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Rule2024-09676

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

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Published

May 13, 2024

Effective

August 1, 2024

Issuing agencies

Health and Human Services Department

Abstract

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.

Full Text

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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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

[[Page 41726]]

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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. <a href="https://www.cdc.gov/media/pressrel/2007/r070907.htm">https://www.cdc.gov/media/pressrel/2007/r070907.htm</a>. Accessed June 1, 2023.
\2\ World Bank (2012). People, Pathogens and Our Planet: The
Economics of One Health. Retrieved from <a href="https://openknowledge.worldbank.org/handle/10986/11892">https://openknowledge.worldbank.org/handle/10986/11892</a>. 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.'' <a href="https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html">https://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html</a>. 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 <a href="https://www.cdc.gov/rabies/medical_care/index.html">https://www.cdc.gov/rabies/medical_care/index.html</a>.
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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: <a href="http://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/vaccine-certificate.html">www.cdc.gov/importation/bringing-an-animal-into-the-united-states/vaccine-certificate.html</a>.
\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\ <a href="https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/usda-animal-care-overview">https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/usda-animal-care-overview</a>.
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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.
<a href="https://www.avma.org/resources-tools/pet-owners/petcare/microchips-reunite-pets-families/microchipping-faq">https://www.avma.org/resources-tools/pet-owners/petcare/microchips-reunite-pets-families/microchipping-faq</a>. 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

[[Page 41728]]

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. <a href="http://www.aphis.usda.gov/pet-travel/us-to-another-country-export">www.aphis.usda.gov/pet-travel/us-to-another-country-export</a>.
\24\ International Pet and Animal Transportation Association.
<a href="http://www.ipata.org">www.ipata.org</a>.
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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

[[Page 41729]]

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. <a href="https://www.transportation.gov/individuals/aviation-consumer-protection/service-animals">https://www.transportation.gov/individuals/aviation-consumer-protection/service-animals</a>, 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.
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\29\ CDC quarantine stations are also known as U.S. Port Health
Stations.
\30\ CDC quarantine station jurisdictions, available at:
<a href="http://www.cdc.gov/quarantine/quarantine-stations-us.html">www.cdc.gov/quarantine/quarantine-stations-us.html</a>.
\31\ U.S. Department of Agriculture. Notifiable Diseases and
Conditions. <a href="https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-Reference-Guide/Animal-Health-Emergency-Management/Notifiable-Diseases-and-Conditions">https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/nvap/NVAP-Reference-Guide/Animal-Health-Emergency-Management/Notifiable-Diseases-and-Conditions</a>.
---------------------------------------------------------------------------

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:
<bullet> Importers of dogs from countries that are DMRVV-free or
are low risk for DMRVV;
<bullet> Importers of dogs from countries that are at high risk of
DMRVV;
<bullet> Airlines and other carriers;
<bullet> CBP;
<bullet> CDC;
<bullet> USDA; and
<bullet> 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:
<bullet> The fees charged by ACF have increased relative to CDC's
preliminary estimates.
<bullet> 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.
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\32\ <a href="http://www.airline-pet-policies.com/united-airlines-pet-policy.php">http://www.airline-pet-policies.com/united-airlines-pet-policy.php</a>. Accessed 15 Nov 2023.
\33\ Katie Morrell (March 3, 2021) How Much Does It Cost To Fly
With Your Dog on a Plane? <a href="http://Dailypaws.com">Dailypaws.com</a> <a href="https://www.dailypaws.com/living-with-pets/pet-travel/how-much-does-it-cost-to-fly-a-dog-on-a-plane">https://www.dailypaws.com/living-with-pets/pet-travel/how-much-does-it-cost-to-fly-a-dog-on-a-plane</a>. Accessed: 06 February 2022.
\34\ Feathers and Fur Express (2023) How much does it cost to
fly a pet/s internationally? <a href="https://ffexpresspets.com/international-pet-shipping-costs/">https://ffexpresspets.com/international-pet-shipping-costs/</a>. 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: <a href="https://www.bls.gov/data/inflation_calculator.htm">https://www.bls.gov/data/inflation_calculator.htm</a>. 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\ <a href="http://www.airline-pet-policies.com/united-airlines-pet-policy.php">http://www.airline-pet-policies.com/united-airlines-pet-policy.php</a>. Accessed 15 Nov 2023.
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<bullet> 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]]

<bullet> 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
official government veterinarian in the exporting country. 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.
<bullet> 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.
<bullet> 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.
<bullet> 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
comments suggesting 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:
<bullet> 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.
<bullet> 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.

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.
---------------------------------------------------------------------------

\39\ Centers for Disease Control. DMRVV high-risk country list.
Available at: <a href="http://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html">www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html</a>.
\40\ The Program for Monitoring Emerging Diseases (ProMED) is a
program of the International Society for Infectious Diseases and is
available at <a href="https://promedmail.org/">https://promedmail.org/</a>.
\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).
---------------------------------------------------------------------------

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.
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\44\ World Organisation for Animal Health. Self-declared Disease
Status. Available at: <a href="http://www.woah.org/en/what-we-offer/self-declared-disease-status/">www.woah.org/en/what-we-offer/self-declared-disease-status/</a>.
\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). <a href="https://doi.org/10.1038/s41598-023-30984-3">https://doi.org/10.1038/s41598-023-30984-3</a>.
\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.
---------------------------------------------------------------------------

(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.
---------------------------------------------------------------------------

\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.
---------------------------------------------------------------------------

(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:
<bullet> 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.
<bullet> Confirmation of microchip number.
<bullet> Confirmation of age through dental examination by a USDA-
Accredited Veterinarian.
<bullet> Vaccination against rabies with a USDA-licensed rabies
vaccine and administered by a USDA-Accredited Veterinarian.
<bullet> 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.
---------------------------------------------------------------------------

\50\ CDC technical instructions are posted on CDC's website at
<a href="http://www.cdc.gov/dogtravel">www.cdc.gov/dogtravel</a>.
---------------------------------------------------------------------------

(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:
<bullet> The bill of lading (or other alternative documentation if
the airline has been granted a waiver under paragraph (dd)) for each
shipment;
<bullet> The name, address, phone number, and email address of the
importer and owner (if different from the importer);
<bullet> The number of animals in each shipment;
<bullet> The identity of each animal in each shipment, including
name, microchip number, date of birth, sex, breed, and coloring;
<bullet> The airline, flight number, date of arrival, and port of
each shipment; and
<bullet> 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.
---------------------------------------------------------------------------

\51\ <a href="https://www.osha.gov/safety-management">https://www.osha.gov/safety-management</a>.
\52\ <a href="http://www.nasphv.org/Documents/VeterinaryStandardPrecautions.pdf">http://www.nasphv.org/Documents/VeterinaryStandardPrecautions.pdf</a>.
\53\ CDC. Rabies pre-exposure prophylaxis recommendations.
Available at: <a href="http://www.cdc.gov/rabies/prevention/pre-exposure_vaccinations.html">www.cdc.gov/rabies/prevention/pre-exposure_vaccinations.html</a>.
---------------------------------------------------------------------------

(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.
<a href="https://www.iata.org/en/programs/cargo/live-animals">https://www.iata.org/en/programs/cargo/live-animals</a>. 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:
<bullet> Veterinary examination by a USDA-Accredited Veterinarian
within one business day of arrival;
<bullet> Verification of microchip and confirmation that the
microchip number matches the animal's health records;
<bullet> Verification of animal's age via a dental examination (or
other CDC-approved method);
<bullet> Vaccination against rabies using a USDA-licensed vaccine;
and

[[Page 41742]]

<bullet> 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.
<a href="https://www.iata.org/en/programs/cargo/live-animals">https://www.iata.org/en/programs/cargo/live-animals</a>. Accessed June
7, 2023.
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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. <a href="http://www.aphis.usda.gov/pet-travel/us-to-another-country-export">www.aphis.usda.gov/pet-travel/us-to-another-country-export</a>.
\57\ International Pet and Animal Transportation Association.
<a href="http://www.ipata.org">www.ipata.org</a>.
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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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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).
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> Any foreign-vaccinated dog imported from a DMRVV high-risk
country that arrives without a reservation at an ACF.
<bullet> Any dog from a DMRVV-restricted country that arrives
without a valid CDC Dog Import Permit.
<bullet> 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.
<bullet> 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.
<bullet> Any dog arriving in the United States that is under six
months of age.
<bullet> 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\ <a href="https://www.avma.org/resources-tools/avma-policies/avma-guidelines-euthanasia-animals">https://www.avma.org/resources-tools/avma-policies/avma-guidelines-euthanasia-animals</a>.
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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
<a href="http://www.cdc.gov/dogtravel">www.cdc.gov/dogtravel</a>.
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 <a href="http://www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html">www.cdc.gov/importation/bringing-an-animal-into-the-united-states/high-risk.html</a> 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. <a href="https://doi.org/10.12834/VetIt.1876.9968.2">https://doi.org/10.12834/VetIt.1876.9968.2</a>.

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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. <a href="https://doi.org/10.12834/VetIt.1876.9968.2">https://doi.org/10.12834/VetIt.1876.9968.2</a>.
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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. <a href="https://doi.org/10.12834/VetIt.1876.9968.2">https://doi.org/10.12834/VetIt.1876.9968.2</a>.
\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:
<bullet> A limited exception to accommodate personal pet owners who
travel by land between the U.S. and Canada or Mexico.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> Estimates of the number of dogs any small individual
entity currently imports annually or the average number of imported
dogs across entities.
<bullet> 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\
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\67\ World Health Organization (2018). WHO Expert Consultation
on Rabies (WHO Technical Report Series 1012). Retrieved from <a href="https://www.who.int/publications/i/item/WHO-TRS-1012">https://www.who.int/publications/i/item/WHO-TRS-1012</a>.
\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. <a href="https://doi.org/10.1371/journal.pntd.0003709">https://doi.org/10.1371/journal.pntd.0003709</a>.
\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.
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\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.
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\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. <a href="https://doi.org/10.1371/journal.pntd.0003709">https://doi.org/10.1371/journal.pntd.0003709</a>.
\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\
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\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.
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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: <a href="http://www.cdc.gov/ncezid/dgmq/feature-stories/operation-dog-catcher.html">www.cdc.gov/ncezid/dgmq/feature-stories/operation-dog-catcher.html</a>.
\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.
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\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: <a href="http://www.cdc.gov/rabies/specific_groups/hcp/serology.html#What%20Does%20A%20Rabies%20Virus%20Titer%20Mean">www.cdc.gov/rabies/specific_groups/hcp/serology.html#What%20Does%20A%20Rabies%20Virus%20Titer%20Mean</a>?
\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.
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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. <a href="https://doi.Org/10.15585/mmwr.mm6449a2">https://doi.Org/10.15585/mmwr.mm6449a2</a>.
\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. <a href="https://doi.org/10.15585/mmwr.mm6750a3">https://doi.org/10.15585/mmwr.mm6750a3</a>.
---------------------------------------------------------------------------

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 <a href="https://www.cdc.gov/rabies/medical_care/index.html">https://www.cdc.gov/rabies/medical_care/index.html</a>.
\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.
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In June 2021, 33 dogs and one cat were imported into the United
States from Azerbaijan by an animal rescue organization. All dogs had
rabies vaccination documents that appeared valid upon arrival in the
United States. Three days after arrival, one dog developed signs of
rabies. 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\
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\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
<a href="https://www.cdc.gov/worldrabiesday/disease-detectives/rabies-imported-dog.html">https://www.cdc.gov/worldrabiesday/disease-detectives/rabies-imported-dog.html</a>.
\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.
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\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.
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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\
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\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
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\124\ <a href="https://www.theatlantic.com/health/archive/2022/07/not-enough-veterinarians-animals/">https://www.theatlantic.com/health/archive/2022/07/not-enough-veterinarians-animals/</a> 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\ <a href="https://www.thebusinessresearchcompany.com/report/companion-animal-veterinary-vaccines-global-market-report">https://www.thebusinessresearchcompany.com/report/companion-animal-veterinary-vaccines-global-market-report</a>.
\127\ <a href="https://7news.com.au/lifestyle/pets/aussie-dog-owners-warned-of-national-vaccine-shortage-as-deadly-bacterial-disease-spreads-c-8568550">https://7news.com.au/lifestyle/pets/aussie-dog-owners-warned-of-national-vaccine-shortage-as-deadly-bacterial-disease-spreads-c-8568550</a>.
\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: <a href="http://www.thedailybeast.com/i-adopted-my-dog-cannoli-from-overseas-its-easier-than-you-think">http://www.thedailybeast.com/i-adopted-my-dog-cannoli-from-overseas-its-easier-than-you-think</a>.
\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: <a href="http://www.cdc.gov/ncezid/dgmq/feature-stories/operation-dog-catcher.html">www.cdc.gov/ncezid/dgmq/feature-stories/operation-dog-catcher.html</a>.
\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.
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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\
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\145\ Pet dog supply and demand in the United States. 2022.
Available at: <a href="http://wellbeingintl.org/pet-dog-supply-and-demand-in-the-united-states/">wellbeingintl.org/pet-dog-supply-and-demand-in-the-united-states/</a>.
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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.
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<bullet> 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;
<bullet> Undergo examination the day prior to shipment to ensure
the animal is not showing signs of rabies;
<bullet> Are permanently identified (e.g., microchip) with the
identification number listed on the certificate;
<bullet> Are vaccinated against rabies in accordance with
manufacturer's recommendations with a vaccine that was produced in
accordance with the WOAH Terrestrial Manual;
<bullet> 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
<bullet> 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.
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\147\ Unpublished data (C. Williams, CDC). October 24, 2023.
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The HHS/CDC requirements outlined in this final rule are less
burdensome than WOAH standards in the following ways:
<bullet> 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.
<bullet> 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;
<bullet> 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;
<bullet> 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.
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\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.
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<bullet> 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.
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\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.
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C. Comments on Exemptions for Certain Groups

Comment: HHS/

[…truncated; see source link]

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Indexed from Federal Register on May 13, 2024.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.