRVV high-risk countries. At the same time, CDC
believes that the number of dogs denied admission and returned to their
countries of origin would decrease if the provisions included in the
NPRM are finalized as proposed.
---------------------------------------------------------------------------
\146\ Id.
\147\ Id.
---------------------------------------------------------------------------
The estimated impact of the NPRM (if finalized as proposed) on the
number of dog imports is summarized in Table 8. CDC lacks data on what
fraction of dogs arriving by air are less than six months old under the
baseline. In the absence of this information, CDC assumes five percent
(range: three to eight percent) of dogs currently arriving by air are
less than six months and would not be eligible to be imported into the
United States under the NPRM (if finalized as proposed). CDC also lacks
data on the importers who would want to bring in more than three dogs
less than six months of age within a calendar year, which would no
longer be allowed with the NPRM (if finalized as proposed). CDC notes
that these provisions should primarily impact individuals traveling
with their personal pets because the importation of dogs for resale or
adoption that are less than six months of age is already prohibited by
USDA regulations (7 CFR 2148). Another provision of the NPRM (if
finalized as proposed) would require importers of dogs from DMRVV low-
risk countries to submit written documentation, such as veterinary
medical records, documenting that the animal has been in a DMRVV low-
risk or DMRVV-free country for the six months prior to importation into
the United States. CDC does not anticipate denying admission to dogs
that may arrive from DMRVV low-risk countries without such
documentation if the NPRM is finalized as proposed, but there may be
delays at U.S. ports while CDC confirms dogs from DMRVV low-risk
countries have not been in a DMRVV high-risk country within the
previous six months.
CDC assumes that the additional costs associated with importing
dogs from DMRVV high-risk countries with foreign-issued rabies
vaccination documentation would reduce the
[[Page 44010]]
number of imports by about 20 percent (range: 10 to 30 percent) if the
NPRM is finalized as proposed. In addition, CDC believes the number of
dogs from DMRVV high-risk countries that are denied entry will decrease
if the provisions of the NPRM are finalized as proposed because CDC
will be able to require the use of standardized forms to confirm rabies
vaccination and animal care facility follow-up requirements should be
clear to importers. Based in part on the number of dogs denied entry
during CDC's temporary suspension, CDC estimated that about 50 dogs
from DMRVV high-risk countries would be denied entry under the
provisions of the NPRM (if finalized as proposed). Overall, the
provisions in the NPRM (if finalized as proposed) are expected to have
a small impact on the total number of dogs imported (from about 799,000
at baseline to 770,000 with the provisions of the NPRM in effect and
finalized as proposed).
---------------------------------------------------------------------------
\148\ CDC. Guidance Regarding Agency Interpretation of ``Rabies-
Free'' as It Relates to the Importation of Dogs Into the United
States. 84 FR 724 (Jan. 31, 2019).
\149\ Id.
Table 8--Estimated Average Annual Numbers of Dog Imports by DMRVV Risk Category and by Immunization Status
----------------------------------------------------------------------------------------------------------------
Lower bound Upper bound
Best estimate \b\ \c\
----------------------------------------------------------------------------------------------------------------
Baseline estimate of dog imports
From rabies-free, DMRVV-free, or DMRVV low-risk countries under previous guidance
----------------------------------------------------------------------------------------------------------------
Total........................................................... 733,787 619,229 848,344
Airports...................................................... 371,507 297,205 445,808
Land ports.................................................... 362,280 322,024 402,536
Canada-U.S. land ports \148\.............................. 120,780 96,624 144,936
Mexico-U.S. land ports \149\.............................. 241,500 225,400 257,600
Dogs denied entry from rabies-free, DMRVV-free, or low-risk... 0 0 0
----------------------------------------------------------------------------------------------------------------
Dogs from countries at high risk of DMRVV
----------------------------------------------------------------------------------------------------------------
Total........................................................... 65,560 32,780 98,340
Dogs approved entry with rabies vaccination documentation..... 65,060 32,480 97,590
Estimated fraction of imported dogs from DMRVV high-risk 50% 65% 35%
countries that are U.S.-vaccinated.......................
Estimated U.S.-vaccinated dogs............................ 32,530 21,112 34,157
Estimated foreign-vaccinated dogs......................... 32,530 11,368 63,434
Dogs denied entry \a\......................................... 500 300 750
Total imported dogs \a\......................................... 798,847 651,709 945,934
----------------------------------------------------------------------------------------------------------------
With NPRM (if finalized as proposed)
From rabies-free, DMRVV-free, or low-risk countries
----------------------------------------------------------------------------------------------------------------
Fraction of dogs who are unable to be imported with NPRM (if 5% 3% 8%
finalized as proposed) at airports (due to age restrictions)...
Airports...................................................... 352,931 288,289 410,143
Dogs approved entry....................................... 352,578 288,145 409,528
Dogs temporarily denied entry............................. 353 144 615
Fraction of dogs unable to be imported with NPRM (if finalized 1.0% 0.5% 1.5%
as proposed) at land ports (due to age restrictions)...........
Land ports.................................................... 358,657 320,414 396,498
Canada-U.S. land ports.................................... 119,572 96,141 142,762
Dogs approved entry................................... 119,453 96,093 142,548
Dogs temporarily denied entry......................... 120 48 214
Mexico-U.S. land ports.................................... 239,085 224,273 253,736
Dogs approved entry................................... 238,846 224,161 253,355
Dogs temporarily denied entry......................... 239 112 381
Dogs temporarily denied entry from rabies-free, DMRVV-free, or 712 304 1,210
low-risk (total).............................................
----------------------------------------------------------------------------------------------------------------
Dogs from countries at high risk of DMRVV
----------------------------------------------------------------------------------------------------------------
Fraction of dog imports that would not occur under the 20% 30% 10%
provisions of the NPRM (if finalized as proposed) due to the
higher costs associated with importing foreign-vaccinated dogs
from DMRVV high-risk countries.................................
Total........................................................... 58,554 29,070 91,247
Number of U.S.-vaccinated dogs approved entry................. 32,530 21,112 34,157
Number of foreign-vaccinated dogs approved entry.............. 25,974 7,928 57,090
Total dogs approved entry....................................... 58,504 29,040 91,172
Dogs denied entry and returned to country-of-origin \a\....... 50 30 75
Total imported dogs (with NPRM, if finalized as proposed) \a\... 770,093 637,743 897,813
Total imported dogs (Baseline) \a\.............................. 798,847 651,709 945,934
----------------------------------------------------------------------------------------------------------------
\a\ Since these dogs are denied entry and returned to their countries of origin, they are not included in the
total number of imports.
[[Page 44011]]
CDC did not attempt to project future changes to the volume of dogs
imported annually because of insufficient data. CDC believed that
introducing another factor to project future volumes was not prudent.
HHS/CDC requests public comment from airlines on whether the number of
imported dogs has increased, decreased, or remained relatively constant
in recent years. Such data may be available to airlines if they track
the number of dogs transported each year. While CDC observed an
increase in the number of dogs arriving with fraudulent paperwork prior
to implementing the temporary suspension, this may not correspond to
changes in the total number of dogs imported, of which only a small
fraction arrive with fraudulent paperwork.
The most likely estimates of the annual monetized costs and
benefits for each interested party or implementing partner are
summarized in Table 9 over a 10-year period from 2023 through 2032
using the estimated values presented in Sections B1 through B8 of the
Appendix found in the Supplemental Materials tab of the docket. The
most likely estimate of monetized costs across interested parties is
$39 million in the first year and $27 million in subsequent years. The
most likely estimate of monetized benefits across interested parties
was estimated to be $1.9 million each year.
The annual costs and benefits for importers are split into
importers of dogs from DMRVV-free or DMRVV low-risk countries versus
importers of dogs from DMRVV high-risk countries. However, it is likely
that some importers of dogs from DMRVV high-risk countries may also be
importers of dogs from DMRVV-free or low-risk countries. In addition,
the provisions of the NPRM (if finalized as proposed) may result in
some importers switching from importing dogs from DMRVV high-risk
countries to those from DMRVV-free or low-risk countries.
As a percentage of total costs, importers were estimated to incur
79 to 85 percent of the total costs (most likely estimates), with a
higher fraction of total costs incurred in the subsequent years after
the first year of implementation. Importer costs are approximately 3.8
times greater for dogs imported from DMRVV high-risk countries compared
to dogs from DMRVV-free or low-risk countries. In addition, it is
important to note that more than 10 times as many dogs are estimated to
be imported from DMRVV-free or low-risk countries. Thus, the cost per
dog for importers of dogs from DMRVV high-risk countries is
significantly greater than for importers of dogs from DMRVV-free or
low-risk countries. This is especially true for foreign-vaccinated dogs
from DMRVV high-risk countries.
The costs to airlines are expected to comprise 8.0 to 8.8 percent
of total costs. Among Federal government agency costs for the
provisions included in the NPRM (if finalized as proposed), CBP's
additional costs (0.5 to 2.8 percent of the total) are expected to be
less than CDC's additional costs (6.2 to 10.4 percent of the total).
Table 9--Most Likely Estimates of Annual Monetized Costs and Benefits by Affected Party or Implementing Partner From 2023-2032 Relative to Baseline in
2020 USD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importers Importers of State/local
of dogs dogs from Customs and Centers for public health
Year from DMRVV DMRVV-free or Airlines Border Disease and animal Total
high-risk low-risk Protection Control and health
countries countries Prevention departments
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual monetized costs (million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2023................................................... $24.6 $6.5 $3.2 $1.1 $4.1 $0 $39
2024................................................... 18.1 4.8 2.4 0.004 1.7 0 27
2025................................................... 18.1 4.8 2.4 0.004 1.7 0 27
2026................................................... 18.1 4.8 2.4 0.004 1.7 0 27
2027................................................... 18.1 4.8 2.4 0.004 1.7 0 27
2028................................................... 18.1 4.8 2.4 0.004 1.7 0 27
2029................................................... 18.1 4.8 2.4 0.004 1.7 0 27
2030................................................... 18.1 4.8 2.4 0.004 1.7 0 27
2031................................................... 18.1 4.8 2.4 0.004 1.7 0 27
2032................................................... 18.1 4.8 2.4 0.004 1.7 0 27
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual monetized benefits (million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2023................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2024................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2025................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2026................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2027................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2028................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2029................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2030................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2031................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
2032................................................... 0.81 0.088 0.18 0.65 0.22 0.0049 1.9
--------------------------------------------------------------------------------------------------------------------------------------------------------
The greatest fractions of the most likely estimates of the
monetized benefits associated with the provisions in the NPRM (if
finalized as proposed) would accrue to importers of dogs from DMRVV
high-risk countries (41 percent) and to CBP (33 percent). For both
groups, the costs of screening dogs at U.S. ports would be reduced
since documentation of rabies vaccination would be standardized. This
would result in cost savings for both groups at U.S. ports, although
costs for importers to obtain the standardized forms would increase (as
documented in the cost estimates). Additional benefits are estimated to
accrue to importers of dogs from DMRVV high-risk countries, airlines,
CBP, and CDC from a reduction in the number of dogs denied entry and
returned to their countries of origin.
[[Page 44012]]
The estimates included in this economic impact analysis are highly
uncertain. HHS/CDC requests comments on several parameter estimates and
assumptions in the Appendix found in the Supplemental Materials tab of
the docket. Specifically, HHS/CDC is requesting comment from the public
on the topics listed below:
Procedures applicable at U.S. land and seaports and
whether and how procedures for U.S. land or seaports should differ from
procedures for U.S. airports.
The numbers of dogs imported each year and the numbers of
dogs imported from DMRVV high-risk countries. Such data may be
available from airline operating data for air imports. Public comment
about dogs imported at land or seaports could help to improve
estimates.
The impact of the requirements of this NPRM (if finalized
as proposed) to reduce the number of dogs imported from DMRVV high-risk
countries.
The fraction of imported dogs arriving on air conveyances
that are less than six months of age.
The number of importers that bring in more than three dogs
at land or seaports that are less than six months of age during a
calendar year.
Data showing whether the number of imported dogs has
increased, decreased, or remained relatively constant in recent years.
Such data may be available to airlines if they track the number of dogs
transported each year.
The number of dogs imported at one time or as part of one
shipment on average and if the requirements of this NPRM (if finalized
as proposed) would impact how dogs are imported (e.g., would importers
wait to import a larger group of dogs in a single shipment).
The number of times individuals who travel internationally
with their dogs enter the United States each year.
How this proposed rulemaking would impact the ability of
individuals with foreign-vaccinated service dogs to enter the United
States.
How frequently importers of dogs for adoption or resale
import dogs (i.e., among businesses that import dogs for commercial
purposes, how many shipments are received each year on average). This
information would be used to improve CDC's estimate of the number of
repeat importers.
Costs to owners of young dogs who would have to forego
international travel with their pets.
The additional travel costs and travel time associated
with re-routing travel through an airport with a CDC quarantine station
or an airport with a CDC-registered Animal Care Facility.
The average cost to return a dog to the country of
departure after denial of entry and the cost to importers whose dogs
have been denied entry.
The appropriate range of estimates from airlines for the
profit margin per dog imported on international flights.
The cost to airlines if they were prevented from
transporting dogs on flights in the future.
The cost to CDC-registered Animal Care Facilities to
comply with proposed CDC requirements for these facilities.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act, as amended by the Small
Business Regulatory Enforcement Fairness Act (SBREFA), agencies are
required to analyze regulatory options to minimize the significant
economic impact of a rule on small businesses, small governmental
units, and small not-for-profit organizations. CDC examined the
potential impact of the provisions of this NPRM (if finalized as
proposed) on small entities, including small businesses that may import
dogs for commercial purposes as well as airlines that transport dogs
internationally. HHS/CDC lacks key data on the number of dogs imported
and requests public comment from airlines and small businesses on the
number of dogs imported and the impact of the provisions of the NPRM
(if finalized as proposed) on their standard practices. In the absence
of data on the number of dogs imported, CDC made several assumptions to
estimate revenues from small businesses for different categories of
businesses that may import dogs and used these revenue estimates to
calculate how many dogs could be imported such that the costs
associated with the provisions of this NPRM (if finalized as proposed)
would be less than two percent of estimated revenues.
Based on these analyses, CDC believes that the only small entities
for which this NPRM (if finalized as proposed) would have significant
impacts would be those that specialize in importing dogs from DMRVV
high-risk countries. The provisions of this NPRM (if finalized as
proposed) would not have a significant economic impact on small
airlines and probably would not have a significant impact on small
entities that import dogs from DMRVV-free or DMRVV low-risk countries.
CDC notes that the importation of dogs less than six months of age for
resale or adoption in the United States is already prohibited by USDA
regulations (7 CFR 2148). Thus, the minimum age requirements in this
proposed NPRM (if finalized as proposed) should not impact entities
that sell or resell imported dogs but may impact entities that import
young dogs for commercial purposes other than resale. The NPRM (if
finalized as proposed) does not include provisions that would reduce
costs for small entities relative to other categories of importers.
As part of the economic impact analysis, CDC calculated the
marginal cost associated with the proposed provisions in the NPRM per
dog imported from DMRVV-free or DMRVV low-risk countries ($9.10, range:
$2.60 to $25 per imported dog). The marginal cost associated with the
proposed provisions in the NPRM per dog imported from DMRVV high-risk
countries was further subdivided between foreign-vaccinated dogs
(vaccinated outside the United States) ($810, range: $550 to $1,180)
compared to U.S.-vaccinated dogs ($110, range: $44 to $510). These
estimates cover the first year of implementation after a final rule is
published, assuming the NPRM requirements are finalized as proposed.
Marginal costs in the second year and later are estimated to be about
25 percent less per dog compared to the first year of implementation.
The estimates summarized below are subject to a great degree of
uncertainty. CDC does not know how many dogs any small individual
entity currently imports or the average number of imported dogs across
entities. However, based on the relative estimates of annual revenues
by type of entity and subdivided by the number of employees, CDC
calculated how many dogs each entity could import before this NPRM (if
finalized as proposed) would have a significant economic impact on
their businesses. HHS/CDC welcomes public comments to improve and
refine these estimates.
Small Entities That Import Dogs for Commercial Purposes
The estimated revenues of small businesses likely to import and
resell dogs are summarized in Table 10. Since there are no specific
codes in the North American Industry Classification System (NAICS)
specific to dog importers, CDC used the codes 115210, 423820, 424990,
485991, 812910, and 813312 to estimate the revenue of the small
businesses that may import and resell dogs. The businesses affected by
the NPRM (if finalized as proposed) would be a fraction of the firms
summarized in Table 10, as CDC does not know how many dog importers are
in these categories. Small business status was determined based on
either firms' revenue or the numbers of employees, according to the
Small Business Association's (SBA) table of
[[Page 44013]]
small business size standards.\150\ The revenue of firms in each
business category subdivided by the number of employees was not
available. Using annual payroll data from the Statistics of U.S.
Businesses (SUSB),\151\ CDC estimated the revenue based on the
assumption that each firm's payroll expense would be approximately 15
to 30 percent.\152\
---------------------------------------------------------------------------
\150\ SBA, Table of small business size standards. Effective
August 19, 2019. https://www.sba.gov/document/support-table-size-standards.
\151\ 2019 SUSB Annual Data Tables by Establishment Industry.
https://www.census.gov/data/tables/2019/econ/susb/2019-susb-annual.html.
\152\ How to figure the gross percent of payroll. https://smallbusiness.chron.com/figure-gross-percent-payroll-66395.html.
Table 10--Estimated Revenue of Small Businesses That May Import Dogs for Commercial Purposes, 2020 USD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Revenue per firm (thousand USD) \a\
payroll per --------------------------------------
NAICS code Description Number of Firms firm Lower bound Upper bound Most likely
employees (thousand (payroll/ (payroll/ estimate
USD) 30%) 15%) (midpoint)
--------------------------------------------------------------------------------------------------------------------------------------------------------
115210.................................. Support Activities for Animal <5 3,633 $48 $161 $321 $241
Production. 5-9 585 181 605 1,210 907
10-19 238 406 1,355 2,709 2,032
20-99 118 1,259 4,197 8,394 6,296
423820.................................. Farm and Garden Machinery and <5 1,808 90 300 599 450
Equipment Merchant Wholesalers. 5-9 958 308 1,026 2,053 1,539
10-19 835 693 2,309 4,619 3,464
20-99 820 2,094 6,980 13,960 10,470
424990.................................. Other Miscellaneous Nondurable <5 7,068 75 249 499 374
Goods Merchant Wholesalers. 5-9 1,493 299 996 1,992 1,494
10-19 791 657 2,191 4,383 3,287
20-99 670 1,755 5,850 11,700 8,775
485991.................................. Special Needs Transportation.... <5 1,553 55 184 368 276
5-9 554 148 493 986 740
10-19 500 338 1,127 2,254 1,691
20-99 611 1,050 3,500 6,999 5,249
812910.................................. Pet Care (except Veterinary) <5 12,257 43 142 283 213
Services. 5-9 4,026 140 466 931 698
10-19 2,580 280 932 1,863 1,398
20-99 1,213 663 2,210 4,421 3,316
813312.................................. Environment, Conservation and <5 3,575 75 249 498 373
Wildlife Organizations. 5-9 1,262 263 875 1,751 1,313
10-19 922 516 1,720 3,441 2,580
20-99 745 1,551 5,169 10,338 7,754
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Revenue was estimated from the annual payroll reported in the 2019 SUSB Annual Data Tables by Establishment Industry (https://www.census.gov/data/tables/2019/econ/susb/2019-susb-annual.html). Estimated were updated to 2020 USD using the Consumer Price Index for All Urban Consumers (CPI-U).
CDC assumes that the costs associated with the proposed provisions
of the NPRM (if finalized as proposed) would be significant if the
additional costs would exceed two percent of the estimated revenue
shown in Table 10 by category. Unless a small entity only specialized
in importing dogs for resale or adoption, the costs associated with dog
importation would only constitute a portion of each firm's operational
costs. Other operational costs by an entity should be unaffected by the
proposed provisions included in this NPRM (if finalized as proposed).
CDC is unaware of the proportion of dog import costs relative to all
the other activities for each type of entity. Thus, CDC was not able to
directly estimate the impact of the NPRM (if finalized as proposed) as
a fraction of total revenue. Instead, CDC calculated a threshold for
each category representing the number of imported dogs at which the
cost of the provisions in the NPRM to importers (if finalized as
proposed) would begin to exceed two percent of the revenue of firms in
each category. To calculate the number of dogs at which point the costs
associated with the NPRM (if finalized as proposed) would be likely to
exceed two percent of revenue for each category of the firm, the
category-specific revenue per firm in Table 10 (most likely estimate,
lower bound, and upper bound) were multiplied by 2 percent and then
divided by the marginal cost per foreign-vaccinated dog from high-risk
countries ($810, range: $550 to $1,180). This was repeated for U.S.-
vaccinated dogs from DMRVV high-risk countries ($110, range: $44 to
$510) and dogs from DMRVV-free or DMRVV low-risk countries ($9.10,
range: $2.60 to $25). The estimated thresholds for the number of
imported dogs per firm for each small business category are summarized
in Tables 11a and 11b. For example, if a Wildlife Organization (NAICS
code 813312) with fewer than five employees import more than ten
foreign-vaccinated dogs (most likely NPRM cost estimate and midpoint
revenue estimate) from high-risk countries, the costs associated with
the NPRM (if finalized as proposed) would be expected to exceed two
percent of revenue. For U.S.-vaccinated dogs, the threshold would
increase from about ten dog imports to 68 dog imports using the most
likely cost estimate and midpoint revenue estimate. This NAICS category
may include dog rescue organizations that are likely to work with dogs
imported from DMRVV high-risk countries, most or all of which would be
foreign-vaccinated. Because the marginal cost estimate per dog imported
from DMRVV-free or DMRVV low-risk countries (assuming the NPRM is
finalized as proposed) is much less than per dog imported from DMRVV
high-risk countries, the threshold numbers of dogs that may be imported
from DMRVV-free or DMRVV low-risk countries are much greater than for
DMRVV high-risk countries. The values shown in Tables 11a and 11b are
estimated by assuming that all dogs imported by each firm are either
from DMRVV-free or DMRVV low-risk
[[Page 44014]]
countries or, alternatively, from DMRVV high-risk countries. Some firms
may import dogs from both types of countries, in which case, the
threshold values would be in between the two sets of estimates. The
difference in costs may also cause some entities to shift from
importing dogs from DMRVV high-risk countries to dogs imported from
DMRVV-free or DMRVV low-risk countries if the NPRM is finalized as
proposed. In this case, for a business with NAICS code of 813312, the
estimated threshold number of dogs would increase from ten imported
foreign-vaccinated dogs from DMRVV high-risk countries to 823 dogs
imported from DMRVV-free or DMRVV low-risk countries (both thresholds
calculated using most likely NPRM cost estimate and midpoint revenue
estimate). HHS/CDC welcomes public comments from the dog importation
industry to improve these threshold estimates.
Table 11a--Estimated Threshold for the Number of Imported Dogs From DMRVV High-Risk Countries Per Firm at Which NPRM Costs (if Finalized as Proposed)
Would Exceed Two Percent of Revenue During the First Year of Implementation of the Proposed Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Foreign-vaccinated dogs from high-risk U.S.-vaccinated dogs from high-risk countries
countries -----------------------------------------------
NAICS code Number of ------------------------------------------------
employees Most likely Most likely Lower bound Upper bound
estimate Lower bound Upper bound estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Marginal NPRM cost per dog (USD, if finalized as $810 $553 $1,178 $110 $44 $507
proposed)..............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of imported dogs per year at which NPRM cost 2 percent of revenue
--------------------------------------------------------------------------------------------------------------------------------------------------------
115210, Support Activities for Animal <5 6 6 6 44 72 13
Production............................. 5-9 23 22 21 164 271 48
10-19 51 49 46 366 606 106
20-99 156 152 143 1,132 1,876 328
423820, Farm and Garden Machinery and <5 12 11 11 81 134 24
Equipment Merchant Wholesalers......... 5-9 38 37 35 277 459 81
10-19 86 84 79 623 1,032 181
20-99 259 252 237 1,882 3,119 545
424990, Other Miscellaneous Nondurable <5 10 9 9 68 112 20
Goods Merchant Wholesalers............. 5-9 37 36 34 269 445 78
10-19 82 79 75 591 979 172
20-99 217 211 199 1,577 2,614 457
485991, Special Needs Transportation.... <5 7 7 7 50 83 15
5-9 19 18 17 133 221 39
10-19 42 41 39 304 504 88
20-99 130 127 119 944 1,564 274
812910, Pet Care (except Veterinary) <5 6 6 5 39 64 12
Services............................... 5-9 18 17 16 126 208 37
10-19 35 34 32 252 417 73
20-99 82 80 75 596 988 173
813312, Environment, Conservation and <5 10 9 9 68 112 20
Wildlife Organizations................. 5-9 33 32 30 236 392 69
10-19 64 62 59 464 769 135
20-99 192 187 176 1,394 2,310 404
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 11b--Estimated Threshold for the Number of Imported Dogs from DMRVV-Free or DMRVV Low-Risk Countries per
Firm at Which NPRM Costs (if Finalized as Proposed) Would Exceed Two Percent of Revenue During the First Year of
Implementation of the Proposed Requirements
----------------------------------------------------------------------------------------------------------------
Foreign-vaccinated dogs from
high-risk countries
NAICS code Number of -------------------------------
employees Most likely Lower Upper
estimate bound bound
----------------------------------------------------------------------------------------------------------------
Marginal NPRM cost per dog (if finalized as proposed, USD)...................... $9.10 $2.60 $25
----------------------------------------------------------------------------------------------------------------
Number of imported dogs per year at which NPRM cost two percent of revenue
----------------------------------------------------------------------------------------------------------------
115210, Support Activities for Animal Production................... <5 531 1,257 258
5-9 1,999 4,736 973
10-19 4,476 10,605 2,177
20-99 13,867 32,856 6,744
423820, Farm and Garden Machinery and Equipment Merchant <5 991 2,347 482
Wholesalers....................................................... 5-9 3,391 8,034 1,649
10-19 7,630 18,079 3,711
20-99 23,061 54,641 11,215
424990, Other Miscellaneous Nondurable Goods Merchant Wholesalers.. <5 824 1,953 401
5-9 3,291 7,797 1,601
10-19 7,240 17,155 3,522
20-99 19,327 45,794 9,400
[[Page 44015]]
485991, Special Needs Transportation............................... <5 608 1,441 296
5-9 1,630 3,860 793
10-19 3,725 8,825 1,812
20-99 11,562 27,396 5,623
812910, Pet Care (except Veterinary) Services...................... <5 469 1,110 228
5-9 1,539 3,645 749
10-19 3,079 7,294 1,497
20-99 7,303 17,305 3,552
813312, Environment, Conservation and Wildlife Organizations....... <5 823 1,949 401
5-9 2,893 6,853 1,407
10-19 5,684 13,468 2,765
20-99 17,078 40,466 8,306
----------------------------------------------------------------------------------------------------------------
The marginal cost per dog imported (if the NPRM is finalized as
proposed) relative to the reported commercial values of imported dogs
were estimated using data from CBP for dogs imported under Harmonized
Tariff Schedule code 0106.19.91.20, Other live animals, other, other,
dogs is shown in Table 12. The estimated ratio of the marginal cost of
NPRM requirements (if finalized as proposed) relative to the reported
value of the commercially imported dogs from DMRVV-free or DMRVV low-
risk countries is 1.2 percent (range: 0.33 percent to 3.2 percent).
Based on this ratio, the expected marginal increase in cost per dog
imported should not change much for dogs imported from DMRVV-free or
low-risk countries.
However, for the foreign-vaccinated dogs imported from DMRVV high-
risk countries, the estimated ratio is 227 percent (range: 155 percent
to 330 percent). This ratio is much larger both because the marginal
cost per dog imported (assuming the NPRM is finalized as proposed) is
much greater and because the reported commercial value of dogs imported
from DMRVV high-risk countries is lower compared to dogs imported from
DMRVV-free or low-risk countries. Since CBP's commercial values of
imported dogs only provide a comparison of the estimated marginal cost
of the NPRM (if finalized as proposed) to reported commercial value,
these ratios cannot be directly compared to the revenue estimates by
firm since the costs associated with dog imports would only be a
portion of each firm's operational cost. However, it does provide an
estimate of the potential increase in cost per dog imported from either
DMRVV-free or low countries or from DMRVV high-risk countries if the
NPRM is finalized as proposed. For this analysis, CDC assumes that most
of the dogs imported from DMRVV high-risk countries for commercial
purposes would have been vaccinated outside the United States.
Table 12--Estimated Impact of the NPRM (if Finalized as Proposed) on the
Cost per Dog Imported for Commercially Imported Dogs
[2020 USD]
------------------------------------------------------------------------
Most likely
estimate Lower bound Upper bound
------------------------------------------------------------------------
Importers from DMRVV-free or low-risk countries
------------------------------------------------------------------------
Baseline: \a\
--Total dogs imported (A)... 57,860 ............ ............
--Average commercial value $777 ............ ............
per dog (B)................
--Total commercial value (C) $44,957,220 ............ ............
= (A) x (B)................
With NPRM (if finalized as
proposed):
--Estimated marginal NPRM $9.08 $2.55 $24.89
cost per dog imported (if
finalized as proposed) (D).
--Total marginal NPRM costs $525,369 $147,543 $1,440,135
for dogs imported for
commercial purposes (if
finalized as proposed) (E)
= (D) x (A)................
Estimated ratio of marginal 1.17% 0.33% 3.20%
NPRM costs to commercial
value of imported dogs (E)/
(C)..........................
------------------------------------------------------------------------
Importers from high-risk countries of foreign-vaccinated dogs
------------------------------------------------------------------------
Baseline: \a\
--Total dogs imported (F)... 43,382 ............ ............
--Average commercial value $357 ............ ............
per dog (G)................
--Total commercial value (H) $15,487,374 ............ ............
= (F) x (G)................
With NPRM (if finalized as
proposed):
--Estimated marginal NPRM $810 $553 $1,178
costs per dog imported (if
finalized as proposed) (I).
--Total marginal NPRM costs $35,139,420 $23,990,246 $51,103,996
for dogs imported for
commercial purposes (if
finalized as proposed) (J)
= (I) x (F)................
[[Page 44016]]
Estimated ratio of marginal 227% 155% 330%
NPRM costs to commercial
value of imported dogs (J)/
(H)..........................
------------------------------------------------------------------------
\a\ Baseline values were based on the data received from CBP, not
publicly available (HTS code 0106.19.91.20).
U.S. Airlines
The provisions of this NPRM (if finalized as proposed) would affect
U.S. airlines conducting international flight operations arriving in
the United States. Of the 60 U.S. airlines with international flights
in 2020, 35 airlines can be identified as small business entities. This
is based on the size standard of ``fewer than 1,500 employees'' from
the SBA for small businesses within NAICS Code 481111, Scheduled
Passenger Air Transportation, and those within NAICS Code 481211,
Nonscheduled Chartered Passenger Air Transportation in 2019.\153\ For
the analysis, airline employee counts were estimated from the U.S.
Department of Transportation's Bureau of Transportation
Statistics.\154\ Monthly average numbers of employees in 2019,
including part- and full-time employment, were used for U.S. airlines.
---------------------------------------------------------------------------
\153\ Small Business Association (SBA), Table of small business
size standards. Effective August 19, 2019. https://www.sba.gov/document/support-table-size-standards. Accessed: February 21, 2022.
\154\ Bureau of Transportation Statistics. Air Carrier Financial
Reports (Form 41 Financial Data). Air Carrier Financial: Schedule P-
1(a) Employees. Bureau of Transportation Statistics. https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=GEF&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny Accessed: February 21, 2022.
---------------------------------------------------------------------------
The annual revenue per U.S. airline was estimated based on the 2019
revenue of each airline.\155\ Lower-bound and upper-bound estimates
were calculated by multiplying by 75 and 125 percent (Table 13). Among
the selected 35 airlines, seven had zero U.S. international arrivals in
2019.\156\
---------------------------------------------------------------------------
\155\ Bureau of Transportation Statistics. Air Carrier Financial
Reports (Form 41 Financial Data). Air Carrier Financial: Schedule P-
1.1, and P-1.2 Operating revenues. https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=FMD&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny; and https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=FMI&QO_fu146_anzr=Nv4percent20Pn44vr4percent20Sv0n0pvny. Accessed: February 21, 2022.
\156\ Air Carriers: T-100 International Market (U.S. Carriers
Only) https://www.transtats.bts.gov/DL_SelectFields.asp?gnoyr_VQ=GDJ&QO_fu146_anzr=Nv4percent20Pn44vr45.
Accessed: February 21, 2022.
Table 13--Estimated Annual Revenue of Small Business U.S. Airlines
----------------------------------------------------------------------------------------------------------------
Total revenue (million USD)
------------------------------------------------ 2019 U.S.
Airline Most likely arrivals
estimate Lower bound Upper bound
----------------------------------------------------------------------------------------------------------------
1............................................... $290 $218 $363 317
2............................................... 78 58 97 279
3............................................... 112 84 140 169
4............................................... 241 181 301 136
5............................................... 38 28 47 116
6............................................... 44 33 55 114
7............................................... 230 173 288 113
8............................................... 541 406 677 111
9............................................... 218 164 273 96
10.............................................. 115 87 144 86
11.............................................. 558 419 698 80
12.............................................. 1,296 972 1,620 75
13.............................................. 42 31 52 73
14.............................................. 52 39 66 57
15.............................................. 169 127 212 57
16.............................................. 37 28 46 55
17.............................................. 104 78 130 49
18.............................................. 147 110 183 46
19.............................................. 265 199 331 45
20.............................................. 7 6 9 41
21.............................................. 40 30 50 40
22.............................................. 2 1 2 31
23.............................................. 105 79 131 18
24.............................................. 59 44 74 13
25.............................................. 20 15 25 12
26.............................................. 19 14 23 6
27.............................................. 9 7 12 2
28.............................................. 313 235 391 1
29.............................................. 12 9 14 0
30.............................................. 115 86 143 0
31.............................................. 117 88 146 0
32.............................................. 13 10 16 0
33.............................................. 10 7 12 0
34.............................................. 21 16 27 0
[[Page 44017]]
35.............................................. 19 14 23 0
----------------------------------------------------------------------------------------------------------------
The threshold numbers of dogs that may be transported by each
airline such that the costs associated with the provisions of this NPRM
(if finalized as proposed) to airlines would be less than two percent
of annual revenue were estimated using the same methodology as for the
dog importers above. However, the annualized marginal cost per dog
transported by airlines was only estimated to be about $6.00 per dog
(range: $3.20 to $10.30 per dog) if the requirements in the NPRM are
finalized as proposed. This was calculated based on the annualized
costs to airlines divided by the number of dogs transported. However,
costs were estimated to be higher in the first year of implementation
and some airlines may be disproportionately affected if their customers
are proportionally more likely to reduce the number of dogs transported
to the United States. The estimated number of dogs was calculated by
multiplying the revenue per airline in Table 13 by 2 percent and then
dividing by the marginal airline cost per dog imported if the NPRM is
finalized as proposed. As shown in Table 14, the estimated numbers of
dogs that each airline could transport were significantly greater than
the number of international passengers reported in 2019 and, in most
cases, greater than the total estimated number of dogs estimated to be
imported into the United States each year. CDC did not separately
estimate marginal costs to airlines for dogs imported from DMRVV-free
or DMRVV low-risk countries versus dogs imported from DMRVV high-risk
countries. The estimated marginal cost per dog may be higher for
airlines to transport dogs imported from DMRVV high-risk countries
because dogs from these countries are more likely to be denied entry
and abandoned by importers. Thus, marginal costs may be slightly higher
for airlines that specialize in travel to DMRVV high-risk countries.
However, the general finding still holds that the provisions of this
NPRM (if finalized as proposed) should not have a significant impact on
airlines.
Table 14--Estimated Threshold of the Annual Number of Imported Dogs per Airline at Which the Marginal Costs of
the NPRM (if Finalized as Proposed) Begin To Exceed 2 Percent of Annual Revenue
----------------------------------------------------------------------------------------------------------------
Most likely 2019 U.S.
Airline estimate Lower bound Upper bound arrivals
----------------------------------------------------------------------------------------------------------------
Marginal NPRM cost per dog (if finalized as proposed)....... $6.00 $3.20 $10.30 ...........
----------------------------------------------------------------------------------------------------------------
Annual number of transported dogs at which NPRM cost 2 percent of annual revenue
----------------------------------------------------------------------------------------------------------------
1........................................................... 48,333,333 68,125,000 35,242,718 317
2........................................................... 13,000,000 18,125,000 9,417,476 279
3........................................................... 18,666,667 26,250,000 13,592,233 169
4........................................................... 40,166,667 56,562,500 29,223,301 136
5........................................................... 6,333,333 8,750,000 4,563,107 116
6........................................................... 7,333,333 10,312,500 5,339,806 114
7........................................................... 38,333,333 54,062,500 27,961,165 113
8........................................................... 90,166,667 126,875,000 65,728,155 111
9........................................................... 36,333,333 51,250,000 26,504,854 96
10.......................................................... 19,166,667 27,187,500 13,980,583 86
11.......................................................... 93,000,000 130,937,500 67,766,990 80
12.......................................................... 216,000,000 303,750,000 157,281,553 75
13.......................................................... 7,000,000 9,687,500 5,048,544 73
14.......................................................... 8,666,667 12,187,500 6,407,767 57
15.......................................................... 28,166,667 39,687,500 20,582,524 57
16.......................................................... 6,166,667 8,750,000 4,466,019 55
17.......................................................... 17,333,333 24,375,000 12,621,359 49
18.......................................................... 24,500,000 34,375,000 17,766,990 46
19.......................................................... 44,166,667 62,187,500 32,135,922 45
20.......................................................... 1,166,667 1,875,000 873,786 41
21.......................................................... 6,666,667 9,375,000 4,854,369 40
22.......................................................... 333,333 312,500 194,175 31
23.......................................................... 17,500,000 24,687,500 12,718,447 18
24.......................................................... 9,833,333 13,750,000 7,184,466 13
25.......................................................... 3,333,333 4,687,500 2,427,184 12
26.......................................................... 3,166,667 4,375,000 2,233,010 6
27.......................................................... 1,500,000 2,187,500 1,165,049 2
28.......................................................... 52,166,667 73,437,500 37,961,165 1
29.......................................................... 2,000,000 2,812,500 1,359,223 0
30.......................................................... 19,166,667 26,875,000 13,883,495 0
31.......................................................... 19,500,000 27,500,000 14,174,757 0
32.......................................................... 2,166,667 3,125,000 1,553,398 0
33.......................................................... 1,666,667 2,187,500 1,165,049 0
[[Page 44018]]
34.......................................................... 3,500,000 5,000,000 2,621,359 0
35.......................................................... 3,166,667 4,375,000 2,233,010 0
----------------------------------------------------------------------------------------------------------------
C. Paperwork Reduction Act of 1995
HHS/CDC has determined that this NPRM includes proposed information
collections and recordkeeping 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. 3501-3520). A description of
these proposed provisions is given below, with an estimate of the
annual reporting and recordkeeping burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information. Comments are invited on the following
subjects:
Whether the proposed collection of information is
necessary for the proper performance of the functions of CDC, including
whether the information will have practical utility.
The accuracy of CDC's estimate of the burden of the
collection of information.
Ways to enhance the quality, utility, and clarity of the
information to be collected.
Ways to minimize the burden of the collection of
information on respondents, including by using information technology.
Under the PRA, Federal agencies must obtain approval from OMB for
each collection of information they conduct or sponsor. In addition,
the PRA also requires Federal agencies to provide a 60-day notice in
the Federal Register concerning each proposed collection of
information, including each new proposed collection, each proposed
extension of an existing collection of information, and each
reinstatement of previously approved information collection before
submitting the collection to OMB for approval. To comply with this
requirement, we are publishing this notice of a revised data collection
as described below.
OMB is particularly interested in comments that will help:
1. Evaluate whether the revised collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submissions of responses); and,
5. Assess information collection costs.
Proposed Project
Importation Regulations (42 CFR 71 Subpart F)--Revised Information
Collection--National Center for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This information collection is a revision to OMB Control Number
0920-1383 related to the importation of animals, animal products, and
human remains. HHS/CDC is amending the CDC Import Certification of
Rabies Vaccination and Microchip Record Form and renaming it CDC Import
Certification of Rabies Vaccination and Microchip Required for Live Dog
Importations into the United States Form. HHS/CDC is instituting a new
import submission system that will collect information similar to what
is currently approved to be collected for the Application for Special
Exemption for a Permitted Dog Import form. CDC is also proposing to
require per 42 CFR 71.51 that importers of dogs have either a CDC
Import Certification of Rabies Vaccination and Microchip Required for
Live Dog Importations into the United States Form or a Certification of
U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United
States Form, which is a form approved under OMB Control No. 0579- 0020,
0036, 0048, 0101, 0156, 0278, and 0432. The Certification of U.S.-
issued Rabies Vaccination for Live Dog Re-entry into the United States
Form will be revised as part of information collection OMB Control No.
0579-0020, 0036, 0048, 0101, 0156, 0278, and 0432.
Section 361 of the PHS Act (42 U.S.C. 264) authorizes the Secretary
of HHS to make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases from
foreign countries into the United States. The existing regulations
governing foreign quarantine activities (42 CFR 71) authorize
quarantine officers and other personnel to inspect and undertake
necessary control measures with respect to conveyances, persons,
shipments of animals, articles, and other items to protect the public's
health.
CDC regulations govern the importation of animals and animal
products capable of causing human disease. Animals that are regulated
by CDC include dogs, cats, turtles, nonhuman primates (NHPs), civets,
African rodents, and bats. CDC controls the importation of these
animals to ensure that these animals, or animal products, being
imported into the United States meet CDC regulations. CDC does this
through a permitting process for certain animals.
The currently approved form (Application for Special Exemption for
a Permitted Dog Import) for individuals to apply for a CDC Dog Import
Permit is an online form that includes a series of questions. It also
requires applicants to upload proof of eligibility to import under the
current requirements, serology results, a proof of rabies vaccination,
and photos of their dog's teeth.
The process for dog importation under the provisions of the NPRM
(if finalized as proposed) will require issuing far fewer CDC Dog
Import Permits compared to the currently approved information
collection, since only people seeking approval to import dogs from
DMRVV-restricted countries would need to apply. Under the currently
approved information collection, importers of foreign-vaccinated dogs
from high-risk countries can apply for a CDC Dog Import Permit in lieu
of making a reservation with a CDC-approved animal care facility. The
option to apply for a CDC Dog Import Permit for
[[Page 44019]]
importers of foreign-vaccinated dogs from high-risk countries, however,
is not being proposed in this NPRM. At this time, CDC is not including
any countries on the DMRVV-restricted countries list; therefore, the
annual burden in the burden table reflects a change in burden hours to
zero hours for the Application for Special Exemption for a Permitted
Dog Import form. The most significant changes to the current
information collection will be the requirement to complete a
standardized form for U.S.-vaccinated dogs (Certification of U.S.-
issued Rabies Vaccination for Live Dog Re-entry into the United States;
approved under OMB Control No. 0579-0020, 0036, 0048, 0101, 0156, 0278,
and 0432) or an amended standardized form for foreign-vaccinated dogs
(CDC Import Certification of Rabies Vaccination and Microchip Required
for Live Dog Importations into the United States) and a new CDC Import
Submission Form. The CDC Import Submission Form will contain similar
information to the current Application for Special Exemption for a
Permitted Dog Import form and is proposed to be required for all dog
importations.
The standardized rabies vaccination forms will be completed by the
importers' veterinarian to ensure all required information is on the
form and signed by a government official. Currently, to be valid,
rabies vaccination documentation must include the name and address of
the owner; dog's breed, sex, date of birth, color, and markings;
microchip number; date of vaccination and vaccine product information,
including product expiration date; date the vaccination expires; and
name, license number, address, and signature of the veterinarian who
administered the vaccination. CDC found that despite these being
requirements for importation, many people submitted incomplete rabies
vaccination documentation, which both delayed the issuance of the
requestor's permit and used staff time for multiple communications with
requestors to ensure they obtained complete rabies vaccination
documentation. It also meant some requestors made multiple requests to
their veterinarian, increasing the time burden on them as well. CDC is
attempting to solve this issue by requiring that importers have their
veterinarian complete one of the standardized CDC forms that contains
all the required information and have it verified by a government
official, making the form harder to falsify.
Additionally, CDC proposes to require importers to submit a CDC
Import Submission Form online via a new CDC import submission system
for each dog being imported. Importers would submit contact information
and details about the dog similar to what is currently collected in the
Application for Special Exemption for a Permitted Dog Import form. The
new information that would be collected in this system compared to what
is currently approved to be collected in the Application for Special
Exemption for a Permitted Dog Import form is: whether the submission is
a new CDC submission or a change to an existing submission; the method
by which someone is traveling to the United States (air, sea, or land);
and, if they marked change to an existing submission, an explanation of
that change. It would also not require that an importer upload their
rabies vaccination documentation.
The burden table below has been updated to reflect the burden hours
on veterinarians to complete the rabies vaccination forms and the total
amount of time it will take an importer to complete the online import
submission form.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total
Type of respondents Form name respondents responses per response burden (in
respondent (in hours) hours)
----------------------------------------------------------------------------------------------------------------
Dog Importers with Foreign- CDC Import 13,671 1 15/60 3,418
vaccinated dogs. Certification of
Rabies Vaccination
and Microchip
Required for Live
Dog Importations
into the United
States.
Veterinarians for Foreign- CDC Import 13,671 1 15/60 3,418
vaccinated dogs. Certification of
Rabies Vaccination
and Microchip
Required for Live
Dog Importations
into the United
States.
Official Government Veterinarian CDC Import 13,671 1 15/60 3,418
in Exporting Country. Certification of
Rabies Vaccination
and Microchip
Required for Live
Dog Importations
into the United
States.
Importers of U.S.-vaccinated dogs. Certification of U.S.- 17,121 1 15/60 4,280
issued Rabies
Vaccination for Live
Dog Re-entry into
the United States.
Veterinarians for U.S.-vaccinated Certification of U.S.- 17,121 1 15/60 4,280
dogs. issued Rabies
Vaccination for Live
Dog Re-entry into
the United States.
Importers of Dogs from DMRVV- Application for 0 0 60/60 0
restricted Countries. Special Exemption
for a Permitted Dog
Import.
All dog importers................. CDC Import Submission 800,000 1 7/60 93,333
Form.
Animal Care Facilities............ Application.......... 10 1 60/60 10
------------------------------------------------------
Total......................... ..................... ........... .............. ........... 112,157
----------------------------------------------------------------------------------------------------------------
D. National Environmental Policy Act (NEPA)
HHS/CDC has determined that amendments to 42 CFR part 71 will not
have a significant impact on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
needed.
E. Executive Order 12988: Civil Justice Reform
HHS/CDC has reviewed this rule under Executive Order 12988 on Civil
Justice Reform and determines that this NPRM meets the standard in the
Executive Order.
F. Executive Order 13132: Federalism
Under Executive Order 13132, if the rulemaking would limit or
preempt State, local, or tribal authorities, then a federalism analysis
is required. The agency must consult with State, local, and tribal
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 on them.
HHS/CDC has determined that this NPRM will not have sufficient
federalism implications to warrant the
[[Page 44020]]
preparation of a federalism summary impact statement.
G. Plain Language Act of 2010
Under 63 FR 31883 (June 10, 1998), Executive Departments and
Agencies are required to use plain language in all proposed and final
rules. HHS/CDC has attempted to use plain language in this proposed
rulemaking to make our intentions and rationale clear and requests
input from the public in this regard.
List of Subjects in 71.50, 71.51
Airline, animal, border, canine rabies virus variant, carrier, cat,
communicable diseases, confinement, DMRVV, Director, dog, exemption,
importation, importer, microchip, necropsy, permit, public health,
quarantine, rabies, rabies vaccination, rabies virus, serologic
testing, valid rabies vaccination certificate, zoonotic diseases.
For the reasons discussed in the preamble, we propose to amend 42
CFR part 71 as follows:
PART 71--FOREIGN QUARANTINE
0
1. The authority citation for part 71 continues to read as follows:
Authority: Secs. 215 and 311 of Public Health Service (PHS) Act.
as amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as amended
(42 U.S.C. 264-272).
0
2. Amend Sec. 71.50 by:
0
a. Adding in alphabetical order to paragraph (b) definitions for
``Authorized veterinarian'', ``Cat'', ``Dog'', ``Histopathology'',
``In-transit shipment'', ``Microchip'', ``Necropsy'', and ``Official
government veterinarian''; and
0
b. Adding paragraph (c).
The additions read as follows:
Sec. 71.50 Scope and definitions.
* * * * *
(b) * * *
Authorized veterinarian means an individual who has obtained both
an advanced degree and valid license and is authorized to practice
animal medicine in the exporting country.
* * * * *
Cat means all domestic cats (Felis catus).
* * * * *
Dog means all domestic dogs (Canis familiaris).
* * * * *
Histopathology means the study of changes in human or animal tissue
caused by disease.
* * * * *
In-transit shipment means a cargo shipment originating in a foreign
country that is moved through one or more U.S. ports of entry while
transiting through the United States to a third-country destination.
In-transit shipments pass through a U.S. port of entry and a U.S. port
of exit, which may be in the same location, or which may involve
numerous stopping points.
* * * * *
Microchip means an implanted radio-frequency device placed under
the skin of an animal that contains a unique identification tag that
meets the International Standards Organization (ISO) compatibility
through ISO 11784 or ISO 11785, or similar technologies as approved by
the Director.
Necropsy means an animal autopsy in which the cause of death may be
determined through the examination and collection of tissues, organs,
or bodily fluids post-mortem.
Official government veterinarian means a veterinarian who performs
work on behalf of an exporting country's government and can verify the
license or credentials of an Authorized Veterinarian.
* * * * *
(c) Any provision of this subpart held to be invalid or
unenforceable by its terms, or as applied to any person or
circumstance, shall be construed so as to continue to give the maximum
effect to the provision permitted by law, unless such holding shall be
one of utter invalidity or unenforceability, in which event the
provision shall be severable from this subpart and shall not affect the
remainder thereof or the application of the provision to persons not
similarly situated or to dissimilar circumstances.
0
3. Amend Sec. 71.51:
0
a. In paragraph (a) by:
0
i. Adding in alphabetical order definitions for ``Animal'', CDC-
registered animal care facility'', ``CDC import submission form'',
``CDC Import Certification of Rabies Vaccination and Microchip Required
for Live Dog Importations into the United States'', ``Certification of
U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United
States'', and ``Conditional release'';
0
ii. Revising the definition of ``Confinement'';
0
iii. Adding in alphabetical order definitions for ``DMRVV'', ``DMRVV-
free countries'', ``DMRVV high-risk countries'', ``DMRVV low-risk
countries'', ``DMRVV-restricted countries'', ``Importer'', ``SAFE
TraQ'', ``Serologic testing'', ``USDA-accredited veterinarian'', and
``USDA official veterinarian''; and
0
iv. Redesignating paragraphs (1) through (4) in the definition of
``Valid rabies vaccination certificate'' as paragraphs (i) through
(iv);
0
d. By revising paragraphs (b) through (g); and
0
e. By adding paragraphs (h) through (ff).
The additions and revisions read as follows:
Sec. 71.51 Dogs and cats.
(a) * * *
Animal means, for purposes of this section, all domestic cats
(Felis catus) or domestic dogs (Canis familiaris).
* * * * *
CDC-registered animal care facility means a facility registered by
CDC for the purpose of providing veterinary care and housing to animals
imported into the United States.
CDC import submission form means an OMB-approved declaration
submitted to CDC through an online portal that includes the importer's
name and contact information; description of the dog, including
microchip number and current photographs of the dog's face and body;
purpose of importation; travel information, including dates of
departure and arrival, country of departure, countries visited in the
past six months, and U.S. port of entry; and other information as
described in CDC technical instructions.
CDC Import Certification of Rabies Vaccination and Microchip
Required for Live Dog Importations into the United States means the
OMB-approved form that must be:
(i) Completed by an authorized veterinarian in the exporting
country, which may include an official government veterinarian in the
exporting country; and
(ii) Reviewed and signed by an official government veterinarian in
the exporting country attesting that the information listed is true and
correct.
Certification of U.S.-issued Rabies Vaccination for Live Dog Re-
entry into the United States means the OMB-approved form that must be
completed by a U.S. Department of Agriculture (USDA)-accredited
veterinarian and certified by a USDA official veterinarian prior to
exporting the dog from the United States in order to demonstrate
compliance with admissibility requirements upon returning to the United
States.
Conditional release, when applied to an animal, means the temporary
release of an animal from the custody of a carrier into the care of a
licensed veterinarian approved by the Director for the purpose of
receiving emergency medical care or a public health evaluation, pending
removal of the animal from the United States. The
[[Page 44021]]
licensed veterinarian must return animals immediately to the carrier's
custody upon the conclusion of such medical care or evaluation for
removal from the United States.
Confinement, when applied to an animal, means restriction to a
building or other enclosure at a U.S. port or other location approved
by the Director, including en route to a destination, separate from
other animals, and from persons except for contact necessary for its
care. If the animal is allowed out of the enclosure, it must be muzzled
and kept on a leash.
DMRVV means dog-maintained rabies virus variant and includes any
rabies virus variant that is known or suspected to have an enzootic
transmission cycle in which dogs are essential for the maintenance of
the viral variant. This includes epidemiologic situations in which dogs
are the only recognized reservoir species, as well as situations in
which dogs and other species (typically wildlife) both play an
epidemiologically relevant role in maintaining enzootic transmission.
DMRVV-free countries mean countries determined by the Director as
not having DMRVV present based on internationally accepted standards.
DMRVV high-risk countries mean countries determined by the Director
as having high risk for DMRVV transmission based on factors such as the
presence and geographic distribution of the virus or low quality of or
low confidence in rabies surveillance systems or dog vaccination
programs.
DMRVV low-risk countries mean countries determined by the Director
as having low risk for DMRVV transmission based on factors such as the
virus being limited to a localized area, adequacy of surveillance and
dog vaccination programs to prevent further geographic distribution of
the virus, and the virus being in a controlled status with the country
or countries heading toward eventual DMRVV-free status.
DMRVV-restricted countries means countries for which the export of
dogs into the United States has been prohibited or otherwise restricted
based on the countries' export of dogs infected with DMRVV to any other
countries within a timeframe determined by the Director or based on the
countries' lacking adequate controls, as determined by the Director, to
monitor and prevent the export of dogs to the United States with
falsified or fraudulent vaccine credentials, invalid rabies vaccination
documentation, or other fraudulent, inaccurate, or invalid importation
documents.
* * * * *
Importer for purposes of this section means any person importing or
attempting to import an animal into the United States, including an
owner or a person acting on behalf of an importer, such as a broker
registered with U.S. Customs and Border Protection (CBP). Individuals
compensated or hired to transport animals must have a valid USDA
license or registration.
* * * * *
SAFE TraQ means the System for Animal Facilities Electronic
Tracking of Quarantine or other system as approved by the Director for
tracking the quarantine of animals approved for admission into the
United States.
Serologic testing, when applied to an imported animal, means a
rabies antibody titration test performed by a CDC-approved rabies
laboratory using a CDC-approved technique. The serology sample must be
drawn, submitted and tested in accordance with CDC technical
instructions. The current list of CDC-approved laboratories is
available online on CDC's website. CDC will update its website as
needed.
USDA-accredited veterinarian shall have the same definition as
accredited veterinarian under 9 CFR 160.1.
USDA official veterinarian means the Animal and Plant Health
Inspection Service (APHIS) veterinarian who is assigned by the USDA
Administrator to supervise and perform the official work of APHIS in
any U.S. State or several U.S. States.
* * * * *
(b) Authorized U.S. airports for dogs and cats. (1) Cats may arrive
at and be admitted into the United States through any U.S. airport.
(2) Dogs arriving to the United States from DMRVV low-risk or
DMRVV-free countries that have not been in any DMRVV high-risk country
within the last six months may arrive at and be admitted into the
United States through any U.S. airport.
(3) Dogs that have been in a DMRVV high-risk country within the
last six months and were vaccinated against rabies in the United States
must arrive at and may only be admitted through a U.S. airport with a
CDC quarantine station.
(4) Dogs that have been in a DMRVV high-risk country within the
last six months and were vaccinated against rabies in a foreign country
must arrive at and may only be admitted through a U.S. airport with a
CDC quarantine station and a CDC-registered Animal Care Facility.
(5) Dogs that have been in a DMRVV high-risk country within the
last six months that arrive at an unauthorized U.S. airport shall be
denied admission and returned to their countries of departure via air
pursuant to paragraph (v) of this section.
(6) The current list of U.S. airports with CDC quarantine stations
is available on CDC's website. CDC also maintains a list of U.S.
airports with CDC-registered Animal Care Facilities on its website. CDC
will update these lists as needed.
(c) Authorized U.S. land ports for dogs and cats. (1) Cats may
arrive at and be admitted into the United States through any U.S. land
port.
(2) Dogs arriving to the United States from DMRVV low-risk or
DMRVV-free countries that have not been in any DMRVV high-risk country
within the last six months may arrive at and be admitted into the
United States through any U.S. land port.
(3) Dogs that have been in a DMRVV high-risk country within the
last six months are not authorized to enter the United States through
any U.S. land port and shall be denied admission into the United
States.
(d) Authorized U.S. seaports for dogs and cats. (1) Cats may arrive
at and be admitted into the United States through any U.S. seaport.
(2) Dogs arriving to the United States from DMRVV low-risk or
DMRVV-free countries that have not been in any DMRVV high-risk country
within the last six months may arrive at and be admitted into the
United States through any U.S. seaport.
(3) Dogs that have been in a DMRVV high-risk country within the
last six months are not authorized to enter the United States through
any U.S. seaport and shall be denied admission into the United States.
(4) Notwithstanding paragraph (d)(3) of this section, a dog meeting
the definition of a ``service animal'' under 14 CFR 382.3 that has been
in a DMRVV high-risk country within the last six months may be admitted
through a U.S. seaport if:
(i) The dog is accompanied by an ``individual with a disability''
as defined under 14 CFR 382.3 and the dog does work or performs tasks
that are directly related to the individual's disability; and
(ii) The dog was vaccinated against rabies in the United States and
is accompanied by a valid Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into the United States form; or
(iii) The dog was vaccinated against rabies in a foreign country
and is accompanied by a valid foreign-issued CDC Import Certification
of Rabies Vaccination and Microchip Required for
[[Page 44022]]
Live Dog Importations into the United States form and a valid serologic
titer from a CDC-approved laboratory.
(e) Limitation on U.S. ports for dogs and cats. The Director may
limit the times, U.S. ports, or conditions under which dogs or cats may
arrive at and be admitted to the United States based on an importer's
or carrier's failure to comply with the provisions of this section or
as needed to protect the public's health. If the Director determines a
limitation is required, the Director will notify importers or carriers
in writing of the specific times, U.S. ports, or conditions under which
dogs and cats may be permitted to arrive at and be admitted to the
United States.
(f) Age requirement for all dogs. All dogs presented for admission
into the United States must be at least six (6) months old at the time
of arrival into the United States. However, an importer may present for
admission up to three (3) individual dogs within the same calendar year
below the age of six (6) months if the dogs are arriving in the United
States by land from Canada or Mexico and the dogs have not been in a
DMRVV high-risk or DMRVV-restricted country since birth.
(g) Microchip requirements for all dogs. (1) All dogs presented for
admission into the United States must have a microchip implanted prior
to arrival at the U.S. port.
(2) The microchip number must be documented on the CDC Import
Certification of Rabies Vaccination and Microchip Required for All Live
Dog Importations into the United States form or the Certification of
U.S.-issued Rabies Vaccination for Live Dog Re-entry into the United
States form or documented on the veterinary health records of the dog
if arriving from a DMRVV low-risk or DMRVV-free country. The microchip
number must also be documented on the CDC import submission form.
(3) The importer must consent to the scanning of the dog's
microchip upon arrival by CDC quarantine public health officers or
their representatives.
(4) Dogs arriving in the United States without a microchip, with a
microchip that cannot be detected, with a microchip that does not match
the accompanying documentation, or if the importer refuses to have the
dogs' microchip scanned, may be denied admission and returned to the
country of departure pursuant to paragraph (v) of this section.
(h) CDC Import Submission Form for all dogs. (1) All importers of
dogs into the United States must submit a CDC Import Submission Form to
CDC via a CDC-registered system prior to the dogs' arrival. This
includes accompanied or unaccompanied dogs arriving by air, land, and
sea regardless of whether arriving as cargo, checked-baggage, or hand-
carried baggage.
(2) Dogs that arrive without a complete and accurate CDC import
submission form filed prior to arrival may be denied admission and
returned to the country of departure pursuant to paragraph (v) of this
section, regardless of the value of the shipment.
(3) Dogs arriving by air without a complete and accurate CDC import
submission form may be held on a space-available basis for up to 24
hours after arrival in the care of a CDC-registered animal care
facility or a licensed veterinarian if the animal care facility cannot
house the dog until the form is filed or if the dog arrives at an
airport without a CDC-registered animal care facility. The importer (or
airline if the importer abandons the animal) is responsible for making
all necessary arrangements with a CDC-registered animal care facility
or a veterinary clinic if the animal care facility cannot house the dog
or is not available at the airport, including arranging transportation
to the facility. The airline may require reimbursement from an importer
for any associated costs incurred by the airline on the importer's
behalf.
(4) Dogs arriving by sea without a complete and accurate CDC import
submission form may be held onboard the vessel until the form is filed.
The vessel's owner or operator may require reimbursement from an
importer for any associated costs incurred by the vessel on the
importer's behalf.
(5) Dogs arriving by land without a complete and accurate CDC
import submission form shall be denied admission and returned
immediately to the dogs' country of departure, but such denial does not
prevent the importer from reapplying for admission of the dogs after
the form is filed.
(6) A receipt confirming submission of the form to CDC must
accompany all dogs departing foreign locations for travel to the United
States. For dogs departing from foreign airports to the United States,
the airline must deny boarding to dogs unless the importer has
presented this receipt prior to boarding.
(7) Airlines are required to create a bill of lading for all dogs
arriving in the United States prior to arrival. This includes dogs
transported as cargo, checked-baggage, or hand-carried baggage.
(8) Dogs arriving by air for which a bill of lading has not been
filed prior to arrival in the United States may be denied admission and
returned to the country of departure pursuant to paragraph (v) of this
section.
(i) Inspection requirements for admission of all dogs and cats. (1)
All animals arriving at a U.S. port shall be inspected upon arrival,
and only those animals that show no signs of communicable disease as
defined in 42 CFR 71.1 shall be admitted into the United States.
(2) All animals presented for admission into the United States may
be subject to additional examination and disease surveillance screening
for the purpose of communicable disease surveillance. Ill animals may
be required to undergo additional diagnostic testing prior to release
of the animal; such testing is not considered surveillance screening.
(3) The Director may require confinement of an animal and
examination by a veterinarian when necessary to determine whether the
animal is admissible into the United States, for instance, if dental
examination would assist in determining the animal's age.
(4) Importers who refuse to consent to inspection, examination, or
disease surveillance screening of the animal upon arrival may have the
animal denied admission and returned to its country of departure
pursuant to paragraph (v) of this section.
(j) Examination by a USDA-accredited veterinarian and confinement
of exposed dogs and cats or those that appear unhealthy. (1) If an
animal, upon inspection, does not appear to be in good health (e.g., it
has symptoms such as emaciation, lesions of the skin, discharge of the
eyes or nose, coughing, sneezing, nervous system disturbances,
inability to stand or walk, difficulty breathing, jaundice, vomiting,
or diarrhea), or appears healthy but, during shipment, may have been
exposed to a sick or dead animal (including an animal other than a dog
or cat) suspected of having a communicable disease, the Director may
require prompt confinement and veterinary examination.
(2) In the case of animals that appear unhealthy or those that were
potentially exposed and arriving by air or sea, the Director may
require the airline or vessel's master or operator to arrange for a
licensed veterinarian to examine the animal and give or arrange for any
tests or treatment indicated. In the case of animals that appear
unhealthy or those that were potentially exposed and arriving by land,
the Director may deny admission, but such denial does not prevent the
importer from reapplying for admission after providing the Director
with satisfactory evidence that a licensed veterinarian has examined
[[Page 44023]]
the animal and administered any tests or treatment as needed.
(3) Carriers shall maintain a record of sickness of animals
occurring while en route to the United States and shall submit the
record upon arrival to the CDC quarantine station with jurisdiction for
the U.S. port.
(4) Animals that become sick while en route or on arrival shall be
separated from other animals (including an animal other than a dog or
cat) as soon as the sickness is discovered and shall be held in
confinement pending any necessary examination as determined by the
Director.
(5) Airlines (in the case of arrivals by air) or a vessel's master
or operator (in the case of arrivals by sea) shall immediately arrange
for medical evaluation by a licensed veterinarian of any animals that
arrive sick and for transportation as needed to a facility for
confinement or medical evaluation of any sick animals. In the case of
sick animals arriving by land, the Director may deny admission, but
such denial does not prevent the importer from reapplying for admission
after providing the Director with satisfactory evidence of confinement
(as needed) and examination by a licensed veterinarian.
(6) The Director will consider the findings of the examination and
tests in determining whether the animal may have a communicable
disease.
(7) The airline or vessel's master or operator shall arrange for
confinement at a CDC-registered animal care facility or CDC-approved
veterinary clinic which, in the judgment of the Director, affords
protection against transmission of any communicable disease and
suitable housing in accordance with the Animal Welfare Act (7 U.S.C.
2131 et seq., as may be amended).
(8) The importer shall bear the expenses of confinement,
examination, tests, and treatment under this paragraph. If an importer
fails to arrange for or pay for such expenses or cooperate with any
CDC-mandated public health evaluations, then the animal will be
considered abandoned, and the carrier shall assume financial
responsibility pursuant to paragraph (z) of this section.
(9) Confinement shall be subject to conditions specified by the
Director to protect the public's health.
(10) CDC may request that CBP conditionally release animals in need
of medical evaluation or treatment. Animals eligible for conditional
release shall remain under the legal custody of the carrier or CDC-
registered animal care facility for the purpose of receiving emergency
veterinary medical care or examination. Such animals must be returned
immediately to a CDC-registered animal care facility or other CDC-
approved kennel or veterinary facility (if a CDC-registered animal care
facility is not available) once medical treatment is no longer required
or upon request by either CDC or CBP.
(11) If an importer (or carrier if the animal is abandoned by the
importer) opts to have an animal euthanatized (e.g., under
circumstances where the animal is fatally ill or injured), the importer
or carrier shall promptly communicate this decision to CDC and CBP in
writing and prior to euthanasia. Euthanasia does not relieve importers
or carriers of the obligation to arrange and pay for testing and
necropsy required by CDC.
(k) Veterinary examination and revaccination against rabies at a
CDC-registered animal care facility for foreign-vaccinated dogs. (1)
All dogs arriving from DMRVV high-risk countries that do not have a
valid certification of U.S.-issued rabies vaccination for live dog re-
entry into the United States form shall undergo veterinary examination
and revaccination against rabies at a CDC-registered animal care
facility upon arrival.
(2) The importer is responsible for making all arrangements
relating to the examination, revaccination, and quarantine of dogs with
a CDC-registered animal care facility prior to arrival in the United
States. The costs of examination, vaccination, or quarantine shall be
borne by the importer and not at the government's expense.
(3) Importers are required to present to airlines documentation
confirming their reservation at a CDC-registered animal care facility
prior to their dogs boarding a flight to the United States. Airlines
must deny boarding to dogs if the importer fails to present such
documentation.
(4) Prior to granting a reservation, CDC-registered animal care
facilities must ensure they have received the following:
(i) The completed CDC Import Certification of Rabies Vaccination
and Microchip Required for Live Dog Importations into the United States
form;
(ii) Serologic test results collected in accordance with CDC's
technical instruction from a CDC-approved laboratory (if applicable);
(iii) Photos of the dog's teeth to assist with age verification;
(iv) The travel itinerary for the dog confirming that the dog will
only be arriving at a U.S. airport with a CDC quarantine station and a
CDC-registered animal care facility and will not be arriving at any
other U.S. port; and
(v) A receipt confirming submission of the CDC import submission
form.
(5) Airlines must deny boarding to any foreign-vaccinated dog for
which the importer has not presented a receipt confirming submission of
the CDC import submission form and proof of a reservation at a CDC-
registered animal care facility, or that is being presented for travel
to an unauthorized U.S. airport.
(6) The airline shall arrange for dogs to be transported by a CBP-
bonded transporter to a CDC-registered animal care facility immediately
upon arrival at the U.S. airport.
(7) The dog shall remain in the custody of the CDC-registered
animal care facility until the following requirements are met:
(i) Veterinary health examination by a USDA-accredited veterinarian
for signs of illness. All illnesses must be documented in SAFE TraQ.
CDC will review these illness case reports and determine admissibility
prior to the animal's release. Suspected or confirmed zoonotic or
foreign animal diseases, including the presence of ecto-parasites
(i.e., ticks and fleas), must be reported to CDC, USDA, the State or
county public health veterinarian, and the State veterinarian prior to
release of the animal.
(ii) Vaccination against rabies with a USDA-licensed rabies vaccine
that is administered by a USDA-accredited veterinarian.
(iii) Confirmation of microchip number.
(iv) Confirmation of age through dental examination by a USDA-
accredited veterinarian.
(v) Verification of adequate rabies serologic test from a CDC-
approved laboratory. Serologic tests must be drawn within a timeframe
as specified in CDC technical instructions. Dogs that arrive without an
adequate rabies serologic test results from a CDC-approved laboratory,
or with a serologic test result drawn outside the acceptable timeframe,
or with serologic test results outside acceptable parameters, shall be
housed, at the CDC-registered animal care facility for a 28-day
quarantine period following administration of the USDA-licensed rabies
vaccine.
(l) Registration or renewal of CDC-registered animal care
facilities. (1) Before housing any live dog imported into the United
States, a facility must register with and receive written approval from
the Director to function as a CDC-registered animal care facility.
Applications and all required
[[Page 44024]]
documents must be submitted to [email protected].
(2) To register or to renew a registration certificate, a facility
must submit the following documents to CDC:
(i) A completed registration/application form;
(ii) A statement of intent that describes the number and types of
animals the facility can house at one time, including the number of
animals that can be housed in the quarantine area;
(iii) Written standard operating procedures that include all
elements required in paragraphs (k) through (q) of this section;
(iv) A copy of all Federal, State, or local registrations,
licenses, and/or permits; a facility must have a USDA Class H
intermediate handlers license (and any additional class licenses or
registrations as deemed appropriate by USDA) and a CBP Facilities
Information and Resource Management System (FIRMS) code.
(v) A self-certification signed by the owner or manager of the CDC-
registered Animal Care Facility stating that the facility is in
compliance and agrees to continue to comply with the regulations in
this section.
(3) Upon receiving the documentation required by this section, the
Director will review the application and either grant or deny the
application for registration as a CDC-registered Animal Care Facility.
Applications that are denied may be appealed under paragraph (r) of
this section.
(i) Before issuing a registration, the Director may inspect any
animal health record, facility, vehicle, or equipment to be used in
management, examination, and clearance of imported animals. Thereafter,
animal health records, facilities, vehicles, and equipment used in
importing animals may be inspected during annual site inspection visits
or when otherwise needed to protect the public's health.
(ii) Unless revoked in accordance with paragraph (r) 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) A CDC-registered animal care facility must apply to CDC for
renewal of the registration certificate not less than 60 days and not
more than 90 days before the existing registration expires.
(4) The Director may deny an application to register, renew, or
reinstate a facility as a CDC-registered animal care facility if the
registrant has had a previous registration revoked in accordance with
paragraph (r) of this section within the last five years.
(5) All CDC-registered animal care facilities must comply with the
requirements of paragraphs (k) through (q) of this section.
(m) Record-keeping requirements at CDC-registered animal care
facilities. (1) A CDC-registered animal care facility must retain
records regarding each imported animal for three years after the
distribution or transfer of the animal. Each record must include:
(i) The bill of lading for each shipment;
(ii) The name, address, phone number, and email address of the
importer and owner (if different from the importer);
(iii) The number of animals in each shipment;
(iv) The identity of each animal in each shipment, including name,
microchip number, date of birth, sex, breed, and coloring;
(v) The airline, flight number, date of arrival, and port of
arrival of each shipment;
(vi) Veterinary medical records for each animal, including:
(A) CDC import certification of rabies vaccination and microchip
required for live dog importations into the United States form and
rabies serology obtained before arrival in the United States (if
applicable);
(B) The USDA-licensed rabies vaccine administered upon arrival;
(C) Veterinary examination records upon arrival and while in
quarantine;
(D) Rabies serology performed while in quarantine in the United
States (if applicable);
(E) All diagnostic test results performed during quarantine; and
(F) Necropsy reports for imported animals that die while in the
care of the CDC-registered animal care facility.
(2) A CDC-registered animal care facility must maintain these
records electronically in SAFE TraQ.
(i) Copies of all records must be entered directly into or uploaded
into SAFE TraQ;
(ii) Records must be uploaded and complete prior to the animal's
release from the facility; and
(iii) CDC will audit records remotely as needed and in-person
during the annual site inspection visit(s) at the facility.
(n) Worker protection plan and personal protective equipment (PPE).
(1) A CDC-registered Animal Care Facility must establish and maintain a
worker protection plan with standards comparable to those in the
National Institute for Occupational Safety and Health (NIOSH)
Veterinary Safety and Health guidelines and the National Association of
Public Health Veterinarians (NASPHV) Compendium of Veterinary Standard
Precautions for Zoonotic Disease Prevention in Veterinary Personnel.
(2) In addition to complying with the requirements of this section,
a facility must comply with all relevant Federal and State requirements
relating to occupational health and safety.
(3) Rabies pre-exposure prophylaxis is required for workers
handling imported animals in rabies quarantine.
(4) Post-exposure procedures that provide potentially exposed
workers with direct and rapid access to a medical consultant.
(5) Procedures for documenting the frequency of worker training,
including for those working in the quarantine area.
(6) As part of the worker protection plan, a facility must
establish, implement, and maintain hazard evaluation and worker
communication procedures that include the following:
(i) Descriptions of the known zoonotic disease and injury hazards
associated with handling animals;
(ii) The need for PPE when handling animals and training in the
proper use of PPE, including re-training and reinforcement of
appropriate use; and
(iii) Procedures for disinfection of garments, supplies, equipment,
and waste.
(o) CDC-registered animal care facility standard operating
procedures, requirements, and equipment standards for crating, caging,
and transporting live animals. (1) Equipment standards for crating,
caging, and transporting live animals must be in accordance with USDA
Animal Welfare regulation standards (9 CFR parts 1, 2, and 3) and
International Air Transport Association standards.
(2) Animals must not be removed from crates during transport.
(3) Used PPE, bedding, and other potentially contaminated material
must be removed from the ground transport vehicle upon arrival at the
animal care facility and disposed of or disinfected in a manner that
would destroy potential pathogens of concern.
(p) Health reporting requirements for animals at CDC-registered
animal care facilities. (1) A CDC-registered animal care facility must
provide the following services for each animal upon arrival and ensure
each animal meets CDC entry requirements prior to release from the
facility:
(i) Veterinary examination by a USDA-accredited veterinarian within
one business day of arrival;
(ii) Verification of microchip and confirmation that the microchip
number matches the animal's health records;
[[Page 44025]]
(iii) Verification of animal's age via a dental examination;
(iv) Revaccination against rabies using a USDA-licensed vaccine;
and
(v) Verification of a valid serology test from a CDC-approved
laboratory drawn from a dog prior to arrival within a timeframe and
results within parameters as specified in CDC technical instructions or
28-day quarantine after administration of the USDA-licensed rabies
vaccine.
(2) A CDC-registered animal care facility must provide the
following services upon the occurrence of any morbidity or mortality in
an imported animal in the facility:
(i) Notification to CDC within 24 hours of the arrival of an ill
animal or occurrence of any illness or death occurring in an animal.
(ii) Examination by a USDA-accredited veterinarian immediately upon
detection of illness and diagnostic testing to determine the cause of
illness. All costs associated with examination and diagnostics are the
responsibility of the importer.
(iii) Reporting of suspected or confirmed zoonotic diseases and
ecto-parasites to CDC and the State or county public health
veterinarian within 24 hours of identification. Suspected or confirmed
foreign animal diseases or infectious animal diseases must be reported
to USDA and the State or county veterinarian within 24 hours of
identification.
(iv) Necropsy and diagnostic testing to determine the cause of
death. The importer is responsible for all costs associated with
necropsy and testing.
(3) Upon completion of the quarantine period and before a facility
releases any animal from quarantine, the facility must ensure that the
facility's USDA- accredited veterinarian has verified the health status
of the animal and all required paperwork is uploaded into SAFE TraQ.
(4) Any report required under this paragraph must be uploaded to
SAFE TraQ prior to the release of the animal.
(q) Quarantine requirements for animals at CDC-registered animal
care facilities. (1) A CDC-registered animal care facility must
maintain a quarantine area for holding dogs during the required
quarantine period. Dogs must be quarantined for 28 days after
revaccination with a USDA-licensed rabies vaccine at the facility if
they do not have a valid rabies serologic test from a CDC-approved
laboratory. CDC may extend the quarantine period if a facility or CDC
finds or suspects that a dog is infected with, or has been exposed to,
a zoonotic disease or if a facility or CDC determines that additional
diagnostic testing is warranted.
(2) For any quarantine area established or maintained under this
section, a facility must establish, implement, maintain, and adhere to
standard operating procedures that meet the following physical security
requirements:
(i) The CDC-registered animal care facility must be locked and
secure, with access limited to authorized, trained, and knowledgeable
personnel.
(ii) A CDC-registered animal care facility must limit access to
animal quarantine areas to authorized personnel responsible for the
transport, care, or treatment of the animals.
(3) During the quarantine period, a CDC-registered animal care
facility must monitor animals for signs of any zoonotic illness,
including, but not limited to, signs consistent with rabies,
brucellosis, leptospirosis, leishmaniasis, or ecto- or endo-parasites.
(4) If any animals appear ill during quarantine, the CDC-registered
animal care facility must notify CDC through SAFE TraQ and monitor that
animal for signs of zoonotic illness and ensure appropriate treatment.
Suspected or confirmed zoonotic diseases in animals or facility workers
must be reported to CDC within 48 hours.
(5) A CDC-registered animal care facility must not knowingly
release any ill animal from quarantine under paragraph (q)(3) of this
section without prior consultation with and written approval from CDC.
(6) Quarantined animals must be housed in such a manner that they
do not expose non-quarantined animals (including an animal other than a
dog or cat) to other potentially infectious materials, including soiled
bedding, caging, and other potentially contaminated items.
(7) If CDC notifies a CDC-registered animal care facility of any
evidence that animals have been exposed to a zoonotic disease, the
facility must, at the facility's expense, implement or cooperate in the
CDC's implementation of additional measures to rule out the spread of
suspected zoonotic disease before releasing an animal or shipment of
animals from quarantine, including examination, additional diagnostic
procedures, treatment, detention, isolation, seizure, or destruction of
exposed animals.
(8) A CDC-registered animal care facility must establish,
implement, and adhere to standard operating procedures for safe
handling and necropsy of any animal that dies in quarantine.
(r) Revocation and reinstatement of a CDC-registered animal care
facility's registration. (1) If the Director determines that a CDC-
registered animal care facility has failed to comply with any
applicable provisions of this section, including failure to abide by
the facility's standard operating procedures, the Director may revoke
the facility's registration.
(2) CDC will send the CDC-registered animal care facility a notice
of revocation stating the grounds upon which the proposed revocation is
based.
(3) If the CDC-registered animal care facility wishes to contest
the revocation, the facility must file a written response to the notice
within five business days after receiving the notice.
(4) As part of the response, a CDC-registered animal care facility
may request that the Director review the written record.
(5) If a CDC-registered animal care facility fails to file a
response within five business days, all of the grounds listed in the
proposed revocation will be deemed admitted, in which case the notice
shall constitute final agency action.
(6) If a CDC-registered animal care facility'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.
(7) 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 provide the facility
with a copy of the written decision.
(8) The Director may reinstate a revoked registration after
inspecting the facility, examining its records, conferring with the
facility, and receiving information and assurance from the facility of
compliance with the requirements of this section.
(s) Requirement for the CDC Import Certification of Rabies
Vaccination and Microchip Required for Live Dog Importations into the
United States form to import foreign-vaccinated dogs from DMRVV high-
risk countries. (1) Importers of foreign-vaccinated dogs from DMRVV
high-risk countries must submit the CDC Import Certification of Rabies
Vaccination and Microchip Required for Live Dog Importations into the
United States form to the CDC-registered animal care facility in order
to make a reservation at that facility.
(2) Importers must present documentation confirming the dog's
reservation at a CDC-registered animal care facility to the airline
prior to boarding and to CBP upon arrival at a U.S. port for admission
of foreign-
[[Page 44026]]
vaccinated dogs from DMRVV high-risk countries.
(3) The CDC Import Certification of Rabies Vaccination and
Microchip Required for Live Dog Importations into the United States
form must be truthful and accurate, completed in English, and include:
(i) The name of person importing the dog (consignee), physical
address, phone number, email address, passport number and date of
birth;
(ii) The owner's name, phone number, and email address;
(iii) The destination address (physical address) where the dog will
reside upon arrival in the United States;
(iv) The dog's name, microchip number, microchip implant date,
breed, sex, date of birth or approximate age if the date of birth is
unknown, and color or markings of the dog;
(v) Rabies vaccination information for the dog administered within
a timeframe and in accordance with the vaccination schedule as
specified in CDC technical instructions;
(vi) Rabies vaccine product information (product name,
manufacturer, lot number, and product expiration date);
(vii) Rabies vaccine expiration date (date when next vaccine is
due), which must be after the dog's date of arrival at a U.S. port;
(viii) The name, license number or official stamp, address,
telephone number, email address, and signature of the authorized
veterinarian or official government veterinarian that examined the dog
in the exporting country; and
(ix) The name, address, official seal or stamp, and signature of an
official government veterinarian attesting that the authorized
veterinarian is licensed or authorized to practice veterinary medicine
in the exporting country and further attesting that the information
listed on the form is true and correct.
(4) Importers who fail or refuse to present the CDC Import
Certification of Rabies Vaccination and Microchip Required for Live Dog
Importations into the United States form or present a form that is
untruthful, inaccurate, and incomplete may result in the dog denied
admission and returned to the country of departure pursuant to
paragraph (v) of this section.
(t) Requirement for Certification Of U.S.-Issued Rabies Vaccination
for Live Dog Re-entry into the United States form for importers seeking
to import U.S.-vaccinated dogs from DMRVV high-risk countries. (1)
Importers returning to the United States from a DMRVV high-risk country
with their U.S.-vaccinated dog may present their dog for admission
without a rabies serologic test from a CDC-approved laboratory, without
the dog undergoing veterinary examination (unless ill, injured, or
exposed), and without revaccination against rabies at a CDC-registered
animal care facility upon arrival under the following circumstances:
(i) The importer presents a Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into the United States form that is
truthful, complete, and accurate.
(ii) The dog must arrive by air and entry must be made through a
U.S. airport with a CDC quarantine station.
(iii) The importer presents a valid Certification of U.S.-issued
Rabies Vaccination for Live Dog Re-entry into the United States form
that sufficiently and reliably demonstrates that a USDA-licensed rabies
vaccine was administered within a timeframe and age parameters as
specified in CDC technical instructions.
(2) The Certification of U.S.-issued Rabies Vaccination for Live
Dog Re-entry into the United States form must be completed prior to the
dog leaving the United States and cannot be completed upon arrival at a
U.S. port or after the dog has left the United States.
(3) Importers returning to the United States from a DMRVV high-risk
country with their U.S.-vaccinated dog that are unable to meet the
requirements of this paragraph (t) shall have the dog treated as if it
was vaccinated in a foreign country in accordance with the provisions
of paragraph (k) of this section and this paragraph (t) or,
alternatively, have the dog denied admission and returned to the
country of departure pursuant to the paragraph (v) of this section.
(4) If an importer fails to immediately (within 24 hours of
arrival) arrange for the dog's return to the country of departure, then
the animal will be considered abandoned pursuant to paragraph (z) of
this section.
(u) Requirement for proof that a dog has only been in a DMRVV low-
risk or DMRVV-free country. Dogs arriving, including those returning to
the United States, from a DMRVV low-risk or DMRVV-free country may be
admitted into the United States subject to the requirements in this
section if the importer submits written documentation (i.e., veterinary
records, veterinary import/export certificate) satisfactory to the
Director that for the six months before arrival, the dog has been only
in a DMRVV low-risk or DMRVV-free country.
(v) Denial of admission of dogs and cats. (1) The Director may deny
admission to the following categories of animals:
(i) Any dog arriving from a DMRVV low-risk or DMRVV-free country
without written documentation (i.e., veterinary records, veterinary
import/export certificate) that the dog has only been in a DMRVV low-
risk or DMRVV-free country for the six months prior to the attempted
entry, or if the Director reasonably suspects fraud.
(ii) Any dog that is not accompanied by a receipt confirming that a
CDC import submission form has been submitted to CDC through a CDC-
approved system.
(iii) Any dog arriving by air for which a bill of lading has not
been created by the airline prior to arrival.
(iv) Any dog arriving by land to the United States from DMRVV high-
risk countries.
(v) Any dog arriving by sea to the United States from DMRVV high-
risk countries, except for a dog qualifying as a service animal and
meeting the standards set forth in paragraph (d)(4) of this section.
(vi) Any dog imported by an importer who refuses to comply with the
requirement (if applicable) to undergo disease surveillance screening,
microchip scanning, veterinary examination, revaccination, provide
proof of sufficient rabies serologic tests, or quarantine at a CDC-
registered animal care facility or other CDC-approved facility (if a
CDC-registered Animal Care Facility is not available) upon arrival.
(vii) Any dog that has been in a DMRVV high-risk country in the
previous six months and arrives without a valid Certification of U.S.-
issued Rabies Vaccination for Live Dog Re-entry into the United States
form or a valid CDC import certification of rabies vaccination and
microchip required for live dog importations into the United States
form.
(viii) Any dog that has been in a DMRVV high-risk country in the
previous six months and does not arrive via air at a U.S. airport with
a CDC quarantine station and a CDC-registered animal care facility,
except for a dog arriving by sea that qualifies as a service animal and
meets the standards set forth in paragraph (d)(4) of this section.
(ix) Any dog imported from a DMRVV high-risk country that arrives
without a reservation at a CDC-registered animal care facility (if
applicable).
(x) Any dog from a DMRVV-restricted country that arrives without a
valid CDC dog import permit.
(xi) Any dog imported from a DMRVV high-risk country if the
Director reasonably suspects fraud in any documentation required for
admission or if such documentation is otherwise untruthful, inaccurate,
or incomplete.
[[Page 44027]]
(xii) Any animal, regardless of country of departure, that poses a
public health risk, including animals that appear unhealthy upon
arrival or demonstrate signs or symptoms of communicable disease.
(xiii) Any dog under six months of age that is arriving via air or
sea into the United States, or any dog under six months of age imported
via a land port if the importer has imported more than three individual
dogs under six months of age in the same calendar year (January-
December).
(2) Animals arriving by air that are awaiting an admissibility
determination or denied admission must be held in CDC-registered animal
care facilities or other CDC- or USDA-approved veterinary clinics (if a
CDC-registered animal care facility is not available) in such a way as
to prevent the potential spread of communicable diseases.
(3) Pursuant to 9 CFR 3.14(f), animals arriving by air that are
denied admission must be transported to a CDC-registered animal care
facility (or other boarding, kennel, or veterinary clinic approved by
CDC if a CDC-registered animal care facility is not available) by the
airline within six hours of denial of admission into the United States
while awaiting return to the country of departure, excluding animals
transiting through the United States. Animals arriving by sea that are
denied admission must remain on the vessel while awaiting return to the
country of departure.
(4) An importer must meet the admission requirements of all U.S.
Government agencies for the admission of an animal into the United
States. Satisfaction of CDC's requirements for the admission of animals
does not fulfill the admission requirements of other U.S. Government
agencies.
(w) Disposal or disposition of dogs and cats denied admission to
the United States. (1) Animals shall be subject to such additional
requirements, including denial of admission, as may be deemed necessary
by the Director to protect the public's health or suspension of entry
under 42 CFR 71.63.
(2) Animals denied admission to the United States that were
transported to the United States via air must be returned by the
airline to the country of departure at the importer's expense on the
next available outbound flight (no later than 72 hours after arrival),
regardless of airline or route, if fit to travel. Pending the animal's
return, the animal shall be detained at the importer's expense in the
custody of the carrier at a CDC-registered animal care facility (or
other boarding, kennel, or veterinary clinic approved by CDC if a CDC-
registered animal care facility is not available).
(3) Animals denied admission to the United States that were
transported to the United States via sea shall be reembarked
immediately by the vessel's master or operator and returned to its
country of departure on the next voyage.
(4) Animals denied admission to the United States that were
transported to the United States via land shall be returned immediately
by importer or carrier to their country of departure.
(5) If an animal is not fit to travel, poses a public health risk,
or would pose a risk to other animals, then the carrier shall arrange
for the animal to be transported to a CDC-registered animal care
facility or a CDC- approved veterinary clinic (if a CDC-registered
animal care facility is not available) for either housing and treatment
by a licensed veterinarian until approved for travel by CDC or humanely
euthanized (e.g., under circumstances where the animal is fatally ill
or injured) by a licensed veterinarian. The importer shall be
responsible for all costs associated with the denial, veterinary
evaluation, care, or disposal of the animal. If the importer refuses to
pay for any costs associated with the denial, evaluation, care, or
disposal of the animal, then it will be considered abandoned, and the
carrier shall assume custody and financial responsibility for these
costs.
(6) If humane euthanasia is recommended by a veterinarian or chosen
by an importer or carrier (e.g., under circumstances where the animal
is fatally ill or injured), the animal must be euthanized by a U.S.-
licensed veterinarian in accordance with American Veterinary Medical
Association guidelines. Euthanasia does not relieve carriers or
importers of the obligation to arrange and pay for testing and necropsy
required by CDC.
(7) The Director may grant temporary extensions of returns for
animals that are not fit for travel as determined by a CDC
veterinarian, but the importer (or carrier in the case of abandonment)
must arrange for the return of the animal to its country of departure
as soon as CDC notifies the carrier that the animal is fit for travel.
(8) The requirements of this paragraph shall additionally apply to
dogs or cats abandoned by the importer prior to the dogs' or cats'
admission into the United States. A dog or cat may be deemed abandoned
pursuant to the provisions of paragraph (z) of this section.
(9) Carriers must provide transportation to/from and holding at a
CDC-registered animal care facility (or other boarding, kennel, or
veterinary clinic approved by CDC if a CDC-registered animal care
facility is not available) while determining admissibility, undergoing
veterinary evaluation or care, or upon denial of entry. Carriers may
require reimbursement from an importer for any costs incurred on behalf
of the importer.
(10) Importers must comply with CDC requirements for the return of
an animal or for the veterinary assessment of an animal. Refusal to
cooperate, including refusal to pay any associated veterinary fees,
will result in the animal being considered abandoned by the importer,
and custody of the animal will be transferred to the carrier who will
assume financial responsibility for costs relating to the denial,
evaluation, care, or disposal of the animal.
(11) A carrier may enter into contractual arrangements with an
importer or a third party relating to the expenses of returning an
animal to its country of departure, for veterinary care, or otherwise
disposing of an animal, provided that no government costs are incurred.
The return of an animal to its country of departure or the initiation
of veterinary care shall not be delayed while the carrier attempts to
enter into or negotiate contractual arrangements.
(12) The provisions of this paragraph may be applied to importers
of animals and to carriers transporting such animals in circumstances
where an animal is denied entry at a land port or seaport of the United
States and the animal cannot be immediately returned to its country of
departure (e.g., because it is unfit to travel).
(x) Appeals of CDC denials to admit a dog or a cat upon arrival
into the United States. (1) If CDC denies admission to an animal upon
arrival, then the importer may appeal that denial to the Director.
(2) The importer must submit the appeal in writing to the Director,
stating the reasons for the appeal and demonstrating that there is a
genuine and substantial issue of fact in dispute.
(3) The importer must submit the appeal within one (1) business day
of the denial by emailing [email protected]
(4) Submitting an appeal will not delay the return of the animal to
the country of departure.
(5) The Director will issue a written response to the appeal, which
shall constitute final agency action.
(y) Record of death of dogs and cats en route to the United States
and disposition of dead animals. (1) Carriers shall maintain a record
of the death of animals occurring while en route to the United States
and shall submit the record to the CDC quarantine station of
[[Page 44028]]
jurisdiction for the U.S. port upon arrival.
(2) Animals that become sick or die en route or are identified as
sick or dead upon arrival shall be separated from other animals
(including animals other than dogs or cats) as soon as the sickness or
death is discovered and shall be held in confinement pending any
necessary examination as determined by the Director. Sick animals shall
be examined pursuant to the provisions of paragraph (j) of this section
or disposed of pursuant to the provisions of paragraph (w) of this
section.
(3) The carrier shall arrange for any animals that die en route to
the United States or that die while detained pending determination of
their admissibility to undergo a necropsy (gross and histopathologic
examination are required), and any subsequent infectious disease
testing based on gross or histopathology findings or as determined by
CDC. The carrier or CDC-registered animal care facility must contact
the CDC quarantine station of jurisdiction prior to transporting an
animal for necropsy to determine whether rabies testing is required. In
the event an importer abandons an animal, the carrier will become the
owner and shall assume responsibility for all expenses described in
this paragraph (y)(3).
(4) The carrier shall send copies of the final necropsy report and
all test results to the CDC quarantine station of jurisdiction.
(5) Pursuant to paragraphs (p) and (w) of this section, the
importer is responsible for costs associated with the necropsy,
testing, and disposal of the body. In the event an importer abandons an
animal, then pursuant to paragraph (z) of this section, the carrier
will become the owner and shall assume responsibility for all expenses
described in paragraph (y)(3) of this section.
(z) Abandoned shipments of dogs and cats. (1) In the event an
importer abandons an animal under this section, the carrier will become
the owner and shall assume responsibility for all expenses described in
this section.
(2) An animal shipment will be deemed abandoned under the following
circumstances:
(i) When explicitly stated by the importer verbally or in writing
to the carrier, CDC, or CBP; or
(ii) If the importer fails to cooperate with or respond to the
carrier's attempts to comply with the provisions of this section within
24 hours; or
(iii) If the importer refuses payment within 24 hours for CDC-
mandated examinations, testing, holding, or treatment needed to ensure
the safe importation of dogs and cats into the United States.
(aa) Sanitation of cages and containers of dogs and cats. When the
Director finds that the cages or other containers of animals arriving
in the United States are in an unsanitary or other condition that may
constitute a communicable disease risk, the animals shall not be
admitted in such containers unless the carrier has the containers
cleaned and disinfected or the animals are removed and placed in clean
containers in accordance with USDA and, in the case of airlines, the
International Air Transport Association (IATA) shipping requirements.
Discarded containers must be cleaned and disinfected or destroyed in
accordance with carrier policies. CDC may require documentation of
crate disinfection or destruction by the carrier.
(bb) Requirements for in-transit shipments of dogs and cats. (1)
In-transit shipments of live animals are not eligible for release into
the United States.
(2) In-transit shipments must be maintained under continuous
confinement with USDA APHIS oversight onboard a conveyance until export
or off-loaded and maintained under continuous confinement and APHIS
oversight at a USDA APHIS-preapproved holding facility with a CBP-
issued FIRMS code while awaiting a connecting conveyance, and then
loaded and maintained under USDA APHIS oversight onboard the connecting
conveyance until export.
(3) The provisions of this section shall apply to animals
transiting through the United States from one foreign country to
another, except as provided in paragraphs (bb)(3)(i) and (ii) of this
section:
(i) Animals that appear healthy but have been exposed to a sick or
dead animal (including an animal other than a dog or cat) suspected of
having a communicable disease are not required to undergo examination
or tests as provided in paragraph (j) of this section if the Director
determines that the conditions under which the animals are being
transported afford adequate protection against introduction of
communicable disease into the United States.
(ii) The CDC Import Certification of Rabies Vaccination and
Microchip Required For Live Dog Importations into the United States
form or Certification Of U.S.-Issued Rabies Vaccination For Live Dog
Re-entry into the United States form is not required for dogs that are
transported by aircraft and are being transited through the United
States if retained in the custody of the airline under conditions that
would prevent transmission of communicable diseases.
(cc) Bill of lading and other airline requirements for dogs. (1)
Airlines are required to create a bill of lading for all dogs arriving
in the United States prior to arrival. This includes dogs transported
as cargo, checked-baggage, or hand-carried baggage.
(2) Dogs arriving by air for which a bill of lading has not been
filed prior to arrival in the United States may be denied admission and
returned to the country of departure pursuant to paragraph (v) of this
section.
(3) Airlines must deny boarding to any dogs for which the importer
has not presented to the airline before boarding a receipt confirming
submission of the CDC import submission form. Airlines must also deny
boarding if the dog presented for travel does not match the description
on the receipt of the CDC import submission form.
(4) For U.S.-vaccinated dogs that have been in a DMRVV high-risk
country within the last six months, airlines must deny boarding unless
the importer presents prior to boarding a valid certification of U.S.-
issued rabies vaccination for live dog re-entry into the United States
form. Airlines must also deny boarding if the dog presented for travel
does not match the description on the Certification of U.S.-Issued
Rabies Vaccination for Live Dog Re-entry into the United States form or
if the dog is scheduled to arrive in the United States at a U.S.
airport that does not have a CDC quarantine station.
(5) For foreign-vaccinated dogs that have been in a DMRVV high-risk
country within the last six months, airlines must deny boarding unless
the importer presents documentation to the airline before boarding of a
reservation at a CDC-registered animal care facility and the dog is
scheduled to arrive in the United States at the U.S. airport where the
CDC-registered animal care facility is located.
(6) For dogs from DMRVV-free or low-risk countries, airlines must
deny boarding unless the importer presents documentation to the airline
before boarding by showing that the dog is over six months of age, has
a microchip, and has not been in a DMRVV high-risk country in the
previous six months. Airlines must also deny boarding if the dog
presented for travel does not match the description on the documents
presented by the importer for travel.
(7) A representative of an airline transporting live dogs into the
United States must be on-site at the U.S. airport and available to
coordinate the entry/
[[Page 44029]]
clearance of the dogs with Federal Government officials until all live
dogs transported on an arriving flight into the United States have
either been cleared for entry or arrangements have been made to
transport the dogs to a CDC-registered animal care facility or other
facility (e.g., veterinary clinic or kennel) approved by CDC pending an
admissibility determination.
(dd) Order prohibiting carriers from transporting dogs and cats.
(1) If the Director determines that a carrier has endangered the public
health of the United States by acting or failing to act to prevent the
introduction of DMRVV, as would occur through failure to comply with
any applicable provisions of this section, the Director may issue an
order revoking the carrier's permission to transport live animals into
the United States, which shall be served on the carrier's owner or
operator.
(2) The Director may rescind the order after inspecting the
carrier's facilities; examining its records; conferring with the
carrier's owners or operators, its contractors, or staff; or receiving
information and written assurances from the carrier owner or operator
that it has taken remedial steps to ensure future compliance with the
requirements of this section.
(3) A carrier owner or operator may appeal a revocation of a
carrier's permission to transport live animals into the United States.
The appeal shall be in writing, addressed to the Director, state the
reasons for the appeal, and demonstrate that there is a genuine and
substantial issue of fact in dispute. The appeal must be submitted via
email to [email protected]
(4) As soon as practicable after completing the appeal review, the
Director will issue a decision in writing that shall constitute final
agency action. The Director will serve the carrier with a copy of the
written decision.
(ee) Prohibition on imports of dogs from DMRVV-restricted
countries. (1) The Director may prohibit or otherwise restrict the
import of dogs into the United States from certain countries designated
as DMRVV-restricted countries. CDC will maintain a list of DMRVV-
restricted countries for which the import of dogs into the United
States has been prohibited or otherwise restricted based on the
countries' prior export of dogs infected with DMRVV to any other
countries within a time frame determined by CDC or based on inadequate
controls, as determined by CDC, in the countries to monitor and prevent
the export of dogs to the United States with falsified or fraudulent
rabies vaccine credentials, invalid rabies vaccination certificates, or
other fraudulent, inaccurate, or invalid exportation/importation
documents.
(2) DMRVV-restricted countries may be subject to additional
restrictions, including a complete prohibition on the importation of
dogs into the United States from those countries as needed to prevent
the reintroduction of DMRVV.
(3) The Director may maintain such additional restrictions or
prohibitions in place until the Director is satisfied that the DMRVV-
restricted country has established sufficient controls to prevent the
reintroduction of DMRVV into the United States, including measures to
prevent the use of falsified or fraudulent vaccine credentials or
invalid rabies vaccination certificates.
(4) The addition or removal of DMRVV-restricted countries from the
list shall be announced through notification in the Federal Register,
and a list will be maintained on CDC's website.
(5) Notwithstanding the prohibition on imports of dogs from DMRVV-
restricted countries, the Director may allow the importation of dogs
for scientific purposes, when used as a service animal (as defined in
14 CFR 382.3) for individuals with disabilities, or in furtherance of
an important government interest. In such instances CDC will issue a
CDC dog import permit for the importation of dogs from DMRVV-restricted
countries. Instructions for how to apply for a permit will be included
in CDC technical instructions.
(ff) Request for issuance of additional fines or penalties. CDC may
request that U.S. Customs and Border Protection (CBP), pursuant to 19
U.S.C. 1592 and 19 U.S.C. 1595a, issue additional fines, citations, or
penalties to importers, brokers, or carriers when the Director has
reason to believe that an importer, broker, or carrier has violated any
of the provisions of this section or otherwise engaged in conduct
contrary to law.
Dated: June 30, 2023.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-14343 Filed 7-6-23; 4:15 pm]
BILLING CODE 4163-18-P
