Federal Register, Volume 89 Issue 93 (Monday, May 13, 2024)

[Federal Register Volume 89, Number 93 (Monday, May 13, 2024)]
[Rules and Regulations]
[Pages 41726-41848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09676]

[[Page 41725]]

Vol. 89

Monday,

No. 93

May 13, 2024

Part VI

Department of Health and Human Services

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42 CFR Part 71

Control of Communicable Diseases; Foreign Quarantine: Importation of
Dogs and Cats; Final Rule

Federal Register / Vol. 89, No. 93 / Monday, May 13, 2024 / Rules and
Regulations

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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: Final rule.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), in the
Department of Health and Human Services (HHS), issues this final rule
to provide clarity and safeguards that address the public health risk
of dog-maintained rabies virus variant (DMRVV) associated with the
importation of dogs into the United States. This final rule addresses
the importation of cats as part of overall changes to the regulations
affecting both dogs and cats, but the final rule does not require that
imported cats be accompanied by proof of rabies vaccination and does
not substantively change how cats are imported into the United States.

DATES: This final rule is effective August 1, 2024.

FOR FURTHER INFORMATION CONTACT: Ashley C. Altenburger, J.D., Division
of Global Migration Health, 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:
Dr. Emily Pieracci, D.V.M., Division of Global Migration Health,
Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS
H16-4, Atlanta, GA 30329; Telephone: 1-800-232-4636.

SUPPLEMENTARY INFORMATION: This rule 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. Regulatory History
IV. Summary of the Final Rule
V. Alternatives Considered
VI. Summary of Public Comment and Responses
VII. Required Regulatory Analyses
a. Executive Orders 12866, 13563, and 14094
b. The Regulatory Flexibility Act
c. The Paperwork Reduction Act
d. National Environmental Policy Act (NEPA)
e. Executive Order 12988: Civil Justice Reform
f. Executive Order 13132: Federalism
g. The Plain Language Act of 2010

I. Executive Summary

A. Purpose of This Regulatory Action

Through this final rule, HHS/CDC is revising 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 is also
revising 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. This rule also
includes requirements for dogs from DMRVV-free and low-risk countries
to confirm that the dog has not been in a high-risk country during the
six months before arriving in the United States. 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. Accessed December
19, 2023.
\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/index.html.
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Through this final rule, 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 out of an
estimated 32,530 foreign-vaccinated dogs arriving annually from DMRVV
high-risk countries as reported in Section VIIA).^{9 10} This
troubling trend continued from January through June 2021, prior to the
implementation of the temporary suspension in July 2021,\11\ with an
additional 24 percent increase of dogs ineligible for admission in just
the first half of the year, compared to the full 2020 calendar year
(January-December) (approximately 560 dogs with falsified or fraudulent
documentation).\12\ This final rule will also support CDC's efforts to
improve data collection related to dog importation, including tracking
the total number of dog importations which CDC has been unable to do
previously across all ports and for all importations.
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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\ Pieracci EG, Wallace R, Maskery B, Brouillette C, Brown C,
Joo H. Dogs on the move: Estimating the risk of rabies in imported
dogs in the United States, 2015-2022. Zoonoses and Public Health
2024; 00:1-9 DOI: 10.1111/zph.13122.
\11\ Temporary Suspension of Dogs Entering the United States
from High-Risk Rabies Countries. Federal Register, 86 FR 32041 (June
16, 2021).
\12\ Centers for Disease Control and Prevention. Port Health
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, January 1, 2021-July 14, 2021. Accessed: 01 October 2021.
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The use of a single false rabies vaccination certificate (RVC) \13\
or other rabies vaccination document as part of a larger shipment of
multiple dogs raises suspicion that the rabies vaccination documents
for the remaining dogs may also be false. This is not an uncommon
occurrence \14\ and creates an additional

[[Page 41727]]

burden on CDC and State health departments to track, test, and evaluate
the remaining dogs in the shipment.
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\13\ 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.
\14\ Centers for Disease Control and Prevention. Port Health
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2021. Accessed: 26 March 2024.
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CDC has documented numerous importations every year in which flight
parents ^{15 16} 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 \17\ 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.
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\15\ ``Flight parent'' means any person transporting one or more
animals on behalf of an importer for purposes of resale, adoption,
or to transfer ownership. A flight parent is typically solicited
through social media and may be compensated (including through goods
and services, e.g., complimentary airplane ticket, paid baggage
fees, other paid fees) or be uncompensated. Flight parents must
possess all required Federal licenses or registrations to transport
animals.
\16\ Centers for Disease Control and Prevention. Port Health
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2021. Accessed: 15 April 2024.
\17\ https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/usda-animal-care-overview.
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The documented increase in fraudulent vaccine documentation and
importers circumventing dog import regulations was shortly followed by
the emergence 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.\18\ The temporary suspension created a
system that, among other things, implemented the use of standardized
forms, required test results demonstrating the presence of rabies
antibodies in dogs, and developed a network of animal care facilities
authorized by CDC for the purpose of allowing for the immediate
quarantine of dogs from DMRVV high-risk countries arriving with
inadequate proof of test results. During the temporary suspension, CDC
has documented decreased instances of fraud, fewer dogs being denied
admission into the country, and fewer sick and dead dogs arriving in
the United States from both DMRVV high-risk and DMRVV-free and low-risk
countries, all of which have resulted in fewer Federal and State agency
resources devoted to addressing issues related to inadequate rabies
vaccination and/or documentation. This final rule implements a similar
regulatory framework, expanded to dogs from DMRVV-free and low-risk
countries, based on the documented successes of the temporary
suspension.
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\18\ 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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B. Summary of Major Provisions

In this final rule, HHS/CDC aligns 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. The final rule requires for all
dog imports: a microchip, six-month minimum age requirement for
admission, and importer submission of a CDC import form (CDC Dog Import
Form). The rule requires airlines to confirm documentation, provide
safe housing for animals, and assist public health officials in
determining cause of animal illness or death.

B.i. Requirements for All Dogs

Per this final rule, HHS/CDC requires that all dogs arriving from
any country, including dogs returning to the United States after
traveling abroad, be microchipped with an International Standards
Organization (ISO)-compatible microchip prior to travel into the United
States. The microchip information must 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 or other
documents. CDC has documented several instances of importers attempting
to present records of vaccinated dogs as the vaccination records for
dogs that lacked appropriate veterinary paperwork in an attempt to
import the unvaccinated dogs into the United States without
detection.\19\ Because microchips were not required for entry into the
United States at that time and the dogs in question were not
microchipped, the public health investigations to confirm the identity
of those dogs were both resource-intensive and challenging. Microchips
are used frequently by pet owners and required for international
transit by many foreign countries, including for importation in many
DMRVV-free countries. Microchips are also recommended by the
international veterinary community and animal rescue and welfare
organizations to reunite lost animals with their owners and ensure that
the veterinary records for an animal can be linked to the animal.\20\
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.
Therefore, CDC's requirement has minimal impact on dog importations,
although costs to some importers may still be incurred.
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\19\ Centers for Disease Control and Prevention. Port Health
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2018-2020. Accessed: February 15, 2021.
\20\ 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.
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To address concerns about importations of puppies that are too
young to be properly vaccinated against rabies, through this final
rule, HHS/CDC requires 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.\21\ 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
and will better protect the public's health from rabies.\22\
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\21\ National Association of State Public Health Veterinarians.
Compendium of animal rabies prevention and control, 2016. JAVMA
2016; 248 (5):505-517.
\22\ 7 U.S.C. 2148.
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In this final rule, HHS/CDC also requires all dog importers to
submit a CDC Dog Import 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 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,
importers must present a receipt confirming they submitted a completed
CDC Dog Import Form; additionally, importers arriving by air must
present the receipt to the airline prior to boarding. The receipt
contains the information submitted on the CDC Dog

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Import Form, which allows government officials to verify that the
details from the CDC Dog Import Form match the dog being presented for
entry. CDC's import submission system is a free online system.
Requiring documentation for all imported dogs allows CDC to track the
total number of dog importations (including the number imported from
DMRVV high-risk countries), something CDC has been unable to do
previously.
To improve vaccination verification systems and deter fraud, CDC's
required forms (not including the electronically submitted CDC Dog
Import Form) need to be endorsed by official government veterinarians
in the country of export. Importers should contact their local
veterinarian who can submit the required form to an official government
veterinarian in the exporting country. Importers may also use the USDA
pet travel website or IPATA website to contact a pet shipper to request
assistance.^{23 24}
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\23\ USDA Pet Travel. www.aphis.usda.gov/pet-travel/us-to-another-country-export.
\24\ International Pet and Animal Transportation Association.
www.ipata.org.
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All dogs arriving by air are required to have an air waybill (AWB).
An AWB is a legally binding document issued by a carrier to a shipper
or importer that details the type, quantity, and destination of the
goods (i.e., dogs) being carried. It serves as a tracking number that
can assist Federal agencies in monitoring the dog throughout the
lifecycle of the dog's travel from the point of origin to the final
destination. Additionally, a bill of lading serves as undisputed proof
of shipment, and it represents the agreed upon terms and conditions for
the transportation of the goods. All commercial airlines and many
private cargo aircraft are capable of generating AWB. Additionally, CDC
has successfully piloted the generation of AWB for dogs transported as
hand-carried or excess baggage with several foreign air carriers during
the temporary suspension to ensure air carriers can generate AWB for
dogs transported as hand-carried or excess baggage.
B.ii. Requirements for Dogs From DMRVV-Free or DMRVV Low-Risk Countries
This final rule further permits dogs imported from DMRVV-free or
DMRVV low-risk countries to arrive at any U.S. port.\25\ In lieu of a
CDC vaccination form, which is required for dogs imported from DMRVV
high-risk countries, these importers may instead provide proof
(examples outlined in paragraph (u)) that the dogs have been in DMRVV-
free or DMRVV low-risk countries only during the six months prior to
arriving in the United States.
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\25\ 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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TB.iii. Requirements for Dogs From DMRVV High-Risk Countries
Per this final rule, HHS/CDC requires all importers of dogs that
have been in a DMRVV high-risk country within the last six months,
regardless of whether foreign- or U.S.-vaccinated, to submit a
standardized vaccination form verifying the rabies vaccination status
of the dog. This final rule permits dogs that have been in a DMRVV
high-risk country in the past six months and have a valid U.S.-issued
rabies vaccination form to arrive at any U.S. port. For dogs that have
been in a DMRVV high-risk country in the past six months, and were
vaccinated in a foreign country, this final rule requires that the dog
arrive at a U.S. airport with a CDC quarantine station (also known as a
port health station) and a CDC-registered animal care facility (ACF).
HHS/CDC is removing the current requirement for a valid RVC in 42
CFR 71.51(c) and replacing it with new rabies vaccination forms for
dogs imported from DMRVV high-risk countries. The rabies vaccination
forms include the rabies vaccination status of the dog and other
required information similar to the previous valid RVC requirement.
However, unlike the previous requirement for a valid RVC, the rabies
vaccination forms are standardized.
The rabies vaccination form for foreign-vaccinated dogs from DMRVV
high-risk countries must also be endorsed by a government official in
the exporting country, as an added measure to prevent falsification.
The name for the rabies vaccination form to fulfill this requirement
for foreign-vaccinated dogs from DMRVV high-risk countries was
shortened from CDC Import Certification of Rabies Vaccination and
Microchip Required for Live Dog Importations into the United States as
proposed in the notice of proposed rulemaking (NPRM) to Certification
of Foreign Rabies Vaccination and Microchip. The requirement for this
standardized form helps ensure that foreign-vaccinated dogs imported
from DMRVV high-risk countries meet CDC entry requirements prior to
traveling to the United States and allows for follow-up with the
exporting country's government officials if repeated import violations
occur.
Under this final rule, importers of U.S.-vaccinated dogs, including
dogs that have been in a DMRVV high-risk country within the last six
months, may arrive at any U.S. port. Prior to traveling out of the
United States with a U.S.-vaccinated dog that will be present in a
DMRVV high-risk country, the dog owner must obtain a form titled
Certification of U.S.-issued Rabies Vaccination that must be completed
and signed by a USDA-Accredited Veterinarian. The name for this rabies
vaccination form was shortened from Certification of U.S.-issued Rabies
Vaccination for Live Dog Re-entry into the United States as proposed in
the NPRM to Certification of U.S.-issued Rabies Vaccination. CDC is
partnering with USDA to utilize the USDA export process to verify an
animal was vaccinated in the United States. This form must be endorsed
by a USDA Official Veterinarian prior to the dog's departing the United
States and must be presented by the importer to the airline to board
the dog on its return flight to the United States. The importer must
also present this form when requested to do so by U.S. government
officials upon arrival. By having USDA-accredited veterinarians certify
documents before export from the United States, CDC can confirm the
dogs were previously vaccinated in the United States. The use of this
form decreases the likelihood of missing or incomplete vaccination
documentation because it includes all required information in a
standardized format and relies on USDA's existing veterinary
accreditation system for animal exportation. This form will also reduce
instances of fraud or falsification because it can be verified by any
U.S. government agency online through USDA's website after the USDA
official veterinarian certifies the document. Dogs from DMRVV high-risk
countries arriving with this form are not subject to the requirement
for veterinary examination (unless ill, injured, or exposed),
revaccination, confirmation of adequate rabies serologic tests, and/or
post-vaccination quarantine at a CDC-registered ACF.
HHS/CDC is requiring importers of foreign-vaccinated dogs that have
been in a DMRVV high-risk country within the last six months to enter
the United States through an airport with a CDC quarantine station and
a CDC-registered ACF. The importer must have a reservation at the CDC-
registered ACF and have their dog(s) undergo a veterinary exam and
revaccination with a USDA-licensed rabies vaccine at the CDC-registered
ACF. The importer must obtain a rabies serologic test from a CDC-
approved laboratory for their foreign-vaccinated dogs demonstrating
adequate titer levels. Importers of foreign-vaccinated dogs that have
been

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in a DMRVV high-risk country within the last six months who cannot
obtain serologic test results prior to importation are required to have
their dog remain under quarantine at the facility for 28 days after
revaccination or until confirmation of adequate rabies serologic test
from a CDC-approved laboratory is obtained, whichever occurs first.
CDC is requiring the use of CDC-registered ACF as opposed to
community veterinary clinics because (1) ACF are trained to quarantine
animals, and to observe and report abnormalities in quarantined animals
to CDC; (2) ACF undergo, at a minimum, an annual inspection to ensure
compliance with CDC regulations; (3) ACF are experienced in pet
transportation and trained to meet requirements established by
airlines, exporting countries, and U.S. importation requirements; and
(4) ACF are bonded facilities that have special equipment and insurance
for goods (i.e., dogs) that are awaiting clearance into the United
States.
B.iv. Exemption for Foreign-Vaccinated Service Dogs at U.S. Seaports
In this final rule, HHS/CDC is allowing foreign-vaccinated service
dogs that have been in a DMRVV high-risk country within the last six
months to enter the U.S. at a U.S. seaport if the dog is at least six
months of age; has a microchip; has a complete, accurate, and valid
Certification of Foreign Rabies Vaccination and Microchip form; and has
sufficient and valid titer results from a CDC-approved laboratory. To
be considered a valid service dog, the dog must meet the definition of
a ``service animal'' \26\ under 14 CFR 382.3 and accompany an
``individual with a disability'' \27\ as defined under 14 CFR 382.3.
This exemption is limited to foreign-vaccinated service dogs entering
the United States via seaports and is not available to foreign
vaccinated dogs entering via air or at land ports. Under this final
rule, airlines must confirm that foreign vaccinated dogs, including
foreign vaccinated service dogs meet all CDC requirements prior to
allowing dogs to board an aircraft. Therefore, CDC had determined that
a special exemption for foreign-vaccinated service dogs arriving via
air is not needed because airlines must confirm that these dogs meet
all CDC requirements prior to arrival. Under such circumstances, an
individual with a disability can choose to remain with their service
animal and seek to rebook their flights after all CDC requirements have
been met. Similarly, CDC has determined that a special exemption for
foreign vaccinated service dogs is not needed at land ports because if
the dogs do not meet all CDC requirements for entry, the dogs will be
denied entry to the United States. Under these circumstances, the
individual can choose to remain with their dogs on the non-U.S. side of
the land border and then seek admission after all CDC requirements have
been met. CDC further notes that there are fewer available ACFs close
to land ports and allowing an exemption for foreign vaccinated service
animals at land ports would be operationally impracticable. Regarding
the exemption for service animals entering via seaports, CDC believes
that this exemption would most likely be used by individuals with
disabilities traveling with their service animals on board cruise ships
and that these individuals would presumably be visiting the United
States for a very short period of time before reboarding the ship
(e.g., under circumstances where an individual with a disability is
participating on a shore excursion). Based on the limited amount of
time that these service animals will be spending in the United States
and the fact that cruise operators maintain their own vaccination
requirements for service dogs, CDC believes that the rabies risk
presented by foreign-vaccinated service dogs temporarily visiting the
United States via cruise ship is low. The volume of foreign-vaccinated
service dogs arriving from high-risk countries on board non-cruise sea
vessels is also believed to be very small, compared to the number of
foreign-vaccinated service dogs arriving from high-risk countries
entering the US via land and air which presents a greater public health
risk and the need for enforcement of the requirements without an
exemption.
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\26\ Under 14 CFR 382.3, Service animal means ``a dog,
regardless of breed or type, that is individually trained to do work
or perform tasks for the benefit of a qualified individual with a
disability, including a physical, sensory, psychiatric,
intellectual, or other mental disability. Animal species other than
dogs, emotional support animals, comfort animals, companionship
animals, and service animals in training are not service animals for
the purposes of this part.''
\27\ Under 14 CFR 382.2, Individual with a disability ``means
any individual who has a physical or mental impairment that, on a
permanent or temporary basis, substantially limits one or more major
life activities, has a record of such an impairment, or is regarded
as having such an impairment.
As used in this definition, the phrase: (a) Physical or mental
impairment means:
(1) Any physiological disorder or condition, cosmetic
disfigurement, or anatomical loss affecting one or more of the
following body systems: neurological, musculoskeletal, special sense
organs, respiratory including speech organs, cardio-vascular,
reproductive, digestive, genito-urinary, hemic and lymphatic, skin,
and endocrine; or
(2) Any mental or psychological disorder, such as mental
retardation, organic brain syndrome, emotional or mental illness,
and specific learning disabilities.
The term physical or mental impairment includes, but is not
limited to, such diseases and conditions as orthopedic, visual,
speech, and hearing impairments; cerebral palsy, epilepsy, muscular
dystrophy, multiple sclerosis, cancer, heart disease, diabetes,
mental retardation, emotional illness, drug addiction, and
alcoholism.''
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B.v. Requirements for Dogs From DMRVV-Restricted Countries
The final rule also authorizes HHS/CDC to prohibit or otherwise
restrict the importation of dogs into the United States from certain
countries that have a history of exporting dogs infected with DMRVV or
have demonstrated a lack of appropriate veterinary controls to prevent
the exportation of rabid dogs. HHS/CDC will maintain a ``List of DMRVV-
Restricted Countries'' from which the importation of dogs into the
United States would be prohibited on CDC's website; however, HHS/CDC is
not including any countries on this list at this time. Additions or
removals of countries will be announced in notices published in the
Federal Register and would include a timeline for implementation. CDC
retains the ability to allow certain importers to apply for and for CDC
to issue CDC Dog Import Permits 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 service animal for individuals with
disabilities,\28\ or in furtherance of an important government
interest).
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\28\ 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.
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B.vi. Requirements for Airlines
The final rule further requires that an airline, prior to accepting
a dog for transport, confirm that the dog possess all required import
documentation based on the country of origin. Airlines must also ensure
that foreign-vaccinated dogs from DMRVV high-risk countries are
entering the United States only through a designated U.S. airport with
both a CDC quarantine station and a CDC-registered ACF and that the
importer possesses a reservation with the CDC-registered ACF for
examination, vaccination, and quarantine (if required). Air carriers
are required to create bill of lading (e.g., air waybill (AWB)) for all
dogs entering the United States via air, including dogs

[[Page 41730]]

transported as cargo, hand-carried and checked-baggage. As needed, CDC
will coordinate with the airline regarding transport of the dog to the
CDC-registered ACF. These regulatory actions 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.
The final rule requires that airlines return dogs or cats denied
admission to the country of departure within 72 hours after arrival,
unless the animal is ill or injured and CDC has approved delaying the
return of the animal. 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 requires that the airline that flew
a dog or cat to the United States must arrange for and ensure
transportation, housing, and care until the animal is either returned
to the county of departure or cleared for entry into the United States.
This final rule also includes 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 requires that they arrange for
transportation of deceased dogs and cats and 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 transportation, necropsy and testing and
providing the CDC quarantine station \29\ with the final necropsy
report and all test results. The airline is also required to notify the
CDC quarantine station of jurisdiction \30\ prior to transporting a
dead dog or cat for a necropsy to determine whether rabies testing is
required. These measures will help CDC rule out foreign animal diseases
of public health concern \31\ as a potential cause of death, enable CDC
to take responsive measures as needed, 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 States, or
the animal dies while detained pending determination of admissibility.
---------------------------------------------------------------------------

\29\ CDC quarantine stations are also known as U.S. Port Health
Stations.
\30\ CDC quarantine station jurisdictions, available at:
www.cdc.gov/quarantine/quarantine-stations-us.html.
\31\ 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.
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The final rule requires airlines to confirm prior to boarding a
foreign-vaccinated dog from a DMRVV high-risk country that the dog is
scheduled to arrive at an approved U.S. airport and the importer has
documentation confirming a reservation at the CDC-registered ACF. This
ensures that CDC and USDA can follow up with airlines more easily to
confirm 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 requires
airlines to arrange transportation of all sick or dead animals
(regardless of vaccination status and country of origin) to a CDC-
registered ACF or, under certain conditions, to another CDC-approved
veterinary clinic as soon as possible.
The final rule requires airlines to transport healthy-appearing
animals that are denied admission and awaiting return to their country
of departure, or are awaiting a determination as to their
admissibility, to a CDC-registered ACF within 12 hours. CDC
acknowledges that extraordinary circumstances, such as extreme weather,
may delay the transport of animals beyond the 12-hour window. Under
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.
B.vii. Other Requirements and Summary
HHS/CDC is establishing requirements for businesses that wish to
become CDC-registered ACF. Requirements include a USDA intermediate
handlers registration and approved by CBP to act as a CBP-bonded
facility with an active Facilities Information and Resource Management
System (FIRMS) code. This ensures 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. CDC-
registered ACF must be located within 35 miles of a CDC quarantine
station.
The requirements HHS/CDC is finalizing for dog importation into the
United States are summarized below in Table E1. Since HHS/CDC is not
substantially changing cat importation requirements, Table E1 does not
apply to cats.
BILLING CODE 4163-18-P

[[Page 41731]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.000

[[Page 41732]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.001

The forms HHS/CDC is requiring per this final rule for dog
importation into the United States are summarized below in Table E2.
Since HHS/CDC is not substantially changing cat importation
requirements, Table E2 does not apply to cats.

[[Page 41733]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.002

The documentation HHS/CDC is requiring be presented at the U.S.
port upon arrival for dog importation into the United States is
summarized below in Table E3. Because HHS/CDC is not substantially
changing cat importation

[[Page 41734]]

requirements, Table E3 does not apply to cats.
[GRAPHIC] [TIFF OMITTED] TR13MY24.003

[[Page 41735]]

BILLING CODE 4163-18-C

C. Costs and Benefits

CDC conducted an analysis to estimate the distributions of costs
and benefits incurred with the final rule relative to regulatory
baseline. The provisions of this final rule 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.
The requirements of this final rule 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. The
worst-case scenario would include the reintroduction of DMRVV into the
United States. Federal regulation is necessary to mitigate the risk of
importing infected dogs. Federal action allows this risk 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
primary public health benefit is a reduction in the risk of importing
dogs infected with DMRVV. The regulatory changes in this final rule 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 provisions in the final rule 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 2024 through 2033 using three percent and seven percent discount
rates are summarized below. The annualized, monetized costs (2020 USD)
of the final rule are estimated to be $59 million (range: $13.1 to $207
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 (87
percent of costs is the most likely estimate). The estimated monetized
costs are about three times greater for importers of dogs from DMRVV
high-risk countries compared to importers of dogs from DMRVV-free or
low-risk countries. The requirements in the final rule 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 ACF for foreign-vaccinated dogs from
DMRVV high-risk countries in section 71.51(k), costs for titer testing
of foreign-vaccinated dogs from DMRVV high-risk countries, additional
costs associated with the CDC Dog Import Form requirement, the minimum
age for imported dogs, and the 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 requirement to
arrive at one of six U.S. airports with CDC-registered ACF (required
for foreign-vaccinated dogs arriving from DMRVV high-risk countries),
and (3) the requirement to obtain a Certification of Foreign Rabies
Vaccination and Microchip form or a Certification of U.S.-issued Rabies
Vaccination form with certification by an official government
veterinarian for all dogs from DMRVV high-risk countries. Dogs imported
from DMRVV-free or low-risk countries would also require a document
certified by an official government veterinarian, but HHS/CDC will
allow a greater number of potential documents as specified in 42 CFR
71.51(u).
Airlines are estimated to incur about 7.0 percent of the estimated
annualized costs associated with the final rule. Most airline costs
would result from ensuring that all transported dogs comply with the
new requirements in the final rule, the costs associated with creating
bills of lading or a CDC-approved alternative for all imported dogs,
and from a small reduction in the number of dogs transported. Airline
costs may be passed along to dog importers.
HHS/CDC is estimated to incur about 3.3 percent of the annualized,
monetized costs (most likely estimate) associated with the provisions
of this final rule. 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 3.0 percent of the annualized costs
(most likely estimate) associated with the provisions of this final
rule. Most CBP costs would result from additional screening time at
U.S. ports for dogs from DMRVV-free or low-risk countries.
The annualized monetized benefits of the provisions in the final
rule are estimated to be about $1.8 million (range: $0.75 to $3.6
million) using a three percent or seven percent discount rate. Most
benefits will accrue to importers (47 percent of the most likely
estimates) and to CBP (30 percent of the most likely estimate). Some of
the benefits estimated for both importers and CBP will result from
reduced time spent on screening dogs from high-risk countries at U.S.
ports because fewer dogs will be imported with the requirements
included in the final rule. The requirements in the final rule are
estimated to reduce the amount of time required to verify admissibility
per U.S.-vaccinated dog from DMRVV high-risk country at U.S. ports
because rabies vaccination documentation forms will be standardized.
The provisions in this final rule 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. USDA
is expected to receive payments commensurate with its cost to provide
the Certification of U.S.-issued Rabies Vaccination form for U.S.-
vaccinated dogs traveling internationally.
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 final rule. The net annualized, monetized
costs (total cost estimate - total benefit estimate) were estimated to
be about $57 million per year (range: $12 to $203 million) using a
three percent discount rate. The annualized estimates were relatively
unaffected by using a seven percent discount rate.
Because the estimated costs for foreign-vaccinated dogs from DMRVV
high-risk countries are much higher than costs for other dog imports,
importers may choose to import dogs from DMRVV-free or low-risk
countries instead of from DMRVV high-risk countries. In addition,
individuals who

[[Page 41736]]

travel from the United States to DMRVV high-risk countries with their
pet dogs for long-term visits may take the additional step to have
their dogs revaccinated with a three-year rabies vaccine prior to
departure, which would allow up to three years for return to the United
States with a Certification of U.S.-issued Rabies Vaccination. These
changes should result in lower overall costs than the above estimates
for the final rule in which HHS/CDC assumed individuals would be unable
to change the countries from which dogs are imported into the United
States.
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. The social cost of the consequences associated with the
importation of a single DMRVV-infected dog is estimated to be $270,000
(range: $210,000 to $510,000) for conducting public health
investigations and administering rabies PEP to exposed persons. The
primary public health benefit of the provisions in the final rule 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 reintroduction 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 detected, the wildlife species in which DMRVV was
transmitted, and the geographic area over which reintroduction
occurred.
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. HHS/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 central estimate of $11.6 million and a range of
$5.5 to $17.7 million (2020 USD). HHS/CDC is unable to estimate the
potential magnitude of the mortality risk reduction associated with the
final rule. Based on the central VSL, averting five human deaths per
year would mean the benefits of the final rule would exceed its costs.
HHS/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 regulation also inhibits
the Federal government's ability to target interventions for dogs
imported from specific countries. Of note, the COVID-19 pandemic
diverted resources from and weakened rabies control programs in some
DMRVV high-risk countries, increasing the risk that imported dogs may
be infected with DMRVV. The provisions of this final rule will 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 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. The potential economic benefits of
reducing the risk of the importation of African swine fever could be
significant; in fact, a 2019 outbreak in China was estimated to have
total economic losses equivalent to 0.78 percent of China's gross
domestic product. Thus, some of the requirements in this final rule may
mitigate the risks of introduction and transmission of diseases that
impact livestock in addition to reducing the risk of importing dogs
infected with DMRVV.
The monetized cost estimate has increased considerably relative to
the estimates included in the NPRM. The primary reasons for the
increase in cost include:
The fees charged by ACF have increased relative to CDC's
preliminary estimates.
Some U.S. ports require that dogs needing follow-up care
at ACF arrive as cargo. This requirement was not anticipated by HHS/CDC
and will increase costs for importers of foreign-vaccinated dogs from
DMRVV high-risk countries who otherwise would have chosen to transport
their dogs as hand-carried or checked baggage. The fee charged for
cargo shipments are highly variable.^{32 33} The future costs
associated with this rule will depend on U.S. port policies that are
subject to change. The average cost for the follow-up visit at ACF is
estimated to be $900 (range: $500 to $1,300 per dog). The average costs
associated with shipping dogs as cargo is estimated to be $2,000
(range: $1,500 to $2,500) \34\ compared to an average of $300 (range:
$200 to $400) for dogs shipped as hand-carried or checked baggage.\35\
Under the regulatory baseline, HHS/CDC assumes 25%, range: 17% to 50%
of dogs going to ACF are shipped as cargo. With the final rule, HHS/CDC
assumes that 60% of dogs going to ACF, range: 60% to 70% of dogs will
be shipped as cargo.
---------------------------------------------------------------------------

\32\ http://www.airline-pet-policies.com/united-airlines-pet-policy.php. Accessed 15 Nov 2023.
\33\ Katie Morrell (March 3, 2021) How Much Does It Cost To Fly
With Your Dog on a Plane? Dailypaws.com https://www.dailypaws.com/living-with-pets/pet-travel/how-much-does-it-cost-to-fly-a-dog-on-a-plane. Accessed: 06 February 2022.
\34\ Feathers and Fur Express (2023) How much does it cost to
fly a pet/s internationally? https://ffexpresspets.com/international-pet-shipping-costs/. Accessed November 10, 2023. Note
that the costs reported in this reference include cargo shipping
costs to Germany, the United Kingdom, Japan, and Australia. The
reference includes costs for small and large dogs shipped to each
country. Costs are much higher for larger dogs or for dogs shipped
over longer distances. The highest costs were for Australia, which
may be more representative of shipping costs from DMRVV high-risk
countries in Africa. The European costs may be similar to shipping
costs for dogs imported from DMRVV high-risk countries in Europe or
Central America or South America. The costs for Japan may be similar
to costs for DMRVV high-risk countries in Asia. The simple average
cost across the four countries and dog sizes is $1,931 in 2023 USD.
This would correspond to $1,622 in 2020 after adjustment with the
consumer price index: https://www.bls.gov/data/inflation_calculator.htm. The most likely estimate is increased to
$2,000 in case the costs to importers from DMRVV high-risk countries
would be higher than for the countries for which data are available.
This increase from $1,600 to $2,000 would also allow some importers
to choose to hire shippers to facilitate the importation process or
brokers to support customs clearance. The need to hire shippers may
be reduced by the need to visit CDC-registered ACF, who may be able
to review documentation in advance of arrival when reservations are
made.
\35\ http://www.airline-pet-policies.com/united-airlines-pet-policy.php. Accessed 15 Nov 2023.
---------------------------------------------------------------------------

The cost estimate for foreign-vaccinated dogs from DMRVV
high-risk countries to re-route travel destinations to arrive at
authorized U.S. ports with ACF was increased.

[[Page 41737]]

II. Background

a. Legal Authority

The primary legal authority supporting this final rule 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.\36\ 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.\37\
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\36\ 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, sec. 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.
\37\ 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 final rule 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.\38\ Through this statutory provision, U.S. Customs and
Border Protection (CBP) within the Department of Homeland Security
(DHS) 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.
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\38\ 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. HHS/CDC may refer violators to the U.S. Department
of Justice for criminal prosecution. To implement section 368, HHS/CDC
would request assistance from other departments and agencies to address
violations.
Through this final rule, HHS/CDC is also including 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, brokers, or carriers whenever the
CDC Director (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. 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

[[Page 41738]]

believes it important to include this language to advise individuals
and organizations that it may request that DHS/CBP pursue such actions.
Through this final rule, HHS/CDC is also including new language
advising individuals and organizations that it may request that the
U.S. Department of Justice investigate, and based on the results of
such investigation, prosecute, potential violations of Federal law
arising under its dog importation regulations. This includes potential
violations of 18 U.S.C. 111 which prohibits persons from forcibly
assaulting, resisting, opposing, impeding, intimidating, or interfering
with government employees in the conduct of or on account of their
official government duties and 18 U.S.C. 1505 which prohibits
disrupting agency proceedings. See, e.g., United States v. Schwartz,
924 F.2d 410, 423 (2d Cir. 1991) (holding that a U.S. Customs Service
interview of defendants for purposes of determining whether to seize
potentially illegal arms was an ``agency proceeding'' under 18 U.S.C.
1505).
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) regarding 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.'').
b. Regulatory Background
On July 10, 2023, HHS/CDC published an NPRM to update 42 CFR 71.50
and 71.51 within its Foreign Quarantine regulations to address the risk
to public health from the importation of dogs and cats into the United
States. The provisions contained within the NPRM were designed to
enhance HHS/CDC's ability to prevent the importation and spread of dog-
maintained rabies virus variant (DMRVV) into the United States and
interstate by implementing requirements that are used throughout other
rabies-free countries and are recommended by animal health
organizations (e.g., World Organisation for Animal Health). CDC
evaluates and updates the DMRVV high-risk country list every year and
generally posts the updated list on CDC's website \39\ by April 1. For
this annual country risk assessment, CDC subject matter experts review
publicly available data, including data from international
organizations (including the World Health Organization (WHO); the WHO
Rabies Bulletin--Europe; the Pan-American Health Organization, and the
World Organisation for Animal Health (WOAH)); published government
reports; scientific publications; and outbreak report alerts such as
ProMED,\40\ as well as information provided by national and
international rabies experts. HHS/CDC will also review the information
and re-assess a country's status when presented with additional
substantial data to support canine rabies-free status by a foreign
country's officials. Lastly, CDC has published the criteria for how it
determines a country's classification as a high-risk, low-risk and
DMRVV-free country in peer-reviewed journal articles which are publicly
available.^{41 42} Because of an ongoing risk of reintroduction
of DMRVV due to insufficient veterinary controls in countries where
DMRVV is still endemic and in parallel with the publication of the NPRM
on July 10, 2023, CDC published an extension of the temporary
suspension of dogs from DMRVV high-risk countries.\43\ Today's final
rule has no effect on the temporary suspension, which expires on July
31, 2024. This final rule will go into effect August 1, 2024.
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\39\ Centers for Disease Control. DMRVV high-risk country list.
Available at: www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html.
\40\ The Program for Monitoring Emerging Diseases (ProMED) is a
program of the International Society for Infectious Diseases and is
available at https://promedmail.org/.
\41\ Henry RE, Blanton JD, Angelo KA, Pieracci EG, Stauffer K,
et al. A country classification system to inform rabies prevention
guidelines and treatment. Journal of Travel Medicine,
2022;29(4):taac046. doi: 10.1093/jtm/taac046. PMID: 35348741.
\42\ Minhaj FS, Bonaparte SC, Boutelle C, Wallace RM. Analysis
of available animal testing data to propose peer-derived
quantitative thresholds for determining adequate surveillance
capacity for rabies. Scientific Reports 2023; 13: 3986.
\43\ Extension of Temporary Suspension of Dogs Entering the
United States from High-Risk Rabies Countries. Federal Register, 88
FR 43570 (July 10, 2023).
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III. Summary of the Final Rule

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.
After considering public comment received to the NPRM, HHS/CDC is
adding the following definitions to 42 CFR 71.50(b): Authorized
veterinarian, cat, dog, histopathology, in-transit shipments,
microchip, necropsy, official government veterinarian. CDC is replacing
the definition for ``in-transit'' with the definition ``in-transit
shipments,'' as proposed in the NRPM.
This final rule also adds a new paragraph at 42 CFR 71.50(c) that
addresses 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 communicable disease threats, HHS/CDC intends that
these provisions have maximum legal effect. Accordingly, HHS/CDC is
adding language to ensure that, if 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, 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.

Changes to 71.51

Under this final rule, and after considering public comment
received to the NPRM, Section 71.51(a) now contains definitions that
are specifically applicable to the importation of dogs and cats under
this section. HHS/CDC is adding the following definitions: animal, CDC-
registered Animal Care Facility, Certification of Foreign Rabies
Vaccination and Microchip, CDC Dog Import Form, Certification of U.S.-
issued Rabies Vaccination, Certification of Dog Arriving from DMRVV-
free or

[[Page 41739]]

DMRVV Low-risk Country, conditional release, confinement, DMRVV, DMRVV-
free countries, DMRVV high-risk countries, DMRVV low-risk countries,
DMRVV-restricted countries, flight parent, importer, SAFE TraQ,
serologic testing, USDA-Accredited Veterinarian, and USDA Official
Veterinarian. In response to public comment, CDC has modified the
definition of importer and added definitions for ``flight parent'' and
``Certification of Dog Arriving from DMRVV-free or DMRVV Low-risk
Country,'' definitions that were not in the NPRM. CDC has also added a
definition for CDC Dog Import Permit, and modified and shortened the
names of the required rabies vaccination forms. CDC is removing the
current definition for Valid rabies vaccination certificate in 42 CFR
71.51 because other rabies vaccination forms will now be required. CDC
is also moving the definitions for cat and dog from 71.51(a) to
71.50(a).
In 71.51(b) through 71.51(d), HHS/CDC is finalizing the section as
proposed with the exception that U.S.-vaccinated dogs may enter through
any U.S. port. CDC has a high degree of confidence in USDA-licensed
rabies vaccines administered in the United States; therefore, the risk
of a U.S.-vaccinated dog importing rabies when returning to the United
States is very low. CDC also has confidence in DMRVV-free countries
that have declared themselves to be free of canine rabies using WOAH's
self-declared validation process in which their surveillance and
vaccination data are available for external review.\44\ Additionally,
CDC has confidence in DMRVV-free and low-risk countries which
demonstrate adequate surveillance capacity and vaccination control
measures in accordance with CDC published metrics, but have not pursued
a WOAH self-declaration status.^{45 46} HHS/CDC is reducing the
burden on importers of U.S.-vaccinated dogs by allowing greater
flexibility to be admitted through any U.S. port and is finalizing as
proposed the ability of importers of cats and dogs from DMRVV-free and
low-risk countries to be admitted through any U.S. port.
---------------------------------------------------------------------------

\44\ World Organisation for Animal Health. Self-declared Disease
Status. Available at: www.woah.org/en/what-we-offer/self-declared-disease-status/.
\45\ Minhaj, F.S., Bonaparte, S.C., Boutelle, C. et al. Analysis
of available animal testing data to propose peer-derived
quantitative thresholds for determining adequate surveillance
capacity for rabies. Sci Rep 13, 3986 (2023). https://doi.org/10.1038/s41598-023-30984-3.
\46\ Henry RE, Blanton JD, Angelo KA, Pieracci EG, Stauffer K,
et al. A country classification system to inform rabies prevention
guidelines and treatment. Journal of Travel Medicine,
2022;29(4):taac046. doi: 10.1093/jtm/taac046. PMID: 35348741.
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(b) Authorized U.S. airports for dogs and cats.
Section 71.51(b) is finalized as proposed with the exception that
HHS/CDC is allowing U.S.-vaccinated dogs to enter through any U.S.
airport if the dog is six months of age, microchipped, and accompanied
by a valid Certification of U.S.-issued Rabies Vaccination form and CDC
Dog Import Form receipt. Dogs that have been only in DMRVV-free or
DRMVV low-risk countries during the last six months and all cats may
also enter through any U.S. airport.\47\ Foreign-vaccinated dogs that
have been in any DMRVV high-risk country within the last six months
must enter through a U.S. airport with a CDC quarantine station and an
ACF.
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\47\ There are no vaccination requirements for dogs that have
been only in DMRVV-free or DRMVV low-risk countries during the last
six months.
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(c) Authorized U.S. land ports for dogs and cats.
Section 71.51(c) has been finalized as proposed with the exception
that HHS/CDC is allowing U.S.-vaccinated dogs that have been in a DMRVV
high-risk country in the past six months to enter through any U.S. land
port if the dog is six months of age, microchipped, and accompanied by
a valid Certification of U.S.-issued Rabies Vaccination form and CDC
Dog Import Form receipt. Dogs that have been only in DMRVV-free or
DRMVV low-risk countries during the last six months and all cats may
enter through any U.S. land port.
(d) Authorized U.S. seaports for dogs and cats.
Section 71.51(d) has been finalized as proposed with the exception
that HHS/CDC is allowing U.S.-vaccinated dogs that have been in a DMRVV
high-risk country in the past six months to enter through any U.S.
seaport if the dog is six months of age, microchipped, and is
accompanied by a valid Certification of U.S.-issued Rabies Vaccination
form and a CDC Dog Import Form receipt. Dogs that have been only in
DMRVV-free or DRMVV low-risk countries during the last six months and
all cats may enter through any U.S. seaport.
HHS/CDC is finalizing as proposed the prohibition of entry into the
United States through a U.S. seaport for unvaccinated or foreign-
vaccinated dogs that have been in a DMRVV high-risk country within the
last six months with an exception for dogs meeting the definition of a
``service animal'' under 14 CFR 382.3. This final rule allows entry if
a foreign-vaccinated dog that has been in a DMRVV high-risk country
within the last six months accompanies an ``individual with a
disability'' as defined under 14 CFR 382.3. The dog must meet all other
CDC requirements for admission of a foreign vaccinated dog from a high-
risk country, including that it be microchipped, at least six months of
age, have a valid Certification of Foreign Rabies Vaccination and
Microchip form, a valid serologic titer from a CDC-approved laboratory,
and a CDC Dog Import Form receipt.
(e) Limitation on U.S. ports for dogs and cats.
Section 71.51(e) is finalized as proposed with the exception that
HHS/CDC is clarifying that CBP will prescribe the time, place, and
manner in which dogs are presented upon arrival at a port of entry,
which may include prohibiting dogs from being presented within the
Federal Inspection Station. This provision of the final rule also
explicitly authorizes the CDC 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 CDC Director determines such a
limitation is required, the CDC 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. This provision is applicable to all
U.S. ports, including land, sea, and air.
(f) Age requirement for all dogs.
Section 71.51(f) is finalized as proposed with the exception that
HHS/CDC removed the exemption for importers to import up to three dogs
under six months of age at U.S. land borders if arriving from DMRVV-
free or DMRVV low-risk countries. This provision of the final rule
requires that all dogs arriving into the United States (regardless of
whether from DMRVV-free, DMRVV low-risk, or DMRVV high-risk countries)
at air-, land-, and seaports be, at minimum, six months of age. As
explained in further detail below, HHS/CDC originally proposed a
limited exemption for dogs under six months old primarily to reduce the
burden on U.S. travelers who frequently travel across the U.S. and
Canada/Mexico borders and choose to travel with young dogs. However,
upon further consideration and careful evaluation of the comments
received, HHS/CDC has removed the exemption proposed in the NPRM to
create a uniform standard for all dogs, ensure U.S.-land borders are
not overwhelmed with dog importations, and reduce the risk of importers
fraudulently claiming that

[[Page 41740]]

their dog has not been in DMRVV high-risk country.
(g) Microchip requirements for all dogs.
Section 71.51(g) is finalized as proposed with the exception that
HHS/CDC is clarifying that an imported dog's microchip must have been
implanted on or before the date the most recent rabies vaccine was
administered. Rabies vaccines administered prior to the implantation of
an imported dog's microchip are invalid. HHS/CDC is making this
clarification to ensure that the dog receiving the rabies vaccine is
properly identified by the microchip. Through this final rule, HHS/CDC
is requiring that all dogs have an International 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 Dog Import Form for all dogs.
Section 71.51(h) is finalized as proposed. This provision of the
final rule requires that importers submit a CDC Dog Import Form (OMB
Control Number 0920-1383; expiration date 04/30/2027) (formerly
referred to as the CDC Import Submission Form) via a CDC-approved
system for each imported dog. The CDC Dog Import Form must be submitted
to CDC prior to a dog's departure from the foreign country. The CDC Dog
Import Form receipt must be presented to the airline prior to boarding
and to Federal officials upon arrival.
(i) Inspection requirements for admission of dogs and cats.
Section 71.51(i) is finalized as proposed. This final rule requires
that dogs and cats may be denied admission if an importer refuses to
consent to required inspection, examination, diagnostic testing, or
disease surveillance screening.
(j) Examination by a USDA-Accredited Veterinarian and confinement
of exposed dogs and cats or those that appear unhealthy.
Section 71.51(j) is finalized as proposed with minor reorganization
of the paragraph. This final rule requires that, in the event a dog or
cat arrives ill, is denied admission, or is exposed to a sick animal in
transit,^{48 49} the airline must arrange for confinement in an
ACF or CDC-approved veterinary clinic (if an ACF is not available or is
unable to adequately care for the ill or injured animal) and transport
to the facility in a way that does not expose transportation personnel
or the public to communicable diseases. 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. The
importer bears the expenses of transportation, confinement,
examination, testing, and treatment. The final rule further clarifies
an airline's responsibilities in the event an importer abandons a dog
or cat. 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.
---------------------------------------------------------------------------

\48\ National Association of State Public Health Veterinarians.
Compendium of animal rabies prevention and control, 2016. JAVMA
2016; 248 (5):505-517.
\49\ 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.
---------------------------------------------------------------------------

(k) Veterinary examination, revaccination against rabies, and
quarantine at a CDC-registered animal care facility for foreign-
vaccinated dogs.
Section 71.51(k) is finalized as proposed with the exception that
the paragraph name has been modified to reflect all the required
components of the paragraph. However, the requirements within the
paragraph have not changed. HHS/CDC is clarifying that suspected or
confirmed communicable diseases need only be reported to CDC.
Additional notification of Federal, state, and local public health
partners will be done by CDC. HHS/CDC now requires that all foreign-
vaccinated dogs arriving from DMRVV high-risk countries have a valid
Certification of Foreign Rabies Vaccination and Microchip form and
undergo veterinary examination and revaccination against rabies at an
ACF upon arrival. The importer is responsible for making a reservation
and all arrangements relating to the examination, revaccination, and
quarantine (if quarantine is required) of dogs with an ACF 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 Dog Import Form (OMB Control
Number 0920-1383; expiration date 04/30/2027) and confirmation of a
reservation at an ACF. The costs of examination, vaccination, and
quarantine (if required) are the responsibility of the importer and not
the United States Government. Animals that are abandoned before meeting
requirements outlined below become the legal responsibility of the
airline.
This final rule further requires that the dogs remain in the
custody of an ACF until all of the following requirements are met:
Veterinary health examination by a USDA-Accredited
Veterinarian for signs of disease. Suspected or confirmed communicable
or foreign animal diseases would be required to be reported to CDC and
may delay release of the animals.
Confirmation of microchip number.
Confirmation of age through dental examination by a USDA-
Accredited Veterinarian.
Vaccination against rabies with a USDA-licensed rabies
vaccine and administered by a USDA-Accredited Veterinarian.
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.\50\ Dogs that arrive without an adequate rabies serologic
test results from a CDC-approved laboratory will be housed at the ACF
for a 28-day quarantine following administration of the USDA-licensed
rabies vaccine or until an adequate rabies serologic test from a CDC-
approved laboratory is confirmed.
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\50\ CDC technical instructions are posted on CDC's website at
www.cdc.gov/dogtravel.
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(l) Registration or renewal of CDC-registered animal care
facilities.
HHS/CDC is finalizing section 71.51(l) as proposed with the
exception that CDC may conduct inspections of ACF which will be guided
by the USDA Animal Welfare regulation standards (9 CFR parts 1, 2, and
3) and other standards outlined in CDC's Technical Instructions for
CDC-registered Animal Care Facilities. Failure to adhere to standard
operating procedures (SOP) requirements as outlined in USDA Animal
Welfare regulation standards or CDC's Technical Instructions for CDC-
registered Animal Care Facilities would constitute grounds for not
registering or renewing an ACF's registration.
Per this final rule, HHS/CDC is requiring that an animal care
facility register with and receive written approval from CDC, USDA, and
CBP to submit their facility application before housing any imported
live dog in the United States. The applicant must provide written SOP
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 will also be
required to be submitted to CDC. Additionally, HHS/CDC requires the
facility to have a USDA intermediate handlers registration (and any
other licenses or

[[Page 41741]]

registrations required by USDA) and a FIRMS code issued by CBP.
This section has been finalized as proposed with the clarification
that an ACF must be located within 35 miles of a CDC quarantine
station. The facility is 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 are also subject to
inspection.
(m) Record-keeping requirements at CDC-registered animal care
facilities.
Section 71.51(m) is finalized as proposed with the exception that
the section references a document other than a bill of lading if the
airline has been granted a waiver to the bill of lading requirement
under paragraph (dd). The waiver to the bill of lading requirement is
discussed more fully in explanation text to section (dd). Per this
final rule, HHS/CDC requires that any ACF retain records regarding each
imported animal for three years after the distribution or transfer of
the animal. Records must be uploaded into CDC's System for Animal
Facility Tracking during Quarantine (SAFE TraQ) and completed prior to
the animal's release from the facility. HHS/CDC is clarifying that
records for necropsy results should be uploaded into SAFE TraQ within
30 days of an animal's death. Each record must include:
The bill of lading (or other alternative documentation if
the airline has been granted a waiver under paragraph (dd)) for each
shipment;
The name, address, phone number, and email address of the
importer and owner (if different from the importer);
The number of animals in each shipment;
The identity of each animal in each shipment, including
name, microchip number, date of birth, sex, breed, and coloring;
The airline, flight number, date of arrival, and port of
each shipment; and
Veterinary medical records for each animal, including:
[ssquf] Certification of Foreign Rabies Vaccination and Microchip
form (OMB Control Number 0920-1383; expiration date 04/30/2027) and
rabies serology obtained before arrival in the United States (if
applicable);
[ssquf] The USDA-licensed rabies vaccine administered upon arrival;
[ssquf] Veterinary exam records upon arrival and while in
quarantine;
[ssquf] Rabies serology performed while in quarantine in the United
States (if applicable); and
[ssquf] All diagnostic test, histopathology and necropsy results
performed during quarantine (if applicable).
The facility is required to maintain these records electronically
and allow CDC to inspect the records.
(n) Worker protection plan and personal protective equipment (PPE).
Section 71.51(n) is finalized as proposed with the exception that
HHS/CDC is noting that procedures for reporting suspected or confirmed
communicable diseases associated with handling animals in facility
workers must be reported to CDC within 48 hours. This requirement was
included in the NPRM in paragraph (q) and has been moved to paragraph
(n) for clarity. Today's final rule requires that an ACF establish and
maintain a worker protection plan with standards comparable to those in
the Occupational Safety and Health Administration's Recommended
Practices for Safety and Health Programs \51\ and the National
Association of Public Health Veterinarians (NASPHV) Compendium of
Veterinary Standard Precautions for Zoonotic Disease Prevention in
Veterinary Personnel.\52\ Such a worker protection plan must include
rabies pre-exposure prophylaxis consistent with CDC guidance \53\ for
workers who handle imported animals with signs of illness or in
quarantine, and for staff who perform necropsies of imported animals;
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 must also establish, implement, and maintain hazard
evaluation and worker communication procedures that include
descriptions of the known communicable 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 or safe disposal of garments, supplies, equipment, and
waste.
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\51\ https://www.osha.gov/safety-management.
\52\ http://www.nasphv.org/Documents/VeterinaryStandardPrecautions.pdf.
\53\ CDC. Rabies pre-exposure prophylaxis recommendations.
Available at: www.cdc.gov/rabies/prevention/pre-exposure_vaccinations.html.
---------------------------------------------------------------------------

(o) CDC-registered animal care facility standard operating
procedures, requirements, and equipment standards for crating, caging,
and transporting live animals.
Section 71.51(o) is finalized as proposed and requires that
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.\54\ Animals must not be removed from crates during
transport, and used PPE, bedding, and other potentially contaminated
material must be removed from the ground transport vehicle upon arrival
at the ACF and disposed of or disinfected in a manner that would
destroy potential pathogens of concern.
---------------------------------------------------------------------------

\54\ International Air Transport Association. Live Animals.
https://www.iata.org/en/programs/cargo/live-animals. Accessed June
7, 2023.
---------------------------------------------------------------------------

(p) Health reporting and veterinary service requirements for
animals at CDC-registered animal care facilities.
Section 71.51(p) is finalized as proposed with the exception that
HHS/CDC may allow veterinarians to confirm the age of a dog using
alternative methods approved by CDC, such as ocular lens examination or
radiographs. Additionally, HHS/CDC is clarifying that if an animal is
suspected of having a communicable disease, it must be immediately
isolated and CDC-registered ACF must implement infection prevention and
control measures in accordance with industry standards and CDC
technical instructions. HHS/CDC is clarifying that suspected or
confirmed communicable diseases need only be reported to CDC and not to
other public health entities. Additional notification of Federal,
State, and local public health partners will be done by CDC. HHS/CDC
also notes the paragraph name has been modified to reflect all the
required components of the paragraph. However, the requirements within
the paragraph have not changed. Today's final rule establishes health
reporting requirements for all dogs evaluated at an ACF. Under this
provision, a facility must 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:
Veterinary examination by a USDA-Accredited Veterinarian
within one business day of arrival;
Verification of microchip and confirmation that the
microchip number matches the animal's health records;
Verification of animal's age via a dental examination (or
other CDC-approved method);
Vaccination against rabies using a USDA-licensed vaccine;
and

[[Page 41742]]

Confirmation of an adequate serologic test from a CDC-
approved laboratory OR completion of a 28-day quarantine after
administration of the USDA-licensed rabies vaccine.
This provision also requires 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 during transport or while in quarantine
at a ACF is 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 ACF must be examined by a USDA-Accredited Veterinarian
immediately and must undergo diagnostic testing to determine the cause
of illness prior to release from the facility. Suspected or confirmed
communicable diseases in animals must be reported to CDC within 24
hours of identification.
(q) Quarantine requirements for CDC-registered animal care
facilities.Section 71.51(q) is finalized as proposed with the exception
that HHS/CDC is clarifying that quarantined animals must be housed in
such a manner that they do not expose other quarantined animals or non-
quarantined animals (including animals other than dogs or cats).
Additionally, animals in quarantine may not be housed together even if
they were transported as part of the same shipment. After consideration
of public comments, this final rule establishes requirements for the
quarantine area at ACF to ensure animals are safely housed and do not
present a public health risk to humans or other animals. These
requirements include security measures within the facility to prevent
unintended public exposure to quarantined animals, limited access to
animal quarantine areas, monitoring animals for signs of any
communicable illness, and timely notification of CDC of animals that
becomes ill during quarantine. Additionally, suspected or confirmed
communicable diseases in animals or facility workers must be reported
to CDC. ACF must also establish 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. Section 71.51(r) is finalized as proposed with
the exception that it explicitly references the ability of the
Secretary to review a CDC revocation of an ACF registration if the
Secretary so chooses. The Secretary has authority to act as final
arbiter and review the CDC Director's decisions relating to animal
importations if the Secretary so chooses.
Section 71.51(r) establishes procedures to revoke an ACF's
registration if the Director determines that it has failed to comply
with any applicable provisions of this section, including failure to
abide by the facility's standard operating procedures, USDA Animal
Welfare regulation standards (9 CFR parts 1, 2, and 3), or the
International Air Transport Association standards.\55\ Under the terms
of this provision, CDC will send the facility a notice of revocation
stating the grounds upon which the proposed revocation is based. If the
facility contests the revocation, the facility may file a written
response to the notice within five business days. All the grounds
listed in the proposed revocation will be deemed admitted if the
facility does not respond within five business days, in which case
CDC's notice of revocation will constitute final agency action, unless
the Secretary, within one business day, decides to excuse the
facility's failure to respond on a timely basis.
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\55\ International Air Transport Association. Live Animals.
https://www.iata.org/en/programs/cargo/live-animals. Accessed June
7, 2023.
---------------------------------------------------------------------------

If a facility's response is timely, the Director will review the
registration, the notice of revocation, and the response. As soon as
practicable after completing the written record review, the Director
will issue a decision in writing that shall constitute final agency
action, unless the Secretary, within one business day, decides to
review the Director's decision. The Director will provide the facility
with a copy of the written decision. The Director, in the Director's
discretion, 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 Certification of Foreign Rabies Vaccine and
Microchip form to import a foreign-vaccinated dog from DMRVV high-risk
countries.
Section 71.51(s) is finalized as proposed with the exception that
HHS/CDC shortened the name of the form to the Certification of Foreign
Rabies Vaccine and Microchip (OMB Control Number 0920-1383; expiration
date 04/30/2027). Through this final rule, HHS/CDC is requiring a new,
standardized rabies vaccination form for all foreign-vaccinated dogs
that have been in any DMRVV high-risk countries within the last six
months. In addition to details about the dog, importer, and
veterinarian, the form must be completed by an Authorized Veterinarian
that examined the dog in the exporting country and certified by an
official government veterinarian attesting that the authorized
veterinarian is licensed or authorized to practice veterinary medicine
in the exporting country. The authorized veterinarian and the official
government veterinarian must further attest that the information listed
on the form is true and correct.
(t) Requirement for Certification of U.S.-Issued Rabies Vaccination
Form for importers seeking to import U.S.-vaccinated dogs from DMRVV
high-risk countries.
Section 71.51(t) is finalized as proposed with the exception that
HHS/CDC shortened the name of the form to the Certification of U.S.-
Issued Rabies Vaccination (OMB Control Number 0920-1383; expiration
date 04/30/2027). HHS/CDC now requires that U.S.-vaccinated dogs re-
entering the United States from DMRVV high-risk countries be
accompanied by a Certification of U.S.-issued Rabies Vaccination Form.
The form must be completed by a USDA-Accredited Veterinarian and
endorsed by a USDA Official Veterinarian prior to the dog departing the
United States. 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.
(u) Requirement for proof that a dog has been only in DMRVV low-
risk or DMRVV-free countries.
Section 71.51(u) is finalized as proposed with the exception that,
based on public comment, CDC is now including a list of acceptable
documents importers may provide to confirm a dog has been only in DMRVV
low-risk or DMRVV-free countries during the last six months before
arriving in the United States. This list includes a valid USDA export
certificate, a valid foreign export certificate, a valid Certification
of Dog Arriving from DMRVV-free or DMRVV Low-risk Country form, or
other records or documents satisfactory to the Director. Importers may
also provide proof of rabies vaccination, which is recommended but not
required for dogs arriving from DMRVV-free or DMRVV low-risk countries,
using the Certification of Foreign Rabies Vaccination and Microchip
form or the Certification of U.S.-Issued Rabies Vaccination form. All
forms must be endorsed by an official government veterinarian to be
considered valid.

[[Page 41743]]

Certification of Foreign Rabies Vaccination and Microchip forms must be
endorsed by an official government veterinarian in a DMRVV-free or
DMRVV low-risk country to be used as proof that a dog has been only in
DMRVV low-risk or DMRVV-free countries. Importers should contact their
local veterinarian who can submit the required form to an official
government veterinarian in the exporting country. Importers may also
use the USDA pet travel website or IPATA website to contact a pet
shipper to request assistance.^{56 57} The list of acceptable
documents is also located on CDC's website. This final rule requires
that dogs imported from DMRVV low-risk or DMRVV-free countries be
accompanied by appropriate written documentation demonstrating that
they have been only in DMRVV low-risk or DMRVV-free countries during
the last six months. The documentation must also confirm that the dog
is at least six months of age and is microchipped. There have been no
changes made for cat rabies vaccination importation requirements.
Instead, CDC continues to recommend that importers comply with State or
Territorial requirements for rabies vaccination in cats and dogs from
DMRVV-free or DMRVV low-risk countries.
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\56\ USDA Pet Travel. www.aphis.usda.gov/pet-travel/us-to-another-country-export.
\57\ International Pet and Animal Transportation Association.
www.ipata.org.
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(v) Denial of admission of dogs and cats.
Section 71.51(v) is finalized as proposed with the exception that
HHS/CDC may additionally deny entry to an animal if an importer refuses
to comply with CDC-required diagnostic tests to rule out communicable
diseases. Diagnostic tests are crucial to determine the cause of an
illness and ensure the animal does not pose a public health threat.
This section also references alternative documentation to a bill of
lading if the airline has been granted a waiver to the requirement that
it create a bill of lading for dogs prior to the dogs' arrival in the
United States.
This section outlines the categories of dogs and cats that are
inadmissible to the United States. CDC will coordinate with CBP to
enforce this action whenever CDC determines that an animal is
inadmissible. This includes:
Any dog arriving from a DMRVV low-risk or DMRVV-free
country without written documentation that the dog has been only in
DMRVV low-risk or DMRVV-free countries during the six months prior to
the attempted entry, or if the CDC Director reasonably suspects fraud.
Any dog that is not accompanied by a receipt confirming
that a CDC Dog Import Form has been submitted to CDC through a CDC-
approved system.
Any dog arriving by air for which a bill of lading,
including an air waybill, has not been created by the airline prior to
the dog's arrival in the United States (regardless of the value of the
shipment) unless the airline transporting the dog has been granted a
waiver pursuant to paragraph (dd) and the airline's handling and
transport of the dog is consistent with the terms of that waiver.
Any unvaccinated or foreign-vaccinated 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 unvaccinated or foreign-vaccinated 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 section (d).
Any foreign-vaccinated dog that has been in a DMRVV high-
risk country within the last six months and does not arrive at a U.S.
airport with a CDC quarantine station and an ACF.
Any animal imported by an importer who refuses to comply
with the requirement (if applicable) for the animal to undergo disease
surveillance screening, veterinary examination, revaccination,
diagnostic testing, provide proof of sufficient rabies serologic tests,
or quarantine at an ACF upon arrival.
Any dog that has been in a DMRVV high-risk country within
the last six months and arrives without a valid Certification of U.S.-
Issued Rabies Vaccination form or a valid Certification of Foreign
Rabies Vaccination and Microchip form.
Any foreign-vaccinated dog imported from a DMRVV high-risk
country that arrives without a reservation at an ACF.
Any dog from a DMRVV-restricted country that arrives
without a valid CDC Dog Import Permit.
Any dog imported from a DMRVV high-risk, DMRVV low-risk,
or DMRVV-free country if the CDC 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 arriving in the United States that is under six
months of age.
Any dogs arriving in the United States without a microchip
or without their microchip number documented on the importation
paperwork required by CDC.
(w) Dogs and cats awaiting an admissibility determination or return
to their country of departure.
HHS/CDC has split section 71.51(v) as written in the NPRM into two
sections for ease of reading and greater clarity. Section 71.51(w) is a
new paragraph, but the final requirements in section 71.51(w) were
included in the NPRM under section 71.51(v). These requirements are
finalized as proposed with the exception that based on public comment
CDC is changing the timeframe for airlines to transport a healthy
animal to an ACF or another CDC-approved facility (if an ACF is not
available) from 6 hours to 12 hours. However, airlines must arrange to
transport an obviously ill or injured animal immediately.
Animals arriving by air must be held in an ACF or another CDC-
approved facility (if an ACF is not available) pending an admissibility
determination or pending return to their country of departure if denied
admission. As finalized, airlines must transport healthy animals to a
ACF or other CDC-approved facility (if an ACF is not available) within
12 hours of arrival.
An airline must immediately report an obviously ill or injured
animal (e.g., the animal is unable to stand, has difficulty breathing,
is bleeding, has broken bones or disfigured limbs, or is experiencing
seizures, vomiting, or discharge from the nose, mouth, or eyes)
arriving into the United States to the CDC quarantine station of
jurisdiction. As finalized, the airline must immediately arrange to
transport an obviously ill or injured animal to an ACF or veterinary
clinic as directed by HHS/CDC.
Animals arriving by sea that are denied admission must remain on
the vessel while awaiting return to the country of departure.
(x) Disposal or disposition of dogs and cats denied admission or
abandoned prior to admission that were transported to the United
States.
Section 71.51(x) is finalized as proposed. HHS/CDC has developed an
operational framework primarily applicable to airlines regarding how
dogs denied admission will be handled by carriers and importers. HHS/
CDC clarifies that airlines must provide housing for animals awaiting
return to their country of departure at an ACF or a CDC-approved animal
facility if an

[[Page 41744]]

ACF 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.
Airlines are able to request extensions for an animal's return in the
event the animal is not medically fit for travel. This 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.
Under this framework, 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 \58\ 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.
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\58\ https://www.avma.org/resources-tools/avma-policies/avma-guidelines-euthanasia-animals.
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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.
HHS/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, HHS/CDC acknowledges
that there may be rare and unforeseen circumstances where it may be
necessary to apply such procedures. Accordingly, HHS/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). Section 71.51(x) is finalized as proposed.
(y) Appeals of CDC denials to admit a dog or a cat upon arrival
into the United States.
Section 71.51(y) is finalized as proposed with the exception that
it explicitly references the ability of the Secretary to review a CDC
decision to deny admission to dogs and cats if the Secretary so
chooses. The Secretary has authority to act as final arbiter and review
the CDC Director's decisions relating to animal importations if the
Secretary so chooses. This section outlines the appeal process for
importers of dogs and cats in the event their animals are denied
admission to the United States upon arrival.
Because denial of admission to dogs and cats under these limited
circumstances is likely to occur at a port, HHS/CDC requires that any
appeal be submitted to CDC 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. Instructions on how to submit an appeal are
included in the regulatory text. Pending a determination regarding the
appeal the animal will remain the legal responsibility of the carrier.
The Director will issue a written response to the appeal, which shall
constitute final agency action, unless the Secretary, within one
business day, decides to review the Director's decision.
(z) Record of death of dogs and cats while en route to the United
States and disposition of dead animals.
Section 71.51(z) is finalized as proposed. The requirement that
carriers maintain a record of sickness or death for any animals that
die during transit is longstanding. Through this final rule, HHS/CDC
will now 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 is including these
amendments to ensure it can detect, provide referrals to appropriate
agencies, and respond to potential communicable disease importation
risks in a timely manner. Importers are responsible for the costs
unless they abandon the animal, in which case the airline or master or
operator of a vessel will assume responsibility for the costs.
(aa) Abandoned shipments of dogs and cats.
Section 71.51(aa) is finalized as proposed. Through this final
rule, HHS/CDC is providing 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.
The provisions of Section 71.51(aa) 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.
(bb) Sanitation of cages and containers of dogs and cats.
Section 71.51(bb) is finalized as proposed. This section requires
that cages or other containers of animals arriving in the United States
be cleaned and disinfected or the animals removed and placed in clean
containers if the cages or other containers constitute a communicable
disease risk.
(cc) Requirements for in-transit shipments of dogs and cats.
Section 71.51(cc) is finalized as proposed. Under today's final
rule, CDC's definition of an ``in-transit shipment'' now aligns with
that of the USDA. This provision further clarifies that dogs and cats
can only be considered in-transit if they are transported as cargo and
not as hand-carried baggage or checked baggage. In-transit shipments
may only be transported as cargo. HHS/CDC is also clarifying that a
microchip 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.
(dd) Bill of lading and other airline requirements for dogs.
Section 71.51(dd) has been finalized as proposed with the exception
that airlines that lack the technical ability to generate a bill of
lading (including an air waybill (AWB)) to transport dogs may request a
waiver from CDC and provide a SOP outlining how they will ensure care
for any ill, injured, or abandoned animals or animals denied entry in
the absence of an AWB. This final rule requires 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.
As a condition of granting a waiver to the bill of lading
requirement, HHS/CDC may require the airline to work with a broker to
file the appropriate paperwork and identify suitable housing

[[Page 41745]]

accommodations (such as an ACF or a local kennel approved by CDC and
CBP) for any dogs detained pending admissibility. The SOP must include
the location of an ACF or other suitable alternative approved by CBP
and CDC prior to transport of animals. HHS/CDC may require the airline
to submit documentation outlining a timetable and steps that will be
taken to develop the technical capacity to generate an AWB (or another
suitable alternative to an AWB) to transport dogs. CDC has provided
additional details for airlines seeking exemption for the AWB
requirement in technical instructions available on CDC's website at
www.cdc.gov/dogtravel.
Section 71.51(dd) also requires that airlines confirm that all
importers have a receipt of a completed CDC Dog Import Form prior to
boarding. For U.S.-vaccinated dogs that have been in a DMRVV high-risk
country within the last six months, CDC requires that airlines confirm
that importers have a valid Certification of U.S.-issued Rabies
Vaccination form. For foreign-vaccinated dogs that have been in a DMRVV
high-risk country within the last six months, airlines must confirm
that importers have a reservation at an ACF. For dogs from DMRVV-free
or DMRVV low-risk countries, HHS/CDC will require that airlines confirm
that the importer has documentation as outlined in paragraph (u)
showing that the dog is over six months of age, has a microchip, and
has been only in DMRVV-free or DMRVV low-risk countries within the last
six months.
Finally, section 71.51(dd) requires 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, arrangements have been made to transport the dogs to an
ACF or other facility (e.g., veterinary clinic or kennel) approved by
CDC pending admissibility determination, or arrangements have been made
for return of dogs not meeting CDC entry requirements.
(ee) Order prohibiting carriers from transporting dogs and cats.
Section 71.51(ee) is finalized as proposed. This final rule
outlines procedures for the CDC 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.
(ff) Prohibition on imports of dogs from DMRVV-restricted
countries.
Section 71.51(ff) is finalized as proposed. This section of the
final rule explicitly states that HHS/CDC may prohibit or otherwise
restrict the import of dogs into the United States from certain
countries that have repeatedly exported rabid dogs to any country or
that lack adequate controls to monitor and prevent the export of dogs
to the United States with falsified or fraudulent rabies vaccine
credentials, invalid rabies vaccination forms, or other fraudulent,
inaccurate, or invalid exportation/importation documents. Such a
prohibition or other restriction will remain in place until there is
sufficient evidence for CDC to be assured that adequate controls have
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 HHS/CDC will maintain a list
of DMRVV-restricted countries. The list will be maintained on CDC's
website at www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html and updated annually. Amendments to the list of
DMRVV-restricted countries will be published as a notice in the Federal
Register. HHS/CDC may allow the importation of certain categories of
dogs from DMRVV-restricted countries, such as service animals or
government-owned animals.
(gg) Request for issuance of additional fines or penalties.
Section 71.51(gg) is finalized as proposed with the exception that
CDC is adding language informing the public that it may also refer
potential violations of Federal law to the U.S. Department of Justice
for investigation, and based on the results of such investigation,
prosecution. Specifically, CDC may refer a matter to the U.S.
Department of Justice if the Director has reason to believe that an
individual or organization has violated Federal law, including by
forcibly assaulting, resisting, opposing, impeding, intimidating, or
interfering with a U.S. government employee while engaged in or on
account of the performance of their official duties in violation of 18
U.S.C. 111, by obstructing an agency proceeding in violation of 18
U.S.C. 1505, or by otherwise engaging in conduct contrary to law. This
provision also serves to inform the public of actions that CDC may take
to request DHS/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.

IV. Alternatives Considered

In developing this final rule, HHS/CDC considered more and less
costly policy alternatives. The provisions included in the final rule
were determined to minimize the cost and burden of the regulatory
provisions while protecting and reducing risks to the public's health.
To reduce the costs associated with the provisions of the final rule,
many 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 I summarizes alternatives to selected requirements expected
to be associated with most of the monetized costs and benefits for this
rule relative to the current status quo. A quantitative analysis of the
cost and benefits is available in an Appendix found in the Supplemental
Materials tab of the docket and summarized in Section VII(A).
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\59\ The current requirements do not take account of the
temporary suspension of dogs from DMRVV high-risk countries, because
it is a temporary measure.
\60\ Roccaro, M., & Peli, A. (2020). Age determination in dog
puppies by teeth examination: legal, health and welfare
implications, review of the literature and practical considerations.
Veterinaria Italiana, 56(3), 149-162. https://doi.org/10.12834/VetIt.1876.9968.2.

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\61\ Roccaro, M., & Peli, A. (2020). Age determination in dog
puppies by teeth examination: legal, health and welfare
implications, review of the literature and practical considerations.
Veterinaria Italiana, 56(3), 149-162. https://doi.org/10.12834/VetIt.1876.9968.2.
---------------------------------------------------------------------------

HHS/CDC determined that the set of lower-cost alternatives would
likely not have a significant impact on reducing the risk of dogs being
imported with DMRVV compared to the regulatory baseline. The
requirements in the final rule would more effectively reduce this risk.
If the age requirements were reduced, importers may be more likely to
attempt to circumvent CDC rules to move dogs from DMRVV high-risk to
DMRVV-free or low-risk countries prior to importation into the United
States. It is difficult to age dogs under six months,\62\ and CDC has
documented cases of fraud involving the movement of dogs under six
months of age from DMRVV high-risk countries to DMRVV-free and DMRVV
low-risk countries to avoid rabies vaccination requirements. By
requiring all dogs to be at least six months of age, CDC can better
confirm that the dog presented matches the documentation presented,
particularly the age listed for the dog, and that it is old enough to
be adequately vaccinated for rabies. This age requirement also more
closely aligns with the WOAH standard for dogs from high-risk countries
that states dogs should be imported 90 days after a serologic sample
has been drawn.\63\
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\62\ Roccaro, M., & Peli, A. (2020). Age determination in dog
puppies by teeth examination: legal, health and welfare
implications, review of the literature and practical considerations.
Veterinaria Italiana, 56(3), 149-162. https://doi.org/10.12834/VetIt.1876.9968.2.
\63\ WOAH Terrestrial Manual 2023, chapters 3.1.18 and 8.15.7.
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In addition, transporting dogs under six months of age under
conditions with unstable and fluctuating air temperatures, such as
those present in the cargo area of a plane, may subject these young
animals to adverse events (illness or death) because young animals
cannot regulate their body temperature as efficiently as adult
animals.\64\ International travel often results in prolonged time
between feeding and watering of animals leading to potential adverse
events (illness and death) in young animals due to physiologic
stressors associated with or exacerbated by low blood glucose levels,
low oxygen environments (such as the cargo area of a plane),
dehydration, and the stress of travel.\65\ This could result in more
ill and dead dogs arriving on flights (reducing the benefits estimated
for the final rule). CDC would lack data on the total number of dogs
imported into the United States and would have less data to conduct
public health investigations in the event that a sick dog is imported
from DMRVV-free or low-risk country. In the absence of official
certification of the Certification of U.S.-issued Rabies Vaccination
form, CDC believes it would be much easier for importers of dogs from
DMRVV high-risk countries to present fraudulent documentation of U.S.
rabies vaccination. It would be more difficult for CDC to verify the
identity of dogs arriving with tattoos instead of microchips
(increasing the risk of fraudulently imported dogs). Microchips are
also already widely used throughout the world and are a WOAH

[[Page 41753]]

standard for the international movement of animals.\66\
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\64\ Hardy J. Physiology of temperature regulation. Physiologic
reviews 1961: 41; 521-606.
\65\ Jahn K, Ley J, DePorter T, Seksel K. How Well Do Dogs Cope
with Air Travel? An Owner-Reported Survey Study. Animals (Basel).
2023 Oct 4;13(19):3093. Doi: 10.3390/ani13193093. PMID: 37835699;
PMCID: PMC10571552.
\66\ WOAH Terrestrial Manual 2023, chapters 3.1.18 and 8.15.7.
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Follow-up examination and revaccination of dogs by any U.S.-
licensed veterinarian would be less costly in comparison to services
provided by CDC-registered ACF; however, this would increase the public
health risk associated with foreign-vaccinated dogs from DMRVV high-
risk countries. CDC would have limited capacity to follow up with
importers to ensure that the dogs had been appropriately examined and
revaccinated in a timely manner. Prior to the examination, the dog
could come into contact with additional people and potentially other
pets or wildlife. Finally, staff at CDC-registered ACF will operate
according to CDC regulations and guidance to minimize the risk of
disease transmission to humans and other animals.
CDC would have very limited oversight of the laboratories
conducting serological tests. Importers would also find it easier to
obtain fraudulent serological tests from laboratories that are not
approved by CDC or may get inaccurate test results from unapproved
laboratories. If CDC allowed foreign-vaccinated dogs to arrive at any
U.S. port with a CDC quarantine station (also known as a CDC port
health station), the government (i.e., CBP and CDC) would not be able
to ensure that the dogs had been cleared by a CDC-registered ACF prior
to admitting the dogs into the United States. In summary, the lower-
cost alternatives would result in significantly less costs for
importers and airlines but would also significantly limit the ability
of CDC to prevent the importation of inadequately vaccinated dogs from
DMRVV high-risk countries. CDC has observed that many importers have
tried to circumvent CDC requirements for dog importation and the
provisions in this final rule are chosen to mitigate these risks. The
lower-cost alternatives would lead to a significantly increased risk
that dogs infected with DMRVV would be imported.
CDC did not select any of the higher-cost alternatives described
above because most of these alternatives do not address the highest-
risk category of imported dogs, i.e., foreign-vaccinated dogs from
DMRVV high-risk countries. As a result, the public health benefits
associated with these higher-cost alternatives would not decrease the
risk to the public health sufficiently to balance the costs of these
alternatives. CDC has not observed any DMRVV infections among U.S.-
vaccinated dogs imported from DMRVV high-risk countries or among dogs
imported from DMRVV-free or low-risk countries. In addition, CDC can
obtain the data it needs from the lower-cost CDC import data submission
system and does not require a tattoo in addition to a microchip to
confirm the identity of imported dogs. Because of the limited public
health benefit relative to the additional costs, HHS/CDC believes the
requirements in the final rule address the risks associated with
imported dogs infected with DMRVV or other exotic pathogens more cost
effectively than the alternatives.

VI. Summary of Public Comments and Responses

On July 10, 2023, HHS/CDC published a NPRM proposing to amend the
current foreign quarantine regulations at 42 CFR 71.50 and 71.51 to
provide additional clarity and safeguards to address the public health
risk of DMRVV associated with the importation of dogs into the United
States (88 FR 43978). In the NPRM, HHS/CDC specifically requested
public comment on the following:
A limited exception to accommodate personal pet owners who
travel by land between the U.S. and Canada or Mexico.
The proposed requirement that airlines transport and
assume responsibility (if the importer abandons the animal) for
necropsy of dogs and cats that die en route to the United States or
that die pending an admissibility determination. Necropsy would include
gross and histopathologic examination and any subsequent infectious
disease testing based on the findings.
The proposed requirement for the rabies vaccination form
for foreign-vaccinated dogs to be certified by a foreign government
official in the exporting country, as an added measure to prevent
falsification.
The proposed 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 to or eligible for
removal from the list. Additionally, 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.
The potential costs to carriers of dogs arriving by land
or sea (as opposed to airlines) to comply with the requirements
proposed in the NPRM.
Estimates of the number of dogs any small individual
entity currently imports annually or the average number of imported
dogs across entities.
Estimated thresholds 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.
During the public comment period, HHS/CDC received 2,106 comments
from individuals, groups, organizations, and the airline industry. This
included one comment from a group of organizations involved in animal
rescue that included 118,312 signatures.
The following is a discussion of public comments received that are
applicable and within the scope of the regulation.

A. Comments on Necessity of the Rule

Numerous commenters made general remarks either supporting or
opposing the importation requirements. In the following paragraphs, we
discuss and respond to such comments.
Comment: HHS/CDC received comments from several agencies and
organizations that supported many of the provisions proposed in the
NPRM and adopted in this final rule. These comments generally
recognized the significant public health threat posed by the
importation of rabid dogs. Most of the supportive comments were
submitted as part of a write-in campaign, which stated that the
proposals in the NPRM would ``add much needed safeguards to protect
animals and the public from the introduction of rabies via imported
dogs.'' These entities were particularly supportive of the six-month
age minimum for dog importation, microchip requirement, greater
veterinary oversight, and verification of animals' rabies
documentation. Other commenters supported the proposals in the NPRM
because they believe the requirements would help prevent imported dogs
from introducing diseases into the U.S. dog population. Organizations
involved in veterinary medicine supported the updated dog importation
requirements outlined in the NPRM. Organizations and individuals
involved in purebred dog activities (e.g., breeding) generally
supported many of the provisions in the NPRM except for the six-month
age requirement. Associations and government entities involved in
protecting public health and animal health generally supported the
proposal.
Response: HHS/CDC agrees with the comments that suggest this action
and specific requirements are necessary for continued control of DMRVV
from

[[Page 41754]]

imported dogs. This includes specific provisions including the six-
month age minimum for dog importation, microchip requirement, greater
veterinary oversight, and verification of animals' rabies
documentation, which are discussed in further length below.
Comment: CDC received numerous comments that the rule was
unnecessary because DMRVV was not a serious problem in the United
States. Commenters noted that no person has died from rabies in the
United States during the past 20 years, that CDC should instead focus
on wildlife rabies which they considered a greater risk than DMRVV and
is already present in the United States, and that the rule was
overcompensating for rare events (citing the low number of imported
rabid dogs and the uncommon occurrence of rabies in dogs in the United
States).
Response: CDC disagrees with these comments and considers DMRVV a
serious threat that requires effective controls to prevent its re-
introduction into the United States. Rabies is one of the deadliest
zoonotic diseases and accounts for an estimated 59,000 human deaths
globally each year.\67\ Over 98 percent of those deaths are due to
DMRVV.\68\ The rabies virus can infect any mammal and, once clinical
signs appear, the disease is almost always fatal.\69\ 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. Of note, DMRVV has
been highly successful at adapting to new host species, particularly
wildlife, that can further transmit the virus.\70\
---------------------------------------------------------------------------

\67\ 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.
\68\ 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.
\69\ 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.
\70\ 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.
---------------------------------------------------------------------------

The goal of the revised regulation is to update and strengthen the
U.S. dog importation system to maintain effective control of DMRVV.
From 2015-2022, the incidence rate of DMRVV-infected dogs imported into
the United States from DMRVV high-risk countries was approximately 16
times higher (range, 13.24-19.36) than the annual incidence of
domestically acquired endemic rabies variants among the U.S. domestic
dog population.\71\ This is a disease with near 100% mortality in
infected people. There is no treatment available for persons ill with
rabies. As rabies kills approximately 59,000 people, mainly children,
per year globally from dog bites, HHS/CDC is committed to preventing
the reintroduction of DMRVV into the United States.
---------------------------------------------------------------------------

\71\ Pieracci EG, Wallace R, Maskery B, Brouillette, Brown C,
Joo H. Dogs on the move: Estimating the risk of rabies in imported
dogs in the United States, 2015-2022. Zoonoses and Public Health
2024; 00:1-9 DOI: 10.1111/zph.13122.
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DMRVV is still a serious public health threat in the more than 100
countries where it remains enzootic.\72\ Although the U.S. Government
does not track the precise 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.\73\ This estimate was based on information
provided by airlines, CBP, and a public health study conducted at a
U.S.-Mexico land border crossing.\74\ The re-establishment of DMRVV in
the United States would near certainly result in human death, cost
millions of dollars, and require years of dedicated State and Federal
efforts to eliminate the virus again.
---------------------------------------------------------------------------

\72\ 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.
\73\ 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).
\74\ 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.
---------------------------------------------------------------------------

The consequences of failure to control DMRVV importations remain
extraordinary and significant. In 1988, when DMRVV found in Mexico
began spreading in U.S. coyote populations, it spread to wildlife and
dogs in Texas where DMRVV had been previously eliminated. Two people
died and the subsequent re-elimination of DMRVV cost $56 million (in
2023 USD) and required over 10 years of effort.^{75 76} The
experience of other countries also speaks to the importance of
maintaining continued effective control of DMRVV importation. For
instance, Malaysia recently experienced the reintroduction of dog
rabies with significant consequences for the country, including 59
human deaths since the outbreak began.\77\
---------------------------------------------------------------------------

\75\ 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.
\76\ 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.
\77\ Sarawak records 9 rabies deaths so far this year. The
Straits Times. May 16,2023.
---------------------------------------------------------------------------

Regarding commenters' assertion that HHS/CDC should focus on
wildlife rabies as posing a greater threat than DMRVV, there is an
important distinction between rabies variants circulating in wildlife
species (including foxes, raccoons, skunks, and bats) in the United
States and DMRVV, which has not been endemic in the United States since
2007. Through mutation DMRVV is highly adaptable to new hosts. One
DMRVV-infected dog infecting one animal in the wild is not of major
concern. However, if the DRMVV mutates within that wild animal, the
wild animal can create an entirely new rabies variant that can spread
across the U.S. Indeed, five out of eight wildlife variants within the
U.S. originated through DMRVV infection. DMRVV thus risks exponentially
increasing the risk to human and animal life.\78\
---------------------------------------------------------------------------

\78\ 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.
---------------------------------------------------------------------------

Comment: HHS/CDC received more than 200 comments that the proposed
rule was unnecessary given the rarity of DMRVV importations and that no
one in the United States has died from DMRVV from an imported dog in
more than 20 years. Fourteen commenters claimed that ``this rule is
overcompensating for rare events,'' citing the low number of imported
rabid dogs or the uncommon occurrence of rabies in dogs in the United
States. Another comment claimed that a response to a Freedom of
Information Act request revealed that there has not actually been an
increase in dogs with rabies entering the country, so these proposed
changes are discriminatory and arbitrary. The commenter stated that
over a million dogs are imported into the United States every year and
only 3 imported dogs have been found to be infected with rabies since
2015.
Response: While DMRVV importations remain uncommon and thankfully
no one in the United States has died from rabies following exposure to
an imported dog in the last 20 years, HHS/CDC disagrees that the recent
success in preventing deaths from imported rabies means that the United

[[Page 41755]]

States should not update its regulations to ensure the continued
effectiveness of its dog importation requirements.
Specifically, updates to dog importation requirements are necessary
to (1) adapt to increased fraud in importations of dogs; (2) avoid the
severe disruptions and health risks posed by the re-introduction of
DMRVV into the United States; and (3) stay ahead of growing gaps in
rabies control efforts, both abroad and in the United States.
Addressing Increasing Fraud
HHS/CDC continues to document a marked increase in fraud committed
by importers of dogs from DMRVV high risk countries.^{79 80 81}
^{82 83 84 85} Internationally, there has been significant
growth within the companion animal breeding industry with increasing
international trade.\86\ Multiple international and U.S. investigations
have identified importations of puppies that were too young to meet
rabies vaccination requirements.^{87 88 89 90} 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.^{91 92 93}
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\79\ Centers for Disease Control and Prevention. Quarantine
Activity Reporting System (version 4.9.8.8.2.2A). Dog importation
data, 2021-2024. Accessed: 26 March 2024.
\80\ Centers for Disease Control and Prevention. Dog Import
Permit Application System. Dog permit importation data, 2021-2024.
Accessed: 26 March 2024.
\81\ 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.
\82\ Kaila M, Marjoniemi J, Nokireki T. Comparative study of
rabies antibody titers of dogs vaccinated in Finland and imported
street dogs vaccinated abroad. Acta Vet Scand 2019; 61:15.
\83\ Maher J, Wyatt T. European illegal puppy trade and
organized crime. Trends in Organized Crime. 2021; 24(4) 506-525.
\84\ 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.
\85\ 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.
\86\ Maher J, Wyatt T. European illegal puppy trade and
organized crime. Trends in Organized Crime. 2021; 24(4) 506-525.
\87\ 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.
\88\ 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.
\89\ 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.
\90\ 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.
\91\ 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.
\92\ 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.
\93\ British Broadcasting Corporation. Illegal puppy trade
warning as sales boom during the COVID pandemic. 18 NOV 2020.
British Broadcasting Corporation News.
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Additionally, reports of international movement of animals with
missing microchips, no proof of rabies vaccination, or underage dogs
with fraudulent vaccination records have been documented in the United
States and abroad.^{94 95} A rabies serological (antibody)
titer is an estimation of an immune response against rabies virus
(either through exposure or vaccination). While there is no
``protective'' titer against rabies virus, survival against rabies
virus infection is often more likely to occur the higher the animal's
titer at the time of infection.\96\ The World Organisation for Animal
Health considers a level of 0.5 IU/mL a ``passing'' antibody titer
level. A 2015 study found that 53% of imported rescue dogs arriving in
Norway with rabies vaccinations administered at least 21 days before
arrival had titers less than 0.5 IU/mL.\97\ Nineteen percent of dogs in
the study had titers less than 0.1 IU/mL, ``raising concerns as to
whether they had been vaccinated against rabies at all.'' \98\ A study
of over 20,000 dogs imported into Italy between 2006 and 2012 found 13%
of imported dogs had titers less than 0.5 IU/mL, raising similar doubts
about compliance with vaccination requirements.\99\ A Canadian study
conducted between October 2021 and November 2022 found that nearly half
(32/67; 47.8%) of imported rescue dogs had titers less than 0.5 IU/mL
and 34% (23/67) had no detectable rabies titer, despite all dogs having
been imported within one month with a current rabies vaccination
certificate.\100\ Importers are increasingly resorting to falsifying
the ages of dogs and submitting certificates for other animals while
also submitting titer results from other animals or changing the titer
results of the dogs being imported. This increase in instances of
fraudulent rabies vaccination documents combined with increases in
international dog movement presents an ongoing and significant risk of
importation of DMRVV.
---------------------------------------------------------------------------

\94\ 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.
\95\ 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.
\96\ CDC. Rabies Serology. Available at: www.cdc.gov/rabies/specific_groups/hcp/serology.html#What%20Does%20A%20Rabies%20Virus%20Titer%20Mean?
\97\ Klevar S, Hogasen HR, Davidson RK, Hammes IS, Treiberg
Berndtsson L, LundA. Cross-border transport of rescue dogs may
spread rabies in Europe. The Veterinary Record. 2015; 176 (26): 672.
\98\ Id.
\99\ Rota Modari E, Alonso S, Mancin M, De Nardi M, Hudson-Cooke
S, Veggiato C, et al. Rabies vaccination: higher failure rates in
imported dogs than those vaccinated in Italy. Zoonoses and Public
Health 2022; 64 (2): 146-55.
\100\ Weese S. Rabies titers in dogs imported into Ontario,
Canada (2021-2022). Abstract submitted to Canadian Association of
Veterinary Epidemiology and Preventative Medicine (CAVEPM)
Conference 2023.
---------------------------------------------------------------------------

For instance, 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.\101\ 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.\102\
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\101\ 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.
\102\ 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.
---------------------------------------------------------------------------

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.

[[Page 41756]]

veterinarian examined the dog one day after its arrival and tested the
dog for rabies. A rabies test showed that the dog was positive for
DMRVV.\103\ 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 likelihood of falsified rabies vaccination documentation
presented on entry to the United States.\104\
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\103\ 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.
\104\ 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.
---------------------------------------------------------------------------

In 2019, 26 dogs 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 later tested
positive for DMRVV. The resulting public health investigation raised
suspicions that the rabies vaccination documents and serological test
results had been 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. As a result, 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.\105\ The public health
investigations and administration of rabies PEP to exposed persons in
this case cost more than $400,000 in State resources.^{106 107}
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.^{108 109}
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\105\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
\106\ Id.
\107\ Centers for Disease Control and Prevention (2022). Rabies
Postexposure Prophylaxis. Retrieved from https://www.cdc.gov/rabies/medical_care/index.html.
\108\ 84 FR 20628 (May 10, 2019).
\109\ 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.
---------------------------------------------------------------------------

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. 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.\110\ 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.\111\ The 33 exposed animals
were revaccinated and placed in quarantine for periods ranging from 45
days to six months.\112\
---------------------------------------------------------------------------

\110\ 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.
\111\ 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.
\112\ 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.
---------------------------------------------------------------------------

Avoiding Disruption of DMRVV Re-Introduction
The disruption to public health associated with even a single rabid
dog importation can be significant. For every imported rabid dog, an
average of 20 people and 21 animals receive post-exposure prophylaxis
(PEP) or undergo vaccination and quarantine, respectively, resulting in
a substantial disruption to State and local public health services, a
considerable cost burden to states, and a significant toll on the
physical and mental health of exposed persons and animals.
To manage even one instance of DMRVV exposure, State public health
officials must immediately pivot from routine or less life-threatening
responses and initiate multiple actions, some of which are extensive.
First, the State health department must initiate an in-depth
investigation to locate all persons and animals who were exposed to the
rabid dog from the 10 days prior to the dog showing symptoms until the
dog dies or is euthanized. In many instances, multiple health
departments are involved and, based on the results of the
investigation, CDC may be required to notify the World Health
Organization pursuant to the International Health Regulations. Next,
State health departments must conduct a rabies risk assessment of all
individuals affected to determine if they need post-exposure
prophylaxis (PEP), and if they are determined to be at risk, to
administer post-exposure prophylaxis. Finally, if any of the
individuals were scratched or bitten, they may also need wound care,
tetanus boosters, and/or antibiotics.
CDC estimates a range of costs for public health investigations and
subsequent cost of care for people exposed to rabid dogs to be between
$210,00 and $510,000 per importation event, as summarized in Section
VI.^{113 114} 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. Finally, these costs do not include the
cost of re-eliminating DMRVV if it were to be re-established in the
United States, making this estimate an underestimate of the total cost
associated with an imported rabid dog.
---------------------------------------------------------------------------

\113\ Raybern, C et al. Rabies in a dog imported from Egypt-
Kansas, 2019. MMWR Morb Mort Wkly Rep 2020; 69 (38): 1374-1377.
\114\ 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).
---------------------------------------------------------------------------

It bears noting that while the cost of public health investigations
and administering PEP is borne by public health departments, the
individuals who are the subjects of the investigations and who may
receive PEP will experience great disruption and physical and emotional
burden: rabies PEP can be painful (specifically, rabies immunoglobulin
administered at the

[[Page 41757]]

site of the wound) and protracted; DMRVV is 99% fatal in humans, a
statistic certain to engender fear and anxiety; and the need to
quarantine exposed pets can create a sense of great disruption and
concern.
Finally, DMRVV becoming re-established in the United States would
result in costly efforts over many 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 $56 million
(in 2023 USD) and required over 10 years of effort.^{115 116}
---------------------------------------------------------------------------

\115\ 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.
\116\ 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.
---------------------------------------------------------------------------

Addressing Potential Gaps in Rabies Control
The rule is further necessitated by two new threats to rabies
control efforts domestically and abroad, which could increase the risk
of the re-introduction of DMRVV in the United States--drops in
vaccination coverage among U.S. dogs and disruptions to rabies control
programs in high-risk countries.
The risk of re-introduction of DMRVV is compounded by potential
gaps in rabies vaccine coverage among U.S. dogs. Researchers recently
documented canine vaccine hesitancy, which is defined as ``a dog
owners' skepticism about the safety and efficacy of administering
routine vaccinations to their dogs,'' in 53% of the U.S. population.
Rabies vaccination in pets creates a protective barrier between people
and wildlife infected with rabies by disrupting the virus transmission
chain. Declines in canine rabies vaccination rates increases the chance
of people being exposed to and infected with the rabies virus.
This perspective among dog owners could lead to decreases in rabies
vaccination coverage in pets, creating a potential susceptible pet
population primed for DMRVV re-introduction.\117\ Canine vaccine
hesitancy has specifically been associated with rabies non-vaccination.
While existing importation regulations have been instrumental in
decreasing and preventing the importation of rabid dogs, updates to
these regulations, as provided for in the final rule, are necessary to
sustain and advance effective control of DMRVV.
---------------------------------------------------------------------------

\117\ Motta, M., Motta, G., Stecula, D. (2023). Sick as a dog?
The prevalence, politicization, and health policy consequences of
canine vaccine hesitancy (CVH). Vaccine, 41: 5946-5950.
---------------------------------------------------------------------------

The COVID-19 pandemic also negatively impacted global canine rabies
vaccination campaigns, which have yet to recover. Successful canine
rabies control requires canine mass vaccination coverage equal to or
greater than 70% of a country's dog population.^{118 119}
Achieving pre-pandemic vaccination rates for countries that were moving
toward canine rabies control and elimination prior to the COVID-19
pandemic could take years to recover, and some countries may require
even longer periods of time to attain pre-pandemic vaccination levels.
During the COVID-19 pandemic, canine rabies vaccination campaigns were
disrupted in many high-risk countries, which resulted in an increase in
canine and human rabies cases.^{120 121} This disruption to
canine vaccination campaigns has been contemporaneous with other
factors, including: a high volume of dogs being imported into the
United States, insufficient veterinary controls in DMRVV high-risk
countries to prevent the export of inadequately vaccinated dogs,
inadequate global 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.
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\118\ Coleman PG, Dye C. Immunization coverage required to
prevent outbreaks of dog rabies. Vaccine. 1996 Feb;14(3):185-6. Doi:
10.1016/0264-410x(95)00197-9. PMID: 8920697.
\119\ Zinsstag J, D[uuml]rr S, Penny MA, Mindekem R, Roth F,
Menendez Gonzalez S, Naissengar S, Hattendorf J. Transmission
dynamics and economics of rabies control in dogs and humans in an
African city. Proc Natl Acad Sci U S A. 2009 Sep 1;106(35):14996-
5001. Doi: 10.1073/pnas.0904740106. Epub 2009 Aug 17. PMID:
19706492; PMCID: PMC2728111.
\120\ Kunkel, A., Jeon, S., Joseph, H., Dilius, P., Crowdis, K.,
Meltzer, M., Wallace, R. (2021). The urgency of resuming disrupted
dog rabies vaccination campaigns: a modeling and cost-effectiveness
analysis. Scientific Reports, 11, 12476. Doi:10.1038/s41598-021-
92067-5.
\121\ Raynor, B., D[iacute]az, E., Shinnick, J., Zegarra, E.,
Monroy, Y., Mena. C., . . . Castillo-Neyra, R. (2021). The impact of
the COVID-19 pandemic on rabies reemergence in Latin America: The
case of Arequipa, Peru. PLoS Neglected Tropical Diseases, 15(5),
e0009414. doi:10.1371/journal.pntd.0009414.
---------------------------------------------------------------------------

A survey of global, regional, national, and local partners from the
network of the United Against Rabies Forum \122\ and rabies
practitioners found that the global COVID-19 pandemic impacted rabies
control efforts in many high-risk countries during 2020. The study
authors reported that dog vaccinations were administered as planned in
just four percent of the countries for which data were available.
Around half of respondents reported that funds for rabies control were
diverted to COVID-19 activities. Respondents who reported diversion of
rabies control funds to COVID-19 responses further reported that animal
rabies vaccines and dog vaccination campaigns were often the first
rabies control activities to be cut.\123\
---------------------------------------------------------------------------

\122\ A forum supported by the Food and Agriculture Organization
of the United Nations, the World Organisation for Animal Health, and
the World Health Organization (the Tripartite), which takes a multi-
sectoral, One Health approach bringing together governments, vaccine
producers, researchers, non-governmental organizations and
development partners to end human deaths from dog-mediated rabies.
\123\ Nadal D, Abela-Ridder B, Beeching S, Cleaveland S, Cronin
K, Steenson R and Hampson K (2022). The Impact of the First Year of
the COVID-19 Pandemic on Canine Rabies Control Efforts: A Mixed-
Methods Study of Observations About the Present and Lessons for the
Future. Front Trop Dis 3:866811.doi: 10.3389/fitd.2022.866811.
---------------------------------------------------------------------------

Global veterinary workforce capacity and veterinary supply chain
shortages that have led to delayed or disrupted care for dogs (and
other pets), and that were exacerbated by the COVID-19 pandemic, still
remain today. The lack of veterinarians, veterinary technicians, and
other animal care staff who are available to provide care for dogs
prior to travel, combined with a lack of veterinary supplies such as
drugs and vaccines, increase the likelihood dogs imported into the
United States may pose a public health
threat.^{124 125 126 127} Challenges with rabies vaccine
administration, distribution, potency, quality, and storage in many
countries also contribute to inadequate protection against rabies prior
to the pandemic; these challenges continue as public health
infrastructure recovers post-pandemic.^{128 129 130 131}
---------------------------------------------------------------------------

\124\ https://www.theatlantic.com/health/archive/2022/07/not-enough-veterinarians-animals/ 661497/.
\125\ https://www.agcanada.com/2021/07/is-the-veterinarian-
shortage-real-or-
regional#:~:text=A%20perceived%20global%20shortage%20of%20veterinaria
ns%20is%20creating,for%20the%20quality%20of%20care%20they%20can%20off
er.
\126\ https://www.thebusinessresearchcompany.com/report/companion-animal-veterinary-vaccines-global-market-report.
\127\ https://7news.com.au/lifestyle/pets/aussie-dog-owners-warned-of-national-vaccine-shortage-as-deadly-bacterial-disease-spreads-c-8568550.
\128\ Hu RL, Fooks AR, Zhang SF, Liu Y, Zhang F. Inferior rabies
vaccine quality and low immunization coverage in dogs in China.
Epidemiol Infect. 2008; 136: 1556-63.
\129\ Yale G, Sudarshan S, Taj S, Patchimuthu GI, Mangalanathan
BV, et al. Investigation of protective level of rabies antibodies in
vaccinated dogs in Chennai, India. VetRecord. 2021; 8: e8.
\130\ 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.
\131\ Rota Modari E, Alonso S, Mancin M, De Nardi M, Hudson-
Cooke S, Veggiato C, et al. Rabies vaccination: higher failure rates
in imported dogs than those vaccinated in Italy. Zoonoses and Public
Health 2022; 64 (2): 146-55.

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[[Page 41758]]

Comment: CDC received comments stating that the current regulation
for dogs and cats is sufficient or that CDC should keep its current
importation system in place. Because the commenter did not elaborate on
what they meant by the term ``current importation system,'' CDC assumes
that this refers to requirements under the temporary suspension.
Response: CDC disagrees that current regulations are sufficient to
prevent the reintroduction of DMRVV into the United States. CDC notes
that its Federal quarantine regulations (currently found at 42 CFR
71.51) controlling the entry of dogs and cats into the United States
have not been substantively updated in decades. The final rule includes
many improvements in terms of public health protection against the
reintroduction of DMRVV over the current regulations. Among other
things, the final rule removes the current requirement for a valid
rabies vaccine certificate in 42 CFR 71.51(c) and replaces it with
standardized rabies vaccination forms that better prevents importers
from submitting fraudulent rabies documentation. The use of
standardized forms also helps ensure that foreign-vaccinated dogs
imported from DMRVV high-risk countries meet CDC entry requirements
prior to traveling to the United States and allows for follow-up with
the exporting country's government officials if needed. The final rule
further requires pre-arrival rabies serologic testing, as well as
revaccination, examination, and, in some cases, quarantine upon arrival
at a CDC-registered ACF for foreign-vaccinated dogs from DMRVV high-
risk countries. Additionally, the final rule requires that all dogs be
microchipped at the time of admission. Microchips are a widely used
method of confirming the dogs' identity and help prevent importers from
fraudulently presenting dogs for admission that do not match the dogs'
accompanying health records. Finally, the provisions in this final rule
are estimated to reduce the number of dogs arriving ill or dead, which
should in turn conserve agency resources by diminishing the need for
CDC to conduct public health investigations to rule out whether the
dogs may have died of a zoonotic disease of public health concern,
including DMRVV.
CDC also disagrees that it should maintain the same system in place
as it used during the temporary suspension. Beginning in June 2021, CDC
published a temporary suspension of dogs entering the United States
from DMRVV high-risk countries. 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 authorized a private network of ACF allowing
for the immediate quarantine of dogs from DMRVV high-risk countries
arriving with inadequate proof of titers. Although this final rule
implements a similar regulatory framework based on the documented
successes of the temporary suspension, there are important differences.
Unlike during the temporary suspension, the final rule does not rely on
CDC issuing CDC Dog Import Permits for foreign-vaccinated dogs from
DMRVV high-risk countries. Rather, the final rule relies on the network
of private ACF to examine, revaccinate, and quarantine (if necessary)
foreign-vaccinated dogs from DMRVV high-risk countries. The final rule
adopts this system instead of the permit system used during the
temporary suspension because issuing permits costs CDC more in terms of
personnel and IT services. By replacing the permitting system for
foreign-vaccinated dogs from DMRVV high-risk countries with a system of
ACF, CDC anticipates a reduction in costs and staff time associated
with dog importation because the importer will bear the costs of
examination, revaccination, and quarantine (if needed) at an ACF.
During the temporary suspension CDC also continued to document
attempts by importers to submit fraudulent documentation to receive a
CDC Dog Import Permit. CDC recognized there is limited value in
reviewing paperwork alone because physical inspection of animals in
combination with a review of paperwork submitted by importers has a
greater likelihood of allowing CDC to detect both fraudulent paperwork
and communicable diseases of concern in dogs. For example, in 2002-
2023, ACF found several ticks on imported dogs. Investigation by CDC
and USDA determined these were novel, exotic ticks that had never been
found in the Western hemisphere. The health impacts of these ticks on
people, livestock, wildlife, and pets are unknown because they have not
been studied previously. Physical examination of dogs, which is crucial
for rabies detection, at the ACF was also instrumental in detecting and
preventing the introduction of these novel ticks in the United States.
Comment: HHS/CDC received comments that the NPRM is not needed
because U.S. states already regulate rabies control within the United
States.
Response: HHS/CDC disagrees with these comments. Although U.S.
States establish requirements relating to rabies vaccination and
control within their own jurisdictions, it is HHS/CDC's role to
regulate the importation of dogs into the United States from foreign
countries. The final rule should reduce the burden on state, local, and
territorial public health and animal health agencies and support U.S.
State requirements. As noted above, a single importation of a DMRVV-
infected dog can cost affected State governments hundreds of thousands
of dollars for the ensuing public health investigations and rabies
post-exposure prophylaxis (PEP) treatments administered to exposed
persons. The cost to State and local governments can balloon
significantly in the case of 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.
There have been significant challenges for State and Federal
agencies in enforcing or verifying vaccination requirements in
internationally imported animals. In 2021, the importation of a rabid
dog resulted in a ten-state multi-agency investigation to locate all
people and animals exposed to the rabid dog. It was the largest
investigation of an imported rabid dog, to date, and required immense
resources and time from multiple states to complete. Furthermore, HHS/
CDC received comments from Federal, State, and Local government
agencies in support of this rule. State and local government agencies
expressed support for requiring veterinary examination, revaccination,
and quarantine (if needed) of dogs on arrival to reduce the burden on
these agencies. These commenters also noted that these practices would
also reduce the public health risk that imported dogs pose to U.S.
communities, domestic pets, and wildlife and would improve the
government's ability to identify dogs with diseases or external
parasites before they enter the United States.
This final rule will reduce the enforcement burden on jurisdictions
and help to ensure all foreign-vaccinated dogs are vaccinated with a
USDA-licensed vaccine on arrival, thereby reducing the public health
risk of these dogs and bringing the dogs into

[[Page 41759]]

compliance with rabies control requirements.
Comment: One commenter asserted the rule was unnecessary because
the increase in numbers of imported dogs was due to the COVID-19
pandemic and the pandemic has now ended.
Response: CDC disagrees with this comment because demand for dogs
from abroad has remained high since the pandemic. Further, the pandemic
disrupted rabies control programs in high-risk countries, a trend that
persists today and increases the risk of DMRVV importations.
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.^{132 133 134 135} Internationally, there has been
significant growth within the companion animal breeding industry with
increasing international trade.\136\ Multiple international and U.S.
investigations have identified importations of puppies that were too
young to meet rabies vaccination
requirements.^{137 138 139 140} 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.^{141 142 143} 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.\144\
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\132\ 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.
\133\ Wynne E. Dog lovers find prices rise steeply amid COVID-
fueled demand. Australian Broadcasting Corporation News. 20 May
2021.
\134\ 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.
\135\ Velez M. I adopted my dog Cannoli from overseas. It's
easier than you think. 9/20/2020. Available at: http://www.thedailybeast.com/i-adopted-my-dog-cannoli-from-overseas-its-easier-than-you-think.
\136\ Maher J, Wyatt T. European illegal puppy trade and
organized crime. Trends in Organized Crime. 2021; 24(4) 506-525.
\137\ 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.
\138\ 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.
\139\ 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.
\140\ 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.
\141\ 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.
\142\ 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.
\143\ British Broadcasting Corporation. Illegal puppy trade
warning as sales boom during the COVID pandemic. 18 NOV 2020.
British Broadcasting Corporation News.
\144\ 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.
---------------------------------------------------------------------------

HHS/CDC received 118,312 signatures from supporters of
international dog rescues, suggesting the demand for dogs and the
desire to import dogs from DMRVV high-risk countries remains high.
Additionally, a recent report published in 2022 found that retail pet
stores and shelters/rescues provide less than 15% of the puppies needed
to meet annual U.S. demand. The report suggests that the importation of
dogs may be one of the main ways to supply the current demand for dogs
in the United States.\145\
---------------------------------------------------------------------------

\145\ Pet dog supply and demand in the United States. 2022.
Available at: wellbeingintl.org/pet-dog-supply-and-demand-in-the-united-states/.
---------------------------------------------------------------------------

B. General Comments on Burden

Comment: Most of the 200 comments stating that the rule was
unnecessary also made some type of assertion that the rule was
generally excessive or too burdensome, without citing specific
requirements of the rule that the commenters believed were excessive or
too burdensome.
Response: HHS/CDC address comments about the burden of specific
provisions of the rule (e.g., titer and quarantine requirements) in
more detail below. Regarding the claim that the rule is generally too
burdensome, HHS/CDC disagrees. As noted above, the risk of DMRVV
importation is a high-consequence event and increased fraud, the severe
disruptions posed by DMRVV re-introduction, and new gaps in domestic
and international rabies control efforts demand an update of U.S. dog
importation requirements to ensure continued effective DMRVV control.
Further, the requirements of the rule itself align U.S. importation
requirements with the best practices advanced by WOAH, and the
practices of member countries (including the United States). In fact,
this final rule is less burdensome than WOAH standards and the
requirements of many other DMRVV-free countries, which reflects HHS/
CDC's considered efforts to reduce the burden of the rule on importers
while advancing best public health and importation practices.
WOAH has long recognized the risk of rabies to human and animal
health. WOAH has led the development of longstanding international
animal movement standards to ensure that dogs imported from DMRVV high-
risk countries are vaccinated, have an adequate antibody titer, appear
healthy at the time of importation, and undergo a sufficient waiting
period before importation (or quarantine after arrival) to ensure they
do not develop signs of rabies. WOAH's Terrestrial Manual \146\ states
that all dogs, cats, and ferrets from rabies-endemic countries should
meet the following standards for international movement:
---------------------------------------------------------------------------

\146\ WOAH Terrestrial Manual 2023, chapters 3.1.18 and 8.15.7.
---------------------------------------------------------------------------

Receive an international veterinary certificate prior to
travel which confirms administration of a rabies vaccine and a rabies
antibody titer collected and tested in accordance with the WOAH
Terrestrial Manual;
Undergo examination the day prior to shipment to ensure
the animal is not showing signs of rabies;
Are permanently identified (e.g., microchip) with the
identification number listed on the certificate;
Are vaccinated against rabies in accordance with
manufacturer's recommendations with a vaccine that was produced in
accordance with the WOAH Terrestrial Manual;
Have a titer test conducted not less than 3 months and not
more than 12 months prior to travel, with a titer test result >=0.5 IU/
mL; or
Are kept in a Federal quarantine station for six months
prior to shipment.
Seventy-one percent of rabies-free countries meet or exceed the
WOAH standards for the international movement of dogs from rabies-
endemic areas whereas the current HHS/CDC regulation for the
importation of dogs and cats (42 CFR 71.51) does not align with WOAH
standards.\147\ This final rule adopts many but not all WOAH

[[Page 41760]]

standards. HHS/CDC carefully considered the WOAH standards when
drafting the final rule. Consultation with rabies subject matter
experts and review of peer-reviewed literature allowed HHS/CDC to
identify several areas in which HHS/CDC could reduce the burden on
importers while protecting public health.
---------------------------------------------------------------------------

\147\ Unpublished data (C. Williams, CDC). October 24, 2023.
---------------------------------------------------------------------------

The HHS/CDC requirements outlined in this final rule are less
burdensome than WOAH standards in the following ways:
HHS/CDC is not requiring cats or ferrets meet the
standards outlined by WOAH as HHS/CDC is not aware of any previous
reports of imported rabid cats or ferrets.
HHS/CDC is not requiring examination of dogs the day
before travel and is allowing a longer time period between examination
and travel to assist importers in submitting all required documentation
to the airlines in a timely manner to make flight reservations;
HHS/CDC is not requiring the use of rabies vaccines
manufactured in accordance with the WOAH Terrestrial Manual as this
would exclude individuals from importing dogs from most DMRVV high-risk
countries due to lack of availability of these high-quality vaccines;
Peer-reviewed findings suggest a shorter waiting period is
adequate to prevent the importation of a rabid dog that is incubating
rabies at the time the titer is collected.\148\ CDC will publish the
length of the waiting period in technical instructions. The technical
instructions will be based on the latest scientific information and may
be updated in the future based on new scientific information and
advancements in veterinary medicine related to vaccination and titer
testing.
---------------------------------------------------------------------------

\148\ Smith TG, Fooks AR, Moore SM, Freuling CM, Muller T, et
al. Negligible risk of rabies importation in dogs thirty days after
demonstration of adequate serum antibody titer. Vaccine 2021; 39
(18): 2496-2499.
---------------------------------------------------------------------------

HHS/CDC is not requiring a six-month quarantine prior to
shipping an animal without a titer as most countries do not have this
capacity. Instead, HHS/CDC has identified CDC-registered Animal Care
Facilities that can provide quarantine services after arrival for dogs
unable to receive a titer prior to shipment.
HHS/CDC is not requiring a quarantine period of six months and is
instead requiring 28-days based on peer-reviewed findings, if the
importer does not have rabies serologic test results.\149\ This
represents a significantly lower time and cost burden for importers.
---------------------------------------------------------------------------

\149\ Smith TG, Fooks AR, Moore SM, Freuling CM, Muller T, et
al. Negligible risk of rabies importation in dogs thirty days after
demonstration of adequate serum antibody titer. Vaccine 2021; 39
(18): 2496-2499.
---------------------------------------------------------------------------

C. Comments on Exemptions for Certain Groups

Comment: HHS/CDC received various comments suggesting that certain
categories of importers or types of dogs should not be subject to
specific provisions of this rule, referenced as ``exemptions'' here.
These commenters proposed that the final rule should exempt (1) U.S.
government (USG) employees and military members (both routinely and
during emergencies); (2) certain U.S. citizens; (3) certified rescue
organizations; (4) U.S.-based rescue organizations; (5) breeders; and
(6) certain types of dogs such as specific dog breeds, service dogs,
government-owned dogs, dogs used in research, U.S.-vaccinated dogs, and
personal pets. Many commenters noted that all of the rabid dogs
imported into the United States since 2015 were imported by rescue
organizations; thus they contended that imposing requirements on other
types of importers was not necessary. Commenters suggested that HHS/CDC
implement different import requirements for different importers and
tailor its requirements based on the risk profile of the importer, and
that CDC add definitional terms to distinguish between different types
of importers (e.g., pet owners, rescue groups). Other comments
suggested creating a separate registration or inspection system for
commercial importers or rescue organizations or limiting the number of
dogs imported by rescue organizations.
Response: HHS/CDC disagrees with these comments. The final rule is
designed to address and reduce the risk of the importation of a dog
with DMRVV. That risk exists based on two factors: (1) the likelihood
that an animal was exposed to DMRVV; and (2) whether the animal was
sufficiently vaccinated to protect against infection. Based on these
factors, available evidence, and CDC's experience with importations, a
dog's recent presence in a high-risk DMRVV country and the dog's
vaccination status (U.S.-versus foreign-vaccinated) are the best ways
to evaluate the risk that an imported dog may have DMRVV. An importer's
statement regarding the intended use of the dog (e.g., show dog,
personal pet); the dog's breed; whether it is a service animal or
working dog; the nationality of the importer; and the importer's
occupation do not provide useful evidence for evaluating the risk of
DMRVV presented by that animal. While it is accurate that since 2015
dog rescue organizations have imported four dogs for adoption that were
subsequently found to be rabid, differentiating between commercial dog
importations and dogs imported as personal pets is operationally
impracticable and increases opportunities for fraud. For example, CDC
has documented many importers who claimed to own the dogs they were
importing as personal pets, but upon further investigation by CBP,
USDA, and CDC it was determined that they were transporting the dogs
for resale or on behalf of a rescue organization. These importers
admitted to being flight parents and misrepresented that they were the
personal owners of the dogs. They confirmed that they were unable to
verify the vaccination history or health status of the dogs they were
transporting. Many had just met the dogs for the first time at the
airport on the day the flight departed. In 2017, a dog with rabies was
imported by a flight parent who was bitten during the flight and could
not attest to the legitimacy of the dog's rabies vaccination
paperwork.\150\ CDC suspected the paperwork was falsified because the
dog developed rabies and died.
---------------------------------------------------------------------------

\150\ 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.
---------------------------------------------------------------------------

False claims of ownership raise public health concerns because the
importer does not know the true health history of the dog and cannot
accurately attest to their vaccination status and rabies exposure
history. This creates an increased risk of a rabid dog being imported
and these fraudulent claims also place importers at risk of exposure to
rabies and other zoonotic diseases of concern. Applying standardized
importation requirements for dogs based on their vaccination status and
recent presence in a high-risk country grounds the rule's requirements
in the factors that actually determine DMRVV risk, helps ensure dogs
are adequately protected against rabies, and minimizes the risk of
human exposure to rabies. Additionally, creating different importation
requirements for pets and rescue dogs could also create confusion and
increase the regulatory burden for airlines and the transportation
industry who would be responsible for documenting and ensuring that the
importer is not misrepresenting the purpose of the import.
Differentiating importation requirements based on the type of
importer has also proven impracticable based on CDC's recent experience

[[Page 41761]]

implementing the temporary suspension on importation of dogs from DMRVV
high-risk countries. On June 16, 2021, HHS/CDC announced that temporary
suspension to protect the public's health. Through the temporary
suspension, CDC implemented requirements for importers of dogs from
DMRVV high-risk countries. 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 to alleviate the
potential burden of the temporary suspension for these categories of
importers.
On June 10, 2022, HHS/CDC modified the temporary suspension to
allow commercial importations of dogs from DMRVV high-risk countries
through ACF. On July 10, 2023, HHS/CDC extended the temporary
suspension without modifications through July 31, 2024, 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.
During the period of the temporary suspension, HHS/CDC attempted to
differentiate between personal pets and commercial dog imports and
received hundreds of applications from commercial importers claiming to
be importing dogs as personal pets. Although CDC was able to identify
some of these cases and revoke dog import permits for ineligible
importers, doing so was difficult and required extensive communication
between CDC and other port partners such as CBP and USDA. As this
experience shows, the stronger approach provided for in this final rule
is to tailor importation requirements based on factors with a
relationship to DMRVV risk, namely the country of origin and the dog's
vaccination status (U.S.-versus foreign-vaccinated), as opposed to the
category of importer (e.g., commercial importer) or type of dog (e.g.,
personal pet). Further, this approach conserves Federal agency
resources that would otherwise be used in investigating and responding
to potential instances of fraud.
In sum, basing importation requirements on a dog's vaccination
status and its potential exposure to DMRVV (i.e., whether it has been
recently been in a high-risk DMRVV country) is the best way to evaluate
the DMRVV risk of an imported dog; basing requirements on the purpose
of the importation, occupation or nationality of the importer, or the
breed or working status of the dog would be an ineffective means for
evaluating DMRVV risk, would increase incentives for fraud in the ways
mentioned above, and be difficult to implement. Because HHS/CDC is not
basing importation requirements on the type of importer, there is no
reason for the final rule to define specific categories of importer
(e.g., pet owner, rescue organization, commercial importer).
Comment: HHS/CDC received over 400 comments from U.S. Government
(USG) employees and members of the U.S. military objecting to the
proposed rule. Some of these commenters stated that these groups should
be given special exemption to import dogs without meeting some or all
of the proposed requirements. Other commenters stated that they
believed that the proposed rule was specifically targeting USG
employees. Some of these commenters asserted that the proposed rule is
unnecessary because USG employees and military members are less likely
to commit fraud and purportedly provide a higher standard of care for
their dogs when compared to other dog owners, thereby negating the
rabies risk. Commenters noted potential financial burdens and hardships
when having to route through ports with ACF or having to pay for
titers.
Response: HHS/CDC disagrees that USG employees and members of the
U.S. military should be exempt from any or all importation
requirements. CDC has no data to support the proposition that dogs
owned by USG employees or members of the U.S. military are better cared
for than other dogs or that individuals in these groups are less likely
to attempt to import dogs with falsified documents or fraudulent or
insufficient titers. CDC has documented multiple instances of falsified
documents, including intentionally altered import permits, forged titer
results, and falsified rabies vaccination records, submitted by U.S.
government employees and military service members both during and prior
to CDC's temporary suspension of dogs entering the United States from
high-risk countries. CDC reported violations to the USDA, the
Department of Defense, and the State Department for internal
investigation. Additionally, CDC has documented numerous reports of
U.S. government employees, including military service members, adopting
stray dogs while stationed overseas. CDC supports the human-animal bond
and recognizes the important role these animals play in the lives of
government employees and service members stationed overseas; however,
the employment status of the importer does not affect the dog's
potential risk of carrying DMRVV. Adopted stray dogs often have unknown
rabies exposure history, have received little or no veterinary care or
vaccines, and can present a risk of DMRVV just like any other dog that
has been in a high-risk country with an unconfirmed vaccination status.
Vaccination, titer, and quarantine requirements are essential to
protect USG employees, service members, and their families as well as
the U.S. communities these dogs are being introduced into when they
arrive in the United States. Furthermore, HHS/CDC strongly disagrees
that this final rule specifically targets USG employees. This rule
bases its importation requirements on the risk profile of the dog's
country of origin and the dog's vaccination status (U.S.-versus
foreign-vaccinated), and not the type of importer. It imposes no
additional requirements on USG employees or members of the U.S.
military compared to any other importers. Finally, the State Department
has made relocation funds available to U.S. government staff for
quarantine fees or titer services. Additionally, there are CDC-approved
laboratories providing discounted services for USG employees. In sum,
the risk of DMRVV importation is best determined based on a dog's
vaccination status and its recent presence in a DMRVV high-risk country
rather than the employer of the importer. Thus HHS/CDC declines to
create a specific exemption for USG employees and military members.
Comment: HHS/CDC received comments noting that USG employees,
members of the U.S. military, U.S. citizens, and U.S. permanent
residents often need to return to the United States quickly with their
families when an unexpected crisis develops in a foreign country, and
that exemptions should be provided in these instances. Some comments
said exceptions should be made or requirements should be different for
emergency situations without specifying a category of importer that
should be exempted.
Response: HHS/CDC recognizes that USG employees, members of the
U.S. military, U.S. citizens, and U.S. permanent residents often need
to return to the United States quickly with their families when an
unexpected crisis develops in a foreign country. In these scenarios,
CDC works closely with the U.S. State Department on a case-by-case
basis regarding emergency departures from foreign countries. CDC has
assisted the U.S. State Department with more than ten evacuations
during the

[[Page 41762]]

temporary suspension, including evacuations of USG staff from Ukraine,
Ethiopia, Nigeria, Haiti, and China, and has ensured foreign services
officers were able to evacuate safely with their pet dogs. However,
HHS/CDC declines to create a specific exemption under these
circumstances because dogs from high-risk rabies countries continue to
present a potential DMRVV importation risk regardless of whether
imported in emergent or non-emergent circumstances. HHS/CDC plans to
continue to support importers during emergency situations by assisting
them in making reservations at ACF and educating importers about the
importance of maintaining their dog's current rabies vaccination.
Potential importers of foreign-vaccinated dogs from DMRVV high-risk
countries should also always maintain a valid rabies titer for their
dogs from a CDC-approved laboratory in the event of an unplanned
emergency. Additionally, HHS/CDC is reducing the burden on importers to
maintain a valid titer from a CDC-approved laboratory by reducing the
frequency with which titers must be drawn and tested compared to the
annual titer requirement during the temporary suspension, which will
assist importers in the event of an emergency (see CDC technical
instructions available at www.cdc.gov/dogtravel). Given the
demonstrated and close effective working relationship between CDC and
the U.S. Department of State, CDC does not believe a specific exemption
for emergencies is necessary in the final rule.
Comment: HHS/CDC received five individual comments and one form
letter from an organization representing foreign service officers
stating that the proposed requirements in the NPRM on government
employees with dogs would result in U.S. employees retiring from public
service or would cause them to avoid working in DMRVV high-risk
countries.
Response: HHS/CDC appreciates these comments but believes the
updated regulation is necessary to protect the public's health and to
prevent 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. HHS/CDC is addressing the various risks
associated with the importation of dogs observed in recent years by
establishing a regulatory framework based on the documented successes
of the temporary suspension. In addition, the requirements and
standards in the rule will help ensure the health and safety of the
public while also protecting animal health and preventing the
reintroduction of DMRVV into the United States.
HHS/CDC is easing the burden on all importers, including USG
employees, by relaxing the entry requirements for U.S.-vaccinated dogs
so they may enter through any U.S. port if they meet the criteria
outlined in Sec. 71.51(t) of the final rule. HHS/CDC is also revising
the titer requirements for foreign-vaccinated dogs to reduce both the
waiting period before entry into the United States, and the frequency
with which titers must be collected.
Further, HHS/CDC's requirements remain less burdensome when
compared to WOAH standards that are widely used in other rabies-free
countries. As noted above, HHS/CDC carefully considered the WOAH
standards when drafting the final rule, consulting with rabies subject
matter experts and reviewing peer-reviewed literature. Based on these
considerations and experience during the temporary suspension, HHS/CDC
eased requirements on importers, including USG employees, relative to
WOAH standards in several key areas, including but not limited to: (1)
applying requirements only to dogs; (2) not requiring examination the
day before travel; (3) not requiring use of vaccines manufactured in
accordance with the WOAH Terrestrial Manual; (4) not requiring a six-
month quarantine prior to shipping an animal without a titer; and (5)
requiring only a 28-day quarantine rather than six months. The approach
in this final rule represents an appropriate balance between
flexibility for importers while protecting against importation of DMRVV
from high-risk countries.
Additionally, HHS/CDC's requirements remain less burdensome when
compared to other countries, such as European Union member states and
Australia, that have strengthened their importation requirements for
the international movement of dogs (even for animals merely transiting
through such countries). The increased challenges that some government
employees may face when stationed abroad reflect an international
effort to reduce the spread of foreign animal diseases associated with
the movement of animals and are not solely a result of this final rule.
Comment: HHS/CDC received a comment that USG-owned dogs (as
distinguished from dogs owned by USG employees) should be exempt from
HHS/CDC entry requirements.
Response: An exemption for USG-owned dogs is unnecessary because
based on CDC's discussions with USG agencies that utilize government-
owned working dogs the dogs owned by the USG are all over six months of
age, are microchipped, and maintain a current and valid U.S. rabies
vaccination prior to deployments. HHS/CDC does not consider the final
rule to be overly burdensome in this regard such than any form of
exemption is needed.
Comment: HHS/CDC received a comment stating that dogs imported for
research purposes should be exempt from entry requirements.
Response: HHS/CDC has determined that a research exemption is not
necessary given the infrequency with which dogs are imported for
research purposes from DMRVV high-risk countries. For instance, in the
past five years, CDC has not received any requests to import dogs for
research purposes. Furthermore, during the more recent period of the
temporary suspension, CDC has not documented any dogs imported for
research from DMRVV high-risk countries. The final rule allows for the
importation of unvaccinated dogs from DMRVV-free or DMRVV low-risk
countries if the dogs have been only in those countries during the six
months before arriving in the United States. Therefore, importers
seeking to import unvaccinated dogs for research purposes may do so
from DMRVV-free or DMRVV low-risk countries. Thus, considering the
infrequency with which dogs are imported for research purposes and the
availability of dogs from DMRVV-free or DMRVV low-risk countries that
can be used for research, HHS/CDC does not believe an exemption for
individuals seeking to import dogs for research purposes is needed.
Comment: HHS/CDC received comments that the rule may be detrimental
to animal welfare and inhibit rescue organizations' ability to import
dogs.
Response: While HHS/CDC acknowledges that the final rule will
result in additional requirements for some rescue groups to operate
from high-risk countries, these difficulties do not outweigh the
benefits to U.S. public health. HHS/CDC believes that, in

[[Page 41763]]

addition to protecting public health, the rule will likely better
ensure the health of dogs prior to their release into the United
States. This helps protect the domestic dog and animal populations, as
well as people, from communicable diseases that imported dogs may carry
and spread into U.S. communities. There is no clear reason why dogs
imported by rescue organizations would be at a lower risk of DMRVV than
other dogs from high-risk rabies country. Nothing in the rule prevents
rescue dogs from being imported if they meet entry requirements. HHS/
CDC further notes that commercial importers and rescue groups were
adept at responding to changes in import requirements established
during the period of the temporary suspension and that this rule adopts
many of those same practices. Accordingly, HHS/CDC believes an
exemption is not required.
Comment: HHS/CDC received comments that the proposed requirements
for individual pet owners were excessive because there have been few
rabid dog importations, and these were all from animal rescue
organizations, and that personal pets should be exempt from the
importation requirements.
Response: Although the final rule is more burdensome for
individuals importing dogs as pets when compared to the current
regulation, HHS/CDC believes it is less burdensome when compared to dog
importation standards among other WOAH member countries. As more
countries have strengthened their importation requirements for the
international movement of dogs, the requirements in HHS/CDC's final
rule remain less cumbersome than what other countries, such as European
Union member states, Australia and New Zealand, require for the
movement of animals, including for animals merely transiting through
such countries. The increased challenges that some pet owners may face
when traveling abroad reflects an international effort to reduce the
spread of foreign animal diseases associated with the movement of
animals and are not solely a result of this final rule.
Further and as noted above, although recent rabid dog importations
have been associated with rescue groups, HHS/CDC has determined that
the public health risk from dog imports is based primarily on the dog's
country of origin and vaccination status (U.S.- vs. foreign-
vaccinated), and not the type of importer. HHS/CDC further notes that
attempting to distinguish between pet owners and rescue groups would be
difficult to enforce and creates opportunities for fraud. In CDC's
experience, as noted above, it is not unusual for importers to
misrepresent the reasons why dogs are being imported. As noted above
there has been an increase in fraudulent importations and importers
misrepresenting that they were the personal owners of the dogs. Such an
increase in importers misrepresenting the purpose for which dogs are
being imported could increase the risk of a rabid dog being imported
and also place importers at risk of exposure to rabies and other
zoonotic diseases of concern.
Applying standardized importation requirements for all dogs
regardless for the reasons why dogs are being imported (i.e., rescue,
resale, personal pet) helps minimize the risk of human exposure to
rabies and ensure dogs are adequately protected against rabies.
Therefore, HHS/CDC has decided to apply the rule's requirements equally
to all importers to ensure imported dogs do not present a public health
risk.

D. Comments on Specific Provisions of the Proposed Rule

Definitions
Comment: HHS/CDC received specific comments on the following
sections and paragraphs of the proposed rule.
Section 71.50
Paragraph (a)--Definitions.
HHS/CDC received comments on the following definitions:
Authorized Veterinarian
Comment: HHS/CDC received a comment requesting that CDC ``define
the term `Authorized Veterinarian' in order to establish a single
documentation standard all carriers can follow.''
Response: HHS/CDC has finalized the definition for authorized
veterinarian that was proposed in the NPRM with minor modifications for
clarification. Per the final rule, authorized veterinarian means an
individual who has an advance degree relevant to the practice of
veterinary medicine, has a valid license or accreditation, and is
authorized to practice animal medicine in the exporting country.
DMRVV Low-Risk Countries
Comment: HHS/CDC received a comment that instead of using the terms
``low-risk countries'' or ``rabies-free countries'' it should use the
terms ``countries free of canine rabies'' and ``countries with low risk
of canine rabies.''
Response: HHS/CDC appreciates this comment but declines to
incorporate the suggested changes. HHS/CDC notes that the commenter's
concerns relate solely to grammar and the commenter has proposed terms
conveying the same meaning as those used in the proposed rule. HHS/CDC
has chosen the terms DMRVV-free and DMRVV low-risk because HHS/CDC
believes these terms are easy to use and likely to be understood by
stakeholders.
Importer
Comment: HHS/CDC received comments to define and clarify the term
``flight parent.''
Response: In the proposed rule, HHS/CDC did not include a
definition for ``flight parent'' but used this term in the preamble to
describe a person that transports one or more dogs for the purpose of
resale, adoption, or transfer of ownership. The flight parent may be
compensated (e.g., provided with a complimentary airplane ticket,
baggage fees, or other paid fee) for the transport of the animal or
agree to transport the animal as an uncompensated volunteer. CDC added
a definition for ``flight parent'' to the final rule. Per this final
rule, if required by CBP or USDA, flight parents transporting animals
must have a valid license or registration to transport animals.
Comment: HHS/CDC received a comment stating that friends and family
who transport dogs belonging to USG employees should be excepted from
the definition of flight parent.
Response: HHS/CDC reiterates that flight parents are limited to
those individuals transporting one or more dogs for purposes of resale,
adoption, or transfer of ownership. If a friend or family member is
transporting a dog for purposes of returning the dog to its owner, who
was previously in physical possession of the dog, then the friend or
family member would not be considered a flight parent. Alternatively,
if the dog's owner in the United States merely purchased a dog from
another owner or breeder in a foreign country and never previously
physically possessed the animal, then the individual transporting the
dog would be considered a flight parent regardless of their
relationship to the U.S. owner.
Official Government Veterinarian
Comment: HHS/CDC received questions about how HHS/CDC defines a
government veterinarian.
Response: HHS/CDC's definition of an official government
veterinarian is outlined in 71.50 and states it is ``a veterinarian who
performs work on behalf of an exporting country's government and can
verify the license or credentials of an Authorized Veterinarian.''

[[Page 41764]]

Forms
Comment: HHS/CDC received comments on the definitions of CDC Import
Certification of Rabies Vaccination and Microchip Required for Live Dog
Importations into the United States and Certification of U.S.-issued
Rabies Vaccination for Live Dog Re-entry into the United States.
Response: These comments are addressed below in our replies to
paragraph (s) and paragraph (t). HHS/CDC notes that it has shortened
the names of these forms in the final rule to Certification of Rabies
Vaccination and Microchip and Certification of U.S.-issued Rabies
Vaccination, respectively.
Importation
Comment: HHS/CDC received a comment that HHS/CDC ``needs to better
define what conditions they are considering when they are talking about
`importation' and what activity they are trying to regulate.'' The
comment stated that U.S. government personnel bringing a pet dog or cat
back to the United States are not ``importing'' an animal.
Response: HHS/CDC welcomes the opportunity to further explain what
it means by ``importation'' but disagrees that individuals, including
U.S. government personnel, bringing dogs or cats into the United States
from foreign countries are not ``importing'' an animal just because the
animal is returning to the United States from a foreign country. HHS/
CDC considers an importation to occur whenever a dog or cat is entering
the United States from a foreign country, regardless of whether the
animal was in the United States previously and is seeking to reenter
the United States. Through this final rule, HHS/CDC is seeking to
regulate the importation of dogs and cats into the United States.
Although HHS/CDC acknowledges that pets may have emotional value to
their owners, animals are considered to be ``goods'' (i.e., merchandise
or property that can be moved) that are imported into the United States
if arriving from foreign countries. Per the definition for importer in
this final rule, importer 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 CBP or a flight parent. If required by USDA or CBP, an individual
transporting an animal on behalf of an importer, including a flight
parent must possess all required Federal licenses or registrations to
transport animals.'' U.S. government personnel bringing dogs or cats
into the United States from foreign countries would be included under
this definition of ``importer.''
HHS/CDC did not receive comments on the following definitions
proposed for 42 CFR 70.50: cat, dog, histopathology, in-transit
shipment, microchip, and necropsy.
HHS/CDC also did not receive comments on the following definitions
proposed for 42 CFR 71.51: animal, CDC-registered animal care facility,
CDC Dog Import Form, conditional release, DMRVV, DMRVV-restricted
countries, SAFE TraQ, serologic testing, USDA-accredited veterinarian,
or USDA official veterinarian.
Sections 71.51
Paragraphs (b)--Authorized U.S. airports for dogs and cats and
(c)--Authorized U.S. land ports for dogs and cats.;
Comment: HHS/CDC received several comments regarding permissible
ports of entry. Some commenters opposed any restrictions on ports of
entry for any dog being imported into the United States. Other
commenters opposed restrictions only for U.S-vaccinated dogs,
suggesting that these dogs should be able to enter through any U.S.
port and/or be able to enter at U.S. land ports. Some comments
suggested that entry be allowed for all personal pets at U.S. ports
with CDC quarantine stations. Some comments suggested that entry be
allowed at all U.S. ports for all dogs, at all U.S. ports for U.S.-
vaccinated dogs, for all personal pets at ports with CDC quarantine
stations, and for dogs from DMRVV high-risk countries at land-borders.
HHS/CDC also received comments acknowledging the need to limit the
number of authorized ports to reduce fraud and provide greater
government oversight to adequately regulate dog imports from DMRVV
high-risk countries and inspect shipments of dogs on arrival.
Response: HHS/CDC disagrees with comments suggesting that there
should be no restrictions on ports of entry for any dogs entering the
United States from foreign countries. The port of entry requirements
proposed in the NPRM and finalized through this rulemaking safeguard
the public's health by ensuring that adequate staff and facilities are
available to provide care for and evaluate foreign-vaccinated dogs from
DMRVV high-risk countries for rabies and other diseases that may pose a
public health risk. CDC has documented previous instances of dogs not
meeting CDC requirements that arrived at U.S. ports that lack adequate
facilities to care for and house abandoned dogs or dogs denied entry
into the United States. In other instances, adequate housing facilities
and care were arranged only with great difficulty, which potentially
endangers the health of both dogs and animal handlers. The port of
entry requirements are further designed to reduce the burden on
airlines, CBP, state/local health departments, and the local veterinary
community by ensuring foreign-vaccinated dogs from DMRVV high-risk
countries arrive only at a U.S port with an ACF.
However, based on comments received and its review of available
data, HHS/CDC has revised the requirements proposed in the NPRM
regarding imports of U.S.-vaccinated dogs. CDC has a high degree of
confidence in the safety and effectiveness of USDA-licensed rabies
vaccines administered by U.S. veterinarians within the United States.
Therefore, HHS/CDC is revising its proposal to allow dogs from DMRVV
high-risk countries that are at least six months old, microchipped, and
have a valid Certification of U.S.-issued Rabies Vaccination form and a
CDC Dog Import Form receipt to re-enter the United States through any
U.S. port (by air, land, or sea).
Comment: HHS/CDC received comments that there are too few U.S.
ports with ACF for foreign-vaccinated dogs to enter the U.S.
Response: HHS/CDC believes there is an adequate number of ACF
currently available for the volume of foreign-vaccinated dog
importations into the United States (less than 1% of dogs imported into
the United States require quarantine). CDC recognizes that more ACFs
would further reduce the burden on travelers, and is working to expand
the network of ACF to provide importers with greater flexibility for
ports of arrival. ACF are able to receive, examine, vaccinate and
release dogs within 1 business day of arrival, most of which are
cleared the same day they arrive. Additional ACF would provide
importers additional travel flexibility for ports of arrival, and CDC
is dedicated to expanding the number of available ACF. CDC worked with
USDA, CBP, and local businesses to identify and approve five ACF in
2021 and 2022 as part of the strategic shift towards safer importation
controls. HHS/CDC notes that since the publication of the NPRM, it has
registered two additional ACF at Los Angeles International Airport and
Philadelphia International Airport. As of April 1, 2024, there are
seven CDC-registered ACF with a USDA intermediate handlers registration
and a FIRMS code issued by CBP. The facilities are located at Atlanta

[[Page 41765]]

Hartsfield-Jackson International Airport, John F. Kennedy International
Airport (New York), Los Angeles International Airport (2), Miami
International Airport, Philadelphia International Airport, and
Washington Dulles International Airport (Washington DC Metropolitan
Area). The registration of new ACF at additional ports continues to be
a priority for HHS/CDC.
Comment: Commenters noted travel with animals in cargo into certain
ports of entry can be restricted during times of the year due to
extreme temperatures.
Response: HHS/CDC acknowledges that some airlines may restrict dogs
flying as cargo into certain ports during different times of the year
but notes that this is an airline requirement put in place for the
protection and safety of animals and is not a function of this
rulemaking process. Transportation restrictions due to extreme
temperatures is a component of the Animal Welfare Act which is enforced
by USDA APHIS Animal Care. However, HHS/CDC acknowledges that
international travel is stressful for animals and can result in illness
and death in young or old animals, specialty breeds (i.e., snub-nosed
breeds, hairless breeds, etc.), or those with pre-existing medical
conditions that cannot compensate for the stresses they undergo during
travel, including extreme temperatures. Therefore, HHS/CDC defers to
USDA APHIS AC to determine appropriate regulatory requirements for the
movement of animals during extreme weather conditions and encourages
all air carriers to comply with USDA APHIS AC standards.
Comment: Commenters recommended that HHS/CDC seek greater
uniformity among U.S. ports handling dog imports. It was noted that
each U.S. port has their own procedure, often with their own ``job
aid'' document requirements, which can be unhelpful and lead to
unnecessary confusion. It was suggested by a commenter that HHS/CDC's
requirements should supersede and preclude duplicate data requirements
or job aids at U.S. ports.
Response: HHS/CDC appreciates this comment but notes that several
Federal agencies have authority over operations at U.S. ports and CDC
does not establish procedures for how those agencies conduct their own
operations. However, HHS/CDC does work closely with port partners to
develop and disseminate standardized documents (e.g., job aids,
trainings, presentations) to promote consistency between ports and will
continue to do so as the final rule is implemented. For example, during
the temporary suspension, CDC worked closely with CBP and airlines to
disseminate standardized job aids nationwide to streamline importation
operations at the ports.
Paragraph (e)--Limitation on U.S. ports for dogs and cats.
HHS/CDC received no public comment on this provision of the rule.
Paragraph (f)--Age requirement for all dogs.
Comment: HHS/CDC received comments in support of the six-month age
requirement from individuals concerned about animal welfare and from
public health and animal health organizations and agencies. HHS/CDC
also received numerous comments opposing the six-month age requirement
for dogs as too high. Commenters, including representatives of the
airline industry, breeders, breed enthusiasts, and trade groups, stated
that dogs should be allowed entry at either 12 weeks of age (the
earliest age at which dogs can be vaccinated against rabies), or 16
weeks of age (the earliest age at which the vaccine is considered
effective), or at any age (if arriving from a DMRVV low-risk or DMRVV-
free country).
Response: HHS/CDC agrees that establishing a six-month age
requirement for all dogs will assist in protecting public health while
simultaneously improving safety and welfare benefits for young animals
subjected to stressful travel environments in which their health could
be compromised.
HHS/CDC disagrees, however, with comments suggesting that dogs
should be admitted into the United States if under six months of age.
The purpose of an age requirement in the context of dogs arriving from
DMRVV high-risk countries is to ensure (1) that imported dogs are old
enough to be vaccinated for rabies; (2) that the vaccination has time
to be effective and confer immunity on the dog; (3) that protection is
verifiable; and (4) that there is an appropriate waiting period after
drawing the titer to ensure the dog does not develop symptoms of
rabies. In short, it is not sufficient that a dog be old enough to be
vaccinated; there must be sufficient time for immunity to develop, and
authorities must be able to verify the immunity. CDC has also
documented cases of importers moving dogs too young to be vaccinated
effectively from DMRVV high-risk countries to DMRVV-free or DMRVV low-
risk countries to avoid rabies vaccination requirements. Therefore, CDC
is also requiring that dogs from DMRVV-free or DMRVV low-risk countries
be at least six months old to prevent importers from trying to
circumvent CDC's requirements by moving dogs from DMRVV high-risk
countries through DMRVV-free or DMRVV low-risk countries.
The WOAH established vaccine and titer standards set seven-months
as the minimum age for importation of dogs from DMRVV high-risk
countries.\151\ Countries following WOAH standards do not allow entry
of dogs younger than seven months old if following vaccine and titer
timeline recommendations. Many rabies vaccines are licensed for use in
dogs on or after 12 weeks of age and laboratories suggest titer
collection occur 30 days after initial rabies vaccination. WOAH's
standards call for importation to occur a minimum of 90 days after
titer collection (i.e., earliest age for importation is seven months of
age).
---------------------------------------------------------------------------

\151\ WOAH Terrestrial Manual 2023, chapters 3.1.18 and 8.15.7.
---------------------------------------------------------------------------

The final rule departs from the WOAH standard to provide additional
flexibility and less burden to importers without compromising public
health goals. HHS/CDC agrees that vaccine administration must follow
manufacturer's guidelines (i.e., with vaccination occurring on or after
12 weeks of age) and a 30-day period between vaccination and titer
collection is essential to ensure the animal has developed an adequate
antibody response to vaccination. However, based on available
scientific evidence,\152\ HHS/CDC concluded that a 30-day waiting
period (rather than WOAH's 90-day waiting period) between titer
collection and travel is sufficient for monitoring the dog to ensure it
does not develop signs of rabies.
---------------------------------------------------------------------------

\152\ Smith TG, Fooks AR, Moore SM, Freuling CM, Muller T, et
al. Negligible risk of rabies importation in dogs thirty days after
demonstration of adequate serum antibody titer. Vaccine 2021; 39
(18): 2496-2499.
---------------------------------------------------------------------------

HHS/CDC is also establishing a six-month age requirement for all
dogs because it can be difficult for veterinarians to determine with
specificity whether a dog has reached the age at which it can be fully
protected by the rabies vaccine before six months of age. Veterinarians
rely on dental patterns to age dogs. However, it is difficult to
accurately assess the age of dogs that are between four and six months
old due to variability in an individual dog's dental eruption patterns
(loss of baby teeth).\153\ Dogs lose all their deciduous (baby) teeth
by six months of age making it easier to accurately assess the age of a
dog. CDC has documented over 1000 cases of

[[Page 41766]]

importers providing vaccine records that falsely stated the dog was
over six months of age, but upon examination, the dog presented was
much younger (often 6-8 weeks of age). Because the rabies vaccine is
not considered effective in dogs under 12 weeks of age these puppies
were not protected against rabies and presented a threat to the
families that purchased or adopted them. By requiring all dogs to be at
least six months of age, CDC can better confirm that the dog presented
matches the documentation presented, particularly the age listed for
the dog, and that the dog is old enough to have been adequately
vaccinated for rabies.
---------------------------------------------------------------------------

\153\ Roccaro, M., & Peli, A. (2020). Age determination in dog
puppies by teeth examination: legal, health and welfare
implications, review of the literature and practical considerations.
Veterinaria Italiana, 56(3), 149-162. https://doi.org/10.12834/VetIt.1876.9968.2.
---------------------------------------------------------------------------

The six-month requirement for all dogs also aligns with USDA
importation rules, eases enforcement of the vaccination requirements,
and reduces opportunities for fraud. USDA requires dogs imported for
commercial purposes (e.g., resale, rescue, or adoption) to be at least
six months of age. Aligning with USDA requirements for commercial dog
imports will help minimize confusion among travelers importing dogs
from outside the United States, and among airlines and port partners
that enforce HHS/CDC and USDA entry requirements for dogs.
Setting the minimum age for importation below six months would
undermine the ability of authorities to ensure dogs are fully,
effectively, and verifiably vaccinated. A 12- or 16-week age
requirement for importation would require potentially compromising the
full 28-day development of immunity and/or risk importation of a rabid
dog because screening fully for signs of rabies was not done. Screening
for rabies can be difficult in puppies because they can often exhibit
dyskinetic or uncoordinated movement as part of their normal growth and
development. These awkward movements can also be seen in rabid dogs and
may be mistaken in young puppies for normal movement patterns. Contrary
to some common misconceptions, puppies are susceptible to rabies and
rabies has been diagnosed in young puppies. For these reasons, the
final rule sets six months as the appropriate minimum age for dog
importation.
Comment: HHS/CDC received comments opposing its proposal to allow
importers to import up to three dogs under the age of six months if
arriving into the United States from Mexico or Canada, contending that
the requirements between land and air should be the same. Some
commenters also opposed any limit on the number of dogs under six
months of age that an importer could import through U.S. land ports.
Specifically, HHS/CDC received a comment from the airline industry
stating that requiring a six-month age limit for all dogs arriving by
air, but not for all dogs arriving by land, was neither fair nor
equitable. Additionally, commenters noted that allowing dogs under six
months of age at the land border potentially created a loophole for
importers from DMRVV high-risk countries to exploit.
Response: HHS/CDC agrees that dogs should be subject to the same
age requirement regardless of whether arriving by air, land, or sea.
Furthermore, HHS/CDC also agrees that allowing some dogs under six
months of age to arrive via the land border potentially creates a
loophole for unscrupulous importers to exploit. CDC and CBP have
documented numerous instances in which importers transported dogs from
a DMRVV high-risk country to Mexico (a DMRVV-free country) and who then
made claims that their dogs had not been in a DMRVV high-risk country.
CDC worked with CBP and airlines and were able to confirm the importers
had traveled with the dogs from a DMRVV high-risk country and were
attempting to avoid U.S. entry requirements. If CDC were to allow dogs
under six months of age to enter via land border crossings, CBP and CDC
believe this could create a significant burden on CBP officers at U.S.-
Mexico border crossings as more importers would attempt to enter the
United States through a land border crossing. This could potentially
lead to dogs from DMRVV high-risk countries arriving in the United
States via land borders to circumvent HHS/CDC entry requirements. Given
that CDC has no ACF at land border crossings this creates a potentially
dangerous situation for dogs that must be held pending determination of
their admissibility since neither CBP nor CDC have safe housing options
at land ports of entry.
HHS/CDC originally proposed a limited exemption for dogs under six
months old primarily to reduce the burden on U.S. travelers who
frequently travel across the U.S. and Canada/Mexico borders and choose
to travel with young dogs. Although data suggests more dogs enter the
United States by air each year, extrapolated data from 2006 estimated
that 287,000 dogs entered the United States through land border
crossings that year.\154\ CDC does not have recent data to confirm the
volume of dogs crossing at land borders, but unofficial statements from
CBP officers stationed at U.S.-Mexico land border crossings suggest the
volume remains high. However, upon further consideration and careful
evaluation of the comments received, HHS/CDC has removed the exemption
proposed in the NPRM to create a uniform standard for all dogs, ensure
U.S.-land borders are not overwhelmed with dog importations, and reduce
the risk of importers fraudulently claiming that their dog has not been
in DMRVV high-risk country.
---------------------------------------------------------------------------

\154\ McQuiston JH, Wilson T, Harris S, Bacon RM, Shapiro S, et
al. Importation of dogs into the United States: risks from rabies
and other zoonotic diseases. Zoonoses and Public Health; 2008: 1-6.
---------------------------------------------------------------------------

HHS/CDC has documented many instances of young dogs under six
months of age being routed from DMRVV high-risk countries through
DMRVV-free countries, such as Canada or Mexico, to circumvent U.S.
entry requirements. To prevent this type of fraud, HHS/CDC believes
there is reasonable need to require a standardized age for all dogs,
regardless of the purported country of origin or port of entry.
Accordingly, HHS/CDC has removed from the final rule the exemption at
land borders proposed in the NPRM for an importer to import up to three
dogs under six months of age through Canada or Mexico via a U.S. land
port if the dog has not been in a DMRVV high-risk country or DMRVV-
restricted country since birth.
Comment: There were also comments that a six-month minimum age
requirement for all imported dogs could lead to the decline of
specialty breeds. Commenters stated that breeders in other countries
would not want to house and care for dogs bred for resale for six
months due to increased cost. Additional commenters said dogs need to
be socialized with their owner prior to six months of age.
Response: HHS/CDC disagrees with these comments. First, USDA
prohibits the importation of dogs under six-months of age for
commercial purposes, which includes any transfer of ownership;
therefore, the comment that breeders need to be able to import dogs
under six months of age is invalid because it is already prohibited.
CDC's age requirement is aligning with a currently existing regulatory
requirement from a partner Federal agency. CDC's requirement is not new
and therefore, there is no new or additional burden on commercial dog
importations (i.e., dogs imported for rescue, resale, or transfer of
ownership). Additionally, CDC notes that a six-month age requirement
aligns more closely with WOAH requirements for the international
movement of dogs and that 67% of DMRVV-free countries require dogs to
be at least six months of

[[Page 41767]]

age for importation.\155\ Furthermore, because dogs under six months of
age are sexually immature and cannot be used for breeding, delaying
their importation will not negatively impact their use as breeding
animals.
---------------------------------------------------------------------------

\155\ Internal CDC data. Accessed January 30, 2024.
---------------------------------------------------------------------------

Second, although the primary public health reason for requiring a
six-month age limitation for importation has been described above, HHS/
CDC notes that socialization of puppies may be done overseas at the
breeding facility or another overseas location such as a kennel or
foster family prior to the dogs arriving in the United States.
Additionally, the rule will likely better ensure the health of dogs
during international travel to the United States, which is stressful
for young animals and can result in illness and death. As noted above,
the six-month age requirement for importation helps protect the health
and safety of all dogs. HHS/CDC further notes that breeders and
commercial importers effectively adapted to changing import
requirements during the temporary suspension and that this rule adopts
many of those same practices.
HHS/CDC further notes that separating puppies from the mother and
littermates when they are too young may adversely impact dogs' behavior
and socialization.^{156 157} In HHS/CDC's view, separating the
puppies from their mothers and littermates has the potential to affect
their social and mental development greatly and negatively. In HHS/
CDC's view, this risk outweighs the possible associated costs. HHS/CDC
has also documented hundreds of cases where puppies under eight weeks
of age (who are not yet protected against rabies due to their age) have
been imported for resale. Although HHS/CDC acknowledges that some
overseas breeders may choose to change their operations based on HHS/
CDC's dog import requirements, HHS/CDC believes that the public health
benefits of this change outweigh the theoretical possibility of some
specialty breeders choosing to import fewer dogs into the United
States.
---------------------------------------------------------------------------

\156\ McMillan FD. Behavioral and psychological outcomes for
dogs sold as puppies through pet stores and/or born in commercial
breeding establishments: Current knowledge and putative causes.
Journal of Veterinary Behavior. 2017; 19: 14-26.
\157\ Pierantoni L, Albertini M, Pirrone F. Prevalence of owner-
reported behaviors in dogs separated from the litter at two
different ages. Vet Record. 2011; 169: 468.
---------------------------------------------------------------------------

Comment: HHS/CDC received comments that there should be exemptions
for service dogs under six months of age or that HHS/CDC should create
an accreditation system for service dogs.
Response: HHS/CDC disagrees with these commenters. To be considered
a valid service dog, a dog needs to meet the definition of a ``service
animal'' under 14 CFR 382.3 and be accompanied by an ``individual with
a disability'' as defined under 14 CFR 382.3. Most dogs under six
months of age are not yet capable of being trained to work or perform
tasks directly related to an individual's disability. Therefore, it is
HHS/CDC's determination that the requirement for dogs to be at least
six months of age is unlikely to impact importers with service dogs.
Additionally, it is not operationally feasible for CDC to provide
certification or accreditation of service dogs.
Paragraph (g)--Microchip requirements for all dogs.
Comment: HHS/CDC received comments that microchips are too
expensive and that microchips may be difficult to obtain in some low-
income countries. Some USG employees also opined that their dogs should
be exempt from microchip requirements.
Response: HHS/CDC disagrees with these comments. HHS/CDC notes that
microchips are already used and available globally for the
international movement of animals. Microchips are required by 86% of
DMRVV-free countries for the importation of dogs from DMRVV high-risk
countries and microchips are a WOAH standard for the international
movement of animals.\158\ Microchips are recommended by WOAH, 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.\159\ HHS/
CDC's rule aligns the United States with international standards and
practice.
---------------------------------------------------------------------------

\158\ Personal communication with C. Williams, CDC. October
24,2023.
\159\ 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 information recorded on the rabies vaccination records and prevent
fraud. CDC has documented several instances of importers attempting to
import an unvaccinated dog using the vaccination paperwork for another
dog.\160\ By requiring microchips, which will be verified by the ACF
during revaccination and examination, CDC can ensure the paperwork for
foreign-vaccinated dogs from DMRVV high-risk countries matches the
microchip implanted in the dog.
---------------------------------------------------------------------------

\160\ Centers for Disease Control and Prevention. Public Health
Activity Reporting System (previously the Quarantine Activity
Reporting System, version 4.9.8.8.2.2A). Dog importation data, 2018-
2020. Accessed: February 15, 2021.
---------------------------------------------------------------------------

Further, during the period of CDC's temporary suspension of dogs
entering the United States from DMRVV high-risk countries, CDC
documented that 99 percent 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. Given these
existing practices and the ubiquity of microchipping of dogs, the
microchip requirement is not likely to impose a burden on importers and
would have minimal impact on dog importations.
CDC did not receive specific public comments on when a dog's
microchip should be implanted. However, through this final rule, HHS/
CDC is clarifying that a dog's microchip must have been implanted on or
before the date the current rabies vaccine was administered. Rabies
vaccines administered prior to the implantation of a microchip are
invalid because without the microchip the identity of the dog that
received the rabies vaccine cannot be properly verified. The microchip
is required to be able to verify a rabies vaccine was administered to
an individual dog.
Comment: One commenter stated microchipping their dog would run
counter to their religious beliefs and requested an exemption based on
religious grounds.
Response: The Religious Freedom Restoration Act (RFRA), 42 U.S.C
2000bb et seq., provides that the U.S. government shall not
substantially burden a person's exercise of religion, even if the
burden results from a rule of general applicability, unless it
demonstrates that application of the burden to the person is in
furtherance of a compelling governmental interest; and is the least
restrictive means of furthering that compelling governmental interest.
HHS/CDC complies with RFRA where applicable and will make
determinations arising under RFRA on a case-by-case basis. If
individuals believe they may be entitled to an exemption or
accommodation based on religious beliefs under RFRA, they should
contact CDC through [email protected] for additional guidance
concerning how to submit their request. Requests for an exemption or
accommodation under RFRA must be made 120 days prior to importing a dog
into the United States.

[[Page 41768]]

HHS/CDC further wishes to emphasize the importance of microchips.
Microchips are a critical component of a dog importation system
designed to mitigate occurrences of fraud in dog importations because
microchips ensure that veterinary records for a dog can be linked to
that specific dog. Microchips are also recommended by WOAH, the
international veterinary community, and animal rescue and welfare
organizations to reunite lost animals with their owners.\161\ HHS/CDC's
rule aligns the United States with international standards and practice
in regards to microchipping.
---------------------------------------------------------------------------

\161\ 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.
---------------------------------------------------------------------------

Comment: Two comments asked that tattoos be permitted in lieu of
microchips, with one comment stating, ``Not everyone in the dog
industry is comfortable with microchips.''
Response: HHS/CDC declines to permit use of tattoos in lieu of
microchips because tattoos do not provide the same level of assurance
against fraud compared to microchips. Specifically, it would be more
difficult for CDC to verify the identity of dogs arriving with tattoos
instead of microchips because tattoos can be altered and can fade over
time making identification challenging. Altered or indistinguishable
tattoos could lead to attempts to falsify or forge vaccine or titer
documentation to circumvent U.S. entry requirements. HHS/CDC notes that
microchips are already used and available globally for the
international movement of animals. Microchips are required by 86% of
DMRVV-free countries for the importation of dogs from DMRVV high-risk
countries and microchips are a WOAH standard for the international
movement of animals.\162\ Furthermore, during the period of CDC's
temporary suspension of dogs entering the United States from DMRVV
high-risk countries and as noted above, 99 percent of permit
applications CDC received were for dogs that had microchips implanted
prior to the announcement of the suspension.
---------------------------------------------------------------------------

\162\ Personal communication with C. Williams, CDC. October 24,
2023.
---------------------------------------------------------------------------

Comment: Some commenters expressed concerns that because ``the
proposed rule does not distinguish between personal and commercially
imported dogs, requiring all dogs to be at least six months old, bear a
microchip and submit a CDC import form prior to travel'' would
``dramatically increase[ ] [CDC's] regulatory volume.''
Response: CDC disagrees that it would be unable to handle an
increase in regulatory volume based on requirements in the final rule
relating to age, microchips, or submission forms, or that this
regulatory volume would be alleviated by distinguishing between
personally owned and commercially imported dogs. Many of the provisions
of this final rule are designed to reduce instances of fraud and
improve the ability of Federal agencies including CDC to ensure that
dogs meet entry requirements. In particular, the six-month age
requirement is designed to reduce instances of importers presenting
dogs for import that are too young to be effectively vaccinated against
rabies and will make it easier for veterinarians to appropriately age
dogs based on dental eruptions. Microchips will reduce CDC's regulatory
burden by providing an ability to confirm a dogs' identity. Importers
can demonstrate that their dog has a microchip by including the number
on their documentation. Importer documentation will be examined by
government officials upon entry in the same manner that it was examined
prior to this regulatory update. Microchips for foreign-vaccinated dogs
from DMRVV high-risk countries will be scanned and confirmed by ACF;
therefore, requiring microchips does not create an unmanageable burden
on CDC. The final rule further replaces the current requirement for a
valid RVC with standardized forms that will make it easier for CDC and
CBP to process dogs for entry to the United States because there will
be less variability in documentation. Furthermore, distinguishing
between dogs imported for commercial reasons and those imported as
personal pets would increase rather than decrease CDC's regulatory
burden because importers often misrepresent the reasons why dogs are
being imported into the United States.
Comment: One commenter stated that ``CDC references `larger
shipments' of dogs from importers as an issue not individual dog owners
. . . Microchipping would not solve the alleged large shipment problem.
It simply moves the problem while imposing additional cost and a new
potential failure point. The idea of using trusted vaccination sites is
far more workable and would yield higher confidence levels.''
Response: HHS/CDC disagrees. CDC will be able to verify the
identity and vaccination status of the dogs in large shipments through
the use of microchips. Previously, CDC has documented large shipments
of dogs imported with fraudulent paperwork whereby one dog's paperwork
was ``swapped'' with another dog's paperwork. Microchips are the safest
and least expensive way to confirm a dog matches the paperwork
presented by the importer. CDC is requiring microchips because it helps
prevent fraud, particularly for the highest risk category of dogs--
foreign-vaccinated dogs from DMRVV high-risk countries. These dogs will
have their microchip scanned upon arrival at the ACF. The ACF will then
be able to confirm that the scanned microchip number matches the number
on the importer's documentation. Furthermore, CDC notes that this final
rule does include trusted vaccination sites, which are ACF. ACF are
facilities registered with CDC that will be revaccinating all foreign-
vaccinated dogs from DMRVV high-risk countries upon entry.
Paragraph (h)--CDC Dog Import Form for all dogs.
Comment: Several commenters expressed support for the CDC Dog
Import Form requirement. Commenters supported CDC improving its ability
to track how many dogs enter the United States. Commenters also
suggested CDC create a system whereby frequent travelers could login
and pre-populate the form to reduce the time spent filling out the
form.
Response: HHS/CDC agrees with these comments and believes use of
the CDC Dog Import Form will improve CDC's ability to track the number
of dogs being imported into the United States. HHS/CDC appreciates the
suggestion to use a system with login capabilities for frequent
travelers. CDC does not have the funding available to establish the
suggested system at this time but will work in the future to establish
a system that addressees the unique need of frequent travelers.
Comment: HHS/CDC received a number of comments regarding the CDC
Dog Import Form (OMB approval number 0920-1383, exp 04/30/2027).
Commenters requested clarification about the information to be
collected, and whether foreign veterinarians will need to verify the
form. One comment said the form should not become a requirement until
it is available to the public. Another comment stated, ``disabled
individuals and veterans with US vaccinated service dog canines would
be burdened with extra work due to the additional tracking systems.''
CDC takes this to be referring to the CDC Dog Import Form. This
commenter also stated, ``Citizens in the US will be further burdened
with extra work due to the additional tracking systems and . . .
Citizens returning to their country are

[[Page 41769]]

already tracked [and] should not need to submit further tracking data
for data collection.'' Additional commenters questioned the purpose of
the CDC Dog Import Form and did not support its use due to cost and
burden on importers.
Response: HHS/CDC seeks to clarify several points raised by
commenters. The CDC Dog Import Form has been available to the public
since the publication of the NPRM. It is available on www.reginfo.gov
under the information collection review (ICR) number 0920-1383.
Importers must submit the CDC Dog Import Form prior to travel via an
online automated system that is accessible from a smartphone, tablet,
or computer. It is free for importers to submit the form; therefore,
there is no cost to importers. The form will collect identifying
information about the importer, their dog, and the dog's travel
itinerary. Importers will need to upload a photo of their dog as part
of the submission. No U.S. government agency is currently collecting
this information for all dog importations; therefore, it is not
information that is already tracked. Neither veterinarians nor
government officials will be asked to complete, verify, or submit any
information as part of this form. The form is intended to help CDC
capture the number of dogs imported, the locations from which these
dogs arrive, and to provide assistance to CBP, USDA, CDC, and State
government agencies in conducting contact tracing when there is a
public health need. Upon successfully submitting the form, importers
will immediately receive an automated receipt for presentation to their
airline, if arriving by air, and CBP and the ACF (for foreign-
vaccinated dogs from DMRVV high-risk countries), upon arrival at a U.S.
port. CBP and the ACF, if applicable, will review and confirm that the
information matches the animal presented. HHS/CDC estimates that an
importer can complete the form in less than 15 minutes. HHS/CDC
believes this new requirement places a small burden on importers and
that the benefits of the requirement (the collection of data on all dog
importations) outweighs the minimal burden being placed on importers.
CDC also disagrees that these measures place an extra or
disproportionate burden on disabled individuals and or U.S. veterans
traveling with U.S. vaccinated service dogs.
Comment: Some comments asked how the CDC Dog Import Form will be
reviewed and verified by CDC with some seeming to believe this form
would be the same as the CDC Dog Import Permits CDC issued during the
temporary suspension or some saying to require the CDC Dog Import
Permit instead. Some of these comments also questioned whether CDC has
the capacity to handle the volume of forms received. Comments from the
airline industry asked how airlines would be expected to verify the CDC
Dog Import Form. Another comment questioned why the ``CDC import
permit'' should be required for U.S.-vaccinated dogs since it is not
currently required for U.S.-vaccinated dogs. CDC understood this
comment to mean that the commenter confused the CDC Dog Import Form
with the CDC Dog Import Permit.
Response: The CDC Dog Import Form is not the same as the CDC Dog
Import Permit application. CDC will discontinue issuing CDC Dog Import
Permits when the temporary suspension expires and this final rule goes
into effect. In the future, CDC will only issue CDC Dog Import Permits
for importers of dogs from DMRVV-restricted countries; however, CDC is
not including any countries on the DMRVV-restricted list at the time of
publication of this final rule. Unlike the CDC Dog Import Permit,
however, the CDC Dog Import Form does not require review by CDC staff
prior to the issuance of the auto-generated receipt. CBP will confirm
the information on the form upon arrival, along with other documents
required for entry. Because the system is automated, the volume of
forms submitted will not adversely impact CDC's workload nor will it
impact the time that importers will need to wait for the receipt;
whereas issuing CDC Dog Import Permits does require CDC staff time and
requires importers to await review by CDC before receiving their
permit. The wait time for a CDC Dog Import Permit can take anywhere
from one to eight weeks, particularly if the importer did not submit
all required information. CDC is also requiring that all importers use
the CDC Dog Import Submission Form, including those importing U.S.
vaccinated dogs, because the form includes important information such
as the importer's contact information and information related to each
dog being imported, and will allow CDC to more easily track the
frequency and number of dog imports.
Additionally, CDC will not require that airlines verify information
on the form. For example, airlines will not be required to scan dogs'
microchips to ensure the microchip number matches the number listed on
the form. Rather, airlines will only be required to confirm that the
importer has a CDC Dog Import Form receipt and either a Certification
of U.S.-Issued Rabies Vaccination form, a reservation at an ACF, or
documentation the dog has resided only in a DMRVV-free or DMRVV low-
risk country for the six months prior to boarding the dog on the plane.
Comment: One comment said the CDC Dog Import Form may infringe on
privacy without stopping the reintroduction of rabies. The commenter
did not elaborate further on how they believed the CDC Dog Import Form
may infringe on privacy or why use of this form would not help mitigate
the reintroduction of DMRVV into the United States.
Response: Although the commenter did not elaborate on how they
believe the CDC Dog Import Form may infringe on privacy interests, HHS/
CDC does not believe that requiring importers to complete this form
will infringe on privacy. CDC notes that it will maintain and use the
information collected via the CDC Dog Import Form in accordance with
the Privacy Act of 1974 (5 U.S.C. 552a) and its applicable System of
Records Notice.\163\ Personally identifiable information may be used
and shared only for lawful purposes, including with authorized
personnel of HHS, State and local government agencies, and other
cooperating authorities, as authorized by law.
---------------------------------------------------------------------------

\163\ HHS System of Records Notice (SORN) 09-20-0171. https://www.hhs.gov/foia/privacy/sorns/09200171/index.html.
---------------------------------------------------------------------------

Furthermore, although the commenter did not elaborate on why they
believe use of the CDC Dog Import Form would not help mitigate the
reintroduction of DMRVV into the United States, CDC disagrees that this
form will not be useful in preventing the reintroduction of DMRVV. The
information that importers will submit to CDC via the CDC Dog Import
Form will allow CDC to better track the overall number and frequency of
dog importations to the United States. This information in turn will
help CDC better determine the risk of human exposure incidence to DMRVV
from imported dogs, improve CDC's ability to conduct a contact tracing
investigation if a rabid dog were to be imported into the United
States, and provide CDC with data about which countries are responsible
for importing dogs of public health concern to the United States. This
information will further help CDC assess the DMRVV risk to the United
States based on the level of DMRVV present in each country and the
number of importations from DMRVV countries.
Comment: HHS/CDC received comments that the CDC Import Certificate
should be certified by an official veterinarian. HHS/CDC interprets
this to mean the Certification

[[Page 41770]]

of Foreign Rabies Vaccination and Microchip form.
Response: HHS/CDC agrees with this comment. HHS/CDC is implementing
requirements in this final rule that veterinary documentation be
certified by official government veterinarians in order to reduce the
use of fraudulent documentation by importers. Official government
veterinarians are able to certify that an accredited veterinarian is
authorized to practice veterinary medicine in the exporting country.
Additionally, engaging foreign government official veterinarians in the
exportation process of an animal provides a pathway to communicate with
a foreign government when cases of fraud are detected by CDC.
Currently, there is no recourse or follow-up that a foreign government
can perform when CDC identifies fraudulent paperwork because CDC does
not require foreign governments to certify the paperwork prior to
export. Official government veterinarians currently review and certify
dog exportation paperwork for most other countries in the world, but
the United States does not have this requirement. The final rule will
align the United States requirements more closely with other countries
that already require official government certification of export
documentation in order to prevent fraud and provide an official pathway
to engage with foreign government officials when cases of fraud are
detected.
Comment: HHS/CDC received comments from foreign government
representatives requesting that the CDC Dog Import Form not require
involvement from a licensed veterinarian or from an official government
veterinarian.
Response: HHS/CDC agrees with these comments and does not think it
is necessary to have this form certified by a veterinarian because a
purpose of this form is to collect data on the number of dogs arriving
into the United States and the proportion arriving from DMRVV high-risk
countries which is something the U.S. government was previously unable
to do. The form is administrative in nature and does not capture
medical information about the dog; therefore, a veterinarian does not
need to certify the form.
Comment: One comment stated it is illogical to require the CDC Dog
Import Form for importations at the land borders and the commenter
questioned the intended purpose of the form.
Response: HHS/CDC disagrees. The information that importers will
submit to CDC via the CDC Dog Import Form will help CDC prevent the
reintroduction of rabies. It allows CDC to track all dog importations,
including those arriving at U.S. land ports, which helps CDC better
determine the risk of human exposure incidence to DMRVV from imported
dogs. It will allow CDC to better conduct contact tracing if a rabid
dog were to be imported into the United States. It would also provide
data to CDC about the countries from which dogs are being imported.
This information helps CDC assess the DMRVV risk to the United States
based on the level of DMRVV present in each country and the number of
importations from DMRVV countries.
Paragraph (i)--Inspection requirements for admission of all dogs
and cats.
Comment: HHS/CDC received comments that a health certificate or
certificate of veterinary inspection (CVI) should be required in
addition to rabies vaccine documentation because this is a basic
protection adopted by other countries. A health certificate or CVI is a
document used by some foreign countries for the export of animals from
those countries.
Response: HHS/CDC declines to accept this suggestion. Although
health certificates can contain valuable information regarding the
dog's health status, health certificates often do not contain all the
necessary information that would allow HHS/CDC to confirm valid rabies
vaccination. Therefore, HHS/CDC has adopted its own documentation
requirements for this final rule.
Comment: Commenters also noted that EU pet passports should be
accepted or that CDC should create a passport that is compatible with
or comparable to the EU pet passport.
Response: HHS/CDC declines to accept these suggestions. CDC has
documented numerous instances of importers using falsified or
fraudulent EU pet passports. EU pet passports are not certified by
official government veterinarians. HHS/CDC is implementing requirements
in this final rule that veterinary documentation be certified by
official government veterinarians in order to reduce the use of
fraudulent documentation by importers. Official government
veterinarians are able to certify that an accredited veterinarian is
authorized to practice veterinary medicine in the exporting country.
Additionally, engaging foreign government official veterinarians in the
exportation process of an animal provides a pathway to communicate with
a foreign government when cases of fraud are detected by CDC.
Currently, there is no recourse or follow-up that a foreign government
can perform when CDC identifies fraudulent paperwork because CDC does
not require foreign governments to certify the paperwork prior to
export. Official government veterinarians currently review and certify
dog exportation paperwork for most other countries in the world, but
the United States does not have this requirement. The final rule will
align the United States requirements more closely with other countries
that already require official government certification of export
documentation in order to prevent fraud and provide an official pathway
to engage with foreign government officials when cases of fraud are
detected.
Comment: HHS/CDC received comments that dogs and cats should have
the same vaccination and entry requirements or that cats should have to
be vaccinated for rabies to enter the United States. HHS/CDC also
received comments asking that HHS/CDC not render it harder to import
cats and exempt various groups (e.g., military members and Foreign
Service Officers) from the requirements for cats to be imported into
the United States. Additional comments asked to clarify what the
requirements are for cats or if there were proposed updates to cat
requirements in the NPRM.
Response: HHS/CDC would like to clarify that this final rule does
not substantively update requirements to import a cat into the United
States. The NPRM did not propose, nor is this final rule establishing,
vaccination requirements for importing cats into the United States.
Although HHS/CDC recommends that cats be vaccinated against rabies
prior to importation because cats can acquire rabies from other animals
(i.e., be an incidental host of the virus), this final rule does not
require vaccination of cats because cats are not considered a reservoir
of rabies. Additionally, HHS/CDC has never documented a report of an
imported rabid cat. This final rule is updating the requirements for
the care and transport of cats that appear unhealthy upon arrival, by
requiring that any ill cat undergo a veterinary examination immediately
upon arrival to ensure it receives timely care, and that CDC is
notified of any potential zoonotic diseases that could be transmitted
to people. The final rule is also updating requirements for necropsy of
cats that arrive dead in order to determine the cause of death and
ensure CDC is notified of any potential zoonotic diseases that could be
transmitted to people. Because the final rule is not imposing new
requirements to import cats, no exemption, including for specific
groups such as military

[[Page 41771]]

members and Foreign Service Officers, is not needed.
Paragraph (j)--Examination by a USDA-Accredited Veterinarian and
confinement of exposed dogs and cats or those that appear unhealthy.
HHS/CDC received no public comment on this paragraph of the
proposed rule.
Paragraph (k)--Veterinary examination, revaccination against
rabies, and quarantine at a CDC-registered Animal Care Facility for
foreign-vaccinated dogs from DMRVV high-risk countries.
Comment: Many State and local public health and animal health
agencies expressed support for requiring veterinary examination,
revaccination, and quarantine (if needed) of dogs on arrival to reduce
the burden on these agencies. These commenters also noted that these
practices would also reduce the public health risk that imported dogs
pose to U.S. communities, domestic pets, and wildlife and would improve
the government's ability to identify dogs with diseases or external
parasites before they enter the United States.
Response: HHS/CDC agrees with the commenters regarding the public
health benefit of these provisions in preventing rabies as well as
additional zoonotic diseases. In drafting this final rule, HHS/CDC
recognized that there is limited value in reviewing paperwork alone
because physical inspection of animals in combination with a review of
paperwork submitted by importers has a greater likelihood of allowing
CDC to detect both fraudulent paperwork and communicable diseases of
concern in dogs.
Comment: HHS/CDC received comments objecting to the revaccination
requirements for foreign-vaccinated dogs from DMRVV high-risk countries
because the dogs have already been vaccinated overseas.
Response: HHS/CDC disagrees with these comments. There is a high
degree of variability in the quality and efficacy of rabies vaccines
produced in some countries.^{164 165} Therefore, re-vaccination
with a high-quality USDA-licensed vaccine is necessary to ensure
adequate protection against rabies. CDC has also documented instances
in DMRVV high-risk countries in which rabies vaccines have been
improperly administered.\166\ USDA-licensed rabies vaccines undergo
rigorous testing to ensure they are safe and effective. Requiring a
rabies booster vaccine on arrival ensures dogs are adequately protected
against rabies and do not pose a public health risk.
---------------------------------------------------------------------------

\164\ Hu RL, Fooks AR, Zhang SF, Liu Y, Zhang F. Inferior rabies
vaccine quality and low immunization coverage in dogs in China.
Epidemiol Infect 2008;136: 1556-1563.
\165\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M,
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5):961. Doi:
10.3390/vaccines11050961. PMID: 37243065; PMCID: PMC10222363.
\166\ 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
---------------------------------------------------------------------------

Comment: Some commenters expressed concerns regarding revaccinating
dogs upon arrival that were already vaccinated overseas and the impact
of multiple rabies vaccines on dogs' health.
Response: HHS/CDC appreciates these concerns but finds them
unwarranted because revaccinating a dog with a USDA-licensed rabies
vaccine upon arrival in the United States is not likely to result in an
adverse vaccine event. A 2023 review of more than 4.5 million
veterinary records for dogs vaccinated in the United States found
adverse rabies vaccine reactions occurred in less than 0.25% of
dogs.\167\ Furthermore, studies have noted dogs that did experience
adverse vaccine reactions were more likely to do so when multiple
vaccines (four or more) were administered
concurrently.^{168 169} CDC is only requiring the
administration of a single rabies vaccine upon arrival.
---------------------------------------------------------------------------

\167\ Moore GE, Morrison J, Saito EK, Spofford N, & Yang M.
Breed, smaller weight, and multiple injections are associated with
increased adverse event reports within three days following canine
vaccine administration. Journal of the American Veterinary Medical
Association, 2023; 261(11), 1653-1659.
\168\ Frana TS, Clough NE, Gatewood DM, Rupprecht CE.
Postmarketing surveillance of rabies vaccines for dogs to evaluate
safety and efficacy. JAVMA 2008; 232:1000-1002.
\169\ Moore GE, Morrison J, Saito EK, Spofford N, & Yang M.
Breed, smaller weight, and multiple injections are associated with
increased adverse event reports within three days following canine
vaccine administration. Journal of the American Veterinary Medical
Association, 2023; 261(11), 1653-1659.
---------------------------------------------------------------------------

The results of this study demonstrate that the benefits of rabies
vaccination continue to outweigh the risks. CDC rabies subject matter
experts receive reports of dogs infected with wildlife rabies virus
variants each year corresponding to an annual rate of rabies infections
acquired domestically of about four cases per one million unvaccinated
dogs.\170\ If no U.S. dogs were vaccinated and the rate of infection
observed in the unvaccinated U.S. dog population was applied to the
entire U.S. dog population (85 million dogs), HHS/CDC can estimate the
number of rabies infections averted through vaccination. Thus, these
vaccinations are estimated to prevent nearly 300 dogs from developing
rabies virus infection each year. This compares very favorably to the
reported number of annual severe adverse events (60 per year). On
average, CDC subject matter experts estimate that each dog infection
would be associated with 2.2 human exposures. As a result, HHS/CDC
estimates that dog rabies vaccination prevents more than $3 million in
healthcare-associated costs for rabies PEP each year. High rabies
vaccination coverage also reduces the risk that dog owners may die in
the event of an exposure to their infected dogs. The United States
spent several decades and hundreds of millions of dollars to eliminate
the circulation of rabies in U.S. dogs. Maintaining a high level of
herd immunity prevents rabies from becoming reestablished in U.S. dog
populations, which if it were to occur, would result in far more dog
and human deaths from rabies.\171\ HHS/CDC believes vaccination against
rabies is unlikely to pose a significant risk to the dog's health and
requiring vaccination would result in the significant public health
benefits outlined above.
---------------------------------------------------------------------------

\170\ Huang P. Vaccine hesitancy affects dog-owners, too, with
many questioning the rabies shot. October 11,2023. Available at:
www.npr.org/sections/health-shots/2023/10/11/1205016558/canine-vaccine-hesitancy-dogs-rabies.
\171\ Huang P. Vaccine hesitancy affects dog-owners, too, with
many questioning the rabies shot. October 11,2023. Available at:
www.npr.org/sections/health-shots/2023/10/11/1205016558/canine-vaccine-hesitancy-dogs-rabies.
---------------------------------------------------------------------------

Comment: HHS/CDC received comments objecting to the titer
requirements for foreign-vaccinated dogs from DMRVV high-risk countries
on the basis that only a rabies vaccine should be sufficient for entry
into the United States. Some comments asked why CDC does not trust
vaccines from other countries.
Response: HHS/CDC disagrees with these comments. WOAH and the
international community have long recognized vaccination paperwork
alone is not sufficient to ensure a dog is adequately vaccinated
against rabies. There is a high degree of variability in the quality
and efficacy of rabies vaccines produced in some
countries.^{172 173 174} Therefore, re-

[[Page 41772]]

vaccination with a high-quality USDA-licensed vaccine is necessary to
ensure adequate protection against rabies. CDC has also documented
instances in DMRVV high-risk countries in which rabies vaccines have
been improperly administered.\175\ A titer provides supportive evidence
that a dog has been adequately vaccinated against rabies. Rabies
vaccination documentation can also be falsified. Requiring a titer in
addition to rabies vaccination documentation makes it more difficult
for importers to falsify documents.
---------------------------------------------------------------------------

\172\ Hu RL, Fooks AR, Zhang SF, Liu Y, Zhang F. Inferior rabies
vaccine quality and low immunization coverage in dogs in China.
Epidemiol Infect 2008;136: 1556-1563.
\173\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M,
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5):961. Doi:
10.3390/vaccines11050961. PMID: 37243065; PMCID: PMC10222363.
\174\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M,
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5).
\175\ 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.
---------------------------------------------------------------------------

Titers or quarantine are the WOAH recommended importation standards
that should be implemented for dogs arriving from DMRVV high-risk
countries. HHS/CDC has provided alternative entry pathways through an
ACF with a 28-day quarantine if an importer is unable or unwilling to
receive a titer prior to arriving in the United States.
Comment: HHS/CDC received comments objecting to the requirement for
dogs with titers to go to an ACF because titers demonstrate the
presence of rabies antibodies in dogs and that should be sufficient for
entry. The comments stated that requiring these dogs to be revaccinated
and examined at ACF is unnecessary.
Response: HHS/CDC disagrees with these comments. As noted above,
there is a high degree of variability in the quality and efficacy of
rabies vaccines produced in some countries,^{176 177} as well
as evidence that some rabies vaccines administered in DMRVV high-risk
countries contain an additive that may cause an initial robust immune
response that quickly wanes and provides no protection against an
exposure to the rabies virus.\178\ This can result in titer test
results falsely demonstrating adequate antibodies for rabies.
Additionally, elevated (or passing) titers suggest an animal has either
been vaccinated against rabies or could be infected with the rabies
virus. Re-vaccination with a high-quality USDA-licensed vaccine
provided at an ACF is necessary to ensure adequate protection against
rabies. USDA-licensed rabies vaccines undergo rigorous testing to
ensure they are safe and effective. Requiring a rabies booster on
arrival ensures dogs are adequately protected against rabies and do not
pose a public health risk.
---------------------------------------------------------------------------

\176\ Hu RL, Fooks AR, Zhang SF, Liu Y, Zhang F. Inferior rabies
vaccine quality and low immunization coverage in dogs in China.
Epidemiol Infect 2008;136: 1556-1563.
\177\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M,
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5):961. Doi:
10.3390/vaccines11050961. PMID: 37243065; PMCID: PMC10222363.
\178\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M,
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5):961. Doi:
10.3390/vaccines11050961. PMID: 37243065; PMCID: PMC10222363.
---------------------------------------------------------------------------

Although not a primary reason for this final rule, it is also
important for CDC-registered ACF to examine animals on arrival to
ensure sick animals are not released into U.S. communities. During the
period of the temporary suspension, CDC and ACF detected or ruled out
numerous cases of dogs with foreign ticks, leishmaniasis, brucellosis,
canine influenza, or COVID-19 through physical examination and testing
prior to clearing an animal for entry into the United
States.^{179 180} Prior to the establishment of ACF and the
requirement for dogs to undergo physical examination upon arrival,
State health departments detected these diseases, as well as rabies,
only after dogs had been released into U.S. communities. Examination of
the highest-risk category of dog imports--foreign-vaccinated dogs from
DMRVV high-risk countries--on arrival by a network of ACF helps reduce
the risk of ill or rabid dogs entering U.S. communities. While this
rule primarily addresses the importation of rabies into the United
States, the ability to safely house and care for animals while they
undergo screening for other zoonotic diseases is an additional benefit
and further protects public health in the United States.
---------------------------------------------------------------------------

\179\ Williams C, Swisher S, Miller N, Pinn-Woodcock T, Austin
C, et al. Human exposures to Brucella canis from a pregnant dog
imported during an international flight: Public health risks,
diagnostics challenges and future considerations. Zoonoses and
Public Health 2024; 00:1-13 DOI: 10.1111/zph.13121.
\180\ Centers for Disease Control and Prevention. System for
Animal Facility Electronic Tracking of Quarantine (SAFE TraQ) dog
import surveillance data. 2023-2024. Accessed 26 March 2024.
---------------------------------------------------------------------------

Comment: HHS/CDC received comments objecting to dogs undergoing
quarantine even when there is a rabies vaccination document.
Response: HHS/CDC disagrees with these comments. WOAH and the
international community have long recognized vaccination paperwork
alone is not sufficient to ensure a dog is adequately vaccinated
against rabies due to the high frequency of falsified documents. There
is a high degree of variability in the quality and efficacy of rabies
vaccines produced in some countries.^{181 182} Therefore,
documentation of a rabies vaccine alone is not sufficient to ensure a
dog is adequately protected from rabies. According to WOAH, adequate
titer or a sufficient period of quarantine are the importation
standards that should be implemented for dogs arriving from DMRVV high-
risk countries. HHS/CDC has provided both options to importers
depending on an importer's preference, logistical considerations, and
feasibility. Importers may provide either proof of an adequate titer or
undergo quarantine at an ACF to meet U.S. entry requirements.
---------------------------------------------------------------------------

\181\ Hu RL, Fooks AR, Zhang SF, Liu Y, Zhang F. Inferior rabies
vaccine quality and low immunization coverage in dogs in China.
Epidemiol Infect 2008;136: 1556-1563.
\182\ Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M,
Thibault JC, Cliquet F. Potency of Veterinary Rabies Vaccines
Marketed in Sri Lanka. Vaccines (Basel). 2023 May 9;11(5):961. Doi:
10.3390/vaccines11050961. PMID: 37243065; PMCID: PMC10222363.
---------------------------------------------------------------------------

Foreign-vaccinated dogs arriving from DMRVV high-risk countries
must undergo revaccination and, for dogs without a titer result from a
CDC-approved laboratory, a quarantine period of 28 days. This
quarantine period allows CDC to be confident the dog is not incubating
rabies. Dogs that have been exposed to rabies and are subsequently
vaccinated will either (1) adequately respond to vaccination and
develop sufficient antibodies to prevent clinical infection and death;
or (2) succumb to the virus within an accelerated timeframe (<28 days).
Quarantining dogs ensures that if a dog is going to develop rabies and
die, it will do so in an environment where no other animals are
exposed, and where it is cared for by only a limited number of people
who are trained to wear personal protective equipment and administer
veterinary care as needed.
Comment: HHS/CDC received comments that unvaccinated dogs should be
quarantined or vaccinated only upon arrival or that HHS/CDC should not
require dogs to be vaccinated overseas if they have to undergo
vaccination and/or quarantine upon arrival.
Response: HHS/CDC disagrees with these comments. It is critical
that dogs from DMRVV high-risk countries be vaccinated overseas prior
to their arrival in the United States to prevent the reintroduction of
rabies into the United States and help prevent people and animals from
being exposed to rabid dogs in transit and upon arrival. Additionally,
HHS/CDC notes that if dogs were not vaccinated prior to arrival, then
every dog from a DMRVV

[[Page 41773]]

high-risk country would be required to undergo a 28-day quarantine. The
cost to quarantine these dogs for 28 days on arrival would be a
financial burden on importers. There is also limited space available
for quarantine at the AFC, making this option unfeasible for many
importers. HHS/CDC notes that the titer requirement combined with
revaccination upon arrival would serve a similar purpose at a fraction
of the cost for importers.
Comment: Some commenters said that HHS/CDC should not ban dogs and
cats from being imported into the U.S. and instead allow quarantine and
vaccination upon arrival.
Response: First, HHS/CDC would like to clarify it is not banning
the importation of dogs and cats. Second, as mentioned above, to
require quarantine for all dogs from DMRVV high-risk countries would
increase costs for most importers. It is significantly less expensive
for importers to have their dogs vaccinated prior to travel and provide
rabies documentation and titer results, if applicable, for entry into
the United States compared to quarantining their dogs upon arrival.
Comment: HHS/CDC received comments that in lieu of revaccination,
examination, and quarantine (if required) at an ACF for foreign-
vaccinated dogs from DMRVV high-risk countries, HHS/CDC should continue
to issue the CDC Dog Import Permits, which were issued during the
temporary suspension. HHS/CDC also received comments that in lieu of
requiring that dogs go to an ACF, HHS/CDC should allow home quarantine
and verify revaccination through compliance checks after a dog has been
cleared for entry and released into the community.
Response: HHS/CDC disagrees. ACF visits are critical because
physical examinations by a veterinarian who can identify signs of
rabies in dogs and verify the microchip matches all rabies vaccination
and titer paperwork presented for the dog have a greater public health
benefit than review of paper-based forms or records (such as the permit
system HHS/CDC used during the temporary suspension) that can be
fraudulent or falsified. Home quarantine and verification of
revaccination through random compliance checks also does not ensure
that dogs have been physically examined by a veterinarian prior to
their release into U.S. communities. HHS/CDC would also have to rely on
states and localities to follow-up with home-quarantined dogs. Prior to
2018, HHS/CDC allowed home quarantine of dogs through the issuance of
confinement agreements; \183\ however, this practice proved to be too
burdensome for the states and localities. Therefore, HHS/CDC did not
propose this option in the NPRM due to poor feasibility.
---------------------------------------------------------------------------

\183\ CDC. Issuance and Enforcement Guidance for Dog Confinement
Agreements. 79 FR 39403 (July 10, 2014): 39403-39406.
---------------------------------------------------------------------------

Because of the above-listed reasons, foreign-vaccinated dogs
arriving from DMRVV high-risk countries must undergo revaccination and,
for dogs without a titer result from a CDC-approved laboratory, a
quarantine period of 28 days. This quarantine period allows HHS/CDC to
be confident the dog is not incubating rabies. As discussed above, dogs
that have been exposed to rabies and are subsequently vaccinated will
either (1) adequately respond to vaccination and develop sufficient
antibodies to prevent clinical infection and death; or (2) succumb to
the virus within an accelerated timeframe (<28 days). Quarantining dogs
ensures that if a dog is going to develop rabies and die, it will do so
in an environment where no other animals are exposed, and where it is
surrounded only by a limited number of people who are trained to wear
personal protective equipment and administer veterinary care as needed.
Comment: HHS/CDC received comments that there are too few ACF and
that ACF are too expensive. Some of these comments expressed concern
about ACF' ability to accommodate all foreign-vaccinated dogs from
DMRVV high-risk countries while other comments said the limited number
of ACF places a burden on importers who are forced to arrive into the
United States at a port with an ACF.
Response: HHS/CDC appreciates this comment and notes that it has
registered two additional ACF since the publication of the proposed
rule. The registration of new ACF at additional ports continues to be a
priority for CDC; however, CDC believes there is an adequate number of
ACF currently available to handle the volume of dogs being imported.
CDC is making efforts to expand the network of CDC-registered ACF to
additional ports of entry in order to provide greater flexibility for
importers arriving from DMRVV high-risk countries with foreign-
vaccinated dogs. CDC notes that the agency does not set prices charged
by an ACF, which are privately owned and operated. Additionally, based
on data during the temporary suspension, the vast majority of importers
of foreign-vaccinated dogs from DMRVV high-risk countries chose to
submit titer results in lieu of having their dogs complete a 28-day
quarantine. These dogs were usually examined, re-vaccinated and
released back to the owner the same day they arrived in the United
States. The cost to importers of these dogs is significantly less than
for dogs without titer results, which require quarantine. Only a small
percentage (<3%) of importers are required to pay the highest cost of
quarantine for 28 days.
Comment: HHS/CDC received comments requesting that HHS/CDC consider
allowing a single titer for the lifetime of an animal instead of annual
titers, and to consider new technologies that might be available in the
future. HHS/CDC also received comments that the titer takes too long,
is too expensive, or that it is difficult to ship blood samples from
countries that do not have a CDC-approved laboratory.
Response: HHS/CDC notes that, as proposed in the NPRM, prior to
granting a reservation, an ACF must ensure they have received serologic
test results obtained from a CDC-approved laboratory on a blood sample
collected in accordance with CDC's technical instructions (if
applicable); otherwise, the dog will be required to quarantine for 28
days upon revaccination at an ACF. HHS/CDC intends to provide
additional information relating to titers through technical instruction
posted on CDC's website. HHS/CDC's current intent is to align the
frequency of titer testing and waiting periods between the time of
titer collection and date of importation with the most recent peer-
reviewed literature, WOAH guidelines, and input from CDC rabies subject
matter experts. During the temporary suspension, CDC has required
titers to be drawn 45 days to 365 days prior to importation; however,
CDC will periodically review its titer requirements and provide updates
through technical instructions as needed and consistent with the best
scientific practices.
Although no public comments were received, HHS/CDC is clarifying
that suspected or confirmed communicable diseases need only be reported
to CDC and not to other public health entities. Additional notification
of Federal, State, and local public health partners will be done by
CDC.
CDC is updating the name of this paragraph to reflect all the
required components of the paragraph. However, the requirements within
the paragraph have not changed.
Paragraph (l)--Registration or renewal of CDC-registered Animal
Care Facilities.
HHS/CDC received no public comment on this paragraph of the
proposed rule. However, HHS/CDC will

[[Page 41774]]

be amending this provision of the final rule to require that an ACF be
located within 35 miles of a CDC quarantine station. Although the NPRM
did not propose that an ACF be located within a certain distance from a
CDC quarantine station, HHS/CDC is confident that the public could
infer that HHS/CDC would consider physical location, distance, and
travel times when deciding to register a facility as an ACF. As
explained extensively throughout the preamble to the NPRM (88 FR 43992)
the rule is intended, in part, to address the difficulty that airlines
encountered finding appropriate housing for dogs denied admission and
the lack of facilities that maintain an active CBP FIRMS code. If an
animal arriving at an airport is sick or injured, it will also need to
be transported to an ACF which must, therefore, be located within a
reasonable distance from the airport to ensure the animal's health and
safety as well as the safety of transport personnel. Accordingly, it is
reasonable for the public to have inferred that HHS/CDC would only
approve and register facilities as an ACF that were located within a
reasonable distance from an airport where a CDC quarantine station was
located. HHS/CDC further notes that the 35-mile distance requirement
for an ACF aligns with CBP's Bonded Warehouse Manual \184\ and ensures
inspection of animals at the facility can occur in a timely manner when
the ACF requests assistance from CDC.
---------------------------------------------------------------------------

\184\ Bonded Warehouse Manual for CBP Officers and Bonded
Warehouse Proprietors. Available at: www.cbp.gov/document/guidance/bonded-warehouse-manual-cbp-officers-and-bonded-warehouse-proprietors.
---------------------------------------------------------------------------

HHS/CDC also takes this opportunity to clarify that in its
inspections, an ACF will be guided by the standards published by the
Association of Shelter Veterinarians' Guidelines for Standards of Care
in Animal Shelters.\185\ These guidelines provide standards applicable
to all personnel caring for shelter animals in a variety of settings,
including foster-based organizations, nonprofit humane societies,
municipal animal services facilities, and sanctuaries. These guidelines
are also applicable to any other organization that routinely cares for
populations of mobile companion animals with unknown medical histories
and possible exposures to unknown pathogens. HHS/CDC notes that the
NPRM explained that facilities applying for registration as an ACF
would be subject to inspection by CDC at least annually and required to
renew their registration every two years (88 FR 43994). HHS/CDC further
explained that animal health records, facilities, vehicles, or
equipment to be used in receiving, examining, and processing imported
animals would also be subject to inspection, see id. Accordingly, HHS/
CDC believes that the public was reasonably apprised that CDC would be
conducting inspections of facilities seeking to register as ACF and, by
necessity, these inspections would need to be guided by the industry
standard for facilities that care for populations of mobile companion
animals.
---------------------------------------------------------------------------

\185\ Guidelines for Standards of Care in Animal Shelters.
Available at: www.sheltervet.org/resources/guidelines-for-standards-of-care.
---------------------------------------------------------------------------

Paragraph (m)--Record-keeping requirements at CDC-registered Animal
Care Facilities.
HHS/CDC received no public comment on this section of the rule;
however, HHS/CDC is clarifying that records for necropsy results should
be uploaded into SAFE TraQ within 30 days of an animal's death.
Paragraph (n)--Worker protection plan and personal protective
equipment (PPE).
HHS/CDC received no public comment on this paragraph of the
proposed rule. HHS/CDC is noting that procedures for reporting
suspected or confirmed communicable diseases associated with handling
animals in facility workers must be reported to CDC within 48 hours.
This requirement was included in the NPRM in proposed paragraph (q) and
has been moved to paragraph (n) for clarity.
Paragraph (o)--CDC-registered Animal Care Facility standard
operating procedures, requirements, and equipment standards for
crating, caging, and transporting live animals.
HHS/CDC received no public comment on this paragraph of the
proposed rule.
Paragraph (p)--Health reporting and veterinary service requirements
for animals at CDC-registered Animal Care Facilities.
Comment: HHS/CDC received a comment from a veterinary professional
organization stating, ``if the animal requires veterinary care prior to
export to its country of origin, the organization supports an exception
if the animal is taken directly to a veterinary facility for treatment
with appropriate quarantine.''
Response: HHS/CDC seeks to clarify that this is the current
standard of care and HHS/CDC has no intent to change this current
practice. Although protecting the public's health is CDC's chief
priority, CDC takes reasonable steps to ensure the health and safety of
ill or injured animals and will continue to work with airlines, the
animal transportation industry, and port partners so that ill or
injured animals arriving in the United States receive veterinary care
in a timely manner. Further, HHS/CDC does not require the return of ill
or injured animals to the country of departure until such animals are
deemed fit to travel if that action would be in violation of USDA's
Animal Welfare Act.
Additionally, although HHS/CDC did not receive public comment on
this issue, HHS/CDC is clarifying that if an animal is suspected of
having a communicable disease, it must be immediately isolated and CDC-
registered Animal Care Facilities must implement infection prevention
and control measures in accordance with industry standards and CDC
technical instructions.
Although no public comments were received, HHS/CDC is clarifying
that suspected or confirmed communicable diseases need only be reported
to CDC and not to other public health entities. Additional notification
of Federal, State, and local public health partners will be done by
CDC.
HHS/CDC notes the paragraph name has been modified to reflect all
the required components of the paragraph. However, the requirements
within the paragraph have not changed.
Paragraph (q)--Quarantine requirements for animals at CDC-
registered Animal Care Facilities.
HHS/CDC received no public comment on this paragraph of the
proposed rule. However, HHS/CDC is clarifying that although implicit in
its use of the term ``quarantine'' that quarantined animals must be
housed in such a manner that they do not expose other quarantined
animals. Additionally, animals in quarantine may not be housed together
even if they were transported as part of the same shipment. This
clarification is considered a veterinary industry standard of care.
Paragraph (r)--Revocation and reinstatement of a CDC-registered
Animal Care Facility's registration.
HHS/CDC received no public comment on this paragraph of the
proposed rule.
Paragraph (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.
Comment: HHS/CDC received comments that importers should not be
required to have an official government veterinarian certify rabies
vaccination forms prior to travel.
Response: HHS/CDC disagrees with these comments. HHS/CDC has
documented numerous instances of

[[Page 41775]]

importers who falsify vaccination documents with the names of persons
who are not authorized to practice veterinary medicine within their
countries or who alter the vaccine records of animals unbeknownst to
the veterinarian. Official government veterinarians are able to certify
a veterinarian's authorization to practice veterinary medicine and can
help detect cases of fraud before an animal is shipped to the United
States. Additionally, engaging foreign government official
veterinarians in the exportation process of an animal provides a
pathway to communicate with a foreign government when cases of fraud
are detected by CDC. Currently, there is no recourse or follow-up that
a foreign government can perform when CDC identifies fraudulent
paperwork because CDC does not require foreign governments to certify
the paperwork prior to export. Official government veterinarians
currently review and certify dog exportation paperwork for most other
countries in the world, but the United States does not have this
requirement. The final rule will align the United States' requirements
more closely with other countries that already require official
government certification of export documentation to prevent fraud and
provide an official pathway to engage with foreign government officials
when cases of fraud are detected. This is a critical public health
intervention in the pre-departure phase of preparing an animal for
travel.
Lastly, many DMRVV-free and DMRVV high-risk countries currently
require importers to obtain health certificates or vaccination records
certified by official government veterinarians in the exporting country
as part of the importation requirements for those countries.
Comment: HHS/CDC received comments expressing concern that
individuals in low-income countries (which tend to be DMRVV high-risk
countries), may have trouble identifying government officials to
certify paperwork and that issues of poor governance and bureaucracy in
these countries may lead to bribery.
Response: Although issues of poor governance, including bribery and
corruption, in foreign countries fall outside the scope of this final
rule, HHS/CDC notes that through this rulemaking at Sec. 71.51(ee),
HHS/CDC will be able to prohibit exports of dogs to the United States
from countries that are unable to prevent the export of dogs with
fraudulent vaccination paperwork or other fraudulent documentation. In
addition, through the use of the Certification of Rabies Vaccination
and Microchip form, HHS/CDC will be utilizing an existing framework
that already includes official government veterinarians that are
trained and experienced in certifying standardized veterinary
documentation for the international movement (import and export) of
animals. HHS/CDC is updating U.S. importation requirements in a way
that will more closely align with international practices and WOAH
standards. By leveraging the current international animal movement
system overseen by official government veterinarians in exporting
countries, HHS/CDC will be streamlining documentation requirements
while strengthening the validity of importer documentation. HHS/CDC
defined official government veterinarian in Sec. 71.50(a) of the final
rule.
Comment: A commenter stated that veterinarians who vaccinate or
falsify the rabies vaccination documentation of rabid dogs imported
into the U.S. should be banned instead of restricting the importation
of dogs from that country. Additionally, HHS/CDC received comments to
consider creating a list of approved veterinarians abroad for tracking
the administration of rabies vaccines in foreign countries.
Response: HHS/CDC appreciates these comments and notes that this is
the purpose of having official government veterinarians certify the
rabies vaccination form. Official government veterinarians are able to
verify which veterinarians are authorized to vaccinate dogs against
rabies in their country. Additionally, engaging foreign government
official veterinarians in the exportation process of an animal provides
a pathway to communicate with a foreign government when cases of fraud
are detected by CDC. Currently, there is no recourse or follow-up that
a foreign government can perform when CDC identifies fraudulent
paperwork because CDC does not require foreign governments to certify
the paperwork prior to export. Official government veterinarians
currently review and certify dog exportation paperwork for most other
countries in the world, but the United States does not have this
requirement. The final rule will align the United States requirements
more closely with other countries that already require official
government certification of export documentation in order to prevent
fraud and provide an official pathway to engage with foreign government
officials when cases of fraud are detected. It is not feasible for HHS/
CDC to maintain a list of veterinarians globally nor for USG officials
to verify that an importer does not present documentation signed by a
banned veterinarian; therefore, HHS/CDC is leveraging the existing
international animal movement system that is overseen by official
government veterinarians in each respective country.
Comment: HHS/CDC received a comment that having official government
veterinarians verify vaccination forms may result in significant
delays.
Response: HHS/CDC disagrees with the comment. The rabies
vaccination form can be completed during an animal's health examination
prior to export, and most official government veterinarians can certify
paperwork within 3-10 days of submission. Owners and importers should
plan ahead as wait times to have the forms certified can vary. However,
HHS/CDC is utilizing the existing international animal movement system
which already has a process in place for issuing travel documents for
international pet movement, therefore, HHS/CDC does not anticipate
significant delays in certifying paperwork prior to exportation.
Comment: HHS/CDC also received a comment that rather than provide
the vaccination form, importers should be required to test tissue
samples from dogs to prove they do not have rabies.
Response: HHS/CDC would like to clarify that testing tissue samples
for rabies can only be done after an animal has died because the
tissues are obtained from the animal's brain. There is no test that can
be done to prove an animal does not have rabies while the animal is
still alive. Serologic blood tests (titers) can be run to measure
antibodies against rabies while an animal is alive, but titer tests do
not prove an animal does not have rabies. In fact, elevated (or
passing) titers suggest an animal has either been vaccinated against
rabies or is infected with the rabies virus. This is why HHS/CDC
requires a waiting period between the time a titer is collected and
when an animal can be imported, or the time between ACF vaccination and
the 28-day quarantine on arrival in the United States. The waiting
period or quarantine period helps to ensure the animal is not infection
with the rabies virus.
Paragraph (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.
Of note: CDC has shortened the name of this form in the final rule
to Certification of U.S.-Issued Rabies Vaccination.
Comment: HHS/CDC received comments that an importer should not

[[Page 41776]]

be required to have USDA certify rabies vaccination forms prior to
travel.
Response: HHS/CDC disagrees. As noted above, HHS/CDC has documented
instances of importers who falsify vaccination documents with the names
of persons who are not accredited to practice veterinary medicine in
the United States, or who alter the U.S. vaccine records of animals
unbeknownst to the veterinarian. USDA official veterinarians can
certify a veterinarian's authority to practice veterinary medicine in
the United States through an electronic system that is less susceptible
to fraud. CDC, CBP and other government agencies can verify all
documentation on USDA's website enhancing importer compliance and
reducing risk of fraud.
Comment: HHS/CDC received questions from the public concerning how
a U.S. person traveling abroad would be able to have the Certification
of U.S.-issued Rabies Vaccination for Live Dog Reentry into the United
States form completed by a U.S. veterinarian and endorsed by USDA if
they have already left the country.
Of note: CDC has shortened the name of this form in the final rule
to Certification of U.S.-Issued Rabies Vaccination.
Response: HHS/CDC has taken steps to address these concerns. HHS/
CDC will plan for a transition period to allow personal pet owners to
return to the U.S. with their U.S.-vaccinated dog without providing a
titer or needing to quarantine at an ACF if they left the United States
without obtaining the rabies vaccination form if they can provide a
USDA-issued export health certificate that includes proof of a current,
valid rabies vaccine. During this transition period, HHS/CDC will have
additional guidance available on its website for U.S. veterinarians
regarding how to document U.S. rabies vaccination in the event an
importer has already left the United States with their U.S.-vaccinated
dog.
Comment: HHS/CDC also received comments encouraging HHS/CDC to work
with USDA to create joint documents, or to align with USDA requirements
and documentation. Commenters also asked what coordination with USDA
has occurred and how CDC plans to engage with USDA-accredited
veterinarians to communicate the new requirements.
Response: HHS/CDC notes that it works closely with USDA regarding
dog importation requirements and believes the current, close
coordination is sufficient. CDC has engaged with USDA Veterinary
Service to leverage the Veterinary Export Health Certification System
already used by USDA-accredited veterinarians for the completion of
CDC's Certification of U.S.-Issued Rabies Vaccination Form during a
dog's export process. CDC plans to distribute website materials through
CDC and USDA websites and communicate directly with veterinary
organizations, such as the American Veterinary Medical Association, the
National Association of State Public Health Veterinarians, and the U.S.
Animal Health Association.
CDC is also aligning with USDA APHIS Animal Care's age requirement
for the importation of commercial dog imports by requiring all dogs to
be at least six-months of age for importation; partnering with USDA to
ensure only USDA-accredited veterinarians complete the Certification of
U.S.-Issued Rabies Vaccination form; and requiring the form be endorsed
by USDA official veterinarians during the exportation process to reduce
fraud. CDC and USDA also work closely with ACF to ensure all dogs meet
both agencies importation requirements. However, CDC notes that current
USDA APHIS Animal Care requirements do not apply to all dogs and USDA
APHIS Veterinary Service's importation requirements do not focus on
protecting human health, therefore, CDC requirements are needed in
addition to USDA requirements to protect both human and animal health
against the reintroduction of DMRVV.
Paragraph (u)--Requirement for proof that a dog has been only in
DMRVV low-risk or DMRVV-free countries.
Comment: Commenters expressed various concerns relating to the
ability of an importer, airline, or veterinarian to provide
documentation confirming that a dog has been only in DMRVV low-risk or
DMRVV-free countries during the six months before its arrival into the
United States. Commenters also requested greater clarity regarding
acceptable forms of documentation.
Response: HHS/CDC appreciates these comments. Based on these public
comments, HHS/CDC has included a list of acceptable documents in the
regulatory text that an importer may use to confirm that a dog has been
only in DMRVV-free or DMRVV low-risk countries during the six months
prior to its importation into the United States. Importers may provide
proof of rabies vaccination, which is recommended but not required,
using the Certification of Foreign Rabies Vaccination and Microchip
form or the Certification of U.S.-Issued Rabies Vaccination form listed
below.
All forms must be endorsed by an official government veterinarian
to be considered valid. Importers should contact their local
veterinarian who can submit the required form to an official government
veterinarian in the exporting country. Importers may also use the USDA
pet travel website or IPATA website to contact a pet shipper to request
assistance.^{186 187} This list also appears on CDC's website
at www.cdc.gov/dogtravel. These documents include, but are not limited
to:
---------------------------------------------------------------------------

\186\ USDA Pet Travel. www.aphis.usda.gov/pet-travel/us-to-another-country-export.
\187\ International Pet and Animal Transportation Association.
www.ipata.org.
---------------------------------------------------------------------------

A valid Certification of Foreign Rabies Vaccination and
Microchip form if completed in a DMRVV-free or DMRVV low-risk country
and the dog is arriving into the United States from the same DMRVV-free
or DMRVV low-risk country as that listed on the form. This form must be
completed by an authorized veterinarian, which may include an Official
Government Veterinarian, and must be endorsed by an official government
veterinarian in the exporting country.
A valid Certification of U.S.-Issued Rabies Vaccination
form completed by a USDA-accredited veterinarian and endorsed by a USDA
official veterinarian.
A valid USDA export certificate if the certificate is
issued by a USDA-accredited veterinarian and endorsed by a USDA
official veterinarian to allow the dog to travel to a DMRVV-free or
DMRVV low-risk country and the dog is returning to the United States
from the same DMRVV-free or DMRVV low-risk country as that listed on
the export certificate.
A valid foreign export certificate from a DMRVV-free or
DMRVV low-risk country that has been certified by a government
veterinarian in that country. The export certificate must be
accompanied by veterinary records (such as the EU pet passport) or
proof of payment for veterinary services establishing that veterinary
services were performed in the exporting country at least six months
before traveling to the United States.
A Certification of Dog Arriving from DMRVV-free or DMRVV
low-risk Country form if accompanied by veterinary records or proof of
payment for veterinary services establishing that veterinary services
were performed in the same DMRVV rabies-free or DMRVV low-risk country
at least six months before traveling to the United States. This form
must be completed by an authorized veterinarian, which may include an
official government veterinarian, and must be endorsed by

[[Page 41777]]

an official government veterinarian in the exporting country.
Regarding airlines, CDC does not require that airlines confirm that
a dog has been only in DMRVV low-risk or DMRVV-free countries during
the six months before its arrival into the United States. Rather,
airlines must confirm that importers have presented required
documentation to the airline before boarding the dog. CDC will specify
in communication materials how airlines can confirm an importer has
presented the required documentation.
HHS/CDC further notes that it is the importer and not the
veterinarian who is responsible for providing documents to the airline
confirming that a dog has been only in DMRVV low-risk or DMRVV-free
countries during the six months before its arrival into the United
States.
Comment: HHS/CDC also received comments from public health agencies
expressing concern that allowing dogs from DMRVV-free countries to
enter the United States without proof of vaccination creates potential
loopholes for unscrupulous importers to exploit.
Response: HHS/CDC shares this concern. However, HHS/CDC believes
there should be reduced importation requirements for countries that
have eliminated canine rabies in order to encourage other countries to
implement canine rabies elimination plans and to reduce the burden on
importers traveling from DMRVV-free countries to the United States.
HHS/CDC acknowledges that there have been numerous cases documented by
CBP, CDC, and USDA of importers moving dogs from DMRVV high-risk
countries through DMRVV-free countries to avoid U.S. entry
requirements. HHS/CDC is attempting to address this issue by requiring
documentation from importers arriving with dogs from DMRVV-free
countries attesting that the dog has been in a DMRVV-free country for
the six months before arrival. This documentation must be certified by
an official government veterinarian in the exporting country. Through
this rulemaking HHS/CDC has attempted to balance the needs of public
health with the desire to not unnecessarily burden the vast majority of
importers who enter the United States with dogs from DMRVV-free or
DMRVV low-risk countries. HHS/CDC is not requiring proof of rabies
vaccination, serologic titers, quarantine, or limiting ports of entry
for dogs arriving from DMRVV-free or DMRVV low-risk countries with
appropriate paperwork. HHS/CDC believes that this rule appropriately
strikes this balance.
Paragraph (v)--Denial of admission of dogs and cats.
Comment: HHS/CDC received a comment from an airline industry
organization stating that the proposed ``six-hour window from which an
animal denied admission into the United States should be relocated to a
CDC-facility or a CDC-registered facility'' was too short. The
commenter suggested ``that airlines notify the CDC within six (6) hours
of an animal being denied admission into the U.S. with transport
scheduled within 24 hours.''
Response: HHS/CDC has split Sec. 71.51(v) as written in the NPRM
into two paragraphs. Paragraph (w) is a new paragraph in the final
rule. In response to public comment, under paragraph (w), HHS/CDC now
requires airlines to transport healthy animals to a CDC-registered ACF
or other CDC-approved facility (if a CDC-registered ACF is not
available) within 12 hours of arrival. Ill or injured animals must be
transported by the airline immediately to a CDC-registered Animal Care
Facilities or other CDC-approved veterinary clinic as directed by CDC.
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-approved facility (if a CDC-registered
Animal Care Facility is not available).
An airline must immediately report an obviously ill or injured
animal (e.g., the animal is unable to stand, has difficulty breathing,
is bleeding, has broken bones or disfigured limbs, or is experiencing
seizures, vomiting, or discharge from the nose, mouth, or eyes)
arriving into the United States to the CDC quarantine station (also
known as the port health station) of jurisdiction. The airline must
immediately arrange to transport an obviously ill or injured animal to
a CDC-registered Animal Care Facility or veterinary clinic as directed
by CDC.
Animals arriving by sea that are denied admission must remain on
the vessel while awaiting return to the country of departure.
HHS/CDC is also clarifying that it may deny entry to an animal if
an importer refuses to comply with CDC-required diagnostic tests to
rule out communicable diseases. Diagnostic tests are crucial to
determine the cause of an illness and ensure the animal does not pose a
public health threat.
Paragraph (w)--Disposal or disposition of dogs and cats denied
admission to the United States.
HHS/CDC addressed comments above in ``General Comments'' that
inaccurately interpreted HHS/CDC's NPRM as proposing to euthanize dogs
that do not meet HHS/CDC entry requirements. Additionally, comments
noted in paragraph (z) may also be applicable to paragraph (w).
Paragraph ((x))--Appeals of CDC denials to admit a dog or a cat
upon arrival into the United States.
HHS/CDC received no public comment on this paragraph of the
proposed rule.
Paragraph (y)--Record of death of dogs and cats en route to the
United States and disposition of dead animals.
Comment: HHS/CDC received a comment that charging importers for the
cost of a necropsy is egregious because it imposes an extra burden on a
grieving family. The comment stated that only, ``if the autopsy
revealed that the importer had falsified documentation then fines and
any other action against the importer would be appropriate.''
Response: HHS/CDC disagrees with this comment. CDC acknowledges the
important role pets play in the lives of people and their families;
however, determining the cause of death of an imported dog or cat is
crucial to ensuring an importer, their family members, and other people
or animals were not exposed to a potential communicable disease that
could threaten the health and safety of an importer, their family, or a
community. Necropsies are performed by licensed veterinarians who can
arrange for the remains or cremated ashes of an animal to be returned
to the importer if the cause of death is determined not to be a
communicable disease, which provides grieving families the ability to
mourn their dog or cat while ensuring the safety of travelers and U.S.
communities. Importers are financially responsible for the animals they
import, including the cost of any diagnostic tests needed to ensure a
dog or cat is not carrying a communicable disease, including post-
mortem diagnostic tests. While the focus of this final rule is DMRVV,
there are other communicable diseases that dogs and cats can spread to
people, so requiring an importer to pay for a necropsy only if the
rabies vaccination paperwork is falsified is not sufficient to protect
public health.
Paragraph (z)--Abandoned shipments of dogs and cats.
Comment: HHS/CDC received numerous letters from public health
partners, animal welfare groups, importers, and rescue groups that
stated that HHS/CDC should identify resolutions for the issues of
abandoned animals at ports of entry and the public health risks
associated with delayed care or evaluation for sick or injured animals
that arrive in the United States.

[[Page 41778]]

However, other commenters, including an airline industry member
organization, objected to airlines being identified as the responsible
party for dogs they transport in the event an importer abandons the
dog. An airline industry member organization suggested that CDC and CBP
should be financially responsible for abandoned animals. Commenters
stated the responsibility for finding appropriate housing for dogs
denied admission should not be shifted to airlines. In their view, the
care of a dog denied admission into the United States should be the
responsibility of the Federal agency denying entry and/or the facility
where entry is denied. Commenters argued there is no justification for
shifting the consequences of enforcing Federal agency rules onto
carriers, and that this was akin to an unfunded mandate for airlines.
Response: HHS/CDC notes that abandonment of animals arriving in the
United States is a genuine, documented problem, which can create public
health risks (exposures to sick or rabid animals), animal welfare
concerns, and additional costs for housing and care. The final rule
seeks to reduce the incidence of abandoned animals by requiring
airlines to confirm entry requirements prior to boarding, which will
likely reduce the number of dogs denied entry and abandoned on arrival.
The final rule further provides that when an airline accepts an animal
for boarding, whether in cargo or in the cabin, the airline must
provide care for the animal in the event an importer abandons it or to
transport the animal to a veterinary clinic on behalf of the importer
if it becomes ill or injured prior to being cleared for entry into the
United States. Such costs have never been borne by Federal agencies,
and this requirement does not represent a shifting of this
responsibility. This is consistent with existing practice, as carriers
are already assigned responsibility for the goods they transport (if
there is an AWB). For the rare occasions in which an animal is
abandoned, carriers have the ability to use contractual provisions to
ensure importers are responsible for associated costs, as discussed at
more length below.
HHS/CDC would like to note that this requirement would not be
considered an unfunded mandate, as that term is understood under the
Unfunded Mandate Reform Act, 2 U.S.C. 1501 et seq., for several
reasons. First, HHS/CDC is not imposing a cost of $177M USD or more
onto airlines, as required to be an unfunded mandate under the 1995
Unfunded Mandate Reform Act of 1995. HHS/CDC estimated that between 300
and 750 dogs would be denied entry each year under the regulatory
baseline (i.e., under the dog importation requirements specified prior
to this final rule going into effect and assuming the temporary
suspension was not in effect). With the requirements in the final rule,
CDC assumed that between 30 and 75 dogs would be denied entry because
HHS/CDC believes that the standardization of rabies vaccination
documentation will facilitate the ability of airlines to check this
documentation is in place prior to boarding dogs for flights to the
United States. Only a small portion of all imported dogs would be
abandoned by importers such that the costs of the dogs' care and their
return to their countries of origin would be incurred by airlines. CDC
estimated that the costs to airlines under the regulatory baseline
would range from $42,000 to $650,000. These costs would be further
reduced by the requirements in the final rule. Second, the costs for
transportation, care, and housing are not being shifted from the
government to the airline because these costs have never been a
government responsibility. Third, ensuring airlines are responsible for
confirming entry requirements for dogs prior to boarding is likely to
result in fewer dogs denied entry and abandoned at the U.S. port,
reducing the number of abandoned animals that airlines may be
responsible for and resulting in fewer costs to airlines for abandoned
animals. HHS/CDC acknowledges that the need for airlines to review
additional documents and create bills of lading (or other CDC-approved
alternative) as required in this final rule will also increase costs
for airlines to transport dogs to the United States. In addition, this
final rule is expected to reduce the number of dogs flown into the
United States, which would reduce the revenue and profit earned by
airlines to transport dogs.
Comment: HHS/CDC received comments requesting that it require
importers to either reimburse airlines for costs relating to care and
transporting an animal to a veterinary clinic or require that the
importer be the financially responsible if the animal is abandoned.
Response: HHS/CDC notes that the importation of animals and other
goods involves multiple parties (importers, carriers, etc.), each with
its own sets of responsibilities. The final rule outlines these
responsibilities in ways that best protect public health. Airlines have
responsibilities for the animals they carry, and the final rule is
designed to minimize this burden where possible while protecting public
health from the importation of rabid dogs. HHS/CDC agrees that an
airline may pursue reimbursement from importers for any expenses
incurred on behalf of the importer if an animal arrives ill, is denied
admission, or is exposed to a sick animal in transit. Both the NPRM and
the final rule include regulatory text that states that an airline may
make ``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.'' Airlines would also
be able to include reimbursement for costs incurred relating to animal
importations as part of their contract for carriage with an importer.
To the extent that the commenters argue that HHS/CDC should directly
reimburse carriers for costs incurred on behalf of an importer
abandoning an animal, HHS/CDC notes that it would lack the legal
authority to provide such indemnification. The cost of caring for a dog
denied admission has never been a government responsibility. Long-
standing regulations at 42 CFR 71.51(g) have provided that animals
denied admission shall be detained at the owner's expense, and not at
government expense. Although the rule may have the effect of
transferring immediate responsibility from the owner to the carrier,
this is to ensure that animals abandoned by their owners after import
are housed appropriately pending return to their country of departure,
and as noted above, contractual mechanisms are available to carriers to
pursue reimbursement from importers for any expenses incurred on behalf
of the importer if an animal arrives ill, is denied admission, or is
exposed to a sick animal in transit. This shifting of responsibility is
justified because airlines can establish the conditions by which they
accept goods and cargo transported into the United States. It is also
the airline, not the owner, that establishes flight schedules and can
therefore arrange to return a dog denied admission quickly to its
country of departure, thereby reducing potential housing costs, or
otherwise disposing of an animal, provided that no government costs are
incurred.
Comment: HHS/CDC also received comments that veterinary clinics
should be acceptable housing alternatives for animals abandoned at
ports of entry in the event an ACF is not available.
Response: HHS/CDC works closely with the airlines, USDA, and CBP
when an animal is abandoned at a port of entry. In the event an ACF is
not available, CDC may contact local veterinary clinics to determine
whether

[[Page 41779]]

there is available housing for an abandoned animal. Abandoned animals
are the responsibility of the airline and the animal's ultimate
disposition is determined in collaboration with the airline. CDC
veterinarians will contact local veterinary clinics or veterinary
teaching hospitals to determine whether they are equipped to house an
imported dog. CDC may request verification from the clinic or hospital
that it is equipped to handle a variety of scenarios, such as an
isolation or quarantine, emergency surgery, diagnostic testing
capabilities, or overnight (24 hours a day) monitoring to determine
whether a hospital or clinic is suitable to house an animal pending
admissibility determination. These determinations are made based on the
health status of the dog and assessment of potential communicable
disease risks. In the past, CDC has allowed dogs to be held at local
veterinary clinics or veterinary teaching hospitals when ACF are not
available for short periods of time. HHS/CDC agrees that if an ACF is
not available, a CDC-approved alternative facility such as a veterinary
clinic or kennel may be a suitable alternative for animals abandoned at
ports of entry. The facility must be approved by HHS/CDC prior to
transport.
Comment: HHS/CDC received a comment stating that an importer should
not be allowed to abandon an animal if the animal has not been cleared
to enter the United States with its importer.
Response: HHS/CDC notes that in practice it is very difficult to
prevent importers from abandoning animals after the animals arrive in
the United States. In general, there is a large amount of inanimate
goods that are abandoned by importers upon arrival. Although HHS/CDC in
theory could attempt to penalize importers from abandoning dogs upon
arrival, to do so, HHS/CDC must request assistance from other
departments and agencies to address violations which can be a time-
consuming process. This process would also not address the immediate
concern of port partners who would still need to find adequate housing
and care for abandoned animals and determine their ultimate disposition
on a timely basis. Considering the enforcement needs and practical
difficulties in preventing an individual importer from abandoning a
dog, HHS/CDC has sought alternative solutions as explained in this
final rule.
Paragraph (aa)--Sanitation of cages and containers of dogs and
cats.
HHS/CDC received no public comment on this paragraph of the
proposed rule.
Paragraph (bb)--Requirements for in-transit shipments of dogs and
cats.
Comment: HHS/CDC received a comment clarifying that in-transit
shipments only include dogs transported as cargo.
Response: HHS/CDC confirms that this is accurate. HHS/CDC is
aligning with the USDA's definition of in-transit which only applies to
dogs in cargo. This is because animals in-transit must remain under the
care of the airlines to minimize contact with members of the public or
illegal entry into the United States. Dogs flown in the passenger
environment (hand-carried or checked baggage) do not meet the
definition of in-transit and must meet HHS/CDC entry requirements.
Comment: HHS/CDC received a comment that in-transit shipments
should be required to contain an entry number on the in-bond form.
Response: HHS/CDC disagrees. In-transit shipments are, by
definition, not entering the U.S.; therefore, an entry number is not
needed. HHS/CDC believes that the addition of an entry number could
lead to confusion and the accidental admission of animals that do not
meet U.S. entry requirements.
Although HHS/CDC did not receive public comment about microchip
requirements for dogs in-transit, HHS/CDC is clarifying that a
microchip 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.
Paragraph (cc)--Bill of lading and other airline requirements for
dogs.
Comment: HHS/CDC received comments from airlines that they should
not be held responsible for confirming that importers meet entry
requirements before boarding dogs. Other commenters requested more
information on how they can confirm the CDC Dog Import Form has been
completed.
Response: HHS/CDC is requiring airlines to confirm entry
requirements in order to decrease the likelihood a dog will be denied
entry and abandoned at upon arrival. Airlines can ensure importers have
appropriate paperwork prior to departure, and airlines are best
positioned to confirm required documentation at the point of departure.
Additionally, these requirements align with other airline
responsibilities in other contexts (verifying traveler passport and
visa information, screening cargo and baggage). Airlines will be
required to confirm all necessary paperwork is present and that the
information on documents is consistent when multiple documents are
presented to the airline. For example, airlines should deny boarding
based on discrepancies in paperwork that would be obvious to a
reasonable observer. CDC will issue guidance on how to confirm
documentation. It will not be an onerous process for airlines to
confirm importers have a CDC Dog Import Form receipt as importers will
be able to present the emailed receipt digitally or a paper print-out
of the receipt to an airline representative at check-in.
Comment: HHS/CDC received comments supporting the requirement that
airlines should deny boarding dogs whose importer does not present
required documentation to prevent inadmissible dogs from flying to the
United States.
Response: HHS/CDC agrees with this comment. Federal agencies that
work at ports strongly support airlines confirming importer
documentation prior to the flight to limit the number of inadmissible
dogs that arrive at ports in the United States. Many State agencies
also voiced support for required document review and visual screening
of dogs by airlines prior to accepting dogs for transport to prevent
inadmissible dogs from flying to the United States and entering their
jurisdictions. These requirements align with other airline
responsibilities in other contexts (verifying traveler passport and
visa information, screening cargo and baggage).
Comment: HHS/CDC received comments from airlines that they believed
the proposed rule would require them to buy specialized equipment
(microchip scanners) and opposed this requirement.
Response: HHS/CDC clarifies it is not asking airlines to scan dogs'
microchips. Scanning is performed at the ACF or by the importer with
assistance from CDC's quarantine station officers (also known as CDC
port health station officers). Airlines will be required to confirm all
necessary paperwork is present and that the information on documents is
consistent when multiple documents are presented to the airline. For
example, airlines should deny boarding based on discrepancies in
paperwork that would be obvious to a reasonable observer. CDC will
issue guidance on how to confirm documentation.
Comment: HHS/CDC received numerous comments from public health
partners, animal welfare groups, importers, and rescue groups that
airlines should be responsible for the animals they transport.
Response: HHS/CDC agrees with these comments and believes the best
way to ensure airline responsibility for the animals they transport is
through an existing process called a bill of lading. A bill of lading
(including an AWB) is

[[Page 41780]]

a legally binding document issued by a carrier to a shipper or importer
that details the type, quantity, and destination of the goods (i.e.,
dogs) being carried. A bill of lading serves as a shipment receipt when
the carrier delivers the goods at a predetermined destination. A bill
of lading is a key document to ensure theft or abandonment of goods
does not occur while the goods are being shipped to the final
destination. Additionally, a bill of lading serves as undisputed proof
of shipment, and it represents the agreed upon terms and conditions for
the transportation of the goods. Dogs that arrive ill, injured, or who
are denied entry upon arrival in the United must have a bill of lading
to ensure the animal receives timely care and can be tracked by Federal
agencies and airlines throughout the clearance or return process. A
bill of lading gives the Federal Government authority to leverage the
carrier's bond in cases of noncompliance. HHS/CDC encourages airlines
with limited cargo operations to work with sales supervisors in their
local offices or partner airlines to create AWB. CDC and several
foreign-based air carriers have successfully piloted the creation of
AWB for dogs transported in the passenger environment.
Comment: HHS/CDC received a comment that the rule usurps the USDA's
authority by treating all pets as imports and by forcing all dogs to
travel by air as cargo.
Response: HHS/CDC disagrees because it is not unusual for different
Federal agencies to possess overlapping legal authority and HHS/CDC's
requirements complement and do not conflict with applicable USDA
requirements. Additionally, dogs and cats are goods that are imported
into the United States if entering from a foreign country regardless of
whether the owner/importer considers the animal to be a personal pet.
An importation occurs whenever a dog or cat is presented for admission
at a U.S. port, regardless of whether the animal is being presented for
admission for the first time or returning to the United States after
traveling abroad. Dogs and cats must meet the United States'
importation requirements to be eligible for entry or re-entry. HHS/CDC
has authority to create requirements based on public health concerns
for the importation of dogs into the United States. USDA is the
competent authority for animal export and animal welfare during
transport. HHS/CDC's final rule is focused on dog and cat importation
and protecting the public health by establishing requirements specific
to preventing the reintroduction of DMRVV into the United States. HHS/
CDC's requirements for airlines to confirm documentation before
boarding and create a bill of lading or record of transport serve a
public health function by preventing inadmissible dogs from being
transported to the United States. These requirements also allow HHS/CDC
more easily track and identify dogs upon arrival that require further
public health evaluation, such as examinations needed for sick or dead
dogs or cats.
Additionally, HHS/CDC clarifies that the proposed rule and this
final rule do not require that all dogs fly as cargo. HHS/CDC does note
that some U.S. ports may require dogs to enter as cargo based on the
ACF and CBP Port Director's authority. CBP Port Directors have
authority to direct how dogs are processed and cleared at their ports.
This is done at the CBP Port Director's discretion and is not a
requirement of this final rule. HHS/CDC also notes that travelers can
choose to import dogs through another port if they want to import their
dog in the passenger environment (hand-carried or checked baggage).
HHS/CDC's final rule requires airlines to create an Airway Bill (AWB)
or other suitable bill of lading for the movement of dogs in the
passenger environment.
Comment: Some commenters stated that the creation of AWB is not
possible for dogs transported in the passenger environment (hand-
carried or checked baggage). CDC also received comment from the public
that flying with an AWB will force dogs to fly as cargo. One commenter
requested that HHS/CDC require importers and dogs transported in the
passenger environment be cleared together (which can only occur in the
Federal Inspection Station) and multiple comments stated that importers
should be able to continue to fly imported dogs as checked baggage or
hand-carried or both because it is more expensive to fly a dog as cargo
and because importers do not want to be separated from their dogs.
Commenters also stated that some airlines do not have cargo operations
so they cannot create an AWB.
Response: HHS/CDC disagrees with these comments. CDC has
successfully piloted the creation of AWB for dogs transported in the
passenger environment with several airlines, therefore, HHS/CDC
believes this approach can be adopted by other air carriers so that
dogs can continue to fly as hand carried or checked baggage. HHS/CDC
has also revised the requirements in this final rule to allow greater
flexibility for airlines that are unable for technical reasons to
generate an AWB to transport dogs as cargo, checked baggage, or hand-
carried baggage. Airlines that lack the technical ability to generate
an AWB to transport dogs as checked baggage or as hand-carried must
request a waiver from CDC and provide a standard operating procedure
(SOP) outlining how they will ensure care for any ill, injured, or
abandoned animals in the absence of an AWB. CDC may grant an annual
waiver. As a condition of granting a waiver, CDC may require the
airline to work with a broker to file the appropriate paperwork and
identify suitable housing accommodations for any dogs detained pending
admissibility (such as an ACF or local kennel). The SOP must include
the location of a bonded facility or other suitable alternative
approved by CBP and CDC prior to transport of animals. As a further
condition of granting a waiver, CDC may require the airline to submit
documentation outlining a timetable and steps that will be taken to
develop the technical capacity to generate an AWB (or another suitable
alternative to an AWB) to transport dogs. CDC will provide additional
details for airlines seeking exemption for the AWB requirement in
technical instructions available by emailing [email protected].
Comment: One commenter noted that HHS/CDC should utilize CBP's
Automated Commercial Environment (ACE) 2.0 system for dog importations.
Response: HHS/CDC carefully considered this comment but declines
this option because using ACE would require importers to hire a broker
which would significantly increase importer costs. Additionally, ACE is
only accessible by CBP personnel as authorized by their respective
agency role and provisioned for cargo environments, and would not be
provisioned for use by CBP officers located in the FIS in verifying
whether an owner has uploaded all required documentation prior to
arrival. Instead, by requiring that dog importers use the CDC Dog
Import Form, CDC is able to track dog imports in a manner similar to
ACE through a web-based system that does not require importers to use
brokers. Importers will present the paper-based CDC Dog Import Form
receipt to CBP officers in the FIS, or the receipt can be uploaded into
ACE for dogs traveling in cargo. This ensures the receipt is accessible
by all Federal officers at ports of entry. Additionally, CDC does not
currently have access to ACE and obtaining access would be costly for
CDC at this time. CDC, however, may consider use of this system in the
future.
Comment: HHS/CDC also received comments from the airline industry
on the six-hour timeline for airlines to

[[Page 41781]]

transport abandoned, ill, or injured dogs and dogs denied entry
awaiting return to their country of origin to an HHS/CDC-approved
facility. The commenter suggested that the six-hour window is arbitrary
and not supported by corroborative evidence and requested 24 hours to
transport these dogs from cargo warehouses to veterinary clinics or
kennel facilities, and six hours to notify HHS/CDC of the abandoned,
ill, or injured dogs. HHS/CDC also received many comments from public
health partners, animal welfare groups, importers, and rescue groups
supporting the six-hour timeframe for airlines to transport abandoned,
ill, or injured dogs or dogs awaiting return to their country of origin
to a veterinary or kennel facility for examination or care.
Response: HHS/CDC appreciates these comments and notes that it has
carefully considered the proposed 6-hour timeframe based on concerns
relating to the burden on the carrier and to the health and safety of
animals detained pending a determination as to their admissibility and
workers who may interact with these animals. HHS/CDC anticipates that
significantly increasing the time airlines are allowed to keep dogs in
cargo warehouses (from 6 hours to 24 hours) would result in an increase
in illness and deaths in dogs. An increase in ill dogs and dogs dead on
arrival would negatively impact Federal and State public health
resources because CDC would need to conduct a public health
investigation into the cause of the illness or death. CDC conducted an
average of 38 animal health investigations per year between 2019-2023.
Each illness/death investigation can cost between $100-$5,500 per event
($3,800-$209,000 per year in public health costs to State or Federal
agencies).\188\
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\188\ 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. Transboundary and Emerging Diseases, 2022; 1-9.
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Additionally, CDC notes that cargo warehouse staff are not trained
to feed/water/care for animals and that detaining animals for long
periods of time increases the health risks to the animals as well as
the potential risk of injury or expose to workers. Expanding the
timeframe for airlines to house dogs in cargo warehouses necessitates
additional care from cargo warehouse staff, thereby increasing the risk
of bites, scratches, and other injuries from dogs. Additionally, the
stress dogs experience during transport could exacerbate the risk of
injury to cargo warehouse workers. CDC has documented instances of
cargo warehouse staff leaving animals unattended in their crates
without food, water, or access to elimination areas outside their
crates for prolonged periods of time. Prolonged wait times in cargo
warehouses have also led to illness and death in multiple animals (five
illnesses and one death in 2019; and two deaths in 2023).
Consistent with USDA regulations, animals should receive food at a
minimum every 24 hours and water every 12 hours during
transport.\189\Additionally, animals must have their enclosures and
food and water receptacles cleaned every 24 hours. CDC and USDA have
documented numerous shipments of animals that did not have adequate
food and water during transport, nor were their cages cleaned as
required. Lengthy international flights, which can begin for a crated
animal up to 4 hours before the flight departs and includes the flight
time (6-16 hours) plus a 24-hour wait in a cargo hold, will leave many
animals exceeding this feeding/watering/cleaning period leading to
dehydration, hypoglycemia, illness, or death. Neglect of basic animal
care, such as feeding and watering, has a direct public health impact
on CDC as noted above because CDC must investigate every report of
illness or death in an imported animal to determine the public health
risk.
---------------------------------------------------------------------------

\189\ USDA. Animal Welfare Act and Animal Welfare Regulations.
Title 9, Chapter 1, Subpart A, Part 3.9, 3.10, 3.14, 3.17). https://www.aphis.usda.gov/animal_welfare/downloads/AC_BlueBook_AWA_508_comp_version.pdf.
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However, HHS/CDC recognizes that some airlines may need additional
time to find suitable housing for animals; therefore, HHS/CDC is
modifying the language in the final rule to allow airlines up to 12
hours to move dogs from cargo warehouses to an ACF or other CDC-
approved location if the animal is healthy. Obviously ill or injured
animals must be reported immediately to the CDC quarantine station of
jurisdiction and must be transported immediately thereafter to a
veterinary clinic or as directed by CDC. Notification to CDC should be
made based on visual observation of illness in animals (e.g., unable to
stand, difficulty breathing, bleeding, broken bones or disfigured
limbs, seizures, vomiting, or discharge from the nose, mouth, or eyes)
by the airline employees or its agents (including contracted cargo
warehouse staff) or by Federal government officials (e.g., CDC or CBP
staff). Delaying the care of ill or injured animals will likely result
in more deaths, increased potential public health risks, and would be
considered inhumane.
Comment: HHS/CDC received comments from the public that it will be
difficult to ensure airlines comply with these requirements.
Response: HHS/CDC has outlined options for addressing noncompliant
air carriers in Sec. 71.51(ee) of the final rule. Failure to comply
with CDC requirements can result in CDC prohibiting carriers from
transporting animals. However, CDC will develop training materials for
airline partners and animal shippers in the industry and work
collaboratively with the animal transportation industry to ensure
compliance. Diligence is needed from importers as well as the airlines
to ensure compliance with U.S. entry requirements. CDC will continue to
develop job aids, presentations, website information, and other
materials to distribute to those in the animal transport industry.
Comment: HHS/CDC received a comment that ``since airlines have
transport registrations with USDA, it is the USDA's responsibility to
set the rules and regulations for transportation of live animals.''
Response: Although HHS/CDC agrees that USDA's regulations govern
many aspects of animal transportation, this final rule is authorized
under section 361 of the Public Health Service Act (PHS Act) (42 U.S.C.
264), which authorizes the HHS Secretary to 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. The final rule's
provisions, among other things, are designed to prevent the importation
of inadequately vaccinated, ill, or dead animals which can lead to
communicable disease spread. This is both a public health issue and an
animal health issue. HHS/CDC regulates public health risks and works
closely with USDA to align requirements where possible; however, the
agencies have different mandates, and the purpose of this final rule is
to protect the public's health.
Comment: HHS/CDC also received comments that airline costs would
increase or that airlines will stop transporting dogs.
Response: HHS/CDC appreciates these comments and notes that the
comment from an airline industry organization did not state that HHS/
CDC's proposed requirements would cause airlines to stop transporting
dogs. For the NPRM, HHS/CDC attempted to estimate the costs to airlines
but lacked data on the potential costs to airlines for additional
document review and to create bills of lading. HHS/CDC did not receive
data

[[Page 41782]]

from commenters that would help refine these cost estimates, but HHS/
CDC understands that commenters may believe the cost estimates for
airlines are too low. In the NPRM, HHS/CDC estimated the costs to
airlines would include an additional five minutes per dog from DMRVV-
free or low-risk countries and 15 minutes per dog from DMRVV high-risk
countries. This resulted in an estimate of about $3.2 million (range:
$1.3 to $6.6 million) to airlines. On average, this would correspond to
between $6.25 to $17.29 per dog transported. CDC could only assume how
much time would be required for airlines to review documentation.
However, based on comments from the airline industry about the
potential difficulties for some airlines to produce bills of lading and
other commenters expressing concern that the cost to airlines were
underestimated, HHS/CDC increased the amount of time that would assume
to be required for airlines to comply with the requirements of this
final rule. In the analysis in the final rule, HHS/CDC assumed the
amount of time per dog would be 50% more than the estimate for the NPRM
for dogs from DMRVV high-risk countries and 100% more for dogs from
DMRVV-free or low-risk countries. This amount should not significantly
impact airlines' costs to transport dogs on international flights.
On an individual dog basis, the greatest costs to airlines would be
incurred when dogs are denied entry and abandoned by an importer.
However, this would only occur for a fraction of the dogs transported
and HHS/CDC believes the additional requirements included in this final
rule should reduce the number of dogs denied entry by standardizing the
forms used to verify rabies vaccination documentation. As noted above,
the annual costs to airlines for abandoned dogs was estimated to be
between $42,000 and $650,000 per year. Assuming the number of dogs
denied entry with the final rule is less than under the regulatory
baseline, the costs to airlines for abandoned dogs should decrease.
In addition, HHS/CDC has included language in the final rule that
allows airlines to seek reimbursement from importers that abandoned
animals on arrival, thereby mitigating the potential cost burden on
airlines and making it unlikely that airlines will stop transporting
animals. They may modify their transportation process to ensure animals
are healthy and meet CDC entry requirements prior to transporting the
animal. Furthermore, the clearance process at airports may have to be
modified to reflect CDC's requirements that are being put in place to
control the public health risk of dogs arriving from DMRVV high-risk
countries, but CDC will work with airlines and other port partners to
continue the safe transportation of dogs from DMRVV high-risk
countries.
Paragraph (dd)--Order prohibiting carriers from transporting dogs
and cats.
HHS/CDC received no public comment on this paragraph of the
proposed rule.
Paragraph (ee)--Prohibition on imports of dogs from DMRVV-
restricted countries.
Comment: HHS/CDC received several comments and questions regarding
DMRVV-restricted countries. The questions included how the list would
be determined, whether data would be publicly available, and whether a
country could appeal their status. Suggestions were offered to ban
veterinarians instead of countries and to issue permits for dogs
arriving from DMRVV-restricted countries. Some commenters expressed
concern that people could get stuck overseas with pets when a country
was added to the DMRVV-restricted list.
Response: HHS/CDC will 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 HHS/CDC's website. The addition of countries to the
DMRVV-restricted country list will also be announced in notices
published in the Federal Register and the data supporting the
announcement will also be published in the Federal Register. HHS/CDC is
aware of the risk of some travelers being unable to return with their
dogs, and HHS/CDC will consider ways to provide adequate notice to
importers of changes to the DMRVV-restricted country list, such as
including as much time as possible between the announcement of a change
to the list and the effective date. HHS/CDC will also retain the
ability to issue, at its discretion, a special exemption permit on an
extremely limited basis for certain dogs that have been in a DMRVV-
restricted country in the six months prior to their importation into
the United States.
Although there is no formal appeal process, a listed country's
officials may submit additional information to CDC if they believe that
the country has been added to the ``List of DMRVV-Restricted
Countries'' in error or if they believe the listing is no longer
current. However, HHS/CDC may maintain 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 vaccination credentials or invalid rabies
vaccination certificates, or the use of expired, ineffective, or
unapproved vaccine products within a country.
HHS/CDC notes that maintaining a list of individual veterinarians
would be extremely cumbersome, operationally difficult to revise and
maintain, and raise concerns regarding HHS/CDC's ability to effectively
enforce such a restriction. Therefore, HHS/CDC declines to implement
this proposal. HHS/CDC further notes that the goal of having an
official government veterinarian certify the export documentation is to
ensure that the exporting country is monitoring the activity of their
veterinarians and not certifying any documents they deem suspicious or
fraudulent. This also allows CDC to communicate concerns directly with
exporting country officials if fraudulent paperwork is noted. Each
country has its own rules and regulations governing veterinary medicine
and it would be inappropriate and likely ineffective for HHS/CDC to
focus on individual foreign veterinarians.
Paragraph (ff)--Request for issuance of additional fines or
penalties.
HHS/CDC received no public comment on this paragraph of the
proposed rule. However, CDC is adding language informing the public
that it may also refer potential violations of Federal law to the U.S.
Department of Justice for investigation, and based on the results of
such investigation, prosecution. Specifically, CDC may refer a matter
to the U.S. Department of Justice if the Director has reason to believe
that an individual or organization has violated Federal law, including
by forcibly assaulting, resisting, opposing, impeding, intimidating, or
interfering with a U.S. government employee while engaged in or on
account of the performance of their official duties in violation of 18
U.S.C. 111, by obstructing an agency proceeding in violation of 18
U.S.C. 1505, or by otherwise engaging in conduct contrary to law. CDC
believes that this provision serves an important function in informing
the public and potentially deterring bad actors from engaging in
conduct that forcibly interferes with CDC and CBP's ability to carry
out its official duties or obstructing an agency proceeding under this
section.
Comment: HHS/CDC received public comment on matters that were not
part

[[Page 41783]]

of HHS/CDC's proposed changes to its regulations and thus are outside
of the scope of this final rule. These comments included statements
about saving wildlife and suggestions for the regulation of other
animals such as nonhuman primates.
Response: HHS/CDC is not updating its regulations for species other
than dogs and cats in this rule.
Comment: HHS/CDC also received comments asking to end the temporary
suspension of dogs entering the United States from countries with a
high risk of rabies.\190\
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\190\ CDC. Extension of temporary suspension of dogs entering
the United States from countries with a high risk of rabies. 88 FR
43570 (July 10, 2023): 43570-43581.
---------------------------------------------------------------------------

Response: HHS/CDC notes that these comments are outside the scope
of the proposed rulemaking which did not solicit any comments or
propose changes to the temporary suspension. However, HHS/CDC clarifies
that the purpose of this rulemaking is to mitigate the need for future
suspensions by reducing the likelihood of DMRVV being reintroduced into
the United States. HHS/CDC further intends to let the temporary
suspension expire on July 31, 2024. These comments are beyond the scope
of this final rule.
Comment: HHS/CDC received comments about focusing efforts on other
areas rather than this rulemaking such as vaccinating immigrants or
``illegal immigrants,'' addressing drug trafficking, addressing human
trafficking, and working to prevent the next pandemic.
Response: HHS/CDC notes that these comments are outside the scope
of the proposed rulemaking, which is focused on dog and cat
importation.

E. General Comments Relating to DMRVV High-Risk Countries

Comment: HHS/CDC received a number of comments stating that too
many countries were on the DMRVV high-risk country list. Commenters
also requested that HHS/CDC make publicly available the data used to
determine the DMRVV high-risk list.
Response: HHS/CDC notes that none of the comments it received
questioned HHS/CDC's proposed definition for DMRVV high-risk countries,
which HHS/CDC proposed to define as ``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.'' Rather, these comments were directed solely at
the number of countries that are categorized as high-risk, how the list
is compiled, and the criteria used to develop the list. There are over
100 countries currently on the DMRVV high-risk country list which
reflects the fact that rabies is a neglected tropical disease.
Neglected tropical diseases (NTDs) are a diverse group of conditions
caused by a variety of pathogens (including viruses, bacteria,
parasites, fungi and toxins) and are associated with devastating
health, social, and economic consequences. NTDs are mainly prevalent
among impoverished communities in tropical areas, although some have a
much larger geographical distribution.\191\
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\191\ World health Organization. www.who.int/news-room/fact-sheets/detail/rabies.
---------------------------------------------------------------------------

The robust rabies control programs present in the United States do
not exist in many other countries due to a variety of factors, such as
access to veterinary care, sufficient infrastructure to support
adequate vaccination, and lack of veterinarians or animal support staff
trained to vaccinate animals.\192\ Many DMRVV high-risk countries do
not have adequate rabies surveillance and testing capacity and
therefore do not report cases to WOAH even though rabies is widespread
within their country. For example, in 2021 only 35 countries reported
rabies case data to WHO and none reported on the number of suspected
cases that underwent testing. Until countries report complete data
routinely, relying on international organizations' data to make risk
determinations will remain problematic. A lack of rabies surveillance
data is more likely to reflect a poor public health infrastructure for
rabies case detection within a country than the absence of rabies.
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\192\ Wallace RM, Undurraga EA, Blanton JD, Cleaton J, Franka R.
Elimination of Dog-Mediated Human Rabies Deaths by 2030: Needs
Assessment and Alternatives for Progress Based on Dog Vaccination.
Front Vet Sci. 2017 Feb 10;4:9. doi: 10.3389/fvets.2017.00009. PMID:
28239608; PMCID: PMC5300989.
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CDC evaluates and updates the DMRVV high-risk country list every
year and posts the updated list on CDC's website by April 1. For this
annual country risk assessment, CDC subject matter experts review
publicly available data, including data from international
organizations (including the World Health Organization (WHO); the WHO
Rabies Bulletin--Europe; the Pan-American Health Organization, and
WOAH); published government reports; scientific publications; and
outbreak report alerts such as ProMED,\193\ as well as information
provided by national and international rabies experts. HHS/CDC will
also review the information and re-assess a country's status when
presented with additional substantial data to support canine rabies-
free status by a foreign country's officials. Lastly, CDC has published
the criteria for how it determines a country's classification as a
high-risk, low-risk and DMRVV-free country in a peer-reviewed journal
which is publicly available.^{194 195}
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\193\ The Program for Monitoring Emerging Diseases (ProMED) is a
program of the International Society for Infectious Diseases and is
available at https://promedmail.org/.
\194\ Henry RE, Blanton JD, Angelo KA, Pieracci EG, Stauffer K,
et al. A country classification system to inform rabies prevention
guidelines and treatment. Journal of Travel Medicine,
2022;29(4):taac046. doi: 10.1093/jtm/taac046. PMID: 35348741.
\195\ Minhaj FS, Bonaparte SC, Boutelle C, Wallace RM. Analysis
of available animal testing data to propose peer-derived
quantitative thresholds for determining adequate surveillance
capacity for rabies. Scientific Reports 2023; 13: 3986.
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Comment: HHS/CDC received questions asking why HHS/CDC's DMRVV
high-risk country list differs from those used by other countries,
including the European Union.
Response: HHS/CDC notes that it is not unusual for different
countries to use different methods, criteria, or data for determining a
country's rabies risk level. CDC's list is very similar and closely
aligns with the lists used by the EU, Australia, New Zealand, and
Canada. However, HHS/CDC notes that the entry requirements for dogs
from DMRVV high-risk countries differ significantly for the EU and
Australia because those countries having stricter entry requirements
than those outlined in this final rule. CDC's method for developing the
high-risk country list is described in detail above.
Comment: HHS/CDC received questions asking why CDC's list of
approved laboratories differs from the laboratories on the EU list.
Commenters also noted there were limited or no laboratories in certain
regions of the world, or that shipping samples was cost prohibitive and
challenging. Commenters noted the lack of CDC-approved laboratories in
Asia, Africa, and South America was discriminatory toward U.S. citizens
and tourists from those regions.
Response: CDC acknowledges that there are limited or no
laboratories in certain regions of the world. For this reason, CDC has
included the option to quarantine at an ACF if they cannot obtain a
titer for their dog. Prior to 2022, the Nancy Laboratory for Rabies and
Wildlife which is part of the French Agency for Food, Environmental and
Occupational Health Safety (ANSES) conducted the global proficiency
testing

[[Page 41784]]

program for rabies serology laboratories worldwide. CDC uses the ANSES-
approved rabies laboratory list, excluding several laboratories that
have been associated with fraudulent titers resulting in the
importation of rabid dogs into rabies-free countries. Laboratory
proficiency testing is an essential tool for helping to ensure that a
laboratory gets its results right. Proficiency testing allows
participating laboratories to compare their results and performance
with their peers across the world. It helps to identify testing or
measurement problems. A proficiency testing program is critical to
ensure laboratories are qualified to test samples to ensure the results
they produce are valid. In the case of rabies serology laboratories, it
is imperative that an animal that receives a passing titer --which can
suggest that an animal is protected against rabies virus infection--is
truly protected from infection. CDC is working to establish a
proficiency testing program to further expand the current list of CDC-
approved laboratories. CDC intends to work with laboratories to enhance
coverage and accessibility.
HHS/CDC will add laboratories that have successfully completed
ANSES proficiency testing (or other CDC-approved proficiency testing
equivalent) to the CDC-approved laboratory list (assuming they have not
issued fraudulent titers). Additionally, HHS/CDC recognizes there are
currently three ANSES-approved labs in the United States. Due to the
limited availability of approved laboratories in some countries, CDC
strongly encourages U.S. citizens have their dogs vaccinated against
rabies while in the United States before traveling, and submit a titer
to a U.S. laboratory while in the United States to minimize cost and
shipping challenges, and ensure U.S. citizens can return to the United
States with their dogs after traveling to a DMRVV high-risk country for
a prolonged period of time (i.e., when their U.S.-issued rabies
vaccination may be expired). HHS/CDC notes that the requirement for
titers is a WOAH standard for the international movement of any dog
that has been in a DMRVV high-risk country; therefore, HHS/CDC
disagrees that the final rule is discriminatory toward U.S. citizens
and tourists.
Comment: Other commenters asked that HHS/CDC only use the number of
cases of human and dog rabies for a country to determine the DMRVV
high-risk list because only countries that report cases of rabies in
humans and/or dogs should be considered high-risk.
Response: HHS/CDC disagrees with this request because many DMRVV
high-risk countries do not have adequate rabies surveillance and
testing capacity and therefore do not report cases to WOAH even though
rabies is widespread within their country. For example, in 2021 only 35
countries reported rabies case data to WHO and none reported on the
number of suspected cases that underwent testing. Until countries
report complete data routinely, relying on international organizations'
data to make risk determinations will remain problematic. A lack of
rabies surveillance data is more likely to reflect a poor public health
infrastructure for rabies case detection within a country than the
absence of rabies.
As discussed above, there are over 100 countries currently on the
DMRVV high-risk country list which reflects the fact that rabies is a
neglected tropical disease.\196\ The robust rabies control programs
present in the United States do not exist in many other countries due
to a variety of factors, such as access to veterinary care, sufficient
infrastructure to support adequate vaccination, and lack of
veterinarians or animal support staff trained to vaccinate
animals.\197\ CDC evaluates and updates the DMRVV high-risk country
list every year and posts the updated list on CDC's website by April 1.
For this annual country risk assessment, CDC subject matter experts
review publicly available data, including data from international
organizations (including the World Health Organization (WHO); the WHO
Rabies Bulletin--Europe; the Pan-American Health Organization, and
WOAH); published government reports; scientific publications; and
outbreak report alerts such as ProMED,\198\ as well as information
provided by national and international rabies experts. CDC has
published the criteria for how it determines a countries classification
as a high-risk, low-risk and DMRVV-free country in a peer-reviewed
journal which is publicly available.^{199 200} HHS/CDC also
believes that countries will be more motivated to share their rabies
surveillance data to be removed from the DMRVV high-risk list, which
will result in improved rabies global surveillance.
---------------------------------------------------------------------------

\196\ World health Organization. www.who.int/news-room/fact-sheets/detail/rabies.
\197\ Wallace RM, Undurraga EA, Blanton JD, Cleaton J, Franka R.
Elimination of Dog-Mediated Human Rabies Deaths by 2030: Needs
Assessment and Alternatives for Progress Based on Dog Vaccination.
Front Vet Sci. 2017 Feb 10;4:9. Doi: 10.3389/fvets.2017.00009. PMID:
28239608; PMCID: PMC5300989.
\198\ The Program for Monitoring Emerging Diseases (ProMED) is a
program of the International Society for Infectious Diseases and is
available at https://promedmail.org/.
\199\ Henry RE, Blanton JD, Angelo KA, Pieracci EG, Stauffer K,
et al. A country classification system to inform rabies prevention
guidelines and treatment. Journal of Travel Medicine,
2022;29(4):taac046. Doi: 10.1093/jtm/taac046. PMID: 35348741.
\200\ Minhaj FS, Bonaparte SC, Boutelle C, Wallace RM. Analysis
of available animal testing data to propose peer-derived
quantitative thresholds for determining adequate surveillance
capacity for rabies. Scientific Reports 2023; 13: 3986.
---------------------------------------------------------------------------

Comment: Some commenters expressed concerns that sudden changes to
the DMRVV high-risk country list could result in animals being
abandoned overseas.
Response: In HHS/CDC's experience, such concerns are unfounded.
Since the inception of the list in 2018, only one country has been
added to the list, which was based on a widespread outbreak of DMRVV
along a porous international border. CDC has, however, removed multiple
countries after they demonstrated improvement in their rabies control
programs (moving the countries from DMRVV high-risk to DMRVV low-risk
or DMRVV-free status). Additionally, if a country were to be added to
the DMRVV high-risk country list, CDC would publish the information on
its website and allow for a transition period which would provide
importers sufficient time to come into compliance with new importation
requirements for dogs arriving from that country. HHS/CDC further
encourages people intending to travel to the United States to review
the DMRVV high-risk list before traveling and maintain a valid rabies
vaccination record and titer (if required) for the dog they wish to
bring into the United States.
Comment: HHS/CDC also received comments that it should not maintain
a list or differentiate between DMRVV-free, DMRVV low-risk and DMRVV
high-risk countries because all imported dogs should be subject to the
same requirements regardless of the endemicity of DMRVV within a
country. Some comments included statements that any imported dog
potentially poses a public health threat and could threaten the health
of the U.S. domestic dog population.
Response: HHS/CDC appreciates these comments and recognizes there
could be challenges in confirming whether a dog has been only in DMRVV-
free or DMRVV low-risk rabies countries during the six months prior to
the dog's arrival in the United States. HHS/CDC further acknowledges
that some importers have, in the past, moved dogs from DMRVV high-risk
countries to DMRVV-free countries solely to circumvent HHS/CDC entry

[[Page 41785]]

requirements. HHS/CDC defines risk based on the dog's country of origin
(or countries the dog has been present in during the previous six
months), the risk of rabies within countries (based on endemicity and
rabies control programs), and the dog's vaccination status (U.S.- vs.
foreign-vaccinated). Although HHS/CDC acknowledges that holding all
imported dogs to one standard could theoretically reduce the burden of
confirming a dog's country of origin, the final rule does not adopt
this approach because it would be unduly burdensome for importers
arriving with dogs from countries that have demonstrated adequate
control of DMRVV.
Comment: HHS/CDC received three comments specific to Ecuador's
inclusion on the DMRVV high-risk list and one comment specific to
Ukraine's inclusion on the DMRVV high-risk list.
Response: Ecuador and Ukraine are on the DMRVV high-risk list
because they currently meet HHS/CDC's criteria for inclusion on the
DMRVV high-risk list.
As noted above, CDC evaluates and updates the DMRVV high-risk
country list annually and posts the updated list on CDC's website by
April 1. CDC subject matter experts review publicly available data,
including data from international organizations (including the WHO; the
WHO Rabies Bulletin--Europe; the Pan-American Health Organization, and
WOAH); published government reports; scientific publications; and
outbreak report alerts such as ProMED,\201\ as well as information
provided by national and international rabies experts. HHS/CDC will
also review the information and re-assess a country's status when
presented with additional substantial data to support canine rabies-
free status by a foreign country's officials. Lastly, CDC has published
the criteria for how it determines a countries classification as a
high-risk, low-risk and DMRVV-free country in a peer-reviewed journal
which is publicly available.^{202 203} HHS/CDC continues to
review its list of DMRVV high-risk countries annually and will update
the listed based on available data.
---------------------------------------------------------------------------

\201\ The Program for Monitoring Emerging Diseases (ProMED) is a
program of the International Society for Infectious Diseases and is
available at https://promedmail.org/.
\202\ Henry RE, Blanton JD, Angelo KA, Pieracci EG, Stauffer K,
et al. A country classification system to inform rabies prevention
guidelines and treatment. Journal of Travel Medicine,
2022;29(4):taac046. Doi: 10.1093/jtm/taac046. PMID: 35348741.
\203\ Minhaj FS, Bonaparte SC, Boutelle C, Wallace RM. Analysis
of available animal testing data to propose peer-derived
quantitative thresholds for determining adequate surveillance
capacity for rabies. Scientific Reports 2023; 13: 3986.
---------------------------------------------------------------------------

F. Comments Relating to the Economic Impact of the Proposed Rule

Comment: HHS/CDC received a number of comments stating the economic
impact analysis underestimated the cost to importers. Some commenters
reported facing higher costs relative to estimates included in the NPRM
and provided additional cost information relevant to the analysis. HHS/
CDC received a number of comments around the cost for post-arrival
follow-up at ACF and the costs for transporting dogs as cargo, which is
required by some U.S. ports with ACF.
Response: HHS/CDC considered these comments and notes that it is
challenging to extrapolate costs incurred by some importers to generate
the average cost of importation for an estimated 800,000 dogs per year.
HHS/CDC increased the average cost estimate for post-arrival care at
ACF to $900 per dog with a range from $500 to $1,300. These costs
depend in part on how many dogs arrive in a shipment such that if more
dogs arrive in a single shipment, the cost per dog would be less. HHS/
CDC does not require any dogs to be shipped as cargo; this decision may
be made by some U.S. ports as part of their working relationships with
ACF and the CBP Port Director. HHS/CDC acknowledges that such a
requirement would increase costs for some importers. Both of these
costs (ACF prices and need to ship dogs as cargo) would only be
incurred by the subset of foreign-vaccinated dogs imported from DMRVV
high-risk countries. However, the additional costs associated with
shipping via cargo would only apply to importers who would have hand-
carried their dogs or checked them as baggage without this requirement
and arrive at a U.S. port with the cargo shipping requirement. The
average costs associated with shipping dogs as cargo are estimated to
be $2,000 (range: $1,500 to $2,500) \204\ compared to an average of
$300 (range: $200 to $400) for dogs shipped as hand-carried or checked
baggage. Under the regulatory baseline, HHS/CDC assumes 25%, range: 17%
to 50% of dogs going to ACF are shipped as cargo. With the final rule,
HHS/CDC assumes that 60%, range: 60% to 70% of dogs going to ACF will
be shipped as cargo. HHS/CDC also increased the cost estimate
associated with the need for importers of foreign-vaccinated dogs from
high-risk countries to arrive at authorized U.S. ports with ACF to a
range of between $292 and 984 per dog shipment.
---------------------------------------------------------------------------

\204\ Feathers and Fur Express (2023) How much does it cost to
fly a pet/s internationally? International Pet Shipping Costs--
Feathers & Fur Express (ffexpresspets.com). Accessed November 10,
2023. Note that the costs reported in this reference include cargo
shipping costs to Germany, the United Kingdom, Japan, and Australia.
The reference includes costs for small and large dogs shipped to
each country. Costs are much higher for larger dogs or for dogs
shipped over longer distances. The highest costs were for Australia,
which may be more representative of shipping costs from DMRVV high-
risk countries in Africa. The European costs may be similar to
shipping costs for dogs imported from DMRVV high-risk countries in
Europe or Central America or South America. The costs for Japan may
be similar to costs for DMRVV high-risk countries in Asia. The
simple average cost across the four countries and dog sizes is
$1,931 in 2023 USD. This would correspond to $1,622 in 2020 after
adjustment with the consumer price index: CPI Inflation Calculator
(bls.gov). The most likely estimate is increased to $2,000 in case
the costs to importers from DMRVV high-risk countries would be
higher than for the countries for which data are available. This
increase from $1,600 to $2,000 would also allow some importers to
choose to hire shippers to facilitate the importation process or
brokers to support customs clearance. The need to hire shippers may
be reduced by the need to visit CDC-registered ACF, who may be able
to review documentation in advance of arrival when reservations are
made.
---------------------------------------------------------------------------

Comment: HHS/CDC received a comment inquiring about the estimated
costs incurred by different categories of importers with the final
rule. HHS/CDC received a request to provide separate cost estimates for
deployed Federal employees.
Response: HHS/CDC does not have a specific cost breakdown per
category of importer but believes that costs would be most impacted by
the foreign country from which importers choose to import dogs and not
by the category of importer. The costs to importers would primarily
depend on whether dogs are imported from DMRVV high-risk countries
versus DMRVV-free or low-risk countries and from which specific
countries importers choose to import dogs. Even among dogs imported
from DMRVV high-risk countries, the costs would depend on whether the
dog was vaccinated in the United States or vaccinated in a foreign
country. The costs to Federal employees would then depend on whether
they are deployed to DMRVV high-risk countries and whether they had
their dogs vaccinated in the United States prior to deploying to the
high-risk DMRVV country. For commercial importers, their costs would
depend on which foreign countries they choose to import dogs. If
commercial importers currently import dogs from DMRVV high-risk
countries, their future costs will depend on whether they could shift
their operations to instead import dogs from DMRVV-free or low-risk
countries.

[[Page 41786]]

The average estimated marginal cost of the final rule to importers
of dogs from DMRVV-free or low-risk countries is $23 per dog (range
$7.70 to $48 per dog). In contrast, the average estimated marginal cost
for dogs from DMRVV high-risk countries is $870 per dog (range $260 to
$2,400 per dog). These cost estimates are net of the costs estimated
under the regulatory baseline. Among dogs from DMRVV high-risk
countries, the costs depend on whether the dog was vaccinated in the
United States (estimated average marginal cost per dog range: $15 to
$73 per dog) or another country (estimated average marginal cost per
dog range: $910 to $3,800 per dog). Finally, among foreign-vaccinated
dogs from DMRVV high-risk countries, the costs to importers are likely
to vary considerably depending on the country from which dogs would be
imported, which will influence costs associated with obtaining titer
tests and shipping costs (especially for dogs arriving as cargo).
The estimates reported above represent the average cost per dog for
each type of dog import in the first year of implementation. The
estimated cost per dog is expected to decrease slightly in subsequent
years depending on the introduction of more HHS/CDC-registered ACF and
CDC-approved laboratories. However, the costs faced by any individual
importer may be higher than these average cost estimates. The most
complete data on the countries from which dogs were imported prior to
the temporary suspension is for dogs shipped as cargo. HHS/CDC only has
data for dogs that are imported as cargo. During 2018 through 2020,
about 75% of these dogs arrived from four countries: Ukraine, Colombia,
Russia, and China, in order. Almost of half (47%) of dogs arrived from
two countries (Ukraine and Colombia) among dogs imported from DMRVV
high-risk countries as cargo. The dogs imported from these countries
may have lower costs than dogs imported from DMRVV high-risk countries
because these countries either have a CDC-approved laboratory or share
a border with a country with an approved laboratory.
In addition, HHS/CDC updated the cost estimates for importers from
DMRVV-free or low-risk countries by accounting for the additional costs
associated with being unable to import dogs younger than six months of
age at land borders. The costs associated with the requirement for
proof that a dog has been only in DMRVV low-risk or DMRVV-free
countries have increased because HHS/CDC added more examples of the
types of proof required. Each type of document requires certification
by a USDA or foreign official government veterinarian. Examples
include: (a) a valid foreign export certificate from a DMRVV-free or
DMRVV low-risk country that has been certified by an official
government veterinarian in that country; (b) a USDA export certificate
if the certificate is issued to allow the dogs to travel to a DMRVV-
free or DMRVV low-risk country, (c) a valid Certification of Foreign
Rabies Vaccination and Microchip form if completed in a DMRVV-free or
DMRVV low-risk country, or (d) a valid Certification of U.S.-Issued
Rabies Vaccination form. These documents are often required for
individuals to travel internationally with their pets but are not
required for travel to Canada or Mexico. These documents may be used as
long as they specify travel to or from the country from which a dog is
imported. Individuals who frequently travel to and from Canada and
Mexico (or any other country) can obtain a valid Certification of U.S.-
Issued Rabies Vaccination form, which will remain valid for multiple
trips for up to three years corresponding to the duration of protection
for dog rabies vaccines.
HHS/CDC also accounted for the reduction in costs associated with a
dog only needing one titer test during its lifetime if a dog is
imported more than once from a DMRVV high-risk country and maintains a
current rabies vaccination. HHS/CDC also accounted for the reduction in
transportation costs for U.S.-vaccinated dogs imported from DMRVV high-
risk countries, which will no longer have to arrive at U.S. ports with
CDC quarantine stations. HHS/CDC did not revise estimates for titer
shipment costs but notes that, per technical instructions being
published in conjunction with this rule, a single titer test will be
valid for a dog's lifetime (provided the dog remains current with
rabies vaccinations). The cost for shipping may be reduced since
importers may obtain the titer test at any time. This change may allow
some importers to pool samples for shipment to HHS/CDC-approved
laboratories to reduce their costs.
In general, importers of dogs originating from African countries
may face higher costs to comply with the requirements finalized in this
rule because there are fewer HHS/CDC-approved laboratories on this
continent, which would increase the costs for importers to ship samples
for titer testing or require quarantine if a titer test cannot be
conducted. However, it is challenging to extrapolate costs from
individual situations to the total costs for imported dogs from DMRVV
high-risk countries because HHS/CDC lacks data on both the total number
of dogs imported as well as the proportion of dogs imported from each
DMRVV high-risk country. HHS/CDC acknowledges that individual importers
may face higher costs than those estimated for the average cost
estimates and that importers of foreign-vaccinated dogs from DMRVV
high-risk countries will face higher costs than other importers. This
group faces higher costs because the dogs they import present a greater
risk of DMRVV importation and thus require more substantial and costly
measures to mitigate that elevated risk.
HHS/CDC believes the cost per dog estimates presented above would
apply to deployed Federal government employees and that their costs to
import dogs would be similar as for other dog importers within each
category (i.e., importers of dogs from DMRVV-free or low-risk
countries, importers of U.S.-vaccinated dogs from DMRVV high-risk
countries, or importers of foreign-vaccinated dogs from DMRVV high-risk
countries). Deployed Federal government employees may be able to reduce
their costs by vaccinating their dogs in the United States and
obtaining a Certification of U.S.-issued Rabies Vaccination form prior
to departing the United States. As noted above, the costs for U.S.-
vaccinated dogs imported from DMRVV high-risk countries are much less
than for foreign-vaccinated dogs. The Certification of U.S.-issued
Rabies Vaccination form will remain valid for three years after a dog
receives a three-year rabies vaccine in the United States. Dog rescue
organizations operating in DMRVV high-risk countries would face the
highest costs assuming all of their dogs would be foreign-vaccinated
(and not U.S.-vaccinated). However, as noted above, the last four dogs
imported while infected with DMRVV were rescue dogs from DMRVV high-
risk countries. Thus, this category of importer likely poses the
greatest public health risk.
Comment: HHS/CDC received some comments that the changes proposed
in the NPRM and finalized in this final rule underestimate the costs to
airlines. The commenters did not provide further details regarding
which specific costs they believed HHS/CDC had underestimated.
Response: In the NPRM, HHS/CDC attempted to estimate the costs to
airlines but lacked data on the potential costs to airlines for
additional document review and to create bills of lading. HHS/CDC did
not receive specific comments requesting refinement of these cost
estimates but understands that airlines may believe the cost

[[Page 41787]]

estimates are too low. In the NPRM, HHS/CDC estimated that the costs to
airlines for document review and processing would include an additional
five minutes per dog from DMRVV-free or low-risk countries and 15
minutes per dog from DMRVV high-risk countries. This resulted in an
estimate of about $3.2 million (range: $1.3 to $6.6 million) to
airlines.
In the analysis in the final rule, CDC increased the estimated
costs to airlines by 100% for dogs imported from DMRVV-free or low-risk
countries and by 50% for dogs imported from DMRVV high-risk countries
to account for a number of commenters who suggested that costs to
airlines should be higher than the estimates included in the NPRM
analysis. The average cost corresponds to between $7.12 to $20.42 per
dog transported as a result of the provisions of this final rule. This
amount should not significantly impact airlines' costs to transport
dogs on international flights. On an individual dog basis, the greatest
costs would be incurred when dogs are denied entry to the United States
and abandoned by an importer. However, this would only occur for a
small proportion of the dogs transported, and HHS/CDC believes the
additional requirements included in this final rule should reduce the
number of dogs denied entry by requiring airlines to confirm
documentation before boarding dogs and by requiring government
certification of rabies vaccination documentation. The use of
standardized forms should facilitate and streamline review of rabies
vaccination documentation. This will be the primary new requirement for
U.S.-vaccinated dogs. The review of documentation for foreign-
vaccinated dogs is greater, and CDC will develop guidance to support
airlines in reviewing these new documentation requirements. Further,
the final rule will provide stability to requirements relative to the
temporary suspension. Finally, the annual costs to airlines for
abandoned dogs was estimated to be between $42,000 and $650,000 per
year. Assuming the number of dogs denied entry with the final rule is
less than under the baseline, the costs to airlines for assuming
responsibility for abandoned dogs should decrease.
Comment: One commenter stated $400,000 is not that much money to
conduct a rabies investigation when HHS/CDC gave $455,151,295 in
funding to the State of Kansas, for example, in fiscal year 2021.
Response: HHS/CDC disagrees with this statement and the
characterization of State and local public health resources. With
regard to the example of Kansas, the funding Kansas (and other states)
received from HHS/CDC in 2021 was primarily for COVID-19 response
efforts. Kansas only received $2.1M in core public health funding for
2021 \205\ which means a single imported rabid dog event could have a
substantial adverse impact on the state's public health budget. States
also have very limited funding dedicated to rabies control and
response. In 2023, for instance, HHS/CDC awarded $200,000 in total to
U.S jurisdictions, or approximately $3,500 per state, for rabies
response activities, which is not enough to cover the cost of a typical
rabies investigation. State health departments conduct a multitude of
activities with HHS/CDC funds and the cost associated with a rabid dog
investigation are additional costs for which the states do not receive
routine funding. The funding limitations in local jurisdictions can be
even more significant than those at the State level.
---------------------------------------------------------------------------

\205\ CDC Epidemiology and Laboratory Capacity 2021 funding
table. Available at: www.cdc.gov/elc/funding/2021-funding-table.html.
---------------------------------------------------------------------------

Comment: Some commenters suggested that the costs of this final
rule exceed the potential benefits associated with mitigating the risk
of DMRVV reintroduction to the United States. Specially, other
commenters suggested that the costs to importers of personal pets were
too high because the four most recent imports of dogs from DMRVV high-
risk countries with rabies were by animal rescues.
Response: HHS/CDC disagrees that the costs of this final rule
exceed the potential benefits or that the final rule is overly
burdensome on importers of personal pets. The cost of public health
investigations following the importation of rabid dogs is estimated to
be between $210,000 and $510,000. While this cost is much less than the
estimated annualized net cost of this rule (best estimate: $57 million,
range: $12 to $203 million), the main benefit is a significant
reduction in the risk of DMRVV reintroduction in the United States.
This is a low-probability, but high-consequence outcome, which could
significantly increase DMRVV costs in the United States, especially if
reintroduction was associated with an increase in human rabies cases.
As noted above, when DMRVV found in Mexico began spreading in U.S.
coyote populations, it spread to wildlife and dogs in Texas where DMRVV
had been previously eliminated in dogs. Wildlife and domestic dog
vaccination programs were implemented over the period from 1995 through
2003, costing more than $56 million (in 2023 USD) to eliminate the
virus; before the virus was eliminated, two people died from
DMRVV.^{206 207 208} The potential costs and the number of
human rabies cases during a future reintroduction of DMRVV are
difficult to predict in advance and would depend on how the virus would
be transmitted to wildlife species and the contact rates between
infected animals and humans.
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\206\ CDC. Human Rabies--Alabama, Tennessee, and Texas, 1994.
MMWR 1995; 44(14): 269-272.
\207\ Sidwa, T., 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.
\208\ 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.
---------------------------------------------------------------------------

Malaysia provides a pertinent example of the risks of DMRVV
reintroduction. Malaysia had been declared DMRVV-free, but the virus
was reintroduced around 2017. Despite a large public health response,
DMRVV has not yet been eliminated in Malaysia and 45 people have died
after having been infected between 2017 and 2022.\209\ The probability
of DMRVV reintroduction in the United States is likely to be much less
than in Malaysia, which shares a land border with Indonesia, which is a
DMRVV high-risk country. However, the potential risk for the United
States would increase if the U.S. dog rabies vaccination rates were to
decrease or if the number of imported DMRVV-infected dogs from DMRVV
high-risk countries were to increase. The requirements included in this
final rule would reduce the risk of importations of DMRVV-infected
dogs.
---------------------------------------------------------------------------

\209\ Tuah L., Sabri MSM, Hashim M, Hashim M. (Dec. 8, 2022)
Spatial Risk Assessment on Spread of Dog-Mediated Rabies in Sarawak.
SEACFMD Joint EpiNet and LabNet Virtual meeting. https://rr-asia.woah.org/wp-content/uploads/2022/12/4-seacfmd__mcda-spatial-risk-assessment-on-rabies-in-sarawak.pdf. Accessed November 9, 2023.
---------------------------------------------------------------------------

While the estimated monetized costs of this final rule
significantly exceed estimated monetized benefits, HHS/CDC was not able
to monetize the potential benefits associated with reducing the risk of
re-introduction of DMRVV in the United States. This could increase
costs for dogs traveling from the United States to DMRVV-free countries
for all dogs leaving the United States. This would include dogs that
later return to the United States. These costs would be in addition to
any public health response efforts as discussed above when DMRVV was
re-introduced from Mexico to Texas.
HHS/CDC also disagrees that the final rule is overly burdensome on
importers

[[Page 41788]]

of personal pets considering the enforcement burden involved in
attempting to distinguish between different types of importers.
Although it appears that the risks associated with personal pets may be
less than for dogs imported for adoption or resale, HHS/CDC has limited
ability to verify which dogs are imported as personal pets versus which
dogs are imported as rescue or for resale because it is not unusual for
importers to misrepresent the reasons why they are importing a dog into
the United States. As discussed above, owners of personal pet dogs who
travel from the United States to a DMRVV high-risk country will incur
significantly less cost if they obtain a three-year vaccine prior to
departure and a Certification of U.S.-Issued Rabies Vaccination. This
would reduce costs for some importers of personal pets.
Comment: HHS/CDC received many comments from breeders and breed
enthusiasts reporting that the costs to import dogs from DMRVV-free or
low-risk countries would increase as a result of the six-month age
requirement. Other breeders and enthusiasts did not mention an increase
in costs, but suggested the change in regulations would reduce the
number of exporters willing to send dogs to the United States, which
would decrease genetic diversity.
Response: HHS/CDC disagrees that costs for breeders and breed
enthusiasts importing dogs from DMRVV-free or low-risk countries will
increase as a result of the six-month age requirement because most
breeders should already be complying with this requirement. Breeders
frequently import dogs for resale, rescue, adoption, or transfer of
ownership, which are defined by USDA as commercial importations. USDA
regulations already require that commercially imported dogs be six
months or older. In addition, because dogs under six months of age are
sexually immature and cannot be used for breeding, delaying their
importation will not negatively impact their use as breeding animals.
Thus, HHS/CDC did not consider this as a change to the regulatory
baseline.
HHS/CDC also believes that the six-month age requirement helps
protect the health and safety of all dog breeds because dogs that are
at least six months old or older are better able to endure the stresses
of international travel (e.g., long travel times, temperature
fluctuations, oxygen or altitude changes, and food/water deprivation).
The six-month age requirement for importation will further reduce the
burden on Federal and State government agencies of conducing public
health investigations. Any time a dog becomes ill or dies during
international travel, regardless of country of import, Federal and
State government agencies must conduct public health investigations to
ensure the animal is not infected with a zoonotic disease that could be
transmitted to people (or did not die from a zoonotic disease). These
investigations take considerable resources away from other public
health priorities. Therefore, because the six-month age requirement
helps ensure that dogs are less stressed during international travel
and arrive in a healthier state, the burden on Federal and State
government agencies of conducting public health investigations should
be reduced.
While HHS/CDC acknowledges that this comment was specific to dogs
from DMRVV-free countries, HHS/CDC notes that breeders and commercial
importers were adept at responding to changes in import requirements
established during the period of the temporary suspension and that this
rule adopts many of those same practices. HHS/CDC believes that the
benefits in improved animal health and public health strongly support
this rulemaking.

G. Other Comments

Comment: Some commenters suggested that the proposed rule would
result in an increase in pet abandonment in foreign countries and/or at
U.S. ports for dogs that do not meet HHS/CDC entry requirements.
Response: HHS/CDC disagrees with these commenters. Throughout the
temporary suspension, which has had similar importation requirements in
place, HHS/CDC did not document an increase in pets being abandoned by
importers at U.S. ports. HHS/CDC does not track the number of dogs
abandoned in foreign countries. Although HHS/CDC appreciates the
efforts of animal rescue organizations in foreign countries, HHS/CDC's
mandate is the protection of human lives and prevention of the
consequences that the reintroduction of DMRVV could have on people,
pets, and wildlife populations in the United States. Additionally, HHS/
CDC has no reason to believe that the final rule will increase animals
abandoned in foreign countries because it expects importers to adapt to
the new regulatory requirements which align with, but are less
burdensome than, WOAH standards. Thus, an exemption is not needed.
Comment: HHS/CDC received comments that the proposed rule seeks to
enrich vaccine and microchip manufactures as well as the ACF, and that
ACF fees are too high. One comment asked, ``Who has shares in microchip
companies and Rabies vaccine manufacturers?''
Response: HHS/CDC disagrees with this comment. The intent of this
rulemaking is to protect public health--not to enrich private
companies. Vaccination is broadly recognized by international health
experts, including the World Health Organization and WOAH, as essential
to the effective prevention and control of rabies.\210\ Microchips are
one of the only ways to confirm the identity of a dog and match the
vaccination and titer documents to the animal presented for
importation. While other permanent identification methods, such as
tattoos, do exist, they are subject to alteration and fading, creating
opportunities for importers to falsify documents to circumvent entry
requirements. Microchipping is a key component required for the
international movement of animals, including livestock, zoo animals,
wildlife, and pets. It is an international standard required by other
countries for the importation of pets and is also a WOAH standard for
the international movement of dogs, cats, and ferrets. Regarding fees,
HHS/CDC does not set prices charged by privately owned and operated
businesses, including manufacturers of vaccines, microchips, or ACF.
Although HHS/CDC acknowledges some costs such as vaccination and
examination of dogs at the ACF may be higher than those charged by
other providers (U.S. average $86 ^{211 212} vs. ACF average
$208), it has found that other fees such as those for boarding (U.S.
average $40-$280/night \213\ vs. ACF average $137/night) are comparable
with those charged by other providers.
---------------------------------------------------------------------------

\210\ World Health Organization. Prevent Rabies by Vaccination.
Available at: www.who.int/activities/vaccinating-against-rabies-to-save-lives.
\211\ Kilroy, A. How much do dog vaccinations cost? March 29,
2023. Available at: www.forbes.com/advisor/pet-insurance/pet-care/how-much-do-dog-vaccinations-cost/.
\212\ Kilroy, A. How much does a vet visit cost? March 29, 2023.
Available at: www.forbes.com/advisor/pet-insurance/pet-care/how-much-does-vet-visit-cost/.
\213\ Coy, W. How much does dog boarding cost? Available at:
www.rover.com/blog/how-much-does-dog-boarding-cost/.
---------------------------------------------------------------------------

Comment: HHS/CDC received 14 comments suggesting that the proposed
rule would make it more difficult for breeders and breed enthusiasts to
import rare dog breeds and prevent inbreeding in U.S. dog populations
through the importation of dogs from other countries.
Response: Although HHS/CDC acknowledges that the final rule will
result in additional requirements to

[[Page 41789]]

import dogs from high-risk countries and will prevent breeders and
breed enthusiasts from importing dogs under six months of age, these
difficulties do not outweigh the benefits to U.S. public health. HHS/
CDC believes that, in addition to protecting public health by ensuring
all imported dogs are adequately protected against rabies, the rule
will likely better ensure the health of dogs during international
travel and prior to their release into the United States. As noted
above, international travel is stressful for animals and can result in
illness and death in young animals or specialty breeds (e.g., snub-
nosed breeds, hairless breeds) that cannot compensate for the stresses
they undergo (length of travel time, temperature fluctuations, oxygen
or altitude changes, food/water deprivation).
As noted above, the six-month age requirement for importation helps
protect the health and safety of all dogs, including rare dog breeds.
Since dogs under six months of age are sexually immature and cannot be
used for breeding, delaying their importation will not negatively
impact their use as breeding animals. Additionally, waiting until a dog
is six months of age to import the dog will help ensure the safety and
welfare of the dog during international travel when they are subjected
to the stresses of international travel mentioned above (e.g., long
travel times, temperature fluctuations, oxygen or altitude changes, and
food/water deprivation). Rare dog breeds may be imported under the
final rule if they meet entry requirements. Although HHS/CDC
acknowledges that it lacks data to quantify whether specific types of
breeds of dogs imported into the United States will change, HHS/CDC
believes that the final rule is not overly burdensome in regard to dog
breeders and breed enthusiasts because the final rule has strong public
health benefits and will help ensure the safety and welfare of dogs
engaged in international travel. Thus, an exemption is not needed.
Comment: HHS/CDC received comments that the final rule will make it
harder to travel abroad with pets.
Response: HHS/CDC does not believe that the final rule is overly
burdensome with regard to individuals traveling abroad with their pets
in large part because the rule does not apply to animals being exported
from the United States. Other countries set their own importation
requirements, separate from HHS/CDC's import requirements.
Additionally, HHS/CDC does not believe travel will be more difficult
for importers with U.S.-vaccinated dogs because HHS/CDC has amended the
final rule to allow these importers to enter the United States at any
U.S. port, rather than only at one of the 18 U.S. airports with a CDC
quarantine station as proposed in the NPRM. Therefore, importers who
maintain their dog's valid Certification of U.S.-issued Rabies
Vaccination can easily return to the United States with their dog from
any country through any U.S. port provided their dog is at least six
months old, microchipped, and accompanied by a Certification of U.S.-
issued Rabies Vaccination form and a CDC Dog Import Form receipt. Also,
as noted more extensively above, the final rule aligns U.S. importation
requirements with practices in other rabies-free countries while
providing significant additional flexibilities relative to WOAH
importation standards to alleviate unnecessary burden on pet owners and
importers.
Comment: HHS/CDC received comments stating that the NPRM was
unclear and suggesting that HHS/CDC reorganize the rule into different
categories, such as ``Family Pets,'' ``On-line Sales and/or Commercial
Sales,'' Service Animals,'' and ``Cats.''
Response: HHS/CDC declines to reorganize the final rule as
suggested by the commenters because it believes that the final rule is
sufficiently clear and that some of the proposed categories are
unneeded and would be more difficult to enforce. HHS/CDC has determined
that the public health risk from dog imports is based primarily on the
dog's country of origin (high-risk DMRVV countries) and vaccination
status (U.S.-vs. foreign-vaccinated) and has, through this final rule,
established different requirements based on these factors.
In CDC's experience, because importers frequently misrepresent the
reasons why a dog is being imported, CDC cannot reliably ensure that
dogs presented as ``personal pets'' are not being imported for other
reasons, including commercial resale after the dogs have been permitted
to enter the United States. For instance, USDA APHIS Animal Care (AC)
currently requires dogs imported for commercial purposes to apply for
and receive a USDA AC dog import permit, however, over the past several
years, USDA, CDC, and CBP have documented hundreds of instances of
commercial importers attempting to avoid USDA entry requirements by
misrepresenting the reasons why dogs are being imported. HHS/CDC also
notes that service animals are subject to the same public health risk
as other dogs from DMRVV high-risk countries and that the final rule
already includes a separate provision for service animals entering
through a U.S. seaport. For these reasons, HHS/CDC declines to
reorganize the final rule as suggested in this comment.
Comment: HHS/CDC received a comment that the changes would make the
process of dog importation more confusing, expensive, time consuming,
and difficult for people without financial and educational resources.
Response: HHS/CDC acknowledges that animal transportation can be a
confusing and frustrating process. However, CDC believes the changes it
is implementing will reduce confusion among importers, government
officials, airlines, and the animal transportation industry. For
example, with CDC's implementation of standardized forms certified by
official government veterinarians, CDC will be less likely to deny
animals entry due to missing, incomplete, or fraudulent vaccination
forms. Airline staff and CBP officers will no longer have to search
through multiple documents to ascertain whether all required
information for a dog is present for entry into the United States.
Instead, a single form can be referenced and used to streamline the
process, avoid confusion, and ensure entry requirements are met. The
microchip requirement will reduce confusion and uncertainty about an
animal's identity and vaccination history. Having ACF at multiple ports
will provide a place for sick or injured pets to receive prompt
veterinary care and will reduce an owner's stress in those unfortunate
circumstances.
HHS/CDC also acknowledges there is an increased cost to importers
under the final rule, however, CDC's requirements align more closely
with WOAH standards, which have already been implemented by the
majority of DMRVV-free countries around the world. The additional
expense associated with international animal travel is not a U.S.-
phenomenon due solely to CDC's updated final rule, but rather reflects
an international commitment by numerous countries to prevent DMRVV
importations through enhanced entry requirements, including
microchipping, certified vaccination records, serologic titers, and
quarantine. HHS/CDC notes that it is limiting costs to importers by not
enacting all WOAH standards (as outlined above).
Finally, HHS/CDC plans to engage in a proactive education campaign
for importers, government officials, U.S. and foreign-based
veterinarians, airlines, and the animal transportation industry in
order to ensure importers are aware of the new requirements. Many of
the requirements under the

[[Page 41790]]

final rule were implemented during the temporary suspension and are
therefore, already in place and are general, widespread knowledge.
Importers were able to adapt quickly under the temporary suspension and
CDC anticipates the same will be true of the final rule given the
similarities with the requirements already in place through the
temporary suspension.
Comment: HHS/CDC received comments that the proposed requirements
infringe on individuals' rights and freedoms. The commenter did not
specify further which individual rights and freedoms they believed
would be infringed by the final rule.
Response: Because the commenter did not specify further, HHS/CDC
assumes that the commenter meant to refer to due process rights that
may be protected by the Fifth and Fourteenth Amendments to the U.S.
Constitution. However, HHS/CDC disagree that the final rule implicates
any rights or interests protected by the Due Process Clause. Where
applicable, the Due Process Clause ``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, the final rule does not infringe upon any due
process rights protected by the U.S. Constitution. 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.'').
Comment: CDC received a comment stating that ``CDC is a quasi-
governmental agency, it's difficult to understand the authority allowed
for this proposed rule (and current rules on the books).''
Response: CDC is a U.S. government agency within HHS. The primary
legal authority supporting this final rule 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. 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.
In addition to section 361, other sections of the PHS Act relevant
to this final rule 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.
Comment: HHS/CDC received several comments that proposed CDC issue
fines or citations against importers who violate U.S. entry
requirements, present fraudulent documentation, or import rabid dogs.
Response: HHS/CDC appreciates this comment, but notes that it must
rely on other U.S. Federal agencies, such as the U.S. Department of
Justice, to seek criminal penalties for individuals who violate
quarantine regulations, including those relating to the importation of
dogs into the United States. Under section 368 of the PHS Act (42
U.S.C. 271) any person who violates regulations implementing sections
361 (42 U.S.C. 264) or 362 (42 U.S.C. 265) 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. Because these penalties are criminal in nature, to
implement section 368, HHS/CDC would refer potential violators to the
U.S. Department of Justice for criminal prosecution.
Through this final rule, HHS/CDC is also including 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, brokers, or carriers whenever the
CDC Director (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. 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.
Comment: HHS/CDC received comments that funding should not be spent
implementing the provisions in this final rule as well as comments that
the final rule will increase CDC costs and require additional staff.
Another comment stated, ``I do not see the CDC having staff to
coordinate this quarantine process and how will it be funded? This
seems like tax payers will pay the burden.''
Response: This final rule implements an importation system relying
on a network of privately operating ACF for the examination,
revaccination, and quarantine (if necessary) of foreign-vaccinated dogs
from DMRVV high-risk countries. During the temporary suspension, CDC
was issuing CDC Dog Import Permits for foreign-vaccinated dogs from
DMRVV high-risk countries. Issuing permits required costs to CDC in the
form of personnel and IT services. By replacing the permitting system
for foreign-vaccinated dogs from DMRVV high-risk countries with a
system of ACF, CDC anticipates a reduction in costs and staff time
associated with dog importation. CDC will not bear any costs for
quarantining dogs. The costs of examination, revaccination, and
quarantine at ACF will be paid for by the importer.
Comment: HHS/CDC also received comments suggesting that HHS/CDC
should spay and neuter animals or consider spaying and neutering
animals in lieu of euthanizing animals.
Response: The final rule also contains no requirements relating to
imported animals being spayed or neutered because HHS/CDC does not
typically regulate the control of animal populations. HHS/CDC
reiterates that the rule does not require that animals be euthanized if
they do not meet HHS/CDC import requirements. If an animal is not fit
to travel, poses a public health risk, or would pose a risk to other
animals, then the carrier must arrange for the animal to be transported
to an ACF or a CDC-approved veterinary

[[Page 41791]]

clinic (if an ACF is not available) for either housing and treatment by
a licensed veterinarian until approved by CDC for entry or denied entry
to the United States and returned to its country of departure. If the
veterinarian recommends humane euthanasia (e.g., under circumstances
where the animal is fatally ill or injured), or if this option is
chosen by the importer or carrier, then the animal must be euthanized
by a U.S.-licensed veterinarian in accordance with American Veterinary
Medical Association guidelines. Under these circumstances, the decision
to euthanize an animal is made by the animal's custodian (i.e., the
importer or the carrier if the importer abandons the animal) and not
HHS/CDC.
Comment: HHS/CDC received 29 comments stating support for ``Option
2.'' HHS/CDC believes ``Option 2'' referred to Table 4 in the NPRM,
which is a ``Summary Table of Important Changes to Regulatory
Requirements Based on the Provisions of this NPRM and Alternatives
Considered.'' Option 2 is described as the less restrictive option and
included no age requirement, no certification of rabies vaccination
forms, acceptance of titers from any lab, follow-up vaccination
performed by local veterinarian in the United States, and no port of
entry restrictions.
Response: HHS/CDC disagrees with the request to adopt components of
``Option 2'' with the exception of providing additional flexibility
regarding the ports of entry at which U.S.-vaccinated dogs may arrive
in the United States. This final rule allows U.S-vaccinated dogs from
DMRVV high-risk countries to enter at any U.S. port instead of only
arriving via air at a U.S. airport with a CDC quarantine station as
proposed in the NPRM. HHS/CDC addresses the justification for each of
the remaining requirements outlined in Table 1. Additional details on
the costs the lower cost and higher cost alternatives is provided in
section (VIIA: Required Regulatory Analyses).

VII. Required Regulatory Analyses

A. Executive Orders 12866, 13563, and 14094

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'' under E.O. 12866.
The provisions of this rule 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
provisions of this rule relative to a regulatory baseline without any
change in requirements. HHS/CDC also reports the costs and benefits of
the set of lower-cost alternatives and higher-cost alternatives
relative to the same regulatory baseline. HHS/CDC requested 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.
The economic regulatory baseline is based on the provisions
included in the existing 42 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.\214\ The economic baseline does not account for the temporary
suspension but does account for a change to the definition of DMRVV-
free country published in 2019.\215\ This baseline is used as a
comparator to assess the impact of the provisions of the final rule.
The summary of the regulatory baseline is defined further in Appendix
Section A3 found in the Supplemental Materials tab of the docket.
---------------------------------------------------------------------------

\214\ On June 14, 2021, CDC published the ``Notice of Temporary
Suspension of Dogs Entering the United States from High-Risk Rabies
Countries.'' Through that notice, CDC informed the public that,
effective July 14, 2021, it was temporarily suspending the
importation of dogs from: countries classified by CDC as having 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).
\215\ 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 rule addresses the market inefficiency in which dog importers
do not consider or bear the potential detrimental impacts to the
public's health that may result from the importation of ill dogs,
especially dogs infected with DMRVV. At the societal level, this could
include the reintroduction of DMRVV into the United States. Regulation
at the Federal level is necessary to address the public health risk of
infectious diseases from the importation of ill or unhealthy dogs.
Federal action allows risks to be addressed and mitigated prior to
dogs' arrival in the United States. The rule is 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 rule incorporates different requirements
depending on whether dogs are imported from DMRVV high-risk countries
compared to countries that are DMRVV-free or DMRVV low-risk.
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. Foreign-
vaccinated dogs imported from DMRVV high-risk countries would have to
arrive at one of currently six airports with a CDC-registered Animal
Care Facility. Importers of foreign-vaccinated dogs

[[Page 41792]]

from DMRVV high-risk countries would make reservations prior to arrival
with a CDC-registered ACF for a veterinary examination and
revaccination. As part of the entry requirements, importers would
either agree to a 28-day post-arrival quarantine period for the dog or
prior to arrival submit samples of the dog's blood to a CDC-approved
laboratory for serologic testing at a time interval specified in CDC
technical instructions 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 need a Certification of Foreign Rabies Vaccination and
Microchip form or Certification of U.S.-issued Rabies Vaccination form,
which require certification by an Official Government Veterinarian in
the country of origin or a USDA Official Veterinarian, respectively.
However, dogs imported from DMRVV-free or DMRVV low-risk countries and
importers of U.S.-vaccinated dogs from DMRVV high-risk countries do not
require examination at CDC-registered Animal Care Facilities and are
eligible to arrive at any U.S. port.
In lieu of the Certification of Foreign Rabies Vaccination and
Microchip form or Certification of U.S.-issued Rabies Vaccination form,
importers may provide documentation that the dogs have been only 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). This documentation must be certified by
an official government veterinarian, but many importers must already
obtain a foreign export certificate from a DMRVV-free or DMRVV low-risk
country that has been certified by an official government veterinarian
in that country prior to importing dogs into the United States. In
addition, importers who make multiple trips to and from the United
States (e.g., across land borders) may use the Certification of U.S.-
issued Rabies Vaccination form for U.S.-vaccinated dogs, which will
remain valid for three years after a dog receives a three-year rabies
vaccine in the United States. Thus, the additional costs will only be
incurred for a subset of dogs imported from DMRVV-free or low-risk
countries.
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. In addition, all dogs, other than those in transit, need
to be implanted with microchips for identification purposes. All dogs,
regardless of country of origin, must be listed on a bill of lading or
CDC-approved alternative by the airline, if entering the U.S. via air.
All importers of dogs arriving at an air, land, or seaport must submit
a CDC Dog Import Form to CDC via a CDC-approved system prior to the
dog's departure from the foreign country. The form must be presented to
the airline or other carrier prior to boarding and to Federal officials
upon arrival in the United States.
The annualized and present value estimates of monetized costs and
benefits over the 10-year period from 2024 through 2033 using three
percent and seven percent discount rates are summarized in Tables 2 and
3. The annualized, monetized costs (2020 USD) of the provisions in the
final rule are estimated to be $59 million (range: $13 to $207 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 (87 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 provisions
estimated to result in the greatest increase in costs for importers of
dogs imported from DMRVV-free or low-risk countries were associated
with the additional costs associated with the documentation
requirements to show that the dogs have not been in a DMRVV high-risk
country, minimum age, and with the microchip requirements, and
completing the new CDC Dog Import 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 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 reroute
travel to an airport with a CDC quarantine station (also known as a CDC
port health station) and CDC-registered Animal Care Facility, and (4)
the costs with providing a CDC Import Certification of Rabies
Vaccination and Microchip Record form or Certification of U.S.-issued
Rabies Vaccination form (certified by an Official Government
Veterinarian or USDA Official Veterinarian, respectively). Most of
these requirements are specific to foreign-vaccinated dogs from DMRVV
high-risk countries.
Airlines are expected to incur the greatest costs among carriers
and their costs are estimated to comprise about 7.0 percent of the
estimated annualized, monetized costs, with most of their costs
associated with ensuring that all transported dogs comply with the bill
of lading or CDC-approved alternative requirements of the final rule
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. Specifically, CDC does not have any data on how the six-month
age requirement may impact surface transportation conveyances importing
dogs from Canada or Mexico (although CDC notes that importation of dogs
less than six months of age for resale is already prohibited by USDA
regulations). CDC is estimated to incur about 3.3 percent of the
annualized, monetized costs (most likely estimate) associated with the
provisions of this final rule. 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 3.0 percent of the annualized costs (most
likely estimate) associated with the provisions of this final rule.
Most CBP costs would result from the additional time spent on reviewing
documentation for importers of dogs from DMRVV-free or low-risk
countries and for training personnel to enforce the requirements. USDA
is expected to receive payments commensurate with its cost to provide
Certification of U.S.-issued Rabies Vaccination forms for U.S.-
vaccinated dogs traveling internationally.
The annualized monetized benefits of the provisions in the final
rule are estimated to be about $1.8 million (range: $0.75 to $3.6
million) using a three percent or seven percent discount rate, with
most of the benefits accruing to importers (47 percent of the most
likely estimates) and to CBP (30 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 final rule are also estimated to reduce the number
of dogs

[[Page 41793]]

denied entry or arriving ill or dead, with benefits estimates 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
final rule. The net annualized, monetized costs (total cost estimate--
total benefit estimate) are estimated to be about $57 million per year
(range: $12 to $203 million) using a three percent discount rate.
Since the estimated costs for foreign-vaccinated dogs from DMRVV
high-risk countries are much higher than costs for other dog imports,
importers may choose to import dogs from DMRVV-free or low-risk
countries instead of from DMRVV high-risk countries. In addition,
individuals who travel from the United States to DMRVV high-risk
countries with their pet dogs for long-term visits may take the
additional step to have their dogs revaccinated with a three-year
rabies vaccine prior to departure (e.g., many deployed Federal
employees may obtain the Certification of U.S.-issued Rabies
Vaccination, which would allow up to three years for return to the
United States). These changes should result in lower overall costs than
the above estimates for the final rule in which HHS/CDC assumed
individuals would be unable to change the countries from which dogs are
imported into the United States.
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The present value of the estimated monetized cost over a 10-year
period for the provisions in the final rule is estimated to be $502
million (range: $111 to $1,750 million) using a three percent discount
or $416 million (range: $91 to $1,450 million) using a seven percent
discount rate. The present value of monetized benefits over a 10-year
period of the provisions in the final rule is estimated at $15 million
(range: $6.4 to $30 million) using a three percent discount rate or $13
million (range: $5.2 to $25 million) using a seven percent discount
rate. The net annualized monetized cost (total costs-total benefits) is
estimated at $486 million (range: $104 to $1,720 million) using a three
percent discount rate and $403 million per year (range: $86 to $1,430
million) using a seven percent discount rate.

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As discussed in the response to public comments section of the
preamble above, the estimated monetized cost estimate has increased
considerably

[[Page 41798]]

relative to the estimates included in the NPRM. The primary reasons for
the increase in cost include:
The fees charged by CDC-registered ACF have increased
relative to CDC's preliminary estimates.
Some U.S. ports require that dogs that need follow-up care
at CDC-registered ACF arrive as cargo. This requirement was not
anticipated by CDC and will increase costs for importers of foreign-
vaccinated dogs from DMRVV high-risk countries who otherwise would have
chosen to transport their dogs as hand-carried or checked baggage. The
fee charged for cargo shipments are highly variable.^{216 217}
The future costs associated with this rule will depend on U.S. port
policies that are subject to change. The average cost for the follow up
visit at CDC-registered ACF is estimated to be $900 (range: $500 to
$1,300 per dog). The average costs associated with shipping dogs as
cargo is estimated to be $2,000 (range: $1,500 to $2,500) \218\
compared to an average of $300 (range: $200 to $400) for dogs shipped
as hand-carried or checked baggage.\219\ Under the regulatory baseline,
HHS/CDC assumes 25%, range: 17% to 50% of dogs going to ACF are shipped
as cargo. With the final rule, HHS/CDC assumes that 60%, range: 60% to
70% of dogs going to ACF will be shipped as cargo.
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\216\ http://www.airline-pet-policies.com/united-airlines-pet-policy.php. Accessed: 15 Nov 2023.
\217\ Katie Morrell (March 3, 2021) How Much Does It Cost To Fly
With Your Dog on a Plane? Dailypaws.com https://www.dailypaws.com/living-with-pets/pet-travel/how-much-does-it-cost-to-fly-a-dog-on-a-plane. Accessed: 06 February 2022.
\218\ Feathers and Fur Express (2023) How much does it cost to
fly a pet/s internationally? International Pet Shipping Costs--
Feathers & Fur Express (ffexpresspets.com). Accessed November 10,
2023. Note that the costs reported in this reference include cargo
shipping costs to Germany, the United Kingdom, Japan, and Australia.
The reference includes costs for small and large dogs shipped to
each country. Costs are much higher for larger dogs or for dogs
shipped over longer distances. The highest costs were for Australia,
which may be more representative of shipping costs from DMRVV high-
risk countries in Africa. The European costs may be similar to
shipping costs for dogs imported from DMRVV high-risk countries in
Europe or Central America or South America. The costs for Japan may
be similar to costs for DMRVV high-risk countries in Asia. The
simple average cost across the four countries and dog sizes is
$1,931 in 2023 USD. This would correspond to $1,622 in 2020 after
adjustment with the consumer price index: CPI Inflation Calculator
(bls.gov). The most likely estimate is increased to $2,000 in case
the costs to importers from DMRVV high-risk countries would be
higher than for the countries for which data are available. This
increase from $1,600 to $2,000 would also allow some importers to
choose to hire shippers to facilitate the importation process or
brokers to support customs clearance. The need to hire shippers may
be reduced by the need to visit CDC-registered ACF, who may be able
to review documentation in advance of arrival when reservations are
made.
\219\ http://www.airline-pet-policies.com/united-airlines-pet-policy.php. Accessed: 15 Nov 2023.
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The costs associated with the requirement for proof that a
dog has been only in DMRVV low-risk or DMRVV-free countries have
increased because HHS/CDC added more examples of the types of proof
required. Each type of document requires certification by a USDA or
foreign official government veterinarian. Examples include: (a) a valid
foreign export certificate from a DMRVV-free or DMRVV low-risk country
that has been certified by an official government veterinarian in that
country; (b) a USDA export certificate if the certificate is issued to
allow the dogs to travel to a DMRVV-free or DMRVV low-risk country, (c)
a valid Certification of Foreign Rabies Vaccination and Microchip form
if completed in a DMRVV-free or DMRVV low-risk country, or (d) a valid
Certification of U.S.-Issued Rabies Vaccination form. These documents
are often required for individuals to travel internationally with their
pets but are not required for travel to Canada or Mexico. These
documents may be used as long as they specify travel to or from the
country from which a dog is imported. Individuals who frequently travel
to and from Canada and Mexico (or any other country) can obtain a valid
Certification of U.S.-Issued Rabies Vaccination form, which will remain
valid for multiple trips for up to three years corresponding to the
duration of protection for dog rabies vaccines.
The cost estimate for foreign-vaccinated dogs from DMRVV
high-risk countries to re-route travel destinations to arrive at
authorized U.S. ports with ACF was increased.
CDC increased the estimated costs associated with shipping
blood samples to CDC-approved laboratories for serological testing
based on a number of comments from individuals suggesting their
shipping costs were higher.
CDC changed the requirement for importing dogs from DMRVV-
free or low-risk countries such that no dogs less than six months may
be imported at land borders. This will increase costs for individuals
who wish to travel with their young dogs to or from Canada and Mexico.
CDC increased the estimated costs to airlines by 100% for
dogs imported from DMRVV-free or low-risk countries and by 50% for dogs
imported from DMRVV high-risk countries to account for a number of
commenters who suggested that costs to airlines should be higher than
the estimates included in the NPRM analysis.
Some of the cost estimates for the final rule have also decreased
due to changes made between the NPRM and the final rule. These include:
The costs to importers of U.S.-vaccinated dogs from DMRVV
high-risk countries were reduced because the final rule will not
require that such dogs arrive at U.S. ports with CDC quarantine
stations (also known as CDC port health stations).
The costs for serological testing for foreign-vaccinated
dogs from DMRVV high-risk countries were reduced because CDC plans to
implement a policy that only one serological test will be required
during the lifetime of such dogs as long as they remain current with
their rabies vaccinations.
The most significant increase in estimated costs is for importers
of foreign-vaccinated dogs from high-risk countries, because the
expected fees charged by CDC-registered ACF have increased and because
some U.S. ports or ACF now require dogs who need to visit to CDC-
registered ACF to be shipped as cargo. HHS/CDC did not anticipate that
some U.S. ports would require that dogs going to ACF be shipped as
cargo in analyzing costs for the NPRM. Other U.S. ports do not require
dogs going to ACF to be shipped as cargo. U.S. port-specific policies
may change in the future, which, in conjunction with the uncertainty
around the number of dogs imported, significantly complicates the
project of future costs for the requirements in the final rule. As of
March 2024, one U.S. port requires dogs going to ACF to be shipped as
cargo, one U.S. port recommends dogs be shipped as cargo to avoid
clearance delays and four U.S. ports do not have requirements or
recommendations for shipping dogs as cargo. In total six U.S. ports
have CDC-registered ACF.
The next key change, which will increase the costs for importers of
dogs from DMRVV-free or low-risk countries. In response to public
comment, HHS/CDC further defined the required documentation needed for
importers to prove that a dog has been only in DMRVV low-risk or DMRVV-
free countries. For the NPRM, HHS/CDC had assumed that veterinary
records from DMRVV-free or low-risk countries would be sufficient.
However, after observing a number of importers using fraudulent
documentation to circumvent requirements for DMRVV high-risk countries
by moving dogs to DMRVV-free or low-risk countries prior to entering
the United States. As a result, HHS/CDC is requiring at least one
record certified by an official veterinarian in 42 CFR 71.51(u). A

[[Page 41799]]

second change is that HHS/CDC is eliminating the exemption for
importers of dogs from DMRVV-free or low-risk countries to import three
or fewer dogs less than six months of age at land borders. Both of
these changes will increase costs to importers of dogs from DMRVV-free
or low-risk countries and these changes are reflected in the higher-
cost estimates.
The United States was declared DMRVV-free in 2007. Importing dogs
from DMRVV high-risk countries involves a significant public health
risk. The provisions of this final rule 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 standards in the WOAH Terrestrial Manual for dogs
imported from DMRVV high-risk countries to DMRVV-free countries.\220\
One DMRVV-infected dog may cause transmission to humans, domestic pets,
livestock, or wildlife. The social cost of the consequences associated
with the importation of a DMRVV-infected dog was estimated to be
$270,000 (range: $210,000 to $510,000) to conduct public health
investigations and administer rabies PEP to exposed persons.
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\220\ 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.
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Historically, CDC has denied entry to approximately 200 dogs
annually due to fraudulent, incomplete, or inaccurate paperwork.\221\
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.\222\ The diversion of public health resources globally to
COVID-19 response activities contributed to a lapse in dog 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,\223\ in addition to the potential increase in the
prevalence of DMRVV in high-risk countries,\224\ 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.
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\221\ 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.
\222\ 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.
\223\ 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.
\224\ A. Kunkel, Jeon S., Haim, Dilius C.J.P., Crowdis K.,
Meltzer M.I., Wallace R. (2021). The urgency of resuming disrupted
dog rabies vaccination campaigns: a modeling and cost-effectiveness
analysis. Scientific Reports; 11:12476. https://doi.org/10.1038/s41598-021-92067-5.
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CDC is unable to predict future trends with or without the
provisions included in this final rule 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.\225\ 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 final
rule are expected to substantively reduce the risk of importation of
dogs infected with DMRVV relative to baseline.
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\225\ Outbreak News Today (Feb. 10, 2022) Rabies case reported
in Toronto in a dog imported from Iran. http://outbreaknewstoday.com/rabies-case-reported-in-toronto-in-a-dog-imported-from-iran-46958. Accessed: February 14, 2022.
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The primary public health benefit of this final rule is the reduced
risk that a dog infected with DMRVV will be imported from a DMRVV high-
risk country. Using the most likely estimates of the net monetized cost
estimate ($57.0 million) and the most likely estimate of the potential
benefit of averting the social cost of the consequences associated with
an importation of one dog with DMRVV from a high-risk country
($270,000), it is possible to calculate the change in the number of
imported dogs infected with DMRVV with the provisions of the final rule
relative to the baseline such that the benefit would equal cost. The
most likely estimate of the net cost ($57.0 million) divided by the
most likely estimate of the social cost of the consequences associated
with an importation of a dog infected with DMRVV ($270,000) suggests
that the provisions of the final rule relative to baseline would have
to avert the importation of 211 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 reintroduction 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 over 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.\226\ However, CDC is unable to
estimate the potential magnitude of the mortality risk reduction
associated with the final rule. Based on the central VSL, the
provisions of the final rule would need to avert 4.9 or more human
deaths per year, on average, for the benefits to exceed costs.
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\226\ 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.
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Efforts to eliminate DMRVV if re-established in the United States
would also prove costly. A previous campaign

[[Page 41800]]

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,^{227 228} or $56 million in 2023
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.
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\227\ 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.
\228\ 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.
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At the same time, hesitancy towards vaccinating dogs may be
increasing in the United States. In a recent survey, about half of
survey respondents reported skepticism toward dog vaccination; however,
84% of these survey respondents reported that their dogs were up to
date with required vaccinations.\229\ If this skepticism leads to
reduced coverage rates for U.S. dog rabies vaccination, the United
States would become more vulnerable to the reintroduction of DMRVV. In
the worst-case scenario, a large-scale reintroduction of DMRVV could
result in much greater costs than were reported for the elimination of
the fox variant discussed previously.
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\229\ Motta M, Motta G, Stecula D. Sick as a dog? The
prevalence, politicization, and health policy consequences of canine
vaccine hesitancy (CVH). Vaccine2023 41 (2023): 5946-5950.
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Malaysia had been declared DMRVV-free, but the virus was
reintroduced around 2017. Despite a large public health response, DMRVV
has not yet been eliminated in Malaysia and 45 people have died after
having been infected between 2017 and 2022.\230\ The probability of
DMRVV reintroduction in the United States is likely to be much less
than in Malaysia, which shares a land border with Indonesia, which is a
DMRVV high-risk country. However, the potential risk for the United
States would increase if the U.S. dog rabies vaccination rates were to
decrease or if the number of imported DMRVV-infected dogs from DMRVV
high-risk countries were to increase. The requirements included in this
final rule would reduce the risk of importations of DMRVV-infected
dogs.
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\230\ Tuah L., Sabri MSM, Hashim M, Hashim M. (Dec. 8, 2022)
Spatial Risk Assessment on Spread of Dog-Mediated Rabies in Sarawak.
SEACFMD Joint EpiNet and LabNet Virtual meeting. https://rr-asia.woah.org/wp-content/uploads/2022/12/4-seacfmd__mcda-spatial-risk-assessment-on-rabies-in-sarawak.pdf. Accessed November 9, 2023.
---------------------------------------------------------------------------

The provisions of the final rule would also ensure that dogs that
are denied admission or arrive ill will be housed appropriately and
receive the 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 with the potential to
expose workers who are not trained to handle live animals safely.\231\
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\231\ 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 in this final rule through the CDC Dog
Import Form will 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 Dog Import Form
as required in this final rule may also benefit other agencies such as
USDA/Animal and Plant Health Inspection Service (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.\232\ 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.\233\ The requirement in the final rule 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.
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\232\ 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.
\233\ 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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Viruses exploiting new host species have led to some of the most
devastating disease epidemics, such as influenza, Ebola, and the HIV/
AIDS pandemic.\234\ 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.\235\
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-
mediated communicable 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.
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\234\ 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.
\235\ 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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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
\236\ 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.^{237 238 239} In August and September of 2020,
Denmark documented a mink-associated SARS-CoV-2 variant strain found in
12

[[Page 41801]]

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
using data from U.S. Fish and Wildlife Service who regulate and track
mink importations, it was 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 communicable disease outbreak because dog imports
are neither accurately nor completely tracked in any government data
system in the absence of the CDC Dog Import Form requirement included
in this final rule. This would limit HHS/CDC's ability to accurately
quantify the risks presented from specific countries because the United
States does not have data on the number of dogs imported from each
country.
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\236\ Koopmans M. SARS-CoV-2 and the human-animal interface:
outbreaks on mink farms. The Lancet Infectious Diseases 2021; 21
(1): 18-19.
\237\ 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.
\238\ 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.
\239\ 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.
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The 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 now required 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 or foreign animal
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 final rule are expected to reduce the risk of
dogs arriving 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; ^{240 241}
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.\242\
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\240\ 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.
\241\ 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.
\242\ 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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The required veterinarian examinations of foreign-vaccinated dogs
from DMRVV high-risk countries should lead to the earlier detection of
other exotic pathogens. A recent study from the United Kingdom
performed additional screening for Babesia canis, Ehrlichia canis,
Hepatozoon canis, Leishmania infantum, Brucella canis, and Dirofilaria
immitis among 133 recently imported rescue dogs. They identified one or
more of these pathogens in 24% (32/133) of the fully tested dogs.\243\
Although the authors found no significant association between infected
dogs and presenting clinical signs, this study helps demonstrate how
the mandatory veterinarian examination of foreign-vaccinated dogs from
DMRVV high-risk countries may lead to early detection of other diseases
prior to spreading into the U.S. dog population.
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\243\ Wright I, Whitfield V, Hanaghan R, et al. (2023) Analysis
of exotic pathogens found in a large group of imported dogs
following an animal welfare investigation. Vet Rec 4;193(9):e2996.
doi: 10.1002/vetr.2996.
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In addition to the unmonetized benefits described above, there may
be additional unmonetized costs. CDC plans to monitor countries with
high risk of DMRVV and may suspend entry of dogs from countries with
repeated instances of falsified or fraudulent dog vaccine credentials
or invalid rabies vaccination documents (defined as DMRVV-restricted
countries in this final rule). 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 will have 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 be on-site at the U.S. airport and available to
coordinate the entry/clearance of dogs with Federal government
officials. The representative must remain on site until all live
imported dogs have either been cleared for entry or arrangements have
been made to transport the dogs to a facility (either a CDC-registered
ACF or other veterinary facility approved by CDC) pending admissibility
determination. CDC believes this will only incur additional costs on
occasion since airline staff are typically available on-site.
Analysis of the Costs and Benefits of the Alternatives
The summary costs and benefits of the lower and higher-cost
alternatives are presented assuming that either all of the lower-cost
alternatives or all of the higher-cost alternatives are selected. The
annualized monetized costs and benefits are calculated relative to the
same regulatory baseline used to evaluate the impacts of the final
rule. The alternatives are presented above in Table 1. More detail on
the impacts of each section is presented in the appendix in the
supplemental materials tab of this docket. Some of the key assumptions
for the lower-cost alternative include:
If the age limit were reduced from six months to four
months for dogs arriving by air, the estimated reduction in the number
of dogs arriving by air would decrease by two percent relative to the
regulatory baseline. This is less than the five percent reduction
assumed for the six-month age requirement included in the final rule.
Also, there would be no reduction in dogs arriving at land borders if
there were no age limit for dog imports arriving by land (or sea).
If dogs were allowed to have either a microchip or tattoo
(instead of allowing only microchips), the cost of implementation is
assumed to be reduced by 25%. Since dog tattoos usually cost more than
microchips,\244\ the benefit is mostly due to some importers preferring
the tattoo to the microchip. Thus, the additional cost of the tattoo
would have to be offset by the utility to dog owners from owners who
strongly prefer to have the option of choosing either a tattoo or
microchip.

[[Page 41802]]

The reduction of cost is tied to the increase in options available to
dog importers, especially for importers who strongly prefer not to have
microchips implanted. This is an approximation since HHS/CDC is unable
to measure the disutility for dog owners who are strongly opposed to
microchip implantation.
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\244\ Gibeault S. (2021) Are ID Tags Enough? The Importance of
Identifying Your Dog. American Kennel Club. https://www.akc.org/expert-advice/home-living/id-tags-enough-importance-identifying-dog/.
---------------------------------------------------------------------------

If only importers of dogs from DMRVV high risk countries
are required to provide advance data submission to CDC and airlines
only need to provide a bill of lading or CDC-approved alternative for
such dogs, the costs for airlines and importers of dogs imported from
DMRVV-free or low-risk countries would decrease accordingly (i.e.,
these costs would only be incurred for importing dogs from DMRVV high-
risk countries).
If importers of U.S.-vaccinated dogs from DMRVV high-risk
countries no longer need to have the form Certification of U.S.-issued
Rabies Vaccination endorsed by a USDA Official veterinarian, importer
costs would decrease. CDC assumed that the vaccinating veterinarians
would be willing to fill out the appropriate form at no additional
cost.
If importers of foreign-vaccinated dogs from DMRVV high-
risk countries were allowed to have their dogs examined and
revaccinated by any licensed U.S. veterinarian instead of visiting a
CDC-registered ACF, the cost to these importers would decrease
considerably. This alternative process would not require dogs to be
transported as cargo (as required for dogs transported to CDC-
registered ACF at some U.S. ports). Also, the average fees charged by
U.S.-licensed veterinarians (assumed to be $100 to $200 per dog versus
$500 to $1,300 per dog at CDC-registered ACF) would be lower. Owners
could transport their own dogs to a U.S.-licensed veterinarian. In
addition, other U.S.-licensed veterinarians would not have to comply
with CDC requirements that are specific to CDC-registered ACF. The
change in costs also incorporate the costs to ship dogs as cargo, as
described above, which are much higher than for dogs that may be
transported as hand-carried or checked baggage.
If CDC accepted serological test results from any
laboratory as opposed to only CDC-approved laboratories, the costs to
importers of foreign-vaccinated dogs from DMRVV high-risk countries
would be reduced. CDC assumed that blood sample shipping costs would be
reduced by 50% and the costs for serological testing would be reduced
by 25%. This is because importers could choose from more potential
laboratories and may choose laboratories with lower fees since these
laboratories would not have to adhere to the requirements for CDC
approval.
If CDC allowed foreign-vaccinated dogs imported from DMRVV
high-risk countries to arrive at any U.S. port instead of only U.S.
ports with CDC-registered ACF, CDC assumed a much lower percentage of
importers would have to change their travel plans (20% instead of 60%).
These importers would no longer incur additional ticket costs and
travel time costs. This change would probably only affect costs in
conjunction with another lower-cost alternative that would allow
foreign-vaccinated dogs from DMRVV high-risk countries to be evaluated
by any licensed U.S. veterinarian rather than at a CDC-registered ACF).
In the absence of a simultaneous change to that requirement, there
would be little benefit to arriving at a U.S. port without a CDC-
registered ACF for this lower-cost alternative.
The total annualized monetized costs associated with the set of
lower-cost alternative are summarized in Table 4. The costs to
importers and to airlines would decrease considerably relative to the
requirements included in the final rule ($16.7 million versus $51.0
million for annualized monetized importer costs and $1.2 million versus
$4.1 million for annualized monetized airline costs, 3% discount rate).
The total annualized monetized costs for these alternatives are $22
million (range: $7.0 to $60 million, 3% discount rate). The annualized
monetized benefits also decrease for these lower-cost alternatives
($1.3 million, range: $0.54 to $2.6 million).
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However, this set of lower-cost alternatives would likely not have
a significant impact on reducing the risk of dogs being imported with
DMRVV compared to the regulatory baseline. The requirements in the
final rule would more effectively reduce this risk. If the age
requirements were reduced, importers may be more likely to attempt to
circumvent CDC rules to move dogs from DMRVV high-risk to DMRVV-free or
low-risk countries prior to importation into the United States. It is
difficult to age dogs under six months, and CDC has documented cases of
fraud involving the movement of dogs under six months of age from DMRVV
high-risk countries to DMRVV-free and DMRVV low-risk countries to avoid
rabies vaccination requirements. By requiring all dogs to be at least
six months of age, CDC can better confirm that the dog presented
matches the documentation presented, particularly the age listed for
the dog, and that it is old enough to be adequately vaccinated for
rabies.
In addition, transporting dogs under six months of age under
conditions with unstable and fluctuating air temperatures, such as
those present in the cargo area of a plane, may subject these young
animals to adverse events (illness or death) because young animals
cannot regulate their body temperature as efficiently as adult
animals.\245\ International travel often results in prolonged time
between feeding and watering of animals leading to potential adverse
events (illness and death) in young animals due to physiologic
stressors associated with or exacerbated by low blood glucose levels,
low oxygen environments (such as the cargo area of a plane),
dehydration, and the stress of travel.\246\ This could result in more
ill and dead dogs arriving on flights (reducing the benefits estimated
for the final rule). CDC would lack data on the total number of dogs
imported into the United States and would have less data to conduct
public health investigations in the event that a sick dog is imported
from DMRVV-free or low-risk country. In the absence of official
certification of the Certification of U.S.-issued Rabies Vaccination
form, CDC believes it would be much easier for importers of dogs from
DMRVV high-risk countries to present fraudulent documentation of U.S.
rabies vaccination. It would be more difficult for CDC to verify the
identity of dogs arriving with tattoos instead of microchips
(increasing the risk of fraudulently imported dogs).
---------------------------------------------------------------------------

\245\ Hardy J. Physiology of temperature regulation. Physiologic
reviews 1961: 41; 521-606.
\246\ Jahn K, Ley J, DePorter T, Seksel K. How Well Do Dogs Cope
with Air Travel? An Owner-Reported Survey Study. Animals (Basel).
2023 Oct 4;13(19):3093. doi: 10.3390/ani13193093. PMID: 37835699;
PMCID: PMC10571552.
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Follow-up examination and revaccination of dogs by any U.S.-
licensed veterinarian would be less costly in comparison to services
provided by CDC-registered ACF; however, this would increase the public
health risk associated with foreign-vaccinated dogs from DMRVV high-
risk countries. CDC would have limited capacity to follow up with
importers to ensure that the dogs had been appropriately examined and
revaccinated in a timely manner. Prior to the examination, the dog
could come into contact with additional people and potentially other
pets or wildlife. Finally, staff at CDC-registered ACF will operate
according to CDC regulations and guidance to minimize the risk of
disease transmission to humans and other animals.
CDC would have very limited oversight of the laboratories
conducting serological tests. Importers would also find it easier to
obtain fraudulent serological tests from laboratories that are not
approved by CDC or may get inaccurate test results from unapproved
laboratories. If CDC allowed foreign-vaccinated dogs to arrive at any
U.S. port with a CDC quarantine station (also known as a CDC port
health station), the government (i.e., CBP and CDC) would not be able
to ensure that the dogs had been cleared by a CDC-registered ACF prior
to admitting the dogs into the United States. In summary, the lower-
cost alternatives would result in significantly less costs for
importers and airlines but would also significantly limit the ability
of CDC to prevent the importation of inadequately vaccinated dogs from
DMRVV high-risk countries. CDC has observed that many importers have
tried to circumvent CDC requirements for dog importation and the
provisions in this final rule are chosen to mitigate these risks. The
lower-cost alternatives would lead to a significantly increased risk
that dogs infected with DMRVV would be imported. However, CDC is unable
to quantify the magnitude of this risk directly.
Some of the key assumptions that increase costs for the higher-cost
alternative include:
If the age limit were increased from six months to seven
months for imported dogs, the estimated reduction in the number of
imported dogs would be six percent instead of five percent as estimated
for the final rule.
If dogs were required to have both a microchip and a
tattoo (instead of requiring only microchips), the cost of
implementation is assumed to be increased by 125% because dog tattoos
tend to cost more than microchips (i.e., the cost for this requirement
would 2.25 times the cost of the microchip only.)
If all importers of dogs had to use the CBP formal entry
process for imported dogs, it would require more time to register for
(20 minutes on average) and file an entry (15 minutes on average) with
the CBP data systems relative to the estimated time required to submit
entry data to CDC (seven minutes on average). This would also increase
costs for CBP to review the formal entry documentation.
If all dog importers had to obtain either the
Certification of U.S.-issued Rabies Vaccination or Certification of
Foreign Rabies Vaccination and Microchip form endorsed by an USDA
Official Veterinarian or Official Government Veterinarian, the costs to
importers of dogs from DMRVV-free or low-risk countries would increase
because they currently do not need to

[[Page 41805]]

obtain these documents (with an assumed cost of $35 per document on
average).
If importers of U.S.-vaccinated dogs from DMRVV high-risk
countries were required to visit a CDC-registered ACF, their costs
would increase commensurate with estimates for foreign-vaccinated dogs.
CDC also assumed that five percent fewer U.S.-vaccinated dogs would be
imported from DMRVV high-risk countries due to the additional cost
associated with this requirement.
If CDC required a 90-day waiting period from the time a
dog blood sample was drawn to perform a serological titer test (instead
of 30 days as required in CDC technical instructions), there would be
additional costs to some importers who would be unable to plan further
in advance. These costs could range from staying in the country for an
extra 60 days to no cost if importers could arrange to have the blood
sample taken earlier relative to when they plan to enter the United
States. CDC assumed that it would cost an extra $200 on average,
although this cost would vary considerably according to importer
circumstances.
If CDC required all dogs imported from DMRVV high-risk
countries (including U.S.-vaccinated dogs) to arrive at U.S. ports with
CDC-registered ACF instead of limiting this requirement to foreign-
vaccinated dogs, the costs to importers of U.S.-vaccinated dogs would
increase commensurately and 60% of all imported dogs from DMRVV high-
risk countries would have to re-route their travel plans to a U.S. port
with a CDC-registered ACF instead of their preferred U.S. port.
The total annualized monetized costs associated with the higher-
cost alternative are summarized in Table 5. The costs to importers
would increase considerably relative to the requirements included in
the final rule ($108 million versus $51.0 million for annualized
monetized importer costs). The total costs for these alternatives are
$122 million (range: $31 to $320 million, 3% discount rate). The
annualized monetized benefits this set of higher-cost alternatives is
$1.3 million (range: $0.51 to $3.0 million).
CDC did not select any of these higher-cost alternatives because
most of these alternatives do not address the highest-risk category of
imported dogs, i.e., foreign-vaccinated dogs from DMRVV high-risk
countries. As a result, the public health benefits associated with
these higher-cost alternatives would not decrease the risk to the
public health sufficiently to balance the costs of these alternatives.
CDC has not observed any DMRVV infections among U.S.-vaccinated dogs
imported from DMRVV high-risk countries or among dogs imported from
DMRVV-free or low-risk countries. In addition, CDC can obtain the data
it needs from the lower-cost CDC import data submission system and does
not require a tattoo in addition to a microchip to confirm the identity
of imported dogs. Because of the limited public health benefit and
excessive costs, HHS/CDC believes the requirements in the final rule
address the risks associated with imported dogs infected with DMRVV or
other exotic pathogens more cost effectively than the alternatives.
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Impact of the Final Rule on Dog Import Volumes
CDC did not receive any additional data to update its estimates of
the number of imported dogs and used the same set of estimates
presented in the NPRM analysis. In total, CDC estimates 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 (Table 6). 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.
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\247\ Id.
\248\ Id.
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The provisions of the final rule 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 or DMRVV-free countries; and (2) 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, HHS/CDC believes that the
number of dogs denied admission and returned to their countries of
origin would decrease with the provisions included in the final rule
because the standardized forms, requirements for carriers to confirm
required documentation, and the requirement for foreign-vaccinated dogs
from DMRVV-high-risk countries to have reservations at and arrive at
U.S. ports with CDC-registered ACF should reduce the number of dogs
denied entry.
The estimated impact of the final rule on the number of dog imports
is summarized in Table 7a. HHS/CDC lacks data on what fraction of dogs
arriving by air or land are less than six months old under the
baseline. In the absence of this information, HHS/CDC assumes five
percent (range: three to eight percent) of imported dogs currently are
less than six months of age and would not be eligible to be imported
into the United States under the final rule. HHS/CDC notes that these
provisions should primarily impact individuals traveling with their
personal pets because the importation of dogs for resale or adoption
(including transfer of ownership) that are less than six months of age
is already prohibited by USDA regulations (7 CFR 2148). Another
provision of the final rule requires importers of dogs from DMRVV-free
or low-risk countries to submit verified documentation 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-free or low-risk
countries without such documentation when the final rule goes into
effect, but there may be delays at U.S. ports while HHS/CDC confirms
dogs from DMRVV-free or low-risk countries have not been in a DMRVV
high-risk country within the last six months.
HHS/CDC assumes that the additional costs associated with importing
dogs from DMRVV high-risk countries with foreign-issued rabies
vaccination documentation would reduce the number of imports by about
20 percent (range: 10 to 30 percent) with the final rule. In addition,
CDC believes the number of dogs from DMRVV high-risk

[[Page 41808]]

countries that are denied entry will decrease with the provisions of
the final rule because CDC will be able to require the use of
standardized forms to confirm rabies vaccination and CDC-registered ACF
follow-up requirements should be clear to importers. The number of dogs
denied entry after arriving by air in calendar year 2022 was 96. Based
in part on the number of dogs denied entry during HHS/CDC's temporary
suspension and assuming that number would continue to decrease with a
final rule in place, HHS/CDC estimates that about 50 dogs per year from
DMRVV high-risk countries would be denied entry under the final rule.
Overall, the final rule is expected to have a small impact on the total
number of dogs imported (from about 799,000 [range: 652,000 to 946,000]
at baseline to 755,000 [range: 630,000 to 872,000] with the provisions
of the final rule in effect).
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\249\ 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).
\250\ Id.
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The estimated numbers of imported dogs arriving in the United
States with lower-cost alternatives and the higher-cost alternatives
are summarized in Tables 7b and 7c. With the set of lower-cost
alternatives, the reduction in the

[[Page 41811]]

number of imported dogs relative to baseline is relatively small (most
likely estimate: 790,000 [range: 648,000 to 926,000] with lower-cost
alternatives compared to a most likely estimate of 799,000 for the
regulatory baseline). The costs associated with the potential
requirements to import foreign-vaccinated dogs from DMRVV high-risk
countries would be less than with the final rule. In addition, the age
restrictions for all imported dogs would be mitigated for the lower-
cost alternatives versus the final rule. As a result, the total number
of dogs would be greater with the lower-cost alternatives than with the
final rule requirements. With the set of higher-cost alternatives, the
reduction in the number of imported dogs relative to baseline is
greater (most likely estimate: 747,000 [range: 623,000 to 868,000] with
higher-cost alternatives compared to a most likely estimate of 799,000
for the regulatory baseline). With the potential higher-cost
alternatives, there would be an additional reduction in the estimated
number of U.S.-vaccinated dogs from DMRVV high-risk countries because
many of the requirements in the final rule that are limited to foreign-
vaccinated dogs would also apply to U.S.-vaccinated dogs. In addition,
all imported dogs would have to be seven months of age instead of six
months of age, which also result in fewer imported dogs from DMRVV-free
or low-risk countries compared to the requirements in the final rule.

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HHS/CDC has not attempted to project future changes to the volume
of dogs imported annually because of insufficient data. HHS/CDC
believes that introducing another factor to project future volumes is
not prudent. While HHS/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 arrives with fraudulent
paperwork.
The most likely estimates of the annual monetized costs and
benefits for each interested party or implementing partner with the
final rule relative to the regulatory baseline are summarized in Table
8a over a 10-year period from 2024 through 2033 using the estimated
values presented in Sections B2 through B9 of the Appendix found in the
Supplemental Materials tab of the docket. The most likely estimate of
monetized costs across interested parties is $79 million in the first
year and $56 million in subsequent years for the final rule relative to
the regulatory baseline. The most likely estimate of monetized benefits
across interested parties is estimated to be $1.8 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 final rule may result in some importers switching
from importing dogs from DMRVV high-risk countries to dogs from DMRVV-
free or low-risk countries.
As a percentage of total costs, importers were estimated to incur
85 to 87 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. Total costs are approximately 3.2 to
3.3 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.

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The costs to airlines are expected to comprise 6.7 to 7.0 percent
of total costs. Among Federal government agency costs for the
provisions included in the final rule, CBP's additional costs (2.9 to
3.4 percent of the total) are expected to be less than CDC's additional
costs (3.0 to 5.2 percent of the total).
The greatest fractions of the most likely estimates of the
monetized benefits associated with the provisions in the final rule
would accrue to importers of dogs from DMRVV high-risk countries (45
percent) and to CBP (30 percent). For both groups, the costs of
screening dogs at U.S. ports would be reduced for two reasons. First,
documentation of rabies vaccination for U.S.-vaccinated dogs from DMRVV
high-risk countries would be standardized to reduce the amount time
required for screening. Second, fewer dogs would be screened at U.S.
ports, reducing time spent on screening. This would result in cost
savings for both groups at U.S. ports, although costs for importers to
obtain the standardized forms and to forgo importing some dogs 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.
The most likely estimates of the annual monetized costs and
benefits for each interested party or implementing partner for the
lower-cost alternatives relative to the regulatory baseline are
summarized in Table 8b over a 10-year period using the estimated values
presented in the Appendix found in the Supplemental Materials tab of
the docket. For the lower-cost alternatives, the most likely estimates
of monetized costs across interested parties are $31 million in the
first year and $21 million in subsequent years. These estimates are
substantially lower than the costs for the final rule as summarized in
Table 8a. The most likely estimate of monetized benefits across
interested parties is estimated to be $1.3 million each year.
As a percentage of total costs, importers are estimated to incur 72
to 77

[[Page 41817]]

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 similar for dogs
imported from DMRVV high-risk countries and dogs from DMRVV-free or
low-risk countries for the lower-cost alternatives. The costs to
airlines are expected to comprise 5.1 to 5.8 percent of total costs.
Among Federal government agency costs for the provisions included in
the final rule, CBP's additional costs (9.4 percent of the total) are
expected to be less than CDC's additional costs (13.0 percent of the
total) in the first year and slightly greater (8.9 percent of the total
versus 8.1 percent of the total) in subsequent years.
[GRAPHIC] [TIFF OMITTED] TR13MY24.027

The most likely estimates of the annual monetized costs and
benefits for each interested party or implementing partner for the
higher-cost alternatives relative to the regulatory baseline are
summarized in Table 8c over a 10-year period using the estimated values
presented in the Appendix found in the Supplemental Materials tab of
the docket. The most likely estimates of monetized costs across
interested parties are $164 million in the first year and $117 million
in subsequent years. The most likely estimate of monetized benefits
across interested parties is estimated to be $1.3 million each year.
These estimates are substantially higher than the costs summarized in
Table 8a.
As a percentage of total costs, importers are estimated to incur 88
percent of the total costs (most likely estimates). Importer costs are
approximately 3.0 to 3.3 times greater for dogs imported from DMRVV
high-risk countries compared to dogs from DMRVV-free or low-risk
countries. The costs to airlines are expected to

[[Page 41818]]

comprise 3.3 to 3.4 percent of total costs. Among Federal government
agency costs for the provisions included in the final rule, CBP's
additional costs (6.7 percent of the total) are expected to be more
than CDC's additional costs (1.4 to 2.5 percent of the total).
[GRAPHIC] [TIFF OMITTED] TR13MY24.028

BILLING CODE 4163-18-C

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act, as amended by the Small
Business Regulatory Enforcement Fairness Act, 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 rule
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.
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 rule would be less than two percent of
estimated revenues. HHS/CDC published an initial regulatory flexibility
analysis with the NPRM, invited public comments, but did not receive
any comments on the RFA. HHS/CDC did receive some comments from
breeders, some of which identified as hobbyists, indicating that the
six-month age requirements would impact their ability to import dogs
for breeding purposes. HHS/CDC received some comments from breeders and
breed enthusiasts reporting that the

[[Page 41819]]

costs to import dogs from DMRVV-free or low-risk countries would
increase as a result of the six-month age requirement. Other breeders
and enthusiasts did not mention an increase in costs, but suggested the
change in regulations would reduce the number of exporters willing to
send dogs to the United States, which would decrease genetic diversity.
USDA prohibits the importation of dogs under six-months of age for
commercial purposes, which includes any transfer of ownership;
therefore, importing dogs under six months of age is already
prohibited. Thus, HHS/CDC did not consider this as a change to the
regulatory baseline. Additionally, HHS/CDC believes that the six-month
age requirement for importation helps protect the health and safety of
all dog breeds. Since dogs under six months of age are sexually
immature and cannot be used for breeding, delaying their importation
may not negatively impact their use as breeding animals. Additionally,
waiting until a dog is six months of age to import the dog will help
ensure the safety and welfare of the dog during international travel
when they are subjected to the stresses of international travel (e.g.,
long travel times, temperature fluctuations, oxygen or altitude
changes, and food/water deprivation). Any time a dog becomes ill or
dies during international travel, regardless of country of import,
Federal and State government agencies must conduct public health
investigations to ensure the animal is not infected with a zoonotic
disease that could be transmitted to people (or did not die from a
zoonotic disease). These investigations take a tremendous amount of
resources. HHS/CDC believes that the six-month age requirement for
importation helps protect the health and safety of all dogs and will
result in a reduced burden on Federal and State government agencies.
Based on these analyses, CDC believes that the only small entities
for which this rule would have significant impacts would be those that
specialize in importing dogs from DMRVV high-risk countries. The
provisions of this rule would probably 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. The requirement most likely to impact small airlines is
Sec. 71.51(dd), which requires airlines to provide bills of lading for
all imported dogs. However, there is a waiver process for airlines to
have an alternative process while preparing to provide bills of lading.
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
rule should not impact entities that sell or resell imported dogs but
may impact entities that import very young dogs for commercial purposes
other than resale assuming no transfer of ownership.
As part of the economic impact analysis, CDC calculated the
marginal cost associated with the rule per dog imported from DMRVV-free
or DMRVV low-risk countries ($23, range: $7.74 to $48 per imported
dog). The marginal cost associated with the requirements in the final
rule per dog imported from DMRVV high-risk countries was further
subdivided between foreign-vaccinated dogs (vaccinated outside the
United States) ($1,910, range: $910 to $3,800) compared to U.S.-
vaccinated dogs ($41, range: $15 to $73). These estimates cover the
first year of implementation after a final rule is published. 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.
As discussed in the response to public comments section of the
preamble above, the estimated monetized cost estimate has increased
considerably relative to the estimates included in the NPRM. The
primary reasons for the increase in cost include:
The fees charged by CDC-registered ACF have increased
relative to CDC's preliminary estimates.
Some U.S. ports require that dogs that need follow-up care
at CDC-registered ACF arrive as cargo. This requirement was not
anticipated by CDC and will increase costs for importers of foreign-
vaccinated dogs from DMRVV high-risk countries who otherwise would have
chosen to transport their dogs as hand-carried or checked baggage. The
fee charged for cargo shipments are highly variable.^{251 252}
The future costs associated with this rule will depend on U.S. port
policies that are subject to change. The average cost for the follow up
visit at CDC-registered ACF is estimated to be $900 (range: $500 to
$1,300 per dog). The average costs associated with shipping dogs as
cargo is estimated to be $2,000 (range: $1,500 to $2,500) \253\
compared to an average of $300 (range: $200 to $400) for dogs shipped
as hand-carried or checked baggage.\254\ Under the regulatory baseline,
HHS/CDC assumes 25%, range: 17% to 50% of dogs going to ACF are shipped
as cargo. With the final rule, HHS/CDC assumes that 60%, range: 60% to
70% of dogs going to ACF will be shipped as cargo.
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\251\ http://www.airline-pet-policies.com/united-airlines-pet-policy.php. Accessed 15 Nov 2023.
\252\ Katie Morrell (March 3, 2021) How Much Does It Cost To Fly
With Your Dog on a Plane? Dailypaws.com https://www.dailypaws.com/living-with-pets/pet-travel/how-much-does-it-cost-to-fly-a-dog-on-a-plane. Accessed: 06 February 2022.
\253\ Feathers and Fur Express (2023) How much does it cost to
fly a pet/s internationally? International Pet Shipping Costs--
Feathers & Fur Express (ffexpresspets.com). Accessed November 10,
2023. Note that the costs reported in this reference include cargo
shipping costs to Germany, the United Kingdom, Japan, and Australia.
The reference includes costs for small and large dogs shipped to
each country. Costs are much higher for larger dogs or for dogs
shipped over longer distances. The highest costs were for Australia,
which may be more representative of shipping costs from DMRVV high-
risk countries in Africa. The European costs may be similar to
shipping costs for dogs imported from DMRVV high-risk countries in
Europe or Central America or South America. The costs for Japan may
be similar to costs for DMRVV high-risk countries in Asia. The
simple average cost across the four countries and dog sizes is
$1,931 in 2023 USD. This would correspond to $1,622 in 2020 after
adjustment with the consumer price index: CPI Inflation Calculator
(bls.gov). The most likely estimate is increased to $2,000 in case
the costs to importers from DMRVV high-risk countries would be
higher than for the countries for which data are available. This
increase from $1,600 to $2,000 would also allow some importers to
choose to hire shippers to facilitate the importation process or
brokers to support customs clearance. The need to hire shippers may
be reduced by the need to visit CDC-registered ACF, who may be able
to review documentation in advance of arrival when reservations are
made.
\254\ http://www.airline-pet-policies.com/united-airlines-pet-policy.php. Accessed 15 Nov 2023.
---------------------------------------------------------------------------

The cost estimate for foreign-vaccinated dogs from DMRVV
high-risk countries to re-route travel destinations to arrive at
authorized U.S. ports with ACF was increased.
The costs associated with the requirement for proof that a
dog has been only in DMRVV low-risk or DMRVV-free countries have
increased because HHS/CDC added more examples of the types of proof
required. Each type of document requires certification by a USDA or
foreign official government veterinarian. Examples include: (a) a valid
foreign export certificate from a DMRVV-free or DMRVV low-risk country
that has been certified by an official government veterinarian in that
country; (b) a USDA export certificate if the certificate is issued to
allow the dogs to travel to a DMRVV-free or DMRVV low-risk country, (c)
a valid Certification of Foreign Rabies Vaccination and Microchip form
if completed in a DMRVV-free or DMRVV low-risk country, or (d) a valid
Certification of U.S.-Issued Rabies Vaccination form. These documents
are often required for individuals to travel internationally with their
pets but are not required for travel to Canada or Mexico. These

[[Page 41820]]

documents may be used as long as they specify travel to or from the
country from which a dog is imported. Individuals who frequently travel
to and from Canada and Mexico (or any other country) can obtain a valid
Certification of U.S.-Issued Rabies Vaccination form, which will remain
valid for multiple trips for up to three years corresponding to the
duration of protection for dog rabies vaccines.
CDC increased the estimated costs associated with shipping
blood samples to CDC-approved laboratories for serological testing
based on a number of comments from individuals suggesting their
shipping costs were higher.
CDC changed the requirement for importing dogs from DMRVV-
free or low-risk countries such that no dogs less than six months may
be imported at land borders. This will increase costs for individuals
who wish to travel with their young dogs to or from Canada and Mexico.
CDC increased the estimated costs to airlines by 100% for
dogs imported from DMRVV-free or low-risk countries and by 50% for dogs
imported from DMRVV high-risk countries to account for a number of
commenters who suggested that costs to airlines should be higher than
the estimates included in the NPRM analysis.
Some of the cost estimates for the final rule have also decreased
due to changes made between the NPRM and the final rule. These include:
The costs to importers of U.S.-vaccinated dogs from DMRVV
high-risk countries were reduced because the final rule will not
require that such dogs arrive at U.S. ports with CDC quarantine
stations (also known as CDC port health stations).
The costs for serological testing for foreign-vaccinated
dogs from DMRVV high-risk countries were reduced because CDC plans to
implement a policy that only one serological test will be required
during the lifetime of such dogs as long as they remain current with
their rabies vaccinations.
The most significant increase in estimated costs is for importers
of foreign-vaccinated dogs from high-risk countries, because the
expected fees charged by CDC-registered ACF have increased and because
some U.S. ports or ACF now require dogs who need to visit to CDC-
registered ACF to be shipped as cargo. HHS/CDC did not anticipate that
some U.S. ports would require that dogs going to ACF be shipped as
cargo in analyzing costs for the NPRM. Other U.S. ports do not require
dogs going to ACF to be shipped as cargo. U.S. port-specific policies
may change in the future, which, in conjunction with the uncertainty
around the number of dogs imported, significantly complicates the
project of future costs for the requirements in the final rule. As of
March 2024, one U.S. port requires dogs going to ACF to be shipped as
cargo, one U.S. port recommends dogs be shipped as cargo to avoid
clearance delays and four U.S. ports do not have requirements or
recommendations for shipping dogs as cargo. In total six U.S. ports
have CDC-registered ACF.
The next key change, which will increase the costs for importers of
dogs from DMRVV-free or low-risk countries. In response to public
comment, HHS/CDC further defined the required documentation needed for
importers to prove that a dog has been only in DMRVV low-risk or DMRVV-
free countries. For the NPRM, HHS/CDC had assumed that veterinary
records from DMRVV-free or low-risk countries would be sufficient.
However, after observing a number of importers using fraudulent
documentation to circumvent requirements for DMRVV high-risk countries
by moving dogs to DMRVV-free or low-risk countries prior to entering
the United States. As a result, HHS/CDC is requiring at least one
record certified by an official veterinarian in Sec. 71.51(u). A
second change is that HHS/CDC is eliminating the exemption for
importers of dogs from DMRVV-free or low-risk countries to import three
or fewer dogs less than six months of age at land borders. Both of
these changes will increase costs to importers of dogs from DMRVV-free
or low-risk countries and these changes are reflected in the higher-
cost estimates. More information regarding these cost estimates is
available in the Appendix found in the Supplemental Materials tab in
the docket.
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 final
rule would have a significant economic impact on their businesses.
Small Entities That Import Dogs for Commercial Purposes
The estimated revenues of small businesses likely to import and
resell dogs are summarized in Table 9. 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 final rule would be a fraction of the firms summarized in Table 9,
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 small business size standards.\255\ 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),\256\ CDC estimated the revenue based on the
assumption that each firm's payroll expense would be approximately 15
to 30 percent.\257\
---------------------------------------------------------------------------

\255\ SBA, Table of small business size standards. Effective
August 19, 2019. https://www.sba.gov/document/support-table-size-standards.
\256\ 2019 SUSB Annual Data Tables by Establishment Industry.
https://www.census.gov/data/tables/2019/econ/susb/2019-susb-annual.html.
\257\ How to figure the gross percent of payroll. https://smallbusiness.chron.com/figure-gross-percent-payroll-66395.html.
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BILLING CODE 4163-18-P

[[Page 41821]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.029

CDC assumes that the costs associated with the provisions of the
final rule would be significant if the additional costs would exceed
two percent of the estimated revenue shown in Table 9 by category.
Unless a small entity only specializes 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 provisions

[[Page 41822]]

included in this final rule. CDC is unaware of the proportion of dog
import costs relative to all the other activities for each type of
entity. Thus, CDC is not able to directly estimate the impact of the
final rule as a fraction of total revenue. Instead, CDC calculates a
threshold for each category representing the number of imported dogs at
which the cost of the provisions in the final rule to importers 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 final rule would be likely to exceed two percent of revenue
for each category of the firm, the category-specific revenue per firm
in Table 9 (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 ($1,910, range: $910 to
$3,800 per dog). This was repeated for U.S.-vaccinated dogs from DMRVV
high-risk countries ($41, range: $15 to $73) and dogs from DMRVV-free
or DMRVV low-risk countries ($23, range: $7.70 to $48).
The estimated thresholds for the number of Imported dogs per firm
for each small business category are summarized in Tables 10a and 10b.
For example, if a wildlife organization (NAICS code 813312) with fewer
than five employees imports more than 3.9 foreign-vaccinated dogs (most
likely final rule cost estimate and midpoint revenue estimate) from
high-risk countries, the costs associated with the final rule would be
expected to exceed two percent of revenue. For U.S.-vaccinated dogs,
the threshold would increase from about four dog imports to 182 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 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 10a and 10b are estimated by assuming
that all dogs imported by each firm are either from DMRVV-free or DMRVV
low-risk 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. In this case, for a business
with NAICS code of 813312, the estimated threshold number of dogs would
increase from four imported foreign-vaccinated dogs from DMRVV high-
risk countries to 327 dogs imported from DMRVV-free or DMRVV low-risk
countries (both thresholds calculated using most likely final rule cost
estimate and midpoint revenue estimate).

[[Page 41823]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.030

[[Page 41824]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.031

The marginal cost per dog imported for the final rule relative to
the reported commercial values of imported dogs are 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
11. The estimated ratio of the marginal cost of final rule requirements
relative to the reported value of the commercially imported dogs from
DMRVV-free or DMRVV low-risk countries is 2.9 percent (range: 1.0
percent to 6.1 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 536 percent (range: 256 percent
to 1059 percent). This ratio is much larger both because the marginal
cost per dog imported for the final rule 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 final rule
to reported commercial value, these ratios cannot be directly compared
to the revenue

[[Page 41825]]

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-risk countries or from DMRVV high-risk
countries for the final rule. 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.
[GRAPHIC] [TIFF OMITTED] TR13MY24.032

[[Page 41826]]

U.S. Airlines
The provisions of this final rule 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.\258\ For the analysis,
airline employee counts were estimated from the U.S. Department of
Transportation's Bureau of Transportation Statistics.\259\ Monthly
average numbers of employees in 2019, including part- and full-time
employment, were used for U.S. airlines.
---------------------------------------------------------------------------

\258\ 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.
\259\ 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.
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The annual revenue per U.S. airline was estimated based on the 2019
revenue of each airline.\260\ Lower-bound and upper-bound estimates
were calculated by multiplying by 75 and 125 percent (Table 12). Among
the selected 35 airlines, seven had zero U.S. international arrivals in
2019.\261\
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\260\ 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.
\261\ 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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[[Page 41827]]

[GRAPHIC] [TIFF OMITTED] TR13MY24.033

The threshold numbers of dogs that may be transported by each
airline such that the costs associated with the provisions of this
final rule to airlines would be less than two percent of annual revenue
are estimated using the same methodology as for the dog importers
above. The annualized marginal cost per dog transported by airlines is
estimated to be about $12.81 per dog (range: $7.12 to $20.42 per dog)
for the requirements in the final rule. This is calculated based on the
annualized costs to airlines divided by the number of dogs transported.
However, costs are 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 is
calculated by multiplying the revenue per airline in Table 12 by two
percent and then dividing by the marginal airline cost per dog imported
in the final rule. As shown in Table 13, the estimated numbers of dogs
that each airline could transport were significantly greater than

[[Page 41828]]

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 is 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
will be higher for airlines that specialize in travel to DMRVV high-
risk countries. However, the general finding still holds that the
provisions of this final rule should not have a significant impact on
airlines. Smaller airlines will also be eligible to receive a waiver
for the bill of lading requirements included in Sec. 71.51(dd). This
should help to reduce the costs of this requirement during the period
shortly after the final rule goes into effect since it would allow
smaller airlines more time to comply.

[[Page 41829]]

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BILLING CODE 4163-18-C

[[Page 41830]]

C. Paperwork Reduction Act of 1995

HHS/CDC has determined that this rule includes 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 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 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 the NPRM,
HHS/CDC published a 60-day notice in the Federal Register concerning
the collection of information related to proposed updates to 42 CR
71.50 and 71.51. HHS/CDC addressed all comments above in Section VI. To
comply with this requirement, OMB is publishing a notice of a revised
data collection in conjunction with this final rule.
Data Collection
Importation Regulations (42 CFR 71 Subpart F) OMB Control No. 0920-
1383, Exp. 1/31/2026)--Revision--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 No. 0920-
1383 related to the importation of animals, animal products, and human
remains. 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 (also known as port health officers) and other U.S.
government 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
(and other animals in Family Viverridae), African rodents, and bats.
CDC controls the importation of these animals to ensure that these
animals, or animal products, imported into the United States meet
requirements of CDC regulations. CDC does this through a permitting
process for certain animals.
HHS/CDC is adding or amending the following information collection
instruments:
CDC is adding a form titled Certification of Foreign
Rabies Vaccination and Microchip form. This form will capture the
rabies vaccination and microchip information for foreign-vaccinated
dogs and it must be completed by an authorized veterinarian and
certified by a government official from the exporting country. CDC is
including certification by an exporting country to prevent fraud and
falsification of documentation.
CDC is adding a new form titled Certification of U.S.-
issued Rabies Vaccination. This is a standardized form to capture
rabies vaccination information for U.S-vaccinated dogs. It must be
completed by a USDA-accredited veterinarian and endorsed by USDA during
the exportation process to prevent fraud and falsification of
documentation. CDC is creating this standardized form to assist
importers in ensuring they provide all required information and to
prevent fraud and falsification of documentation.
CDC is adding the new form titled Certification of Dog
Arriving from DMRVV-free or DMRVV low-risk Country form. The form can
be used to demonstrate that a dog has not been in a DMRVV high-risk
country within the last six months if accompanied by veterinary records
or proof of payment for veterinary services establishing that
veterinary services were performed in a DMRVV-free or DMRVV low-risk
country at least six months before traveling to the United States. This
form must be completed by an Authorized Veterinarian and must be
certified by an Official Government Veterinarian in the exporting
country. This is one option among multiple options that importers of
dogs from DMRVV-free or DMRVV low-risk countries can use to certify
that their dog has not been in a DMRVV high-risk country within the
last six months. Since this is one of multiple options, CDC is
estimating that only a small percentage of importers of dogs from these
countries will use this form. Additional options for these importers
are outlined in technical instructions.
CDC will continue using the Application for Special
Exemption for a Permitted Dog Import until the expiration of the
temporary suspension on July 31, 2024. Applicants complete this form to
apply for a CDC Dog Import Permit. CDC has been issuing CDC Dog Import
Permits to importers of foreign-vaccinated personal pet dogs with a
valid rabies vaccine and serologic titer results during the temporary
suspension. CDC will discontinue issuing permits to that category of
importer once this final rule goes into effect on August 1, 2024.
Starting August 1, 2024, CDC will instead use this form to issue
permits to importers of dogs from DMRVV-restricted countries. Since CDC
is not adding any countries to the DMRVV-restricted country in
concurrence with the publication of this rule, CDC does not anticipate
using this form in 2024.
CDC is adding a new form--CDC Dog Import Form--which will
collect information similar to what is currently approved to be
collected on the Application for Special Exemption for a Permitted Dog
Import form. The CDC Dog Import Form is an online form that all
importers must complete for each dog imported. It collects contact
information for the importer and details about the dog being imported.
CDC has added this form to gather data on the number of annual
importations of dogs as well as where they originate. This information
will assist CDC in its public health investigations related to imported
dogs with communicable diseases.
CDC is adding four new forms related to CDC-registered
animal care facilities. Per this final rule, CDC-registered animal care
facilities are facilities that are registered with CDC for the
revaccination, examination, and quarantine (if applicable) of foreign-
vaccinated dogs from DMRVV high-risk countries. In order to register
with CDC, representatives of the facility need to complete and sign the
following documents to attest to their understanding of the
requirements and recommendations for CDC-registered Animal Care
Facilities.

[[Page 41831]]

[cir] Application to Operate as a CDC-registered Animal Care Facility
[cir] Technical Instructions for CDC-Registered Animal Care Facilities
(ACF)
[cir] Standard Operating Procedures for SAFE TraQ data use by CDC-
registered Animal Care Facilities Participating in Public Health
Evaluations of Imported Animals
[cir] Rules of Behavior Agreement for Access to Centers for Disease
Control and Prevention (CDC) Division of Global Migration Health (DGMH)
System for Animal Facility Electronic Tracking of Quarantine (SAFE
TraQ)

CDC will make available to air carriers two new forms to
assist in the implementation of our requirements for dogs arriving into
the United States. Both forms are optional and may be filled out by the
air carriers to help them ensure dogs flown on their flights meet entry
requirements. One form is for dogs flown as checked baggage or carried-
on and the other form is for dogs flown as cargo.
CDC may collect information from air carriers that are
unable to complete a bill of lading for all dogs arriving into the
United States on their flights. In order to transport dogs, these air
carriers must request a waiver from CDC by submitting the information
outlined in the document titled Technical Instructions for Air Carriers
that are Unbale to Create Air Waybills.
In addition to the forms listed above related to the importation of
dogs, CDC is also revising the following forms related to the
importation of nonhuman primates (NHP). These are existing forms
currently approved under this information collection. All edits are
minor and non-substantive.

CDC Notification of Proposed Nonhuman Primate (NHP)
Importation to the United States
Application for Registration as an Importer of Nonhuman
Primates
Registration Form for NHP Importation (Part 2--Full Quarantine
Standard Operating Procedures)
Registration Form for NHP Importation (Part 2--Lab-to-Lab
Standard Operating Procedures
Registration Form for NHP Importation (Part 2--Zoo-to-Zoo
Standard Operating Procedures)

The burden table below has been updated to reflect updated burden
hours for the new and amended forms.
BILLING CODE 4163-18-P

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BILLING CODE 4163-18-C

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 final rule under Executive Order 12988 on
Civil Justice Reform and determines that this

[[Page 41837]]

rule 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 final rule will
not have sufficient federalism implications to warrant the 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 regulation
to make our intentions and rationale clear.

List of Subjects in 42 CFR Part 71

Airline, Animal, Carrier, Cat, CDC-registered animal care facility,
Communicable diseases, DMRVV, Dog, Dog-maintained rabies virus variant,
Entry, Importation, Importer, Microchip, Necropsy, Port, Public health,
Quarantine, Rabies, Rabies vaccination, Rabies virus, Serologic
testing, Titer, Travel, Zoonotic diseases.

For the reasons discussed in the preamble, the Department of Health
and Human Services amends 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. In paragraph (b); adding in alphabetical order definitions for
``Authorized veterinarian'', ``Cat'', ``Dog'', ``Histopathy'', and
``In-transit shipment'';
0
b. Adding in alphabetical order definitions for ``Microchip'',
``Necropsy'', and ``Official government veterinarian;'' and
0
c. Adding paragraph (c).
The revision and additions read as follows:

Sec. 71.50 Scope and definitions.

* * * * *
(b) * * *
Authorized veterinarian means an individual who has an advanced
degree relevant to the practice of veterinary medicine, has a valid
license or accreditation, and is authorized to practice animal medicine
in the exporting country.
Cat means any domestic cat (Felis catus).
* * * * *
Dog means any domestic dog (Canis familiaris).
* * * * *
Histopathology means the study of changes in human or animal
tissues 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. 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, post-mortem, of
tissues, organs, or bodily fluids.
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 by:
0
a. In paragraph (a), adding in alphabetical order the definition for
``Animal'',
0
b. Removing the definition for ``Cat'';
0
c. Adding in alphabetical order definitions for ``Certification of
foreign rabies vaccination and microchip'', ``CDC dog import form'',
``CDC dog import permit'', ``CDC-registered animal care facility'',
``Certification of dog arriving from DMRVV-free or DMRVV low-risk
country'', ``Certification of U.S.-issued rabies vaccination'', and
``Conditional release'',
0
d. Revising the definition of ``Confinement'';
0
e. Removing the definition for ``Dog'';
0
f. Adding in alphabetical order definitions for ``DMRVV'', ``DMRVV-free
country'', ``DMRVV high-risk country'', ``DMRVV low-risk country'', and
``DMRVV-restricted country'', ``Flight parent'', ``Importer'', ``SAFE
TraQ'', ``Serologic testing'', ``USDA-accredited veterinarian'', and
``USDA official veterinarian'';
0
g. Removing the definition for ``Valid rabies vaccination
certificate'';
0
h. Removing paragraphs (b) through (g);
0
i. Adding new paragraphs (b) through (g); and
0
j. Adding paragraphs (h) through (ff).
The revision and additions read as follows:

Sec. 71.51 Dogs and cats.

(a) * * *
Animal means, for purposes of this section, any domestic cat (Felis
catus) or domestic dog (Canis familiaris).
Certification of foreign rabies vaccination and microchip means the
Office of Management and Budget (OMB)-approved form that must be:
(i) completed by an authorized veterinarian, 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.
CDC dog import form means an OMB-approved form 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 the dog has been physically present in within
the last six months, and U.S. port of entry; and other information as
described in CDC technical instructions.
CDC dog import permit means a document issued by CDC granting
approval to import a dog into the United States from a DMRVV-restricted
country. To receive a permit, eligible

[[Page 41838]]

importers submit information to CDC 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 the dog has been physically
present in within the last six months, and U.S. port of entry; and
other information as described in CDC technical instructions.
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.
Certification of dog arriving from DMRVV-free or DMRVV low-risk
country means the OMB-approved form that together with other records
may be used by an importer to demonstrate that a dog has been only in
DMRVV-free or DMRVV low-risk countries during the six months before the
dog's arrival in the United States.
Certification of U.S.-issued rabies vaccination means the OMB-
approved form that must be completed by a U.S. Department of
Agriculture (USDA)-Accredited Veterinarian and endorsed by a USDA
Official Veterinarian prior to a dog's departure from the United States
in order to demonstrate compliance with admissibility requirements upon
the dog's return to the United States from a DMRVV high-risk country.
Conditional release, when applied to an animal, means the temporary
release of an animal from the custody of a carrier or a CDC-registered
animal care facility 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 an admissibility determination or
removal of the animal from the United States. The licensed veterinarian
must return conditionally released animals immediately to the custody
of the carrier or the CDC-registered animal care facility upon the
conclusion of such medical care or evaluation.
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
epidemiologically relevant roles in maintaining enzootic transmission.
DMRVV-free country means a country determined by the Director as
not having DMRVV present based on internationally accepted standards.
DMRVV high-risk country means a country 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. A list of the DMRVV high-risk countries is available on CDC's
website.
DMRVV low-risk country means a country 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's heading toward eventual DMRVV-free status.
DMRVV-restricted country means a country from which the import of
dogs into the United States has been prohibited or otherwise
restricted. Designation of a DMRVV-restricted country may be based on
the country's export of dogs infected with DMRVV to any other country
within a timeframe determined by the Director or based on the country's
lacking adequate controls, as determined by the Director, to monitor
and prevent the export of dogs to the United States with falsified or
fraudulent rabies vaccination credentials, inaccurate or invalid rabies
vaccination documentation, or other fraudulent, inaccurate, or invalid
importation documents.
Flight parent means any person transporting one or more animals on
behalf of an importer for purposes of resale, adoption, or transfer of
ownership. A flight parent is typically solicited through social media
and may be compensated (including through goods and services, e.g.,
complimentary airplane ticket, paid baggage fees, other paid fees) or
be uncompensated. If required by USDA, flight parents must possess all
required Federal licenses or registrations to transport animals.
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) or a flight
parent. If required by USDA, an individual transporting an animal on
behalf of an importer, including a flight parent must possess all
required Federal licenses or registrations to transport animals.
* * * * *
SAFE TraQ means CDC's System for Animal Facility Electronic
Tracking of Quarantine or other system as approved by the Director for
tracking pre-clearance management (e.g., quarantine, medical
examinations, vaccinations, diagnostic testing, screening, and travel
information) of animals arriving in the United States through a CDC-
registered animal care facility.
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 and with documentation confirming that they have
been only in DMRVV low-risk or DMRVV-free countries during the last six
months may arrive at and be admitted into the United States through any
U.S. airport.
(3) Dogs that have a valid certification of U.S.-Issued rabies
vaccination form may arrive at and be admitted into the United States
through any U.S. airport.
(4) Dogs that have been in a DMRVV high-risk country within the
last six months and have a valid certification of foreign rabies
vaccination and microchip form must arrive at and may be admitted only
through a U.S. airport with a CDC quarantine station (also known as a
U.S. port health station) and a CDC-registered animal care facility.
(5) Dogs that have been in a DMRVV high-risk country within the
last six

[[Page 41839]]

months that arrive at an unauthorized U.S. airport or that arrive
without a valid certification of U.S.-issued rabies vaccination or
certification of foreign rabies vaccination and microchip form 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-registered animal
care facilities is available on CDC's website. CDC will update the list
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 and with documentation confirming that they have
been only in DMRVV-free or DMRVV low-risk countries during the last six
months may arrive at and be admitted into the United States through any
U.S. land port.
(3) Dogs that have a valid certification of U.S.-issued rabies
vaccination form may arrive at and be admitted into the United States
through any U.S. land port.
(4) Dogs that have been in a DMRVV high-risk country within the
last six months and do not have a valid certification of U.S.-issued
rabies vaccination form 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 and with documentation confirming that they have
been only in DMRVV-free or DMRVV low-risk countries during the last six
months may arrive at and be admitted into the United States through any
U.S. seaport.
(3) Dogs that have a valid certification of U.S.-issued rabies
vaccination form may arrive at and be admitted into the United States
through any U.S. seaport.
(4) Dogs that have been in a DMRVV high-risk country within the
last six months and do not have a valid certification of U.S.-issued
rabies vaccination form are not authorized to enter the United States
through any U.S. seaport and shall be denied admission into the United
States.
(5) Notwithstanding paragraph (d)(4) 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 and was
vaccinated against rabies in a foreign country may be admitted through
a U.S. seaport if:
(i) The dog accompanies an ``individual with a disability'' as
defined under 14 CFR 382.3; and
(ii) The dog has a valid and complete certification of foreign
rabies vaccination and microchip form and a valid serologic titer from
a CDC-approved laboratory.
(e) Limitation on U.S. ports for dogs and cats. (1) 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, CDC-registered animal care facility'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, CDC-registered animal
care facilities, and 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.
(2) CBP will prescribe the time, place, and manner in which dogs
are presented upon arrival at a port of entry, which may include
prohibiting dogs from being presented within the Federal Inspection
Station.
(f) Age requirement for all dogs. (1) All dogs presented for
admission into the United States must be at least six (6) months old at
the time of their arrival into the United States.
(2) Dogs arriving into the United States that are not at least six
(6) months old at the time of their arrival shall be denied admission
and returned to the country of departure pursuant to paragraph (v) of
this section.
(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 must have been implanted on or before the date
the current rabies vaccine was administered. Rabies vaccines
administered prior to the implantation of a microchip are invalid.
(3) The microchip number must be documented on the certification of
foreign rabies vaccination and microchip form, the certification of
U.S.-issued rabies vaccination form, or if the dog is arriving from a
DMRVV low-risk or DMRVV-free country, documented on one of the forms
listed in paragraph (u)(2) of this section and all accompanying
veterinary records. The microchip number must also be documented on the
CDC dog import form.
(4) Importers must consent to the scanning of the dogs' microchip
by CDC quarantine public health officers, CDC-registered animal care
facility staff, or their representatives, upon the dogs' arrival at a
U.S. port.
(5) 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, shall be denied admission and returned to the
country of departure pursuant to paragraph (v) of this section.
(h) CDC dog import form for all dogs. (1) All importers of dogs
must submit a complete and accurate CDC dog import form to CDC via a
CDC-approved system prior to the dogs arriving in the United States.
This includes accompanied or unaccompanied dogs arriving by air, land,
or sea regardless of where the dogs originated or whether arriving as
cargo, checked-baggage, or hand-carried baggage. This excludes dogs
that are transiting through the United States without making an entry
in accordance with paragraph (cc) of this section.
(2) Dogs that arrive without a receipt confirming that the CDC dog
import form was submitted before the dogs' arrival in the United States
may be denied admission and returned to their country of departure
pursuant to paragraph (v) of this section, regardless of the value of
the shipment.
(3) Dogs arriving by air without a receipt confirming that the CDC
dog import form was submitted before the dogs' arrival in the United
States may be held in the care of a CDC-registered animal care
facility, on a space-available basis, for up to 24 hours after their
arrival. If the dogs arrive at an airport without a CDC-registered
animal care facility or if the animal care facility lacks space to
house the dogs, the dogs may be held in the care of a licensed
veterinarian approved by CDC for up to 24 hours after their arrival
until the CDC Dog Import Form is filed. 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 CDC-registered animal care facility is unavailable at
the airport or lacks space to house the dogs), 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 receipt confirming submission of
a CDC dog import form may be held on board the vessel until the form is
filed. The

[[Page 41840]]

vessel's owner or operator may require reimbursement from an importer
for any associated costs incurred by the vessel's owner or operator on
the importer's behalf.
(5) Dogs arriving by land without a receipt confirming submission
of a CDC dog import 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 CDC dog import form 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, unless granted a waiver in accordance with paragraph
(dd) of this section, are required to create a bill of lading for all
dogs arriving in the United States prior to the dogs' arrival. This
includes dogs transported as cargo, checked-baggage, or hand-carried
baggage. If granted a waiver to the bill of lading requirement, the
airline's handling and transport of the dogs must be consistent with
the terms of that waiver.
(8) Unless being transported by an airline for which a waiver to
the bill of lading requirement has been granted pursuant to paragraph
(dd) of this section, dogs arriving by air for which a bill of lading
has not been filed prior to their arrival in the United States (or if
the airline's handling and transport of the dogs is inconsistent with
the terms of the waiver) shall be denied admission and returned to
their 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,
disease surveillance screening, or diagnostic testing of the animal
upon arrival shall 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 signs 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
the animal and administered any tests or treatment as needed to ensure
the animal does not have a communicable disease.
(3) Carriers shall maintain a record of sickness of animals
occurring while en route to the United States and shall submit the
record 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 animals other than dogs or
cats) 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 the masters or
operators of vessels (in the case of arrivals by sea) shall immediately
arrange for confinement and medical evaluation of any ill or injured
animals at a CDC-registered animal care facility or CDC-approved
veterinary facility (if a CDC-registered animal care facility is not
available) 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). In the case of ill or injured 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 airline or vessel's master or operator shall immediately
thereafter arrange for transportation of any ill or injured animals by
a CBP-bonded transporter to the CDC-registered animal care facility or
other CDC-approved veterinary facility (if a CDC-registered animal care
facility is not available) for confinement and medical evaluation. The
airline or vessel's master or operator shall arrange to have ill or
injured animals transported in a way that does not expose
transportation personnel or the public to communicable diseases.
(7) The Director will consider the findings of the examination and
tests in determining whether the animal may have a communicable
disease.
(8) The importer shall bear the expenses of transportation,
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 (aa) 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 for
medical evaluation and treatment in emergency or exigent circumstances.
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 veterinary medical care. If such animals are
conditionally released to a CDC-approved veterinary facility (if a CDC-
registered animal care facility is not available or cannot provide the
level of care needed), then the animal must be immediately returned to
the custody of the carrier or CDC-registered animal care facility once
medical treatment is

[[Page 41841]]

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 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, revaccination against rabies, and
quarantine at a CDC-registered animal care facility for foreign-
vaccinated dogs from DMRVV high-risk countries. (1) All dogs arriving
into the United States that have been in DMRVV high-risk countries
within the last six months and that do not have a valid certification
of U.S.-issued rabies vaccination 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 (if
applicable) at a CDC-registered animal care facility prior to the dog's
arrival in the United States. The costs of examination, vaccination,
and quarantine (if applicable) shall be borne by the importer and not
at the government's expense.
(3) Prior to granting a reservation, CDC-registered animal care
facilities must ensure they have received the following:
(i) The completed certification of foreign rabies vaccination and
microchip form;
(ii) Serologic test results (if applicable) obtained from a CDC-
approved laboratory on a blood sample drawn, submitted, and tested in
accordance with CDC's technical instructions;
(iii) Photos of the dogs' teeth to assist with age verification;
(iv) The travel itinerary for the dogs confirming that the dogs
will be arriving only at a U.S. airport with 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 dog import form.
(4) Importers must present documentation to airlines 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.
(5) Airlines must deny boarding to any foreign-vaccinated dog that
has been in a DMRVV high-risk country within the last six months for
which the importer has not presented a receipt confirming submission of
the CDC dog import 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 the CDC-registered animal care facility
immediately upon arrival at the U.S. airport.
(7) The dogs 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 dog's release. Suspected or confirmed communicable
diseases, including the presence of ectoparasites (i.e., ticks and
fleas), must be reported to CDC prior to release of the dog;
(ii) Confirmation of microchip number;
(iii) Confirmation of age through dental examination by a USDA-
accredited veterinarian;
(iv) Vaccination against rabies with a USDA-licensed rabies vaccine
that is administered by a USDA-accredited veterinarian; and
(v) Confirmation of adequate rabies serologic titer from a CDC-
approved laboratory. Blood samples for 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) A facility must register with and receive written
approval from the Director to function as a CDC-registered animal care
facility before housing any live dog imported into the United States.
Applications and all required documents must be submitted to
[email protected].
(2) The CDC-registered animal care facility must be located within
35 miles of a CDC quarantine station.
(3) To register or 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 safely house at any 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 required Federal, State, or local registrations,
licenses, and/or permits; a facility must have a USDA Class H
intermediate handlers registration (and any additional class licenses
or registrations as deemed appropriate by USDA) and a CBP Facilities
Information and Resource Management System (FIRMS) code; and
(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) CDC may conduct unannounced inspections of facilities seeking
to register or renew their status as a CDC-registered animal care
facility or when otherwise needed to protect the public's health.
(iii) CDC inspections will be based on USDA Animal Welfare
regulation standards (9 CFR parts 1, 2, and 3) and other standards as
outlined in CDC's Technical Instructions for CDC-registered Animal Care
Facilities.
(iv) 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.
(v) A CDC-registered animal care facility must apply to CDC for
renewal

[[Page 41842]]

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) 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
release or return of the animal. Each record must include:
(i) the bill of lading (or other alternative documentation if the
airline has been granted a waiver under paragraph (dd) of this section)
for the 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 the 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 the shipment; and
(vi) veterinary medical records for the animal, including:
(A) Certification of foreign rabies vaccination and microchip 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 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 (or for necropsy results within 30 days of an
animal's death); and
(iii) CDC will audit records remotely as needed and in-person
during 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
Occupational Safety and Health Administration's Recommended Practices
for Safety and Health Programs 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 who
handle imported animals with signs of illness or in quarantine, and for
staff who perform necropsies of imported animals. Rabies pre-exposure
prophylaxis must be administered in accordance with the Advisory
Committee on Immunization Practices guidelines for pre-exposure
prophylaxis vaccination to prevent human rabies.
(4) Post-exposure procedures that provide potentially exposed
workers with direct and rapid access to a medical consultant are
required.
(5) Procedures for documenting the frequency of worker training,
including for those working in the quarantine area, are required.
(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 known communicable 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;
(iii) Procedures for disinfection or safe disposal of garments,
supplies, equipment, and waste; and
(iv) Procedures for reporting to CDC within 48 hours suspected or
confirmed communicable diseases in facility workers associated with
handling imported animals.
(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 disinfected in a manner that would destroy
potential pathogens of concern or safely disposed of in a manner that
prevents the spread of communicable disease.
(p) Health reporting and veterinary service requirements for
animals at CDC-registered animal fare facilities. (1) A CDC-registered
animal care facility must provide the following services for each
animal upon arrival and ensure that 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;
(iii) verification of an animal's age via a dental examination or,
if dental examination cannot be reliably performed, verification
through another CDC-approved diagnostic method (e.g., ocular lens
examination, radiographs);
(iv) revaccination against rabies using a USDA-licensed vaccine;
and
(v) confirmation of a valid serology test from a CDC-approved
laboratory on a sample drawn from a dog prior to arrival within a
timeframe and results within parameters as specified in CDC technical
instructions, or completion of a 28-day quarantine at the CDC-
registered animal care facility 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) Immediate isolation of the animal and implementation of
infection prevention and control measures in accordance with industry
standards and CDC technical instructions if a communicable disease is
suspected.
(ii) Notification to CDC within 24 hours of the arrival of an ill
animal or occurrence of any illness or death occurring in an animal.
(iii) 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.

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(iv) For any animal that dies or is euthanized due to fatal illness
or injury, necropsy (gross and histopathologic examination are
required), and any subsequent infectious disease testing based on gross
or histopathology findings or as determined by CDC, to determine the
cause of death. The importer is responsible for all costs associated
with necropsy and testing.
(v) Suspected or confirmed communicable diseases, including the
presence of ectoparasites (i.e., ticks and fleas), must be reported to
CDC within 24 hours of identification.
(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.
(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 animals when quarantine is
required. Foreign-vaccinated dogs that have been in a DMRVV high-risk
country within six months of arrival 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 also require quarantine or extend the quarantine
period if a facility or CDC finds or suspects that an animal is
infected with, or has been exposed to, a communicable disease or if 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 and trained 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 communicable disease,
including, but not limited to, signs consistent with rabies,
brucellosis, leptospirosis, leishmaniasis, or ecto- or endoparasites.
(4) If any animals appear ill during quarantine, the CDC-registered
animal care facility must, in accordance with paragraphs (p)(2)(i)
through (v) of this section, ensure appropriate evaluation, monitoring,
and treatment. Suspected or confirmed communicable diseases in animals
must be reported to CDC within 24 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 other quarantined animals or non-quarantined animals
(including animals other than dogs or cats) to potentially infectious
materials, including soiled bedding, caging, and other potentially
contaminated items. Animals in quarantine may not be housed together.
(7) If CDC notifies a CDC-registered animal care facility of any
evidence that animals have been exposed to a communicable disease, the
facility must, at the facility's expense (subject to reimbursement by
the importer or carrier (in case of abandonment)), implement or
cooperate in the CDC's implementation of additional measures to rule
out the spread of suspected communicable disease before releasing an
animal or shipment of animals from quarantine, including examination,
additional diagnostic procedures, treatment, detention, extended
quarantine, 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) The Director may revoke a CDC-registered
animal care facility's registration if the Director determines that the
facility has failed to comply with any applicable provisions of this
section, the facility's standard operating procedures, USDA Animal
Welfare standards (9 CFR parts 1, 2, and 3), or other standards as
outlined in CDC's Technical Instructions for CDC-registered Animal Care
Facilities.
(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, unless the Secretary, within one
business day, decides to excuse the facility's failure to respond on a
timely basis.
(6) If a CDC-registered animal care facility's response is timely,
the Director will review the registration, the notice of revocation,
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, unless the Secretary, within one
business day, decides to review the Director's decision. 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 certification of foreign rabies vaccination
and microchip 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 certification of foreign rabies
vaccination and microchip 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-vaccinated dogs from DMRVV high-risk countries.
(3) The certification of foreign rabies vaccination and microchip
form must be truthful and accurate, completed in English, and include:
(i) The name of the 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;

[[Page 41844]]

(iv) The dog's name, 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) Microchip number and microchip implant date, which must be
on or before the date of administration of the most recent rabies
vaccination included on this form;
(ix) 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
(x) 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 certification of
foreign rabies vaccination and microchip form or present a form that is
untruthful, inaccurate, and incomplete may result in the dog being
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
form for importers seeking to import U.S.-vaccinated dogs from DMRVV
high-risk countries. (1) Importers returning to the United States with
a U.S.-vaccinated dog that has been in a DMRVV high-risk country within
the last six months 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 or quarantine 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 form that is truthful, complete, and accurate.
(ii) The importer presents a valid certification of U.S.-issued
rabies vaccination 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 form must
have been completed and endorsed 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 shall have the dog treated as if it was
vaccinated in a foreign country in accordance with the provisions of
paragraphs (k) and (s) of this section 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 (aa) of
this section.
(u) Requirement for proof that a dog has been only in DMRVV low-
risk or DMRVV-free countries. (1) 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 satisfactory to the Director that for the six months
before arrival, the dog has been only in DMRVV low-risk or DMRVV-free
countries.
(2) For purposes of paragraph (u)(1) of this section, written
documentation satisfactory to the Director shall include any one of the
following:
(i) A valid certification of foreign rabies vaccination and
microchip form if completed in a DMRVV-free or DMRVV low-risk country
and the dogs are arriving into the United States from the same DMRVV-
free or DMRVV low-risk country as that listed on the form. This form
must be completed by an authorized veterinarian, which may include an
official government veterinarian, and must be certified by an official
government veterinarian in the exporting country;
(ii) A valid certification of U.S.-issued rabies vaccination form
completed by a USDA-accredited veterinarian and endorsed by a USDA
official veterinarian;
(iii) A valid USDA export certificate if the certificate is issued
to allow the dogs to travel to a DMRVV-free or DMRVV low-risk country
and the dogs are returning to the United States from the same DMRVV-
free or DMRVV low-risk country as that listed on the export
certificate. The form must be completed by a USDA-accredited
veterinarian and endorsed by a USDA official veterinarian;
(iv) A valid foreign export certificate from a DMRVV-free or DMRVV
low-risk country that has been certified by an official government
veterinarian in that country. The export certificate must be
accompanied by veterinary records (such as the European Union pet
passport) or proof of payment for veterinary services establishing that
veterinary services were performed in the exporting country at least
six months before traveling to the United States;
(v) A certification of dog arriving from DMRVV-free or DMRVV low-
risk country form if accompanied by veterinary records or proof of
payment for veterinary services establishing that veterinary services
were performed in the same DMRVV-free or DMRVV low-risk country at
least six months before travel to the United States. This form must be
completed by an authorized veterinarian, which may include an official
government veterinarian, and must be certified by an official
government veterinarian in the exporting country; or
(vi) Other records or documents satisfactory to the Director that
CDC may establish through technical instructions and publish on its
website.
(v) Denial of admission of dogs and cats. (1) The following
categories of animals are inadmissible to the United States:
(i) Any dog arriving from a DMRVV low-risk or DMRVV-free country
without written documentation satisfactory to the Director that the dog
has been only in DMRVV low-risk or DMRVV-free countries during 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 dog import form has been submitted to CDC through a CDC-approved
system.
(iii) Any dog arriving by air for which a bill of lading, including
an air waybill, has not been created by the airline prior to the dog's
arrival in the United States (regardless of the value of the shipment)
unless the airline transporting the dog has been granted a waiver
pursuant to paragraph (dd) of this section and the airline's handling
and transport of the dog is consistent with the terms of that waiver.
(iv) Any unvaccinated or foreign-vaccinated dog arriving by land to
the

[[Page 41845]]

United States if the dog has been in a DMRVV high-risk countries within
the last six months.
(v) Any unvaccinated or foreign-vaccinated dog arriving by sea to
the United States if the dog has been in a DMRVV high-risk country
within the last six months, except for a foreign-vaccinated dog
qualifying as a service animal and meeting the standards set forth in
paragraph (d)(5) of this section.
(vi) Any animal imported by an importer who refuses to comply with
the requirements (if applicable) for disease surveillance screening,
microchip scanning, veterinary examination, diagnostics tests to rule
out communicable diseases, revaccination, providing proof of sufficient
rabies serologic tests, or quarantine (if applicable) 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 within the
last six months and arrives without a valid certification of U.S.-
issued rabies vaccination form or a valid certification of foreign
rabies vaccination and microchip form.
(viii) Any foreign-vaccinated dog that has been in a DMRVV high-
risk country within the last 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 foreign-vaccinated dog arriving by
sea that qualifies as a service animal and meets the standards set
forth in paragraph (d)(5) 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, regardless of country of departure, if the Director
reasonably suspects fraud in any documentation required for admission
or if such documentation is otherwise untruthful, inaccurate, or
incomplete.
(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 arrives in the United
States.
(xiv) Any dog that arrives in the United States without a microchip
or without its microchip number documented on the importation paperwork
required by CDC.
(2) 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) Dogs and cats awaiting an admissibility determination or return
to their country of departure. (1) Animals arriving by air that are
denied admission and awaiting return to their country of departure or
awaiting a determination as to their admissibility must be held in a
CDC-registered animal care facility or other CDC-approved facility (if
a CDC-registered animal care facility is not available) in such a way
as to prevent the potential spread of communicable diseases.
(2) An airline must arrange to transport an animal arriving by air
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) if the animal is denied admission and is
awaiting return to its country of departure or is awaiting a
determination of its admissibility. If the animal is apparently
healthy, the airline must transport the animal (by a CBP-bonded
transporter) within 12 hours of its arrival.
(3) An airline must immediately report an obviously ill or injured
animal (e.g., the animal is unable to stand, has difficulty breathing,
is bleeding, has broken bones or disfigured limbs, or is experiencing
seizures, vomiting, or discharge from the nose, mouth, or eyes)
arriving into the United States to the CDC quarantine station of
jurisdiction. The airline must immediately arrange to transport an
obviously ill or injured animal by a CBP-bonded transporter to a CDC-
registered animal care facility or veterinary clinic as directed by
CDC.
(4) Animals arriving by sea that are denied admission must remain
on the vessel while awaiting return to the country of departure.
(x) Disposal or disposition of dogs and cats denied admission to
the United States. (1) Animals shall be subject to such additional
requirements as authorized under this part or 42 CFR part 70 as may be
deemed necessary by the Director to protect the public's health,
including suspension of entry under Sec. 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 their
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 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

[[Page 41846]]

abandoned pursuant to the provisions of paragraph (aa) of this section.
(9) Carriers must provide transportation to/from and holding at a
CDC-registered animal care facility or another CDC-approved facility
(if a CDC-registered animal care facility is not available) while the
animal is pending an admissibility determination, 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).
(y) 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, unless the Secretary, within one
(1) business day, decides to review the Director's decision.
(z) 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
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 (x) 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.
(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 (x) 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 (aa) of this section, the carrier
will become the owner and shall assume responsibility for all expenses
described in this paragraph.
(aa) 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.
(bb) 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 shipping requirements.
Discarded containers must be cleaned and disinfected or destroyed in
accordance with carrier policies. CDC may require documentation of
container disinfection or destruction by the carrier.
(cc) 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 and may only be transported as cargo and not as hand-
carried baggage or checked/excess baggage.
(2) In-transit shipments must be maintained under continuous
confinement with USDA APHIS oversight on board 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 on board 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 below:
(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

[[Page 41847]]

communicable disease into the United States.
(ii) The certification of foreign rabies vaccination and microchip
form, certification of U.S.-issued rabies vaccination form,
certification of dog arriving from DMRVV-free or DMRVV low-risk country
form, or CDC dog import 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.
(iii) There is no minimum age requirement 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.
(iv) A microchip 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.
(dd) Bill of lading and other airline requirements for dogs. (1)
Airlines are required to create a bill of lading, which includes air
waybills (AWB), for all dogs arriving in the United States prior to
arrival. This includes dogs transported as cargo, checked-baggage, or
hand-carried baggage.
(2) Airlines that lack the technical ability to generate a bill of
lading to transport dogs as checked baggage or as hand-carried baggage
may request a waiver from CDC by emailing [email protected].
(i) The airline's request for a waiver must be accompanied by a
written standard operating procedure (SOP) describing how the airline
will ensure care, transportation, and housing for any ill, injured, or
abandoned animals in the absence of a bill of lading. The SOP must also
identify and provide the location of a CDC-registered animal care
facility or other suitable alternative approved by CBP and CDC that
will provide care and suitable housing for any ill, injured, or
abandoned animals prior to any animals being transported to the United
States.
(ii) As a condition of granting a waiver, CDC may require the
airline to obtain the services of a licensed U.S. customs broker who
will be responsible for coordinating on behalf of the airline the entry
and clearance of any dogs imported into the United States, including
compliance with CDC's requirements relating to the admission of dogs.
(iii) As a condition of granting a waiver, CDC may require the
airline to provide a timetable and identify steps that the airline will
take to develop the technical capacity to generate an AWB (or another
suitable alternative to an AWB) to transport dogs as cargo, checked-
baggage, or hand-carried baggage.
(iv) The Director may revoke a waiver granted to an airline upon
notice to the airline and a finding that an airline has acted
inconsistent with the terms of the waiver, including any provision of
its SOP.
(v) CDC may publish additional technical instructions on its
website for airlines seeking a waiver from the bill of lading
requirement.
(3) Any dog arriving by air for which a bill of lading, including
an AWB, has not been created by the airline prior to the dog's arrival
in the United States will be denied admission and returned to the
country of departure pursuant to paragraph (v) of this section, unless
the airline transporting the dog has been granted a waiver and the
airline's handling and transport of the dog are consistent with the
terms of that waiver.
(4) 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 dog import form; if the dogs are scheduled to
arrive at a different U.S. port than the one listed on the receipt of
the CDC dog import form; or if the dogs presented for travel do not
match the description on the receipt of the CDC dog import form.
(5) 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 form or if the dogs presented for travel do
not match the description on the certification of U.S.-issued rabies
vaccination form.
(6) 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.
(7) For dogs from DMRVV-free or DMRVV low-risk countries, airlines
must deny boarding unless the importer before boarding presents
documentation as described in paragraphs (g)(2) and (u)(2)
demonstrating that the dog is over six months of age, has a microchip,
and has been only in DMRVV low-risk or DMRVV-free countries during the
last 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.
(8) 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/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.
(ee) 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 written record
review, the Director will issue a decision in writing that shall
constitute final agency action, unless the Secretary, within one
business day, decides to review the Director's decision. The Director
will serve the carrier with a copy of the written decision.
(ff) 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 based on

[[Page 41848]]

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 notice 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 service animals (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.
(gg) Request for issuance of additional fines or penalties. (1) CDC
may request that 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.
(2) CDC may request that the U.S. Department of Justice
investigate, and if determined appropriate based on the outcome of such
investigation, prosecute any person who the Director has reason to
believe may have violated Federal law, including by forcibly
assaulting, resisting, opposing, impeding, intimidating, or interfering
with a U.S. government employee while engaged in or on account of the
performance of their official duties in violation of 18 U.S.C. 111, by
obstructing an agency proceeding in violation of 18 U.S.C. 1505, or by
otherwise engaging in conduct contrary to law.

Dated: April 30, 2024.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-09676 Filed 5-8-24; 11:15 am]
BILLING CODE 4163-18-P